Clinical Research Study Agreement - Novoste Corp. and Emory University
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. ---------------------- 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. -------------- 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. 1 <PAGE> (3) INDEMNIFICATION. --------------- An "Indemnification Agreement for Clinical STUDY" is attached as Exhibit C and is incorporated for reference. (4) UNIVERSITY AND NOVOSTE CONTACTS. ------------------------------- 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. --------------------- 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. ---------------- (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 2 <PAGE> committed pursuant to the protocol. Any unexpended funds not due under this calculation but already paid shall be returned to Novoste. (7) INDEPENDENT CONTRACTOR. ---------------------- 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. ------------ 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. --------------- (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. 3 <PAGE> (b) PROPRIETARY INFORMATION. ----------------------- (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 4 <PAGE> contained in this Agreement for a period of five (5) years after the termination of this Agreement. (10) INVENTIONS AND PATENTS RIGHTS. ----------------------------- 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. (11) DATA OWNERSHIP. -------------- 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. 5 <PAGE> 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. (13) TERMINATION. ----------- 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 reasons: (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 6 <PAGE> 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. (14) MODIFICATIONS. ------------- 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 effective. (15) GOVERNING LAW. ------------- This Agreement shall be governed by and construed in accordance with the laws of the state of Georgia. (16) ARBITRATION. ----------- 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. (17) SEVERABILITY. ------------ 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. 7 <PAGE> IN WITNESS WHEREOF, the undersigned Parties have caused this Agreement to be executed by their duty authorized representatives. EMORY UNIVERSITY By: /s/ 1/30/96 ------------------------------------- ------------------ Authorized Official Date By: /s/ 1-30-96 ------------------------------------- ------------------ Principal Investigator Date /s/ ------------------------------------- Title NOVOSTE By: /s/ ------------------------------------- Date: 1/30/96 ------------------ Title: President & CEO ---------------------------------- Witness: -------------------------------- Date: ---------------------------------- 8 <PAGE> 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. <PAGE> Exhibit B Emory HIC Study Approval Emory Committee I Approval <PAGE> [LETTERHEAD OF EMORY UNIVERSITY SCHOOL OF MEDICINE] 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 approval. 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. Sincerely, /s/ T. Hersh Theodore Hersh, M.D. Chairman Human Investigations Committee cc: Department Chair Office of Sponsored Programs THE ROBERT W. WOODRUFF HEALTH SCIENCES CENTER <PAGE> [LETTERHEAD OF EMORY UNIVERSITY SCHOOL OF MEDICINE] 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 <PAGE> Exhibit C Indemnification Agreement <PAGE> EXHIBIT C INDEMNIFICATION AGREEMENT FOR CLINICAL STUDY --------------------------------------------- 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. WITNESSETH THAT: 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 follows: 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 party's 9 <PAGE> 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 employees. 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. 10 <PAGE> 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 below. 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 ----------------------------- --------------- <PAGE> Exhibit D Proposed Budget Payment Schedule <PAGE> Preliminary Budget NOVOSTE 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 ------- $150,727 Overhead @ 30% 45,218 TOTAL $195,945 4/25/95 <PAGE> [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 Definitions: ----------- 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.