Services Agreement - Vascular Sciences and Promedica International
PROMEDICA INTERNATIONAL
7777 Center Avenue
Suite 500
Huntington Beach, CA
92647 USA
Telephone 714.799.1617
Fax 714.799.1680
AGREEMENT
This agreement is entered into as of July 11, 2003 by and between Vascular
Sciences ("Client") and Promedica International, a California corporation,
("Promedica International") as follows:
1. SERVICES
A. Promedica International will render during effectiveness of this
agreement such services as outlined in the scope of work in the
attached proposal and Client will review any work specified for
review within the timeframe indicated.
B. Special Services. In addition to the proposed services, Promedica
International is prepared to provide additional special services, as
Client shall request. Before Promedica International begins any such
Special Services, Client and Promedica International shall agree
upon the services to be provided and Promedica International's
compensation thereof.
2. CONFIDENTIALITY
Promedica International agrees not to divulge to any third party any
proprietary or confidential information, or other materials provided by
Client, except as authorized by Client or as required by legal process.
Promedica International also agrees that any reports, marketing
information, or other materials provided by Client for Promedica
International's exclusive use shall not be divulged by Promedica
International to any third party.
3. COMPENSATION
In consideration of the services to be performed by Promedica
International, Client will compensate Promedica International in
accordance with the following standard billing practices:
(a) Client will compensate Promedica International for the Project
as defined in the associated proposal. A deposit amount, as
established in the attached proposal, will be due at project
initiation. Promedica International will retain the deposit
until project completion, termination of this agreement, or at
its discretion, apply the deposit against invoices over 60
days late. In the event the deposit is applied toward late
invoices, the full deposit amount will be due prior to
continuation of contract services. Upon project completion or
termination of this agreement, this deposit will be applied
toward any unpaid fees and expenses.
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Promedica International - Vascular Sciences Agreement Page 2 of 4
Confidential
(b) Client will reimburse Promedica International for reasonable
expenses incurred; including postage and travel, and also
including any other expenses that have been approved in
advance by Client.
4. BILLING PROCEDURES
(a) All invoices shall be due fifteen (15) days after the date of
issue.
(b) If Client fails to make any payment due hereunder within
fifteen (15) days after the same falls due, Client shall pay,
in addition to the amount due, interest thereon at 12% per
annum as of the due date of such payment.
5. TERM AND TERMINATION
(a) The term of this agreement shall commence as of July 11, 2003
and will continue until Client or Promedica International
terminate with or without cause by giving the other thirty
(30) days' written notice. In the event of premature
termination, Client will pay for services rendered and
expenses incurred through the date of termination and
Promedica International shall refund any unused portion of the
deposit paid by Client to Promedica International under
paragraph 3(a) above.
(b) Upon the effective date of the termination of this Agreement,
all property in Promedica International's possession belonging
to Client pursuant to the terms of Section 6 thereof and all
contracts for services and materials entered into by Promedica
International for Client shall be returned/or assigned to
Client.
6. OWNERSHIP
With the exception of database programs, formulas, modifications, and
algorithms (collectively, "Programs") which shall in all events remain the
property of Promedica International, all other materials submitted or
developed by Promedica International for Client during the term of this
agreement and paid for by Client shall be Client's property provided that
either: (a) Client uses such materials at least once prior to the
termination hereof; or (b) Client indicates in writing to Promedica
International during the term hereof that such materials are specifically
within the Client's designated plans for adoption and exploitation. All
such materials not so used or designated shall be Promedica
International's property. Client understands that certain materials
obtained by Promedica International from third parties, including database
software, have been or may be obtained pursuant to a license with a vendor
and Promedica International has not obtained title to those products.
Accordingly, Client understands that it is obtaining no legal right or
title to these specific materials. Client hereby sells, transfers, and
assigns to Promedica International all rights Client may now or hereafter
have in the Programs.
7. INDEMNIFICATION
A. Client shall be responsible for the accuracy, completeness and
propriety of information concerning its organization, capabilities,
products, services, and data, which it furnishes to Promedica
International. It will be Client's responsibility to review all
materials prepared by Promedica International under this agreement
to confirm that representations, direct or implied, with respect to
Client are supportable by competent and reliable tests or other
objective data then possessed by Client, as well as to confirm the
accuracy and legality of the descriptions of Client's products or
services.
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Promedica International - Vascular Sciences Agreement Page 3 of 4
Confidential
B. Except for claims based on the gross negligence or willful
misconduct of Promedica International, Client shall defend,
indemnify and hold Promedica International harmless from and against
any and all losses, damages, liabilities, claims, demands, suits,
and expenses (including reasonable attorneys' fees) that Promedica
International may incur or be liable for as a result of any claim,
suit, or proceeding made or brought against Promedica International
based upon or arising out of:
(a) any descriptions of Client's products or services contained in
clinical or market research material created, placed, or
produced by Promedica International that has been approved by
Client prior to release of such material;
(b) any service performed by Promedica International for Client
hereunder; or
(c) any alleged or actual defects in Clients products.
C. Subject to Section 7.D below, except for claims based on the gross
negligence or willful misconduct of Client, Promedica International
shall defend, indemnify and hold Client harmless from and against
any and all losses, damages, liabilities, claims, demands, suits and
expenses (including reasonable attorneys' fees) that Client may
incur or be liable for as a result of any claim, suit or proceeding
made or brought against Client based on or arising out of any
services provided by Promedica International to Client under this
Agreement.
D. CLIENT AGREES THAT PROMEDICA INTERNATIONAL SHALL HAVE NO LIABILITY
FOR ANY CONSEQUENTIAL, INCIDENTAL, OR SPECIAL DAMAGES, OR FOR LOSS
OF PROFITS ARISING OUT OF SERVICES PERFORMED OR OMITTED TO BE
PERFORMED BY PROMEDICA INTERNATIONAL HEREUNDER, OR OUT OF ANY BREACH
OR ALLEGED BREACH OF THIS AGREEMENT. CLIENT FURTHER AGREES THAT THE
AMOUNT OF ANY DAMAGE TO WHICH IT MAY BE ENTITLED FROM PROMEDICA
INTERNATIONAL FOR ANY BREACH OR ALLEGED BREACH OF THIS AGREEMENT OR
OTHERWISE IN CONNECTION WITH THE SERVICES TO BE PERFORMED BY
PROMEDICA INTERNATIONAL HEREUNDER SHALL BE LIMITED TO THE AMOUNT
PAID TO PROMEDICA INTERNATIONAL UNDER THIS CONTRACT.
E. After Promedica International has issued material to the press or to
another third party, its use is no longer under Promedica
International's control. Promedica International can therefore not
assure the use of its press material by any publication, nor, if
published, that it will be accurate.
8. DOCUMENT STORAGE
Client agrees that Promedica International's duty regarding document
storage is limited to retaining study records in a normal business manner.
Promedica International has no liability for loss of records caused by
third parties or acts of God.
9. CRO/CLIENT
In purchasing materials or services on Client's behalf as set forth in the
attached proposal, Promedica International will be acting as Client's
agent. All orders placed will be under Promedica International's name, and
Client will reimburse the expenses upon receipt of Promedica
International's invoice.
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Promedica International - Vascular Sciences Agreement Page 4 of 4
Confidential
10. ENTIRE AGREEMENT
This Agreement and the attachments hereto constitute the entire agreement
with respect to the subject matter hereof, and may only be modified or
amended in writing signed by the party to be charged.
11. CONSTRUCTION
This Agreement shall be construed in accordance with and governed by the
laws of the State of California.
12. TITLES
Titles are for reference only. In the event of a conflict between a title
and the content of a section, the content of the section shall control.
13. MISCELLANEOUS
The parties agree and stipulate that this Agreement is made in California.
Any controversy that cannot be settled by agreement of the parties shall
be settled by arbitration in Orange County, California in accordance with
the civil reference procedures set forth in the California Code of Civil
Procedure, and judgment upon the award rendered shall be entered in any
court having jurisdiction thereof.
This Agreement is accepted by:
Promedica International Vascular Sciences
a California corporation
By: /s/ E. Palo By: /s/ Irving Siegel
-------------------- --------------------
Its: (President) Its: (President)
Date: 8/11/03 Title: 8/13/03
<PAGE>
EXHIBIT A
CONFIDENTIAL PROPOSAL
CLINICAL STUDY SERVICES: MIRA-1 STUDY FOR TREATMENT OF AMD
FOR VASCULAR SCIENCES
Revised July 21, 2003
<PAGE>
BACKGROUND
Vascular Sciences and Promedica International have worked together since early
1999 on the company's clinical study of the safety and effectiveness of
Rheopheresis using membrane differential filtration for treatment of age related
macular degeneration. As the company's CRO, Promedica has provided study and
data management services for this trial. Funding difficulties have necessitated
project stops/ slowdowns, as follows in mid 2000, Promedica was notified to stop
work on the project. Subjects enrolled in the study continued to be followed by
study sites; however, field monitoring and all but essential data collection
activities were placed on hold, and management of study activities was taken
in-house.
In mid-2001, additional funding was received and Vascular Sciences requested
that Promedica resume work on the trial. Planned activities were organized into
two sequential phases, as follows:
The initial phase involved monitoring and data compilation for sites that
remained active since the trial was stopped. Work in this phase is substantially
complete.
The second phase involved activities associated with resumption of the study
utilizing an amended protocol and additional study sites. The current proposal
has been developed to cover services anticipated during this phase.
Promedica's proposal assumes that clinical study services provided will be
governed by Promedica's Standard Operating Procedures (SOPs), with the exception
that Vascular Sciences will have responsibility for quality assurance audits of
Promedica' management and administration of project activities.
The proposed project Scope of Work, along with associated estimated fees and
expenses, is organized as follows:
- Ongoing Study Activities
Included, are revisions to clinical and administrative databases, updates
to project and monitoring plans, site initiation activities, site
monitoring visits, ongoing site management activities, clinical data
collection, compilation and management; and maintenance of project systems
and controls.
- Study Close out Activities
This section includes collection of site closeout documentation, as data
cleaning/database lock for generation of the final study report, and site
closeout visits.
Promedica has significant previous experience with ophthalmology device trials,
and has established systems and personnel to facilitate management and execution
of this project.
SCOPE OF WORK
Following is a detailed assignment of responsibilities for this project. Please
reference Attachment 1 for assumptions and Promedica's associated estimated
budget. In the event that assumptions change during the course of this project,
actual fees and expenses will be based on the terms set forth in Attachment 2
(Pricing Schedule & Travel Expense Guidelines) of this document.
ONGOING STUDY ACTIVITIES
PROTOCOL & RELATED DOCUMENTS
1. Sponsor is responsible for amendments to study protocol and Case Report
Forms (CRFs), along with Informed Consent Document (ICD) template.
2. Promedica reviews protocol and CRF amendments and provides suggestions as
appropriate to facilitate study execution efficiency.
CONFIDENTIAL PROPOSAL, Page 1 of 5
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SITE AGREEMENTS/TRAINING
1. Sponsor recruits new study sites, negotiates study budgets, executes
Investigator/Financial Agreements and issues investigator. compensation in
accordance with financial agreements. Sponsor works with sites to develop
study subject recruitment programs, as necessary.
2. Promedica collects and maintains essential study documents for each study
site.
3. Sponsor provides support (review of ICD changes, primary contact for
questions re: liability, etc.) as necessary for study site submission of
protocol/ICD to IRBs for review and approval. Sponsor acts as primary
contact with commercial IRB.
4. Sponsor is responsible for site training on study procedures. Promedica is
responsible for site training on protocol, capture of study data and
maintenance of study regulatory documentation. Promedica provides
regulatory binder "shells" to study sites as necessary.
5. Sponsor is responsible for shipment of study product to sites, and
maintains records of product shipment and returns.
STUDY MONITORING/SITE MANAGEMENT
1. As directed by Sponsor, Promedica schedules and conducts STUDY INITIATION
SITE VISITS where activities are performed in accordance with monitoring
plan & SOPs. Note: Sponsor may accompany Promedica at any time during site
visits.
2. As directed by the monitoring plan or joint agreement between Sponsor and
Promedica, Promedica schedules and conducts ONGOING MONITORING VISITS
during which the activities are performed in accordance with monitoring
plan & SOPs. Note: Sponsor may accompany Prome&ca at any time during site
visits.
3. Throughout the active study period, Promedica communicates with sites as
required to facilitate subject follow-up, and accountability; clarify
protocol issues; resolve queries; assist with processing or follow-up on
complication and Adverse Event reports as requested by Sponsor; update
essential regulatory document for the study; and facilitate study related
communications with IRBs.
4. Sponsor submits to FDA reports of unanticipated device-related adverse
events occurring during the course of the study.
DATA MANAGEMENT/STATISTICS/CLINICAL STUDY REPORTS
1. Promedica prepares revised Data Management Plan for Sponsor review and
approval. Plan includes annotated CRFs, field definitions, data entry
guidelines and database validation plan.
2. Promedica is responsible for clinical and administrative database(s)
revisions, and for activities associated with maintenance of data
integrity within the database. All data will reside on Promedica's network
server.
3. Upon receipt of site CRFs, Promedica logs in & forwards for data
entry/verification. Programmed edit checks are applied and queries
generated.
4. Entered CRFs and associated DCFs are forwarded for secondary review by
in-house CRA. Upon completion of review, DCFs are forwarded to sites for
resolution and CRFs/DCFs are filed in a secure, easily retrievable
location.
5. Upon receipt of query resolution, Promedica revises/verifies database
entries as necessary and files DCFs.
CONFIDENTIAL PROPOSAL, Page 2 of 5
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6. Promedica performs cleaning and internal audits of study data and
transfers to Sponsor at intervals mutually agreed to by Sponsor and
Promedica.
7. Sponsor prepares statistical analyses and generates statistical reports.
8. Sponsor prepares study reports for FDA submission.
PROJECT MANAGEMENT/ADMINISTRATION
1. Promedica updates project management and study monitoring plans for
Sponsor review and feedback, and provides internal team training on
protocol amendments, as well as amendments to project and monitoring
plans.
2. Promedica maintains ongoing monitoring visit calendar and communicates to
Sponsor, reviews site visit reports, and takes action as required with
Sponsor and/or sites.
3. Promedica maintains study documentation binders for each site, the
Sponsor, affiliated consultants, and CRAs.
4. Promedica participates in development of plans for GCP audits of study
sites. Sponsor or a designee are responsible for execution of audits.
5. Throughout this phase, Promedica Project Manager:
- Reviews Promedica work products to check for accuracy and adherence
to SOP
- Reviews project expenditures vs. budget and timelines vs. plan
- Conducts regular project team (CRAs, in-house coordinator, data
management) meetings & interfaces verbally and in writing with
Sponsor/ consultants to keep them apprised of study-related issues
and follow-up on issues outstanding
- Provides regular project status reports to Sponsor
- Participates in meetings at Sponsor's facility and at major industry
tradeshows as requested by Sponsor
STUDY CLOSEOUT ACTIVITIES
STUDY MONITORING/SITE MANAGEMENT
1. Promedica is responsible for scheduling and completing study closeout
activities for sites as they complete study subject follow up or as they
withdraw from the study. Activities performed are in accordance with
monitoring plan and SOPs.
2. As directed by Sponsor, Promedica schedules and conducts study CLOSEOUT
VISITS during which activities are performed in accordance with monitoring
plan & SOPS. Note: Sponsor may accompany Promedica at any time during site
visits.
DATA MANAGEMENT/STATISTICS/CLINICAL STUDY REPORT
1. In preparation for final study report, Promedica cleans database,
generates and verifies line listings for primary efficacy variables and
adverse events for all subject CRFs, and performs database lock.
2. Sponsor prepares statistical analyses and generates statistical reports as
necessary.
3. Sponsor prepares final study report for FDA submission.
CONFIDENTIAL PROPOSAL, Page 3 of 5
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PROJECT MANAGEMENT/ADMINISTRATION
1. Throughout this phase, Promedica Project Manager:
- Reviews Promedica work products to check for accuracy and adherence
to SOP
- Reviews project expenditures vs. budget and timelines vs. plan
- Conducts regular project team (CRAs, in-house coordinator, data
management) meetings & interfaces verbally and in writing with
Sponsor/consultants to keep them apprised of study-related issues
and follow up on issues outstanding
- Provides regular project status reports to Sponsor
- Participates in meetings at Sponsor's facility and at major industry
tradeshows as requested by Sponsor
2. At project completion, Promedica transfers study regulatory binders and
subject files back to Sponsor.
COMPENSATION TERMS
Services performed and expenses incurred will be billed on a monthly basis.
A deposit of 10% of estimated costs for the project ($100,374) will be required.
Promedica will retain this deposit until project completion, termination of the
agreement, or at its discretion, apply the deposit against invoices over 60 days
late. In the event the deposit is applied toward late invoices, the full deposit
amount will be due prior to continuation of contract services. Upon project
completion or termination of this agreement, this deposit will be applied toward
any unpaid fees and expenses, with excess monies refunded to Client.
CONFIDENTIAL PROPOSAL, Page 4 of 5
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ATTACHMENT 1
PROMEDICA INTERNATIONAL,
ESTIMATED BUDGET - MIRA-1 AMD STUDY
<PAGE>
EXHIBIT A, ATTACHMENT 1
VASCULAR SCIENCES MIRA-1 STUDY FOR TREATMENT OF AMD
PROMEDICA INTERNATIONAL BUDGET ASSUMPTIONS
1. 75 eyes followed for 12 months to establish safety & efficacy
2. Subjects to be enrolled at 6 US "sites" (each "site" consists of an
ophthalmology & a nephrology center). Of the 6 sites, 2 (NC & Chicago) are
currently active, 2 (NYC & Phila) are new, and 2 (LA, Baltimore) are sites
that have been inactive for the past 12+ mo.
3. Five US sites and the Los Angeles nephrology center that previously
participated in the study will be closed out upon resumption of the
project.
4. 15 follow-up visits/subject (Qualifying, Baseline, Treatment 1-8, Pre5th,
2 week Post, Months 9, 12)
5. 126 CRF pages/subject
6. Budget for "time required" estimates used in this proposal are based on
the values noted below
PROJECT TIMEFRAMES BY ACTIVITY TIME REQUIRED (MO)
------------------------------ ------------------
Pre-study activities 2.0
Subject enrollment (75 patients) 6.0
Follow-up (12 mo.) 12.5
Subtotal active study period 20.5
Database closure/statistical analysis/file PMA 1.0
Site close-out visits/study files return 2.0
Subtotal remaining study surveillance/close-out period 3.0
ESTIMATED TOTAL PROJECT LENGTH 23.5
EXHIBIT A, ATTACH 1 Vascular Sciences AMD Study Budget, Rev 07-16-03.xls,
Assumptions
CONFIDENTIAL
<PAGE>
VASCULAR SCIENCES MIRA-1 STUDY
FOR TREATMENT OF AMD
ESTIMATED PROMEDICA INTERNATIONAL BUDGET SUMMARY
THE PROJECTED BUDGET IS AN ESTIMATE ONLY, AND IS SUBJECT TO CHANGE BASED ON
PROJECT LENGTH, "DIFFICULT" STUDY SITES REQUIRING MORE MONITORING TIME, SITE
STUDY STAFF TURNOVER, TRAVEL DELAYS, EFFICIENCY/DECISIVENESS OF SPONSOR OR
SPONSOR AGENTS WITH RESPECT TO PROMEDICA STUDY OR DATA MANAGEMENT/ADMINISTRATION
REQUESTS, AND CHANGES TO APPLICABLE REGULATORY REQUIREMENTS.
STUDY PHASE PROJECTED BUDGET COMMENTS
----------- ---------------- --------
Ongoing study (fees)* $ 847,321
Travel expense - study qualification $ 42,063
visits/study monitoring/ auditing
Study close-out (fees)* $ 106,708
Travel expense - study close-out visits $ 7,650
GRAND TOTAL** $1,003,742 10% DEPOSIT REQUIRED: $ 100,374
* Promedica fees are subject to increase by up to 5% per year based on the cost
of inflation
**Expenses for telephone, document copying, mail, project-related supplies,
off-site document storage (if applicable), or document shredding are not
included in this estimate. These expenses are billed at cost.
Note: Budget dollars may not tally exactly due to rounding during calculations.
EXHIBIT A, ATTACH 1 Vascular Sciences AMD Study Budget, Rev 07-16-03.xls, Total
CONFIDENTIAL
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VASCULAR SCIENCES MIRA-1 STUDY FOR TREATMENT OF AMD
ESTIMATED PROMEDICA INTERNATIONAL BUDGET - ONGOING STUDY ACTIVITIES
PRE-STUDY ACTIVITIES: SITE QUALIFICATION/AGREEMENTS/
TRAINING RESPONSIBILITY RATE/HR. # HR. # VISITS # SITES BUDGET COMMENTS
----------------------------------------------------- -------------- ------- ----- -------- ------- ------ --------
Site recruitment Client
Site qualification visits (includes prep & follow-up) N/A $ 0
Site budget negotiations Client
Collection & logging of essential regulatory documents Promedica $ 126 8.0 6 $ 6,048
Develop subject recruitment programs Client/Sites
Initial IRB submissions Client $ 0
ONGOING ACTIVITIES: STUDY MONITORING / SITE
MANAGEMENT RESPONSIBILITY RATE/HR. # HR. # VISITS
-------------------------------------------- -------------- -------- ----- --------
Study initiation visits (including prep & follow-up) Promedica $ 126 24.0 1
Visit travel Promedica $ 95 16.0 1
Collection & logging of essential regulatory documents Promedica $ 126 1.0
Ongoing site visits (includes prep & follow-up) - Promedica $ 126 24.0 2
initial 2 visits
Visit travel Promedica $ 126 16.0 2
Ongoing site visits (includes prep & follow-up) - Promedica $ 126 16.0 1
final visit
Visit travel Promedica $ 126 16.0 1
Site visit report review/follow-up - Proj Mgr Promedica $ 160 2.0 4
Site visit prep & follow-up - Coordinator Promedica $ 65 2.0 4
Ongoing CRA communications with sites - enrollment Promedica $ 126 4.0
period
Ongoing CRA communications with sites - remainder of Promedica $ 126 2.0
study
AE initial contact & follow-up Promedica/Client $ 126 1.3
Medical oversight / AE reporting Client
Site regulatory binders & aux supplies prep / shipment Promedica $ 65 0.7
Product shipment / inventory Client
ONGOING ACTIVITIES: STUDY MONITORING / SITE
MANAGEMENT # SITES # MO. BUDGET COMMENTS
-------------------------------------------- ------- ----- --------- --------
Study initiation visits (including prep & follow-up) 6 $ 18,144 Assumes 1 initiation
visit/site done prior to
Visit travel 6 $ 9,120 1/04. For NYC & Phila,
qualification & initiation
activities are combined into
this visit
Collection & logging of essential regulatory documents 6 20.5 $ 15,496
Ongoing site visits (includes prep & follow-up) - 6 $ 36,288
initial 2 visits
Visit travel 6 $ 24,192
Ongoing site visits (includes prep & follow-up) - 6 $ 12,096 Assume visits every 6 months
final visit
Visit travel 6 $ 12,096
Site visit report review/follow-up - Proj Mgr 6 $ 7,680
Site visit prep & follow-up - Coordinator 6 $ 3,120
Ongoing CRA communications with sites - enrollment 6 6.0 $ 18,144
period
Ongoing CRA communications with sites - remainder of 6 14.5 $ 21,924
study
AE initial contact & follow-up 20.5 $ 3,444 Assume only UADE rpts involved
Medical oversight / AE reporting
Site regulatory binders & aux supplies prep / shipment 6 20.5 $ 5,330
Product shipment / inventory
ONGOING ACTIVITIES: CLOSE-OUT OF 5.5 SITES RESPONSIBILITY RATE/HR. # HR. # VISITS # SITES # MO. BUDGET COMMENTS
------------------------------------------- -------------- -------- ----- -------- ------- ----- ------ --------
Collection & logging of essential
regulatory documents Promedica $ 126 8.0 5.5 $ 5,544
AE initial contact & follow-up N/A $ 0
Medical oversight / AE reporting N/A $ 0
Note: Budget dollars may not tally exactly due to rounding during calculations.
EXHIBIT A, ATTACH 1 Vascular Sciences AMD Study Budget, Rev 07-16-03.xls,
Ongoing Study
CONFIDENTIAL
<PAGE>
Closeout visits (includes preparation
& follow-up) Promedica $ 126 16.0 1 5.5 $ 11,088
Visit travel Promedica $ 95 16.0 1 5.5 $ 8,316 Assumes 1 close-out
Site visit report review / visit / site to be done
follow-up - Project Manager Promedica $ 160 2.0 1 5.5 $ 1,760 prior to 1/04
Site visit report prep /
follow-up - Coordinator Promedica $ 65 2.0 1 5.5 $ 715
Investigator / patient payments
per financial agreement Client
PRE-STUDY ACTIVITIES: DATA MANAGEMENT RESPONSIBILITY RATE/HR. # HR. # SUBJECTS # REPS # MO. BUDGET COMMENTS
-------------------------------------- -------------- -------- ----- ---------- ------ ---- ------ --------
Protocol / ICD / CRF review - Proj Mgr Promedica $ 160 4.0 $ 640 Assumes time for initial
review; each add'l
review cycle would be
billed hourly
Data management plan & SOP development
/ review Promedica $ 160 80.0 $ 12,800 Assumes time for initial
document development &
review; each add'l
review cycle would be
billed hourly
Database development - Data Manager Promedica $ 160 24.0 $ 3,840
Database development - Systems Analyst Promedica $ 130 160.0 $ 20,800 Includes database table
& data entry screen
design, edit programming
& database verification
/ validation
Database development - CRA Promedica $ 126 8.0 $ 1,008 Time required for
validation testing
Database development - Coordinator Promedica $ 65 8.0 $ 520 Time required for
validation testing
Program listings per sponsor requirements Promedica $ 130 8.0 5.0 $ 5,200 Assumes 5 reports /
listings. Additional
reports / listings will
be billed hourly.
Program data cleaning routines Promedica $ 130 24.0 $ 3,120
Data import from existing database Promedica $ 130 40.0 $ 5,200 Includes import of CRF
data, Jules Stein data,
smoking questionnaire,
CDF log
QC audit of line listings vs. CRFs / DCFs Promedica
Primary efficacy / safety variables
(100%) $ 126 0.5 103 $ 6,489
Comprehensive (10%) $ 126 1.5 11 $ 2,079
Prepare audit report $ 160 6.0 $ 960
Monthly Data Manager team communications Promedica $ 160 20.0 4.0 $ 12,800
PRE-STUDY ACTIVITIES: STATISTICAL ANALYSIS RESPONSIBILITY RATE/HR. # HR. BUDGET COMMENTS
------------------------------------------- -------------- -------- ----- ------ --------
Statistical analysis plan development Client
Statistical analysis plan review Promedica $ 160 8.0 $ 1,280
Project mgmt database modifications N/A $ 0
Note: Budget dollars may not tally exactly due to rounding during calculations.
EXHIBIT A, ATTACH 1 Vascular Sciences AMD Study Budget, Rev 07-16-03.xls,
Ongoing Study
CONFIDENTIAL
<PAGE>
ONGOING ACTIVITIES: DATA MANAGEMENT RESPONSIBILITY RATE/HR. # HR. # SUBJECTS # REPS # MO. BUDGET COMMENTS
----------------------------------- -------------- -------- ----- ---------- ------ ----- ------ --------
CRF receipt / log-in Promedica $ 65 1.5 75 $ 7,313
Data entry / verification Promedica $ 65 16.8 75 $ 81,900 Assumes double data
entry verification
In-house secondary review of CRFs Promedica $ 126 2.8 75 $ 25,988
Review query resolution / perform required
edits Promedica $ 126 1.0 75 $ 9,450
Provide monthly reports / listings Promedica $ 65 2.0 20.5 $ 2,665
IDE annual progress report development /
revisions Client $ 0
Monthly team communications - Data Manager Promedica $ 160 10.0 16.5 $ 26,400
Promedica project team training - Data
Manager Promedica $ 160 0.7 20.5 $ 2,187
PROJECT MANAGEMENT / ADMINISTRATION RESPONSIBILITY RATE/HR. # HR. # STAFF # MO. BUDGET COMMENTS
----------------------------------- -------------- -------- ----- ------- ----- ------ --------
Project management plan development /
review Promedica $ 160 40.0 $ 6,400
Monitoring plan & SOP development /
review Promedica $ 160 32.0 $ 5,120 Assumes time for
initial document
development & review;
add'l review /
revisions would
be billed hourly
Client audit of CRO facilities &
procedures N/A $ 0
Promedica team training - Proj Mgr Promedica $ 160 12.0 1 $ 1,920 Assumes time for
Promedica team training - CRAs Promedica $ 126 8.0 3 $ 3,024 initial protocol /
Promedica team training - Coordinators Promedica $ 65 8.0 4 $ 2,080 procedures / forms
training only;
additional training
due to changes would
be billed hourly.
Monthly schedule / budget management Promedica $ 160 6.0 20.5 $ 19,680
Monthly project management plan review /
update Promedica $ 160 0.8 20.5 $ 2,460 Assume performance
Monthly monitoring plan review / update Promedica $ 160 1.0 20.5 $ 3,280 2x / year
Monthly team management - Proj Mgr -
enrollment period Promedica $ 160 60.0 1 6.0 $ 57,600
Monthly team management - Proj Mgr -
remainder of study Promedica $ 160 40.0 1 16.5 $ 105,600
Monthly team communications - CRAs -
enrollment period Promedica $ 126 20.0 3 6.0 $ 45,360
Monthly team communications - CRAs -
remainder of study Promedica $ 126 12.0 3 16.5 $ 74,844
Monthly team communications - Coordinator Promedica $ 65 40.0 1 20.5 $ 53,300
Monthly team communications - Exec Mgmt Promedica $ 250 0.5 1 20.5 $ 2,563
QA audits - study sites Client Audit plan
development covered
in PM monthly team
management.Client
responsible for
audit
implementation.
Investigator / patient payments per
financial agreement Client
Note: Budget dollars may not tally exactly due to rounding during calculations.
EXHIBIT A, ATTACH 1 Vascular Sciences AMD Study Budget, Rev 07-16-03.xls,
Ongoing Study
CONFIDENTIAL
<PAGE>
Ongoing Promedica team training - Proj Mgr Promedica $ 160 0.7 1 20.5 $ 2,187 to changes in
Ongoing Promedica team training - CRAs Promedica $ 126 0.7 3 20.5 $ 5,166 protocol, data
Ongoing Promedica team training - collection
Coordinators Promedica $ 65 0.7 4 20.5 $ 3,553 requirements, or
changes in
SUBTOTAL - ALL FEES $ 847,321 regulatory
requirements
# TRIPS
ONGOING MONITORING VISIT EXPENSES RESPONSIBILITY RATE # SITES /SITES # DAYS BUDGET COMMENTS
--------------------------------- -------------- ---- ------- ------- ------ ------ --------
Airfare (per trip) Promedica $ 1,000 6 4 $ 24,000 Budget provided
Lodging / food / ground transportation is based on
(per day) - 1 day on-site Promedica $ 275 6 1 1.0 $ 1,650 "average" expenses
Lodging / food / ground transportation across all sites
(per day) - 2 days on-site Promedica $ 275 6 3 2.0 $ 9,900
CLOSEOUT VISIT EXPENSES - 5.5 SITES
-----------------------------------
Airfare (per trip) Promedica $ 1,000 5 1 $ 5,000 Budget provided is
Lodging / food / ground transportation based on "average"
(per day) Promedica $ 275 5.5 1 1.0 $ 1,513 expenses across all
sites
SUBTOTAL - TRAVEL EXPENSES $ 42,063
Note: Budget dollars may not tally exactly due to rounding during calculations.
EXHIBIT A, ATTACH 1 Vascular Sciences AMD Study Budget, Rev 07-16-03.xls,
Ongoing Study
CONFIDENTIAL
<PAGE>
VASCULAR SCIENCES MIRA-1 STUDY FOR TREATMENT OF AMD ESTIMATED PROMEDICA
INTERNATIONAL BUDGET - STUDY COMPLETION ACTIVITIES
DATA MGMT / STATISTICS / CLINICAL STUDY RPTS RESPONSIBILITY RATE/HR. # HR. # SUBJECTS # MO. BUDGET COMMENTS
-------------------------------------------- -------------- -------- ----- ---------- ----- ------ --------
Data cleaning prior to database lock -
Systems Analyst Promedica $ 130 12.0 $ 1,560
Data cleaning prior to database lock -
Data Manager Promedica $ 160 16.0 $ 2,560
Data cleaning prior to database lock - CRA Promedica $ 126 16.0 $ 2,016
Independent QC audit - 10% sample Promedica $ 126 1.5 8 $ 1,512
Independent QC audit - critical variables Promedica $ 126 0.5 75 $ 4,725
Prepare audit report Promedica $ 160 6.0 $ 960
Database lock Promedica $ 130 4.0 $ 520
Database transfer Promedica $ 130 6.0 $ 780
Statistical analysis Client
Final study report development / revisions Client
File transfer at study close-out Promedica $ 65 100.0 $ 6,500
Monthly team communications - Data Manager Promedica $ 160 24.0 3.0 $ 11,520
STUDY MONITORING / SITE MANAGEMENT RESPONSIBILITY RATE/HR. # HR. # VISITS # SITES # MO. BUDGET COMMENTS
---------------------------------- -------------- -------- ----- -------- ------- ----- ------ --------
Collection & logging of essential regulatory
documents Promedica $ 126 1.0 6 3.0 $ 2,268
Ongoing CRA communications with sites Promedica $ 126 1.0 6 3.0 $ 2,268
AE initial contact & follow-up Promedica /
Client $ 126 1.3 3.0 $ 504 Assume only UADE
rpts involved
Medical oversight / AE reporting Client
Closeout visits (includes preparation &
follow-up) Promedica $ 126 16.0 1 6 $ 12,096
Visit travel Promedica $ 126 16.0 1 6 $ 12,096 Assumes 1 close-
Site visit report review / follow-up - out visit /site
Project Manager Promedica $ 160 2.0 1 6 $ 1,920
Site visit report prep & follow-up -
Coordinator Promedica $ 65 2.0 1 6 $ 780
Investigator / patient payments per
financial agreement Client
PROJECT MANAGEMENT / ADMINISTRATION RESPONSIBILITY RATE/HR. # HR. # STAFF # MO. BUDGET COMMENTS
----------------------------------- -------------- -------- ----- ------- ----- ------ --------
Monthly schedule / budget management Promedica $ 160 4.0 3.0 $ 1,920
Monthly team communications - Proj Mgr Promedica $ 160 40.0 1 3.0 $ 19,200
Monthly team communications - CRAs Promedica $ 126 12.0 3 3.0 $ 13,608
Monthly team communications - Coordinator Promedica $ 65 36.0 1 3.0 $ 7,020
Note: Budget dollars may not tally exactly due to rounding during calculations.
EXHIBIT A, ATTACH 1 Vascular Sciences AMD Study Budget, Rev 07-16-03.xls,
Study Completion
CONFIDENTIAL
<PAGE>
Monthly team communications - Exec Mgmt Promedica $ 250 0.5 3.0 $ 375
SUBTOTAL - ALL FEES $ 106,708
# TRIPS /
CLOSEOUT VISIT EXPENSES RESPONSIBILITY RATE #SITES SITE # DAYS BUDGET COMMENTS
----------------------- -------------- ---- ------ ---- ------ ------ --------
Airfare (per trip) Promedica $ 1,000 6 1 $ 6,000 Budget provided is
Lodging / food / ground transportation based o "average"
(per day) Promedica $ 275 6 1 1.0 $ 1,650 expenses across all
sites
SUBTOTAL - TRAVEL EXPENSES $ 7,650
Note: Budget dollars may not tally exactly due to rounding during calculations.
EXHIBIT A, ATTACH 1 Vascular Sciences AMD Study Budget, Rev 07-16-03.xls,
Study Completion
CONFIDENTIAL
<PAGE>
ATTACHMENT 2
PROMEDICA INTERNATIONAL
PRICING SCHEDULE & TRAVEL EXPENSE GUIDELINES
CONFIDENTIAL PROPOSAL
<PAGE>
PROMEDICA INTERNATIONAL
PROJECT PRICING SCHEDULE & TRAVEL EXPENSE GUIDELINES
PROMEDICA FEES
Fees for contracted activities are as specified in the "Rate/Hr." column in the
estimated budget contained in Attachment 1. In the event of "unplanned" or
"rush" requests, in order to cover the costs of resource reallocation, Promedica
reserves the right to assign a surcharge of up to 25% over specified fees.
Labor rates utilized are valid through the remainder of 2003. At the beginning
of each year thereafter, rates are subject to adjustment of up to 5%, based on
the cost of inflation.
Travel time is accrued from time of departure to time of arrival at the
designated destination. For the remainder of 2003, travel time will be billed at
75% of the standard rate for the resource utilized. Effective January 1, 2004,
travel time will be billed at 100% of the standard rate for the resource
utilized.
STANDARD PROMEDICA EXPENSE SCHEDULE
Document copying $0.10/page
Facsimile $0.20/page
Postage/Quick Mail Rate dependent on mail class or delivery requirements
Off-site document storage & retrieval $0.335/std. carton - storage
$2.42/carton - retrieval
$45.15/hr. - delivery & pick-up
- Study supplies (binders, tabs, files, labels, etc.) costs are based on
Promedica's cost for procurement.
- Document shredding & telephone costs are allocated based on Promedica's
cost and client monthly usage.
All expenses noted above are billed monthly as they are incurred. The schedule
is reviewed periodically, and is subject to change based on Promedica's cost for
providing such services.
PROMEDICA TRAVEL EXPENSE GUIDELINES
Airfare Coach class booking
Local Transportation Rental car/taxi/public
transportation decisions are based on cost
effectiveness given site location,
incoming/outgoing air travel schedule &
baggage/supplies carried. When used, rental
cars are booked at economy rates.
When personal cars are used, mileage is billed at the
IRS-specified rate in effect at the time.
<PAGE>
- 2 -
Food The lesser of actual expenses or $60/person/day
Lodging The lesser of actual expenses or $175/person/day
<PAGE>
DISTRIBUTION AGREEMENT
This agreement ("Agreement") is made on 01. January 2002 between MESYS GMBH, a
company organized under the laws of Germany with offices at Beneckeallee 30,
D-30419 Hannover ("MESYS") and OccuLogix Corporation, 612 Florida Avenue, Palm
Harbor, Florida 34683 USA.
MESYS developed and produces on the order of DIAMED a blood-and plasma therapy
device. This device has been introduced into the market under the tradenames
Octo Nova and Octo Therm. These tradenames have been registered, among others,
by DIAMED in various countries. Furthermore, DIAMED holds all rights worldwide
on Octo Nova and Octo Therm. MESYS is the manufacturer of the plasma therapy
devices "Octo Nova / Octo Therm" and shall be authorized to enter into
distribution agreements with distributors outside Germany, provided that the
exclusive marketing agreement between DIAMED and OccuLogix Corp. has been
concluded (Exhibit D).
OccuLogix Corp. is the exclusive distributor for Octo Nova and Octo Therm in the
territory of United States, Canada and Mexico.
MESYS manufactures Octo Nova/ Octo Therm including accessories and spare parts,
according to the terms of this Agreement, and for which MESYS has the necessary
facilities, equipment, qualified personnel and experience.
Accordingly, the parties agree as follows:
1. MANUFACTURE OF PRODUCT
1.1 MESYS shall manufacture and sell to OccuLogix Corp. the device(s),
accessories, spare parts, and other tools (hereinafter "Product(s)") as
described in Exhibit A, attached to this Agreement and in the quantity
agreed between the parties. MESYS shall also furnish the Product and spare
parts and meet other conditions as set forth in this Agreement, including
those provided in Exhibit A and in the following specifications,
descriptive literature, and other documents ("Specifications").
Exhibit A: List of Product(s) and Quantities
Exhibit B: Spare Parts
Exhibit C: Price List
Exhibit D: Marketing Agreement
MESYS reserves the right to change the Specifications at any time in
agreement and upon a written notice to OccuLogix Corp.
No change to the Product shall be made by OccuLogix Corp. without MESYS's
prior written consent. During the term of this agreement OccuLogix Corp.
shall submit to MESYS for their approval and acceptance in writing all
proposed enhancements to the Product during the term of this Agreement.
All cost related to such product enhancements will be paid by OccuLogix
Corp. Procedures for handling of property
<PAGE>
- 2 -
rights in case of product enhancements have been included in the marketing
agreement between DIAMED and OccuLogix Corp. (Exhibit D)
1.2 MESYS shall furnish OccuLogix Corp. the following services for the Product
purchased under this Agreement:
1.2.1 Adequate technical and maintenance training for personnel. OccuLogix
Corp. will bear the costs of those training. The first training is
free of charge at MESYS.
1.2.2 Meetings between OccuLogix Corp. and MESYS shall take place in so
far as reasonable at Hannover. Upon appropriate notification by
OccuLogix Corp. participation of MESYS personnel shall also be
possible at other places.
1.3 If requested by OccuLogix Corp. in writing, MESYS shall have sufficiently
spare parts available, during a period of five (5) years after expiration
of this Agreement and sell to OccuLogix Corp. within agreed delivery times
and at reasonable prices.
1.4 MESYS warrants that the Products delivered to OccuLogix Corp. are free
from defects in materials, workmanship and manufacturing and is
merchantable, fit for the purpose intended, and in compliance with the
requirements of this Agreement. MESYS shall replace or repair any Product,
Product component, work, or other item furnished by it under this
Agreement, that fails to conform to the requirements of this Agreement if
such non-conformance appears within a period of twelve (12) months s of
delivery of the Product by MESYS to OccuLogix Corp.
2. ORDER, PAYMENT AND TERMS OF DELIVERY
2.1 Forecast and orders
2.1.1 Upon execution of this Agreement, and no later than thirty (30) days
after each succeeding anniversary date of this Agreement, OccuLogix
Corp. shall submit to MESYS an annual rolling forecast. OccuLogix
Corp. guarantees that for the term of this Agreement will purchase
25 units of the Product Octo Nova per year beginning after FDA
approval (12 month period).
2.1.2 OccuLogix Corp. shall submit to MESYS purchase orders indicating the
type and quantity of Product required. OccuLogix Corp. shall submit
such purchase orders regularly in the form of a rolling forecast
over a period of 12 months, whereby the running and the following 3
subsequent months shall be binding orders allowing lead time of
thirty (30) business days for MESYS to fill the orders. OccuLogix
Corp. purchase orders shall be deemed accepted by MESYS unless it
notifies OccuLogix Corp. to the contrary within ten (10) business
days of its receipt thereof.
2.1.3 All sales of the Products by MESYS to OccuLogix Corp. and orders
from OccuLogix Corp. to MESYS shall be subject to the provisions of
this Agreement,
<PAGE>
- 3 -
and shall not be subject to the terms and conditions contained in
any purchase order of MESYS or OccuLogix Corp.
2.2 Delivery
2.2.1 OccuLogix Corp. or its agent shall collect Products at MESYS
facility in Hannover. Till collection the Products remain under the
custody and the responsibility of MESYS. The following shall be
agreed as delivery term: "ex works MESYS".
2.2.2 After the Product has passed all required test, verification and
approvals and has been properly packed by MESYS, MESYS will inform
in writing OccuLogix Corp. of availability of the Product.
2.3 OccuLogix Corp. shall pay MESYS the prices for the Product as stipulated
in Exhibit C. These prices include not freight and packing costs. MESYS
shall be authorized to raise the prices as per 1st January of every year
according to the general price increase. Exceptional price increases shall
be proven separately and can be enforced if deemed essential.
2.4 OccuLogix Corp. shall pay accepted MESYS invoices within tweeny (30) days
of the date of invoice or per letter of credit. Invoices are payable in
DEM or EURO.
2.5 In the event OccuLogix Corp. were not to purchase the full guaranteed 25
units per year of Product within the terms of this Agreement specified in
Section 7, the parties agree that OccuLogix Corp. would pay MESYS DEM
5,000 or EURO 2.560 for every not purchased unit up to the limit of 25
units per year.
3. QUALITY REQUIREMENTS
All Products shall be manufactured and packaged in accordance with EU /
MDD with FDA and UL standards.
4. REGISTRATION/REGULATORY MATTERS
The Octo Nova/Octo Term is labelled with CE mark and have the registration
for all EU States. OccuLogix Corp. is responsible for FDA approval.
5. EXCLUSIVITY
During the terms of this Agreement, MESYS shall not enter into any
agreement with third parties for the sale of the Octo Nova in United
States, Canada and Mexico.
6. CONFIDENTIALITY
Any information conveyed to OccuLogix Corp. by MESYS in connection with
this Agreement, and specifically identified as confidential, shall be used
by OccuLogix Corp. only for the purposes of this Agreement and shall not
be disclosed to third parties during
<PAGE>
- 4 -
the term of this Agreement or for a period of five years thereafter,
provided, however, that such obligation of confidentiality shall not apply
to information that:
(a) was known prior to its disclosure by the transferring Party;
(b) is received at any time in good faith from a third party with the
legal right to disclose the same; or
(c) is in the public domain or subsequently enter the public domain
other than by reason of acts or omissions of the employees or
agents.
7. TERM, TERMINATION
7.1 This Agreement shall be in effect for the initial term beginning with the
execution date and for a duration of three (3) years after the date of FDA
approval. It will expire at that date without requiring termination. Any
prolongation must be agreed upon in advance and in writing.
7.2 Either party may immediately terminate this Agreement if any breach of its
terms is not cured within sixty (60) days following receipt of written
notice from the other Party.
7.3 Either party may terminate this Agreement, effective immediately upon the
giving of notice, if:
(a) the other Party shall file a petition in bankruptcy, or shall be
adjudicated a bankrupt, or shall become insolvent, or shall make an
assignment for the benefit of creditors, or shall be voluntarily or
involuntarily dissolved, or shall have a receiver, trustee or other
court officer appointed for its property.
(b) the production contract between DIAMED and MESYS is terminated.
(c) the marketing contract between DIAMED and OccuLogix Corp. is
terminated.
7.4 Termination shall not relieve or release either party from performing all
obligations hereunder and making any and all payments which may be due and
owing under the terms of this Agreement.
8. INTELLECTUAL PROPERTY RIGHTS
8.1 This Agreement shall not affect the rights of the parties in their
respective trademarks or patents.
8.2 OccuLogix Corp. shall not retain any MESYS documents, files, records,
correspondence, notes, or other items, including copies, relating to the
business of MESYS, except as its association with MESYS shall require and
then only with permission of MESYS. In cases where MESYS permits OccuLogix
Corp. to retain such items, OccuLogix Corp. shall promptly return them to
MESYS upon request or upon completion or termination under this Agreement.
<PAGE>
- 5 -
8.3 All drawings, specifications, proposals, photographs, recordings, samples,
prototypes and products given to OccuLogix Corp. by MESYS or produced by
OccuLogix Corp. under this Agreement and which incorporates any of MESYS's
ideas or technology, shall not be shown or displayed by OccuLogix Corp. to
any third party.
8.4 OccuLogix Corp. shall not disclose to any third party in any manner the
fact or nature of its association with MESYS without first obtaining the
express written permission.
8.5 OccuLogix Corp. may disclose MESYS's information to subcontractors,
regulatory authorities, and others, as required to meet OccuLogix Corp.
obligations under this Agreement, provided:
(1) MESYS has approved such disclosure, and
(2) OccuLogix Corp. secures confidential/and proprietary treatment of
any information thus disclosed in a manner accepted by MESYS.
9. INDEMNITY
OccuLogix Corp. shall indemnify and hold MESYS harmless from all claims
resulting from any act or omission. OccuLogix Corp. agrees to maintain
product liability coverage in an amount sufficient to meet its obligations
under this Section 9. MESYS's liability shall be limited to liability in
compliance with German law. OccuLogix Corp. shall fulfil its obligations
as representative in accordance with FDA requirements.
10. RECALLS, INSPECTIONS AND PRODUCT COMPLAINTS
10.1 The parties shall notify and cooperate with each other as to any
complaints, inspections and recalls concerning the Product.
10.2 In the event of a recall of the Product, OccuLogix Corp. shall assume
complete responsibility for the conduct of the recall. MESYS shall provide
OccuLogix Corp. with any manufacturing information required by OccuLogix
Corp. in connection with the recall. The cost of any recall hereunder
shall be equitably allocated between the parties in accordance with their
responsibility for its underlying cause.
11. TECHNICAL SERVICE
OccuLogix Corp. is responsible for the technical service in United States,
Canada and Mexico. OccuLogix Corp. has the necessary equipment, stock of
spare parts and qualified personnel to realize the technical service in
accordance with MESYS requirements. OccuLogix Corp. should only use
original spare parts delivered from MESYS for repair. Maintenance and
safety checks for Octo Nova/Octo Therm has to be done in accordance with
MESYS requirements.
<PAGE>
- 6 -
12. CUSTOMER TRAINING
OccuLogix Corp. is responsible for customer training in United States,
Canada and Mexico. OccuLogix Corp. has the necessary equipment and
qualified personnel to realize the training in accordance with MESYS
requirements.
13. FORCE MAJEURE
Neither party shall be liable to the other party for failure to perform
any of its obligations hereunder because of any cause beyond the control
of or occurring without the fault of such party.
14. NOTICES
All notices or communications shall be effective when sent via registered
mail, with sufficient postage, prepaid, addressed to the recipient party
at the address of that party first above written, or to such other
address(es) as either party shall specify by notice to the other party.
15. MISCELLANEOUS
15.1 This Agreement shall be binding upon the parties, their successors and
assigns. Neither party shall assign this Agreement without the prior
consent in writing of the other party, except that either party may assign
this Agreement to an entity under common control.
<PAGE>
MESYS
Medizinische Systeme
MeSys GmbH
Beneckeallee 30
30419 Hannover
Fon: 0511 679999-0
Fax: 0511 679999-11
Email: mesys@aol.com
SPARE PART LIST 2000
OCTO NOVA
05/2000
Valid from 01.05.2000
Price changes and errors excepted. All Prices without packaging and
transportation costs. For Shipments with a goods worth below DM 50.-a fee of DM
35.- will be charged.
<PAGE>
DOOR INSIDE VIEW
PART NO. DESCRIPTION EURO DM
-------- ----------- ---- --
KM E039-10 Chargeable Battery Pack Octo Nova LCR 24V/2,2P 168,73 330,00
BG-F467-00 Power Supply Octo Nova complete 762,34 1491,00
AN-F028-00 Fan Octo Nova 39,88 78,00
SZ-E030-00 Fuse 5x20 T10A 0,92 1,80
BG-E313-04 Motherboard 220,88 432,00
BG-E300-04 PCB, CPU-517 315,47 617,00
BG-E325-00 PC/104 CPU complete 1692,37 3310,00
BG-E308-02 PCB, Scale 140,61 275,00
BG-E309-01 PCB, Bloodleak detector 87,43 171,00
BG-E310-00 PCB, Alarmtone 78,74 154,00
BG-E319-00 PCB, Drip Counter 108,39 212,00
SZ-E027-00 Fuse 5x20 T200mA 0,92 1,80
IT-E020-00 Toroidal Transformer 119,64 234,00
IE-E007-00 Line Filter 75,16 147,00
<PAGE>
DOOR OUTSIDE VIEW
PART NO. DESCRIPTION EURO DM
-------- ----------- ---- --
SE-F022-00 Fuse Holder 6,44 12,60
SE-F020-00 Power Connector 37,32 73,00
SZ-E029-00 Fuse 5x20 2AmT 0,92 1,80
SI-F148-00 Label Technical Service 2,53 4,95
SI-F144-00 Label Fuses 0,82 1,60
SI-F147-00 Label Connector Octo Therm 2,30 4,50
SI-F016-00 Label Potential Equalization 0,61 1,20
KK-F037-00 Power Cord 8,08 15,80
KT-F326-00 T-Clip Cableguiding Cart 1,64 3,20