Exhibit 10.38
CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN
SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
Amendment No. 4
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
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WHEREAS, Antares Pharma IPL AG, Zug, Switzerland ("Antares") and BioSante
Pharmaceuticals, Inc. ("BioSante") have previously entered into a License
Agreement dated June 13, 2000 ("Agreement"), regarding the grant of a license
with the right to sublicense specified products, as well as a Supply Agreement
of the same date; and
WHEREAS, Antares and BioSante have also entered into a series of three
amendatory agreements subsequent to June 13, 2000, each of which has made
specified amendments to the terms of the Agreement, as follows: Amendment No. 1,
dated May 20, 2001; Amendment No. 2, dated July 5, 2001; and Amendment No. 3,
dated August 30, 2001; and
WHEREAS, Antares and BioSante each acknowledge that the other is, as of this
date, in material compliance with all aspects of the License Agreement and
Supply Agreement, but that Antares and BioSante have identified issues involving
interpretation of the Agreement and the amendments regarding which they
disagree, including issues relating to the Products covered by the Agreement,
and desire to resolve those differences and continue their business relationship
subject to some altered terms; and
WHEREAS, in order to effectuate these purposes, Antares and BioSante desire to
enter into an agreement that will effectuate a fourth set of amendments to the
Agreement, with the terms set forth below;
NOW THEREFORE, the Parties hereby agree pursuant to this Amendment No. 4 to the
License Agreement dated 13th of June 2000 ("Amendment No. 4") to amend the
Agreement as follows:
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I. Amendments to Agreement
[I-l] Covered Products
Paragraph 2.1 License, as amended by Amendment No. 1, is further modified
to provide that BioSante is granted a license, with the right to grant
sublicenses, to Develop the Products and any improvements or modifications
thereof created, developed or devised by BioSante or Antares. It therefore
follows that:
A. The Products include all estrogen gels, all testosterone gels, all E+T
gels, and all E+P gels, whether or not their formulations contain
*****************, except as noted in B below;
B. BioSante owns, on an exclusive worldwide basis all rights to Bio-T-Gel, the
**************** ****************, and has no obligation to share any
information regarding Bio-T-Gel with Antares, including data generated
during development.
[I-2] Assistance
I-2-1 Paragraph 2.3 Assistance: Paragraph 2.3 Assistance of the Agreement is
amended by the addition of an alternative means for Antares to provide
assistance, as follows: if and when requested by BioSante in its sole
discretion, provision of assistance will be negotiated on a project basis with
an agreed-upon budget before the work commences. The final charges will be based
an this budget only and will be invoiced at +/- 10% of the agreed upon budget.
No additional work beyond the agreed project will commence, nor charges
reimbursed, without the written agreement of Antares and BioSante.
I-2-2 Manufacturing Assistance Agreement: The parties acknowledge and agree that
the Manufacturing Assistance Agreement between the parties creation of which was
provided for by Amendment No. 3 has not been created, and that, as a result of
different agreements of the parties embodied in this Amendment no. 4, the
parties no longer desire that such a Manufacturing Assistance Agreement should
be created or entered into between them.
[I-3] Royalty
Paragraph 3.2 Royalty Payments of the Agreement, as amended by Amendment No. 3,
is further amended to provide that BioSante's obligation to pay a royalty is
amended from ***** percent (**%) to ***** (**%) in the case of licensed
Products, and BioSante will pay to Antares a royalty of **% of the royalty
received by Biosante, up to a maximum of **% of net sales, in the case of
sub-licensed Products.
[I-4] Sub-licensee up-front, sublicense or milestone payments
Paragraph 3.4 of the Agreement is amended to provide that:
A. Upon sub-license by BioSante of any Product covered in this Agreement or
Amendments No.s 1, 2, or 3 (other than *****), BioSante will pay to Antares
the proportion of such upfront payments defined in C below or Milestone
Payments defined in paragraph 3.3 actually received, as follows: a) where
the payments received by BioSante are ***** from BioSante to Antares then
***** will be due to Antares, b) where the payments to BioSante are *****
above the commitment to Antares, the additional amount payable to Antares
will be **% of this excess, and c) where payments received by BioSante are
***** the amounts due to Antares, then BioSante will pay Antares **% of
this excess. (For example, if a Milestone Payment of $***** is due from
BioSante to Antares, and a sub-licensee pays BioSante a Milestone Payment
upon the same milestone of $*****, BioSante will pay Antares **% of the
***** excess over ***** the $***** Milestone Payment, or $*****) for a
total of $*****;
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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.
B. In the case of ****, BioSante will pay to Antares **% of all sums received
from sub-licensees for the same Milestone in excess of the Milestone
Payment payable under paragraph 3.3;
C. For purposes of calculating the appropriate amount of upfront payments,
Antares and BioSante agree that the $1.0 million BioSante paid upfront to
Antares is deemed to be attributed ***** to each of Bio-E-Gel, LibiGel and
***** ($****** each);
D. BioSante has no obligation to pay to Antares any portion of payments made
to it for equity investments by sub-licensees, except to the extent that
such equity investment incorporates payment of a per-share premium over the
then-current market price, in which case BioSante shall pay Antares **% of
such premiums received.
[I-5] BioSante's Development and Marketing obligations/United States and Non-US
Paragraphs 5.3 BioSante's Development and Marketing obligations/United States
and 5.4 BioSante's Development and Marketing obligations/Non-US are amplified by
the agreement that at its risk, BioSante will make final decisions as to data
requirements for US submissions.
[I-6] Reduction in Royalty
Paragraph 8.2.3 Reduction in Royalty is amended to provide that in the instance
in which arise the triggering circumstances described in that Paragraph 8.2.3,
relating to the existence an A/B rated generic equivalent, the royalty owing is
to be reduced from ***** percent (**%) to ***** percent (**%).
[1-7] Terms
Paragraph 10.3.2 Terms, regarding E2/T Combi Gel is amended to provide that
A. the license fee totals ****** Dollars ($******); and
B. ******* Dollars ($******) of the license fee has been satisfied by
Amendment No. 1, and royalty to **% from **%.
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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.
[I-8] Payments
I-8-I 10.3.3.2 Manufacturing of clinical batches: The provisions of
sub-paragraph 10.3.3.2 of the Agreement are entirely deleted, extinguished and
eliminated.
I-8-2 10.3.3.3 Filing of the Product: The provisions of sub-paragraph 10.3.3.3
are amended to provide that the maximum milestone payment owed by BioSante upon
filing of the product is ****** Dollars ($******).
II. Supply Agreement
----------------
[II-1] Supply Agreement Termination
The Supply Agreement between Antares (formerly known as Permatec Technologie,
AG) and BioSante dated June 13, 2000, by agreement of Antares and BioSante, is
hereby terminated, extinguished and eliminated in its entirety pursuant to
Article 18 (Modification) of the Supply Agreement. Antares and BioSante
acknowledge that all manufacturing is being transferred to a U.S. based GMP
manufacturer and that Antares has no similar capacity. Any assistance in
manufacturing will be governed by Paragraph 2.3 as amended above. Antares and
BioSante each acknowledge that (a) neither has accrued any rights to its benefit
under the Supply Agreement prior to this date, and that (b) neither has any
obligations under the Supply Agreement that survive this termination.
[II-2] Antares to Involve BioSante in Manufacturing Communications
In order to maintain efficiency and accuracy in manufacturing, which will
benefit both Antares and BioSante, Antares agrees to assure that BioSante will
be fully involved and informed in conversations and communications with *****
regarding BioSante products, Bio-E-Gel, LibiGel, LibiGel E/T and any other
product that may be developed.
III. General
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[III-1] Package Development
In the event that another Antares licensee uses a package or labeling developed
by BioSante, BioSante will be reimbursed by Antares for development expenses in
an amount to be negotiated by the parties in good faith. In the event another
Antares licensee uses packaging for which BioSante provides dies, tooling, and
similar equipment, BioSante will be reimbursed by Antares for the expense of
such equipment.
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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.
[III-2] Governance
In addition to and preceding the mechanisms in 11.2 Dispute Resolution of the
Agreement, the parties agree that Steering Committee, made up of Xxxxx Xxxxxxx,
Xxxxx Xxxxxxxx, Xxxxxxx Xxxxx and Xxxx Xxxxxx or replacements to be named by the
respective companies. The Operational Committee will be Holger, Xxxxx and Xxxx
or replacements to be named by the respective companies.
[III-3] Continued effect
The parties agree that the Agreement shall, except for and in due incorporation
of the amendments agreed upon in Amendment No. 1, dated May 20, 2001; Amendment
No. 2, dated July 5, 2001; and Amendment No. 3, dated August 30, 2001 and this
Amendment No.4, remains in full force and effect and are not otherwise changed,
altered or amended. The parties further agree that in the event that any further
amendment, change or alteration to the language or wording if any section of the
Agreement or this Amendment No. 4 is determined by the parties to be required to
give full effect to any of' the changes agreed upon in this Amendment No. 4,
then the parties agree to execute in writing any such further amendment, change
or alteration.
IN WITNESSETH WHEREOF, the Parties have duly executed this Amendment effective
as of the 8th day of August, 2002.
Antares Pharma IPL AG
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Exton, PA, July 30, 2002
Place and Date /s/ Xxxxx X. Xxxxxxxx
---------------------------------
By: Xxxxx X. Xxxxxxxx
Its: CEO and President
BioSante Pharmeceuticals, Inc.
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Lincolnshire, IL, August 8, 2002
Place and Date
/s/ Xxxxxxx X. Xxxxx
---------------------------------
By: Xxxxxxx X. Xxxxx
Its: President and CEO
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