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EXHIBIT 10.27A
AMENDED AND RESTATED ADDENDUM 1097
This Amended and Restated Addendum (hereinafter "Addendum 1097R")
effective as of the 29th day of October 1997, between VIVUS International
Limited, a company organized under the laws of Bermuda and having a place of
business at Xxxxxxxxx Xxxxx, Xxxxxx Xxxxxx, Xxxxxxxx, Xxxxxxx ("VIVUS"), a
wholly-owned subsidiary of VIVUS, Inc., a Delaware corporation ("VIVUS, Inc."),
and Xxxxxxx Pharmaceutica International, a division of Cilag AG International,
and having its registered office at Xxxxxxxxxxxxx 00, XX-0000, Xxx., Xxxxxxxxxxx
("Xxxxxxx").
RECITALS
WHEREAS VIVUS and Xxxxxxx along with certain of their Affiliates have entered
into a Distribution Agreement dated January 22, 1997 ("Agreement 197").
WHEREAS VIVUS and Xxxxxxx entered into an addendum to Agreement 197 dated
October 29, 1997, pursuant to which the parties expanded the Territory for which
Xxxxxxx is responsible under Agreement 197 ("Addendum 1097").
WHEREAS VIVUS and Xxxxxxx wish to supersede and replace Addendum 1097 in its
entirety with this Addendum 1097R.
NOW, THEREFORE, VIVUS and Xxxxxxx agree to modify or supplement obligations
under Agreement 197 as follows:
1. This Addendum 1097R hereby amends and revises Agreement 197 to incorporate
the terms and conditions set forth in this Addendum 1097R. In addition, this
Addendum 1097R hereby supersedes and replaces Addendum 1097. The relationship of
the parties shall continue to be governed by the terms and conditions of the
Agreement 197, as amended and revised herein; and in the event that there is any
conflict between the terms and conditions of the Agreement 197 and this Addendum
1097R, the terms and conditions of this Addendum 1097R shall control. As used in
this Addendum 1097R all capitalized terms shall have the meanings defined for
such terms in this Addendum 1097R or, if not defined in the Addendum 1097R, the
meanings defined in the Agreement 197.
2. "Territory" as defined in Section 1.15 shall be expanded to include the
countries listed in Exhibit 1097A ("Expansion Territory") along with the Xxxxxxx
Subdistributors presently responsible for each country.
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3. Addendum 1097 Initial and Milestone Payments. Without modification of the
rights and obligations of Agreement 197, in consideration of the costs incurred
by VIVUS in connection with the research and development of the Product and in
exchange for the exclusive rights granted herein, Xxxxxxx shall pay VIVUS the
following non-refundable one time fees:
(a) [*] of the end of the first year in which [*] of Product in the Expansion
Territories [*];
(b) [*] of the end of the first year in which [*] of Product in the Expansion
Territories [*];
(c) [*] of the end of the first year in which [*] of Product in the Expansion
Territories [*];
and
(d) [*] of the end of the first year in which [*] of Product in the Expansion
Territories [*]. For avoidance of doubt, the milestone payments for (a) through
(d) above are cumulative. For example, if in the first year of sales of Product
[*] in the Expansion Territory were in [*] then Xxxxxxx would owe VIVUS [*] ([*]
for [*] in [*] for [*] in [*] and [*] for [*] in [*]).
As additional consideration for the exclusive rights granted herein, Xxxxxxx
paid to VIVUS $2 million on or about November 7, 1997, the receipt of which is
hereby acknowledged by VIVUS.
4. For the "fraction" calculated in Section 4.1.2, the calculation of the
numerator and the denominator will include only the countries of [*].
5. Add a Section 4.3:
4.3 Expansion Territory Diligence and Marketing.
4.3.1 Diligence. Xxxxxxx will meet all obligations of Agreement 197 for
countries of the Expansion Territory as if they were countries of the
Territory as defined in Section 1.15. Regardless of the foregoing,
Xxxxxxx shall be presumed to meet (i) its required [*] to register First
Product of Section 3.3 and (ii) its required [*] to launch and sell
First Product of Section 4.1.1 and (iii) its requirement to "launch" the
First Product [*] of MAA approval of Section 4.1.2 for the countries of
the Expansion Territory listed as follows:
(a) [*];
(b) [*];
(c) [*];
(d) [*];
[*] In each case of (a) through (d) for so long as Xxxxxxx is using
[*] 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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4.3.2 Expansion Territory Reversion. In the event that one of the
following countries cease to be a part of the Territory or of the
Expansion Territory then the countries named below in association
therewith may at VIVUS' option on a country by country basis also cease
to be a part of the Territory or of the Expansion Territory if Xxxxxxx
and/or its Affiliates or Sublicensees are not marketing in such
associated country or countries:
(a) [*];
(b) [*];
(c) [*];
(d) [*];
(e) [*].
4.3.3 Marketing. For the Expansion Territory, [*], Xxxxxxx may meet its
obligation to "prepare reasonably detailed marketing plans" of Section
3.4.1 by consolidating the individual country plans into [*] regional
plans.
6. In accordance with the terms of Section 4.2, VIVUS will provide one-time
training in English at two additional locations.
7. In Section 6.2.1(b), for "All other countries together" the value of [*] will
be amended to [*] and [*] will be amended to [*].
8. In accordance with the terms of Section 9.3, VIVUS agrees to file, register,
and maintain a registration for the VIVUS Trademark in the countries of the
Expansion Territory listed as follows: [*].
9. The Parties agree to adhere strictly to applicable laws of the United States
in the conduct of international commercial transactions. Notwithstanding
anything herein to the contrary, where the United States maintains an embargo
against a country of the Territory, Xxxxxxx shall be presumed to meet (i) its
required [*] to register First Product of Section 3.3 and (ii) its required [*]
to launch and sell First Product of Section 4.1.1 and (iii) its requirement to
"launch" the First Product [*] of MAA approval of Section 4.1.2 for the term of
such embargo.
10. Sales of Product in the countries [*] will not operate to begin the running
of the two year period referred to in Section 6.2.1(c)(i).
11. The Agreement 197, Addendum 497 and this Addendum 1097R and the Exhibits
[*] 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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hereto and thereto constitute the entire agreement between the parties in
connection with the subject matter thereof and supersede all prior and
contemporaneous agreements, understandings, negotiations and discussions,
whether oral or written, of the parties, including without limitation Addendum
1097.
IN WITNESS WHEREOF, the parties hereto have caused this Addendum 1097R to be
executed by their duly authorized representatives on the dates indicated below.
VIVUS XXXXXXX
BY: /s/ Xxxxxx X. Xxxxxx BY: /s/ Xxxxx Xxxxxx
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Xxxxx Xxxxxx
General Manager
DATE: Jan. 7, 1998 DATE: Jan. 16, 1998
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EXHIBIT 1097A
EXPANSION TERRITORY
COUNTRIES OF RESPONSIBILITY AND
XXXXXXX AFFILIATES AND SUBDISTRIBUTORS
Countries of the Former Soviet Union and Related Area
-----------------------------------------------------
Armenia Lambron Pharmimpex Co., Ltd.
22 K. Parpetsi Street
Yerevan, 375002
Republic of Armenia
(currently representing XxXxxx Tylenol)
Azerbaijan agency agreements currently being negotiated
Belarus Belpharm
Masherov Ave. 23
220004 Minsk
Belarus
Georgia Beta-2 Ltd.
00, Xxxxx Xxxxxxxx Xxx.
Xxxxxxx, Xxxxxxx
Kazachstan Interfarma K
Park of Republic
Spartak Stadium, Build. 1
480100 Almaty
Kazachstan
Krygyzstan currently no representation
Mongolia currently no representation
Russia Xxxxxxx-Cilag
A division of Xxxxxxx & Xxxxxxx Ltd.
00, Xxxxxxxx Xxxxxxxx
Xxxxxx 000000
Xxxxxx
Tajikistan currently no representation
Turkmenistan agency agreements currently being negotiated
Ukraine X. X. Xxx XX
Xxxxxxxxxxx Xxx. 0
-0-
0
000000 Xxxx
Xxxxxxx
Uzbekistan Berlin Chemie (Xxxxxxx-Cilag)
Xxxxxxxxxxxxx xx. 00
Xxxxxxxx 000000
Xxxxxxxxxx
Countries of the Mideast and Related Area
-----------------------------------------
Afghanistan currently no representation
Bahrain Wael Pharmacy & Drug Store
P. O. Box 648 Manama
Arabian Gulf
Egypt Sofico Pharm
00 Xxxxxx Xx Xxxxxx Xxxxxx
Xxxx Xxxx, Xxxxx
Iran Jahan Behbood Co.
Farbro Xxxx. Xx. 00
Xxxxxxx Xxx. Xxxx Xxx., Xxxxxxxx Xxxx.
Teheran
Iraq currently no representation
Xxxxxx Xxxx Drug Stores & Co.
P. O. Xxx 0000, Xxxxxx Xxx,
00000 Xxxxx
Xxxxxx Al Mojil Drug Co.
P. O. Box 2761 - Al-Kwful Bldg. Xx. 00
Xxxx 00, Xxxxxx Xxx.
Xxxxx 00000
Lebanon Mersaco X.X.X.
Xxxx Xxxx Street
P. O. Box 11-9073
Beirut
Libya A. M. Mangion Ltd.
U.B. 42 Industrial Estate, San Gwann
Malta
Oman Waleed Pharmacy
P. O. Xxx 000 Xxxxxx 000
Sultanate of Xxxx
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Xxxxx XXX Xxxx Medical Est.
X.X. Xxx 000, Xxx Xxxxxx Xx Xxxxx
Xxxx
Xxxxx Xxxxxx Al Haya Medical Company
X. X. Xxx 000
Xxxxxx Xxx Xxxxx Xxx., Xxx Xx Xxx'xxxxx
Riyadh 11411
Sudan Dr. Xxxxx Pharmaceutical Ent.
P.O. Box 2989
Khartoum West
Syria Damascus Scientific Office
Ain el Kurch, Jadet Zarka, Xxxxxx Xxxxxx Bldg.
No. 10, 0xx Xxxxx
X.X. Xxx 0000 Xxxxxxxx
Xxxxxx Xxxx Xxxxxxxx City Pharmacy
X.X. Xxx 00000
Xxxxx
U.A.R.
Yemen Arra'Afah Corporation
Ali Abdulmughni Street
P. O. Box 1090 Sana'a
Countries of the Indian Sub-Continent and Related Area
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Bangladesh Fisons Ltd.
Fisons House
0/0/X Xxxxx Xxxxxxx
XXX Xxx 000
Xxxxxx - 0000
Xxxxx J&J/Xxxxxxx Cilag
00 Xxxxxxx Xxxxxx
X.X. Xxx 0000 Xxxxxx
Bombay 400 036
Pakistan J&J/Xxxxxxx Cilag
Plots 10 + 25, Sektor 20
Korangi, Industrial Area
Xxxxxxx 00000
Xxx Xxxxx Pettah Pharmacy Ltd.
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8-4/2 Leyden Xxxxxxx Road
York Aecade Building
Colombo 1
Countries of Africa
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Burundi Dispopharm XX
Xxxxxxx Xxxxxxx 000
X.X. Xxx 00
XX-0000 Xxxxxxxxx
Ethiopia 640-123Pharma (Share Company)
P. O. Box 1122, Addis Abada
Xxxxxxxx Xxxxxx Road, Addia Ababax
Ghana Abba Promotions, West Africa
P. O. Xxx 0000 Xxxxxxxx Xxxxx
0xx Xxxxx, Sedco Publishing House
Xxxxx Street, North Ridge, Accra
Kenya Twiga Chemical Industries Limited
P. O. Box 30172 Nairobi
16th Floor, View Park tower
Uhuru Highway, Nairobi
Malawi Pharma Chemie Ltd.
P. O. Box 392 Blantyre
Kidney Crescent, off Kamazu, Blantyre
Pharma Vet
P. O. Box 2957, Blantyre, Malawi
Namibia Geka Pharma Pty. Ltd.
Xxx 000, Xxxxxxxx, Xxxxxxx
00 Xxxxxxx Xxxxxxxxx Xxx.
Xxxxxxxx
Rwanda Dispopharm XX
Xxxxxxx Strasse 364
P. O. Xxx 00
XX-0000 Xxxxxxxxx
Xxxxxxxx Diocare Limited
P. O. Box 70257, Dar Es Salaam
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Xxxxxxx Xxxx Chemicals Limited
P. O. Box 2999 Dar Es Salaam
JPS Building, Pugu Road, Dar Es Salaam
Medipharm Limited
P. O. Box 77032 Dar Es Xxxxxx
Xxxxxx Avenue, Dar Es Salaam
Twiga Chemical Industries (Tanzania) Ltd.
P. O. Box 20786, Dar Es Salaam
Saza Rd., Xxxxx'ombe
Dar Es Salaam
Uganda Twiga Chemical Industries (Uganda) Ltd.
P. O. Box 4800, Kampala
Xxxx Xx. 00, 0xx Xxxxxx, Xxxxxxxxxx Xxxx
Xxxxxxx
Zaire Dispopharm XX
Xxxxxxx Strasse 364
P. O. Xxx 00
XX-0000 Xxxxxxxxx
Xxxxxx Gamma Pharmaceuticals Ltd.
P O. Xxx 00000 Xxxxx
Xxxxxx Road, Ndola
Zimbabwe Xxxxxxx & Xxxxxxx (Pvt.) Limited
P. X. Xxx 0000, Xxxxxx
000 Xxxxxxxxx Xxxxxx
Masasa, Harare
Other
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North Korea currently no representation
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EXHIBIT 1097A
COUNTRY RESPONSIBLE COUNTRY
Algeria Xxxxxxx-Cilag France
Benin Xxxxxxx-Cilag France
Burkina Faso Xxxxxxx-Cilag France
Cameroon Xxxxxxx-Cilag France
Central African Republic Xxxxxxx-Cilag France
Xxxx Xxxxxxx-Cilag France
Comoros Xxxxxxx-Cilag France
Congo Xxxxxxx-Cilag France
Cote d'Ivoire Xxxxxxx-Cilag France
Djibouti Xxxxxxx-Cilag France
Gabon Xxxxxxx-Cilag France
Guinea Xxxxxxx-Cilag France
Ivory Coast Xxxxxxx-Cilag France
Madagascar Xxxxxxx-Cilag France
Xxxx Xxxxxxx-Cilag France
Mauritania Xxxxxxx-Cilag France
Morocco Xxxxxxx-Cilag France
Niger Xxxxxxx-Cilag France
Senegal Xxxxxxx-Cilag France
Togo Xxxxxxx-Cilag France
Tunisia Xxxxxxx-Cilag France
Angola Xxxxxxx-Cilag South Africa
Bophuthatswana Xxxxxxx-Cilag South Africa
Botswana Xxxxxxx-Cilag South Africa
Ethiopia Xxxxxxx-Cilag South Africa
Xxxxx Xxxxxxx-Cilag South Africa
Lesotho Xxxxxxx-Cilag South Africa
Malawi Xxxxxxx-Cilag South Africa
Mozambique Xxxxxxx-Cilag South Africa
Namibia Xxxxxxx-Cilag South Africa
Swaziland Xxxxxxx-Cilag South Africa
Tanzania Xxxxxxx-Cilag South Africa
Tanskei Xxxxxxx-Cilag South Africa
Uganda Xxxxxxx-Cilag South Africa
Zambia Xxxxxxx-Cilag South Africa
Zimbabwe Xxxxxxx-Cilag South Africa
Zansibar Xxxxxxx-Cilag South Africa
Burundi Xxxxxxx-Cilag Zug
Egypt Xxxxxxx-Cilag Zug
Eritrea Xxxxxxx-Cilag Zug
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Gambia Xxxxxxx-Cilag Zug
Ghana Xxxxxxx-Cilag Zug
Liberia Xxxxxxx-Cilag Zug
Libya Xxxxxxx-Cilag Zug
Nigeria Xxxxxxx-Cilag Zug
North Korea Xxxxxxx-Cilag Zug
Rwanda and Burundi Xxxxxxx-Cilag Zug
Seychelles Xxxxxxx-Cilag Zug
Sierra Xxxxx Xxxxxxx-Cilag Zug
Somalia Xxxxxxx-Cilag Zug
Sudan Xxxxxxx-Cilag Zug
Zaire Xxxxxxx-Cilag Zug
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