Exhibit 10.27
[PORTIONS OF THIS EXHIBIT HAVE
BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIALITY UNDER RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. A
COPY OF THIS EXHIBIT WITH ALL SECTIONS INTACT HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
Amendment No. 6
to the
License Agreement
dated 13th of June 2000
by and between
Antares Pharma IPL AG, Zug,
Switzerland as Licensor
(formerly known as Permatec Technologies AG)
and
BioSante Pharmaceuticals, Inc.,
Lincolnshire, IL, USA as Licensee
WHEREAS , Antares Pharma IPL AG, Zug, Switzerland
(“Antares”) and BioSante Pharmaceuticals, Inc.,
Lincolnshire, Illinois, United States of America
(“BioSante”) have previously entered into a License
Agreement dated June 13, 2000 (“License Agreement”), as
amended in a series of five amendments, as follows: Amendment
No. 1, dated May 20, 2001; Amendment No. 2, dated July 5, 2001;
Amendment No. 3, dated August 30, 2001; Amendment No. 4, dated
August 8, 2002; and Amendment No. 5, dated December 30, 2002
(collectively the Amendments and with the License Agreement, the
“Agreement”); and
NOW THEREFORE
, Antares and BioSante agree
pursuant to this Amendment No. 6 dated October 20, 2006 to the
Agreement (“Amendment No. 6”) to amend the Agreement as
follows:
1.
License Grant
. The licenses granted under
the Agreement are hereby amended as follows:
(a)
Paragraph 1.10 of the Agreement is
hereby amended and restated in its entirety as follows:
“Products” shall have
the meaning set forth in Exhibit B of this License
Agreement.”
(b)
Exhibit B of this Agreement is
hereby amended and replaced in its entirety as follows:
“A.
Products shall include all estrogen
gels, all testosterone gels, all E and T gels, and all E and P
gels, whether or not if any of the above gel formulations contain
lauryl alcohol, except as noted in Section B below.
[PORTIONS OF THIS EXHIBIT HAVE
BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIALITY UNDER RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. A
COPY OF THIS EXHIBIT WITH ALL SECTIONS INTACT HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
B.
BIOSANTE owns on an exclusive
worldwide basis, free and clear of any claims by ANTARES, its
product and formulation currently known as and referred to as
Bio-T-Gel (XXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXX), and has no obligation to share
information regarding Bio-T Gel with ANTARES, including data
generated during development.
C.
Notwithstanding the above, AP-108l
(gel containing norelgestromin and ethinyl estradiol and which is a
competitor to Ortho Evra) shall not be included in
Products.
D.
Notwithstanding the above, Nestorone
(gel formulation made pursuant to Joint Development Agreement with
The Population Council) shall not be included in
Products.
E.
Notwithstanding the above, Antares
shall retain its rights to testosterone gels for prevention or
treatment of diseases in males in the Territory but only for
products for which regulatory approval is sought and obtained by
submission of (what in the United States would be known as) a full
New Drug Application, and not an Abbreviated New Drug Application,
“paper NDA” under section 505(b)(2) of the United
States FD&C Act, or other form of application that relies on
clinical studies conducted by others as to which the applicant does
not have a right of reference.”
(c)
Paragraph I-1 of Amendment No. 4 to
the License Agreement is no longer applicable and is deleted in its
entirety.
(d)
Paragraph 2.1 of the Agreement is
hereby amended and replaced in its entirety as follows:
“2.1.1
ANTARES hereby grants to BIOSANTE an
exclusive license, with the right to grant sublicenses as provided
in this License Agreement, to Develop the Products in the field of
transdermal gel preparations (“Field”) in the Territory
for purposes of obtaining Approvals, and upon receipt of the
Approvals, to Market and sell the Products in the Field in the
Territory, and to use the Patents and Know-How exclusively for that
purpose, all in accordance with provisions contained in this
Agreement. It is the parties’ intention that any
product characterized by its marketing approval, as opposed to
Products, developed by BIOSANTE and based on PERMATECH’S
Technology will be and remain the property of BIOSANTE but BIOSANTE
will not be allowed to use or market the products in case this
License Agreement between ANTARES and BIOSANTE is
terminated.
2
2.1.2
ANTARES hereby grants to BIOSANTE a
non-exclusive license, with the right to grant sublicenses as
provided in this License Agreement, under the Patents and Know-How,
to make and have made Bio-E-Gel in the Territory.
2.1.3
ANTARES additionally grants to
BIOSANTE a non-exclusive license with the right to grant
sublicenses as provided in this License Agreement, to conduct the
following activities: investigation, research, conduct
clinical trials and perform market research in any country outside
of the Territory. For purposes of clarity the above license
shall not include a license or right to apply or seek any
regulatory approval/marketing authorization for any Product outside
the Territory.”
(e)
Paragraph B(2) of Amendment No. 5 to
the License Agreement is no longer applicable and is deleted in its
entirety.
(f)
Paragraph 2.2 of the Agreement is
hereby amended by the deletion of “(with only the commercial
terms redacted)” from the last sentence therein.
(g)
Paragraph 2.2 of the Agreement is
hereby further amended by the insertion of the following sentence
after the end of the sentence beginning with “Furthermore,
BIOSANTE undertakes . . .” with the following
sentence:
“Additionally, BIOSANTE
covenants that any and all sublicense agreements, in which
Bio-E-Gel is sublicensed, shall provide that (i) all up-front,
sublicense and milestone payments due from such sublicense
agreement shall be paid into an interest bearing escrow account
established for the benefit of both ANTARES and BIOSANTE and shall
be the account designated by both ANTARES and BIOSANTE
(“Escrow Account”) and (ii) that ANTARES is a third
party beneficiary of such sublicense agreement solely with respect
to subsection (i) above. The parties agree that the terms of
the Escrow Account shall provide that (a) ANTARES is responsible
for all costs and fees to establish and maintain the Escrow
Account, (b) seventy-five (75%) of funds deposited shall
immediately be released to BIOSANTE, and (c) the remaining
twenty-five (25%) of funds deposited plus any and all interest
accrued shall be released to ANTARES upon thirty days from
deposit.”
2.
Credit for Sublicense Payments
for Bio-E-Gel . In
the event that BioSante (i) terminates a sublicense agreement for
Bio-E-Gel (“Sublicense Agreement”) prior to February
15, 2007 and where such termination is based on BioSante failing to
receive regulatory approval for Bio-E-Gel by the FDA (as defined
below) and (ii) has to return all or a portion of the upfront
consideration received pursuant to such Sublicense Agreement, then
Antares will credit the pro rata portion of such upfront
consideration that it received to future payments due by BioSante
for Bio-E-Gel.
3.
Disclosure of Confidential
Information . Each
party may disclose non-public confidential information of the other
party to subcontractors or potential licensees who are under a
binding obligation of confidentiality to such party, at least as
strict as in the Agreement and so long as such party remains
responsible for the potential licensees’
compliance.
3
[PORTIONS OF THIS EXHIBIT HAVE
BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIALITY UNDER RULE
24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. A
COPY OF THIS EXHIBIT WITH ALL SECTIONS INTACT HAS BEEN FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
4.
Patent Prosecution and
Maintenance . From
the effective date of this Amendment No. 6, Antares will, at its
cost and expense, file, prosecute, and maintain the Patents,
including, but not limited to, those listed on Appendix A
hereto. If Antares determines to abandon or not file any
Patent, then Antares shall provide BioSante with written notice at
least thirty (30) days or if less, as long as reasonably
practicable, prior to the date such abandonment or failure to file
would become effective for BioSante to act in its stead, provided,
that BioSante has received from Antares any and all reasonable
documentation and information it reasonably needs to make a
decision and take the necessary action in reasonable sufficient
time to avoid abandonment. For purposes of clarity,
discontinuance shall be elected on a country-by-country basis.
BioSante may elect at its sole discretion to continue
prosecution or maintenance of any discontinued Patent at its sole
expense. BioSante shall then own any such Patent, and Antares
shall execute such documents and perform such acts, at
BioSante’s cost, as may be reasonably necessary for BioSante
to continue prosecution or maintenance, including assigning and
transferring ownership of such Patent to BioSante and directing its
counsel to tr