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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 10-Q/A
(Mark One)
[X] Quarterly Report Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934.
For the quarterly period ended June 30, 1997
[ ] Transition Report Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934.
For the transition period from _____ to_____
Commission file number: 0-22890
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SANGSTAT MEDICAL CORPORATION
(Exact name of registrant as specified in its charter)
Delaware 94-3076-069
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
1505 Adams Drive
Menlo Park, California 94025
(650) 328-0300
(Address, including zip code, of Registrant's principal
executive offices and telephone number, including area code)
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Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
Yes [X] No [ ]
Indicate the number of shares outstanding of each of the issuer's classes of
common stock, as of the latest practicable date.
Common Stock, $0.001 par value 16,015,701
(Class of common stock) (Shares outstanding at March 16, 1998)
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ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) Exhibits:
10.24* Cyclosporine Amended and Restated Supply and License
Agreement.
(b) No reports on Form 8-K were filed for the period for which
this report is being filed.
* Specified portions of this agreement have been omitted and have been filed
separately with the Commission pursuant to a request for confidential
treatment.
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SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the
Registrant has duly caused this Report to be signed on its behalf by the
undersigned thereunto duly authorized.
SANGSTAT MEDICAL CORPORATION
(Registrant)
Dated: May 26, 1998 By:
/s/ Phillipe Pouletty, M.D.
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Philippe Pouletty, M.D.
President and Chief Executive Officer
Dated: May 26, 1998 By:
/s/ James F. Hinrichs
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James F. Hinrichs
Chief Financial Officer
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EXHIBIT INDEX
10.24* Cyclosporine Amended and Restated Supply and License Agreement.
* Specified portions of this agreement have been omitted and have been filed
separately with the Commission pursuant to a request for confidential
treatment.
E-1
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EXHIBIT 10.24
CYCLOSPORINE
AMENDED AND RESTATED
SUPPLY AND LICENSE AGREEMENT
THIS AMENDED AND RESTATED SUPPLY AND LICENSE AGREEMENT (the
"Restated Agreement") is entered into as of March 31, 1997 (the "Restatement
Date"), by GENSIA SICOR INC., a company existing and organized under the laws of
the state of Delaware, with offices at 9360 Towne Centre Drive, San Diego,
California ("GENSIA SICOR"), and the assignee of ALCO CHEMICALS LTD., a company
existing and organized under the laws of Guernsey, Channel Islands, having
offices at Via San Salvatore 7, CH-6902, Lugano, Switzerland (hereinafter
referred to as "ALCO"), VINCHEM, INC., a corporation organized and existing
under the laws of New York, with offices at 301 Main Street, Chatham, New Jersey
07928 ("VINCHEM"), SICOR S.p.A., an Italian corporation with offices at via
Senato 19 20121 Milan, ITALY and SANGSTAT MEDICAL CORPORATION, a corporation
existing and organized under the laws of the State of Delaware and having its
principal place of business at 1505-B Adams Drive, Menlo Park, California 94025,
United States of America (hereinafter referred to as the "PURCHASER").
WITNESSETH
WHEREAS, SICOR S.p.A., a company existing and organized under the
laws of Italy, having its registered head office at Via Senato 19, 20121 Milan,
Italy (hereinafter referred to as "SICOR"), a wholly-owned subsidiary of GENSIA
SICOR is the manufacturer of Cyclosporine (the "Product," as hereinafter
defined.
WHEREAS, for the purposes of this Agreement, VINCHEM is the
exclusive agent in the United States for Cyclosporine sold by SICOR through
GENSIA SICOR;
WHEREAS, GENSIA SICOR intends to establish a wholly-owned
subsidiary which may act as its distributor for the Product and to which GENSIA
SICOR may assign this Restated Agreement pursuant to Section 15.1 hereof;
WHEREAS, for the purpose of developing, registering, testing,
manufacturing, marketing and selling one or more products formulated and derived
from the Product, the PURCHASER desires to purchase the Product from GENSIA
SICOR in its own name and for its own account, and GENSIA SICOR (through SICOR)
desires to supply such Product to the PURCHASER on the terms and conditions set
forth herein;
WHEREAS, the parties, having first entered into the License and
Supply Agreement as of November 23, 1994 (the "Effective Date"), now desire to
amend and restate the Agreement to reflect certain agreements reached among
them;
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
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NOW, THEREFORE, the parties hereto agree as follows:
ARTICLE 1
DEFINITIONS
1.1 Affiliate shall mean (i) any person, corporation or other
entity which directly owns, is owned by or is under common ownership with any
party hereto to the extent of at least thirty percent (30%) (or such lesser
percentage as is the maximum allowed to be owned by a foreign corporation in a
particular jurisdiction) of the equity having power to the vote on or to direct
the affairs of the entity, and (ii) any person, corporation or other entity
actually controlled by, controlling or under common control with any party
hereto.
1.2 Cyclosporine Formulations shall mean drug products that are
formulated or otherwise derived from the Product, but shall not mean the Product
itself.
1.3 Effective Date shall mean the date referred to in the
Recitals set forth above; "Restatement Date" shall mean the date referred to in
the first paragraph above.
1.4 Regulatory Authorities shall mean (A), with respect to the
United States, the United States Food and Drug Administration or such other
agency or instrumentality of the United States to which the responsibilities and
authority of the FDA are given or delegated from time to time, and (B) with
respect to each other country in the Territories, the agencies or
instrumentalities that have substantially the same responsibilities and
authorities as the FDA.
1.5 Product shall mean the Cyclosporine product produced by or
for SICOR and more particularly described in Exhibit 1 hereto.
1.6 Proprietary Rights shall mean, with respect to the Product,
the patent rights, copyrights, trade secret rights and similar industrial and
intellectual property rights.
1.7 Q/C Specifications shall mean the quality control performance
specifications and product release criteria specifications set forth in Exhibit
2 hereto.
1.8 Technical Information shall mean all trade secrets, know-how,
technology, technical assistance, computer software, means, materials,
documentation, methods, processes, practices, formulas, techniques, procedures,
designs, drawings, apparatus and any other information or data of whatever
nature, whether or not confidential or proprietary, which is relevant to use or
exploitation of Product pursuant to the terms of this Agreement, but which
information shall not include information about third party Cyclosporine
Formulations.
1.9 Exclusive Territory shall mean the United States of America
(including its territories and possessions) and the other countries identified
on Exhibit 6 hereto.
1.10 Nonexclusive Territory shall mean all of the world except
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
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1.11 Territories shall mean the Exclusive Territory and the
Nonexclusive Territory.
1.12 Net Sales shall mean the amount actually received by
PURCHASER (excluding sales to affiliates) on sales of product including the
Product to third parties including its distributors, less deductions for (i)
[ * ], (ii) [ * ], (iii) [ * ], and (iv) [ * ] provided such costs are
separately indicated on the customer invoice. [ * ] and [ * ] shall be excluded
from the computation of Net Sales.
ARTICLE 2
LICENSE
2.1 Grant of license.
2.1.1 Subject to the terms of this Agreement, GENSIA SICOR (for
itself and through SICOR) hereby grants to PURCHASER and its Affiliates (i) a
non-exclusive, royalty-free right and license under the Proprietary Rights and
to the Technical Information to directly and indirectly formulate, develop, use,
register, market, distribute and sell Cyclosporine Formulations in the
Non-exclusive Territory; and (ii) an exclusive, royalty-free right and license
under the Proprietary Rights and to the Technical Information to directly and
indirectly formulate, develop, use, register, market, distribute and sell
Cyclosporine Formulations in the Exclusive Territory; provided, however, that
the exclusive licenses granted pursuant to clause (ii) herein shall be
co-exclusive in each jurisdiction in which GENSIA SICOR (or, ALCO or SICOR, as
the case may be) has binding written agreements, or binding written commitments
that will lead to binding written agreements, to sell Product on the Restatement
Date (which is limited to only those [ * ] and the [ * ] with whom GENSIA SICOR
has commitments that are in existence on the Restatement Date), but only with
respect to such third parties and only until the earlier of expiration or
termination of such agreements; and provided, further that GENSIA SICOR shall
use all diligent efforts (without any obligation to violate or alter the terms
of such agreements existing on the Restatement Date) to provide PURCHASER with
exclusive rights to sell the Products in the Exclusive Territory as soon as
possible.
2.1.2 Subject to the terms of this Agreement, GENSIA SICOR shall
(and GENSIA SICOR shall cause SICOR to) promptly deliver to PURCHASER, from time
to time upon the reasonable request of PURCHASER, all materials, technology,
documentation and other information comprising the Technical Information,
provided, however, that GENSIA SICOR (and/or SICOR) shall provide such Technical
Information only to the extent that such information is reasonably necessary to
permit PURCHASER to exercise its rights under Section 2.1.1 above.
2.1.3 PURCHASER may, from time to time, request specific
additional technical assistance from GENSIA SICOR, and GENSIA SICOR shall cause
SICOR and/or SICOR's personnel (and/or agents), and SICOR shall, if requested,
provide such technical assistance to PURCHASER, including, but not limited to,
assistance to enable PURCHASER to make and complete all required regulatory
agency submissions (including, without limitation, FDA AADA, NDA and Canadian
NDS, as well as regulatory submissions for the European
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
3
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Union and throughout the world). For the purposes of this Section 2.1.3,
technical assistance shall include cooperating with PURCHASER in preparing
PURCHASER's filings, applications and submissions, with Regulatory Authorities,
being available to answer questions from representatives of PURCHASER and
Regulatory Authorities relating to such filings, applications and submissions,
and such other matters as the parties may mutually agree. Technical assistance
that is provided by fax, telephone, courier, mail or personal interview at SICOR
or GENSIA SICOR's facilities shall be at no charge to PURCHASER. All other
technical assistance shall be subject to mutual agreement of the parties as to
both the scope of such assistance and the compensation therefor.
2.1.4 Notwithstanding anything to the contrary, PURCHASER may
sublicense the rights under Section 2.1.1 above to its Affiliates, authorized
distributors and agents in the Territories provided that each sublicensee agrees
to be bound by the terms and conditions of this Agreement relating to such
rights.
2.1.5 Subject to Article 14 below, GENSIA SICOR (through SICOR)
shall retain at all times all manufacturing rights to Product for the
Territories and shall deliver such Product under the terms and conditions as
provided for in the following clauses of this Agreement.
2.2 Each of PURCHASER and GENSIA SICOR agrees (and GENSIA SICOR shall
cause SICOR to do the same) to advise and keep the other party informed (and
GENSIA SICOR shall cause SICOR to do the same) of any adverse events associated
with clinical trials with the Cyclosporine Formulations in which said adverse
events are attributed to the Product, but which shall not include information
relating to the Cyclosporine Formulations.
2.3 GENSIA SICOR (for itself and SICOR) represents and warrants that:
(i) it has and will, at all times during the term of this
Agreement, have the right to manufacture and sell Product;
(ii) neither the processes used in production of the Product, nor
the use of the fungus strain used in those processes (A) infringe any
proprietary industrial or intellectual property rights of any third party
(including, but not limited to, U.S. Letters Patent 4,215,199, 4,177,118 and the
foreign patents corresponding thereto), or (B) use any misappropriated trade
secrets of any third party (including, but not limited to, Ciba-Geigy AG, Sandoz
AG, and their respective Affiliates);
(iii) it will all reasonably diligent efforts to continuously
improve the Product strain and Product manufacturing process;
(iv) to the best of its knowledge, no other licenses or
permissions are required to exploit the Product; and
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
4
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(v) during the term of this Agreement, it will not directly or
indirectly develop, license, supply, distribute or sell any Cyclosporine
Formulations; provided, however, that this Section 2.3(v) shall not apply in any
of the circumstances set forth in Exhibit 11.
ARTICLE 3
SUPPLY OF PRODUCT
3.1 In accordance with the terms of this Agreement, GENSIA SICOR
(through SICOR) shall supply all of PURCHASER'S ordered requirements for Product
in bulk form for use by PURCHASER in the Territories in accordance with the
provisions of this Agreement. The right and license of PURCHASER to obtain, use
and distribute Product (including, without limitation, the right to make or have
made Product) from GENSIA SICOR and SICOR shall be (i) non-exclusive in the
Non-exclusive Territory, and (ii exclusive in the Exclusive Territory; provided,
however, that the rights and licenses set forth in clause (ii) above shall be
co-exclusive in each jurisdiction in which GENSIA SICOR (or ALCO or SICOR, as
the case may be) has binding written agreements, or binding written commitments
that will lead to binding written agreements, to sell Product on the Restatement
Date (which is limited to only those [ * ] and the [ * ] with whom GENSIA SICOR
has commitments that are in existence on the Restatement Date), but only with
respect to such third parties and only until the earlier of expiration or
termination of such agreements; and provided, further that GENSIA SICOR shall
use all diligent efforts (without any obligation to violate or alter the terms
of such agreements existing on the Restatement Date) to provide PURCHASER with
exclusive rights and licenses to sell the Products in the Territory as soon as
possible. All Product hereunder shall be manufactured at SICOR's GMP facilities
at Rho, Italy, the facility identified in Exhibit 9 hereto, the Santia Facility
and additional (as necessary and as provided in Section 6 below) GMP qualified
facilities that are approved in advance by PURCHASER (which approval will not be
unreasonably withheld). In addition, all Product shall be manufactured (A) in
accordance with drug substance manufacturing and quality control procedures
existing on the Effective Date, which drug substance manufacturing and quality
control procedures have been included in manufacturer's Abbreviated Antibiotic
Drug Application ("AADA") submitted to the FDA in 1996, and that will be
submitted to other Regulatory Authorities in the Territory (which AADA shall
include at least the elements set forth in the Drug Master File) in accordance
with U.S. FDA current Good Manufacturing Practices, and (B) to the Q/C
Specifications. GENSIA SICOR shall cause SICOR to use its diligent efforts to
[ * ] in order to produce and supply all Product ordered by Purchaser hereunder
and to meet the Product [ * ] that will be set forth in Schedule 1 hereto within
[ * ] after the Restatement Date. In addition, GENSIA SICOR agrees to the
following (and GENSIA SICOR agrees to cause SICOR to undertake):
(i) Within [ * ] after PURCHASER submits an [ * ] (i.e., [ * ])
for its Cyclosporine Formulation, GENSIA SICOR shall submit a [ * ] for the
Product to [ * ] for the [ * ];*
(ii) Within [ * ] days of notice from PURCHASER that PURCHASER
intends to file a registration for a Cyclosporine Formulation with a Regulatory
Authority or Regulatory Authorities, it shall file in each [ * ], a [ * ] or
[ * ] with the
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
5
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appropriate Regulatory Authorities in order to permit PURCHASER to obtain
approval to [ * ] as soon as possible; and
(iii) GENSIA SICOR shall maintain the party identified on Exhibit
9, or such other party as PURCHASER approves in its reasonable discretion, (and
provide PURCHASER with evidence that is reasonably satisfactory to PURCHASER of
such designation) to manufacture and supply Product to PURCHASER pursuant to
this Agreement.
3.2 GENSIA SICOR (through SICOR) shall deliver the Product in quantities
comprised of single, Q/C-released lots in accordance with Firm Orders
established pursuant to Article 4 hereof; provided, however, that PURCHASER may,
prior to any shipment, waive the requirement that such shipment be comprised of
a single, Q/C-released lot. In addition, in the event that a Firm Order for
Product is not in a multiple of [ * ] or [ * ], PURCHASER acknowledges that any
quantity of a Q/C-released lot (within a Firm Order) greater and additional to
the minimum batch size then in effect may be delivered as a separate lot under
such Firm Order. The packaging specifications will be established by the parties
based on results of stability testing of the Product, which testing shall be
completed by no later than December 31, 1995, and shall be set forth in Exhibit
3 hereto; the parties may revise and update such specifications by separate
agreement between the parties hereto.
3.3 GENSIA SICOR (through SICOR) shall satisfy all of PURCHASER's
requirements for Product. GENSIA SICOR (through SICOR) shall make all Product
produced and sold to PURCHASER as per validated processes and procedures. GENSIA
SICOR (through SICOR) shall not change, deviate from or otherwise modify any
aspect of the procedures or processes employed in manufacturing the Product
using a process or procedure different from the procedures and processes filed
with the Regulatory Authorities (including, without limitation, the FDA) or as
otherwise specified herein without the prior written consent of PURCHASER and
PURCHASER agrees to promptly respond to any request for consent from GENSIA
SICOR (through SICOR).
3.4 In the event that GENSIA SICOR (through SICOR) is unable to supply
the full amount of Product which shall be the subject of any Firm Order (as
defined in Article 4 below) in accordance with any delivery schedule provided
for in Article 4 below, GENSIA SICOR (through SICOR) shall notify the PURCHASER
of such situation as soon as possible and shall supply to PURCHASER an
allocation of Product at least equal to the ratio of (i) the amount supplied
from the [ * ] during the [ * ] of [ * ] to such inability, to (ii) the [ * ].
In no event shall PURCHASER [ * ] with respect to the [ * ] and [ * ] and [ * ]
of Product than [ * ].
ARTICLE 4
FORECASTS AND ORDERS
4.1 In order that GENSIA SICOR may properly and economically forecast
procurement planning with respect to the Product, PURCHASER shall, commencing
with the [ * ] immediately following approval of a Cyclosporine Formulation of
PURCHASER, submit to GENSIA SICOR within [ * ] business days after the beginning
of such [ * ] and
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
6
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each [ * ] thereafter during the term of this Agreement, rolling forecasts of
its good faith, non-binding estimates of its requirements of Product for the
forthcoming [ * ] period. PURCHASER shall within [ * ] days after the
Restatement Date provide its initial non-binding forecast. In addition, at the
time of delivery of each forecast, PURCHASER shall place a firm order in writing
for Product to be delivered to it during the [ * ] after receipt of such order
by GENSIA SICOR ("Firm Order").
4.1.1 A Firm Order may not be canceled, and, following
performance by GENSIA SICOR (for itself and through SICOR, as appropriate) of
its obligations hereunder with respect to such order, PURCHASER shall be
obligated to pay the price for said order as provided in Article 5 hereof. The
total amount of each Product ordered by PURCHASER for delivery in any [ * ] for
which an order is required may not be less than [ * ] percent ([ * ]) of
PURCHASER's [ * ] of its [ * ]. In addition, GENSIA SICOR's supply obligation
will not extend to more than [ * ] percent ([ * ]) of PURCHASER's [ * ] of its
[ * ]. If a PURCHASER Product requirement for any quarter exceeds [ * ] of
PURCHASER's [ * ], GENSIA SICOR and PURCHASER will discuss in good faith the
additional amount, if any, that GENSIA SICOR is willing to supply consistent
with its other obligations and PURCHASER will adjust its order accordingly.
4.2 The parties shall meet from time to time to review the estimated
quantities in each forecast and any Firm Order then outstanding and to consult
on matters relating to the scheduling of manufacture, import and delivery of the
Product but without prejudice and subject to the obligations of the parties set
forth in this Agreement.
4.3 Concurrent with execution of this Restated Agreement, Purchaser
hereby places Firm Orders (and GENSIA SICOR hereby acknowledges receipt and
acceptance of the same on its behalf and by SICOR) for the quantities of the
Product set forth in Exhibit 7 hereto. Notwithstanding the foregoing, the
parties acknowledge that those Firm Orders set forth in Exhibit 7 with a
scheduled delivery date after [ * ], are conditioned upon earlier receipt of
AADA approval by GENSIA SICOR from the FDA to manufacture Product at its [ * ]
facility.
ARTICLE 5
CERTAIN OBLIGATIONS OF PURCHASER
5.1 Commencing on the [ * ] of commercial launch of PURCHASER's
Cyclosporine Formulation in [ * ], and provided that GENSIA SICOR is in good
standing hereunder, PURCHASER agrees to purchase [ * ] from GENSIA SICOR the
minimum quantities of Product set forth on Exhibit 10 hereto.
5.2 PURCHASER shall use commercially reasonable efforts to obtain
approval to market its Cyclosporine Formulations in the Exclusive Territory
(including [ * ]). In addition, PURCHASER agrees that if it has not commenced
marketing of its Cyclosporine Formulation in [ * ] and in [ * ] within [ * ]
after obtaining such approval in each such jurisdiction, then the exclusive
license and supply rights granted pursuant to Article 2 and Article
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
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3 shall become non-exclusive, but only with respect to the [ * ]. PURCHASER also
agrees to dedicate [ * ] in the [ * ] and [ * ].
ARTICLE 6
PRICE AND PAYMENT
6.1 Transfer Price. The prices for the Product supplied hereunder is set
forth in Exhibit 4 hereto, F.C.A. SICOR's facility in [ * ]. Such prices shall
apply to any commercial and pre-commercial batches of Product (each determined
on a jurisdiction by jurisdiction basis).
6.2 Payment Terms. Neither VINCHEM nor GENSIA SICOR (through SICOR)
shall invoice for any stock of Product prior to the shipment date for such
stock. The PURCHASER shall pay to VINCHEM the price of each shipment of Product
within (a) [ * ] days after the invoice date, with respect to commercial
quantities, and (b) [ * ] days after the invoice date, with respect to
quantities used in development and clinical trials, in each case if such
quantity is accepted (and, if not initially accepted, then in accordance with
Section 12.1). All payments and prices shall be in United States dollars.
Payment shall be remitted by wire transfer in the invoice currency to a bank
account to be designated in writing from time to time by VINCHEM. No invoices
shall be submitted to PURCHASER until the date the subject Product is released
for shipment from VINCHEM's facilities.
6.3 Facility Improvement and Funding.
(a) Within thirty (30) days after the Restatement Date, GENSIA
SICOR shall [ * ] (and shall use all diligent effort to [ * ] of its [ * ] (the
[ * ]) to [ * ] additional [ * ].
(b) PURCHASER shall provide GENSIA SICOR U.S. $3,000,000 in
funding, which shall be used solely for the purpose of completing the Santia
Facilities expansion. Fifty percent (50%) of such funds shall be provided
pursuant to a promissory note, and be reasonably secured by the equipment and
other tangible assets (other than real property) included in the Santia
Facilities expansion, and the other fifty percent (50%) of such funds shall be
provided as an advance payment against future purchase orders from PURCHASER.
PURCHASER shall provide (i) $2,000,000 promptly following (a) execution and
delivery of a promissory note and loan agreement that is reasonably acceptable
to the parties, and (b) proof reasonably satisfactory to PURCHASER that GENSIA
SICOR has entered into a binding written supply agreement with the third party
identified on Exhibit 9 hereto as an additional supplier to fulfill PURCHASER's
Product requirements, and (ii) the balance of $1,000,000 promptly after
receiving notice from GENSIA SICOR that the license granted pursuant to clause
(ii) of Section 2.1.1 has become fully exclusive and approval by the U.S.
Regulatory Authorities of GENSIA SICOR's AADA to produce Product at GENSIA
SICOR's existing Rho, Italy facility. Amounts provided as a loan shall be repaid
in full on the third anniversary of the Restatement Date. Amounts provided as an
advance against purchase orders shall be applied against Product orders shipped
on or after July 1, 1997, provided that no more than twenty-five percent (25%)
of such amount may be applied against any purchase order.
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
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(c) At PURCHASER'S option (the "Capacity Option"), GENSIA SICOR
shall expand the Santia Facilities to add manufacturing capacity to [ * ]. If
(and only if) PURCHASER exercises the Capacity Option, PURCHASER shall provide
GENSIA SICOR with U.S. $2,000,000 in funding, which shall be provided subject to
the same repayment conditions, in the same manner and during the same time
period as set forth in subparagraphs (a) and (b) above. GENSIA SICOR shall use
all diligent effort to complete such expansion, file with the Regulatory
Authorities in the United States and the European Union for approval to produce
commercial quantities of Product, and produce validated Product from the
expanded facilities by no later than [ * ].
(d) SICOR shall [ * ] that are reasonably acceptable to
PURCHASER, but in each instance, only for sale to PURCHASER, its agents and
Affiliates.
(e) Except for the funds described in subsection (b) and, at
PURCHASER's option, subsection (c) above, GENSIA SICOR shall be solely
responsible for any amounts or resources required to complete and fully validate
the Santia Facility.
ARTICLE 7
DELIVERY AND RISK OF LOSS
7.1 With respect to Product to be delivered to the United States,
VINCHEM shall deliver or arrange for the delivery of the Product to a carrier or
agent designated by PURCHASER, F.C.A. (1990 ICC INCOTERMS) SICOR facility at
[ * ] and as otherwise mutually agreed.
7.2 With respect to Product to be delivered to outside the United
States, GENSIA SICOR shall deliver or arrange (by itself or through an agent or
subagent that is reasonably acceptable to PURCHASER) for the delivery of the
Product to a carrier or agent designated by PURCHASER, F.C.A. (1990 ICC
INCOTERMS) SICOR facility at [ * ] and as otherwise mutually agreed.
7.3 Title to the Product sold hereunder shall pass to PURCHASER upon
delivery to the carrier or agent designated by PURCHASER, provided that with
respect to Product to be delivered to the United States under Section 7.1,
VINCHEM shall be the importer of record, and PURCHASER agrees to promptly
reimburse VINCHEM for [ * ] incurred in [ * ] to PURCHASER upon submission of
[ * ].
7.4 Product shall be tendered for shipment only after such Product has
cleared the Q/C Specifications and quality assurance procedures set forth in
Exhibit 2 and in accordance with the lot size set forth in the Firm Order.
ARTICLE 8
SUPERIORITY
8.1 Except for the purchase orders referred to in Section 4.3 above, no
provision on PURCHASER's purchase order form or on GENSIA SICOR's (or SICOR's)
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
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general conditions of sale or invoice which may purport to impose different
conditions upon PURCHASER or GENSIA SICOR (or SICOR) or VINCHEM shall modify or
otherwise alter the terms of this Agreement.
8.2 The United Nations Convention on the International Sale of Goods
(1980) shall not apply to this Agreement, nor to any sale of Product made
pursuant to this Agreement.
ARTICLE 9
CONFIDENTIALITY
9.1 Except as otherwise provided herein, during the term of this
Agreement and for a period of [ * ] years following expiration or termination of
this Agreement, each party shall maintain in confidence all confidential or
proprietary information and materials disclosed or provided by the other party
hereto or the other party's Affiliate, which such party knows or has reason to
know are or contain trade secrets or other proprietary or confidential
information relating to the business or properties of the other party, or the
business plans of the other party hereto prior to the date hereof, and shall not
use such trade secrets or proprietary or confidential information for any
purpose, including, without limitation, for the purpose of developing products
except as permitted by this Agreement or disclose the same to anyone other than
those of its Affiliates, employees, consultants, agents or subcontractors as are
necessary in connection with such party's activities as contemplated in this
Agreement. Each party shall obtain a written agreement from any such employees,
consultants, agents and subcontractors, prior to disclosure, to hold in
confidence and not make use of such trade secrets or proprietary or confidential
information for any purpose other than those permitted by this Agreement.
Notwithstanding the foregoing sentence, with respect to employees or
consultants of a party or such party's Affiliates who have signed a
confidentiality agreement in favor of such party or Affiliate as employer, if
such confidentiality agreement binds the employee or consultant to protect
proprietary information disclosed hereunder to the same extent (or greater) as
required by this Article, then it shall be sufficient for the employing party to
(i) notify such employees or consultants of the fact that information disclosed
hereunder is governed by such confidentiality agreements and (ii) identify to
such employees the information which is so governed. Each party shall be
responsible for ensuring compliance with these obligations by such party's
Affiliates, employees, consultants, agents and subcontractors. Each party shall
use a similar effort to that which it uses to protect its own most valuable
trade secrets or proprietary information to ensure that its Affiliates,
employees, consultants, agents and subcontractors do not disclose or make any
unauthorized use of trade secrets or proprietary information of the other party
hereto. Each party shall notify the other promptly upon discovery of any
unauthorized use or disclosure of the other's trade secrets or proprietary
information. Each party agrees that upon termination of this Agreement, each
party shall return and/or destroy (and certify such destruction to the other
party) all confidential and proprietary information of the other to such other
party, except as may be required by law or regulation and except that each party
may retain one (1) copy for archival purposes and resolution of disputes.
9.2 The obligation of confidentiality and non-use contained in this
Agreement shall not apply to the extent that (a) the party who has received
information (the "Recipient") is
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required to disclose information by order or regulation of a governmental agency
or a court of competent jurisdiction or (b) the Recipient can demonstrate that
(i) the disclosed information was at the time of such disclosure by the
Recipient already in the public domain or later entered the public domain other
than as a result of actions of the Recipient, its Affiliates, employees, agents
or subcontractors in violation hereof; (ii) the disclosed information was
rightfully known by the Recipient or its Affiliates (as shown by its written
records) prior to the date of disclosure to the Recipient in connection with the
negotiation, execution or performance of this Agreement; (iii) the disclosed
information was received by the Recipient or its Affiliates from a source
unrelated to any party to this Agreement and not under a duty of confidentiality
to the other party; or (iv) the information can be shown to have been
independently developed by the Recipient, its Affiliates, employees, agents or
subcontractors, without the aid, application or use of any disclosed information
hereunder, or (c) disclosure is made to the appropriate Regulatory Authorities
(including, but not limited to, the FDA) as part of such Regulatory Authorities'
product license review or approval process, or (d) disclosure is made to
Affiliates, employees, consultants, agents or subcontractors or purchasers in
connection with the transactions contemplated by this Agreement, provided such
disclosures are made subject to restrictions identical in substance to those
contained in Section 9.1 above, or with respect to information provided to
purchasers of Product hereunder, information that is necessary (in the
reasonable discretion of GENSIA SICOR) for use of the Product, provided that in
each instance Recipient takes advantage of any available protective provisions
regarding such disclosures of confidential information. In addition, each of the
parties hereto agrees to keep confidential the existence of this Agreement,
unless such existence otherwise becomes known pursuant to this paragraph, and
except to the extent that disclosure is required by law or, in the case of
PURCHASER, to actual or potential investors of PURCHASER, or, in the case of
GENSIA SICOR, to the second source referred to in Section 3.1 above.
9.3 From the Effective Date, PURCHASER shall be entitled to receive from
GENSIA SICOR (and SICOR, and GENSIA SICOR shall cause SICOR to provide) all
confidential and proprietary information necessary in PURCHASER's reasonable
judgment for PURCHASER to comply with its obligations set forth herein and to
determine GENSIA SICOR's (and SICOR's) ability to comply with its obligations
set forth herein and the accuracy of GENSIA SICOR's (and SICOR's) prior
representations regarding Product.
9.4 The parties acknowledge and agree that all information, technology,
materials, know how, regulatory filings and permissions (except where prohibited
by law or regulation) developed or prepared by or on behalf of PURCHASER in
connection with this Agreement shall be and remain the confidential and
proprietary information of PURCHASER.
ARTICLE 10
TRADEMARKS
This Agreement does not constitute a grant to either party of any
property right or interest in or license, whether express or implied, to any
party's trademarks.
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ARTICLE 11
ADVERSE REACTION REPORTING
11.1 Subject to Section 2.2 above, each party agrees that throughout the
duration of this Agreement it will notify the other party (and GENSIA SICOR
shall cause SICOR to do the same) (i) immediately with respect to any
information concerning any serious or unexpected complaint anywhere involving
the possible failure of the Product to meet any specifications, and any serious
or unexpected side effect, injury, toxicity or sensitivity reaction or any
unexpected incidents and the severity thereof associated with the distribution
of the Product, whether or not determined to be attributable to the Product, and
(ii) within a reasonable period of time that is at least consistent with
applicable regulatory guidelines with respect to any other complaints.
11.2 Subject to Section 2.2, PURCHASER and GENSIA SICOR shall (and
GENSIA SICOR shall cause SICOR to) immediately notify the other party (and
GENSIA SICOR shall cause SICOR to do the same) of any information it receives
regarding any threatened or pending action, inspection or communication by or
from a concerned regulatory agency which may affect the safety or efficacy
claims of the Product or the continued marketing of the Product. Upon receipt of
such information, the parties shall consult in an effort to arrive at a mutually
acceptable procedure for taking appropriate action.
11.3 If at any time or from time to time any regulatory agency having
jurisdiction in the Territory requests either party to recall the Product or a
Cyclosporine Formulation due to a defect in the manufacture, formulation,
processing, packaging or labeling of the Product or a Cyclosporine Formulation
or for any reason whatsoever, the party to whom such request is made shall
immediately notify the other party. The recall shall be carried out by PURCHASER
in as expeditious a manner as reasonably possible.
ARTICLE 12
WARRANTY AND LIMITATIONS
12.1 EXCEPT AS EXPRESSLY PROVIDED HEREIN, GENSIA SICOR MAKES NO
WARRANTIES OF ANY KIND, EXPRESS OR IMPLIED, INCLUDING ANY IMPLIED WARRANTS OF
MERCHANTABILITY. Subject to the following provisions of this Article 12, GENSIA
SICOR shall cause SICOR to warrant that all Product at the time title to such
Product passes to the PURCHASER (A) is of good and merchantable quality,
conforms to the Q/C Specifications, and has been manufactured in accordance with
all applicable regulatory requirements (including, without limitation all
current Good Manufacturing Practices), as provided by the Regulatory Authorities
of the Territory and the jurisdiction in which it is manufactured, (B) shall
have, at least, minimum shelf life initially to be [ * ], and (C) that Product
performance/potency/efficacy throughout the shelf life period shall be within
the Q/C Specifications so long as Product is properly stored as per
specifications set forth in Exhibit 2. In that regard, GENSIA SICOR acknowledges
(and SICOR through GENSIA SICOR acknowledges) that any change, deviation from or
other modification to the manufacturing process, facilities or materials
reviewed and, where required, approved by the appropriate Regulatory
Authorities, may require additional approval and/or review from such authority,
and
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that the manufacturing process, facilities and materials that are the subject of
such review and/or approval, constitute a material part of the Q/C
Specifications and other applicable regulatory requirements covered by this
warranty. Except with respect to claims relating to the
performance/potency/efficacy of the Product throughout the shelf-life specified
above, claims that any given shipment of Product does not meet such Q/C
Specifications or otherwise fails the requirements set forth in this Article 12
shall be made by PURCHASER to GENSIA SICOR in writing within [ * ] after
discovery by PURCHASER that such Q/C Specifications or other requirements have
not been met.
12.2 If PURCHASER claims that any shipment of Product did not conform to
the warranties set forth in Section 12.1, conform to the Q/C Specifications or
other requirements hereunder, GENSIA SICOR (through SICOR) shall conduct or have
conducted an assay of its retained samples from such shipment. If GENSIA SICOR
agrees with PURCHASER's claim, GENSIA SICOR (through SICOR) at its option shall
either replace such shipment of Product or give credit for payment if such
payment has already been made by PURCHASER for such shipment including any
related reasonable expenses to PURCHASER. If the parties do not agree on
PURCHASER's claim, then the parties shall designate by mutual agreement a third
party laboratory to make such determination from samples obtained from the batch
or other quantity shipped. The decision of the third party laboratory shall be
binding. Should such laboratory confirm PURCHASER's claim, GENSIA SICOR (through
SICOR) may exercise the option described above in this Section 12.2 should such
laboratory find no basis for PURCHASER's claim, then PURCHASER shall bear the
costs of the third party laboratory and reasonable costs incurred by GENSIA
SICOR (through SICOR) for conducting an assay of retained samples. If PURCHASER
identifies Product that it believes does not conform to the warranty set forth
in this Article 12, PURCHASER may withhold payment to GENSIA SICOR (and SICOR),
or in the case of Product supplied hereunder into the United States, to VINCHEM
of any amount due in respect of such Product and deposit such withheld payment
in a [ * ] certificate of deposit account with Silicon Valley Bank, until such
time as the parties have determined whether such Product conforms to the
warranty described in this Article 11, or PURCHASER receives replacement Product
that conforms to such warranty. In the event that the subject Product is
determined to be conforming, GENSIA SICOR shall receive all amounts in such
certificate of deposit account.
12.3 Subject to Section 12.5 below, GENSIA SICOR shall (and GENSIA SICOR
shall cause SICOR to) indemnify PURCHASER, and VINCHEM in the case of Product
supplied hereunder into the United States, from and against all or any actions,
proceedings, costs, claims, demands, liabilities and/or third party expenses
(including but not limited to reasonable attorneys' fees and expenses) arising
out of any breach of the warranties made in this Article 12 or the
representations and warranties set forth in Section 2.3.
12.4 Subject to Sections 12.3 and 12.5 hereof, PURCHASER shall indemnify
GENSIA SICOR (and SICOR), and VINCHEM in the case of Product supplied hereunder
into the United States, from and against all or any actions, proceedings, costs,
claims, demands, liabilities and/or third party expenses (including but not
limited to reasonable attorneys' fees and expenses) arising out of the
development, manufacture, use or sale of the Cyclosporine Formulations by
PURCHASER.
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12.5 In the event of any claim being made against a party hereto ("the
Indemnified Party") for which the other party (the "Indemnifying Party") has
agreed to indemnify the Indemnified Party pursuant to this Article 12, the
Indemnifying Party shall be promptly notified thereof and may, in its discretion
and at any time, assume and control all negotiations for the settlement of the
same and any litigation (including, but not limited to, the defense of any
claim) that may arise therefrom. The Indemnified Party shall provide such
assistance with respect to any settlement or litigation efforts by the
Indemnifying Party as the Indemnifying Party may reasonably request. Subject to
the other provisions of this Section 12.5, the Indemnifying Party may, at its
sole expense, participate in the defense of any claim hereunder with counsel of
its own choice.
12.6 IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY
SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES ARISING IN ANY WAY OUT OF
THIS AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY.
ARTICLE 13
TERM AND TERMINATION
13.1 This Agreement shall take effect for the Territory as of the
Effective Date and shall continue in effect for a period of fifteen (15) years
following first approval for commercial sale by a Regulatory Authority of a
European Union country, Switzerland, Norway, the United States or Canada of a
Cyclosporine Formulation submitted by PURCHASER (the "Approval Date") and shall
automatically renew for an additional five (5) year period, subject to notice
from one of the parties hereto to the contrary given no later than the
fourteenth anniversary of the Approval Date, unless terminated earlier according
to Sections 13.2 or 13.3 hereinafter; provided, however, that, if, at the
seventh anniversary of the Approval Date, GENSIA SICOR demonstrates to the
reasonable satisfaction of PURCHASER, that SICOR and GENSIA SICOR cannot, taken
together, as a result of substantially changed market conditions, make Product
without achieving a profit, the parties shall meet and confer in good faith as
to how to address such situation, which may allow for, if the disposition of
Proprietary Rights at such time so permits, the license or purchase from GENSIA
SICOR and SICOR of the rights and know-how necessary to make Product. In
addition, notwithstanding anything to the contrary, PURCHASER's exclusive
license and purchase rights described in Articles 2 and 3, shall become
non-exclusive on the tenth (10th) anniversary of the Approval Date.
13.2 This Agreement may be terminated by either party, in the event the
other substantially fails to perform or otherwise substantially breaches any of
its material obligations under this Agreement, by giving notice of its intent to
terminate and stating the grounds therefor. The party receiving the notice shall
have thirty (30) days from the date of receipt thereof to commence good faith
efforts to cure the failure or breach, which failure or breach shall in any
event be cured within one hundred and twenty (120) days of notice thereof. In
the event such breach is not cured within the time period set forth herein, then
this Agreement shall, without any further action, terminate at the end of the
applicable period.
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13.3 This Agreement may be terminated by GENSIA SICOR or PURCHASER upon
thirty (30) days notice upon the filing of a petition in bankruptcy, insolvency
or reorganization against or by the other party, or such other party going into
receivership, and such petition is not dismissed within one hundred and twenty
(120) days thereafter.
13.4 In addition, anything herein to the contrary notwithstanding, the
following provisions of this Agreement shall survive termination of this
Agreement with respect to Product delivered or Technical Information and
business plans disclosed prior to termination: (Articles 6, 8, 9, 11-15 and
Sections 2.1) and for Product ordered pursuant to Section 14.5, in addition to
the foregoing Articles and Sections: (Section 6.1 and 6.2).
13.5 Upon termination of this Agreement, PURCHASER shall be permitted to
use the Product which has been ordered by it in good faith from GENSIA SICOR in
accordance with the terms of this Agreement prior to termination; provided that
PURCHASER shall be obliged to make all payments to GENSIA SICOR required under
this Agreement for the Product so delivered, in accordance with the pricing and
payment provisions of this Agreement which shall be deemed to continue in force
following termination of this Agreement to the extent necessary for the purposes
of this Section 13.5. In the event that this Agreement is terminated by GENSIA
SICOR for a breach by PURCHASER, GENSIA SICOR shall be permitted to deliver any
Firm Order given prior to such termination, and if such Product is otherwise
made in conformance with this Agreement, PURCHASER agrees to accept such
Product.
ARTICLE 14
OPTION
14.1 Option. In the event (i) that SICOR is unable to supply all ordered
quantities of Product to PURCHASER as a result of a Force Majeure, or (ii) that
SICOR for any reason refuses or is otherwise unable to supply Product in
accordance with the terms of this Agreement, or (iii) of the direct or indirect
acquisition of substantially all of SICOR or GENSIA SICOR's assets or of a
controlling interest in SICOR or GENSIA SICOR by any of the parties identified
on Exhibit 8 hereto, or any of their Affiliates (each of the foregoing, a
"Transfer Event"), and, if the Transfer Event falls under (and only under)
clause (ii) above, and SICOR does not cure such failure within ninety (90) days
from the date such Transfer Event commences and, if the Transfer Event falls
under (and only under) clause (i) above, SICOR is not diligently pursuing such a
cure within one hundred and fifty (150) days from the date such Transfer Event
commences, PURCHASER shall have the option, in its sole discretion (the
"Option") to (A) acquire a perpetual, exclusive, worldwide license (subject to
reversion as set forth in Section 14.4 hereof) to fully exploit all
manufacturing rights (including, but not limited to, all proprietary rights in
and to the Product strain) know-how and documentation necessary or useful to
manufacture the Product, the Specifications, approvals obtained or required from
Regulatory Authorities, and as it is then being manufactured, (B) receive
technical assistance reasonably required by PURCHASER, to manufacture and
perform quality control on the Product(s) for marketing, registration,
distribution and sale in the Territories, (C) acquire GENSIA SICOR and SICOR's
existing inventory of Product and work-in-progress at the purchase price
provided in Article 6 above, and (D) acquire from GENSIA SICOR and SICOR the
right, free of charge, to use, free of any interruption, the Santia Facilities
to make cyclosporine.
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In connection with the foregoing, upon the occurrence of a Transfer
Event (i) PURCHASER shall be permitted to [ * ] upon reasonable notice, (ii)
SICOR will [ * ] and [ * ] for reasonable consultation [ * ] and (iii) PURCHASER
shall be permitted to [ * ] of all [ * ] and other [ * ] related to the [ * ].
In that regard, (i) GENSIA SICOR and SICOR each hereby authorizes (and shall
advise the appropriate [ * ] in the [ * ] and [ * ]) PURCHASER to have access to
(including the right to make copies thereof) the [ * ] upon notice to such [ * ]
by PURCHASER that a Transfer Event has occurred, (ii) GENSIA SICOR and SICOR
shall, upon the occurrence of a Transfer Event, promptly provide to PURCHASER
[ * ] of the [ * ] and all other [ * ] and (iii) upon the occurrence of a
Transfer Event, GENSIA SICOR, SICOR and PURCHASER shall [ * ] providing that
[ * ] and [ * ] identified on Exhibit 9 hereto are [ * ] effective upon exercise
of the Option by PURCHASER.
14.2 Option Period: Unless otherwise agreed, PURCHASER shall have the
irrevocable right to exercise the Option at any time during the term of the
Agreement upon the occurrence of a Transfer Event, or upon termination of this
Agreement by PURCHASER pursuant to Section 13.2 hereof.
14.3 Financial Terms: Unless otherwise agreed, financial terms for the
licenses, leases and assets transferred pursuant to Section 14.1 shall be as
follows:
(i) PURCHASER shall pay GENSIA SICOR [ * ] percent ([ * ]) of
[ * ] subject to reduction until PURCHASER has recovered its costs of [ * ]
(including, but not limited to, [ * ], and has reduced its manufacturing costs
with respect to the Product for a period of [ * ] continuous months, to the
level of SICOR's [ * ] as measured over the [ * ] month period prior to the date
of the Transfer Event.
(ii) PURCHASER shall receive, free of charge, the [ * ] of the
equivalent of [ * ] of SICOR directly involved in the manufacture, purification
and quality control of Product for a period of [ * ] months for the purpose of
[ * ]. During the same [ * ] month period, at no additional cost to PURCHASER,
such [ * ] shall be [ * ]. Thereafter, PURCHASER shall [ * ] not to exceed [ * ]
for any additional [ * ].
(iii) Purchaser may purchase the [ * ] and [ * ] from GENSIA
SICOR and its suppliers at [ * ].
(iv) Purchaser shall have the option to acquire all right, title
and interest in and to the Santia Facility at [ * ].
14.4 Reversion. In the event PURCHASER exercised the Option due to a
Force Majeure event, and GENSIA SICOR is able to cure such Force Majeure event,
on the date GENSIA SICOR demonstrates such capability to PURCHASER (the
"Reversion Date"), the license granted under Section 14.1 hereof shall
immediately terminate and GENSIA SICOR shall have the right to resume supply of
Product in accordance with the terms of the Agreement; provided, however, that
the purchase price for the Product [ * ] during the time period during
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which the Option has been exercised, which [ * ] following the Reversion Date.
On the Reversion Date, the parties shall meet, confer and negotiate in good
faith whether such [ * ].
ARTICLE 15
MISCELLANEOUS PROVISIONS
15.1 No Assignment.
Neither party shall transfer or assign this Agreement, in whole or in
part, without the prior written consent of the other; except that either party
may, without such consent, assign and delegate this Agreement to any Affiliate
or upon a merger, reorganization or sale of substantially all of its assets;
provided, however, that in the event of a merger, reorganization or sale of
substantially all of the assets of GENSIA SICOR or SICOR, any loans advanced to
GENSIA SICOR by PURCHASER pursuant to Section 6.3 shall become immediately due
and payable in full, and any amounts paid to GENSIA SICOR pursuant to Section
6.3 as advances on Firm Orders shall be repaid to PURCHASER immediately. Subject
to the foregoing restrictions on assignment, this Agreement shall inure to the
benefit of and bind the successors and assigns of each of the parties.
15.2 Notices.
Notices and other communications required or called for under this
Agreement shall be in writing, shall be transmitted by certified mail, postage
prepaid, and shall be deemed delivered upon receipt by the party to whom it is
addressed.
In the case of PURCHASER such communications shall be addressed to:
SANGSTAT MEDICAL CORPORATION
1505-B Adams Drive
Menlo Park, California 94025
USA
Attention: Chief Executive Officer
In the case of GENSIA SICOR, such communications shall be addressed to:
GENSIA SICOR INC.
9360 Towne Centre Drive
San Diego, California 92121
Attention: Executive Vice President
with a copy to:
General Counsel
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In the case of SICOR, such communications shall be addressed to:
SICOR S.p.A.
via Senato 19
20121 Milan
ITALY
Attention: Managing Director
In the case of VINCHEM, such communications shall be addressed to:
VINCHEM, INC.
301 Main Street
P.O. Box 639
Chatham, New Jersey 07928
U.S.A.
Attention: Vincent Ursino
or to the attention of such other individual or to such other address as either
party may give to the other in writing.
15.3 Entire Agreement.
This Agreement, as amended and restated, constitutes the entire
agreement and understanding between the parties regarding the subject matter
hereof and no promises, representations, conditions, provisions or terms other
than those set forth in this Agreement exist. However, the Agreement, as in
effect on the Effective Date, shall remain effective with respect to the rights
and obligations of the parties until the Restatement Date, and shall thereafter
be superseded by this Restated Agreement. Any other previous understandings,
agreements and representations between the parties, written or oral with respect
to its subject matter are superseded. This Agreement may not be changed,
modified, or amended except by a writing signed by parties.
15.4 No Waiver.
The failure of either party to enforce at any time for any period the
provisions hereof shall not be construed to be a waiver of such provisions or of
the right of such party thereafter to enforce each such provision.
15.5 Severance.
If any provision of this Agreement should be or become fully or partly
invalid or unenforceable for any reason whatsoever or violate any applicable
law, this Agreement is to be considered divisible as to such provision and such
provision is to be deleted from this Agreement, and the remainder of this
Agreement shall be deemed valid and binding as if such provision were not
included. A suitable provision which, as far as legally possible, comes nearest
to what the parties desired according to the sense and purpose of this Agreement
had this
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point been considered when concluding this Agreement shall be substituted for
any such provision deemed to be deleted.
15.6 Arbitration.
Any and all disputes between the parties relating in any way to the
entering into of this Agreement, the validity, construction, meaning,
enforceability, or performance of this Agreement or any of its provisions, or
the intent of the parties in entering into this Agreement, or any of its
provisions, or any dispute relating to patent validity or infringement arising
under this Agreement shall be settled by arbitration. Such arbitration shall be
conducted in San Francisco, California, in English, and in accordance with the
commercial rules of the American Arbitration Association, with one (1)
arbitrator. If the parties cannot agree on a arbitrator within thirty (30) days
of the date of receipt by a party hereto of a notice of intention to arbitrate,
then the presiding judge of the Superior Court of the County of San Francisco
shall select the arbitrator. Reasonable discovery as determined by the
arbitrator shall apply to the arbitration proceeding.
The law of the State of California shall apply to the arbitration
proceedings without regard to the conflict of laws provisions thereof. Judgment
upon the award rendered by the arbitrators may be entered in any court having
jurisdiction thereof. The successful party in such arbitration, in addition to
all other relief provided, shall be entitled to an award of all its reasonable
costs and expenses including attorney costs.
Notwithstanding the foregoing, either party may seek interim injunctive
or other equitable relief from a court of competent jurisdiction pending
completion of arbitration proceedings.
15.7 Governing Law.
All matters affecting the interpretation, validity and performance under
this Agreement shall be governed by the internal laws of the State of California
without regard for its conflict of laws principles.
15.8 Headings.
The Articles and article headings included in this Agreement are for
reference purpose and shall not affect the meaning or interpretation of this
Agreement.
15.9 Force Majeure.
If and to the extent that either party hereto is prevented, by
circumstances not now reasonably foreseeable and not within its reasonable
ability to control which shall include (but not by way of limitation) delays in
the review process (but not through a fault of either party) occasioned by a
Regulatory Authority or any other government agency having authority over the
subject matter of this Agreement (but which shall not include compliance with
any directives or requests by such agencies), performing any of its obligations
under this Agreement and promptly so notifies the other party full particulars
of the circumstances in question, then the party affected
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shall be relieved of its obligations to the other for failure to perform such
obligations, but shall nevertheless use its best efforts to complete full
performance thereof without avoidable delay, and pending such resumption shall
consult the other party and shall permit and shall use its best efforts to
facilitate any efforts the other party make to effect the performance of such
obligations by other means.
15.10 Insurance. GENSIA SICOR maintain a comprehensive general liability
insurance policy providing sufficient extensive coverage for personal injury,
bodily injury, property damages, or such coverage as is usual and customary in
the pharmaceutical industry. GENSIA SICOR shall also provide adequate coverage
for product liability insurance for a minimum of $3 million (U.S.), and that
said policy includes human in vivo use of said Product approval by the
applicable Regulatory Authorities in all locations, including but not limited to
the [ * ]. A certificate of said product liability insurance shall be attached
hereto as Exhibit 5.
15.11 Patent Review. PURCHASER agrees to notify GENSIA SICOR (on behalf
of GENSIA SICOR, VINCHEM and SICOR) as soon as the Cyclosporine Formulation is
set forth by PURCHASER and in no event later than forty-five (45) days after the
Restatement Date. Within such forty-five (45) day period, the PURCHASER and
GENSIA SICOR (on behalf of GENSIA SICOR, VINCHEM and SICOR) shall each cause its
respective U.S. patent counsel, or in the case of GENSIA SICOR if so desired by
GENSIA SICOR, VINCHEM's U.S. patent counsel (each of which counsels is
reasonably acceptable to the other party) to conduct a comprehensive patent
infringement analysis of the other party's products (i.e., the subject
Cyclosporine Formulation, in the case of PURCHASER, and the Product, in the case
of GENSIA SICOR) under conditions of strict confidentiality with regard to any
information examined therefor of the other counsel's client, and to complete
such analysis and issue an opinion with respect to the subject matter of his
review within such forty-five (45) day period. In the event that either counsel
issues an opinion (or advises the parties in writing that, if asked it will
issue an opinion) that there are compelling reasons to believe that the other
party's product will clearly infringe the patent rights of a third party, then
PURCHASER and GENSIA SICOR shall jointly designate qualified U.S. patent counsel
from two independent firms who shall evaluate the subject product. If (and only
if) such patent counsel both concur with the opinion of the party's patent
counsel with respect to the likelihood of infringement, then each party shall
have thirty (30) days to terminate this Agreement (which termination shall be
without cause). In the event this Agreement is terminated pursuant to this
Section 15.11, all amounts provided to GENSIA SICOR pursuant to Section 6.3
shall be re-paid in full within five (5) business days and, at PURCHASER's
option, the Firm Orders described in Exhibit 7 shall be canceled.
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
20
<PAGE> 21
IN WITNESS WHEREOF, the parties hereto have caused these presents to be
signed by their respective corporate officers, duly authorized as of the day and
year first above written.
SANGSTAT MEDICAL CORPORATION GENSIA SICOR INC.
By: /s/ Philippe Pouletty By: /s/ David P. Hatt
- ------------------------------------- -------------------------------------
Name: Philippe Pouletty Name: David P. Hatt
Title: Chairman and Chief Executive Title: President and CEO
Officer Date: 4/2/97
Date: 4/2/97
VINCHEM, INC. SICOR S.p.A.
By: /s/ Vincent Ursino By: /s/ Carlo Salvi
- ------------------------------------- -------------------------------------
Name: Vincent Ursino Name: Carlo Salvi
Title: President Title: Chairman
Date: 4/10/97 Date: 4/10/97
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
21
<PAGE> 22
EXHIBIT 1
PRODUCT
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
1
<PAGE> 23
EXHIBIT 2
QUALITY CONTROL SPECIFICATIONS
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
2
<PAGE> 24
EXHIBIT 3
PRELIMINARY PACKAGING SPECIFICATIONS
[IN BULK]
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
3
<PAGE> 25
EXHIBIT 4
1. Price to PURCHASER for commercial Product to be [ * ] [ * ] per [ * ]
2. Price to PURCHASER for commercial Product to be[ * ] [ * ] per [ * ]
Notwithstanding the foregoing, the parties hereby agree that in the event that
PURCHASER deems it necessary (whether by [ * ] or otherwise) to establish (or
thereafter reduce) the [ * ] of a [ * ] in a [ * ] for a [ * ] to a price that
is at least [ * ] in the calendar quarter immediately preceding [ * ], the
transfer price for the Product shall be [ * ] in the following manner:
<TABLE>
<CAPTION>
Percentage [ * ]
from the [ * ] Transfer Price
--------------
<S> <C>
[ * ] [ * ]
[ * ] [ * ]
[ * ] [ * ]
</TABLE>
In the event that [ * ] at more than [ * ], PURCHASER and GENSIA SICOR agrees in
good faith to negotiate the prices for the Product sold to PURCHASER to take
into account such [ * ], and in any event GENSIA SICOR agrees to sell Product to
PURCHASER at the [ * ]. For the purposes of this Exhibit 4, "ASP" shall mean
[ * ].
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
4
<PAGE> 26
EXHIBIT 5
CERTIFICATE OF INSURANCE
[TO BE ATTACHED FOLLOWING ISSUANCE OF THE MODIFIED POLICY]
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
5
<PAGE> 27
EXHIBIT 6
EXCLUSIVE TERRITORY
United States
Canada
Mexico
European Economic Area
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
6
<PAGE> 28
EXHIBIT 7
FIRM ORDERS
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
7
<PAGE> 29
EXHIBIT 8
[ * ]
[ * ]
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
8
<PAGE> 30
EXHIBIT 9
[ * ]
[ * ]
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* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
9
<PAGE> 31
EXHIBIT 10
MINIMUM PURCHASE REQUIREMENTS
<TABLE>
<CAPTION>
Year* Quantity
- ----- --------
<S> <C>
[ * ] [ * ]
[ * ] [ * ]
[ * ] and thereafter during such period
of time as [ * ] [ * ]
</TABLE>
*commencing on the [ * ] of the date [ * ]. Notwithstanding the foregoing, in
the event that [ * ], PURCHASER's [ * ] shall [ * ].
**provided, however, if [ * ], then, at PURCHASER's option and upon notice to
GENSIA SICOR, (i) [ * ] specified in [ * ] shall be [ * ] of the Restatement
Date, or (ii) PURCHASER's [ * ].
If [ * ], the [ * ] set forth in [ * ] shall be re-negotiated in good faith.
- ----------------------
* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
10
<PAGE> 32
EXHIBIT 11
Clause (v) of Section 2.3 shall not apply to the following third parties:
(i) a [ * ] that [ * ], but only to the extent that such [ * ] already
[ * ], and only in the [ * ];
(ii) a [ * ] whose principle place of business (on the Restatement Date) is
[ * ], that [ * ];
(iii) [ * ], but only in [ * ] and only the currently approved [ * ], and the
parties shall negotiate in good faith to explore entering into a [ * ].
- ----------------------
* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
11
<PAGE> 33
SCHEDULE 1
MANUFACTURING (INCLUDING PURIFICATION) SCALE-UP TIMETABLE
- ----------------------
* Confidential Treatment Requested; confidential portion has been filed
separately with the SEC.
12
