EXHIBIT 10.3
SPONSORED RESEARCH AGREEMENT, AS AMENDED, BETWEEN CDI AND UMB
Amendment To Research Agreement Dated August 27, 1999
Between Cancer Diagnostics, Inc. and University of Maryland, Baltimore
Upon signature by both parties, Article 2 subsection 2.1 - RESEARCH WORK will
now read:
ARTICLE 2 - RESEARCH WORK
2.1 University will commence the performance of the Project Work on January
4, 2000, and will undertake to perform such Project Work substantially
in accordance with the terms and conditions of this Agreement. Sponsor
and University may at any time enter into written agreements to make
changes to and amend the Project Work by mutual agreement of Sponsor
and University.
This agreed to by the following parties:
CANCER DIAGNOSTICS, INC.
By: /s/ UWE REISCHL
Uwe Reischl, Ph.D., M.D.
Date: Sept. 23, 1999
UNIVERSITY OF MARYLAND, BALTIMORE
By: /s/ MARJORIE FORSTER
Marjorie Forster, Executive Director
Office of Research and Development
Date: 9/28/99
RESEARCH AGREEMENT
THIS RESEARCH AGREEMENT ("Agreement") effective this 27th day of
August, 1999, ("Effective Date") by and between Cancer Diagnostics, Inc.
("Sponsor"), a corporation organized under the laws of the State of Florida, and
the University of Maryland, Baltimore ("University"), a constituent institution
of the University System of Maryland, an agency of the State of Maryland.
WITNESSETH
WHEREAS, Sponsor desires the research assistance of certain technically
qualified persons employed by the University who have access to University and
equipment;
WHEREAS, Sponsor desires to fund said research entitled: "Development
of an Immunoassay for Telomerase in Human Plasma" and described in the protocol
attached hereto as Appendix A;
WHEREAS, University is willing to cooperate with and assist Sponsor by
furnishing the services of its personnel as described in Appendix A;
WHEREAS, the research activities to be conducted by UM under this
Agreement are in furtherance of the scientific or educational activities of UM;
and
WHEREAS, University and Sponsor acknowledge that they are executing the
License Agreement (see Section 1.4) Agreement and that the funding under this
Agreement is given by Sponsor to UM solely in consideration of the Project Work
(see Section 1.6) and not in consideration of the License Agreement.
NOW THEREFORE, in consideration of the promises and mutual covenants
herein contained, University and Sponsor agree as follows:
ARTICLE 1 - DEFINITIONS
As used herein, the following terms will have the following meanings:
1.1 "Confidential Information" means any knowledge, know-how, practice,
process or other information which has not been made public and which
Sponsor receives from UM or UM Personnel, or UM or UM Personnel
receives from Sponsor. Confidential Information includes, without
limitation, any documents, drawings, sketches, models, designs, data,
memoranda, tapes, records, formulae and algorithms, given orally, in
hard copy form, or in electronic form.
1.2 "Contract Period" is January 4, 2000 through January 3, 2002 during
which the University will perform the Project Work.
1.3 "Intellectual Property" means individually and collectively all
inventions, improvements and/or discoveries - patentable or
unpatentable, copyrightable or uncopyrightable - including but not
limited to software and biological materials, which are conceived
and/or made in performance of the Project Work. For the purposes of
this Section, the "making" of inventions will be governed in accordance
with 35 USC Section 101 et seq. "University Intellectual Property"
means Intellectual Property made solely by one or more employees of
University. "Joint Intellectual Property" means Intellectual Property
made jointly by one or more employees of University and one or more
employees of Sponsor. "Sponsor
Intellectual Property" means Intellectual Property made solely by one
or more employees of Sponsor.
1.4 "License Agreement" means the license agreement executed between UM and
CDI, with an effective date of August 23, 1999, concerning the
invention entitled "Telomerase Assay of Body Fluids for Cancer
Screening and Assessment of Disease Stage and Prognosis".
1.5 "Project Description" means the description of the project in Appendix
A, authored by Dr. W. Edward Highsmith, an employee of the University.
1.6 "Project Work" means the scope of work as described in Appendix A to be
undertaken by University, or by University and Sponsor, under this
Agreement.
1.7 "Research Data" means information including, without limitation,
documents, drawings, models, designs, data, memoranda, tapes, records,
formulae and algorithms, in hard copy form, or in electronic form
resulting from the Project Work.
1.8 "UM Personnel" means employees, students, trainees, and other persons
using UM resources and subject to the UM patent policy.
ARTICLE 2 - RESEARCH WORK
2.1 University will commence the performance of the Project Work promptly
after the Effective Date of this Agreement, and will undertake to
perform such Project Work substantially in accordance with the terms
and conditions of this Agreement. Sponsor and University may at any
time enter into written agreements to make changes to and amend the
Project Work by mutual agreement of Sponsor and University.
2.2 The University's Principal Investigator for the Project Work is Dr. W.
Edward Highsmith. If the Principal Investigator should be unable to
continue for any reason, the University may terminate this Agreement if
a substitute Principal Investigator is not identified by the University
within a reasonable time. Sponsor may not reject a substitute Principal
Investigator without reasonable cause.
ARTICLE 3 - REPORTS AND CONFERENCES
3.1 Quarterly written progress/program reports will be provided by
University to Sponsor and a final report will be submitted by
University within sixty (60) days after the conclusion of the Contract
Period (as defined above or as amended by the parties), or within sixty
(60) days following termination of this Agreement before conclusion of
the Project Work.
3.2 If necessary during the term of this Agreement, representatives of
University will meet the representatives of Sponsor at times and places
mutually agreed upon to discuss the progress and results, as well as
ongoing plans, or changes therein, of the Project Work to be performed
hereunder. Sponsor will reimburse University for travel costs
associated with these meetings if such costs have not been included in
the approved budget.
ARTICLE 4 - COST, BILLINGS, AND OTHER SUPPORT
4.1 It is agreed to and understood by the parties hereto that, subject to
changes in the Project Work pursuant to ARTICLE 2, total costs to
Sponsor hereunder will not exceed the sum of Two Hundred and Forty-Nine
Thousand, Four-Hundred and Fifty Eight Dollars
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($249,458). These costs will be allocated as set forth in Appendix B
attached hereto for use in the Project Work. A payment by Sponsor of
$124,921 will be made within thirty (30) days of execution of this
Agreement. Final payment of $124,537 will be made one year from the
Effective Date of this Agreement.
Payment should be made to: University of Maryland
and sent to: University of Maryland
P.O. Box 41428
Baltimore, Maryland 21203-6428
4.2 Anything herein to the contrary notwithstanding, should this Agreement
be subject to early termination pursuant to ARTICLE 9 hereof, Sponsor
will pay all costs accrued by University as of the date of
termination, or thereafter as a result of termination. In addition,
Sponsor will reimburse University for non-cancelable obligations,
which will include all non-cancelable contracts and fellowships,
postdoctoral or faculty appointments called for in the Project
Description, Appendix A, incurred prior to the effective date of
termination.
ARTICLE 5 - PUBLICITY
5.1 Neither Sponsor nor UM will use the name of the other or the name of
any employee of the other, or any adaptation of such names, in any
advertising, promotional, or sales literature without obtaining the
prior written consent from the other party. Either party may publicize
the fact that the parties have made this Agreement and the general
nature of the Project Work.
5.2 Either party may take this Agreement available for public inspection on
the condition that Confidential Information will remain confidential in
accordance with Article 12.
ARTICLE 6 - RESEARCH DATA AND PUBLICATIONS
6.1 Research Data is owned by UM subject to Sponsor's right to use it in
accordance with the terms of this Agreement. If the Project Work
involves any collaborative effort between UM and sponsor, any Research
Data generated by employees of Sponsor may be obtained and used by UM
at any time for research and educational purposes.
6.2 Sponsor recognizes that under University academic policy, the results
of a University research project must be publishable and agrees that
University Personnel engaged in the Project Work will be permitted to
present at symposia and national or regional professional meetings, and
to publish in journals, theses, dissertation, or otherwise of their own
choosing, the method and results of the Project Work and the Research
Data.
6.3 UM will submit materials relating to a planned written publication or
other public disclosure to Sponsor for review at least 30 days prior to
the date of the planned submission for written publication. Sponsor
will advise UM within 30 days after receipt of the materials whether
patent applications should be filed related to the materials submitted
by UM. Written publication or public disclosure by UM will be deferred
up to a maximum of 90 days after the date Sponsor receives the
materials to enable UM to file any patent applications recommended by
Sponsor. Any such proposed patent applications will be filed in
accordance with the terms of the License Agreement.
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ARTICLE 7 - INTELLECTUAL PROPERTY
7.1 UM Intellectual Property is owned by UM. Joint Intellectual Property is
owned jointly by Sponsor and UM. Sponsor Intellectual Property is owned
by Sponsor.
7.2 UM and Sponsor agree that UM Intellectual Property, Sponsor
Intellectual Property and Joint Intellectual Property will be subject
to the terms and conditions of the License Agreement. Sponsor will have
no rights in any UM Intellectual Property that does not meet the
definition of "UM Improvement" as defined in the License Agreement, and
Sponsor will have no rights in UM's rights in any Joint Intellectual
Property that does not meet the definition of "Joint Improvements" as
defined in the License Agreement.
ARTICLE 9 - TERM AND TERMINATION
9.1 This Agreement will become effective upon the Effective Date and will
continue in effect for the full duration of the Contract Period unless
sooner terminated in accordance with the provisions of this ARTICLE 9.
The parties hereto may, however, extend the term of this Agreement for
additional periods as desired under mutually agreeable terms and
conditions, which the parties reduce to writing and sign. Either party
may terminate this Agreement upon sixty (60) days prior written notice
to the other.
9.2 In the event that either party hereto will commit any breach of or
default in any of the terms or condition of this Agreement, and also
will fail to remedy such default or breach within sixty (60) days after
receipt of written notice thereof from the other party hereto, the
party giving notice may, at its option and in addition to any other
remedies which it may have at law or in equity, terminate this
Agreement by sending notice of termination in writing to the other
party to such effect, and such termination will be effective as of the
date of the receipt of such notice. Notwithstanding the foregoing
provision, University may terminate this Agreement upon ten (10) days
notice if any payment due from Sponsor is not received before or upon
the date specified in this Agreement or in Appendix A, or within ten
(10) day notice period.
9.3 Termination of this Agreement by either party for any reason will not
affect the rights and obligations of the parties accrued prior to the
effective date of termination of this Agreement. No termination of this
Agreement, however effectuated, will affect the parties' rights and
duties with respect to Intellectual Property, or release the parties
hereto from their rights and obligations under ARTICLES 4, 5, 6, 7, 10,
11, 12, 17 and 19.
ARTICLE 10 - INDEPENDENT CONTRACTOR
10.1 In the performance of all services hereunder:
10.1.1 University will be deemed to be and will be an independent
contractor and as such neither University or its personnel
will be entitled to any benefits applicable to employees of
Sponsor;
10.1.2 University will comply with all governmental laws and
regulations, such as EPA, OSHA and like regulations, which are
applicable to University in its performance of
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the Project Work hereunder;
10.1.3 Neither party is authorized or empowered to act as agent for
the other for any purpose. Neither party will enter into any
contract, warranty or representation as to any matter on
behalf of the other party. Neither party will be bound by the
acts or conduct of the other party.
ARTICLE 11 - CLAIMS, INDEMNIFICATION, AND INSURANCE
11.1 UM and its officers and employees acting within the scope of their
employment by UM are subject to the Maryland Tort Claims Act ("the
Act"), Title 12, Subtitle 1, State Government Article, Annotated Code
of Maryland, which permits claims in tort against the State of Maryland
under certain circumstances. In order to file a claim under the Act,
Sponsor must submit a written claim to the Treasurer of the State of
Maryland or a designee of that office within one year after the injury
to the person or property that is the basis of the claim.
11.2 Sponsor warrants and represents that it maintains comprehensive
liability and property damage insurance coverage for itself, its
officers, employees and agents, in the following minimum amounts per
policy period:
(a) Comprehensive liability: (bodily injury and loss of life)
$1,000,000 per claim; $2,000,000 aggregate;
(b) Property damage: $50,000 per claim; $2,000,000 aggregate.
Sponsor warrants that its comprehensive liability insurance covers
contractually assumed liabilities referred to in Section 11.3, and
agrees to maintain such coverage throughout the term of this Agreement.
A certificate evidencing required insurance coverage will be delivered
to UM at or before execution of this Agreement. Sponsor also warrants
that its comprehensive liability insurance is an occurrence policy, or
if it is a claim made policy, Sponsor will purchase extended reporting
insurance.
11.3 Sponsor will defend, indemnify, and hold harmless UM, the University
System of Maryland, and the State of Maryland, and regents, officers,
employees, students, and agents of UM (each individually a "UM Party"
and all, collectively, "UM Parties") against any and all claims, costs
or liabilities, including attorney's fees and court costs at both trial
and appellate levels, for any loss, damage, personal injury, or loss of
life, (a) caused by the actions of Sponsor or its officers, servants,
or agents, or third parties acting on behalf of or under authorization
from Sponsor in the performance of this Agreement; (b) arising out of
use by Sponsor, its officers, servants, or agents, or by any third
party acting on behalf of or under authorization from Sponsor of
products, processes, or protocols (including licensed University
Intellectual Property or Joint Intellectual Property) developed by
Sponsor, its officers, servants, or agents, or by third parties acting
on behalf of or under authorization from Sponsor; or (c) arising out of
use, by UM or its employees or students, of products, processes, or
protocols developed by Sponsor, its officers, servants, or agents, or
by third parties acting on behalf of or under authorization from
Sponsor. Sponsor's agreement to defend, indemnify and hold harmless the
UM Parties is conditioned upon (a) UM promptly notifying Sponsor in
writing after UM receives notice of any claim, and (b) UM and any
involved UM Party fully cooperating with Sponsor in the defense of any
such claim. Sponsor's agreement to defend, indemnify and hold harmless
the UM Parties will not apply to any claim, cost, or liability
attributable solely to
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the negligence or willful misconduct of an UM Party.
11.4 UM and Sponsor further agree that nothing in this Agreement will be
interpreted as: (a) a denial to either party of any remedy or defense
available to it under the laws of the State of Maryland; (b) the
consent of the State of Maryland or its agents and agencies to be sued;
or (c) a waiver of sovereign immunity or any other governmental
immunity of the State of Maryland and the UM beyond the extent of any
waiver provided by law.
ARTICLE 12 - CONFIDENTIALITY
12.1 (a) It may be necessary for either party to disclose to the other
certain Confidential Information. Disclosures by UM are deemed to refer
to disclosures by any UM Personnel. Disclosures by Sponsor are deemed
to refer to disclosures by Sponsor officers, directors, employees or
agents. Confidential Information may be disclosed only in accordance
with the following provisions:
Except as hereafter specifically authorized in writing by the
disclosing party, the receiving party will not, for a period of 5 years
after the date of receipt of Confidential Information, disclose or use
the Confidential Information.
(b)(1) These obligations of non-disclosure and nonuse do not apply to
any Confidential Information, which the receiving party can
demonstrate by reliable written evidence:
(i) was generally available to the public at the time of
disclosure to the receiving party; or
(ii) was already in the possession of the receiving party at the
time of the disclosure, other than pursuant to a
confidential disclosure agreement between the parties and
not due to any unauthorized act by the receiving party; or
(iii)was developed by the receiving party prior to the
disclosure; or
(iv) the receiving party is required by law to disclose.
(b)(2) These obligations of non-disclosure and nonuse will not
continue to apply to any Confidential Information, which the receiving
party can demonstrate by reliable written evidence:
(i) has become generally available to the public other than
through a breach of this Agreement by the receiving party
after disclosure;
(ii) has been acquired by the receiving party on a
nonconfidential basis from any third party having a lawful
right to disclose it to the receiving party; or
(iii)corresponds to information developed by the receiving party
independent of and with no reliance upon the disclosing
party's Confidential Information.
(c) Each party will use that level of care to prevent the use or
disclosure of the other party's Confidential Information as it
exercises in protecting its own Confidential Information.
(d) All Confidential Information will be clearly marked as
confidential by the disclosing party and if not in written or tangible
form when disclosed, will be so indicated on disclosure as
confidential and then summarized in writing and so marked as
confidential within 30 days after disclosure to the receiving party.
(e) Notwithstanding the foregoing, Sponsor is permitted to disclose
and use the Confidential Information to the extent reasonably
necessary to enable Sponsor to exercise its option under this License
Agreement, provided that any disclosure is made subject to
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confidentiality restrictions consistent with those accepted by Sponsor
in this Agreement.
(f) Sponsor recognizes that UM is an educational institution with
standards and practices for protection of Confidential Information
which differ from Sponsor's standards and practices. By this Agreement
UM undertakes to use reasonable efforts to protect the confidentiality
of Sponsor's Confidential Information. Sponsor agrees that, provided
such efforts are made, it will not seek to hold UM or UM Personnel
liable in the event of disclosure of Sponsor's Confidential
Information.
(g) Sponsor recognizes that the records of UM are subject to the
Maryland Access to Public Records Law. Sponsor asserts that any
Confidential Information of Sponsor is confidential, proprietary, and
trade secret information, not subject to disclosure under Maryland's
Access to Public Records Law. UM agrees to assert this position in
response to any request for public information applicable to Sponsor's
Confidential Information or annual sales reports, and to promptly
notify Sponsor upon receipt of requests for its Confidential
Information. The Maryland Access to Public Records Law is at Title 10,
Subtitle 6, Part III, State Government Article, Annotated Code of
Maryland.
(h) Upon termination of this Agreement for any reason, Sponsor will
return to UM all material provided to Sponsor which is Confidential
Information, together with all copies and other forms of reproduction,
except that a single archive copy may be kept in Sponsor's legal
files. Each party agrees that termination of this Agreement does not
alter the 5 year obligation of confidentiality set forth in Section
12.1(a).
ARTICLE 13 - GOVERNING LAW
13.1 This Agreement will be governed and construed in accordance with the
laws of the State of Maryland.
ARTICLE 14 - ASSIGNMENT
14.1 This Agreement will not be assigned by either party without the prior
written consent of the other party.
ARTICLE 15 - AGREEMENT MODIFICATION
15.1 Any agreement changing the terms of this Agreement in any way will be
valid only if the change is made in writing and the writing is executed
by authorized representatives of the parties hereto.
ARTICLE 16 - NOTICES
16.1 Notices, invoices, communications, and payments hereunder will be made
by first class postage prepaid, and addressed to the party to receive
such notice, invoice, or communication at the address given below, or
such other address as may hereafter be designated by notice in writing:
If to Sponsor: Dr. Uwe Reischl
Cancer Diagnostics, Inc.
202 South Wheeler Street
Plant City, Florida 33566
If to University: Marjorie Forster, Executive Director
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University of Maryland
Office of Research and Development
515 West Lombard Street, 5th Floor
Baltimore, Maryland 21201
With a copy to: Dr. W. Edward Highsmith
Department of Pathology
University of Maryland, Baltimore
685 West Baltimore Street, Room 7-22
Baltimore, Maryland 21201
ARTICLE 17 - GOVERNMENT FUNDING
17.1 The Parties recognize that Background Intellectual Property may have
been funded in whole or in part by agencies of the federal government
of the United States. The parties hereto acknowledge that the federal
government may have certain rights to such Background Intellectual
Property pursuant to the provision of Public Laws 95-517 and 98-620 as
amended, or any future federal laws or regulations concerning the
federal government's interest.
ARTICLE 18 - FORCE MAJEURE
18.1 No party will be liable to the other parties for its failure to perform
any of its obligations hereunder during any period in which such
performance is delayed by circumstances beyond its reasonable control
including, but not limited to, acts of God, acts or omissions of any
government or any agency thereof, unavailability of essential personnel
due to disability or death, compliance with request, recommendations,
rules, regulations or orders of any governmental authority or any
department, agency or instrumentality thereof, fire, storm, flood,
earthquake, accident, acts of the public enemy, war, rebellion,
insurrection, riots, sabotages, invasion, quarantine, restrictions,
strikes, lockouts, disputes or differences with workers, transportation
embargoes or failure or delay in transportation arising from any of the
foregoing causes. The party effected by force majeure will notify the
other party promptly should such circumstances arise, giving an
indication of the likely extent and duration thereof, and will use all
commercially reasonable efforts to resume performance of its
obligations as soon as practical.
ARTICLE 19 - EXPORT CONTROLS
19.1 The use and disclosure of technical information generated in the United
State pursuant to this Agreement and the exercise of licenses granted
pursuant to the Option and License Agreement will be subject to the
export, assets, and financial control regulations of the United States
of America, including, but without limitation, restrictions under
regulations of the United States that may be applicable to direct or
indirect re-exportation of such technical information or of equipment,
products or services directly produced by use of such technical
information.
ARTICLE 20 - MATERIAL TRANSFER
20.1 The transfer of biological material related to the Project Work will be
governed by a separate written agreement in the format of Appendix C.
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ARTICLE 21 - ENTIRE AGREEMENT
21.1 This Agreement, including its Appendices, represents the entire
understanding between the parties, and supersedes and merges all other
agreements, express or implied, discussions or understandings between
the parties with respect to the subject matter hereof. This Agreement
may be executed in counterparts, all of which will be deemed original
for all purposes.
IN WITNESS WHEREOF, the parties have caused this Agreement to be
executed in duplicate as of the date and year first above written.
CANCER DIAGNOSTICS, INC. UNIVERSITY OF MARYLAND, BALTIMORE
By: /s/ UWE REISCHL By: /s/ MARJORIE FORSTER
Uwe Reischl, Ph.D., M.D. Marjorie Forster, Executive Director
President Office of Research and Development
Date: Aug. 30, 1999 Date: 8/27/99
READ AND AGREED:
/s/ W. EDWARD HIGHSMITH 8/27/99
W. Edward Highsmith, Ph.D.
Principal Investigator