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EXHIBIT 10.13
CLINICAL TRIAL AGREEMENT
This Clinical Trial Agreement (the "Agreement") is made as of the 7th
day of January, 2000 (the "Effective Date" by and between Northwest
Biotherapeutics, Inc., a Delaware corporation (the "Sponsor"), and THE REGENTS
OF THE UNIVERSITY OF CALIFORNIA, on behalf of its Los Angeles campus, a
California corporation (hereinafter the "Institution").
RECITALS
The Sponsor desires to test its therapy of autologous recombinant
prostate specific membrane antigen loaded dendritic cells (the "Product") for
metastatic, hormone refractory prostate cancer in a clinical setting. The
Institution seeks the advancement of health care through research and clinical
investigation, and as such is willing to permit testing of the Product in
accordance with the terms of this Agreement.
AGREEMENT
In consideration of the foregoing and of the mutual promises contained
in this Agreement, the parties agree as follows:
1. STATEMENT OF WORK. The Institution agrees to conduct a clinical study
(the "Study") of the Product in accordance with study protocol no. DC1-HRPC
attached hereto as Exhibit A (the "Protocol"). In the event of any conflict
between the Protocol and the provisions of this Agreement, the provisions of
this Agreement shall govern.
2. PRINCIPAL INVESTIGATOR. The Study will be conducted under the direct
supervision of Arie Belldegrun, M.D. (hereinafter the "Principal Investigator")
with the participation of other Institution clinical and research personnel. The
Institution agrees to conduct the Study in strict accordance with the Protocol
and all applicable federal, state, and local laws and regulations. If Principal
Investigator becomes permanently unavailable, for any reason, and a successor
acceptable to both the institution and Sponsor is not available, this Agreement
may be terminated pursuant to Article 17.
3. IRB APPROVAL. The Institution's obligations to conduct the Study are
expressly conditional upon the approval of its Investigational Review Board,
which the parties and the Principal Investigator will cooperate to obtain.
4. REPORTS AND CONFERENCES.
A. The Principal Investigator, or his designate, will make informal
verbal reports to the Sponsor (or the Sponsor's representatives) at least
monthly, and will meet with the Sponsor's representatives upon reasonable
request at the Institution's facilities to discuss the progress of the Study. A
final written report shall be submitted to the Sponsor within ninety (90) days
after completion of, or any premature termination of, the Study and, if
requested, the Principal Investigator shall assist the Sponsor in interpreting
such report. All clinical data as
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embodied in the case report forms and questionnaires, other records and reports
required to be submitted under the Protocol will be promptly provided to the,
Sponsor (or the Sponsor's representative), and shall be freely usable by the
Sponsor consistent with good business judgment. Sponsor shall be provided access
to source data and records relating to the Study during normal business hours
and at mutually agreeable times, and, if necessary, may copy same in such a
manner that the privacy of the Study patients is protected, including redacting
the name, address and other individual identifiers prior to copying.
B. The Principal Investigator and the Institution agree to notify the
Sponsor within twenty-four (24) hours after learning of any serious and/or
unexpected adverse Product reaction affecting any patient in the Study. The
Principal Investigator and the Institution further agree to follow up such
notification of adverse Product reaction with appropriate reports in compliance
with the Protocol and all applicable legal and regulatory requirements.
C. The Principal Investigator and the Institution agrees to notify
the Sponsor within seventy-two (72) hours in the event that the FDA or any other
regulatory authority notifies the Institution of a pending inspection/audit. In
addition, the Principal Investigator and the Institution will forward to the
Sponsor any written communication related to the use of the Sponsor's Product
received as a result of the inspection/audit within seventy-two (72) hours of
receipt of such communication and agrees to allow the Sponsor to assist in
responding to any citations. Such responses shall be made within three (3) weeks
of issuance of any citations or within any earlier deadline set by the issuing
regulatory authority. The Principal Investigator and the Institution shall also
provide to the Sponsor copies of any documents provided to any inspector or
auditor. In the event of the FDA or other regulatory authority requests or
requires any action to be taken to address any citations, the Principal
Investigator and the Institution agree, following consultation with the Sponsor,
to take such action as necessary to address such citations, and agree to
cooperate with the Sponsor with respect to any such citation and/or action
taken.
5. PAYMENTS. The Sponsor will pay to the Institution, as the
Institution's total compensation under this Agreement, the amounts and in
accordance with the schedule set forth in Exhibit B attached hereto.
6. PUBLICITY. Neither party shall use the name of the other party,
including any trademark, trade name, or any contraction, abbreviation,
simulation, or adaptation thereof of the other party, or the name of the party's
employees, in any publicity, advertising or news release without the prior
written approval of an authorized officer of the other party.
7. INSTITUTION NAME. California Education Code section 92000 prohibits
use of the Institution's name to suggest that the Institution endorses a product
or service. The Sponsor will not use the Institution's names, including "UCLA",
without prior written approval, except to identify the Institution as the Study
site or when required to do so by law.
8. CONFIDENTIAL INFORMATION. During the performance of the Study and
during the term of this Agreement, the Institution may receive confidential or
trade secret information, including information concerning the Sponsor's present
and future business, marketing plans, regulatory submissions, product lines,
product plans, date testing and research techniques,
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inventions, processes, practices, trade secrets, and like information
(collectively, "Confidential Information") from the Sponsor. The Institution
agrees to hold in confidence all such Confidential Information and not to
disclose or make such Confidential Information available to any third parties
without the Sponsor's written permission, for a period of five (5) years from
the termination of this Agreement. This obligation will apply only to
information which the Sponsor has designated in writing or orally as
"confidential" and will not apply to any such information which:
(i) was known to the Institution prior to its receipt from the
Sponsor, as evidenced by written documentation.
(ii) was or becomes a matter of public information or publicly
available through no fault on the part of the Institution;
(iii) which to the best of Institution's knowledge is acquired from a
third party entitled to disclose the information to the Institution; or
(iv) was developed independently by the Institution, as evidenced by
written documentation;
(v) is required to be disclosed by law.
9. PUBLICATION RIGHTS. The Sponsor acknowledges that the Institution is
dedicated to free scholarly exchange and to public dissemination of the results
of their scholarly activities. The Principal Investigator and the Institution
shall retain the right to publish research results in pursuit of educational and
scientific purposes. However, the Institution expressly agrees that prior to
submission for publication of any manuscript or presentation of any poster,
presentation, abstract or other written or oral material that describes the
results of the Study, Institution and/or Principal Investigator shall provide
Sponsor sixty (60) days to review any such manuscript or presentation. Such
publications and presentations shall not divulge any of the Sponsor's
Confidential Information without prior written approval of the Sponsor, and the
Institution shall promptly remove any Confidential Information identified and
requested by the Sponsor. If requested by the Sponsor, the Principal
Investigator and the Institution shall delay the submission of any publication
or presentation up to sixty (60) days from the date of the Sponsor's request for
such a' delay to permit the preparation and filing of related patent
applications. In addition, the Sponsor shall have the right to require that any
publication or presentation concerning the work performed hereunder acknowledge
the Sponsor's support.
10. INVENTIONS. The Sponsor and the Institution do not expect that
inventions will be conceived or reduced to practice during the Study. However,
in the event that inventions are conceived and reduced to practice during the
Study, the Institution agrees that all patentable and unpatentable inventions,
discoveries, and improvements, (a) directly related to the Company's Product or
Confidential Information and (b) conceived, and reduced to practice during
performance of the Study shall be the solo property of the Sponsor. The
Institution agrees that all such inventions, and discoveries will promptly be
disclosed to the Sponsor and will assure and obtain the assistance of the
Principal Investigator in making application for Letters of Patent in any
country in the world at the Sponsor's request and expense. The Institution
agrees to assist
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in prosecuting such patent applications, including executing or obtaining the
execution of all papers necessary to transfer to the Sponsor all of
Institution's right, title and interest in such inventions, and discoveries and
all applications patent and letters patent. The obligation to disclose, assist
and execute shall survive the expiration or termination of this Agreement. The
Sponsor shall reimburse the Institution for any reasonable and necessary
expenses actually incurred in the course of such assistance. In no event shall
the Institution obtain or acquire any rights of any kind with respect to the
Product or the Sponsor's Confidential Information, or any other materials or
information provided by the Sponsor in connection with the Study.
11. INDEMNIFICATION BY SPONSOR. The Sponsor will indemnify, hold
harmless and defend the institution, and its trustees, directors, officers,
employees, physicians and agents, including the Principal Investigator
(collectively the "Indemnitees" against all actions, suits, claims, demands and
prosecutions (hereinafter a "Claim") that may be brought or instituted, and all
judgments, damages, liabilities, costs and expenses resulting therefrom, arising
out of the performance of the Study, but only to the extent that any such Claim
is not caused by or the result of: (a) any negligence or willful act or omission
of any Indemnitees; or (b) failure to adhere to the terms of the protocol
provided by the Sponsor hereunder. The Sponsor's indemnification obligations
under this Section 11 only arise if: (1) the Institution notifies the Sponsor
promptly after Institution's receipt of written notice of any Claim-, (ii) the
Institution permits the Sponsor control the defense and settlement, at the
Sponsor's expense, of any such Claim; (iii) the Institution and Principal
Investigator fully cooperate with the Sponsor in the defense of any such claim,
and (iv) the Institution does not settle any such Claim without the prior
written approval and consent of the Sponsor. The Sponsor will not settle any
claim which admits the fault of Institution without prior written approval of
Institution, which shall not be unreasonably withheld. Institution's policy
requires that research subjects be provided any and all medical treatment
reasonably necessary for any injury sustained as direct result of participation
in the Study. Sponsor agrees that it will reimburse Institution for the
reasonable costs it incurs in providing reasonably necessary medical treatment
to research subjects who are injured as a direct result of participation in the
Study conducted in accordance with the Protocol. Sponsor will not be responsible
for any injuries that are the result of negligence or misconduct of any agent or
employee of Institution.
12. INDEMNIFICATION BY INSTITUTION. The Institution will indemnify, hold
harmless and defend the Sponsor, and its directors, officers, employees, and
agents, (collectively the "Indemnitees") against all actions, suits, claims,
demands and prosecutions (hereinafter a "Claim") that may be brought or
instituted, and all judgments, damages, liabilities, costs and expenses
resulting therefrom, arising out of any negligence or willful act or omission of
the Institution, or its trustees, directors, officers, employees physicians and
agents, including the Principal Investigator. The Institution's indemnification
obligations under this Section 12 only arise if the Sponsor: (i) notifies the
Institution promptly after Sponsors receipt of written notice of any Claim; (ii)
permits the Institution control the defense and settlement, at the Institution's
expense, of any such Claim; and (iii) does not settle any such Claim without the
prior written approval and consent of the Institution. Institution will not
settle any claim which admits the fault of Sponsor without the prior written
approval of Sponsor, which shall not be unreasonably withheld.
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13. LIABILITY INSURANCE. The Sponsor will maintain during the term of
this Agreement liability insurance with minimum limits of not less than
$1,000,000. As soon as practicable upon execution of this Agreement, the Sponsor
will deposit with the Institution certificates of insurance evidencing this
coverage. Such coverage may not be changed or terminated except upon at least
thirty (30) days prior written notice to the Institution. In addition, the
Sponsor will at all times comply with all statutory workers' compensation and
employers' liability requirements covering its employees with respect to
Activities performed under this Agreement. Sponsor is to maintain Liability
Insurance in the following amounts:
General Liability:
Comprehensive or Commercial Form (Minimum Limits)
(1) Each Occurrence $ 500,000
(2) Products/Completed Operations
Aggregate $5,000,000
(3) Personal and Advertising Injury $1,000,000
(4) General Aggregate* $5,000,000
*(not applicable to comprehensive form)
14. RELATIONSHIP OF THE PARTIES. The Institution shall be deemed
to be an independent contractor for all purposes and for all services to be
provided under this Agreement, and neither the agent nor the employee of the
Sponsor. The Institution shall have no authority to make any statements,
representations or commitments of any kind, or to take any action, which shall
be binding upon the Sponsor, ex get as expressly provided for in this Agreement
or authorized in writing by the Sponsor.
15. REPRESENTATIONS OF INSTITUTION. The Institution represents that the
covenants set forth in this Agreement shall apply to and am binding on any
individual employed to perform the Study under this Agreement.
16. WARRANTIES; LIMITATION OF LIABILITY. Without limiting Sponsor's
obligations under Articles 11, SPONSOR DOES HEREBY DISCLAIM ANY AND ALL
REPRESENTATION AND WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESSED OR IMPLIED.
WITH RESPECT TO THE PRODUCT, INCLUDING WITHOUT LIMITATION, ANY REPRESENTATION OR
WARRANTY OF QUALITY, PERFORMANCE, MERCHANTABILITY OR FITNESS FOR A PARTICULAR
USE OR PURPOSE, OR THAT THE USE OF THE PRODUCT FOR PURPOSES OTHER THAN SPECIFIED
IN THIS AGREEMENT WILL NOT INFRINGE THE RIGHTS, PATENT OR OTHERWISE, OF ANY
THIRD PARTY.
17. TERM. This Agreement shall be effective from the Effective Date of
this Agreement and shall expire thirty (30) days after receipt by Sponsor of the
final summary of work accomplished during the Study. This Agreement may be
terminated by the Sponsor upon
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thirty (30) days' written notice. Performance under this Agreement may be
terminated upon sixty (60) days' written notice by the Institution. If the Study
should terminate prior to its completion, Institution shall be paid for work
performed to date in accordance with the Protocol and for any reasonable
uncancellable obligations incurred in accordance with the Protocol prior to the
termination date.
18. RETURN OF PRODUCT. Upon termination of this Agreement the
Institution will return to the Sponsor all non-disposable Product, devices and
materials, as well as all copies of drawings, specifications, manuals and other
printed or reproduced material (including information stored on machine-readable
media) provided by the Sponsor to the Institution or the Principal Investigator.
The Sponsor may, at the Sponsor's option, request that such Product, devices,
and materials be destroyed
19. MISCELLANEOUS.
(a) AMENDMENTS AND WAIVERS. Any term of this Agreement may be
amended or waived only with the written consent of the parties or their
respective successors and assigns. Any amendment or waiver effected in
accordance with this Section 18(a) shall be binding upon the parties and their
respective successors and assigns.
(b) NOTICE. Any notice required or permitted by this Agreement shall
be in writing and shall be deemed sufficient upon receipt, when delivered
personally or by courier, overnight delivery service or confirmed facsimile, or
five (5) days after being deposited in the regular mail as certified or
registered mail (airmail if sent internationally) with postage prepaid, if such
notice is addressed to the party to be notified at such party's address or
facsimile number as set forth below, or as subsequently modified by written
notice.
INSTITUTION: SPONSOR:
University of California Northwest Biotherapeutics, Inc.
Office of Sponsored Research 2203 Airport Way S., Suite 200
10945 Le Conte Avenue, Suite 1401 Seattle, WA 98134
Los Angeles, CA 90095-1406
ATTENTION: Carli V. Rogers ATTENTION: Daniel 0. Wilds
Industry Contract Officer President and CFO
If by FAX: (310) 206-3619 If by FAX: (425) 608-3026
If by express mail: same address as above If by express mail: same address as above
(c) ASSIGNMENT. The Institution agrees not to assign any of its rights or
obligations under this Agreement to any other party without first obtaining the
Sponsor's written approval. The terms and conditions of this Agreement shall
inure to the benefit of and be binding upon the respective permitted successors
and assigns of the parties. Nothing in this Agreement, express or implied, is
intended to confer upon any party other than the parties hereto or their
respective successors and assigns any rights, remedies, obligations, or
liabilities under or by reason of this Agreement, except as expressly provided
in this Agreement.
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(d) GOVERNING LAW; JURISDICTION. This Agreement and all acts and
transactions pursuant hereto and the rights and obligations of the parties
hereto shall be governed, construed and interpreted in accordance with the laws
of the State of California, without giving effect to principles of conflicts of
law.
(e) SEVERABILITY. If one or more provisions of this Agreement are
held to be unenforceable under applicable law, the parties agree to renegotiate
such provision in good faith. In the event that the parties cannot reach a
mutually agreeable and enforceable replacement for such provision, then (i) such
provision shall be excluded from this Agreement, (ii) the balance of the
Agreement shall be interpreted a if such provision were so excluded and (iii)
the balance of the Agreement shall be enforceable in accordance with its terms.
(f) FORCE MAJEURE. Performance of this Agreement by each party shall
be pursued with reasonable due diligence in all requirements hereof; however,
neither party shall be liable to the other for any loss or damages for delay or
for nonperformance due to causes not reasonably within its control. The party
affected shall promptly notify the other in writing of the nature cause, date of
commencement thereof, the anticipated extent of such delay.
(g) ENTIRE AGREEMENT. This Agreement is the product of both of the
parties hereto, and constitutes the entire agreement between such parties
pertaining to the subject matter hereof, and merges all prior negotiations and
drafts of the parties with regard to the transactions contemplated herein. Any
and all other written or oral agreements existing between the parties hereto
regarding such transactions are expressly canceled.
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The parties hereto have caused this Agreement to be executed on their
behalf by their duly authorized representatives to be effective on the year and
date first above written.
NORTHWEST BIOTHERAPEUTICS, INC.
By: /s/ Daniel O. Wilds
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Name: Daniel O. Wilds
Title: President & C.E.O.
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Date: December 29, 1999
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THE REGENTS OF THE UNIVERSITY OF
CALIFORNIA
By: /s/ Carli V. Rogers
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Name: Carli V. Rogers
Title: Industry Contract Officer
Date: January 19, 2000
Read and acknowledged:
/s/ Arie Belldegrun 1/18/00
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Arie Belldegrun, M.D. Date
PRINCIPAL INVESTIGATOR
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EXHIBIT A
NORTHWEST BIOTHERAPEUTICS INC. STUDY PROTOCOL NO. DC1-HRPC
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EXHIBIT B
PAYMENT SCHEDULE
The Sponsor will pay to the Institution a total of sixteen thousand two hundred
two and 50/00 dollars ($16,202.50) based on the attached budget itemization for
each patient who completes the Protocol and for whom the Sponsor receives and
approves all reports required by the Protocol (the "Cost per Patient") up to a
maximum of thirty (30) patients. The Sponsor will make an initial payment of
twenty thousand and 00/00 dollars ($20,000,00), equal to five hundred forty and
00/00 dollars ($540.00) per patient (the "Initial Payment") within thirty (30)
days of the execution of this Agreement. The Initial Payment will be credited
toward the first twenty-five percent (25%) [per patient amount] of the Cost per
Patient(s) that becomes due and payable by the Sponsor. The Initial Payment will
be refunded to the Sponsor to the extent, if any, by which the Initial Payment
exceeds the total Cost per Patient which becomes due. The Cost per Patient will
become due as follows:
- [25%] when the patient is registered
- [55%] when the completed Case Report for that patient is delivered
to and accepted by the Company for the primary study endpoint; and
- [20%] when the patient has completed the followup period specified
in the Protocol.
The amount payable by the Sponsor will be pro-rated for any patient who fails to
complete the Protocol. IN ALL CASES, PATIENT EXPENSES ELIGIBLE FOR THIRD-PARTY
REIMBURSEMENT ARE THE RESPONSIBILITY OF THE INSTITUTION AND WILL NOT BE CHARGED
TO THE SPONSOR. SPONSOR UNDERSTANDS THAT COSTS OF RESEARCH PROCEDURES DONE IN
ACCORDANCE WITH THE PROTOCOL WILL NOT BE BILLED TO A PATIENT'S INSURANCE
COMPANY.
The Sponsor will withhold the final five hundred and 00/00 dollars ($500.00) of
the total Cost per Patient(s) until all Case Reports and the Clinical Trial
summary report have been delivered to and accepted by the Company, and both the
Company and the Institution's IRB have been notified that the Clinical Trial has
been completed.
The Institution will invoice Sponsor on a calendar monthly basis for expenses
for work under this Agreement. Except for the Initial Payment; the Sponsor will
not be obligated to make any payments until an invoice has been received. All
amounts due will be payable within thirty (30) days of receipt.
Checks Payable to THE REGENTS OF THE UNIVERSITY OF CALIFORNIA and mailed to:
UCLA Remittance Center
10920 Wilshire Boulevard, Suite 107
Los Angeles, California 90024-6503
Reference:
Protocol number: DC1 -HRPC
UCLA Project number 023496
Tax ID: 95-6006143
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PROTOCOL TITLE : PHASE I CLINICAL TRIAL OF RECOMBINANT PROSTATE SPECIFIC
MEMBRANE ANTIGEN (rPSMA) - LOADED MATURE AUTOLOGOUS
DENDRITIC CELLS (CaPVax) FOR THE TREATMENT OF METASTATIC
HORMONE REFRACTORY PROSTATE CANCER.
PRINCIPAL INVESTIGATOR : ARLE BELLDEGRUN, M.D., DEPARTMENT OF UROLOGY, UCLA SCHOOL
OF MEDICINE
PROTOCOL # : DC1-HRPC
SPONSOR : NORTHWEST BIOTHERAPEUTICS, INC.
BUDGET ITEMIZATION
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PROFESSIONAL SERVICES FIXED COST COST CLINICAL COSTS TOTAL STUDY
(1 YEAR) (PER PT.) (X30 PATIENTS) COST
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Pharmacy
PRN Medication(1)
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IRB 2,000.00
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Radiation Safety Administrative Service Fee(2) 100.00
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Clinical Research Center (CRC)
Skin Tests NW Biotherapeutics Provides Antigens 400.00 12,000.00
I.D. Injection of DCs and 2 hours of observation 600.00 18,000.00
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Clark Urology Clinic
Room Charge 400.00 12,000.00
Blood for Immune Monitoring, 100 ml each 125.00 3,750.00
Shipment costs (x 8)(3)
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Clinical Laboratory tests
Testosterone, total @ wk 14 40.00 1,200.00
CBC/Differential/Platelet(4) 120.00 3,600.00
Chemistry Panel Chem 22(4) 180.00 5,400.00
PAP(4) 105.00 3,150.00
PSA(4) 120.00 3,600.00
ANA 140.00 4,200.00
Erythrocytic Sedimentation Rate 60.00 1,800.00
Urinalysis(4) 20.00 600.00
Virology 125.00 3,750.00
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PROFESSIONAL SERVICES FIXED COST COST CLINICAL COSTS TOTAL STUDY
(1 YEAR) (PER PT.) (X30 PATIENTS) COST
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Radiology
Chest X-Ray ($125.00 @ week 26) 125.00 3,750.00
Bone Scan ($1,000.00 @ week 26) 1,000.00 30,000.00
CT Scan abdomen/pelvis ($2,000.00 @ week 26) 2,000.00 60,000.00
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Procedures
Leukapheresis; includes supplies(5) 1,200.00 36,000.00
Femoral Catheter Insertion, to include procedure and supplies(6)
Specimen processing and shipping(3)
EKG 125.00 3,750.00
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Miscellaneous 1,000.00
Advertising; done only after IRB approval
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Principal Investigator 1,500.00 45,000.00
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Clinical Research Nurse Coordinator 2,000.00 60,000.00
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Data Manager 2,000.00 60,000.00
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Sub-Total: 3,100.00 12,385.00 371,550.00 374,650.00
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Indirect Costs (22.5%): 697.50 2,786.63 83,598.75 84,296.25
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TOTAL: 3,797.50 15,171.63 455,148.75 458,946.25
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(1) PRN Medication charged to sponsor.
(2) Annual Renewal Fee of $50.00 charged to sponsor.
(3) Shipment costs paid for by sponsor.
(4) Charges for Day 1, Week 14, and Week 23. All clinical labs paid for by
sponsor if not covered by insurance.
(5) If second procedure needed, additional related costs will be charged to
sponsor.
(6) If femoral catheter needed, all related costs will be charged to sponsor.
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