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EXHIBIT 10.31A
AMENDMENT TO MANUFACTURE AND SUPPLY AGREEMENT
This Amendment ("Amendment"), effective as of December 12, 1998
("Amendment Date") by and between VIVUS, Inc., having a principal place of
business at 000 Xxxx Xxxxxxxxx Xxxxx, Xxxxxxxx Xxxx, XX 00000, Xxxxxx Xxxxxx
of America ("VIVUS"), and Spolana Chemical Works, A.S., having a place of
business at 27711 Neratovice, Czech Republic ("Spolana") including all Exhibits
and addenda thereto (VIVUS and Spolana collectively, the "Parties"), amends
that certain Manufacturing and Supply Agreement by and between the Parties as
of May 1997, including all Exhibits and addenda thereto (the "Agreement") as of
the Amendment Date.
The Parties desire to amend the Agreement as set forth herein below:
NOW, THEREFORE, the Parties agree as follows:
1. AMENDMENT. This Amendment hereby amends the Agreement to incorporate the
terms and conditions set forth in this Amendment. The relationship of the
Parties shall continue to be governed by the terms and conditions of the
Agreement, as amended herein; and in the event that there is any conflict
between the terms and conditions of the Agreement and this Amendment, the terms
and conditions of this Amendment shall control. As used in this Amendment, all
capitalized terms shall have the meanings defined for such terms in this
Amendment or, if not defined in the Amendment, the meanings defined in the
Agreement.
2. MODIFICATION TO THE AGREEMENT.
2.1 VIVUS agrees to pay to Spolana the remaining balance of invoices
outstanding as of the Amendment Date, which total [*], within fifteen (15)
business days after the Amendment Date.
2.2 Sections 2.2, 2.3.1 and 2.3.3 of the Agreement are hereby deleted in
their entirety.
2.3 The Parties agree that VIVUS shall not be required to purchase from
Spolana any amount of the Product in the remainder of calendar year 1998 or in
calendar year 1999 and VIVUS shall have only the following commitment to
purchase the Product from Spolana:
a) VIVUS shall purchase from Spolana [*]
*Certain information on this page has been omitted and filed separately with
the Commission. Confidential treatment has been requested with respect to
omitted portions.
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(b) VIVUS agrees to place any new orders of the Product with
its existing suppliers on a pro rata basis (based on historical quantities
purchased from such suppliers) until the Existing Inventory is fully delivered.
2.4 The Parties agree that, other than as provided in Section 2.3 of
this Amendment, during the period from the Amendment Date until the termination
of the Agreement, VIVUS shall not be required to purchase from Spolana any
minimum amount of the Product.
2.5 The Agreement is hereby amended to add the following new Section
3.7:
"3.7 Change Notification. Spolana shall notify VIVUS through written
correspondence to Vice President, Regulatory Affairs, Mountain View, California,
copied to Director, Corporate QA, Lakewood, New Jersey, of any proposed changes
in the chemistry, manufacturing or controls for pharmaceutical grade Alprostadil
(Prostaglandin E(1))(for purposes of this Section 3.7, a "Proposed Change").
VIVUS shall provide written acknowledgement of the receipt of such
correspondence within ten (10) business days. The Parties understand that such
acknowledgement of receipt does not necessarily represent VIVUS' agreement with
or acceptance of the proposed change. Within thirty (30) working days following
such acknowledgement of receipt, VIVUS will inform Spolana that (i) VIVUS
accepts such Proposed Change, (ii) VIVUS does not accept such Proposed Change,
or (iii) VIVUS requires further clarification, information or action by Spolana
before it can assess such Proposed Change (for purposes of this Section 3.7,
such communication a "Change Assessment"). The Parties understand and agree that
in the event that Spolana does not receive from VIVUS a Change Assessment with
respect to a particular Proposed Change, Spolana may assume VIVUS accepts such
Proposed Change."
2.5 Section 6.1 of the Agreement is hereby amended to read in its
entirety as follows:
"6.1 Term. The term of this Agreement shall commence on the
Effective Date and shall continue in full force until the second anniversary of
the Amendment Date, unless this Agreement is terminated earlier in accordance
with this Article 6."
2.6 Section 6.2 of the Agreement is hereby amended to read in its
entirety as follows:
"6.2 Termination for Convenience. Spolana may terminate this
Agreement upon thirty (30) days prior written notice to VIVUS; provided,
however, that VIVUS shall not be required to purchase any amount of the Product
from Spolana that VIVUS has not ordered prior to such termination."
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3. ENTIRE AGREEMENT. The Agreement and any Exhibits and addenda thereto
together with this Amendment constitute the entire agreement between the Parties
with respect to the subject matter thereof and supersede all prior and
contemporaneous communications, representations, agreements or understandings,
either written or oral, between the Parties.
IN WITNESS WHEREOF, the Parties have executed this Amendment.
VIVUS, INC. SPOLANA CHEMICAL WORKS, A.S.
By: /s/ XXXXXX X. XXXXXX By: /s/ JIRI ZERZANI
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Name: Xxxxxx X. Xxxxxx Name: Jiri Zerzani
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Title: President and CEO Title: Commercial Director
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