MASTER SERVICES AGREEMENT PREAMBLE
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6TH
March
2007
PREAMBLE
This
Master Services Agreement (“Agreement”)
effective as of the last day to be signed by all parties (hereinafter the
“Effective Date”), between MDS Pharma Services (US) Inc.,
a
Nebraska corporation, with principal offices at 000 Xxxx Xxxxxx, Xxxxxxx,
Xxxxxxxx, 00000, along with its Affiliates, including but not limited to MDS
Pharma Services, a division of MDS (Canada) Inc., (“MDSPS”)
and
Gentium S.p.A. (“Sponsor”),
an
Italian corporation, with principal offices at Xxxxxx
XX
Xxxxxxxxx, 0, 00000 Xxxxx Xxxxxxx (XX) - Xxxxx. MDSPS and Sponsor shall
individually be referred to as a “Party” and collectively as the “Parties”.
WITNESSETH:
WHEREAS
Sponsor is
in the
business of developing, manufacturing, and marketing pharmaceutical products;
and;
WHEREAS
MDSPS is a worldwide company that provides full-service contract research
organization (“CRO”) services, including but not necessarily limited to clinical
research, drug development, statistics, data management, regulatory, central
laboratory, and other services associated with the clinical trial management
process for companies such as Sponsor and;
WHEREAS
Sponsor and MDSPS wish to enter into this Agreement to provide the terms and
conditions under which Sponsor may
engage MDSPS from time to time to provide services for studies or projects
by
executing Statements of Work (as that term is defined below) specifying the
details of the services to be rendered.
NOW
THEREFORE, the Parties agree as follows:
1.
AFFILIATE:
DEFINED
For
purposes of this Agreement, “Affiliate”
shall
mean any corporation, firm, partnership or other entity that directly or
indirectly controls, is controlled by, or is under common control with either
of
the Parties.
2.
SCOPE
OF AGREEMENT
2.1
MASTER
AGREEMENT
2.1.1 PURPOSE
As
a
general form of contract, this Agreement allows the Parties to contract multiple
projects or services through the issuance of Statements of Work without having
to renegotiate the basic terms and conditions contained in this Agreement.
This
Agreement covers the provision of services by MDSPS and its Affiliates and,
accordingly, this Agreement represents a vehicle by which Sponsor can
efficiently contract with MDSPS and its Affiliates for a broad range of services
related to the matters covered under this Agreement. The terms and conditions
of
this Agreement shall govern the services to be provided by MDSPS to
Sponsor under
any
individual agreement for specific services to be rendered, which will be
referred to for purposes of this Agreement as the “Statement
of Work”.
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
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2.1.2 MODIFICATION
The
Parties may only modify the provisions hereof by an instrument in writing duly
executed by the Parties.
2.1.3 TERM
This
Agreement is valid for a period of 5 years from the Effective Date subject
to
the provisions of Section 10 (Termination); however, in the event there is
an
ongoing Statement of Work, this Agreement shall remain in full force as it
relates to the Statement of Work in place. This Agreement may be renewed for
additional yearly terms if agreed to in writing by the Parties.
2.2 STATEMENT
OF WORK
2.2.1 DEFINITION
The
specific details of each project under this Agreement (“Project”)
shall
be separately negotiated and specified in writing in a form acceptable to the
Parties, and shall be attached to this Agreement and be deemed an integral
part
thereof (each such writing, a “Statement
of Work”).
A
sample Statement of Work is attached to this Agreement as Exhibit 1. Each
Statement of Work will include, as applicable, the name of the Parties and
their
Affiliates, a description of the obligations that Sponsor is transferring to
MDSPS pursuant to the Statement of Work, scope of work, timeline, budget and
payment schedule. Each Statement of Work shall be subject to the terms and
conditions of this Agreement, and to the extent any terms or provisions of
a
Statement of Work conflict with the terms and provisions of this Agreement,
the
terms and provisions of this Agreement shall control, unless the applicable
Statement of Work expressly states that it shall supersede this Agreement on
a
specific matters, in which case it shall supersede this Agreement with regard
to
the specific matter that is the subject to that Statement of Work.
Any
regulatory obligations transferred to MDSPS pursuant to any applicable
governmental statute or regulation, including but not limited to 21 C.F.R.
Part
312 shall be explicitly listed in the Statement of Work or in an attachment
to a
Statement of Work. The Sponsor retains full responsibility for any regulatory
obligation not transferred to MDSPS in a Statement of Work.
2.2.2 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, clerical,
project management,
regulatory,
central
laboratory services, preclinical services, pharmaceutical sciences services,
medical device services, and other research and development services requested
by Sponsor and agreed to by MDSPS as set forth in the relevant Statement of
Work
(collectively, the “Services”)
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
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2.2.3. COMMENCEMENT
OF PROJECTS
Each
Statement of Work shall set forth the projected date of commencement of each
Project, with such commencement date contingent only upon obtaining applicable
approvals and all materials required from Sponsor.
2.2.4 CHANGES
Sponsor
may change a Statement of Work after it is signed, and Sponsor agrees to follow
the procedures specified in this Section 2.2.4 when providing for such change.
The Sponsor shall submit a written document to MDSPS containing a description
of
the changes, including but not limited to any additional services that Sponsor
is requesting. Upon receipt of that description, MDSPS shall advise Sponsor
of:
i) any
adjustment in fees or other costs that would result from the
change;
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ii)
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any
other changes to the Statement of Work that would result from the
requested changes, for example to the Project timeline or
personnel.
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MDSPS
shall also prepare a draft Change Order for Sponsor’s review that incorporates
the requested changes to the applicable Statement of Work tasks, responsibility,
duties, budget, schedule and all relevant matters. MDSPS shall not perform
any
work related to such a Change Order until Sponsor has given written approval
to
proceed.
2.2.4 COORDINATION
MDSPS
shall appoint in each Statement of Work a primary contact for the work to be
performed.
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2.3
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PROTOCOL/STUDY
PLAN
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2.3.1 DEFINITION
Where
applicable, MDSPS will perform services for Sponsor in accordance with a
protocol (“Protocol”)
for a
clinical study sponsored by Sponsor (“Study”),
which
will be provided by Sponsor or, upon Sponsor’s request, will be prepared by
MDSPS under Sponsor's direction and approved by Sponsor. The Protocol will
specify the Study design, purpose, desired information, experimental procedures,
estimated duration of the Study, and any other relevant matters, and, where
relevant, will be made a part of the applicable Statement of Work. Where there
is no Protocol for a Project, a detailed plan for a Study or the Services may
be
developed and included as an Appendix to the Statement of Work (each such
detailed plan a “Study
Plan”
or
“Service
Plan”).
MDSPS
shall not make any changes to a Protocol, a Study Plan, or a Service Plan unless
such changes are first approved in writing by Sponsor. Any Protocol changes
must
be documented as numbered amendments, properly dated and signed.
2.3.2 PROTOCOL
OR STUDY PLAN DEVELOPMENT BY MDSPS
If
requested by Sponsor, MDSPS will assist in developing the Protocol or Service
Plan, and advising Sponsor on the Protocol or Service Plan, in a manner
consistent with current applicable laws and regulations and industry standards.
The Sponsor shall have the right of final approval of the Protocol or Service
Plan and MDSPS makes no warranty, express or implied, that the Protocol or
Service Plan will satisfy the requirements of any Regulatory Authority at the
time of submission.
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
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3. RESOURCES
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3.1
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PROVIDED
BY SPONSOR
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Sponsor
will provide MDSPS with the following:
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i)
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sufficient
amount of all required materials for a Study (“Study
Materials”)
as further detailed in the Statement of
Work;
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| ii) | safety data sheets for the Study Materials, where available; |
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iii)
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sufficient
and comprehensive data as may be required by MDSPS concerning the
stability of the Study Materials, storage and safety
requirements.
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3.2
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PROVIDED
BY MDSPS
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MDSPS
will provide Sponsor with the following:
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i)
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Materials
related to a Project or the Services (other than the Study Materials
described in Section 3.1(i));
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ii)
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labor
and any MDSPS required facilities for the conduct of each Project
as
necessary to conduct the Services as requested by
Sponsor;
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iii)
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analytical
services, as requested;
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iv)
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raw
data generated from the Services, where
appropriate;
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v)
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a
final report setting forth a full summary of the results of the Services
or Projects, as requested;
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vi)
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necessary
professional and support personnel for each Study, Project, or Services
requested; and
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vii)
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all
other documents and work products that are described in a Statement
of
Work.
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3.3
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IDENTITY
OF PROJECT MATERIALS
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Sponsor
attests that Study Materials provided to MDSPS will be identical to any
description provided in a relevant Protocol or Service Plan. Sponsor will
furnish, on request, the Study Materials’ identification and content tests when
appropriate.
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3.4
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DELAYS
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MDSPS
agrees to complete the Services and Projects according to the timelines
specified in the applicable Statement of Work. If at any time MDSPS anticipates
a delay in meeting any timelines or target completion dates set forth in any
Statement of Work, MDSPS shall promptly notify Sponsor of such delay. In the
event any such anticipated delay is due to events, conditions or decisions
beyond MDSPS’ direct control, including but not limited to: (i) delays in
obtaining regulatory approval; or (ii) Sponsor’s inability to supply MDSPS with
Study Materials or information required to perform the Services, then the
Parties shall cooperate in good faith to amend the timelines and budgets set
forth in the applicable Statement of Work.
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
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3.5
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CHANGES
in MDSPS PERSONNEL
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If
MDSPS
desires to change an existing or assign a new team member to Sponsor’s Projects,
MDSPS must first notify Sponsor of the details of the proposed change. Upon
Sponsor’s approval, which will not be unreasonably withheld, MDSPS may change
the team members.
4. CONDUCT
OF SERVICE
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4.1
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MDSPS
COMPLIANCE
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MDSPS
agrees to perform its Services in accordance with all applicable laws,
regulations, and industry standards including, but not limited to the Federal
Food, Drug, and Cosmetic Act and the federal regulations promulgated there
under
(including but not limited to the regulations set forth in 21 CFR Parts 50,
56
and 312), Good Clinical Practices as may be published from time to time,
International Conference on Harmonization (ICH) Guidelines, and laws and
regulations pertaining to the use, dissemination and disclosure of individually
identifiable patient information, to the extent such laws and regulations apply
to MDSPS. MDSPS acknowledges that Sponsor is entering into certain Data Use
Agreements with respect to the Study in a form substantially similar to that
attached as Exhibit 2, and MDSPS agrees to comply with the same restrictions
and
conditions as apply to Sponsor under the terms of such Data Use
Agreements.
MDSPS
further agrees to perform all laboratory analyses in accordance with applicable
laws and regulations, industry standards, and Sponsor’s specifications,
including but not limited to the Clinical Laboratory Improvement Amendments
of
1988 and FDA Good Laboratory Practices, where applicable. In the event of a
change in laws, regulations, or industry standards, MDSPS will make every
reasonable effort to satisfy any new requirements and will immediately notify
Sponsor if it cannot satisfy such requirements. Applicable laws, regulations,
and industry standards in addition to the ones noted in this Section (if any)
shall be set out in the Statement of Work for each Service; provided, however,
that the failure of the Parties to set forth such additional legal or regulatory
requirements does not relieve MDSPS from the obligation to comply with such
requirements.
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4.2
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SPONSOR
COMPLIANCE
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Sponsor
agrees to notify MDSPS promptly of any changes to a Protocol relevant to a
Statement of Work. Unless designated as an MDSPS responsibility in an applicable
Statement of Work, an Investigational New Drug Application (IND) or equivalent
approval to conduct clinical research has been filed with the FDA or the
appropriate country regulatory authorities with respect to the drug involved
in
a Study, and no applicable law, rule or regulation prohibits the conduct of
the
Project.
All
data,
information, drug, facilities and equipment which are to be supplied by Sponsor
under a Statement of Work and are necessary for MDSPS’ effective performance of
the Services, shall be made available to MDSPS and/or the investigators
conducting a Study (“Investigators”)
in
accordance with the timelines as defined in the Statement of Work and shall
be
in full compliance with all applicable regulations.
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
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4.3
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QUALITY
CONTROLS
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MDSPS
shall implement appropriate quality controls in order to monitor Investigator
compliance with the Protocol or Service Plan and the Statement of Work,
including but not limited to MDSPS’ standard operating procedures. MDSPS shall
train and monitor those personnel associated with the Statements of Work to
ensure compliance with such standard operating procedures.
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4.4
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AUDITS
AND FACILITIES
EXAMINATION
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MDSPS
shall promptly inform Sponsor of any request by an officer or employee of any
government or regulatory agency or authority (“Regulatory
Authority”)
to
have access to or verify any record, report, documentation or data in MDSPS’
possession, custody or control relating to the Services, a Project, or a
Statement of Work; and, upon verification that such officer or employee is
properly authorized, shall arrange appropriate access for such officer or
employee.
Each
Party agrees to notify the other Party promptly, but in no event later than
two
(2) business days, upon receipt of notification of an impending inspection
by
any Regulatory Authority related to a Project, the Services, or a Statement
of
Work. Each Party shall forward the other Party copies of correspondence from
any
Regulatory Authority relating to a Project, the Services, or a Statement of
Work, even if they do not mention the other Party. Without limiting the
foregoing, MDSPS shall provide Sponsor with a copy of any written correspondence
to a Regulatory Authority regarding a Project or Services for Sponsor’s input
prior to submitting it to such Regulatory Authority.
During
the term of this Agreement, MDSPS will permit Sponsor’s representatives to
examine or audit the Services performed under this Agreement and any Statement
of Work, which shall include the right to audit the MDSPS facilities at which
Services will be conducted. Sponsor
shall provide reasonable notice, not less than ten (10) business days, of its
intent to audit and shall conduct the audit during regular business hours.
During
such examination, Sponsor’s representatives may review and verify documents,
facilities, records, results of all quality assurance inspections performed
by
MDSPS, methodology, procedures and any other relevant item relating to the
Services, and may conduct interviews of MDSPS personnel. Sponsor’s
representatives may also visit MDSPS’ premises at reasonable times and
frequency, during normal business hours, to observe the progress of a Project,
and MDSPS will provide access solely to the areas relating to a Project.
Should
Sponsor wish to retain a third party to conduct the audit, it will not retain
a
direct competitor of MDSPS in the business of a contract research organization.
Auditors, including third party auditors, shall be identified (including any
affiliations) to MDSPS Quality Assurance Director prior to scheduling and
conducting the audit. MDSPS
agrees to remediate audit findings to ensure compliance with applicable laws
and
regulations, MDSPS standard operating procedures, this Agreement, and Statements
of Work, and agrees to provide objective evidence to Sponsor of such remediation
upon Sponsor’s request.
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
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4.5
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DEBARMENT
CERTIFICATION
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MDSPS
certifies that it has not been debarred, and has not been convicted of or
indicted for a crime that could lead to debarment, or otherwise engaged in
conduct for which a person can be debarred under sections 306(a) and (b) of
the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 335(a) and (b)) and that it
will not permit any employee, agent, representative, or contractor that has
been
so debarred, indicted, or convicted to perform any Services under this
Agreement. Sponsor represents that it shall not request MDSPS to perform
Services that violate any applicable law or regulation.
5. OWNERSHIP
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5.1
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WORK
PRODUCT AND INVENTIONS
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All
data
and information generated or derived by MDSPS as the result of Services
performed by MDSPS shall be and remain the exclusive property of Sponsor. MDSPS
shall disclose all discoveries, inventions, improvements, new uses, processes,
copyrights, trade secrets, techniques and compounds (“Inventions”),
whether patentable or not, arising from Services performed under each Statement
of Work or
otherwise relating
to
Sponsor’s Study Materials or Confidential Information. All Inventions shall
become the sole and exclusive property of Sponsor without further consideration.
Upon request by Sponsor and at Sponsor’s expense, MDSPS will promptly execute or
cause to be executed any and all applications, assignments or other instruments
necessary or useful in transferring the right, title and interest to such
Inventions and applying for, obtaining, or maintaining patents or other
intellectual property rights or protection. Sponsor shall be free to exploit
both the patents it holds as a result of the Services as well as any unpatented
results of the Services without any additional compensation to
MDSPS.
Notwithstanding
the foregoing, Sponsor acknowledges that MDSPS possesses certain processes,
know-how, trade secrets, and other intellectual properties, including but not
limited to data processing and management systems that have been independently
developed by MDSPS and which relate to MDSPS’ business and operations
(“MDSPS
Property”).
The
Parties agree that any MDSPS Property or improvements to MDSPS Property that
are
developed by MDSPS under or during the term of this Agreement and without the
use of Sponsor’s Confidential Information are the sole and exclusive property of
MDSPS.
MDSPS
shall timely communicate in full detail and disclose to Sponsor all data,
information, reports, results and other work product collected, generated,
prepared or derived by MDSPS during resulting from Services performed under
a
Statement of Work.
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5.2
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PUBLICATIONS
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Data
generated in conjunction with a Project or the Services are the property of
Sponsor and may be used in any manner by Sponsor in its sole discretion. As
such, Sponsor shall retain the right to publish all documentation, records,
raw
data, specimens or other work product generated in connection with this
Agreement. MDSPS may not publish or refer to Project results without the prior
written consent of Sponsor.
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
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5.3
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USE
OF NAMES
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Neither
Party will use the other Party’s name in connection with any publication or
promotion, without the other Party’s prior written consent; provided, however,
that Sponsor may use MDSPS's name and disclose the existence and terms of
this Agreement in and/or file this Agreement as an exhibit to registration
statements and/or reports filed under the Securities Act of 1933, as amended
and/or the Securities Exchange Act of 1934, as amended, with any applicable
stock exchange and as otherwise required by any applicable law, rule,
regulation or order.
6. CONFIDENTIAL
INFORMATION
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6.1
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DEFINITION
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"Confidential
Information"
shall
mean any written, electronic, oral, tangible, or intangible, information, data,
reports, or documents of any kind, including but not limited to scientific,
technical, trade or business information, that is disclosed to or received,
learned, or generated by a Party in connection with or concerning the subject
matter of this Agreement, a Project, a Statement of Work, and/or the Study
Materials (“Confidential
Information”).
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6.2
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DISCLOSURE
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The
Parties acknowledge that an exchange of Confidential Information is necessary
in
order to enable them to engage in meaningful business discussions and/or
collaboration. With respect to such Confidential Information, the Parties agree:
(i) to cause their agents, officers, employees and other representatives to
hold
in strict confidence all Confidential Information; (ii) not to use Confidential
Information for any purpose, other than as may be required or permitted to
perform any obligation under this Agreement or as directed in writing by
authority of Sponsor; (iii) to not reveal, publish, or otherwise disclose
Confidential Information to any third party without the prior written consent
of
the other Party; and (iv) Confidential Information shall remain the sole
property of the Party that disclosed the Confidential Information.
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6.3
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EXCEPTIONS
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The
obligations of confidentiality set forth in Section 6.2 will not apply
to
Confidential Information which either Party can clearly demonstrate falls within
any of the following categories:
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a)
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Information
that is or becomes available to the public through no fault of the
other
Party;
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b)
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Information
that, as of the time of disclosure, was already known to and in the
lawful
possession of the Party receiving the information, as evidenced by
written
records maintained by the receiving Party prior to the
disclosure;
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c)
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Information
obtained from a third party lawfully in possession of such information
and
having the right to disclose the
same;
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Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
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d)
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Information
that is required to be disclosed pursuant to operation of law; provided
that if the law requires disclosure, the Party that needs to disclose
the
Confidential Information will notify the other Party immediately
and will
give that Party time and opportunity to take appropriate action to
project
the confidentiality of such
information;
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e)
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Information
that was developed independently of any disclosure by, or information
received from, the other Party, as evidenced by written records maintained
by the receiving Party prior to the
disclosure.
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6.4
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DURATION
OF OBLIGATION
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The
obligation of confidentiality under this Agreement shall, as to each Statement
of Work, survive the completion of that Statement of Work for the length of
time
set out in the Statement of Work; provided that no obligation of confidentiality
shall endure for less than five (5) years.
7. PAYMENT
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7.1
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METHOD
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For
performing the Services agreed upon pursuant to the Statement of Work, MDSPS
shall be compensated in accordance with the payment schedule annexed to or
included as part of the Statement of Work. The payment schedule shall set forth
how MDSPS will be compensated for all costs and expenses relating to the
Services.
Notwithstanding
the above, unless otherwise provided in a Statement of Work, Sponsor shall
make
final payment upon MDSPS’ completion of Service under a Statement of Work and
receipt by Sponsor of MDSPS’ final deliverable or final report issued pursuant
to the Statement of Work in a format set forth within the Statement of Work.
Terms of payment shall be net thirty (30) days after the receipt of the invoice.
All payments shall be made via wire transfer as specified in the Statement
of
Work, or, in the absence of any specification in the Statement of Work
to:
MDS
Pharma Services (US) Inc.
NW
5080
P.
O. Xxx
0000
Xxxxxxxxxxx,
XX 00000-0000
Please
provide bank info
Employer
Tax ID # 00-0000000
The
currency to be used for invoicing and payments shall be set forth in the
Statement of Work. Where MDSPS may incur costs or expenses in a currency
differing from that used for invoicing as specified in the relevant Statement
of
Work, the Statement of Work shall address how these costs shall be invoiced
and
reimbursed. If the Statement of Work does not provide for this, reimbursable
costs will be reimbursed using the Interbank exchange rates prevailing at the
invoice date as specified on xxx.xxxxx.xxx.
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
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7.2
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DUE
DATE
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Payment
is due within thirty (30) days of the date of each invoice provided by MDSPS.
Sponsor shall promptly notify MDSPS of any portion of an invoice that Sponsor
disputes. In the event of a dispute, the Parties agree to work promptly to
resolve the dispute, and payment for the disputed invoice shall be due thirty
(30) days after the dispute is resolved.
8. INDEMNIFICATION
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8.1
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BY
SPONSOR
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Sponsor
shall indemnify, defend and hold harmless MDSPS and its agents and employees
from and against any and all losses, damages, liabilities, reasonable attorney
fees, court costs, and expenses resulting or arising from any claims, actions,
proceedings, investigations or litigation (including personal injury or wrongful
death) (“Losses”)
relating to or arising from: (a) Losses in connection with this Agreement,
to
the extent they did not arise from any actions described in Sections 8.2 (a)
or
(b) of this Agreement, (b) the negligence or intentional misconduct of Sponsor;
(c) any product or potential product to which this Agreement or any Work Order
relates, (d) the breach by Sponsor of any term or provision of this Agreement
or
any applicable laws and regulations.
Sponsor
does not have an obligation to indemnify any Investigators or other Study staff
providing services at a facility not owned or operated by MDSPS under the terms
of this Agreement.
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8.2
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BY
MDSPS
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MDSPS
shall indemnify, defend and hold harmless Sponsor and its agents and employees
hereunder, from and against any and all Losses relating to or arising from:
(a)
the negligence or intentional misconduct of MDSPS; or (b) the breach by MDSPS
of
any term or provision of this Agreement, a Statement of Work, written relevant
and material recommendations, information, instructions, rules and guidelines
furnished by Sponsor for use in conjunction with a Statement of Work, or
applicable laws and regulations.
MDSPS
does not have an obligation to indemnify any Investigators or Study staff
providing services at a facility not owned or operated by MDSPS under the terms
of this Agreement.
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8.3
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CONDITIONS
FOR INDEMNIFICATION
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The
indemnitee shall provide the indemnitor with prompt notice (including a copy
thereof), of any claim or lawsuit served upon it that is related to this
Agreement or any Statement of Work. The indemnitee shall fully cooperate with
the indemnitor and its representatives in the investigation of any claim or
lawsuit related to the Services provided in this Agreement or any Statement
of
Work. The indemnitee shall not unreasonably withhold its approval of the
settlement of any claim, liability, or action covered by this indemnification
provision.
The
indemnitees must have conducted their activities in
accordance with any relevant Protocols, this Agreement, applicable laws and
regulations, and all instructions delivered by Sponsor concerning the
administration or use of the Study Materials.
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
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9. LIMITATION OF LIABILITY
9.1
ERRORS
AND OMISSIONS
In
the
event of a material error by MDSPS in the performance of a Study which renders
all or a portion of the Study invalid, the sole liability incurred by MDSPS
shall be, at the discretion of Sponsor, to (a) repeat the affected portion
of
the Study, or (b) refund to Sponsor the contract price paid for such affected
portions of the Study.
Without
limiting the indemnification obligations of either party, neither party, nor
any
of its agents or employees, shall have any liability of any type for any
special, incidental, indirect or consequential damages, including, but not
limited to the loss of opportunity, loss of use, loss of revenue or profit,
in
connection with or arising out of this Agreement, except if resulting from
the
gross negligence or willful or intentional misconduct of the Party against
which
relief is sought.
10. TERMINATION
10.1 BY
EITHER PARTY
|
10.1.1
|
MATERIAL
BREACH
|
Either
Party may terminate this Agreement for material breach by giving written notice
and specifying the nature of the breach, unless the other Party has provided
a
plan to substantially cure the breach within twenty (20) business days of
receipt of the notice of breach and has substantially cured the breach within
thirty (30) business days of receipt of the notice of breach.
|
10.1.2
|
SAFETY
OR EFFICACY HAZARD
|
If
a
Party determines that termination is needed to protect the safety of human
subjects who are participating in a Study, that Party may terminate a Statement
of Work effective immediately upon notification by telephone, which shall then
be followed by written confirmation.
|
10.1.3
|
INSOLVENCY
AND/OR DISSOLUTION
|
In
the
event that a Party becomes insolvent, makes an assignment for the benefit of
creditors, files for bankruptcy, or ceases or threatens to cease to carry on
the
whole or any relevant part of its business or trade, the other Party may
terminate this Agreement effective upon delivery of a written
notice.
10.2 BY
SPONSOR
Sponsor
shall have the right at any time to terminate this Agreement or a Statement
of
Work prior to completion by giving thirty (30) days advance written notice
to
MDSPS. In the event of such written notice of termination: (i) MDSPS shall
cease
performing all Services that are not necessary for the orderly close-out of
affected Projects or to ensure the safety of any subjects enrolled in a Study;
(ii) MDSPS shall promptly use its best commercial efforts to reduce cost to
Sponsor; and (iii) the Parties shall promptly negotiate in good faith a mutually
acceptable close-out schedule and procedure to wind down affected Statements
of
Work in accordance with applicable laws and regulations and the interests of
any
subjects enrolled in a Study. In case of such termination, Sponsor shall pay
MDSPS for Services completed prior to the date of termination including any
close-out or uncancellable costs or expenses, or for Services MDSPS is
irrevocably obligated to complete. If Sponsor terminates the project early
for a
cause that is unrelated to MDSPS’ performance of the Services, MDSPS is entitled
to compensation that reflects the direct costs of this early termination.
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
12 of
26
10.3 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, disease, weather,
war, insurrection, riots, or power failure, strikes,
lockouts, or other industrial action taken by the employees of any Party or
of
any third party (whether or not the Party against whom such action is taken
could have avoided the same by acceding to the demands of the employees
responsible for such action), civil commotion, embargo, governmental action,
legislation or regulation, invasion, threat of or preparation of
war.
Performance
shall be excused only to the extent of and during the reasonable continuance
of
such disability. Any deadline or time for performance specified in the Statement
of Work or the Protocol which falls due during or subsequent to the occurrence
of any of the disabilities referred to in this Section shall be automatically
extended for a period of time equal to the period of such disability.
In
addition, the provision of this paragraph shall apply where the failure to
perform is caused by the withdrawal of approval of a Project by the relevant
governing regulatory body including, but not limited to, the FDA, Therapeutic
Products Directorate (TPD), and Medicines Control Agency (MCA), representing
the
respective regulatory agencies in the United States, Canada and United
Kingdom.
10.4 SURVIVAL
OF OBLIGATIONS
Termination
of this Agreement shall not relieve either Party of its obligation to the other
in respect of maintaining the confidentiality of information, obtaining consents
for advertising and publications purposes, indemnification, compensation for
services performed through the date of termination, except as set forth in
Section 10.2, the obligation to maintain insurance, work product and inventions,
and dispute and arbitration.
10.5 RETURN
OF ALL MATERIALS
Upon
termination of this Agreement or any Statement of Work, MDSPS shall return
all
Study Materials, documentation, data, reports and any other item related to
a
Project or the Services rendered to Sponsor upon request, except for those
materials or copies thereof that are required by law or regulation to be
retained by MDSPS.
11. TRANSFER
OF OBLIGATIONS
11.1 BETWEEN
THE PARTIES
MDSPS
shall perform the Services as an independent contractor and shall have complete
and exclusive control over its employees and agents. The Services rendered
by
MDSPS under this Agreement are those of an independent contractor and not those
of Sponsor. No Services rendered pursuant to this Agreement shall be construed
to deem MDSPS an employee, agent or joint-venturer with Sponsor.
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
13 of
26
11.2 ASSIGNMENT
TO SUB-CONTRACTORS
If
MDSPS
is obligated under any Statement of Work to contract with subcontractors, then
MDSPS shall ensure that such subcontractors are bound by the terms and
conditions of this Agreement and the applicable Statement of Work. An
Investigator and site staff shall not be considered a subcontractor of MDSPS
unless the Investigator or site staff are providing services at a facility
owned
or operated by MDSPS. Any exceptions to this shall be specifically addressed
in
the applicable Statement of Work.
12.
RELATIONSHIP
WITH AFFILIATES
MDSPS
may
use the services of its Affiliates to fulfill MDSPS’ obligations under this
Agreement or a Statement of Work; provided that (a) MDSPS shall use Affiliates
as its agents and shall remain responsible for the Services the Affiliate
provides; (b) MDSPS shall ensure that each Affiliate is bound by the terms
and
conditions at least as stringent as this Agreement and each applicable Statement
of Work; and (c) Affiliates are designed in a Statement of Work that Sponsor
has
approved prior to the commencement of any Services by the Affiliate.
13. INSURANCE
Each
Party will maintain, for the duration of this Agreement, insurance in an amount
reasonably adequate to cover its obligations hereunder, and, upon request,
each
Party will provide to the other Party a certificate of insurance showing that
such insurance is in place.
14. LANGUAGE
This
Agreement and all notices given pursuant to this Agreement shall be drafted
in
the English language.
15. NOTICES
Any
notice required or permitted to be given under this Agreement by either Party
shall be in writing and shall be deemed given on the date received if delivered
personally or by reputable overnight delivery service, or three days after
the
date postmarked if sent by registered or certified mail, return receipt
requested, postage prepaid to the following addresses:
|
Gentium
SpA
|
MDS
Pharma Services (US) Inc.
|
|
Xxxxxx
XX Xxxxxxxxx, 0
00000
Xxxxxxxxxxxx (Xxxx)
|
The
Triad
0000
Xxxxxxxxxxx Xxxx., Xxxxx 000
|
|
Xxxxx
|
King
of Prussia, PA 19406-2755
|
|
Attn:
Xx. Xxxxxxx Xxxxxxxxx
|
Attn:
VP Finance
|
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
14 of
26
Copy
to:
|
Xxxxxxxxxxx
X. Xxxxx
|
MDS
Pharma Services
|
|
Xxxxxxx,
Xxxxxx & Green P.C.
|
Vice
President, Legal Services
|
|
000
Xxxx Xxxxxx
|
000
Xxxx Xxxxxx
|
|
Xxx
Xxxx, XX 00000
|
Xxxxxxx,
XX 00000
|
16. SEVERABILITY
In
the
event that any provision contained in this Agreement is held to be invalid
or
unenforceable whether by reason of legislation or by reason of any decision
of a
regulatory body of judicial authority having jurisdiction over the subject
matter of this Agreement and the Parties, such affected provision shall be
deemed severable and deleted from all other provisions contained in this
Agreement and the latter shall remain enforceable to the fullest extent
permitted by law.
17. DISPUTE
AND ARBITRATION
Any
dispute, controversy or claim arising out of or in connection with this
Agreement, or the breach, termination or validity thereof, shall be settled
by
final and binding arbitration in accordance with the Commercial Arbitration
Rules of the American Arbitration Association. The arbitration shall be heard
and determined by an arbitration tribunal of three (3) members. Each Party
shall
select one arbitrator. The third, presiding arbitrator of the tribunal shall
be
selected by the Party-appointed arbitrators.
The
place
of arbitration shall be New
York and
the
award shall be deemed a United
States award
unless the Parties agree to a different location prior to the arbitration
proceeding. The English language shall be used in the arbitration
proceedings.
The
award
shall be made and shall be payable in US dollars free of any tax and other
deduction.
The
award
shall include interest from the date the claims are submitted to the other
Party. The arbitrators shall also fix an appropriate rate of interest from
the
date of the breach or other violation to the date when the award is paid in
full. In no event, however, should that interest rate during such a period
be
lower than the prime commercial lending rate for ninety (90) day loans for
responsible and substantial commercial borrowers.
The
Parties agree that the award of the arbitration tribunal will be the sole and
exclusive remedy between them regarding any and all claims and counterclaims
presented to the tribunal.
All
notices to be given in connection with the arbitration shall be in writing.
All
notices shall be sent by registered airmail, return receipt requested, to the
addresses set forth in Section 15 of this Agreement.
The
arbitrators shall apply the appropriate governing laws set forth in Section
18
below.
18. APPLICABLE
LAW
This
Agreement shall be construed, governed, interpreted, and applied in accordance
with the laws of New York, applicable to contracts to be performed fully within
the State of New York exclusive of its conflicts of laws provisions. Sponsor
consents to personal jurisdiction and service and venue in any Court within
the
State of New York for the purpose of any action or suit arising out of this
Agreement.
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
15 of
26
19. COUNTERPARTS
This
Agreement will become binding when any one (1) or more counterparts of this
Agreement, individually or taken together, bear the signatures of each Party
to
this Agreement. This Agreement may be executed in any number of counterparts,
each of which will be an original as against any Party whose signature appears
on this Agreement, but all of which together will constitute but one and the
same instrument.
20.
EFFECT
OF FUTURE LAWS
In
the
event of the enactment, promulgation, recession, modification or interpretation
of any law or regulation after the date of this Agreement which would materially
adversely affect the manner in which either Party is obligated to perform under
this Agreement, Sponsor and MDSPS agree to enter into good faith negotiations
in
order to seek to agree on reasonable terms for maintaining the intent of this
Agreement.
IN
WITNESS WHEREOF, the Parties have caused this Agreement to be executed in
duplicate original copies, by their duly authorized representatives, as of
the
last date written below.
|
MDS
PHARMA SERVICES (US) INC.
|
|
|
Per:
/s/
Xxxxx
Xxxxxxxx
|
Per:
/s/
Xxxxx Xxxx Xxxxx,
M.D.
|
|
Name:
Xxxxx
Xxxxxxxx
|
Name:
Xxxxx
Xxxx Xxxxx, M.D.
|
|
Title:
Global Head of Finance
|
Title:
President,
Chairperson, and CEO
|
|
Date:
March 6, 2007
|
Date:
March 14, 0000
|
Xxxxxxx
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
16 of
26
Exhibit
1 - Sample Statement of Work
Piazza
XX
Settembre,
2,
22079
Villa Guardia (CO)
Italy
Study:
Number
Short
Name
Statement
of Work
Date
Version
prepared
by
Name
Title
Email
Phone:
MDS
Pharma Services legal
entity
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
17 of
26
Table
of
Contents
BETWEEN 1
AND 1
MASTER
SERVICES
AGREEMENT...................................................................................................................................................2
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
18 of
26
STATEMENT OF WORK
Re:
Statement of Work between Gentium S.p.A (“Sponsor”) and MDS Pharma Services
(Legal Entity) (“MDSPS”), Protocol
Number [Number]
(the
“Protocol”) entitled
[Protocol Title]
(the
“Study”), and dated
[Date - format dd/mm/yyyy],
attached
hereto as Attachment
A.
As
a
Master Services Agreement by and between the Parties identified above was
executed and effective on [Date
- format dd/mm/yyyy]
(“Master
Agreement”), Sponsor hereby contracts with MDSPS to provide the services as
described in this Statement of Work.
|
1.
|
Transfer
of Obligations
|
Sponsor
and MDSPS agree that responsibility for compliance with European Directive
2001/20/EC, ICH Guidelines or 21 CFR Part 312, Subpart D-Responsibilities of
Sponsors and Investigators is transferred from Sponsor to MDSPS as outlined
in
Attachment
B.
[If
applicable - Sponsor has filed an appropriate Investigational New Drug ("IND")
application, IND #[Number. The drug is subject to all the requirements of the
FDA's IND regulations, which are codified in the Code of Federal Regulations
(CFR) at 21 CFR Part 312.]
|
2.
|
Term
of Services
|
This
Statement of Work is effective as of [Date
- format dd/mm/yyyy]
and will
expire [Date
- format dd/mm/yyyy].
The
term of this Statement of Work may be extended upon the written request of
Sponsor by [Date
- format dd/mm/yyyy]
and/or
the mutual agreement by Sponsor and MDSPS.
|
3.
|
Services
to Be Performed
|
Attachment
C sets forth the following information:
-
Detailed
Scope of Services:
(a)
Project specifications including study timelines, country and site
distribution
(b)
Division of Responsibilities checklist
-
Study Budget and Payment:
As
compensation for MDSPS’s services, Sponsor shall pay MDSPS a project budget of
XXXXXX
€,
distributed as follows :
|
·
|
Professional
Fees of XXXXXX
€
|
|
·
|
Estimated
Pass Through Costs of XXXXXX
€.
|
|
·
|
Central
Lab Cost of XXXXXX
€.
(if applicable)
|
|
·
|
Centralized
ECG & Xxxxxx Costs of XXXXXX
€.
(if applicable)
|
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
19 of
26
|
4.
|
Invoices
|
Invoices
should be issued separately by type of costs:
|
-
|
Professional
fees
|
|
-
|
Investigators
fees
|
|
-
|
Central
Lab/ECG costs
|
|
-
|
Other
pass through costs
|
|
-
|
All
invoices will be sent to the following address :
Gentium
Specify
Address
Gentium
shall make payments via wire transfer to the following MDSPS
account:
[Bank
Name]
[Bank
Adress]
[Bank
Account Number]
The
currency to be used for invoicing and payments shall be XXXX, as detailed in
the
budget attached. Where MDSPS incurs Pass Through Costs or Investigator Grants
in
a currency differing from that used for invoicing, these will be translated
using the Interbank rate from Oanda (xxx.xxxxx.xxx) prevailing
at the invoice date.
|
5.
|
Incorporation
by Reference.
|
The
terms
and conditions of this Statement of Work are hereby incorporated into and made
a
part of the Master Agreement. In the event of any inconsistency between the
Master Agreement and this Statement of Work, the Master Agreement will govern
unless specifically specified.
|
6.
|
Correspondence
/ contacts
|
6.1
Key contacts
(operational, billing and contractual personnel) :
|
Function
|
Gentium
(name + details)
|
MDSPS
(name + details)
|
|
Clinical
Project Manager
|
Name
Phone:
Email:
|
Name
Phone:
Email:
|
|
Clinical
Project Assistant/Secretary
|
Name
Phone:
Email:
|
Name
Phone:
Email:
|
|
Clinical
Program Leader
|
Name
Phone:
Email:
|
Name
Phone:
Email:
|
|
Project
Physician
|
Name
Phone:
Email:
|
Name
Phone:
Email:
|
|
Central
Lab
|
Name
Phone:
Email:
|
Name
Phone:
Email:
|
|
Data
Management
|
Name
Phone:
Email:
|
Name
Phone:
Email:
|
|
Quality
Assurance
|
Name
Phone:
Email:
|
Name
Phone:
Email:
|
|
Billing
contact
|
Name
Phone:
Email:
|
Name
Phone:
Email:
|
|
Contractual
contact
|
Name
Phone:
Email:
|
Name
Phone:
Email:
|
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
20 of
26
ACCEPTED AND AGREED FOR MDSPS:
|
MDS
Pharma Services (Legal
Entity)
|
Sponsor:
Gentium
|
|
Signature
|
Signature
|
|
<<Name>>
|
Name
|
|
<<Title>>
|
Title
|
|
<<Date>>
|
Date
|
|
Signature
|
|
|
Name
|
|
|
Title
|
|
|
Date
|
|
|
Signature
|
|
|
Name
|
|
|
Title
|
|
|
Date
|
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
21 of
26
ATTACHMENTS
:
Attachment
A:
PROTOCOL dated: [Date - format dd/mm/yyyy]
Attachment
B:
TRANSFER OF SPONSOR OBLIGATIONS
Attachment
C
:
INFORMATION FROM THE PROPOSAL
|
-
|
Project
Overview
|
|
-
|
Project
Management
|
|
-
|
Budget
Estimate
|
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
22 of
26
Exhibit
2
Data
Use
Agreement
Data
Use Agreement: Limited Data Set
This
Data
Use Agreement (this “Agreement”), effective as of the date to be signed by both
parties (the “Effective Date”), is made by and between _____________________
(hereinafter “Institution”) and Gentium S.p.A. with its headquarters at Xxxxxx
XX Xxxxxxxxx, 0, 00000 Xxxxx Xxxxxxx (Xxxx) Xxxxx (“Sponsor”).
WHEREAS,
Institution performs certain research, public health, and/or healthcare
operations functions;
WHEREAS,
Institution agrees to disclose a Limited Data Set, as defined in this Agreement,
to Sponsor for use in performance of the Activities as set forth
below;
WHEREAS,
Sponsor
agrees to limit use of the Limited Data Set and protect the Limited Data Set
according to the terms and conditions of this Agreement and the Health Insurance
Portability and Accountability Act of 1996, including the Privacy Rule and
its
implementing regulations, as may be amended from time to time
(“HIPAA”).
NOW,
THEREFORE,
in
consideration of the mutual promises, covenants and agreements contained in
this
Agreement, and other good and valuable consideration, the receipt and
sufficiency of which each party acknowledges, Sponsor and Institution agree
as
follows:
Section
1.0 Sponsor
requests the Limited Data Set, as defined in Section 2.0, to be accessed by
the
parties or individuals described in Section 3.0, for the following research
activities (“Activities”):
|
A.
|
Conduct
of the clinical trial pursuant to the Protocol entitled “Defibrotide for
the Treatment of Severe Hepatic Xxxx-Occlusive Disease in Hematopoietic
Stem Cell Transplant Patients: A Historically-Controlled, Multi-Center
Phase 3 Study To Determine Safety & Efficacy” (the
“Study”);
|
|
B.
|
Examination
under the Study of the efficacy and safety of defibrotide in patients
with
severe Xxxx-Occlusive Disease (“VOD”) using a historical control group as
a comparator;
|
|
C.
|
Creation
of an historical control group that will include patients diagnosed
with
severe VOD according to the definition described in the
Protocol.
|
Section
2.0 The
parties agree that the limited data set to be created under this Agreement
(“Limited Data Set”) includes the provision of the following information, which
Sponsor represents is the minimum necessary to achieve the
Activities:
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
23 of
26
|
A.
|
Dates
associated with the patient and their disease (including date of
birth,
date of death, hospital admission date, stem cell transplant date,
and
other relevant dates associated with the history of their disease
and
their course of treatment);
|
|
B.
|
Patient
gender;
|
|
C.
|
Inclusion/exclusion
criteria (including details of severe VOD and MOF
diagnoses);
|
|
D.
|
Admission
form for SCT;
|
|
E.
|
Demographic
information;
|
|
F.
|
Disease/transplant
history;
|
|
G.
|
General
medical and surgical histories;
|
|
H.
|
Progress
notes;
|
|
I.
|
Abdominal
ultrasound results;
|
|
J.
|
Liver
pathology reports;
|
|
K.
|
Any
Glomerular Filtration Rate (GFR)
studies/reports;
|
|
L.
|
Laboratory
reports;
|
|
M.
|
ICU
records;
|
|
N.
|
Medication
Administration Record (MAR);
|
|
O.
|
Blood
Product Transfusions Records; and
|
|
P.
|
Other
medical information relevant to the Activities that HIPAA does not
exclude
from a Limited Data Set.
|
Section
3.0 The
parties agree that the following individuals or classes of individuals shall
be
the recipients of the Limited Data Set:
|
A.
|
Sponsor
and representatives of Sponsor;
|
|
B.
|
Agents,
subcontractors and third parties to Sponsor, including, but not limited
to: MDS Pharma Services, Inc., the applicable Data and Safety Monitoring
Board (data and safety monitoring group for the Study), and the applicable
Medical Review Committee (medical experts who will review patient
medical
data); and
|
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
24 of
26
|
C.
|
Federal
and state regulatory agencies with oversight authority of Sponsor
and
Institution.
|
Section
4.0 In
consideration of Institution making available the Limited Data Set to Sponsor,
Sponsor agrees as follows:
|
A.
|
To
use and disclose the Limited Data Set only as permitted under this
Agreement or as required by law, and to not use or further disclose
the
Limited Data Set in a manner that would violate the Privacy Rule
if done
by the Institution;
|
|
B.
|
To
permit only the individuals or entities specified in Section 3.0
to use or
receive the Limited Data Set;
|
|
C.
|
To
use appropriate safeguards to prevent use or disclosure of the Limited
Data Set other than as provided for by this
Agreement;
|
|
D.
|
To
report promptly to Institution any use or disclosure in violation
of this
Agreement of which Sponsor becomes aware;
|
|
E.
|
To
ensure that any agents, subcontractors and third parties to which
Sponsor
provides the Limited Data Set agree to the same restrictions and
conditions that apply to Sponsor with respect to the Limited Data
Set;
|
|
F.
|
It
will not use the Limited Data Set to identify or to contact the
individuals; and
|
|
G.
|
In
the event of a breach or violation of this Agreement, Institution
has the
right to report the breach to the Secretary of the U.S. Department
of
Health and Human Services and to take other appropriate action, including
but not limited to terminating this
Agreement.
|
Signatures
on following page
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
25 of
26
IN
WITNESS THEREOF, the parties caused this Agreement to be executed by their
duly
authorized representatives as of the date first written above.
|
Sponsor:
|
By:________________________________________
Name:
Xxxxx
Xxxx Xxxxx,
M.D.
Title:
President
and CEO, Gentium
S.p.A.
|
Date:
______________
|
|
Institution:
|
By:
_______________________________________
Name:
_____________________________________
Title:
______________________________________
|
Date:
______________
|
Gentium
SpA & MDS Pharma Services Inc.
MASTER
SERVICES AGREEMENT - FINAL VERSION, 6th
March
2007
Page
26 of
26
