CLINICAL TRIAL AGREEMENT
BETWEEN
THE PENNSYLVANIA STATE UNIVERSITY AND
THE MILTON S. HERSHEY MEDICAL CENTER
AND
____________________________________________
This Clinical Trial Agreement (hereinafter referred to as "Agreement") is entered into by and
between The Pennsylvania State University [if applicable -and The Milton S. Hershey Medical Center,
located at 500 UNIVERSITY Drive, Hershey, PA 17033] located at
________________________________(collectively "UNIVERSITY") and
___________________________, located at ________________________________(“SPONSOR”).
Collectively the SPONSOR and UNIVERSITY may be referred to as “the Parties,” or individually as “a
Party.”
WHEREAS, SPONSOR wants to enlist the assistance of UNIVERSITY to conduct clinical research
(“Study”) and the clinical research is of mutual interest and benefit to UNIVERSITY and SPONSOR, and
will further the instructional and research objectives of UNIVERSITY in a manner consistent with its status
as a nonprofit educational and health care UNIVERSITY;
WHEREAS, SPONSOR desires to provide funding and drug/devices (hereinafter “Drug or Device”)
to enable UNIVERSITY to conduct the Study;
NOW, in consideration of the mutual promises and covenants set forth herein, the Parties therefore
agree as follows.
1. Performance of Study and Compliance with Applicable Laws.
The Study shall be performed as described in the Study protocol entitled:
"__________________________" (“Protocol”) under the direction of _____________ (Principal
Investigator). This Study Protocol is registered on ClinicalTrials.gov with the identified NCT#
______________. University does not represent, or guarantee that any specific results shall be achieved.
UNIVERSITY understands that the Principal Investigator is essential to the Study, and UNIVERSITY
will not substitute another person to perform the duties of Principal Investigator without the prior written
consent of SPONSOR. If the Principal Investigator becomes unable or unwilling to fulfill his or her
duties, UNIVERSITY shall promptly nominate one or more qualified successor(s) to serve as Principal
Investigator, if possible. If, despite such nomination by UNIVERSITY, a successor acceptable to both
SPONSOR and UNIVERSITY is not found within thirty (30) days, either Party may terminate this
Agreement and the Study in accordance with Section 12.
UNIVERSITY will conduct the Study according to the provisions of the Protocol and this Agreement
and in conformance with all applicable laws, regulations, and standards of local, state and Federal
government agencies, and the International Conference on Harmonization Guidelines for Good Clinical
Practice (“Applicable Laws”).
SPONSOR will arrange and direct the Study according to the provisions of the Protocol and this
Agreement and in conformance with all applicable laws, regulations, and standards of local, state and
Federal government agencies, and the International Conference on Harmonization Guidelines for Good
Clinical Practice (“Applicable Laws”).
During the Study and for two years after Study completion, sponsor shall provide notice to Institution of
any findings that may (i) affect the safety and welfare of current or former Study participants, (ii) affect
the willingness of Study participants to continue their participation in the Study, (iii) influence the
conduct of the Study or (iv) alter the IRB's approval to continue the Study. Institution will communicate
findings to the Study participants, as appropriate, pursuant to Institution procedure.
SPONSOR will monitor the Study and shall provide data and safety monitoring plans prior to IRB
approval of the research. During the term of this Agreement, and at mutually agreeable times and during
normal business hours, UNIVERSITY will permit SPONSOR’s access to UNIVERSITY's premises,
facilities, medical and research records, and research staff to monitor the Study in accordance with
SPONSOR’s obligations under applicable FDA regulations. SPONSOR’s access is subject to
compliance with UNIVERSITY’s policies regarding confidentiality of medical records and information
systems. SPONSOR will complete the UNIVERSITY Guest Account Access form in order to access
UNIVERSITY’s electronic medical records. SPONSOR agrees to promptly report to UNIVERSITY any
monitoring findings from any Study Site that could: (1) affect the safety of participants; and/or (2) alter
the IRB’s approval to continue the Study.
The parties agree to abide by all applicable laws and regulations regarding subject privacy,
confidentiality and data security, specifically including the Health Insurance Portability and
Accountability Act (“HIPAA”) and the Health Information Technology for Economic and Clinical
Health Act (“HITECH”) and their respective implementing regulations.
1. Study (Drug or Device).
SPONSOR will, at its expense and in accordance with Applicable Laws, provide UNIVERSITY with
sufficient numbers of its proprietary drug or device (“Study Drug/Device”) to enable UNIVERSITY to
conduct the Study.
Study Drug/Device supplied to UNIVERSITY by SPONSOR under this Agreement will be considered
Confidential Information (defined below) of SPONSOR and will not be distributed by UNIVERSITY to
any third party.
Study Drugs/Devices provided to UNIVERSITY under this Agreement will be returned to SPONSOR,
at SPONSOR’s expense, at Study completion.
2. Ownership of Records and Use of Data.
UNIVERSITY shall ensure that the Investigator promptly remits to SPONSOR all clinical data,
including, without limitation, Case Report Form (CRF) and appropriate backup medical reports, as well
as other information generated by the Study (“Study Data”). All such information, excluding Source
Data and Source Documents as defined in Sections 1.51 and 1.52 of the ICH Guidelines entitled
“Guidance for Industry: E6 Good Clinical Practice: Consolidated Guidance” published in the Federal
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Register on May 9, 1997 (62 FR 25692), shall be the property of SPONSOR. SPONSOR shall use Study
Data in accordance with HIPAA and the Study’s mutually agreed upon informed consent.
Subject to Section 5 (Publication), UNIVERSITY shall have the right to use the Study data and results
for research, educational and patient care purposes as well as to comply with any federal, state or local
government laws or regulations.
SPONSOR agrees to collect, use and disclose Study Data only for the purpose of the Study and for the
purpose of complying with Applicable Laws, and agrees that all such uses will be disclosed in the
informed consent form.
3. Confidential Information.
Information of a confidential and proprietary nature, provided that such information shall be clearly
identified by the disclosing Party at the time of the disclosure, or, if transmittal occurs orally, the
disclosing Party will within thirty (30) days reduce such transmittal to writing and provide record thereof
to the receiving Party indicating its confidentiality, shall be considered confidential (“Confidential
Information”). Study results shall not be considered Confidential Information for purposes of
Publication.
Confidential Information shall not include information that: (i) is developed independently by an
employee not in receipt of Confidential Information; (ii) is or later becomes generally available to the
public by use, publication or the like, other than by violation of this Agreement by receiving Party; (iii) is
obtained from a third party who had the legal right to disclose the same; or (iv) the receiving party
already possesses, as evidenced by its written records, predating receipt thereof from the disclosing party;
or (v) is required to be disclosed by order of a court, administrative agency, or other governmental body.
Each Party will maintain the Confidential Information of the other party in confidence and will employ
all appropriate procedures to prevent its unauthorized publication or disclosure.
The foregoing obligations of confidentiality shall apply for three (3) years following conclusion or
termination of the Study.
4. Publication/Publicity.
UNIVERSITY and Investigator shall be free, consistent with academic standards, to publish or present
the Study Data and Results of the Study. UNIVERSITY or Investigator shall submit any such
manuscript or presentation to SPONSOR at least thirty (30) days prior to submission for publication for
review and comment.
SPONSOR shall ensure registration of the Study on ClinicalTrials.gov. pursuant to the registration
requirements for clinical trials established by the International Committee of Medical Journal
Editors ("ICMJE") in order to preserve publication rights.
Notwithstanding anything to the contrary herein, UNIVERSITY and Investigator shall not publish
Confidential Information of SPONSOR.
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Neither Party to this agreement will use the name of the other Party, nor the other party’s employees, in
any publicity, advertising, or news release without the prior written approval of an authorized
representative of that party. SPONSOR and UNIVERSITY may acknowledge in general terms the
existence of this Agreement and UNIVERSITY’s receipt of financial support from SPONSOR, project
title and dates without the prior approval from the other Party.
Notwithstanding the foregoing, UNIVERSITY agrees that if the Study is part of a multi-center study, the
first publication of the results of the Study shall be made in conjunction with the results from the
Investigators at the other study centers. However, if a multi-center publication is not forthcoming
within one year following the completion of this agreement, UNIVERSITY will be free to publish.
5. Limitation of Liability.
In no event shall university be liable for any indirect, punitive, consequential, or special damages,
including lost revenues or profits, arising from breach of the terms in this agreement, negligence, strict
liability or other tort.
6. Indemnification.
SPONSOR will indemnify, defend, and hold harmless UNIVERSITY, each Principal Investigator, all
Subinvestigators, UNIVERSITY’s IRB, its affiliated corporations, and its and their respective directors,
trustees, officers, employees and agents (individually an “Indemnitee” and collectively, the
"Indemnitees"), from and against any and all amounts paid or payable by an Indemnitee resulting from
third party liability, loss, injury, harm, damage, or expense (including reasonable attorneys fees and costs
of litigation) incurred or imposed upon an Indemnitee in connection with any third party claims, suits,
actions, demands or judgments (individually a “Claim” and collectively, "Claims") to the extent such
Claims arise out of: (i) personal injury (including death) to a Study subject where such injury is
sustained as a direct result of, a) the administration of the Study drug as prescribed under the Protocol or
b) a properly performed procedure required by the Protocol; (ii) the SPONSOR’s use or
commercialization of Study data or results, or (iii) any theory of product liability (including but not
limited to, actions in the form of tort, warranty, or strict liability) concerning the Study drug. Such
indemnification obligation shall not apply to the extent a Claim is attributable to what has been
determined by a court of competent jurisdiction to be the result of:
(a) the failure of any UNIVERSITY Indemnitee or any other UNIVERSITY personnel involved
in the performance of the respective Study to adhere to the terms of such Study Protocol or any
written instructions (including, without limitation, package inserts, where appropriate) relative to the
use of any drugs or devices used in the performance of the Study, or comply with applicable FDA or
other governmental requirements; or
(b) any negligent or wrongful act or omission, malpractice, willful malfeasance, or breach of any
a material representation or warranty given by any UNIVERSITY Indemnitee or any other
UNIVERSITY personnel (including employees, agents or independent contractors) involved in the
performance of such Study.
UNIVERSITY and each Principal Investigator understand that the sole liability of SPONSOR to any
Indemnitee, with regard to third party Claims, will be the indemnification described above.
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Conditions. It is a condition precedent to SPONSOR's indemnification obligations under Section 7.A.
above that each Indemnitee seeking indemnity hereunder must:
(a) promptly notify SPONSOR of the assertion of any Claims against it/him/her;
(b) authorize and permit SPONSOR to conduct and exercise sole control of the defense
and disposition (including all decisions relative to litigation, appeal or settlement) of such
Claims, however SPONSOR shall not settle a Claim on behalf of the UNIVERSITY without
prior written consent, such consent not to be unreasonably withheld or delayed;
(c) fully cooperate with SPONSOR regarding any such Claims (including access to
pertinent records and documents and provision of relevant testimony) and in determining the
scope of SPONSOR's obligations hereunder; and
(d) not compromise or settle any Claim, nor make any admission prejudicial to the
defense of such Claim, without the prior express written approval of SPONSOR, such
approval not to be unreasonably withheld or delayed.
Subject to the foregoing, each Indemnitee may participate in any such Claims at its/his/her own cost and
expense. Further, at any time and at its own expense, an Indemnified Party may waive its rights to
indemnification from SPONSOR and retain counsel on its own behalf. In the event any notice is not
timely received or is otherwise prejudicial to SPONSOR’s ability to timely or adequately defend such
Claim, the SPONSOR’s obligations under Section 7 are null and void.
7. Insurance.
The Sponsor shall, at its own expense, carry and maintain the following insurance or self-insurance
during the term of this Agreement, in amounts not less than that specified for each type:
a) Commercial General Liability including coverage for premises and operations, products and
completed operations, and contractual liability for all operations, with limits not less than
$1,000,000 per occurrence and $2,000,000 annual aggregate.
b) Workers’ Compensation insurance or approved self-insurance for statutory obligations imposed
by workers’ compensation and occupational disease laws. Employers’ Liability insurance with
limits not less than $500,000 for each subcategory of coverage.
c) Professional Liability with limits not less than $5,000,000 per incident and $5,000,000 aggregate
for the Sponsor, its employees, directors or officers.
Insurance coverages must be written with an insurer rated not less than A- by A. M. Best, or through an
approved self-insurance or trust program. An Insurance Certificate evidencing the above required
insurances and providing thirty (30) days written notice of cancellation must be provided to the “The
Pennsylvania State University” or “The Milton S. Hershey Medical Center”. “The Pennsylvania State
University” or “The Milton S. Hershey Medical Center” must be named as an additional insured.
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8. Subject Injury.
SPONSOR will provide reimbursement for the standard charges for the reasonable and necessary
treatment required by the Study participant for any Research Injury (defined below) caused by or derived
from the administration of the Study Drug or procedures performed under the agreed upon Protocol.
Research Injury. For purposes of this indemnification and subject injury section, the term “Research
Injury” means physical injury caused by treatment or procedures required by the Protocol that the Study
subject would not have received if the Study participant had not participated in the Study.
UNIVERSITY agrees to provide or arrange for prompt diagnosis and treatment of any Research Injury
experienced by a Study participant as soon as UNIVERSITY becomes aware of the Research Injury. It
is the policy of the UNIVERSITY to provide neither financial compensation nor free treatment for
research-related injury. Accordingly, any such treatment will be provided at the usual charge.
UNIVERSITY further agrees to promptly notify SPONSOR of any Research Injury upon becoming
aware of such injury.
9. Intellectual Property
It is recognized and understood that the original existing inventions and technologies of each Party are
the separate property or license of SPONSOR (including without limitation Study Drug/Devices) or
UNIVERSITY and are not affected by this Agreement, and neither Party shall have any claims to or
rights in such separate inventions and technologies of the other Party.
UNIVERSITY shall disclose and assign title to any new inventions, developments, or discoveries arising
directly as a result of the conduct of the Study under this Agreement ("Study Inventions") to SPONSOR.
Any invention made by employees of the UNIVERSITY, which cover a scientific process, technique,
procedure, application, device, or other process which is not unique to SPONSOR’s proprietary materials
or does not derive from SPONSOR-provided materials or information shall be owned by the
UNIVERSITY.
If the U.S. federal government asserts itself under any laws or regulations related to federally funded
research, then any intellectual property rights related to this Agreement shall be subject to such
governmental action.
10. Compensation.
SPONSOR will pay UNIVERSITY as set forth in the budget attached to this Agreement as Exhibit B.
(“Budget”).
Changes in the Budget necessitated by Protocol amendments will be subject to written amendment of this
Agreement by authorized representatives of UNIVERSITY and SPONSOR.
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11. Term and Termination.
This Agreement will commence on the date of the last signature below (the “Effective Date”) and will
continue until: (i) Study completion and receipt of final payment; or, (ii) the termination of this
Agreement by either Party in accordance with the provisions set forth below.
Either Party may terminate this Agreement for any reason at any time upon thirty (30) days prior written
notice to the other Party.
In the event of termination of this Agreement before or between a payment milestone as set forth in
Exhibit B, SPONSOR shall reimburse UNIVERSITY for the following (to the extent not covered by a
previous milestone payment): all work completed prior to termination; all reasonable non-cancellable
expenses incurred prior to termination; and, all reasonable commitments by UNIVERSITY or Principal
Investigator in accordance with the budget. Further, if applicable, SPONSOR shall reimburse
UNIVERSITY for any expenses required to bring the Study to a medically safe conclusion.
It is agreed that any duty, obligation, or liability of either Party assumed by this Agreement or any
subsequent addenda or revisions hereto shall continue until such time as the duty, obligation, or liability
ceases to exist.
12. Miscellaneous.
Notices. Any notice required under this Agreement shall be given in writing and shall be deemed
effectively given upon personal delivery to the Party to be notified, or upon receipt when sent by a
National Post Office (for dispatch by registered or certified mail, postage prepaid) or by recognized
express courier (all charges prepaid). All such notices shall be addressed to the Party to be notified at the
address set forth below, or at such other address as such party may designate by ten (10) days' advance
written notice to the other Party.
If to SPONSOR:
[Insert]
If to UNIVERSITY:
Office of Research Affairs
Room C1604 - Mail Code H138
The Pennsylvania State UNIVERSITY
College of Medicine
The Milton S. Hershey Medical Center
P.O. Box 850
500 UNIVERSITY Drive
Hershey, PA 17033
UNIVERSITY’s Principal Investigator:
______________________, M.D.
The Pennsylvania State UNIVERSITY
The Milton S. Hershey Medical Center
Department of _______________
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Room ___________
Mail Code _______
500 UNIVERSITY Drive
Hershey, PA 17033
Independent Contractor. Each Party shall be considered to be an independent Party and shall not be
construed to be an agent or representative of the other Party. In addition, neither Party, nor any of its
employees, agents, or subcontractors, shall be deemed to be employees or agents of the other Party.
Therefore, neither Party nor any of its employees, agents or subcontractors, shall be entitled to
compensation, workers compensation, or employee benefits of the other Party by virtue of this
Agreement. Furthermore, neither Party shall be deemed an agent or employee of the other and neither
shall have actual, apparent or implied authority to bind the other to any obligation whatsoever.
Assignment. Neither Party shall assign, or transfer any of its rights or obligations under this Agreement
to a third party without the prior written consent of the other Party, such consent not to be unreasonably
withheld. If there is a valid assignment or transfer, this Agreement shall be binding upon and inure to
the benefit of the Parties hereto and their respective successors or assigns.
Force Majeure. If either Party hereto shall be delayed or hindered in, or prevented from, the
performance of any act required hereunder for any reason beyond such party’s direct control, including
but not limited to, strike, lockouts, labor troubles, governmental or judicial actions or orders, riots,
insurrections, war, acts of God, inclement weather or other reason beyond the Party’s control (a
“Disability”) then such Party’s performance shall be excused for the period of the Disability. Any Study
timelines affected by a Disability shall be extended for a period equal to the delay and any affected
Study budget shall be adjusted to account for cost increases or decreases resulting from the Disability.
The Party affected by the Disability shall notify the other Party of such Disability as provided for herein.
Severability & Waiver. In the event that any provision in this Agreement will, for any reason, be held
to be invalid, illegal or unenforceable in any respect, that invalidity, illegality or unenforceability will
not affect any other provisions of this Agreement and all other provisions will remain in full force and
effect. No waiver of any term, right or condition under this Agreement on any one occasion shall be
construed or deemed to be a waiver or continuing waiver of any such term, right or condition on any
subsequent occasion or a waiver of any other term, right or condition hereunder.
Governing Law. This Agreement shall be governed in all respects by, and be construed in accordance
with, the laws of theCommonwealth of Pennsylvania.
Order of Precedence. In the event of an inconsistency between the terms and conditions of this
Agreement and the Protocol, or between this Agreement and any of its attachments, the provisions of
the Protocol shall take precedence with respect to matters of science, medical practice and patient safety.
In all other matters, the provisions of this Agreement shall take precedence.
Amendments. No modification or waiver of the provisions of this Agreement shall be valid or
binding on either party unless in writing and signed by both Parties.
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Entire Agreement. This Agreement, together with the Proposal, constitutes the entire agreement of the
Parties, superseding any and all previous agreements and understandings, whether oral or written, as to
the same subject matter.
[This remainder of this section is intentionally blank]
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IN WITNESS WHEREOF, duly authorized representatives of the Parties have executed this Agreement as
set forth below.
SPONSOR
Approved by:
Date
Name:
Title:
THE PENNSYLVANIA STATE UNIVERSITY
Approved by:
Vincent A. Falvo Date
Associate Controller, College of Medicine
THE MILTON S. HERSHEY MEDICAL CENTER
Approved by:
Kevin J. Haley Date
Chief Financial Officer
Read and Acknowledged By Principal Investigator:
_____________________________, M.D. Date
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EXHIBIT A
[PROTOCOL]
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EXHIBIT B
BUDGET
[Terms and Payment Schedule to be inserted]
INVOICE:
UNIVERSITY shall send invoices to SPONSOR at the following address:
[Insert]
Checks should be made payable to:
The Pennsylvania State UNIVERSITY
Tax i.d. #24-6000376
Payment should be mailed to:
(USPS)
The Pennsylvania State UNIVERSITY/College of Medicine
Controller's Office - Mail Code G230
P.O. Box 850
Hershey, PA 17033
ATTENTION: DEBBIE MUSSER
(Ground Delivery Only)
The Pennsylvania State UNIVERSITY/College of Medicine
Controller's Office - Mail Code G230
44 East Granada Avenue – Suite 1100
Hershey, PA 17033
ATTENTION: DEBBIE MUSSER
Please reference Principal Investigator and Protocol/Study Number on the Check and include detailed
remittance with payment.
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EXHIBIT C
CASE REPORT FORM
Subject I.D.#
Data
Page 13 of 13
