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EXHIBIT 10.22A
AMENDMENT ONE
TO THE MANUFACTURING AGREEMENT
BY AND BETWEEN VIVUS AND CHINOIN
This AMENDMENT ONE to the Manufacturing Agreement by and between VIVUS,
Inc., having a principal place of business at 545 Middlefield Road, Suite 200,
Menlo Park, CA 94025, United States of America ("VIVUS"), and CHINOIN
PHARMACEUTICAL AND CHEMICAL WORKS CO., LTD., having a principal place of
business at H-1045 Budapest, To u. 1-5 Hungary ("Chinoin") is entered into as of
December 11, 1997. Terms that are capitalized in this Amendment and not defined
herein shall have the meanings ascribed to them in the Agreement (as defined
below).
WHEREAS, VIVUS and Chinoin have entered into that certain Manufacturing
Agreement dated December 12, 1995 (the "Agreement");
WHEREAS, the parties desire to amend the Agreement to modify, among
other things, terms related to price and quantity;
NOW, THEREFORE, in consideration of the mutual covenants and promises
herein contained, the parties hereto agree to amend the Agreement as follows:
1. The parties hereby acknowledge and agree that the Agreement was
between Chinoin and VIVUS, Inc., a California corporation, which has
been merged into its wholly subsidiary, VIVUS, Inc., a Delaware
corporation. The parties hereby agree that VIVUS, Inc., a Delaware
corporation, assumes all rights and benefits of VIVUS, Inc., a
California corporation, under the Agreement. The parties further
agree that for purposes of the Agreement and this Amendment, "VIVUS"
shall mean VIVUS, Inc., a Delaware corporation.
2. The parties hereby agree that the First Agreement Year as defined in
the Agreement is 1997.
3. Section 2.6 of the Agreement is hereby amended in its entirety to
read as follows:
2.6 Maximum Quantities. Chinoin shall not be obligated to supply
to VIVUS more than [*] of the Product in any Agreement Year,
provided that Chinoin agrees to use all reasonable efforts
to supply any quantities in excess of such amounts as VIVUS
may order at a price agreed between the parties pursuant to
Section 2.7.
[*] Certain information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
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4. Section 2.7 of the Agreement is hereby amended in its entirety to
read as follows:
2.7 Price. The price to be paid by VIVUS per gram of the Product
ordered by VIVUS shall be based upon the quantities of the
Product ordered by VIVUS for delivery during the particular
Agreement Year, as follows:
Quantity Ordered for Delivery
During the Agreement Year U.S. $/gram
[*] [*]
[*] [*]
[*] [*]
The price of any quantity in excess of [*] grams in each Agreement
Year, if any, shall be agreed upon by the parties. It is understood
that the foregoing prices are based upon the total cumulative
quantities ordered by VIVUS for delivery during the particular
Agreement Year, and not only on the size of the particular order. It
is also understood that the prices are for the incremental quantities
(i.e. the first [*] will be at [*], the next quantities will be at
[*] and so on). These prices shall be effective beginning calendar
year 1998.
5. Section 2.9 of the Agreement is hereby amended in its entirety to
read as follows:
2.9 Terms. All prices set forth in section 2.7 shall be
Delivered Duty Unpaid (DDU) to a U.S. airport (in the case
of shipment by airfreight) or to any U.S. address ( in the
case of shipment by courier service). The manner of shipment
shall be designated by Chinoin and the U.S. airport or
address shall be designated by VIVUS. The title and risk of
loss will transfer to VIVUS at such a delivery point.
Payments shall be made in U.S. dollars by settling each of
Chinoin's invoices in two equal installments, the first of
which shall be made thirty (30) days from the date of the
invoice accompanying the shipment and the second of which
shall be made sixty (60) days from the date of the invoice
accompanying the shipment. Payment shall be made by direct
bank transfer to an account designated by Chinoin.
6. Section 2.11 of the Agreement is hereby amended in its entirety to
read as follows:
2.11 Packaging. [*]
[*] Certain information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
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7. Section 2.12.1 of the Agreement is hereby amended in its entirety to
read as follows:
2.12.1 Minimum Quantities. VIVUS agrees to purchase the [*]
during the [*] Areement Years, provided, however, that
VIVUS is experiencing ordinary business conditions. In the
case of an unexpected decrease of its consumption of
Product, VIVUS may notify Chinoin that it will be unable
to meet the Initial Annual quantity obligation, and it may
purchase a lower quantity of the Product in the Agreement
Year concerned, provided, however, that in no event shall
the minimum quantity purchased by VIVUS in such Agreement
Year fall below [*].
8. Sections 2.12.2 and 2.12.3 of the Agreement are hereby deleted in
their entirety.
9. Section 2.12.4 of the Agreement is hereby amended in its entirety to
read as follows:
2.12.4 Effect of the Minimum Quantities. The minimum quantities
indicated in 2.12.1 above shall have no effect on the
obligations of the parties with respect to quantities
already ordered for supply or included in the [*]
stipulated in Section 2.3.
10. Schedule A of the Agreement is hereby amended in its entirety and is
replaced with Amended Schedule A attached hereto.
11. All other terms of the Agreement shall remain in full force and
effect. In the event there is an inconsistency between this
Amendment and the Agreement, this Amendment shall prevail.
[*] Certain information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
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IN WITNESS WHEREOF, the parties hereto have caused their duly authorized
representatives to execute this Amendment.
VIVUS, INC. CHINOIN PHARMACEUTICAL
AND CHEMICAL WORKS, CO. LTD.
By: /s/ Leland F. Wilson By: /s/ Philpee Besse
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Name: Leland F. Wilson Name: Philippe Besse
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Title: Presidend and CEO Title: Executive Vice Presidnent
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A
Manufacturing Agreement between VIVUS and CHINOIN
CHINOIN QUALITY Code:
Quality Control - Prostaglandins SPECIFICATION A-PGU/SZME/0648/01/97
PGE(1)
Prepared on: 20-Oct-97 ID#:
Effective from: 01-Dec-97 Page: 1/12
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ALPROSTADIL
(PGE1)
QUALITY REQUIREMENTS
[*] [*]
[*] [*]
[*] [*]
[*] [*]
[*] [*]
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Translated by: Pal Vofely
[*] Certain information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
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Controlled by: Ervin Vajda /s/ Ervin Vajda
PG Chemical Development
Approved by: /s/ Dr. Zoltan Szeverenyi
PG Quality Control manager
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A
Manufacturing Agreement between VIVUS and CHINOIN
CHINOIN QUALITY Code:
Quality Control - Prostaglandins SPECIFICATION A-PGU/SZME/0648/01/97
PGE(1)
Prepared on: 20-Oct-97 ID#:
Effective from: 01-Dec-97 Page: 1/12
- --------------------------------------------------------------------------------
[*]
- --------------------------------------------------------------------------------
Translated by: Pal Vofely
Controlled by: Ervin Vajda /s/ Ervin Vajda
PG Chemical Development
Approved by: /s/ Dr. Zoltan Szeverenyi
PG Quality Control manager
[*] Certain information on this page has been omitted and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.
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