COMMISSION AGREEMENT
This
Agreement made and entered into this 26th
day of
July 2007 by and between
Response Genetics, Inc.,
a
corporation duly organized and existing under the laws of the State of Delaware,
having its principal office at 0000 Xxxxxxx Xxxxxx, 0xx Xxxxx Xxx Xxxxxxx,
XX
00000, U.S.A (hereinafter referred to as “RGI”),
and.
HITACHI CHEMICAL CO., LTD.,
a
corporation duly organized and existing under the laws of Japan, having its
business office at 9-25, Xxxxxxxx 0-xxxxx, Xxxxxx-xx, Xxxxx 000-0000, Xxxxx
(hereinafter referred to as “HCC”)
WITNESSETH:
WHEREAS,
RGI is engaged in the business of offering Testing Services to the
pharmaceutical industry such as in support of clinical trials;
WHEREAS,
HCC is engaged in manufacture and sale of diagnostics in Japan and other areas;
and
WHEREAS,
RGI desires to commission HCC to undertake Testing Services in the Territory,
and HCC is willing to comply with such desire of RGI pursuant to the terms
and
conditions of this Agreement.
NOW,
THEREFORE, in consideration of mutual covenants and agreements herein contained,
the Parties hereto agree as follows:
Article
1 Definitions.
The
words
and phrases set forth below shall have the meanings respectively described
thereto:
1.1 “Effective
Date”
shall
mean the date first written above.
1.2 “Intellectual
Property Rights”
shall mean
all
patents, copyrights, design rights, trade marks, service marks, trade secrets,
know-how, database rights, goodwill and other rights related to Testing Services
(hereinafter defined) in the nature of intellectual property rights (whether
registered or unregistered) and all applications for the same, anywhere in
the
world.
1.3 “Confidential
Information”
shall
mean any and all commercial and technical information relating to any of the
existing or planned products, businesses, research and/or development
activities, customers and suppliers of either Party whether in written, verbal
or any other form, tangible or intangible, which either Party may acquire or
may
have access from time to time, provided such information is marked as
“Confidential and Proprietary” and provided that information which is orally
disclosed shall be confirmed in writing within 30 days from oral disclosure.
Confidential Information includes and is not limited to: (a) any information
generated in connection with the provision of the Testing Services (such as
the
results or findings thereof and the contents of any report) under this
Agreement, (b) information concerning inventions, discoveries, concepts, ideas,
techniques, processes, designs, specifications, drawings, diagrams, models,
samples, flow charts, computer programs, algorithms, data, databases, studies,
mathematical calculations, finances and plans, customer lists, business plans,
contracts, marketing plans, production plans, distribution plans, system
implementation plans, business concepts, supplier information, business
procedures and business operations and all materials related thereto; (c) the
existence, contents or terms of this Agreement, (d) all know-how and
intellectual property, (e) all unpublished copyrightable material, (f) any
use,
variation, application, reduction to practice, or any discussion and any other
communication thereof regarding or relating to the Confidential Information,
and
(g) any information concerning how any part of the above information is related
to and/or fits together with any other part of the above information, or any
other technology or business; Notwithstanding the foregoing, the Parties agree
that any and all data, reports, laboratory work sheets, results, materials
or
information provided by either Party or its Affiliates or Third Parties on
behalf of a Party and any other documents or information furnished to a Party,
or to which a Party is given access, by the other Party or its Affiliates or
such Third Parties in connection with the performance of this Agreement, or
prepared or generated by a Party in connection with performing any and all
Testing Services hereunder, shall be deemed to be the Confidential Information
of the Party which owns such disclosed information. All Technical Information
(hereinafter defined) shall be considered the Confidential
Information.
[***] 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 24b-2 of the Securities Exchange Act of
1934.
1.4 “Agreement”
shall
mean this Agreement between HCC and RGI for Testing Services by
HCC.
1.5 “Technical
Information”
shall
mean any and all technical information and know-how necessary for the Testing
Services hereunder such as the information on the methods and procedures
of the
Testing Services.
1.6 “Minimum
Quantities”
shall
mean the minimum quantities of the Testing Services to be ordered by RGI
to HCC
for each period of one calendar month.
1.7 “Samples”
shall
mean paraffin-embedded
tissue specimen for the
Testing Services.
1.8 “Party”
shall
mean HCC or RGI as the context requires and “Parties”
shall
mean both HCC and RGI.
1.9 “Person”
and
words importing persons shall be construed as to include individuals, firms,
bodies corporate, joint ventures, governments, states or agencies of state
or
any undertaking (whether or not having separate legal personality and
irrespective of the jurisdiction in or under the laws of which it was
incorporated or exists).
1.10 “Purpose”
shall
mean the provision of the Testing Services pursuant to this
Agreement.
1.11 “Relevant
Staff”
shall
mean employees and sub-contractors involved in providing the Testing Services
and such sub-contractors shall be named in the relevant Exhibit or otherwise
agreed to in writing by RGI.
1.12 “Testing
Services”
shall
mean conducting molecular-based tumor tissue profiling using a proprietary
and
patented process developed by RGI which involves a complex molecular analysis
of
specific molecular markers that provides valuable tumor specific gene expression
information obtained from Samples.
[***] 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 24b-2 of the Securities Exchange Act of
1934.
2
1.14 “Affiliate”
with
respect to a Person shall mean any other Person that directly, or indirectly
through one of more intermediaries, controls, is controlled by or is under
common control with such Person; for the purposes of this clause 1.14 only,
“control” and, with correlative meanings, the terms “controlled by” and “under
common control with”, shall mean (a) the possession, directly or indirectly, of
the power to direct the management or policies of a Person, whether through
the
ownership of voting securities, by contract or otherwise, and/or (b) the
ownership, directly or indirectly, of at least fifty percent (50%) of the
voting
securities or other ownership interest of a Person.
1.15 “Third
Party”
shall
mean any Person who is not a Party hereto.
Article
2 Testing
Services .
2.1 HCC
agrees to perform Testing Services in
accordance with a
Statement of Work agreed between the Parties in the form of Exhibit
A attached
hereto (“SOW”)
provided by RGI through mutual consultation. HCC shall be deemed to have
accepted RGI’s order so long as the number of samples is within the updated
forecast provided by RGI under Article 6, unless HCC provides RGI with written
notice within five (5) business days of HCC’s receipt of such RGI’s order. HCC
shall not unreasonably withhold its acceptance of RGI’s order. In the case that
HCC accepts RGI’s order of any Testing Services, RGI shall deliver the Samples
for such Testing Services under RGI’s responsibility and expenses.
2.2 RGI
shall
not commission any Third Party in the Territory to perform Testing Services
for
any Sample taken in the Territory without
the prior written consent of
HCC.
2.3 HCC
shall
perform the Testing Services for the Samples provided by RGI or its designee,
based upon the SOW agreed between the Parties, using RGI’s Intellectual Property
Rights and Technical Information disclosed by RGI as set forth in Article
4,
below and shall deliver the results of the Testing Services for such Samples
to
RGI.
2.4 HCC
shall
not have any Third Party render the Testing Services without the prior written
consent of RGI.
2.5 HCC
shall
not, in any case, render the Testing Services for any Third Party.
2.6 RGI
will
communicate with customers and respond to customer inquiries regarding the
results of the Testing Services of the data and the reports of test results.
HCC
will cooperate with RGI at its request to assist in responding to customer
inquiries regarding the performance of the Testing Services, storage of the
samples and other record keeping.
[***] 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 24b-2 of the Securities Exchange Act of
1934.
3
Article
3 Performance
Of The Services.
3.1
In the
case that HCC should perform the Testing Services for clinical trials, HCC
shall
comply with Good Laboratory Practice, provided, however, that RGI shall disclose
any and all necessary information regarding Good Laboratory Practice to HCC
and,
if needed, shall provide outside consultant support at RGI’s cost. HCC also
will, within the scope of the information that RGI should disclose to HCC,
comply with the applicable laws, regulations, and guidelines governing the
performance of the Testing Services, including those relating to Good Laboratory
Practice in case of the Testing Services for clinical trials. HCC shall
establish Good Laboratory Practice, provided, however, that RGI shall request
HCC to prepare to establish Good Laboratory Practice at least six (6) months
prior to the starting date of the Testing Services for clinical trials by
HCC.
3.2 HCC
shall
make reasonable efforts to use facilities, supplies and staff necessary to
complete the Testing Services as provided in the applicable SOWs, as it may
be
modified as provided herein, and in accordance with the terms of this Agreement.
HCC will obtain any necessary authorizations and permissions for all equipment
and reagents which it uses in performing Testing Services from RGI in accordance
with RGI’s directions.
3.3 RGI’s
representatives may visit HCC’s laboratory and premises at reasonable times, on
reasonable prior notice, and with reasonable frequency during normal business
hours to observe the progress of the Testing Services, and any and all Samples,
Study Archives (hereinafter defined), information and results derived therefrom.
HCC shall assist RGI in scheduling such visits. RGI shall comply with HCC’s
reasonable access and control procedures relating to such Samples and
information. RGI may also, at a reasonable time upon reasonable prior notice,
obtain access to the samples and Study Archives, provided that RGI complies
with
HCC’s reasonable access and control procedures relating to such
materials.
3.4 All
reports prepared by HCC hereunder shall be prepared in a format specified
in the
applicable SOW. RGI shall have access to all documentation, records, raw
data,
specimens or other work product generated during the performance of each
Testing
Services. HCC agrees to maintain appropriate records in paper or magnetic
form,
in a manner which complies with regulatory requirements, as provided by
RGI.
3.5 RGI
shall
have the responsibility to disclose necessary information for the Testing
Services regarding the requirement of Generic Drug Enforcement Act of 1992
to
HCC. HCC agrees to comply with such information. HCC further agrees to submit
to
RGI, upon request upon completion or termination of the Testing Services,
a
certification that neither HCC nor any of its employees has been debarred
by the
FDA under the provisions of the Act and that HCC did not use in any capacity
in
connection with the Testing Services any individual debarred by the FDA under
the provisions of the above referenced Act in accordance with RGI’s
directions.
[***] 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 24b-2 of the Securities Exchange Act of
1934.
4
3.7 In
the
event of a conflict in government regulations, RGI shall, on its responsibility,
designate which regulations shall be followed by HCC in its performance of
a
particular Testing Services.
3.8 HCC
agrees to use reasonable care in safeguarding, inventorying and handling
all SOW
data, materials and supporting documentation (hereinafter collectively termed
“Study
Archives”)
originating from any SOW conducted under this Agreement by HCC, whether written
or physical (such as notebooks, original or raw data, protocols, interim
or
final report copies) in accordance with RGI’s appropriate directions. The Study
Archives shall be considered to be Confidential Information of RGI. HCC will
maintain the Samples provided to it for Testing Services under this Agreement
in
accordance with the usual and customary standards for maintaining such
materials. Upon request by RGI, HCC will provide Samples to RGI or a copy
of
documents from the Study Archives, at RGI’s expense. To the extent that Samples
are transferred to RGI, responsibility for maintaining such samples will
then be
undertaken by RGI. The Samples and Study Archives are to be retained and
archived by HCC for a period of not less than ten (10) years following the
completion of the relevant SOW.
3.9 Following
the end of the relevant ten (10) year retention period, HCC may, at its
discretion, after providing written notice to RGI of HCC’s intention, dispose of
or destroy the Samples and Study Archives. In the case RGI should request
the
further retaining and archiving of the Samples and Study Archives at RGI's
cost,
RGI and HCC shall negotiate in good faith regarding the terms and conditions
thereof, or RGI has the option to transfer the Samples and Study Archives
at
RGI’s expense.
3.10 HCC
represents that each of its personnel, employees, agents, representatives,
subcontractors or invitees who shall perform Testing Services hereunder shall
abide by the provisions of Article 3 hereof. HCC agrees that each of its
personnel, employees, agents, representatives, subcontractors or invitees
who
shall perform Testing Services hereunder shall be at least eighteen (18)
years
old.
3.11 HCC
agrees to maintain all electronic information or data on secure systems which
are dedicated mainly to information and data generated under this Agreement.
HCC
shall also cooperate with RGI to implement, use and maintain any software
or
computer systems specified by RGI, provided, however, that RGI shall, free
of
charge, provide HCC with all necessary software and/or special computer
systems.
[***] 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 24b-2 of the Securities Exchange Act of
1934.
5
4.1 As
soon
as practicable after the execution of this Agreement, RGI shall, free of
charge,
provide HCC with sufficient written documents describing the Technical
Information, and, free of charge, dispatch its technically capable people
to HCC
or accept HCC’s employee at RGI’s facilities for training, the term and
conditions of which are mutually agreed, to disclose to HCC the Technical
Information which RGI considers necessary for the Testing Services to be
performed by HCC hereunder.
Article
5 Technical
Assistance .
5.1 Upon
the
request of HCC made from time to time during the term of this Agreement,
RGI
shall, free of charge, provide HCC with technical assistance relating to
the
Testing Services including dispatch of RGI’s employees and acceptance
of HCC’s employees for training.
5.2 RGI
shall, free of charge, furnish HCC with any and all modification or improvement
related to the Testing Services during the term of this Agreement which are
necessary to perform a SOW.
Article
6 Forecast
of RGI’s Orders for Testing Services.
6.1 Starting
on the Effective Date of this Agreement and every March, June, September
and
December thereafter, RGI shall provide HCC with a non-binding updated forecast
indicating RGI’s orders for the Testing Services for
the
following twelve (12) month period with monthly breakdowns. Each updated
forecast shall control over any preceding forecast provided by RGI hereunder.
6.2 In
the
event that HCC should anticipate that each forecasted quantity cannot be
fully
made by HCC, HCC shall notify RGI thereof in writing within fourteen (14)
days
after the receipt of such RGI’s forecast.
6.3 If
RGI
should forecast that RGI’s orders for the Testing Services to HCC in any month
will be more than [***]
Samples,
RGI and HCC shall discuss
HCC’s
investment in equipment and facilities for the Testing Services and setting
of
the Minimum Quantities after such investment.
Article
7 Investments.
7.1 In
the
case that HCC should make an investment in equipment and facilities for the
Testing Services after the beginning of rendering Testing Services to RGI
under
this Agreement, RGI and HCC shall agree with the future plan for specific
period
to use such new equipment and facilities for Testing Services considering
the
depreciation of such new equipment and facilities through mutual consultation
prior to the decision of such investment. If such agreed plan should fail
through no fault of HCC, RGI shall compensate to HCC for the reasonable amount
of investment not properly used for Testing Services.
[***] 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 24b-2 of the Securities Exchange Act of
1934.
6
Article
8 Compliance.
8.1 HCC
shall
be responsible to comply with the Japanese governmental requirement for the
necessary applications and approvals required in laws and regulations applied
for HCC’s fulfillment of Testing Services. RGI shall be responsible for any
other governmental requirement for the necessary applications and approvals
required in laws and regulations applied for HCC’s fulfillment of Testing
Services in the Territory.
Article
9 Corrective
Measures.
9.1 If,
at
any time during the term of this Agreement, HCC becomes aware that the
applicable SOW was not followed, or that HCC otherwise made a material error
or
mistake in conducting the Testing Services, HCC agrees to notify RGI of such
occurrence in writing promptly following the day such discovery is made.
Upon
receipt of such notice, RGI will notify HCC in writing, within a reasonable
time, whether corrective measures which may include retesting are required
to
ensure validity of results, and RGI will not be invoiced for any necessary
corrective measures. HCC agrees to promptly implement necessary corrective
measures. Any retest data will be reported by HCC to RGI within a reasonable
time from the receipt by HCC of notification from RGI that retesting is
required.
Article
10 Payment
Term .
10.1 The
fees
paid to HCC by RGI for the Testing Services shall be determined in accordance
with the standard fee specified in Exhibit
B
attached
hereto and reviewed periodically between the Parties before the beginning
of
April and October every year for each kind and type of Testing
Services.
10.2 RGI
shall
pay fees for Testing Services within thirty (30)
days
after receiving of the invoices issued by HCC by telegraphic transfer of
funds
to the bank account designated by HCC. Other terms and conditions of payment
for
the Testing Services shall be discussed and agreed upon between the Parties
separately.
[***] 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 24b-2 of the Securities Exchange Act of
1934.
7
11.1 HCC
represents and warrants that HCC and the Relevant Staff:
11.1.1 have
the
appropriate level of expertise and qualifications, and the necessary ability
to
undertake the Testing Services under this Agreement, which shall be required
by
RGI in an SOP; and
11.1.2 are
not
prevented or restricted by any obligations owed to a Third Party or otherwise
in
any way from performing the Testing Services.
11.2 Each
Party represents and warrants that it has the right to enter into this Agreement
and is not in conflict with any Third Party obligation during the performance
of
the Testing Services under this Agreement.
11.3 In
addition to any other indemnification provided herein, HCC agrees to indemnify,
defend and hold RGI and its affiliates, shareholders, officers, directors,
employees, agents, successors and assigns harmless from and against ordinary
and
direct claims, suits, actions, liabilities, losses, costs, reasonable attorneys'
fees, expenses, judgments or damages, (collectively, the “Indemnified Amounts”),
arising out of (i) HCC's negligence in the performance of the Testing Services,
(ii) any wrongful acts or omissions in the performance by HCC of any Testing
Services, whether such actions are of HCC, its employees, agents,
representatives, subcontractors or invitees or (iii) any material breach
of this
Agreement by HCC, its employees, agents, representatives, subcontractors
or
invitees. Notwithstanding the foregoing, the amount which should be paid
to RGI
and/or any Third Party for such indemnification shall be limited to the amount
of [***] dollars
($[***]).
11.4 In
addition to any other indemnification provided herein, RGI agrees to indemnify,
defend and hold HCC and its affiliates, shareholders, officers, directors,
employees, agents, successors and assigns harmless from and against any and
all
Indemnified Amounts arising out of (i) RGI's negligence in the conduct of
the
activities to be performed by RGI under this Agreement, (ii) any wrongful
acts
or omissions in the conduct of the activities to be performed by RGI under
this
Agreement, whether such actions are of RGI, its employees, agents,
representatives, subcontractors or invitees, (iii) any material breach of
this
Agreement by RGI, its employees, agents, representatives, subcontractors
or
invitees or (iv) any infringement of Third Party’s intellectual property rights
resulting from or claimed to be resulting from the fulfillment or procedure
of
Testing Services and delivery of the results of Testing Services or any other
act or omission relating to Testing Services. Notwithstanding the foregoing,
the
amount which should be paid to HCC and/or any Third Party for such
indemnification shall be limited to the amount of [***] dollars
($[***]).
11.5 Where
claims relate to those by Third Parties and in the event either Party incurs,
or
expects to incur expenses, damages, claims or liability for which it intends
to
seek indemnification from the other Party, the Party claiming indemnification
(the “Indemnitee”)
shall
promptly notify the other Party (the “Indemnitor”)
and
shall permit the Indemnitor, at the Indemnitor’s sole discretion, to settle any
such claim or suit and agrees to the complete control of the defense or
settlement of such claim or suit by the Indemnitor, and the Indemnitor shall
not
be responsible for any legal fees or other costs incurred other than as provided
in this Agreement. The Indemnitee, its employees, consultants and agents,
shall
cooperate fully with the Indemnitor and its legal representatives in the
investigation and defense of any claims or suits covered by the indemnification
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 24b-2 of the Securities Exchange Act of
1934.
8
12.1 Save
as
otherwise provided in this Agreement, any Confidential Information which
is
disclosed by or on behalf of either Party (the “Disclosing
Party”)
to the
other Party (the “Receiving
Party”)
at any
time after the date of this Agreement shall remain the property of the
Disclosing Party and the Receiving Party hereby undertakes:
12.1.1 to
use
the Confidential Information received from the Disclosing Party and subject
to
the provisions of Article 12 hereto, solely and exclusively for the Purpose;
and
12.1.2 to
maintain the confidentiality of the Confidential Information and not to disclose
it directly or indirectly to any other company, organization, individual
or
Third Party, save as permitted by clause 12.2; and
12.1.3 at
the
request of the Disclosing Party to return, delete or destroy all copies of
the
Confidential Information, in whatever form it is held, provided that the
Receiving Party may retain one copy of the Confidential Information for the
sole
purpose of determining its obligations under this Agreement but may make
no
further use of such Confidential Information whatsoever.
12.2 Notwithstanding
clause 12.1, if HCC is the Receiving Party, it may disclose Confidential
Information to any of its Relevant Staff who need to know the Confidential
Information in order to fulfill the Purpose, provided that HCC shall procure
that each such Person to whom or which Confidential Information is to be
disclosed:
12.2.1 is
made
aware of the obligations contained in this Agreement prior to such disclosure;
and
12.2.2 agrees
to
abide by such terms of this Agreement as if it were a Party to it.
12.3 Nothing
in clause 12.1 shall preclude disclosure of any Confidential Information
required by any governmental, quasi-governmental or regulatory agency or
authority or court entitled by law to disclosure of the same, or which is
required by law to be disclosed. The Receiving Party shall promptly notify
the
Disclosing Party when such requirement to disclose has arisen to enable the
Disclosing Party to seek an appropriate protective order and to make known
to
the said agency or authority or court the proprietary nature of the Confidential
Information and to make any applicable claim of confidentiality in respect
thereof. The Receiving Party agrees to co-operate in any appropriate action
which the Disclosing Party may decide to take. If the Receiving Party is
advised
to make a disclosure in accordance with this clause 12.3 it shall only make
a
disclosure to the extent to which it is obliged.
[***] 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 24b-2 of the Securities Exchange Act of
1934.
9
a. is
already known to the Receiving Party at the time of receipt from the Disclosing
Party as evidenced by written documentation; or
b. is
disclosed to the Receiving Party by a Third Party having no obligation to
the
Disclosing Party to hold the Confidential Information secret; or
c. either
is
published or otherwise available to the public at the time of its receipt
by the
Receiving Party or shall become published or available to the public through
no
fault of the Receiving Party; or
d. is
independently developed by the Receiving Party as evidenced by contemporaneous
written documentation.
Article
13 Intellectual
Property.
13.1 Except
as
otherwise provided herein, all title to any and all inventions, improvements
and
data, whether or not patentable, and copyrightable works, which are conceived
and reduced to practice solely by HCC from the performance of any Testing
Services hereunder shall reside with HCC (“HCC IP”), provided, however, that HCC
hereby grants to RGI an irrevocable, co-exclusive with HCC, royalty-free
license
to the HCC IP outside the Territory, with the right to grant sub-license
therefor (in the case of HCC, such license shall be granted only to its
subsidiaries), and hereby grants to RGI an irrevocable, non-exclusive,
royalty-free license to the HCC IP in the Territory, with the right to
sub-license therefor. All title to any data or copyrightable works which
is
generated by HCC under the payment of the commission fee by RGI from the
performance of any Testing Services and as a result of such Testing Services
which is rendered to RGI’s customers hereunder shall reside with RGI. The
handling of all title to any and all inventions, improvements and data, whether
or not patentable, and copyrightable works, which are conceived and reduced
to
practice under the contribution of both HCC and RGI from the performance
of any
Testing Services hereunder shall be decided considering the degree of
contribution of each Party through mutual consultation.
13.2 HCC
will
make reasonable efforts to disclose to RGI all inventions and improvements
(whether patentable or not) and all copyrightable works made by it which
are
governed by Section 12.1. In the case that HCC should apply for a patent
or
other Intellectual Property Rights, HCC shall notify to RGI and maintain
the
confidentiality of the RGI’s Confidential Information under Article
12.
13.3 Subject
to the remaining provisions of this Article 13, HCC agrees that all original
works of authorship prepared by or for HCC in the results of any Testing
Services hereunder shall be works for hire, and RGI shall own such works
and all
copyrights therein. For any original such works of authorship in the results
of
any Testing Services that, under the copyright laws of the United States,
may
not be considered works for hire, HCC agrees to reasonably cooperate with
RGI in
protecting its rights in such works. Such works shall be deemed to be the
property of RGI, and shall be included in the Confidential Information of
RGI
under 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 24b-2 of the Securities Exchange Act of
1934.
10
13.5 The
Parties will observe all copyright in written material, including computer
software, belonging to the other Party or any Third Party, will not make
any
unauthorized copies of such material or software.
13.6 Each
Party acknowledges that the other Party owns certain inventions, processes,
know-how, trade secrets, improvements and other intellectual property which
have
been independently developed by each Party and which relate to that Party’s
business or operations. It is acknowledged that the intellectual property
owned
by either Party on the date of this Agreement will remain the exclusive property
of the owning Party.
Article
14 Publication.
14.1 Either
Party shall not, without consent of the other Party, submit any publications
related to the Testing Services. The request for consent to the other Party
shall contain details of the article to be published and the expected date
of
such publications. Neither Party may submit a publication containing
Confidential Information of the other Party without prior written consent
of the
other.
Article
15 Term.
15.1 This
Agreement shall take effect on the date and year first above written and
continue to be effective through March
31, 2010
and
shall be renewed automatically for each period of one (1) year under the
same
terms and conditions at the end of each original or renewed period, unless
six
(6) month prior written notice not to renew this Agreement should be given
by
either Party to the other.
15.2 Notwithstanding
the expiration or termination provided in Articles 15.1 and Article 16, Articles
11, 12, 13, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26 and 27 shall survive the
expiration or termination of this Agreement.
Article
16 Early
Termination.
16.1 Either
Party may forthwith terminate this Agreement without payment of any additional
compensation by giving notice of termination to the other Party in any of
the
following cases:
a. if
the
other Party shall be dissolved, liquidated or declared insolvent or bankrupt;
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 24b-2 of the Securities Exchange Act of
1934.
11
16.2 In
the
event this Agreement is terminated pursuant to clause 16.1 above, the defaulting
Party shall not be entitled to claim its losses or damages thereby incurred
to
the other Party.
16.3 Upon
termination of this Agreement pursuant to clause 16.1 with fault of HCC,
HCC
shall complete any outstanding Testing Services that was agreed to by the
Parties prior to the termination of this Agreement, and RGI will compensate
HCC
for any such Testing Services.
16.4 On
termination, HCC will cease any use of RGI’s Technical Information and
Intellectual Property Rights, except as provided in this Article.
16.5 In
the
event of termination of this Agreement and/or any Testing Services performed
under this Agreement, HCC shall use all reasonable efforts to minimize any
further costs and HCC shall be reimbursed for the services actually performed
and the expenses actually and reasonably incurred as of the effective date
of
such termination, unless the Parties agree or HCC is otherwise obliged to
provide services after such termination.
16.6 Upon
termination of this Agreement, if requested by the other Party, each Party
shall
immediately deliver up to the other Party or, if the other Party agrees,
destroy
all copies of and other embodiments of any of the Confidential Information
and
all other correspondence, documents, specifications, and any other property
belonging to the other Party which may be in its/his/her possession. One
archival copy of such materials may be maintained in the possession of legal
counsel for the Party.
Article
17 Independent
Contractor.
17.1
It
is
understood that in the performance of this Agreement HCC will be acting in
the
capacity of an independent contractor and that nothing in this Agreement
shall
be construed as creating any contract of employment or relationship of principal
and agent between RGI and HCC or RGI or any of the Relevant Staff.
17.2
HCC
shall
perform this Agreement solely as an independent contractor, and as such shall
select, engage and discharge its employees and otherwise direct and control
the
performance of the Studies. Neither HCC nor anyone employed by it shall be,
represent, act, or purport to act as, or be deemed to be, the agent,
representative, employee, or servant of RGI nor shall RGI nor anyone employed
by
it be, represent, act, or purport to act as, or be deemed to be, the agent,
representative, employee, or servant of HCC.
17.3
Neither
HCC nor RGI shall have authority to make any statement, representation, or
commitment of any kind or to take any action binding upon the other Party
without the other Party's prior written authorization.
[***] 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 24b-2 of the Securities Exchange Act of
1934.
12
18.1 The
waiver, express or implied, by either Party of any right hereunder or any
failure to perform this Agreement or breach hereof by the Party, shall not
constitute or be deemed as a waiver of any other right hereunder or of any
other
failure to perform this Agreement or breach hereof by such other Party, whether
of a similar or dissimilar nature hereto.
Article
19 Assignment
19.1 This
Agreement or any right or obligation hereunder is not assignable or transferable
in whole or in part by either Party to any Third Party without the prior
written
consent of the other Party, except in connection with any merger or sale
of all
or substantially all of its assets to which this Agreement relates. Subject
to
the foregoing, all terms, conditions, covenants and agreements contained
herein
shall inure to the benefit of, and be binding upon, any such successor
entity.
Article
20 Severability
20.1 If
any
provision of this Agreement is deemed to be illegal, unenforceable, or invalid,
in whole or in part, for any reason, the validity and enforceability of the
remaining provisions, or portions of them, shall not be affected or impaired
and
shall continue in full force and effect.
Article
21 Governing
Law.
21.1 This
Agreement will be governed by and construed in accordance with the laws of
the
State of New York, without regard to its conflict of laws or choice of laws
principles. The
Parties agree that any controversy
or claim arising out of or relating to this Agreement, or the breach thereof,
shall be determined by arbitration administered by the American Arbitration
Association in accordance with its International Arbitration Rules. The
arbitration shall be conducted in English and the place of arbitration shall
be
Singapore.
The
award thereof shall be final and binding for both RGI and HCC.
Article
22 Force
Majeure.
22.1
In
this
Agreement, “force majeure” shall mean any cause preventing either Party from
performing any or all of its obligations which arises from or is attributable
to
acts, events, omissions or accidents beyond the reasonable control of the
Party
so prevented including, without limitation, strikes, lock-outs or other
industrial disputes (whether involving the workforce of the Party so prevented
or of any Third Party), act of God, war, terrorism, riot, civil commotion,
malicious damage, compliance with any law or Governmental order, rule,
regulation or direction, accident, breakdown of plant or machinery, fire,
flood
or storm (each a “Force
Majeure Condition”).
Subject to clause 22.3, each Party shall be released from its obligations
under
this Agreement to the extent that its performance hereunder is delayed, hindered
or prevented by force majeure.
22.2
If
either
Party is prevented or delayed in the performance of any of its obligations
under
this Agreement by Force Majeure Condition, that Party shall forthwith serve
notice in writing on the other Party specifying the nature and extent of
the
circumstances giving rise to Force Majeure Condition, and shall subject to
service of such notice and to clauses 22.3 and 22.4, have no liability in
respect of the performance of such of its obligations as are prevented by
Force
Majeure Condition during the continuation of such events, and for such time
after they cease as is necessary for that Party, using all reasonable endeavors,
to recommence its affected operations in order for it to perform its
obligations.
[***] 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 24b-2 of the Securities Exchange Act of
1934.
13
22.4
If
either
Party is prevented from performance of its obligations for a continuous period
in excess of three (3) months due to Force Majeure Condition, the other Party
may terminate this Agreement forthwith on service of written notice upon
the
Party so prevented, in which case neither Party shall have any liability
to the
other except that rights and liabilities which accrued prior to such termination
shall continue to subsist.
Article
23 FDA
Visits.
23.1
At
RGI’s
request, a representative of HCC shall accompany RGI to FDA (or other regulatory
agency) to explain or discuss any and all aspects of the Testing Services,
with
RGI’s full cooperation. Such visit or visits to the FDA shall be arranged at
times mutually agreeable to RGI and HCC. All reasonable travel and living
expenses incurred by HCC in connection with such visits shall be reimbursed
by
RGI.
23.2
HCC
shall
notify RGI of any request from FDA, other federal or state agencies or any
other
Third Party to inspect or otherwise gain access to the information, gene
expression values, Samples, or materials pertaining to the Testing Services.
HCC
shall notify RGI of such request prior to permitting any Third Party access,
unless prior notice is not reasonably feasible.
23.3
HCC
agrees to permit inspection of such information, gene expression values,
Samples, or other materials by authorized representatives of FDA and as
otherwise required by law. During such inspections, HCC shall provide
appropriate scientific and quality assurance support. HCC shall promptly
send
RGI a copy of any inspection reports received by HCC as a result of any such
inspection.
Article
24 Counterparts.
24.1
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.
Article
25 Exhibits.
25.1
Any
Exhibit or SOW to this Agreement is hereby incorporated into and made a part
of
this Agreement. In the event of a conflict between the provisions contained
in
this Agreement and any such Exhibit or SOWs, the terms of the Agreement shall
prevail over the Exhibit or SOW, except to the extent an Exhibit or SOW
specifically states that one of its provisions supersedes a similar provision
in
the 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 24b-2 of the Securities Exchange Act of
1934.
14
Article
26 Notice.
26.1
Any
notice required by this Agreement to be given to either Party shall be in
writing and shall be served by first class post, express mail or airmail
and
being addressed to the address of the other Party stated in this Agreement
or
such other address as may from time to time have been notified by a notice
given
in accordance with this clause. The initial details for the purposes of this
clause are:
For
HCC:
Xxxxxxx
Xxx
General
Manager
Life
Science Division
Hitachi
Chemical Co., Ltd.
9-25,
Shibaura 4-choume, Minato-ku
Tokyo,
108-0023
-and-
Baku
Maekawa
Manager
Life
Science Division
Hitachi
Chemical Co., Ltd.
9-25,
Shibaura 4-choume, Minato-ku
Tokyo,
108-0023
For
RGI:
Xxxxxxxx
Xxxxxxxxx
President
and CEO
Response
Genetics, Inc.
0000
Xxxxxxx Xxxxxx Xxxxx 000
Xxx
Xxxxxxx, XX 00000
-and-
Xxxxxx
Xxxxxx, Esq.
Xxxxxxx
Xxxx & Xxxxxxxxx LLP
000
Xxxxxxx Xxxxxx
Xxx
Xxxx,
XX 00000-0000
Article
27 Entire
Agreement
27.1 This
Agreement constitutes the entire and only agreement among the Parties with
respect to the subject matter hereof and supersedes all negotiations or
communications between the Parties prior to the execution 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 24b-2 of the Securities Exchange Act of
1934.
15
IN
WITNESS WHEREOF, the Parties hereto have caused this Agreement in duplicate
to
be executed by the duly authorized representatives of the Parties as of the
date
and year first above indicated.
|
Response Genetics, Inc.
By:
____________________________
Name:
Title:
|
Hitachi Chemical Co., Ltd.
By:
____________________________
Name:
Title:
|
[***] 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 24b-2 of the Securities Exchange Act of
1934.
16
Statement
of Work for Taiho Samples
THIS
Statement of Work is made and entered into this __ th
day of
__________, by and between Response Genetics, Inc. (“RGI”), a company
incorporated in the State of Delaware, whose principal place of business
is
situated at 0000 Xxxxxxx Xxxxxx, 0xx
Xxxxx,
Xxx Xxxxxxx, XX 00000 and Hitachi Chemical (“HCC”), a corporation registered
under the laws of Japan and having its corporate offices at Shibaura Square
Building, 9-25, Shibaura 4-chome, Minato-ku Tokyo, 108-0023 .
WHEREAS,
a Commission Agreement (the “Agreement”) by and between RGI and HCC was executed
on __July 2007; and
WHEREAS,
pursuant to Article 2 of the Agreement, the parties now enter into this
Statement of Work for the purposes of setting forth the responsibilities
and
obligations of the parties.
A.
Order and Sample delivery
RGI
or
Taiho will send HCC tissue sections thereof, as detailed and briefly summarized
below.
The
sender of Taiho is to notify HCC and RGI via e-mail when specimen(s) are
shipped. The e-mail must include the list of specimens (including specimen
ID
and number of slides included in the shipment) and the shipment tracking
number
to the following email addresses:
[***]
[***]
[***]
[***]
[***]
[***]
The
information of sender of Taiho is as follows;
Xxxxxx
Xxxxxxxxx
Tokushima
Research Center
Taiho
Pharmaceutical Co., Ltd.
[***]
Tel: [***]
(ext. [***]) FAX: [***]
HCC
should notify RGI that the order is acceptable or not within five business
day
after receiving the order e-mail.
Samples
should be shipped after the order is accepted by HCC.
[***] 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 24b-2 of the Securities Exchange Act of
1934.
17
The
sender will send batches of samples slides containing sections from the tumor
block. HCC requires tumor tissue containing adequate material for histological
diagnosis and laboratory assay. The sections should contain representative
tumor
cells as determined by a trained pathologist.
At
least
five 10-micron unstained slides and one (or two) 5-micron unstained slide
are
required.
Samples
should be stored and shipped at ambient temperature. Extreme temperatures
should
be avoided. In hot weather, place a cool pack in the mailer.
All
shipments to HCC must be shipped on Monday-Wednesday by Yamato or Sagawa
overnight delivery in Japan (in case of a shipment from the USA, FedEx or
World
Courier can be used). HCC will provide pre-printed vouchers with the following
address:
Xxxxxx
Xxxxxxx
c/o
Endo
Katsuya
Hitachi
Chemical Co., Ltd., Yamazaki Works
13-1,
Xxxxxxx-xxx 4-chome
Hitachi-shi
Xxxxxxx
000-0000,
Xxxxx
Tel
:
[***], FAX : [***]
B.
Sample
Receipt/QA
Upon
receipt of samples, HCC will verify that the inventory of samples received
match
the list of samples on the shipment email and sent by the sender. If
discrepancies are noted, HCC personnel will contact the sender via email
to
clarify the contents and specimen/patient information. Once the samples are
verified, they will be accessioned using the RGI Database as stated in
SOP [***] or equivalent SOP made by HCC. The day when all samples in the
shipment are accessioned is deemed as the date of the batch of sample receipt.
The sample slides will then be stored in a secure room until a batch is ready
for processing.
HCC
will
notify the sender of the date of sample receipt. HCC will cc the representative
from RGI regarding all communications with the sender and Taiho.
C.
Sample
Storage
Samples
are stored at ambient temperatures at HCC in the Archive equipment. They
are
organized by the project and received date of the samples. All slides for
each
sample will be stored together in an area designated specifically for the
project. If the sample test needs to be repeated and more tissue is required,
HCC may request that specific sample slides be resent to HCC.
[***] 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 24b-2 of the Securities Exchange Act of
1934.
18
HCC
will
process all the samples in a shipment (1 sample per patient) or as requested.
The results will be released to RGI four weeks after the start of processing
the
samples.
Samples
are processed through “DTP specimen flow” as stated in SOP [***]
or
equivalent SOP made by HCC, which includes:
Accessioning
(detailed procedure: SOP [***])
Slide
preparation and staining (detailed procedure: [***])
Dissection
(detailed procedure: SOP [***] and
[***])
RNA
extraction ([***])
Reverse
transcription (detailed procedure: [***])
Actin
screening (detailed procedure: SOP [***])
PCR
preparation (detailed procedure: SOP [***])
QPCR
analysis (detailed procedure: SOP [***])
Results
analysis (detailed procedure: SOP [***]);
and
Material
release (detailed procedure: SOP [***]).
HCC
will
not repeat sample analysis except in the event that data requirements stated
in
SOPs are not satisfied.
E.
Report
Type
Reporting
is deemed to be done when Results analysis (SOP[***])
is
concluded by transferring data to RGI via RGI’s e-store system or via e-mail to
the following contact addresses: [***] and [***].
F.
Confidentiality of Results
HCC
will
provide results or result reports only to RGI.
G.
Communication
Communication
between RGI and HCC contacts will be via telephone or e-mail. All requests
or
special instructions, however, shall be in writing.
Any
questions arising upon receipt of tissue samples from sender (e.g., mislabeled
samples, missing samples) will initially be directed through the sender via
e-mail. HCC will attempt clarification of discrepancies from the sender via
email.
H.
Fees
The
fees
for the analysis of four (4) mutually agreed upon genes and a housekeeping
gene
(beta-Actin) per sample will be $[***] per
sample. Samples will be archived and additional genes can be analyzed at
$[***]/gene
per
sample. The fees will be divided as follows: 80% to HCC and 20% to RGI
(excluding any costs of reagents purchased by RGI).
These
are
the fees under the current Taiho Service Agreement. If RGI revises the fees,
RGI
shall notify HCC within five (5) business days of such revision.
HCC
will
be charged for reagents purchased by RGI. The costs for HCC to purchase these
reagents from RGI will include cost of the reagent plus shipping and
tax.
[***] 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 24b-2 of the Securities Exchange Act of
1934.
19
Testing
Services Fees and Reagents
|
HCC
Services
|
Cost
|
Explanation
of Service
|
|||||
|
RNA
Extraction and qRT-PCR Service
|
80
% of the Testing Service Fee
|
Tissue
Staining with H/E and NFR;
Pathology
Review;
Microdissection
achieving >80% tumor per extraction;
RNA
extraction;
qRT-PCR;
and
Analysis
of resulting data.
|
|||||
|
RGI
Services and Reagents
|
Cost
|
Reagent
|
Manufacturer
|
Unit
|
Bulk
Cost Total
(July
2007)
|
Reagent
Mix Aliquots
|
Volume
per Aliquot
|
|
Prepare
Testing Reagents
|
HCC
will reimburse RGI, at RGI’s cost, for reagents requested by
HCC.
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||
|
[***]
|
[***]
|
[***]
|
|
||||
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
[***]
|
||
|
[***]
|
TBD*
|
||||||
*
To Be Determined
[***] 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 24b-2 of the Securities Exchange Act of
1934.
20
