EXHIBIT 10(tt)
CLINICAL TRIAL AGREEMENT
This Clinical Trial Agreement ("Agreement") is entered into by and between
Thermal Medical Imaging, Inc. ("Sponsor") and Mt. Sinai Medical Center
("Institution"), a nonprofit institution incorporated under the laws of
Florida.
RECITALS
WHEREAS, the clinical trial contemplated by this Agreement is of mutual interest
and benefit to Institution and to Sponsor, will further the study objectives of
Institution in a manner consistent with it's non-profit, tax exempt health care
institution and may derive benefits for both Sponsor and Institution through the
discovery of new knowledge;
NOW, THEREFORE, in consideration of the premises and mutual covenants herein
contained, the parties hereto agree to the following:
DEFINITIONS
"Monitor" shall mean the individual or firm retained by Sponsor to provide
monitoring services for the Study utilizing Sponsor's Protocol and Study Device,
initially being QBRI International, Inc.
"Principal Investigator" shall be M.D. who is acting as a representative for the
Institution in activities associated with this study.
"Protocol" shall mean the Protocol and Statement of Work as attached hereto as
Exhibit "A".
"Study" shall mean the clinical studies, examinations and collection of patient
data using the Study Device as described in the Protocol, conducted and
collected at the Institution's premises from patients examined by the
Investigator.
"Study Device" shall mean integrated thermal imaging data acquisition system for
breast cancer detection, the interpretive algorithm analysis process and the
clinical evaluation and display device/software which are to be used or
administered during the Study in accordance with the provisions of the Protocol.
"Sponsor Intellectual Property" shall mean all inventions, improvements and
discoveries whether or not covered by intellectual property protection, which
are conceived or made by one or more employees of Sponsor's organization or
sub-contractor hired by Sponsor.
1. CONTENTS AND ORDER OF PRECIDENCE
This Agreement consists of this Agreement and the following documents which
shall be referred to collectively herein as the "Transaction Documents":
a. Exhibit "A"- Protocol; and
b. Exhibit "B" - Budget
In the event of any conflict between such Exhibits and this Agreement shall
control.
2. PERFORMANCE OF THE STUDY
2.1 Institution shall perform the Study substantially in accordance
with the protocol and the terms and conditions of this Agreement.
Sponsor and Institution may at any time amend the Study and this
Agreement by mutual written consent.
2.2 In the event that the Principal Investigator becomes unable or
unwilling to continue the Study and a mutually acceptable
substitute is not available, both the Institution and the Sponsor
shall have the option
to terminate this Agreement. The Principal Investigator and any
and all other persons involved in the Study (collectively the
"Investigator(s) "shall execute the Investigator Agreement)
prior to beginning any activities associated with the Study.
2.3 Nothing in the Agreement shall be construed to limit the freedom
of the Investigators, whether participants in this Agreement or
not, from engaging in similar studies made independently under
other grants, contracts or agreements with parties other than
Sponsor, provided said investigations are not in conflict or
violate the terms and conditions of this Agreement.
2.4 In performing the Study, Institution and Principal Investigator
shall at times undertake, comply with, and complete the
following:
1. The Protocol;
2. This Agreement;
3. Generally accepted standards of good clinical practice;
4. Instructions provided in writing by Sponsor or Monitor;
5. All applicable federal, state and local laws and
regulations applicable to the conduct of the Study and
the performance of clinical investigators generally
including but not limited to the Federal Food, Drug and
Cosmetic Act and regulations of the Food and Drug
Administration;
6. Prepare an appropriate patient informed consent
document sufficient to comply with all local, state,
and federal statutory and regulatory requirements and
in form acceptable to each of the parties to initiation
of any procedures required by the Study;
7. Obtain and forward to Sponsor and Monitor evidence of
Institutional Review Board ("IRB") approval of the
Study and the informed consent document prior to
beginning the Study;
8. Obtain and forward to Sponsor and Monitor evidence of
ongoing review of the Study and Informed Consent
document by the IRB at least annually;
9. Obtain and forward to Sponsor and Monitor evidence of
IRB approval of any advertisement used for the Study
prior to the publication or other use of the
advertisement;
10. Review the clinical investigators' manual and all
updates provided;
11. Maintain Study and related medical records according to
local, state and federal statutory and regulatory
requirements;
12. Immediately notify Sponsor and Monitor, according to
procedures specified by Monitor, of any and all serious
and/or unexpected adverse events as defined by the
Study and promptly record such events on an appropriate
case report for ("CRF") provided by Sponsor;
13. Promptly notify Sponsor and Monitor of any pregnancy of
any subject enrolled in the Study;
14. Enroll only qualified subjects in the Study as provided
in the Protocol, or as directed by Sponsor and Monitor;
3. MAINTENANCE OF RECORDS AND FORMS
3.1 Institution agrees to fulfill the obligations imposed by Sponsor
for maintenance of records and reports, and those obligations
included in Subpart D of 21 CFR Chapter 1, Responsibilities of
Sponsor and Investigators, a copy of which is provided by Monitor
as part of the study manual.
3.2 Principal Investigator shall be responsible for the completion
and return of accurate CRF's to Sponsor as described in the
Study. Principal Investigator also agrees to ensure the data
captured on the CRF's is consistent with the patient medical
records, to complete the case report forms in a timely, coherent,
legible fashion, and to have the CRF's completed in advance of
any planned monitoring visits.
3.3 Institution shall retain all records from the Study (including
medical records of enrolled patients) for the period of five (5)
years and will permit inspection by Sponsor or its authorized
representatives of all such records during normal business hours.
During the period of performance and for a reasonable period
thereafter, Sponsor may make copies of and/or extract
non-confidential information from such records at Sponsor's
expense. For purposes of this paragraph, confidential information
shall mean information which identifies a specific patient.
4. LICENSES AND QUALIFICATIONS
4.1 Principal Investigator shall have and maintain in full force and
effect any and all professional and other licenses, certificates
or documents required to render the services described in this
Agreement and agree to provide copy of these licenses,
certificates or documents to Sponsor or Monitor on request. If
any such license is suspended or revoked during the course of the
Principal Investigator's participation in the Study, Institution
agrees to notify Sponsor and Monitor promptly in writing.
4.2 Principal Investigator represents and warrants that he has not
been barred from conducting clinical studies by the US Food and
Drug Administration or any other applicable governmental
regulatory agency. Institution agrees to immediately notify
Sponsor and Monitor in writing if the Principal Investigator is
barred during the course of the Study.
4.3 Principal Investigator agrees to provide a current curriculum
vitae which is true, complete and accurate up to the start date
of this Agreement, Investigator agrees that Sponsor may supply
copies of the Curriculum Vitae to Monitor, the FDA and any other
government regulatory bodies in connection with the Study.
4.4 Institution represents and certifies that no investigation or
study in which Principal Investigator has been engaged has been
terminated for Principal Investigator's failure to adhere to
protocol, guidelines, or Federal or State regulations.
5. PERIOD OF PERFORMANCE
This estimated period of performance is from 8/01/98 to 12/31/98.
However, the patient enrollment goal for the trial may be reached before or
after this estimated date. The agreement will remain in effect until the accrual
for all clinical sites reaches the goal of 300 malignant patients. This
Agreement shall become effective upon the date of the last signature hereto and
shall continue in effect for the full duration of the period of performance
unless sooner terminated in accordance with the provisions of article 2 or 15.
6. REPORTS
Institution shall furnish Sponsor reports, in the form of case report
forms and logs, in such frequency and format as mutually agreed to by the
parties, but in no event less than every 30 days. A final report setting forth
the accomplishments and significant Study findings or lack thereof shall be
prepared by Institution and submitted to Sponsor within 90 days of the
expiration of the Agreement.
7. COSTS, XXXXXXXX AND OTHER SUPPORT
7.1 It is agreed and understood by the parties hereto that, subject
to Article 2, payments shall be made by Sponsor to Institution on
a monthly basis as set forth in Exhibit B. Sponsor shall make
payments based on completed case report forms for qualified
patients enrolled in the trial during the prior month in addition
to any other amounts mutually agreed to by parties in Exhibit A.
7.2 Completed cases for which Sponsor will reimburse Institution will
include (i)case report forms including (ii)pathology information
as well as (iii)properly captured and labeled images.
7.3 Checks shall be made payable to:
Mount Sinai Medical Center
Attn: Cost Center #7535
X.X. Xxx 00-0000
Xxxxx Xxxxx, XX 00000-0000
7.4 In the event of termination of this Agreement pursuant to Article
15 hereof, Sponsor shall pay all costs directly attributable to
the Study accrued by Institution as of the date of termination,
including all costs directly attributable to the Study accrued by
Institution as of date of termination, including all non-
cancelable obligations, and for all costs associated with patient
follow-up as required by the Protocol of those already enrolled
in the Study.
8. PUBLICITY
Neither party shall use the name, trade name, trademark or other designation of
the other party in connection with any products, promotion or advertising
without the prior written permission of the other party.
9. PUBLICATIONS
The Study to be performed under this Agreement is part of a Multi-Center
Collaborative project. The Institution recognizes that the results generated by
this Study may have added scientific significance when combined and published
together with data generated by other centers involved in the project.
Accordingly, Institution expressly acknowledges that the right to publish the
combined results of the collaborative project belongs to Sponsor. The
Institution shall have the rights to publish the results of this Study but
agrees to refrain from publishing until the project is complete, the data
analyzed and the combined results submitted for publication, and until the
Sponsor has received final Food and Drug Administration Pre-Market approval or
disapproval. Sponsor shall notify the Institution within 30 days of notification
from FDA of their decision.
10. CONFIDENTIALITY
10.1 During the term of this Agreement, Sponsor expects to provide
Institution with the Study Device, Protocol, and other
information, data and materials related thereto (collectively,
the "Confidential Property") which Sponsor considers confidential
or proprietary in nature and which shall be prominently marked or
identified as confidential or proprietary. Institution shall
receive and hold such Confidential Property in confidence and
agrees to prevent disclosure of said Confidential Property to all
parties other than those involved in conducting the Study, in the
manner Institution treats its own similar information.
10.2 Institution shall not consider information disclosed to it by
Sponsor to be confidential which: (1)is now common knowledge or
subsequently becomes such through no breach of this Agreement (2)
is rightfully in Institution's possession prior to Sponsor's
disclosure as shown by written records (3) is disclosed to
Institution by an independent third party that is not under a
separate confidentiality agreement relating thereto; or (4) is
independently developed by or for Institution without benefit of
confidential information received from Sponsor.
11. INTELLECTUAL PROPERTY
Notwithstanding anything to the contrary in this Agreement, all right, title and
interest to any intellectual property, including without limitation inventions,
improvements, results, data and discoveries, that arise from, relate to or are
direct and specific result of performance of the Protocol and is directly
related to the Study Device, shall belong to the Sponsor.
12. ARBITRATION
Any controversy or claim between the parties arising out of or relating to this
agreement, or a breach thereof, which cannot be resolved relating to this
agreement, or a breach thereof, which cannot be resolved by mutual agreement
shall be settled by binding arbitration conducted by a single arbitrator in
accordance with the commercial arbitration rules of the American Arbitration
Association. Any judgment upon the award rendered by the arbitrator may be
entered in any court having jurisdiction thereof, each such arbitration shall be
held in the county of Dade.
All federal and state substantive and procedural laws applicable to this
agreement relating to arbitration of conflict shall be fully complied with by
the parties.
Unless the parties otherwise agree, each party may conduct discovery prior to
any arbitration hearing in accordance with the State of Florida rules of civil
procedure and evidence. Additionally, there shall be no evidence by affidavit
allowed, and each party shall disclose a list of all documentary evidence to be
used, a list of all witnesses and experts to be called by the party at least 20
(twenty) days prior to the arbitration hearing.
13. EXPORT
Sponsor agrees that it will at all times be in compliance with the United States
government export regulations and laws and that Any sub-Sponsor agreement will
require that the sub-sponsor Agreement will require that the sub-Sponsor is in
compliance with these regulations and laws. Sponsor asserts that it is not now
doing business with any country to which the United States government prohibits
export of products under consideration in this Study.
14. TERMINATION
14.1 If a party hereto breaches a material term, covenant or
condition of the Transaction Documents or this Agreement, the
non-breaching party may terminate this Agreement. Prior to
termination, the non-breaching party shall provide written notice
of default, which shall inform the breaching party of the facts
and circumstances upon which such default is based and which
shall provide the breaching party with 30 (thirty) days in which
to cure such breach or such longer period as the parties may
agree or as applicable law may require. If such breach is not
cured within the specified time period, the non-breaching party
may terminate this Agreement by providing written notice of such
termination to the defaulting party.
14.2 This Agreement may be terminated immediately by Sponsor upon
written notice to Institution in the event of any adverse patient
reaction. Upon receipt of a termination notice from Sponsor, the
Institution shall stop enrolling and treating patients under the
Study to the extent consistent with generally accepted standards
of good medical practice and patient safety.
14.3 Termination of this Agreement by either party for any reason
shall not effect the rights and obligations of the parties
accrued prior to the effective date of termination
14.4 Principal Investigator's participation in the Study will
automatically terminate upon receipt of notice that:
1. Any license required to be held by Investigator is suspended
or revoked; or
2. Investigator has been debarred from conducting clinical
studies by the US Food and Drug Administration.
14.5 In addition to termination under 16.1 and 16.2, Sponsor may
terminate Institution's participation in the Study upon written
notice to Institution in the event that:
1. Sponsor terminates the Study; or
2. Overall study enrollment goals have been met, even if
Investigator's individual enrollment has not been reached.
14.6 Institution may terminate participation in the Study if
Investigator becomes unwilling or unable to serve, provided
Sponsor is provided at least thirty (30) days advance written
notice, in order to give Sponsor an opportunity to identify and
engage a replacement Investigator.
14.7 Upon termination of this Agreement: (I) the Investigator shall
stop enrolling patients in the Study; (ii) shall cease conducting
procedures on patients already enrolled in the Study, except to
the extent such procedures are medically necessary and
permissible, and (iii) both Institution and Investigator shall
return to Sponsor any and all Confidential Property which is in
Institution's, Investigator's, or any of their employee's or
agent's possession or control.
15. WARRANTIES
15.1 Institution agrees to perform the Study in accordance with the
prevailing professional standards.
15.2 INSTITUTION MAKES NO WARRANTIES FOR ANY PURPOSE WHATSOEVER,
EXPRESS OR IMPLIED, AS TO THE STUDY OR THE RESULTS OF THE STUDY,
INCLUDING THE MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE
OF THE STUDY OR THE RESULTS OF THE STUDY UNDER THIS AGREEMENT.
Neither the Principal Investigator, Sponsor, nor any other person
is authorized to give any such warranty in the name or on behalf
of the Institution.
15.3 Sponsor agrees that it will not rely solely on technical
information provided by the Institution or the Principal
Investigator in developing any invention or product, but will
independently test, analyze and evaluate all inventions and
products prior to manufacture and distribution of such inventions
and products.
15.4 Neither Institution or Investigator shall make any warranty or
representation, including but not limited to a warranty or
representation of the efficacy of the Study Device, without the
express permission of the Sponsor, and Sponsor will not be liable
for any unauthorized warranty or representation made by
Investigator.
16. INSURANCE AND INDEMNIFICATION
16.1 At all times during the conduct of the Study under this
Agreement, Institution agrees to maintain at its sole cost and
expense appropriate and adequate professional and general
commercial liability insurance, such protection being applicable
to and covering negligent acts/omissions of officers, employees
and agents while acting within the scope of their employment by
Institution, on an occurrence made basis in single limit coverage
of not less than One Million Dollars ($1,000,000) per claim or
incident and One Million Dollars ($1,000,000) annual aggregate
for death, bodily injury, illness or property damage to support
indemnification obligations of Institution in Section 18.4
hereof. A Certificate evidencing such policy shall be delivered
to Sponsor upon written request.
16.2 Sponsor will hold harmless, indemnify and defend Institution
it's trustees, and agents from demands, claims or costs of
judgments that may be made or instituted against any of them by
reason of injury or death to any person, or damage to property
arising out of or related to performance of the study, provided
however, Sponsor will have no liability for loss or damage
resulting from: (I) failure to adhere to the protocol or
Sponsor's written instructions concerning use of the study
device, (ii) Failure to comply with applicable FDA or other
government requirements, or (iii) negligence or willful
malfeasance by Institution, it's trustees, officers, agents or
employees.
16.3 At all times during the study, Sponsor agrees to maintain at
it's sole cost and expense a policy or program of comprehensive
general liability insurance or self-insurance on an occurrence
made basis in single limit coverage of not less than one million
dollars ($1,000,000) per incident, and an annual aggregate of 1
million dollars ($1,000,000), for death, bodily injury, illness
or property damage to support the indemnification obligations
assumed herein. Sponsor shall maintain such comprehensive general
liability insurance during the period that the Study or any
modification thereof is being administered, manufactured, sold or
distributed to humans by Sponsor and a reasonable period
thereafter which in no event shall be less than two years. A
Certificate evidencing the comprehensive general liability policy
shall be delivered to Providence Hospital upon request.
16.4 Institution agrees to hold harmless, indemnify and defend
Sponsor from all liabilities, demands, expenses, and losses
arising out of and related to Institution's or Principal
Investigator's gross negligence or willful misconduct.
17. INDEPENDENT CONTRACTOR
17.1 Institution is an independent contractor and not an agent, joint
venture partner of Sponsor.
17.2 Investigator is a member of Institution which is an independent
contractor of Sponsor for all purposes and not an employee, as
that term is understood for purposes of federal and state law.
Nothing in this Agreement shall be deemed to constitute a
partnership or joint venture between Sponsor and Institution, nor
shall anything in this Agreement be deemed to constitute
Investigator or Sponsor as the agent of the other. Neither
Investigator, Institution nor Sponsor shall become liable or
bound by an representation, act or omission whatsoever of the
other, except to the extent expressly provided in this Agreement.
18. GOVERNING LAW
This Agreement shall be governed and construed in accordance with the laws of
the State of as adjudicated by a court of competent jurisdiction.
19. ATTORNEY'S FEES
In any action on or concerning this Agreement, the prevailing party shall be
awarded its reasonable attorney's fees, costs and necessary disbursements, to be
paid by the non-prevailing party.
20. ASSIGNMENT
Neither party shall assign it's rights or duties under this Agreement to another
without the prior written consent of the other party, except to any party
succeeding to substantially all of the business interests of the assigning
party.
21. INSPECTION AND ACCESS
Sponsor's authorized representatives and regulatory authorities may examine and
inspect the Institution's facilities as required for performance of the Study
and inspect and copy all data and work products relating to the Study.
Inspections will be conducted during regular business hours upon reasonable
notice and to the extent permitted by law and until the Sponsor has received
final Food and Drug Administration Pre-Market approval or disapproval.
22. RESEARCH MATERIALS
22.1 Institution acknowledges that the Study Device and all other
property and materials provided to the Investigator by Sponsor in
connection with the Study is to be used only for research
purposes in connection with the Study. Institution and
Investigator shall have no license or authority to use any such
item in any other context or for any other purpose.
22.2 Institution also agrees to use the Study Device only in the
space approved by Monitor or Sponsor in accordance with
documentation provided by Monitor or Sponsor. Investigator agrees
to maintain adequate records of the use of the Study Device. In
addition, Institution agrees to return Study Device and all other
property and materials being provided to Investigator by Sponsor
in connection with the Study upon termination or completion of
the Study.
23. WAIVER AND SEVERABILITY
23.1 No waiver by either party of any breach of any provision hereof
shall constitute a waiver of any other breach of that or of any
other provision hereof.
23.2 In the event a court or governmental agency of competent
jurisdiction holds any provision of this Agreement to be invalid,
such holding shall have no effect on the remaining provisions of
this Agreement, and they shall continue in full force and effect.
Upon such holding, the parties shall, within a reasonable period
of time, determine whether the severed provision(s) detrimentally
and materially affect the obligations or performance of either or
both parties. If so affected, the parties shall, within a
reasonable period of time, negotiate in good faith to modify this
Agreement to relieve such effects. If such negotiations do not
result in mutually agreeable modifications to this Agreement,
wither effected party may terminate this Agreement upon providing
the other party with thirty (30) days written notice of such
termination.
23.3 Sections 3.3, 6, 7.3, 9,10, 11,12,15,20,22 and this 23.3 shall
survive the termination of this Agreement for any and all reasons
whatsoever.
24. AGREEMENT MODIFICATION
This Agreement may be modified or amended, including extension of the term of
this Agreement, at any time only by the written concurrence of both parties.
25. NOTICES
Any notices given under this Agreement shall be in writing and delivered to the
following addresses by return receipt mail, postage prepaid, or by overnight
courier service. Such notices shall be effective upon the third business day
following mailing, if by mail, or upon receipt, if by courier.
For Sponsor:
Thermal Medical Imaging, Inc.
0000 Xxxxx Xxxxxxxxx Xxxx, Xxxxx 000
Xxxxxxxxxx Xxxxx, XX 00000
For Institution:
Mt. Sinai CCOP
0000 Xxxxx Xxxx
Xxxxx Xxxxx, Xxxxxxx 00000
With a copy to Xx. Xxxxxxxx
For Monitor:
QBRI International, Inc.
0000 Xxxxx 00xx Xxxxxx
Xxxxxxxxx, XX 00000
Attention: Xxx Xxxxx
26. THIRD PARTY RIGHTS
This Agreement shall not create any rights, including without limitation third
party beneficiary rights, in any person or entity not a party to this Agreement.
27. ENTIRE AGREEMENT
This Agreement constitutes the entire understanding between the parties hereto
and there are no collateral, oral or written agreements or understandings. This
Agreement supersedes any prior oral or written agreements or understandings
between the parties.
IN WITNESS WHEREOF, the parties have executed this Agreement in two or more
counterparts, each as an original and all together as one instrument as of the
date of last signature below written.
THERMAL MEDICAL IMAGING, INC. MT. SINAI MEDICAL CENTER
By: /s/ Xxxxxx Xxxxxxxxx By: /s/ Xxxxx X. Xxxxxxx
------------------------------ ------------------------------
Name: Xxxxxx Xxxxxxxxx Name: Xxxxx Xxxxxxx
Title: Director, Marketing & Title: Vice President
Regulatory Affairs
Date: 8 May 1998 Date: 6/4/98
By: /s/ Xxxx Xxxxxxxx, M.D.
------------------------------
Name: Xxxx Xxxxxxxx M.D.
Title: Principal Investigator
EXHIBIT A
PROTOCOL
[SEE EXHIBIT 10(vv)]
EXHIBIT B
BUDGET
TMI CLINICAL TRIALS BUDGET TEMPLATE
----------------------------------------------------------------------------------------------------------------
ONE TIME COSTS TOTAL
----------------------------------------------------------------------------------------------------------------
Facilities/Build Out $4,500.00 $ 4,500.00
----------------------------------------------------------------------------------------------------------------
RECURRING EXPENSES
----------------------------------------------------------------------------------------------------------------
Personnel Percent Effort Annual Cost Benefits @ 20% Monthly Cost 6 Month Total
----------------------------------------------------------------------------------------------------------------
Study Coordinator 100% $ 30,000.00 $6,000.00 $3,000.00 $18,000.00
----------------------------------------------------------------------------------------------------------------
Technologist 50% $ 24,000.00 $4,800.00 $2,400.00 $ 7,200.00
----------------------------------------------------------------------------------------------------------------
Investigator 10% $200,000.00 $ - $1,666.67 $10,000.00
----------------------------------------------------------------------------------------------------------------
Co-Investigator ?
----------------------------------------------------------------------------------------------------------------
PERSONNEL TOTAL $35,200.00
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Space & Admin. Costs
----------------------------------------------------------------------------------------------------------------
Space $25/sq.ft.(200 sq. ft.) $ 5,000.00 $ 416.66 $ 2,499.00
----------------------------------------------------------------------------------------------------------------
Housekeeping/Mnt. $5/sq. ft. (200 sq. ft.) $ 1,000.00 $ 83.00 $ 498.00
----------------------------------------------------------------------------------------------------------------
Office Supplies $100/mnth $ 100.00 $ 600.00
----------------------------------------------------------------------------------------------------------------
Mailing $200/mnth $ 200.00 $ 1,200.00
----------------------------------------------------------------------------------------------------------------
Phone/Fax $200/mnth $ 200.00 $ 1,200.00
----------------------------------------------------------------------------------------------------------------
SPACE & ADMIN. Total $ 5,997.00
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
Variable Costs
----------------------------------------------------------------------------------------------------------------
Medical Records $ 15.00 $ 675.00 $ 4,050.00
----------------------------------------------------------------------------------------------------------------
Film Duplication $ 15.00 $ 675.00 $ 4,050.00
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
VARIABLE COSTS TOTAL $ 8,100.00
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Total Cost $53,797.00
----------------------------------------------------------------------------------------------------------------
Overhead (20%) $10,759.40
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
TRIAL TOTAL $64,556.40
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PER PATIENT TOTAL $ 239.10
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Assumes 45 patients per
month
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