EXHIBIT 10.1
MASTER SERVICES AGREEMENT
This Master Services Agreement ("Agreement") is made between Cubist
Pharmaceuticals, Inc. which has a place of business at 00 Xxxxx Xxxxxx,
Xxxxxxxxx, XX 00000 (hereinafter "Sponsor"), and Quintiles, Inc., a North
Carolina corporation having its principal place of business at 0000 Xxxxx Xxxxx
Xxxx., Xxxxxx, XX 00000 (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 to provide
the terms and conditions upon which Sponsor may engage Quintiles to provide
services for projects by executing individual Work Orders (as defined below)
specifying the details of the services and the related terms and conditions.
AGREEMENT:
1.0 SCOPE OF THE AGREEMENT; WORK ORDERS; NATURE OF SERVICES;
(a) SCOPE OF AGREEMENT. As a "master" form of contract, this
Agreement allows the parties to contract for multiple projects
through the issuance of multiple Work Orders (as discussed in
Section 1(b) below), without having to re-negotiate the basic
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terms and conditions contained herein. This Agreement covers
the provision of services by Quintiles and Quintiles'
corporate affiliates (see Section 17) and, accordingly, this
Agreement represents a vehicle by which Sponsor can
efficiently contract with Quintiles and its corporate
affiliates for a broad range of services.
(b) WORK ORDERS. The specific details of each project under this
Agreement (each "Project") shall be separately negotiated and
specified in writing on terms and in a form acceptable to the
parties (each such writing, a "Work Order"). A sample Work
Order is attached hereto as Exhibit A. Each Work Order will
include, as appropriate, the scope of work, time line, and
budget and payment schedule. Each Work Order shall be subject
to all of the terms and conditions of this Agreement, in
addition to the specific details set forth in the Work Order.
To the extent any terms or provisions of a Work Order conflict
with the terms and provisions of this Agreement, the terms and
provisions of this Agreement shall control, except to the
extent that the applicable Work Order expressly and
specifically states an intent to supersede the Agreement on a
specific matter. All Work Orders and other exhibits hereto
shall be deemed to be incorporated herein by reference.
(c) NATURE OF SERVICES. The services covered by this Agreement may
include strategic planning, expert consultation, clinical
trial services, statistical programming and analysis, data
processing, data management, regulatory, clerical, project
management, central laboratory services, preclinical services,
pharmaceutical
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sciences services, medical device services, and other research
and development services requested by Sponsor and agreed to by
Quintiles as set forth in the relevant Work Order
(collectively, the "Services"). Quintiles and Sponsor, where
appropriate, shall cooperate in the completion of a Transfer
of Obligations Form in conjunction with the relevant Work
Order. Any responsibilities not specifically transferred in
the Transfer of Obligations Form shall remain the regulatory
Responsibility of Sponsor. The obligations that have been
transferred to Quintiles will be provided in the 1571 form to
the FDA.
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 contained in each Work Order. Sponsor agrees that the
budget and payment schedule for each Work Order will be structured in
an effort to maintain cash neutrality for Quintiles (with respect to
the payment of professional fees, pass-through costs and otherwise).
Sponsor agrees that a prepayment may be necessary for Quintiles to
maintain cash neutrality over the term of the Work Order taking into
account payment terms agreed upon between the parties. Unless otherwise
agreed in a particular Work Order, the following shall apply: (a)
Quintiles will invoice Sponsor monthly for the fees, expenses and
pass-through costs incurred in performing the Services; and, (b)
Sponsor shall pay each invoice within thirty (30) days of the date of
the invoice. 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 one percent (1%) per month of all
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undisputed amounts owing hereunder and not paid within thirty (30)
days of the date of the invoice.
3.0 TERM. This Agreement shall commence on the date it has been signed by
all parties and shall continue for a period of five (5) years from the
date of execution, or until terminated by either party in accordance
with Section 16 below. The Agreement will automatically renew each year
thereafter for a period of one year, unless either party notifies the
other party in writing at least 30 days prior to the renewal date that
it does not want to renew the Agreement.
4.0 CHANGE ORDERS. Any (a) change in the details of a Work Order, even if a
fixed price Work Order, or (b) change in the assumptions upon which the
Work Order is based (including, but not limited to, changes in an
agreed starting date for a 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 Work Order (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 will include a specified period of time (as agreed
upon by the parties) within which Quintiles will implement the changes.
Both parties agree to act in good faith and promptly when considering a
Change Order requested by the other party. Quintiles 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
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Obligations Form. Sponsor shall provide such changes to the FICA on the
1571 form and will file such amendment where appropriate, or as
required by law or regulation.
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. All such
data and information (hereinafter "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 or
any Work Order to any third party without the prior 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 five (5) years after the completion or termination of
the applicable Work Order.
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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,
provided however that the other party is promptly notified in writing
of such requirement prior to, if practicable, disclosure and given an
opportunity to obtain a suitable protective order.
6.0 OWNERSHIP AND INVENTIONS. All data, information, inventions,
improvements in know-how, new uses, processes and compounds relating to
the study drug(s) and or products(s) covered by this Agreement and/or
applicable Work Orders that are conceived, generated, derived, or
reduced to practice by Quintiles as the result of the Services
performed by Quintiles under this Agreement shall be and remain the
exclusive property of 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
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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 arc the sole and exclusive property of
Quintiles.
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, subject to the payment obligations set forth in Section 2
herein. 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 for its corporate files. 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.
8.0 INDEPENDENT CONTRACTOR RELATIONSHIP. Except as provided in Article 10.0
herein, 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
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and neither party shall have the power or right to bind or obligate the
other party or 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
does not have an office in those countries, then sponsor may request
that Quintiles or its affiliates serve as its agent for that purpose,
and the parties will include in the Work Order an attachment regarding
local representative duties.
9.0 REGULATORY COMPLIANCE; INSPECTIONS. Quintiles agrees that its Services
will be conducted in compliance with ICH Guidelines, Good Clinical
Practices, all applicable laws, rules and regulations, including but
not limited to the Federal Food, Drug and Cosmetic Act and the
regulations promulgated pursuant thereto, and with the standard of care
customary in the contract research organization industry. Quintiles'
standard operating procedures will be used in performance of the
Services, unless otherwise specifically stated in the Work Order.
Quintiles certifies that it has not been debarred by the FDA pursuant
to Section (a) or (b) of 21 U.S.C. Section 335a, 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 or potentially would violate any
applicable law or regulation or scientific standard. 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.
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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. Sponsor may review and approve Quintiles' response
with respect to Sponsor's study or Project, but such approval shall not
be unreasonably withheld. Each party, however, shall: a) notify the
other party promptly of any FDA or other governmental or regulatory
inspection or inquiry concerning any study or Project of Sponsor in
which Quintiles is providing Services and such inspection or inquiry
relates to or affects such Services, including but not limited to,
inspections of investigational sites or laboratories; b) forward to the
other party copies of any correspondence from any regulatory or
governmental agency relating to such a study or Project, including, but
not limited to, FDA Form 483 notices, and FDA refusal to file,
rejection or warning letters, even if they do not specifically mention
the other party; and, c) obtain the written consent of the other party,
which will not unreasonably be withheld, before referring to the other
party or any of its affiliates in any regulatory correspondence. Where
reasonably practicable, each party will be given the opportunity to
have a representative present during an FDA or regulatory inspection.
Each party, however, acknowledges that it may not direct the manner in
which the other party fulfills its obligations to permit inspection by
governmental entities.
Each party agrees that, during an inspection by the FDA or other
regulatory authority concerning any study or Project of Sponsor in
which Quintiles is providing Services, it will not disclose information
and materials that are not required to be disclosed to such agency,
without the prior written consent of the other party, which consent
shall not unreasonably be withheld. Such information and materials
includes, but are not limited to, the following: 1) financial data and
pricing data
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(including, but not limited to, the budget and payment sections of the
Work Order); 2) sales data (other than shipment data); and 3) personnel
data (other than data as to qualification of technical and professional
persons performing functions subject to regulatory requirements.)
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 Project
assignment is being conducted in accordance with the agreed task and
that the facilities are adequate. All information disclosed, revealed
to or ascertained by Sponsor in connection with any such audit or
examination or in connection with any correspondence between Quintiles
and any regulatory authorities (including any FDA Form 483 notices)
shall be deemed to constitute Quintiles Confidential Information for
purposes of this Agreement. 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 Investigation finds
that Quintiles breached this Agreement or any applicable law or
regulation.
10.0 RELATIONSHIP WITH INVESTIGATORS. If a particular Work Order obligates
Quintiles to contract with investigators or investigative sites
(collectively, "Investigators") then Quintiles will use the approved
Clinical Trial Agreement ("CTA") form, a copy of which is attached
hereto as Exhibit B, which Quintiles will execute as the authorized
agent of Sponsor. If the agreed-upon CTA form is updated by Sponsor,
Quintiles will use the then current CTA form as of the time of the Work
Order. If
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an Investigator insists upon any material changes to any provisions
that directly relate to Sponsor, then Quintiles shall submit the
proposed material charge to Sponsor, and Sponsor shall review, comment
on and/or approve such proposed changes within five (5) working days.
If the CTA form, or any changes approved by Sponsor, differ from the
terms of this Agreement or a Work Order (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 including any such approved provisions or changes. 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 and the applicable Work Order.
If Quintiles will be paying Investigators on behalf of Sponsor, the
parties will agree in the applicable Work Orders 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.
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11.0 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 terms 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 in any study
or project without the written consent of Quintiles, which will not be
unreasonably withheld.
12.0 RESTRICTIONS ON ANNOUNCEMENTS. Quintiles shall not make any oral
presentation or publications relating to any Project without Cubist's
prior written consent except as required by law or by court or
administrative order, or as provided below with regard to Sponsor's
publication rights. Neither party shall employ or use the name of the
other party in any announcement, publication or promotional material or
in any form for public distribution, without the prior written consent
of the other party, except as required by law or by court or
administrative order. Sponsor shall have the exclusive, unrestricted
right to publish the results of a particular study.
13.0 [OMITTED]
14.0 INDEMNITY. Sponsor shall indemnify and hold Quintiles and its
affiliates and its and their directors, officers, employees, and agents
harmless and hereby forever releases and discharges Quintiles and its
affiliates and its and their directors, officers, employees, and agents
from and against all losses, liabilities, damages and expenses
(including reasonable attorneys' fees and cost's) ("Losses") that
Quintiles its
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affiliates and its and their directors, officers, employees, and agents
may suffer or incur as a result of any claims, demands, actions or
other proceedings made or instituted by a third party against any of
them arising out of or relating to the Services performed under this
Agreement or any Work Order for these Losses that arise out of (a) any
injury to or death of any person participating in any project or study,
(b) the negligence or intentional misconduct of Sponsor or its
affiliates, or its or their directors, officers, employees or agents,
(c) any breach of this Agreement or any Work Order by Sponsor or its
affiliates, or its or their directors, officers, employees or agents;
(d) any theory of product liability (including, without limitation,
actions in the form of tort, warranty or strict liability) or; e) any
patent infringement action relating, to Sponsor's compounds or products
accept to the extent that such Losses result from (a) any material
breach by Quintiles of its obligations under this Agreement, or (b) the
negligence, recklessness or intentional acts or omissions in connection
with the work performed by or on behalf of Quintiles hereunder. In no
event shall Sponsor indemnify Quintiles for any loss, liability, damage
or expense suffered or incurred as a result of activity which is
outside the scope of a Work Order hereunder.
Quintiles shall indemnify and hold Sponsor and its affiliates and its
and their directors, officers, employees, and agents harmless and
hereby forever releases and discharges Sponsor and its affiliates and
its and their directors, officers, employees, and agents from and
against all losses, liabilities, damages and expenses (including
reasonable attorneys' fees and costs) that Sponsor and its affiliates
and its and their directors, officers, employees, and agents may suffer
or incur as a result of any claims, demands, actions or other
proceedings made or instituted by a third party against any of them
arising out of or relating to the Services
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performed under this Agreement or any Work Order to the extent that
such claims, demands, actions or other proceedings result from (a) any
material breach of Quintiles of its obligations under this Agreement,
or (b) the negligence, recklessness or intentional acts or omissions in
connection with the work performed by or on behalf of Quintiles
hereunder.
15.0 Procedure. The party that intends to claim indemnification under this
Article (the "Indemnitee") shall promptly notify the indemnifying party
(the "Indemnitor") for any loss, claim, damage, liability or action
with respect to which the Indemnitee intends to claim such
indemnification, and the Indemnitor shall assume the defense thereof
with counsel mutually satisfactory to the Indemnitee whether or not
such loss, claim, damage, liability or action is rightfully brought;
provided, however, that an Indemnitee shall have the right to retain
its own counsel, with the fees and expenses to be paid by the
Indemnitor if Indemnitor does not assume the defense, or, if
representation of such Indemnitee by the counsel retained by the
Indemnitor would be inappropriate due to actual or potential differing
interests between such Indemnitee and any other person represented by
such counsel in such proceedings. The indemnity agreement in this
Article shall not apply to amounts paid in settlement of any loss,
claim, damage, liability or action if such settlement is effected
without the consent of the Indemnitor, which consent shall not be
withheld or delayed unreasonably. The failure to deliver notice to the
Indemnitor within a reasonable time after the commencement of any such
action, only if prejudicial to its ability to defend such action, shall
relieve such Indemnitor of any liability to the Indemnitee under this
Article, but the omission to deliver notice to the Indemnitor will not
relieve it of any liability that it may have to any Indemnitee
otherwise
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than under this Article. The lndemnitor shall not settle the action or
otherwise consent to an adverse judgement in such action that
diminishes the rights or interest of the Indemnitee without the express
consent of the Indemnitee. The Indemnitee under this Article, its
employees and agents, shall cooperate fully with the Indemnitor and its
legal representatives in the investigations of any action, claim or
liability covered by this indemnification. The Indemnitee shall keep
the Indemnitor informed of any investigation and the Indemnitor shall
have the right to review and comment on the conduct of the
investigation.
16.0 TERMINATION. Sponsor may terminate this Agreement or any Work Order
without cause at any time during the term of the Agreement on
forty-five (45) days' prior written notice to Quintiles. Either party
may terminate this Agreement or any Work Order 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. Either
party may terminate this Agreement or any Work Orders immediately upon
provision of written notice if the other party becomes insolvent or
files for bankruptcy. Any written termination notice shall identify the
specific Work Order or Work Orders that are being terminated.
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If this Agreement or any Work Order is terminated, Sponsor shall pay
Quintiles for all Services performed in accordance with this Agreement
and any applicable Work Order 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 this Agreement and the applicable Work Order, even
if the parties' original payment schedule spreads-out payments for
certain services (examples are unit or milestone-based payments) or
defers payments for certain services until the end of the Study.
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 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 twenty percent (20%) of the budget
for the remainder of Services that have not yet been performed, to
cover Quintiles' costs associated with early termination.
17.0 RELATIONSHIP WITH AFFILIATES. Sponsor agrees that Quintiles may use the
Services of its corporate affiliates, subject to prior written consent
by the Sponsor, to fulfill Quintiles' obligations under this Agreement
and any Work Order. Any affiliate so used shall be subject to all of
the terms and conditions applicable to Quintiles under this Agreement
or any Work Order, entitled to all rights and protections afforded
Quintiles under this Agreement or any Work Order. Quintiles
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agrees that Sponsor's affiliates may use the services of Quintiles (and
its affiliates) under this Agreement. In such event, such Sponsor's
affiliates shall be bound by all the terms and conditions of this
Agreement and any Work Order and entitled to all rights and protections
afforded Sponsor under this Agreement and any Work Order. The term
"affiliate" shall mean all entities controlling, controlled by or under
common control with Sponsor or Quintiles, as the case may be. 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 policies and direction of an entity.
18.0 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 or any Work Order 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. If Sponsor delays a project from its agreed starting
date or suspends performance of a project for a period longer than 10
working days, 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 beginning on the eleventh working day, 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 retraining 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
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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.
19.0 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 strike, lockouts, labor troubles, inability to procure
materials or services, failure of power or restrictive government or
judicial orders, or decrees, riots, insurrection, wear, 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.
20.0 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:
If to Quintiles. If to Sponsor:
Quintiles, Inc. Cubist Pharmaceuticals
0000 Xxxxx Xxxxx Xxxxxxxxx 00 Xxxxx Xxxxxx
Xxxx xxxx, XX 00000 Xxxxxxxxx, XX 00000
Attention: Xxxxxxx X. Xxxxx, Ph.D. Attention: Xxxxx Xxxxxxx
Vice President Clinical Trial Manager
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With a copy to: With a copy to:
Quintiles Transnational Xxxxx X. Xxxxxxxx
Legal Department Executive Director
X.X. Xxx 00 979 Business Development
Xxxxxxxx Xxxxxxxx Xxxx, Xxxxxx Xxxxxxxxxxxxxxx
Xxxxx Xxxxxxxx 00000-0000 00 Xxxxx Xxxxxx
Attention: Xxxx Xxxxxxx Xxxxxxxxx, XX 00000
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, provided that Quintiles followed Sponsor's written
instructions for the materials that were delivered, shipped, or mailed.
Quintiles disclaims any liability for the actions or omissions of third
party delivery services or carriers.
21.0 INSURANCE. Each party will maintain, for the duration of this
Agreement, insurance in an amount reasonably adequate to cover its
obligations hereunder, and, upon request, each party will provide to
the other party a certificate of insurance showing that such insurance
is in place.
22.0 INFLATION ADJUSTMENTS. Where services in a Work Order are provided by
Quintiles over multiple calendar years, Quintiles may increase its fees
at the beginning of each calendar year to reflect increases in
Quintiles' business costs on a prospective basis only. Quintiles'
overall cost increase for the next twelve (12) month period shall not
exceed the percentage charge in the wages/earnings survey as published
in the Economist (or as reported at XXX.XXXXXXXXX.XXX) or the
equivalent inflation index of the country where services are performed
over the preceding twelve (12) month period.
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23.0 BINDING AGREEMENT AND ASSIGNMENT. Except as stated above in Section 17,
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, provided, however, that without such consent, either party
may assign this Agreement in connection with the transfer or sale of
all or substantially all of its assets, stock or business, or its
merger with another entity, provided further, however, the assignee has
the financial ability to fulfill assignor's obligations hereunder.
Subject to the foregoing, this Agreement shall be binding upon, inure
to the benefit of and be enforceable by the parties and their
respective successors and permitted assigns.
24.0 CHOICE OF LAW, WAIVER AND ENFORCEABILITY. This Agreement shall be
construed, governed, interpreted, and applied in accordance with the
laws of the Commonwealth of Massachusetts, 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.
25.0 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,
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discoveries and improvements, indemnification and liability
limitations) shall survive the termination of this Agreement or any
Work Order.
26.0 ARBITRATION. Any controversy or claim arising out of or relating to
this Agreement or the breach thereof may be settled by arbitration
administered by the American Arbitration Association ("AAA") under its
Commercial Arbitration Rules, and judgment on the award rendered by the
arbitrator shall be binding and may be entered in any court having
jurisdiction thereof. If arbitration is demanded by Quintiles, such
arbitration shall take place in Cambridge, Massachusetts and if
demanded by Sponsor, in Durham, North Carolina. Such arbitration shall
be conducted in English by one arbitrator mutually acceptable to the
parties selected in accordance with AAA rules. The arbitrator shall not
have the power to award any punitive damages or any damages excluded by
this Agreement.
27.0 ENTIRE AGREEMENT, HEADINGS AND MODIFICATION. This Agreement, together
with the applicable Work Orders, 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.
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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, INC. CUBIST PHARMACEUTICALS, INC.
By: /s/ XXXXXXX X. XXXXXXX By: /s/ XXXXX X. XXXXXXXX
---------------------------------- ---------------------------------
Print Name: XXXXXXX X. XXXXXXX, PH.D. Print Name: XXXXX X. XXXXXXXX
--------------------------- -------------------------
Title: VICE PRESIDENT Title: CEO
------------------------------- -----------------------------
Date: 4/24/01 Date: 4/25/01
-------------------------------- -----------------------------
FEDERAL ID# 00-0000000
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