ULRF SubPSC CTA May ’05 Revised Nov ’06 Oct ‘07 Page 1 of 10

THIS AGREEMENT is made this ___________day of ___________ 200__ by and between the University of Louisville Research Foundation, Inc. (hereinafter “ULRF”) a Kentucky non-profit corporation having an office at MedCenter One, Suite 200, 501 E. Broadway, Louisville, KY 40202-1798 as the agent of the University of Louisville (hereinafter "UofL") for receiving grants and research agreements from external funding sources and which owns and controls intellectual property on behalf of UofL (collectively “INSTITUTION”) and _______________________ with a principal place of business at
_________________________, (hereinafter “SUBCONTRACTOR”).

WHEREAS, __________________________ (hereinafter “SPONSOR”) desires to provide funding in support of the clinical research study in return for receiving certain rights in the study results;

WHEREAS, INSTITUTION and SPONSOR have entered into a separate agreement (a copy of which has been provided to SUBCONTRACTOR under separate cover) that outlines the rights and obligations of each other in conducting a clinical research study (“Study”) entitled,
“_______________________________________________________” according to the Study Description or Protocol No. _______________ (“Protocol”) incorporated into this Agreement by
reference (referred to as “SPONSOR CTA”.)

WHEREAS, SUBCONTRACTOR desires to participate in this clinical research study can provide the services as outlined in this Agreement, and is willing to do so in accordance with this Agreement and the applicable provisions of the SPONSOR CTA; and

WHEREAS, the study contemplated by this Agreement is of mutual interest and benefit to INSTITUTION, SUBCONTRACTOR and SPONSOR;

NOW, THEREFORE, the parties hereto agree as follows:

1. DEFINITIONS

As used herein, the following terms shall have the following meanings:

1.1. “Principal Investigator” shall mean the investigator of INSTITUTION under whose supervision the Study is conducted and shall mean   _________________________., Department of
_________________ at the University of Louisville.

1.2. “Participating Investigator” shall mean the individual of SUBCONTRACTOR who will supervise and/or manage the services to be provided under this Agreement and shall mean ____________________________ the same person as identified in Section 1.1.

1.3. Effective Date and Term are to run concurrent to the SPONSOR CTA including any amendments thereto between ULRF and the SPONSOR.

1.4. “Services” shall mean the description of services to be provided by SUBCONTRACTOR for the Study described in the protocol entitled
“ _________________________________________________” which, together with any amendments, is incorporated into this Agreement by reference.

1.5. Study Materials will be provided as outlined in SPONSOR CTA.

2. CONDUCT OF THE STUDY
SUBCONTRACTOR shall commence the performance of the Services promptly after the effective
date of this Agreement, provided approvals have been obtained as required pursuant to Section 10,
and shall use reasonable efforts to perform such Services substantially in accordance with the terms
and conditions of this Agreement and in accordance with the applicable terms and conditions of the
SPONSOR CTA. SUBCONTRACTOR agrees (1) to comply with all applicable additional terms and
conditions imposed on INSTITUTION by SPONSOR, (2) to comply with all applicable laws, rules and
regulations relating to the conduct of such Study, including any applicable laws, rules and regulations
concerning or promulgated by the Food and Drug Administration (FDA) and (3) to perform the
activities in accordance with Good Clinical Practice (GCP) and International Conference on
Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)
requirements if applicable.
3. PAYMENT SCHEDULE
3.1. Payments by ULRF shall be made payable to the SUBCONTRACTOR and forwarded to the
following address:
________________________
________________________
________________________
3.2. It is understood that payments to the SUBCONTRACTOR are dependent upon prompt
payment by the SPONSOR to INSTITUTION. INSTITUTION will pay an amount not to exceed
the maximum of the primary agreement including any amendments thereto less the facilities
and administrative (“F&A”) costs the INSTITUTION receives in accordance with the approved
budget and payment schedule attached as Exhibit A. SUBCONTRACTOR acknowledges that
the INSTITUTION has included F&A costs for this Study. For purposes of identification,
invoices from SUBCONTRACTOR for payment(s) due SUBCONTRACTOR will include the
project number OIC______________, title of the Study and the name of the Participating
Investigator, SPONSOR and Principal Investigator.
3.3. In the event of termination, the sum for professional services and expenses payable under this
Agreement shall be limited to the pro-rated fees based on actual work performed and actual
expenses committed pursuant to the Study Protocol. Any unexpended funds not due under
this calculation but already paid shall be returned to INSTITUTION.
4. CONFIDENTIALITY
4.1. In performance of the Services, either party may disclose information to the other party that it
considers to be proprietary and confidential (hereinafter “Confidential Information”). All
information supplied to INSTITUTION by SPONSOR that is supplied to SUBCONTRACTOR
shall be deemed Confidential Information unless specified in writing to the contrary. The
disclosing party shall designate all such information confidential, either orally or in writing, at
the time of disclosure. If designated confidential orally, the disclosing party shall within 30 days
of the date of disclosure confirm in writing the confidential nature of such information. The
receiving party shall use reasonable efforts to ensure the disclosing party’s Confidential
Information is kept confidential. Except as otherwise provided herein, for the longer of (1) a
period of five (5) years following the date of such disclosure or (2) the time period specified by
the SPONSOR for this Study, the receiving party will not disclose the disclosing party’s
Confidential Information without the consent of the disclosing party and shall use the disclosing
party’s Confidential Information only for the purposes of this Agreement. Notwithstanding the
foregoing, the receiving party may transfer the disclosing party’s Confidential Information to
those of its employees, officers, directors and agents as may be reasonably necessary to carry
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out the performance of this Agreement. Information shall not be subject to the aforementioned
restrictions where the:
a) information was possessed by receiving party prior to receipt from disclosing party other
than through prior disclosure by the disclosing party as evidenced by receiving party’s
business records;
b) information was published or becomes available to the general public otherwise than
through a breach of this Agreement;
c) information is obtained by receiving party from a third party with a valid right to disclose it,
provided that said third party is not under a confidentiality obligation to the disclosing
party;
d) information was independently developed by employees, agents or consultants of
receiving party who had no knowledge of or access to the information as evidenced by
receiving party’s business records;
e) information is published or disclosed by the receiving party with the disclosing party’s prior
written permission to publish or is disclosed in the necessary course of the prosecution of
patent applications upon intellectual property developed pursuant to this Agreement; or
f) information is required to be disclosed by operation of law, regulation, Attorney General
opinion that carries the force of law, or court order.
4.2. SPONSOR and INSTITUTION shall be provided patient information as allowed by law and will
maintain the confidentiality of all such patient information, unless specifically required to
disclose such information by law and as permitted by the provisions of the SPONSOR CTA.
5. PUBLICITY
SUBCONTRACTOR will not use the name of (1) the ULRF, UofL, nor of any employee, student,
trustee or officer thereof, or (2) SPONSOR, in advertising or publicity, including news releases,
without the prior written consent of the INSTITUTION or SPONSOR respectively. INSTITUTION will
not use the name of the SUBCONTRACTOR, nor any employee of SUBCONTRACTOR, in any
advertising or publicity, including news releases, without the prior written approval of
SUBCONTRACTOR.
6. PUBLICATIONS
6.1. SUBCONTRACTOR agrees to abide by the provisions of the SPONSOR CTA regarding
publications and will provide copies for review of any planned publication or presentation at
least five (5) business days in advance of the times specified in the SPONSOR CTA.
6.2. Notwithstanding the preceding, if the parties or SPONSOR disagree concerning whether
certain information in a planned publication or presentation should be deleted or modified, the
parties agree to meet, and include SPONSOR as appropriate, for the purpose of making good
faith efforts to discuss and resolve any issues or disagreements. SUBCONTRACTOR agrees
to delete Confidential Information (of SPONSOR or INSTITUTION) as defined in Section 4,
prior to any publication or presentation.
7. INTELLECTUAL PROPERTY
7.1. It is recognized and understood that certain existing inventions and technologies are the
separate property respectively of the INSTITUTION, SPONSOR and SUBCONTRACTOR and
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are not affected by this Agreement, and neither party shall have any claims to or rights in such
separate inventions and technologies.
7.2. It is understood and agreed that any intellectual property (including inventions, copyrights, or
other proprietary information) authored, conceived, invented, improved, created, modified or
reduced to practice by SUBCONTRACTOR in conducting or performing services under this
Agreement or arising otherwise from the services under this Agreement shall be assigned in
accordance with SPONSOR CTA. Should the SPONSOR CTA call for INSTITUTION to assign
or otherwise transfer its rights to SPONSOR, SUBCONTRACTOR agrees to assign or
otherwise transfer any rights it may have to INSTITUTION (for transfer to SPONSOR) or
directly to SPONSOR as SPONSOR may direct.
8. CLINICAL DATA AND REPORTING
8.1. As SPONSOR directs, SUBCONTRACTOR shall provide reports and any reporting or
notifications as required either (1) directly to SPONSOR or (2) to INSTITUTION, with copy to
the other. SUBCONTRACTOR agrees to provide information and/or to inform INSTITUTION of
progress and status as needed to keep SPONSOR informed of progress of the Study and to
enable INSTITUTION to properly bill or invoice SPONSOR for services.
8.2. Within the timeframes specified by SPONSOR, SUBCONTRACTOR, after the occurrence of a
serious adverse event, will report the event to SPONSOR, with copy to INSTITUTION as
specified by SPONSOR in the manner specified by SPONSOR.
9. TERMINATION
9.1. The Services may be terminated prior to completion by written notice from the INSTITUTION
for any of the following reasons:
a) Notification to the SPONSOR or INSTITUTION from Federal or State Regulatory
Authorities to terminate the Study;
b) Determination by the SPONSOR or INSTITUTION that the SUBCONTRACTOR, after
reasonable opportunity, is unable for any reason to perform the Services satisfactorily as
required in the Study Protocol;
c) Inability of the Participating Investigator to continue the Services at the
SUBCONTRACTOR and a successor acceptable to both INSTITUTION and SPONSOR is
not available;
d) Termination by SPONSOR of SPONSOR CTA or other request by SPONSOR to
terminate this Agreement between INSTITUTION and SUBCONTRACTOR; or
e) Termination by INSTITUTION upon thirty (30) days prior notice.
9.2. Immediately upon receipt of a notice of termination by SUBCONTRACTOR,
SUBCONTRACTOR shall stop entering subjects into the Study, cease providing
Services/cease conducting procedures, to the extent medically permissible, but in any event
within thirty (30) days of notice of termination, on subjects already entered into the Study. In
the event of termination, expenses payable to the SUBCONTRACTOR shall be as stated in
Section 3.3.
9.3. Termination or completion of this Agreement shall not relieve the obligations undertaken by the
parties in Sections 4, 5, 6, 7, 8, 10, 12, 13, 14,16 and 17.
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10. INSTITUTIONAL REVIEW BOARD APPROVAL
10.1. If SUBCONTRACTOR is required to have approval of an Institutional Review Board or other
review committee (e.g. IACUC) other than UofL’s respective designated IRB or review
committee, Participating Investigator, as appropriate, shall prepare and file the Study Protocol,
informed consent form, and other information with SUBCONTRACTOR's Institutional Review
Board (“IRB”) or appropriate review committee.
10.2. The Services shall not begin until appropriate SUBCONTRACTOR and UofL IRB/review
committee approvals are obtained.
10.3. INSTITUTION acknowledges that SUBCONTRACTOR reserves the right to terminate the
Services if the IRB, or other applicable review committee, subsequently suspends or withdraws
its approval of the Study.
11. INDEPENDENT PARTIES
For the purposes of this Agreement, the parties shall be independent contractors. Nothing contained
herein shall be deemed or construed to create between the parties hereto a partnership or joint
venture or the relationship of agent and principal.
12. SUBCONTRACTOR INDEMNIFICATION
12.1. For the purposes of this Section, Participating Investigator and any of SUBCONTRACTOR’s
employees, trustees, officers, affiliates and agents and their respective successors, heirs and
assigns performing services or other activities in support of this Agreement are referred to
collectively as the “Responsible Persons.” SUBCONTRACTOR shall (1) defend, indemnify and
hold harmless UofL and ULRF any of ULRF’s or UofL’s faculty, students, employees, trustees,
officers, affiliates and agents and their respective successors, heirs and assigns (hereinafter
referred to collectively as the “Indemnified Persons”) and (2) assume responsibility from and
against any and all liability, claims, lawsuits, losses, damages, costs, expenses (including
attorney’s fees) and other liabilities asserted by third parties, both government and nongovernment,
(collectively “Losses”) resulting from or arising out of the Study carried out
pursuant to this Agreement to the extent such Losses are attributable to the negligence or
willful misconduct of any of the Responsible Persons or failure by Responsible Persons to
comply with the terms and condition of this Agreement or the SPONSOR CTA.
12.2. SUBCONTRACTOR shall notify INSTITUTION upon learning of the institution or threatened
institution of any such liability, claims, lawsuits, losses, damages, costs and expenses.
12.3. SUBCONTRACTOR represents that it carries insurance coverage to protect against
professional malpractice and general liability in amounts equal to at least one million dollars
($1,000,000) per occurrence and an aggregate of at least three million dollars ($3,000,000).
SUBCONTRACTOR agrees to furnish INSTITUTION a certificate of insurance acceptable to
INSTITUTION indicating the required coverage upon written request.
13. ASSIGNMENT
This Agreement shall not be assigned or Services subcontracted by SUBCONTRACTOR without the
prior written consent of the INSTITUTION (and/or SPONSOR as applicable.)
14. GOVERNING LAW
This Agreement shall be governed and construed in accordance with the laws of the Commonwealth
of Kentucky without giving effect to the conflict of laws provisions.
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15. NOTICES
All notices, invoices, payments and other communications that any of the parties hereto are required
or may desire to deliver to the other party hereto shall be in writing and shall be deemed given as of
the date it is received by the other party. Notices shall be given to the parties at the addresses listed
below:
If to SUBCONTRACTOR:
_____________________
______________________
______________________
If to INSTITUTION:
For administrative notice: Director, Office of Industry Contracts
University of Louisville
MedCenter One
501 East Broadway, Suite 200
Louisville, KY 40202-1798
For technical notice: For U.S. Postal Service:
___________________
Department of __________
University of Louisville
Louisville, KY 40292
16. MONITORING AND ACCESS TO RECORDS
16.1 SUBCONTRACTOR may receive an on-site review(s) from INSTITUTION, SPONSOR, or their
duly authorized representative(s) to assess technical, administrative, and/or financial activity
relating to the terms of this Agreement. Notwithstanding any other conditions of this
Agreement, with reasonable notice, INSTITUTION, SPONSOR or their duly authorized
representative(s) shall have full and complete access to and the right to examine any books,
documents, papers, records and other information of the SUBCONTRACTOR related to the
performance of the Services under this Agreement for the purpose of making audits,
examinations, excerpts and transcriptions, and to ensure compliance with Study activities,
applicable regulations, and consistently applied costs for the Services.
16.2 SUBCONTRACTOR shall provide to INSTITUTION, SPONSOR and their authorized
representative(s) all assistance and information needed to enable INSTITUTION to perform its
monitoring function. This assistance from the SUBCONTRACTOR includes, but is not limited
to, information about the SUBCONTRACTOR’s Services operation, accounting, and database
systems.
16.3 SUBCONTRACTOR's and SPONSOR’s right to access and examine the designated records
begins on the Effective Date of this Agreement and expires on the later of three (3) years after
the date of final payment to SUBCONTRACTOR under this Agreement or three (3) years from
the end date of this Agreement. Financial reports, supporting documents, and other records
pertinent to this Agreement shall be retained by the SUBCONTRACTOR for at least as long as
required under applicable Federal law or regulation, and with regard to records that relate to
audits, appeals, litigation or the settlement of claims arising out of performance of this
Agreement, until such audits, appeals, litigation or claims have been disposed of. If
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SUBCONTRACTOR’s performance of Services under this Agreement is funded, in whole or in
part, by the Federal government, then the audit rights of this paragraph shall extend to the
Federal awarding agency, the Comptroller General of the United States, or any of their duly
authorized representatives.
16.4 Through audits, reviews, monitoring, or other means, INSTITUTION or SPONSOR may find
the SUBCONTRACTOR to have program or financial deficiencies in the performance of this
Agreement. Such deficiencies may include, but are not limited to, the areas of accounting,
financial controls, budgeting, and/or Services compliance issues. If deficiencies are found,
INSTITUTION or SPONSOR may require the SUBCONTRACTOR to take corrective action
and to submit a written corrective action plan to address identified deficiencies. All corrective
action plans must be accepted by INSTITUTION and/or SPONSOR or their authorized
representatives. Any corrective action must be satisfactorily completed within thirty (30) days
from the date that the corrective action plan is accepted by INSTITUTION and/or SPONSOR.
16.5 INSTITUTION and SPONSOR shall be informed by SUBCONTRACTOR of any audit of
SUBCONTRACTOR’s records and operations related to records associated with the
performance of the Services under this Agreement and shall receive a full report of any such
audits.
17. ADDITIONAL PROVISIONS
17.1 In the event any part, article, section, subsection, clause, paragraph or subparagraph of this
Agreement shall be held to be indefinite, invalid, illegal or otherwise voidable or unenforceable,
the entire Agreement shall not fail on account thereof, and the balance of the Agreement shall
continue in full force and effect.
17.2 A waiver by either party of a breach or violation of any provision of this Agreement will not
constitute or be construed as a waiver of any subsequent breach or violation of that provision
or as a waiver of any breach or violation of any other provision of this Agreement.
17.3 No exercise of a specific right or remedy by any party precludes it from or prejudices it in
exercising another remedy or maintaining an action to which it may otherwise be entitled either
at law or in equity.
17.4 During the performance of this Agreement, SUBCONTRACTOR and INSTITUTION shall not
discriminate against any employee or applicant for employment because of race, color, sex,
sexual preference, age, religion, national or ethnic origin, handicap, or because he or she is a
disabled veteran or veteran of the Vietnam era.
17.5 Each party shall comply with all laws, regulations and other legal requirements applicable to
them in connection with this Agreement.
17.6 SUBCONTRACTOR represents that neither the SUBCONTRACTOR or its Participating
Investigator (or others providing Services under this Agreement) are presently debarred,
suspended, proposed for debarment, declared ineligible or voluntarily excluded from receiving
funds from any Federal department or agency (“ineligible individual”) and that they are not
delinquent on any Federal debt. SUBCONTRACTOR agrees to promptly notify ULRF of any
change in its status or that of its Participating Investigator (or others providing Services under
this Agreement) and shall not permit any ineligible individual to provide Services under this
Agreement.
17.7 SUBCONTRACTOR represents that it is in compliance with the Drug Free Workplace Act of
1998, that it is in compliance with applicable restrictions on the use of federal funds for the
purpose of lobbying, that it has annually filed any applicable forms governing Misconduct in
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Science, Civil Rights, Handicapped Individuals, Sex Discrimination and Age Discrimination with
applicable federal compliance offices and that they have an established policy as required 42
CFR Part 50 Objectivity in Research.
17.8 Equal Employment Opportunity: SUBCONTRACTOR agrees that, unless exempted by rules,
regulations, or orders of the Secretary of Labor issued pursuant to Section 204 of Executive
Order No. 11246 of September 24, 1965, as amended by Executive Order No. 11375 of
October 13, 1967, during the performance of this Agreement they will comply with the
provisions of paragraphs 1 through 7 of Section 202 of E.O. No. 11246, and as such will submit
an executed “Certificate of Nonsegregated Facilities” for services having a dollar value of
$10,000 or more. Procurements having a dollar value of $2,500 or more shall adhere to the “A
Listing or Employment Opening” clause and “A Employment of the Handicapped” clause.
18. AGREEMENT MODIFICATION
This Agreement is the final and complete understanding of the parties with respect to the subject
matter hereof superseding all prior agreements, understandings and discussions relating thereto. No
amendments or changes to this Agreement shall be valid unless the change is made in writing and
signed by authorized representatives of the parties hereto. The appendices and exhibits will be
binding upon the parties hereto except to the extent they may conflict with the terms and conditions
contained within this Agreement, in which case the terms and conditions of the Agreement will
govern.
[The remainder of this page is blank. A signature page follows:]
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IN WITNESS WHEREOF, the parties have caused this Agreement to be executed by their duly
authorized representatives,
THE UNIVERSITY OF LOUISVILLE ________________________________
RESEARCH FOUNDATION, INC. PSC
Signature: ____________________________ Signature: _________________________
Printed Name: ________________________ Printed Name: _______________________
Title: ________________________________ Title: ______________________________
Date: ________________________________ Date: ______________________________
Participating Investigator, while not a party to this Agreement, by his/her signature acknowledges that
he/she: (1) has read and agrees to abide by the terms and conditions that apply to the Participating
Investigator, (2) agrees to conduct/perform the Services as outlined in the Agreement, the SPONSOR
CTA and its associated Study Protocol, and (3) if applicable, will see that the Services are performed in
accordance with an approved management plan.1
Signature: ________________________________________________________
Participating Investigator: ____________________________________________
Title: _____________________________________________________________
Date: _____________________________________________________________
1 “Management Plan" means a written plan for the management, reduction or elimination of a potential financial
conflict of interest relating to research. It relies upon, and is therefore limited by, good faith disclosures about
significant financial interests made, and other information provided by, a covered individual to the University and/or
SUBCONTRACTOR.
ULRF SubPSC CTA May ’05 Revised Nov ’06 Oct ‘07 Page 10 of 10
EXHIBIT A
SUBCONTRACTOR will be paid only for reimbursements for study-related activities upon submission of
invoices. The total amount paid to SUBCONTRACTOR will not exceed the amount paid to ULRF by
SPONSOR less F&A. and any individual charges for specific items shall not exceed the amount specified
in the budget specified in SPONSOR CTA’s budget.