Exhibit 10.5
Confidential Treatment has been
requested for portions of this exhibit. The copy filed herewith
omits the information subject to the confidentiality request.
Omissions are designated as “***”. A complete version
of this exhibit has been filed separately with the Securities and
Exchange Commission.
June 18, 2009
Dr. Robert Tiebout
The Sanquin Blood Supply Foundation
Plesmanlaam 125
1 066CX Amsterdam
The Netherlands
Dear Dr. Tiebout
Reference is made to the
Distribution and Manufacturing Services Agreement between Lev
Pharmaceuticals Inc. (“Lev”) and Sanquin Blood Supply
Foundation (“Sanquin) dated January 16, 2004, as amended
through the date hereof (the “DMS Agreement”).
ViroPharma Biologics, Inc. (“ViroPharma”) is the
successor to Lev under the DMS Agreement. All capitalized terms
used in this letter agreement (this “Agreement”) that
are not defined below shall have the meanings ascribed to them in
the DMS Agreement.
Parties have evaluated the
requirements made by *** and pursuant to supplements submitted to
the BLA for Cinryze. It was concluded that additional resources are
needed to meet such requirements and that a revision of the
purchase price for Cinryze is warranted.
Below you will find a brief
description of the additional resources as discussed and the
understanding between the parties in this respect.
Part of the additional resources
that were not foreseen before relate to equipment.
Sanquin and ViroPharma agree that it
is in the best interests of the parties for Sanquin to purchase a
*** and to *** to the *** for *** (“***”) system as
well as to the *** system (“***”) (collectively, the
“Equipment”) for use in manufacturing Cinryze for
ViroPharma.
Sanquin shall purchase the
Equipment, install it and qualify it for use in accordance with the
timelines described in the Work Plan (defined below).
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2.
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Hiring of
Additional Employees.
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Another part of the additional
resources needed relate to staffing.
(a) Sanquin shall hire approximately
*** additional full time equivalent employees (FTEs). The
FTE’s shall include persons hired in the following
capacities:
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QA/QC
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***
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Trend Analysis
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***
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483 Follow Up
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***
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Engineering/Qualification
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***
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Look Back Handling
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***
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(b) *** of the FTEs shall include
employees that will be dedicated to Cinryze manufacturing efforts
(the “Dedicated Employees”), and in the following
capacities:
1) Project Manager/Coordinator
and back-up . This key role will provide:
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Overall project tracking,
communication, and coordination.
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First point of contact for any
questions relating to Cinryze that ViroPharma management and
personnel may have.
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Key contact for all
manufacturing/engineering projects and issues, responding to daily
questions and issues.
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Update management on key issues,
emerging concerns.
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Support the Supply Team
administratively.
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2) Regulatory Coordinator .
This role communicates and coordinates all issues related to
regulatory files and variations thereof, including all FDA and EMEA
responses.
The FTEs shall be hired and trained
in accordance with the Work Plan.
(a) Equipment . Sanquin shall
accomplish the purchase, installation and qualification of the
Equipment as follows:
(i) ***. Sanquin shall immediately
undertake to start a comprehensive study (as per commitments made
to FDA pursuant to April 2009 audit in Brussels) for the ***, and
shall submit a purchase order for the *** by ***. Assuming that the
manufacturer of the *** deli
