EXHIBIT 10.41
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[CONFIDENTIAL TREATMENT REQUESTED CERTAIN PORTIONS OF THIS AGREEMENT HAVE BEEN
MARKED CONFIDENTIAL AND HAVE BEEN SEPARATELY FILED WITH THE COMMISSION.]
AMENDMENT NO. ONE TO
CYCLOSPORINE
AMENDED AND RESTATED
SUPPLY AND LICENSE AGREEMENT
The Amended and Restated Supply and License Agreement (the "Restated
Agreement") entered into as of March 31, 1997, among GENSIA SICOR INC., a
Delaware corporation ("GENSIA SICOR"), VINCHEM, INC., a New York corporation
("VINCHEM"), SICOR S.p.A., an Italian corporation ("SICOR"), and SANGSTAT
MEDICAL CORPORATION, a Delaware corporation (the "PURCHASER"), is hereby amended
as follows. The Restated Agreement, as amended by this Amendment No. One, shall
hereinafter constitute and be referred to as the Agreement.
1. The definition of Affiliate in Section 1.1 is amended by deleting the
words "thirty percent (30%)" and inserting the words "fifty percent (50%)."
2. The first sentence of the definition of Net Sales in Section 1.13 is
amended in full to read as follows: "Net Sales shall mean the amount actually
received by PURCHASER and its Affiliates (excluding sales to Affiliates) on
sales of Cyclosporine Formulations including the Product to third parties
including its distributors, less deductions for (i) ***, (ii) ***; (iii) ***,
and (iv) *** such costs are separately indicated on the customer invoice, ***.
3. The first paragraph of Section 2.1.1 is amended to read in full as
follows: "Subject to the terms of the Agreement, GENSIA SICOR (for itself and
through SICOR) hereby grants to PURCHASER (i) a nonexclusive, royalty-free right
and license under the Proprietary Rights and to the Technical Information to use
and obtain the Product but only to directly and indirectly formulate, develop,
use, register, market, distribute and sell Cyclosporine Formulations in the
Nonexclusive Territory; and (ii) an exclusive, royalty-free right and license
under the Proprietary Rights and to the Technical Information to use and obtain
with the Product but only 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
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clause (ii) herein shall be co-exclusive in each jurisdiction in which GENSIA
SICOR (or, GENCHEM PHARMA 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 three European companies and the U.S. company with whom GENSIA SICOR has
commitments that are in existence on the
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Restatement Date), but only with respect to such third parties and only until
the earlier of expiration or termination of such agreements."
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4. Section 2.1.5 is deleted.
5. Section 2.2 is amended to read in full as follows: "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 of which it is aware associated with the
Cyclosporine Formulations."
6. Clause 2.3(iii) is hereby amended to read in full as follows: "It will
use commercially reasonable efforts to improve the Product strain and Product
manufacturing process." Clause (iv) is hereby amended to read in full as
follows: "To the best of its knowledge, and except as set forth herein, no
other licenses or permissions are required to supply the Product to PURCHASER
under the terms of this Agreement."
7. The first two sentences of Section 3.1 are amended to read as follows:
"In accordance with the terms of the Agreement, GENSIA SICOR (through SICOR)
shall supply PURCHASER's ordered requirements for Product in bulk form for use
by PURCHASER in the Territories. The right and license of PURCHASER to purchase
Product from GENSIA SICOR and obtain, use and distribute Cyclosporine
Formulations containing the Product (including the right to make or have made
Cyclosporine Formulations containing the Product to the extent provided in
Article 14 of the Agreement) from GENSIA SICOR and SICOR shall be (i)
nonexclusive in the Nonexclusive Territory, and (ii) exclusive in the Exclusive
Territory; provided, however, that the rights and licenses set forth in clause
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(ii) above shall be co-exclusive in each jurisdiction in which GENSIA SICOR (or
GENCHEM PHARMA 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 three
European companies and the U.S. company 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."
8. Clause (iii) of Section 3.1 is amended to insert the words "use
reasonable commercial efforts to" after the word "shall" and before the word
"maintain."
9. The first sentence of Section 3.3 is hereby amended to read as follows:
"In accordance with the terms of the Agreement, GENSIA SICOR (through SICOR)
shall supply PURCHASER's ordered requirements for Product."
10. Section 5.1 is deleted in full.
11. The first two sentences of Section 5.2 are amended to read in full as
follows: "PURCHASER shall use commercially reasonable efforts to obtain
approval to market its Cyclosporine Formulations in ***. In addition, PURCHASER
agrees that if it has not commenced marketing of its Cyclosporine Formulation
*** and in *** within *** after obtaining such approval in each such
jurisdiction, and provided that GENSIA SICOR has provided quantities of Product
in accordance with its obligations hereunder, then the exclusive license and
supply rights granted pursuant to Article 2 and Article 3 shall become
nonexclusive, but only with respect to the jurisdiction in which PURCHASER has
failed to meet its obligations under this Section 5.2."
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12. Section 6.3(a) is hereby amended to read in full as follows: "GENSIA
SICOR shall use reasonable commercial efforts to commence the expansion
(promptly following receipt of necessary governmental expansion permits and
approvals and to pursue and complete such expansion and obtain such approvals in
accordance with Schedule I hereto), file with the Regulatory Authorities in ***
and the *** for approval to produce commercial quantities of Product, and
produce validated Product from the facility currently owned by GENSIA SICOR (or
its Affiliates) in ▇▇▇▇▇▇▇, Italy (the "▇▇▇▇▇▇▇ Facility") that adds
manufacturing capacity to produce at such facility initially *** of Product (on
an annual basis) and, possibly, *** of Product (on an annual basis). The
capacity at the ▇▇▇▇▇▇▇ Facility shall not include the production of Product at
other facilities including, without limitation, the current capacity of GENSIA
SICOR to produce *** of Product from its Rho facility. This ▇▇▇▇▇▇▇ capacity is
hereinafter referred to as the "▇▇▇▇▇▇▇ #1 Capacity Expansion" and includes the
building and all equipment necessary to fully purify (as required by Regulatory
Authorities) *** per year of Product, and approvals relating to the foregoing,
from *** and *** Regulatory Authorities that authorize the manufacture,
marketing and sale in the *** and *** of Product from the ▇▇▇▇▇▇▇ Facility.
Certain additional ▇▇▇▇▇▇▇ Capacity Expansion (the "▇▇▇▇▇▇▇ #2 Capacity
Expansion") is described in Section 6.3(c) below. If such capacity is added, the
"▇▇▇▇▇▇▇ #2 Capacity Expansion" shall include the building and all equipment
necessary to fully purify (as required by Regulatory Authorities) an additional
*** per year of Product at the ▇▇▇▇▇▇▇ Facility, and approvals relating to the
foregoing, from *** and *** Regulatory Authorities to authorize the manufacture,
marketing and sale in *** and *** from such facility. GENSIA SICOR shall use
commercially reasonable efforts to maintain the ▇▇▇▇▇▇▇ Facility (including
▇▇▇▇▇▇▇ #1 Capacity Expansion and, if built, ▇▇▇▇▇▇▇ #2 Capacity Expansion) at
the production levels (i.e. for ***, and an additional *** of Product annually,
respectively) for which AADA approval is obtained."
13. Section 6.3(b) is hereby amended to read in full as follows:
"PURCHASER shall promptly provide (and no later than December 29, 1997) GENSIA
SICOR U.S. $2,500,000 in equity funding through the direct purchase from GENSIA
SICOR of its Common Stock (price based on a 20 prior day trading average), which
shall be used solely for the purpose of completing the ▇▇▇▇▇▇▇ #1 Capacity
Expansion. In addition, PURCHASER shall promptly (and no later than December
29, 1997) prepurchase from SICOR *** of Product against future purchase orders
deliverable from GENSIA SICOR. Amounts provided as an advance against purchase
orders shall be applied against any Product orders following approval from the
FDA of the AADA supplement for PURCHASER'S Cyclosporine Formulation that
contains Product manufactured at the ▇▇▇▇▇▇▇ #1 Capacity Expansion, provided
that no more than *** of such amount may be applied against any purchase order.
PURCHASER may accelerate recovery of the advance against Firm Orders if the
▇▇▇▇▇▇▇ #1 Capacity Expansion is not completed and operating according to the
timetable described in Section 6.3(a)."
14. Section 6.3(c) is hereby amended in full as follows: "At the
reasonable request of PURCHASER within one (1) year after approval by the FDA of
the AADA filed by SICOR
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to market and sell Product in *** from the ▇▇▇▇▇▇▇ #1 Capacity Expansion, and
provided that the parties have agreed to extend the commitments set forth in
clauses A and B of Exhibit 10 until December 31, 2005 (without affecting the
other rights and obligations of the parties under the Agreement), the parties
shall negotiate in good faith with respect to the form of financing through
which PURCHASER shall provide to GENSIA SICOR up to $2,000,000, to build and
complete the ▇▇▇▇▇▇▇ #2 Capacity Expansion. The parties agree that PURCHASER's
obligation to provide financing shall not exceed the same proportional financial
commitment as its contribution to the cost of the ▇▇▇▇▇▇▇ #1 Capacity Expansion
bears to the total cost of such expansion, and GENSIA SICOR shall be under no
obligation to accept such financing."
15. Section 6.3(d) is hereby amended to read in full as follows: "So long
as PURCHASER purchases *** of its requirements of bulk Cyclosporine (which,
commencing on the one year anniversary after the date of approval by the FDA of
AADA supplement for PURCHASER's Cyclosporine Formulation that contains Product
manufactured at the ▇▇▇▇▇▇▇ #1 Capacity Expansion and ending on the second
anniversary of such date, and then in each year thereafter, is at least *** per
year of Product), SICOR shall use the ▇▇▇▇▇▇▇ #1 Capacity Expansion for (and
only for) the production and refinement of Product originating from SICOR,
Diaspa or third party facilities that are reasonably acceptable to PURCHASER,
but in each instance for sale of Product to PURCHASER for production of
PURCHASER's Cyclosporine Formulations. Provided that PURCHASER has agreed to
provide $2,000,000 of funding towards building the ▇▇▇▇▇▇▇ #2 Capacity
Expansion, such facility shall be dedicated to PURCHASER's potential Product
requirements, provided, however, that any unused capacity in the ▇▇▇▇▇▇▇ #2
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Capacity Expansion may be used by GENSIA SICOR to manufacture non-
immunosuppressant cyclosporine (as described in Paragraph 21 below) on behalf of
third parties, as long as such manufacturing does not affect the ability of
GENSIA SICOR to manufacture Product to meet PURCHASER's Firm Orders."
16. Section 6.3(e) is hereby amended to read in full as follows: "Except
for the funds described in subsection (b) above, GENSIA SICOR shall be solely
responsible for funding required to complete and fully validate the ▇▇▇▇▇▇▇ #1
Capacity Expansion and the ▇▇▇▇▇▇▇ #2 Capacity Expansion."
17. Section 9.4 is hereby amended to read in full as follows: "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, GENSIA SICOR and
SICOR, respectively, in connection with the Agreement shall be and remain the
confidential and proprietary information of PURCHASER, GENSIA SICOR and SICOR,
respectively."
18. Section 14.1 is hereby amended by adding the following words prior to
the first sentence: "For so long as PURCHASER purchases at least *** of its
requirements of bulk Cyclosporine product for its Cyclosporine Formulations from
GENSIA SICOR, ..." Section 14.1 is hereby amended by adding the following new
paragraph following the first paragraph: "Notwithstanding the above, with
respect to clauses 14.1(i) and (ii), SICOR shall have six months to cure the
events mentioned therein before they will be deemed a Transfer Event, so long as
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during such six month period, SICOR is exercising reasonable commercial efforts
to cure such events."
19. Section 15.10 is hereby amended to read in full as follows: "Each of
GENSIA SICOR and PURCHASER shall 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. Each of GENSIA SICOR and PURCHASER shall also
provide commercially reasonable coverage for product liability insurance for a
minimum of $3 million (U.S.), and that said policies include, in the case of
GENSIA SICOR, human in vivo use of the Product (if such coverage is feasible)
and, in the case of PURCHASER, PURCHASER's Cyclosporine Formulations. A
certificate of said product liability insurance policies shall be promptly
delivered to each other by GENSIA SICOR and PURCHASER, respectively."
20. Exhibits 4, 6 and 10 are amended in full as set forth in the Exhibits
hereto.
21. Other:
(a) The parties agree that SICOR retains all rights to the Product as
it relates to an intermediate and/or raw material regarding chemical derivatives
of Cyclosporine which are not (i) immuno-suppressants, (ii) to be used in
transplantation, or (iii) to be used in auto-immune diseases.
(b) GENSIA SICOR represents and warrants that it has entered into a
binding written supply agreement with Diaspa to assist with SICOR's supply of
Product to PURCHASER.
(c) Should SICOR eliminate one or more of the *** companies referred
to in Sections 2.1.1 and 3.1 hereof, SICOR and PURCHASER will discuss whether or
not to increase the basic purchases provided in the Agreement from *** to ***.
(d) The parties agree that SICOR shall be deleted as a signatory to
this Agreement provided that SICOR remains a wholly-owned subsidiary of GENSIA
SICOR and GENSIA SICOR is responsible for ensuring that SICOR and GENSIA SICOR's
other Affiliates (to the extent that the obligations of GENSIA SICOR are
delegated to other Affiliates as permitted hereunder) fulfill the obligations
set forth in the Agreement.
22. Except as set forth herein, the Restated Agreement shall remain in
full force and effect.
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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, M.D. By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
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Name: Philippe Pouletty, M.D. Name:
Title: Chairman and Chief
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Executive Officer Title: Executive Vice President
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Date: December 22, 1997 Date: December 22, 1997
VINCHEM, INC.
By: /s/ ▇▇▇▇▇▇ ▇▇▇▇▇▇
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Name: ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
Title: President
Date: December 22, 1997
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EXHIBIT 4
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For the period beginning *** and ending *** (the "***"), the following
additional terms and conditions shall apply to the obligations of the parties
with respect to the supply and purchase of Product.
PRICE PER KILOGRAM OF PRODUCT
***
The parties will negotiate in good faith to review the *** purchase
commitment and exclusivity provisions of the Agreement not less than nine (9)
months prior to the end of the ***. Should the parties fail to reach an
agreement, then any additional purchases of Product by PURCHASER after the ***
shall be at prices established for year ***, adjusted from the last day of the
*** for (i) inflation at a standard governmental index for Milan, Italy, and
(ii) foreign exchange variances between the U.S. dollar and the Italian Lira (or
it equivalent in Euro currency) from those in effect on the date hereof.
The parties 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 *** calendar quarter
of ***, the parties shall in good faith negotiate the prices for the Product
sold to PURCHASER to take into account such changing market conditions, and in
any event GENSIA SICOR agrees to sell Product to PURCHASER at ***.
For the purposes of this Exhibit 4, "ASP" shall mean ***.
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EXHIBIT 6
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EXCLUSIVE TERRITORY
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EXHIBIT 10
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A. Subject to Paragraphs B and C below, during the ***, Period, PURCHASER
agrees to purchase at least *** of its worldwide requirements for Cyclosporine
bulk product from SICOR.
B. If in a calendar year during the ***, *** or more of the aggregate net
kilogram quantity of Product sold by SICOR and its Affiliates are to the *** and
*** company described in Section 3.1 of the Agreement then, subject to SICOR's
ability to supply PURCHASER in accordance with its firm orders PURCHASER shall
be required to purchase no more than *** of its worldwide requirements for
Cyclosporine bulk product from SICOR during the immediate succeeding calendar
year, and *** of its worldwide requirements for Cyclosporine bulk product during
the next succeeding calendar year. The obligations of the parties under this
Paragraphs B. shall apply only if, after the one year anniversary of the date of
approval by the FDA of the AADA supplement for PURCHASER'S Cyclosporine
Formulation that contains Product manufactured at the ▇▇▇▇▇▇▇ #1 Capacity
Expansion (which is measured commencing on the one year anniversary after such
date and ending on the second anniversary of such date, and then in each year
thereafter), PURCHASER is purchasing a minimum of *** per year of Product from
SICOR; in the event that PURCHASER fails to purchase a minimum of *** in any
such year, then the obligations of the parties under this Paragraph B shall not
apply in the succeeding year. However, if in such succeeding year, PURCHASER
purchases *** of Product, then the obligations of the parties shall apply in the
next succeeding year (provided, that such year is within the *** and any
extensions of the commitments made with respect thereto).
C. During the ***, PURCHASER may purchase from third parties the greater
of either (a) *** of its worldwide requirements for Cyclosporine bulk product,
or (b) *** Kg in ***, *** Kg in ***, and *** in *** and each of the ***, of
Cyclosporine bulk product.
D. For the avoidance of doubt, after the ***, unless the obligations set
forth in Paragraphs A. and B of this Exhibit 10 have been extended pursuant to
Section 6.3(c) or otherwise, (i) PURCHASER shall have no obligation to purchase
quantities of Cyclosporine bulk product from SICOR and (ii) SICOR's obligation
to supply Product to PURCHASER shall become nonexclusive, the license grant in
Section 2.1.1 shall become nonexclusive license, and Section 2.3(iii) and
Section 2.3(v) of Article 2, Article 5, Section 6.3 of Article 6, the final
sentence of Section 13.1 of Article 13 and Article 14 shall terminate.
E. Audit Rights. Each party agrees to keep complete and accurate records
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so that the other party may confirm compliance with the provisions of this
Amendment. Upon fifteen (15) days prior written notice, each party shall have
the right to have a Big Six (or one of their successors in interest) Deloitte &
Touche accounting firm review the books and records of the other party to
confirm compliance with the provisions of this Amendment, provided that such
accounting firm (i) shall execute and deliver the standard confidentiality
agreement of the party that will be subject of the audit, and (ii) shall only
disclose to the party requesting the audit, the extent (and no other substantive
matters) of any discrepancy between the books and records and the obligations
hereunder.
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SCHEDULE I
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MANUFACTURING (INCLUDING PURIFICATION) SCALE-UP TIMETABLE
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