BioSante agreement with Bradley Pharmaceuticals
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
__________________
FORM
8-K
Current
Report
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of
1934
__________________
Date
of
Report (Date of earliest event reported):
November
7, 2006
BIOSANTE
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
001-31812
|
58-2301143
|
|
(State
or other jurisdiction of incorporation)
|
(Commission
File Number)
|
(I.R.S.
Employer Identification Number)
|
|
111
Barclay Boulevard
Lincolnshire,
Illinois
|
60069
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
(847)
478-0500
(Registrant’s
telephone number, including area code)
N/A
(Former
name or former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
| £ |
Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
|
| £ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
| £ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
|
| £ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13e-4(c))
|
Section
1 — Registrant’s Business and Operations
Item
1.01 Entry
into a Material Definitive Agreement
On
November 7, 2006, BioSante Pharmaceuticals, Inc. entered into an exclusive
sublicense agreement with Bradley Pharmaceuticals, Inc. for the marketing of
Bio-E-Gel®,
which
is a transdermal gel estradiol product for the treatment of hot flashes, in
the
United States. Upon execution of the agreement, Bradley paid BioSante a $2.625
million upfront signing payment and agreed to pay BioSante certain regulatory
and sales based milestone payments. In addition, Bradley agreed to pay BioSante
royalties on sales of Bio-E-Gel, if and when Bio-E-Gel is approved by the U.S.
Food and Drug Administration, or FDA, and marketed by Bradley. The upfront
payment amount is net of BioSante’s obligations to Antares Pharma IPL AG,
BioSante’s licensor of the transdermal estradiol gel formulation in
Bio-E-Gel.
BioSante
has prepared and filed a New Drug Application, or NDA, with the FDA, with
respect to Bio-E-Gel, and the NDA was accepted by the FDA as filed in April
2006, and is currently under review. Under the license agreement, BioSante
agreed to use commercially reasonable efforts for the good faith prosecution
of
its pending NDA for Bio-E-Gel for the treatment of hot flashes, including
performing all regulatory and clinical work required by the FDA for approval
of
Bio-E-Gel in the United States, at its sole expense, not to exceed, however,
a
certain specified amount, and has agreed to fund, in part up to a certain
specified amount, any Phase IV study that may be required by the
FDA.
The
license agreement will expire on the later of the 12th
anniversary of the first commercial sale of Bio-E-Gel in the United States
or
the expiration of the last patent right to Bio-E-Gel. Either party may terminate
the agreement earlier upon the other party’s breach of the agreement after
written notice specifying the alleged breach and a reasonable opportunity to
cure the breach or upon the other party’s insolvency or bankruptcy. In addition,
if further or additional regulatory work and clinical studies are required
by
the FDA in order to obtain FDA approval of Bio-E-Gel and the cost of such work
and studies to BioSante would exceed a specified amount, and if neither Bradley
nor BioSante funds the excess of such amount, either party will have the right
to terminate the agreement. Upon such termination, BioSante would be required
to
refund to Bradley the upfront signing payment previously paid to BioSante.
In
addition, if FDA approval of Bio-E-Gel is obtained, but Bradley’s share of the
costs of any post-approval studies required by the FDA, together with Bradley’s
share of the costs of any additional studies required to obtain approval by
the
FDA, exceeds a specified amount, Bradley will have the right to terminate the
agreement upon 90 days prior written notice to BioSante and the payment to
BioSante of a specified termination fee.
The
license agreement also contains other terms and conditions that are standard
and
customary for agreements of this type, including certain representations,
warranties and covenants.
SIGNATURE
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
BIOSANTE
PHARMACEUTICALS, INC.
By: /s/
Stephen M. Simes
Stephen
M. Simes
President
and Chief Executive Officer
Dated:
November 8, 2006