Master Consulting Agreement - Interneuron Pharmaceuticals Inc. and Quintiles Inc.
MASTER CONSULTING AGREEMENT
This Master Consulting Agreement (hereinafter "Agreement") when signed by both
parties will set forth the terms and conditions between Interneuron
Pharmaceuticals, Inc. (hereinafter "Interneuron") and Quintiles, Inc.
(hereinafter "Quintiles") under which Quintiles agrees to provide consulting
services as described below to Interneuron as hereinafter set forth.
1.0 TERM. This Agreement shall commence on the date of execution and shall
continue until terminated as hereinafter provided by either party.
2.0 CONFIDENTIALITY. It is understood that during the course of this
Agreement, Quintiles and its employees may be exposed to data and
information which is confidential and proprietary to Interneuron. All
such data and information (hereinafter "Interneuron 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
Interneuron. All information regarding clinical trials or clinical
trial management and all information regarding Quintiles' operations,
including but not limited to Quintiles Property (as defined in Section
3.0 below), disclosed by Quintiles to Interneuron in connection with
this Agreement is proprietary, confidential information belonging to
Quintiles (the "Quintiles Confidential Information", and together with
the Interneuron Confidential Information, the "Confidential
Information"). The Confidential Information shall be marked as
confidential or otherwise represented by the disclosing party as
confidential either before or within a reasonable time after its
disclosure. 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, provided that the foregoing obligations shall not
apply to Confidential Information which:
(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 by a legal, contractual or fiduciary obligation to the
disclosing party;
(c) the receiving party develops independently of any disclosure by
the disclosing party;
(d) was in the receiving party's possession or known to the receiving
party prior to its receipt from the disclosing party; or
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(e) is required by law to be disclosed.
This obligation of confidentiality and non-disclosure shall remain in
effect for a period of five years after the termination of this
Agreement.
3.0 SERVICES TO BE PROVIDED. Quintiles shall provide strategic planning,
expert consultation, clinical, statistical, statistical programming,
data processing, data management, regulatory, clerical, and project
management services as requested by Interneuron. The specific details
of each assignment or task will be separately negotiated and contracted
for in writing subject to the terms and conditions of this Agreement.
All data and information necessary for Quintiles to conduct project
assignments will be forwarded by Interneuron to Quintiles. 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 Interneuron. Any inventions that may evolve from
the data and information described above or as the result of services
performed by Quintiles under this Agreement shall belong to Interneuron
and Quintiles agrees to assign all inventions and/or patents to
Interneuron. It is acknowledged that Quintiles is possessed of certain
computer technical expertise and software which have been independently
developed by Quintiles without the benefit of any information provided
by Interneuron. Interneuron and Quintiles agree that any computer
software programs, statistical methodologies or other formulae or
analyses used by Quintiles under or during the term of this Agreement
are the product of Quintiles' technical expertise possessed and
developed by Quintiles prior to the date of the Agreement and are the
sole and separate property of Quintiles. It is further acknowledged
that Quintiles' professional staff is possessed of certain technical
expertise and conceptual expertise in areas of drug development which
have been independently developed by Quintiles without the benefit of
any information provided by Interneuron. Interneuron and Quintiles
agree that such technical expertise processes, methods, approach or
analyses used by Quintiles under or during the term of the Agreement
are the product of Quintiles' technical expertise possessed and
developed by Quintiles prior to the date of this Agreement and are the
sole and separate property of Quintiles.
At the completion of services by Quintiles, all materials and all other
data, regardless of the method of storage or retrieval, shall either be
(i) delivered to Interneuron at its offices in Lexington,
Massachusetts, and in such form as is then currently in the possession
of Quintiles, (ii) retained by Quintiles for Interneuron for a period
of two years, or (iii) disposed of, at the direction and written
request of Interneuron unless such materials are otherwise required to
be stored or maintained by Quintiles as a matter of law or regulation.
4.0 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
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joint venturers. Quintiles agrees that it shall have no power or right
to bind or obligate Interneuron, nor shall Quintiles hold itself out as
having such authority.
5.0 PERFORMANCE OF SERVICES. In carrying out its responsibilities under
this Agreement, Quintiles agrees to assure that these services are
conducted in compliance with, when appropriate, any applicable protocol
and specifications and with all applicable laws, rules and regulations
including, but not limited to, the U.S. Food, Drug and Cosmetic Act and
the regulations promulgated pursuant thereto.
6.0 CONFLICT OF AGREEMENT. Quintiles represents and warrants to Interneuron
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 will not enter into an agreement to
provide services which would in any way prevent it from providing the
services contemplated under this Agreement.
7.0 PUBLICATION. From time to time it may be to the mutual interest of
Quintiles and Interneuron to publish articles relating to services
performed as a part of this Agreement. Publication of project
assignment results in whole or in part, shall be within the sole and
absolute discretion of Interneuron. Results may not be published or
referred to, in whole or in part, without the prior expressed written
consent of Interneuron. Interneuron reserves the unqualified right to
reject any article utilizing any data generated from Quintiles'
services under this Agreement before such article is presented or
submitted for publication.
8.0 LIMITATION OF LIABILITY. Neither Quintiles nor its affiliates nor any
of its or their respective directors, officers, employees or agents
shall have any liability whatsoever under this Agreement or otherwise
except with respect to damages attributable to Quintiles' gross
negligence or intentional misconduct. Notwithstanding the foregoing,
neither Quintiles, nor its affiliates, nor any of its or their
respective directors, officers, employees or agents shall have any
liability for any special, incidental, or consequential damages,
including, but not limited to the loss of opportunity, loss of the use
of any data or information supplied hereunder, loss of revenue or
profit, in connection with or arising out of this Agreement, the
services performed by Quintiles hereunder or the existence, furnishing,
functioning, or Interneuron's use of any information, documentation or
services provided pursuant to this Agreement, even if Quintiles shall
have been advised of the possibility of such damages. In addition, in
no event shall the collective, aggregate liability of Quintiles and its
affiliates and its and their respective directors, officers, employees
and agents under this Agreement exceed the amount of compensation
actually received by Quintiles from Interneuron pursuant to this
Agreement for the assignment or task from which such liability arose;
provided, however, if Quintiles is determined to have acted in a manner
that constitutes gross negligence or intentional misconduct, then, with
respect to such acts, the collective, aggregate liability shall not
exceed 1.5 times the amount of compensation specified above (but in no
event shall the collective, aggregate liability of Quintiles and its
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affiliates and its and their respective directors, officers, employees
and agents under this Agreement for all tasks and assignments exceed
the amount of compensation actually received by Quintiles from
Interneuron pursuant to this Agreement).
9.0 INDEMNIFICATION. Interneuron shall indemnify, defend and hold harmless
Quintiles, its affiliates and its and their respective directors,
officers, employees and agents (each, an "Indemnified Party") from and
against any and all losses, claims, actions, damages, liabilities,
costs and expenses, (including reasonable attorney's fees and court
costs) (collectively, "Losses"), relating to or arising from or in
connection with this Agreement (including, without limitation, any
Losses alleged to arise from or in connection with any study, test,
product or potential product to which this Agreement relates) or any
litigation, investigation or other proceeding relating to any of the
foregoing, except to the extent such Losses are determined to have
resulted solely from gross negligence or intentional misconduct of the
Indemnified Party seeking indemnity hereunder. Interneuron shall not
indemnify, hold harmless, or defend an Indemnified Party from claims or
damages to the extent such claims or damages are determined to have
resulted solely from the following:
a. negligent acts and/or omissions of any of the Indemnified Parties;
b. failure of any of the Indemnified Parties to adhere to all
provisions of the protocol relating to the Study furnished to
Quintiles by Interneuron and to written recommendations and written
instructions that have been delivered by Interneuron to Quintiles
concerning the administration and use of any of the drug
substances, including placebo, involved in the Study; or
c. failure of any of the Indemnified Parties to comply with any
applicable laws or regulations.
10.0 INDEMNIFICATION PROCEDURE. Quintiles shall: (a) give Interneuron notice
of any such claim or law suit (including a copy thereof served upon
Quintiles) and all relevant data relating thereto within fifteen (15)
days after such claim or law suit was served upon Quintiles; and (b)
Quintiles and its employees shall fully cooperate with Interneuron and
its legal representatives in the investigation of any matter the
subject of indemnification; (c) Quintiles shall not unreasonably
withhold its approval of the settlement of any such claim, liability,
or action by Interneuron the subject of this Indemnification provision;
; and (d) Quintiles shall not, except at its own cost, voluntarily make
any payment or incur any expense in connection with any Losses without
the prior written consent of Interneuron.
11.0 TERMINATION. This Agreement may be terminated without cause by
Interneuron or by Quintiles at any time during the term of the
Agreement on ninety (90) days prior written notice to Quintiles or
Interneuron, as appropriate. In the event this Agreement is
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terminated, Interneuron's sole obligation to Quintiles shall be to pay
to Quintiles any fees for services rendered then due and owing to
Quintiles because of any completed performance of Quintiles'
obligations hereunder; Interneuron will pay all actual costs to
complete activities associated with the termination and close out of
projects; Interneuron will pay all additional costs incurred by the
project that are required to fulfill regulatory requirements, provided
that Interneuron shall not pay any such costs incurred after ninety
(90) days from the date of written notice of termination, unless
approved in writing by Interneuron. Upon the termination of this
Agreement, Quintiles shall deliver to Interneuron all data and
materials provided by Interneuron to Quintiles for the conduct of
services under this Agreement. All statistical data, all statistical
reports, all data entries and any other documentation produced as the
result of services performed by Quintiles under the terms of this
Agreement shall be delivered to Interneuron at such time as payment has
been made to Quintiles for all services performed.
In the event this Agreement is terminated, Quintiles reserves the right
to retain one copy of all materials provided to Interneuron as the
result of services performed by Quintiles under this Agreement for a
period of five (5) years which will remain sealed unless a dispute
arises regarding the services performed by Quintiles hereunder.
12.0 FORCE MAJEURE. In the event Quintiles 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, failure of power or restrictive government or judicial
orders, or decrees, riots, insurrection, war, Acts of God, inclement
weather or other similar reason or cause beyond Quintiles' control,
then performance of such act shall be excused for the period of such
delay.
13.0 FEE SCHEDULE. It is the understanding of the parties that the total
cost of project assignments under this Agreement will not exceed the
amounts which may be agreed to in individual assignment agreements
which must be separately negotiated and contracted for.
Quintiles will invoice Interneuron monthly or as separately agreed for
services rendered hereunder and payment shall be made by Interneuron
within thirty (30) days of receipt of itemized invoices for work
completed.
14.0 EXPENSES. Quintiles shall be reimbursed by Interneuron for all usual
and customary travel and lodging expenses incurred in the performance
of services provided herein which have been requested or approved by
Interneuron. Payment for such services shall be made to Quintiles
within thirty (30) days of receipt by Interneuron of invoices or other
evidence of such expenditures.
15.0 REVIEW OF WORK. During the term of this Agreement, Quintiles will
permit Interneuron's representative(s) to examine the work performed
hereunder and the facilities at which the work is conducted at
reasonable times and in a reasonable manner to determine that the
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project assignment is being conducted in accordance with the agreed
task and that the facilities are adequate. Furthermore, upon reasonable
prior notice, Interneuron shall be permitted to inspect all potential
patient records, and all pertinent information pertaining to the Study
and, at its option, monitor the Study or any portion thereof, at the
various clinical sites prior to, during and for a reasonable time after
the Study is completed, all subject any applicable legal restrictions
regarding the confidentiality of patient records.
16.0 NOTICES. 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 three days after the date
postmarked if sent by registered or certified U.S. mail, return receipt
requested, postage prepaid or by nationally recognized overnight
delivery service to the following addresses:
If to Quintiles: Kenneth A. Williams, Dr.P.H.
Vice President, Contracts Management and
Planning Quintiles, Inc.
P.O. Box 13979
Research Triangle Park, North Carolina 27709-3979
If to Interneuron: Bobby W. Sandage, Jr., Ph.D.
Executive Vice President Research and Development
Interneuron Pharmaceuticals, Inc.
99 Hayden Avenue, Suite 340
Lexington, Massachusetts 02173
17.0 ASSIGNMENT. Quintiles may assign or subcontract all or a portion of the
work provided for in any separately contracted amendment to this
Agreement to an affiliate of Quintiles; provided, however, that in no
event shall such assignment or subcontracting of work to an affiliate
release Quintiles from any of its obligations hereunder and any such
affiliate shall be bound by the terms and conditions of this agreement
as if such affiliate was an original party hereto.
18.0 GOVERNING LAW. This Agreement shall be construed, governed,
interpreted, and applied in accordance with the laws of the State of
North Carolina. If any one or more provisions of this Agreement shall
be found to be illegal or unenforceable in any respect, the validity,
legality and enforceability of the remaining provisions shall not in
any way be affected or impaired thereby.
19.0 SURVIVAL. The obligations of the parties contained in Sections 2.0, 7.0
and 8.0 hereof, including, without limitation, the indemnity
obligations contained in Sections 9.0 and 10.0 shall survive the
closing of this Agreement.
20.0 ENTIRE AGREEMENT. This Agreement contains the entire understandings of
the parties with respect to the subject matter herein, and supersedes
all previous Agreements (oral
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and written), negotiations and discussions. The parties, from time to
time during the term of this Agreement, may modify any of the
provisions hereof only by an instrument in writing duly executed 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. Interneuron Pharmaceuticals, Inc.
By: /s/ K.A. Williams By: /s/ Glenn L. Cooper
-------------------------- -----------------------------
K. A. Williams, Dr. P.H. Glenn L. Cooper
Vice President President
Contracts Management and Planning
Date: July 12, 1996 Date: July 12, 1996
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FEDERAL ID # 56-1323952
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