Contract of Monitoring Services - Cubist Pharmaceuticals Inc. and Clindev (Pty) Ltd.
CONFIDENTIAL TREATMENT
CONTRACT OF MONITORING SERVICES
Between
CUBIST PHARMACEUTICALS, INC
Duly represented by MICHAEL F DEBRUIN
(Hereinafter referred to as "SPONSOR")
And
CLINDEV (PROPRIETARY) LIMITED
Duly represented by MRS. A. LESSING
(Hereinafter referred to as "Clindev")
WHEREAS
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Now, therefore, in consideration of the mutual covenants and promises
hereinafter set forth, the parties hereby agree as follows:
1 INTERPRETATION
For the purposes of this agreement, including the Annexures attached hereto
("the Agreement"):
1.1 the section0 headings are for reference purposes only and shall not
be used in the interpretation thereof.
1.2 unless the context indicates a contrary intention, expressions,
which denote any gender, shall include the other gender.
1.3 the singular shall include the plural and vice versa.
1.4 "The signature date" means the date on which this agreement is
signed by the last party to do so.
1.5 Whenever a number of days is prescribed in this agreement, such
number of days shall be calculated excluding the first and including
the last day, unless the last day falls on a Saturday, Sunday or
official public holiday, in which case, the last day shall be the
next day which is not a Saturday, Sunday or public holiday.
1.6 All currencies are $US.
2 APPOINTMENT
SPONSOR hereby grants Clindev the right to provide monitoring services on
behalf of SPONSOR pursuant to the study (the "Study") set forth in PROTOCOL
DAP-SST9901 (the "Protocol") a copy of which is attached hereto as Annex 1,
as amended from time to time upon mutual agreement of the parties hereto
pursuant to section 14.
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Clindev shall exercise its best efforts to perform the Study. Clindev shall
perform the Study in strict accordance with the Protocol and in strict
accordance with the terms and conditions of this Agreement. During the term
of this Agreement, Clindev will not enter into any agreement to provide
services which would in any way materially impair its ability to completing
its services to SPONSOR hereunder in a timely fashion.
3 DURATION OF CONTRACT
This Agreement shall commence from [ ]* and terminate on [ ]* unless
terminated earlier as provided herein.
4. PAYMENT FOR SERVICES
4.1 SPONSOR shall pay to Clindev $[ ]* (the "Contract Price) for the
services rendered under the Agreement in accordance with the payment
schedule set forth in section 4.2.
For the purposes of this Agreement, the contract value is based on
inclusion of [ ]* patients ($[ ]* per completed patient) and
includes all activities from the first review of the Protocol till
the Study is finally closed out and all correction log forms have
been processed subject to Section 3.
4.2 Payment of the aforesaid sum stipulated in Section 4.1 shall be made
as follows.
4.2.1. [ ]*.
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4.2.2. [ ]*;
4.2.3. [ ]*. Each invoice will reflect a proportional amount
of the payment set forth in section 4.2.1. and 4.2.2.
4.3 All relevant and pre-approved costs reasonably incurred by Clindev
for the performance of this Study will be for SPONSOR'S account,
based upon submission of receipts, where applicable.
4.4 Should the Study require additional monitoring and management, costs
will be re-assessed in consultation with SPONSOR and such costs
shall be based upon submission of itemised monitoring activities;
provided, however, that the costs of the Study shall not be
increased without SPONSOR'S prior written consent.
5 OBLIGATIONS OF CLINDEV
Clindev shall perform the following monitoring requirements in particular:
5.1 Perform monitoring duties and responsibilities according to the
SPONSOR'S Standard Operating Procedures ("SOP's"). The SOP's may be
amended by SPONSOR from time to time. Monitoring procedures shall
comply with good clinical practice guidelines to ensure the
acceptability of the data from the Study for international
registration purposes.
5.2 Initiate Study centres as selected by the SPONSOR in consultation
with Clindev.
5.3 Assess Protocol for monitoring requirements,
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5.4 Assess Clinical Case Record Form for monitoring requirements,
5.5 Perform pre-study consultation/communications,
5.6 Obtain the appropriate Regulatory Authority and Ethics Committee
approvals in respect of the investigational sites,
5.7 Verify source data. Level of source data verification to be mutually
agreed upon by the parties; provided, however, that in all events
such level of verification shall meet the minimum requirements set
forth in SOP's;
5.8 Check each study book for completeness and clarity, cross-check with
pre-specified source documents giving due consideration to data
protection and medical confidentiality.
5.9 Monitor and update trial master file documentation and review the
Investigator's file,
5.10 Monitor all centres at regular intervals throughout the Study by
personal visits (at least every six weeks) and telephone contacts
(at least every other week).
5.11 Complete monitoring reports according to the SOP's and verify source
data as specified by the responsible study manager. Submit completed
monitoring reports within 14 (fourteen) working days,
5.12 Report adverse events and serious adverse events ("SAE") according
to the SOP's,
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5.13 Communicate all SAE's to the SPONSOR, copying the responsible study
manager as per the SOP's. If applicable, the investigator will
forward the SAE report to the applicable ethics committee,
otherwise, a copy of the SAE report must be forwarded on behalf of
the investigator to the ethics committee and also the Medicines
Control Council. Clindev will provide additional information
regarding the SAE to the SPONSOR copying the responsible study
manager.
5.14 Account and reconcile the Study drug supply and other Study
materials,
5.15 Close the Study out,
5.16 Assist the investigator with correction log forms,
5.17 Be available and assist during audits from regulatory affairs
bodies, (FDA, MCC, etc.) or from SPONSOR personnel. Clindev
undertakes to grant the SPONSOR full and complete access to all
Study-related documents and facilities after having received 72
(Seventy-Two) hours written notice from the SPONSOR.
SPONSOR may (a) examine and inspect Clindev's facilities required to
perform the Study, and (b) inspect and copy all data and work
product related to the Study. Clindev shall co-operate with any
regulatory authority and allow them access to relevant records and
data to the extent permitted by law.
5.18 Submit a monthly status report to the SPONSOR within [ ]* working
days after the last working day of the month.
5.19 Deliver data on the Study in English (the "Case Reports") for each
patient or subject participating in the Study (each a "Study
Subject") as provided in the Protocol to the SPONSOR on an
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ongoing basis; and deliver all Case Reports to SPONSOR no later than
[ ]* days after the date of termination of this Agreement or the
date on which SPONSOR reasonably requests delivery of the Case
Reports.
5.20 Meet with representatives of SPONSOR at times and places mutually
agreed upon to discuss progress, results and future direction of the
Study.
6. OBLIGATIONS OF THE SPONSOR
6.1 SPONSOR will provide information on the chemical, pharmaceutical,
toxicological and clinical information of DAPTOMYCIN, as well as any
relevant new information arising during the Study.
6.2 SPONSOR will provide the necessary quantity of materials for the
Study and all Study documentation (Case report forms, informed
consent forms etc).
6.3 SPONSOR will provide training to Clindev for issues related to
SPONSOR processes as and when required.
6.4 SPONSOR will arrange and hold the start-up meetings prior to
commencement of the Study to ensure adequate knowledge of the Study
procedures. The SPONSOR will pay all related costs, including travel
and accommodation costs for all attendees.
6.5 SPONSOR will pay for all material transport costs and additional
administration costs, such as informed consent translation, all
International and local courier fees, submission and approval fees
levied by regulatory bodies or ethics
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committees, investigator fees and all laboratory costs. (Clindev
shall charge a [ ]*% handling fee for expenses paid on behalf of the
SPONSOR.)
7. CONFIDENTIALITY
Clindev shall hold all negotiations with the SPONSOR in the strictest
confidence and shall not disclose any information to third parties,
including all past and proposed future studies.
During the term of this Agreement and for a period of Five years thereafter
Clindev shall maintain in the strictest confidence all information received
from the SPONSOR for the performance of the Study, as well as the data and
results of the Study. Such data and results, whether patentable or not,
shall be the exclusive property of the SPONSOR, who shall be free to protect
them as it deems expedient, to use them and to disclose them to any third
party.
Clindev shall therefore neither publish nor disclose to any third party,
without the SPONSOR'S prior written approval, the information disclosed by
the SPONSOR and the results obtained from the Study, as long as they are not
in the public domain through no fault of Clindev. Clindev shall impose such
commitment upon any person in charge of the Study, including its own
personnel. Clindev may use the information disclosed by the SPONSOR only to
the extent required to accomplish the purposes of the Agreement. Clindev
shall promptly notify the SPONSOR upon discovery of any unauthorised use or
disclosure of the information disclosed by the SPONSOR.
Unless otherwise required by law, regulation or government agency, the
SPONSOR on its part will not publish or disclose the activities of Clindev,
without the prior written consent of Clindev, which consent shall not be
unreasonably withheld.
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8. INDEMNIFICATION
8.1 Sponsor agrees to defend and indemnify, and hold harmless Clindev
and its employee, directors and agents from and against any loss,
damage, cost and expense (including reasonable attorneys' fees and
expenses) to which Clindev, may become subject as a result of any
claims, proceedings, or investigations directly caused by the
testing and/or reporting results of testing daptomycin in strict
accordance with the Protocol.
Insurance. The indemnifying parties shall secure and maintain in
full force and effect through the performance of the Study (and
following termination of the Study to cover any claims arising from
the Study) insurance coverage in amounts appropriate to the conduct
of Clindev's business activities and the services contemplated by
the Study and shall provide evidence of insurance coverage in an
acceptable form upon request.
9 TERMINATION
9.1 SPONSOR, for any reason may terminate this Agreement or any specific
project performed under this Agreement at any time with or without
cause by giving Clindev at least [ ]* days prior written notice.
During the [ ]* day period between the notice of termination and the
effective date of such termination, Clindev will use all reasonable
efforts to complete such project as soon as practicable in
accordance with its responsibilities under this Agreement and
applicable law and regulation, in order to reduce or eliminate
further costs, and to cancel, if permitted under the terms of
applicable agreements, any third party obligations.
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9.2 Within [ ]* days after the completion or termination of a project
hereunder, Clindev will provide SPONSOR with a written itemised
statement in English in reasonably specific detail of
(a) all work performed in connection with such project and (b) all
expenditures by Clindev (determined in accordance with generally
accepted accounting principles consistently applied) in conducting
such project prior to the completion or termination of such project.
In the event of termination of any project pursuant to this Section
9, Clindev will be entitled to a payment based on the amount of
services properly rendered and monies properly expended by Clindev
in connection with such project through the date of termination. If
the amount paid by SPONSOR to Clindev in connection with any such
project exceeds such amount, then Clindev will promptly refund such
excess to SPONSOR, and if such amount exceeds the amount already
paid by SPONSOR to Clindev in connection with such project, then
SPONSOR will promptly pay the amount of such excess to Clindev.
Clindev shall keep complete and accurate records in English in
sufficient detail to properly reflect all expenditures by Clindev in
conducting the Study and to permit SPONSOR to confirm the accuracy
of all payments due hereunder. Upon, written request, SPONSOR shall
have the right to cause an independent, certified public accounting
firm of internationally recognised standing reasonably acceptable to
Clindev to audit such records to verify the accuracy of the
expenditure report provided
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hereunder. SPONSOR shall bear the cost of any such audit. The
parties shall use best efforts to resolve expeditiously any
disagreement related to any amounts due under the Agreement and,
9.3 Notwithstanding the forgoing, should this Agreement be terminated by
the SPONSOR, any reason other than the breach of any material
provision of this Agreement by Clindev, then Clindev will be
entitled to payments or retention of payments equal to the amount
set forth in Section 4.2.1. (i.e. [ ]*).
9.4 Any undisputed refund or payment under this Section 9 will be made
within [ ]* days after SPONSOR'S receipt of Clindev's itemised
statement.
9.5 This Agreement may be terminated by either party upon the breach of
any material provision of this Agreement by the other party,
provided that the breaching party will be given not less than [ ]*
days prior written notice of such breach and the opportunity to cure
such breach during such [ ]*-day period. In the event this Agreement
is terminated by Clindev pursuant to this Section 9.3 Clindev will
provide SPONSOR with a written itemised statement and a
reconciliation will be made as provided for in Section 9.2.
9.6 This Agreement may be immediately terminated by either party upon
written notice to the other party if the other party becomes
insolvent, is dissolved or liquidated, makes a general assignment
for the benefit of its creditors, or files or had filed against it,
a petition in bankruptcy or has a receiver appointed for a
substantial part of its assets.
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9.7 This Agreement may be terminated by either party upon written notice
to the other party if any of the following conditions occur: (a) if
the authorisation and approval to perform the Study in South Africa
is withdrawn by the appropriate regulatory agency; (b) if the
emergence of any adverse reaction, side effect or toxicity with any
drug administered in the Study is of such magnitude or incidence in
the opinion of either the SPONSOR or Clindev to support termination.
9.8 Immediately upon receipt of a notice of termination, Clindev shall
stop enrolling Study Subjects into the Protocol and shall cease
conducting procedures on Study Subjects already enrolled in the
Protocol as directed by the SPONSOR, to the extent medically
permissible.
9.9 Upon termination or completion of the Study, all unused compounds,
drugs, devices, Case Reports, whether completed or not completed,
and other related materials that were furnished to Clindev by or on
behalf of SPONSOR shall be promptly returned to SPONSOR at the
SPONSOR'S expense.
9.10 Expiration or termination of this Agreement shall not relieve the
parties of any obligation accruing prior to such expiration or
termination.
10. ADDRESSES
The parties choose the following addresses to which notices may be given,
and at which documents in legal proceedings may be served, (i.e. their
domicilia citandi et executandi) in connection with this Agreement:
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In the case of Clindev:
Postal address: P.O. Box 1417
Wingate Park
0153
South Africa
Physical address: 42 Ingersol Road
Lynwood Glen
Pretoria
0081
South Africa
Fax: (012) 348 0552
In the case of the SPONSOR:
Postal address: Cubist Pharmaceuticals, Inc.
24 Emily Street
Cambridge
MA 02139
USA
Physical address: Cubist Pharmaceuticals, Inc.
24 Emily Street
Cambridge
MA 02139
USA
Fax (617) 576 1999
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10.1 Notices given to the above addresses shall be deemed to have been
duly given:
10.1.1 14 days after posting if posted by first-class registered or
certified post to the party's postal address;
10.1.2 on delivery, if delivered to the party's physical address;
10.1.3 on confirmation of receipt, if sent to the party's fax
number; or
10.1.4 on receipt, if sent by overnight delivery service.
10.2 A party may change that party's address for this purpose, by notice
in writing to the other party.
11. NO REPRESENTATIONS
A party may not rely on any representation, which allegedly induced that
party to enter into this Agreement, unless the representation is recorded in
this Agreement.
11 ENTIRE AGREEMENT; AMENDMENT
This Agreement, including the annexes attached hereto, constitutes the
entire contract between the parties relative to the subject matter hereof
and supersedes all representations, warranties, agreements or undertakings
previously made relative to such subject matter, and no such
representations, warranties, agreements or undertakings shall be any force
and effect unless contained herein. In the event of any inconsistency
between the provisions of this Agreement and the Protocol, the provisions of
this Agreement shall govern.
No modification or amendment variation of any of the terms and conditions of
this Agreement will be binding on the parties unless committed to writing
and signed by both parties.
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12 CESSION; ASSIGNMENT
A party may not cede, assign or otherwise transfer that party's rights or
obligations under this Agreement without the prior written consent of the
other party, which consent may not be unreasonably withheld; provided,
however, SPONSOR may assign this Agreement without the prior written consent
of Clindev (a) in connection with the transfer or sale of all or
substantially all of the business of SPONSOR to which this Agreement
relates, whether by merger, sale of stock, sale of assets or otherwise, or
(b) to any affiliate of SPONSOR.
The rights and obligations of the parties under this Agreement shall inure
to the benefit of and be binding upon the successors and permitted assigns
of the parties. Any assignment not in accordance with this Agreement shall
be void. No assignment shall relieve either party of its responsibilities
for the performance of accrued obligation that such party may then have
under this Agreement.
13 INDULGENCES
The grant of any-indulgence by a party under this Agreement shall not
constitute a waiver or any right by the grantor or prevent or adversely
effect the exercise by the grantor of any existing future right of the
grantor.
15 ARBITRATION
Any dispute arising out of or in connection with this Agreement, including
any question regarding its existence, validity or termination, shall be
referred to and finally resolved by arbitration under the London Court of
International Arbitration Rules, which Rules are deemed to be incorporated
by reference into this clause. The number of
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arbitrators shall be three unless the dispute involves a claim of damages
for less than $[ ]* USD, in which case the number of arbitrators shall be
one. The seat, or legal place, of arbitration shall be London, England. The
language to be used in the arbitral proceedings shall be English. The
governing law of the contract shall be the substantive law of England.
Judgment upon the arbitrator's award may be entered in any court of
competent jurisdiction. Nothing contained in this Section or any other
provisions of this Agreement shall be construed to limit or preclude a party
from bringing any action in any court of competent jurisdiction for
injunctive or other provisional relief to compel the other party to comply
with its obligations hereunder before or during the pendency of arbitration
proceedings.
16 AUTHORITY; WARRANTY DISCLAIMER; LIMITATION OF LIABILITY
16.1 Each party represents and warrants to the other party that (a) such
party is duly organised, validly existing, and in good standing
under the laws of the place of its establishment or incorporation;
(b) such party has taken all action necessary to authorise it to
enter into this Agreement and perform its obligations under this
Agreement; (c) this Agreement shall constitute the legal, valid and
binding obligations of such party; and (d) neither the execution of
this Agreement, nor the performance of such party's obligations
hereunder, shall conflict with, result in breach of, or constitute a
default under any provision of the Articles of Incorporation,
business license, Bylaws or similar organisational documents of such
party, or of any law, rule, regulation, authorisation's or approval
of any government entity, or of any agreement to which it is party
or by which it is bound.
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16.2 Except as expressly set forth in this Agreement, neither party makes
any representation or warranty to the other party of any kind,
express, or implied, including, without limitation, any warranty of
non-infringement, merchantability or fitness for a particular
purpose.
16.3 Neither party shall be entitled to recover from the other party and
special incidental, exemplary, consequential or punitive damages in
connection with this Agreement or study performed hereunder.
17 PATENTS AND INVENTIONS
In consideration of the SPONSOR'S payment of all costs of the Study, any New
Invention or Discovery (as defined below) and any ideas, know-how and data
(including results of the Study) generated in direct performance of work in
connection with the Study, shall be the sole and exclusive property of
SPONSOR. Clindev will take all acts reasonably required to facilitate patent
prosecution and convey title in such property to SPONSOR. For purposes of
this Agreement, "New Invention and Discovery" means any invention or
discovery conceived of and reduced to practise during and as a part of the
Study by Clindev's staff, employees, volunteers, agents or representatives,
or jointly by such an individual or individuals with one or more contractors
or employees of SPONSOR, as determined in accordance with the rules of
inventorship under the United States patent law. Clindev shall promptly
notify SPONSOR in writing of any New Inventions or Discovery. Such notice
shall provide a full written description of the New Invention or Discovery.
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18 USE OF CLINDEV'S OR SPONSOR'S NAME
Clindev and SPONSOR shall obtain the prior written consent from the other
party before using the name, symbols and/or marks of the other party, in any
form of publicity in connection with the Study, except legally required
disclosures by Clindev or SPONSOR, reports generated in the normal course of
business by Clindev or SPONSOR, or where acknowledgement of sponsorship is
required by the guidelines of a scientific publication or organisation.
19 CHANGES TO THE PROTOCOL
If at a future date changes to the Protocol appear desirable, such changes
may be made through prior written agreement between SPONSOR and Clindev. If
such changes increase the costs for the Study, Clindev shall submit to
SPONSOR a written estimate of such cost for approval. If in the course of
performing this Agreement, however, one party determines that generally
accepted standards of clinical research and medical practice relating to the
safety of the Study Subjects require a deviation from the Protocol, the
parties will commence discussions immediately regarding such deviation and
will promptly amend the Protocol to bring the Protocol into conformity with
such standards.
20 CONFORMANCE WITH LAW AND ACCEPTED PRACTICE
Clindev shall perform the Study in conformance with generally accepted
standards of good clinical practice, with the Protocol, instructions
provided by SPONSOR, and with all applicable local,
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state and federal laws and regulations, including, but not limited to, the
Federal Food, Drug and Cosmetic Act and regulations of the Food and Drug
Administration (the "FDA"). Clindev shall retain all records resulting from
the Study for the time required by applicable federal regulations (SPONSOR
shall notify Clindev of the FDA application filing and approval status), and
allow for inspection of all study specific records.
21 NO TRANSFER OF PROPRIETRY RIGHTS
Neither the SPONSOR nor Clindev hereby transfers to the other party by
operation of this Agreement any patent, patent application, copyright,
trademark or other intellectual property right owned by or under the control
of either party, except as specifically set forth in this Agreement.
22 FORCE MAJEURE
Neither party shall be held responsible to the other party nor be deemed to
have defaulted under or breached this Agreement for failure or delay in
fulfilling or performing any term of this Agreement when such failure or
delay is caused by or results from causes beyond the reasonable control of
the affected party, including, without limitation, fire, floods,
earthquakes, natural disasters, embargoes, war, acts of war (whether war be
declared or not), insurrections, riots, civil commotion, strikes, lockouts
or other labour disturbances, acts of God or acts, omissions or delays in
acting by any governmental authority or the other party.
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22 WAIVER
Except as specifically provided for herein, the waiver from time to time by
either party of any right or failure to exercise any remedy shall not
operate or be construed as a continuing waiver of the same right or remedy
or of any other of such party's rights or remedies provided under this
Agreement.
23 SEVERABILITY
In case any provision of this Agreement shall be invalid, illegal or
unenforceable, the validity, legality and enforceability of the remaining
provisions shall not in any way be affected or impaired hereby.
24 GOVERNING LANGUAGE
This Agreement is entered into in the English language. All meetings,
correspondence and notices between the parties, and all Case Reports,
records, accounts, notes, reports, data, work product and proposed
publications or presentation materials related to the Study, shall be in
English. In the event of any dispute concerning the construction or meaning
of this Agreement, reference shall be made only to this Agreement as written
in English and not to any translation into any other language.
25 INDEPENDENT CONTRACTORS
It is expressly agreed that SPONSOR and Clindev shall be independent
contractors and that the relationship between the parties shall not
constitute a partnership, joint venture or agency of any kind. Neither party
shall have authority to make statements or commitments of any kind, or take
any action, which shall be binding on the other party, without the prior
written consent of the other party.
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26 YEAR 2000 COMPLIANCE
Clindev assures that its computer systems and processes shall be able to
accommodate and process date information later than 31 December 1999 such
that the year 2000 shall be recognized as the year 2000, rather than 1900.
Clindev assures that its computer systems will be Y2K compliant
26 COUNTERPARTS
This Agreement may be executed in two or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one
and the same instrument.
In witness whereof, the parties have caused this Agreement to be executed by
the respective duly authorised officers as of the dates set forth below.
Thus done and signed at: Cambridge, MA, USA on this the 17th Day of December
1999.
For: the SPONSOR
WITNESS:
1. By: /S/ MICHAEL F. DEBRUIN
---------------------------
Name: Michael F. DeBruin
Title: Vice President - Clinical Research
2. By: /S/ DAVID GRISHAM
---------------------------
Name: David Grisham
Title: Sr. Director, Global Project Management
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Thus done and signed at: Pretoria, RSA on this the 10th Day of January 2000.
For: Clindev (Pty) Ltd
WITNESS:
1. By: /S/ ANITA LESSING
-------------------------
Name: Anita Lessing
Title: Director, Clindev
2. By: /S/ SONIA SUTHERLAND
-------------------------
Name: Sonia Sutherland
Title: Director, Clindev
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CONFIDENTIAL TREATMENT
CONTRACT OF MONITORING SERVICES
AMENDMENT 1
Between
CUBIST PHARMACEUTICALS, INC
Duly represented by Michael F. de Bruin
(Hereinafter referred to as "SPONSOR")
And
CLINDEV (PROPRIETARY) LIMITED
Duly represented by MRS. A. LESSING
(Hereinafter referred to as "Clindev")
*Confidential treatment requested: Material has been omitted and filed with
the Commission.
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-2-
Upon mutual agreement of the parties the following sections of the contract are
amended as follows:
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the Commission.
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-3-
SECTION 4. PAGE 3
PAYMENT FOR SERVICES
4.1 SPONSOR shall pay to Clindev $[ ]* (the "Contract Price") for the
services rendered under the Agreement in accordance with the payment
schedule set forth in section 4.2.
For the purposes of the Agreement, the contract value is based on the
inclusion of [ ]* patients ($[ ]* per completed patient) and includes
all activities from the first review of the Protocol till the Study is
finally closed out and all correction log forms have been processed
subject to section 3.
In witness whereof, the parties have caused this Amendment to the Agreement to
be executed by the respective duly authorized officers as of the dates set forth
below.
Thus done and signed at: CPI on this the 21st Day of June, 2000.
For: the SPONSOR
By: /s/ MICHAEL F. DEBRUIN
----------------------
Name: Michael F. DeBruin
Title: Vice President, Clinical Research
WITNESS:
1. By: /s/ EDWARD S. CAMPANARO
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Name: Edward S. Campanaro
Title: Director, Clinical Operations
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-4-
2. By: /s/ TANIA ASSAYLEEN
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Name: Tania Assayleen
Title: Clinical Trial Manager
Thus done and signed at Lynnwood, Pretoria, on this the
22nd Day of June 2000.
For: Clindev (Pty) Ltd
By: /s/ ANITA LESSING
-----------------
Name: Anita Lessing
Title: Director
WITNESS:
1. By: /s/ SONIA SUTHERLAND
--------------------
Name: Sonia Sutherland
Title: Research Associate
2. By: /s/ C.S. NASH
-------------
Name: C.S. Nash
Title: Clinical Research Associate
*Confidential treatment requested: Material has been omitted and filed with
the Commission.
CONFIDENTIAL TREATMENT
CONTRACT OF MONITORING SERVICES
AMENDMENT 2
Between
CUBIST PHARMACEUTICALS, INC
Duly represented by Michael F. de Bruin
(Hereinafter referred to as "SPONSOR")
And
CLINDEV (PROPRIETARY) LIMITED
Duly represented by MRS. A. LESSING
(Hereinafter referred to as "Clindev")
*Confidential treatment requested: Material has been omitted and filed with
the Commission.
<PAGE>
-2-
Upon mutual agreement of the parties the following sections of the contract are
amended as follows:
*Confidential treatment requested: Material has been omitted and filed with
the Commission.
<PAGE>
-3-
SECTION 4. PAGE 3
PAYMENT FOR SERVICES
4.1 SPONSOR shall pay to Clindev $[ ]* (the "Contract Price") for the
services rendered under the Agreement in accordance with the payment
schedule set forth in section 4.2.
For the purposes of the Agreement, the contract value is based on the
inclusion of [ ]* patients ($[ ]* per completed patient) and includes
all activities from the first review of the Protocol till the Study is
finally closed out and all correction log forms have been processed
subject to section 3.
In witness whereof, the parties have caused this Amendment to the Agreement to
be executed by the respective duly authorized officers as of the dates set forth
below
Thus done and signed at: Cambridge, MA, USA on this the 20th Day of December
2000.
For: the SPONSOR
By: /s/ MICHAEL F. DEBRUIN
----------------------
Name: Michael F. DeBruin, M.D.
Title: Vice President, Clinical Research
WITNESS:
1. By: /s/ EDWARD S. CAMPANARO
------------------------
Name: Edward S. Campanaro
Title: Sr. Director, Clinical Operations
*Confidential treatment requested: Material has been omitted and filed with
the Commission.
<PAGE>
-4-
2. By: /s/ ANDREW G. KNAPP
--------------------
Name: Andrew G. Knapp
Title: Director, Clinical Research
Thus done and signed at Lynnwood, Pretoria, on this the 8th Day of November
2000.
For: Clindev (Pty) Ltd
By: /s/ ANITA LESSING
-----------------
Name: Anita Lessing
Title: Director
WITNESS:
1. By: /s/ SONIA SUTHERLAND
--------------------
Name: Sonia Sutherland
Title: Director
2. By: /s/ CATHY NASH
--------------
Name: Cathy Nash
Title: Project Manager
*Confidential treatment requested: Material has been omitted and filed with
the Commission.