1
EXHIBIT 10.8
AGREEMENT
This Agreement, is by and between Advanced Corneal Systems, Inc., (hereinafter
"ACS"), with offices at 00000 Xxxxx Xxxxxxx, Xxxxx 000, Xxxxxx, XX 00000 and
CroMedica Global Inc., (hereafter "CroMedica") located at 000 Xxxx Xxxxxx, Xxxxx
000, Xxxxxxxx, Xxxxxxx Xxxxxxxx X0X 0X0.
WHEREAS ACS intends to submit the results of the Investigation to the Food and
Drug Administration ("FDA") and other international regulatory agencies in
support of marketing approval;
WHEREAS, ACS desires to have certain research conducted (as described herein)
with respect to the compound known as Vitrase(TM) a hyaluronidase solution (the
"Investigation") in accordance with the protocols attached hereto as Exhibit A,
which is incorporated herein together with all amendments thereto, (hereinafter,
the "Protocols"); and
WHEREAS, CroMedica is experienced in such research and has the qualified
personnel available to perform these services for ACS; and
WHEREAS, ACS intends to enter into a contract substantially similar to this
Agreement with Covance Clinical and Periapproval Services, Inc. ("COVANCE"), for
the purpose of having Covance assist ACS with the execution of substantially the
same clinical investigation of the Drug in the United Kingdom, the Netherlands,
Poland and Brazil ("COVANCE STUDY"); and ACS intends to enter into a contract
substantially similar to this Agreement with Verum Staticon ("VERUM"), for the
purpose of having Verum assist ACS with the execution of substantially the same
clinical investigation of the Drug in Germany and Hungary ("VERUM STUDY"); and
has entered into a contract substantially similar to this Agreement with
CroMedica for the purpose of having CroMedica assist ACS with the execution of
substantially the same clinical investigation of the Drug in South Africa
("CROMEDICA SOUTH AFRICA STUDY"); and
NOW THEREFORE, in consideration of the premises and of the mutual promises and
undertakings herein contained, the parties intending to be legally bound do
hereby agree as follows:
I. SCOPE OF SERVICES
The Investigation shall consist of the services set forth in Attachment
1 (Scope of Services) which is incorporated herein. CroMedica shall not
undertake any additional work without a written modification of this
Agreement pursuant to Section XVII (Modifications). To the extent that
any conflict exists between the terms of
1
2
this Agreement and Attachment 1 (Scope of Services), the terms of this
Agreement shall take precedence.
CroMedica agrees to conduct, and to cause its employees, officers,
directors and representatives to conduct, the Investigation in
accordance with the terms of this Agreement (as applicable to the
particular Investigation), the Protocols, and in full compliance with
all applicable Federal, State, and local laws and regulations,
including without limitation FDA guidelines pertaining to clinical
investigations and the use of investigational drugs in humans.
CroMedica hereby certifies that it has not and will not use in any
capacity the services of any individual, corporation, partnership or
association which has been debarred under 21 U.S.C. 306(a) or (b). In
the event that CroMedica becomes aware of the debarment or threatened
debarment of any individual, corporation, partnership or association
providing services to CroMedica or to an Investigator retained by
CroMedica which directly or indirectly relate to Investigator's
activities under this Agreement, CroMedica shall notify ACS
immediately. Any Investigator retained by CroMedica will understand
that ACS shall have the right to terminate this Agreement immediately
upon receipt of such notice.
CroMedica will undertake to assure that Investigators retained by
CroMedica in the INVESTIGATION certify that they have not been debarred
under the provisions of the Generic Drug Enforcement Act of 1992, 21
U.S.C. 306(a) or (b). In the event that an Investigator:
(i) becomes debarred; or
(ii) receives notice of action or threat of action with respect to
debarment, during the term of this Agreement, CroMedica agrees
to notify ACS immediately. In the event that Investigator
becomes debarred as set forth in clause (i) Investigators
retained by CroMedica understands that this Agreement shall
automatically terminate without any further action or notice
by either party. In the event that an Investigator receives
notice of action or threat of action as set forth in clause
(ii) above, CroMedica and Investigators retained by CroMedica
understands that ACS shall have the right to terminate this
Agreement immediately.
CroMedica will be responsible for coordinating the collection of data
from the COVANCE STUDY, VERUM STUDY, and CROMEDICA SOUTH AFRICA STUDY
for inclusion in the
2
3
regulatory submissions, or parts thereof. CroMedica will not be
responsible for any delays, and/or deficiencies that are caused by
COVANCE's or VERUM's failure to implement the agreed to Protocols or
deliver the data from the COVANCE STUDY and VERUM STUDY to CroMedica on
an agreed to schedule; provided, however, that CroMedica has provided
ACS with timely notice of potential delays and/or deficiencies once it
has a reasonable basis to believe either or both are likely.
II. PERFORMANCE SCHEDULE
The Performance Schedule by which CroMedica shall perform the services
specified in this Agreement is set forth in Attachment 2. (Payment and
Performance Schedule), which is incorporated herein.
III. COMPENSATION
A. CroMedica Compensation
This is a fixed unit price contract. ACS shall pay to
CroMedica in the manner specified in Attachment 2 (Payment and
Performance Schedule), as compensation for all services
performed under this Agreement, the sum of US $2,817,625. This
amount represents all of CroMedica's professional fees, and
all expenses other than Reimbursable Expenses as described
below.
B. Payment Schedule
CroMedica shall invoice ACS on a milestone-completion basis,
according to the Payment Schedule set forth in Attachment 2
(Payment and Performance Schedule), which is incorporated
herein. Invoices shall include, for recurring activities, the
number of such activities included in the invoiced amount.
C. Reimbursement of Expenses
1. ACS will reimburse CroMedica for the "actual cost"
(defined below) of expenses incurred by CroMedica
for:
(a) travel; provided that such expenses are (i)
reasonable and necessary; and (ii) incurred
consistent with CroMedica's travel policy;
3
4
(b) Other costs incurred in the performance the Scope
of Services as outlined in Attachment 1 of this
Agreement, such as printing, photographing,
telephone and facsimile charges.
As used herein, "actual cost" means the dollar cost
paid by CroMedica, without any management fee,
commission or xxxx-up by CroMedica, and less any
discount, rebate or other allowance paid to CroMedica
by a supplier, whether reflected on the original
billing or thereafter.
2. Expenses reimbursable under (a) and (b) above are
referred to herein as "Reimbursable Expenses". Except
for Reimbursable Expenses, all costs incurred by
CroMedica in performing this Agreement shall be the
responsibility of CroMedica.
3. CroMedica shall submit monthly invoices for travel
expenses paid in the preceding month, together with
back-up documentation as requested by ACS, to the
person identified on Attachment 3 (Contact Persons).
IV. PROTOCOLS
The Investigation shall be conducted in full accordance with the
Protocols and any amendments to the Protocols. CroMedica shall make no
change in the Protocols during the course of the Investigation without
the prior written approval of ACS, except where necessary to eliminate
apparent immediate hazards to human subjects. ACS shall have the right
at any time to initiate such changes in the Protocols, as ACS deems
necessary or appropriate, including suspending the Investigation
temporarily or permanently.
V. CROMEDICA MANAGEMENT OF CLINICAL INVESTIGATIONS
A. Investigator Brochure/Product Monograph
Before the Investigation begins, and from time to time
throughout the course of the Investigation, as determined by
ACS, ACS shall provide CroMedica and all Investigators with a
current Investigator Brochure and Product Monograph for the
study compound.
4
5
B. Field Monitoring Guidelines
Unless supplied by ACS, in consultation with ACS, CroMedica
shall develop, Protocol-specific Field Monitoring Guidelines
to facilitate study monitoring.
C. On-Site Monitoring
1. Before the commencement of the Investigation at a new
study site, CroMedica shall conduct an on-site study
initiation visit to each Investigator site. During
the study initiation visit, CroMedica shall inspect
and inventory clinical supplies and review the
Protocols and CRF form with site staff to ensure
understanding and compliance.
2. CroMedica shall conduct periodic on-site monitoring
visits to each Investigator site during the course of
the Investigation at a frequency to be directed by
ACS, but in no event less that one visit every eight
weeks. During each such visit, CroMedica shall
ensure, by review of relevant investigator records,
and otherwise, that the investigator and the
investigational site continue to meet all applicable
federal, state, and local laws, statutes and
ordinances and regulations, and FDA Guidelines for
the Conduct of Clinical Investigations. CroMedica
will promptly notify ACS of any investigator that is
not complying with their agreement, and attempt to
obtain compliance. If compliance is not promptly
obtained, and after written approval is received from
ACS, CroMedica will end the investigators
participation in the study.
3. CroMedica shall conduct an on-site, close-out visit
at each investigational site at the conclusion of the
study. During the close-out visit, CroMedica shall
ensure that the Investigator has maintained the
standards specified in Paragraph 2, above, and, in
addition, shall:
a. Obtain a reconciliation of all drug
inventories;
b. Resolve any final inquiries concerning CRF
issues; and
5
6
c. Confirm that the Investigator has maintained
all required documentation.
4. CroMedica shall prepare and maintain reports of each
on-site visit performed pursuant to this sub-Section
(On-Site Monitoring). The monitoring visit reports
shall be in a format mutually agreed upon by the
parties.
D. Supply of Drug
1. Supply of Drug to Investigators
ACS shall supply all of the drug to be used in the
Investigation.
2. Return of Unused Drug Supplies
CroMedica shall ensure that each investigator whose
participation in the Investigation has been completed
or discontinued shall either (a) return any unused
drug supplies to CroMedica or ACS, as directed by
ACS; or (b) dispose of the unused drug supplies as
directed by ACS. CroMedica shall require that each
Investigator account for any drug supplies that are
missing.
3. Non-Diversion; Labeling
All drug supplied to CroMedica and to Investigators
shall remain the exclusive property of ACS until
administered or dispensed to patients during the
course of the Investigation. In no event shall any
drug supplied to CroMedica for any purpose other than
as contemplated by the Protocols and this Agreement,
or be delivered to any person other than an
Investigator and, CroMedica shall use all reasonable
efforts to ensure that the Investigators comply with
the terms of this Agreement, the Attachments hereto
and the Protocols in all material respects.
4. Study Drug Disposition Records
Unless otherwise specified by ACS, CroMedica shall
maintain records relating to the disposition of the
drug, which shall include, without limitation: (1)
the amounts of drug
6
7
supplies received from ACS (with respective dates); (2) the
Investigator sites to which the drug has been delivered
(with respective dates and amounts); (3) the amount of the
drug spilled or otherwise lost (with respective dates, if
known); (4) the amount of the drug returned to CroMedica
(with respective dates); and (5) the amount of the drug
returned by CroMedica to ACS (with respective dates).
E. Maintenance and Inspection of Records
CroMedica shall prepare and maintain complete, accurate, legible
written records, accounts, notes, reports and data on the
Investigation in a timely fashion. CroMedica shall maintain all
records under this Section (CROMEDICA Management of Clinical
Investigation) pertaining to the management of the clinical
Investigation for a period of 15 years from the date of creation.
ACS authorized representative(s), and regulatory authorities to
the extent permitted by law, may, during regular business hours,
arrange in advance with CroMedica to inspect and copy all data
and work products related to the Investigation. CroMedica shall
cooperate with any regulatory authority and allow them access to
relevant records and data to the extent permitted by law.
VIII. CONTACT PERSONS AND STAFFING
CroMedica shall assign a sufficient number of personnel to complete
the Scope of Services set forth on Attachment 1 (Scope of Services).
In the event that ACS determines that any CroMedica personnel are not
performing to ACS satisfaction, ACS shall have the right to request
that such personnel be replaced by personnel acceptable to ACS. ACS
and CroMedica have designated appropriate personnel to be available to
CroMedica to answer questions and resolve problems relating to the
Investigation. The names of these individuals, and the respective
subjects on which they may be consulted, are set forth in Attachment 3
(Contact Persons).
IX. PERIOD OF PERFORMANCE
This Agreement shall take effect as of the last date of execution by
the last of the parties to execute this Agreement, and shall remain in
effect until the completion of the services performed by CroMedica
under
7
8
the Agreement, or until earlier termination in accordance with the
Section on Termination, below.
X. TERMINATION
A. ACS Right to Terminate
ACS reserves the right to immediately terminate this Agreement
in whole or in part, with or without cause, upon written
notice to CroMedica. In the event this Agreement is terminated
by ACS prior to completion, CroMedica shall use its best
efforts to conclude or transfer the project, as directed by
ACS, as expeditiously as possible. CroMedica shall not
undertake further work, incur additional expenses, or enter
into further commitments with regard to the Investigation
after receiving such notice of termination from ACS, except as
mutually agreed upon by the parties. Upon termination of the
Agreement, CroMedica shall return to ACS all of ACS property
(as defined in the Section covering Property Ownership) in
CroMedica's possession, unless otherwise agreed to in writing.
B. CroMedica's Right to Terminate
CroMedica may terminate this Agreement upon default of any
material provision of this Agreement; provided, however, that
prior to terminating, CroMedica shall notify ACS in writing of
such default, and shall allow ACS thirty (30) days to remedy
such default. In the event that ACS fails to remedy the
default within the 30-day period, CroMedica may terminate the
Agreement effective immediately.
C. Compensation to CroMedica upon Termination
In the event of a termination under this Section, CroMedica
shall be entitled to compensation as follows:
1. All payments due and owing under this Agreement at
the time of CroMedica's receipt of the notice of
termination for work completed and in progress;
2. Reimbursement for any noncancelable services and
commitments entered into by CroMedica in order to
carry out this Agreement, provided CroMedica provides
ACS with documentation of completion of work or
expenses incurred.
8
9
3. CroMedica shall credit or return to ACS any funds not
expended or obligated by CroMedica in connection with
the Investigation prior to the effective termination
date indicated in the notice of termination.
Termination of this Agreement by either party shall
not affect the rights and obligations of the parties
accrued prior to the effective date of termination.
The rights and duties under Articles III, V, VI, X,
XI, XII, XIII, XIV, XVI, XVII, XX, XXI, XXII, XXIII
and XXIV shall survive the termination or expiration
of this Agreement.
XI. CONFIDENTIAL INFORMATION
A. Definition
For purposes of this Agreement, "Confidential Information"
means any knowledge or information that is (1) acquired by
CroMedica from ACS prior to or during the course of the
Investigation whether written, graphic or oral, or (2)
prepared, developed or generated by CroMedica during the
course of the Investigation; provided, however, that
"Confidential Information" does not, whether written, graphic
or oral, include knowledge or information that CroMedica can
demonstrate by written records was known by it prior to the
receipt of such knowledge or information from ACS, or that is
publicly disclosed by ACS either prior to or subsequent to
receipt of the knowledge or information by CroMedica.
B. Non-Disclosure
CroMedica (1) shall not publish, disseminate, or otherwise
disclose to any third party (except as may be required by this
Agreement or by law) any Confidential Information without the
prior written consent of ACS; (2) shall use the same care and
discretion in maintaining the confidentiality of the
Confidential Information that CroMedica uses with similar
information that it considers confidential; provided that such
care and discretion shall not be less than the standard of
care and discretion that would be employed by a prudent person
under similar circumstances; (3) shall restrict the
dissemination of the Confidential Information within its own
organization to persons who have a need to know;
9
10
and (4) shall not, without the prior written consent of ACS,
make any use whatever of the Confidential Information except
for the purpose of conducting the Investigation. In the event
CroMedica is required by applicable law to disclosure
Confidential Information to a proper authority, CroMedica
shall first notify ACS, and CroMedica and ACS shall then
attempt in good faith to agree upon a mutually satisfactory
way to disclose such Confidential Information as necessary for
this limited purpose. CroMedica shall ensure that its
employees, officers, directors, affiliates, agents and
representatives comply with the terms of this Article XI and
otherwise with the terms of this Agreement.
C. Return of Confidential Information
At the expiration or earlier termination of this Agreement,
CroMedica shall return to ACS all written Confidential
Information, and all written material that incorporates any
Confidential Information.
D. Survival of Obligation of Confidentiality
The obligation of confidentiality set forth in this Section
shall continue for ten years following the date of expiration
or earlier termination, for any reason, of this Agreement, and
shall be binding upon permitted assignees, administrators and
other legal representatives of CroMedica.
E. CroMedica shall obtain ACS prior written permission before
using ACS name, symbols and/or marks in any form of publicity
in connection with the Investigation. The foregoing sentence
shall not exclude legally required disclosure by CroMedica or
reports generated in the normal course of business by
CroMedica.
XII. PROPERTY OWNERSHIP
A. Rights in Property
All materials, documents, data, software and information of
every kind and description supplied to CroMedica by ACS or
prepared, developed, or generated by CroMedica pursuant to
this Agreement, (except for CroMedica procedural manuals,
personnel data, methods, procedures, and policies) shall be
the sole and exclusive property of ACS and ACS
10
11
shall have the right to make whatever use it deems desirable
of any such property. CroMedica shall not, without the prior
written consent of ACS, publish, disseminate, or otherwise
disclose to any third party any such property (except such
disclosure as may be required by law), or use any such
property for any purpose other than the performance of this
Agreement. CroMedica warrants by the execution of this
agreement that they have not entered, and will not enter into
any contractual agreement or relationship which would in any
way conflict with or compromise ACS's proprietary interest in,
or rights to any inventions, discoveries or technology
existing at the time of the execution of this Agreement or
arising out of or related to the performance thereunder.
B. Retention of Property
Unless otherwise required by law or the terms of this
Agreement, any property specified in Subsection A, above, that
CroMedica shall have in its possession shall be maintained by
CroMedica for a period of not less than five (5) years from
the date of receipt thereof and shall be organized in such
manner that it will be ready for immediate reference. ACS
shall have the right at any time to examine or obtain from
CroMedica copies of any or all such property. After five (5)
years, CroMedica may dispose of such property in accordance
with instructions provided by ACS. If ACS fails to provide
such instructions, CroMedica shall so notify ACS, and if
instructions are still not forthcoming within thirty (30) days
of such notification, CroMedica may destroy such property.
C. Survival of obligation
The rights and obligations set forth in this Section shall
survive the expiration or earlier termination, for any reason,
of this Agreement, and shall be binding upon permitted
assignees, administrators and other legal representatives of
CroMedica.
XIII. RIGHTS IN INTELLECTUAL PROPERTY AND PATENTS
A. Inventions, Discoveries, and Know-How
With respect to any and all inventions, discoveries, and
know-how (including, without
11
12
limitation, all ideas, improvements, and creations) that are
conceived, gained, or reduced to practice by CroMedica in the
course of performing its obligations under this Agreement,
CroMedica agrees:
1. To disclose promptly to ACS or its nominee any such
inventions, discoveries and know-how;
2. To assign and transfer to ACS all rights, title, and
interest in and to any and all such inventions,
discoveries, and know-how upon the request of ACS;
and
3. To perform any and all lawful acts that in the
judgment of ACS are necessary or desirable to secure
or maintain for the benefit of ACS adequate patent
and other property rights in the United States and
all foreign countries with respect to any such
inventions, discoveries and know-how, including,
without limitation, making or delivering to ACS
United States and foreign patent applications, powers
of attorney, assignments, oaths and affirmations, and
applications for securing, protecting or registering
any property rights relating to such inventions,
discoveries and know-how, and cooperating with ACS in
the defense of patents related to such inventions,
discoveries and know-how in infringement actions.
ACS shall compensate CroMedica at standard hourly rates for
the time devoted to said activities and reimburse it for all
reasonable expenses incurred.
B. Copyrights
CroMedica agrees to assign to ACS all right, title, and
interest in and to any Work, as defined below, including
without limitation all right, title, and interest in and to
copyright of the Work, in the United States or anywhere
throughout the world, in the name of ACS (or otherwise, as
directed by ACS), for the sole benefit of ACS, and to secure
renewals or extensions of such copyrights in ACS name (or
otherwise, as directed by ACS). CroMedica shall execute any
assignments or other documents that ACS deems necessary to
effectuate the purposes of this Subsection B. For purposes of
this Section, "Work" means all reports, documents, research,
drafts, materials, computer software, and data that are
recorded in any form (including, without
12
13
limitation, written, electronic, or photographic form) and
that are prepared, developed, or generated by CroMedica in the
course of performing its obligations under this Agreement.
C. Survival of Obligations
The obligations imposed by this Section shall survive the
expiration or earlier termination, for any reason, of this
Agreement with respect to inventions, discoveries and know-how
conceived, gained, or reduced to practice by CroMedica, and
Work prepared, developed, or generated by CroMedica, in the
course of performing this Agreement. Such obligations shall be
binding upon permitted assignees, administrators and other
legal representatives of CroMedica. It is agreed that neither
CroMedica nor ACS transfers to the other by operation of this
Agreement any patent right, copyright, or other proprietary
right of either party, except as specifically set forth in
this Agreement.
XIV. INDEMNIFICATION
A. Indemnification of ACS
CroMedica shall hold harmless and indemnify ACS, its
employees, agents and assigns, from and against all claims,
complaints, or lawsuits for damages that arise or are alleged
to arise as a result of the intentional misconduct,
negligence, malfeasance or violation of law, statute or
regulation of CroMedica, or any of its employees, agents, or
representatives, in conducting the Investigation, or from
CroMedica's failure to adhere to the terms of the Protocols or
this Agreement or fails to comply with all applicable
Provincial, Federal, state and local laws, and guidelines and
regulations. For purposes of this Article XIV only,
Investigators are not agents or representatives of CroMedica.
B. Indemnification of CroMedica
ACS shall indemnify and hold harmless CroMedica, its
representatives and employees, from and against all claims,
complaints, or lawsuits for damages that arise as a result of
personal injury or death that is alleged to have been caused
by or attributed to any substance provided by ACS and
13
14
dispensed or administered in accordance with the provisions of
the Protocols; provided that:
1. ACS shall be promptly notified of any such claim,
complaint, or lawsuit;
2. ACS shall have the right, in its sole discretion, to
undertake the defense, compromise, or settlement, at its
own expense and by its own counsel, of any such claim,
complaint, or lawsuit; and
3. CroMedica shall cooperate fully in the investigation and
defense of any such claim, complaint, or lawsuit.
The indemnification provided for in this Subsection B shall not
apply to any loss, damage, cost or expense that is caused by or
attributable to the intentional misconduct, negligence,
malfeasance or violation of law, statute or regulation of
CroMedica, or any of its employees, agents, or representatives.
XV. INSURANCE
A. CroMedica shall maintain in force at all times during the term of
this Agreement, with an insurance company acceptable to ACS, the
following insurance, including any special terms indicated and shall,
prior to signing this Agreement, provide to ACS certificates of
insurance for each type of insurance specifying that ACS will receive
no less than thirty (30) days' notice of cancellation, non-renewable or
material change.
1. Comprehensive General Liability insurance including products and
completed operations, personal injury, broad form property damage
including completed operations, independent contractors, and blanket
contractual liability with the product/completed operations exclusion
removed. ACS will be named as additional insured. Combined Single Limit
for bodily injury and property damage - $2,000,000.
2. Workers' Compensation Insurance Coverage - statutory.
3. Employers' Liability Coverage - $500,000.
4. Professional Liability Insurance - Covering all claims for
damages arising out of errors and omissions in the performance of
professional duties of CroMedica
14
15
under this Agreement. The Limits of Liability shall be $2 million per
claim subject to a $2 million annual aggregate.
XVI. NOTICES AND PAYMENTS
Except as otherwise provided herein, any notice or other communications
or any payment required under this Agreement shall be delivered by
hand, first class mail, a nationally recognized overnight courier
service, or facsimile transmission, to the party at the address listed
below:
If to Advanced Corneal Systems: X.X. XxxXxx
ADVANCED CORNEAL SYSTEMS, INC.
00000 Xxxxx Xxxxxxx, Xxxxx 000
Xxxxxx, XX 00000
If to CroMedica Global Inc.:
Xxx Xxxxxxx
CroMedica Global Inc.
000-000 Xxxx Xxxxxx
Xxxxxxxx, Xxxxxxx Xxxxxxxx
X0X 0X0
Any such notice shall be effective (1) in the case of a hand delivery,
when received; (2) in the case of an overnight delivery service, on the
next business day after being placed in the possession of such delivery
service, with delivery charges prepaid; (3) in the case of the mail,
three days after deposit in the postal system, first class postage
prepaid; and (4) in the case of facsimile transmission, when electronic
indication of receipt is received.
XVII. MODIFICATIONS
No changes shall be made in this Agreement except by written agreement
of the parties, signed by authorized representatives. ACS authorized
representative shall be designated in Attachment 3 (Contact Persons).
15
16
XVIII. ENTIRE AGREEMENT
This Agreement, together with its Attachments, including the Protocols,
shall be the entire and complete understanding between the parties in
regard to the covered subject matter. This Agreement merges all prior
discussions between the parties and neither party shall be bound by
conditions, definitions, warranties, understandings, or representations
concerning such subject matter except as provided in this Agreement or
as specified on or subsequent to the effective date of this Agreement
in a writing signed by properly authorized representatives of both the
parties.
XIX. ASSIGNMENT
Neither party may assign, delegate or otherwise transfer any of its
rights or obligations under this Agreement without the prior written
consent of the other party. Notwithstanding the previous sentence, ACS
may assign its obligations under this Agreement to any affiliate of ACS
or in connection with the transfer or sale of all or substantially all
of its assets or business relating to the drug(s) being studied
hereunder or its merger or consolidation with another organization,
provided that the rights of CroMedica under this Agreement are not
materially prejudiced.
XX. INDEPENDENT CONTRACTOR
CroMedica shall function as an independent contractor and shall not
hold itself out as an agent of ACS in any way.
XXI. GOVERNING LAW
This Agreement shall be construed, interpreted and enforced under the
laws (excluding the laws governing conflicts of laws) of the State of
California.
XXII. WAIVER
The failure of a party in any instance to insist on the strict
performance of the terms of this Agreement shall not be construed to be
a waiver or relinquishment of any of the terms of this Agreement,
either at the time of the party's failure to insist upon strict
performance or at any subsequent time.
16
17
XXIII. SEVERANCE
Each clause of this Agreement is a distinct and severable clause and if
any clause is deemed illegal, void, or unenforceable, the validity,
legality, or enforceability of any other clause or portion of this
Agreement shall not be affected thereby.
XXIV. HEADINGS
All headings contained in this Agreement appear only for convenience
and reference. They do not define, limit, extend, or describe the scope
of this Agreement or the intent of any of its provisions.
ACCEPTED AND AGREED:
ADVANCED CORNEAL SYSTEMS, INC. CROMEDICA GLOBAL INC.
BY: /s/ [ILLEGIBLE] BY: /s/ [ILLEGIBLE]
------------------------------- -------------------------------
TITLE: Vice President TITLE: President
DATED: May 18, 1999 DATED: May 19, 1999
17
18
ATTACHMENT 1
Scope of Services
18
19
FEE SCHEDULE - NORTH AMERICAN TRIAL
------------------------------------------------------------------------------------------------------------------------------------
HOURLY RATE($US)
HOURS ------------------------ TOTAL
ACTIVITY PERSONNEL OF EFFORT CDN-BASED US-BASED ($US) CALCULATIONS/COMMENTS
SERVICES SERVICES
------------------------------------------------------------------------------------------------------------------------------------
STUDY PREPARATION
------------------------------------------------------------------------------------------------------------------------------------
Medical Writer 32 90 2,880 Based on estimated 70 CRF
pages (data and information
Case Report Clinical Data Manager 16 75 1,200 pages). Includes correction,
Form Update reviews, print coordination
and Printing Data Manager 12 75 900 and distribution of all CRFs
and Distribu- in the US and Non-US trials.
tion Storage, Distribution & All printing and shipping
Printing Management not applicable 3,600 costs will be passed through
to ACS
------------------------------------------------------------------------------------------------------------------------------------
Canada-based CRAs 32 75 2,400 32 sites will be evaluated
to identify 24 sites (12 in
US-based CRAs 32 90 2,880 Canada, 12 in the U.S.)
Includes: 2 hrs/site x 32 sites
Site Recruit- Canada-On site Visit 120 75 9,000 12 new sites will have on site
ment & Evalua- validation
tion
US-On site Visit 120 90 10,800 12 new sites will have on site
validation
------------------------------------------------------------------------------------------------------------------------------------
Canada-based CRA(s) 56 75 4,200 IRB submission, and pre-study
documentation will be compiled
IRB Submission US-based CRA(s) 56 90 5,040 for new sites (12 Canadian and
& Pre-Study 12 US sites).
Documentation Includes: 8 hours prep +
for New Sites 4 hrs/site
------------------------------------------------------------------------------------------------------------------------------------
Review/compilation of all in-
house documentation from curr-
In-house Study ent CRO for completeness. A
Documentation Canada Based CRAs 189 75 14,175 list of contents and document
Review for requirements will be created to
Current Sites ensure matching documentation
at sites.
3 hrs/site x 63 sites
------------------------------------------------------------------------------------------------------------------------------------
All documentation at all sites
Study Documenta- will be compiled/reviewed by
tion Review US-based CRAs 126 90 11,340 CroMedica CRAs. This includes
for Current a full review of regulatory
Sites documentation.
Includes: 2 hrs/site x 63 sites
------------------------------------------------------------------------------------------------------------------------------------
CONFIDENTIAL CroMedica Global Inc. May 18, 1999
20
HOURLY RATE ($US)
------------------------
HOURS CDN-BASED US-BASED TOTAL
ACTIVITY PERSONNEL OF EFFORT SERVICES SERVICES ($US) CALCULATIONS/COMMENTS
------------------------------------------------------------------------------------------------------------------------------------
Project Manager 30 110 3,300 PM & Clin. Ops. Dir: 30 hours each
Clinical Operations Canada-based CRAs: 20 hrs X 2 CRAs
Director 30 125 3,750 US-based CRAs: 20 hrs/CRA X 6 CRAs
STUDY-SPECIFIC TRAINING Canada-based CRAs 40 75 3,000 Data Manager & Dir., Biometry: 20
SESSION US-based CRAs 120 90 10,600 hrs each. Includes travel time,
Data Manager 20 75 1,500 participation and preparation.
Director of Biometry 20 110 2,200
------------------------------------------------------------------------------------------------------------------------------------
Director of Biometry 60 110 6,600 Dir. Biometry: 60 hrs.
TRANSITION ASSISTANCE Director, Clinical Ops. 60 125 7,500 Dir. Clinical Ops.: 60 hrs
President 40 200 NC -- President: 40 hrs @ no charge
------------------------------------------------------------------------------------------------------------------------------------
STUDY CONDUCT
------------------------------------------------------------------------------------------------------------------------------------
Project Manager 2697 110 296,670 172 hrs/month x 6 months (full
time initially)
120 hrs/month x 4.5 months
75 hrs/month x 15 months
PROJECT MANAGEMENT -----------------------------------------------------------------------------------------------------------
In-House CRA 990 75 74,250 60 hrs/month x 6 months
40 hrs/month x 4.5 months
30 hrs/month x 15 months
------------------------------------------------------------------------------------------------------------------------------------
Clinical Operations 172 hrs/month x 6 months (full-
Assistant 2697 40 107,680 time initially)
120 hrs/month x 4.5 months
75 hrs/month x 15 months
------------------------------------------------------------------------------------------------------------------------------------
Medical Monitor/ 272 SAEs
SAE MANAGEMENT Physician 300/SAE 81,600 (680 patients x 40% expected
SAE rate)
------------------------------------------------------------------------------------------------------------------------------------
Canada-based CRAs 96 75 7,200 Canada: 8 hrs/site x 12 sites
SITE INITIATION US-based CRAs 208 90 18,720 US: 6 hrs/site x 26 sites
Includes preparation, all on-site
activities; report and travel
time.
------------------------------------------------------------------------------------------------------------------------------------
CONFIDENTIAL CroMedica Global Inc. May 18, 1999
21
------------------------------------------------------------------------------------------------------------------------------------
HOURLY RATE ($US)
------------------
HOURS CDN-BASED US-BASED TOTAL
ACTIVITY PERSONNEL OF EFFORT SERVICES SERVICES ($US) CALCULATIONS/COMMENTS
------------------------------------------------------------------------------------------------------------------------------------
INTERIM MONITORING Canada-based CRAs 2448 75 183,600 Canada: [(8.25 visits x 12 sites)+ (4.5
(INCLUDES ADDITIONAL SITE visits x 12 sites)] x 16 hrs/site
TRAINING WHERE REQUIRED) US:[(8.25 visits x 63 sites)+(4.5 visits
x 63 sites)] x 16 hrs/site
-----------------------------------------------------------------------------------------
US-based CRAs 12852 90 1,156,680 Based on monitoring visits every 4 to 6
weeks during enrollment and every 3
months during follow up. Includes
preparation, all on- and off-site
activities, report and travel time. We
have assumed that all new sites (12 Can,
12 US) complete the trial.
------------------------------------------------------------------------------------------------------------------------------------
UNMASKED MONITORING Canada-based CRAs 144 75 10,800 1 visits x 12 sites x 12 hours
------------------------------------------------------------------------------------------------------------------------------------
US-based CRAs 756 90 68,040 1 visits x 63 sites x 12 hours
------------------------------------------------------------------------------------------------------------------------------------
SITE CLOSEOUT Canada-based CRAs 144 75 10,800 87 sites x 12 hrs/site
-----------------------------------------------------------------------------------------
US-based CRAs 900 90 81,000
------------------------------------------------------------------------------------------------------------------------------------
SITE AUDITS North American Trial 62,500 25 sites audits @ $2,500 each
------------------------------------------------------------------------------------------------------------------------------------
Non North American Trial 62,500 25 sites audits @ $2,500 each
------------------------------------------------------------------------------------------------------------------------------------
2,329,305
----------------------------------------------------
22
FEE SCHEDULE AUSTRALIA TRIAL
---------------------------------- --------- -------------------- --------- --------------------------------------------------
HOURS TOTAL
ACTIVITY OF EFFORT HOURLY RATE ($US) ($US) CALCULATIONS/COMMENTS
---------------------------------- --------- -------------------- --------- --------------------------------------------------
REGULATORY CONSULTING 80 125 10,000 80 hrs x $125/hr (est.)
---------------------------------- --------- -------------------- --------- --------------------------------------------------
IRS SUBMISSION 38 80 3,040 8 hrs + (3 hrs x 10 sites) x $80/hr
---------------------------------- --------- -------------------- --------- --------------------------------------------------
PRE STUDY DOCUMENTATION 24 80 1,920 4 hrs + (2 hrs x 10 sites) x $80/hr
---------------------------------- --------- -------------------- --------- --------------------------------------------------
IDENTIFY SITES 30 80 2,400 15 sites evaluated to find 10
15 x 2 hrs x $80
---------------------------------- --------- -------------------- --------- --------------------------------------------------
INVESTIGATOR MEETING COORDINATION -- -- 12,000 Includes: organization, logistics, attendance,
clinical assistance, presentations by specialists
---------------------------------- --------- -------------------- --------- --------------------------------------------------
80 80 6,400 10 sites x 8 hrs x $80/hr
INITIATIONS VISITS
--------- -------------------- --------- --------------------------------------------------
40 110 4,400 5 sites x 8 hrs x $110/hr
---------------------------------- --------- -------------------- --------- --------------------------------------------------
CLOSE OUT VISITS 120 80 9,600 10 sites x 12 hrs x $80/hr
---------------------------------- --------- -------------------- --------- --------------------------------------------------
840 80 67,200 August '99-Feb. '00; every 4-6 weeks
10 sites x 16 hrs x 5.25 visits x $80
MONITORING --------- -------------------- --------- --------------------------------------------------
720 80 57,600 Mar. '00-April '01; every 12 weeks
10 sites x 16 hrs x 4.5 visits x $60
---------------------------------- --------- -------------------- --------- --------------------------------------------------
640 110 70,400 40 hrs/mth x 16 mths x $110
PROJECT MANAGEMENT
--------- -------------------- --------- --------------------------------------------------
95 110 10,560 16 hrs/mth x 6 mths x $110
---------------------------------- --------- -------------------- --------- --------------------------------------------------
255,520
--------- --------------------------------------------------
CONFIDENTIAL CroMedica Global Inc. May 18, 1999
23
FEE SCHEDULE DATA MANAGEMENT
------------------------------------------------------------------------------------------
VIT-02-08961X &
VIT-03-08961X
ACTIVITY PERSONNEL HOURLY RATE (GLOBAL SITES)
---------------
EFFORT TOTAL
HOURS
--------------------------- ---------------- ----------- ------ -------
DATABASE DESIGN & DATA Data Manager 75 180 13,500
MANAGEMENT GUIDELINES
--------------------------- ---------------- ----------- ------ -------
CRF QA & DOCUMENT CONTROL Data Assistant 50 640 32,000
--------------------------- ---------------- ----------- ------ -------
DATA ENTRY Data Entry Tech. 40 1,060 42,400
--------------------------- ---------------- ----------- ------ -------
DATA CODING, EDIT CHECKS, Data Manager 75 1,932 144,900
QUERY RESOLUTION & LISTINGS
--------------------------- ---------------- ----------- ------ -------
232,800
==========================================================================================
BY COMBINING DATA MANAGEMENT SERVICES FOR BOTH PROTOCOLS, CROMEDICA IS ABLE TO
PASS ON A DIRECT SAVINGS OF 10 PER CENT OVER THE INDIVIDUAL COSTS FOR EACH
PROTOCOL.
-------------------------------------
SUMMARY
-------------------------------------
NORTH AMERICA TRIAL $ 3,040
AUSTRALIA TRIAL 0
DATA MANAGEMENT 232,800
--------
GRAND TOTAL $235,840
========
CONFIDENTIAL Cromedica Global Inc. May 18, 1999
24
ATTACHMENT 2
PAYMENT AND PERFORMANCE SCHEDULE
PAYMENT SCHEDULE
----------------
Sponsor shall reimburse reasonable costs and expenses at net thirty (30) days
terms upon receipt of invoice and any associated original receipts, and/or at
the occurrence of the below incidents enacted at Sponsor's request, pending
review for acceptableness and/or completeness. All figures are in US dollars:
FIXED-UNIT PRICE PAYMENT STRUCTURE
-----------------------------------------------------------------------------------------------------------------------------------
Unit Cost Study Maximum
-----------------------------------------------------------------------------------------------------------------------------------
Up front (20%) $563,525
-----------------------------------------------------------------------------------------------------------------------------------
Australia Regulatory Submission $10,000 10,000
-----------------------------------------------------------------------------------------------------------------------------------
CRF Finalization 6,180 8,580
-----------------------------------------------------------------------------------------------------------------------------------
Site Recruitment:
Canadian 200 2,400
U.S. 240 2,880
Australia 240 2,400
-----------------------------------------------------------------------------------------------------------------------------------
Initiation Visits:
Canadian 600 7,200
U.S. 720 18,720
Australia 1,080 10,800
-----------------------------------------------------------------------------------------------------------------------------------
Interim Visits:
Canadian 1,200 183,600
U.S. 1,440 1,156,680
Australia 1,280 124,800
-----------------------------------------------------------------------------------------------------------------------------------
Unmasked Visits:
Canadian 900 10,800
U.S. 1,080 68,040
-----------------------------------------------------------------------------------------------------------------------------------
Close Out Visits:
Canadian 900 10,800
U.S. 1,080 81,000
Australia 960 9,600
-----------------------------------------------------------------------------------------------------------------------------------
Site Audits 2,500 125,000
-----------------------------------------------------------------------------------------------------------------------------------
Australia Investigator Meeting 12,000 12,000
-----------------------------------------------------------------------------------------------------------------------------------
Study Training 24,550 24,550
-----------------------------------------------------------------------------------------------------------------------------------
SAE Management $300 per SAE 81,600
-----------------------------------------------------------------------------------------------------------------------------------
Database Design 13,500 13,500
-----------------------------------------------------------------------------------------------------------------------------------
Data Entry:
1/3 Data Entered 50,000 50,000
2/3 Data Entered 50,000 50,000
3/3 Data Entered 50,000 50,000
-----------------------------------------------------------------------------------------------------------------------------------
Project Management Fee 5,556 139,150
(per month for 25 months)
-----------------------------------------------------------------------------------------------------------------------------------
Total Contract $2,817,625
-----------------------------------------------------------------------------------------------------------------------------------
PASS-THROUGH COSTS: SPONSOR shall reimburse CONTRACTOR for reasonable pass-
through costs (e.g., travel, lodging, meals) at net thirty (30) days term upon
receipt of original receipt(s)/invoice. Interest at 15% shall apply in net
thirty (30) days terms are not satisfied.
24
25
ATTACHMENT 3
CONTACT PERSONS
Advanced Corneal Systems, Inc. Contractual/Financial Matters:
X.X. XxxXxx
Vice President
00000 Xxxxx Xxxxxxx, Xxxxx 000
Xxxxxx, XX 00000
Clinical/Investigation Matters:
Xxxx Xxxxx Xxxxxxxxxxx
00000 Xxxxx Xxxxxxx, Xxxxx 000
Xxxxxx, XX 00000
CroMedica Global Inc. Xxx Xxxxxxx
CroMedica Global Inc.
000 Xxxx Xxxxxx, Xxxxx 000
Xxxxxxxx, Xxxxxxx Xxxxxxxx
X0X 0X0
25
26
Exhibit A
Protocols
26
27
ATTACHMENT 1
Scope of Services
Agreed to and approved by:
/s/ XXXX XXXXX XXXXXXXXXXX
-------------------------------
XXXX XXXXX XXXXXXXXXXX 5/18/99
28
page 19
FEE SCHEDULE -- NORTH AMERICAN TRIAL
----------------------------------------------------------------------------------------------------------------------------------
HOURLY RATE ($US)
HOURS ----------------------- TOTAL
ACTIVITY PERSONNEL OF EFFORT CDN-BASED US-BASED ($US) CALCULATIONS/COMMENTS
SERVICES SERVICES
----------------------------------------------------------------------------------------------------------------------------------
STUDY PREPARATION
----------------------------------------------------------------------------------------------------------------------------------
Medical Writer 32 90 2,860 Based on estimated 70 CRF (data and
------------------------------------------------------------------------ information pages). Includes
CASE REPORT FORM Clinical Data Manager 16 75 1,200 correction, reviews, print
UPDATE AND PRINTING ------------------------------------------------------------------------ coordination and distribution of
AND DISTRIBUTION Data Manager 12 75 900 all CRFs in the US and Non-US
------------------------------------------------------------------------ trials. All printing and shipping
Storage, Distribution not applicable 3,600 costs will be passed through to ACS.
& Printing Management
----------------------------------------------------------------------------------------------------------------------------------
Canada-based CRAs 32 75 2,400 32 sites will be evaluated to
------------------------------------------------------------------------ identify 24 sites (12 in Canada,
US-based CRAs 32 90 2,880 12 in the U.S.)
Includes: 2hrs/site x 32 sites
SITE RECRUITMENT -------------------------------------------------------------------------------------------------------------
& EVALUATION Canada - On site Visit 120 75 9,000 12 new sites will have on site
validation
-------------------------------------------------------------------------------------------------------------
US - On site Visit 120 90 10,600 12 new sites will have on site
validation
----------------------------------------------------------------------------------------------------------------------------------
IRB SUBMISSION & IRB submissions and pre-study
PRE-STUDY Canada-based CRA(s) 56 75 4,200 documentation will be compiled for
DOCUMENTATION FOR ------------------------------------------------------------------------ new sites (12 Canadian and 12 US
NEW SITES US-based CRA(s) 56 90 5,040 sites).
Includes: 8 hours prep + 4 hrs/site
----------------------------------------------------------------------------------------------------------------------------------
Review/compilation of all in-house
documentation from current CRO for
IN-HOUSE STUDY completeness. A list of contents
DOCUMENTATION Canada based CRAs 189 75 14,175 and document requirements will
REVIEW FOR be created to ensure matching
CURRENT SITES documentation at sites.
3hrs/site x 63 sites
----------------------------------------------------------------------------------------------------------------------------------
STUDY All documentation at all sites will
DOCUMENTATION be compiled/reviewed by CroMedica
REVIEW FOR US-based CRAs 126 90 11,340 CRAs. This includes a full review
CURRENT SITES of regulatory documentation.
Includes: 2hrs/site x 63 sites
----------------------------------------------------------------------------------------------------------------------------------
29
page 20
----------------------------------------------------------------------------------------------------------------------------------
HOURLY RATE ($US)
HOURS ----------------------- TOTAL
ACTIVITY PERSONNEL OF EFFORT CDN-BASED US-BASED ($US) CALCULATIONS/COMMENTS
SERVICES SERVICES
----------------------------------------------------------------------------------------------------------------------------------
Project Manager 30 110 3,300
------------------------------------------------------------------------
Clinical Operations 30 125 3,750
Director PM & Clin. Ops. Dir. 30 hours each
STUDY-SPECIFIC ------------------------------------------------------------------------ Canada-based CRAs: 20 hrs x 2 CRAs
TRAINING SESSION Canada-based CRAs 40 75 3,000 US-based CRAs: 20 hrs/CRA x 6 CRAs
------------------------------------------------------------------------ Data Manager & Dir., Biometry: 20
US-based CRAs 120 90 10,800 hrs each Includes travel time,
------------------------------------------------------------------------ participation and preparation
Data Manager 20 75 1,500
------------------------------------------------------------------------
Director of 20 110 2,200
Biometry
----------------------------------------------------------------------------------------------------------------------------------
Director of 60 110 6,600
Biometry
------------------------------------------------------------------------ Dir. Biometry: 60 hrs
TRANSITION Director, Clinical 60 125 7,500 Dir. Clinical Ops.: 60 hrs
ASSISTANCE Ops. President: 40 hrs @ no charge
------------------------------------------------------------------------
President 40 200 N/C --
----------------------------------------------------------------------------------------------------------------------------------
STUDY CONDUCT
----------------------------------------------------------------------------------------------------------------------------------
172 hrs/month x 6 months (full-time
Project Manager 2697 110 296,670 initially)
120 hrs/month x 4.5 months
75 hrs/month x 15 months
PROJECT MANAGEMENT -------------------------------------------------------------------------------------------------------------
60 hrs/month x 6 months
In-House CRA 990 75 74,250 40 hrs/month x 4.5 months
30 hrs/month x 15 months
----------------------------------------------------------------------------------------------------------------------------------
172 hrs/month x 6 months (full-time
Clinical Operations 2697 40 107,880 initially)
Assistant 120 hrs/month x 4.5 months
75 hrs/month x 15 months
----------------------------------------------------------------------------------------------------------------------------------
SAE Management Medical Monitor/ 300/SAE 81,600 272 SAEs
Physician (680 patients x 40% expected
SAE rate)
----------------------------------------------------------------------------------------------------------------------------------
Canada-based CRAs 96 75 7,200 Canada: 8 hrs/site x 12 sites
SITE INITIATION ------------------------------------------------------------------------ US: 8 hrs/site x 26 sites
US-based CRAs 208 90 18,720 Includes preparation, all on-site
activities, report and travel time.
----------------------------------------------------------------------------------------------------------------------------------
30
page 21
Hourly Rate ($US)
-------------------
Hours Cdn-based US-based Total
Activity Personnel of Effort services services ($US) Calculations/Comments
------------------------------------------------------------------------------------------------------------------------------------
Canada: [(8.25 visits x 12 sites) +
Canada-based CRAs 2448 75 183,600 (4.5 visits x 12 sites)] x 16 hrs/site
US: [(6.25 visits x 63 sites) + (4.5
Interim Monitoring visits x 63 sites) x 16 hrs/site
(includes additional -------------------------------------------------------------------- Based on monitoring visits every 4 to 6
site training where weeks during enrolment and every 3
required) months during follow up. Includes
preparation, all on- and off-site
US-based CRAs 12652 90 1,156,680 activities, report and travel time. We
have assumed that all new sites (12 Can,
12 US) complete the trial.
------------------------------------------------------------------------------------------------------------------------------------
Canada-based CRAs 144 75 10,800 1 visits x 12 sites x 12 hours
Unmasked Monitoring --------------------------------------------------------------------------------------------------------------
US-based CRAs 756 90 88,040 1 visits x 63 sites x 12 hours
------------------------------------------------------------------------------------------------------------------------------------
Canada-based CRAs 144 75 10,800
Site Closeout -------------------------------------------------------------------- 67 sites x 12 hrs/site
US-based CRAs 900 90 61,000
------------------------------------------------------------------------------------------------------------------------------------
North American Trial 62,500 25 sites audits @ $2,500 each
Site Audits --------------------------------------------------------------------------------------------------------------
Non North American Trial 62,500 25 sites audits @ $2,500 each
------------------------------------------------------------------------------------------------------------------------------------
2,329,305
------------------------------------------------------------------------------------------------------------------------------------
31
Page 22
FEE SCHEDULE AUSTRALIA TRIAL
Hours Total
Activity of Effort Hourly Rate ($US) ($US) Calculations/Comments
--------------------------------------------------------------------------------------------------------------------------------
Regulatory Consulting 80 125 10,000 80 hrs x $125/hr (est.)
IRS Submission 36 80 3,040 8 hrs + (3 hrs x 10 sites) x $80/hr
Pre Study Documentation 24 80 1,920 4 hrs + (2 hrs x 10 sites) x $80/hr
Identify Sites 30 80 2,400 15 sites evaluated to find 10
15 x 2 hrs x $80
Investigator Meeting Coordination -- -- 12,000 Includes: organization, logistics, attendance,
clinical assistance, presentations by specialists.
Initiations Visits 80 80 6,400 10 sites x 8 hrs x $80/hr
40 110 4,400 5 sites x 6 hrs x $110/hr
Close Out Visits 120 80 9,600 10 sites x 12 hrs x $60/hr
Monitoring 840 80 67,200 August '99-Feb. '00; every 4-6 weeks
10 sites x 16 hrs x 5.25 visits x $80
720 80 57,600 Mar. '00-April '01; every 12 weeks
10 sites x 16 hrs x 4.5 visits x $80
Project Management 640 110 70,400 40 hrs/mth x 16 mths x $110
96 110 10,560 16 hrs/mth x 6 mths x $110
255,520
32
Page 23
FEE SCHEDULE DATA MANAGEMENT
VIT-02-08961X &
VIT-03-08961X
ACTIVITY PERSONNEL HOURLY RATE (GLOBAL SITES)
----------------
EFFORT
HOURS TOTAL
-----------------------------------------------------------------------------------
Database Design & Data
Management Guidelines Data Manager 75 180 13,500
-----------------------------------------------------------------------------------
CRF QA & Document Control Data Assistant 50 640 32,000
-----------------------------------------------------------------------------------
Data Entry Data Entry Tech. 40 1,060 42,400
-----------------------------------------------------------------------------------
Data Coding, Edit Checks,
Query Resolution & Listings Data Manager 75 1,932 144,900
-----------------------------------------------------------------------------------
232,800
-------
By combining data management services for both protocols, CroMedica is able to
pass on a direct savings of 10 per cent over the individual costs for each
protocol.
SUMMARY
North America Trial $ 3,040
Australia Trial 0
Data Management 232,800
--------
Grand Total $235,840
========
33
ATTACHMENT 2
PAYMENT AND PERFORMANCE SCHEDULE
PAYMENT SCHEDULE
Sponsor shall reimburse reasonable costs and expenses at net thirty (30) days
terms upon receipt of invoice and any associated original receipts, and/or at
the occurrence of the below incidents enacted at Sponsor's request, pending
review for acceptableness and/or completeness. All figures are in US dollars:
FIXED-UNIT PRICE PAYMENT STRUCTURE
Unit Cost Study Maximum
--------- -------------
Up Front (20%) $563,525
Australia Regulatory Submission $10,000 10,000
CRF Finalization 6,180 8,580
Site Recruitment:
Canadian 200 2,400
U.S. 240 2,880
Australia 240 2,400
Initiation Visits:
Canadian 600 7,200
U.S. 720 18,720
Australia 1,080 10,800
Interim Visits:
Canadian 1,200 183,600
U.S. 1,440 1,156,680
Australia 1,280 124,800
Unmasked Visits:
Canadian 900 10,800
U.S. 1,080 68,040
Close Out Visits:
Canadian 900 10,800
U.S. 1,080 81,000
Australia 960 9,600
Site Audits 2,500 125,000
Australia Investigator Meeting 12,000 12,000
Study Training 24,550 24,550
SAE Management $300 per SAE 81,600
Database Design 13,500 13,500
Data Entry:
1/3 Data Entered 50,000 50,000
2/3 Data Entered 50,000 50,000
3/3 Data Entered 50,000 50,000
Project Management Fee
(per month for 25 months) 5,566 139,150
Total Contract $2,817,625
Pass-through Costs: SPONSOR shall reimburse CONTRACTOR for reasonable
pass-through costs (e.g., travel, lodging, meals) at net thirty (30) days term
upon receipt of original receipt(s)/invoice. Interest at 15% shall apply in net
thirty (30) days terms are not satisfied.
24
