MASTER CLINICAL TRIAL/RESEARCH AGREEMENT

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MASTER CLINICAL TRIAL/RESEARCH AGREEMENT Powered By Docstoc
					                    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
____________________________________________________ (Sponsor).

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
                       Protocol.
       (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
                     regulations.
     (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
                     obligations.

     (E)    If any terms of this Agreement are in conflict with any terms of this Study, the
                    terms of this Agreement shall govern.

3.   Payment
     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
     10(C).
5.   Confidentiality
     (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
                       "Confidential".
     (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.
6.   Publications
     (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
      Sponsor.
      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.
9.    Term
      This Agreement shall become effective on the Effective Date and shall continue in force
      until it is terminated in accordance with Section 10.
10.   Termination
      (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.
13.   Indemnification
      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
      Agreement immediately.
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
      regulations.
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.
19.    Assignment
      This Agreement may not be assigned by Institution without prior written consent of
      Sponsor.
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
      Sponsor.
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
      Agreement.
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.
23.     Notices
       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.
25.     Counterparts
       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.
26.     Validity
       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: ___________________________

                                            Exhibit 1
                        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
Agreement.

                                 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
letter.


                                         Attachment A

                                          Work Order

This Work Order is issued pursuant to the Master Clinical Trial Agreement, dated as of April 1,
1999, between:

Sponsor, with its office and place of business at

And

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: ___________________________________

                                     ____________________________________

           Phone:    ___________________
           FAX:     ___________________

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
reference.

Sponsor's Clinical Leader: _________________________________________
Correspondence to Sponsor's Clinical Leader can be addressed to the address first listed
above.

Study Schedule:

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
                  date").

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
       hereunder.

4.     The name and address of the payee for all payments due to Institution
       hereunder is:

       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
      for payments.

       Dorothy Baker
       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


___________________________         _____________________________
Signature                              Signature


___________________________         _____________________________
Typed Name & Title                    Typed Name & Title


__________________________          _____________________________
Date                                    Date

				
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