Exhibit 10.20
CERTAIN CONFIDENTIAL INFORMATION
CONTAINED IN THIS DOCUMENT, MARKED AS "(CONFIDENTIAL TREATMENT
REQUESTED)" IN THE TEXT, HAS BEEN OMITTED AND FILED SEPARATELY WITH
THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2
OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED.
AMIFOSTINE MANUFACTURING AND SUPPLY
AGREEMENT
This
Agreement ("Agreement"), entered into as of the 1st day of January,
2001 (the "Effective Date"), by and between MedImmune
Oncology, Inc. (formerly U.S. Bioscience, Inc.,
hereinafter referred to as "MedImmune Oncology"), a corporation
duly formed and existing under the laws of the State of Delaware,
having a place of business at One Tower Bridge, 100 Front Street,
West Conshohocken, Pennsylvania 19428, and PPG
Industries, Inc., having a place of business as One PPG Place,
Pittsburgh, Pennsylvania 15272, USA, and its wholly-owned
subsidiary PPG-Sipsy, having a place of business at Z.I.
la Croix Cadeau, B.P. 79, 49242 Avrille Cedex, France
(Individually & Collectively "PPG"), a corporation duly
formed and existing under the laws of the State of
Pennsylvania.
WITNESSETH
WHEREAS,
the parties to this Agreement are parties to a Manufacturing and
Supply Agreement between U.S. Bioscience, Inc. and Sipsy, S.A.
(the "Prior Agreement") relating to the manufacture of
amifostine;
WHEREAS,
MedImmune Oncology has certain proprietary technical information
(including, without limitation, patents, patent applications and
trade secrets) relating to the Product which has been disclosed, in
part, to PPG under the terms of the Prior Agreement and which will
be disclosed, in part, to PPG under the terms of this
Agreement;
WHEREAS,
the parties desire to have this Agreement supersede the Prior
Agreement from and after the Effective Date;
WHEREAS,
MedImmune Oncology desires to contract with PPG for the continued
manufacture of amifostine (hereinafter defined in Section 1.4
and referred to as the "Product"); and
WHEREAS,
PPG desires to manufacture the Product for MedImmune Oncology and
represents that it possesses the requisite expertise, personnel and
facilities for the manufacture and supply of Product on the terms
and in the quantities contemplated by this Agreement.
NOW
THEREFORE, in consideration of the foregoing and of the mutual
covenants and conditions herein contained, the parties hereby agree
as follows:
ARTICLE I
DEFINITIONS
For
purpose of this Agreement:
Section 1.1 "cGMPs"
shall mean the current Good Manufacturing Practices promulgated by
the United States Food and Drug Administration ("FDA") and other
applicable government regulatory agencies. MedImmune Oncology shall
keep PPG regularly informed about any amendment or modification to
relevant portions of its regulatory registrations for the
Product.
Section 1.2 "Confidential
Information" shall have the meaning set forth in
Section 7.1.
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Section 1.3 "Preparation"
and/or "Prepare" shall mean any and all steps and operations
required in the sourcing of raw material, synthesis, manufacture,
processing, subdividing, quality control, quality assurance,
testing, storage and packaging of Product for shipment.
Section 1.4 "Product"
shall mean Amifostine Drug Substance together with changes,
modifications and improvements instituted during the term hereof as
described more fully on Exhibit "C" attached and made a part
hereof.
Section 1.5 "Specifications"
shall have the meaning set forth in Section 4.1
hereof.
Section 1.6 "Contract
Year" shall mean a calendar year under this Agreement.
ARTICLE II
SALE AND DELIVERY OF PRODUCT
Section 2.1 Subject
to the terms and conditions set forth in this Agreement, PPG agrees
to Prepare and sell, and MedImmune Oncology agrees to purchase from
PPG, the Product as follows:
Prior
to the beginning of each calendar quarter, MedImmune Oncology shall
provide to PPG, in writing, a (CONFIDENTIAL TREATMENT REQUESTED)
forecast of its requirements for deliveries of the Product during
the next (CONFIDENTIAL TREATMENT REQUESTED) (hereinafter the
"Delivery Schedule"). The quantities forecast for delivery in the
(CONFIDENTIAL TREATMENT REQUESTED) in a Delivery Schedule shall be
firm commitments to purchase and sell; and the (CONFIDENTIAL
TREATMENT REQUESTED) included in a Delivery Schedule shall be for
planning purposes and may be revised up or down by MedImmune
Oncology. Exhibit "A" sets forth MedImmune Oncology's
non-binding requirements forecast for the Contract Years
2001-2003.
Section 2.2 PPG
agrees, at the request of MedImmune Oncology, to provide Product at
the agreed upon price set forth in the Price Schedule attached
hereto as Exhibit "B" and subject to the provisions of
Section 3.1.
Section 2.3 Subject
to Section 2.5, PPG shall provide (CONFIDENTIAL TREATMENT
REQUESTED) to (CONFIDENTIAL TREATMENT REQUESTED) of MedImmune
Oncology's requirements for the Product, at MedImmune Oncology's
option. Subject to Section 2.5, MedImmune Oncology shall
purchase from PPG a minimum of (CONFIDENTIAL TREATMENT REQUESTED)
to (CONFIDENTIAL TREATMENT REQUESTED) of MedImmune Oncology's
global requirements for the Product, provided however, that PPG may
elect to qualify a second manufacturing location for production of
Product by informing of its intent to do so in writing. Within
90 days of such notification, PPG will provide to MedImmune
documentation which describes PPG's qualification protocols and
validation plans. PPG and MedImmune will cooperate to complete such
qualification in a timely manner. Upon successful qualification of
the alternate manufacturing location by MedImmune, MedImmune shall
be obligated to purchase (CONFIDENTIAL TREATMENT REQUESTED) of
MedImmune Oncology's global requirement for Product.
Section 2.4 PPG
shall at all times maintain a minimum inventory of at least
(CONFIDENTIAL TREATMENT REQUESTED) of the amount of the Product
purchased by MedImmune Oncology during the preceding (CONFIDENTIAL
TREATMENT REQUESTED). PPG shall at all times maintain a minimum
annual capacity reserved for production of the Product for
MedImmune Oncology of the quantity of Product specified for
delivery in the most recent Delivery Schedule. Notwithstanding
anything to the contrary in this Section 2.3, should PPG be
required to replace Product pursuant to its obligations in
Article 4, PPG may utilize the inventory of the Product even
though that may result in a temporary situation in which inventory
is less than required by this Section 2.4. PPG shall rebuild
the
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inventory to once again meet the
requirements of this Section 2.4 within (CONFIDENTIAL
TREATMENT REQUESTED) days of removing Product to use as replacement
Product.
Section 2.5 If
PPG has not qualified an alternative manufacturing site subject to
Section 2.3, MedImmune Oncology may qualify an alternative
source(s) of supply other than PPG and may secure Product from such
alternative source(s) for amounts in excess of (CONFIDENTIAL
TREATMENT REQUESTED) of its requirements. MedImmune Oncology shall
not make the alternative source(s) MedImmune Oncology's principal
supplier of Product unless PPG has materially failed to meet
MedImmune Oncology's orders in a period of more than (CONFIDENTIAL
TREATMENT REQUESTED) or this Agreement is terminated or has by its
terms expired. After (CONFIDENTIAL TREATMENT REQUESTED) in which
PPG has materially failed to meet MedImmune Oncology's orders, both
parties agree that MedImmune Oncology may use an alternate source
to supply MedImmune Oncology's needs until PPG is able to again
furnish MedImmune Oncology's needs.
Section 2.6 PPG
agrees to sell the Product exclusively to MedImmune for
pharmaceutical applications. PPG agrees that during the term of
this Agreement and for a period of (CONFIDENTIAL TREATMENT
REQUESTED) thereafter, it will not compete, or assist third parties
to compete, directly or indirectly with MedImmune Oncology in the
sale of the Product.
Section 2.7 MedImmune
Oncology shall submit purchase orders for Product to PPG at least
(CONFIDENTIAL TREATMENT REQUESTED) prior to the date of shipment
specified therein. MedImmune Oncology's purchase orders shall
(i) reference this Agreement; (ii) be submitted in
writing; (iii) state the quantity of Product ordered;
(iv) specify the delivery location; and (v) state the
desired date of shipment. In no event shall the use of any form of
purchase order be effective to vary, alter, modify or add to the
terms and provisions of this Agreement; nor will the acceptance of
any such purchase order have the effect of substituting the
provisions set forth on such form for the provisions contained in
this Agreement. MedImmune Oncology may reschedule such purchase
order no later than (CONFIDENTIAL TREATMENT REQUESTED) prior to the
date of scheduled manufacturing. In no event shall MedImmune
Oncology's right to reschedule such Purchase Order abrogate any of
its obligations under Section 2.1.
Section 2.8 PPG
shall exercise reasonable, diligent efforts to ship Product in the
quantities and on the dates specified in MedImmune Oncology's
purchase orders. Sales of Product by PPG to MedImmune Oncology
shall be made CIP (as in Incoterms 1990), to MedImmune Oncology's
facility in Nijmegen, the Netherlands, or such other location as
may be specified by MedImmune Oncology to PPG from time to time
hereunder.
ARTICLE III
PAYMENT TERMS
Section 3.1 The
Base Prices to be paid by MedImmune Oncology for quantities of
Product purchased pursuant to this Agreement are set forth in
Exhibit "B", except for freight and insurance which will be
billed (CONFIDENTIAL TREATMENT REQUESTED). The prices set forth on
Exhibit "B" shall be subject to the following adjustments, as
applicable:
PPG
and MedImmune Oncology will adjust the prices in Exhibit B
such that any benefit or loss due to the change in exchange rate
will be shared equally by the parties according to the
following:
Average Exchange Rate ("AER") is
defined as the average Euro per US$ exchange rate which has
prevailed for the previous (CONFIDENTIAL TREATMENT REQUESTED) prior
to the date of invoicing.
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"Invoice Price" is defined as
such:
For invoices for which the AER is
greater than or equal to (CONFIDENTIAL TREATMENT REQUESTED) Euro
per US$ and less than or equal to (CONFIDENTIAL TREATMENT
REQUESTED) per US$ the Invoice Price is equal to (CONFIDENTIAL
TREATMENT REQUESTED) divided by the AER multiplied by the Base
Price then in effect
For invoices for which the AER is
greater than (CONFIDENTIAL TREATMENT REQUESTED) the Invoice Price
is equal to (CONFIDENTIAL TREATMENT REQUESTED) multiplied by the
Base Price then in effect.
For invoices for which the AER is
less than (CONFIDENTIAL TREATMENT REQUESTED) the Invoice Price is
equal to (CONFIDENTIAL TREATMENT REQUESTED) multiplied by the Base
Price then in effect.
In summary:
For AER>(CONFIDENTIAL
TREATMENT REQUESTED) Invoice price = (CONFIDENTIAL TREATMENT
REQUESTED)× Base Price in effect
For (CONFIDENTIAL TREATMENT
REQUESTED) < AER < (CONFIDENTIAL TREATMENT
REQUESTED) Invoice price= (CONFIDENTIAL TREATMENT
REQUESTED)/AER × Base Price in effect
For AER<(CONFIDENTIAL
TREATMENT REQUESTED) Invoice price = (CONFIDENTIAL TREATMENT
REQUESTED) × Base Price in effect
In
the event that MedImmune Oncology makes changes to the
Specifications which result in material increases in the cost to
PPG to Prepare the Product, PPG and MedImmune Oncology shall
negotiate in good faith an appropriate and reasonable price
adjustment. In the event that the regulatory authorities other than
the regulatory authorities of the United States, the EC countries
or Japan, require additional cGMP requirements or changes to the
Specifications in order to allow commercialization of Product in
their respective countries, the parties shall negotiate in good
faith an appropriate and reasonable price adjustment relating
solely to quantities of Product for which such changes are
necessary.
In
the event that the parties do not agree on such price adjustment,
then both parties will appoint a mutually acceptable independent
expert whose findings will be binding on both PPG and MedImmune
Oncology. Said expert shall transmit to both parties its findings
within three months from the date of its appointment. If the
parties are unable to agree on an independent expert, the matter
shall be settled in accordance with Section 12.3
hereof.
Section 3.2 All
prices of Product shall be on the basis of (CONFIDENTIAL TREATMENT
REQUESTED) as in Incoterms 1990.
Section 3.3 The
purchase price for Product shall be paid to PPG no later than
(CONFIDENTIAL TREATMENT REQUESTED) days after the date of PPG's
invoice to MedImmune Oncology. In no event shall PPG invoice
MedImmune Oncology for the Product prior to delivery. All invoices
from PPG to MedImmune Oncology covering Product shipped to
MedImmune Oncology shall be stated in, and all payments to PPG by
MedImmune Oncology shall be made in United States Dollars (US$).
However, the parties hereto may agree at the beginning of each
Contract Year that such invoices and payments will be in European
Monetary Units (Euro), provided, however, that said prices may be
adjusted by mutual agreement of the parties by an amount sufficient
to cover PPG'S currency exchange risk and costs.
In
the event that the Euro to US$ exchange rate is greater than
(CONFIDENTIAL TREATMENT REQUESTED) or less than (CONFIDENTIAL
TREATMENT REQUESTED) for
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more than (CONFIDENTIAL TREATMENT
REQUESTED), then either party may request a renegotiation of the
Base Prices in Exhibit "B" in writing to the other party. Both
parties will commence such negotiations within 30 days of
receipt of the written request. If the parties fail to agree to a
modification of the base prices within 60 days of commencement
of the negotiation, then the dispute will be settled in accordance
with Section 12.3.
Section 3.4 Payments
due to PPG shall be made by wire transfer or by a mutually
agreeable method to the bank account of PPG of which PPG shall
advise MedImmune Oncology from time to time.
ARTICLE IV
MANUFACTURE AND SUPPLY
Section 4.1 Prior
to the date of the Prior Agreement, MedImmune Oncology (then U.S.
Bioscience, Inc.) transferred to PPG, and PPG hereby
acknowledges receipt of, copies of MedImmune Oncology's
specifications for the manufacture and testing of the Product, and
such specifications have been revised from time to time under the
Prior Agreement. The current specifications for the Product are
attached hereto as Exhibit "C" and made a part hereof (such
specifications, as revised in accordance with this
Section 4.1, hereinafter being defined as the
"Specifications"). The Preparation of the Product shall be carried
out by PPG in accordance with applicable cGMPs and established
quality standards. The Product shall meet Specifications. MedImmune
Oncology shall provide PPG with all revisions to the Specifications
in a timely manner after such revisions are approved by MedImmune
Oncology, as appropriate, such revisions to be reasonably required
for the Product. All revisions or deviations from Specifications
for Product must be made in accordance with the Change Control
Procedures set forth in Exhibit "D".
Section 4.2 PPG
shall prepare and make available to MedImmune Oncology for review
and comment comprehensive and complete documentation including the
Drug Master File(s) with regard to the manufacture and testing of
Product which will include, but not be limited to, testing of all
raw materials, in-process and finished product applications; and
review of master and working batch records for processing and
packaging and all supporting analytical documentation. Such
documentation shall be in a format consistent with cGMP's or FDA or
other regulatory agencies requirements, and shall be prepared with
respect to the manufacture of each batch of Product.
Section 4.3 PPG
shall prepare and maintain a current master production batch record
in English. At the time of execution of this Agreement, PPG shall
provide MedImmune Oncology with a copy of the then current master
production batch record in English. Thereafter, PPG shall provide
to MedImmune Oncology any updates of this master record in English
within (CONFIDENTIAL TREATMENT REQUESTED) of any such update being
submitted. PPG shall not change the master production batch record
without the prior written approval of MedImmune
Oncology.
Section 4.4 For
each batch Prepared, PPG shall provide MedImmune Oncology with a
certificate of analysis and a certificate of compliance,
specifically providing that the Product meets Specifications, in
the English language, for the Product no later than (CONFIDENTIAL
TREATMENT REQUESTED) after completion of manufacture of such
batch.
Section 4.5 Within
(CONFIDENTIAL TREATMENT REQUESTED) from receipt by MedImmune
Oncology of the certificate of analysis for Product set forth in
Section 4.4, MedImmune Oncology shall notify PPG in writing
whether it approves of the release of Product for shipment. Upon
receipt of such notification from MedImmune Oncology, PPG shall
within one (1) week ship the certificated amount of Product to
MedImmune Oncology's designee.
MedImmune
Oncology shall confirm to PPG in writing within (CONFIDENTIAL
TREATMENT REQUESTED) of arrival of a shipment of Product, the
identity and amount of Product received, and
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condition of the shipment based
solely upon a visual inspection. Such MedImmune Oncology
confirmation shall not constitute acceptance of the Product, nor
shall it be construed as any indication of whether or not the
Product conforms to Specifications.
Section 4.6 MedImmune
Oncology or its designee shall have (CONFIDENTIAL TREATMENT
REQUESTED) after shipment to inspect each shipment of Product to
determine whether the Product included in such shipment conforms to
the Specifications. MedImmune Oncology shall promptly give PPG
written notice of any aspect in which Product fails to conform to
Specifications. If MedImmune Oncology fails to notify PPG of any
nonconformity within such (CONFIDENTIAL TREATMENT REQUESTED)
period, MedImmune Oncology shall be deemed to have accepted the
Product as shipped, provided, however, that with respect to any
nonconformity due to latent defects, MedImmune Oncology shall be
entitled to reject the nonconforming Product within (CONFIDENTIAL
TREATMENT REQUESTED) after discovering the latent
defects.
