Clinical Research Study Agreement

EXHIBIT 10.3


CLINICAL RESEARCH STUDY AGREEMENT


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").


WITNESSETH THAT:


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:


(1) PRINCIPAL INVESTIGATOR.
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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 INVESTIGATORs).


(2) HUMAN SUBJECTS.
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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.


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


(4) UNIVERSITY AND NOVOSTE CONTACTS.
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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.


(5) PERIOD OF PERFORMANCE.
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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.


(6) PAYMENT SCHEDULE.
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(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


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


(7) INDEPENDENT CONTRACTOR.
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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.


(8) PUBLICATIONS.
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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.


(9) CONFIDENTIALITY.
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(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 INVESTIGATORs.


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(b) PROPRIETARY INFORMATION.
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(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 provisions


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


(10) INVE ...