EXHIBIT 10.53A
FIRST AMENDMENT AND WAIVER
MANUFACTURE AND SUPPLY AGREEMENT
EFFECTIVE FEBRUARY 13, 2006
This first amendment and waiver (the "Amendment and Waiver") to the Manufacture
and Supply Agreement dated December 22, 2003 (the "Original Agreement"), by and
between VIVUS, Inc., having a principal place of business at 1172 Castro Street,
Mountain View, California 94040, United States of America ("VIVUS"), and
NeraPharm spol., s.r.o., having a place of business at Ulice Prace 657, 277 11
Neratovice, Czech Republic ("NeraPharm") (each, a "Party" and collectively, the
"Parties").
WHEREAS, Article 2 of the Original Agreement obligates NeraPharm to supply VIVUS
specific amounts of the Product and VIVUS to purchase from NeraPharm minimum
quantities of the Product;
WHEREAS FURTHER, given the failure by VIVUS to order minimum quantities of the
Product during calendar year 2005 and the current market conditions for VIVUS'
product, the Parties wish to amend the Original Agreement to provide that
(i) VIVUS shall order the minimum quantity of the Product for calendar year 2005
(i.e., [***]) for delivery by NeraPharm on or before April 30, 2006 and (ii) the
minimum quantity of the Product to be ordered by VIVUS in 2006 (i.e., [***])
shall be postponed until 2008, with such order and delivery occurring on or
before December 31, 2008;
WHEREAS FURTHER, NeraPharm desires to waive any and all alleged past breaches of
the Original Agreement by VIVUS (e.g., the minimum quantity purchase
requirements and the forecasting requirements of Article 2 of the Original
Agreement);
NOW, THEREFORE, the Parties agree as follows:
1.
SECTION 2.3 OF THE ORIGINAL AGREEMENT SHALL BE AMENDED AND
RESTATED IN ITS ENTIRETY TO READ AS FOLLOWS:
OBLIGATION TO SUPPLY.
SUBJECT TO THE TERMS OF THIS ARTICLE 2, NERAPHARM SHALL
ACCEPT AND FILL ALL ORDERS PLACED BY VIVUS FOR THE PRODUCT QUANTITIES SET FORTH
IN BINDING SIX (6) MONTH FORECASTS AS PROVIDED FOR HEREIN.
PER SECTION 2.1 OF
THIS AGREEMENT, THE YIELD OF THE MANUFACTURED LOT SIZE THAT NERAPHARM WILL
VALIDATE FOR PRODUCT SUPPLY TO VIVUS UNDER THIS AGREEMENT IS EXPECTED TO BE
[***] TO [***].
FORECASTS PROVIDED BY VIVUS TO NERAPHARM FOR PRODUCT SUPPLY
WILL BE IN WHOLE LOT QUANTITIES WITH A TARGET YIELD OF [***] PER LOT.
BEGINNING
IN 2006, VIVUS SHALL PROVIDE TO NERAPHARM A BINDING SIX (6) MONTH FORECAST AND A
NON-BINDING TWELVE (12) MONTH FORECAST
*** Confidential treatment requested pursuant to a request for confidential
treatment filed with the Securities and Exchange Commission. Omitted portions
have been filed separately with the Commission.
1
STARTING FROM THE END OF THE BINDING SIX (6) MONTH PERIOD.
THE NON-BINDING
TWELVE (12) MONTH FORECAST WILL ASSIST NERAPHARM IN PLANNING AND CAPACITY
ALLOCATION AND THE BINDING SIX (6) MONTH FORECAST WILL SET FORTH QUANTITIES, IF
ANY, THAT VIVUS WILL BE OBLIGATED TO ORDER AND THAT NERAPHARM WILL BE OBLIGATED
TO DELIVER; PROVIDED THAT DUE TO MANUFACTURING BATCH YIELD VARIANCES, NERAPHARM
SHALL SUPPLY QUANTITIES IN AMOUNTS THAT ARE PLUS OR MINUS [***] OF THE VIVUS
ORDERED QUANTITY IN [***]; PROVIDED FURTHER THAT VIVUS MAY