EXHIBIT
10.3.2
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.
AMENDMENT NO. 2
TO
DISTRIBUTION AND
MANUFACTURING
SERVICES
AGREEMENT
This Amendment No. 2 to Distribution and
Manufacturing Services Agreement is made as of January 31, 2006
(this “ Amendment ”) and amends the Distribution
and Manufacturing Services Agreement, dated as of January 16, 2004,
by and between Lev Development Corp.(formerly known as Lev
Pharmaceuticals, Inc.), a Delaware corporation (“
LEVPHARMA ”), and Sanquin Blood Supply Foundation
(“ SANQUIN ”), a not-for-profit corporation
organized under the laws of The Netherlands, as amended by a First
Amendment (the “ Original Agreement ” and
together with this Amendment, the “ Agreement
”). Terms used in this Amendment without definition shall
have the meanings given them in the Agreement.
WHEREAS, LEVPHARMA and SANQUIN entered into the
Original Agreement in January 2004;
WHEREAS, the parties to the Original Agreement
desire to amend the Original Agreement as more fully set forth
herein to reflect developments in the relationship between the
parties and the status of the manufacturing of the
Product.
NOW THEREFORE, in consideration of the premises
and the agreements hereinafter set forth, and for other good and
valuable consideration, the receipt and sufficiency of which are
hereby acknowledged by the each of the parties, the parties hereby
amend the Original Agreement as follows:
1. Preamble. The Preamble to the Agreement is hereby amended
by deleting the address for Lev Development Corp. and replacing it
with the following address: 122 East 42nd Street, Suite
2606, New York, New York 10168.
2. Section 3.2: Pre-approval.
Section 3.2 of the Agreement is
hereby amended by adding the following new section (d):
“(d) Commencing with the first calendar
quarter in 2006, LEVPHARMA shall provide to SANQUIN within 45 days
after the end of the calendar quarter, written progress reports on
the status of the Clinical Study.”
3. Section 4.1(a): Supply for the Clinical
Study. Section 4.1(a) of
the Agreement is hereby amended by deleting the third and fourth
sentence in their entirety and replacing them with the
following:
“SANQUIN shall provide an additional *
Units to LEVPHARMA by March 1, 2006. In addition, SANQUIN will
provide the remaining * Units to LEVPHARMA in accordance with
Schedule 4.1(a) attached hereto.”
4. Section 4.1(c)(ii): Scale Up
. Section 4.1(c)(ii) of the
Agreement is hereby amended by deleting the language in Section
4.1(c)(ii) in its entirety and replacing it with the
following:
“SANQUIN agrees to perform an
analysis of the feasibility of scaling up the production of the
Product and provide the results of this analysis to LEVPHARMA no
later than May 30, 2006. The parties shall then make a mutual
decision on whether or not to scale u
