Exhibit 10.16
                                 






EXECUTION VERSION  






 


PORTIONS OF THIS
EXHIBIT HAVE BEEN OMITTED PURSUANT TO A                  REQUEST FOR

  CONFIDENTIAL
TREATMENT. THE OMITTED                  PORTIONS, MARKED BY [***], HAVE BEEN

  SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE
                                   COMMISSION. 



EXCLUSIVE SUBLICENSE
AGREEMENT 



        This
AGREEMENT (“Agreement”), dated November 7, 2006 (the “Effective Date”),
is made by and between BioSante Pharmaceuticals, Inc., 111 Barclay Boulevard,
Lincolnshire, IL 60069 (“BPA”), and Bradley Pharmaceuticals, Inc., 383 Route 46
West, Fairfield, New Jersey 07004-2402 (“Company”). 



        WHEREAS,
BPA has certain rights under that certain License Agreement dated as of June 13, 2000, as
amended in a series of six 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; Amendment No. 5 dated December 30, 2002; and Amendment No. 6
dated October 10, 2006 with three clarifying letters dated October 27, 2006, November 6,
2006, and November 7, 2006 (the foregoing collectively the “Prime License Agreement”)
from Antares Pharma IPL AG (“Antares”), successor in interest to Permatec
Technologie, AG (“Permatec”). 



        WHEREAS,
pursuant to the rights under the Prime License Agreement, BPA has developed a product
referred to as Bio-E-Gel®, which is a transdermal gel estradiol product
for the treatment of hot flashes. 



        WHEREAS,
as part of its development, BPA has prepared and filed a New Drug Application (“NDA”)
with the United States Food and Drug Administration (“FDA”) with respect to
Bio-E-Gel and the NDA has been accepted as filed by the FDA in April 2006, and is
currently under review. 



        WHEREAS,
BPA desires to grant and Company desires to accept an exclusive sublicense for Bio-E-Gel
in the Territory of the United States in the Field, subject to the limitations and
applicable terms of the Prime License Agreement. 



        1.
Definitions. 



        (a)
“Affiliate” shall mean any corporation or other business entity that directly
or indirectly controls, is controlled by, or is under common control with a party.
Control means ownership or other beneficial interest in 50% or more of the voting stock
or other voting interest of a corporation or other business entity. 



        (b)
“Field” shall mean all uses licensed and permissible under the Prime License
Agreement. 




 
	 	
1	 










EXECUTION VERSION  



        (c)
 “Generic Equivalent” shall mean an A/B rated generic equivalent or substitute
of a Product on sale in any part of the Territory. 



        (d)
       “Know How” shall mean all information and data, which are not
           generally known including, but not limited to, patent claims and
           related information not yet disclosed to the public, formulae,
           procedures, protocols, manufacturing processes, regulatory filings
           including NDAs, techniques and results of experimentation and
           testing, which (i) relate to any of the Products, and (ii) are
           necessary or useful to the development, marketing or manufacture of
           any of the Products in the Territory (in the case of manufacture,
           worldwide), all to the extent as of the effective date of this
           Agreement owned or otherwise controlled by and at the free
           disposition of BPA. 



        (e)
       “Launch Indication” shall mean the treatment of hot flashes in
           menopausal women. 



        (f)
       “Net Sales” shall mean the aggregate arms-length gross price invoiced
           by Company for the sale for commercial use of Products to
           non-affiliated third parties during the relevant period, less
           deductions for (i) normal and customary trade and cash discounts,
           credits and allowances (for rejection or return of Products), rebates
           or refunds incurred or granted; and (ii) sales, use or excise taxes
           and duties, and freight and insurance, to the extent included in the
           gross price charged. 



        (g)
       “New Indication” shall mean the development and commercialization of
           Products in any other indication but the Launch Indication. 



        (h)
       “Patents” shall mean those patents and patent applications that are
           (1) owned by BPA or (2) licensed to BPA at any time during the term
           of this Agreement with the right to sublicense under the Prime
           License Agreement and that claim (i) the Product (including methods
           of manufacture and/or use) in the United States; or (ii) the
           manufacture of Product outside of the United States. [***]. A list of
           the Patents in each of (i) and (ii) as of the Effective Date is
           attached as Exhibit A, which shall from time-by-time be updated as
           necessary to reflect the then-current status of the Patents. 



        (i)
       “PDE” will mean a Primary Detail Equivalent calculated as follows:
           for a given time period, PDE shall equal the sum total of (1) the
           number of Primary Product Presentations occurring during such time
           period multiplied by 1.0 and (2) the number of Secondary Product
           Presentation occurring during such time period multiplied by 0.5.
           “Primary Product Presentation” shall mean a presentation in which
           Product attributes are verbally presented for at least fifty percent
           (50%) or more of the total presentation time. “Secondary Product
           Presentation” shall mean a presentation in which Product attributes
           are verbally presented for less than fifty percent (50%) of the total
           presentation time. 



	[***]  	  	Omitted
pursuant to a confidential treatment request. The            confidential portion has
been filed separately with the Securities            and Exchange Commission 








 
	 	
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EXECUTION VERSION  





        (j)
“Products” shall mean that certain product, currently known as Bio-E-Gel®and
described in the NDA filed by BPA with the FDA in April 2006, together with any
improvements or modifications thereto. 



        (k)
“Royalty Term” means the period starting with the first commercial sale of
Product in the Territory and ending upon the later of (i) the expiration of the last to
expire of the Patents with at least one Valid Claim covering such Product (including its use or
manufacture) in the Territory and (ii) the twelfth (12th) anniversary of the first
commercial sale of such Product in such country. However, if BPA or Antares obtains a patent during the term of
this Agreement that achieves exclusivity for the Product in the Territory, then the
Royalty Term shall continue for the life of that patent. 



        (l)
“Territory” shall mean the United States of America and those of its
territories and possessions over which the FDA has regulatory authority. 



        (m)
“Trademark” shall mean the registered trademark BIO-E-GEL (U.S. Registration
No. 3,046,494) for use on or in connection with pharmaceutical products (including the
Product), and all goodwill associated therewith and symbolized thereby. In the event that
FDA requests or requires that a different trademark be used in connection with the
Product, then such trademark submitted by BPA shall be the Trademark in lieu of
BIO-E-GEL; provided that if BPA has not submitted such different trademark to the FDA on
or before the Effective Date, BPA shall reasonably consult with Company on the selection
of such different trademark. 



        (n)
“Valid Claim” means any claim of an issued and unexpired Patent which has not
been held unenforceable or invalid by a court or other governmental agency of competent
jurisdiction in an unappealed or unappealable decision, and which has not been disclaimed
or admitted to be invalid or unenforceable through reissue or otherwise, which claim
would be infringed by the sale by Company of Products but for the licenses granted herein. 



        2.
License Grant. 



        (a)
BPA grants to the Company, upon and subject to all the terms and conditions of this
Agreement (i) an exclusive sublicense under BPA’s rights under the Patents and an
exclusive license under BPA’s rights to Know How to make, have made, use, sell,
offer for sale, import, and develop Products in the Field in the Territory (and otherwise
to practice and use such Patents and Know How in the Field in the Territory to make, have
made, use, sell, offer for sale, import, and develop Products in the Field in the
Territory) and (ii) a non-exclusive sublicense (limited to Canada, New Zealand, South
Africa, Israel, Mexico, The People’s Republic of China (including Hong Kong), and
Indonesia) under BPA’s rights under the Patents and Know How to make and have made
Product for importation of such Product into the Territory for sale by Company in the
Field in the Territory, provided that Company agrees that it shall not use any such
rights for any other purpose. 





 
	 	
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EXECUTION VERSION  





        (b)
BPA grants to the Company, upon and subject to all the terms and conditions of this
Agreement an exclusive license to use the Trademark on Products in the Field in the
Territory in connection with the foregoing sub-license, as further set forth in Section
15 below. 



        (c)
Company recognizes that certain rights granted in this Agreement derive from and are
subservient to the Prime License Agreement. Notwithstanding any other provision in this
Agreement, this Agreement does not and shall not be read to grant to Company any rights
regarding any intellectual property that is the subject of the Prime License Agreement
that are not granted to BPA under that Prime License Agreement. The provisions of the
Prime License Agreement that are required to be incorporated into this Agreement are
reproduced in full on the attached Exhibit B. Such provisions of the Prime License
Agreement in the form attached are hereby incorporated into this Agreement. Further,
Company agrees that it shall be bound by those obligations set forth in the Prime License
Agreement but only to the extent that the Prime License Agreement affirmatively imposes
or requires such obligations to be imposed on sublicensees of BPA and only to the extent
such obligations were in effect on the Effective Date. As for any additional obligations
under the Prime License Agreement binding upon sublicensees which arise after the
Effective Date, by amendment of the Prime License Agreement or otherwise, Company shall
be bound only to those specific additional obligations to which it has agreed to be bound
in a written amendment to this Agreement duly executed by Company. Company shall not
knowingly take any action (or refuse to take any action) that would cause a breach of the
Prime License Agreement, and any termination of rights resulting from such a breach shall
not be an event of a breach by BPA. In connection with the foregoing, Company shall
reasonably cooperate with BPA in all respects (including making available relevant
employees, records, papers, information, samples, specimens, and the like) to timely cure
or resolve any dispute between Antares and BPA relating to the Prime License Agreement,
or any alleged breach of the Prime License Agreement. Such cooperation shall be at BPA’s
expense unless the underlying dispute or alleged breach results from action or inaction
by Company in contravention of Company’s obligations and rights hereunder, in which
case it shall be at Company’s expense. 



        (d)
BPA covenants with Company that during the term of this Agreement (i) BPA shall not take
any action (or refuse to take any action) that would cause a breach of the Prime License
Agreement or termination of the rights granted under the Prime License Agreement; (ii)
BPA shall take all reasonable actions to timely cure any breach of the Prime License
Agreement, and (iii) if BPA becomes aware of any alleged or actual breach by BPA of the
Prime License Agreement (including without limitation by receipt of a notice from Antares
thereof), BPA shall promptly provide Company a detailed notice of the nature and
circumstances of such breach and a copy of any notice provided by Antares to BPA. 



        (e)
All rights and interests not expressly granted to Company are reserved by BPA. 



        (f)
Company and its Affiliates and sublicensees shall not sell or otherwise distribute
Products to customers outside of the Territory or to any party who the Company or BPA has
reasonable grounds to believe is likely to export the Products outside the Territory.
Company shall require its distributors who sell or otherwise distribute Products to make
a covenant similar to that provided by Company in this Section 2(f) with respect to
Products. All inquiries or orders received by Company for the Products to be delivered
outside the Territory shall be referred to 





 
	 	
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EXECUTION VERSION  





BPA.       BPA and its Affiliates
and sublicensees shall not sell or otherwise            distribute Products to customers
within the Territory or to any party            who the Company or BPA has reasonable
grounds to believe is likely to            import the Products into the Territory. BPA
shall require its            distributors who sell or otherwise distribute Products to
make a            covenant similar to that provided by BPA in this Section 2(f) with
           respect to Products. All inquiries or orders received by BPA for the
           Products to be delivered within the Territory shall be referred to
           Company. 



        (g)
       Within thirty (30) days of the Effective Date, BPA shall provide
           Company with a written report setting forth a summary and status of
           all Patents and Know How as of such date. Thereafter, on each
           anniversary of the Effective Date during the term of this Agreement,
           BPA shall provide Company with a detailed written report setting
           forth a summary and status of (i) all additional BPA Know How that
           BPA may develop or acquire or that BPA has not previously disclosed
           to Company pursuant to this Section 2(g) and (ii) all BPA Patents
           that have not been previously disclosed to Company pursuant to this
           Section 2(g). 



        (h)
       During the term of this Agreement, BPA shall, at Company’s request,
           exercise commercially reasonable efforts to enforce the exclusivity
           of the license rights granted to BPA pursuant to the Prime License
           Agreement if such rights are violated by Antares or any third-party
           licensee of BPA outside the Territory. 



        3.
        Up-Front License Fees, Royalties and Milestones. 



        (a)
       In consideration of the rights granted herein, the Company shall pay            to
BPA: 



        (i)
       a royalty of [***]% of Net Sales of the Product distributed or sold            in
the Territory in all years during the Royalty Term, as adjusted as            provided
below. 



        (1)
       Generic Competition. If a Generic Equivalent is reasonably notified            by
either party under Section 14(b) to infringe a Patent available            for a Product
in a country in the Territory during the Royalty Term,            and Company furnishes
evidence that the marketing of such Generic            Equivalent has led to a reduction
in sales of the affected Product in            such country of the Territory by more than
[***] percent [***]% and            (i) in the case of notification of infringement
[***], BioSante takes            no action against the third party, but Company does take
action under            Section 14(b)(i), or (ii) in the case of notification of
infringement            [***], Company takes action under Section 14(b)(ii), then the
royalty            rates set forth in Section 3(a)(i) with respect to such Product in
           such country shall be reduced by [***] percentage [***] (i.e. from
           [***]% to [***]%) on a going-forward basis for such Products in such
           country, during all times in which the Generic Equivalent with
           respect to such Products remains on sale in such country. 



        (2)
       Single Royalty. The royalty provided in Section 3(a)(i), as adjusted,
           shall not increase for a Product by reason of such Product being
           covered by more than one Valid Claim or such Product being covered
           both by one or more Valid Claims and by Know How. 



	[***]  	  	Omitted
pursuant to a confidential treatment request. The            confidential portion has
been filed separately with the Securities            and Exchange Commission 








 
	 	
5	 










EXECUTION VERSION  





        (ii)
      milestone payments as follows: 



        (1)
       $3.5 million on signing of this Agreement; and 



        (2)
       $7 million that becomes fully earned and accrued in favor of BPA 



        (3)
       on receipt of FDA approval to commence marketing a Product for the
           Launch Indication in the United States (“FDA Approval”), provided
           that Company may for its convenience delay the actual payment of such
           milestone until the earlier of fourteen weeks after FDA Approval or
           first commercial sale of a Product in the United States; and 



        (4)
       $3 million on the first anniversary of achievement of the milestone
           described in Section 3(a)(ii)(2); provided, however, that in the
           event that FDA Approval is received for the lowest dose that BPA
           tested in Phase III clinical trials, BPA shall be entitled to an
           additional $500,000 (total of $3.5 million) for this milestone. 



        (iii)
     additional milestone payments as follows: 



        (1)
       $[***] upon the first achievement of $[***] of Net Sales of the Product in the
Territory in a calendar year; 



        (2)
       and additional $[***] upon the first achievement of $[***] of  Net Sales of the
Product in the Territory in a calendar year; 



        (3)
       an additional $[***]  upon the first achievement of $[***]  of Net Sales of the
Product in the Territory in a calendar year; 



        (4)
       an additional $[***]  upon the first achievement of $[***]  of Net Sales of the
Product in the Territory in a calendar year; 



        (5)
       after the achievement of the milestone provided in Section            3(a)(iii)(4)
and after commercial launch of the Product in the            Territory for the Launch
Indication, a bonus sales milestone of            either (A) an additional $[***] if Net
Sales of the Product in the            Territory in the immediately following calendar
year is at least            $[***] but less than $[***] or (B) an additional $[***] if
Net Sales            of the Product in the Territory in the immediately following
calendar            year is at least $[***] (but not both (A) and (B)); 



        (6)
       after the achievement of the milestone provided in Section
           3(a)(iii)(5), a bonus sales milestone of either (A) an additional
           $[***] if Net Sales of the Product in the Territory in the
           immediately following calendar year is at least $[***] but less than
           $[***] or (B) an additional $[***] if Net Sales of the Product in the
           Territory in the immediately following calendar year is at least
           $[***] (but not both (A) and (B)); and 



	[***]  	  	Omitted
pursuant to a confidential treatment request. The            confidential portion has
been filed separately with the Securities            and Exchange Commission 








 
	 	
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EXECUTION VERSION  





        (7)
after the achievement of the milestone provided in Section 3(a)(iii)(6), a bonus sales
milestone of either (A) an additional $[***] if Net Sales of the Product in the Territory
in the immediately following calendar year is at least $[***] but less than $[***] or (B)
an additional $[***] if Net Sales of the Product in the Territory in the immediately
following calendar year is at least $[***] (but not both (A) and (B)). 



        Company
shall make each of the payments provided in 3(a)(iii) within ten (10) business days after
the occurrence of the applicable milestones. Company shall make the payments provided in
3(a)(ii), and (iii) above only once, upon the first achievement of the applicable
milestone by the first Product in a country in the Territory, no matter how many
additional times the applicable milestone is achieved. 



        With
the exception of the initial payment required by 3(a)(ii)(1), Company shall make the
payments provided in 3(a)(ii) and 3(a)(iii) above into an escrow account identified to
Company by BPA that is established for the benefit of both BPA and Antares. BPA agrees
that each such payment by Company into such escrow account shall satisfy Company’s
obligation for such payment to BPA notwithstanding any dispute that may arise concerning
the operation of the escrow account. Antares is a third party beneficiary of this
Agreement solely with respect to this provision concerning payments into the escrow
account. Company shall make the initial payment required by 3(a)(ii)(1) by paying 75%
($2,625,000) to BioSante and 25% ($875,000) to Antares by wire transfer as follows: 



	  	
For
Antares: 






	  	
Bank
name and address: 






	  	
[***]

      Account name:  [***]

      Account number: [***]

      ABA: [***] 






	  	
For
BioSante: 






	  	
[***]

      ABA  [***]

      Acct  [***]

      Account Name  [***] 






	  	
4.
        Reports and Payments. 






	[***]  	  	Omitted
pursuant to a confidential treatment request. The            confidential portion has
been filed separately with the Securities            and Exchange Commission 








 
	 	
7	 










EXECUTION VERSION  





        (a)
On or before the last business day of January, April, July, and October of each year of
this Agreement, the Company shall submit to BPA a written report with respect to the
preceding calendar quarter (the “Payment Report”) stating: 



        (i)
Gross sales and Net Sales made by the Company during such quarter and an itemization of
deductions from gross sales to Net Sales; 



        (ii)
In the case of transfers of Products to an Affiliate of the Company for sale, rental, or
lease of such Products by the Affiliate to third parties, Net Sales by the Affiliate to
third parties during such quarter; 



        (iii)
     A calculation under Section 3 of the amounts due to BPA, making reference to the
application subsection thereof. 



        (b)
Simultaneously with the submission of each Payment Report, the Company shall make
payments to BPA of the amounts due for the calendar quarter covered by the Payment Report. 



        (c)
Inspections and Audit. Company shall keep full, true and accurate books of account
containing particulars and reasonable supporting documentation which may be necessary for
the purpose of determining the Net Sales of Products, royalties due thereon and the
statements provided by Company pursuant to Section 4(a) above. Such records shall be kept
at Company’s principle place of business, and shall be open at all reasonable times
and upon reasonable advance notice to the inspection of Antares, BPA, or an independent
certified public accounting firm retained by Antares or BPA, and reasonably acceptable to
Company, for the purpose of verifying any payment made under this Agreement. The party
initiating the inspection and audit (Antares or BPA) shall bear the full cost of any such
audit, unless the audit discloses that the amount due during any period audited exceeds
the amount paid by (i) ten percent (10%) or more during the first two (2) years following
first commercial sale of a Product in any country in the Territory; or (ii) five percent
(5%) or more thereafter, in which case Company shall bear the full cost of such audit.
Any additional royalty found in such audit to be due BPA shall be paid by Company within
thirty (30) days after such finding. 



        (d)
Interest. In the event any amount due and payable under this Agreement is not paid by the
due date, then the party owing such amount shall pay to the other party, without being
requested by such other party, interest on the total outstanding amount at one and one
half percent (1.5%) per month, in United States Dollars. 



        5.
Product Approvals. 



        (a)
Launch Indication Approval. BPA shall use its commercially reasonable efforts for the
good faith prosecution of its pending NDA for Bio-E-Gel for the Launch Indication;
provided, BPA’s commercially reasonably efforts shall include, at a minimum,
performing all regulatory and clinical work for FDA Approval in the United States of
Product for the Launch Indication (except for changes arising out of non-FDA required
marketing, packaging, or 






 
	 	
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EXECUTION VERSION  






manufacturing changes) at its sole
expense not to exceed a fully burdened cost of $[***]. After the Effective Date, Company
will have the right to participate in all formal meetings with the FDA regarding such FDA
Approval. BPA agrees to provide Company with copies of all correspondence and documents
to and from FDA and all notices received from FDA and to also provide Company with
regular updates as Company may reasonably request. If further or additional regulatory
work and clinical studies are required by the FDA in order to obtain such FDA Approval
and the fully burdened cost to BPA will exceed $[***], Company shall have the option, but
not the obligation, to fund the excess. If Company declines to fund the excess, and if
BPA also declines to fund the excess, then either party shall be permitted to terminate
this Agreement and such termination will be deemed not to be caused by the breach of
either party and will be deemed not to be a termination by Company under Section 16(d).
In the event of termination under this Section 5(a), BPA agrees to refund to Company the
$3,500,000 initial payment paid by Company to BPA pursuant to Section 3(a)(ii)(1), less
any amount actually paid by Company to Antares on account of such initial payment under
the Prime License Agreement; provided, however, BPA shall use its commercially reasonable
efforts to obtain a refund of any portion of sub-licensee payments paid to Antares under
the Prime License Agreement, and shall promptly pay over to Company any such amounts
recovered from or credited by Antares. 



        (b)
       Transfer of NDA. Upon FDA Approval of Bio-E-Gel for the Launch
           Indication, BPA agrees to assign, and hereby assigns, all right,
           title and interest in and to its NDA for Bio-E-Gel for the Launch
           Indication to Company, shall promptly transfer all documentation
           related to such NDA to Company and agrees to take all such further
           commercially reasonable action and promptly execute such further
           documents as may be reasonably necessary or desirable to give full
           effect to such assignment (including without limitation filing any
           related documents with the FDA). After such transfer Company shall be
           solely responsible for (i) post FDA Approval regulatory obligations
           for the Product, including without limitation the preparation and
           submission of annual reports, the reporting of adverse events, and
           cooperating with governmental regulatory agencies; (ii) communication
           with third parties regarding the Product in the Field in the
           Territory, including without limitation responding to complaints and
           medical inquiries; (iii) investigating all complaints and adverse
           drug experiences related to the Product in the Field in the
           Territory; and (iv) conducting any voluntary or involuntary recalls
           of Product in the Territory, including without limitation recalls
           required by any governmental authority and recalls deemed reasonably
           necessary by Company or BPA. 



        (c)
       Post-Approval Studies. In the event the FDA requires a Phase IV            study,
BPA shall conduct such study but shall only be responsible for            [***]% of the
fully burdened cost and expense of any Phase IV            commitment up to a maximum of
$[***], with Company responsible for            the excess. BPA shall from time to time
invoice Company for Company’s            share of such costs and expenses, and
Company shall pay such invoices            within thirty (30) days of receipt. 



	[***]  	  	Omitted
pursuant to a confidential treatment request. The            confidential portion has
been filed separately with the Securities            and Exchange Commission 









 
	 	
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EXECUTION VERSION  





        (d)
       Pre-Approval Changes. Without limiting BPA’s responsibilities
           pursuant to Section 5(a), Company shall be solely responsible, at its
           own expense, for all regulatory or clinical work, requirements, cost
           or expense arising out of any marketing, manufacturing or packaging
           changes initiated or requested by Company in writing prior to FDA
           Approval. By way of example and not limitation, Company has requested
           that BPA develop [***]formats of Product for detailing and sample
           purposes, which such development BPA has commenced, and Company shall
           going forward direct such development at its discretion and shall be
           responsible for all such fully burdened development costs and
           expenses for such formats incurred after the Effective Date. If
           Company determines to discontinue such development, it shall give
           reasonable advance written notice to BPA, and BPA shall then have the
           right, but not the obligation, to continue such development at its
           sole cost and expense. 



        (e)
       New Indications. Company shall have the right, in its sole            discretion,
to conduct development and commercialization of the            Product for any New
Indication in the Territory, subject to and in            accordance with the terms and
conditions of this Agreement. If            Company decides to pursue any such New
Indication, Company shall be            solely responsible at its sole cost and expense
for accomplishing all            Product development and commercialization, including
without            limitation (1) any pre-clinical, clinical and regulatory work,
           additional clinical testing or other studies and manufacturing
           requirements relating to the Product for such New Indication; (2) all
           FDA and other regulatory obligations post approval for such New
           Indication; and (3) any other Product and medical requirements
           relating to the sale or marketing of the Product for such New
           Indication. Subject to Section 5(f), Company agrees to provide BPA
           with copies of all correspondence and documents to and from FDA and
           all notices received from FDA regarding such New Indication and to
           also provide BPA with regular updates as BPA may reasonably request. 



        (f)
       Data Sharing. BPA and Company agree to provide one another immediate,
           full and free access to the clinical data and results generated by or
           on behalf of each (including by Affiliates and sublicensees of such
           party and, in the case of BPA, information received from Antares)
           with respect to the Products, and each agrees that the other may
           utilize all such data and results directly or through permitted (sub)
           licensees in pursuit of product approvals in their respective
           geographical areas (the Territory for Company and all other areas for
           BPA). BPA shall use commercially reasonable efforts to obtain such
           data from other licensees or sublicensees, but BPA shall have no
           obligation to share or provide any such information and data
           regarding Products with Company under this Section 5(f) if such
           information is not freely available to BPA with the right to share
           same with Company. For the avoidance of doubt, BPA shall have the
           absolute right to freely share all such data and results obtained
           from Company with Antares. 



        (g)
       Adverse Events. The parties shall promptly notify each other of any
           material information related to adverse events with Products to the
           extent required by applicable law to 



	[***]  	  	Omitted
pursuant to a confidential treatment request. The            confidential portion has
been filed separately with the Securities            and Exchange Commission 









 
	 	
10	 










EXECUTION VERSION  






allow the parties to timely comply
with their adverse event and safety data reporting legal obligations worldwide (including
as these legal obligations may be updated in future). Each party shall require its
Affiliates and Product licensees and sublicensees to comply with this Section 5(g). 



6.         Diligence; Compliance
With Law. 



        (a)
       The Company shall use its best commercially reasonable efforts to
           manufacture, market, sell and distribute Products for commercial sale
           and distribution throughout the Territory. 



                (i)
       Company shall provide a minimum of [***]sales representatives to            detail
the Product for the commercial launch for Launch Indication in            the Territory
at the time of such commercial launch, and a minimum of            [***] sales
representatives to detail the Product for the Launch            Indication in the
Territory [***] after such commercial launch.            Without limiting the foregoing,
Company shall provided a minimum            cumulative total of [***] PDEs as of [***]
after commercial launch of            the Product for the Launch Indication in the
Territory, a minimum            cumulative total of [***] PDEs as of [***] after such
commercial            launch and a minimum cumulative total of [***] PDEs as of [***]
after            such commercial launch. Company shall use promotional and sales
           efforts for the Product for the Launch Indication in the Territory
           that is not less than such promotional and sales efforts and
           financial commitment for other products of similar size and market
           potential promoted and sold by Company in the Territory and not less
           than such promotional and sales efforts and financial commitment made
           by other similarly situated pharmaceutical companies for products of
           similar size and market potential. Company shall use best
           commercially reasonable efforts to fully launch its promotion and
           sale of the Product for the Launch Indication in the Territory within
           [***] following FDA Approval, but no later than [***] following
           receipt of commercial quantities of salable Product for commercial
           sale after FDA Approval. Failure to launch with [***] following
           receipt of such commercial quantities of Product after FDA Approval
           shall be deemed a material breach of this Agreement. 



                (ii)
      During the term of the Agreement the Company shall not make, have            made,
market, sell, offer for sale, or distribute transdermal            estrogen-only products
(delivered as a gel and not with a patch or            another transdermal delivery
method) for once daily application that            directly compete with the Product for
the Launch Indication in the            Territory. However, in the event that Company is
acquired by a third            party that is marketing a competing product in at the time
of            acquisition, this Section 6(a)(ii) shall not require the acquiring
           company to discontinue sales of such product so long as the acquiring
           company complies in all other respects with the obligations to
           diligently sell and promote the Product. 



        (b)
       The Company shall at all times comply with and adhere to all            statutes,
ordinances, laws, regulations, and the like in its conduct            of all of its
activities under this Agreement, 



	[***]  	  	Omitted
pursuant to a confidential treatment request. The            confidential portion has
been filed separately with the Securities            and Exchange Commission 








 
	 	
11	 










EXECUTION VERSION  





including without limitation in the
manufacture, marketing, advertising, promotion, distribution, and sale of the Products. 



        (c)
The Company shall promptly provide BPA with copies of all promotional materials used by
Bradley for marketing the Product in the Field in the Territory. The Company shall also
provide BPA an annual summary report of its commercialization of the Product, including
copies of the Company’s actual draft sales and marketing plans, and afford BPA a
reasonable opportunity to provide input into same and meet with the Company to discuss;
provided, however, that this shall not be construed as a right of BPA to approve such
sales and marketing plans. In addition, the Company shall provide BPA a mid-year update
to such report summarizing any further developments in the commercialization of the
Product. 



        (d)
The Company shall provide BPA with copies of all correspondence and documents to and from
FDA and all notices received from FDA concerning the Product, and also provide BPA with
regular updates as BPA may reasonably request. 



7. Proprietary Rights. Company
acknowledges and agrees that as between Company and BPA, BPA shall have and obtain title
to and ownership in the formulation of the Products, the Patents and the Know How (as
that term is defined in the Prime License Agreement), including, but not limited to, any
and all improvements, developments, and inventions thereof that cover the Products, if
any. For the avoidance of doubt, any inventions made by Company during the term of the
Agreement that do not cover the Products shall remain the property of Company. Nothing in
this Agreement shall be interpreted to grant any ownership, license or other right to any
party in or to any improvement, development or invention of Company arising from its
research and development activities generally to the extent such activities are not
directed toward the Product. Nothing in this Agreement shall be interpreted to cause any
information relating to Company’s research and development activities generally to
the extent such activities are not directed toward the Product to be considered the
Confidential Information of any party other than Company. 


8. Manufacturing.


        (a)
The Company shall use its best commercially reasonable efforts to have the Product
manufactured at all times in sufficient quantities to supply any demand and any
government or commercial requirements, and at all times shall ensure that such
manufacture complies with applicable law. 



        (b)
Technology Transfer. 



        (i)
Promptly after the Effective Date, BPA and its Affiliates shall, and BPA shall use its
good faith efforts to cause its contractors, including without limitation DPT
Laboratories, Ltd., 4040 Broadway, Suite 401, San Antonio, TX, 78209 (“DPT”),
who have been manufacturing Product (in any and all forms) to, perform all technology
transfer required to establish all then-current manufacturing processes (including
analytical methods) for Products (in any and all forms) at Company’s manufacturing
facility or the manufacturing facility of Company’s chosen supplier. To be clear,
this technology transfer shall include without limitation the transfer by BPA of all
manufacturing data and Know How and copies of any FDA correspondence with respect to
manufacture of Product. Company shall have the right to share 






 
	 	
12	 










EXECUTION VERSION  





all such manufacturing data and Know
How with any manufacturer the Company engages to manufacture Product, under terms of
confidentiality and non-use no less stringent than those present in this Agreement.
Notwithstanding anything to the contrary in this Section, Company’s right and
ability to receive such information from DPT is subject to the Research and Development
Services Agreement between BPA and DPT dated as of May 28, 2003 (the “DPT Agreement”),
and Company may be required by DPT to undertake certain confidentiality obligations
provided in Section 8 of the DPT Agreement and exclusivity obligations provided in
Section 7 of the DPT Agreement, in each case as imposed on BPA in accordance with the DPT
Agreement, in order to receive information from DPT, it being understood, however, that
such exclusivity obligation is conditioned upon DPT honoring its obligations under the
DPT Agreement and the DPT Agreement being in full force and effect. If requested by
Company, BPA shall use commercially reasonable efforts (not requiring the payment of
money or assumption of other obligations) to assist Company in negotiating with DPT a
commercially reasonable manufacturing price for the Product for the benefit of Company. 



        (ii)
At the request of Company, BPA shall reasonably assist Company with   arranging for
manufacture of Product to be performed after the Effective Date   by DPT, including
without limitation by facilitating introductions of   Company’s representatives to,
and the commencement of discussions by such   representatives with, such contacts within
DPT as are then reasonably   available to BPA or any of its Affiliates, and offering
assistance and   consultation to Company’s representatives with respect to the
conduct of any   such discussions with DPT. BPA shall request that DPT, and give DPT the
right   to, work collaboratively with and disclose BPA Confidential Information to
  Company regarding the manufacture of Product in the Field in the Territory   subject to
this Agreement and the Prime License Agreement. Company shall   request that DPT, and
give DPT the right to, work collaboratively with and   disclose Company Confidential
Information to BPA regarding the manufacture of   Product in the Field in the Territory
subject to this Agreement and the Prime   License Agreement. 



        (iii)
Promptly after the Effective Date, BPA shall assign to Company, and   Company shall
accept assignment, of the DPT Agreement, provided that BPA shall   remain responsible for
any obligations that it may have to DPT under the DPT   Agreement that are due and
existing at the time of such assignment (including,   to be clear, indemnification
obligations for actions occurring prior to the   time of such assignment). Company agrees
that any confidential information of   BPA held by DPT shall remain the property of BPA
and be governed by the   confidentiality provisions of this Agreement. Upon the
termination or   expiration of this Agreement, the Company shall reassign the DPT
Agreement to   BPA and BPA shall accept assignment, provided that the Company shall
remain   responsible for any obligations that it may have to DPT under the DPT
  Agreement that are due and existing at the time of such reassignment   (including, to
be clear, indemnification obligations for actions occurring   prior to the time of such
reassignment). 



        (c)
Tag Along Manufacturing. BPA shall have the right to place orders for   reasonable
quantities of Product for sale by BPA or BPA’s licensees outside   the Territory
when Product is being made by or for Company; provided, however,   if BPA and BPA’s
licensees intend to order sufficient quantities of Product to   comprise a complete
manufacturing batch of Product, BPA and its licensees   shall place their own order for
such Product independently of Company’s   orders. Company shall give BPA as much
advance notice as reasonably possible, 






 
	 	
13	 










EXECUTION VERSION  





but
in no event less than best commercially reasonable notice, for each   manufacturing run
to enable BPA to exercise its rights under this Section   8(c). BPA shall pay Company’s
actual out of pocket cost for such manufacture   including any surcharges imposed by the
manufacturer for partial batches and   special packaging and labeling requirements. BPA
shall make payments for its   orders either directly to the manufacturer or to Company,
and shall take   delivery either directly from manufacturer or from Company, with the
details   of same to be negotiated in good faith between BPA and Company (subject to the
  default rules of the Uniform Commercial Code if agreement on the details is   not
reached). In the event that the manufacturer is not able to fill the   entire quantity
ordered by Company and BPA, it shall fill the orders on a pro   rata basis. 



9. Confidentiality. 



        (a)
Confidential Information. In connection with this Agreement, the parties may provide to
each other Confidential Information, including without limitation each party’s
invention disclosures, proprietary materials and/or technologies, economic information,
business or research strategies, trade secrets and material embodiments thereof. As used
herein, “Confidential Information” means any information of a confidential or
proprietary nature disclosed by a party to this Agreement to the other party, including,
in the case of Company, royalty reports or development reports submitted pursuant to this
Agreement. For the avoidance of doubt, any such Confidential Information related to the
Product shall be considered BPA’s Confidential Information. 



        (b)
Confidentiality and Non Use. The recipient of the disclosing party’s Confidential
Information shall use such Confidential Information solely to exercise its rights and
perform its obligations under this Agreement, and in the case of BPA only, under the
Prime License Agreement (including, without limitation, the right to use and disclose
such Confidential Information in regulatory applications and filings), unless otherwise
mutually agreed in writing. The recipient of a disclosing party’s Confidential
Information shall maintain such Confidential Information in confidence, and shall
disclose such Confidential Information only to those of its employees, agents,
consultants, sublicensees, attorneys, accountants, advisors, and in the case of BPA only,
licensor with respect to the Product who have a reasonable need to know such Confidential
Information and who are bound by obligations of confidentiality and non-use no less
restrictive then those set forth herein. The recipient of the other party’s
Confidential Information shall take the same degree of care that it uses to protect its
own confidential and proprietary information of a similar nature and importance (but in
any event no less than reasonable care). 



        (c)
Exclusions. Confidential Information shall not include information that: (i) is in the
recipient’s possession prior to receipt from the disclosing party as demonstrated by
contemporaneous documentation; (ii) is or becomes, through no fault of the recipient,
publicly known; (iii) is furnished to the recipient by an unaffiliated third party
without breach of a duty to the disclosing party; (iv) is independently developed by the
recipient without use of, application of or reference to the disclosing party’s
Confidential Information as demonstrated by contemporaneous documentation. 



        (d)
Legal Disclosures. It shall not be a violation of this Section 9 to disclose Confidential
Information to the extent required to be disclosed under applicable law, provided 






 
	 	
14	 










EXECUTION VERSION  





that the recipient, to the extent
possible and in accordance with applicable law, shall give the disclosing party prior
written notice of the proposed disclosure and shall cooperate fully with the disclosing
party to minimize the scope of any such required disclosure. 



        (e)
Survival. All obligations of confidentiality and non-use imposed under this Section 9
shall survive for five (5) years after the termination or expiration of this Agreement. 



        (f)
Communications with BPA’s Licensor. For clarity and without limitation, during the
term of this Agreement, the Company shall not directly communicate with BPA’s
licensor with respect to the Product unless specifically provided for in this Agreement
or unless otherwise specifically authorized in writing by BPA. 



10. Warranty. 



        (a)
BPA represents and warrants to, and covenants with, Company as follows: 



	                    (i)
Title; Encumbrances. As of the Effective Date, (a) it is the sole and lawful owner or
exclusive licensee of the entire right, title and interest in the Patents and Know How in
the Territory; and (b) there are no material outstanding liens, security interests,
pledges, charges, mortgages, restrictions, interests and/or encumbrances of any kind in
or burdening any of the Patents or Know How in the Territory. 







	                    (ii)
Prime License Agreement. As of the Effective Date, (a) the Prime License Agreement is in
full force and effect; (b) the copy of the Prime License Agreement that BPA has disclosed
to Company on or before the Effective Date is a true and accurate copy of such agreement
as in effect as of the Effective Date; (c) the Prime License Agreement is fully
enforceable against Antares to the same extent as it would have been against Permatec
upon execution thereof; (d) BPA has made all payments and fulfilled all material
obligations due and/or owed under the Prime License Agreement for which the payment or
other obligation arose on or before the Effective Date; (e) BPA is not in material breach
of the Prime License Agreement and has received no notice of breach thereunder; and (f)
the only Patents that as of the Effective Date have been in-licensed were in-licensed
pursuant to the Prime License Agreement. 







	                    (iii)
Other Licenses. As of the Effective Date, BPA has not granted, and shall not grant during
the term of this Agreement, expressly or otherwise, any assignment, license or other
extension or rights, covenant not to sue, or other similar interest or benefit, exclusive
or otherwise, to, under or in the Patents or the Trademark, in the Field and in the
Territory, that remains in effect or in force as of the Effective Date, other than to
Company pursuant to this Agreement. 







	                    (iv)
Non-infringement of Third Party Rights. To the best knowledge of BPA’s executive
officers without a duty of inquiry, no patents or trade secret rights owned or controlled
by an unaffiliated third party dominate, or would be infringed or misappropriated by the
manufacture, use, sale, offer for sale or importation of Products (in the case of all
activities other than manufacture, in the Territory), and BPA has received no written
claims relating to any claims of such domination, infringement or misappropriation 










 
	 	
15	 










EXECUTION VERSION  





	                    (v)
Claims. As of the Effective Date, (a) there are no claims, actions, suits or proceedings
commenced, pending or threatened against it or any of its Affiliates that will, could or
might in any way materially affect or relate to the rights and benefits granted to
Company hereunder; and (b) BPA has not received written notice that any third party
intends to challenge the patentability or validity of any Patent or Trademark. 







	                    (vi)
Third-Party Activities; Grounds. As of the Effective Date, to the best knowledge of BPA’s
executive officers without a duty of inquiry, BPA is unaware of any (a) activities by
third parties that would constitute material infringement or misappropriation of the
Patents or Trademark (in the case of pending claims, evaluating them as if they were
issued); and (b) grounds existing on which any claims, actions, suits or proceedings
might be commenced against Company with respect to the Patents or Trademark. 







	                    (vii)
Patents. Exhibit A contains a complete list of all Patents that it or any of its
Affiliates owns or controls, as of the Effective Date, that cover the Products or their
manufacture. 







	                    (viii)
Clinical Data. As of the Effective Date, (a) the NDA pending for the Product contains a
complete data package that is to the best knowledge of BPA’s executive officers
without a duty of inquiry and BPA’s good faith belief sufficient for FDA Approval of
such NDA; (b) BPA has disclosed all material pre-clinical and clinical data regarding the
Product in the Territory to both the FDA and Company; (c) BPA has provided Company with
copies of all correspondence and documents to and from FDA and all notices received from
FDA regarding the Product or the NDA; (d) BPA has performed all clinical studies
regarding the Product in material compliance with all applicable laws and guidelines and
good clinical practice; (e) to the extent post-FDA Approval studies are required by the
FDA as further described in Section 5(c) for the Launch Indication for the Product, BPA
shall perform all such studies in material compliance with all applicable law and
guidelines and good clinical practice. 







	                    (ix)
Safety and Efficacy Data. As of the Effective Date, BPA has disclosed to Company all
material safety- and efficacy-related data and information (including without limitation
toxicology, carcinogenicity and mutagenicity data and information) generated by,
disclosed to and/or known to BPA (or that BPA reasonably should know) regarding Products
and any information required to fairly and accurately interpret such data and information
and make BPA’s disclosures thereof to Company complete, accurate and not misleading. 







	                    (x)
No Debarment. As of the Effective Date, in the course of developing Products, BPA has
not, and to its knowledge no other party has, engaged any person who has been debarred by
the FDA or is the subject a debarment proceedings by the FDA, and BPA hereby covenants
that it and its Affiliates shall not do so during the Term. 







	                    (xi)
Competing Products. During the term of the Agreement BPA shall not make, have made,
market, sell, offer for sale, or distribute transdermal estrogen-only products (delivered
as a gel and not with a patch or another transdermal delivery method) for once daily
application that directly compete with the Product for the Launch Indication in the
Territory. However, in the event that BPA is acquired by a third party that is marketing
a competing product in at the time of acquisition, this Section 10(a)(xi) shall not
require the acquiring 










 
	 	
16	 










EXECUTION VERSION  






company to discontinue sales of such
product so long as the acquiring company complies in all other respects with the terms of
this Agreement. 



        (b)
Other than as expressly provided in this Agreement, neither party makes any warranty and
makes no representation, express or implied, regarding the Product, Patents or the
Trademark or Materials. IN PARTICULAR, BUT WITHOUT LIMITATION OF THE GENERALITY OF THE
PRECEDING SENTENCE, EACH PARTY HEREBY EXPRESSLY DISCLAIMS AND DOES NOT GIVE ANY WARRANTY
AND MAKES NO REPRESENTATION WITH RESPECT TO THE PRODUCTS, PATENTS, AND TRADEMARK AND
MATERIALS OR ANY CLINICAL TRIALS CONDUCTED BY EITHER PARTY REGARDING THE PRODUCT AND THE
RESULTS THEREOF, INCLUDING WITHOUT LIMITATION, ANY WARRANTY OF COMPLETENESS, ACCURACY,
VALIDITY, ENFORCEABILITY, NON-INFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE THEREOF, IN PARTICULAR WITH RESPECT TO FDA APPROVAL OF THE NDA. ALL LIABILITIES,
REPRESENTATIONS, AND WARRANTY BY EACH PARTY ARE EXPRESSLY DISCLAIMED. 



        (c)
IN NO EVENT WILL EITHER PARTY HAVE ANY LIABILITY TO THE OTHER FOR ANY INDIRECT,
INCIDENTAL, SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, EVEN IF ADVISED OF THE
POSSIBILITY THEREOF. THE ALLOCATION OF LIABILITY IN THIS PARAGRAPH REPRESENTS THE AGREED
AND BARGAINED FOR UNDERSTANDING WITH RESPECT TO THE ALLOCATION OF RISKS INHERENT IN THIS
AGREEMENT. 



11. Prohibition Against Use of
Names; Confidentiality of Agreement. 



        (a)
Neither party shall use the name, insignia, or symbols of the other party, its faculties
or departments, or any variation or combination thereof, or the name of any director,
officer, employee, agent or representative of such other party for any advertising,
packaging or other promotional or publicity purpose without such other party’s prior
written consent; provided, however, that either party may identify the other party if
required by law, regulation, court order or the rules of any securities exchange on which
the identifying party’s stock is traded. Upon execution of this Agreement, BPA and
Company may each issue a press release in the form annexed hereto as Exhibit C1 and
Exhibit C2, respectively. Either party may issue future press releases regarding this
Agreement with the prior written approval of the other party, such approval not to be
unreasonably withheld or delayed (and in any event provided within three (3) days). Once
the content of a press release has been approved by the other party, a party may release
future press releases that contain substantially the same content without additional
approval. Upon issuing any press release, the party doing so shall simultaneously copy
the other party. 



        (b)
Subject to the provisions of this Section 11, including the exception for any public
disclosures made in compliance with the terms of Section 11(a), the parties agree that
the terms of this Agreement are confidential and will not be disclosed by either party to
any third party (except to a party’s professional advisor) without advance written
permission of the other party, provided that either party may make any filings or
disclosures of this Agreement or its terms 






 
	 	
17	 










EXECUTION VERSION  






required by law or regulation in any
country so long as such party uses its reasonable efforts to obtain confidential
treatment for portions of this Agreement as available, consults with the other party, and
permits the other party to participate, to the extent practicable, in seeking a
protective order or other confidential treatment, and further provided that either party
may disclose the terms of this Agreement to a third party (and its professional advisors)
when such disclosure is reasonably necessary in connection with (i) a merger,
acquisition, placement, investment, or other such transaction with such third party, or
(ii) the sale of securities to or other financing from such third party or a financing
underwritten by such third party, in which case disclosure may be made to any person or
entity to whom such third party sells such securities (and its professional advisers).
Advance written permission for disclosure will not be required when a party is ordered to
disclose information concerning the Agreement by a competent tribunal or such disclosures
are required by law, regulation, or stock exchange rules, except that such party will
make all reasonable efforts to limit any disclosure as may be required in the course of
legal proceedings by entry of an appropriate protective and confidentiality order, and
will provide the other party with as much advance notice of such circumstances as is
practicable. 



12. Compliance with Governmental
Obligations. 



        (a)
Each party shall comply upon reasonable notice from the other party with all governmental
requests related to the Product or this Agreement directed to either party, including
without limitation by providing all information, data and assistance necessary to comply
with legitimate governmental requests related to the Product or this Agreement. Each
party shall promptly notify the other party of all such governmental requests. 



        (b)
The Company shall ensure that its activities under this Agreement including but not
limited to marketing, sale and commercial distribution of the Product comply with all
government regulations in force and effect including, but not limited to, federal, state,
and municipal legislation and regulations. 


13. Indemnity and Insurance.

        (a)
The Company will indemnify and hold BPA, its Affiliates and their respective officers,
directors, employees and agents (collectively the “BPA Indemnitees”) harmless
against any and all losses, damages, liabilities, judgments, fines, amounts paid in
settlement, expenses and costs of defense (including without limitation reasonable
attorneys’ fees) (collectively “Losses”) resulting from any action, suits,
claims, demands, or prosecutions brought or initiated by a third party (each a “Third
Party Claim”) to the extent such Third-Party Claim arises out of (i) the breach or
alleged breach of any representation, warranty or covenant by Company contained herein;
(ii) the negligence or willful misconduct of any Company Indemnitee; and (iii) the
development, manufacture, storage, handling, use, sale, offer for sale or importation of
Product by or for Company and its Affiliates, sublicensees and distributors; provided
that such indemnity shall not apply to the extent BPA has an indemnification obligation
pursuant to Section 13(b)(ii) for such Loss. 



        (b)
BPA shall indemnify, hold harmless and defend Company, its Affiliates and sublicensees,
and their respective officers, directors, employees and agents (the “Company
Indemnitees”) from and against any and all Losses resulting from any Third Party
Claim against 






 
	 	
18	 










EXECUTION VERSION  






them to the extent that such Third
Party Claim arises out of (i) the breach or alleged breach of any representation,
warranty or covenant by BPA contained herein; (ii) the negligence or willful misconduct
of any BPA Indemnitee, or (iii) the development, manufacture, storage, handling, use,
sale, offer for sale or importation of Products by or for BPA Indemnitees; provided that
such indemnity shall not apply to the extent Company has an indemnification obligation
pursuant to Section 13(a)(ii) for such Loss. 



        (c)
Procedure. A party whose BPA Indemnitee or Company Indemnitee is entitled to be
indemnified pursuant to this Section 13 (the “Indemnified Party”) shall give
prompt notice of the Third Party Claim to the other party (the “Indemnifying Party”)
and the Indemnifying Party shall defend against such Third Party Claim with the
reasonable cooperation of the Indemnified Party; provided that the Indemnifying Party
shall not make any settlement of any such Third Party Claim that includes an admission of
liability by the Indemnified Party or adversely affects the intellectual property of the
Indemnified Party without the prior written consent of the Indemnified Party, which
consent shall not be unreasonably withheld, conditioned or delayed. The Indemnified Party
shall have the right to be present in person or through counsel at substantive legal
proceedings relating to the Third Party Claim giving rise to the Indemnified Party’s
right to indemnification hereunder. If the parties cannot agree as to the application of
Sections 13(a) and 13(b) to any Loss or Third Party Claim, the parties may conduct
separate defenses of such Third Party Claim. In such case, each party further reserves
the right to claim indemnity from the other in accordance with Sections 13(a) and 13(b)
upon resolution of such underlying Third Party Claim. 



        (d)
Company shall maintain, during the term of this Agreement, comprehensive products
liability insurance with reputable and financially secure insurance carriers reasonably
acceptable to BPA (but in no event less than rated A by AM Best) to cover the activities
of the parties related to the Product hereunder, for minimum limits of $10,000,000
combined single limit for bodily injury and property damage per occurrence and in the
aggregate. Such insurance shall include BPA as an additional named insured. Such
insurance shall be written to cover claims incurred, discovered, manifested, or made
during or within three (3) years after the expiration of this Agreement. 



        (e)
Each of BPA and Company shall at all times comply with all statutory workers’ compensation
and employers liability requirements covering its employees with respect to activities
performed under this Agreement. 



        (f)
BPA shall add Company as an additional named insured on BPA’s clinical trial
insurance, solely with respect to clinical trials conducted by BPA relating to the
Product in the Field in the Territory, should it be necessary to conduct Phase IV
clinical trials as per Section 5(c). BPA shall maintain: (i) comprehensive general
liability insurance and (ii) during any such clinical trials conducted by BPA related to
the Product in the Field in the Territory, comprehensive clinical trial liability
insurance to cover such clinical trials, in each case with reputable and financially
secure insurance carriers reasonably acceptable to Company (but in no event less than
rated A by AM Best). 





 
	 	
19	 










EXECUTION VERSION  




14. Intellectual Property. 



        (a)
       Patent Prosecution. As between the parties and to the extent that BPA
           has the right to do so under the Prime License Agreement: (i) BPA
           shall be responsible for the preparation, filing, prosecution and
           maintenance of the Patents in the Territory; provided, however, that
           Company shall reimburse BPA for any such costs and (ii) BPA shall
           reasonably cooperate with Company to seek Company’s input and
           comments on prosecution strategy, and shall provide Company with a
           copy of each submission made by BPA to a patent authority in the
           Territory regarding a Patent. Notwithstanding anything in the
           foregoing, if BPA (and any third party with the right to prosecute or
           maintain any Patent under the Prime License Agreement) determines in
           its sole discretion to abandon or not maintain such Patent anywhere
           in the Territory, then BPA shall provide Company with thirty (30)
           days prior written notice before any relevant deadline relating to
           the relevant Patent and shall offer in writing to Company the
           transfer of the respective Patent (if owned by BPA) or transfer of
           the right to prosecute and maintain the relevant Patent (if
           in-licensed to BPA). In the event Company accepts such offer to
           transfer the Patent within thirty (30) days after receipt of the
           offer, BPA shall take all measures necessary for the transfer and
           assignment of the Patent to Company and shall execute all documents
           necessary therefore. In the event Company does not accept BPA’s offer
           within the thirty (30) days time period, BPA is free to abandon the
           respective Patent. Further, to the extent permissible under the Prime
           License Agreement, BPA agrees to use good faith efforts to persuade
           Antares to add independent claims that solely cover estrogen-only
           products to any U.S. patent applications within the Patents. The cost
           and expense associated therewith shall be borne and reimbursed by
           Company. 



        (b)
       Patent Enforcement. [***] 



        (c)
       Parallel Importation Enforcement. BPA will use commercially            reasonable
efforts to take such legal action as may be appropriate            against its licensees
or sublicensees causing the importation into            the Territory of Product sold and
intended for sale outside of the            Territory (so called “grey market” goods). 



        (d)
       Patent Term Restoration and Regulatory Exclusivity. The parties shall
           take commercially reasonable efforts to cooperate with each other in
           obtaining patent term restoration or extension, supplementary
           protection certificates, regulatory data extensions or exclusivity,
           or their equivalents, in the Territory where applicable, with any
           expense for same directed at the Product to be paid by Company. For
           the avoidance of doubt, this paragraph imposes no obligation on BPA
           to conduct or fund clinical studies. 



        (e)
       Patent Marking and Rights. Prior to the issuance of patents, the
           Company will mark Products made, sold, or otherwise disposed of by it
           under the license granted in this Agreement with the words “Patent
           Pending,” and following the issuance of one or more patents, with the
           numbers of such patents, in accordance with the requirements set
           forth in 35 U.S.C. ss. 287(a), in each case subject to regulatory
           restrictions imposed by the FDA or any other regulatory agency with
           jurisdiction over approval of human pharmaceuticals in the Territory. 



	[***]  	  	Omitted
pursuant to a confidential treatment request. The            confidential portion has
been filed separately with the Securities            and Exchange Commission 









 
	 	
20	 










EXECUTION VERSION  






The Company shall not challenge or
contest, or assist or encourage others to challenge or contest, the validity and
enforceability of the Patents. 



        15.
Trademark. 



        (a)
Quality. The Company shall ensure that the Products, as well as all packaging,
advertisements, and marketing materials (collectively, “Materials”) shall be of
high quality and comply in all respects with all applicable laws, regulations, FDA
requirements, and the descriptions and standards of the NDA. 



        (b)
Use of Trademark. 



        (i)
Company may brand all Products and Materials with the Trademark and if so shall use the
notation ® in association with the Trademark along with an indication
that the Trademark is registered to BPA. To be clear, Company shall also be free to
market the Products and Materials within the Territory with trademark(s) of its own
choosing; provided, however, that upon any termination of this Agreement other than
termination by Company pursuant to Sections 16(b) or 16(c) (and, to be clear, other than
expiration of this Agreement), ownership of any such trademark shall be transferred to
BPA along with any applicable goodwill. Company shall not join any term to the Trademark
to create a new trademark. 



        (ii)
Company shall use the Trademark in accordance with usual trademark practice. Company
shall not, by any act or omission, tarnish, disparage, degrade, dilute or injure the
reputation of the Trademark or BPA and/or the goodwill associated therewith. The
Trademark must not be used in any manner that causes confusion as to the source or origin
of the Product. Company shall not use any other trade name, trademark or service mark, in
combination with the Trademark in such a manner as to create or appear to create a
combination or unitary trademark. 



        (c)
Ownership. Company agrees that notwithstanding any provision of this Agreement, all uses
of the Trademark (and the goodwill represented thereby) shall inure to the benefit of
BPA. Company acknowledges the exclusive ownership of the Trademark by BPA and shall not
do anything inconsistent with or in derogation of such ownership. 



        (d)
The Trademark Rights. The Company shall not challenge or contest, or assist or encourage
others to challenge or contest, the validity and enforceability of the Trademark. 



        16.
Term of Agreement. 



        (a)
This Agreement shall be effective as of the date first set forth above and shall continue
in full force and effect until its expiration or termination in accordance with this
Section 16. 



        (b)
This Agreement may be terminated by either party upon written notice after written notice
specifying such alleged breach in reasonable detail and a reasonable opportunity to cure.
In the case of non-payment, such reasonable opportunity to cure shall not be greater than
ten (10) calendar days and BPA and Company shall not be relieved of any obligations as a
result of any termination of this Agreement for reason of non-payment. 






 
	 	
21	 










EXECUTION VERSION  






        (c)
       Either party may immediately terminate this Agreement upon written
           notice should the other party file a petition under any bankruptcy or
           insolvency act or have any such petition filed against it that is not
           dismissed within ninety (90) days. 



        (d)
       If FDA Approval in the United States of Product for the Launch
           Indication is obtained, but the total of (i) Company’s share of the
           fully burdened cost of post-approval studies required by FDA and (ii)
           the fully burdened cost of any additional studies required to obtain
           approval by the FDA for the lowest dose of the Product that BPA
           tested in Phase III clinical trials together exceeds $[***], Company
           shall have the right to terminate this Agreement and return the
           rights granted hereunder to BPA upon ninety (90) days prior written
           notice to BPA; provided, however, that Company must within thirty
           (30) days after the effective date of such termination pay BPA $[***]
           plus any further amounts that as of the effective date of such
           termination had accrued or were due BPA under any other provisions of
           this Agreement, excluding, however, any milestone payments under
           Sections 3(a)(ii)(2) ($7 million) or 3(a)(ii)(3) ($3.0 million or
           $3.5 million) regardless of whether or not such milestone payment has
           then accrued. For clarity, Company shall not have the obligation to
           pay BPA under this Section 16(d) if Company terminates this Agreement
           under Section 5(a). 



        (e)
       If not terminated under (b)-(d) above, this Agreement shall expire            upon
the expiration of the Royalty Term in the Territory with respect            to the
Product. Upon such expiration, the licenses granted under            Sections 2(a) and
2(b) shall survive, the licenses granted in Section            2(a) shall automatically
become non-exclusive, irrevocable, fully            paid-up, and royalty-free licenses,
and the license granted in            Section 2(b) shall automatically become an
exclusive, irrevocable,            fully paid-up and royalty-free license. 



        (f)
       Upon any termination of this Agreement other than termination by
           Company pursuant to subsections (b) or (c) above (and, to be clear,
           other than expiration of this Agreement), the licenses granted under
           Sections 2(a) and 2(b) to Company shall terminate and any and all
           information, trademarks, documents, Patents, and Know How (as that
           term is defined in Section 1.6 of the Prime License Agreement)
           relating to the Product, including all copies in whatever form or
           media, shall be immediately provided to and assigned to BPA;
           provided, however, Company may maintain one copy of any such
           information solely for purposes of exercising its legal rights
           hereunder. After such transfer Company agrees to provide BPA with
           copies of all correspondence and documents to and from FDA and all
           notices received from FDA and to also provide BPA with regular
           updates as BPA may reasonably request. Further, upon any such
           termination of this Agreement, Company assigns all right, title and
           interest in and to the NDA to BPA, shall promptly transfer all
           documentation related to such NDA to BPA, and agrees to take all such
           further best commercially reasonable action and promptly execute such
           further documents as may be reasonably necessary or desirable to give
           full effect to such assignment, including without limitation
           submitting a letter to the FDA requesting transfer and any related
           documents with the FDA to effect such transfer. After such transfer
           of the NDA to BPA, Company agrees to cooperate with BPA, at Company’s
           own expense for a reasonable transition period, regarding (i) post
           FDA Approval regulatory obligations for the Product, including 



	[***]  	  	Omitted
pursuant to a confidential treatment request. The            confidential portion has
been filed separately with the Securities            and Exchange Commission 









 
	 	
22	 










EXECUTION VERSION  






without limitation the preparation
and submission of annual reports, the reporting of adverse events, and cooperating with
governmental regulatory agencies; (ii) communication with third parties regarding the
Product, including without limitation responding to complaints and medical inquiries;
(iii) investigating all complaints and adverse drug experiences related to the Product;
and (iv) giving such notice as BPA may request to the FDA and to DPT or any other
contract manufacturer of Product. 



        (g)
Upon termination of this Agreement by Company pursuant to subsections(b) or (c) above,
the licenses granted in Sections 2(a) and 2(b) to Company shall survive such termination
until expiration of the Royalty Term. In such case, upon expiration of the Royalty Term
in the Territory with respect to the Product, the provisions of Section 16(e) shall take
effect as if this Agreement had expired. 



        (h)
If this Agreement terminates for any reason, Company shall have the right to sell any
Product that it has in process or in inventory as of the effective date of notice of such
termination, provided that Company pays all royalties and milestones due on Net Sales
thereof in accordance with Section 3 and further provided that such sell-off period shall
be limited to 90 days from termination. Upon termination of this Agreement, Company shall
remain liable for any involuntary or voluntary recalls of Product sold pursuant to this
Agreement. 



        (i)
In the event that the Prime License Agreement terminates for breach by BPA that is not
caused by the action or inaction of Company, this Agreement together with all of BPA’s
rights and obligations hereunder (including all future payments and performance under
this Agreement by Company) shall be deemed to be irrevocably assigned to Antares
automatically without the need for any further action by any party, and this Agreement
shall thereafter continue in full force and effect between Company as the direct licensee
and Antares as licensor. For the avoidance of doubt, upon such assignment all obligations
of Company to BPA other than confidentiality obligations shall cease to be of any further
force or effect, with the exception of amounts due or payable to BPA on account of sales
or other activities that occurred prior to such assignment (even if the date for actual
payment of such amounts is under the terms of this Agreement after such assignment),
which shall be paid to BPA when they would otherwise be due under this Agreement. 



        (j)
In the event that the Prime License Agreement terminates for liquidation or bankruptcy of
BPA, this Agreement together with all of BPA’s rights and obligations hereunder
(including all future payments and performance under this Agreement by Company) shall be
deemed to be irrevocably assigned to Antares automatically without the need for any
further action by any party, and this Agreement shall thereafter continue in full force
and effect between Company as the direct licensee and Antares as licensor. For the
avoidance of doubt, upon such assignment all obligations of Company to BPA other than
confidentiality obligations shall cease to be of any further force or effect, with the
exception of amounts due or payable to BPA on account of sales or other activities that
occurred prior to such assignment (even if the date for actual payment of such amounts is
under the terms of this Agreement after such assignment), which shall be paid to BPA when
they would otherwise be due under this Agreement. 



17. Notices. Any notice required or
permitted to be given under this Agreement shall be sufficient if sent by certified mail
(return receipt requested), postage pre-paid, to the attention of 






 
	 	
23	 










EXECUTION VERSION  






the Chief Executive Officer of the
respective company at the address set forth above or to such other address as a party may
specify by notice hereunder. 



18. No Agency or Joint Venture. The
Company is not an agent, joint venturer or partner of BPA, and the parties do not intend
to create an agency, joint venture or partner relationship. Company and BPA shall be
independent contractors. Neither Company nor BPA shall have the authority to make any
statements, representations or commitments of any kind, or take any action, which shall
be binding on the other, without the prior consent of the party to do so, except as
expressly provided for herein. 



19. Assignment. Neither party may
assign this Agreement without the prior written consent of the other, which consent shall
not be unreasonably withheld or delayed. Such consent shall not be required for any
assignment to a party that succeeds to all or substantially all of the assigning party’s
(or, in the case of Company, the Kenwood Therapeutics Products division of Company’s)
business or assets (whether by sale, merger, operation of law or otherwise), provided
that such assignee agrees in writing to be bound by the terms and conditions of this
Agreement. Notwithstanding the foregoing, Company may assign this Agreement without BPA’s
consent to its Kenwood Therapeutics Products division or other Affiliate of Company,
provided that Company guarantees the performance of such assignee. Any purported
assignment in contravention of this provision shall be null and void. 



20. Non-Waiver and Entirety. Any
failure of either party to enforce any obligations under this Agreement shall not be
deemed a waiver of such obligations. This Agreement constitutes the entire agreement and
understanding of the parties and supersedes all previous communication between the
parties. Notwithstanding the foregoing, the parties acknowledge that certain rights
granted to Company under this Agreement are derived from, and subservient to, the rights
granted to BPA under the Prime License Agreement. 



21. Governing Law. This Agreement is
governed by and construed in all respects in accordance with the laws of the State of
Illinois, USA and the United States of America (without regard to conflicts of laws
principles), excluding the United Nations Convention on Contracts for the International
Sale of Goods. 



22. Dispute Resolution. 



        (a)
Conciliation. The parties wish first to seek an amicable settlement of all disputes,
controversies or claims arising out of or relating to this Agreement by conciliation in
accordance with the UNCITRAL Conciliation Rules now in force. The conciliation shall take
place in Chicago, Illinois (USA) before a conciliator. If assistance is needed in
connection with the appointment of a conciliator or other administrative matters, JAMS
Endispute, Inc., 222 S. Riverside Plaza, Chicago, Illinois, US (telephone 312-739-0200)
shall be the institution to render such assistance. The language to be used in the
conciliation proceedings shall be English. 



        (b)
Arbitration. Subject to possible court proceedings under Section 22(d) of this Agreement,
if any conciliation proceedings under Section 22(a) of this Agreement are terminated in
accordance with Article 15 of the UNCITRAL Conciliation Rules or rejected in accordance
with Article 2 of those Rules, without resolution of the disputes, controversies or
claims, then all 






 
	 	
24	 










EXECUTION VERSION  






said disputes, controversies or
claims shall be determined by arbitration in accordance with the UNCITRAL Arbitration
Rules now in force, as supplemented by the IBA Rules on the Taking of Evidence in
International Commercial Arbitration, as adopted June 1, 1999, insofar as said IBA Rules
are not inconsistent with the express provisions of this Agreement. The language to be
used in the arbitral proceedings shall be English. There shall be three (3) arbitrators,
the place of arbitration shall be Chicago, Illinois (USA) and the appointing authority
shall be JAMS Endispute, Inc. In rendering the award, the arbitrator shall follow and
apply the substantive laws of the State of Illinois (without regard to conflict or choice
of laws principles). The arbitrator shall have the authority to award compensatory
damages only, subject to the limitations described in this Agreement. Each party shall
pay the fees of its own attorneys, expenses of witnesses and all other expenses and costs
in connection with the presentation of such party’s case (collectively, “Attorneys’ Fees”).
The remaining cost of the arbitration, including without limitation, fees of the
arbitrator, costs of records or transcripts and administrative fees (collectively, “Arbitration
Costs”) shall be borne equally by the parties. Notwithstanding the foregoing, the
arbitrator in the award may apportion said Attorneys’ Fees and Arbitration Costs,
pursuant to Articles 38 through 40 of the UNCITRAL Arbitration Rules. The award rendered
by the arbitrator shall be final, and judgment may be entered in accordance with the
applicable law by any court having jurisdiction thereof. 



        (c)
Confidentiality. The existence and resolution of any conciliation and/or arbitration
shall be kept confidential, and the parties, the conciliator and the arbitrator shall not
disclose to any person any information about such arbitration. 



        (d)
Court Proceedings. Notwithstanding the arbitration provisions in Section 22(b) of this
Agreement, either party shall have the right to sue in any court of competent
jurisdiction to collect from the other party funds due and owing such party hereunder.
Section 22(b) of this Agreement shall not be construed to prevent either party from
seeking injunctive relief against the other party from any judicial or administrative
authority of competent jurisdiction to enjoin that party from breaching this Agreement
pending the resolution of a dispute by arbitration, pursuant to said Section 22(b). Any
action to confirm an arbitration award or any other legal action related to this
Agreement between the parties may be instituted in any court of competent jurisdiction.
BPA and Company each waive their right to a trial by jury in any such court proceedings. 



23. Severability. Each party hereby
acknowledges that it does not intend to violate any public policy, statutory or common
laws, rules, regulations, treaty or decision of any government agency or executive body
thereof of any country or community or association of countries. Should one or more
provisions of this Agreement be or become invalid, the parties agree that it is their
intent that the remainder of the Agreement shall continue in effect, and shall
substitute, by mutual consent, valid provisions for such invalid provisions which valid
provisions in their economic effect are sufficiently similar to the invalid provisions
that it can be reasonably assumed that the parties would have entered into this Agreement
with such valid provisions. 



24. Headings. Section headings
contained in this Agreement are for convenience of reference only and shall not in any
way affect the interpretation of this Agreement. 






 
	 	
25	 










EXECUTION VERSION  






        25.
Further Assurances. Each party agrees to take or cause to be taken such further actions,
and to execute, deliver and file or cause to be executed, delivered and filed such
further documents and instruments, and to obtain such consents, as may be reasonably
required or requested in order to effectuate fully the purposes, terms and conditions of
this Agreement. 



        26.
Execution. This Agreement may be executed in two or more counterparts, each of which
shall be deemed an original, but all of which together shall constitute one and the same
instrument. 



[signature page follows] 






 
	 	
26	 










EXECUTION VERSION  






        IN
                               WITNESS THEREOF, BPA and the
                                             Company have caused this Agreement
                                             to be executed by their duly
                                             authorized representatives as of
                                             the day and year first written
                                             above. 

	 	 
      
         BioSante Pharmaceuticals, Inc. 
        
 
      


    
	 	
      By:

    	
      /s/ Stephen M. Simes
  
      


      Stephen M.  Simes

                                                         Chief Executive Officer and
President 

    


 



	 	 
      
         Bradley Pharmaceuticals, Inc. 
        
 
      


    
	 	
      By:

    	
      /s/ David Glassman
  
      


      Daniel Glassman

        President and Chief Executive
Officer 

    


 

 




	 	
27	 










EXECUTION VERSION  






EXHIBIT A 


  PATENTS


  	
        (i) – United States Patents

          U.S. Patent No. 5,891,462

          U.S. Patent Application No. 10/798,111

          U.S. Patent Application No. 10/798,161

          [***]

      	


        

(ii) Ex-U.S. Patents

          PCT Application No. PCT/US04/007291

          Canadian Application
No. 2,515,426

          Canadian Application No. 2,207,144

          China Application No.
200480005123.9

          Indonesian Application No. W-00200502415

          Israeli Application No.
170454

          Mexican Application No. PA/a/2005/008648

          New Zealand Patent No. 328021

          New Zealand Application No. NZ 541854

          South African Patent No. 97/4981
        
 
      



  



	[***]  	  	Omitted
pursuant to a confidential treatment request. The            confidential portion has
been filed separately with the Securities            and Exchange Commission 









 
	 	
28	 










EXECUTION VERSION  






EXHIBIT B 



PRIME LICENSE AGREEMENT FLOW-THROUGH PROVISIONS




[See the License Agreement, dated
June 13, 2000, between Permatec Technologie, AG (now known as Antares Pharma) and
BioSante Pharmaceuticals, Inc., as amended by Amendments Nos. 1, 2, 3 and 4 thereto, that
are Exhibits 10.10, 10.13, 10.14, 10.15 and 10.16, respectively, to the Annual Report on
Form 10-K for the year ended December 31, 2005 of BioSante Pharmaceuticals, Inc., as it
may be amended from time to time - portions of those exhibits have previously received
confidential treatment]. 





 
	 	
29	 










EXECUTION VERSION  





EXHIBIT C1 



(Initial Press Release
by BPA) 

 



Previously filed 






 
	 	
30	 










EXECUTION VERSION  





 


EXHIBIT C2 



(Initial Press Release
by Bradley) 

 

Previously filed





   


	 	
31