1
EXHIBIT 10.22(b)
ADDENDUM
--------
This Addendum, when signed by both parties, constitutes a valid and enforceable
addition to the agreement between the parties dated January 15, 1993, relating
to the licensing of CDP-Choline (hereinafter referred to as the "Agreement").
FIRST
-----
Following execution of the Agreement, business relations between the parties
have been duly developed for their mutual benefit.
SECOND
------
Notwithstanding the above, as consequence of the INTERNEURON U.S. Patent
applications US Prior. 08/399.262, US Prior. 08/603.102 and US Prior.
08/609.448, and corresponding (WO)PCT 96/27.380 (hereinafter jointly referred to
as the "New Patent"), the parties have upheld different positions interpreting
whether the New Patent should be included under the stipulations of Article 5.3
of the Agreement.
THIRD
-----
The parties have reached the following agreement for the use of the New Patent,
while in force and also as long as pending, in those countries other than the
United States of America, Canada, and Puerto Rico (referred to as the
"Territory" in the Agreement and hereinafter):
a) Pursuant to Article 5.3 of the Agreement, XXXXXX, its associates, its
licensees, and its distributors have an exclusive right to freely use
and dispose of the New Patent in all the countries other than the
Territory.
b) Notwithstanding the above, and as compensation of the aforementioned
exclusive right for the license or distribution agreements granted by
XXXXXX to third parties following execution of this Addendum which
relate to the Compound and/or the Preparation, XXXXXX shall xxxxx to
INTERNEURON the right to receive, separately for each one of the
countries other than the Territory, the following payments, when
applicable:
i) twenty percent (20%) of the royalties that XXXXXX would
receive from the relevant country, or
ii) two percent (2%) of the Compound exports done by XXXXXX to the
relevant country, or
iii) one and a half percent (1.5%) of XXXXXX exports if done as
finished pharmaceutical speciality or in its bulk form to the
relevant country.
2
In the given case that XXXXXX undertakes with respect to any country
outside the Territory more than one of the activities described above
in paragraphs (i), (iii) and (iii), then XXXXXX shall pay INTERNEURON
the relevant corresponding amounts as set forth above as applicable to
payments received by XXXXXX in respect of such activities.
c) XXXXXX shall give notice of any infringement or claim by a third party
related to the New Patent of which XXXXXX has knowledge of in those
countries other than the Territory.
d) Pursuant to Article 4 of the Agreement, it is understood and agreed
that XXXXXX shall communicate and provide to INTERNEURON all
experimental and clinical data relating to the Compound and the
Preparation which XXXXXX and its sublicensees may generate after the
date of execution of this Addendum and which XXXXXX is legally entitled
to disclose.
FOURTH
------
4.1 It is provided that the terms set forth in provision THIRD b) are not
applicable to all those agreements already subscribed up to the date of
execution of this Addendum by and between XXXXXX and third parties but
shall be applicable to (i) all sublicense, distributor or other similar
agreements relating to the Preparation which XXXXXX shall grant after
the date of this Addendum in which the New Patent is included or (ii)
any amendments made after the date of execution of this Addendum to the
pre-existing agreements, improving for XXXXXX the economic terms of
such agreements, resulting from the inclusion in such agreements of the
New Patent; in such case only the new economic terms will be notified
to INTERNEURON, and the terms set forth in provision THIRD b) will be
applied based exclusively on the corresponding and resulting economic
increases. To such effect, XXXXXX shall inform INTERNEURON of the
signature of future agreements with third parties as well as of the
economic terms contained therein that make reference to the terms and
conditions set forth in this Addendum.
4.2 In the given case of XXXXXX granting license over the Preparation
and/or the Compound to Takeda Chemical Industries Ltd. (hereinafter
referred to as "Takeda") and in consideration for the negotiating
efforts produced by INTERNEURON, the compensation set forth in
provision THIRD b) would exceptionally be substituted by fifty percent
(50%) of the royalties that XXXXXX would receive relating to such
license from Takeda, Takeda's licensees or its distributors in each one
of the relevant countries. If in the aforementioned case XXXXXX should
not receive royalties but does receive other payments as provided in
provision THIRD b), then XXXXXX will apply to such payments the terms
set forth in such provision.
4.3 In the event that XXXXXX shall xxxxx license over the Preparation
and/or the Compound to Synthelabo or licensees of Synthelabo (or a
replacing third party, in the given case that an agreement with
Synthelabo should not be achieved), XXXXXX will exceptionally apply the
compensation set forth in Section THIRD b) to such license even in the
case of the New Patent being cancelled, rejected or withdrawn in a
country included in such license. Such
-2-
3
exceptional application of the compensation shall follow the terms set
forth in Section THIRD b) and will have a duration of three (3) years,
commencing such term on the date of cancellation, rejection or
withdrawal of the New Patent in the corresponding country.
FIFTH
-----
The terms and conditions set forth in this Addendum in respect of the New Patent
are exceptional, so, therefore, the terms and conditions set forth in this
Addendum in respect of the New Patent shall not be understood as a binding
precedent between the parties, so all other terms and conditions of the
Agreement are hereby retained in full force and effect, and are confirmed as of
the date hereof.
In witness whereof, the parties, through their authorized representatives, have
executed this Addendum, whereby they evidence their intent to be legally bound.
Barcelona and Lexington, _________________________.
XXXXXX INTERNACIONAL S.A. INTERNEURON PHARMACEUTICALS, INC.
/s/ Xxxxxx Xxxxxx By: /s/ Xxxx X. Xxxxxx
-------------------------- --------------------------
By: Xxxxxx Xxxxxx Xxxx X. Xxxxxx
Title: Chief Executive Officer Title: Executive Vice President
26-05-98 6/1/98
-3-
4
SECOND AMENDMENT
----------------
This Second Amendment, when signed by both of us, constitutes a valid and
enforceable amendment to the agreement between us dated January 15, 1993,
relating to the licensing of CDP Choline ("the Agreement").
The Agreement is hereby amended as follows:
FIRST
-----
(i) Section 8.2.a. is hereby amended and restated in its entirety to read
as follows:
"a. if INTERNEURON fails to obtain a Registration of the Preparation in
the Territory by January 31, 2002 and/or".
(ii) The last paragraph of Article 8 is hereby amended and restated in its
entirety to read as follows:
"The above-mentioned period (by January 31, 2002) shall be
automatically extended by successive six (6) month periods up to a
maximum two (2) year extension if INTERNEURON provides information to
XXXXXX which tends to establish that INTERNEURON has carried out the
steps for obtaining the Registration of the Preparation and that the
latter has not been obtained for reasons beyond the control of
INTERNEURON."
SECOND
------
All other terms and conditions of the Agreement are hereby retained in full
force and effect, and are confirmed as of the date hereof.
In witness whereof, the parties, through their authorized representatives, have
executed this Amendment, whereby they evidence their intent to be legally bound.
Barcelona and Lexington, _________________________.
XXXXXX INTERNACIONAL S.A. INTERNEURON PHARMACEUTICALS, INC.
/s/ Xxxxxx Xxxxxx By: /s/ Xxxx X. Xxxxxx
-------------------------- --------------------------
By: Xxxxxx Xxxxxx Xxxx X. Xxxxxx
Title: Chief Executive Officer Title: Executive Vice President
26-05-98 6/1/98