MASTER CLINICAL TRIAL/RESEARCH AGREEMENT
This Agreement is entered into as of this ____ day of ____, 1999, (the "Effective Date"), by and
between East Carolina University with an office and place of business located at 600 Moye
Blvd., Greenville, North Carolina 27858 (the "Institution") and
______________________________, with its office and place of business at
WHEREAS, Institution possesses certain expertise in the field of pharmaceutical clinical and
research related research and evaluation of such research; and
WHEREAS, (Sponsor) is interested in engaging Institution in order to obtain the benefit of such
expertise with respect to research/development projects being conducted by (Sponsor).
NOW, THEREFORE, in consideration of the premises and undertakings set forth herein,
Institution and (SPONSOR).
1. Work Orders
(a) Whenever (Sponsor) wishes Institution to perform clinical research on an
identified pharmaceutical compound(s) (the "Compound"), SPONSOR will
provide a copy of the study protocol to Institution and SPONSOR and
Institution shall agree on (a) a budget setting forth the cost for all the
activities described in the study protocol and the payment terms (the
"Budget"), (b) a designated Principal Investigator, and (c) a study
schedule for the clinical study to be performed pursuant to the study
protocol. (the Study protocol and these other items are collectively
referred to as the "Study".)
(b) For each Study in which the Institution shall participate, a Work Order, in the form
attached hereto as Attachment A, shall be prepared by SPONSOR, (a)
have attached to it as Schedule 1 thereto an originally executed Principal
Investigator Certification, (b) have attached to it as Schedule 2 thereto a
copy of the subject Study protocol (the "Protocol") and (c) be executed by
both SPONSOR and Institution. Each Work Order shall be subject to the
terms of this Agreement and is incorporated herein and upon execution
by both SPONSOR and Institution become an integral part of this
Agreement by this reference.
2. Scope of Work
For each Study conducted under the terms of this Agreement:
(A) Institution shall perform those research activities and tests with the
Compound(s) as described in the Protocol for each subject Study,
SPONSOR may, from time-to-time, in its sole discretion modify the
(B) Institution shall comply with all the terms and Requirements of the Study and
Protocol, and shall not make any changes thereto, nor deviate therefrom,
without the prior written consent of SPONSOR.
(C) Institution and Principal Investigator shall perform all services for each Study in
accordance with all generally accepted professional standards as applied
to the monitoring and/or management of clinical trials and all reasonable
efforts will be made to ensure the accuracy of all reports prepared for
SPONSOR. Institution and Principal Investigator warrant that they shall
perform all services hereunder in accordance with all rules and
regulations promulgated by the United States Food and Drug
Administration ("FDS"), including but not limited to FDA regulations
relating to informed consent (currently set forth in 21 C.F.R., Part 56 et
seq), and all other applicable state and federal laws, rules and
(D) Institution shall ensure that all employees and agents of Institution who
are assigned to perform services under this Agreement ("Project
Participants") are made aware of the obligations contained in this
Agreement and the applicable Work Order and are bound by such
(E) If any terms of this Agreement are in conflict with any terms of this Study, the
terms of this Agreement shall govern.
Payments by (SPONSOR) to Institution shall be in accordance with the terms set forth
on the respective Work Order and Budget attached thereto as Schedule 3 and shall
constitute full payment for each Study, and (Sponsor) shall have no other payment
obligations hereunder. The Budget shall be calculated using the overhead rates for the
Institution set forth in Exhibit 1 attached hereto.
4. Principal Investigator
The Principal Investigator for each Study shall be agreed upon between
(Sponsor) and Institution and designated on the Work Order. The Principal Investigator
shall be responsible for performing the Study and the direct supervision of the Project
Participants. In the event the Principal Investigator becomes unable to perform any of
the activities in the Study or complete the Study for any reason, (SPONSOR) and
Institution may mutually agree to a substitute Principal Investigator, in which event the
Work Order shall continue in full force and effect. Institution shall use it best efforts to
identify and obtain a substitute Principal Investigator acceptable to (SPONSOR). If
(SPONSOR) and Institution cannot agree on a substitute Principal Investigator,
(SPONSOR) may immediately terminate the Study in accordance with Section 10(B) and
(A) During the term of this Agreement, Institution may obtain certain confidential
information, as defined in Section 5(B), either from (SPONSOR) or from
performing the Study.
(B) "Confidential Information" shall mean any and all information, data, know-how,
whether written or oral (oral to be followed by written confirmation),
technical or non-technical, as well as tangible materials, including without
limitation, samples, models, drawings, or diagrams which Institution
received from (SPONSOR). All such materials will be marked
(C) Institution agrees to (i.) to use the Confidential Information only in connection
with its performance of this Agreement; (ii) to treat the Confidential
Information as it would its own proprietary and confidential information;
(iii) to disclose the Confidential Information only to Project Participants
that agree to be bound by these confidentiality obligations and who need
to know such Confidential Information because they are assisting with the
Study; and (iv) to take all reasonable precautions to prevent the
disclosure of the Confidential Information to any third-party without the
prior written consent of (SPONSOR).
(D) Institution shall be relieved of all obligations under this Section regarding
Confidential Information which: (1) was know to institution prior to receipt
hereunder set forth in written records; or (2) at the time of disclosure to
Institution was generally available to the public, or which after disclosure
hereunder, becomes generally available to the public through no fault of
the Institution; or (3) is hereafter made available to Institution from any
third-party having a right to do so; or (4) is required by law, regulation,
subpoena or governmental or judicial order to be disclosed, provided
Institution shall notify (SPONSOR) prior to any such disclosure to permit
(SPONSOR) to oppose same by appropriate legal action; or (5) The
Institution is a member of the North Carolina State University System and
has certain reporting obligations. The Institution may report basic
administrative information to is University system's headquarters
consisting of the title of the project (protocol name); the Sponsor; the
name of ECU's Principal Investigator(s); the estimated value of the
contract to ECU; and a layman's abstract of the project.
(A) Institution shall have the right, consistent with academic standards, to publish or
present the results of its work performed pursuant to the Study, provided
that any proposed publication or presentation is first reviewed by
(SPONSOR) in accordance with Section 6(B).
(B) Institution shall forward the Proposed Publication to (SPONSOR) at least thirty
(30) days prior to the planned submission date. (SPONSOR) shall
complete its review of the proposed publication within sixty (60) days after
its receipt of any proposed publication from Institution. If (SPONSOR)
believes that any proposed publication contains any information relating
to patentable items, the disclosure of such proposed publication to any
third party shall be delayed for up to ninety (90) days to permit the filing of
a patent application. Should (SPONSOR) request such a delay, then
upon the written request of Institution, (SPONSOR) shall use its best
efforts consistent with reasonable business and scientific practice to do all
things which it believes would expedite the filing of such patent
application. However, if at the end of such one (1) year period, despite
the use of diligent efforts on the part of (SPONSOR), additional time is
necessary or required in order to complete the filing of a patent
application, (SPONSOR) may request, and Institution shall grant, an
extension of the period of time within which to file the patent application
not to exceed one hundred and eighty (180) days. If (SPONSOR)
believes that any proposed publication contains any Confidential
Information, (SPONSOR) shall so notify Institution, and Institution shall
remove all references to such Confidential Information.
(C) Notwithstanding the foregoing, neither (SPONSOR) nor Institution shall issue a
press release that references or that uses either party's name or
trademarks without the express written consent of the other party.
Institution shall not issue a press release that references this Study or its
results without the express written consent of (SPONSOR).
7. Promotional Activities
Neither party shall use the other party or its affiliates' name or trademark for publicity or
advertising purposes without the prior written consent of the other party.
8. Patent Rights
It is expressly agreed that neither (SPONSOR) nor University transfers by operation of
Agreement to the other party any patent right or copyright right or other proprietary right
either party now owns as of the commencement of the Agreement.
Inventions made solely by University shall be the sole property of the University.
Inventions made solely by Sponsor shall be the sole property of the Sponsor. Inventions
made jointly by University and Sponsor shall be jointly owned by University and
It is further agreed that any inventions, discoveries or improvements arising out of the
study performed shall be promptly disclosed by the University to the Sponsor in writing,
and Sponsor shall have the option to obtain an exclusive, worldwide license to make,
have made, use and sell products incorporating such inventions at reasonable terms to
be negotiated by the parties. This option may be exercised by Sponsor by written notice
to the University at any time during a period of one hundred eighty (180) days after
disclosure is made to the Sponsor. In the event the Sponsor does ot exercise its option
within the specified period, the University shall be free to license to third parties.
This Agreement shall become effective on the Effective Date and shall continue in force
until it is terminated in accordance with Section 10.
(A) Either party may terminate this Agreement with or without cause upon thirty (30)
days prior written notice to the other party.
(B) Termination of this Agreement or any individual Study being performed under the
terms of this Agreement shall not affect any rights or remedies of either
party at law or in equity.
11. Scientific Communications
All scientific communications directed to the Institution, whether or not containing
Confidential Information, shall be addressed to the Principal Investigator for each Study
identified on the Work Order. All scientific communications directed to Sponsor shall be
addressed to Clinical Leader for each Study identified on the Work Order.
12. Supply of Compound
Sponsor shall use reasonable efforts to provide, free of charge, necessary amounts of
each compound(s) required for any Study being performed hereunder.
The University on its behalf accepts responsibility for its tortious acts to the extend
allowed under the North Carolina Tort Claims Act, as set forth in Article 31 of the North
Carolina General Statutes, and accepts responsibility for any and all claims, loss,
liability, demands, damages due to its own negligence or the negligence of its agents or
employees while in the performance of their duties or assignments pursuant to this
Agreement to the extent permitted by law, except that the Institution does not agree to
indemnify and/or hold harmless the Sponsor from any claims which may have resulted
from error or omission by the Sponsor and/or it s agents or employees.
14. Debarment Certification
The Institution hereby certifies that it has not and will not knowingly use in any capacity
the services of any individual, corporation, partnership or association which has been
debarred under 21 U.S.C. 335(a) or (b). In the event that the Institution becomes aware
of the debarment or threatened debarment of any individual, corporation, partnership or
association providing services to the Institution which directly or indirectly relate to
activities under this Agreement, the Institution shall notify Sponsor immediately. Upon
the receipt of such notice by Sponsor or if Sponsor otherwise becomes aware of such
debarment or threatened debarment, Sponsor shall have the right to terminate this
15. Access and Inspection
(A) The Institution agrees to allow Sponsor, its employees and agents, authorized
representatives of the FDA and other similar foreign regulatory authorities
access to the Institution, its personnel and their records for the purpose of
determining compliance with the terms of this Agreement and compliance
with FDA and other applicable laws, rules and regulations.
(B) The Institution shall notify Sponsor immediately of any impending inspection or
audit by the FDA or other federal, state or foreign governmental authority
which relates to any Study conducted under this Agreement. If such an
inspection or audit takes place without prior notice to the Institution, then
the Institution shall notify Sponsor of such inspection or audit
immediately, and in no event later than twenty-four (24) hours following
the arrival of any inspector or auditor.
16. Conflict of Interest
The Institution agrees that during the term of this Agreement it will not perform any
activity for any person or organization that substantially hinders or delays the
development or conduct of any Study to be performed under this Agreement. Nothing
herein shall prohibit the Institution from performing services for others so long as such
services do not involve unauthorized use or disclosure of Confidential Information and
do not substantially hinder or delay the development or conduct of any Study hereunder.
Substantial hindrance or delay will occur where the Institution performs services for
others which, among other things, competes for resources that are necessary for
performance of any Study hereunder and cause the Institution to meet time frames,
budget constraints, or data flow and analysis as agreed hereunder.
17. Compliance with Law
The Institution shall conduct each Study in accordance with all rules and regulations
promulgated by the FDA, and all other applicable federal, state and local laws, rules and
18. Choice of Law
This Agreement shall be construed under, and the rights of the parties hereto shall be
governed by, the law of the State of North Carolina.
This Agreement may not be assigned by Institution without prior written consent of
20. Independent Contractors
For purposes of this Agreement, Institution, Principal Investigator and Project
Participants shall not be deemed agents, servants, partners, joint ventures of employees
of Sponsor. Thus, they do not have the authority to take action on Sponsors' behalf or to
bind Sponsor with Sponsors' prior written consent. The Institution, Principal Investigator
and Projects participation are acting in the capacity of independent contractors of
21. No Waiver
Either partys' failure to require the other party to comply with any provision of this
Agreement shall not be deemed a waiver of such provision or any other provision of this
22. Force Majeure
In the event of a delay caused by inclement weather, fire, flood, strike or other labor
dispute, act of God, act of governmental officials or agencies, or any other cause beyond
the control of the Parties, the Party or Parties so affected shall be excused from
performance other than payments by the Sponsor under this Agreement for the period of
time attributable to such delay. In the event of such delay, this Agreement may be
revised by changing the fixed price, performance period, and other provisions, as
appropriate, by mutual written agreement of the Parties.
Whenever any notice is to be given hereunder to the Institution, it shall be in writing and
sent by certified receipt mail to the address of Institution as set forth above. Notices sent
to Sponsor shall be addressed to the Clinical Leader identified on the Work Order, with a
copy to the "Corporate Secretary," at the address as set forth first above. Notices to the
Principal Investigator shall be sent to the Institution. Any notice given hereunder shall be
deemed effective five (5) days after being mailed. Copies of all notices shall be sent to
the Office of Sponsored Programs, Attn: Dorothy Baker, 178 Ed Warren Life Sciences
Bldg., East Carolina University, 600 Moye Blvd., Greenville, NC 27858.
24. Entire Agreement
This Agreement represents the entire understanding of the parties with respect to the
subject matter hereof. Except for the Protocol which will be attached to each Work
Order, which may be modified in accordance with Section 2(B), any modification,
amendment or supplement to this Agreement or Exhibits and/or Attachments attached
hereto shall be in writing signed by an authorized representative of both parties.
This Agreement may be executed in several counterparts, each of which shall be
deemed an original but all of which shall constitute on and the same instrument.
If any clause, section or paragraph of this Agreement is determined by a court of
competent jurisdiction to be illegal, invalid or unenforceable, it will be deemed severed
from the remainder of this Agreement and will have no effect on the legality, validity or
enforceability of the remaining provision of this Agreement.
27. Non-Disclosure of Agreement Terms
The parties agree not to disclose the terms of this Agreement to any third parties except
for their respective affiliates, and such affiliates shall make no further disclosure of any of
the terms of this Agreement. "Affiliate" shall mean any corporation, partnership and
other business entity, and the employees and agents thereof, which directly or indirectly,
control, are controlled by or are under common control of either party.
28. Survival of Provisions
Sections 5, 6, 7, 8, 13, 15, 17, 18, 20, and 28 hereof shall survive termination or
expiration of this Agreement.
IN WITNESS THEREOF, Sponsor and Institution have caused this Agreement to be
executed by their respective duly authorized representatives as of the date written below.
SPONSOR EAST CAROLINA UNIVERSITY
By: ___________________________ BY: ____________________________
NAME: ________________________ Name: __________________________
Title: __________________________ Title: ___________________________
Date: __________________________ Date: ___________________________
Facilities and Administrative Rates for Institution
The facilities and administrative rates set forth hereon shall be in effect for the period
commencing on the effective date of this Agreement and ending on the second anniversay
thereof. No later than ninety (90) days prior to the second anniversary and each succeeding
biennial anniversary of the effective date of this Agreement, Institution shall provide Sponsor
notice of the new facilities and administrative rate which it intends to charge for the following two
(2) year period, along with a detailed explanation supporting the increase in the prior facilities
and administrative rate. The parties will agree and confirm the new facilities and administrative
rate in writing no later than fifteen (15) business days prior to the anniversary date of this
Facilities and Administrative Rate
Clinical Research 39.5%
Clinical Drug Studies 20%
Institutional IRB Fees
ECU does have a non-refundable $1,500 per protocol IRB fee. Payment of this fee can be
addressed in the body of the agreement, as part of the budget attachment, or in a separate
This Work Order is issued pursuant to the Master Clinical Trial Agreement, dated as of April 1,
Sponsor, with its office and place of business at
East Carolina University, with an office and place of business at 600 Moye Blvd., Greenville, NC
27858, and incorporates all of the terms and conditions therein (the "Agreement").
Any capitalized terms not otherwise defined herein shall have the same meaning ascribed to
them in the Agreement.
Principal Investigator(s) Name: ___________________________________
Principal Investigator(s) Address: ___________________________________
A copy of the Principal Investigator's Certification is attached hereto as Schedule 1 and is
incorporated herein by this reference.
Protocol Title and Number:
________________________________________ (the "Study").
A copy of the Protocol is attached hereto as Schedule 2 and incorporated herein by this
Sponsor's Clinical Leader: _________________________________________
Correspondence to Sponsor's Clinical Leader can be addressed to the address first listed
1. Study Initiation and Completion.
(a) All contractual and regulatory documentation must be completed,
executed and received by Sponsor no later than ______________.
(b) The Study shall be initiated no later than _______________________ ("Initiation
Date") and shall be completed no later than ______________ ("Completion
Study Budget, Payment Recipient and Mailing Address
1. Institution shall provide Sponsor with a detailed budget for the Study.
2. Payment by Sponsor for the Study will be as follows:
(Terms to be determined for each individual study)
3. Payment as set forth in this Work Order shall constitute full payment for
the Study and Sponsor shall have no other payment obligations
4. The name and address of the payee for all payments due to Institution
East Carolina University
Attn: Cashier, SOM Business Office
1N16 Brody Medical Sciences Bldg.
Greenville, NC 27858
Tax ID Number of the payee: 566000403
5. Site mailing address for correspondence (if different from mailing address
Grant and Contract Officer
Office of Sponsored Programs
178 Ed Warren Life Sciences Bldg.
East Carolina University
Greenville, NC 27858
This Work Order is entered into and made effective as of ________________.
ACCEPTED AND AGREED TO BY:
East Carolina University SPONSOR
Typed Name & Title Typed Name & Title