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Exhibit 10.3
MASTER
CLINICAL DEVELOPMENT AGREEMENT
between
AVANIR PHARMACEUTICALS
San Diego, CA 92121
and
SCIREX CORPORATION
Horsham, PA 19044
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MASTER CLINICAL DEVELOPMENT AGREEMENT
THIS AGREEMENT,
made as of the date last signed below is by and between
Avanir Pharmaceuticals, a company having
its principal place of business at
11388 Sorrento Valley Road, Suite 200, San
Diego, CA 92121 ("Avanir"), and
SCIREX Corporation a corporation of the
State of Delaware having its principal
place of business at 755 Business Center
Drive, Horsham, PA 19044 ("SCIREX").
WITNESSETH:
WHEREAS, Avanir
is engaged in the development, manufacture, distribution
and sale of pharmaceutical products and it
currently considers from time to time
the evaluation of new drug(s) ("Drug" or
"Drugs" as the context requires); and
WHEREAS, SCIREX
is in the business of providing services for the
development of experimental new drugs and
marketed drugs; and
WHEREAS, Avanir
desires to contract with SCIREX from time to time, and
SCIREX desires to be contracted by Avanir,
for the purposes of providing such
services to assist Avanir in the execution
of clinical development projects
("Project" or "Projects" as the context
requires) relating to Drugs as outlined
in the project-specific exhibits to this
Agreement ("Exhibit" or "Exhibits" as
the context requires).
NOW, THEREFORE,
the parties hereby agree as follows:
1. OBLIGATIONS OF
SCIREX
SCIREX hereby
agrees to conduct the Projects in accordance with Avanir's
instructions. The details, specifications
and obligations of each Project will
be included as an Exhibit. SCIREX will
conduct the Projects in accordance with
agreed upon protocols and as outlined in
the Exhibits. Projects will be
conducted in accordance with all applicable
federal, state and local laws,
statutes, ordinances and regulations.
2. TRANSFER OF
RESPONSIBILITIES
For compliance
under 21 CFR 312.52, Avanir must identify all
responsibilities which will be transferred
to SCIREX. Each Exhibit will contain
a detailed description of transferred
obligations. Avanir agrees that the same
description and extent of obligations
transferred should be included in form
FDA-1571, Section #13 relating to the
specific Drugs under investigation. SCIREX
agrees to carry out diligently all
transferred obligations.
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3. CLINICAL
SUPPLIES
Unless otherwise
specified in an Exhibit, Avanir will supply the clinical
investigators with the Drugs and other
clinical drug supplies as are agreed upon
by SCIREX and Avanir for the timely
completion of the Projects, and will direct
the shipment of any such supplies to the
location indicated by SCIREX, within a
reasonable time after receipt of
notification from SCIREX of the need for any
such clinical supplies.
4. STATUS
REPORTING
SCIREX will
provide status reports on the Projects as agreed to in each
specific Exhibit. The status reports will
include, but not be limited to, data
regarding the number of patients entering
the Projects, as well as data
regarding the number of patients that
either drop out of the Projects or
complete the Projects. Reports of
monitoring visits will also be provided on a
timely basis as specified in the
Exhibits.
5. CONFIDENTIAL
INFORMATION
All information
received by SCIREX concerning the implementation of the
Projects is considered to be confidential
information to Avanir ("Avanir
Confidential Information"). Avanir
Confidential Information will be held in
confidence by SCIREX and not disclosed to
third parties; provided however, that
Avanir Confidential Information shall not
include, and the obligations of
confidentiality and non-disclosure shall
not apply to, disclosed information
that:
A. is or becomes publicly
available through no fault of SCIREX;
B. is disclosed to SCIREX by a
third party entitled to disclose such
information;
C. is already known to SCIREX
as shown by its prior written records; or
D. is required by law to be
disclosed.
SCIREX will only
use the Avanir Confidential Information for the purpose of
its obligations under this Agreement. Upon
the completion or earlier termination
of this Agreement, SCIREX will promptly
return to Avanir all written Avanir
Confidential Information, as well as all
written material which incorporates any
Avanir Confidential Information, other than
such information that is required by
government regulations to be retained by
it. Notwithstanding the foregoing,
SCIREX shall have the right to retain one
copy of Avanir Confidential
Information for the purposes of
demonstrating compliance with GCPs, SOPS, Avanir
written instructions, and all federal,
state and local laws and regulations.
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SCIREX will not
disclose, without the prior written consent of Avanir, any
Avanir Confidential Information to any
third party other than employees who have
a need to know such information, hospital
authorities, institutional review
board members, clinical investigators, and
others who must be involved the
Projects.
SCIREX will not
use any Avanir Confidential Information for its own benefit
or for the benefit of any third party, and
will not furnish to any third party
any materials which incorporate any
confidential information except as otherwise
provided for herein. All obligations of
confidentiality and non-disclosure set
forth in this Agreement will survive,
without limitation, the expiration or
earlier termination, for any reason, of
this Agreement.
During the term
of this Agreement and thereafter (including following any
termination), Avanir, for itself and its
employees, agents and independent
contractors, agrees to retain in confidence
and not disclose to any third
parties any SCIREX Confidential Information
(defined below) without having first
obtained SCIREX' written consent to such
disclosure. During the term of this
Agreement, but not thereafter (including
following any termination), Avanir may
have access or use SCIREX Confidential
Information only in connection with the
Projects; provided, however, that Avanir
may not run or have or have access to
SCIREX computer programs or computer code
without SCIREX' permission, although
SCIREX will run its computer programs as
part of the services provided hereunder
and as and when requested by Avanir during
the term of this Agreement. "SCIREX
Confidential Information" shall include but
not be limited to confidential and
proprietary know-how, statistical
approaches, computer programs, operating
procedures, formulations, methods,
processes, specifications and all other
intellectual property of SCIREX that SCIREX
considers confidential; provided,
however, that such information shall be to
exceptions based on public knowledge,
prior or lawfully obtained Avanir knowledge
and requirements of law, rules and
regulations corresponding to the exceptions
set forth in A-D above.
6. ACCEPTANCE OF
WORK PRODUCT
Avanir agrees to
review all work products submitted by SCIREX and to advise
SCIREX promptly of any errors or omissions
of which Avanir becomes aware in the
course of its review or thereafter. SCIREX
shall, at its expense, correct all
errors that it discovers or which are
brought to its attention by Avanir within
ninety (90) days after submission of work
product to Avanir. Notwithstanding any
other provision of this Agreement, SCIREX
shall not be liable to Avanir, its
affiliates, successors or assigns for
errors in work product which are not known
to SCIREX and are not brought to SCIREX
attention within the above-stated notice
period. SCIREX' liability within the
above-stated notice period shall be limited
to correction of the errors brought to its
attention and shall not include
consequential or special damages,
including, without limitation, loss of
profits. If errors or omissions are not
known to SCIREX or brought to its
attention within
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the above-stated notice period, the work
product to which they relate shall
be deemed accepted and approved by
Avanir.
7.
COMPENSATION
Avanir shall pay
to SCIREX the investigator fees and other out-of-pocket
costs and fees set forth in the Exhibits.
SCIREX shall complete the transferred
obligations and the Projects by the dates
specified in the Exhibits except for
delays caused by Avanir or others, events
outside of SCIREX control, or mutual
agreement between SCIREX and Avanir.
The payment
schedule for each Project will be contained in the appropriate
Exhibit.
SCIREX will
submit invoices to Avanir according to the schedule described
in the Exhibits. All SCIREX invoices are
payable within thirty (30) days after
date of invoice.
The total cost
of the Projects, individual budget components and time
estimates are based on the specification
and assumptions contained in the
Exhibits, and subject to modification only
as provided for in Section 7 hereof.
8. CHANGE
ORDERS
In the event of
a change in the scope of a Project, a change in the nature
or timely execution of the obligations of
Avanir or SCIREX, or a change in any
specific Project assumptions which are
contained in the Exhibits and outside
SCIREX control, is identified by Avanir or
SCIREX, the identifying party will
notify the other party of such change.
Within twenty (20) working days from the
receipt by SCIREX of such a notice of
changes by Avanir or sending of such a
notice of change by SCIREX, SCIREX shall
provide Avanir with an estimate of the
modification to the timeline and costs
arising from such change ("Change Order")
whether such a change results in an
increase or decrease to the timeline or
costs. Avanir shall have fifteen (15)
working days to approve the Change Order.
If Avanir does not approve such Change
Order and has not terminated the Project,
both parties will use their best efforts to
agree in writing on time a
