SERVICES AGREEMENT
This
SERVICES AGREEMENT, dated as of July 30, 2001 (the "Effective Date")
by
and between
Response Genetics, Inc., a Delaware corporation ("Response"), and Taiho
Pharmaceutical
Co., Ltd., a corporation organized under the laws of Japan, with a principal
place of business at 0-00 Xxxxxxxxxxxx-xxx, Xxxxxxx-xx, Xxxxx 000-0000, Xxxxx
("Taiho") (Response and
Taiho
are sometimes hereinafter referred to as the "Parties").
WHEREAS,
Response is engaged in the business, among other things, of conducting
molecular-based
tumor tissue analyses for use in guiding chemotherapy treatment for cancer
patients
using the Xxxxxxxxx Tumor Profile Platform;
WHEREAS,
Taiho is engaged in the business of developing and marketing pharmaceutical
and diagnostic products for use against cancer, as well as other diseases;
and
WHEREAS,
Taiho desires that Response perform certain testing services using the DTP
Platform for Taiho as the exclusive recipient of such services in Japan,
and
Response desires to do so;
1. Definitions.
(a) "Xxxxxxxxx
Tumor Profile Platform" or "DTP Platform" means the complex molecular
analysis of specific molecular markers that provides tumor specific gene
expression information obtained from a paraffin preserved sample, which can
help
physicians to plan and choose the most appropriate chemotherapy for a
patient.
(b) "Results"
means the data on gene expression, molecular markers, and any other
data generated by, or in the course of performing the Testing
Services.
(c) "Sample"
means the tumor cell material supplied by Taiho to Response hereunder in
the
quantity, and meeting the requirements, specified in Schedule C, as necessary
for Response to perform the Testing Service as contemplated
hereunder.
(d) "Term"
means the period beginning on October 1, 2001 and ending on the second
anniversary thereof, unless extended for an additional year by the Parties
pursuant to paragraph
10(d) herein.
(e) "Territory"
means the country of Japan.
(f) "Testing
Fee" means the amount specified in Schedule A, attached hereto, to be
paid
by Taiho to Response for performance of the Testing Services.
(g) "Testing
Services" means the specific services involving Response's application
of the DTP Platform to Samples provided by Taiho, all pursuant to this Agreement
and
as
more fully described in Schedule A, annexed hereto.
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.
2. Appointment
of Taiho; Territory.
(a) During
the Term (as defined in paragraph l (d) herein) and subject to the terms
and
conditions of this Agreement, Response hereby appoints Taiho as the exclusive
purchaser of the
Testing Services in Japan (for certain molecular markers, compounds and cancer
types described as "Exclusive" in Exhibit A), and, as such, Response will
not
provide the Testing Services
to another entity in Japan (the "Exclusivity"). Response further appoints
Taiho
as the non-exclusive
purchaser of the Testing Services in Japan (for certain molecular markers,
compounds
and cancer types described as "Non-Exclusive” in Exhibit A). Taiho accepts such
appointment
on the terms and conditions herein provided.
(b) As
described in Exhibit A, Response will promptly notify Taiho of new molecular
markers, therapeutic compounds, and diseases for which the DTP Platform may
be
useful, and Taiho will have the right to include such new developments to
the
DTP Platform within its Exclusivity. The operation of such right, and Taiho's
continuing Exclusive and Non- Exclusive rights regarding the DTP Platform
are
decribed in Exhibit A.
3. Consideration.
(a) Investment.
As partial consideration for the rights, including Exclusivity, granted
herein, Taiho shall purchase [***] dollars (U.S. $[***]) of shares of Series
C
Preferred Stock of Response, valued at the price per share of such Series
C
Preferred Stock sold by Response in its next round of equity financing, and
shall promptly, upon Response's request, execute
the subscription documents with respect thereto; provided, however, that
if
Response does
not
consummate its offering of Series C Preferred Stock (meaning that it shall
complete all transactions for the purchase of shares of Series C Preferred
Stock
to investors other than Taiho) within
ninety (90) days after the Effective Date with net cash proceeds to Response
of
at least [***] Dollars ($[***]), Taiho shall pay Response [***] dollars (U.S.
$[***]) as an advance against the Testing Fees which accrue during the Term
(the
"Advance"), for Testing Services purchased in excess of the quarterly Minimum
Testing Services quantities, and/or for Testing Services purchased subsequent
to
the Term, on a non-exclusive
basis. If an advance against the Testing Fees has been made, and Response
consummates
an offering of Series C Preferred Stock, then Taiho may elect to convert
the
unused
balance of the advance into shares of Series C Preferred stock of Response,
valued at the price
per
share of such Series C Preferred Stock sold by Response.
(b) Testing
Fees. Taiho shall pay Response the Testing Fee for each Testing Service
purchased from Response during the Term. The Testing Fee shall cover performance
of the Testing Service for two (2) genes in a Sample. For the testing of
[***],
the Testing Fee shall be an additional [***] dollars (US$[***]) above the
amount
listed in Schedule A. For each additional gene to be tested, the Testing
Fee
shall be an additional [***] dollars (US$[***]) above the amount listed in
Schedule A.
(c) Payment.
(i)
Response shall invoice Taiho on the last day of each calendar month during
the Term for the number of Testing Services performed by Response during
such
month and
for
which Results were delivered to Taiho.
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.
-2-
(ii)
Taiho shall pay amounts due to Response by wire transfer, or as otherwise
mutually
agreed upon by the Parties, within thirty (30) days after Taiho's receipt
of the
invoice sent
by
Response pursuant to paragraph 4(c) above. Payments shall be made in United
States dollars
to a bank account designated by Response.
4. Minimum
Testing Services. Taiho shall purchase from Response a minimum quantity of
Testing Services during the Term as follows (as the case may be, the "Minimum
Amount");
(a) During
the first calendar quarter of the Term, Taiho shall purchase from Response
a minimum aggregate of [***] Testing Services;
(b) during
the second calendar quarter of the Term, Taiho shall purchase from Response
a minimum aggregate of [***] Testing Services; and
(c) in
each
calendar quarter during the remainder of the Term, Taiho shall purchase
from Response a minimum aggregate of [***] Testing Services.
In
the
event Taiho fails to purchase the Minimum Amount in a calendar quarter (the
number of Testing Services constituting the difference between the Minimum
Amount and the actual
number of Testing Services purchased by Taiho in such period shall hereinafter
collectively be
referred to as the "Shortfall"), Taiho shall pay to Response an amount equal
to
the Shortfall times
three [***] dollars (U.S. $[***]). Such amount, if any, shall be paid by
Taiho
to Response within thirty (30) days after Taiho's receipt of an invoice for
such
amount from Response
following the end of each calendar quarter in which such Shortfall
exists.
For
example:
Number
of Testing Services purchased in a calendar quarter:
|
[***]
|
|||
Minimum
Amount for such calendar quarter:
|
[***]
|
|||
Shortfall
([***]):
|
[***]
|
|||
Amount
due Response ($[***]):
|
U.S.
$[***]
|
5. Order
and
Delivery of Testing Services.
(a)
All
Testing Services and any materials used in connection therewith shall be
ordered, and all communications with the testing laboratory shall be performed,
pursuant to (i) Response's
instructions which will be communicated from time to time to Taiho by Response
and
(ii)
the specifications described in Schedule C, annexed hereto, which may be
changed
reasonably
by Response upon reasonable prior notice to Taiho. Such instructions shall
include information regarding shipment and delivery requirements for the
Testing
Service. Anything in this
Agreement to the contrary notwithstanding, Response may process some or all
of
the Testing Services itself, or through any other designated and licensed
laboratory, provided that such other laboratory
is under an appropriate obligation of confidentiality.
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-
(b)
Response shall provide Taiho with the Results for each Testing Service within
seven
(7)
business days from Response's (or its designee's) receipt of Samples, at
Response's designated laboratory. The Results shall include a gene expression
value for any of the molecular
markers set forth on Schedule A, accompanied by descriptive language in English.
Response shall transmit the results of the Testing Services to Taiho via (i)
facsimile or (ii) electronic transmission in a mutually agreeable format, at
Taiho's option, and shall return separately any materials remaining from the
Sample or derived therefrom during, the course of the
Testing Service.
6. Representations
and Warranties.
(a) Taiho
hereby represents and warrants to Response that: Taiho is a corporation
duly organized, validly existing and in good standing under the laws of Japan;
Taiho has all corporate power and authority to execute this Agreement; when
executed this Agreement will
constitute a valid and legally binding agreement of Taiho enforceable against
Taiho in accordance with its terms; and the execution and delivery of this
Agreement, consummation of the
transactions contemplated hereby, and the performance of the obligations of
Taiho hereunder do
not
violate any law, rule or regulation or order, writ, injunction decree, of any
court or governmental authority or other authority applicable to it and located
in the Territory.
(b) Response
hereby represents and warrants to Taiho that:
(i)
Response is a corporation duly organized, validly existing and in good standing
in the State of Delaware; Response has all corporate power and authority to
execute this Agreement; when executed this Agreement will constitute a valid
and
legally binding agreement of Response enforceable against Response in accordance
with its terms; and the execution and delivery of this Agreement and the
consummation of the transactions contemplated, hereby, and the performance
of
the obligations of Response hereunder do not violate
any law, rule or regulation or order, writ, injunction decree, of any court
or
governmental authority or other authority which is applicable to it or give
rise
to a default, right of termination, cancellation or acceleration or otherwise
conflict with or result in a loss of contractual benefit to Response under
the
terms of any agreement or other instrument or obligation to which Response
is
a
party or may be bound, or require any consent, approval or notice under any
agreement to which Response is a party or may be bound;
(ii)
The
performance of the Testing Services by Response shall in all respects
comply with United States state and federal regulations.
(c) Except
as
explicitly provided herein, the rights, information and materials provided
by Response under this Agreement are WITHOUT REPRESENTATION OR WARRANTY
OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OR ANY
OTHER
WARRANTY OR REPRESENTATION, EXPRESS OR IMPLIED. RESPONSE MAKES NO REPRESENTATION
OR WARRANTY THAT EXERCISE OF THE RIGHTS GRANTED
IN THIS AGREEMENT, OR USE OF ANY INFORMATION OR MATERIALS PROVIDED
BY RESPONSE HEREUNDER, WILL NOT INFRINGE ANY THIRD-PARTY INTELLECTUAL
PROPERTY OR OTHER PROPRIETARY RIGHT.
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-
7. Ownership;
Intellectual Property.
(a) No
Infringement. Taiho acknowledges that, as between the Parties, Response
owns and/or controls, except as set forth in paragraph 7(b), (i) the Testing
Services and all of the materials, other than Samples, which comprise the same;
and any accompanying patent applications
filed by Response. It is understood that neither Taiho nor any affiliate of
Taiho shall
acquire or claim any title to the Testing Services by virtue of this
Agreement.
(b) Ownership
of Results. Notwithstanding any other provision hereunder, Taiho
shall own all right, title and interest in and to the Results, and all
intellectual property rights
therein or thereto, all of which Response hereby assigns to Taiho. Response
agrees to hold Results
and Samples in confidence, and agrees not to use for any purpose and not to
disclose to third parties in any manner Results or Samples without the prior
written consent of Taiho.
(c) Use
of
Name. Each Party agrees that it will not, during the Term, use the name
of
the other Party or any reproduction, counterfeit, copy or colorable imitation
thereof, in any way, except to indicate, as specifically authorized therein,
that Taiho has exclusive rights in Japan
to
order the Testing Services.
(d) Sublicense.
Within thirty (30) days after the Effective Date, Response will
submit to the University of Southern California a written request to approve
a
non-exclusive sublicense
of the Testing Services to Taiho for distribution in Japan during the Term,
which sublicense Taiho will not exercise unless and until Taiho terminates
this
Agreement pursuant to Paragraph
10(b). Response will cooperate with taiho as necessary to effectuate the
foregoing, and
Response and Taiho will execute such documents as are necessary to effectuate
the foregoing.
Taiho's sublicense will include other intellectual property owned or controlled
by Response
necessary or useful to perform the Testing Services.
8. Indemnification
(a) Taiho
shall indemnify and hold harmless Response and its officers, directors,
stockholders, independent contractors, employees and agents from any liability,
loss, damages, expense (including, without limitation, reasonable attorneys'
fees and disbursements) or claim by a third party resulting from or arising
out
of: (i) any act or omission by Taiho in the performance of its obligations
hereunder or due to any breach by Taiho of its warranties in paragraph
6; (ii) any actual or alleged personal injury or property damage arising or
resulting out of
the
distribution of the Testing Services by Taiho in the Territory; (iii) any actual
or alleged false
advertising or unfair competition by Taiho in its distribution, marketing,
or
exploitation of Testing
Services; and (iv) any Regulatory Challenge (as defined in paragraph 9(d)
below).
(b) Response
shall indemnify and hold harmless Taiho and its officers, directors,
stockholders, independent contractors, employees and agents from any liability,
loss, damages, expense (including reasonable attorneys' fees and disbursements)
or claim by a third party:
(i) resulting from or arising out of any act or omission by Response in the
performance of its obligations hereunder; (ii) due to any breach by Response
of
its warranties in paragraph 6; or (iii) that the use, performance or
distribution of the Testing Services infringes or misappropriates the
intellectual property rights of a third party.
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-
(c) Notice.
In the event of any claim, action or proceeding for which either Party
is
entitled to indemnity hereunder, such Party shall promptly notify the other
Party of such matter
in
writing. The indemnifying Party shall then promptly, at its sole cost, assume
responsibility
for and shall have control of such matter, including settlement negotiations
and
the institution
and defense of any legal proceedings, provided that the indemnified Party shall
retain the right to be represented, at its sole expense, by separate counsel.
The indemnified Party shall have the right to approve or disapprove any proposed
settlement, which approval shall not be unreasonably withheld. If the
indemnifying Party does not make a timely election to undertake the
good
faith defense or settlement of the claim as aforesaid, or if the indemnifying
Party fails to proceed
with the good faith defense or settlement of the matter after making such
election, then, in either such event, the indemnified Party shall have the
right
to contest, settle or compromise the claim at its exclusive discretion, at
the
risk and expense of the indemnifying Party to the full extent set forth in
paragraphs 8(a) or 8(b), as the case may be.
(d) Regulatory
Action. In the event of a challenge or protest relating to this Agreement
by any U.S. or other governmental agency (including, without limitation,
Japanese or any subdivision thereof), any U.S. state attorney general or any
other regulatory body alleging false or misleading advertising and/or labeling
provisions and/or adulterated or misbranded product
or other matter referred to in paragraph 7(a)(ii) above ("Regulatory
Challenge"), Response
shall (to the extent permitted by law or such governmental agency) have the
right to participate in any settlement proceedings related thereto and to be
consulted by Taiho regarding such
settlement.
9. Insurance.
Response agrees to obtain, at its sole cost and expense, no less than
U.S.
Ten
Million Dollars (U.S. $10,000,000) umbrella comprehensive general liability
insurance, including
product liability coverage, and advertiser's liability coverage, with Taiho
named as an additional
insured. Response shall submit certificates of such insurance to Taiho that
includes a thirty (30) day prior written notice of cancellation provision.
Response shall keep such policies in force during the Term and for at least
three (3) years thereafter, and, upon Taiho's request, shall
submit evidence of renewal prior to the expiration of the original term of
insurance and any renewal
term thereafter.
10. Termination.
(a)
Response shall, at its option, have the right, in addition to any other rights
it may
have
hereunder, at law or otherwise, to terminate this Agreement:
(i)
in
the event of a material breach by Taiho of this Agreement which is not cured
within forty-five (45) days of receipt of written notice of such breach from
Response;
(ii)
upon
the occurrence of any of the following events:
(A) Taiho
becomes insolvent, however evidenced, or makes an assignment for
the
benefit of creditors; or
(B) Taiho
files a petition seeking relief under any provision of any Japanese
statute now or hereafter in effect affording relief to debtors, or any such
application or petition is filed against Taiho, which application or petition
is
not dismissed or withdrawn within forty-five
(45) days from the date of its filing; or
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-
(C)
the
appointment of a receiver for Taiho, and such receivership proceedings
are not dismissed within forty-five (45) days after the receiver's appointment;
or
(D)
the
commencement by Taiho of liquidation, dissolution or winding-up proceedings,
or the commencement against Taiho of a proceeding to liquidate, wind-up or
dissolve Taiho which proceeding is not dismissed within forty-five (45)
days.
(b) Taiho
shall have the right, in addition to any other rights it may have hereunder,
of law or otherwise to terminate this Agreement:
(i)
in
the event of a material breach by Response of this Agreement which breach
is
not cured within forty-five (45) days of receipt of written notice of such
breach from Taiho;
or
(ii)
upon
the occurrence of any of the following events:
(A) Response
becomes insolvent, however evidenced, or makes an assignment
for the benefit of creditors; or
(B) Response
files a petition seeking relief under any provision of the Federal
Bankruptcy Code or any other federal or state statute now or hereafter in effect
affording relief
to
debtors, or any such application or petition is filed against Response, which
application or
petition is not dismissed or withdrawn within forty-five (45) days from the
date
of its filing; or
(C) the
appointment of a receiver for Response or for all or a substantial part
of
the assets of Response and such receivership proceedings are not dismissed
within forty-five
(45)
days after such receiver's appointment; or
(D) Response
ceases to provide or conduct Testing Services or similar services
using the DTP Platform; or
(E) the
commencement by Response of liquidation, dissolution or winding-up
proceedings, or the commencement against Response of a proceeding to liquidate,
wind-up or dissolve Response, which proceeding is not dismissed within
forty-five (45) days.
(c) For
purposes of this Paragraph 10, a failure by Response to timely perform
Testing
Services and deliver the Results to Taiho in accordance with the terms of this
Agreement shall
constitute a material breach of this Agreement.
(d) The
term
of this Agreement may be extended by an additional one (1) year period if (i)
Taiho provides written notice to Response, not less than one hundred eighty
(180) days prior to the second anniversary of the Effective Date, of its intent
to so extend the Term, and
(ii)
within thirty (30) days of the date of such notice, Response does not decline,
in writing to Taiho,
to
extend the Term for an additional year. In the event of such extension, Response
shall continue to provide the Testing Services under the terms and conditions
herein.
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-
(e) It
is
understood that as of the Effective Date, Response does not own or control
an
issued patent that would necessarily prevent the use of a method substantially
similar to that used in the DTP Platform for testing samples from Japanese
patients (i.e. patients being treated
in Japan). Accordingly, in the event that a third party actually provides such
testing services using such a method to evaluate or diagnose Japanese patients,
Response agrees as follows:
(i) if Taiho provides notice of the foregoing prior to the second anniversary
of
the Effective
Date, Response will negotiate in good faith a downward adjustment to the terms
of this Agreement
to reflect such competition as the parties reasonably agree; or (ii) if the
Term
of this Agreement
has been extended under paragraph 10(d) and Taiho provides notice of the
foregoing during
the third year of the Term, Response will negotiate in good faith a downward
adjustment to
the
terms of this Agreement to reflect such competition as the parties reasonably
agree and the obligation
to purchase the Minimum Amount under pargraph 4 shall no longer apply.
However,
if the parties are unable to agree on mutually acceptable terms for the
remaining Term of
this
Agreement, then Taiho shall have the right, upon notice to Response and at
Taiho's sole discretion,
to either (i) terminate this Agreement upon notice to Response; or (ii) if
a
third party actually provides such services to test samples from Japanese
patients at a price lower than the Testing
Fee for any type of test hereunder, terminate its obligations under paragraph
4
applicable to
the
remainder of the Term of this Agreement. In the event Taiho elects (ii) above,
Taiho's appointment
under paragraph 2 as the exclusive purchaser of the Testing Services in Japan
for certain molecular markers, compounds and cancer types described as
"Exclusive" in Exhibit A shall become non-exclusive during the balance of the
third year of the Term.
(f) Termination
or expiration of this Agreement shall not relieve either Party of its
obligations relating to Testing Services ordered or rendered prior to the date
of such termination.
(g) In
the
event of termination or expiration, Taiho will be obligated to pay the
balance
of any Testing Service Fees incurred as of the date of termination, and Response
will be obligated to complete the Testing Service on any Samples received by
Response (or its designee) within
ten (10) days after the date of such termination or expiration. If Taiho is
the
terminating Party,
the uncredited amount of the Advance paid under paragraph 3(a) shall be
converted by Response into shares of Series C Preferred Stock of Response at
a
conversion price equal to the price per share of such Series C Preferred Stock
sold by Response in its next round of equity financing,
if concluded, or if not concluded, into shares of Series B Preferred Stock
of
Response at
a
conversion price of $[***] per share. Notwithstanding the foregoing, termination
of this Agreement
for any reason shall not release either Party from any liability which, at
the
time of such
termination, has already accrued to the other Party or which is attributable
to
a period prior to such termination, nor preclude either Party from pursuing
any
rights and remedies it may have hereunder
or at law or in equity with respect to any breach of this
Agreement.
(h)
In
the event of any termination of this Agreement by Taiho pursuant to Xxxxxxxxx
00(x), Xxxxx may, at its sole option, elect either to: (1) exercise its license
regarding Testing
Services granted under Paragraph 7(d); or (ii) have Xx. Xxxxx Xxxxxxxxx and/or
Xxxxxxxx Xxxxxxxxx
provide the Testing Services for Taiho in the same manner as Response provides
hereunder, as agrees to in the letter attached as Schedule D, and for which
Response grants any rights
and licenses necessary to conduct such Testing Services, provided
that, Taiho
shall pay the costs,
direct and indirect, for equipment, supplies and salaries for such Testing
Services as performed
by either of the Xxxxxxxxx'x, in the form of a research grant or contract which
conforms
to the specifications required by the University of Southern California and
except for the
price
paid by Taiho, both of the Xxxxxxxxx'x shall provide the Testing Services in
accordance
with the same terms and conditions as Response performed such Testing Services
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.
-8-
(i)
In
the event of any termination or expiration of this Agreement, Response will
return
all unused Samples and materials derived from Samples and all copies of Results
to Taiho. Paragraphs
1, 6, 7(a), 7(b), 8, 10(e)-(h), 11 and 12 will survive termination or expiration
of this Agreement
for any reason. Paragraph 7(d) will survive any termination under paragraph
10(b).
11.
Notices. All notices and consents required or permitted hereunder (all of the
foregoing
hereinafter collectively referred to as "Communications") shall be in writing
and shall be deemed to have been duly given and received upon receipt, if
delivered (a) personally with receipt acknowledged, (b) by registered or
certified mail or equivalent, return receipt requested, postage prepaid, (c)
mailed by overnight or international courier for next day or second day
delivery, as the case may be, in each case addressed to the Parties at their
respective addresses set
forth
below or to such other address as any Party shall hereafter specify by
Communication to the
other
Party, or (d) by telecopy to the number set forth below or to such changed
number as any Party shall hereafter specify by Communication to the other
Party:
If
to Response to:
|
Response
Genetics, Inc.
0000
Xxxxxx xx xxx Xxxxxxxx
Xxxxx
0000
Xxx
Xxxx, XX
Attn:
Chief Executive Officer
|
|
with
a copy to:
|
Blank
Rome Xxxxxx Xxxxxxxxxx LLP
000
Xxxxxxxxx Xxxxxx
Xxx
Xxxx, XX 00000
Attn:
Xxxxxxx X. Xxxxx, Esq.
Telecopier
No.: (000) 000-0000
|
|
If
to Xxxxxxxx Xxxxxxxxx to:
|
Xxxxxxxx
Xxxxxxxxx
Vice
President & Chief Scientific Officer
Response
Genetics, Inc.
0000
Xxxxxxx Xxxxxx; 0xx Xxxxx
Xxx
Xxxxxxx, XX 00000
|
|
If
to Taiho to:
|
Taiho
Pharmaceutical Co., Ltd.
0-00
Xxxxxxxxxxxx-xxx, Xxxxxxx-xx, Xxxxx
000-0000, Xxxxx
Attn: Teruhiro
Utsugi, Ph.D.
Telecopier
No.: x00-0-0000-0000
|
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.
-9-
with
a copy to:
|
Xxxxxx
Xxxxxxx Xxxxxxxx & Xxxxxx
Xxx
Xxxxxx
Xxxxx
Xxxxx, Xxxxx 0000
Xxx Xxxxxxxxx, XX 00000 Attn: Xxxxx X. Xxxxx, Esq. Telecopier No.: (000) 000-0000 |
12. Entire
Agreement and Waiver. This Agreement and the Secrecy Agreement dated March
14,
2001, and any amendments to the Secrecy Agreement subsequently executed by
both
parties, contain the entire agreement between the Parties with respect to the
subject matter hereof and supersedes all previous agreements or arrangements
between the Parties relating to the subject matter hereof. No purported waiver
by any Party of any breach by the others of any of its obligations, agreements
or covenants hereunder, or any part thereof, shall be effective unless
made
in
writing, signed by the Party sought to be bound thereby, and no failure to
pursue or elect any
remedy with respect to any default under or breach of any provisions of this
Agreement, or any part thereof, shall be deemed to be a waiver of any other
or
subsequent, similar or different default or breach, or any election of remedies
available in connection therewith, nor shall the acceptance or receipt by either
Party of any money or other consideration due to it under this Agreement, with
or without knowledge of any breach hereunder, constitute a waiver of any
provision of this Agreement with respect to such or any other
breach.
13. Force
Majeure. If the performance of this Agreement or any obligation, action or
transaction under this Agreement by either Party is hindered or prevented
("Impeded") by act of God, action of the elements, fire, accident, riot, strike,
work stoppage or other labor disturbance, war,
invasion, civil commotion, enactment of laws or other casualty or cause, whether
similar or dissimilar,
beyond the reasonable control of the Party required to perform and without
such
Party's fault or negligence (each a "Force Majeure Condition"), performance
by
that Party to the extent so Impeded shall be excused during the period of the
Force Majeure Condition; provided, however,
that no Force Majeure Condition shall relieve Taiho of the obligation to pay
for
Testing Services
which have already been completed by Response; and further provided that, to
the
extent Response or its designee is Impeded by a Force Majeure Condition from
performing the Testing Services, Taiho's obligation to purchase Testing Services
from Response and to pay the Minimum Testing Services Fees shall be suspended
for the same period of time.
14. Assignment;
Binding Effect. Except as otherwise provided herein, neither Party may
assign this Agreement without the prior written consent of the other Party,
except that either Party
may
assign this Agreement without prior consent to an entity that acquires all
or
substantially all of the business or assets of that Party (or that portion
thereof to which this Agreement relates), in each case whether by merger,
acquisition, or otherwise, provided that such
assignee agrees in writing to be bound by the terms and conditions of this
Agreement. This Agreement
shall inure to the benefit of and be binding upon the Parties hereto and their
respective
successors and permitted assigns. Nothing in this Agreement, express or implied,
is intended
to or will confer on any person other than the Parties, and their respective
successors and
permitted assigns, any benefits, rights, remedies, obligations or liabilities
under, or by reason 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.
-10-
15. Independent
Contractors. In all matters relating to this Agreement, the Parties shall
be
deemed independent contractors.- The Parties expressly disclaim any intention
to
create a
partnership, agency or joint venture pertaining to the subject matter of
this
Agreement.
16. Press
Release. Except as otherwise required by law or applicable regulation, and
except
for disclosures made by Response or Taiho with respect to any private or
public
offering of
its
securities, neither Party shall issue any press release or make any public
announcement relating to the subject matter of this Agreement without the
prior
written approval of the other Party, which shall not be unreasonably withheld
or
delayed.
17. Governing
Law/Submissions to Jurisdiction. This Agreement shall be governed and
construed in all respects by the laws of the State of New York applicable
to
contracts entered into
and
to be wholly performed therein, without regard to its conflicts of laws
principles. Each of
the
Parties hereby agrees that any suit, action or proceeding arising out of
this
Agreement or the Secrecy Agreement may be instituted against it in the United
States District Court for the Southern
District of New York. Each of the Parties expressly consents to personal
jurisdiction in the
State
of New York with respect to such suit, action or proceeding. Each Party
irrevocably and unconditionally
waives any objection to the jurisdiction and venue required in this Paragraph
18, and agrees not to plead or claim in any such court that any such suit,
action, or proceeding has been brought in an inconvenient forum.
18. Severability.
If one or more of the provisions contained in this Agreement shall be
determined to be invalid or unenforceable by a court of competent jurisdiction
or by any other legally
constituted body having the jurisdiction to make such determination, the
validity and enforceability of the remaining provisions shall not in any
way be
affected or impaired thereby and said provision shall be (only with respect
to
the operation thereof in the particular jurisdiction
in which such adjudication is made) construed by limiting and reducing it
so as
to be enforceable
to the extent permissible.
19. Headings;
Word Meanings. The headings preceding the text of the various provisions
of this Agreement are for convenience of reference only and are not intended
to
define, limit or in any other way describe the scope of this Agreement or
the
intent of the provisions
hereof. The singular shall include the plural and the masculine gender shall
include the
feminine and neuter, and vice versa, unless the context otherwise
requires.
20. Further
Actions. At any time and from time to time, each Party agrees, without
further
consideration, to take such actions and to execute and deliver such documents
as
may be reasonably necessary to effectuate the purposes 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.
-11-
21.
Counterparts. This Agreement may be executed in any number of counterparts,
each
of
which shall be deemed an original, but all of which together shall constitute
one and the same
instrument.
IN
WITNESS WHEREOF, this Agreement has been executed and delivered by the
Parties hereto on the date and year first above written.
RESPONSE
GENETICS, INC.
|
TAIHO
PHARMACEUTICAL CO., LTD.
|
||
By: | By: | ||
Name:
Xx. Xxxxx X Xxxxxx XX
Title:
President and CEO
|
Name:
Xx. Xxxxx Xxxxxxx
Title:
Senior Managing Director
|
||
I
agree to abide by the terms and obligations of Paragraph
10(h).
|
|||
By: | |||
Name: Xxxxxxxx
Xxxxxxxxx
|
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-
SCHEDULE
A
EXCLUSIVITY
As
of the
Effective Date, Response grants Taiho the right to be the exclusive purchaser
in
Japan
of
tests and testing services based upon the DTP Platform using gene expression
for
the foregoing (collectively referred to as the "Field"):
1) for
any
one or combination of the following molecular markers: [***]; or
2) [***];
or
3) relevant
to the diagnosis or therapeutic treatment of precancerous and cancerous
diseases of the [***].
NON-EXCLUSIVITY
As
of the
Effective Date, Response grants Taiho the right to be a non-exclusive purchaser
in
Japan
of tests and testing services based upon the DTP Platform using gene expression
not covered by an Exclusivity agreement:
1)
for
any one or combination of molecular markers other than those for which
Taiho has Exclusivity; or
2) relevant
to the therapeutic use of any compound or biological product against
cancer
other than those compounds for which Taiho has Exclusivity; or
3) relevant
to the diagnosis or therapeutic treatment of precancerous and cancerous
diseases other than those for which Taiho has Exclusivity.
NEW
MOLECULAR MARKERS, ANTI-CANCER AGENTS, DTP USES
Response
will notify Taiho from time to time of new molecular markers, anti-cancer
agents
and/or uses of the DTP Platform as they are developed and validated by
Response, In such
event, Exclusivity with respect to such new molecular markers, anti-cancer
agents and/or uses
will
be determined by mutually agreed upon pricing, milestones, minimums or other
criteria to
be
negotiated and agreed to by the Parties. In the event the parties fail to
mutually agree upon such
pricing, milestones, minimums or other criteria within thirty (30) days of
Taiho's receipt of notice
of
such new molecular markers, anti-cancer agents and/or uses, Response shall
have
the right to engage any other third party as an exclusive distributor of the
Testing Services outside the Field with respect to such new molecular markers,
anti-cancer agents and/or uses; provided that Taiho will retain non-exclusive
rights to such new molecular markers, anti-cancer agents and/or
uses within the Field in Japan. The following examples illustrate the operation
of such non-exclusivity:
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-
1) Taiho
and
Response do not agree on terms of Exclusivity for new molecular marker
[***].
Therefore, Taiho retains a non-exclusive right to provide the DTP in Japan
using
[***]
in
the Field (i.e., for precancerous and cancerous diseases of the [***],
or
as
relevant to therapeutic use of [***] compounds (either alone or in combination
with other compounds or therapies), or with molecular markers [***]). Response
may grant a third party exclusive distribution rights for such new molecular
marker [***] in Japan outside the Field
(i.e., as relevant for therapeutic use of compounds other than, and not used
in
combination with,
[***] or as relevant for precancerous and cancerous diseases of other than
the
[***]);
provided, however, that Response may not grant a third party distribution rights
in Japan to use [***] in the Field (i.e., for precancerous and cancerous
diseases of the [***],
or as
relevant to therapeutic use of [***] compounds (either alone or in combination
with other compounds or therapies), or with molecular markers
[***]).
2) Taiho
and
Response do not agree on terms of Exclusivity for new use of the DTP
with
respect to [***]. Thereafter, Taiho retains a non-exclusive right to provide
the
new use
of
the DTP in Japan within the Field (i.e., as relevant to therapeutic use of
[***]
compounds (either alone or in combination with other compounds or therapies),
or
for molecular markers [***],
or
as relevant to precancerous and cancerous diseases of the [***]). Response
may grant a third party exclusive distribution rights for such new use of the
DTP in Japan outside the Field (i.e., as relevant for therapeutic use of
compounds other than, and not used in combination with, [***] or as relevant
for
precancerous and cancerous diseases of other than the [***]); provided, however,
that Response may not grant a third party distribution rights in Japan to such
new use of the DTP in the Field (i.e., as relevant to therapeutic use of 5-Fu
compounds (either alone or in combination with other compounds or therapies),
or
for molecular markers [***], or for precancerous and cancerous diseases of
the
[***]).
3) Taiho
and
Response do not agree on terms of Exclusivity for use of the DTP with respect
to
[***]. Therefore, Taiho retains a non-exclusive right to use the DTP as relevant
to use of [***] in Japan within the Field (i.e., as relevant for precancerous
and cancerous diseases of the [***], or for therapeutic use of [***] compounds
(either alone or in combination with other compounds or therapies) or for
molecular markers [***]). Response may grant a third party exclusive
distribution rights in Japan outside the Field (i.e., as relevant
for therapeutic use of compounds other than, and not used in combination with,
[***], or as
relevant for precancerous and cancerous diseases of other than the [***]);
provided, however, that Response may not grant a third party distribution rights
in Japan to use the DTP with [***] in the Field (i.e., as relevant for
precancerous and cancerous diseases of the [***], or for therapeutic use in
combination with [***] compounds, or for molecular markers [***]).
Further,
until such time as Response actually enters into an agreement with a third
party
for exclusive rights outside the Field in Japan with respect to such new
molecular markers, anti-cancer agents and/or uses of the DTP Platform, Taiho
will have the non-exclusive right in Japan to
purchase tests and testing services based upon such new molecular markers,
anti-cancer agents and/or
uses of the DTP Platform, whether inside or outside the Field.
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-
SCHEDULE
B
TESTING
SERVICE FEES
During
each calendar quarter of the Term, the Testing Service Fee shall be as
follows:
Number
of Testing Services purchased
by Taiho during each
calendar quarter of the Term
|
Testing
Service Fee
|
|||
[***]
|
$
|
[***]
|
||
[***]
|
$
|
[***]
|
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-
SCHEDULE
C
INSTRUCTIONS
AND SPECIFICATIONS FOR SENDING TISSUE
SAMPLES
FOR RESPONSE GENETICS' XXXXXXXXX TUMOR
PROFILE
FOR COMMERCIAL PROCESSING
1. Patient
Information
A. Taiho
unique I.D. No.
B. For
each
specimen provided, a diagnosis or provisional diagnosis supplied by a physician
(pathologist or other qualified physician) certified in anatomical pathology,
which diagnosis
shall include (i) the type of tumor, including histomorphology and
histopathology, (ii) source organ of the specimen, (iii) whether the specimen
is
primary or metastatic, and (iv) if the specimen
is metastatic, the origin of the primary tumor.
2. Sample
Preparation
(1) Sample
to
be processed should correlate with stage and site to be treated.
(2) Cut
one 5
µM section, mount on glass slide.
(3) Cut
four
10 µM sections,
mount on four separate regular glass slides. Glass slides should
be
regular glass, uncoated and uncharged. Do not bake slides and do not use
coverslip. Slides
must contain a sufficient quantity of tumor tissue to be successfully
microdissected.
(4) Send
above referenced samples or specimens by overnight delivery in approved slide
holder, placed in a bubble-lined envelope and in a Federal Express Diagnostic
Specimen Envelope,
to the laboratory designated by Response at Response's direction.
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.
-00-
XXXXXXXXXX XX XXXXXXXX XXXXXXXXXX | ||
Xxxx School of Medicine | ||
Department of Biochemistry and Molecular
Biology
USC/Nom's Comprehensive Cancer
Center
|
||
Xxxxx
X. Xxxxxxxxx, Ph.D.
Professor
of Biochemistry and Molecular Biology
|
SCHEDULE
D
July
23,
2001
Teruhiro
Utsugi, Ph.D.
Manager
Product
Research & Licensing
Taiho
Pharmaceutical Co Ltd
0-00
Xxxxxxxxxxxx-xxx, Xxxxxxx-xx,
Xxxxx
000-0000, Xxxxx
Dear
Xx.
Xxxxxx:
This
is
to confirm our commitment that, in the event of a termination in accordance
with
paragraph
10 (b) by Taiho of the Services Agreement of June, 2001 between Taiho
Pharmaceutical
Co, Ltd., and Response Genetics, Inc., we will undertake a research project
for
Taiho
in
which we will provide the Testing Services in the same manner described in
the
Services
Agreement, provided that Taiho pays the costs, direct and indirect, for
equipment, supplies
and salaries for such Testing Services in the form of a research grant or
contract which conforms
to the specifications required by the University of Southern
California.
Best
regards,
By: | By: | ||
Xxxxx
Xxxxxxxxx, PhD
|
Xxxxxxxx
Xxxxxxxxx
|
||
0000
Xxxxxxxx Xxx., Xx. 0000
Xxx
Xxxxxxx, XX 00000
VOX:
000-000-0000
FAX:
000-000-0000
email:
xxxxxxxx@xxx.xxx.xxx
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-
SCHEDULED
Letterhead
of the USC Laboratory of Xx. Xxxxx Xxxxxxxxx
June
,
2001
Teruhiro
Utsugi, Ph.D.
Manager
Product
Research & Licensing
Taiho
Pharmaceutical Co Ltd
0-00
Xxxxxxxxxxxx-xxx, Xxxxxxx-xx,
Xxxxx
000-0000, Xxxxx
Dear
Xx.
Xxxxxx:
This
is
to confirm our commitment that, in the event of a termination in accordance
with
paragraph 10 (b) by Taiho of the Services Agreement of June, 2001 between Taiho
Pharmaceutical
Co, Ltd., and Response Genetics, Inc., we will undertake a research project
for
Taiho
in
which we will provide the Testing Services in the same manner described in
the
Services Agreement, provided that Taiho pays the costs, direct and indirect,
for
equipment, supplies
and salaries for such Testing Services in the form of a research grant or
contract which conforms
to the specifications required by the University of Southern
California.
Best
regards,
By: | By: | ||
Xxxxx Xxxxxxxxx, PhD | Xxxxxxxx Xxxxxxxxx |
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-
September
30, 2004
Teruhiro
Utsugi, Ph.D.
Director
of Product Research & Licensing
Taiho
Pharmaceutical Co., Ltd.
0-00,
Xxxxxxxxxxxx-xxx
Xxxxxxx-xx,
Xxxxx, 000-0000
Xxxxx
Re: |
Services
Agreement ("Agreement") dated July 30, 2001 between Response
Genetics,
Inc. ("Response") and Taiho Pharmaceutical Co., Ltd.
("Taiho")
|
Dear
Xx.
Xxxxxx:
This
letter reflects Response and Taiho's mutual agreement to modify the terms of
the
above referenced
Agreement as follows:
1.
|
All
capitalized terms not herein defined shall have the meaning set forth
in
the Agreement.
Except as set forth in this letter, the terms and conditions of the
Agreement shall
continue in full force and effect. Unless otherwise stated, "Paragraph"
shall refer to paragraphs of the Agreement and "Item" the items of
this
letter.
|
2.
|
Notwithstanding
Paragraph 1(d), the "Term" shall mean the period beginning on October
1,
2001 and ending on October 1, 2007, unless extended in accordance
with
Item 4 below.
|
3.
|
During
the period from October 1, 2004 through October 1, 2007 (the "Extension
Period"), the terms and conditions for the supply of Testing Services
by
Response to Taiho,
including the Testing Fees and Minimum Amounts, shall be the same
as set
forth in the Agreement.
|
4.
|
The
Term may be extended for additional two (2) year periods, each time
upon
the mutual
agreement of the Parties. The parties shall begin discussions concerning
this subsequent extension in good faith upon either Party's request
within
ninety (90) days prior to the conclusion of the then effective Term.
In
the event the Parties cannot agree on
any such extension of the Term, then upon the request of Taiho, Taiho
shall have an irrevocable
non-exclusive right to purchase all Testing Services from Response
at a
price equal to the Testing Fee or the then-current worldwide average
net
sales price charged by Response
for the respective Testing Service, whichever is
lower.
|
5.
|
Response
confirms that it will promptly obtain the approval of the University
of
Southern California
("USC") as set forth in Paragraph 7(d) (and the consent of USC to
have
Taiho's sublicense rights from USC remain in effect, whether as a
sublicense or a direct license, after any termination of the agreement
between USC and Taiho). Response shall hereby grant Taiho a non-exclusive
sublicense under the intellectual property licensed from
USC to Response and a non-exclusive license under any other necessary
intellectual property
owned or controlled by Response, in Japan, to make, use and practice
the
Testing
Services and the DTP Platform, solely for research purposes, on Taiho's
behalf or on
the behalf of its research collaborators, including to have such
activities performed by subcontractors.
This non-exclusive sublicense and license specifically excludes the
right
to
offer to sell and/or sell any diagnostic kits. Taiho confirms that
it will
not exercise such
license and sublicense, unless and until the Agreement and/or its
rights
hereunder are
terminated. In addition, Taiho agrees to comply with Section 24(f)
of
Response's agreement
with USC dated April 19, 2000, entitled "Option and License Agreement,"
as
it applies to Taiho's exercise of its rights under this Item 5. Response
will cooperate with Taiho
as necessary to effectuate such license and sublicense and Taiho's
exercise thereof.
|
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.
September
29, 2004
Page 2
Page 2
6.
|
The
first (ii) clause in Paragraph 10(e) shall be replaced with: "(ii)
if
Taiho provides notice
of the foregoing during the Term after the second year thereof,"
and the
sentence shall continue with "Response will negotiate in good faith
a
downward adjustment to the terms
of this Agreement to reflect such competition as the parties reasonably
agree and the obligation to purchase the Minimum Amount under paragraph
4
shall no longer apply." Except as set forth in this Item 6, Paragraph
10(e) shall remain unchanged.
|
7.
|
In
addition, in the event an in-vitro diagnostic ("IVD") form of any
Testing
Service becomes available in Japan, the obligation to purchase the
Minimum
Amount under Paragraph
4 shall no longer apply.
|
8.
|
After
October 1, 2005, Taiho shall have the right to terminate the Agreement
upon six (6) months notice, in the event the underlying research
of Taiho,
including with its collaborators,
using the DTP Platform has ended. In connection with such termination,
the
Parties may discuss the desirability of Taiho using Response's other
technology platforms for its research; although it is understood
neither
Party shall be obligated by this
Item 8 with respect to use of such other
platforms.
|
9.
|
In
the event of any termination or expiration of the Agreement, the
Paragraphs set forth in Paragraph
10(i) of the Agreement and Items 4 and 5 hereof shall survive any
such
expiration
or termination.
|
If
you
are in agreement with the foregoing, please execute one of the enclosed
duplicate originals in
the
space below and return the signed version to me at your earliest
convenience.
Agreed
to by:
|
|||
09/29/2004 | |||
Xxxxxxxx
Xxxxxxxxx
President
and CEO
Response
Genetics, Inc.
|
|||
Agreed to by: | |||
09/29/2004 | |||
Teruhiro
Utsugi, Ph.D.
Director
of Product Research & Licensing
Taiho
Pharmaceutical Co., Ltd.
|
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.
September
29, 2004
Page 3
Page 3
In
addition, Xxxxx Xxxxxxxxx and Xxxxxxxx Xxxxxxxxx hereby confirm that the
commitment stated
in
the letter dated July 23, 2001 between them and Taiho, attached as Schedule
D to
the Agreement, shall continue to apply during the Term as amended
herein.
09/29/2004 | 09/29/2004 | |||
Xxxxx
X.
Xxxxxxxxx
Professor
of Biochemistry and Molecular Biology
University
of Southern California
|
Xxxxxxxx
Xxxxxxxxx
University
of South California
|
|||
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.