AMENDMENT NO. 2 TO DISTRIBUTION AND MANUFACTURING SERVICES AGREEMENT
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
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: 000 Xxxx 00xx
Xxxxxx, Xxxxx 0000, Xxx
Xxxx,
Xxx Xxxx 00000.
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 up the production of the Product (the “Scale
Up”).
In
the event that a Scale Up is agreed to, the Parties shall negotiate in good
faith to reach an agreement on the details of the Scale Up. Such agreement
shall
also include timelines as to when (a) clinical trial material and (b) commercial
product from Scale Up shall be available, which timelines shall be dependent,
among other things, upon the volume decided upon for Scale Up. Parties shall
use
best efforts to conclude such agreement by July 30, 2006.
5. Section
4.1(e): Clinical Study Specifications and Manufacturing
Standards.
a. Section
4.1(e) of the Agreement is hereby amended by deleting the first sentence in
its
entirety and replacing it with the following: “The Product for the Clinical
Study shall be manufactured by SANQUIN according to the Clinical Specifications
and Manufacturing Standards described in the Investigational New Drug
Application No. 11838 and in any subsequent amendments thereto (collectively,
the “IND
Application”).
Once
the manufacturing of the conformance lots has commenced, the processes and
procedures used to manufacture said lots shall supersede the Clinical
Specifications and Manufacturing Standards described in the IND
Application.”
b. All
references in the Agreement to Exhibit 1 and/or the Quality Agreement are hereby
deleted and are replaced with a reference to “the Clinical Specifications and
Manufacturing Standards described in Section 4.1(e)”.
6. Section
5.1: Purchase
Price.
Section
5.1 of the Agreement is hereby amended by changing the words “recovered plasma”
into “plasma” wherever these words appear in the language.
7. Section
5.2(a): Product Supplied for Clinical Study.
Section
5.2(a) of the Agreement is hereby amended by deleting the last sentence in
its
entirety and replacing it with the following language:
“The
loan
from SANQUIN to LEVPHARMA in the amount of the Purchase Price will be interest
free and due on January 16, 2014, provided, however, upon Regulatory Approval
in
the US, the loan will be cancelled and SANQUIN will provide a release of any
and
all security interests granted by LEVPHARMA to SANQUIN. In the event that the
agreement is terminated prior to either the receipt of Regulatory Approval
of
the Product or January 16, 2014, the loan shall become due immediately.”
8. Section
12.2: Termination.
Section
12.2 of the Agreement is hereby amended by deleting the language in Section
12.2(a)(i) in its entirety and replacing it with the following language:
“(i)
LEVPHARMA after receiving complete and timely support and cooperation from
SANQUIN fails to complete the enrollment (to be interpreted here as “last
patient treated”)(the “Enrollment
Completion”)
of the
Clinical Study by July 1, 2007, provided,
however,
that
completion of either the Acute Study (Part A) or the Prophylaxis Study (Part
B),
shall constitute Enrollment Completion, or”
9. Article
XXII: Notices.
Article
XXII of the Agreement is hereby amended by adding the following language in
subsection (d) after the address for LEVPHARMA and before the address for
SANQUIN:
“With
a
mandatory copy to:
Lev
Pharmaceuticals, Inc.
000
Xxxx
00xx
Xxxxxx
Xxxxx
0000
Xxx
Xxxx,
Xxx Xxxx 00000
Attention:
Xxxxxx X. Xxxxxx, CEO
Telephone:
(000) 000-0000”
10. Full
Force and Effect.
Except
to the extent the Original Agreement is modified by this Amendment, the other
terms and provisions of the Original Agreement shall remain unmodified and
in
full force and effect. In the event of a conflict between the terms of the
Original Agreement and the terms of this Amendment, the terms of this Amendment
shall prevail.
IN
WITNESS WHEREOF, the parties hereto have executed this Amendment No. 2 to
Distribution and Manufacturing Services Agreement as of the date first above
written.
LEV
DEVELOPMENT CORP.
By:
/s/
Xxxxxx X. Xxxxxx
Xxxxxx
X.
Xxxxxx, Ph.D.
Chief
Executive Officer
SANQUIN
BLOOD SUPPY FOUNDATION
By:
/s/
T. J.
F. Buunen
T.
J. F.
Buunen
Chairman
of the Executive Board
Schedule
4.1(a)
Production
Timetable for * Units pursuant to Section 4.1(a) of the Distribution and
Manufacturing Services Agreement dated January 16, 2004, as amended. The Product
volume for each time point shall be produced and ready for delivery no later
than the dates listed below:
Date:
|
Production
(units)
|
|||
June
30, 2006
|
*
|
|||
September
30, 2006
|
*
|
|||
December
31, 2006
|
*
|
|||
March
31, 2007
|
*
|
|||
June
30, 2007
|
*
|
|||
September
30, 2007
|
*
|
|||
Total
|
*
|