Exhibit 10.4.4
AMENDMENT NO. 4 TO THE MANUFACTURING AGREEMENT
This AMENDMENT No. 4 dated as of July 18, 2002 (the "Amendment") to the
Manufacturing Agreement dated as of September 18, 1995, as amended (the
"Manufacturing Agreement"), by and between Merck & Co., Inc. ("MERCK") and
Regeneron Pharmaceuticals, Inc. ("REGENERON"). Capitalized terms used in this
Amendment but not defined herein shall have the meaning set forth in the
Manufacturing Agreement.
WHEREAS, MERCK and REGENERON have been in discussions regarding certain matters
relating to the Manufacturing Agreement;
WHEREAS, both parties wish to amicably settle their differences in order to
facilitate future relations between the parties;
WHEREAS, based upon the foregoing discussions, MERCK and REGENERON with to amend
the Manufacturing Agreement pursuant to the terms and conditions of this
Amendment;
NOW, THEREFORE, in consideration of the mutual covenants and promises herein
contained, the receipt and sufficiency of which are hereby acknowledged, the
parties agree to the following:
1. Over the past few months, REGENERON has raised an issue that the
Manufacturing Agreement does not provide the bargained-for compensation,
including profitability of the Manufacturing Agreement. MERCK disagrees
with REGENERON's position and believes that REGENERON has received the
bargained-for compensation. Notwithstanding the foregoing, and without
agreeing upon nor acknowledging the validity of REGENERON's position, in
order to resolve fully and finally the issue relating to bargained-for
compensation, including, profitability of the Manufacturing Agreement,
MERCK shall pay to REGENERON the amount of One Million U.S. Dollars
($1 Million) no later than thirty (30) days after the execution of this
Amendment. MERCK's decision to make the payment described in this
Paragraph 1 is based solely on its desire to facilitate future relations
between the parties and is not an admission that any such payment is
required under the Manufacturing Agreement and does not establish any
precedent to that effect.
2. In consideration of the payments and compromises set forth herein and with
the intent of facilitating future relations between the parties, the
sufficiency of which is hereby acknowledged, REGENERON hereby releases and
forever waives any claim it has or may have against MERCK relating to the
bargained-for compensation, including, without limitation, the
profitability of the Manufacturing Agreement or any other compensation
required under the Manufacturing Agreement, except for payment of
compensation as expressly set forth in Paragraph 7 or Amendment No. 3 and
Article 13 and Article 19 of the Manufacturing Agreement, or as may
otherwise be agreed to in writing by the parties.
3. REGENERON expressly agrees that it will abide by the terms of the
Manufacturing Agreement, including, without limitation, to deliver
INTERMEDIATE in accordance
with MERCK's delivery schedule, subject to the terms and conditions set
forth in the Manufacturing Agreement.
4. Section 7.1 of the Manufacturing Agreement is hereby amended to add the
following sentence at the end of the existing Section 7.1
"Notwithstanding anything in this Agreement to the contrary, no quarterly
delivery schedule provided by MERCK in any PURCHASE ORDER shall require
the delivery of more than [**] BATCHES, unless otherwise agreed in writing
by the parties."
5. Section 12.3 of the Manufacturing Agreement is hereby amended to add the
following sentences at the end of the existing Section 12.3;
"For purposes of determining if REGENERON has met its quarterly delivery
obligation and the BATCH FEES payable to REGENERON only, REGENERON shall
be deemed to have delivered INTERMEDIATE to MERCK as of the date of
receipt of the conditional release package by MERCK plus thirty (30) days
(the "Deemed Delivery Date").
Notwithstanding the foregoing paragraph, in the event that MERCK has not
been able to deliver MATERIALS and/or SUBSTANCE to REGENERON by the
agreed-up delivery dates for such MATERIALS and/or SUBSTANCE (as agreed
from time to time by MERCK and REEGENERON) or MERCK has delivered to
REGENERON MATERIALS and/or SUBSTANCE which fail to meet the agreed-upon
specifications then with respect to any such affected BATCHES of
INTERMEDIATE, REGENERON shall not be obligated to meet MERCK's delivery
schedule, but rather, shall make all reasonable effort to deliver
INTERMEDIATE to MERCK as soon as possible; provided, however, that, in an
such case, REGERNON shall deliver such affected BATCHES of INTERMEDIATE to
MERCK no later than the CALENDAR QUARTER immediately following REGENERON's
receipt of such delayed MATERIALS and/or SUBSTANCE unless the parties
agree in writing to an alternate delivery schedule; provided, further,
that, REGENERON shall not be obligated to deliver in any CALENDAR QUARTER
more than [*****] BATCHES of INTERMEDIATE. If such affected BATCHES cannot
be made up in full in the first CALENDAR QUARTER immediately following
REGENERON's receipt of such delayed MATERIALS and/or SUBSTANCE due to the
[*****] BATCH limitation set forth in the previous sentence, then such
remaining BATCHES shall be made up in the next CALENDAR QUARTER or
QUARTERS, subject to the [*****] BATCH limitation set forth in the
previous sentence.
6. Section 16.2 of the Manufacturing Agreement is hereby amended to add the
following sentence at the end of the existing Section 16.2;
"Notwithstanding the foregoing, in the event that MERCK gives REGENERON at
least three hundred sixty five (365) days' notice of termination, then
MERCK shall not be obligated to, and shall not, pay to REGENERON the
aforementioned sum of [*****].
A termination notice delivered by MERCK to REGENERON pursuant to this
Section 16.2 shall be non-revocable."
7. Section 13.1 of the Manufacturing Agreement shall be amended by adding an
"(a)" immediately prior to the existing language and adding the following
paragraphs (b), (c) and (d) immediately after the existing Section 13.1;
"(b) Notwithstanding paragraph (a) above and Section 13.2 herein, with
respect to all BATCHES of INTERMEDIATE for which a [***] release package
has been delivered to MERCK prior to a Resumption Date (as such term is
defined in the last sentence of this paragraph (b)), REGENERON shall
invoice MERCK for such BATCHES once the [***] release package has been
delivered to MERCK and MERCK shall pre-pay to REGENERON [***] of the
invoiced amount within forty five (45) days after the later of (i) receipt
of REGENERON's invoice or (ii) the Deemed Delivery Date. The remaining
[***] of the invoiced amount shall be paid by MERCK to REGERNON within
thirty (30) days after the later of actual receipt by MERCK of (a)
INTERMIATE or (b) REGENERON's invoice for such remaining amount. In the
event that any BATCH is subsequently not RELEASED by MERCK, upon notice to
REGENERON of such rejection, REGENERON shall, within thirty (30) days,
either issue a credit or a check, at MERCK's option, to MERCK in the full
amount pre-paid by MERCK for the rejected BATCH. No late than thirty (30)
days after the start of a Prepayment Period (as such term is defined in
the last sentence of this paragraph (b)), MERCK shall pay REGENERON all
amounts due under this paragraph (b) relating to the BATCHES which have
triggered the start of a Prepayment Period. For purposes of this
Agreement, (x) "Prepayment Period" shall mean each period in which MERCK
is making a prepayment pursuant to this paragraph (b) and (y) "Resumption
Date" shall mean the day after the date in which MERCK has RELEASED and
paid REGENERON for [***] consecutive BATCHES of INTERMEDIATE within [***]
days of receipt by MERCK of the [***] release package.
(c) From and after any Resumption Date, Merck shall have no further
obligation to pre-pay any amount, as provided in paragraph (b) above, and
paragraph (a) above shall govern all deliveries until such time that MERCK
fails to RELEASE and pay for [***] consecutive BATCHES of INTERMEDIATE
within [***] days of receipt by MERCK of the applicable [***] release
packages for such BATCHES, at which time a new Prepayment Period shall
commence and the terms of paragraph (b) shall again become in full force
and effect until the ensuing Resumption Date.
(d) For the avoidance of any doubt, the initial Prepayment Period shall
commence as of the date hereof. No later than thirty (30) days after the
receipt by Merck of REGENERON's invoice, MERCK shall prepay all amounts
due under paragraph (b) above for the following BATCHES: [***].
8. Schedule F shall be amended by deleting the existing Schedule F and in its
place by inserting a new Schedule F, attached hereto as Attachment 1.
9. Except as specifically set forth above, all other terms and conditions of
the Manufacturing Agreement shall remain unchanged and in full force and
effect.
10. Each and every referenced to the Manufacturing Agreement shall hereinafter
refer to the Manufacturing Agreement as amended by this Amendment.
11. This Amendment, together with the Manufacturing Agreement, are the only,
entire and complete agreement of the parties relating to the subject
matter hereof. All prior discussions, negotiations and agreements have
been and are merged, cancelled and integrated into, and are superseded by,
the Manufacturing Agreement, as amended by this Amendment. None of the
parties hereto shall be bound by any conditions, definitions, warranties,
understandings or representations with respect to such subject matter
other than as expressly provided herein.
12. The parties acknowledge agreement to the terms of this Amendment by having
an authorized representative sign one copy in the space provided below.
Each party represents and warrants that the authorized representative has
actual power and authority to execute this Amendment on behalf of the
respective company, and that this Amendment shall be binding upon the
respective company, its successors and assigns.
13. This Amendment shall be interpreted by the construed according to the
substantive laws of the State of New York without reference to any rules
of conflict of laws or renvoi.
14. This Amendment may be executed in one or more counterparts, each of which
shall for all purposes be deemed an original and all of which shall
constitute one of the same agreement.
IN WITNESS WHEREOF, the parties have executed this Amendment as of the date
first above written.
MERCK & CO., INC. REGENERON PHARMACEUTICALS, INC.
By: /s/Bernard J. Kelley By: /s/Murray A. Goldberg
----------------------------- ---------------------------------------
Name: Bernard J. Kelley Name: Murray A. Goldberg
Title: President, MMD Title: SVP, Finance & Administration
and CFO
ATTACHMENT 1
SCHEDULE F
[*****]