CONFIDENTIAL
TREATMENT REQUESTED: Certain portions of this document have been
omitted pursuant to a request for confidential treatment and, where
applicable, have been marked with an asterisk (“ [****] ”) to denote where
omissions have been made. Note that four pages of this exhibit
contain omitted material pursuant to this request. The confidential
material has been filed separately with the Securities and Exchange
Commission.
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genzyme
PHARMACEUTICALS
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GENZYME
CORPORATION
CNE KENDALL
SQUARE
CAMBRIDGE, MA
02139-1562, USA
617-252-7500
FAX
617-252-7772
www.genzyme.com
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AMENDED AND RESTATED
SUPPLY AGREEMENT
THIS AMENDED AND RESTATED SUPPLY AGREEMENT
(“Agreement”) dated as of October 8, 2003, is by and
between Genzyme Corporation, with principal offices located at One
Kendall Square, Cambridge, Massachusetts 02139 ("Vendor") and
Photogen Technologies, Inc., through its IMCOR Pharmaceutical
Division, a Nevada corporation with its principal offices located
at 6175 Lusk Boulevard, San Diego, California 92121
("IMCOR").
WHEREAS, Vendor entered into a Supply Agreement
with Alliance Pharmaceutical Corp. dated as of May 16, 2000 (the
"Original Supply Agreement");
WHEREAS, Photogen Technologies, Inc. has
acquired the business of Alliance Pharmaceutical Corp. to which the
Original Supply Agreement relates;
WHEREAS, IMCOR and Vendor now desire to modify
the terms of their relationship and amend and restate the Original
Supply Agreement as provided herein;
WHEREAS, Vendor has by virtue of its proprietary
technologies and know-how developed and manufactures or by virtue
of its distribution relationship with the manufacturer has adequate
access to the material described on Exhibit "A" attached hereto
(the "Material"); and
WHEREAS, IMCOR desires to secure a long-term
supply of commercial quantities of the Material for its
product described on Exhibit "A" (the "Product") if and when such
Product is approved by the FDA and Vendor is willing to supply such
quantities of its Material to IMCOR as IMCOR's exclusive supplier
of the product.
NOW, THEREFORE, in consideration of the mutual
promises and covenants set forth herein, the parties agree as
follows.
1.
Supply. During the term of this Agreement, IMCOR shall
purchase all of its requirements of Material for commercial
manufacturing from Vendor and Vendor shall sell to IMCOR such
quantities of the Material as ordered from time to time by IMCOR.
Nothing herein shall limit Vendor's ability to supply Material to
other customers.
2.
Duration. This Agreement shall have effect upon execution
and shall remain in effect for the initial term indicated on
Exhibit "A" (the "Term") Thereafter, this Agreement shall be
renewed automatically for successive two-year periods unless
terminated by either party by written notice not later than
eighteen months prior to expiration of the initial term or any
renewal period.
3.
Specification and Quality Control
Standards; GMP Compliance.
3.1
The quantities of the Material to be
supplied hereunder shall be manufactured by Vendor in accordance
with all applicable laws, rules and regulations, and in conformity
with the specification and quality control standards set forth in
Exhibit "B" attached hereto (collectively, the "Specifications").
If IMCOR wishes to change the Specifications, Vendor shall use its
reasonable endeavors to carry out such change subject to agreement
on a reasonable change (increase or decrease) in price, if
appropriate, to reflect any costs or savings consequent thereon.
Vendor shall consult with and must obtain written consent from
IMCOR reasonably in advance of making any changes in the
Specifications, or other aspect of the production, storage, and
transport of Material which would or might:
[****] Represents material which has been redacted
pursuant to a request for confidential treatment pursuant to Rule
24B-2 under the Securities Exchange Act of 1934, as amended. The
confidential materials have been filed separately with the
SEC.
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(a)
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Cause a
potential change in the Material purity profile;
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(b)
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Require IMCOR
to revalidate its own process or methods;
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(c)
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Require IMCOR
to re-audit Vendor,
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(d)
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Require IMCOR
or Vendor to submit or resubmit any documentation to the
FDA.
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Subject to the
foregoing, Vendor may otherwise alter the Specifications upon sixty
days prior written notice to IMCOR.
3.2
Vendor shall make available to IMCOR
such data and information in relation to Material as is reasonably
necessary to ascertain compliance with this Agreement and to
qualify the use of Material in the Product with appropriate
regulatory authorities. However, nothing here shall be construed as
placing Vendor under an obligation to disclose to IMCOR any data
relating to the actual production or purification of the Material
except as Vendor deems appropriate for IMCOR to satisfy itself
regarding the security or quality of supply of the Material or
unless IMCOR is required to supply any such data to any appropriate
regulatory authorities, in which case Vendor shall provide such
information to IMCOR or arrange for direct disclosure to such
regulatory authorities at IMCOR's expense. IMCOR may visit and
inspect Vendor's facilities used in the Manufacture and testing of
the Material once per year with reasonable prior notice.
3.3
Vendor shall carry out the
production and purification of the Material to be supplied
hereunder in accordance with the U.S. Food and Drug Administration
("FDA") and Good Manufacturing Practice ("GMP") regulations and
shall allow inspection of Vendor facilities by U.S. or foreign
regulatory authority representatives to enable the said
representatives to verify Vendor's compliance with GMP and all
other relevant regulations. Vendor may altar the production and
purification processes for the Material upon prior written notice
to IMCOR but only if Vendor follows all appropriate regulatory
procedures and obtains any relevant regulatory approvals and there
is no change to the specification and quality control standards for
the Material.
4.
Estimates and Orders.
As soon as practical after the
effective date of this Agreement, and within the last
[****] days
of each calendar quarter thereafter, IMCOR shall deliver to
vendor a [****]
month rolling Forecast (the "Forecast") of the
quantity of material to be purchased by IMCOR. The
[****] of
such Forecast will be considered a firm commitment for
production quantities and the remainder of the Forecast shall be
advisory only. Accordingly, the [****] quantity in each
subsequent Forecast shall be identical to the
[****]
quantity in the previous "Forecast" unless the parties
otherwise agree in writing. Within [****] days of delivery of each
Forecast, IMCOR shall submit to Vendor a written delivery "Order"
for the Material which shall represent the [****] firm commitment as
illustrated by the Forecast.
[****] Represents material which has been redacted
pursuant to a request for confidential treatment pursuant to Rule
24B-2 under the Securities Exchange Act of 1934, as amended. The
confidential materials have been filed separately with the
SEC.
5.
Delivery. The Material shall be supplied D.D.U. San Diego,
California with any and all freight and packaging expenses being
prepaid by Vendor and added to Vendor's invoice to IMCOR for
payment by IMCOR. Title to and risk of loss of the Material shall
pass to IMCOR at the time of delivery to a carrier designated by
IMCOR or, if not delivered but stored by Vendor at IMCOR's request,
at the time such Material is actually segregated and stored in
facilities reasonably designed and maintained for storage of the
materials. All shipments shall meet the specifications set forth in
Exhibit "B" and be accompanied by a Certificate of Analysis.
Material Orders shall be delivered to IMCOR in accordance with a
delivery schedule provided by IMCOR in the Order, provided that no
delivery be required to be made within one hundred and twenty (120)
days of such Order.
6.
Prices and
Payment.
6.1
IMCOR shall pay the prices specified
in Exhibit "C" for the Material delivered by Vendor.
6.2
The price does not include sales,
use, excise or any other similar taxes imposed by Federal, state or
local governments, and accordingly such taxes shall be paid by
IMCOR.
6.3
Invoices for Material shall be sent
to IMCOR on or after the date of shipment of Material. Payment
shall be made by IMCOR as follows: (1) [****] of the payment for the
Material in the Order (the "Order Payment") shall be paid upon
submission of the Order pursuant to Section 4 hereof, (2)
[****] of
the Order Payment shall be due upon delivery of the Material and
(3) [****] of the Order Payment
shall be due within [****] days from the date of
invoice, net of any and all invoice fees or other fees or charges,
other than those specified in this Agreement.
6.4
IMCOR shall pay Vendor a fee of
[****]
United States dollars [****] per calendar
quarter (the "Regulatory Fee") for costs incurred by Vendor that
are associated with the filing and maintenance of the Drug Master
File (DMF) and all supporting documentation. The first quarterly
Regulatory Fee shall be due upon execution and delivery of this
Agreement and the remaining quarterly Regulatory Fees shall be due
on the first day of each calendar quarter thereafter; provided
however, that if IMCOR's total Orders in any calendar year exceed
[****]
United States dollars [****] , IMCOR's obligation to
pay the Regulatory Fee as set forth in this Section 6.4 shall
terminate.
7.
Confidentiality.
Each party hereto (a "Recipient")
recognizes that the other party hereto and its subsidiaries and
affiliated corporations (a "Discloser") own or have licensed
certain confidential information, including but not limited to
secret or confidential data, proprietary information, trade
secrets, technology, formulae, processes, procedures, scientific
studies, regulatory submissions, business plans, information and
the like, whether all of the same be in writing or not, and that
Discloser has disclosed or may disclose to Recipient portions of
such confidential information (all of which is referred to
as "Confidential Information"). Use of the Confidential
Information shall be solely for the purposes of complying with this
Agreement. Recipient agrees to maintain the confidential status of
such Confidential Information and not to disclose the same to
persons not authorized herein or otherwise authorized in writing by
Discloser to receive such Confidential Information. Confidential
Information shall not include information that was (4) in the
public domain prior to the time of its disclosure under this
Agreement; (5) e