Exhibit 10.35
CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN
SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
Amendment No. 1
to the
License Agreement
dated 13th of June 2000 (the "Agreement")
by and between
Antares Pharma IPL AG, Zug, Switzerland as Licensor
(formerly known as Permatec Technologie AG)
and
BioSante Pharmaceuticals, Inc., Lincolnshire, IL, U.S.A. as Licensee
--------------------------------------------------------------------------------
Recitals:
WHEREAS, Permatec Technologie AG has changed its corporate name into Antares
Pharma IPL AG ("ANTARES"); and
WHEREAS, "ANTARES" has secured a third party being interested in a license
package which package would - inter alia - include the rights to certain
Products (all capitalized terms used herein but not defined shall have such
meaning as ascribed to such terms in the Agreement) in specified countries of
the Territory as licensed to BioSante Pharmaceuticals, Inc. ("BIOSANTE") under
the Agreement; and
WHEREAS, BIOSANTE is prepared to return such rights to certain Products in
specified countries included in the license under the Agreement for the
consideration described and under the terms and conditions set forth herein
below.
NOW THEREFORE, the Parties hereby agree pursuant to this Amendment No. 1 to the
License Agreement dated 13th of June 2000 (the "Agreement") ("Amendment No. 1")
to amend the Agreement as follows:
1. Change of Corporate Name
------------------------
Following the change of corporate name from Permatec Technologie AG into
Antares Pharma IPL AG effective as of 15th February 2001, the Agreement is
hereby amended as follows for clarification and to make the Agreement
consistent with this Amendment No. 1:
(a) all references in the Agreement to Permatec Technologie AG shall be
substituted by Antares Pharma IPL AG; and
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(b) all references in the Agreement to PERMATEC shall be substituted by
ANTARES.
2. Return of Rights
----------------
2.1 BIOSANTE hereby returns its rights granted under the Agreement as part of
the license (including without limitation rights to Develop, apply and
receive Approval as applicant, Market, use and sell) to ANTARES with
respect to:
(a) all rights to the Product Patch E2 (where estradiol is the sole active
ingredient and where the patch is applied to the skin) for all
counties of the Territory; and
(b) the rights to the Product Gel E2 (where estradiol is the sole active
ingredient and where the gel is applied to the skin), for the
countries Australia and Malaysia; and
(c) the rights to the Product Gel Testosterone (where testosterone is the
sole active ingredient and where the gel is applied to the skin), for
the counties Australia and Malaysia.
All such rights returned to ANTARES as described in this Section 2.1 shall
be collectively referred to hereinafter as the "Returned Rights".
2.2 In order to give effect to the waiver and return of the Returned Rights,
the parties agree to amend the Agreement as follows:
(a) the Product Patch E2 (where estradiol is the sole active ingredient
and where the patch is applied to the skin) is deleted from the list
of Products attached to the Agreement as Exhibit B, and all references
to Patch E2 in the Agreement are deleted and eliminated without
substitution; and
(b) the definition of the term "Territory" in Section 1.14 of the
Agreement is deleted in its entirety and substituted by the following
definition:
1.14 "Territory" shall mean the United States of America and those of
its territories and possessions over which the FDA has regulatory
authority (the "USA"); Canada; Australia; New Zealand; South Africa;
Israel; Mexico; The People's Republic of China (including Hong Kong)
("China"); Malaysia; and Indonesia, except for the Products Gel E2 and
Gel Testosterone, for which Products the term "Territory" shall mean
the United States of America and those of its territories and
possessions over which the FDA has regulatory authority (the "USA");
Canada; New Zealand, South Africa; Israel; Mexico, The Peoples
Republic of China (including Hong Kong) ("China"); and Indonesia. The
countries are classified according to Exhibit C in three tiers.
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3. Data Sharing
------------
3.1 In order to secure the mutual exchange and sharing of data relating to the
Products in the Territory (as amended hereby) by BIOSANTE and its
Sublicensees, and outside the Territory (as amended hereby) by ANTARES
and/or its third party licensees, the parties hereby agree that Section 5.2
of the Agreement shall in particular also include the use of any data and
results generated in the Territory by BIOSANTE or any of is a sublicensees
(if any) for use by ANTARES or any licensee with respect to the Returned
Rights outside the Territory, and any data and results generated by ANTARES
or any licensee with respect to the Returned Rights for use by BIOSANTE or
its sub-licensees in the Territory.
3.2 ANTARES undertakes to include a respective obligation giving effect to such
data sharing also with respect to the Returned Rights in any eventual
license agreement with a third party on the Returned Rights (or any part
thereof).
4. Changes in Payment Obligations
------------------------------
4.1 As consideration for the Returned Rights by BIOSANTE, the parties agree to
eliminate certain payment obligation of BIOSANTE under the Agreement as
specified herein below:
(a) the payment obligation of BIOSANTE under Section 3.3.1 of the
Agreement in the amount of USD 125,000 upon start of manufacturing of
the first batch of GMP-compliant finished Product for use in a
clinical trial of the first Product to be subjected to such clinical
trial (which is either the Product GEL E2 or GEL Testosterone) shall
be eliminated from the Agreement; and
(b) the payment obligation of BIOSANTE under Section 3.3.2 of the
Agreement in the amount of USD 125,000 upon start of manufacturing of
the first batch of GMP-compliant finished Product for use in a
clinical trial of the second Product to be subjected to such clinical
trial (which is either the Product GEL E2 or GEL Testosterone) shall
be eliminated from the Agreement; and
(c) the milestone payment obligation of BIOSANTE under Section 10.3.3.1 of
the Agreement in the amount of USD ***** E2/T Combi-Gel shall be
eliminated from the Agreement.
4.2 As further consideration for the Returned Rights by BIOSANTE, ANTARES
agrees that its obligation under Section 4.1.3 of the Agreement is not
diminished by this Amendment No. 1, such that ANTARES remains obligated to
expend funds for the formulation and production of the Products remaining
under the Agreement, up to a potential maximum of Six Hundred Thousand
Dollars ($600,000), and such that the funds it was to have expended on the
Product Patch E2, up to One Hundred Fifty Thousand Dollars ($150,000), will
be allocated as additional formulation and production expenditures for
Product Gel E2 and Product Gel Testosterone.
4.3 The parties hereby confirm that the consideration described above is
sufficient and adequate for the Returned Rights.
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***** - Denotes portions omitted pursuant to a request for confidentiality under
Rule 24b-2 of the Securities Exchange Act of 1934. A copy of this agreement with
the omitted information intact has been filed separately with the Securities and
Exchange Commission.
5. No Further Changes
------------------
5.1 The parties hereby agree and acknowledge that the Agreement shall, except
for and in due incorporation of the changes agreed upon in this Amendment
No. 1, remain in full force and effect and, subject to Section 5.2 below,
not be otherwise changed, altered or amended.
5.2 The parties further agree that in the event that any further amendment,
change or alteration of the language or wording of any Section of the
Agreement would be required to give full effect to any of the changes
agreed upon in this Amendment, then such further amendment, change or
alteration of the language or wording shall be made upon reasonable request
of either party.
5.3 This Amendment is agreed to be subject to the provisions of the Agreement
of 11.1 (Governing Law) and 11.2 (Dispute Resolution) by reference.
IN WITNESSETH WHEREOF, the parties hereto have caused this instrument to be
executed by their duly authorized officers with effect as of the 20th day of
May, 2001.
Antares Pharma IPL AG
/s/ Xxxxx Xxxxxxx
----------------------------------
By: Xxxxx Xxxxxxx
Its: Executive Director
BIOSANTE PHARMACEUTICALS, INC.
/s/ Xxxxxxx X. Xxxxx
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By: Xxxxxxx X. Xxxxx
Its: President and CEO
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