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Document Preview Clinical Research Services Agreement |
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Title: |
Clinical Research Services Agreement |
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Date: |
2004 |
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Preview shows 16KB of 54KB total |
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$36 |
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ID: |
#1263538 |
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CLINICAL RESEARCH SERVICES AGREEMENT
This AGREEMENT, entered into as of October 24, 2001, is by and between Clinical Cardiovascular Research, LLC, a limited liability company established under the laws of the Commonwealth of Virginia, with offices located at Montvale Center, 18310 Montgomery Village Avenue, Suite 620, Gaithersburg, Maryland 20879 (hereinafter referred to as C2R), and Cardio Vascular Genetic Engineering, having its principal place of business at 14272 Franklin Avenue, Suite 110, Tustin, CA 92780 (hereinafter referred to as Sponsor).
WHEREAS, C2R is a clinical research organization dedicated to the clinical development of investigational drugs and devices for cardiovascular indications which provides sponsors of investigational drugs and devices comprehensive clinical management services, design, implementation, execution and analysis of clinical trials for drugs and devices to treat cardiovascular disorders, access to patients with a variety of cardiovascular ailments, expert assistance in the medical and commercial evaluation of a products profile in selection of an optimum indication, and assistance in the preparation of detailed clinical development plans, regulatory strategies, and protocols;
WHEREAS, Sponsor desires to utilize the services of C2R to assist Sponsor in the clinical development of an investigational drug for cardiovascular indications;
NOW, THEREFORE, the parties hereto, intending to be legally bound, have entered into this Agreement and do specifically agree as follows:
| 1. | RFP RESPONSE, PAYMENT SCHEDULE AND ADDITIONAL STUDIES |
| 1.1 | The RFP RESPONSE - CVE 2001 describes the services to be performed hereunder and is attached hereto as Exhibit A (RFP Response). C2R will perform services for Sponsor in connection with the studies (Study) referenced in Section E. BUDGET of the RFP Response. The RPF Response describes pricing for the Study and a schedule of specific responsibilities. Exhibit B (Payment Schedule) contains the specific payment schedules for the Study. Exhibit C (Additional Studies) contains the conditions under which C2R will be granted rights to conduct additional studies of FGF-1 for Cardio. The RFP Response, Appendix B and Appendix C, which shall be approved by Sponsor, are deemed part of this Agreement and are incorporated herein by reference; |
| 1.2 | Upon signing this agreement, Cardio shall pay C2R a sum of $10,000 to cover the initial filling of the FDA Form 1572. Within 7 days of notification of the FDA that the Study may proceed, Cardio shall pay C2R the remainder of the prepayment - $154,554.25. |
Clinical Cardiovascular Research, LLC
Clinical Research Services Agreement
| 1.3 | C2Rs Federal Tax ID # is 541832201. After initial prepayment, payments are to be made net 30 days receipt of invoice to the order of: |
Clinical Cardiovascular Research, LLC
Montvale Center
18310 Montgomery Village Avenue, Suite 620
Gaithersburg, Maryland 20879
| 2. | STUDY DEVICE AND MATERIALS |
| 2.1 | Sponsor shall provide C2R with copies of the protocol for the Study and such related materials as may be in Sponsors possession and necessary to enable C2R to fulfill its obligations under this Agreement. |
| 2.2 | Sponsor shall provide sufficient amounts of all devices, materials, or other substances with which to perform the Study, as well as such sufficient and comprehensive data as may be required by C2R concerning the stability of the test materials, storage, and safety requirements. |
| 2.3 | Sponsor guarantees that no device or test material(s) supplied by Sponsor in connection with the Study or the performance of services is adulterated or mislabeled; and that the clinical supplies (including any reference products used in the Study) provided by Sponsor are identical in content to the description provided in the Protocol. |
| 3. | COMPLIANCE WITH GOVERNMENT REGULATIONS |
| 3.1. | C2R will perform the Study in accordance with the Protocol. C2R will also comply in all material respects with all current government regulatory requirements concerning Good Clinical Practices applicable at the time of study initiation. |
| 3.2. | Should such government regulatory requirements be changed, C2R will make every reasonable effort to satisfy the new requirements. In the event that compliance with such new regulatory requirements necessitates a change in the Protocol for the Study, C2R will submit to Sponsor a revised Line Item Charge for Sponsors acceptance prior to making any changes in the Protocol or Study. |
| 4. | SPONSOR VISITS TO FACILITIES |
Sponsors representatives may visit the Investigational clinics with reasonable frequency, upon reasonable notice, during normal business hours to observe the progress of the Study, C2R will assist Sponsor in scheduling such visits.
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Clinical Cardiovascular Research, LLC
Clinical Research Services Agreement
| 5. | CONFIDENTIAL INFORMATION / LEGAL PROCEEDINGS |
| 5.1. | C2R shall not disclose or use for any purpose other than performance of the services to be rendered hereunder, Sponsors Confidential Information. Both parties to this Agreement shall hold in confidence the identity of patients and shall comply with the applicable laws regarding confidentiality of patient records. Disclosures to Investigational Review Boards are understood to be required by Law. |
| 5.2. | If disclosure of Sponsors Confidential Information is required by Law, C2R will promptly notify Sponsor of this requirement and, if possible prior to any disclosure, will permit Sponsor to oppose such disclosure by appropriate legal action. If C2R, shall be obliged to provide assistance, including testimony or records regarding any Sponsor Study in any legal or administrative proceeding, then Sponsor shall reimburse C2R its reasonable out-of-pocket costs and its reasonable standard hourly fee for the time expended by its employees or representatives. |
| 5.3. | Sponsor will not disclose to any business or institution not affiliated with Sponsor, without C2Rs written permission, any information pertaining to C2Rs business or this Agreement, unless such disclosure is required by Law. If such disclosure is required by Law, Sponsor will notify C2R of this requirement promptly, and if possible, prior to any disclosure to permit C2R to oppose such disclosure by appropriate legal action. |
| 5.4. | Sponsor and C2R acknowledge that any remedy at law for the breach or threatened breach of the Confidential Information provisions of this Agreement may be inadequate to fully and properly protect the disclosing party and, therefore, the parties agree that the disclosing party may be entitled to injunctive relief in addition to other available remedies; provided, however, that nothing contained herein shall be construed as prohibiting the disclosing party from pursuing any other remedies available in law or in equity, without limit, for such breach or threatened breach. |
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