Exhibit 10.4
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.
Intermediate Supply
Agreement
This Intermediate Supply Agreement
is entered into, effective as of this 19th day of July, 2009 (the
“ Effective Date ”) by and between
ViroPharma SPRL, a Belgium
corporation, having a place of business at 37, Square de
Meeûs, B-1000, Bruxelles, Belgium (hereinafter referred to as
“ VPS ” or “ Seller
”)
and
Biotest AG, a corporation having a
place of business at Landsteinerstrasse 5, 63303 Dreieich, Germany
(hereinafter referred to as “ Biotest ” or
“ Purchaser ”)
Both, VPS and BIOTEST may be
referred to as the “PARTIES”
RECITALS
Whereas, BIOTEST wishes to purchase
intermediates manufactured from human plasma as starting material,
and whereas, VPS has access to human plasma and is interested to
sell intermediates manufactured out of such plasma by toll
manufacture; and
Whereas, BIOTEST has *** Sanquin
Blood Supply Foundation (“Sanquin”) *** from *** in***
of ***.
Now, therefore, in consideration of
the foregoing and the mutual promises contained herein the Parties
agree as follows:
TERMS
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a)
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“
Products ” are defined as the intermediates
manufactured by fractionation of plasma and specified by
Appendix 1 .
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b)
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“
Plasma ” (“ Plasma for Fractionation
”) is the liquid part of human blood donated by donors and
which satisfies the definition of “Source Plasma”, as
defined by the United States Food and Drug Administration
(“FDA”) in 21 C.F.R. 640.60. ViroPharma agrees to use
reasonable commercial efforts to ensure that the Plasma utilized in
the production of the Products shall have been collected from
sources approved by a European regulatory authority acceptable to
each of the parties.
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c)
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BIOTEST
acknowledges that the Products are manufactured on VPS’s
behalf by Sanquin, located at Plesmanlaan 125, 1066 CX Amsterdam,
Netherlands. Manufacturing site is the facility of CAF/DCF, Avenue
de Tyraslaan 109, 1120 Brussels, Belgium.
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2.1
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Agreement to
purchase and sell .
During the Term of, and in accordance with the terms and
conditions, of this Agreement, Seller shall sell and Purchaser
shall purchase all of the Products (as defined above) produced by
Sanquin on behalf of Seller from the Plasma provided by Seller to
Sanquin that Seller does not require for use in clinical trials of
its product candidates, as it may determine in its reasonable
discretion, at the price, and upon the other terms, described in
Appendix 2. Seller represents to Purchaser that the volume of
Plasma to be processed on its behalf by Sanquin for the calendar
year ending December 31, 2009 shall be approximately ***
liters. Thereafter, and for all subsequent *** month periods during
the term of this Agreement, Seller shall notify Purchaser prior to
November 30 of the prior year of the volume of Plasma that is
anticipated to be processed for Seller by Sanquin for the next
succeeding twelve month period. Notwithstanding the foregoing,
however, Purchaser agrees and acknowledges that the specific
quantities of Products which it hereby agrees to purchase shall
fluctuate throughout the Term, based on Seller’s
requirements, and that Seller makes no commitment or guarantee to
sell any set quantity of Products during the Term. Seller will
estimate, on a periodic basis during the Term, the estimated volume
and schedule for shipments of Products.
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2.2
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Purchaser’s Right of First Refusal for
Plasma .
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(a) If during the Term Seller
determines to sell unprocessed Plasma to an unaffiliated third
party, Seller agrees to offer such Plasma to Purchaser in
accordance with the terms and conditions of this Agreement. In the
event Seller determines to sell unprocessed Plasma, it shall first
provide Purchaser with written notification (the “
Notice ”) of its offer to sell such Plasma, which
Notice shall include at a minimum (i) the volume of Plasma it
is willing to sell (the “ Offered Plasma ”),
(ii) the aggregate purchase price for such Offered Plasma and
(iii) the date by which Seller wishes to consummate such sale.
Seller and Purchaser hereby agree that the purchase price per liter
of Offered Plasma shall be equivalent to Seller’s acquisition
cost for such Offered Plasma.
(b) Purchaser shall have a period of
*** calendar days from the date of Seller’s notice to notify
Seller in writing if it wishes to purchase some or all of the
Offered Plasma on the terms set forth in the Notice. Such election
shall be irrevocable and Purchaser shall be liable to Seller for
the purchase price of such Offered Plasma. In the event Purchaser
elects to purchase some or all of the Offered Plasma, the parties
shall proceed in good faith and use their commercially reasonable
efforts to consummate such transaction within the time frame stated
in Seller’s Notice.
(c) In the event Purchaser declines
to purchase any Offered Plasma, the Seller shall be permitted to
proceed with a sale of such Offered Plasma to any third party on
such other terms and conditions as Seller may elect. In no event
shall any specific volume of Offered Plasma that Purchaser declines
to purchase again be subject to this right of first
refusal.
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2.3
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Seller’s Right of First Refusal for
Fraction V Paste .
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(a) During the Term, if Purchaser
determines to sell any quantity of Fraction V Paste derived from
Plasma supplied to Sanquin by Seller (the “ Paste
”) to a third party, other than as specified below in clause
(b), Purchaser agrees
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to offer such Paste to Seller in
accordance with the terms and conditions of this Agreement. In the
event Purchaser determines to sell such Paste, it shall first
provide Seller with written notification (the “ Notice
”) of its offer to sell the Paste, which Notice shall include
at a minimum (i) the volume of Paste it is willing to sell
(the “ Offered Paste ”), (ii) the aggregate
purchase price for such Offered Paste and (iii) the date by
which Purchaser wishes to consummate such sale. Seller and
Purchaser hereby agree that the purchase price per liter of Offered
Paste shall not exceed the fair market value of such Paste as
determined at any time that this right of first refusal is
triggered.
(b) Notwithstanding the foregoing
right of first refusal, the Purchaser’s obligation to offer
Seller the right to buy Paste shall not extend to the Fraction V
Paste obtained from the residuals derived from the processing by
Sanquin of an initial quantity of *** liters of U.S. Source Plasma
owned by Seller.
(c) Seller shall have a period of
*** calendar days from the date of Purchaser’s Notice to
notify Purchaser in writing if it wishes to purchase some or all of
the Offered Paste on the terms set forth in the Notice. In the
event Seller elects to purchase some or all of the Offered Paste,
the parties shall proceed in good faith and use their commercially
reasonable efforts to consummate such transaction within the time
frame and on the terms stated in the Notice. At the closing,
(a) the Purchaser shall sell, transfer and deliver to the
Seller or its designee full right, title and interest in and to the
Offered Paste so purchased, free and clear of all liens, security
interests or adverse claims of any kind and nature and
(b) Seller shall deliver to the Purchaser the purchase price
of the Offered Paste.
(d) In the event Seller declines to
purchase any Offered Paste, the Purchaser shall be permitted to
proceed with the sale of such Offered Paste specified in the Notice
within 120 days from the date of, and on the same terms set forth
in, the Notice. If the Purchaser does not complete the sale of the
Offered Paste within the 120-day period, or seeks to modify the
terms of the sale as described in the Notice, the provisions of
this Section shall again apply, and no transfer or sale of such
Offered Paste shall be made otherwise than in accordance with the
terms of this right of first refusal.
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2.4
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Invoices. From time to time during the Term, Seller shall
deliver to Purchaser an invoice order reflecting the aggregate
volume of Products to be purchased hereunder (an “
Invoice ”). Seller shall be entitled to deliver
Invoices to Purchaser at such time as the transfer of title of the
Products covered by each such Invoice occurs, as specified in
Section 4(c) of this Agreement. Each Invoice shall specify the
quantity of Products purchased and the corresponding delivery
dates.
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The responsibility for the quality
of the Products, and the specifications thereof, is regulated by a
quality agreement between Biotest and Sanquin (the “
Quality Agreement ”). The responsibility for the
quality of Plasma is regulated by an agreement between ViroPharma
Biologics, Inc. (formerly Lev Pharmaceuticals,
Inc.)(“VBI”) and Sanquin (the “ VBI-Sanquin
Agreement ”). Biotest agrees that neither VPS nor VBI are
a party to the Quality Agreement and shall have no responsibility
for and incur no liability hereunder for failure of the Products to
comply with any requirements of the
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Quality Agreement. Nothing herein
shall make Biotest a party to the VBI-Sanquin Agreement, granting
Biotest any rights or remedies under such VBI-Sanquin Agreement nor
shall Biotest be deemed a third-party beneficiary of the
VBI-Sanquin Agreement.
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a)
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From time to
time during the Term, Seller shall deliver the Plasma from which
Sanquin shall manufacture the Products to Sanquin at such locations
as shall be determined by VPS and Sanquin. On behalf of Sanquin the
Products are produced at the facility of CAF/DCF.
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b)
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From time to
time during the Term, Seller shall generate and deliver to
Purchaser an invoice for the volume of Products sold. Each such
invoice shall specify the quantity of Products sold, the aggregate
price for such Products and the date on which the Products shall be
transferred to Purchaser. Seller agrees to consult with Purchaser
regarding the quantity, frequency and timing of Products tendered
for delivery; however Purchaser agrees and acknowledges that the
exact quantity, frequency and delivery time for Product delivery is
subject to the production output of Sanquin.
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c)
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The transfer of
title, use and risk of loss for the Products shall occur at the
designated shipment or transfer location of Seller. Transfer of
title, use and risk of loss shall occur periodically during the
Term at each time that Seller confirms to Purchaser that Sanquin is
authorized to release a batch of *** and/or *** (as such terms are
defined in Appendix 1) from its quality assurance procedures for
shipment. Accordingly, any damages sustained beyond that point,
will be the responsibility of Purchaser. In the event Purchaser is
notified by Sanquin that a batch of Product (whether it is *** or
*** ) has been released from quality assurance, it shall, prior to
taking delivery of such batch of Product, notify Seller of such
occurrence. In no event may Purchaser accept delivery of and title
to any Products until the release of such Product batch is
confirmed by Seller. Purchaser agrees to bear all costs of
shipments, freight, insurance and all governmental taxes and duties
incurred during shipping of the Products sold hereunder from the
Seller shipping point to Purchaser’s designated receiving
terminal.
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d)
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Products shall
be packed by or on behalf of Seller in such a manner as to mitigate
damage to the Products or containers during shipping and shall be
tendered to Purchaser at Seller’s designated shipping
point.
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The price and payment terms Seller
and Purchaser have agreed upon are specified in Appendix 2
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6.
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Receipt,
Tests and Complaints
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a)
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The receipt,
tests to be performed on Plasma, including NAT testing for HIV,
HBV, HCV, HAV, and Parvo B19, respective documentation, and
possible complaints, as well as handling of look-backs and Post
Donation Information are the responsibility of Sanquin pursuant to
the VPS-Sanquin Agreement.
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b)
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The location
for the receipt of Products purchased hereunder by Purchase is:
BIOTEST at its manufacturing site at Dreieich, Germany for
purchases of *** and CAF/DCF for purchases of *** at its
manufacturing site at Brussels, Belgium for further manufacturing.
Purchaser may, upon prior written notice to Seller, select other
receiving locations for Products.
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c)
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Purchaser
reserves the right for up to 90 days from date of delivery to
inspect Products for deficiencies. In the event a shipment of
Products does not comply with the requirements of this Agreement
because of any failure of the Plasma to comply with the warranty
provided in Section 7.1(i) below, Purchaser may reject all or
party of such shipment by promptly notifying Seller in writing of
such alleged defect in reasonably sufficient detail. The
nonconforming shipment or portion thereof shall be held for
Seller’s disposition, or shall be returned to Seller, in each
case at Seller’s expense, as directed by Seller. Purchaser
shall not be obligated to buy or pay for any shipment which does
not comply with the specifications or is otherwise not as
warranted. Purchaser shall receive a full credit for any rejected
shipment, which shall include Purchaser’s shipping costs,
which shall be Purchaser’s sole remedy hereunder. In the
event the Products are not accepted for any reason other than the
failure of the Plasma to satisfy the warranty of Seller in
Section 7.1(i), Purchaser shall not have any recourse against
Seller, shall be liable to the Seller for the prompt payment of the
purchase price of such Products and shall be limited to pursuing
any remedies it may have pursuant to the Quality Agreement or such
other agreement it may have with Sanquin.
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7.
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Representations and Warranties
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7.1 Seller’s Warranties
. Seller warrants that (i) all Plasma provided to Sanquin
shall be Source Plasma, as defined above, and (ii) all
Products delivered pursuant to this Agreement shall be manufactured
for it by or on behalf of Sanquin.
Seller further warrants that it
shall (a) to the extent permitted by Governmental Authorities:
report serious failures and exceptional incidents to Purchaser;
inform Purchaser immediately about measures taken against it or its
suppliers by Governmental Authorities concerning the Products; and
(b) use commercially reasonable efforts to ensure the source
and traceability of individual plasma units; implement a quality
assurance system including a look-back system and relevant
contractual terms with its suppliers.
SELLER MAKES NO REPRESENTATIONS OR
WARRANTIES, EXPRESS OR IMPLIED OTHER THAN THOSE EXPRESSLY MADE IN
THIS AGREEMENT. ALL OTHER WARRANTIES, EXPRESS OR IMPLIED,
INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF
MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, ARE HEREBY
DISCLAIMED.
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7.2
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Mutual
Representations . Each
Party represents that:
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(a)
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Such Party is a
corporation duly organized, validly existing, and in good standing
under the laws of jurisdiction in which it is
incorporated.
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(b)
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Such Party has
the corporate and legal power and authority to enter into this
Agreement and to perform its obligations hereunder, and such Party
has undertaken all necessary corporate action to authorize the
execution and delivery of this Agreement and to perform its
obligations hereunder. This Agreement, once executed and delivered
by the Parties shall constitute a valid and binding obligation
enforceable against each Party in accordance with the terms
hereof.
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(c)
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Such Party has
not made and, during the term of this Agreement, will not make any
commitments to any other person or entity that is or may be
inconsistent or in conflict with any rights granted under this
Agreement.
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7.3 Purchaser Acknowledgement
. Purchaser agrees that the requirements for the applicable dating
period and for how the Products shall be processed, stored, tested,
packaged, labeled and shipped in accordance with good manufacturing
practices, pursuant to regulations prescribed by the respective
Government Authorities and all other applicable standards, and
methods, practices, procedures and directives, requirements and
specifications stated or referred to therein shal
