Sample Business Contracts

Clinical Research Study Agreement - Novoste Corp. and Emory University

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This Agreement is entered into as of the 30th day of January, 1996, by and
between Novoste Corporation, located at 4350-C INTERNATIONAL BLVD., Norcross,
Georgia 30093 (hereinafter referred to as "Novoste") and Emory University at
1784 North Decatur Road, Suite 510, Atlanta, GA 30322 (hereinafter referred to
as "University").


The University agrees to conduct a clinical research study (the "STUDY")
entitled "Beta Energy Restenosis Trial" according to the protocol attached as
Exhibit A. In this undertaking, the University agrees to devote reasonable
efforts in order to perform efficiently the work required under this Agreement.
The University agrees that it will comply with all applicable laws, rules and
regulations relating to the conduct of such STUDY, particularly such laws, rules
and regulations concerning or promulgated by the Food and Drug Administration.
To the extent any portions of Exhibit A are inconsistent with this Agreement,
the terms of this Agreement shall govern.

NOW THEREFORE, in consideration of the foregoing and the mutual covenants herein
below set forth, the parties hereto agree as follows:


The STUDY performed under this Agreement will be under the direction of Spencer
B. King III, M.D. (hereinafter referred to as "INVESTIGATOR"). All University
employees involved in the clinical research study (hereinafter referred to as


This protocol has been approved by the University's Institutional Review Board
(Exhibit B) and NOVOSTE. The University shall obtain from each of the patients
participating in this STUDY, advance informed consent in compliance with 21 CFR
50.1 through 50.27 and any modifications thereof as may be adopted. Novoste will
reimburse the University and/or the patient for reasonable costs and expenses
incurred in diagnosing and treating unanticipated adverse effects, injuries,
illnesses, or reactions that result from the use or application of Novoste's
investigations, drugs or devices in the course of this STUDY.




An "Indemnification Agreement for Clinical STUDY" is attached as Exhibit C and
is incorporated for reference.


The University's scientific contact for this Agreement will be Dr. King at (404)
712-4467. The University's administrative contact for this Agreement will be
Nancy Wilkinson, at (404) 727-2503. Novoste's scientific contact will be Dr.
Joan Macdonald, at (770) 717-0904. Novoste's administrative contact will be Dr.
Jonathan Rosen at (770) 717-0904.


The term of this Agreement shall be from the date this Agreement is mutually
executed until the STUDY is either completed or terminated. It is anticipated
that the STUDY will begin on or about January 22, 1996 and be completed on or
about December 31, 1996.


    (A) Payments shall be made payable to EMORY UNIVERSITY and forwarded to the
    following address:

        Ms. Marilyn Surbey
        Assistant Vice President for Finance
        Office of Grants and Contracts Accounting
        Emory University
        1784 N. Decatur Road
        Suite 530
        Atlanta, GA 30322
        (404) 727-4240

    It is agreed that Novoste will reimburse the University on a per patient
    basis and for the total amount of the study not to exceed one hundred
    ninety-five thousand nine hundred forty-five dollars ($195,945) in
    accordance with the approved budget and payment schedule attached as Exhibit
    D. Novoste acknowledges that the University has included its indirect costs
    for this clinical STUDY. For purposes of identification, payments will
    include the title of the STUDY and the name of the INVESTIGATOR.

    (B) In the event of termination, the sum for professional services and
    expenses payable under this Agreement shall be limited to the prorated fees
    based on actual work performed and actual expenses


    committed pursuant to the protocol. Any unexpended funds not due under this
    calculation but already paid shall be returned to Novoste.


Each party to this Agreement shall act as an independent contractor and shall
not be construed for any purpose as the agent, employee, servant or
representative of the other party, and neither party shall enter into any
contract or agreement with a third party which purports to obligate or bind the
other party. Neither party shall be liable for any obligation incurred by the
other except as expressly provided for herein.


Novoste acknowledges the University, INVESTIGATOR and INVESTIGATORs publication
privileges under the Agreement. However, notwithstanding the confidentiality
provisions or any other provision, the University, INVESTIGATOR and
INVESTIGATORs acknowledge that Novoste may have proprietary interests and agree
to submit a manuscript to Novoste for review sixty (60) days prior to submission
for any oral presentation or written publication. Novoste shall then have forty-
five (45) days to respond to the University, INVESTIGATOR and INVESTIGATORs with
any requested revisions. Novoste shall have the right to edit such proposed
disclosure to remove any Novoste PROPRIETARY INFORMATION or information
reasonably necessary to protect Novoste's competitive position and to delay the
publication of any invention for a reasonable period of time(not to exceed 4
months), to enable Novoste to file or have filed a Patent application to protect
any invention disclosed therein.


    (a) Novoste acknowledges that the INVESTIGATOR and INVESTIGATORs are
currently employed in Emory University's Department of Cardiology and Radiation
Oncology and as such have full time academic, service and research
responsibilities to Emory. In connection with such Emory employment, the
INVESTIGATOR and INVESTIGATORs have entered into certain Agreements with Emory
relating to the ownership of intellectual property rights, conflicts of interest
and other matters and is subject to certain policy statements of Emory
(collectively defined as the Emory Agreements). If any provision of this
Agreement is in conflict with any Emory Agreement, then the Emory agreement
shall govern to the extent of such conflict and the conflicting provisions of
this Agreement shall not apply. The INVESTIGATOR and INVESTIGATORs agree to
furnish Novoste with copies of any Emory Agreements with the INVESTIGATOR and



        (i) INVESTIGATOR and INVESTIGATORs acknowledge that during the course of
performing services hereunder, Novoste may disclose information to the
INVESTIGATOR and INVESTIGATORs which Novoste considers proprietary trade secret
information. Any such information, shall be disclosed to the INVESTIGATOR and
INVESTIGATORs in written or oral form and marked as Novoste PROPRIETARY
INFORMATION. If Novoste is unable to first disclose such information in written
form, Novoste shall, within sixty (60) days of first disclosing such information
provide the INVESTIGATOR and INVESTIGATORs with a copy of such information in
written form and marked as Novoste PROPRIETARY INFORMATION.

        (ii) The INVESTIGATOR and INVESTIGATORs shall not disclose any Novoste
PROPRIETARY INFORMATION to any third person or entity, other than
representatives or agents of Novoste. The INVESTIGATOR and INVESTIGATORs shall
treat all such information as confidential and proprietary property of Novoste.

        (iii) The term "PROPRIETARY INFORMATION" shall not include information
that: (i) is or becomes generally available to the public other than by
disclosure in violation of this Agreement; (ii) was within the INVESTIGATOR and
INVESTIGATORs possession prior to being furnished to INVESTIGATOR and
INVESTIGATORs by Novoste hereunder; (iii) becomes available to INVESTIGATOR and
INVESTIGATORs on a nonconfidential basis from a party which does not have a
confidential obligation to Novoste respecting such information; or (iv) is
independently developed by INVESTIGATOR and INVESTIGATORs without reference to
any information received from Novoste by INVESTIGATOR and INVESTIGATORs.

        (iv) The INVESTIGATOR and INVESTIGATORs may disclose any PROPRIETARY
INFORMATION that is required to be disclosed by law, government or court order.
If disclosure is required, the INVESTIGATOR and INVESTIGATORs shall give Novoste
advance notice so that Novoste may seek a protective order or take other action
reasonable in light of the circumstances.

        (v) Upon termination of this Agreement, the INVESTIGATOR and
INVESTIGATORs shall promptly return to Novoste all materials containing
PROPRIETARY INFORMATION as well as data, reports, records and other property
furnished by Novoste to the INVESTIGATOR and INVESTIGATORs, together with all
copies of any of the foregoing. Notwithstanding such return, the INVESTIGATOR
and INVESTIGATORs shall continue to be bound by the terms of the confidentiality


contained in this Agreement for a period of five (5) years after the termination
of this Agreement.


10.1 The University understands and acknowledges that Novoste has been engaged
in a continuous research, design development and marketing program with respect
to the Beta Energy Restenosis Project ("THE SYSTEM") and that Novoste has filed
United States patent application, Serial No.: 08/330,327, which names Drs.
Waksman and Crocker, both employees of the University, and certain Novoste
employees as inventors entitled "Method and Apparatus for Treating a Desired
Area in the Vascular System of a Patient". The University acknowledges and
agrees that Novoste shall have a worldwide Exclusive Agreement to make, use and
sell devices, methods or services claimed in such patent application and any
reissues, renewals, extensions, divisionals, continuations, continuations-in-
part, and patents which issue thereon, including reexamined and reissued patents
and any foreign counterparts of such patent applications and issued patents, in
accordance with the Worldwide Exclusive Agreement of even date herewith
("Exclusive Agreement"). Such Exclusive Agreement shall cover any inventions or
discoveries made by University employees during the course of this and any other
research or clinical trials regarding THE SYSTEM sponsored by Novoste
("University Study Inventions").

10.2 The University shall promptly disclose all University Study Inventions to
Novoste in written form. Any such University Study Inventions for which Novoste
pursues patent protection shall be considered a Licensed Patent under the
Exclusive Agreement. Any such University Study Inventions for which Novoste
declines to pursue patent protection shall be considered Licensed Technology
under the Exclusive Agreement. The University shall delay any public disclosure
of any University Study Inventions for at least ninety (90) days from the date
the University discloses it to Novoste to enable Novoste to pursue patent
protection. Such delay may be extended upon the agreement of both parties.


The University shall retain ownership of any medical records, including but not
limited to,  patient specimens, x-rays, angiograms, EKG's, ultrasonic images and
recording, and other patient medical data generated during clinical studies
conducted at Emory University under this Agreement. The University shall, within
the bounds of legal requirements, make such medical records, patient specimens,
x-rays, angiograms, EKG's, ultrasonic images and recording, and other patient
medical data generated under this Agreement available for audit, review and
copying by Novoste.


Novoste shall retain ownership of all completed case medical record forms,
research notebooks prototypes, devices, supplies, radiation sources, and
equipment provided by Novoste. The University shall be entitled to retain a
confidential copy of the case medical record forms, without duplication, subject
to sections 8, 9, 10 of this Agreement.

Subject to the Publications and Intellectual Property provisions of this
Agreement, Novoste shall have access to all clinical data and may freely use
such data in connection with any of its research, development, marketing or
promotional activities and may be disclosed by Novoste to other clinical
centers, consultants, the Food and Drug Administration and other Federal, State
and/or local regulatory agencies.

(12) PUBLICITY.   Novoste will not include the University in any advertising,
sales promotion or other publicity material without the prior written approval
of the University. Likewise, the University will not name Novoste in any
advertising, sales promotion, or publicity without the express written consent
of Novoste. The University will reference Novoste in all scientific and clinical
publications related to the STUDY if Novoste so requests and if Novoste provides
prior written approval.


The STUDY may be terminated prior to completion by written notice from Novoste
to the University or by the University to Novoste for any of the following

(A)  Notification to Novoste or the University from federal or state regulatory
     authorities to terminate said STUDY;

(B)  Determination by Novoste or the University that the University, after a
     reasonable opportunity, is unable for any reason to perform the STUDY
     satisfactorily as required in the protocol; or

(C)  Inability of the INVESTIGATOR to continue the STUDY at the University and a
     successor acceptable to both the University and Novoste is not available.

Written notice of the decision to exercise such termination right shall be given
to the University by Novoste or to Novoste by the University by certified mail,
delivered ten (10) days before said termination of the STUDY. Immediately upon
receipt of a notice of termination by either Novoste or the University, the
University shall stop entering patients into the STUDY and


shall cease conducting procedures, to the extent medically permissible, on
patients already entered into the Study protocol. In the event of termination,
expenses payable to the University shall be as stated in paragraph 6B.

Termination or completion of this Agreement, however, shall not relieve the
obligations undertaken by the parties in paragraphs 3, 8, 9, 10, 12 and 13.


Any alteration in or amendment to this Agreement must be approved in writing by
the University and Novoste prior to such alteration or amendment becoming


This Agreement shall be governed by and construed in accordance with the laws of
the state of Georgia.


In the event that there is any dispute between the parties hereto, the parties
agree to submit the matter to binding arbitration in Atlanta, Georgia in
accordance with the commercial rules of the American Arbitration Association
then applicable before a panel of three arbitrators. The decision of the panel
of arbitrators shall be final, binding and conclusive upon the parties hereto
and judgment thereon may be entered in any court having jurisdiction. The costs
of such arbitration shall be paid or reimbursed by the non-prevailing party.


In the event that any provision of this Agreement is held to be invalid,
prohibited or unenforceable for any reason, such provision shall be ineffective
without invalidating the remaining provisions of this Agreement. Notwithstanding
the foregoing, if such provision could be more narrowly drawn so as not to be
invalid, prohibited or unenforceable, it shall be so narrowly drawn without
invalidating the remaining provisions of the Agreement.


IN WITNESS WHEREOF, the undersigned Parties have caused this Agreement to be
executed by their duty authorized representatives.


By: /s/                                       1/30/96
   -------------------------------------      ------------------
   Authorized Official                        Date
By: /s/                                       1-30-96
   -------------------------------------      ------------------
   Principal Investigator                     Date



By: /s/       

                                             Date:     1/30/96

Title:     President & CEO




                                Exhibit A/(1)/
                            Clinical Study Protocol

                                  Pages 1-29
(1) Confidential treatment has been requested for this entire Exhibit A,
    consisting of 29 pages. The copy filed herewith omits the information
    subject to the confidentiality request. The portions omitted have been filed
    separately with the Securities and Exchange Commission pursuant to such
    request for confidential information.

                                   Exhibit B

                           Emory HIC Study Approval
                          Emory Committee I Approval


February 16, 1995

Spencer King, M.D.
Andreas Gruentzig Cardiovascular Center
F606, Emory University Hospital

RE: HIC Protocol No: 809-94

Dear Dr. King:

Your research proposal entitled "Beta Energy Restenosis Trial" and informed
consent form have been approved by the Human Investigations Committee.

This approval is valid for one year. Any serious reactions resulting reaction
from this study should be reported immediately to the Committee, to the
Departmental Chairperson, and to any sponsoring agency or company. Approval is
contingent upon your agreement to obtain informed consent from your subjects, to
abide by the policies and procedures of Emory University School of Medicine with
regard to use of human subjects in investigation in keeping with the University
Assurance Document, and to keep appropriate records concerning your subjects.
Brochures or manuals describing the study which are given to volunteers or
patients and advertisements for the study must be submitted to the Committee for

Projects which are being submitted to agencies or other sponsors for external
funding must also be approved through the Office of Sponsored Programs prior to
initiation of the study.

Please note that this protocol has been assigned the above referenced HIC
protocol number. All inquiries and correspondence concerning this protocol must
include this number.

/s/ T. Hersh
Theodore Hersh, M.D.
Human Investigations Committee

cc: Department Chair
    Office of Sponsored Programs



TO:      File

FROM:    Stan Wilson, M.M.Sc.
         Deputy RSO

DATE:    March 16, 1995

RE:      New Authorization

The purpose of this note is to announce the issuance of a new authorization for
Human Use of radioactive materials. Committee I, the Human Use Radioisotope
committee has approved ballots for the application for Radiation Oncology
Research Protocols submitted by Dr. Ian Crocker. Current allowed materials are:

         /90/Sr - 2000 mCi in the form of sealed sources and
         /125/I - 1000 mCi in the form of sealed sources.

The file number for this authorization is RH045.

The signed authorization including significant conditions will be prepared soon.

Please call if I may be of any further assistance.

cc:   Dr. Lisella
      Betty Goetz
      Application file
      Reading file

                                   Exhibit C

                           Indemnification Agreement

                                   EXHIBIT C


Beta Energy Restenosis Trial ("BERT") designed to evaluate the safety and
efficacy of low dose beta radiation in the inhibition and prevention of intimal
hyperplasia following balloon angioplasty.

    This Agreement is by and between Emory University, hereinafter referred to
as "UNIVERSITY", and Novoste Corporation, hereinafter referred to as "NOVOSTE".
It shall become effective on or about the 22nd day of January, 1996.


    WHEREAS, NOVOSTE has planned to conduct certain studies as described in the
protocol attached hereto and made a part hereof, which protocol shall be signed
by the physicians responsible for conducting the studies; and

    WHEREAS, the UNIVERSITY is willing to perform said studies and recognizes
the need for medical professional liability indemnification;

    NOW, THEREFORE, IT IS UNDERSTOOD AND AGREED UPON by the parties hereto, as

1.  NOVOSTE agrees to defend, indemnify and hold harmless the UNIVERSITY, its
    trustees, its employees, and its affiliated hospitals and The Emory Clinic,
    its partners and employees, and the UNIVERSITY agrees to defend, indemnify
    and hold harmless NOVOSTE, its executive management and authorized agents,
    from and against any and all liabilities, suits, proceedings, claims,
    demands, debts, costs (including legal costs), obligations and actions of
    any kind by anyone for any loss, damage, injury or loss of life which
    results from the performance of this clinical STUDY and attributable to or
    arising from (a) negligence, wrongful act(s), or wrongful failure to act on
    the part of the indemnifying party, (b) the indemnifying party's violations
    of any federal or state law, rule or regulation, (c) the indemnifying

    actions or inactions in furtherance of the STUDY, (d) the indemnifying
    party's breach or default in the performance of the obligations to be
    performed in connection with the STUDY, (e) the indemnifying party's
    activities or operations, or (f) any material deviation by the indemnifying
    party from the protocol or other written recommendations or instructions
    furnished by NOVOSTE for the STUDY.

2.  NOVOSTE shall provide evidence to the UNIVERSITY, within thirty (30) days
    after the effective date of this Agreement, that it has sufficient liability
    insurance or such other adequate forms of protection, as satisfactory to the
    UNIVERSITY, to satisfy its indemnification obligation.

3.  The UNIVERSITY shall, at the request of NOVOSTE, provide evidence to NOVOSTE
    that it has such liability insurance or other forms of protection as is
    necessary and proper, against negligence, wrongful act(s), or wrongful
    failure to act on the part of the UNIVERSITY, its trustees, its employees,
    or its affiliated hospitals and The Emory Clinic, its partners and

4.  The UNIVERSITY shall obtain from each of the patients participating
    in the STUDY, advance informed consent in compliance with 21 CFR
    50.1 through 50.27 and any modifications thereof as may be adopted by
    the U.S. Government.

5.  The Indemnifying Party shall notify the Indemnified Party in writing of any
    claims of loss, damage, injury or loss of life arising from this clinical
    STUDY within thirty (30) days after the Indemnified Party has knowledge of
    the claim.

6.  The Indemnifying Party shall allow the Indemnified Party and/or its insurer
    the right to assume direction and control of the defense against such claims
    or suits thereon, including without limitation the right to select defense
    counsel and the right to settle such claims or suits at the sole discretion
    of the Indemnified Party or its insurer.


7.  The Indemnifed Party shall in all ways cooperate fully with the Indemnifed
    Party and its insurer in defending against, and disposing of, any such
    claims or suits.

8.  The UNIVERSITY shall have kept and make available to NOVOSTE all records
    concerning the STUDY.

    In Witness Whereof, the undersigned Parties do hereby agree to the terms and
    conditions of this Agreement, as evidenced by the authorized signatures

UNIVERSITY:   By:  /s/ Charles Hatcher             Date:  2/6/96
                 -----------------------------           ---------------
                 Dr. Charles Hatcher
                 Vice President for Health Affairs

NOVOSTE:      By: /s/                              Date:  1/30/96
                 -----------------------------           ---------------

Witness:      By: /s/                              Date:  1/30/96
                -----------------------------           ---------------

                                   Exhibit D

                                Proposed Budget
                               Payment Schedule

                              Preliminary Budget

Radiation charges (beginning of study - $400/patient)   $  400
6 month follow up cath (outpatient cath lab)             1,500
Angiography core lab                                       500
40 patient @                                            $2,400/patient   $96,000

Research Nurse @ 50%                                   $30,631
Coordinator @ 50%                                       24,727
                                                       $54,727            54,727

Overhead @ 30%                                                            45,218

TOTAL                                                                   $195,945


                            [LETTERHEAD OF NOVOSTE]

Payments will bc made to the University on the following basis:

Start of Trial         $ 20,800.00       100% Radiation charges + OH
Start of Trial         $ l7,787.00        25% Admin. Support + OH
Quarterly (3)          $ 17,786.00        25% Admin. Support + OH
Start of F/U           $ 39,000.00        50% Outpatient Cath + OH
End of F/U             $ 39.000.00        50% Outpatient Cath + OH
End of Core            $ 26.000.00       l00% Core Lab Analysis + OH
Totals                 $195,945.00     


Start of Trial:  Procedure performed on first patient
Quarterly:       Admin support paid over twelve months in four payments starting
                 with "Start of Trial".
Start of FIU     First Patient Receives Follow-up Angio at 6 months from "Start
                 of Trial".
End of F/U       40th Patient Receives 6 month Angio
End of Core      Novoste Receives Final Report on Core Lab Analysis
OH               Emory University Overhead Rate of 30.0%

All Payments to be received within l0 days of scheduled events.
All Payments assume completion of Study Protocol with 40 patients.