Exhibit 10.31

 

[Portions of this Exhibit have been omitted pursuant to a request for
confidentiality under Rule 406 of the Securities Act of 1933, as amended.  The
confidential portions of this Exhibit that have been omitted are marked with
“XXXX.” A copy of this Exhibit with all sections intact has been filed
separately 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

 

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:

 

I.              Amendments to Agreement

 

[I-1]         Covered Products

 

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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 lauryl
alcohol, except as noted in B below;

 

B.            BioSante owns, on an exclusive worldwide basis all rights to
Bio-T-Gel, XXXXXXXXXXXXXXXXXXXXXXXXXXXX XXXXX, and has no obligation to share
any information regarding Bio-T-Gel with Antares, including data generated
during development; [A portion of this section has been omitted pursuant to a
request for confidential treatment under Rule 406 under the Securities Act of
1933, as amended.  The confidential portions of this section that have been
omitted are marked with “XXXX.”  A copy of this section with the portion intact
has been filed separately with the Securities and Exchange Commission]

 

[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 on 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 Roya1ty 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 XXXXXX (XXXX) to XXXXXX (XXXX) in the case of licensed Products,
and BioSante will pay to Antares a royalty of XXXX of the royalty received by
BioSante, up to a maximum of XXXX of net sales, in the case of sub-licensed
Products.  [A portion of this section has been omitted pursuant to a request for
confidential treatment under Rule 406 under the Securities Act of 1933, as
amended.  The confidential portions of this Exhibit that have been omitted are
marked with “XXXX.”  A copy of this section with the portion intact has been
filed separately with the Securities and Exchange Commission]

 

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[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 Nos. 1, 2, or 3 (other than E/Neta), 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 XXXXXXXXXXXX from BioSante to
Antares then XXXXXXXXXX will be due to Antares, b) where the payments to
BioSante are XXXXXXXXXXXXXXX above the commitment to Antares, the additional
amount payable to Antares will be XXX of this excess, and c) where payments
received by BioSante are XXXXXXXXXXX the amounts due to Antares, then BioSante
will pay Antares XXX of this excess.  (For example, if a Milestone Payment of
XXXXXX is due from BioSante to Antares, and a sub-licensee pays BioSante a
Milestone Payment upon the same milestone of XXXXXX, BioSante will pay Antares
XXX of the amount from XXXXXX to XXXXXX (that is, XXXXXX) and BioSante will pay
Antares XXX of the XXXXXX excess over XXXXXXXXXXX the XXXXXX Milestone Payment,
or XXXXXX) for a total of XXXXXX;  [A portion of this section has been omitted
pursuant to a request for confidential treatment under Rule 406 under the
Securities Act of 1933, as amended.  The confidential portions of this
Exhibit that have been omitted are marked with “XXXX.”  A copy of this section
with the portion intact has been filed separately with the Securities and
Exchange Commission]

 

B.            In the case of E/Neta, BioSante will pay to Antares XXX of all
sums received from sub-licensees for the same Milestone in excess of the
Milestone Payment payable under paragraph 3.3;  [A portion of this section has
been omitted pursuant to a request for confidential treatment under Rule 406
under the Securities Act of 1933, as amended.  The confidential portions of this
Exhibit that have been omitted are marked with “XXXX.”  A copy of this section
with the portion intact has been filed separately with the Securities and
Exchange Commission]

 

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 XXXXXXX to each of Bio-E-Gel, LibiGel and
E/Neta (XXXXXXXX);  [A portion of this section has been omitted pursuant to a
request for confidential treatment under Rule 406 under the Securities Act of
1933, as amended.  The confidential portions of this Exhibit that have been
omitted are marked with “XXXX.”  A copy of this section with the portion intact
has been filed separately with the Securities and Exchange Commission]

 

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 XXX
of such premiums received.  [A portion of this section has been omitted pursuant
to a request for confidential treatment under Rule 406 under the Securities Act
of 1933, as amended.  The confidential portions of this Exhibit that have been
omitted are marked with “XXXX.” A copy of this section with the portion intact
has been filed separately with the Securities and Exchange Commission]

 

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[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 XXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.  [A portion of
this section has been omitted pursuant to a request for confidential treatment
under Rule 406 under the Securities Act of 1933, as amended.  The confidential
portions of this Exhibit that have been omitted are marked with “XXXX.”   copy
of this section with the portion intact has been filed separately with the
Securities and Exchange Commission]

 

[I-7]         Terms

 

Paragraph 10.3.2 Terms, regarding XXX Combi Gel is amended to provide that

 

A.            the license fee totals XXXXXXXXXXXXXXXXXXXXXXXXXX (XXXXXX); and

 

B.            XXXXXXXXXXXXXXXXXXXXXXXX (XXXXXX) of the license fee has been
satisfied by Amendment No. 1, and royalty to XXXXX from XXXXX.

 

[A portion of these sections have been omitted pursuant to a request for
confidential treatment under Rule 406 under the Securities Act of 1933, as
amended.  The confidential portions of this Exhibit that have been omitted are
marked with “XXXX.”  A copy of these sections with the portion intact has been
filed separately with the Securities and Exchange Commission]

 

[I-8]         Payments

 

I-8-1        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 XXXXXXXXXXXXXXXXXXXXX (XXXXXX).  [A
portion of this section has been omitted pursuant to a request for confidential
treatment under Rule 406 under the Securities Act of 1933, as amended.  The
confidential portions of this Exhibit that have been omitted are marked with
“XXXX.”  A copy of this section with the portion intact has been filed
separately with the Securities and Exchange Commission]

 

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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 an 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 DPT
regarding BioSante products, Bio-E-Gel, LibiGel, LibiGel E/T and any other
product that may be developed.

 

III.           General

 

[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.

 

[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 Dario Cararra,
Roger Harrison, Stephen Simes and Leah Lehman or replacements to be named by the
respective companies.  The Operational Committee will be Holger, Doris and Lisa
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

 

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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

 

 

 

 

 

 

 

/s/ Roger G. Harrison

Place and Date

 

By:

Roger G. Harrison

 

 

Its:

CEO and President

 

 

 

 

 

 

BioSante Pharmaceuticals, Inc.

 

 

 

 

 

Lincolnshire, IL                       8/8/02

 

/s/ Stephen M. Simes

Place and Date

 

By:

Stephen M. Simes

 

 

Its:

President and CEO

 

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