Confidential Materials omitted and filed separately with the Securities and
Exchange Commission. Asterisks denote omissions.
Exhibit 10.21
MASTER SERVICES AGREEMENT
This Master Services Agreement ("Agreement") is made on this 25 day of
February, 2003, between Idenix Pharmaceuticals, Inc., a Delaware corporation
having its principal place of business at 000 Xxxxxxxxx Xxxx Xxxxx, 0xx Xxxxx,
Xxxxxxxxx, Xxxxxxxxxxxxx 00000, on behalf of itself and its affiliates
(hereinafter "Sponsor"), and Quintiles, Inc., a North Carolina corporation
having its principal place of business at 0000 Xxxxx Xxxxx Xxxxxxxxx,
Xxxxxxxxxxx, Xxxxx Xxxxxxxx 00000-0000 (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 discovering, developing,
manufacturing and/or commercializing pharmaceutical products. Quintiles is in
the business of providing clinical trial services, research, and other services
for the pharmaceutical, medical device and biotechnology industries.
B. Sponsor and Quintiles desire to enter into this Agreement to
provide the terms and conditions upon which Sponsor may engage Quintiles from
time-to-time to provide services for individual studies or 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 1.0 (b) below), without having to re-negotiate the
basic terms and conditions contained herein. This Agreement
covers the provision of services by Quintiles and Quintiles'
corporate affiliates (as provided in 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, budget
and payment schedule, and other relevant terms. 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
Idenix Quiniles MSA 1 CONFIDENTIAL
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 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 Transfer of
Obligations Form will be filed with the Food and Drug
Administration ("FDA") by Sponsor where appropriate, or as
required by law or regulation.
(d) Existing Agreement. The parties expressly acknowledge that the
Sponsor has executed a Master Services Agreement with
Quintiles Scotland Ltd, dated as of May 27, 1999, and that
such Master Services Agreement remains in full force and
effect and shall not be terminated, superceded, amended or
otherwise affected by this Agreement.
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. The aggregate fees and
expenses payable by Sponsor to Quintiles for any Work Order shall not
exceed the total fees and expenses included in the applicable budget
and payment schedule for such Work Order, unless otherwise authorized
in advance by Sponsor. Pass-through expenses for any Work Order [**]
pass-through expenses in the applicable budget and payment schedule
[**} by Sponsor. 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, upon
request by Quintiles, it will make an up-front payment (the "Prepayment
Amount".) The Prepayment Amount will be mutually agreed upon by the
parties on a Project-by-Project basis. Unless otherwise agreed in a
particular Work Order, the Prepayment Amount will be credited against
amounts otherwise owed by Sponsor on the final invoice relating to such
Work Order. 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 shall provide a standard expense statement substantiating
all such expenses and pass-through costs with each invoice; and, (b)
Sponsor shall pay each invoice within thirty (30) days of the date of
Sponsor's receipt 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. Quintiles may
assess interest in an amount equal to one percent (1%) per month (or
the maximum lesser amount permitted by law) of all
Idenix Quiniles MSA 2 CONFIDENTIAL
undisputed amounts owing hereunder and not paid within [**] days of the
Sponsor's receipt of the invoice.
3.0 TERM. This Agreement shall commence on the date it has been signed by
all parties and indicated in the first paragraph of this Agreement and
shall continue for a period of five (5) years, 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 terminated in accordance with Section 16 below.
4.0 CHANGE ORDERS. Any material change in the scope of a Work Order or the
stated 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. After discussion with and approval of Sponsor,
Quintiles shall generate a written amendment to the Work Order (a
"Change Order"). A sample Change Order form is attached hereto as
Exhibit C. 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. Quintiles reserves the right
to postpone effecting material changes in the Project's scope until
such time as the parties agree to the final terms of 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.
5.0 CONFIDENTIALITY. It is understood that during the course of this
Agreement, Quintiles and employees, officers, directors, agents and
representatives (collectively "Representatives") of Quintiles may be
exposed to material, data and information that are confidential and
proprietary to Sponsor. All such data and information, including but
not limited to any protocol, investigator brochure, clinical trial
data, chemical compounds, study drugs, materials, trade secrets,
intellectual property and other assets, know-how, processes, technical,
scientific, financial or business information of any kind, whether in
written, oral, electronic, magnetic, optical, tangible or intangible
form (hereinafter "Sponsor Confidential Information"), made available,
disclosed, or otherwise made known to or generated by Quintiles and its
Representatives 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
Representatives 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. Except as may
Idenix Quiniles MSA 3 CONFIDENTIAL
be-required by-law, each party agrees that it will not disclose the
terms of this Agreement including but not limited to the budget and
payment schedule of any Work Order to any third party without the
written consent of the other party, which shall not unreasonably be
withheld; provided however, that Sponsor may disclose the portion of
this Agreement to its affiliates, agents, representatives (not
competitors of Quintiles) or its licensing partners who have a need to
know and who are bound by the obligations of confidentiality and use
similar to those set forth in this Section 5.0. These obligations of
confidentiality and nondisclosure shall remain in effect for a period
of ten (10) years after the completion or termination of the applicable
Work Order.
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, to the extent practicable, the receiving party
shall provide prior notice of such disclosure to the disclosing party
and take all practicable reasonable and lawful actions to cooperate
with the disclosing party in connection with the disclosing party's
efforts to avoid and /or minimize the extent of such disclosure.
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 discoveries, developments, improvements or inventions, whether or
not patentable that may evolve from the Sponsor Confidential
Information, the data and information described above, and/or be
conceived and/or reduced to practice and/or evolve within the scope of
and as the result of services performed by Quintiles under this
Agreement (collectively "Inventions"), shall belong to Sponsor.
Quintiles agrees to promptly disclose all such Inventions to Sponsor,
to assign all of its rights, title and interest, and to cause its
Representatives to execute such assignments, in all such Inventions
and/or related patents to Sponsor. Quintiles further agrees to use
reasonable efforts to assist Sponsor, at Sponsor's cost and expense, to
file patent applications or to obtain other intellectual property
protection on such Inventions. 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.
7.0 RECORDS AND MATERIALS. At the completion of the Services by Quintiles,
or upon termination of this Agreement and/or any Work Order(s), all
Sponsor Confidential Information, study drugs, materials, information
and all other data owned by Sponsor,
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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, copies 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.
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 [**] the parties will include [**] to the extent,
and under the terms, set forth [**].
9.0 REGULATORY COMPLIANCE; INSPECTIONS. Quintiles certifies and represents
that its Services will be conducted in compliance with this Agreement,
each applicable Work Order, the Protocol, Sponsor's written
instructions provided to and agreed to by Quintiles, and all applicable
laws, rules and regulations, including but not limited to the Federal
Food, Drug and Cosmetic Act and the regulations promulgated pursuant
thereto, the applicable laws, rules and regulations of each country in
which Services will be conducted, International Conference on
Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use Guidelines ("ICH Guidelines"), Good
Clinical Practice ("GCP"), and with the standard of care customary in
the contract research organization industry. Regarding the FDA's
electronic records and signatures regulation, 21 CFR Part 11 ("Part
11"), Quintiles has a compliance plan in place as to its applicable
database applications and electronic records systems and it is working
diligently to implement its plan. Quintiles, however, is not
responsible for the compliance or noncompliance of applications or
systems used by third parties (including, but not limited to,
investigative sites or third party laboratories) unless such
applications or systems are owned by Quintiles. 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 under the Generic Drug
Enforcement Act and that it will not knowingly employ any person or
entity that has been so debarred, or is currently under investigation,
to perform any Services under this Agreement. Sponsor
Idenix Quiniles MSA 5 CONFIDENTIAL
represents and certifies that it will not knowingly 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.
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 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, including, but not limited to, inspections of
investigational sites or laboratories. Quintiles shall forward to
Sponsor 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 Sponsor. Sponsor shall forward to Quintiles copies of any
non-routine correspondence from any regulatory or governmental agency
relating to such a Study or Project that is relevant to, involves or
affects Quintiles' Services. Each party shall obtain the written
consent of the other party, which will not be unreasonably withheld,
before referring to the other party or its affiliates in any regulatory
correspondence related to an investigation or other non-routine inquiry
by such regulatory authority, but written consent will not be required
if the party has not responded within five (5) business days of receipt
of the requesting party's request for consent. 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 the
Confidential Information, or any other information and materials that
are not required to be disclosed to such agency, without the prior
consent of the other party, which shall not unreasonably be withheld.
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 Work Order 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 Confidential Information for purposes of this
Agreement. Quintiles shall bear the costs and expenses incurred by
Quintiles in connection with: (a) one audit inspection or investigation
per Project and for any audit; (b) an inspection or investigation that
results solely from the wrongdoing of Quintiles; or (c) in the event
that a governmental authority performs a general audit of Quintiles.
Sponsor shall bear the reasonable costs and expenses of all other
audits, inspections and investigations related to the Project
Idenix Quiniles MSA 6 CONFIDENTIAL
initiated or requested by Sponsor, or initiated by a governmental
authority for a Project of Sponsor.
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 a form of
Clinical Trial Agreement ("CTA") form acceptable to both parties. If an
Investigator insists upon any material changes to any provisions of the
CTA, then Quintiles shall submit the proposed material change to
Sponsor, and Sponsor shall review, comment on and/or approve such
proposed changes within ten (10) working days of receipt of such
proposed material changes. If the standard CTA form, or any changes to
the standard CTA form 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 making any such approved changes to the CTA. 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, the applicable Work Order, and the CTA.
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. Payments for Investigators'
services are pass-through payments to third parties and are separate
from payments for Quintiles' Services. Such pass-through payments for
Investigators' services shall be made by Sponsor to Quintiles in
advance in accordance with the applicable budget and payment schedule
for the specific Work Order. Sponsor acknowledges and agrees that
Quintiles will not make payments to Investigators prior to receipt of
sufficient funds from Sponsor, and that Sponsor will not withhold
Investigator payments except to the extent that it has reasonable
questions about the services performed by a particular Investigator.
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 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 in any study
or Project without the written consent of Quintiles, which will not be
unreasonably withheld.
12.0 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 press release or marketing
materials, without the other party's prior written consent.
13.0 REMEDIES. In addition to any other remedies available to the parties
hereto, each party shall be entitled to seek equitable relief,
including injunctions and specific performance,
Idenix Quiniles MSA 7 CONFIDENTIAL
in the event of a breach of the provisions of this Agreement. Neither
party shall be entitled to, nor shall the other party, its affiliates
or any of the other party's or its affiliates' directors, officers,
employees, subcontractors or agents have any liability for any loss of
profits, opportunity or goodwill, or any type of special, incidental,
indirect or consequential damage or loss in connection with or arising
out of this Agreement, any Work Order, or the Services performed
hereunder. Except in circumstances involving [**], in no event shall
the collective, aggregate liability (including, but not limited to,
contract, negligence and tort liability) [**] or its affiliates, or
[**] or its affiliates' directors, officers, employees, subcontractors
and agents, under this Agreement or any Work Order hereunder [**] under
the applicable Work Order from which such liability arose.
14.0 INDEMNIFICATION.
(a) 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, any Work Order, or the Services
contemplated herein (including, without limitation, any Losses arising
from or in connection with any study, test, product or potential
product to which this Agreement or any Work Order relates), except to
the extent such Losses are determined to have resulted from the
negligence or intentional misconduct of the Quintiles Indemnified Party
seeking indemnity hereunder.
(b) Quintiles shall indemnify, defend and hold harmless Sponsor and its
affiliates, and its and their directors, officers, employees and agents
(each, a "Sponsor 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, any Work Order, or the Services
contemplated herein to the extent such Losses are determined to arise
from the negligence or intentional misconduct of a Quintiles
Indemnified party.
15.0 INDEMNIFICATION PROCEDURE. The Indemnified Party shall give the
Indemnifying Party prompt notice of any such claim or lawsuit
(including a copy thereof) served upon it and shall fully cooperate
with the Indemnifying Party and its legal representatives in the
investigation of any matter the subject of indemnification. The
Indemnifying Party shall be entitled at its option to control the
defense and settlement of any claim on which it may be liable, provided
the Indemnifying Party acts reasonably and in good faith with respect
to all matters relating to the settlement and disposition of the claim
to the extent such disposition or settlement relates to the Indemnified
Party. The Indemnified Party shall not unreasonably withhold its
approval of the settlement of any claim, liability, or action covered
by the Indemnification provisions herein. The Indemnified Party's
breach of any obligation hereunder will not relieve the Indemnifying
Party's obligations
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hereunder unless the Indemnifying Party is materially adversely
affected by the acts or omissions of the Indemnified Party
16.0 TERMINATION.
(a) Sponsor or Quintiles may terminate this Agreement or any Work Order
without cause at any time during the term of the Agreement on sixty
(60) day's prior written notice to Quintiles or Sponsor, as
appropriate.
(b) 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.
(c) If either party reasonably determines, that its continued
performance of the Services contemplated by one or more Work Orders
would constitute a potential or actual violation of regulatory or
scientific standards of integrity, then either party may terminate the
applicable Work Order(s) by giving written notice stating the Work
Order(s) being terminated and the effective date (which may be less
than thirty days from the notice date) of such termination.
(d) Sponsor may terminate this Agreement or any Work Order immediately
by written notice, in the event that (i) authorization and approval to
perform a study in the United States is withdrawn by the FDA; (ii)
animal, human or in vitro test results, in the reasonable determination
of Sponsor, necessitate immediate termination of a study; or (iii) the
emergence of adverse events with a study drug or compound administered
in a study are of such magnitude or significance that, in the
reasonable determination of Sponsor, necessitate immediate termination.
(e) 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.
(f) Upon any notice of termination, the parties shall promptly meet to
discuss and coordinate the Services to be completed during the
termination notice period ("Termination Services"). Quintiles shall
perform such Termination Services as are reasonably necessary to either
sustain the Studies underway pursuant to the applicable Work Order(s),
or to accomplish an orderly wind-down of the Services, as Sponsor may
direct. Quintiles agrees to take all commercially reasonable steps to
minimize the costs and expenses it may incur as a result of
termination.
(g) Sponsor shall pay Quintiles for all Services actually 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 completed units or milestones and all
non-cancelable costs incurred prior to notice of termination. In the
event that termination is by Sponsor for cause, or as a result of
material breach by
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Quintiles, Sponsor may deduct from its payment obligations, amounts
directly related to damages suffered by Sponsor as a result of the for
cause termination. If payments are unit or milestone based, and the
Agreement or a Work Order 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
notice of termination, provided however that such payments for standard
fees shall not exceed the payment that would have been due for a
completed unit or milestone. Sponsor shall pay for all Termination
Services actually performed during the termination notice period, upon
receipt of an itemized statement from Quintiles, in accordance with
Quintiles' standard fees and daily billing rates as specified in an
attachment to each applicable Work Order, or as otherwise agreed by the
parties, as well as reasonable expenses and pass-through costs
necessary to complete activities associated with the termination of
affected Work Orders, including the fulfillment of any regulatory
requirements. If the total amounts pre-paid by Sponsor under any
terminated Work Order exceed the amounts due and owing Quintiles for
Services and Termination Services, Quintiles shall refund to Sponsor
all such excess amounts within forty-five (45) days of the last day of
the termination notice period.
In addition, if the termination of any Work Order is by Sponsor
pursuant to Section 16.0 (a) herein, or by Quintiles pursuant to
Section 16.0 (b) herein, and [**] the Work Order [**], then Sponsor
shall [**] associated with Termination Services, [**] as if the Project
had continued on the timeline until Quintiles' personnel are
re-assigned, but no longer than for a period of sixty (60) days from
the date of notification of termination, to cover Quintiles' costs
associated with early termination (on the basis that Quintiles shall
have a duty to mitigate or minimize its losses).
17.0 RELATIONSHIP WITH AFFILIATES. Quintiles may use the Services of its
corporate affiliates to fulfill Quintiles' obligations under this
Agreement and any Work Order, provided they are included in the Work
Order or Quintiles obtains Sponsor's prior written approval. Any
affiliate so used shall be subject to all of the terms and conditions
applicable to Quintiles under this Agreement or any Work Order, and
entitled to all rights and protections afforded Quintiles under this
Agreement and any Work Order. Quintiles agrees that Sponsor's
affiliates may use the services of Quintiles (and its affiliates) under
this Agreement. In such event, to the extent that Sponsor's affiliates
elect to use the services of Quintiles in connection with a Project,
such Sponsor's affiliates shall be bound by all the terms and
conditions of this Agreement and the Project-related Work Order and
entitled to all rights and protections afforded Sponsor under this
Agreement and the Project-related Work Order. Any such affiliate of
Sponsor or Quintiles may execute a Work Order directly. 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 polices and direction of an entity.
Idenix Quiniles MSA 10 CONFIDENTIAL
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, upon written notice from Quintiles of the delay or
suspension, and at Sponsor's sole discretion, either: a) Sponsor will
pay the standard daily rate of the Quintiles' personnel assigned to the
Project and selected by Sponsor for retention on 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 reasonable costs,
if any, of re-training new personnel. In addition, Sponsor will pay all
non-cancelable costs and expenses reasonably 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.
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, failure of power or
restrictive government or judicial orders, or decrees, riots,
insurrection, war, Acts of God, severe inclement weather or other
reason or cause beyond that party's control, then performance of such
act shall be excused for the period of such delay, and the payment
obligations set forth in Section 18.0 shall not accrue.
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, on the next
business day if sent by confirmed facsimile 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. Idenix Pharmaceuticals, Inc.
0000 Xxxxx Xxxxx Xxxxxxxxx 000 XxxxxxxxxXxxx Xxxxx
Xxxxxxxxxxx, Xxxxx Xxxxxxxx 00000-0000 Xxxxxxxxx, XX 00000
Attention: Xxxxxxx X. Xxxxxxx, Ph.D. Attention: Xxxxxxx Xxxxx
Senior Vice President Associate Director, Clinical Operations
Facsimile: Facsimile: (000) 000-0000
Idenix Quiniles MSA 11 CONFIDENTIAL
With a copy to:
Quintiles Transnational Legal Department Idenix Pharmaceuticals, Inc.
X.X. Xxx 00000 000 XxxxxxxxxXxxx Xxxxx
Research Triangle Park, North Carolina Xxxxxxxxx, XX 00000
27709-3979 Attention: Xxxxxx X. Xxxxxxxx
Attention: Xxxx Xxxxxxx Xx. V.P., Legal & Administration
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.
21.0 INSURANCE. During the term of this Master Agreement, and for two (2)
years thereafter, to cover its obligations hereunder, each party shall
maintain insurance coverage as follows: 1) Professional Liability for
Quintiles and Product Liability for Sponsor in amounts of at least
US$[**]. The insured shall provide the other party with at least thirty
(30) days prior written notice of any material change, cancellation or
expiration of the above-required insurance.
22.0 FOREIGN CURRENCY EXCHANGE. For all Work Orders in which Quintiles will
earn fees or incur expenses in excess of one million U.S. Dollars in a
currency differing from the invoice and payment currency, a foreign
currency exchange provision will be included in the Work Order.
23.0 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 costs may be increased for the next twelve (12) month period
using the actual percentage change in the wages/earnings survey as
published in the Economist (or as reported at xxx.xxxxxxxxx.xxx) or the
equivalent inflation index for each country where Services are
performed, over the preceding twelve (12) month period.
24.0 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. Either party ("Assignor") may assign
any of its rights or obligations under this Agreement to any third
party ("Assignee")with which it merges, affiliates or consolidates, or
to which it transfers all or substantially all of its assets to which
this Agreement or any Work Order relates to the extent that Assignee
has sufficient assets and capital to reasonably satisfy Assignor's
obligations under this Agreement or any Work Order.
25.0 WAIVER AND ENFORCEABILITY. 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
Idenix Quiniles MSA 12 CONFIDENTIAL
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.
26.0 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 or any
Work Order.
27.0 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 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. Such arbitration shall be filed and conducted at
the office of the AAA 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 AAA Rules. The arbitrator shall not have the power to
award any punitive damages or any damages excluded by this Agreement.
Either party may apply to the arbitrators for interim injunctive relief
until the arbitration award is rendered or the dispute is otherwise
resolved. Either Party also may, without waiving any remedy under this
Agreement, seek from any court having jurisdiction any injunctive or
provisional relief necessary to protect the rights or property of that
Party pending the arbitration award.
28.0 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, except as provided in Section 1.0(d) herein. 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, INC. INDENIX PHARMACEUTICALS, INC.
By: /s/ Xxxxxxx X. Xxxxxxx By: /s/ Xxxx-Xxxxxx Sommadossi
--------------------------------- -------------------------------------
(signature) (signature)
Print Name: Xxxxxxx X. Xxxxxxx, Ph.D. Print Name: Xxxx-Xxxxxx Sommadossi, Ph.D.
------------------------- -----------------------------
Title: Senior Vice President Title: Chief Executive Officer
------------------------------ ----------------------------------
Date: 2-25-2003 Date: February 25, 2003
------------------------------- -----------------------------------
FEDERAL ID # 00-0000000
------------------------
Idenix Quiniles MSA 13 CONFIDENTIAL
EXHIBIT A
SAMPLE WORK ORDER
WORK ORDER
This Work Order ("Work Order") is between ____________________
("Sponsor") and _________________________ ("Quintiles") and relates to the
Master Services Agreement dated ________________________, (the "Master
Agreement"), which is incorporated by reference herein. Pursuant to the Master
Agreement, Quintiles has agreed to perform certain services in accordance with
written work orders, such as this one, entered into from time-to-time.
The parties hereby agree as follows:
1. Work Order. This document constitutes a "Work Order" under the
Master Agreement and this Work Order and the services contemplated herein are
subject to the terms and provisions of the Master Agreement.
2. Services and Payment of Fees and Expenses. The specific
services contemplated by this Work Order (the "Services") and the related
payment terms and obligations are set forth on the following attachments, which
are incorporated herein by reference:
SCOPE OF WORK ATTACHMENT 1
PROJECT BUDGET ATTACHMENT 2
TIMELINE ATTACHMENT 3
PAYMENT SCHEDULE ATTACHMENT 4
TRANSFER OF OBLIGATIONS
(if applicable) ATTACHMENT 5
LOCAL REPRESENTATIVE DUTIES
(if applicable) ATTACHMENT 6
3. Term. The term of this Work Order shall commence on the date
of execution and shall continue until the services described in Attachment 1,
are completed, unless this Work Order is terminated in accordance with the
Master Agreement. If the Master Agreement is terminated or expires, but this
Work Order is not terminated or completed, then the terms of the Master
Agreement shall continue to apply to this Work Order until the Work Order is
either terminated or completed.
4. Affiliates and Subcontractors. Quintiles may use the services
of its corporate affiliates to fulfill Quintiles' obligations under this Work
Order, provided below or if it obtains Sponsor's prior written consent. Any such
affiliates shall be bound by all the terms and conditions of, and be entitled to
all rights and protections afforded under, the Master Agreement and this Work
Order. Any subcontractors, consultants or Quintiles' affiliates that will be
used by Quintiles in performing the Services are listed below:
[Insert names of any subcontractors, consultants or Quintiles'
affiliates that will be used]
5. Amendments. No modification, amendment, or waiver of this Work
Order shall be effective unless in writing and duly executed and delivered by
each party to the other.
Idenix Quiniles MSA 14 CONFIDENTIAL
6. Currency Exchange. [Insert currency exchange provision in all
Work Orders in which Quintiles will earn fees or incur expenses in excess of one
million U.S. Dollars in a currency differing from the invoice and payment
currency]
7. Inflation and Cost Adjustment. [Insert cost adjustment
provision and inflation provision, if appropriate.]
ACKNOWLEDGED, ACCEPTED AND AGREED TO:
[Quintiles] [Sponsor]
By: By:
--------------------------------- -------------------------------------
Title: Title:
------------------------------ ----------------------------------
Date: Date:
------------------------------- -----------------------------------
Idenix Quiniles MSA 15 CONFIDENTIAL
EXHIBIT B
SAMPLE LOCAL REPRESENTATIVE DUTIES ATTACHMENT
[To be provided]
EXHIBIT C
SAMPLE CHANGE ORDER FORM
Change Order Number: _____________ Agreement No.: ______________________________
Customer:_________________________________ Quintiles Project Code: _____________
Customer Contact: ________________________
Date of Change Notification Form approval by Customer
(if applicable):________________________________________________________________
Project Name:___________________________________________________________________
Protocol Number(s):_____________________________________________________________
Description and/or date of original agreement:__________________________________
Quintiles Project Manager: _______________ Date of Change Order: _______________
Description of Change Order:
Costs Associated with Change Order:
Does this change the overall timeline?
[ ] Yes* [ ] No [ ] N/A
*If yes, revised timeline attached.
Does this change the Transfer of Obligations from Customer to Quintiles?
[ ] Yes* [ ] No [ ] N/A
*If yes, please attach revised Transfer of Obligations.
Does this change in scope necessitate a revision to the payment schedule?
[ ] Yes* [ ] No [ ] N/A
*If yes, revised payment schedule attached.
Does this change in scope necessitate a revision to any local representative
designation?
[ ] Yes* [ ] No [ ] N/A
*If yes, revised local representative attachment is attached.
BUDGET SUMMARY:
--------------------------------------------------------------------------------
ITEM EFFECTIVE DATE AMOUNT
--------------------------------------------------------------------------------
Original Contract
--------------------------------------------------------------------------------
Change Order No. 1
--------------------------------------------------------------------------------
Idenix Quiniles MSA 19 CONFIDENTIAL
--------------------------------------------------------------------------------
Change Order No. 2, etc.
--------------------------------------------------------------------------------
Total Revised Contract
--------------------------------------------------------------------------------
AGREED TO, ACKNOWLEDGED, AND ACCEPTED
QUINTILES, INC. [CUSTOMER NAME]
------------------------------------- --------------------------------------
Signature Signature
------------------------------------- --------------------------------------
Name (print) Name (print)
------------------------------------- --------------------------------------
Title Title
------------------------------------- --------------------------------------
Date Date
Idenix Quiniles MSA 20 CONFIDENTIAL
