Exhibit 10.9
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 product' s 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 C2R' s 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 Sponsor' s 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 Sponsor' s acceptance prior to making any changes in the Protocol or Study. 4. SPONSOR VISITS TO FACILITIES
Sponsor' s 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, Sponsor' s 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 Sponsor' s 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 C2R' s written permission, any information pertaining to C2R' s 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.
5.5. This Section 5 shall survive the expiration or termination of this Agreement.
6. WORK PRODUCT
6.1. All progress reports will be prepared in C2R' s standard format unless otherwise specified in the Protocol or requested by Sponsor in writing. 6.2. Raw data in paper, magnetic, or other form will be retained by C2R in compliance with regulatory requirements. Upon expiration of any regulatory requirements to maintain such data or after ten (10) years, whichever is later, Sponsor shall upon C2R' s request direct that such data be delivered to Sponsor or be retained by C2R.
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Clinical Cardiovascular Research, LLC Clinical Research Services Agreement
7. TEST ARTICLE
Upon completion of the Study, unless required by applicable law or regulation and so notified by the Sponsor in writing, any remaining samples of test or control materials will be returned to Sponsor, at Sponsor' s expense, for retention in compliance with regulatory requirements. If so notified by the Sponsor, C2R will retain samples of test or control materials for a standard storage fee.
8. INVENTIONS AND PATENTS
8.1. Any trade secrets or any other information of value relating to the business and/or field of interest of Sponsor or any of its Affiliates including, but not limited to, information relating to inventions, disclosures, processes, systems, methods, formulae, devices, patents, patent applications, trademarks, intellectual properties, instruments, materials, products, research or development activities and plans, clinical, preclinical or other data, specifications, computer programs, costs of production, prices or other financial data, volume of sales, promotional methods, marketing plans, strategic plans, lists of names or classes of customers, or lists of suppliers, that C2R obtains through its consultant capacity with Sponsor during the term of this Agreement, or may have acquired through previous dealings with Sponsor or any of its Affiliates, shall be regarded as held by C2R., in a fiduciary capacity solely for the benefit of Sponsor, its successors or assigns, and shall not at any time, either during the term of this Agreement, or thereafter, be disclosed, divulged, furnished, or made accessible by C2R to anyone, or be otherwise used by C2R, except in the regular course of C2R' s providing services for Sponsor under this Agreement. Information shall for purposes of this Agreement be considered to be secret if not known by the public generally, even though such information may have been disclosed to one or more third parties pursuant to agreements entered into by Sponsor or its Affiliates.
8.2. Any trade secrets or any other information of value relating to the business and/or field of interest of C2R or any of its Affiliates including, but not limited to, information relating to inventions, disclosures, processes, systems, methods, formulae, devices, patents, patent applications, trademarks, intellectual properties, instruments, materials, products, research or development activities and plans, clinical, preclinical or other data, specifications, computer programs, costs of production, prices or other financial data, volume of sales, promotional methods, marketing plans, strategic plans, lists of names or classes of customers, or lists of suppliers, that Sponsor obtains through its business relationship with C2R during the term of this Agreement, or may have acquired through previous
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Clinical Cardiovascular Research, LLC Clinical Research Services Agreement
dealings with C2R or any of its Affiliates, shall be regarded as held by Sponsor in a confidential capacity solely for the benefit of C2R, its successors or assigns, and shall not at any time, either during the term of this Agreement, or thereafter, be disclosed, divulged, furnished, or made accessible by Sponsor to anyone, or be otherwise used by Sponsor, except in the regular course of Sponsor receiving services from C2R under this Agreement. Information shall for purposes of this Agreement be considered to be secret if not known by the public generally, even though such information may have been disclosed to one or more third parties pursuant to agreements entered into by C2R or its Affiliates.
8.3. C2R shall not divulge any information to Sponsor pursuant to this Agreement that is the proprietary property of a third party. 8.4. This Section 8 shall survive expiration or termination of this Agreement.
9. REMEDIES / INDEMNITIES
9.1. Should any patient enrolled in the Study suffer any adverse effect directly caused by patient' s participation in the Study, Sponsor will reimburse C2R and/or Study Center for all hospital and medical costs required for diagnosis and emergency treatment. Further, if any such adverse effect gives rise to a claim against C2R, Sponsor shall indemnify, defend and hold harmless C2R and its officers, medical and professional staff, employees, and agents and their respective successors, heirs and assigns (the " indemnitees" ), against any liability, loss, damage, injury, or expense (including reasonable attorneys' fees and expenses of litigation) incurred by or imposed upon the indemnitees or any one of them in connection with any claims, suits, actions, demands or judgments (1) arising out of any theory of product liability (including, but not limited to, actions in the form of tort, warranty, or strict liability) concerning the Study and related materials or any modification thereof; (2) arising out of any side effect or adverse event, illness or injury resulting from indemnitees' performance of services for the Study and occurring to any person involved in the Study; or (3) arising out of damage to any property resulting from and occurring during the indemnittees' performance of services for the Study. 9.2. Sponsor' s indemnification under 9.1 (2) and 9.1 (3) hereabove shall not apply to any liability, damage, loss or expense to the extent that it is attributable to the (a) negligent activities, reckless misconduct or intentional misconduct of the indemnitees; or (b) failure of the indemnitees to adhere to the terms of the Protocol.
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Clinical Cardiovascular Research, LLC Clinical Research Services Agreement
9.3. Sponsor agrees, at its own expense, to provide attorneys reasonably acceptable to C2R to defend against any actions brought or filed against any party indemnified hereunder with respect to the subject of indemnity contained herein, whether or not such actions are rightfully brought.
9.4. This Section 9 shall survive expiration or termination of this Agreement.
10. INSURANCE
10.1. Sponsor shall, at its sole cost and expense, procure and maintain comprehensive general liability insurance in amounts not less than $2,000,000 per incident and $2,000,000 annual aggregate and naming the indemnitees as additional insureds. Such comprehensive general liability insurance shall provide (i) product liability coverage and (ii) broad form contractual liability coverage for the Sponsor' s indemnification under the preceding section. If Sponsor elects to self-insure all or part of the limits described above (including deductibles or retentions which are in excess of $250,000 annual aggregate) such self-insurance program must be acceptable to C2R and the C2R insurance carrier. The minimum amounts of insurance coverage required under this section shall not be construed to create a limit of Sponsor' s liability with respect to its indemnification under the preceding section of this Agreement.
10.2. Sponsor shall provide C2R with written evidence of such insurance upon request of C2R. Sponsor shall provide C2R with written notice at least fifteen (15) days prior to the cancellation, non-renewal or material change in such insurance.
10.3. Sponsor shall maintain such comprehensive general liability insurance during (i) the continuance of the Study and (ii) a reasonable period after the period referred to in 10.3 (i) hereabove which in no event shall be less than fifteen (15) years.
10.4. This Section 10 shall survive expiration or termination of this Agreement.
11. LIMITATION OF LIABILITY AND REMEDIES; INDEMNIFICATION
11.1. THE MAXIMUM AGREED LIABILITY OF C2R SHALL NOT EXCEED THE FEES PAID TO C2R. IN NO EVENT SHALL C2R BE LIABLE TO SPONSOR OR ANY OTHER THIRD PARTY FOR ANY SPECIAL, INDIRECT, EXEMPLARY, INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING BUT NOT LIMITED TO ANY DAMAGES RESULTING FROM LOSS OF DATA, DELAY IN THE STUDY, LOSS OF PROFITS OR LOSS OF BUSINESS ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ANY PRODUCTS, SERVICES OR MATERIALS FURNISHED HEREUNDER, EVEN IF C2R HAS BEEN ADVISED OR SHOULD KNOW OF THE POSSIBILITY OF SUCH DAMAGES.
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Clinical Cardiovascular Research, LLC Clinical Research Services Agreement
11.2. EXCEPT AS EXPRESSLY STATED TO THE CONTRARY, THE LIMITATION STATED IN SECTION 11.1 SHALL APPLY WHETHER THE ASSERTED CLAIM, LIABILITY OR DAMAGES ARE BASED ON CONTRACT (INCLUDING BUT NOT LIMITED TO BREACH OR WARRANTY), TORT (INCLUDING BUT NOT LIMITED TO NEGLIGENCE AND STRICT LIABILITY) OR ANY OTHER LEGAL OR EQUITABLE GROUNDS, AND REGARDLESS OF WHETHER THE ASSERTED CLAIM, LIABILITY OR DAMAGES ARISE FROM PERSONAL INJURY, PROPERTY DAMAGE, ECONOMIC LOSS OR ANY OTHER KIND OR INJURY, LOSS OR DAMAGE. EACH OF SUCH LIMITATIONS IS INTENDED TO BE ENFORCEABLE REGARDLESS OF WHETHER ANY OTHER EXCLUSIVE OR NON-EXCLUSIVE REMEDY UNDER THIS AGREEMENT FAILS OF ITS ESSENTIAL PURPOSE.
11.3. Sponsor acknowledges that the fees set forth in Section E. BUDGET and other economic terms of this Agreement reflect the allocation of risks and the limitations of C2R' s liability hereunder.
12. INDEMNITY FOR SUBCONTRACTOR
The subcontractors involved in the Study will be indemnified by Sponsor. Sponsor hereby agrees to indemnify the subcontractors, subject to limitations 12.1., 12.2., 12.3., and 12.4, herebelow, from and against any and all loss, cost, damage, claim, or action (including reasonable attorney' s fees) which arise in connection with their involvement with the Study, provided: 12.1. The conduct of the subcontractor is not negligent, or if negligent, such conduct is not a proximate cause of the loss, cost, damage, claim, or action; 12.2. Sponsor is properly notified of the claim or lawsuit;
12.3. Sponsor is given control over the conduct and disposition of the claim or lawsuit; and
12.4. Sponsor receives the full cooperation of the subcontractor during pendency of the claim or lawsuit.
13. FORCE MAJEURE
Neither party shall be liable for any unforeseeable event beyond its reasonable control not caused by the fault or negligence of such party, which causes such party to be unable to perform its obligations under this Agreement, and which it has been unable to overcome by the exercise of due diligence.
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Clinical Cardiovascular Research, LLC Clinical Research Services Agreement
In the event of the occurrence of such a force majeure event, the party unable to perform shall promptly notify the other party. It shall further use its best efforts to resume performance as quickly as possible and shall suspend performance only for such period of time as is necessary as a result of the force majeure event.
14. ALLOCATION OF RESOURCES
If delays in performance of the Study are experienced because of Sponsor' s inability to supply C2R with materials or information required to perform the Study, C2R reserves the right to reallocate resources otherwise reserved for performance of the Study without incurring liability to Sponsor.
15. INDEPENDENT CONTRACTOR
C2R shall act solely as an independent contractor and nothing in this Agreement shall be construed to give C2R the power or authority to act for, bind, or commit Sponsor. Nothing herei ...
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