Contract Research Agreement - Target Research Associates Inc. and Cubist Pharmaceuticals Iinc.
CONFIDENTIAL TREATMENT
CONTRACT RESEARCH AGREEMENT
FOR TARGET RESEARCH ASSOCIATES, INC.
TO PROVIDE CLINICAL RESEARCH SERVICES
TO CUBIST PHARMACEUTICALS, INC.
PROTOCOL: DAP-00-05
A RANDOMIZED, DOUBLE-BLIND, PHASE III, COMPARATIVE
STUDY OF CIDECIN(TM)(DAPTOMYCIN) TO ROCEPHIN(R)
(CEFTRIAXONE) IN THE TREATMENT OF MODERATE TO
SEVERE COMMUNITY-ACQUIRED ACUTE BACTERIAL
PNEUMONIA DUE TO S. PNEUMONIAE
*Confidential treatment requested: Material has been omitted and filed with
the Commission.
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This Agreement is made by and between Target Research Associates, Inc.
(hereinafter "TARGET") of 554 Central Avenue, New Providence, New Jersey 07974,
and Cubist Pharmaceuticals, Inc. (hereinafter "CUBIST") of 24 Emily Street,
Cambridge, MA 02139. CUBIST is contracting with TARGET to provide the services
detailed in the attached budgets, one budget for work in the U.S., the other for
work in Poland (hereinafter, collectively referred to as the "Budget") for the
clinical study (hereinafter the "Study") according to Cubist protocol DAP-00-05.
I. BUDGET, INVOICES, AND PAYMENTS
The Budget includes a detailed list of activities to be performed by
TARGET and associated fees and expenses, as well as key study
parameters, timing, and other assumptions on which the Budget is
based. Budget revisions following execution of this Agreement must be
documented by a change order prepared by TARGET and approved in
writing by CUBIST. A change order may be expected in the event of a
change of a key Study assumption or parameter, including significant
changes in timing. It is the responsibility of TARGET to immediately
inform CUBIST of the Budget implications of any such changes.
TARGET's services will be performed on [ ]*. TARGET may not exceed the
total Budget by greater than [ ]*% without first obtaining written
approval from CUBIST.
TARGET will provide monthly invoices to CUBIST for fees and expenses
incurred for that particular month. TARGET's invoices shall be
accompanied by an updated Budget/Expense Reconciliation Report
providing the status of each budget line-item regarding (a) the amount
incurred for that particular month, (b) the total amount incurred to
date, and (c) the remaining budget for that line-item. Back-up reports
and other items will be attached as appropriate, with the aim of
providing CUBIST with sufficient detail in a clear format to enable
thorough financial monitoring of the project. Payment by CUBIST on
invoices issued by Target will be due [ ]*. Balances not paid within
this time will accrue interest at [ ]*% per month or part thereof for
each month after the aforementioned due date.
II. CONFIDENTIALITY
During the term of this Agreement and thereafter (including following
any termination), TARGET agrees to retain in confidence and to refrain
from disclosing and/or using for its benefit (other than for the
purposes indicated herein) or the benefit of any third party, any and
all information and/or data ("Confidential Information") derived from
the Study and/or disclosed to TARGET as a result of its services under
this Agreement and/or obtained by TARGET or its representatives while
visiting CUBIST' facilities and any and all data and/or analysis
arising or derived from such Confidential Information or the subject
Study without the prior written consent of CUBIST. This restriction
shall not apply to Confidential Information:
*Confidential treatment requested: Material has been omitted and filed with
the Commission.
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o which is or becomes public knowledge (through no fault of
TARGET's or its representatives), or
o which is lawfully made available to TARGET by an independent
third party not under an obligation of confidence to CUBIST
(and such lawful availability can be properly demonstrated by
TARGET), or
o which is already in TARGET's possession at the time of the
initial receipt from CUBIST (and such prior possession can be
properly demonstrated by TARGET), or
o which is required by law, regulation, rule, act, or order of
any governmental authority or agency to be disclosed by
TARGET; provided, however that TARGET notifies and consults
with CUBIST prior to such disclosure.
TARGET shall limit disclosure of Confidential Information received
hereunder to only those of its officers, employees, subcontractors
and/or investigators who have a legitimate need to know such
Confidential Information. TARGET shall advise such persons, upon
disclosure to them of any Confidential Information, of the proprietary
nature thereof and the terms and conditions of this Agreement and shall
use all reasonable safeguards to prevent unauthorized disclosure by
such persons.
III. PUBLICATIONS
TARGET agrees that it will not make any publication, including any
abstracts, posters or articles relating to the Study or the services
performed pursuant to this Agreement without the prior written consent
of CUBIST.
IV. OWNERSHIP OF STUDY OUTPUTS AND INVENTIONS
All concepts, inventions, ideas, patent rights, records, data,
trademarks and copyrights, including electronic data, files, and
programs which are related to, arise out of, or are in connection with
TARGET's work or any and all services performed by it pursuant to this
Agreement will be the exclusive property of, and all ownership rights
shall vest in CUBIST.
V. TERM
The term of this Agreement shall begin on the date it is executed by
both TARGET and CUBIST. The term of the Agreement [ ]*.
VI. TERMINATION
CUBIST shall have the right at any time to terminate the Study prior to
completion by giving [ ]* days written notice to TARGET. In the event
of notice of termination,
*Confidential treatment requested: Material has been omitted and filed with
the Commission.
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TARGET shall immediately use its best efforts to reduce and/or
eliminate any and all costs and/or expenses to CUBIST, and CUBIST shall
be obliged to pay TARGET the fees and expenses for (a) all Budget
activities which have been completed, (b) all Budget items which have
been irrevocably committed, and (c) all activities subsequently agreed
to by CUBIST which are required to wind-up TARGET's activities on the
Study.
VII. DEFAULT
TARGET shall be in default under the terms and conditions of this
Agreement if TARGET negligently, recklessly or intentionally fails to
perform any of the contracted services or if TARGET is unable to
continue operations or perform its obligations herein in a manner
acceptable to applicable state, local, federal rules, regulations and
ordinances. Notwithstanding the foregoing, if any default occurs,
CUBIST shall promptly notify TARGET in writing of such default. TARGET
shall have a period of 30 days from the date of such notice within
which to cure such default. If TARGET fails to cure, then this
Agreement shall, at CUBIST's option, immediately terminate, and CUBIST
shall have no liability for such termination except as may be otherwise
set forth in Section VI.
VIII. NOTICES
All notices pertaining to this Agreement shall be in writing and sent
to the respective parties as follows:
TO CUBIST: TO TARGET:
Mr. Ed Campanaro Mr. Lloyd J. Baroody
Director, Clinical Affairs Managing Director
Cubist Pharmaceuticals, Inc Target Research Associates, Inc.
24 Emily Street 554 Central Avenue
Cambridge, MA 02139 New Providence, NJ 07974
IX. RELATIONSHIP
It is understood and agreed that TARGET is an independent contract
research organization and is not an agent or employee of CUBIST.
Accordingly, TARGET will have exclusive control over its employees and
agents.
TARGET will not have authority to bind or commit CUBIST in any manner
whatsoever and will not, at any time, hold itself out to third parties
as having authority to enter into or incur any commitments, expenses,
liabilities, or obligations of any nature on behalf of CUBIST.
X. INDEMNIFICATION
CUBIST agrees to indemnify, defend and hold harmless TARGET, its
affiliates, agents, and employees from and against any and all losses,
costs, expenses
*Confidential treatment requested: Material has been omitted and filed with
the Commission.
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(including reasonable attorneys' fees), claims, actions, liabilities,
damages, or law suits suffered or incurred by TARGET as a result of
bodily injury occurring to a patient in the Study, except to the extent
that any such losses, costs, expenses, claims, actions, liabilities,
damages, or law suits is caused by the negligence or intentional
misconduct of TARGET, its affiliates, agents, or employees.
TARGET agrees to indemnify, defend and hold harmless CUBIST, its
affiliates, agents, and employees from and against any and all losses,
costs, expenses (including reasonable attorneys' fees), claims,
actions, liabilities, damages, or law suits suffered or incurred
resulting from TARGET's negligent performance of the obligations
required herein, or intentional or reckless misconduct.
Each party agrees to provide the other with prompt notice of any such
claim, action, or lawsuit. In the event the aforesaid indemnity is
invoked, the Indemnitor shall have the right, but not the obligation,
to manage and control the defense and settlement of any and all such
claims, actions or lawsuits, and shall have the right to select and
engage counsel of its own choice. Each party shall cooperate fully with
the other in defense of any and all claims, actions or lawsuits.
XI. FORCE MAJEURE
A party shall be excused from performing its obligations under this
Agreement if its performance is delayed or prevented by any cause
beyond such party's control, including but not limited to, acts of God,
fire, explosion, weather, war, insurrection, civil strife, riots,
government action, or power failure not specific to Target's
facilities. Performance shall be excused only to the extent of and
during the reasonable continuance of such disability. TARGET will
immediately notify CUBIST if, by reason of any of the disabilities
referred to herein, TARGET is unable to meet any deadline or time for
performance. In the event that any part of a Study is rendered invalid
as a result of such disability, TARGET will, upon written request from
CUBIST and at CUBIST' sole cost and expense, repeat that part of the
Study affected by the disability.
XII. MISCELLANEOUS
WAIVER. No waiver of any term, provision, or condition of this
Agreement whether by conduct or otherwise in any one or more instances
shall be deemed to be or construed as a further or continuing waiver of
any such term, provision, or condition or of any other term, provision,
or condition of this Agreement.
AMENDMENTS. Any amendments or revisions to this Agreement must be
proposed in writing by either party and accepted in writing by the
other party before they shall become effective and binding.
ACCESS TO RECORDS/AUDITS. TARGET will permit representatives of CUBIST
to have access at reasonable times to TARGET's premises for the purpose
of observing
*Confidential treatment requested: Material has been omitted and filed with
the Commission.
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performance of the Study and/or reviewing data pertaining to the Study.
If any governmental or regulatory authority conducts or gives notice to
TARGET of its intent to conduct an inspection of TARGET or at any
investigational site or take any other regulatory action with respect
to the Study or contracted services provided under this Agreement,
TARGET shall (a) notify CUBIST of such inspection; (b) allow CUBIST the
right to be present at any such inspection; (c) allow CUBIST to have
primary responsibility for preparing any responses which may be
required; and (d) give CUBIST the opportunity to challenge any order of
a regulatory or governmental activity.
LEGAL COMPLIANCE. TARGET shall perform all work under this Agreement in
conformity with all applicable federal, state, and local laws and
regulations.
ASSIGNMENT. This Agreement may not be assigned by either party without
the other's prior written consent, which consent shall not be
unreasonably withheld.
CONTINUITY. In the event that CUBIST is acquired by another entity or
if the invention which is the subject of this Agreement is acquired by
another entity, or if there is an agreement which results in another
entity assuming control of the Study, CUBIST agrees to use its best
efforts to allow for TARGET to continue performing its responsibilities
for the remaining term of the Agreement.
SEVERABILITY. If any provision of this Agreement shall be deemed void
in whole or in part for any reason whatsoever, the remaining provisions
shall remain in full force and effect.
This Agreement constitutes the entire and only Agreement between CUBIST and
TARGET regarding the Study described herein, and all prior negotiation,
representations, agreements, and understandings are superseded hereby.
This Agreement becomes effective and binding on both parties upon its execution.
FOR: TARGET RESEARCH ASSOCIATES, INC.
By (signature): /s/ LLOYD J. BAROODY Date: JULY 7, 2000
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Print Name: Lloyd J. Baroody Title: Managing Director
FOR: CUBIST PHARMACEUTICALS, INC.
By (signature): /s/ ROBERT MCCORMACK Date: AUGUST 1, 2000
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Print Name: Robert McCormack Title: Senior VP, Development
*Confidential treatment requested: Material has been omitted and filed with
the Commission.