GENERAL SERVICES AGREEMENT
This
General Services Agreement (“Agreement”) is made between Prana Biotechnology
Ltd, which has a place of business at Xxxxx 0, 000 Xxxxx Xxxxxx, Xxxxxxxxx,
XXX,
0000 Xxxxxxxxx (hereinafter
“Sponsor”), and Quintiles, Limited having its principal place of business at
Xxxxxxx Xxxxx, Xxxxxx Xxxxxx, Xxxxxxxxx, Xxxxxxxxx, XX00 0XX (hereinafter
“Quintiles”). When signed by both parties, this Agreement will set forth the
terms and conditions under which Quintiles agrees
to
provide certain services to Sponsor as set forth herein.
Recitals:
A. Sponsor
is in the business of developing, manufacturing and/or distributing pharmaceutical
products, medical devices and/or biotechnology products. Quintiles is in the
business
of providing clinical trial services, research, and other services for the
pharmaceutical, medical device and biotechnology industries and has made
significant, up-front investments in technologies
related to those industries, building on important inventions and web-based
technologies.
B. Sponsor
and Quintiles desire to enter into this Agreement whereby Quintiles will
perform
services relating to the Phase IIa randomised placebo controlled trial of PBT2
in a population
of subjects with mild Alzheimer's Disease (the “Project”).
Agreement:
1.0 |
Services
to be Provided. The
services to be performed hereunder (the “Services”) shall be
specified in the Scope of Work attached hereto as Attachment 1. Any
responsibilities not
specifically transferred in this Agreement shall remain the responsibility
of Sponsor.
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2.0 |
Payment
of Fees and Expenses. Sponsor
will pay Quintiles for fees, expenses and pass-through
costs in accordance with the budget and payment schedule attached
hereto
as Attachment
2. Based on the estimated cash flow of the Project, Sponsor agrees
that a
prepayment
may be needed for Quintiles to maintain cash neutrality over the
term of
the Project
taking into account the payment terms agreed to between the parties.
Quintiles will invoice
Sponsor for its fees in accordance with the payment schedule and
monthly
for expenses
and pass-through costs incurred in performing the Services. Expenses
and
pass-through
costs will be supported by a summary sheet. With the exception of
any
prepayment or advances and investigator invoices, which are due and
payable upon receipt, all other invoice payments shall be made to
Quintiles within thirty (30) days of receipt. If any portion of an
invoice
is disputed, then Sponsor shall pay the undisputed amounts as set
forth in
the preceding
sentence and the parties shall use good faith efforts to reconcile
the
disputed amount
as soon as practicable. Sponsor shall pay Quintiles interest in an
amount
equal to four percent (4%) above the base interest rate established
by
Fortis Bank Limited per month of all undisputed amounts owing hereunder
and not paid when due (or the maximum lesser amount
permitted by applicable law). In the event that taxes or duties,
of
whatever nature, are
required to be withheld on payments made pursuant to this Agreement
by any
state, federal, provincial or foreign government, including, but
not
limited to, Value Added Tax,
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Sponsor
shall promptly pay said taxes and duties to the appropriate taxing authority
without any
deduction to any amount owed to Quintiles. Sponsor shall secure and deliver
to
Quintiles
any official receipt for any such taxes paid. Quintiles shall send all
invoices
to the attention
of Xxxxx Xxxxxx at the following address: Prana Biotechnology Ltd, Xxxxx
0, 000
Xxxxx Xxxxxx, Xxxxxxxxx, XXX, 0000, Xxxxxxxxx. Sponsor shall send all payments
to the following address: PSC Xxxxxxxx Xxxxx, Xxxxxxxxxx Xxx, Xxxxxxxxxx
Xxxxxxxx Xxxx, Xxxxxxxxxx, XX00 0XX or by means of BACS Transfer as follows
:
Payable
to:
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Quintiles
Limited
Fortis
Bank
00
Xxxxxxxx Xxxxxx
Xxxxxx
XX0X
0XX
Xxxxxxx
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Sort
Code:
|
40-52-62
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Account Number:
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00000000
|
Swift:
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GEBAGB22
|
IBAN:
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XX00XXXX00000000000000
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3.0 |
Term.
This
Agreement shall commence on the date it has been signed by all parties
and
shall continue until the Services are completed or until terminated
by
either party in accordance
with Section 17 below.
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4.0 |
Change
Orders. Any
change in the details of this Agreement or the assumptions upon
which
this Agreement is based (including, but not limited to, changes in
an
agreed starting
date for the Project or suspension of the Project by Sponsor) may
require
changes in
the budget and/or time lines, and shall require a written amendment
to the
Agreement (a
“Change Order”). Each Change Order shall detail the requested changes to
the applicable
task, responsibility, duty, budget, time line or other matter. The
Change
Order will become effective upon the execution of the Change Order
by both
parties, and Quintiles will be given a reasonable period of time
within
which to implement the changes. Both parties agree to act in good
faith
and promptly when considering a Change Order requested by the other
party.
Without limiting the foregoing, Sponsor agrees that it will not
unreasonably withhold approval of a Change Order, Either party reserves
the right
to postpone effecting material changes in the Project's scope until
such
time as the parties
agree to and execute the corresponding Change Order. For any Change
Order
that
affects the scope of the regulatory obligations that have been transferred
to Quintiles, Quintiles
and Sponsor shall execute a corresponding amendment to the Transfer
of
Obligations Form. Sponsor shall file such amendment where appropriate,
or
as required by
law or regulation.
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5.0 |
Confidentiality.
It
is understood that during the course of this Agreement, Quintiles
and its
employees may be exposed to data and information that are confidential
and
proprietary
to Sponsor. It is understood that project results are Confidential
and
proprietary to the Sponsor and all such data and information (hereinafter
is collectively termed
“Sponsor Confidential Information”) written or verbal, tangible or
intangible, made
available, disclosed, or otherwise made known to Quintiles and its
employees as a result of Services under this Agreement shall be considered
confidential and shall be considered the sole property of Sponsor.
All
information regarding Quintiles' operations, methods, and pricing
and all
Quintiles' Property (as defined in Section 6.0 below), disclosed
by
Quintiles to Sponsor in connection with this Agreement is proprietary,
confidential information belonging to Quintiles (the “Quintiles
Confidential Information”, and together with the Sponsor Confidential
Information, the “Confidential Information”). The Confidential Information
shall be used by the receiving party and its employees only for purposes
of performing the receiving party's obligations hereunder. Each party
agrees that it will not reveal, publish or otherwise disclose the
Confidential Information of the other party to any third party without
the
prior written consent of the disclosing party. Each party agrees
that it
will not disclose the terms of this Agreement to any third party
without
the written consent of the other party, which shall not unreasonably
be
withheld. These obligations of confidentiality and nondisclosure
shall
remain in effect for a period of ten (10) years after the completion
or
termination of the Agreement.
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The
foregoing obligations shall not apply to Confidential Information to the extent
that it: (a) is or becomes generally available to the public other than as
a
result of a disclosure by the receiving party; (b) becomes available to the
receiving party on a non-confidential basis from a source which is not
prohibited from disclosing such information; (c) was developed independently
of
any disclosure by the disclosing party or was known to the receiving party
prior
to its receipt from the disclosing party, as shown by contemporaneous written
evidence; or, (d) is required by law or regulation to be disclosed.
6.0 |
Ownership
and Inventions. All
data and information generated or derived by Quintiles as the result
of
Services performed by Quintiles under this Agreement shall be and
remain
the exclusive property of Sponsor. Any inventions that may evolve
from the
data and information described above or as the result of Services
performed by Quintiles under this Agreement shall belong to Sponsor
and
Quintiles agrees to assign its rights in all such inventions and/or
related patents to Sponsor. Notwithstanding the foregoing, Sponsor
acknowledges that Quintiles possesses certain inventions, processes,
know-how, trade secrets, improvements, other intellectual properties
and
other assets, including but not limited to analytical methods, procedures
and techniques, procedure manuals, personnel data, financial information,
computer technical expertise and software, which have been independently
developed by Quintiles and which relate to its business or operations
(collectively “Quintiles' Property”). Sponsor and Quintiles agree that any
Quintiles' Property or improvements thereto which are used, improved,
modified or developed by Quintiles under or during the term of this
Agreement are the sole and exclusive property of
Quintiles.
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7.0 |
Records
and Materials. At
the completion of the Services by Quintiles, all materials, information
and all other data owned by Sponsor, regardless of the method of
storage
or retrieval, shall be delivered to Sponsor in such form as is then
currently in the possession of Quintiles. Alternatively, at Sponsor's
written request, such materials and data may be retained by Quintiles
for
Sponsor for an agreed-upon time period, or disposed of pursuant to
the
written directions of Sponsor. Sponsor shall pay the costs associated
with
any of the above options and shall pay a to-be-determined fee for
storage
by Quintiles of records and materials after completion or termination
of
the Services. Quintiles, however, reserves the right to retain, at
its own
cost and subject to the confidentiality provisions herein, one copy
of all
materials that may be needed to satisfy regulatory requirements or
to
resolve disputes regarding the Services. Nothing in this Agreement
shall
be construed to transfer from Sponsor to Quintiles any FDA or regulatory
record-keeping requirements unless such transfer is specifically
provided
for in the applicable Transfer of Obligations
Form.
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8.0 |
Independent
Contractor Relationship. For
the purposes of this Agreement, the parties hereto are independent
contractors and nothing contained in this Agreement shall be construed
to
place them in the relationship of partners, principal and agent,
employer/employee or joint venturers. Neither party shall have the
power
or right to bind or obligate the other party, and neither party shall
hold
itself out as having such authority. If, however, Sponsor desires
to
conduct clinical trials in one or more countries that require a local
sponsor or representative, and Sponsor requests that Quintiles or
its
affiliates serve as its agent for that purpose, then Quintiles may
serve
as Sponsor's agent for the purpose of fulfilling local sponsor or
representative duties. Sponsor shall pay Quintiles for such local
representative services at Quintiles' standard daily rates, unless
otherwise specified in the attached
Budget.
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9.0 |
a)
Regulatory Compliance. Quintiles
agrees that its Services will be conducted in compliance
with all applicable laws, rules and regulations and with the standard
of
care customary in the contract research organization industry (excluding
21 CFR Part 11). Quintiles shall process all personal data in accordance
with this Agreement or as otherwise instructed by Sponsor or its
affiliates in compliance with the EU Data Protection Directive 95/46/EC
and any applicable national legislation enacted thereunder (“Data
Protection Legislation”). Sponsor represents and affirms to Quintiles that
Sponsor has complied with, and will continue to comply with its
obligations under the Data Protection Legislation. Quintiles' standard
operating procedures will be used in performance of the Services,
unless
otherwise specifically stated in the Scope of Work. Quintiles certifies
that it has not been debarred under the Generic Drug Enforcement
Act and
that it will not knowingly employ any person or entity that has been
so
debarred to perform any Services under this Agreement. Sponsor represents
and certifies that it will not require Quintiles to perform any
assignments or tasks in a manner that would violate any applicable
law or
regulation. Sponsor further represents that it will cooperate with
Quintiles in taking any actions that Quintiles reasonably believes
are
necessary to comply with the regulatory obligations that have been
transferred to Quintiles.
b)
Inspections and Audits. Each
party acknowledges that the other party may respond independently
to any
regulatory correspondence or inquiry in which such party or its affiliates
is named. Each party, however, shall not respond on behalf of the
other
party to any such regulatory correspondence or inquiry, unless otherwise
agreed by the parties, and shall notify the other party promptly
of any
FDA or other governmental or regulatory inspection or inquiry concerning
the Services. During any such inspection or inquiry, the parties
agree to
make reasonable efforts to disclose only the information required
to be
disclosed.
During the term of this Agreement, Quintiles will permit Sponsor's
representatives
(unless such representatives are competitors of Quintiles) to examine
or
audit the work performed hereunder and the facilities at which the
work is
conducted upon reasonable advance notice during regular business
hours to
determine that the Services
are being conducted in accordance with the agreed task and that the
facilities are adequate.
Sponsor agrees that it shall not disclose to any third party any
information ascertained by Sponsor in connection with any such audit
or
examination, except to the extent
required by law or regulation. Sponsor shall reimburse Quintiles
for its
time and expenses
(including reasonable attorney fees and the costs of responding to
findings) associated with any inspection, audit or investigation
relating
to the Services (“Inspection”)
instigated by Sponsor or by a governmental authority, unless such
Inspection
finds that Quintiles breached this Agreement or any applicable law
or
regulation.
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10.0 |
Relationship
with Investigators. If Quintiles will be obligated to contract
with investigators or investigative sites (collectively, “Investigators”)
then Quintiles will use its standard Clinical Trial Agreement (“Global
CTA”) form, a copy of which is attached hereto as Attachment 3, along
with
certain local CTA forms (“Local CTAs”) that have developed for use in
certain countries based on local requirements with the benefit of
local
legal advice, which have been prepared in local language and English
language where applicable. Any applicable Local CTAs will be made
available for inspection by the Sponsor upon request. If the Global
CTA
form or a Local CTA is updated, Quintiles will use its then current
Global
CTA form (or Local CTA as appropriate) as of the time of the agreement.
If
Sponsor insists that any CTA form other than the Global CTA and Local
CTAs
be used, then Sponsor shall pay all translation costs and additional
negotiation time may be required. If an Investigator insists upon
any
material changes to any provisions that directly affect Sponsor,
then
Quintiles shall submit the proposed material change to Sponsor, and
Sponsor shall review, comment on and/or approve such proposed changes
within five (5) working days. If the Global CTA form (or Local CTA,
where
applicable), or any changes approved by Sponsor, differ from the
terms of
this Agreement (including, but not limited to, provisions allowing
an
Investigator to publish results or data that Quintiles is prohibited
from
revealing), then Quintiles shall have no liability for any such approved
provisions or changes. Unless otherwise stated in the attached Budget,
the
time incurred by Quintiles in negotiating CTA changes proposed by
sites
shall be billed at Quintiles' Standard Rates. The parties acknowledge
and
agree that Investigators shall not be considered the employees, agents,
or
subcontractors of Quintiles or Sponsor and that Investigators shall
exercise their own independent medical judgment. Quintiles'
responsibilities with respect to Investigators shall be limited to
those
responsibilities specifically set forth in this
Agreement.
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If Quintiles will be paying Investigators on behalf of Sponsor, the parties will agree in the attached Payment Schedule as to a schedule of amounts to be paid to Investigators. Sponsor acknowledges and agrees Quintiles will only pay Investigators from advances or pre-payments received from Sponsor for Investigators' services, and that Quintiles will not make payments to Investigators prior to receipt of sufficient funds from Sponsor. Sponsor acknowledges and agrees that Quintiles will not be responsible for delays in a study or Project to the extent that such delays are caused by Sponsor's failure to make adequate pre-payment for Investigators' services. Sponsor further acknowledges and agrees that payments for Investigators' services are pass-through payments to third parties and are separate from payments for Quintiles' Services. Sponsor agrees that it will not withhold Investigator payments except to the extent that it has reasonable questions about the services performed by a particular Investigator. For the avoidance of doubt, nothing contained in this clause, or elsewhere in this Agreement, is intended to confer any right or benefit on any third party including, but not limited to, any Investigator, whether under the provisions of the Contracts (Rights of Third Parties) Xxx 0000 or otherwise. |
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11.0 |
Third
Party Indemnifications and Agreements. If
any investigative sites or any other third parties, including, but
not
limited to, Data Safety Monitoring Boards, independent laboratories,
Advisory Boards, or End Point Adjudication Committees (collectively,
“Third Parties”), request an indemnification for loss or damage caused by
the sponsor's Project, then Sponsor shall be responsible for providing
such indemnification directly to the Third Party, on terms and conditions
to be agreed between Sponsor and the Third Party. If Sponsor requests
Quintiles' assistance in negotiating the terms of such indemnities,
Quintiles shall provide such negotiation services at its standard
daily
rates, unless otherwise agreed in the attached Budget. Quintiles
shall not
sign such indemnifications on Sponsor's behalf unless Sponsor has
expressly authorized Quintiles to act as its agent for such purpose
or has
given Quintiles a written power of attorney to sign such indemnifications.
In countries in which local laws or local ethics committees require
that a
local company must sign such indemnifications and Sponsor has no
local
presence, Quintiles will sign such indemnities only if the parties
have
entered into an agreement regarding local representative duties containing
the terms attached hereto as Attachment B, either as a part of this
Agreement or as a separately signed
agreement.
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If
Sponsor requests that Quintiles enter into agreements to retain Third Parties
to
perform services regarding the Project, such Third Parties shall be independent
contractors and shall not be considered the employees, agents, or subcontractors
of Quintiles or Sponsor. Sponsor shall pay Quintiles for its reasonable time
and
expenses in negotiating and administering any such Third Party Agreements.
These
agreements shall be subject to Sponsors written approval, which shall not be
unreasonably withheld or delayed.
12.0 |
Conflict
of Agreements. Quintiles
represents to Sponsor that it is not a party to any agreement which
would
prevent it from fulfilling its obligations under this Agreement and
that
during the term of this Agreement, Quintiles agrees that it will
not enter
into any agreement to provide services which would in any way prevent
it
from providing the Services contemplated under this Agreement. Sponsor
agrees that it will not enter into an agreement with a third party
that
would alter or affect the regulatory obligations delegated to Quintiles
pursuant to this Agreement without the written consent of Quintiles,
which
will not be unreasonably withheld.
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13.0 |
Publication.
Project
results may not be published or referred to, in whole or in part,
by
Quintiles or its affiliates without the prior expressed written consent
of
Sponsor. Neither party will use the other party's name in connection
with
any publication or promotion without the other party's prior, written
consent.
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14.0 |
Limitation
of Liability.
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a) Neither
Quintiles, nor its affiliates, directors, officers, employees, subcontractors
or
agents shall have any liability (including without limitation, contract,
negligence and tort liability) for any loss of profits, opportunities or
goodwill or any type of indirect or consequential damages in connection with
this Agreement or the Services performed by Quintiles except to the extent
such
liability arises out of Quintiles' recklessness or willful misconduct or a
negligent act or omission. For purposes of this provision, recklessness or
willful misconduct or a negligent act or omission is considered on the basis
of
whether Quintiles failed to institute policies or procedures that could
reasonably have been expected to prevent the recklessness, willful misconduct
or
negligent act or omission in question.
b) In
no
event shall the collective, aggregate liability (including without limitation,
contract, negligence and tort liability) of Quintiles or its affiliates,
directors, officers, employees, subcontractors or agents under this Agreement
exceed the amount of fees actually received by Quintiles from Sponsor under
this
Agreement.
c) Neither
Quintiles, nor its affiliates, directors, officers, employees, subcontractors
or
agents shall have any liability for death or personal injury; except to the
extent that such liability is attributable to a negligent act or omission of
Quintiles.
15.0 |
Third
Party Indemnification.
Sponsor
shall indemnify, defend and hold harmless Quintiles and its affiliates,
and its and their directors, officers, employees and agents (each,
a
“Quintiles Indemnified Party”), from and against any and all losses,
damages, liabilities, reasonable attorney fees, court costs, and
expenses
(collectively “Losses”), joint or several, resulting or arising from any
third-party claims, actions, proceedings, investigations or litigation
relating to or arising from or in connection with this Agreement
or the
Services contemplated herein (including, without limitation, any
Losses
arising from or in connection with any study, test, device, product
or
potential product to which this Agreement relates), except to the
extent
such Losses are determined to have resulted solely from the negligence
or
intentional misconduct of the Quintiles Indemnified Party seeking
indemnity hereunder.
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16.0 |
Indemnification
Procedure. Quintiles
shall give Sponsor prompt notice of any third party
claim or lawsuit (including a copy thereof) served upon it and shall
fully
cooperate with Sponsor and its legal representatives in the investigation
of any matter the subject of indemnification. Quintiles shall not
unreasonably withhold its approval of the settlement of any claim,
liability, or action covered by this Indemnification
provision.
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17.0 |
Termination.
Sponsor
may terminate this Agreement without cause at any time during the
term of
the Agreement on sixty (60) day's prior written notice to Quintiles.
Either party may terminate this Agreement for material breach upon
thirty
(30) days' written notice specifying the nature of the breach, if
such
breach has not been substantially cured within the thirty (30) day
period.
During the 30-day cure period for termination due to breach, each
party
will continue to perform its obligations under the Agreement. If
the
termination notice is not due to a breach, or if the cure period
has
expired without a substantial cure of the breach, then the parties
shall
promptly meet to prepare a close-out schedule, and Quintiles shall
cease
performing all work not necessary for the orderly close-out of the
Services or required by laws or regulations. If Quintiles reasonably
determines that its continued performance of the Services contemplated
by
this Agreement, after discussion with Sponsor, would constitute a
violation of written regulatory or scientific standards of integrity,
then
Quintiles may terminate this Agreement by giving written notice stating
the effective date (which may be less than thirty days from the notice
date) of such termination. Either party may terminate this Agreement
immediately upon provision of written notice if the other party becomes
insolvent or files for bankruptcy.
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If
this
Agreement is terminated, Sponsor shall pay Quintiles for all Services performed
in accordance with the Agreement and reimburse Quintiles for all costs and
expenses incurred in performing those Services, including all non-cancelable
costs incurred prior to termination but paid after the termination date. Sponsor
shall pay for all the work actually performed in accordance with the Agreement,
even if the parties' original payment schedule spreads-out payments for certain
services or defers payments for certain services until the end of the Study.
If
payments are unit or milestone based, and the Agreement is terminated after
costs have been incurred toward achieving portions of one or more incomplete
units or milestones, Sponsor will pay Quintiles' standard fees for actual work
performed toward those incomplete units or milestones up to the date of
termination, in addition to paying for completed units or milestones. Sponsor
shall pay for all actual costs, including time spent by Quintiles personnel
(which shall be billed at Quintiles' standard daily rates in effect as of the
date of the termination notice), incurred to complete activities associated
with
the termination and close-out of affected Projects, including the fulfillment
of
any regulatory requirements. In addition, if the termination is by Sponsor
without cause, or by Quintiles for reasonable cause, and the total fees for
the
Project are greater than one million U.S. dollars in value, then Sponsor shall
pay to Quintiles an amount equal to fifteen percent (15%) of the budget for
the
remainder of Services that have not yet been performed, to cover Quintiles'
costs associated with early termination.
18.0 |
Relationship
with Affiliates. Sponsor
agrees that Quintiles may use the services of its corporate affiliates
as
subcontractors to fulfill Quintiles' obligations under this Agreement.
Quintiles shall remain responsible for all obligations in connection
with
the Services performed by its affiliates, and its affiliates shall
be
subject to all of the terms, conditions and rights applicable to
Quintiles
under this Agreement. The term “affiliate” shall mean all entities
controlling, controlled by or under common control with Quintiles.
The
term “control” shall mean the ability to vote fifty percent (50%) or more
of the voting securities of any entity or otherwise having the ability
to
influence and direct the polices and direction of an
entity.
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19.0 |
Cooperation;
Sponsor Delays; Disclosure of Hazards. Sponsor
shall forward to Quintiles in a timely manner all documents, materials
and
information in Sponsor's possession or control necessary for Quintiles
to
conduct the Services. Quintiles shall not be liable to Sponsor nor
be
deemed to have breached this Agreement for errors, delays or other
consequences arising from Sponsor's failure to timely provide documents,
materials or information or to otherwise cooperate with Quintiles
in order
for Quintiles to timely and properly perform its obligations, and
any such
failure by Sponsor shall automatically extend any timelines affected
by a
time period reasonably commensurate to take into account such failure,
unless Sponsor agrees in writing to pay any additional costs that
would be
required to meet the original timeline. If Sponsor delays a project
from
its agreed starting date or suspends performance of the project then
either: a) Sponsor will pay the standard daily rate of the Quintiles'
personnel assigned to the project, based on the percentage of their
time
allocated to the project, for the period of the delay, in order to keep
the current team members; or, b) Quintiles may re-allocate the personnel
at its discretion, and Sponsor will pay the costs of re-training
new
personnel. In addition, Sponsor will pay all non-cancelable costs
and
expenses incurred by Quintiles due to the delay and will adjust all
timelines to reflect additional time required due to the delay. Sponsor
shall provide Quintiles with all information available to it regarding
known or potential hazards associated with the use of any substances
supplied to Quintiles by Sponsor, and Sponsor shall comply with all
current legislation and regulations concerning the shipment of substances
by the land, sea or air.
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20.0 |
Force
Majeure. In
the event either party shall be delayed or hindered in or prevented
from
the performance of any act required hereunder by reasons of the forces
of
strike, lockouts, labor troubles, inability to procure materials
or
services, failure of power or restrictive government or judicial
orders,
or decrees, riots, insurrection, war, Acts of God, inclement weather
or
other reason or cause beyond that party's control, then performance
of
such act (except for the payment of money owed) shall be excused
for the
period of such delay on the basis that the relevant party will perform
all
reasonable actions to overcome any of the abovementioned
forces.
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21.0 |
Notices
and Deliveries. Any
notice required or permitted to be given hereunder by either
party hereunder shall be in writing and shall be deemed given on
the date
received if delivered personally or by a reputable overnight delivery
service, or three (3) days after the date postmarked if sent by registered
or certified mail, return receipt requested, postage prepaid to the
following addresses:
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If
to Quintiles:
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If
to Sponsor:
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Quintiles
Transnational Legal Department
P.O.
Box 13979
Research
Triangle Park, North Carolina, U.S.A.
27709-3979
Attention:
Xxxx Xxxxxxx
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Xxxxx
0, 000 Xxxxx Xxxxxx,
Xxxxxxxxx,
XXX, 0000
Xxxxxxxxx
Attention:
Xxxxxx Xxxxx
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And,
|
|
Quintiles
Transnational Xxxxx Xxxxxxxxxx Xxxxxxx
Xxxxx
Xxxxxx
Xxxxxx
Xxxxxxxxx
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0
of
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Xxxxxxxxx,
XX00 XXX
XX
If
Sponsor delivers, ships, or mails materials or documents to Quintiles, or
requests that Quintiles
deliver, ship, or mail materials or documents to Sponsor or to third parties,
then the
expense and risk of loss for such deliveries, shipments, or mailings shall
be
borne by Sponsor.
Quintiles disclaims any liability for the actions or omissions of third-party
delivery services or carriers. All information transmitted by Quintiles pursuant
to this Agreement
will be sent by the standard transmission method selected by Quintiles
(telephone,
facsimile, mail, personal delivery or email). Sponsor hereby consents and
authorizes
Quintiles to send facsimiles relating to the Services, or relating to potential
future
services, to any office of Sponsor or Sponsor's affiliates.
22.0 |
Insurance.
During
the term of this Agreement to cover its obligations hereunder, the
parties
shall maintain insurance coverage with a reputable insurance company
as
follows: i)
Clinical Trials insurance for Sponsor of not less than AU$5,000,000
per
annum as provided
in Attachment 4 to this Agreement; ii) Professional Indemnity insurance
for Quintiles of not less than US$5,000,000 per annum; and, iii)
Liability
to third parties insurance
for Quintiles with a limit of $1,000,000 per claim or series of related
claims, or at
the minimum statutory level, whichever is greater, iv) Liability
to third
parties insurance
for Sponsor to AU$20,000,000 as provided in Attachment 4. For Quintiles,
all insurance
amounts may be obtained by full, individual primary policy amount;
a
primary amount of less than minimum requirement enhanced by a blanket
excess umbrella policy; or
a combination of either. Each party shall provide the other party
with a
certificate of insurance
upon request. Each party shall ensure that its policies shall contain
an
endorsement to the effect that it shall not be cancelled or otherwise
materially changed during
that period without thirty (30) days prior written notice to the
other
party. The certificates
specifying the above-referenced Sponsor insurances are provided in
Attachment 4 to this Agreement and is incorporated herein by
reference.
|
23.0 |
Foreign
Currency Exchange. The
currency to be used for invoice and payment shall be the
currency stated in the attached Budget or Table (the “Contracted
Currency”). If Quintiles
incurs pass-through costs in a currency other than the Contracted
Currency, then Sponsor
shall reimburse Quintiles for Quintiles' actual costs in the Contracted
Currency based
on the Oanda foreign currency exchange rate (Xxxxx.xxx)
for the applicable currencies on the last business day of the month
in
which such pass-through costs are submitted.
If a currency referenced within the Budget is replaced by the Euro
or
otherwise
ceases to become legal tender, the applicable replacement currency
will be
substituted for such currency for purposes of this provision at an
established conversion rate.
|
If
this
Agreement involves the performance of Services by Quintiles or its affiliates
in
any
country that uses a currency other than the Contracted Currency, then the Budget
for those
Services will be based on the local rates in the currency used by Quintiles
for
pricing
that country, but converted to and reflected in the Contracted Currency. Sponsor
acknowledges that, due to fluctuations in currency exchange rates, Quintiles'
actual fees may be greater or lesser than the budgeted or estimated amounts
contained in this Agreement.
If the fees for Services in currencies other than the Contracted Currency exceed
$500,000 and the conversion rate between the local currencies and the Contracted
Currency has fluctuated more than 2%, plus or minus, since the Budget was
prepared, Quintiles may calculate a foreign currency exchange adjustment based
upon the following:
10
of
36
a) In
the
case of Fee for Service budgets, fees will be converted on each invoice based
on
the Oanda foreign currency exchange spot rate (Xxxxx.xxx)
from
the last Friday of the preceding month in which services were performed;
or,
b) For
all
other budget types including fixed fee, milestone or unit priced budgets, the
adjustment will be calculated every 12 months after the contract execution
date
(or in the final invoice if the agreement is for less than 12 months). The
foreign currency adjustment will be calculated by comparing the foreign currency
exchange rate stated in the Budget or Table attached to the Agreement to the
Oanda (Xxxxx.xxx)
average
rate over the preceding 12 months. Any resulting decrease in costs will be
credited to Sponsor and any resulting increase in costs will be invoiced to
Sponsor.
24.0 |
Data
Protection. Quintiles
and Sponsor agree to comply with all applicable privacy laws
and regulations. If the Project will involve the collection or processing
of personal data (as defined by applicable data protection legislation)
within the European Economic Area (“EEA”), then Sponsor shall serve as the
controller of such data, as defined by the European Union (“EU”) Data
Protection Directive (the “Directive”), and Quintiles shall act only under
the instructions of the Sponsor in regard to personal data. If Sponsor
is
not based in the EEA, Sponsor must appoint an EEA company to act
as its
local representative for data protection purposes in order to comply
with
the Directive, and such designation is attached hereto and incorporated
by
reference. If Sponsor does not have an affiliate in the EEA and requests
that a Quintiles affiliate in the EEA serve as its local representative,
then the parties shall negotiate a fee for such representative duties
and
shall enter into a Data Transfer Agreement between the parties containing
the Standard Contractual Clauses set forth by the EU Commission Decision
of 15 June 2001 (Decision 2001/497/EC) before Quintiles will assume
any
such representative duties. If Sponsor is not based in the EEA, Quintiles
will not export any personal data from the EEA unless Sponsor has
appointed a local representative.
|
25.0 |
Binding
Agreement and Assignment. This
Agreement shall be binding upon and inure to the benefit of Sponsor
and
Quintiles and their respective successors and permitted assigns.
Except as
stated above in Section 18, neither party may assign any of its rights
or
obligations under this Agreement to any party without the express,
written
consent of the other party.
|
26.0 |
Choice
of Law, Waiver and Enforceability. This
Agreement shall be construed, governed,
interpreted, and applied in accordance with the laws of England,
exclusive
of its conflicts of law provisions. The failure to enforce any right
or
provision herein shall not constitute a waiver of that right or provision.
Any waiver of a breach of a provision shall not constitute a waiver
of any
subsequent breach of that provision. If any provisions herein are
found to
be unenforceable on the grounds that they are overly broad or in
conflict
with applicable laws, it is the intent of the parties that such provisions
be replaced, reformed or narrowed so that their original business
purpose
can be accomplished
to the extent permitted by law, and that the remaining provisions
shall
not in
any way be affected or impaired
thereby.
|
11
of
36
27.0 |
Survival.
The
rights and obligations of Sponsor and Quintiles, which by intent
or
meaning
have validity beyond such termination (including, but not limited
to,
rights with respect to inventions, confidentiality, discoveries and
improvements, indemnification and liability
limitations) shall survive the termination of this
Agreement.
|
28.0 |
Arbitration.
Any
controversy or claim arising out of or relating to this Agreement
or the
breach thereof shall be settled by arbitration administered by the
International Chamber of Commerce (“ICC”) under its International Rules of
Arbitration, and judgment on the award rendered by the arbitrator
shall be
binding and may be entered in any court having jurisdiction thereof.
Such
arbitration shall be filed and conducted at the office of the ICC
closest
to the Quintiles office having responsibility for the Project, and
shall
be conducted in
English by one arbitrator mutually acceptable to the parties selected
in
accordance with ICC
Rules.
|
29.0 |
Entire
Agreement, Headings and Modification. This
Agreement contains the entire understandings
of the parties with respect to the subject matter herein, and supersedes
all previous agreements (oral and written), negotiations and discussions.
The descriptive headings
of the sections of this Agreement are inserted for convenience
only and
shall not control
or affect the meaning or construction of any provision hereof.
Any
modifications to the provisions herein must be in writing and signed
by
the parties.
|
IN
WITNESS WHEREOF, this Agreement has been executed by the parties hereto
through
their duly authorized officers on the date(s) set forth below.
ACKNOWLEDGED,
ACCEPTED AND AGREED TO:
Quintiles
Limited
|
Prana
Biotechnology Limited
|
|||
By:
|
\s\
Xxxxxxxx Xxxxxxxx
|
By:
|
/s/
[Illegible]
|
|
(signature)
|
(signature)
|
|||
Print Name:
|
XXXXXXXX XXXXXXXX
|
Print Name:
|
/s/
[Illegible]
|
|
Title:
|
VP, GLOBAL CONTRACTS
|
Title:
|
[Illegible]
|
|
Date:
|
1
3
NOV 2006
|
Date:
|
7th
November 0000
|
XXXXXXX
XX # _________________________
12
of
36
LIST
OF A TTACHMENTS
ATTACHMENT
1—SCOPE OF WORK
ATTACHMENT
2—BUDGET AND PAYMENT SCHEDULE
ATTACHMENT
3—CLINICAL TRIAL AGREEMENT FORM
ATTACHMENT
4—INSURANCE CERTIFICATE
13
of
36
ATTACHMENT
1
SCOPE
OF WORK
Country
|
|
Sites
|
|
Patients
Screened |
|
Patients
Randomised |
|
Patients
Completing |
|||||
SWEDEN
|
7
|
100
|
80
|
33
|
|||||||||
7
|
100
|
80
|
72
|
GENERAL
STUDY ASSUMPTIONS
Phase
|
II
|
|
Maximum
number of active sites
|
7
|
|
Maximum
number of patients screened
|
100
|
|
Number
of patients randomised
|
80
(20% screen failure rate)
|
|
Number
of patients evaluable
|
72
(10% drop-out rate)
|
|
Recruitment
period (months)
|
4.00
|
|
Treatment
duration (months)
|
3.00
|
|
Follow
up duration (months)
|
0.00
|
|
Maximum
CRF pages per screen failure (including diary where
applicable)
|
5
|
|
Maximum
CRF pages per drop-out (including diary where applicable)
|
21
|
|
Maximum
CRF pages per complete patient (including diary where
applicable)
|
35
|
|
Overall
study length (months)
|
14.96
|
|
Number
of client meetings
|
2
|
|
Duration
of client meetings (hours) -excluding travel
|
8
|
|
Number
of client teleconferences
|
15
|
|
Duration
of client teleconferences (hours)
|
1
|
|
Number
of investigator meetings
|
1
|
|
Duration
of investigator meetings (hours) -excluding travel
|
12
|
MONITORING
ASSUMPTIONS
|
|
|
Maximum
number of sites identified
|
13
|
|
Maximum
number of site selection visits
|
8
|
|
Maximum
number of site initiation visits
|
7
|
|
Maximum
number of monitoring visits
|
49
visits (7 per site)
|
|
-
Average
time on site per monitoring visit (hours)
|
5.00
|
|
-
Average administrative time per monitoring visit
(hours)
|
5.00
|
|
-
Average travel time per monitoring visit (hours)
|
5.00
|
|
-
Average site contact between visits (hours per site per
month)
|
2
00
|
|
%
SDV
|
100%
|
|
Maximum
number of close out visits
|
7
|
Actual
monitoring will be adjusted dependant on support activity required and
recruitment rate per site,
however the budget assumes that the total monitoring hours specified above
will
not be exceeded.
14
of
36
MONITORING
ASSUMPTIONS
|
||
Maximum
number of sites identified
|
13
|
|
Maximum
number of site selection visits
|
8
|
|
Maximum
number of site initiation visits
|
7
|
|
Maximum
number of monitoring visits
|
49
visits (7 per site)
|
|
-
Average
time on site per monitoring visit (hours)
|
5.00
|
|
-
Average administrative time per monitoring visit
(hours)
|
5.00
|
|
-
Average travel time per monitoring visit (hours)
|
5.00
|
|
-
Average site contact between visits (hours per site per
month)
|
2
00
|
|
%
SDV
|
100%
|
|
Maximum
number of close out visits
|
7
|
Actual
monitoring will be adjusted dependant on support activity required and
recruitment rate per site,
however the budget assumes that the total monitoring hours specified above
will
not be exceeded.
PHARMACOVIGILANCE
ASSUMPTIONS
|
||
Maximum
number of SAEs expected
|
24
SAEs (30%)
|
|
Safety
database requirement
|
Quintiles
Pharmacovigilance will set up a Clintrace Database
|
|
SAE
Coding
|
Yes
- MedDRA
|
|
SAE
Narratives
|
Yes
|
|
Quality
Control
|
100%
QC of SAE data fields
|
|
Tracking
database
|
A
tracking system will be set-up to track SAEs and
regulatory assessments to ensure open queries are efficiently identified
and prioritised, and
track submissions to regulatory authorities
|
|
Number
of updates per SAE
|
Initial
and up to two (2) update reports per SAE assumed.
Cycle includes triage, case evaluation, follow-up
with sites (each SAE would generally require
2 follow-up communications with the respective
site to obtain answers to outstanding queries),
regulatory assessment, data entry, generation
of queries, quality control, medical review,
submission to Prana Biotechnology, and submission
to Regulatory Authorities.
|
|
Translation
of SAE documentation
|
Quintiles
will provide translations of source documents
relating to SAEs using either an internal
medical translator or a medically certified translation
agency. These costs will be passed through
to the sponsor.
|
|
SAE
Reconciliation
|
Pharmacovigilance
will assist in the reconciliation
of the safety data in the safety and scientific databases (up to
7-10 data
fields per SAE)
|
|
Reporting
to Regulatory Authorities –
2 regulatory
reports (1 initial and 1 update) per expedited
SAE assumed
|
Quintiles
Pharmacovigilance will report up to 2 expedited
SAEs to Regulatory Authorities (including
the EMEA) as appropriate
|
15
of
36
PHARMACOVIGILANCE
ASSUMPTIONS
|
||
Investigator
alert letters (safety update letters) –
2
alert letters (1 initial and 1 update) per
expedited
SAE assumed
|
Quintiles
Pharmacovigilance will prepare and distribute
non-personalised Investigator alert letters
for up to 2 expedited SAEs to 7 sites (28 mailings)
|
|
Expedited
SAE reports to be sent to Central Ethics Committees (CECs)
|
Quintiles
Pharmacovigilance will distribute up to 2 expedited SAEs (unblinded
if
required) to the applicable
CECs in the 1 EU/EEA country involved
in the study. Quintiles assumes 1 CEC per
country.
|
|
Cross-reporting
of expedited SAEs occurring in other protocols
|
Not
included in the budget
|
|
Interim/annual
regulatory reports
|
Not
included in the pharmacovigilance budget
|
|
Meetings
to be attended by Pharmacovigilance personnel (number of
meetings)
|
1
Client kick off meeting, 1 investigator meeting. Ongoing
communication between Quintiles' pharmacovigilance
group and Prana Biotechnology
has been included.
|
|
Status
reports
|
Monthly
|
DATA
MANAGEMENT ASSUMPTIONS
|
||
CRF
design
|
Quintiles
to design CRF
|
|
Database
platform
|
Inform
EDC
|
|
Duration
of data management (months)
|
10.65
|
|
Number
of patient visits per complete CRF
|
6
|
|
Maximum
number of CRF pages expected
|
2,688
|
|
Number
of unique CRF pages
|
11
|
|
Number
of repeating pages
|
24
|
|
Number
of validation checks per page
|
15
|
|
Total
validation checks programmed
|
165
|
|
SAE
reconciliation required
|
Manual
|
|
Number
of electronic data sources
|
1
|
|
Total
number of electronic imports and transfers
|
10
(10 per source)
|
|
Number
of database exports
|
2
|
|
Number
of queries per 100 pages
|
3
|
|
Total
queries to process
|
81
|
|
Coding
dictionaries:
|
||
Diseases
|
MedDRA
|
|
Adverse
events
|
MedDRA
|
|
Concomitant
medications
|
Internal
|
|
Number
of diseases per patient (up to 50% expected to autoencode)
|
2
|
|
Number
of adverse events per patient (up to 50% expected to
autoencode)
|
3
|
|
Number
of con meds per patient (up to 50% expected to autoencode)
|
3
|
|
Meetings
to be attended by DM personnel (number of meetings)
|
Client
kick off meeting (Y), investigator meeting (Y),
client teleconferences (15), client face to face meetings
(2)
|
16
of
36
BIOSTATISTICS
ASSUMPTIONS
|
||
Statistical
input to protocol development
|
Yes
|
|
Statistical
analysis plan responsibility
|
Quintiles
will produce one draft of the analysis plan for review by Prana.
Prana
will provide one set of consolidated comments and the plan will be
considered
final upon incorporation of these comments.
Confirmation of the planned analyses will
be undertaken prior to database lock, and any minor
adjustments made at this time point.
|
|
Generate
randomisation schedule
|
Yes
|
|
Number
of treatment groups
|
2
|
|
Maximum
total number of tables
|
70
- Note: Table count refers to the number of entries in Table of
Contents
|
|
Maximum
total number of listings
|
30
- Note: Listings count refers to the number of entries in Table of
Contents
|
|
Maximum
total number of graphs
|
5
-
Note: Graph count refers to the number of entries in Table of
Contents
|
|
Laboratory
data source
|
Single
Central
|
|
Number
of interim analyses
|
0
|
|
Type
of report required
|
Quintiles
will prepare an integrated report
|
|
SAS
programming code to be delivered to customer
|
No
|
|
Meetings
to be attended by Biostatistics personnel (number of
meetings)
|
Client
kick off meeting (1), no attendance at investigator
meeting, client teleconferences (4), no
attendance at client face to face meetings
|
|
Additional
Assumptions:
|
||
All Statistical Outputs will undergo QC and Senior Biostatistical Review before issue to Prana Biotechnology. | ||
Quintiles
will provide one draft set of Statistical Outputs for Review by Prana
Biotechnology, who will provide
one
set of consolidated comments, and the Statistical Outputs will be
considered final upon incorporation of
these
comments. |
||
Costs
will be adjusted in the event of differences between final client
requirements agreed in the Analysis Plan,
Tables
and Listings and the assumptions listed
here.
|
MEDICAL
ASSUMPTIONS
|
||
Quintiles
to provide CRA training?
|
Quintiles
is not responsible tor providing CRA training.
|
|
Medical
Monitoring (CRA and Site Support)
|
Quintiles
will provide medical monitoring throughout start up, recruitment,
treatment and close out phases of the
study.
|
17
of
36
MEDICAL
WRITING ASSUMPTIONS
|
||
Study
protocol
|
Prana
to produce study protocol.
|
|
Clinical
Trial Report
|
The
report will be based on an electronic template provided
by Prana, or prepared in Microsoft WORD
in a format compliant with ICH guidelines.
Inputs provided from Prana to the Medical
Writer will be in a format suitable for direct
incorporation into the report. The draft report
will undergo QC, medical and statistical reviews
within Quintiles before issue to Prana. Quintiles
will produce two drafts of the report for review
by Prana, who will provide one set of consolidated comments on each
draft.
The report will
be considered final upon incorporation of the second
draft comments. Costs will be adjusted in the event of appreciable
differences between the actual
final client requirements agreed in the Analysis
Plan and the final statistical outputs, we reserve
the right to renegotiate this quotation.
|
|
Report
Narratives
|
An
estimated maximum 0 patient narratives will be
written in conjunction with the Clinical Trial Report,
Quintiles will provide one draft set of narratives
for review by Prana. Prana will provide one
set of consolidated comments and the narratives
will be considered final upon incorporation
of these comments.
|
|
Meetings
to be attended by Medical Writing personnel
(number of meetings)
|
Client
teleconferences (2), client face to face meetings
(1)
|
|
Additional
Assumptions
|
||
Any
Prana specific requirements for appendix documentation gathered by
Quintiles must be communicated upon contract agreement. Any documentation
to be provided by Prana for the report appendices will be provided
to the
Medical Writer before database lock, and in a format and quality
appropriate for direct inclusion in the report.
|
||
Costs
do not include manipulation or editing of appendix documents, scanning
appendix documents, or through pagination of the report plus appendices.
The costs do not include copying of any completed CRFs for inclusion
in
the report appendices. One loose-leaf paper copy of the final report
is
included in the costings.
|
18
of
36
CENTRAL
LABORATORIES SCOPE OF WORK
Assignment
of responsibilities
Task
|
Quintiles
|
Prana
|
||
Screening
of Subjects
|
X
|
|
||
Analysis
of Safety Samples
|
X
|
|
All
services will be carried out in accordance with Quintiles SOPs unless otherwise
indicated. A change of
SOP’s
may result in a cost change of the affected services. Prana is welcome to
undertake an on-site inspection
of Quintiles SOPs.
Study
Assumptions
Number
of included subjects
|
80
Alzheimer Patients
|
|
Number
of Safety Samples
|
500
Samples
|
|
Clinical
Chemistry:
|
According
to Specification of Clinical Chemistry (See
Attached)
|
Additional
Scope
|
||
þ
|
|
Protocol
amendments
|
þ
|
|
Additional
protocol assessments not detailed in the protocol, i.e. laboratory
sampling etc.
|
þ
|
|
Regulatory
Affairs consulting (involving a technical review of proposed protocol
to
ensure that supportive data is in compliance with European
Regulations).
|
þ
|
|
Subjects
replaced due to study related withdrawals
|
þ
|
|
Courier
costs including documentation transportation
|
þ
|
|
Analysis
of additional safety samples SEK 1 734
|
þ
|
|
Analyses
of samples at non-office hours SEK 1128 per hour
|
þ
|
|
Analysis
report in Excel format according to Quintiles standard, SEK analysis
price
x 2,75
|
þ
|
|
Sample
preparations SEK 60 per sample
|
þ
|
|
Preparation
of labels SEK 1 128 per hour
|
þ
|
|
Analysis
of express samples SEK analysis price x 2,75
|
þ
|
|
Sample
kits for PK samples 50 SEK per kit
|
þ
|
|
Non
Quintiles AB standard photocopying and faxing of source documents
to
Sponsor i.e. CRFs
|
þ
|
|
Storage
of samples and investigational product when clinical part of study
has
been completed
|
þ
|
|
Time
needed for any study specific audits performed by Sponsor or the
authorities.
|
19
of
36
Description
of services provided
|
||
1.
|
Screening
costs
|
|
Includes
haematology,
biochemistry, hepatitis B, C, HIV, urinalysis, drug and alcohol
screen.
|
||
Screening
labs
|
||
þ
|
100
samples
|
SEK
264,050
|
þ
|
100
sampling kits à
SEK
50
|
|
For study
specific assessments please see “Specification of Clinical chemistry”.
|
||
2.
|
In-study
costs (including post-screen)
|
|
In-
|
study
labs
|
|
þ
|
320
samples
|
SEK
420,160
|
þ
|
320
sampling kits à SEK 50
|
|
Post
study labs
|
||
þ
|
80
samples
|
SEK
114,640
|
þ
|
80
sampling kits à SEK 50
|
|
CSF
Sample Kits
|
||
þ
|
SEK
9 000
|
|
þ
|
180
sampling kits at SEK 50
|
|
A.
|
||
B.
|
||
C.
|
Also
included in clinical chemistry services
|
|
þ
|
Sample
description
|
|
þ
|
Written
analytical report in Quintiles AB format, by fax and mail.
|
|
þ
|
Retention
of study data for 10 years.
|
|
See
also “Specification of Clinical chemistry”
Time limit
|
||
Projects
will be active for 12 months following completion of the last scheduled
activity (e.g. last subject out or final report). Any requests
for data
clarifications, copies of archived documentation or similar will
be
handled within the specified budget during this 12-month period.
Thereafter any services will be charged at Quintiles current hourly
rates.
|
20
of
36
Specification
of clinical chemistry
Analyses
to be performed are listed below. Also included Quintiles Uppsala full range
of
analyses for the Prana
to
review
Haematology
|
Screening
|
|
During
|
|
Follow
Up
|
|
||||
B-Differential
white blood cells
|
1
|
4
|
1
|
|||||||
B-Eryt.
Sediment.rate
|
||||||||||
B-Heamoglobin
|
1
|
4
|
1
|
|||||||
B-Hematocrit
(EVF)
|
1
|
4
|
1
|
|||||||
B-MCH
|
||||||||||
B-MCHC
|
1
|
4
|
1
|
|||||||
B-MCV
|
1
|
4
|
1
|
|||||||
B-Platelets
|
1
|
4
|
1
|
|||||||
B-Red
Blood cells
|
1
|
4
|
1
|
|||||||
B-Reticulocytes
|
||||||||||
B-White
blood cells
|
1
|
4
|
1
|
|||||||
Extra
haematology analysis
|
||||||||||
Coagulation
|
||||||||||
P-APTT
|
||||||||||
P-Prothrombin
complex
|
||||||||||
Fibrinogen
|
||||||||||
Antithrombin
III
|
||||||||||
Fibrin
D-Dimer
|
||||||||||
Clinical
Chemistry
|
||||||||||
HbAlC
|
||||||||||
A/G
ratio
|
||||||||||
Laktat
|
||||||||||
S-ALAT
|
1
|
4
|
1
|
|||||||
S-Albumin
|
1
|
4
|
1
|
|||||||
S-alfal-Microglobuline
|
||||||||||
S-Alkaline
phosphat
|
1
|
4
|
1
|
|||||||
S-Amylase
|
||||||||||
S-ASAT
|
1
|
4
|
1
|
|||||||
S-beta2-Microglobuline
|
||||||||||
S-Bicarbonate
|
||||||||||
S-Bilirubin
(conjug)
|
||||||||||
S-Bilirubin
(total)
|
1
|
4
|
1
|
|||||||
S-Bilirubin
(unconj.)
|
||||||||||
S-Calcium
|
1
|
4
|
1
|
21
of
36
S-Calcium
(albmodif)
|
||||||||||
S-Chloride
|
||||||||||
S-Cholesterol
|
||||||||||
S-Creatinine
kinase
|
||||||||||
S-Creatine
kinase MB
|
||||||||||
S-Creatinine
|
1
|
4
|
1
|
|||||||
S-CRP
|
||||||||||
S-Cystatin
C
|
||||||||||
S-Ferritin
|
1
|
4
|
1
|
|||||||
S-Free
fatty acid
|
||||||||||
S-Fruktosamine
|
||||||||||
S-GGT
|
1
|
4
|
1
|
|||||||
S-Glucose
|
1
|
|||||||||
S-Haptoglobin
|
||||||||||
S-HDL
|
||||||||||
S-Iron
|
1
|
4
|
1
|
|||||||
S-LD
|
||||||||||
S-LDL
|
||||||||||
S-Magnesium
|
||||||||||
S-N-acetylglucosaminidase
|
||||||||||
S-Orosomucoid
|
||||||||||
S-Osmolality
|
||||||||||
S-Phosphate
|
1
|
4
|
1
|
|||||||
S-Potassium
|
1
|
4
|
1
|
|||||||
S-Protein
(total)
|
1
|
4
|
1
|
|||||||
S-Sodium
|
1
|
4
|
1
|
|||||||
S-TIBC
|
||||||||||
S-Transferrin
|
||||||||||
S-Triglycerides
|
||||||||||
S-UREA
|
1
|
4
|
1
|
|||||||
S-Uric
Acid
|
||||||||||
S-TIBC
|
||||||||||
S-Myoglobin
|
||||||||||
S-
Zinc (External Lab)
|
1
|
4
|
1
|
|||||||
S-
Copper ( External Lab )
|
1
|
4
|
4
|
|||||||
Extra
serum analyses
|
||||||||||
Urine
|
||||||||||
Creatinine
clearance
|
1
|
4
|
1
|
22
of
36
Creatinine
clearance according to customer
|
||||||||||
U-Albumin
|
||||||||||
U-Alkaline
Phosphatase
|
||||||||||
U-alpha
1 -Microglobuline
|
||||||||||
U-beta2-Microglobuline
|
||||||||||
U-Chloride
|
||||||||||
U-Creatinine
|
||||||||||
U-GGT
|
||||||||||
U-Glucose
|
||||||||||
U-LD
|
||||||||||
U-N-acetylglucosaminidase
|
||||||||||
U-Osmolality
|
||||||||||
U-Potassium
|
||||||||||
U-Pregnancy
test
|
||||||||||
U-Sediment
|
||||||||||
U-Sodium
|
||||||||||
U-Urea
|
||||||||||
Urine
Microscopy for Casts and RBC
|
1
|
1
|
||||||||
Extra
urine analysis
|
||||||||||
Extra
urine analysis
|
||||||||||
U-stix
|
||||||||||
U-Bilirubin
|
1
|
4
|
1
|
|||||||
U-Glucose
|
1
|
4
|
1
|
|||||||
U-Ketones
|
1
|
4
|
1
|
|||||||
U-Nitrite
|
1
|
4
|
1
|
|||||||
U-Opiates
|
1
|
4
|
1
|
|||||||
X-xX
|
0
|
0
|
0
|
|||||||
X-Xxxxxxx
|
0
|
0
|
1
|
|||||||
U-Red
blood cells
|
1
|
4
|
1
|
|||||||
U-Specific
Gravity
|
1
|
4
|
1
|
|||||||
U-Urobilinogen
|
1 |
4
|
1
|
|||||||
U-White
blood cells
|
1
|
4
|
1
|
|||||||
Other
analyses
|
||||||||||
X-Xxxx-XXX
|
0
|
|||||||||
X-Xxxx-XXXx/XXX0
|
1
|
|||||||||
S-B12
|
1
|
4
|
1
|
23
of
00
Xxxxxxxxxx
|
||||||||||
X-X0
|
||||||||||
X-Xxxxxxxxx
|
||||||||||
XXX
|
||||||||||
S-Folat
|
1
|
4
|
1
|
|||||||
S-FSH
( half the population)
|
1
|
|||||||||
S-fT4
|
||||||||||
S-fT3
|
||||||||||
Hbc
IgM
|
||||||||||
S-HBsAg
|
1
|
|||||||||
S-hCG
|
||||||||||
S-Helicobakter
Pylori
|
||||||||||
S-Hepatitis
A IgM
|
1
|
|||||||||
S-Insulin
|
||||||||||
S-Luteinizing
Hormone (LH)
|
||||||||||
S-Prolactine
|
||||||||||
RBC-Folat
|
||||||||||
S-Pregnancy
test
|
||||||||||
S-Sex
Hormone Binding Globuline (SHBG)
|
||||||||||
S-Testosterone
|
||||||||||
S-TSH
|
1
|
|||||||||
CSF
Analyses ( External Lab)
|
||||||||||
Zinc
|
1
(Baseline)
|
|
|
1
(Visit 6)
|
|
|||||
Copper
|
1
(Baseline)
|
|
|
1
(Visit 6)
|
|
24
of
36
TIMELINES
Timelines
|
|
Quintiles
involvement begins
|
May
2006
|
First
patient in
|
September
2006
|
Last
patient in
|
December
2006
|
Last
patient out
|
April
2007
|
Database
lock
|
May
2007
|
Availability
of all statistical outputs
|
June
2007
|
Draft
integrated clinical trial report
|
Mid
June 2007
|
Final
integrated clinical trial report
|
Mid
July 2007
|
Quintiles
involvement ends
|
August
2007
|
25
of
36
ATTACHMENT
2
BUDGET
AND PAYMENT SCHEDULE
ACTIVITY
|
|
UNIT
|
|
NUMBER
OF UNITS
|
|
COST/UNIT
|
|
TOTAL
HOURS
|
|
TOTAL
COST ($)
|
|
ASSUMPTIONS
|
|
||||||
STUDY
MATERIAL DEVELOPMENT
|
68.00
|
12,663.00
|
|||||||||||||||||
Protocol
development/review
|
Protocol
|
1.00
|
1,673.00
|
8.00
|
1,673.00
|
||||||||||||||
CRF
development/review
|
CRF
|
1.00
|
1,389.00
|
8.00
|
1,389.00
|
||||||||||||||
Study
reference manual
|
Manual
|
1.00
|
9,601.00
|
52.00
|
9,601.00
|
||||||||||||||
STUDY
START-UP
|
542.00
|
107,235.00
|
|||||||||||||||||
Kick-off
meeting
|
Meeting
|
1.00
|
20,994.00 |
120.00
|
20,994.00
|
1 Kick off meeting,
attended by PM, PA,
CTL, CTA, DM Lead,
Biostats and
Pharmacovigilance
|
|||||||||||||
Project
planning and team training
|
Study
|
1.00
|
18,827.00
|
70.00
|
18,827.00
|
||||||||||||||
Site
identification
|
Identified
site
|
13.00
|
623.92
|
41.00
|
8,111.00
|
||||||||||||||
Site
selection visits
|
Visit
|
8.00
|
2,600.75
|
104.00
|
20,806.00
|
||||||||||||||
Ethics
committee applications
|
Application
|
1.00
|
857.29
|
30.00
|
6,001.00
|
||||||||||||||
Negotiate
investigator contracts
|
Initiated
site
|
7.00
|
1,067.86
|
42.00
|
7,475.00
|
||||||||||||||
Site
initiation visits
|
Visit
|
7.00
|
3,000.71
|
105.00
|
21,005.00
|
||||||||||||||
Assemble
and ship study documents
|
Initiated
site
|
7.00
|
573.71
|
30.00
|
4,016.00
|
||||||||||||||
REGULATORY
ACTIVITIES
|
77.00
|
12,379.00
|
|||||||||||||||||
Regulatory
Support & Consulting
|
Study
month
|
14.96
|
216.02
|
16.00
|
3,232.00
|
||||||||||||||
Submission
of Regulatory Applications
|
Country
submission
|
1.00
|
8,158.00
|
55.00
|
8,158.00
|
||||||||||||||
European
Clinical Trial Directive Compliance
|
Study
|
1.00
|
989.00
|
6.00
|
989.00
|
||||||||||||||
INVESTIGATOR
MEETING
|
144.00
|
28,739.00
|
|||||||||||||||||
Meeting
planning and coordination
|
Meeting
|
1.00
|
10,414.00
|
44.00
|
10,414.00
|
1
Investigator Meeting,
attended
by PM, CTL,
CTA,
DM Lead, Pharmacovigilance
|
|||||||||||||
Meeting
travel and attendance
|
Meeting
|
1.00
|
18,325.00
|
100.00
|
18,325.00
|
||||||||||||||
CLINICAL
MONITORING & SITE MANAGEMENT
|
1,062.00
|
206,719.00
|
|||||||||||||||||
Interim
monitoring visits
|
Visit
|
49.00
|
3,132.80
|
756.00
|
153,507.00
|
||||||||||||||
Site
contact/in-house monitoring
|
Clinical
month
|
12.19
|
3,095.31
|
196.00
|
37,739.00
|
||||||||||||||
Maintenance
of study files
|
Clinical
month
|
12.19
|
1,009.57
|
91.00
|
12,309.00
|
||||||||||||||
Investigator
Payment Administration
|
Payment
|
4.06
|
778.52
|
19.00
|
3,164.00
|
Assumes
quarterly
payments
|
|||||||||||||
SITE
CLOSE-OUT
|
131.00
|
27,044.00
|
|||||||||||||||||
Close-out
visits
|
Visit
|
7.00
|
3,708.86
|
126.00
|
25,962.00
|
||||||||||||||
Study
archiving
|
Active
site
|
7.00
|
154.57
|
5.00
|
1,082.00
|
||||||||||||||
MEDICAL
SUPPORT
|
188.00
|
45,174.00
|
|||||||||||||||||
CRA
and site support
|
Study
month
|
14.96
|
3,019.34
|
188.00
|
45,174.00
|
26
of
36
PHARMACOVIGILANCE
|
383.00
|
61,142.00
|
|||||||||||||||||
Safety
database and project set-up
|
Study
|
1.00
|
18,048.00
|
94.00
|
18,048.00
|
||||||||||||||
SAE
processing
|
SAE
|
24.00
|
1,188.58
|
216.00
|
28,526.00
|
||||||||||||||
Medical
review of SAEs
|
SAE
|
24.00
|
271.71
|
24.00
|
6,521.00
|
||||||||||||||
Regulatory
reporting
|
Expedited
SAE
|
2.00
|
678.50
|
9.00
|
1,357.00
|
||||||||||||||
Investigator
alert letters
|
Alert
letter
|
28.00
|
17.68
|
4.00
|
495.00
|
||||||||||||||
Project
administration and system maintenance
|
Clinical
month
|
12.19
|
508.11
|
36.00
|
6,195.00
|
||||||||||||||
DATA
MANAGEMENT
|
961.00
|
110,588.00
|
|||||||||||||||||
Database
design and build
|
Unique
CRF
|
11.00
|
4,877.73
|
480.00
|
53,655.00
|
||||||||||||||
Database
QC
|
Patient
|
80.00
|
8.69
|
4.00
|
695.00
|
||||||||||||||
Data
monitoring
|
DCF
issued
|
81.00
|
98.05
|
97.00
|
7,942.00
|
||||||||||||||
Data
import/export
|
Import
|
10.00
|
371.10
|
34.00
|
3,711.00
|
||||||||||||||
Database
maintenance and management
|
DM
month
|
10.65
|
2,697.84
|
235.00
|
28,732.00
|
||||||||||||||
Data
coding
|
Coded
item
|
640.00
|
7.88
|
57.00
|
5,040.00
|
|
|||||||||||||
EDC
training
|
Study
|
1.00
|
10,813.00
|
54.00
|
10,813.00
|
||||||||||||||
BIOSTATISTICS
|
788.00
|
118,966.00
|
|||||||||||||||||
Consulting
and analysis plan
|
Study
|
1.00
|
25,295.00
|
162.00
|
25,295.00
|
||||||||||||||
Data
manipulation
|
Study
|
1.00
|
26,663.00
|
197.00
|
26,663.00
|
||||||||||||||
Final
tables, figures and listings
|
Output
|
105.00
|
509.54
|
391.00
|
53,502.00
|
||||||||||||||
DSMB
support
|
|
|
Study
|
1.00 |
7,958.00
|
37.50 | 7,958.00 | ||||||||||||
Biostatistical
report
|
Report
|
1.00
|
5,548.00
|
38.00
|
5,548.00
|
||||||||||||||
MEDICAL
WRITING
|
265.00
|
51,977.00
|
|||||||||||||||||
Integrated
study report
|
Report
|
1.00
|
51,977.00
|
265.00
|
51,977.00
|
||||||||||||||
PROJECT
MANAGEMENT
|
1,869.00
|
403,802.00
|
|||||||||||||||||
Project
management
|
Study
month
|
14.96
|
5,762.31
|
413.00
|
86,213.00
|
||||||||||||||
Clinical
management
|
Clinical
month
|
12.19
|
16,795.51
|
919.00
|
214,951.00
|
||||||||||||||
Client
meetings
|
Meeting
|
2.00
|
18,793.50
|
188.00
|
37,587.00
|
||||||||||||||
Client
teleconferences
|
Teleconference
|
14.96
|
766.30
|
59.00
|
11,465.00
|
||||||||||||||
Internal
team meetings
|
Study
month
|
14.96
|
3,581.58
|
290.00
|
53,586.00
|
||||||||||||||
27
of
36
CENTRAL
LABORATORIES
Services
|
Cost
(SEK)
|
Cost
(USD)
|
|||||
Screening
Costs
|
|||||||
Screening
labs
|
264,050
|
36,944
|
|||||
In-study
labs (incl post-study)
|
534,800
|
74,826
|
|||||
Administrating/Shipping
Costs
|
|||||||
Administration
Clinical Chemistry
|
28,782
|
3,643
|
|||||
Sample
kit Blood 50SEK/Kit
|
25,000
|
3,498
|
|||||
Sample
Kits CSF 50SEK/Kit
|
9,000
|
1,259
|
|||||
Total
Discount
of 5% on Professional Fees
|
861,632
-43,081
818,551
|
120,554
-6,027
114,527
|
Additional
Samples
to be analysed at Karolinska Hospital Laboratory
Services
|
Cost
(SEK)
|
Cost
(USD)
|
|||||
Sample
|
|||||||
S-Zinc
480x194SEK
|
93,120
|
13,035
|
|||||
S-Copper
480x210SEK
|
100,800
|
14,110
|
|||||
CSF-Zinc160x194SEK
|
31,040
|
4,346
|
|||||
CSF-Copper160x512SEK
|
81,920
|
11,470
|
|||||
Total
(External LAB Costs)
|
306,880
|
42,961
|
TOTAL
Quintiles
Laboratory
|
818,551
|
114,527
|
|||||
Karolinska
Laboratory (External)
|
306,880
|
42,961
|
|||||
Total
Cost
|
1,125,431
SEK
|
157,488
USD
|
TOTAL
LABOUR FEES
|
1,343,916.00
|
|||
Study
Passthroughs
|
117,980.16
|
|||
Regulatory
expenses
|
6,460.00
|
|||
Investigator
meeting expenses
|
11,100.00
|
|||
Clinical
monitoring travel
|
34,944.00
|
|||
Client/training
meeting expenses
|
37,762.00
|
|||
Translations
|
886.00
|
|||
Printing
& courier costs
|
2,217.48
|
|||
Other
expenses (specify)
|
22,624.68
|
|||
GRAND
TOTAL
|
1,461,896.16
|
Currency Exchange Rate Effective as of:
|
Wed:
l-Feb-2006
|
|||
Proposal
Currency:
|
US
Dollar
|
|||
Exchange
Rates:
|
1USD
=
|
|||
0.8257
|
EUR
|
Euro
|
||
1
|
USD
|
US
Dollar
|
||
0.5643
|
GBP
|
United Kingdom Pound
|
||
7.6182
|
SEK
|
Swedish
Krona
|
28
of
36
PAYMENT
SCHEDULE
Professional
Fees
Milestone
Payments
Milestone
|
Total
(USD)
|
|||
Signature
of LOI
|
116,083
|
|||
Signature
of GSA
|
107,513
|
|||
25%
of Patients Randomised
|
89,789
|
|||
75%
of Patients Randomised
|
89,789
|
|||
Last
Patient In Treatment Start
|
53,757
|
|||
100%
Sites Closed
|
53,752
|
|||
Quintiles
Involvement Ends
|
26,878
|
|||
Total
|
537,561
|
Monthly
Payments
Month
|
Total
(USD)
|
|||
July
2006
|
62,027
|
|||
August,
2006
|
62,027
|
|||
September,
2006
|
62,027
|
|||
October,
2006
|
62,027
|
|||
November,
2006
|
62,027
|
|||
December,
2006
|
62,027
|
|||
January,
2007
|
62,027
|
|||
February,
2007
|
62,027
|
|||
March,
2007
|
62,027
|
|||
April,
2007
|
62,027
|
|||
May,
2007
|
62,027
|
|||
June,
2007
|
62,027
|
|||
July,
2007
|
62,027
|
|||
Total
|
806.355
|
|||
Grand
Total
|
1,343,916
|
Estimated
Pass-through Expenses
Pass-through
expenses are estimated to be $117,980.16. Pass-through expenses will be invoiced
monthly based on actual
expenses incurred by Quintiles in conjunction with the services of the contract.
This will be reconciled upon final
invoice.
Third
party costs
Some
additional costs might be incurred during the course of the study, which would
be treated as pass through costs,
and invoiced to Prana Biotechnology with a 5% handling charge where
appropriate.
29
of
36
ATTACHMENT
3 TO GENERAL SERVICES AGREEMENT CLINICAL
TRIAL AGREEMENT
Made
between «INVNAME»,
having
a
place of business at [address]
(the
“Investigator”), «SITENAME»,
having
a
place of business at [address]
(the
“Institution";, [if
applicable, add «Research Company» at «RCADD»]
(the
“Research Company”) and [insert
name of Quintiles entity], having
a
place of business at
[insert
address] (“Quintiles")
representing the interests of [SPONSOR
LEGAL NAME] (the
“Sponsor”).
PROTOCOL
NUMBER:
|
|
PROTOCOL
TITLE:
|
|
PROTOCOL
DATE:
|
|
SPONSOR:
|
|
PRINCIPAL INVESTIGATOR:
|
«INVNAME»
Note:
If Investigator is not a party to the Agreement, then Investigator
must be
an actual employee of the Institution, and the following language
must be
included after the Investigator's
name: “an employee of
Institution"
|
WHEREAS,
the
Investigator and Institution [or “and Research Company”], if any, (hereafter,
jointly, the "Site”)
are willing to conduct a clinical trial (the “Study"), in accordance with the
above-referenced protocol and
any
subsequent amendments thereto (the “Protocol”) and Quintiles requests the Site
to undertake such
Study;
NOW
THEREFORE, the
following is agreed:
1. |
Quintiles
hereby appoints the Site to conduct the Study, and the Site agrees
to
ensure that the Site
and the Site's employees, agents, and staff will conduct the
Study in
accordance with the Protocol,
the terms of this agreement, including the Terms and Conditions
attached
as Attachment
A, the Payment Schedule and Budget attached as Attachment B,
and any other
the attachments
hereto, which all are incorporated by reference herein (the “Agreement”),
good clinical
practices, and all applicable laws and regulations. The Site
hereby
confirms that it has enough
time and resources to perform the Study according to the highest
quality
standards.
|
2. |
Payments
shall be made in accordance with the provisions set forth in
Attachment B,
with the last payment
being made after the Site completes all its obligations hereunder,
and
Quintiles has received
all completed case report forms (“CRFs”) and, if Quintiles requests, all
other Confidential Information
as defined in Attachment A, Section 2 (Confidential and Proprietary
Information). The Site will act as an independent contractor,
and shall
not be considered the employee or agent of Quintiles
or Sponsor. Neither Quintiles nor Sponsor shall be responsible
for any
employee benefits,
pensions, workers' compensation, withholding, or employment-related
taxes
as to the Site.
The Site acknowledges and agrees that Investigator's judgment
with respect
to Investigator's advice to and care of each subject is not affected
by
the compensation Site receives
hereunder. The parties agree that the payee designated below
is the proper
payee for this
Agreement, and that payments under this Agreement will be made
only to the
following payee (the
“Payee”):
|
30
of
36
PAYEE
NAME:
Please
note: This should
be a business name
and must match
the business name used to file for your
tax EIN or other tax
ID number
|
«PayeeName»
|
PAYEE
ADDRESS:
Please
Note: this should
be street address,
not a PO Box
|
«PayeeAddress»
_______________________________________________________
«PayeeAddress2»
_______________________________________________________
«PayeeCity»,
«PayeeState» «PayeePostal_Code»
_______________________________________________________
|
TAX
ID NUMBER
[For
Canada, Insert: GST
& PROVINCIAL TAX
IF APPLICABLE]
|
THE
TAX ID MUST EXACTLY MATCH THE PAYEE NAME INDICATED
ABOVE
_______________________________________________________
For
Canada:
GST
tax number or applicable provincial tax number
_______________________________________________________
or
Tax exempt _____________
|
If
the Payee is in the United States of America (“U.S.”), the Payee's
9
Digit
Tax Identification
Number and SSN/EIN designation will be required before any payments can
be
made under this Agreement.
[For
Canada, include “If the Payee is in Canada, the Payee's applicable tax numbers
or Tax exempt status designation will be required before any payment can be
made
under this Agreement.”]
Site
will have thirty (30) days from the receipt of final payment to dispute any
payment discrepancies
during the course of the Study.
The
parties acknowledge that the designated Payee is authorized to receive all
of
the payments for the services performed under this Agreement. If the
Investigator is not the Payee, then the Payee's
obligation to reimburse the Investigator will be determined by a separate
agreement between
Investigator and Payee, which may involve different payment amounts and
different payment
intervals than the payments made by Quintiles to the Payee. Investigator
acknowledges
that if Investigator is not the Payee, Quintiles will not pay Investigator
even
if
the Payee fails to reimburse Investigator.
3.
|
This
Agreement will become effective on the date on which it is last signed
by
the parties and shall
continue until completion or until terminated in accordance with
the
provision in Attachment A.
In the event of a conflict between the Protocol and this Agreement,
the
terms of the Agreement will govern.
|
4. |
[INSERT
ANY SPECIAL COUNTRY REQUIREMENTS, IF
APPLICABLE]
|
For
Sites in the European Union, the following language must be included due to
Data
Privacy laws
and regulations: Prior
to
and during the course of the Study, the Site and Site staff may provide
personal data relating to its investigators, Site staff or other personnel,
which may be subject
to data privacy laws or regulations. Such personal data may include names,
contact information,
work experience, qualifications, publications, resumes, educational background,
performance information, facilities, staff capabilities, and other information
relating to the Site's conduct of clinical trials. If the Site is in the
European Union, the Sponsor would be the data controller for such personal
data.
The Site hereby consents to the use and processing of its personal data and
the
personal data of its investigators, staff and personnel for the following
purposes: a) the conduct of the Study; b) review by governmental or regulatory
agencies, Sponsor,
Quintiles, and their agents, and affiliates; c) satisfying legal or regulatory
requirements; and,
d)
storage in databases for use in selecting sites in future clinical trials.
The
Site further consents
to the transfer of such data to countries other than the Site's own country,
even though data protection may not exist or be as developed in those countries
as in the Site's own country. The
Site
agrees to ensure that its staff and personnel are aware that their personal
data
will be used,
processed and stored for above-stated purposes and may potentially be
transferred to other
countries and that they consent to such use, storage and transfer.”
31
of
36
For
Sites in the U.S. insert the following provision: “Institution
and Principal Investigator agree that their judgment with respect to the advice
and care of each patient will not be affected by the compensation
they receive from this Agreement, that such compensation does not exceed the
fair
market value of the services they are providing, and that no payments are being
provided to them
for
the purpose of inducing them to purchase or prescribe any drugs, devices or
products. If the
Sponsor or Quintiles provides any free products or items for use in the Study,
Institution and Principal Investigator agree that they will not xxxx any
patient, insurer or governmental agency, or any other third party, for such
free
products or items. Institution and Principal Investigator agree that they will
not xxxx any patient, insurer, or governmental agency for any visits, services
or expenses
incurred during the Study for which they have received compensation from
Quintiles or Sponsor,
or which are not part of the ordinary care they would normally provide for
the
patient.”
ACKNOWLEDGED
AND AGREED BY [Insert
legal name of Quintiles entity]
By:
|
|||
Title:
|
|||
Date:
|
|||
ACKNOWLEDGED
AND AGREED BY THE PRINCIPAL INVESTIGATOR:
|
|||
«INVNAME»
|
|||
Date:
|
|||
ACKNOWLEDGED
AND AGREED BY [Insert
legal name of Institution], if
applicable:
|
|||
By:
|
|||
Title
(must be authorized to sign on Institution's behalf):
___________________
|
|||
Date:
|
|||
ACKNOWLEDGED
AND AGREED BY [Insert
legal name of Research Company], if
applicable:
|
|||
By:
|
|||
Title
(must be authorized to sign on Research Company's behalf):
___________________
|
|||
Date:
|
32
of
36
ATTACHMENT
A
TERMS
AND CONDITIONS
1) Conduct
of the Study. The
parties to the attached agreement (the “Agreement”) agree that the clinical
trial described therein (the “Study”) will be performed in strict accordance
with the applicable protocol, and any subsequent amendments thereto (the
“Protocol”), applicable federal, state, and local laws, regulations and
guidelines, and good clinical practices (“GCPs”). The Principal Investigator
(the “Investigator”) shall review all case report forms (“CRFs”) to ensure their
accuracy and completeness, shall review and understand the information in the
investigator's brochure or device labeling instructions, as applicable, shall
ensure that all informed consent requirements are met, and shall ensure that
all
required reviews and approvals (or favorable opinions) by applicable regulatory
authorities and Institutional Review Boards (“IRBs”) or Independent Ethics
Committees (“lECs”) are obtained. The Investigator and the institution(s) (the
“Institution”), if any, conducting the trial (jointly, the “Site”) agree to
ensure that all clinical data are accurate, complete, and legible. The Site
shall promptly and fully produce all data, records and information relating
to
the Study to Quintiles and the sponsor of the Study (the “Sponsor”) and their
representatives during normal business hours, and shall assist them in promptly
resolving any questions and in performing audits or reviews of original subject
records, reports, or data sources. The Site agrees to cooperate with the
representatives of Quintiles and Sponsor who visit the Site, and the Site agrees
to ensure that the employees, agents and representatives of the Site do not
harass, or otherwise create a hostile working environment for, such
representatives. The Site shall use the drug, device, product or compound being
tested (the “Investigational Product”), and any comparator products provided in
connection with the Study, solely for the purpose of properly completing the
Study and shall maintain all Investigational Product and any comparator products
in a locked, secured area at all times. Upon completion or termination of the
Study, the Site shall return all unused Investigational Product, comparator
products, equipment, and materials and all Confidential Information (as defined
below).
2) Confidential
and Proprietary Information. All
information (including, but not limited to, documents, descriptions, data,
CRFs,
photographs, videos and instructions), and materials (including, but not limited
to, the Investigational Product and comparator products), provided to the Site
by Quintiles, Sponsor, or their agents, (whether verbal, written or electronic),
and all data, reports and information, relating to the Study or its progress
(hereinafter, the “Confidential Information”) shall be the property of Sponsor.
The Site shall keep the Confidential Information strictly confidential and
shall
disclose it only to its employees involved in conducting the Study on a
need-to-know basis. These confidentiality obligations shall continue until
ten
(10) years after completion of the Study, but shall not apply to Confidential
Information to the extent that it: a) is or becomes publicly available through
no fault of the Site; b) is disclosed to the Site by a third party not subject
to any obligation of confidence; c) must be disclosed to IRBs, lECs, or
applicable regulatory authorities; d) must be included in any subject's informed
consent form; e) is published in accordance with Article 3 herein; or, f) is
required to be disclosed by applicable law. The existing inventions and
technologies of Sponsor, Quintiles, or the Site are their separate property
and
are not affected by this Agreement. Sponsor shall have exclusive ownership
of
any inventions or discoveries arising in whole or in part from Confidential
Information or arising as a result of the Study. The Site will, at Sponsor's
expense, execute any documents and give any testimony necessary for Sponsor
to
obtain patents in any country or to otherwise protect Sponsor's interests in
such inventions or discoveries. . The Site agrees to comply with any applicable
data privacy or data protection legislation of the country in which the data
originated.
3) Publication.
At
least
sixty (60) days prior to submitting or presenting a manuscript or other
materials relating to the Study to a publisher, reviewer, or other outside
persons, the Site shall provide to Sponsor a copy of all such manuscripts and
materials, and allow Sponsor sixty (60) days to review and comment on them.
If
the Sponsor requests, the Site shall remove any Confidential Information (other
than Study results) prior to submitting or presenting the materials. No party
hereto shall use any other party's name, or Sponsor's name, in connection with
any advertising, publication or promotion without prior written
permission.
33
of
36
4) Inspection
and Debarment. When
given reasonable notice, the Site agrees to allow authorized Quintiles, Sponsor
or regulatory authority personnel direct access to the Site's records relating
to the Study, including subject medical records, for monitoring, auditing,
and
inspection purposes. The Site shall immediately notify Quintiles of, and provide
Quintiles copies of, any inquiries, correspondence or communications to or
from
any governmental or regulatory authority relating to the Study, including,
but
not limited to, requests for inspection of the Site's facilities, and the Site
shall permit Quintiles and Sponsor to attend any such inspections. The Site will
make reasonable efforts to separate, and not disclose, all confidential
materials that are not required to be disclosed during such inspections. The
Investigator and the Institution, if any, shall be jointly responsible for
maintaining essential Study documents for the time and in the manner specified
by current good clinical practice (“GCP”) guidelines, local laws, and Sponsor
requirements and shall take measures to prevent accidental or premature
destruction of these documents. If the Investigator leaves an institution,
then
responsibility for maintaining Study records shall be determined in accordance
with applicable regulations. If an investigator or sub-investigator leaves
an
institution or otherwise changes addresses, he or she shall promptly notify
Sponsor and Quintiles of his or her new address. The Site represents and
warrants that neither it, nor any of its employees, agents or other persons
performing the Study under its direction, has been debarred, disqualified or
banned from conducting clinical trials or is under investigation by any
regulatory authority for debarment or any similar regulatory action in any
country, and the Site shall notify Quintiles immediately if any such
investigation, disqualification, debarment, or ban occurs.
5) Termination.
Quintiles
may terminate this Agreement effective immediately upon written notice. The
Site
may terminate upon written notice if circumstances beyond the Site's reasonable
control prevent the Site from completing the Study, or if the Site reasonably
determines that it is unsafe to continue the Study. Upon receipt of notice
of
termination, the Site shall immediately cease any subject recruitment, follow
the specified termination procedures, ensure that any required subject follow-up
procedures are completed, and make all reasonable efforts to minimize further
costs, and Quintiles shall make a final payment for visits or milestones
properly performed pursuant to this Agreement in the amounts specified in the
Attachment B; provided, however, that ten percent (10%) of this final payment
will be withheld until final acceptance by Sponsor of all subject CRF pages
and
all data clarifications issued and satisfaction of ail other applicable
conditions set forth in the Agreement. Neither Quintiles nor Sponsor shall
be
responsible to the Site for any lost profits, lost opportunities, or other
consequential damages. If a material breach of this Agreement appears to have
occurred and termination may be required, then, except to the extent that
subject safety may be jeopardized, Quintiles may suspend performance of all
or
part of this Agreement, including, but not limited to, subject
enrollment.
6) Claims
and Disclaimers. The
Site
shall promptly notify Quintiles and Sponsor in writing of any claim of illness
or injury actually or allegedly due to an adverse reaction to the
Investigational Product and allow Sponsor to handle such claim (including
settlement negotiations), and shall cooperate fully with Sponsor in its handling
of the claim. Quintiles
expressly disclaims any liability in connection with the Investigational
Product, including any liability for any product claim arising out of a
condition caused by or allegedly caused by the administration of such product
except to the extent that such liability is caused by the negligence, willful
misconduct or breach of this Agreement by Quintiles. Neither
Quintiles nor Sponsor will be responsible for, and the Site agrees, to the
extent allowed by law, to indemnify and hold them harmless from, any loss,
claim, cost (including reasonable attorney fees) or demand arising from any
injuries or damages resulting from the Site's negligence, failure to adhere
to
the Protocol, failure to obtain informed consent, unauthorized warranties,
breach of this Agreement or willful misconduct. If the Site is in the U.S.,
it
shall maintain professional liability insurance coverage with limits of not
less
than two hundred thousand dollars ($200,000 USD) per occurrence and four hundred
thousand dollars ($400,000 USD) aggregate throughout the term of this Study
if
the policy is an occurrence policy, and for an additional five (5) years after
completion of the Study if such insurance is a claims-made policy, and will
provide, upon request, a certificate of insurance. If the Site is in Canada,
the
Investigator shall obtain, and maintain in good standing, membership with the
Canadian Medical Protective Association. If the Site is outside of the U.S.
or
Canada, it shall maintain a commercially reasonable level of insurance, and,
upon request, shall provide a certificate of insurance to Quintiles; or,
alternatively, if applicable insurance is provided by a governmental agency,
the
Site shall satisfy all requirements necessary to remain eligible for such
governmental insurance during the Study.
34
of
36
7) Financial
Disclosure. If
Quintiles or Sponsor provides financial disclosure forms to the Site pursuant
to
U.S. regulatory requirements, then the Site agrees that, for each listed or
identified investigator or subinvestigator who is directly involved in the
treatment or evaluation of research subjects, it shall promptly return to
Quintiles a financial disclosure form that has been completed and signed by
such
investigator or subinvestigator, which shall disclose any applicable interests
held by those investigators or subinvestigators or their spouses or dependent
children. Quintiles may withhold payments if it does not receive a completed
form from each such investigator and subinvestigator. The Site shall ensure
that
all such forms are promptly updated as needed to maintain their accuracy and
completeness during the Study and for one (1) year after its completion. The
Site agrees that the completed forms may be subject to review by governmental
or
regulatory agencies, Sponsor, Quintiles, and their agents, and the Site consents
to such review. The Site further consents to the transfer of its financial
disclosure data to the Sponsor's country of origin, and to the U.S. if the
Site
is outside of the U.S., even though data protection may not exist or be as
developed in those countries as in the Site's own country.
8) Shipping
of Dangerous Goods and Infectious Materials. The
shipment of dangerous goods and infectious materials (including infectious
subject specimens) is subject to local, national, and international laws and
regulations. The Site is responsible for ensuring that each individual who
packages or handles any dangerous goods or infectious materials for shipping
from the Site complies with all applicable laws and regulations.
9) Additional
Requirements for Medical Device Studies. If
the
Study will be used in support of an FDA investigational device exemption (IDE)
application, then, in addition to all other provisions of this Agreement, the
requirements of this Section shall apply. The Investigator agrees to perform
the
Study in accordance with 21 CFR Section 812, including, but not limited to,
Sections 812. 25, 812.100, 812.110, 812. 140, 812.145, and 812.150, and with
the
investigational plan as defined in Section 812.25, and with all conditions
of
approval imposed by the reviewing IRB or IEC, or FDA. The Investigator shall
supervise all testing of the device involving human subjects. If the Study
is
terminated, the Investigator shall dispose of or return the device as directed
by Quintiles or Sponsor, unless such disposal or return would jeopardize the
rights, safety or welfare of a subject.
10) Additional
Contractual Provisions. This
Agreement, including these Terms and Conditions, constitutes the sole and
complete agreement between the parties and replaces all other written and oral
agreements relating to the Study. No amendments or modifications to this
Agreement shall be valid unless in writing and signed by all the parties.
Failure to enforce any term of this Agreement shall not constitute a waiver
of
such term. If any part of this Agreement is found to be unenforceable, the
rest
of this Agreement will remain in effect. This Agreement shall be binding upon
the parties and their successors and assigns. The Site shall not assign or
transfer any rights or obligations under this Agreement without the written
consent of Quintiles. Upon Sponsor's request, Quintiles may assign this
Agreement to Sponsor or to a third party, and Quintiles shall not be responsible
for any obligations or liabilities under this Agreement that arise after the
date of the assignment, and the Site hereby consents to such an assignment.
Site
will be given prompt notice of such assignment by the assignee. The terms of
this Agreement that contain obligations or rights that extend beyond the
completion of the Study shall survive termination or completion of this
Agreement. This Agreement shall be interpreted under the laws of the state
or
province and country in which such Site conducts the Study.
35
of
36
Attachment
4
Certificate
of Insurance
36
of
36
Secure
Enterprises Pty Ltd as Trustees for the Strathearn Unit Trust
ACN
060 973 908 ABN 94 695 040
625
AFSL
229831
CERTIFICATE
OF CURRENCY
We
confirm that cover has been bound by Lloyds of London (Newline Syndicate) as
outlined below.
CLASS
OF INSURANCE:
No
Fault
Compensation Insurance for Clinical Trials and/or Human Volunteer Studies
Insurance
INSURED:
PRANA
BIOTECHNOLOGY LIMITED
The
definition of ‘Insured’ extends to include the following:
a)
|
any
director or partner of the Insured whilst acting in their respective
capacities for the Insured;
|
b)
|
any
employee of the Insured including Medical Persons but only whilst
acting
within the scope of their duties;
|
c)
|
any
past employee who acted for the Insured and who agrees to be bound
by the
terms of this policy;
|
d)
|
any
sub contractor doctor consultant physician hospital or contract research
organization or nurse who will be performing work for the Insured
in
respect of a Trial covered by this
Policy;
|
e)
|
any
Ethics Committee or its members that has approved a Trial which is
the
subject of this Policy;
|
but
only
in respect of Claims arising out of The Trial covered by this
Policy.
SCOPE
OF COVER
The
Company shall indemnify the Insured against all sums in excess of the Deductible
that the Insured shall become liable to pay as damages or compensation and
claimants costs and expenses in respect of any Claim made by Research Subjects
for Bodily Injury caused by an Occurrence happening after the Retroactive Date
within the Policy Territory and arising out of the Business undertaken by or
on
behalf of the Insured
LIMIT
OF INDEMNITY:
|
AUD$5,000,000
any one claim and in the aggregate
|
EXCESS:
|
AUD$25,000
each and every claim
|
PERIOD
OF INSURANCE:
|
From
|
:
|
23rd
Nov 2005
|
To
|
:
|
23rd
Nov 2006
|
Both
days
at 16:00 Hours Local Standard Time.
|
Ÿ
With effect from 14th August 2006 you cover is endorsed
to include the following
changes.
|
|
/s/
STRATHEARN INSURANCE BROKERS
|
|
STRATHEARN
INSURANCE BROKERS
|
Secure
Enterprises Pty Ltd as Trustees for the Strathearn Unit Trust
ACN
060 973 908 ABN 94 695 040
625
AFSL
229831
It
is
hereby noted and agreed that with effect from the 14th
August
2006, cover is extended to include Liability arising from Protocol PBT2-201-EURO
ENDORSEMENT
ATTACHING TO AND FORMING PART OF THIS POLICY.
With
effect from the 27th
October
2006 your cover is endorsed to include the following changes.
LEGAL
LIABILITY EXTENSION
In
the
event of a Research Subject not being offered or not agreeing to any
compensation being determined in accordance with the Conditions of Compensation
or refusing to accept the award of an Independent Lawyer the Company shall
indemnify the Insured for all sums for which the Insured shall become legally
liable (including the costs and expenses awarded to the Research Subject) as
damages for Bodily Injury caused by the Research Subject’s participation in a
Trial (but excluding any liability which attaches by virtue of any contract
or
agreement and which would not have applied in the absence of such contract
or
agreement) in accordance with the law applicable in the country where the Claim
is made and subject to the Limits of Indemnity stated in the
Schedule
Worldwide
excluding U.S.A and/or Canada
|
RETROACTIVE
DATE:
23rd
November
2004
INSURERS:
Lloyds
of
London (Newline syndicate number 1218)
Suite
5/4
The London Underwriting Centre
0
Xxxxxxx
Xxxxx, Xxxxxxx Xxxx
Xxxxxx
XX0X 0XX
Signed
by and on behalf of Strathearn Insurance Brokers
|
|
/s/
STRATHEARN INSURANCE BROKERS
|
|
Dated:
27-10-06
|
STRATHEARN
INSURANCE BROKERS
|
Elkington Xxxxxx Xxxxxxxxx
|
Xxxxx
0, 000 Xxxxxxxx Xxxxxx,
|
Telephone
|
:
|
(00)
0000 0000
|
Insurance
Brokers Pty Ltd
|
Xxxxxxxxxx,
Xxxxxxxx 0000
|
Facsimile
|
:
|
(00)
0000 0000
|
AFS
Licence No. 246986 ABN 31 009 179 640
|
Email
|
:
|
xxx@xxxxxxxxxxxx.xxx.xx
|
|
Website
|
:
|
xxx.xxxxxxxxxxxx.xxx.xx
|
Ms
K Xxxx
|
TAX
INVOICE
I0537953
|
Prana
Biotechnology Limited
|
|
Xxxxx
0
|
|
000
Xxxxx Xxxxxx
|
|
XXXXXXXXX
XXX 0000
|
Invoice
Date
|
:
|
07.04.2006
|
Premium
|
2,000.00
|
Our
Reference
|
:
|
EBM
XXX P0485 0094642/006
|
Stamp
Duty
|
220.00
|
Invoice
No
|
:
|
I0537953
|
||
Class
|
:
|
Broadform
Liability
|
||
Broker
Fee
|
50.00
|
|||
Placement
with/by
|
:
|
CGU
INSURANCE
|
||
SubTotal
Excl. GST
|
2,270.00
|
|||
Policy
No
|
:
|
10M1091762
|
GST
Total
|
205.00
|
|
|
|
||
Period
|
:
|
30.04.2006
to 30.04.2007
|
Total
Amount
|
$
2,475.00
|
Your
account is managed by:
Xxxx
Xxxxxxxx
|
xxxxx@xxxxxxxxxxxx.xxx.xx
|
Xxxxx
Xxxxx
|
xxxxxx@xxxxxxxxxxxx.xxx.xx
|
TRANSACTION
DESCRIPTION
**
RENEWAL **
INSURED: Prana
Biotechnology Limited
|
|
BRIEF
DESCRIPTION:
|
[SEAL]
|
Public
Liability $20,000,000
|
IMPORTANT
NOTICES
1.
|
We
are confirming your instructions or inviting Renewal and advising
cover
has been arranged. To ensure continuity of cover, please forward
your
remittance within 14 days.
|
2.
|
The
Insured has a legal obligation to reveal to the Insures any material
fact
which might affect their judgement in acceptance of the insurance
and/or
assessing the premium. Failure to do so could void any contract from
inception. Claims must be notified immediately as late notification
may
cause prejudice in some instances.
|
-------tear
here-------------------------------------------------------------------------------------------------------------------------------------
Please
return this with your remittance to:
|
Our
Ref
|
:
|
EBM XXX P0485 0094642/006
|
||
EBM
Insurance Brokers
|
Invoice
No
|
:
|
I0537953
|
||
Xxxxx
0, 000 Xxxxxxxx Xxxxxx
|
Client
Name
|
:
|
Prana
Biotechnology Limited
|
||
XXXXXXXXXX
XXX 0000
|
Contact
|
:
|
Xxxx
Xxxxxxxx
|
||
|
Xxxxxx Code:
Reference:
|
13581
23152204850053795368
|
Brief
Description
Total
Amount
|
:
$
|
Liab
$20,000,000 2006/07
2,475.00
|
Please
see overleaf for payment options.
COVER
SUMMARY
CLIENT
|
PLACEMENT
WITH/BY
|
07.04.06
|
|
Ms
K Xxxx
|
CGU
Insurance Limited
|
||
Prana
Biotechnology Limited
|
XX
Xxx 000X
|
||
Xxxxx
0
|
XXXXXXXXX
XXX 0000
|
||
000
Xxxxx Xxxxxx
|
|||
XXXXXXXXX
XXX 0000
|
Your
account is managed by:
|
|
Xxxx
Xxxxxxxx
|
xxxxx@xxxxxxxxxxxx.xxx.xx
|
Xxxxx
Xxxxx
|
xxxxxx@xxxxxxxxxxxx.xxx.xx
|
CLASS
OF RISK
|
PERIOD
OF INSURANCE
|
||
Broadform
Liability
|
From:
|
4.00
pm on 30th April 2006
|
|
To
:
|
4.00
pm on 30th April 2007
|
||
Policy
No : 10M1091762
|
Our
Ref :
|
EBM
XXX P0485 0094642/006
|
COVER
SUMMARY
|
This
summary is not a policy document and is only an outline of the cover.
The
terms conditions and limitations of the Insurer’s policy shall prevail at
all times.
|
INSURED
|
:
|
Prana
Biotechnology Limited
|
INTEREST
INSURED
|
:
|
The
Insurer will indemnify you against:
|
1.
Public Liability; or
|
||
2.
Products Liability;
|
||
if
shown in the Schedule as an insured item.
|
||
DEFINITIONS
|
:
|
PUBLIC
LIABILITY means:
|
Your
legal liability to pay damages for an Occurrence (and for consequential
loss caused by the Occurrence), in the course of Your Business, but
excludes products Liability.
|
||
PRODUCTS
LIABILITY means:
|
||
Your
legal liability to pay damages for an Occurrence (and for consequential
loss caused by the Occurrence), caused by an Unknown Defect in Your
Products, but excludes Public Liability
|
||
OCCURRENCE
means:
|
||
Personal
Injury or Damage to Property that:
|
||
1. is
neither intended nor expected from the standpoint of a reasonable
person
in your position:
|
||
2. is
caused by an Event; and
|
||
3. occurs:
|
||
(a)
within the Geographical Limits
|
||
(b)
during the Period of Insurance
|
COVER
SUMMARY
|
Page
No. 2
|
Prana
Biotechnology Limited
|
(EBM
XXX P0485 0094642/006)
|
GEOGRAPHICAL
LIMITS
|
:
|
Worldwide
excluding the United States of America and Canada and any state or
territory incorporated in, or administered by, or from, either USA
or
Canada.
|
BUSINESS
|
:
|
A) Testing
and Marketing a cure for Alzheimers and similar age related
diseases
|
B) Property
owners and/or occupiers
|
||
LIMITS
OF LIABILITY
|
:
|
(a) Public
Liability $20,000,000 any one occurrence
|
(b) Products
Liability NOT INSURED
|
||
EXCESS
|
:
|
$500
each Occurrence for Property Damage Claims
|
ENDORSEMENT
|
:
|
We
will not indemnify you against any liability in connection with any
events
or business activities other than as office occupiers and office
administration at and from the premises situated at the 4 listed
locations.
|
MAJOR
EXCLUSIONS
|
:
|
Employer’s
Liability (Workers’ Compensation or accident compensation legislation or
any industrial award, agreement or determination)
|
Discrimination
and harassment
|
||
Assault
and battery
|
||
Waiver
of rights
|
||
Contractual
Liability
|
||
Intentionally
or recklessly caused injury or damage
|
||
Faulty
Workmanship
|
||
Product
recall or repair
|
||
Reinstatement,
repair or replacement of your products
|
||
Loss
of use of Property from delay in or lack of performance by you or
inadequacy of your products
|
||
Aircraft
products
|
||
Watercraft
exceeding 8 metres, Hovercraft and Aircraft and areas used for Aircraft
Vehicles requiring registration, other than as a “Working
Tool”
|
||
Earthquake,
civil commotion and the like Pollution
|
||
Asbestos
|
||
Building
and demolition (other than for buildings owned or occupied by you
where
the total cost of alterations does not exceed $ 1,000)
|
||
Vibration
or removal or weakening of, or interference with, support to land,
buildings or any other property of support
|
||
Treatment,
design and professional risks
|
||
Medical/Clinical
testing
|
||
Libel
and slander made prior to commencement of this insurance, or made
knowing
it’s falsity or related to publishing, advertising, broadcasting or
telecasting activities
|
||
Fines
and punitive damages
|
||
Foreign
non-admitted cover
|
||
Vehicle
mounted cranes
|
COVER
SUMMARY
|
Page
No. 3
|
Prana
Biotechnology Limited
(EBM
XXX P0485 0094642/006)
|
Radioactive
contamination
Electronic
date recognition
War
Terrorism
|
TERRORISM
INSURANCE XXX 0000 - APPLICATION TO THIS POLICY
(This
application is to take effect with all business with an inception date on or
after 1 October 2003).
The
Insurers of this policy have determined that this policy (or part of it) is
a
policy to which the Terrorism Insurance Xxx 0000 applies.
They
have
reinsured their liability under the Act with the Commonwealth Government
reinsurer, The Australian Reinsurance Pool Corporation (ARPC).
As
a
consequent, they are required to pay a premium to ARPC and that amount (together
with the costs of that part of the cover provided by them and administrative
costs associated with the legislation) is reflected in the premium charged
to
you.
As
with
any other part of the premium, it is subject to government taxes and charges
such as GST, Stamp Duty and where applicable Fire Service Levy.
INSURER
|
POLICY
NUMBER
|
PROPORTION
|
CGU
Insurance Limited
|
10M1091762
|
100.0000%
|
A.B.N.
27 004 478 371
|
||
CGU
Centre, Xxxxx 0, 000 XxXxxxx Xxxxxx
|
||
XXXXXXXXX
XXX 0000
|