Exhibit 3.2(cc)
CLINICAL MASTER SERVICE AGREEMENT
This Agreement is made this 28th day of September, 2005 by and between ChemGenex
Pharmaceuticals Limited with business offices located at ▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇
▇, ▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇ (hereinafter referred to as "Sponsor") and Inveresk
Research Limited, with business offices located at Beechwood (Suite 2), Grove
Park, White Waltham, ▇▇▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇, ▇▇▇ ▇▇▇ and its affiliates
(hereinafter referred to as "Inveresk").
WHEREAS, Sponsor is engaged in research and development of pharmaceutical
products; and,
WHEREAS, Inveresk is engaged in the business of clinical trials management,
database management and statistical analysis of clinical research and product
development for pharmaceutical and diagnostic products; and,
WHEREAS, both Sponsor and Inveresk desire to enter into a Clinical Master
Service Agreement for the purpose of delineating in advance the terms and
conditions which will regulate the relationship between the parties and define
the conditions under which Sponsor would award to Inveresk, and Inveresk would
accept from and perform for Sponsor certain services.
Now, therefore, in consideration of the mutual covenants of the parties
hereinafter contained and for good and valuable consideration, the parties
hereto agree as follows:
I. DEFINITIONS
1.1: AFFILIATE: shall mean any corporation or non-corporate business entity
(e.g. division, subsidiary, etc.) that, directly or indirectly, through one or
more intermediates, directly or indirectly controls, is controlled by, or is
under common control with the party to this Agreement.
1.2: CLINICAL MASTER SERVICE AGREEMENT (or "Agreement"): shall refer to the
terms and conditions contained in this document as agreed by the parties hereto.
1.3: PROTOCOL: shall refer to the particular protocol prepared for the Study and
under which the services described in the Task Order ("Attachment A: Protocol")
are to be performed.
1.4: SERVICES (or "SCOPE OF WORK"): shall refer to the particular tasks to be
performed by Inveresk as set out in the Task Order (by "Attachment B: Scope of
Work" affixed to the Task Order) and any documents attached thereto.
1.5: STUDY: shall refer to the clinical trial of the pharmaceutical identified
in the Task Order (by study drug name or protocol number).
1.6: TASK ORDER: shall refer to the written agreement between Sponsor and
Inveresk which sets out with specificity the Services to be performed in
connection with a particular Study or program, including the time line for the
performance of the Services, the costs associated with the Services, the
schedule of payments for the performance of the Services and specifically
incorporates by reference the terms and conditions of this Clinical Master
Service Agreement.
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Draft Master Service Agreement 12/09/05
II. GENERAL TERMS
2.1: From time to time, Inveresk may provide Sponsor certain clinical research
services pursuant to the terms of this Agreement. Prior to the commencement of
such services, Inveresk and Sponsor shall enter into a Task Order describing
either the specific obligations transferred by Sponsor to Inveresk or other work
undertaken by Inveresk for or on behalf of Sponsor in the performance of a
particular trial or study sponsored or conducted by Sponsor. Each Task Order
shall constitute a separate agreement, provided the terms of this Agreement
shall be incorporated by reference into each Task Order. No Task Order shall be
effective until it is accepted in writing by both Sponsor and Inveresk. The
agreed upon form for Task Orders is attached hereto as Exhibit A.
2.2: The existence of this Agreement shall not preclude or limit the ability of
the parties to enter into independent contracts outside of this Agreement when
the nature of the work and particular program requirements make the entry into
independent and freestanding contract both necessary and reasonable. The
existence of any contractual relationship outside of this Agreement shall have
no effect on the validity of this Agreement or any Task Order entered in
accordance with its terms.
2.3: There shall be no limit to the number of Task Orders that may be entered
into and regulated by the terms and conditions of this Agreement. Each Task
Order shall constitute a unique agreement and shall stand alone with respect to
any other Task Order entered under this Agreement. The performance of
obligations under any one Task Order shall not affect, and shall at all times be
unrelated to, the performance of any other Task Order entered under this
Agreement.
III. SCOPE OF WORK
3.1: Inveresk will perform the specific tasks reflected in each individual Task
Order in accordance with the terms and conditions contained herein, as set out
in each Task Order and in accordance with all applicable laws and Food and Drug
Administration ("FDA") laws and regulations.
3.2: Changes in the Scope of Work or assumptions delineated in a particular Task
Order will be negotiated in good faith and approved in writing in advance by
both parties in the form of an executed Change in Scope ("CIS") or by written
authorization from the Sponsor to proceed with such additional work prior to
final agreement and execution of a CIS. Changes that may result in a CIS
include, but are not limited to, a change in the contracted assumptions,
responsibilities or timeline. Each CIS will act as a modification to the
respective Task Order and clearly define the revised Scope of Work and the
resulting budgetary effect on that Task Order. Modifications to specific Task
Orders shall not affect this Agreement or prior, current or future Task Orders
unless it is the express written intent of the parties that the modifications do
so.
3.3: In the event of a conflict between the terms of this Agreement, or the Task
Orders, the terms of the individual Task Order shall govern first followed by
this Agreement.
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Clinical Master Service Agreement 28th September 2005
3.4: If services are extended past the timeline established in a Task Order,
items that are quoted in unit costs may be revisited later and possibly repriced
by Inveresk to match then current market rates.
IV. PERIOD OF THE AGREEMENT
4.1: This Clinical Master Service Agreement shall take effect on the day of
signing of this Agreement and shall remain in effect until the 31st day of May
2008 unless earlier terminated by the parties. Notwithstanding the expiration of
this Agreement, the terms and conditions of this Agreement and each applicable
Task Order shall continue to apply and the parties shall continue to perform
with respect to each Study in which the parties have executed a Task Order prior
to the expiration of this Agreement. Nothing herein shall be construed to
prohibit the parties from entering into a new Clinical Master Service Agreement
upon the completion of this Agreement.
4.2: Certain provisions of this Agreement may survive its termination but only
as necessary to allow completion of any particular Task Order and for the
limited purpose of regulating the obligations and duties of the parties with
respect to particular Task Order obligations that extend beyond contract
termination.
V. PAYMENT AND BUDGET
5.1: Each Task Order shall contain an Estimated Budget for the performance of
the Task Order as well as additional terms and conditions relating to the
Estimated Budget, all of which shall be attached to the Task Order as Attachment
"C" and entitled "Estimated Budget-Terms."
5.2: Sponsor shall make payment to Inveresk in accordance with the "Schedule of
Payments-Terms" attached to the Task Order and labeled Attachment "D."
5.3: Inveresk shall provide to Sponsor a separate invoice for each Task Order
active at that time, which summarizes the services performed during the invoice
period. Sponsor shall pay each invoice within thirty (30) days of the date of
the invoice. In the event a dispute arises between the parties regarding any
portion of any invoice, Sponsor shall pay all undisputed portions of the
invoice(s) while withholding payment of the disputed portions pending good faith
resolution by the parties.
5.4: The parties agree that, because each Task Order shall constitute a unique
agreement, payments due under other Task Orders shall not be set off or applied
to sums due as a result of the performance of other Task Orders without the
prior written consent of the other party.
5.5: Sponsor will reimburse Inveresk on a pass through basis for all reasonable
travel and other reasonable out-of-pocket expenses actually incurred by Inveresk
in connection with the performance of Task Order Services including, but not
limited to, printing, shipping and copying costs unless Inveresk expressly
agrees in advance to waive such reimbursement. Sponsor will reimburse Inveresk
for all such expenses within thirty (30) days of invoice date by remittance to
Sponsor of monthly itemized statements covering such expenses.
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5.6: Sponsor shall be responsible for the financial funding of all services
related to any Task Order. The parties will work in good faith to negotiate a
payment schedule for each Task Order that shall keep Inveresk in a cash neutral
position at all times during the execution of the Services.
5.7: If Inveresk is responsible for administering investigator payments, Sponsor
shall be responsible for the cost of the actual per patient fees to
investigators and other such fees that may be approved in writing by Sponsor.
Such sums shall be paid to investigators by Inveresk making use of funds
provided by Sponsor in advance for that purpose. Inveresk shall have no
liability for any failure to make payments if required funding is not provided
by the Sponsor. Each Clinical Trial Agreement with investigators shall contain a
statement to that effect. Inveresk shall have no duty to pursue the collection
of fees paid to investigators in accordance with Clinical Trial Agreements in
the event the investigator fails to earn such fees.
5.8: Sponsor and Inveresk agree that neither Sponsor nor Inveresk should receive
a benefit or a detriment from differences arising form variations between
foreign currency exchange rates for the currencies used for this project
("Original Rates") and those existing at the dates of the actual invoices, as
published in the Wall Street Journal. If such a difference is larger than +/- 5%
("Difference"), Sponsor and Inveresk have the right to request a re-evaluation
of the future billing rates based on the work performed by Inveresk after such a
difference is observed.
5.9: Any Task Order under this Agreement may be subject to an inflationary
adjustment review every twelve (12) months. Any inflationary adjustment will be
negotiated on an annual basis and in good faith between the parties.
5.10: In the case of late payment by Sponsor, interest may be charged at the
rate of five (5% ) percent over the European interbank rate, calculated on a
daily basis on balances outstanding. See Section 5.3 for the terms of delinquent
payments. All invoices paid within 30 days from date of receipt of invoice are
not considered delinquent and will not be subject to any interest charges.
5.11: Where applicable, if there are amounts payable by Sponsor to Inveresk
under this Agreement that create Value Added Tax, the amount of such tax shall
also be paid by Sponsor to Inveresk on receipt of the relevant invoice.
VI. CONFIDENTIALITY
6.1: During the effective term of this Agreement the parties may exchange
confidential or proprietary information. In each case the party disclosing the
confidential information will be the Disclosing Party ("Disclosing Party") and
the recipient of the information will be the Recipient ("Recipient"). The Study
protocol, case report forms, clinical data, inventions, products, product
development plans, standard operating procedures, costs, profits, markets,
sales, services, investigator lists, key personnel, pricing policies, billing
rates, operational methods, trade secrets, know-how, scientific and technical
processes, other business affairs and methods, plans for future developments,
and other information not readily available to the public relating to the
Disclosing Party or to any aspect of the Disclosing Party's or any affiliate of
the Disclosing Party's business (collectively, the "Confidential Information")
shall be treated as confidential information.
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6.2: Recipient agrees to maintain such Confidential Information in confidence
and shall not use or disclose such Confidential Information except in connection
with the performance of its obligations in connection with the applicable Study.
Recipient shall obtain written agreements with all of its employees and
contractors to maintain the confidentiality of such Confidential Information as
provided herein. Upon the written request of the Disclosing Party, Recipient
agrees, at the option of the Disclosing Party, to (i) return, at the Disclosing
Party's expense, or (ii) destroy all tangible or electronic forms of the
Confidential Information; provided, however, that the Recipient may retain a
single copy of the Confidential Information and related materials in its
archives for the purpose of ensuring its compliance with this Agreement, an
applicable Task Order, laws, or governmental regulations. Recipient agrees to
provide a written certification of destruction upon the written request of the
Disclosing Party.
6.3: For purposes of this Agreement, Confidential Information shall not include:
(a) information which was known to Recipient prior to disclosure by
Disclosing Party as shown by written evidence;
(b) information which is or becomes public through no improper act of
Recipient;
(c) information required to be disclosed in any legal, administrative or
governmental proceeding, or by court order, law or applicable
regulation;
(d) information which becomes available to Recipient from a source other
than Disclosing Party as shown by written evidence; or
(e) information which was developed by or for Recipient independent of the
disclosure of Confidential Information by Disclosing Party as shown by
written evidence.
6.4: The obligations of the Recipient with respect to Confidential Information
shall survive for a period of five (5) years from the expiration of this
Agreement or the completion of the applicable Task Order, unless otherwise
specified in an applicable Task Order or other writing signed by both of the
parties.
6.5: Recipient hereby acknowledges that Disclosing Party may be irreparably
damaged if its Confidential Information were disclosed to, or utilized on behalf
of, others in competition in any respect with Disclosing Party, which damage may
not be adequately compensated for by money damages. In the event of a breach or
threatened breach by Recipient of the provisions hereof, Recipient agrees that
Disclosing Party may seek an injunction restraining Recipient from such breach.
Nothing herein contained will be construed as prohibiting Disclosing Party from
pursuing any other remedies available at law or in equity for any breach or
threatened breach of this Agreement or any applicable Task Order.
VII. TERMINATION
7.1: This Agreement or any Task Order may be terminated by Sponsor at any time
with or without cause by giving Inveresk at least thirty (30) days prior written
notice. As soon as practicable after Inveresk's receipt of such notice, there
will be no further acquisition, screening or entry of patients into the project
or Study affected by such termination. Termination of any
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one Task Order shall have no impact on the duties and obligations required under
other Task Orders.
Notwithstanding the foregoing, any applicable Task Order may be terminated
immediately by written notice from Sponsor, in the following circumstances:
(a) Authorization and approval to perform a Study in the United States
is withdrawn by the FDA;
(b) Human or toxicological test results, in the reasonable determination
of Sponsor, support immediate termination of the Study; or,
(c) The emergence of adverse events with a compound administered in a
Study of such magnitude or significance that, in the reasonable
determination of Sponsor, supports immediate termination of the
Study.
Both Inveresk and Sponsor recognize that early termination of any Task Order
requires both discussion and coordination between the parties to ensure patient
safety, continuity of treatment (if appropriate) and compliance with all
applicable regulations.
7.2: During the thirty (30) day period between the notice of termination and the
effective date of such termination, Inveresk shall use all reasonable efforts to
wind-down the affected Task Order as soon thereafter as practicable, as
permitted under third party contracts, and applicable law and regulation, in
order to reduce or eliminate further costs, and to cancel, if permitted under
the terms of applicable agreements, any third party obligations. Subject to
satisfaction of Sponsor's obligations hereunder, Inveresk shall transfer to
Sponsor all Study data and reports related to the Study prepared, but not yet
submitted to Sponsor; provided, however, Inveresk may retain an archival copy of
all materials provided to Sponsor or developed or used in connection with the
Study.
7.3: Within ninety (90) days after the completion of wind-down of the affected
Task Order (which wind-down includes receipt by Sponsor of any case reports,
statistical analyses, functional database and other deliverables prepared by
Inveresk pursuant to Task Order, if any, prior to the date of termination),
Inveresk shall provide Sponsor with a written itemized statement of all work
performed by it in connection with the terminated Task Order. Such written
itemized statement shall include only those Services listed in the Task Order
which have been completed and shall be prepared in accordance with the budgets
attached to such Task Order.
7.4: This Agreement and/or any Task Order may be terminated by Inveresk upon the
material default in performance by Sponsor or material breach of this Agreement,
provided that Sponsor shall be given thirty (30) days prior written notice of
default and the opportunity to cure the default during such period. Material
default shall arise upon the failure of Sponsor to make any payment when due or
upon any action by Sponsor or any failure of Sponsor to act that either impedes
Inveresk from reasonably performing its obligations under any Task Order or that
serves to defeat the purpose of this Agreement or any Task Order entered
hereunder.
7.5: In the event of termination of any Task Order under either of the above
conditions, Sponsor shall pay to Inveresk all costs incurred or accrued by
Inveresk at the time of termination, costs incurred during the winding down of
the Task Order Services and the portion of the fee earned but remaining unpaid
at the time of termination.
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Clinical Master Service Agreement 28th September 2005
7.6: This Agreement and Task Orders may be immediately terminated by either
party if the other party becomes insolvent, is dissolved or liquidated, makes a
general assignment for the benefit of its creditors, or files or has filed
against it, a petition in bankruptcy or has a receiver appointed for a
substantial part of its assets.
7.7: Sponsor expressly retains the right to instruct Inveresk to terminate a
Study at any investigator site with which Inveresk has a contract pursuant to a
Task Order provided, however, that in no event shall Inveresk be responsible for
any delay resulting from any such termination. In the event such termination
results in an increase or decrease in the effort required by Inveresk, the
amount to be paid by Sponsor to Inveresk under the applicable Task Order shall
be adjusted accordingly.
7.8: In the event of early termination of this Agreement under any of the above
conditions, other than default by Inveresk, Sponsor shall pay Inveresk the:
a) Costs incurred and accrued, costs incurred during the winding down of the
Task Order Services and the portion of the fee earned but remaining unpaid
at the time of termination in accordance with the budget and schedule set
forth in the Task Order based on the amount of services provided by
Inveresk through the effective date of termination. These costs shall be
agreed in good faith between the parties;
b) Subject to 7.9 below, If the amount paid by Sponsor to Inveresk in
connection with the Task Order exceeds such earned amount detailed above,
then Inveresk shall promptly refund the unearned excess to Sponsor. And if
the amount already paid by Sponsor to Inveresk in connection with the Task
Order is less than such earned amount detailed above, then Sponsor shall
promptly pay the total earned amount due Inveresk.
c) Any refund or payment under this Section 7 shall be made within thirty
(30) days after Sponsor's receipt of Inveresk's itemized statement
7.9: In the event of early termination of this Agreement or any Task Orders
under any of the above conditions, other than default by Inveresk, Inveresk
shall be entitled to a termination fee. This fee is separate from the payments
attributed to other termination sections and covers the consequences of such
termination on Inveresk's operational and administrative costs. The
aforementioned termination fee shall be negotiated in good faith between the
parties on a case-by-case basis upon notification of early termination in
writing.
VIII. ASSIGNMENT
8.1: This Agreement may not be assigned by either party, except to an Affiliate,
without the prior written consent of the other which shall not be unreasonably
withheld.
IX. INDEMNIFICATION & LIABILITY LIMITATIONS
9.1: Sponsor agrees to defend, indemnify, and hold harmless Inveresk and its
Affiliates, employees, officers, directors, from and against any and all losses,
costs, damages and expenses, (including without limitation legal fees and
expenses) incurred in connection with any claims, proceedings or investigations
arising out of or in connection with a Study or the performance by Inveresk
pursuant to this Agreement or any Task Order (including, but not
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Clinical Master Service Agreement 28th September 2005
limited to, clinical trials of study drug and the handling and reporting of data
resulting from such clinical trials) provided, however, that:
(a) Inveresk has reasonably adhered to and complied with the obligations
delineated in the specific Task Order from which the claim arose,
material laws and regulations, and all reasonable directions and
recommendations furnished in writing by Sponsor regarding the Services
delineated in the Task Order from which the claim arose; and,
(b) Sponsor is promptly notified of any such claim, proceeding or
investigation; and,
(c) Inveresk cooperates in the handling and defense of any such claim.
9.2: Sponsor at its own expense shall carry out the sole management and defense
of such claims or suits, and will provide attorneys of its sole choosing to
defend against any such claim, proceeding or investigation. Sponsor agrees that
no settlement agreement shall serve to establish fault or liability on the part
of Inveresk.
9.3: Sponsor shall not be obligated with respect to any loss, damage, cost and
expense relating to any claim, proceeding or investigation to the extent that
such claim, proceeding or investigation is based on the negligence or willful
malfeasance of Inveresk or its employees, directors and Affiliates.
9.4: Inveresk agrees to indemnify, defend, and hold harmless Sponsor against and
in respect of any and all losses, costs, expenses, liabilities and damage,
including without limitation, interest, penalties and reasonable attorney's fees
resulting from Inveresk's negligent performance of the obligations required
herein.
9.5: Inveresk agrees to secure and maintain insurance of general liability with
coverage as it deems appropriate with respect to the Services to be provided in
accordance with any Task Order entered hereunder. Inveresk shall provide a
certificate of insurance upon Sponsor's written request.
9.6: Sponsor shall secure and maintain, in full force and effect throughout the
performance of each Study and for five (5) years thereafter, insurance coverage
for clinical trials, product liability, or similar coverage in amounts in
accordance with generally accepted standards for sponsors in connection with the
administration of investigational compounds or clinical trials. Sponsor shall
provide a certificate of insurance upon Inveresk's written request.
9.7: The indemnification obligations set forth in this section 9 are personal to
each individual Task Order and therefore separate and distinct with respect to
every other individual Task Order. Disputes with regard to indemnification
obligations with respect to one individual Task Order shall have no effect or
impact on the indemnification obligations owing under any other independent Task
Order.
9.8: Inveresk's maximum liability for all damages of any kind arising out of
services performed under any Task Order shall not exceed the contract value of
the particular Task Order.
9.9: Neither party shall be liable for consequential, incidental, or exemplary
damages, including loss of profits, business or goodwill.
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X. REGULATORY
10.1: If any governmental or regulatory authority conducts, or gives notice of
its intent to conduct an inspection at any investigational site, or takes any
other regulatory action with respect to any service conducted in accordance with
a Task Order entered pursuant to this Agreement, then the party learning thereof
shall promptly give the other party notice thereof, and each party shall provide
the other with any information reasonably required in connection therewith.
Inveresk shall have the right to be present at any such inspection or other
regulatory action with respect to Inveresk. Sponsor shall have primary
responsibility for preparing any responses which may be required.
10.2: The Transfer of Obligations from Sponsor to Contract Research Organization
as required by 21 CFR ss.312.52, and ICH E6, 5.2 shall be set forth in each Task
Order as applicable. Sponsor shall retain those responsibilities not
specifically listed in the applicable Task Order. Except for those obligations
specifically transferred from Sponsor to ▇▇▇▇▇▇▇ River by Task Order, Sponsor
shall at all times be deemed to be the "Sponsor" of each Study pursuant to the
terms of the Federal Food, Drug and Cosmetic Act, as from time to time amended.
10.3: Neither Sponsor nor ▇▇▇▇▇▇▇ River shall knowingly use in any capacity in
the performance of the Services any individual, corporation, partnership or
association that has been debarred under Article 306 of the Federal Food, Drug
and Cosmetic Act, 21 USC ss.335a (a) or (b). In the event that either party
becomes aware of the debarment of any individual, corporation, partnership or
association providing services to ▇▇▇▇▇▇▇ River which relate to the Services
provided under this Agreement, that party shall notify the other party
immediately.
10.4: During the term of this Agreement, ▇▇▇▇▇▇▇ River agrees to permit Sponsor
or its authorized representatives to examine, with reasonable notice to allow
▇▇▇▇▇▇▇ River to ensure that personnel resources are available to assist and
escort said representatives, and at any reasonable time during ▇▇▇▇▇▇▇ River's
normal business hours: (i) ▇▇▇▇▇▇▇ River's facilities where the Study is being
coordinated; (ii) original source documentation; (iii) databases and software
with respect to the Services; and (iv) any other essential study documents (ICH
E6) considered relevant or useful by Sponsor to confirm that the Services are
being conducted in conformance with this Agreement and all applicable laws and
regulations. Sponsor shall also have the right to copy any essential study
documents referred to in this Section. Commercially reasonable costs associated
with hosting and responding to such audits shall be charged to Sponsor.
Notwithstanding the existence of Sponsor's rights under this section 10.4,
Sponsor shall be under no obligation to exercise these rights.
XI. OWNERSHIP OF DATA, PATENT RIGHTS
11.1: Except as otherwise provided herein, all data, documents and information
provided by Sponsor to ▇▇▇▇▇▇▇ River and the resulting data prepared by ▇▇▇▇▇▇▇
River for Sponsor pursuant to its performance of Task Orders shall be the sole
and exclusive property of Sponsor.
11.2: Sponsor shall have the right to make any use of such information. All such
information shall be disclosed to Sponsor.
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11.3: Notwithstanding the foregoing, ▇▇▇▇▇▇▇ River's data, documents, and all
information of a privileged and/or proprietary nature, ▇▇▇▇▇▇▇ River developed
computer software, processes, procedures and related manuals are the sole and
exclusive proprietary property of ▇▇▇▇▇▇▇ River.
11.4: At the time ▇▇▇▇▇▇▇ River has completed all other obligations set out
herein and upon request by Sponsor, ▇▇▇▇▇▇▇ River will provide Sponsor with the
analysis-ready SAS(R) data sets used to generate the trial summaries, listings,
figures and analyses. The data sets will be organized per ▇▇▇▇▇▇▇ River's
standard structure unless specified otherwise in the Task Order accompanying
this contract. Upon request, Inveresk will provide the SAS(R) statistical
procedure output so that Sponsor can confirm that the appropriate statistical
procedures and models have been used for the trial statistical analyses.
11.5: When Task Order specifications provide for the delivery of SAS(R) program
files (which may include compiled macros) used to generate the trial summaries,
listings, figures and analyses, that executable program code will be delivered
to Sponsor under the following conditions:
(a) Receipt of written request for the SAS(R) program code from the
Sponsor.
(b) Sponsor shall not hold Inveresk responsible for the performance of the
SAS(R) programs if the program code is implemented in a different
computing environment or using a different version of SAS(R) from
which the programs were developed at Inveresk.
(c) Sponsor shall not modify program code in any way, except to
accommodate Sponsor or designee's computer directory structure. Any
other program modifications shall release Inveresk from its technical
support obligations and void any warranty (expressed or implied) as to
the performance of the program code. Any modifications to delivered
data sets will similarly void any warranty as to the performance of
the program code.
(d) Sponsor recognizes that differences between Sponsor's and Inveresk's
computing environment may cause differences in format of analysis
output when produced by Sponsor. Specifically, differences such as
page margins, fonts and print quality may occur.
(e) Sponsor shall delete and destroy the program code at the conclusion of
its use.
(f) Sponsor shall neither copy nor duplicate the program code, nor shall
Sponsor distribute the program code to any person or entity outside of
Sponsor's direct employ (e.g. not to any vendor such as a contractor
or external contract research organization).
(g) Nothing herein shall be construed as a conveyance by Inveresk to
Sponsor of any right, title, or interest in the program code.
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11.6: Following completion of the Services outlined in each Task Order, Inveresk
will return client data or other materials furnished to Inveresk. Sponsor shall
provide written instructions regarding and shall pay all costs associated with
the shipping of the materials to the Sponsor. Subject to the requirements of
Section 6 Inveresk may retain in its possession any and all data, documents or
information related to the performance of this Agreement or Task Order as is
required for regulatory, legal, insurance or record keeping purposes, or as
otherwise instructed by Sponsor.
11.7: The originals of all essential study documents, as defined by ICH
Guideline E6 (including Case Report Forms, Investigator Files, Regulatory files
and any other documents agreed to by both parties) will be promptly returned to
Sponsor at the conclusion of the applicable Study identified in the appropriate
Task Order or at any time during the Study at Sponsor's request. Except as
provided in Section 11.3, copies of all Study documentation and data and all
internal study-related materials may be thereafter disposed six months after the
final payment is received.
11.8: If archival of study material is required by the Sponsor beyond the six
month timeframe noted in Section 11.7, Sponsor shall pay any and all expenses
related to the storage, shipment or disposal of Study related materials, unless
otherwise specified in a individual Task Order.
11.9: With the exception of Inveresk's software, programs, practices,
procedures, policies, methods, manuals, and information privileged and
proprietary to Inveresk, Inveresk will promptly disclose to Sponsor or its
designees any and all inventions, discoveries and improvements conceived or made
by Inveresk or, to the extent Inveresk is aware thereof, by any investigator, in
the course of Services provided under any Task Order entered in accordance with
this Agreement that relate to study drug or to the Study Protocol and agrees to
assign all its interest therein to Sponsor or its designee.
11.10: Any such invention, discovery or improvement shall be the sole and
exclusive property of Sponsor. Whenever requested to do so by Sponsor, and to
the extent it is possible for Inveresk to do so, Inveresk will execute any and
all applications, assignments, or other instruments and give testimony to the
extent reasonably required to apply for and obtain Letters Patent of the United
States or any foreign country or to protect otherwise Sponsor's interest
therein, and Sponsor shall reimburse Inveresk for reasonable expenses incurred
in connection with such activities. The parties' obligation under this section
shall survive the termination of this Agreement and the applicable Task Order.
XII. WARRANTIES AND REPRESENTATIONS
12.1: Sponsor warrants and represents that data delivered to Inveresk under any
Task Order for the performance of Data Management, Quality Assurance and
Bio-Statistics services shall be delivered to Inveresk in a form and condition
reasonably calculated to allow Inveresk to perform the tasks described in Task
Orders in a timely fashion.
12.2: Sponsor further warrants and represents that it shall disclose to
Inveresk, prior to entering into a Task Order all material facts relating to the
Study and the Study data that may affect Inveresk's performance under this
Agreement.
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Clinical Master Service Agreement 28th September 2005
12.3: Sponsor agrees that it shall act to ensure the timely delivery of data and
Study materials to Inveresk.
12.4: Inveresk shall employ generally recognized professional standards and
shall take all reasonable precautions against error in completing its Services
under this Agreement and Task Order, including analyzing the Study data and
preparing statistical reports as required. Such Services shall be performed in
accordance with generally accepted data processing principles as applied to the
monitoring of clinical trials and all reasonable efforts will be made to ensure
the accuracy of all reports prepared for Sponsor. Both parties warrant that they
will perform their obligations and responsibilities hereunder in keeping with
all federal, state and local laws (or applicable governmental laws) and
regulations and with all policies and procedures of the FDA (or applicable
regulatory authority).
12.5: In the event Sponsor elects to use MedDRA(R) or another coding dictionary
requiring a license, Sponsor shall be required to maintain an active
subscription license for that service throughout the term of the program. Proof
of such license shall be required for Inveresk's records.
XIII. INDEPENDENT CONTRACTOR
13.1: Inveresk shall perform Services under this Agreement and each applicable
Task Order as an independent contractor, and nothing herein shall be construed
to be inconsistent with that relationship or status. Inveresk, its employees and
consultants shall not be considered to be employees of Sponsor. This Agreement
shall not constitute, create, or in any way be interpreted as, a joint venture,
partnership or business organization of any kind.
XIV. DELAYS
14.1: With the exception of any monetary payments due hereunder, either party
shall be excused from performing its obligations with respect to this Agreement
or any subsequent Task Order if their performance is delayed or prevented by any
cause beyond such party's control including, but not limited to, acts of God,
fire, explosion, weather, disease, war, insurrection, civil strife, riots,
government action, or power failure. Performance shall be excused only to the
extent of and during the reasonable continuance of such disability. Any deadline
or time for performance specified in any Task Order which falls due during or
subsequent to the occurrence of any of the disabilities referred to herein shall
be automatically extended for a period of time equal to the period of such
disability. The affected party will promptly notify the other party if, by
reason of any of the disabilities referred to herein, the affected party is
unable to meet any deadline or time for performance specified in a Task Order.
14.2: Inveresk shall not be held accountable for delays in its performance of
this Agreement or any Task Order due to the errors, acts or omissions of persons
or entities not under the direct control of Inveresk. Inveresk shall not be
responsible for delays in Study enrollment following site initiation. Delays in
key Sponsor decisions will result in corresponding delays in Inveresk's
performance. Inveresk shall not be held accountable for errors contained in data
delivered to Inveresk from persons or entities not under the direct control of
Inveresk.
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Clinical Master Service Agreement 28th September 2005
XV. DRUG SUPPLIES
15.1: Unless otherwise set forth in an appropriate Task Order, drug supplies
will be shipped properly packaged and labeled directly to the investigators by
Sponsor. Sponsor represents and warrants that all necessary approvals under the
United States Food, Drug and Cosmetic Act, the regulations promulgated
thereunder and other state, federal or regulatory approvals shall be obtained
prior to the shipment of any drugs.
15.2: Unless otherwise set forth in an appropriate Task Order, at the completion
or termination of any Task Order, Inveresk will make an accounting of all
clinical supplies. Inveresk will use all reasonable efforts to obtain return of
all unused drug supplies. During the Study, Inveresk will assure that the
investigator maintains records of the dates and amounts of drug supplies
received at the Study site; the dates, amounts and patients to whom the test
drug has been administered, the dates (when known) and the amount of drug
broken, spilled or lost, and the dates and amounts of drug being returned.
XVI. MISCELLANEOUS
16.1: Any contracts or other agreements that Inveresk enters into with others
for the purposes of this Agreement or Task Orders will solely be between
Inveresk and the others. Neither party shall have the authority to bind the
other party to any agreement whatsoever. Inveresk may, however, delegate part of
the Services provided for in any Task Order to its Affiliates, provided that
Inveresk shall remain responsible for the performance of all Services provided
in the appropriate Task Order.
16.2: During the term of this Agreement and for one year following termination
of this Agreement, neither party will (or will encourage others to) recruit,
solicit or induce, or attempt to induce, any employee of the other party with
whom it comes into contact as a result of this Agreement to terminate his or her
employment or otherwise cease his or her relationship with the other party;
provided however, that the foregoing provision will not prevent a party from
employing any such employee of the other party who contacts such party on his or
her own initiative without any such solicitation from the other party. The term
"solicit" will not be deemed to include general solicitations for employment not
specifically directed towards employees of a party.
16.3: To the extent that there is no conflict with the terms and conditions of
specific Task Orders, this Agreement shall constitute the entire understanding
of the parties hereto relating to the subject matter hereof and shall not be
changed or modified except in writing and signed by authorized representatives
of the parties. All prior Agreements, whether written or oral between the
parties relating to the subject matter hereof are superseded by this Agreement
and are of no further force or effect.
16.4: The covenants and conditions contained herein will apply to and bind the
successors, representatives and assigns of all parties hereto.
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Clinical Master Service Agreement 28th September 2005
16.5: If any provision of this Agreement shall be deemed void in whole or in
part for any reason whatsoever, the remaining provisions shall remain in full
force and effect.
16.6: No failure or delay of one of the parties to execute any of its rights or
powers under this Agreement shall operate as a waiver thereof, nor any other
single or partial exercise of such right or power preclude any other further
exercise thereof. The rights and remedies provided for in this Agreement are
cumulative and not exclusive of any rights or remedies provided by law.
16.7: The validity, interpretation, performance, rights and duties with respect
to this Agreement shall be determined by the laws, and within the jurisdiction,
of Scotland and England.
16.8: No party will be liable for failure or delay in performing the obligations
set forth in this Agreement, and no party shall be deemed in breach of its
obligations, if such failure or delay is due to any causes reasonably beyond the
control of such party.
16.9: Notices hereunder shall be provided by certified mail, return receipt
requested only.
If to Inveresk:
Contracts Department
Inveresk Research Limited
Beechwood (suite 2)
▇▇▇▇▇ ▇▇▇▇,
▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇
▇▇▇ ▇▇▇
If to Sponsor:
ChemGenex Pharmaceuticals Limited
▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇,
▇▇▇▇▇ ▇,
▇▇▇▇▇ ▇▇▇▇,
▇▇ ▇▇▇▇▇
16.10: Neither party shall disclose, except as required by law, or as required
to fulfill regulatory obligations as the Sponsor of an IND or NDA, the existence
of this Agreement or any Task Order entered in accordance therewith, nor use or
publish the other party's name in promotion, advertising or for any other
purpose without the prior written agreement of the other. This Agreement does
not entitle either party to the use of the trademarks of the other party.
16.11: Both parties hereto will perform the obligations as set forth herein in
conformance with applicable federal, state and local laws and ordinances, with
the guidelines promulgated by the U.S. Food and Drug Administration and, as
applicable, with accepted standards of good clinical practice.
16.12: This Agreement and any Task Order entered in accordance with the terms
contained herein may be executed in two or more counterpart originals, each of
which shall be deemed to be an original but all of which together shall
constitute one and the same instrument.
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Clinical Master Service Agreement 28th September 2005
16.13: Sections 6, 9, 11, 16.2, 16.7, 16.8, 16.9, 16.10, and 16.13 shall survive
termination of this Agreement.
IN WITNESS WHEREOF the parties hereto have executed this Agreement as of the day
and year above written.
Inveresk Research Limited ChemGenex Pharmaceuticals Limited
By: ▇▇▇ ▇. ▇▇▇▇▇▇▇▇ By: __________________________
Title: Finance Director Title: __________________________
Date: 28th September 2005 Date: __________________________
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Clinical Master Service Agreement 28th September 2005
Exhibit A - Example Task Order Template
Task Order
Number: 05-001
This Task Order is made and entered by and between ChemGenex Pharmaceuticals
Limited ("Sponsor") and Inveresk Research Limited ("Inveresk") pursuant to and
in accordance with the Master Services Agreement signed and its amendments,
executed by the parties and is entered into this _______ day of _______ 2005.
For good and valuable consideration, the receipt, exchange and sufficiency of
which is acknowledged by the parties, it is agreed that the parties hereto shall
perform the services (monitoring and related activities) set forth herein and in
support of the Protocol entitled:
----------------------------------------------------------
PO Number:______________________
This Task Order contains the following Attachments each of which is made a part
hereof:
Attachment "A" - Protocol
Attachment "B" - Scope of the Work
Attachment "B-1" - Estimated Timeline
Attachment "C" - Estimated Budget, Terms
Attachment "D" - Schedule of Payments, Terms
Attachment "E" - Transfer of Obligations
In the event of any conflict between the terms and conditions of the Master
Services Agreement and the terms and conditions set forth in this Task Order or
any of the Attachments thereto, it is agreed that this Task Order shall take
precedence and supersede the conflicting terms of the Master Services Agreement.
Inveresk Research Limited ChemGenex Pharmaceuticals Limited
By: ___________________________ By: ___________________________
Title: ________________________ Title: ___________________________
Date: _________________________ Date: ___________________________
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Clinical Master Service Agreement 28th September 2005