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EXHIBIT 10.31
REDACTED FOR
CONFIDENTIALITY
CONFIDENTIAL TREATMENT
REQUESTED
The asterisked portions of this document have been
omitted and are filed separately with the Securities and
Exchange Commission.
COLLABORATIVE RESEARCH AGREEMENT
This AGREEMENT entered into this 1st day of October, 2000 between diaDexus,
Inc., a Corporation organized under the laws of the State of Delaware and
having an office at ▇▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇▇▇, ▇▇ ▇▇▇▇▇, hereinafter
referred to as SPONSOR;
and
University of Pittsburgh of the Commonwealth System of Higher Education, a
nonprofit Pennsylvania corporation having an office at Office of Research, ▇▇▇
▇▇▇▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇, hereinafter referred to as
UNIVERSITY.
WITNESSETH
WHEREAS, SPONSOR desires the research services of UNIVERSITY and
UNIVERSITY desires and agrees to provide such services to SPONSOR on a
nonexclusive basis;
WHEREAS, ******* shall be the UNIVERSITY's lead investigator in conducting
the research services for SPONSOR (the 'PRINCIPAL INVESTIGATOR');
NOW, THEREFORE, in consideration of the mutual promises and undertakings
set forth herein, the parties agree as follows:
1.0 COLLABORATION
1.01 UNIVERSITY agrees to use its best efforts to perform services for SPONSOR
as described in the Statement of Work in proposal attached hereto as
Appendix A (PROJECT).
1.02 SPONSOR agrees to use its best efforts to perform the services in
accordance with the Statement of Work attached hereto as Appendix A.
1.03 SPONSOR and UNIVERSITY agree that approval of UNIVERSITY's Institutional
Review Board (the "IRB") and, where applicable or required by law or
regulation, patient informed consent will be required to carry out the
Statement of Work. UNIVERSITY agrees that it will obtain IRB approval, as
may be required, and obtain all patient informed consent that may be
required by law or regulation, which informed consent shall include such
language as may be required to satisfy such law or regulation, and which
language shall include explicit reference to use of patient samples for
commercial purposes. In addition, UNIVERSITY agrees that it will not
transfer any tissue to SPONSOR that in any way identifies any individual
patient or that in any way confers any patient personal identifying
information.
2.0 TERM
2.01 The Term of this Agreement is from October 1, 2000 (Effective Date) through
September 30, 2003.
2.02 Any extension must be in writing upon terms mutually agreeable to the
parties hereto.
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
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3.0 PAYMENT
3.01 SPONSOR agrees to pay *****
***** for the services, payment to be made as follows:
Upon execution of this Agreement *****
January 1, 2001 *****
April 1, 2001 *****
July 1, 2001 *****
October 1, 2001 *****
January 1, 2002 *****
April 1, 2002 *****
July 1, 2002 *****
October 1, 2002 *****
January 1, 2003 *****
April 1, 2003 *****
July 1, 2003 *****
* includes the licensing fee of section 3.04
3.02 UNIVERSITY costs shall follow the proposed budget as contained in
Appendix B.
3.03 In the event that the actual number of processed samples transferred by
UNIVERSITY to SPONSOR on a quarterly basis as measured from the Effective
Date, is less than ***** ***** of the projected number of samples expected
to be transferred on a quarterly basis as indicated in Table 1, Appendix A
(Statement of Work), SPONSOR shall deduct ***** from the subsequent
quarterly payment otherwise due pursuant the schedule in section 3.01
above. In the event that the actual number of processed samples
transferred by UNIVERSITY to SPONSOR on a quarterly basis, as measured
from the Effective Date is greater than ***** of the projected number of
samples expected to be transferred on a quarterly basis as indicated in
Table 1, Appendix A (Statement of Work), SPONSOR shall pay an additional
***** with the subsequent quarterly payment otherwise due pursuant the
schedule in section 3.01 above.
3.04 SPONSOR shall pay UNIVERSITY a one-time fee of ***** for a non-exclusive,
worldwide, fully-paid license to use the Know-How. As used herein, Know-How
shall mean all tangible and intangible information, know-how, methods,
procedures, processes, formulations, technical information, inventions,
instructions, expertise, preclinical, clinical, quality control, and data
related to the collection, analysis, or screening of human tissue which are
used by the principal investigator to carry out microdissection-based
genotyping for this Project. Such payment shall be made within thirty (30)
days after the execution of this Agreement and shall be sent to:
***** Certain information on this page has been omitted and filed separately
with the Securities and Exchange Commission. Confidential treatment has
been requested with respect to the omitted portions.
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Office of Technology Management
▇▇▇ ▇▇▇▇
▇▇▇▇▇▇▇▇▇ & O'Hara Sts.
▇▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
4.0 REPORTS
4.01 UNIVERSITY shall provide a quarterly report to SPONSOR indicating the
number of cases seen, corresponding to the list of tumor types in the
Statement of Work attached as Appendix A, and the number of processed
samples which were transferred to SPONSOR pursuant to the Project, detailed
by tumor type corresponding to the list of tumor types in the Statement of
Work.
4.02 UNIVERSITY shall notify SPONSOR of any contracts which UNIVERSITY executes
with a third party, within thirty (30) days of such execution, if the
implementation of such contract is expected to reduce the availability of
tissue for the Project such that the number of processed samples to be
transferred to SPONSOR is expected to be less than seventy-five percent
(75%) of the number of samples projected to be transferred on a quarterly
basis as indicated in the Statement of Work attached hereto as Appendix A.
4.03 Upon completion of the services by UNIVERSITY, or earlier termination of
this Agreement, UNIVERSITY shall provide a final written report to SPONSOR
describing the services performed and such other information or data as may
be specified in Appendix A. UNIVERSITY shall also, at SPONSOR'S option,
meet with SPONSOR to discuss the services or the content of the final
report.
5.0 INSURANCE
5.01 UNIVERSITY shall provide the necessary ▇▇▇▇▇▇▇'▇ Compensation and
Employer's Liability insurance to meet statutory liability limits of the
Commonwealth of Pennsylvania for the employees of UNIVERSITY involved in
this PROJECT.
6.0 LIABILITY
6.01 UNIVERSITY shall not be responsible or liable for any injuries or losses
which may result from the implementation or use by SPONSOR or third parties
of the results from the PROJECT or research data generated by UNIVERSITY.
6.02 Sponsor agrees to indemnify, defend and hold harmless University, its
trustees, officers, agents and employees with respect to any expense,
claim, liability, loss, damage, or costs (including attorney's fees) in
connection with or in any way arising out of a third party claim based on
or arising out of use of the data or results from the PROJECT by SPONSOR or
any SPONSOR licensee.
7.0 DISCLAIMER OF WARRANTY
7.01 Any information, materials or services furnished by either party pursuant
to this Agreement are on an "as is" basis. UNIVERSITY and SPONSOR each make
no warranties of any kind
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either express or implied as to any matter, including but not limited to
warranty of fitness for a particular purpose, merchantability,
patentability, or that use by the other party of the results obtained will
be free from infringement of patents, copyrights, trademarks or other
rights of third parties. In no event shall either party be liable to the
other for indirect, special, or consequential damages, such as loss of
profits or inability to use the results obtained or any applications and
derivations thereof.
8.0 INTELLECTUAL PROPERTY RIGHTS
8.01 Under UNIVERSITY policy, all rights and title to inventions and/or
discoveries developed under PROJECT solely by employees of UNIVERSITY
("University Inventions") shall belong to UNIVERSITY.
8.02 Rights to inventions and/or discoveries, whether patentable or
copyrightable or not, relating to PROJECT made solely by employees of
SPONSOR shall belong to SPONSOR ("Sponsor Inventions").
8.03 Inventions and/or discoveries jointly developed by employees, agents or
servants of UNIVERSITY and SPONSOR ("Joint Inventions") shall be jointly
owned (each party shall have an undivided interest in the Joint Invention)
and SPONSOR shall have the first right to prepare, file and prosecute
patent applications for such Joint Inventions.
8.04 UNIVERSITY shall grant to SPONSOR a right of first refusal to an exclusive
royalty-bearing (on commercially reasonable terms) license to UNIVERSITY's
interest in University Inventions and Joint Inventions developed under this
Agreement to the extent it is legally able to do so, subject to Public Law
96-517 and to the constraints set forth herein. Within ninety (90) days
from the date of disclosure of such invention to SPONSOR. SPONSOR shall
inform UNIVERSITY of SPONSOR's interest in supporting a patent application
related to such disclosure. If SPONSOR does not agree to support such a
patent application, UNIVERSITY shall be under no obligation to file a
patent application. If SPONSOR does agree to support such a patent
application, SPONSOR will be consulted on the filing of the patent
application, and will be given the opportunity to review a draft of the
patent application prior to its filing. Any expenses paid by SPONSOR to
support such a patent application shall not be refundable nor creditable
against future option or license consideration.
8.05 Within one hundred eighty (180) days from the date of disclosure of
invention by UNIVERSITY to SPONSOR, the parties may enter into a license
agreement or a fee-bearing option agreement, such option agreement to
extend the 180 day right of first refusal to negotiate a license for all or
part of UNIVERSITY's interest in such University Inventions or Joint
Inventions. If SPONSOR exercises its right of first refusal as provided in
Section 8.04, and provided that SPONSOR agrees to reimburse UNIVERSITY for
the costs of patent prosecution and maintenance in the United States and
foreign countries, the UNIVERSITY and SPONSOR shall negotiate a license
agreement to include commercially reasonable royalty rates, a royalty free,
nonexclusive license in favor of the UNIVERSITY to use the inventions
and/or discoveries for noncommercial eduction and research purposes, and
other mutually acceptable terms and conditions within 180 days of the date
of
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the disclosure of invention to SPONSOR. If a mutually acceptable license
or fee-bearing option agreement is not executed and delivered by the end
of such one hundred eighty (180) days, SPONSOR's rights described in
Section 8 hereof shall terminate.
9.0 PUBLICATIONS
9.01 SPONSOR recognizes that under UNIVERSITY policy, the results of
UNIVERSITY's work under the PROJECT must be publishable. UNIVERSITY
agrees to submit to SPONSOR any proposed publication or presentation for
prior review. SPONSOR will, within thirty (30) days after receipt,
advise if there is any proprietary or patentable information which
should not be disclosed at the present time. UNIVERSITY shall take under
due consideration any written exceptions of SPONSOR prior to releasing
any such proposed publication or presentation. Publication of SPONSOR
results under the PROJECT is at the discretion of SPONSOR. If the
PROJECT results in findings that correlate genotyping data with RNA
expression data at a level of significance that the parties agree is a
publishable discovery, the parties agree that manuscripts prepared for
publication on such findings shall include representatives from both
parties as authors, with the primary author being UNIVERSITY's PRINCIPAL
INVESTIGATOR.
9.02 Should SPONSOR desire to have information withheld or redacted from any
proposed publication or presentation in order to file for protection
of intellectual property rights. UNIVERSITY agrees to grant a period
not to exceed six (6) months from the date of the request from SPONSOR
not to publish to permit such filings, and further agrees to redact any
CONFIDENTIAL INFORMATION (as defined below) as may be requested by
SPONSOR.
9.03 UNIVERSITY acknowledges that it may be necessary for SPONSOR to
disclose information which SPONSOR considers proprietary or
confidential in order to perform the PROJECT. If SPONSOR considers any
such information confidential, it shall be clearly marked "CONFIDENTIAL
INFORMATION" and sent by SPONSOR in writing only to the principal
investigator or orally disclosed to the principal investigator and
reduced to writing by SPONSOR, clearly marked "CONFIDENTIAL
INFORMATION," and delivered to the principal investigation within
thirty (30) days of disclosure. SPONSOR's Confidential Information
shall include any and all RNA expression data derived or identified by
SPONSOR during the performance of this Project, whether or not marked
as 'CONFIDENTIAL INFORMATION'. UNIVERSITY shall not disclose or cause
to be disclosed any such Confidential Information revealed to it by
SPONSOR without the prior written approval of SPONSOR; provided,
however, that the foregoing obligation of nondisclosure shall not apply
to any portion of the Confidential Information which:
a. is in the public domain at the time of disclosure.
b. becomes part of the public domain after disclosure through no
fault of UNIVERSITY.
c. is in the possession of the UNIVERSITY at the time of
disclosure by SPONSOR or is disclosed to the UNIVERSITY after
time of disclosure by SPONSOR and not through any fault of
UNIVERSITY.
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10.0 TERMINATION
10.01 Either party may terminate this Agreement prior to the expiration of the
designated term by giving sixty (60) days written notice to the other.
10.02 Upon early termination of this Agreement, SPONSOR shall pay all costs
accrued by UNIVERSITY as of the date of termination including
non-cancelable obligations for the term of the Agreement incurred prior
to the effective date of the termination, provided that payments for
unincurred, non-cancelable obligations shall be limited to the salaries
of the research technicians on the Project, and in no event shall exceed
Fifty-Four Thousand Dollars ($54,000).
11.0 PUBLICITY
11.01 SPONSOR will not use the name of UNIVERSITY nor of any member of
UNIVERSITY Personnel, in any publicity, advertising, or news release
without the prior written approval of UNIVERSITY.
12.0 GOVERNING LAW
12.01 This Agreement shall be deemed to be a contract under, and shall be
governed by and construed and enforced in accordance with the laws of the
Commonwealth of Pennsylvania.
13.0 MISCELLANEOUS
13.01 Nothing contained in this Agreement is to be construed to constitute
UNIVERSITY and SPONSOR as partners or joint venturers of each other, or
to constitute the employees, agents or representatives of either party as
the employees, agents or representatives of the other party, it being
intended that the relationship between UNIVERSITY and SPONSOR shall at
all times be that of independent contractors. Neither party hereto shall
have any express or implied right or authority to assume or create any
obligations on behalf of, or in the name of, the other party; or to bind
the other party to any contract, agreement or undertaking with any third
party. UNIVERSITY agrees, warrants, and represents to SPONSOR, with the
intention that SPONSOR may rely thereon, that SPONSOR does not now
exercise, and will not be permitted during the terms of this Agreement to
exercise any significant degree of control over UNIVERSITY's method of
operation.
13.02 UNIVERSITY agrees that it is responsible for withholding and paying to
appropriate taxing bodies, all statutory payroll taxes that are
applicable to UNIVERSITY Personnel to be supported under the PROJECT.
13.03 Failure of either party hereto to enforce any of the provisions of this
Agreement, or of any rights with respect thereto, or failure to exercise
any election provided for herein, shall in no way be considered a waiver
of such provisions, rights or elections, or in any way affect the
validity of this Agreement. The failure by any party hereto to enforce
any of such provisions, rights or elections shall not prejudice such
party from later enforcing or
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exercising the same or any other provisions, rights or elections which
it may have under this Agreement.
13.04 Should a court of competent jurisdiction later consider any provision of
this Agreement to be invalid, illegal or unenforceable, it shall be
considered severed from the Agreement. All other provisions, rights and
obligations shall continue without regard to the severed provision,
provided that the remaining provisions of the Agreement are in
accordance with the intention of the parties. It is the further
intention of the parties that in lieu of any provision which is invalid,
illegal or unenforceable, there be substituted or added as part of this
Agreement a provision which shall be as similar as possible in economic
and business objectives as intended by the parties to this Agreement.
13.05 This Agreement may not be and shall not be construed to have been
modified, amended, rescinded, cancelled or waived, in whole or in part,
except in writing signed by the parties hereto and making specific
reference to this Agreement.
13.06 The headings used herein are included solely for the purpose of
convenience, and shall not be used in any way to construe, modify,
explain, enlarge or restrict any of the provisions hereof.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed by their respective duly authorized representatives.
WITNESS: UNIVERSITY OF PITTSBURGH - OF THE
COMMONWEALTH SYSTEM OF
HIGHER EDUCATION
/s/ ▇▇▇▇▇ ▇▇▇▇ By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
------------------------------------ ------------------------------------
Typed Name: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
----------------------------
Title: Director, Office of Research
---------------------------------
Date: 10/5/2000
---------------------------------
WITNESS: diaDexus, Inc.
/s/ ▇. ▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇ ▇. ▇▇▇▇
------------------------------------ ------------------------------------
Typed Name: ▇▇▇▇▇ ▇. ▇▇▇▇
----------------------------
Title: V.P., Business Development
---------------------------------
Date: 9/25/2000
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EXHIBIT A
DIADEXUS and UNIVERSITY OF PITTSBURGH
TUMOR TISSUE MICRODISSECTION AND GENOTYPING PROJECT
STATEMENT OF WORK
Description:
diaDexus ("Sponsor") and University of Pittsburgh ("University") will perform
the following major activities in this project:
**************************
***** Certain information on this page and all information on the next six pages
have been omitted and filed separately with the Securities and Exchange
Commission. Confidential treatment has been requested with respect to the
omitted portions.
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BUDGET--APPENDIX B.2
APRIL 1, 2001 TO SEPTEMBER 30, 2001
PERSONNEL ROLE % EFFORT SALARY + FRINGE
--------- ---- -------- ---------------
▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ Principal Investigator 50 $42,685
▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Co-investigator 10 $8,570
TBN Research Spec. III 100 $13,502
TBN Research Spec. III 100 $13,502
-------
SUBTOTAL $78,258
EQUIPMENT
ABI Prisim 700 quantitative themocycler $100,000
-20 Degree Freezer $0
2 computers and printers $0
$100,000
SUPPLIES
Scientific supplies $60,000
TRAVEL $1,000
------
One trip to scientific meeting
SUBTOTAL DIRECT COSTS: $239,258
FACILITIES AND ADMINISTRATION COSTS @ 53% (EXCLUDING EQUIP) $73,807
-------
TOTAL FOR SECOND 6 MONTH BUDGET PERIOD $313,065
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BUDGET-APPENDIX B.3
OCTOBER 1, 2000 TO SEPTEMBER 30, 2001
YEAR ONE TOTALS
LICENSING FEE $ 25,000
PERSONNEL ROLE % EFFORT SALARY + FRINGE
--------- ---- -------- ---------------
▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇▇ Principal Investigator 50 $ 85,370
▇▇▇▇▇▇▇▇ ▇▇▇▇▇ Co-investigator 10 $ 17,140
TBN Research Spec. III 100 $ 27,003
TBN Research Spec. III 100 6 months $ 13,502
--------
SUBTOTAL $143,015
EQUIPMENT
ABI Prisim 700 quantitative thermocycler $100,000
-20 Degree Freezer $ 8,000
2 computers and printers $ 12,000
$120,000
SUPPLIES
Scientific supplies $ 75,000
TRAVEL
One trip to scientific meeting $ 2,000
SUBTOTAL DIRECT COSTS: $340,015
FACILITIES AND ADMINISTRATION COSTS @ 53%
(EXCL. EQUIP. AND LIC. FEE) $116,608
YEAR ONE TOTAL $481,622
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BUDGET-APPENDIX B.4
10/1/01 - 9/30/02 10/1/02 - 9/30/03
----------------- -----------------
Personnel $161,210 $166,046
Supplies $75,000 $75,000
Travel $2,000 $2,000
-------- --------
Subtotal $238,210 $243,046
F&A @ 53% $126,251 $128,814
-------- --------
TOTAL $364,461 $371,860