Exhibit
10.1


 


[Portions of this Exhibit have
been omitted pursuant to a request for confidentiality under Rule 24b-2 of
the Securities Exchange Act of 1934, as amended.  The confidential portions of this Exhibit that
have been omitted are marked with “XXX”. 
A copy of this Exhibit with all sections intact has been filed
separately with the Securities and Exchange Commission.]


 


LICENSE
AGREEMENT


 


This AGREEMENT (“Agreement”), dated December 3, 2008 is made by and between
BioSante Pharmaceuticals, Inc., 111 Barclay Boulevard, Lincolnshire, IL
60069 (“BPA”), and Azur Pharma International II Limited, a Bermuda limited
liability company, Clarendon House, 2 Church Street, Hamilton HM 11, Bermuda
and such of its Affiliates as it may designate from time to time under one or
more provisions of this Agreement (“Company”).


 


WHEREAS, BPA is the owner of know-how associated with the manufacture
and distribution of Elestrin.


 


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 “Antares
License Agreement”) from Antares Pharma IPL AG (“Antares”), successor in interest to
Permatec Technologie, AG, such License Agreement and amendments together being
attached as Exhibit C.


 


WHEREAS, Company desires to obtain a license to BPA’s know-how
concerning Elestrin and to obtain a sublicense under the Antares License
Agreement as it concerns Elestrin.


 


WHEREAS, BPA desires to grant such licenses to
Company, and further to grant such sublicense subject to the limitations and
applicable terms of the Antares License Agreement.


 


NOW THEREFORE, BPA and Company (collectively, the “Parties” and each individually, a “Party”) agree as follows:


 


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)          “Assigned Contracts” means (i) all
purchase orders for the Product received by BPA or any of its Affiliates prior
to the Closing Date but not shipped prior to 11:59 p.m.
(EST) on the Closing Date and (ii) those purchase orders placed by BPA and
set forth on Schedule 1(b) hereto.


 

















 


(c)           “Authorized Marks” has the meaning
set forth in Section 2(c)


 


(d)           “Azur Parent” means Azur Pharma Limited,
an Irish limited liability company.


 


(e)           “Business” means the development,
manufacture, packaging, handling, storage, distribution and transport of the
Product in and outside the Territory as relates to the promotion, marketing and
sale of the Product in the Territory.


 


(f)            “Change in Control” means, with
respect to BPA, (i) the current shareholders of BPA ceasing to own a
majority of the outstanding voting stock of BPA (ii) BPA merging,
consolidating, or otherwise combining with any other Person and, immediately
following such transaction, the current shareholders of BPA cease to own a
majority of the voting stock or other equity interests of the Person surviving
such transaction, (iii) BPA selling or otherwise transferring or disposing
of all or substantially all of its assets or business.


 


(g)           “Commercially Reasonable Efforts” means
efforts and resources used by a participant in the pharmaceutical industry
consistent with the prudent exercise of reasonable business judgment with
respect to a product owned by it or to which it has rights (exclusive or
non-exclusive, as the case may be), which is of similar market potential, at a
similar stage in its product life, taking into account the competitiveness of
the marketplace, including generic competition, applicable regulatory
impediments, and reimbursements available for the product. For clarity, with
respect to the promotion, marketing, and sale of Product, it shall not be
Commercially Reasonable to substantially discontinue the distribution of Product
or to substantially discontinue manufacture (or purchase from DPT) of Product
for sale to customers. In the case of BPA, “Commercially Reasonable Efforts”
means efforts and resources used by a participant in the pharmaceutical
industry consistent with the prudent exercise of reasonable business judgment
with respect to a product out-licensed by it, which is of similar market
potential, at a similar stage in its product life, taking into account the
competitiveness of the marketplace, including generic competition, applicable
regulatory impediments, and reimbursements available for the product.


 


(h)           “Competitive Product” means a
pharmaceutical product that (i) contains estrogen as its sole active
ingredient; (ii) is delivered transdermally other than as a patch or vaginal
delivery; and (iii) is marketed for the Launch Indication.


 


(i)            “Contracts” means all unexpired
contracts, agreements, purchase orders, licenses, or other binding arrangements
with Third Parties to which BPA or any of its Affiliates is a Party, to the
extent and solely to the extent related to the Intellectual Property Rights,
the Business of the Product or the transactions contemplated by this Agreement.
For clarity, “Contracts” does not include the Antares License Agreement.
Contracts are set forth in Schedule 1(i).


 


(j)            “Dollars” and the symbol “$” each
means lawful money of the United States of America.


 


(k)           “FDA” means the Food and Drug
Administration or any successor agency hereof.


 


2

















 


(1)           “Field”
shall mean all uses licensed and permissible under the Antares License
Agreement for the Product, including the field of transdermal gel preparations.


 


(m)          “Force Majeure” shall mean acts of God,
explosion, fire, flood, tornadoes, thunderstorms, earthquake or tremor, war
whether declared or not, civil strife, riots or embargo, or changes in
applicable laws, regulations or orders by any government, governmental agency
or instrumentality, strikes, shortage of labor, fuel, power or raw materials,
inability to obtain supplies, or other circumstances (whether or not similar or
dissimilar to the foregoing), in each case beyond the reasonable control of a
party and having the effect of preventing, prohibiting or delaying such party
from performing its obligations hereunder.


 


(n)           “Fundamental Rep” means any of the
representations and warranties set forth in Section 11(a)(viii) (Power
and Authorization), Section 11(a)(ix) (Authorization of Regulatory
Authorities), Section 11(a)(x) (Noncontravention), Section 11(a)(xi)(Encumbrances),
Section 11(a)(xii(a)) (Title), Section 11(a)(xviii) (Taxes) and Section 11(a)(xx)
(No Brokers).


 


(o)           “Intellectual Property Rights” means,
with respect to the Product, any and all intellectual property rights owned or
controlled (including by means of any license or sublicense, provided that such
rights can be licensed or sublicensed to a Third Party) by BPA or its
Affiliates in or with respect to the Territory that are solely or primarily
directed to the formulation, manufacture, packaging, promotion, distribution,
marketing, sale, offering for sale, use, making, importing or exporting of the
Product, as each such business has been conducted in the ordinary course,
including any and all such rights constituting: (i) Patents, invention
disclosures and invention assignments; (ii) copyrights and other works
including art work used in the labeling of the Product and related digital
files; (iii) the Know-How; (iv) Trade Secrets; (v) all
applications, registrations, or common law or unregistered rights relating to
any of the foregoing; and (vi) all rights to obtain renewals,
continuations, divisions and/or patent term extensions or SPCs or other
extensions of legal protections pertaining to any of the foregoing.


 


(p)           “Know How” shall mean all methods,
processes, techniques, compositions, technology, information, data, results of
tests, studies, statistical and other analyses and expertise, 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 technology relating to Product that is used by BPA or its
Affiliates and is necessary for the formulation, manufacture, packaging,
release testing, and stability and shelf life determination of Product in the
Territory, including, but not limited to, specifications and test methods,
manufacturing and packaging instructions, master formula, validation reports
(process, analytical methods and cleaning), stability data and analytical
methods, clinical and non-clinical safety and efficacy studies, marketing
studies and absorption, excretion and metabolism studies, quality control and
quality assurance processes, regulatory filings including, without limitation,
NDAs, information relating to planned Phase IV trials or planned line
extensions, techniques, and results of experimentation and testing, which (i) relate
to the Product, and (ii) are necessary or useful to the development, marketing
or manufacture of the Product in the Territory (in the case of manufacture,
worldwide), all to the extent as of the Closing Date of this Agreement owned or
controlled (including by means of any license or sublicense, provided that such
rights can be licensed or sublicensed to a Third Party) by BPA or its
Affiliates.


 


3

















 


(q)           “Knowledge”
means, with respect to BPA and with respect to any particular matter,
the actual knowledge of one or more of the employees of BPA as of the Closing
Date.


 


(r)            “Launch Indication” shall mean the
treatment of hot flashes (vasomotor symptoms) in menopausal women or associated
with the menopause.


 


(s)           “Laws” means
all federal, state, and local laws, statutes, ordinances, regulations and rules and
published guidelines or pronouncements having the effect of law promulgated by
any Regulatory Authority, including the United States Food, Drug and Cosmetic
Act, as amended, and the rules and regulations promulgated thereunder, the
Medicare and Medicaid Patient Act of 1987, as amended, and the rules and
regulations promulgated thereunder, the Prescription Drug Marketing Act of
1987, as amended, and the rules and regulations promulgated thereunder,
and including all other laws, rules and regulations governing the
marketing, advertising, distribution and sale of the Product in the Territory.


 


(t)            “Liability” means any liability
(whether known or unknown, asserted or unasserted, absolute or contingent,
accrued or unaccrued, liquidated or unliquidated, and due or to become due),
including any liability for Taxes.


 


(u)           “Losses” has the meaning set forth
in Section 15(a) below.


 


(v)           “Material Adverse Effect” means a
material adverse effect on the assets, financial condition or results of
operations of the Business taken as a whole, or a material adverse effect on
the formulation, manufacture, packaging, promotion, distribution, marketing and
sale of the Product in the Territory, provided that in no event will any of the
following, individually or in the aggregate, be deemed to constitute, nor shall
any of the following be taken into account in determining whether there has
been, or will be, a Material Adverse Effect with respect to such Person, or
with respect to a Business: (A) any change in general economic or
financial market conditions, (B) any change in the general state of the
industry in which such Person operates, (C) any act of terrorism or war, (D) the
announcement of the execution of this Agreement or the transactions
contemplated hereby, or (E) any act or omission by BPA in compliance pursuant
to and in accordance with the terms of this Agreement.


 


(w)          “NDA” means the New Drug Application
for the Product.


 


(x)            “Net Sales”  shall mean the aggregate
arms-length gross price invoiced by Company or its Affiliates for the sale for
commercial use of Product to non-affiliated Third Parties during the relevant
period, less deductions for (i) normal and customary trade and cash
discounts, credits and allowances, normal and customary provisions for
rejections and returns of Product, wholesaler fees, rebates or refunds incurred
or granted; (ii) sales, use or excise taxes and duties, and freight and
insurance, to the extent included in the gross price charged; (iii) normal
credits and chargebacks consistent with customary practices in the industry; (iv) sales
credits, refunds, returns and allowances actually given, paid or received, as
applicable; and (vi) bad debts to the extent that the debt written off was
previously included in calculating Net Sales. Such amounts shall be determined
from books and records maintained by Company in accordance with GAAP,
consistently applied. For clarity, sales between or among Company and/or its


 


4

















 


Affiliates
shall be excluded from the computation of Net Sales, and in such case Net Sales
shall be calculated based on the first sale to a non-affiliated Third Party.


 


In the event that Product is sold together with one or more other
products by the process known as “bundling,” or if discounts and rebates for
Product are calculated in whole or in part based on the sales of other
products, then for the purpose of calculating the applicable Net Sales, Company
shall not apply any proportionately greater discount or rebate to Product than
the smallest applied to any other product with which it is sold; but for the
avoidance of doubt rebates and/or discounts applicable specifically to sales of
the Product shall be counted as deductions in full.


 


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


 


(2)           “Party”
or “Parties” has the
meaning set forth in the preamble above.


 


(aa)      “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 Antares 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. Independent claims of such
Patents that embrace both the Product and other compositions that comprise
hormones other than estrogen shall be deemed, together with any claims that
depend therefrom, “Group One Claims.” Independent
claims of such Patents that embrace the Product and without claims that embrace
compositions that comprise hormones other than estrogen shall be deemed,
together with any claims that depend therefrom, “Group Two  Claims.” The Patents are listed in Schedule
l(aa) hereto.


 


(bb)         “Permitted Encumbrances” means (i) encumbrances
for Taxes (a) not yet due and payable and arising in the ordinary course
of business or (b) being contested in good faith so long as adequate
provision therefor has been made in accordance with GAAP; (ii) statutory
and contractual encumbrances of landlords, carriers, warehousemen, mechanics,
materialmen, suppliers and repairmen, and other like encumbrances, incurred in
the ordinary course of business and not yet delinquent or being contested in
good faith; and (iii) encumbrances and other matters specifically
disclosed by BPA in Schedule 1(bb) hereto.


 


(cc)         “Person” means an individual, a
corporation, a general partnership, a limited partnership, a limited liability
company, a limited liability partnership, an association, a trust or any other
entity or organization, including a governmental authority.


 


(dd)         “Phase IV” means, as applicable, a
study or program designed to obtain additional safety or efficacy data, detect
new uses for or abuses of the Product, or to determine effectiveness for
labeled indications under conditions of widespread usage, which is commenced
after regulatory approval of the Product.


 


(ee)         “Product”  shall mean that certain
product currently known as Elestrin, together with any improvements or
modifications thereto that are under the NDA and for the avoidance of doubt
including such product at the sample unit size.


 


5

















 


(ff)           “Quarter” means a three-month period ending on March 31st,
June 30th, September 30th or December 31st; provided, however,
that (i) the initial Quarter shall begin on the Closing Date and end on December 31,
2008.


 


(gg)         “Regulatory
Authority” means any federal, state, local, foreign or
international governmental regulatory body or agency with regulatory authority
over pharmaceuticals or the Business, including the FDA.


 


(hh)         “Royalty
Term” means the period starting on the Closing Date and ending
upon the later of (i) the expiration of the last to expire of the Patents
with at least one Valid Claim covering the Product (including its use or
manufacture) in the Territory and (ii) December 31, 2023. 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 and provided that such exclusivity is
maintained .


 


(ii)           “Taxes” (and with correlative
meanings, “Tax” and “Taxable”) means all taxes of any kind
imposed by a federal, state, local or foreign governmental authority,
including, but not limited to, those on, or measured by or referred to as,
income, gross receipts, financial operation, sales, use, ad valorem, value
added, franchise, profits, license, withholding, payroll (including all
contributions or premiums pursuant to industry or governmental social security
laws or pursuant to other laws and regulations), employment, excise, severance,
stamp, occupation, premium, property, transfer or windfall profits taxes,
customs, duties or similar fees, assessments or charges of any kind whatsoever,
together with any interest, surcharges and penalties, additions to tax or
additional amounts imposed by such governmental authority with respect to such
amounts.


 


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


 


(kk)         “Third
Party” means any Person other than any Party or any of its
respective Affiliates.


 


(ll)           “Third Party Claim” has the meaning set forth in Section 15(b) below.


 


(mm)       “Trade
Secret” means information, including technical and non-technical
data, a formula, pattern, compilation, program device, method, technique,
process or other information similar to any of the foregoing, that derives
economic value, actual or potential, from not being generally known to, and not
being readily ascertainable by other Persons who can derive economic value from
its disclosure or use, which (i) relate to the Product, and (ii) are
necessary or useful to the development, marketing or manufacture of the Product
in the Territory (in the case of manufacture, worldwide), all to the extent as
of the Closing Date of this Agreement owned or controlled (including by means
of any license or sublicense, provided that such rights can be licensed or
sublicensed to a Third Party) by BPA or its Affiliates.


 


(nn)         “Valid
Claim” means any claim of an issued and unexpired Patent that
has not been held unenforceable or invalid by a court or other governmental
agency of competent jurisdiction in an unappealed or unappealable decision, and
that has not been disclaimed or admitted to be invalid or unenforceable through
reissue or otherwise, which claim would be


 


6

















 


infringed
by the manufacture, use, importation, offer for sale, or sale of Product but
for the license and sublicense granted herein.


 


(oo)                          Other
capitalized expressions in this Agreement have the meanings attributed to them
within the Section(s) of this Agreement in which they first appear.


 


2.                                       License Grant;
the Antares License Agreement.


 


(a)                                BPA grants to
Company and its current Affiliates* upon and subject to all the terms and
conditions of this Agreement, (i) an exclusive sublicense under BPA’s
rights under the Intellectual Property Rights, including the Patents and an
exclusive license under Know How to make, have made, use, sell, offer for sale,
import, and develop Product 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 a nonexclusive license under Know How
to make and have made Product for importation of the 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.


 


In order to permit Company to conduct development
activities outside the Territory for the purpose of furthering Company’s
license rights inside the Territory, BPA additionally grants Company a
non-exclusive license under the Intellectual Property Rights to conduct
clinical trials and further development of Product in any country of what is
defined as the “Territory” in the Antares License Agreement (“Antares
Territory”), but only for the purpose of Company’s exercise of its rights
inside the Territory as granted in this Agreement, and not for the sale,
marketing, registration, or other commercial exploitation of Product (or other
license rights) outside the Territory.


 


In order to permit BPA to conduct development
activities inside the Territory for the purpose of furthering its rights and
interests outside the Territory, the grant of an exclusive license to Company
in this Agreement shall not prohibit BPA from conducting clinical trials and
further development of Product in the Territory (excluding the sale, marketing,
registration, or other commercial exploitation of Product inside the Territory)
for the purpose of BPA’s exercise of rights and interests outside Territory.


 


(b)                               During the
Royalty Term BPA (including its Affiliates) shall not (i) make, have made,
sell, market, or distribute Competitive Product in the Territory, nor (ii) license
any Third Party to develop, make, have made, sell, market, or distribute
Competitive Product in the Territory. However, in the event that BPA is
acquired by a Third Party that is developing or marketing a Competitive Product
at the time of acquisition, this Section 2(b) shall not require the
acquiring company to discontinue the development or sale of such product so
long as the acquiring company complies in all other respects with the
obligations of BPA under this Agreement.


 


(c)                                Subject to the
terms and conditions of this Agreement, BPA hereby grants to Company a
nonexclusive license with respect to BPA’s company names and logos and other
trademarks of BPA appearing in the trade dress or packaging of the Purchased
Inventory


 


7

















 


(“Authorized Marks”), limited and to the extent
necessary to resell and distribute pursuant to this Agreement such items of
Purchased Inventory bearing such names, logos, and other trademarks. In
exercise of its rights under this Section 2(c), Company (i) shall maintain
the quality of such Purchased Inventory to preserve the reputation and goodwill
of the names, logos, and other trademarks, and (ii) shall not modify such
names, logos, and other trademarks. All goodwill associated with such names,
logos, and other trademarks shall remain the property of, and inure to the
benefit of, BPA.


 


(d)           Company
shall have no liability or responsibility for any obligation or liability
arising under the Antares License Agreement to the extent that such obligation
or liability arose during, or relates to, the period prior to the Closing Date
or to any Product sold into the distribution channel prior to the Closing Date.
Company shall have no liability or responsibility for any obligation or
liability arising under the Antares License Agreement to the extent that such
obligation or liability arose during, or relates to, the period after the
Closing Date other than those contemplated by Section 2(e). BPA shall
remain responsible to Antares for all obligations of BPA and its other
licensees under the Antares License Agreement, subject to and in accordance
with the terms thereof, except to the extent that Company has assumed such
obligations pursuant to Section 2(e) of this Agreement.


 


(e)           Company
recognizes that certain rights granted in this Agreement derive from and are
subservient to the Antares License Agreement. Notwithstanding any other
provision in this Agreement, this Agreement does not and shall not be read to
grant to Company any rights in or to Antares’ intellectual property that are
not granted to BPA with the right to sublicense under the Antares License
Agreement. The provisions of the Antares License Agreement that are required to
be incorporated into this Agreement are hereby incorporated into this
Agreement. Further, Company agrees that it shall be bound by those obligations
set forth in the Antares License Agreement but only to the extent that the
Antares 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 Closing Date and relate to the Product in the Territory as are
set forth in Exhibit C. Without prejudice to the generality of the
foregoing, Company shall have no obligation to pay any monies to Antares
pursuant to the Antares License Agreement whether prior to or subsequent to the
Closing Date, and any and all amounts payable thereunder shall remain the
responsibility of BPA. As for any additional obligations under the Antares
License Agreement binding upon sublicensees which arise after the Closing Date,
by amendment of the Antares 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. BPA
shall not without the Company’s prior written consent agree to an amendment of
the Antares License Agreement that would be binding on Company. Company shall
not knowingly take any action (or refuse or omit to take any action) mat would
cause a breach of the Antares License Agreement, and any termination of rights
resulting from such a breach shall not be an event of a breach of this
Agreement 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
Antares License Agreement, or any alleged breach of the Antares License
Agreement. Such cooperation shall be at BPA’s expense unless the underlying
dispute or alleged breach


 


8

















 


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.


 


(f)            BPA
covenants with Company that during the Royalty Term (i) BPA shall not take
any action (or refuse to take any action) that would cause a breach of the
Antares License Agreement or termination of the rights granted under the
Antares License Agreement; (ii) BPA shall take Commercially Reasonable
actions to timely cure any breach of the Antares License Agreement, and (iii) if
BPA becomes aware of any alleged or actual breach by BPA of the Antares 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. BPA further covenants that it will not during the Royalty Term
terminate the Antares License Agreement without Company’s prior written
consent, unless it secures for Company the rights granted to Company under this
Agreement that are derived from the Antares License Agreement on the same or
better terms without increasing the obligations of Company under this
Agreement. BPA will not agree to any amendment to the Antares License Agreement
that adversely effects the Product in the Territory, the rights of Company or the
obligations of Antares with respect to the Product in the Territory without
Company’s prior written consent, which consent shall not be unreasonably
withheld, delayed or conditioned.


 


(g)           Intentionally
omitted.


 


(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 Antares License Agreement with respect to Product in the
Territory if such rights are violated by Antares or any Third-Party licensee of
BPA. BPA agrees that it will use Commercially Reasonable Efforts to enforce its
rights under the Antares License Agreement insofar as such rights pertain to
the Product in the Territory on Company’s behalf, for Company’s benefit, and,
except to the extent prohibited by the Antares License Agreement or applicable
Laws, in consultation with Company. In addition, BPA shall use Commercially
Reasonable Efforts in its dealings with Antares (without being required to pay
any fees or amounts) to procure the benefit of the provisions of Section 16
of this Agreement for Company. Without limiting the generality thereof, the
foregoing shall include keeping Company informed in a timely manner (including
providing Company with copies of all correspondence and notices) of all
material matters arising under the Antares License Agreement pertaining to the
Product in the Territory of which BPA or its Affiliates have Knowledge.


 


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


 


(j)            Company and its
Affiliates shall not sell or otherwise distribute Product to customers outside
of the Territory or to any party who the Company or BPA has reasonable grounds
to believe is likely to export Product outside the Territory. All inquiries or
orders received by Company for Product to he delivered outside the Territory
shall be referred by Company to BPA. BPA and its Affiliates shall not sell or
otherwise distribute Product to customers within the Territory or to any party
who the Company or BPA has reasonable grounds to believe is likely to import
Product into the Territory. BPA shall require its licensees or sublicensees who
sell or otherwise distribute Product to make a covenant similar to that
provided


 


9

















 


by
BPA in this Section 2(j) with respect to Product. All inquiries or
orders received by BPA for the Product to be delivered within the Territory
shall be referred by BPA to Company.


 


(k)                                  Intentionally
omitted.


 


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


 


(a)                                  In
consideration of the grant of the licenses to Know-How and the grant of a
license and sublicense of the Patents, Company shall pay to BPA:


 


(i)                                     an upfront
payment of $500,000 at the Closing;


 


(ii)                                  subject to the
provisions of subparagraph (2) below and Section 16(b) royalty
payments during the Royalty Term as follows:


 


(1)          10%
on Net Sales below $10 million of the Product in the Territory in a calendar
year;


 


(2)          20%
on Net Sales between $10 million and $17.5 million of the Product in the
Territory in a calendar year; and


 


(3)          10%
on Net Sales above $17.5 million of the Product in the Territory in a calendar
year.


 


(1)          Single
Royalty. The royalty provided in Section 3(a)(ii) shall not increase
for the Product by reason of the Product being covered by more than one Valid
Claim or the Product being covered both by one or more Valid Claims and by Know
How.


 


(2)          In
the event that one or more generic versions of the Product that is approved
under 21 U.S.C. 355(j) (or any successor legislation) or which has an “AB”
rating with respect to that Product, is sold by a Third Party in the Territory,
for the remainder of the Royalty Term the Royalty payable pursuant to Section 3(a)(ii) shall
be reduced by XXX% of Net Sales so mat the royalty payments for the remainder
of the Royalty Term shall be as follows:


 


(a)          XXX%
on Net Sales below $XXX million of the Product in the Territory in a calendar
year;


 


(b)          XXX%
on Net Sales between $XXX million and $XXX million of the Product in the
Territory in a calendar year; and


 


(c)          XXX%
on Net Sales above $XXX million of the Product in the Territory in a calendar
year.


 


[Portions
of this Section have been omitted pursuant to a request for
confidentiality under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.  The confidential portions of
this Section that have been omitted are marked with “XXX”.  A copy of this Exhibit with all sections
intact has been filed separately with the Securities and Exchange Commission.]


 


 (iii)         milestone payments, in each case upon the
first achievement of given annual Net Sales of the Product in the Territory
during the Royalty Term, as follows, “annual Net Sales” being Net Sales in an
applicable calendar year:


 


10
















 


(1)          $XXX million upon the first achievement of $XXX
million of Net Sales of the Product in the Territory in a calendar year;


 


(2)          $XXX million upon the first achievement of $XXX
million of Net Sales of the Product in the Territory in a calendar year;


 


(3)          $XXX million upon the first achievement of $XXX
million of Net Sales of the Product in the Territory in a calendar year;


 


(4)          $XXX million upon the first achievement of $XXX
million of Net Sales of the Product in the Territory in a calendar year;


 


(5)          $XXX million upon the first achievement of $XXX
million of Net Sales of the Product in the Territory in a calendar year;


 


(6)          $XXX million upon the first achievement of $XXX
million of Net Sales of the Product in the Territory in a calendar year; and


 


(7)          $XXX million upon the first achievement of $XXX
million of Net Sales of the Product in the Territory in a calendar year.


 


[Portions
of this Section have been omitted pursuant to a request for
confidentiality under Rule 24b-2 of the Securities Exchange Act of 1934,
as amended.  The confidential portions of
this Section that have been omitted are marked with “XXX”.  A copy of this Exhibit with all sections
intact has been filed separately with the Securities and Exchange Commission.]


 


Company shall make each milestone payment within thirty (30) days of
the occurrence of the applicable milestone. For clarity, each milestone payment
will be required only once, upon the first achievement of the applicable
milestone. Each milestone payment shall be made by Company 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 the
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.


 


(iv)          Intentionally
omitted.


 


4.             Reports and Payments.


 


(a)           On or before the end of each
Quarter Company shall submit a good faith estimate of gross sales and Net Sales
made by the Company and its Affiliates during such Quarter and within forty
five (45) days following the end of each Quarter, 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 and its Affiliates to Third Parties during such
Quarter, including an itemization of deductions from gross sales that
separately shows the amount of each category of deduction enumerated in Section l(x).


 

















 


(ii)           intentionally
omitted;


 


(iii)          a calculation
under Section 3 of the amounts due to BPA, making reference to the
applicable subsection thereof; and


 


(iv)          such additional information
as is required by BPA to comply with its obligation to provide a report to
Antares pursuant to the Antares License Agreement.


 


The
first Payment Report shall be due on February 15, 2009, and the first good-faith
estimate shall be due January 10,2009. In addition, reports for milestone
payments shall be provided together with such payment when due. For the
avoidance of doubt, Company shall submit to BPA a Payment Report each Quarter
even if no royalty is due for such Quarter.


 


(b)          On the last business day of
that month in which a Payment Report is due under paragraph (a) above,
Company shall make payment to BPA of the amount due for the period covered by
the Payment Report. Notwithstanding the foregoing, milestone payments shall be
due as set forth Section 3(a)(iii) above.


 


(c)           Inspections and Audit. Company or
one or more of its Affiliates 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, royalties due
thereon, the statements provided by Company pursuant to Section 3(a) above,
and Company’s compliance with Section 7(a)(i). Such records shall be kept
at the principal place of business of Company, Azur Parent, or an Affiliate of
Company in the United States as notified to BPA, 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 for the audited period
exceeds the amount paid for such period by (i) ten percent (10%) or more
during the first two years of this Agreement; or (ii) five percent (5%) or
more thereafter, in which case Company shall bear the full cost of such audit.
Any additional payment 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
Company fails to pay any amount due and payable under this Agreement by the due
date, then it shall pay BPA interest on the total outstanding amount at the
lower of (i) two percentage points above the Prime Rate publicly announced
by J.P. Morgan Chase & Co. at its principal office that
is prevailing on the Due Date, or (ii) the highest rate permitted by law.


 


5.             Closing


 


(a)           Closing. The closing (the “Closing”)
of licenses contemplated by Section 2 hereof shall take place on the date
hereof (the “Closing Date”) concurrently with the execution and delivery
of this Agreement at the offices of Kenyon & Kenyon LLP, located at One
Broadway, New York, NY 10004-1007, or at such other time or in such other
location as the Parties shall mutually agree, including via facsimile and/or
email. The effective time of the Closing shall be 5:00 pm, New York City on the
Closing Date. At the Closing:


 


(i)            BPA shall
deliver to Company counterparts of the following documents, duly executed by
BPA and/or its applicable Affiliate(s):


 

















 


(1)           a certificate, dated as of the Closing Date, of the
Secretary or another officer of BPA certifying that BPA’s and execution,
delivery and performance of this Agreement has been duly authorized by all
necessary corporate action on the part of BPA; and


 


(2)           such other documents, instruments and certificates
as BPA and Company reasonably agree are necessary to effect the transactions to
be consummated at the Closing.


 


(ii)           Company shall
deliver to BPA:


 


(1)          counterparts of each of the agreements referred to
in Section 5(a)(i), above, duly executed by Company;


 


(2)          a certificate, dated as of the Closing Date, of the
Secretary or Assistant Secretary of Company certifying an accurate and complete
copy of the resolutions of the board of directors of Company authorizing the
execution, delivery and performance of this Agreement and the other agreements
to which it is a party;


 


(3)          the payments required at Closing pursuant to Section 3
above; and


 


(4)          such other documents, instruments and certificates
as BPA and Company reasonably agree are necessary to effect the transactions to
be consummated at the Closing.


 


6.             Regulatory and Related
Matters and Transition.


 


(a)           New Indications. Company shall have the
right, in its sole discretion, to pursue a New Indication for the Product in
the Territory (and to engage in development work and clinical trials outside
the Territory for such purpose pursuant to the provisions of Section 2(a)),
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 own 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.


 


(b)          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 of such
party and, in the case of BPA, information received from Antares) and
regulatory and manufacturing information in each case relating to the Product,
and each agrees that the other may utilize all such information 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 information from other licensees or
sublicensees, but BPA shall have no obligation to share or provide any such
information regarding Product with Company if despite such efforts such
information is not freely available to BPA with the right to share same with
Company. For the


 


13

















 


avoidance of doubt, (i) BPA shall have the
absolute right to freely share all information from Company with Antares, and (ii) neither
party shall be required to provide the other with information on new or other
transdermal estrogen products or to modifications or improvements of the
packaging or delivery system for Elestrin.


 


(c)           Transitional Assistance.   For the twelve month period beginning on the
Closing Date, BPA shall provide Company with technical and business support for
the manufacture, regulatory matters, safety matters, marketing, distribution,
and sale of Product as described in this paragraph. Such support shall be in
the form of making available for meetings and consultation with Company, at
mutually agreeable times, such knowledgeable BPA employees as BPA may identify
who have information, know-how, experience, and expertise that may reasonably
assist Company in its activities with respect to the Product under this
Agreement. Unless otherwise agreed to between the Parties, such employees will
be made available for consultations with Company by phone or at their regular
places of business, with Company to cover any out-of-pocket costs for travel if
by agreement of the Parties travel is required. The time provided by BPA shall
not exceed forty hours of executive time and one hundred hours of managerial or
technical/scientific/clinical time


 


(d)          Nycomed and DPT Agreement. To the extent
reasonably required by Company, BPA shall exercise Commercially Reasonable
Efforts to enforce the appropriate rights under mat certain Termination, Release
and Settlement Agreement with Nycomed dated as of August 6, 2008 (the “Nycomed
Agreement”) to procure for Company the benefit of the transitional provisions
for the remainder of the term of the Nycomed Agreement (as amended).


 


7.             Diligence; Compliance With
Laws: Copromotion.


 


(a)           The Company
shall use Commercially Reasonable Efforts to market, sell and distribute
Product for commercial sale and distribution in the Territory.


 


(i)            Company shall
launch the Product within 125 (one hundred and twenty five) days after the
Closing Date. Company shall spend at least $5 million on sales, marketing, and
medical affairs support for the Product during each of (x) the twelve
month period beginning at said launch, and (y) the twelve month period
beginning on the first anniversary of said launch. During the twenty four (24)
month period beginning at said launch, Company shall promote the Product using
its women’s health sales force. The foregoing obligations shall be suspended
for the period in which commercialisation of the Product is materially
adversely affected by a failure to supply outside of Company’s control, Force
Majeure or action by the FDA, provided that Company shall exercise Commercially
Reasonable Efforts to end such period of adversity. For the avoidance of doubt,
each $5 million obligation above (i) shall include all costs relating to
the sales force time spent in relation to the promotion of the Product, sample
costs and related activities whether prior to or after the date of such launch,
but (ii) shall not include any amounts paid to BPA under this Agreement.


 


(ii)           During the
Royalty Term the Company and its Affiliates shall not develop, make, have made,
market, sell, offer for sale, or distribute Competitive Products in the
Territory. However, in the event that Company, or a substantial part of the
assets and business of Company including the Business, is acquired by a Third
Party that is marketing a Competitive Product at


 


14

















 


the time of acquisition, this Section 7(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 where applicable promote the Product. If Company signs a
definitive agreement with respect to a merger or acquisition by which it would
acquire rights (other than residual financial rights) in a Competitive Product
at any time during the Royalty Term, then Company (or its applicable Affiliate)
shall have six (6) months from the closing of such definitive agreement to
divest itself of such rights in the Competitive Product and, during such six (6) month
period, the sale, marketing or distribution of such Competitive Product shall
not be in violation of this Section 7(a)(ii). In the case of divestiture
under the preceding sentence, such divestiture can occur by either (x) an
outright sale of all rights in the Competitive Product to a Third Party or (y) a
license to one or more Third Parties of the right to sell, market and
distribute such Competitive Product so long as Company and its Affiliates only
retain residual financial rights with respect to such Competitive Product and
do not exercise or have the ability to exercise any role or influence in any manner
over the conduct of the business of such Competitive Product (other than the
protection of reputational, intellectual property or similar rights or
interests). For the avoidance of doubt, Company shall not under any
circumstances use the Patents, Know How, Trademark, Trade Secrets, BPA’s
Confidential Information, or any aspect of the Intellectual Property Rights in
connection with or to advance or assist with the research, development, design,
formulation, manufacture, sale, distribution, or marketing of a Competitive
Product.


 


(b)          Company shall at all times materially comply with
and adhere to all Laws in the conduct of all of its activities under this
Agreement, including without limitation in the manufacture, marketing,
advertising, promotion, distribution, and sale of Product.


 


(c)           In connection with the launch of the Product by
Company, Company shall promptly provide BPA with two copies of each item of
advertising, detailing, or promotional materials used by Company for marketing
the Product in the Field in the Territory. Thereafter Company shall provide BPA
with one copy of each advertising, detailing or promotional material at the
same time as providing the annual summary report and the mid year update to
that report as envisaged pursuant to this Section 7(c). 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)          Company shall promptly 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.


 


(e)           For a period beginning twenty four (24) months after
the launch of the Product by Company, or if earlier Company’s failure to comply
with Section 7(a)(i), and ending on the earlier of (A) five (5) years
from the Closing Date or (B) six (6) months after closing of an event
that is a Change in Control of BPA, BPA shall retain the right to commence
copromoting the Product in the Territory with its own sales force (the “Copromotion Sales Force”). If BPA


 


15

















 


elects to exercise such right, the parties shall negotiate in good
faith a copromotion agreement taking into account (i) the then current
level of support then applied by Company to the Product and the status of the
Product and (ii) otherwise on usual commercial terms for the copromotion
of pharmaceutical products, with the material terms of such agreement providing
that (i) BPA shall be responsible for all costs incurred by the
Copromotion Sales Force, (ii) orders for Product obtained or solicited by
the Copromotion Sales Force shall be directed to Company and Company shall fill
such orders in a nondiscriminatory manner and on the same terms as orders
obtained by Company’s own sales force, (iii) Company shall be solely
responsible for setting the price of Product, and for all trade, distribution,
managed markets, medical, safety activities, advertising decisions and other
activities and operational decisions relating to the Product, (iv) the
Copromotion Sales Force shall use only those promotional materials that are
developed by Company, or, if developed by BPA, are approved by Company (such
approval not to be unreasonably withheld), and shall not promote to physicians
or customers targeted by Company and identified to BPA, (v) Company shall
make available to the Copromotion Sales Force the same promotional materials
and Product specific training made available to its own sales force (with the
cost of materials provided to BPA to be paid by BPA), (vi) Company shall
provide to BPA all directives provided to Company’s own sales force concerning
compliance with laws and regulations for marketing and sale of Product, and BPA
shall be responsible to ensure compliance by the Copromotion Sales Force of
such directives, (vii) BPA shall be responsible and shall indemnify
Company for all Losses arising out of for the actions and conduct of the
Copromotion Sales Force, (viii) BPA shall obtain product liability
insurance in the amount specified in Section 14(c), and (ix) the
financial provisions of the co-promotion arrangements shall be negotiated
(provided that the Company shall not be adversely impacted financially by the
copromotion activities compared to its sales, profitability and cash flow
arising from the Product in the absence of such copromotion activities so long
as Company materially maintains at least the same level of sales efforts and
activities as it used prior to the start of copromotion by BPA). For the
avoidance of doubt, if BPA exercises its right within the time period provided
in the first sentence of this paragraph, the duration of the copromotion shall
not conclude at the end of that period and shall rather be part of the
negotiated terms of the copromotion agreement.


 


8.             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 Product,
the Patents and the Know How (as that term is defined in the Antares License
Agreement), including, but not limited to, any and all improvements,
developments, and inventions thereof during the Royalty Term that cover and
solely relate to the Product, if any (which shall promptly be disclosed by
Company to BPA) and any such improvements, developments and inventions shall
constitute Intellectual Property Rights provided however that on or after December 31,
2023 no royalty shall be payable by Company where the only patent which
achieves exclusivity for the Product relates to such improvements, developments
and inventions developed by or on behalf of Company. For the avoidance of
doubt, any inventions made by or on behalf of Company during the term of the
Agreement that do not cover and solely relate to the Product shall remain the
property of Company, except that to the extent that Company has the right to
grant such rights, any such inventions that pertain in part to the Product are
hereby licensed to BPA, its successors and assigns on a nonexclusive,
nonterminable, perpetual basis with respect to Product outside the Territory
(and with respect to Product inside the Territory but limited to the scope and
term of BPA’s rights in the Territory as otherwise provided in this Agreement).
With the exception of the “except that” provision of the preceding sentence,
nothing in this


 


16

















 


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.


 


9.             Manufacturing.


 


(a)           During the Royalty Term Company shall use
Commercially Reasonable Efforts to have the Product manufactured in sufficient
quantities to supply any demand and any government or commercial requirements
in the Territory, and at all times shall ensure that the manufacture of Product
for sale in the Territory materially complies with applicable Laws. The
conclusion by Company of an agreement with, or furnishing purchase orders to,
DPT or another reputable Third Party manufacturer that is approved by the FDA
to manufacture the Product (if any) shall constitute performance of its
obligation under this Section 9(a). Nothing in this Agreement shall
require Company to qualify a source other than DPT to manufacture the Product.


 


(b)           At the request of Company, BPA shall reasonably
assist Company with arranging for manufacture of Product 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, and offering
assistance and consultation to Company’s representatives with respect to the
conduct of any such discussions with DPT. BPA shall request and authorize DPT
to work collaboratively with and disclose BPA Confidential Information to
Company regarding the manufacture of Product. Company shall request and
authorize DPT (or such other entity that Company may engage for manufacture of
Product) to work collaboratively with and disclose Company Confidential
Information to BPA regarding the manufacture of Product.


 


(c)           Company agrees that any Know How, Trade Secrets, or
Confidential Information of BPA held by DPT as of and following the Closing
Date shall as between Company and BPA remain the property of BPA and be
governed by the license and confidentiality provisions of this Agreement.


 


(d)           Subject to compliance with all applicable laws and
regulatory requirements, Company agrees to supply BPA with Product at cost plus
7.5% for use outside the Territory and 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 the Product independently of Company’s orders.
Company shall give BPA reasonable advance notice for each manufacturing run to
enable BPA to exercise its rights under this Section 9(d). Product shall
be packaged in the normal US packaging and Company shall not be responsible for
any changes in packaging or other activities that are not part of the normal
manufacturing practices of Company. BPA shall pay Company’s actual out of
pocket cost for such manufacture plus 7.5% of such cost (which shall only be
payable if such product is purchased from Company)


 


17

















 


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, as
applicable, and shall take delivery either directly from manufacturer or
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, Company
shall be entitled to direct DPT to satisfy the needs of Company and its
customers as reasonably demonstrated by Company to BPA, and if there is
sufficient capacity remaining to supply all or part of the requirement of BPA
and its licensees. In no event shall Company have any responsibility for any
matters relating to the supply of the Product such as failed lots, quality
issues, delays in supply, or product liability or otherwise have any liability
with regard to the supply of such product, and BPA hereby indemnifies and holds
harmless Company with regard to any claim which may be made by any Third Party
and for its part confirms mat Company has no liability to BPA based on or
arising out of the supply of Product under this Section 9(d) (except
for Company’s obligation to supply as set forth in the first sentence of this Section 9(d)).


 


(e)           At the request
of BPA, Company shall send to DPT a letter in substantially the form of Exhibit B
to advise DPT that it is permitted to communicate with BPA as set forth herein.


 


10.           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
Intellectual Property as of and after the Closing Date 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 (including, without limitation, the right to use and disclose
such Confidential Information in regulatory applications and filings and for
Company to use and disclose such Confidential Information to applicable Third
Parties such as appointed or potential manufacturers), and in the case of BPA
only under the Antares License Agreement, 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 (i) those of its employees, agents,
consultants, sublicensees, attorneys, accountants, and advisors 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, and (ii) in the case of BPA only, to Antares. The recipient
of the other Party’s Confidential Information shall take the same degree of
care that it uses to protect its


 


18

















 


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 10 to disclose Confidential Information to the
extent required to be disclosed under applicable law, provided 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 10 shall survive
for five years after the termination or expiration of this Agreement.


 


(f)            Communications with Antares. Company shall
not directly communicate with Antares with respect to the Product during the
Royalty Term unless specifically provided for in this Agreement or expressly
authorized in writing by BPA, provided that Company shall be entitled to notify
Antares of its acceptance of contingent obligations of Antares to Company, in
substantially the form set forth in Schedule 10(f).


 


11.           Representations. Warranties.


 


(a)           Except as set
forth on the corresponding section of the Disclosure Schedule attached hereto
as Schedule 11(a). BPA represents and warrants as of the Closing Date as
follows:


 


(i)             Antares License Agreement, (a) the
Antares License Agreement is in full force and effect; (b) the copy of the
Antares License Agreement that BPA has disclosed to Company on or before the
Closing Date is a true and accurate copy of such agreement as in effect as of
the Closing Date; (c) BPA is not in material breach of the Antares License
Agreement; (d) there is no unresolved material dispute between BPA and
Antares in connection with the Antares License Agreement, and in particular
there is no outstanding allegation of any material breach of the Antares
License Agreement by BPA or Antares; and (e) BPA has disclosed to Company
in writing all material correspondence between BPA and Antares pertaining to
the operation of the Antares License Agreement as it pertains to the rights
sublicensed to Company in this Agreement.


 


(ii)            Other Licenses. BPA has not granted any
license to the Intellectual Property Rights (including the Patents or
Trademark) in the Field and in the Territory that remain in effect or in force
as of the Closing Date, other than to Company pursuant to this Agreement.


 


19

















 


(iii)          Claims, (a) there
are no claims, actions, suits or proceedings commenced, pending or to BPA’s
Knowledge threatened against it or any of its Affiliates relating to any of the
the Intellectual Property Rights or the Business that could reasonably be
expected to have a Material Adverse Effect on the rights and benefits granted
to Company hereunder and, to the Knowledge of BPA, no fact or circumstance
exists that could reasonably be expected to validly give rise thereto; (b) BPA
has not received written notice that any Third Party intends to challenge the
patentability or validity of any Patent or Trademark, with the exception of the
challenge to the Trademark made by Warner Chilcott and which has been resolved
pursuant to the Trademark Coexistence Agreement of July 23,2008; (c) there
is no lawsuit pending or to BPA’s Knowledge threatened, which in any manner
challenges or seeks the rescission of, or seeks to prevent, enjoin, alter or
materially delay the consummation of, or otherwise relates to, this Agreement
or the transactions contemplated hereby; and (d) there is no lawsuit which
BPA presently intends to initiate which directly involves any of the
Intellectual Property Rights or the Business and, to the Knowledge of BPA, no
fact or circumstance exists that could reasonably be expected to validly give
rise thereto. Since December 31,2006, BPA has not been notified in writing
of any claim against it or its Affiliates or insurers relating to product
liability or similar liability relating to Product and no payment or settlement
of any kind has been made in response to or in anticipation of such a claim.


 


(iv)          NDA, Clinical Data and Phase
IV Studies, (a) BPA has made available for inspection by
Company a copy of the NDA and copies of all material correspondence and
documents to and from FDA regarding the Product or the NDA; (b) BPA has
performed all clinical studies regarding the Product in material compliance
with all applicable laws and guidelines and good clinical practice; and (c) the
FDA has not imposed an obligation to conduct one or more Phase IV studies.


 


(v)           Safety and Efficacy Data. 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 regarding
the Product.


 


(vi)          No Debarment. In the course
of developing Product, 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 of
debarment proceedings by the FDA, and BPA hereby covenants that it and its
Affiliates shall not do so with respect to Product during the Royalty Term.


 


(vii)         Organization. BPA is duly
organized, validly existing and in good standing under the laws of its
jurisdiction of formation.


 


(viii)         Power and Authorization. The execution
and delivery by BPA of this Agreement, and the performance of each of its
respective obligations hereunder and thereunder and the consummation of the transactions
contemplated hereby and thereby are within its power and have been duly
authorized by all necessary action on the part thereof. This Agreement (a) has
been or, when executed and delivered in accordance herewith, will be, duly
executed and delivered by a duly authorized representative of BPA and (b) is
or, when executed and delivered in accordance herewith, will be, the legal,
valid and binding obligation thereof, enforceable against such Person in
accordance with their respective terms, except as enforceability may be


 


20
















 


limited
by applicable bankruptcy, insolvency, reorganization, moratorium or other
similar laws now or hereafter in effect relating to or affecting creditors’
rights generally.


 


(ix)           Authorization
of Regulatory Authorities. No action by or in respect of, or filing
with, any Regulatory Authority is required by BPA or any of its Affiliates for,
or in connection with, the valid and lawful (i) authorization, execution
and delivery by BPA and its Affiliates of this Agreement or (ii) the
consummation of the sale of the license of the Intellectual Property Rights, as
contemplated hereby.


 


(x)            Noncontravention.


 


(a)           The execution
and delivery by BPA of this Agreement, and the performance of each of its
respective obligations hereunder and thereunder and the consummation of the
transactions contemplated hereby and thereby does not and will not (i) violate
any Laws or any decree or judgment of any court or other Regulatory Authority
applicable to BPA, the Intellectual Property Rights or the Business; (ii) violate
or conflict with, result in a breach of, constitute a default (or an event
which, with or without notice or lapse of time or both, would constitute a
default) under, permit cancellation of, or result in the creation of any
encumbrance (other than Permitted Encumbrances) upon any of the Intellectual
Property Rights under, any Contracts to which BPA is a party or by which any of
them is bound (subject to BPA obtaining the consents set forth on Schedule
11(x); or (iii) violate or conflict with any provision of the Certificate
of Incorporation or By-laws or other organizational documents of any of BPA.


 


(b)           No material
consents or approvals of, or filings or registrations by BPA with, any
Regulatory Authority or any other Third Party are necessary in connection with the
execution, delivery and performance of this Agreement by BPA.


 


(xi)           Encumbrances. Except for
Permitted Encumbrances, (i) there are no encumbrances on any of the
Intellectual Property Rights owned by BPA, (ii) BPA has not caused there
to be any encumbrances on the Intellectual Property Rights that are licensed to
BPA, and (iii) to the Knowledge of BPA, there are no encumbrances on the
Intellectual Property Rights that are licensed to BPA with the exception of
such encumbrances referred to in Schedule l(bb).


 


(xii)          Title:
Sufficiency.


 


(a)           At the Closing,
BPA will convey to Company a valid license to and under the Intellectual
Property Rights on the terms and conditions of this Agreement.


 


(b)           The
Intellectual Property Rights constitute all of the material assets and rights
that are currently used by BPA solely or primarily in connection with the
conduct of the Business pertaining to the Product.


 


(xiii)        Intellectual Property.


 


(a)           To BPA’s
Knowledge, the use, sale, offer for sale, manufacture, import, promotion,
marketing or distribution of the Product in the Territory (including the
practice of the Intellectual Property Rights with respect to same), in a manner
consistent with the


 


21

















 


manner
in which the Business is conducted as of the Closing Date, does not interfere
with, infringe upon, misappropriate, or otherwise conflict with any
intellectual property right owned or controlled by any Third Party. BPA has not
received any written charge, complaint, claim, demand, or notice within the
past two (2) years alleging any such interference, infringement,
misappropriation, or violation (including any claim that BPA or any of its
Affiliates must license or refrain from using any of the Intellectual Property
Rights). To the Knowledge of BPA, within the past two (2) years no Third
Party has undertaken any activities which challenged, infringed or
misappropriated, or if unabated would constitute infringement or
misappropriation, of any of the Intellectual Property Rights.


 


(b)           Schedule
11(xiii) identifies all current and subsisting trademark,
copyright, domain and patent filings or registrations that have been made or
issued to BPA or its predecessors that relate to the Intellectual Property
Rights. With the exception of the rights licensed to BPA under the Antares
License Agreement, BPA is the sole owner of the Intellectual Property Rights,
free of any Encumbrances other than Permitted Encumbrances, and with respect to
such rights as are licensed to BPA under the Antares License Agreement, that
agreement is in full force and effect. Each item identified in Schedule
l1(xiii) is, to the Knowledge of BPA, valid, subsisting and in full force
and effect, and BPA and Antares has taken all steps necessary to maintain such
registrations, including the payment when due of all registration and
maintenance fees and annuities and the filing of all necessary renewals,
statements and certifications, and all necessary documents and certificates in
connection with such registered Intellectual Property Rights have been filed
with the relevant patent, copyright or other governmental or Regulatory
Authorities for the purposes of maintaining such registered Intellectual
Property Rights.


 


(c)           The
Intellectual Property Rights licensed to Company pursuant to the licenses
granted in Section 2, constitute all of the intellectual property and
proprietary rights owned or licensed to BPA that are necessary for Company to
conduct the Business in the same manner, in all material respects, as the Business
is conducted by BPA and its Affiliates immediately prior to the Closing Date,
except that Company’s ability to use the Authorized Marks shall be limited to
the use contemplated by Section 2(c).


 


(xiv)        Legal
Compliance.


 


(a)           Since December 31,2006,
BPA and its Affiliates have conducted their operations as they pertain to the
Business of the Product in material compliance, in all respects, with all
applicable Laws. Neither BPA nor any of its Affiliates has received any written
notice of a material violation of any applicable Laws from any Regulatory
Authority relating to the Business or the promotion, distribution, marketing,
use and sale of the Product in the Territory within the past twenty-four (24)
months.


 


(b)           With respect to
the manufacture, labeling, packaging, promotion, distribution, marketing, use
and sale of the Product in the Territory, neither BPA nor any of its Affiliates
has received or been subject to, during the past twenty-four (24) months, any
FDA Form 483s relating to the Product, any FDA notices of adverse findings
relating to the Product, or any warning letters or other correspondence from
the FDA or any other Regulatory Authority in which the FDA or such other
Regulatory Authority asserted that the promotion, distribution,


 


22

















 


marketing,
use or sale of any Product in the Territory was not in compliance with
applicable Laws. During the past twenty-four (24) months with respect to the
promotion, distribution, marketing, use and sale of the Product in the
Territory, there has not been any occurrence of any product recall, market
withdrawal or replacement, or post-sale warning conducted by or on behalf of
BPA or its Affiliates concerning the Product or, to the Knowledge of BPA, any
product recall, market withdrawal or replacement conducted by or on behalf of
any Third Party as a result of any alleged defect in the Product.


 


(c)           Since December 31,
2006, all adverse events relating to the Product known to BPA have been duly
reported to the FDA to the extent required by applicable Laws.


 


(xv)         Regulatory Approvals.


 


(a)           Schedule 11(xv) includes a
complete list of all of the NDAs and ANDAs held by BPA or its Affiliates with
respect to the Product. BPA is the sole and exclusive owner of the NDA. The NDA
in respect of the Product is in full force and effect.


 


(b)           To BPA’s
Knowledge, all Product sold under the NDA have been marketed in accordance with
the NDA.


 


(xvi)        Contracts.


 


(a)           Neither BPA or
any of its Affiliates nor, to the Knowledge of BPA, any other party to any
Assigned Contract, is in breach or violation of, or default under, or has
repudiated any provision of, any Assigned Contract, except for such breaches,
defaults, violations or repudiations as would not have a material impact on the
ability of BPA or its Affiliates to conduct the Business in accordance with
past practices of BPA or its Affiliates.


 


(xvii)       No Material
Adverse Effect. Since August 8, 2008, the Business has been
conducted only in the ordinary course and to the Knowledge of BPA there has not
been any change, effect, event or condition that has had, or would reasonably
be expected to have, a Material Adverse Effect.


 


(xviii)      Taxes.


 


(a)           BPA has timely
filed all material Tax Returns required to be filed relating to the Licensed Intellectual
Property Rights (excluding any Tax Returns required to be filed as a result of
the transactions contemplated herein) and such Tax Returns were correct and
compete in all material respects at the time of filing.


 


(b)           BPA has timely
paid all material Taxes shown as due and owing on the material Tax Returns
described in (a) above.


 


(c)           BPA has not
received from any Regulatory Authority any written notice of proposed
adjustment, deficiency or underpayment of any material Taxes relating to the
Licensed Intellectual Property Rights that has not been satisfied by payment or
withdrawn, and no written claims related to such Taxes have been asserted or
threatened against BPA.


 


23

















 


(d)           No agreement
for the extension of time for the assessment of any material taxes relating to
the Licensed Intellectual Property Rights is currently in effect.


 


(e)           There are no
liens for Taxes on the Intellectual Property Rights owned by BPA other than
Permitted Encumbrances, BPA has not caused the creation of any lien for Taxes
on any Intellectual Property Rights that are licensed to BPA and to BPA’s
Knowledge there are no hens for Taxes on any Intellectual Property Rights that
are licensed to BPA.


 


(xix)         Generics. (i) To
the Knowledge of BPA, no AB Rated generic equivalent to the Product (a “Generic”)
has been Launched, (ii) to the Knowledge of BPA, no ANDA seeking approval
of a Generic has been filed with the FDA and (iii) BPA has not received
written notice expressly indicating that any Person intends to submit an ANDA
in respect of a Generic with the FDA.


 


(xx)          No Brokers. BPA and its
Affiliates have no liability of any kind to, and are not subject to any claim
of, any broker, finder or agent in connection with the transactions
contemplated by this Agreement other than those which will be borne by BPA.


 


(b)           Company
represents and warrants to BPA as follows:


 


(i)            Organization. Company is
duly organized and validly existing under the laws of its jurisdiction of
formation.


 


(ii)           Power and
Authorization. The execution and delivery by Company of this
Agreement, and the performance of each of its respective obligations hereunder
and thereunder and the consummation of the transactions contemplated hereby and
thereby are within its power and have been duly authorized by all necessary
action on the part thereof. This Agreement (a) has been or, when executed
and delivered in accordance herewith, will be, duly executed and delivered by a
duly authorized representative of Company and (b) is or, when executed and
delivered in accordance herewith, will be, the legal, valid and binding
obligation thereof, enforceable against such Person in accordance with their
respective terms, except as enforceability may be limited by applicable
bankruptcy, insolvency, reorganization, moratorium or other similar laws now or
hereafter in effect relating to or affecting creditors’ rights generally.


 


(iii)          Authorization
of Regulatory Authorities. No action by or in respect of, or filing
with, any Regulatory Authority is required by Company or any of its Affiliates
for, or in connection with, the valid and lawful (i) authorization,
execution and delivery by Company and its Affiliates of this Agreement or (ii) the
consummation of the sale of the license of the Intellectual Property Rights, as
contemplated hereby.


 


(iv)          Noncontravention.


 


(a)           The execution
and delivery by Company of this Agreement, and the performance of each of its
respective obligations hereunder and thereunder and the consummation of the
transactions contemplated hereby and thereby does not and will not (i) violate
any Laws or any decree or judgment of any court or other Regulatory Authority
applicable to Company, the Intellectual Property Rights or the Business; (ii) violate
or conflict


 


24

















 


with
any provision of the Certificate of Incorporation or By-laws or other
organizational documents of any of Company.


 


(b)           No material
consents or approvals of, or filings or registrations by Company with, any Regulatory
Authority or any other Third Party are necessary in connection with the
execution, delivery and performance of this Agreement by Company.


 


(v)           No Brokers. Company and
its Affiliates have no liability of any kind to, and are not subject to any
claim of, any broker, finder or agent in connection with the transactions
contemplated by this Agreement other than those which will be borne by Company.


 


(c)           Other than as
expressly provided in this Agreement, neither party makes any warranty and
makes no representation, express or implied. IN PARTICULAR, BUT WITHOUT
LIMITATION OF THE GENERALITY OF THE PRECEDING SENTENCE, EXCEPT AS EXPRESSLY SET
FORTH HEREIN 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.


 


12.           Prohibition Against Use of
Names: Confidentiality of Agreement.


 


(a)           Subject to the
provisions of Section 2(c), neither Party shall use the name, insignia, or
symbols of the other party, 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 Al
and Exhibit A2. 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 12, including the exception for any public
disclosures made in compliance with the terms of Section 12(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 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


 


25

















 


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 in
connection with negotiation or closing of (i) a merger, acquisition,
placement, investment, or other such transaction with such Third Party, (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 such
Third Party (and its professional advisers), or (iii) the potential
conclusion by Company of agreements in relation to the performance of its
rights and obligations under this Agreement that reasonably require such
disclosure, including in relation to the manufacture distribution and sale of
Product. Advance written permission for disclosure will not be required when a
party is ordered to disclose information concerning the Agreement by a
Governmental Authority 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.


 


13.           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.


 


14.           Additional Covenants And
Agreements.


 


(a)           Expenses. Except to the
extent otherwise expressly set forth in this Agreement, BPA and Company shall
bear their respective expenses incurred in connection with the preparation,
execution and performance of this Agreement, including, without limitation, all
fees and expenses of agents, representatives, counsel and accountants.


 


(b)           Withholding. Any and all
payments made by Company (or its successors or assigns) to BPA shall be made
without setoff, counterclaim or other defense, and free and clear of, and
without deduction or withholding for or on account of, any withholding taxes,
except to the extent such withholding taxes are required by law. In the event
that due to Company’s assignment of this Agreement or any rights hereunder to
any other Person or Company’s failure to comply with applicable tax laws, any
withholding taxes are imposed and required by law to be deducted or withheld
from any payment required to be made under this Agreement, then the amount of
such payment shall be increased by Company (or its successors or assigns) as
may be necessary such that such payment is made, after withholding or deduction
for or on account of such withholding taxes, in an amount that is not less than
the amount provided for herein, and Company (or its successors or assigns)
shall withhold the full amount of such withholding taxes from such payment and
shall pay such amount to the governmental authority imposing such withholding
taxes in accordance with applicable law. In the event of any tax withholding
not subject to the provisions of the preceding sentence, Company shall provide
to BPA receipts, statements, or other documentation concerning such
withholding, assign to BPA or its designee the right to apply for release of
the withheld amounts, and execute any assignment, permission, certificate or
the like reasonably required for BPA or its designee to make such application.
On


 


26

















 


or
prior to the Closing, and from time to time thereafter upon the reasonable
request of Company for so long as accurate, BPA shall furnish to Company a duly
completed and executed Form W-9 certifying that BPA is a U.S. Person. On
or prior to the date on which any such form or certification expires or becomes
obsolete and after the occurrence of any event requiring a change in the most
recent form or certification previously delivered to Company, including the
assignment by BPA of this Agreement or any rights hereunder to any other Person
or the permitted assumption by any other Person of BPA’s rights under this
Agreement, BPA and the assignee (or assuming Person) shall provide Company duly
completed copies of Internal Revenue Service Forms W-9 or W-8BEN (or any
successor forms), as applicable, or any other documentation prescribed by
applicable law to enable Company to determine whether or not withholding taxes
are required to deducted from any payment required to be made under this
Agreement.


 


(c)           Company shall
obtain and carry in full force and effect product liability insurance in
respect of the applicable Product in the amount of $10,000,000 per occurrence
and in the aggregate and policies of $10,000,000 of excess coverage in the
aggregate. For three years from the Closing Date BPA shall obtain and carry in
full force and effect product liability insurance in respect of the applicable
Product in the amount of $5,000,000 per occurrence and in the aggregate and
policies of $5,000,000 of excess coverage in the aggregate.


 


(d)           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.


 


15.           Indemnity.


 


(a)           Subject to the
limitations set forth in this Section 15, BPA shall indemnify, hold harmless
and defend Company, its Affiliates, and their respective officers, directors,
employees and agents (the “Company
Indemnitees”) from and against any and all losses, damages, liabilities,
judgments, fines, amounts paid in settlement, expenses and costs of defense
(including without limitation reasonable attorneys’ fees) resulting from any
action, suits, claims, demands, or prosecutions brought or initiated by a Third
Party (each a ‘Third Party Claim”) (collectively
“Losses”) incurred or suffered by the Company Indemnitees or any of them as a
result of, arising out of, or relating to:


 


(i)            any breach of,
or inaccuracy in, any representation or warranty made by BPA in this Agreement
or any certificate delivered pursuant hereto (disregarding, for purposes of
determining both the existence of any breach and the extent of any Losses, any
qualification or exception with respect to materiality or Material Adverse
Effect contained therein); or


 


(ii)           any breach,
nonperformance, or violation of any covenant or agreement of BPA (including,
without limitation, under this Section 15) contained in this Agreement.


 


(b)           Subject to the
limitations set forth in this Section 15, 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 resulting from a


 


27

















 


Third
Party Claim incurred or suffered by the BPA Indemnitees or any of them as a
result of, arising out of, or relating to:


 


(i)            any breach of,
or inaccuracy in, any representation or warranty made by Company in this
Agreement or any certificate delivered pursuant hereto (disregarding, for
purposes of determining both the existence of any breach and the extent of any
Losses, any qualification or exception with respect to materiality or Material
Adverse Effect contained therein); or


 


(ii)           any breach,
nonperformance, or violation of any covenant or agreement of Company
(including, without limitation, under this Section 15) contained in this
Agreement.


 


(c)           Inter-Party Claims. In order for a Party to
validly assert a Claim for indemnification under this Article, such Party shall
deliver written notice (a “Claim Notice”) to
the other Party as soon as practicable but in any event no later than thirty
(30) days after such Claim becomes known to the Company Indemnitee or BPA
Indemnitee, as applicable (all such persons collectively, the “Indemnified Person”), specifying (to the
extent known) the facts constituting the basis for, and the amount (to the
extent known) of, such Claim. Failure to deliver a Claim Notice with respect to
a Claim in a timely manner as specified in the preceding sentence shall not be
deemed a waiver of the right of the Indemnified Person to indemnification in
connection therewith except (i) to the extent the other Party (the “Indemnifying Party”) is actually and
materially prejudiced as a result of such failure, in which case the amount of
indemnification to which the Indemnified Person is entitled shall be reduced by
the amount, if any, by which the Indemnified Person’s Damages would or are
reasonably expected to have been lower had such Claim Notice been timely
delivered and, (ii) the Indemnified Person shall be solely responsible for
any expenses incurred by the Indemnified Person during such period of delayed
notice and for any increased costs (such as cost of substituting counsel)
resulting from such delayed notice, and there shall be a rebuttable presumption
that the Indemnifying Party was actually and materially prejudiced as a result
of such failure if the notice is delayed more than six (6) months. The
Indemnified Person shall deliver to the Indemnifying Party, promptly following
the Indemnified Person’s receipt thereof, copies of all notices and documents
(including court papers) received by the Indemnified Person relating to any
Claim made by another Person against the Indemnified Person (a “Third Party Claim”). If the Indemnifying
Party does not notify the Indemnified Person in writing within thirty (30) days
from its receipt of the Claim Notice that the Indemnifying Party disputes such
Claim or reserves its rights (an “Indemnity
Dispute Notice”), the Indemnifying Party shall be deemed to have
agreed with and accepted such Claim. The Indemnified Person may in all events
take all necessary and appropriate actions to defend a Third Party Claim until
defense is undertaken by the Indemnifying Party, and shall in no event concede
liability except as part of a settlement that is approved by the Indemnifying
Party or otherwise permitted under this Section 15 or after giving seven
days’ notice to the Indemnifying Party of its intention to do so in
circumstances where the Indemnifying Party does not undertake such defense
prior to the expiry f such notice.


 


(d)           Third Party Claims. The Indemnifying Party may
assume the defense of any Third Party Claim with counsel selected by the
Indemnifying Party and reasonably acceptable to the Indemnified Person by
providing written notice to the Indemnified Person within thirty (30) days
after receiving the applicable Claim Notice. If the Indemnifying Party fails to
assume the


 


28

















 


defense of a Third Party Claim by providing such written notice, the
Indemnifying Party shall be liable for the fees and expenses of one counsel
selected by the Indemnified Person and reasonably acceptable to the
Indemnifying Party, except that the Indemnifying Party shall retain the right
to substitute counsel of its selection and reasonably acceptable to the
Indemnified Person. If the Indemnifying Party elects to assume the defense of a
Third Party Claim, the Indemnified Person shall have the right to participate
in the defense thereof and to employ counsel, at its own expense, separate from
the counsel employed by the Indemnifying Party, it being agreed, subject to the
following sentence, that the Indemnifying Party shall control such defense, and
the Indemnifying Party shall not be liable to the Indemnified Person for any
legal or other expenses incurred by the Indemnified Person in connection with
the defense thereof. Notwithstanding the preceding sentence, if the named
parties (including any impleaded parties) to an Action in connection therewith
include both an Indemnified Person and the Indemnifying Party (or any of its
Affiliates) and the Indemnified Person reasonably concludes that there may be
legal defenses available to it which are different from or additional to those
available to the Indemnifying Party (or its Affiliates), the Indemnifying Party
shall be liable for the fees and expenses of one separate counsel selected by
the Indemnified Person to represent the Indemnified Person in connection
therewith and, if the Indemnified Person notifies the Indemnifying Party
thereof in writing, the Indemnifying Party shall not have the right to assume
the defense thereof. If the Indemnifying Party elects to defend or prosecute a
Third Party Claim, the Indemnified Person shall fully cooperate in the defense
or prosecution thereof, and such cooperation shall include the retention and
(upon the Indemnifying Party’s request) the provision to the Indemnifying Party
of records and information that are reasonably relevant to such Third Party
Claim, and making the Indemnified Person’s Agents available on a mutually
convenient basis to provide additional information and explanation of any such
materials.


 


The
Indemnifying Party shall not effect, without the prior written consent of the
Indemnified Person, any settlement, compromise or discharge of a Third Party
Claim unless the same (x) involves an unconditional release of the
indemnified claim against the Indemnified Person in form reasonably
satisfactory to the Indemnified Person, (y) does not include any statement
or admission as to fault, culpability, or failure to act by or on behalf of any
Indemnified Person and (z) is limited to the payment of monetary damages
and/or to action solely undertaken by the Indemnifying Party. The Indemnifying
Party shall not be liable for any settlement, compromise or discharge of a
Third Party Claim effected without its prior written consent, but if settled,
compromised or discharged with its written consent or if there is a final Order
for the plaintiff in any such Third Party Claim, the Indemnifying Party shall
indemnify the Indemnified Person in connection therewith.


 


(e)           Intentionally
omitted.


 


(f)            Limits.


 


(i)            BPA will have
no obligation to indemnify any Company Indemnitee pursuant to Section 15(a)(i) unless
(i) any individual Loss contemplated by Section 15(a)(i) exceeds
Twenty Thousand Dollars ($20,000), in which case the total amount of such Loss
(the “Threshold Claim Amount”) shall be taken into account, and (ii) the
cumulative total of Threshold Claim Amounts exceeds One Hundred Thousand
Dollars ($100,000) (the “Deductible Amount”), whereupon the Company Indemnitees
shall be entitled to indemnification in respect


 


29

















 


of
all Losses including those less than the Deductible Amount and including Losses
which are individually less than the Threshold Claim Amount.


 


(ii)           BPA will have
no obligation to indemnify any Company Indemnitee pursuant to Section 15(a)(1) to
the extent that the aggregate amount of all such Losses incurred or suffered by
such Company Indemnitees exceeds $2,000,000, provided however that the foregoing
limitation of $2,000,000 (the “Cap”) shall
not apply with regard to any breach of, or inaccuracy in, any representation or
warranty made by BPA in Sections 11(a) subparagraphs (iv)(b), (vi) and
(xv)(b) in which case the limitation shall be $1,000,000 (the “Alternative Cap”) provided further, that
the foregoing limitations shall not apply to any claim or suit based upon a
breach or inaccuracy of a Fundamental Rep.


 


(iii)          For the
avoidance of doubt, the limitations set forth in Section 15(f)(1) and
(ii) shall not apply in respect of the indemnification obligations of BPA
in Section 15(a)(ii).


 


(iv)          Notwithstanding
anything in this Agreement to the contrary, BPA will have no obligation to
indemnify any Company Indemnitee pursuant to Section 15(a)(i), or for
damages to Company for breach of a representation or warranty other than a
Fundamental Rep, unless the occurrence of a loss or damage to Company became
manifest within eighteen (18) months after Closing and Company gave notice to
BPA of same no more than twenty (20) months after Closing.


 


(g)           Time for Claims. No claim may
be made or suit instituted seeking indemnification pursuant to this Section 15
unless a written notice describing the basis for such claim or suit in
reasonable detail in light of the circumstances then known to the Indemnified
Party is provided to the Indemnifying Party:


 


(i)            at any time
prior to the expiration of the applicable statute of limitations, in the case
of any claim or suit based upon a breach or inaccuracy of a Fundamental Rep;


 


(ii)           at any time
prior to (i) eighteen months after the end of the License Term, in the
case of claims arising from a breach of a covenant to be performed or complied
with during the License Term, or from an inaccurate certification made in a
certificate delivered pursuant to Section 5(a)(i)(1) or 5(a)(ii)(2’)
or (ii) the expiration of the applicable statute of limitations in the
case of claims arising from a breach of any other provision including breach of
a covenant.


 


The representations and warranties made by the Parties under this
Agreement shall survive for a period contemporaneous with the period during
which the applicable Party may assert a claim in respect of a breach thereof,
as set forth above in this Section 15(g).


 


(h)           Consequential
Damages. IN NO EVENT WILL EITHER PARTY HAVE ANY LIABILITY TO THE OTHER FOR ANY
INDIRECT (INCLUDING LOST PROFITS), SPECIAL, CONSEQUENTIAL OR PUNITIVE DAMAGES
EVEN IF ADVISED OF THE POSSIBILITY THEREOF, PROVIDED THAT THE FOREGOING DOES
NOT LIMIT THE PARTIES RESPECTIVE INDEMNITY OBLIGATIONS FOR THIRD PARTY CLAIMS.
THE ALLOCATION OF LIABILITY IN THIS PARAGRAPH REPRESENTS THE AGREED AND


 


30

















 


BARGAINED
FOR UNDERSTANDING WITH RESPECT TO THE ALLOCATION OF RISKS INHERENT IN THIS
AGREEMENT.


 


16.           Intellectual Property.


 


(a)           Patent Prosecution.


 


(i)            As between the
parties and to the extent that BPA has the right to do so under the Antares
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 incurred after the Closing Date to the extent
exclusively relating to the Product or requested by Company, 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 Antares 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.
Company shall treat such information as BPA Confidential Information. 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 Antares 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.
BPA shall use Commercially Reasonable Efforts to maintain all of the Patents in
common ownership, where common ownership is required by one or more terminal
disclaimers in the Territory, whether the terminal disclaimer refers to patents
or patent applications.


 


(ii)           Intentionally
omitted.


 


(iii)          The Parties
acknowledge that Company, as the holder of the NDA, may refer to applicable
Patents in the listing for the Product in the Orange Book.


 


(b)           Patent Enforcement.


 


(i)            Group One
Claims. If requested by Company, BPA shall use Commercially Reasonable
Efforts (including Commercially Reasonable Efforts to persuade Antares to agree
to permit BPA to enforce the Group One Claims pursuant to this paragraph, subject
to the enforcement rights of the Antares License Agreement, to enforce the
Group One Claims against infringement by Third Parties in the Territory,
provided that Company agrees to pay all fees, costs, and expenses incurred by
BPA in or as a result of undertaking such efforts to enforce the Group One
Claims at Company’s request,


 


31
















 


provided
further that if the proceedings relate to the Product and one or more other
products, the Parties shall agree on a fair allocation of the costs to be borne
by Company. If requested by Company, BPA shall also use Commercially Reasonable
Efforts, subject to the enforcement rights of the Antares License Agreement, to
defend the Group One Claims against any challenges in the Territory, provided
that Company agrees to pay all fees, costs, and expenses incurred by BPA in or
as a result of undertaking such efforts to defend the Group One Claims. If
Company so elects BPA to enforce Group One Claims or defend Group One Claims,
Company shall reasonably assist and cooperate in any enforcement or defense at
Company’s sole expense. If BPA finds it necessary or desirable to join Company
as a party, Company shall execute all papers or perform any other acts as may
reasonably be required by BPA, at the expense of Company. BPA shall keep
Company reasonably informed concerning such Group One Claims to the extent that
BPA itself has such information, including (to the extent available to BPA and
permitted by a discovery confidentiality order or the like) providing copies of
any communications received in connection with such litigation to Company
promptly after receipt thereof. To the extent practicable, BPA shall consult
with and consider any comments made by Company (including the development and
implementation of a litigation strategy) and permit Company the opportunity to
review and comment on any proposed written communication, filing pleadings or
other documents or submissions filed with the court in the course of such
proceedings. BPA will seek and reasonably consider Company’s comments on
strategy for dispositive motions and settlement in any action to enforce or
defend the Group One Claims, and Company will reasonably assist and cooperate
in any enforcement or defense; provided, however, that BPA shall retain the
sole right to select counsel of its choosing reasonably acceptable to Company
(it being agreed that Kenyon & Kenyon LLP is acceptable). Any recovery
realized as a result of any infringement actions described in this Section 16(b) (after
reimbursement of the Parties’ reasonable attorneys’ fees for outside counsel
and litigation expenses) shall be treated as Net Sales of Product in the year
of receipt in accordance with Section 3(a) with Company receiving
such amounts and paying to BPA the applicable royalty under Section 3(a)(ii),
but shall not be treated as Net Sales for the purpose of any milestone payments
under Section 3(a)(iii). Neither Party will enter into any withdrawal,
termination or settlement (including the granting of a covenant not to sue or
other rights that have a material impact on the rights granted to Company
pursuant to this Agreement and/or a Related Agreement) of any action brought
under this Section 16(b)(i) that affects the other Party’s rights or
interests without the other Party’s prior written consent, not to be
unreasonably withheld, conditioned or delayed. BPA will notify Company of all
substantive developments with respect to such enforcement or defensive actions
of the Group One Claims including, but not limited to, all material filings,
court papers and other related documents, substantive settlement negotiations
and offers of settlement. Nothing in this Section 16(b)(i) shall
prohibit BPA from independently deciding to bring such enforcement or defense
action regarding the Group One Claims in the Territory at BPA’s sole expense
provided that, BPA shall not agree to any settlement or other compromise of any
litigation or claim, demand or dispute relating to any alleged or threatened
infringement of any Group One Claim in relation to any pharmaceutical product
containing as its sole active ingredient the same active ingredient as the
Product, or otherwise likely to adversely affect the rights granted to Company
hereunder, without Company’s prior written consent if such settlement or other
compromise: (i) provides for a license to any intellectual property used
or useful in or in respect of the product at issue other than the applicable
Group One Claims; (ii) provides for any transfer of technology, know-how
or other proprietary rights; or (iii) involves


 


32

















 


supply of the product in question by BPA or BPA’s Affiliate. For
purposes of clarification, the parties agree that BPA shall have the sole right
to settle or compromise such litigation or claim, demand or dispute, including
without limitation by licensing or otherwise encumbering the applicable BPA
Patent(s) without the consent of Company provided the terms of such
settlement do not fall within clause (i), (ii) or (iii) of the first
sentence of this Section 16(a). BPA further hereby agrees that Company
shall have those rights possessed by BPA vis a vis Antares as set forth in
Sections 8.2.2 and 8.2.4 of the Antares License Agreement, pursuant to Section 6
of Amendment No. 6 thereto.


 


(ii)           Group Two
Claims. At its own expense, Company may, but will not be obligated to, elect
to enforce Group Two Claims against any actual, alleged or threatened
infringement by Third Parties in the Territory and may also elect to defend the
Group Two Claims against any challenges in the Territory. If Company so elects
to enforce Group Two Claims against Third Party infringement, BPA, at Company’s
request and sole cost and expense, will reasonably assist and cooperate in any
enforcement or defense of the Group Two Claims. If Company finds it necessary
or desirable to join BPA as a party, BPA will execute all papers or perform any
other acts as may reasonably be required by Company, at the expense of Company.
BPA agrees that BPA shall abide by any judgment resulting from such enforcement
or defense of the Group Two Claims. Any recovery realized as a result of any
infringement actions described in this Section 16(b)(ii) (after
reimbursement of the parties’ reasonable attorneys’ fees for outside counsel
and litigation expenses) shall be treated as Net Sales of Product in accordance
with Section 3(a) with Company receiving such amounts and paying to
BPA the applicable royalty under Section 3(a)(ii), but shall not be
treated as Net Sales for the purpose of any milestone payments under Section 3(a)(iii).
Company will seek and reasonably consider BPA’s comments on strategy for
dispositive motions and settlement in any action to enforce or defend the Group
Two Claims (provided, however, that Company shall retain the sole right to
select counsel of its choosing) and will notify BPA of all substantive
developments with respect to such enforcement or defensive actions regarding
the Group Two Claims including, but not limited to, all material filings, court
papers and other related documents, substantive settlement negotiations, offers
of settlement, and court hearings and proceedings.


 


(iii)          Paragraph IV
Proceedings.


 


Notwithstanding the provisions of the foregoing Sections (a) and (b) if
a Paragraph IV Certification (as defined in C.F.R. Title 21) is filed
referencing the Product the following provisions shall apply:


 


(a)           in the event
that either BPA or Company receives a Paragraph IV Certification (as defined in
C.F.R. Title 21) it shall inform the other Party verbally and in writing (by
facsimile or by e-mail) as soon as practicable and in any event not later than
two (2) Business Days of receipt of the foregoing certification or notice;


 


(b)           during the
following twenty-one (21) day period, BPA shall consult with Company as to the
commercial reasonableness of suing such Third Party for patent infringement
within the requisite forty-five (45) day period (“Infringement Suit”);


 


33

















 


(c)           if upon,
expiration of the twenty-one (21) day period, the Parties agree to file an
Infringement Suit, the following applies:


 


i               as between BPA
and Company, Company shall have sole discretion to direct the strategy of the
Infringement Suit (with Company recognizing that Antares as patent owner may
itself exercise such control);


 


ii              Company shall
keep BPA informed at all times of the Infringement Suit including providing
copies of any communications received in connection with such litigation to BPA
promptly after receipt thereof. Company shall consult with and consider any
comments made by BPA (including the development and implementation of a litigation
strategy) and permit BPA the opportunity to review and comment on any proposed
written communication, filing pleadings or other documents or submissions filed
with the court in the course of such Infringement Suit;


 


iii             BPA shall
cooperate with Company to enforce the Patents and the Know-How, including
initiation or maintenance as a party to the Infringement Suit to enforce such
rights;


 


iv             Company shall
be responsible for Company’s own external costs and expenses, including legal
fees, associated with the Infringement Suit, and shall also be responsible for
such reasonable costs of BPA as BPA incurs at the request of Company if BPA
joins in the suit at Company’s request.


 


(d)           if, upon
expiration of the twenty-one (21) day period, Company notifies BPA in writing
that Company does not want to initiate the Infringement Suit, the following
applies:


 


i               as between BPA
and Company, BPA shall have, in its sole discretion, the right to file an
Infringement Suit and to direct the strategy thereof;


 


ii              BPA shall keep
Company informed at all times of the Infringement Suit including providing
copies of any communications received in connection with such litigation to
Company promptly after receipt thereof. BPA shall consult with and consider any
comments made by Company (including the development and implementation of a
litigation strategy) and permit Company the opportunity to review and comment
on any proposed written communication, filing pleadings or other documents or
submissions filed with the court in the course of such Infringement Suit;


 


iii             Company shall
cooperate with Company to enforce the Patents and the Know-How, including
initiation or maintenance as a party to the Infringement Suit to enforce such
rights;


 


iv             BPA shall be
responsible for BPA own external costs and expenses, including legal fees,
associated with the Infringement Suit, and shall also be responsible for such
reasonable costs of Company as Company incurs at the request of BPA if Company
joins in the suit at BPA’s request.


 


34

















 


(c)           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.


 


(d)           Patent Marking
and Rights. Company shall mark Product with U.S. Patent No. 7,198,801,
and following the issuance of any additional Patents with the numbers of such
patents, in accordance with the requirements set forth in 35 U.S.C. § 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. The Company shall not challenge or contest, or assist or
encourage others to challenge or contest, the validity and enforceability of
the Patents.


 


(e)           Defense of and
Liability for Infringement Claims.


 


(i)            Each Party
shall promptly notify the other Party in writing of any allegation made,
threatened or brought against either of them alleging infringement or other
unauthorized use of the intellectual property of a Third Party arising from (i) the
development, manufacture, importation, use, offer for sale, sale or other
commercialization of the Product in the Territory or (ii) from the
development or manufacture outside the Territory as relates to the importation,
use, offer for sale, sale or other commercialization of the Product in the
Territory (“Infringement Claim’*). The
provisions of this Section 16(e) are in addition to and separate from
the provisions of Section 11(a)(xiii).


 


(ii)           If a court or
judicial body finds the Parties are required to obtain a Third Party License or
orders the payment of a lump sum or periodic payment (such as a royalty) to the
Third Party, or the Parties agree to settle the infringement Claim by taking a
Third Party License or agreeing to make payments to the Third Party, then,
subject to Section 16(e)(iii) and the following sentence, BPA’s
aggregate cumulative liability under this Section 16(e) shall be
fifty percent (50%) of any lump sum payment due to a Third Party; and fifty
percent (50%) of any royalty amount due to a Third Party; plus ten per cent
(10%) of the external legal fees and expenses incurred by Company in such
proceedings.


 


(iii)          Company will be
entitled to recover amounts due by BPA to Company under Section 16(e)(ii) solely
as a credit against on-going royalties payable by Company to BPA under this
Agreement, provided however that the maximum credit which may be claimed by
Company in any Quarter is limited to an amount that will not reduce royalties
to BPA for that Quarter below 8% of Net Sales. In addition any deficit
remaining in Company’s recovery of amounts due by BPA to Company following
recovery by Company within the limitations set forth in this Section 16(e)(iii) may
be carried over from year to year.


 


(iv)          BPA and Company
shall consult in good faith with respect to any actions BPA or Company proposes
to take in order to mitigate any loss or liability with respect to any
Infringement Claim, such actions may include Company ceasing to sell the
Product, DPT


 


35

















 


ceasing
to manufacture and supply Company with Product, Company ceasing to supply BPA
with Product (for use outside the Territory) and/or the Parties agreeing to
modify the Product.


 


(f)            Third Party
Licenses and Settlements.


 


(i)            Notice. If during the
Royalty Term either Party reasonably believes that the making, importation,
use, offer for sale or sale of the Product in the Field in the Territory would
infringe the intellectual property rights of a Third Party, that Party (“the Notifying Party”) shall so inform the
other Party (“Notified Party”), which
notification shall include documents supporting the Notifying Party’s position.
If the Notifying Party believes a Third Party License is necessary or advisable
to exercise its rights and obligations under this Agreement, including to sell
the Product and/or mitigate any potential liability therefore, the notice shall
include reference to such Third Party License.


 


(ii)           Counter-Notice. Notified
Party shall have thirty (30) days to review the notice issued pursuant to Section 16(f)(i) from
the Notifying Party and to agree or disagree with the Notifying Party’s belief
by counter-notice. If the Notified Party disagrees with the Notifying Party’s
belief, then the Notified Party shall provide the Notifying Party with
documents or other information supporting the Notified Party’s position. The
Notifying Party shall have thirty (30) days from the date of receipt to review
the documents or other information from the Notified Party. Failure by the
Notified Party to respond to the Notifying Party’s notice, or by the Notifying
Party to respond to the Notified Party’s counter-notice, shall be taken for the
purposes of the decision as to whether to obtain a license under this Section 16(f) (but
for the avoidance of doubt, not for any other purpose whatsoever) as acceptance
of the position of the other Party. The Parties agree that the time periods as
set forth in this Section 16(f) may be reasonably extended by the
mutual written agreement of the Parties.


 


(iii)          Resolution. If the
Notified Party disagrees with the Notifying Party’s position pursuant to the
terms as set forth in Section 16(f)(ii) herein and if the Notifying
Party maintains its original position after such review period, then the matter
shall be referred first to the officers of BPA and Company having
responsibility for the subject matter of the dispute, or their designees. Such
officers, or their designees, as the case may be, shall negotiate in good faith
to resolve such dispute in a mutually satisfactory manner. If such efforts do
not result in a mutually satisfactory resolution of the dispute within thirty
(30) days of such referral, the matter shall be referred to the chief executive
officer of each Party, or their respective designees.


 


(iv)          Final
Resolution. If the Parties’ chief executive officers or their
designees do not resolve the dispute within thirty (30) days of the matter
being referred to them (or such longer time periods as may be mutually agreed
in writing by the Parties) under Section 16(f)(iii), an independent
mutually acceptable Third Party law firm with suitable expertise in the field
of intellectual property in pharmaceuticals (the “Firm”) shall be appointed to determine whether, in its
opinion, the making, importation, use, offer for sale or sale of the Products
in the Field and in the Territory would infringe the intellectual property
rights of a Third Party, and that such infringement arises from or relates to
the subject matter described in Section 16(e)(i) and that a Third
Party License is necessary or advisable as referenced in Section 16(e)(ii).
Once appointed, the Firm shall not be used by either Party (or their respective
Affiliates) for matters pertaining to


 


36

















 


the
Licensed Intellectual Property other than subsequent disputes under this Section 16(f).
The costs of the Firm shall be borne by the Party with whom the Firm disagrees.


 


(v)           Disputes Not To
Be Reopened, The procedures in Sections 16(f)(i) to 16(f)(iv) shall
not be used more than once in relation to any particular Third Party
intellectual property identified in a Third Party License of Section 16(e),
absent new and relevant facts.


 


(vi)          Negotiation, If the
Parties or the Firm determine that a Third Party License under Section 16(e) should
be obtained as a Final Resolution of Section 16(f)(iv), Company shall have
the initial right to negotiate such license but shall not grant or obtain a
license or finalize a settlement without BPA’s prior written consent, which may
not be unreasonably withheld, conditioned or delayed. In the event that Company
is unsuccessful in obtaining a license or settlement within one hundred and
twenty (120) days of its first meeting with such Third Party (provided that
this one hundred and twenty (120) day time period shall not include any days
attributed to waiting for BPA to consent to any license or settlement proposal
referred to in the previous sentence in this Section), then BPA shall have the
right to negotiate such license, provided that BPA may only offer or grant to a
Third Party in negotiations or as part of any settlement arising from such a
negotiation a sublicense to the license granted to Company under this Agreement
in accordance with Section 2, but shall not otherwise be entitled to offer
or grant any right whatsoever to the Intellectual Property Rights in such
circumstances without Company’s prior written consent. In all such negotiations
Company and BPA, as the case may be, shall conduct the negotiations with the
Third Party in good faith and shall keep the other Party informed of the
negotiations and, inter alia shall furnish drafts of the agreements shared with
the applicable Third Party. Should Company and BPA fail to agree on one or more
terms of the proposed agreement with a Third Party, they shall submit such
dispute to the procedures set forth in Section 16(f) in which case to
the extent required the Firm shall make a decision on the final form of the
Third Party License. The costs of the Firm shall be borne by the Party with
whom the Firm disagrees.


 


(vii)         Recovery. Company shall
be entitled to recover from BPA a portion of any amounts due pursuant to the
Third Party License from BPA in accordance with the terms of Sections 16(e)(ii) and
16(e)(iii) as are applicable to this Section 16(f). For the avoidance
of doubt, any monies so recovered from BPA by Company shall be considered
together with any other monies recovered under Section 16(e)(ii) in
calculating and determining BPA’s aggregate cumulative liability under this
Agreement.


 


(viii)        Unrelated
Licenses. Nothing in this Clause 3.5 shall be construed as
affecting Company’s rights to obtain licenses wholly unrelated to the
incorporation of the BPA Intellectual Property in the Product, at its own
expense.


 


17.           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. In addition to the
rights of termination provided for elsewhere in this Agreement, either Party
will be entitled forthwith to terminate this Agreement by written notice to the
other Party if that other Party commits a material breach of any of the
provisions of this Agreement, and fails


 


37

















 


to
cure the same within sixty (60) days after receipt of a written notice from a
Party hereto giving full particulars of the breach and requiring it to be
remedied; provided, that if the breaching Party has proposed a course of action
to cure the breach and is acting diligently and in good faith to cure same but
has not cured the breach by the sixtieth (60th) day, such period shall be extended by such period
as is reasonably necessary to permit the breach to be cured, provided that such
period shall not be extended by more than ninety (90) days, unless otherwise
agreed in writing by the Parties, and further provided that in the case of a
breach that is the nonpayment of money, the breaching party shall have a
nonextendible period of fourteen (14) days to cure following notice. The right
to terminate shall be in addition to and not in substitution for any other
available remedy at law or in equity.


 


(b)           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.


 


(c)           At any time
during the Royalty Term Company shall have the right to terminate this
Agreement on ninety (90) days notice in which case it shall return to BPA all
rights and licenses sold and granted to Company under this Agreement, and the
provisions of (h) below shall apply to such return if Company exercises its
option. Upon the expiry of ninety (90) days of the exercise of such termination
right, Company shall not be required to make further payments under this Agreement
to BPA, but shall remain obligated to BPA for all payments or other obligations
based on or required by sales of Product and other events occurring prior to
the termination and effective return to BPA of all such rights and licenses.
For the avoidance of doubt, Company shall not be entitled to a refund of or
credit for payments made (or required to be made) to BPA before such effective
return of rights and BPA shall remain entitled to (i) retain in full all
such payments that were made and (ii) receive all such payments that were
required to be made.


 


(d)           If Company
substantially discontinues distribution of Product and such substantial
discontinuation continues for a period in excess of three (3) months, BPA
shall have the right to terminate unless Company presents a plan to resume
distribution of Product that is reasonably acceptable to BPA, provided that BPA
shall not have a right to terminate where such discontinuation is caused by
Force Majeure provided that Company exercises Commercially Reasonable Efforts
to eliminate or overcome said Force Majeure so as to resume distribution of
Product.


 


(e)           Upon expiration
of the Royalty Term and payment to BPA by Company of all amounts due on account
of sale of Product during the Royalty Term and any other amounts then due or
payable, and provided that Company is not then in breach of this Agreement, the
licenses granted in Section 2 shall become fully paid-up.


 


(f)            On termination
of this Agreement, the licenses granted under Section 2 shall terminate
and any and all information, trademarks, documents, Patents, and Know How (as
that term is defined in Section 1.6 of the Antares 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


 


38

















 


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.


 


(g)           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 Closing 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 farther
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 initiated by Company of Product sold
by Company pursuant to this Agreement.


 


(h)           In the event
that the Antares License Agreement terminates for breach by BPA that is not
caused by the action or inaction of Company, it is agreed that in accordance
with Section 12 of Amendment No. 6 to the Antares License Agreement
(as clarified by a letter agreement dated October 27,2006 between BPA and
Antares), Company’s rights shall not terminate and this Agreement together with
all of BPA’s rights and obligations hereunder shall be deemed to be irrevocably
assigned to Antares automatically without the need for any further action by
any party, and this Agreement and all future payments and performance by
Company hereunder 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.


 


(i)            In the event
that the Antares License Agreement terminates for liquidation or bankruptcy of
BPA, it is agreed that in accordance with Section 12 of Amendment No. 6
to the Antares License Agreement (as clarified by a letter agreement dated November 6,2006
between BPA and Antares), Company’s rights shall not terminate and this
Agreement together with all of BPA’s rights and obligations hereunder shall be
deemed to be irrevocably assigned to Antares automatically without the need for
any further action by any party, and this Agreement and all future payments and
performance by Company hereunder 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)            Bankruptcy: The Parties
intend that (A) the license rights granted hereunder are fundamentally in
the nature of a license to “intellectual property” as defined in the Section 101
of the U.S. Bankruptcy Code, 11 U.S.C. § 101(35A), (B) Company’s continued
enjoyment of the License is fundamental to the basic agreement hereunder and
integral to the operation of Company’s business; and (C) the License
should be deemed “intellectual property” that is subject to Company’s rights
under Section 365(n) of the Bankruptcy Code, 11 U.S.C. § 365(n).


 


39
















 


Upon
any election by Company pursuant to Section 365(n)(l)(B) of the
Bankruptcy Code, Company shall be entitled to (on its own or through agents)
exercise all of its rights and remedies under this Agreement with respect to
the License and to reasonably inform BPA throughout the process. To the extent
permitted under applicable law, Licensor shall have no option to reject or
otherwise terminate this Agreement in any bankruptcy or other similar
proceeding (including where a receiver, liquidator or examiner is appointed) relating
to Licensor and in that instance the License shall continue in mil force and
effect unless terminated by Licensee.


 


18.           Notices. Any notice
required or permitted to be given under this Agreement shall be sufficient if
sent by certified mail (return receipt requested) or recognized commercial
courier that requires a signature for delivery (such as FedEx), to the
attention of the Chief Executive Officer of the respective company at the
address set forth below or to such other address as a party may specify by
notice hereunder, with copies sent in the same manner to the following:


 


In the case of Company:


 


Azur Pharma International II Limited


David J Doyle/Sandra Seymour


Clarendon House


2 Church Street, Hamilton HM 11


Bermuda


Facsimile: (441) 292 4720


 


with copies to:


 


Azur Pharma Limited 45


Fitzwilliam Square Dublin 2


Ireland Attn: David Brabazon


Facsimile: +353 1 634 4170


 


Mr. Colin Sainsbury


BCM Hanby Wallace


88 Harcourt Street


Dublin 2


IRELAND


Facsimile: +353 1 418 6805


 


In the case of BPA:


 


CEO and President BioSante


Pharmaceuticals, Inc. 111


Barclay Boulevard


Lincolnshire, IL 60069 USA


 


40

















 


-with a copy to-


 


Charles A. Weiss, Esq.


Kenyon & Kenyon LLP


1 Broadway New York,


NY 10004


USA


 


19.           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.


 


20.           Assignment. Neither party may assign
this Agreement (including rights and obligations) 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 (i) an
Affiliate, or (ii) to a party that succeeds to all or substantially all of
the assigning party’s business or assets (whether by sale, merger, operation of
law or otherwise), or (iii) in the case of Company to a party that
succeeds to all or substantially all of Company’s business or assets (whether
by sale, merger, operation of law or otherwise) relating to the Company’s Women’s
Health Division, or (iv) in the case of Company on or after the second
anniversary of the Closing Date relating to the Product provided that in each case such assignee
agrees in writing to be bound by the terms and conditions of this Agreement and
further provided that in the case
of assignment to an Affiliate, the assigning Party shall remain bound. Any
purported assignment in contravention of this provision shall be null and void.
The provisions of this Section 20 are subject to the first sentence of
Clause 7(e).


 


21.           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 Antares
License Agreement.


 


22.           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.


 


23.           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.


 


41

















 


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 23(d) of this Agreement, if any conciliation
proceedings under Section 23(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 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 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 23(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 23(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 23(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.


 


(e)           Location The conciliation and
arbitration shall be conducted in New York, New York, unless the dispute also
involves a dispute with respect to the Product between BPA and Antares pursuant
to the Antares License Agreement, in which case they shall be conducted in
Chicago, Illinois.


 


24.           Force Majeure. No party shall
be liable to the other party for delay or failure in the performance of the
obligations on its part contained in this Agreement if and to the extent that


 


42

















 


such failure or delay is due to circumstances beyond its control which
it could not have avoided by the exercise of reasonable diligence. The affected
party shall notify the other party promptly should such circumstances arise,
giving an indication of the likely extent and duration thereof, and shall use
all commercially reasonable efforts to resume performance of its obligations as
soon as practicable.


 


25.           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.


 


26.           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.


 


27.           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.


 


28.           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.


 


29.           Guarantee. Azur Parent
hereby guarantees to BPA the performance by Company of all of Company’s duties
and obligations under this Agreement, including payment obligations, the grant
of rights and licenses, defense and indemnity obligations, and payment of all
damages, liability, costs, expenses and other amounts that may be payable to
BPA or its Affiliates, or recoverable by BPA or its Affiliates, from Company by
virtue of this Agreement. For clarity, Azur Parent agrees to pay any amounts
owed to BPA or its Affiliates by Company under this Agreement in the event that
Company fails to pay such amounts when due under this Agreement and to pay any
amounts of liability or damages owed to BPA or its Affiliates by Company for
Company’s breach of the Agreement if Company fails to pay such amounts when due
under this Agreement upon written request.


 


[signature
page follows]


 


43

















 


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

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  Azur
  Pharma International II Limited

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  By:

  	
  /s/
  Kevin Insley

  
	
   

  	
   

  	
  Kevin
  Insley

  
	
   

  	
   

  	
  Director

  



 


44

















 


Schedule 1(b) to License Agreement


(Assigned Contracts)


 


There are no open purchase orders received by or placed by BP A for the
Product.


 

















 


Schedule 1(i) to License Agreement


(Contracts)


 


Termination, Release and Settlement Agreement between BioSante
Pharmaceuticals, Inc., 111 Barclay Boulevard, Lincolnshire, IL 60069, and
Nycomed US Inc., 60 Baylis Road, P.O. Box 2006, Melville, NY 11747, dated as
of August 6, 2008.


 


Trademark Coexistence Agreement between BioSante Pharmaceuticals, Inc.,
111 Barclay Boulevard, Lincolnshire, IL 60069, and Warner Chilcott Company, Inc.,
Union Street KM 1.1, Fajardo, PR 00738, dated as of July 23, 2008.


 

















 


Schedule 1(aa) to License Agreement


(Patents)


 


Methods and Formulations for Transdermal or Transmucosal Application of
Active Agents


 


U.S. Application
10/798,111


U.S. Application 10/693,988


 


Uses and Formulations for Transdermal or Transmucosal Application of
Active Agents


 


PCT/US04/07291


EP Appl.
04719710.8


JP 2006-507034


CA 2,515,426


CN 200480005123.90


AU 2004220498


NZ 541854


MX
PA/a/2005/008648


BR PI0408153-6


ZA 2005/05985


IL 170454


IN 3902/DELNP/2005


KR 10-2005-7016685


HK 07113840.8


ID W-00200502415


U.S. Provisional 60/453,604


 


Novel Composition for Transdermal and/or Transmucosal Administration of
Active Compounds that Ensure Active Therapeutic Levels


 


CA 2,418,135


AU 2001282064


NZ Patent 524,423


US Patent
7,214,381


US Patent
Application 11/693,988


US Patent Application 11/755,923


 
















 


Formulations for Transdermal or Transmucosal Application


 


US Patent 7,198,801


 


Methods of Treating Hot Flashes with Formulations for Transdermal or
Transmucosal Application


 


PCT/US07/65950


US Patent Applications 11/737,389


 


Transdermal Pharmaceutical Formulation for Minimizing Skin Residues


 


US Patent
7,335,379


EP 04790156.6


JP 2006-530107


CA 2,538,856


AU 2004283431


NZ 546106


MX PA/a/2006/003316


BR PI0414551-8


SA Patent 2006/02046


 


A Novel Composition for Transdermal Administration of an Estrogen, a
Progestin or a Mixture Thereof


 


US Patent
5,891,462


IT Patent 1283102


NZ Patent 328021


SA Patent 97/4981


AU Patent 712465


EP Patent 0811381


AR Patent
P970102497


CA 2,207,144


JP 9-185695


KR Patent
97-0023704


TW Patent 86107807


 


Methods and Apparatus For Transdermal or Transmucosal Application of
Testosterone


 


US Application
11/441,311


PCT/EP06/004993


EP 06753964.5


SA 2006/04286


 

















 


Schedule 1(bb) to License Agreement


(Permitted Encumbrances)


 


Patent Assignment Details


NOTE:  Results display only for issued patents and
published applications.


For pending or abandoned
applications please consult USPTO staff.


 




	
  Reel/Frame: 019991 / 0714

  	
   

  	
  View Recorded Assignment

  	
   

  	
  Pages: 8

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Recorded: 10/22/2007

  
	
   

  
	
  Attorney Dkt #:
  019751-9012

  
	
  Conveyance:  SECURITY AGREEMENT

  






 


Total
properties:  7


 




	
  1         Patent
  #: 6696085

  	
  Issue Dt: 02/24/2004

  	
  Application #: 09353646

  	
  Filing Dt: 07/15/1999

  
	
  Publication #: US20020168404

  	
  Pub Dt: 11/14/2002

  	
   

  
	
  Title:  USE OF AN ACRYLIC TYPE POLYMER AS
  DISINTEGRATING AGENT

  
					






 




	
  2         Patent
  #: 7214381

  	
  Issue Dt: 05/08/2007

  	
  Application #: 10343570

  	
  Filing Dt: 05/19/2003

  
	
  Publication #: US20030199426

  	
  Pub Dt:
  10/23/2003

  	
   

  
	
  Title: NOVEL
  COMPOSITION FOR TRANSDERMAL AND/OR TRANSMUCOSAL ADMINISTRATION OF ACTIVE
  COMPOUNDS THAT ENSURES ADEQUATE THERAPEUTIC LEVELS

  
					






 




	
  3         Patent
  #: NONE

  	
  Issue Dt:

  	
  Application #: 10798111

  	
  Filing Dt: 03/10/2004

  
	
  Publication #: US20040198706

  	
  Pub Dt:
  10/07/2004

  	
   

  
	
  Title: Methods and
  formulations for transdermal or transmucosal application of active agents

  
					






 




	
  4         Patent
  #: 7198801

  	
  Issue Dt: 04/03/2007

  	
  Application #: 10798161

  	
  Filing Dt: 03/10/2004

  
	
  Publication #: US20040219197

  	
  Pub Dt:
  11/04/2004

  	
   

  
	
  Title: FORMULATIONS FOR
  TRANSDERMAL OR TRANSMUCOSAL APPLICATION

  
					






 




	
  5         Patent
  #: NONE

  	
  Issue Dt:

  	
  Application #: 11114537

  	
  Filing Dt: 04/26/2005

  
	
  Publication #: US20050244522

  	
  Pub Dt:
  11/03/2005

  	
   

  
	
  Title: Permeation
  enhancer comprising genus Curcume or germacrone for transdermal and topical
  administration of active agents

  
					






 




	
  6         Patent
  #: 7335379

  	
  Issue Dt:
  02/26/2008

  	
  Application #:
  11371042

  	
  Filing Dt:
  03/07/2006

  
	
  Publication #: US20060153905

  	
  Pub Dt:
  07/13/2006

  	
   

  
	
  Title: TRANSDERMAL
  PHARMACEUTICAL FORMULATION FOR MINIMIZING SKIN RESIDUES

  
					






 




	
  7         Patent
  #: NONE

  	
  Issue Dt:

  	
  Application #:
  11441311

  	
  Filing Dt:
  05/24/2005

  
	
  Publication #: US20060270642

  	
  Pub Dt:
  11/30/2006

  	
   

  
	
  Title:  Method
  and apparatus for transdermal or transmucosal application of testosterone

  
					






 

















 


Assignor


	
  1

  	
  ANTARES PHARMA, INC.

  	
   

  	
  Exec Dt: 02/26/2007

  



 


Assignee


	
  1

  	
  MMY FINANCIAL
  INC.

  	
   

  	
   

  
	
   

  	
  95 WELLINGTON
  STREET WEST

  	
   

  	
   

  
	
   

  	
  22ND FLOOR

  	
   

  	
   

  
	
   

  	
  TORONTO, ONTARIO M5J 2N7

  	
   

  	
   

  



 


Correspondence
name and address


	
   

  	
  MICHAEL
  BEST & FRIEDRICH LLP

  	
   

  	
   

  
	
   

  	
  180 N. STETSON
  AVENUE

  	
   

  	
   

  
	
   

  	
  SUITE 2000

  	
   

  	
   

  
	
   

  	
  CHICAGO, IL
  60601

  	
   

  	
   

  



 


	
  Search Results
  as of 10/28/2008 3:36 p.m.

  	
   

  



 


If you have any comments
or questions concerning the data displayed, contact PRD / Assignments at
571-272-3350.


Web interface last
modified:  October 18, 2005 v.2.0.1


 
















 


PATENT ASSIGNMENT


 


Electronic Version
v1.1


Stylesheet Version
v1.1


 


	
  SUBMISSION TYPE:

  	
  NEW ASSIGNMENT

  
	
  NATURE OF
  CONVEYANCE:

  	
  SECURITY
  AGREEMENT

  
	
  CONVEYING PARTY
  DATA

  	
   

  



 


	
  Name

  	
   

  	
  Execution Date

  
	
  Antares
  Pharma, Inc.

  	
   

  	
  2/28/2007

  



 


RECEIVING PARTY
DATA


	
  Name:

  	
  MMV Financial
  Inc.

  
	
  Street Address:

  	
  95 Wellington
  Street West

  
	
  Internal
  Address:

  	
  22nd Floor

  
	
  City:

  	
  Toronto

  
	
  State/Country:

  	
  ONTARIO

  
	
  Postal Code:

  	
  M5J 2N7

  



 


PROPERTY NUMBERS
Total:  8


 


	
  Property Type

  	
   

  	
  Number

  
	
  Patent Number:

  	
   

  	
  6696085

  
	
  Application
  Number:

  	
   

  	
  11371042

  
	
  Application
  Number:

  	
   

  	
  11120360

  
	
  Application
  Number:

  	
   

  	
  10798111

  
	
  Patent Number:

  	
   

  	
  7214381

  
	
  Patent Number:

  	
   

  	
  7198801

  
	
  Application
  Number:

  	
   

  	
  11114537

  
	
  Application
  Number:

  	
   

  	
  11441311

  



 


CORRESPONDENCE
DATA


	
  Fax Number:

  	
  (312) 222-0818

  
	
  Correspondence will be sent via US
  Mail when the fax attempt is unsuccessful

  
	
  Phone:

  	
  312-222-0800

  
	
  Email:

  	
  chiipdocket@michaelbest.com

  
	
  Correspondence
  Name:

  	
  Michael
  Best & Friedrich LLP

  
	
  Address Line 1:

  	
  180 N. Statson
  Avenue

  
	
  Address Line 2:

  	
  Suite 2000

  
	
  Address Line 4:

  	
  Chicago,
  ILLINOIS 60601

  



 


	
  ATTORNEY DOCKET
  NUMBER:

  	
  019751-9012

  
	
  NAME OF
  SUBMITTER:

  	
  Luke W. DeMarts

  



 


Total
Attachments:  6


source=C0794060#page1.tif


source=C0794060#page2.tif


source=C0794060#page3.tif


source=C0794060#page4.tif


source=C0794060#page5.tif


source=C0794060#page6.tif


 

















 


CONFIRMATION OF GRANT OF SECURTITY INTEREST


 


This will confirm
that, pursuant to a general security agreement (hereinafter referred to as the “GSA”)
dated February 26th, 2007, between Antares Pharma, Inc.,
a corporation organized under the laws of the State of Delaware (hereinafter
referred to as “Antares”), whose full post office address is 250 Phillips
Blvd., Suite 290, Ewing, New Jersey 08618, U.S.A. and MMV Financial Inc.
(hereinafter referred to as “MMV”), a specialty finance corporation incorporated
under the laws of Canada, whose full post office address is 95 Wellington
Street West, 22nd Floor, Toronto, Ontario M5J 2N7, as agent on
behalf of itself and HSBC Capital (Canada) Inc. and for good and valuable
consideration, the receipt and sufficiency of which are hereby confirmed and
acknowledged, Antares confirms that it has granted to MMV a security interest,
lien and charge in all of Antares’ right, title and interest in and to the
intellectual property listed on the Schedule attached hereto, including,
without limitation, the copyrights, trademarks, patents and trademark and
patent applications and registrations listed therein, and in and to any and all
continuations, continuations-in-part, updates, developments, divisions,
reissues and re-examinations which issue therefrom, the same to be held and
enjoyed by MMV, strictly subject to the terms of the GSA.


 


EXECUTED at Ewing,
NJ this 26th day of February, 2007.


 


	
   

  	
  ANTARES PHARMA, INC.

  
	
   

  	
   

  
	
   

  	
   

  
	
   

  	
  Per:

  	
   

  
	
   

  	
   

  	
  Name: Jack E.
  Stover

  
	
   

  	
   

  	
  Title: President
  and Chief Executive Officer

  
	
   

  	
   

  	
   

  
	
   

  	
  I have authority
  to bind the Corporation.

  



 

















 


SCHEDULE
TO INTELLECTUAL PROPERTY


 

















 


INTELLECTUAL
PROPERTY


 


Patents


 


	
  Title

  	
   

  	
  Country

  	
   

  	
  Filing

  Date

  	
   

  	
  Expiration

  Date

  
	
  USE OF AN ACRYLIC TYPE POLYMER AS
  DISINTEGRATING AGENT

  	
   

  	
  UNITED STATES

  	
   

  	
  07/15/1999

  	
   

  	
  07/15/2019

  
	
  TRANSDERMAL PHARMACEUTICAL FORMULATION FOR
  MINIMIZING SKIN RESIDUES

  	
   

  	
  UNITED STATES

  	
   

  	
  03/07/2006

  	
   

  	
  10/06/2024

  
	
  TRANSDERMAL PHARMACEUTICAL FORMULATION FOR
  MINIMIZING SKIN RESIDUES

  	
   

  	
  EUROPEAN PATENT CONVENT

  	
   

  	
  10/06/2004

  	
   

  	
  10/06/2024

  
	
  TRANSDERMAL PHARMACEUTICAL FORMULATION FOR
  MINIMIZING SKIN RESIDUES

  	
   

  	
  JAPAN

  	
   

  	
  10/06/2004

  	
   

  	
  10/06/2024

  
	
  TRANSDERMAL PHARMACEUTICAL FORMULATION FOR
  MINIMIZING SKIN RESIDUES

  	
   

  	
  CANADA

  	
   

  	
  10/06/2004

  	
   

  	
  10/06/2024

  
	
  TRANSDERMAL PHARMACEUTICAL FORMULATION FOR
  MINIMIZING SKIN RESIDUES

  	
   

  	
  AUSTRALIA

  	
   

  	
  10/06/2004

  	
   

  	
  10/06/2024

  
	
  TRANSDERMAL PHARMACEUTICAL FORMULATION FOR
  MINIMIZING SKIN RESIDUES

  	
   

  	
  NEW ZEALAND

  	
   

  	
  10/06/2004

  	
   

  	
  10/06/2024

  
	
  TRANSDERMAL PHARMACEUTICAL FORMULATION FOR
  MINIMIZING SKIN RESIDUES

  	
   

  	
  MEXICO

  	
   

  	
  10/06/2004

  	
   

  	
  10/06/2024

  
	
  TRANSDERMAL PHARMACEUTICAL FORMULATION FOR
  MINIMIZING SKIN RESIDUES

  	
   

  	
  BRAZIL

  	
   

  	
  10/06/2004

  	
   

  	
  10/06/2024

  
	
  TRANSDERMAL PHARMACEUTICAL FORMULATION FOR
  MINIMIZING SKIN RESIDUES

  	
   

  	
  SOUTH AFRICA

  	
   

  	
  10/06/2004

  	
   

  	
  10/06/2024

  
	
  PHARMACEUTICAL COMPOSITION OF NICOTINE AND
  METHOD OF USE THEREOF

  	
   

  	
  UNITED STATES

  	
   

  	
  07/24/2006

  	
   

  	
  10/06/2024

  
	
  PERMEATION ENHANCING COMPOSITION FOR
  ANTICHOLINERGIC AGENTS

  	
   

  	
  UNITED STATES

  	
   

  	
  05/02/2005

  	
   

  	
  05/02/2025

  
	
  PERMEATION ENHANCING COMPOSITION FOR
  ANTICHOLINERGIC AGENTS

  	
   

  	
  WIPO

  	
   

  	
  05/03/2005

  	
   

  	
  11/07/2006

  
	
  METHODS AND FORMULATIONS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS

  	
   

  	
  UNITED STATES

  	
   

  	
  3/10/2004

  	
   

  	
  3/10/2024

  



 

















 


	
  Title

  	
   

  	
  Country

  	
   

  	
  Filing

  Date

  	
   

  	
  Expiration

  Date

  
	
  USES AND FORMULATIONS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS

  	
   

  	
  EUROPEAN PATENT CONVENT

  	
   

  	
  3/11/2004

  	
   

  	
  3/11/2024

  
	
  USES AND FORMULATIONS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS

  	
   

  	
  JAPAN

  	
   

  	
  3/11/2004

  	
   

  	
  3/11/2024

  
	
  USES AND FORMULATIONS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS

  	
   

  	
  CANADA

  	
   

  	
  3/11/2004

  	
   

  	
  3/11/2024

  
	
  USES AND FORMULATIONS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS

  	
   

  	
  CHINA

  	
   

  	
  3/11/2004

  	
   

  	
  3/11/2024

  
	
  USES AND FORMULATIONS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS

  	
   

  	
  AUSTRALIA

  	
   

  	
  3/11/2004

  	
   

  	
  3/11/2024

  
	
  USES AND FORMULATIONS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS

  	
   

  	
  NEW ZEALAND

  	
   

  	
  3/11/2004

  	
   

  	
  3/11/2024

  
	
  USES AND FORMULATIONS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS

  	
   

  	
  MEXICO

  	
   

  	
  3/11/2004

  	
   

  	
  3/11/2024

  
	
  USES AND FORMULATIONS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS

  	
   

  	
  BRAZIL

  	
   

  	
  3/11/2004

  	
   

  	
  3/11/2024

  
	
  USES AND FORMULATIONS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS

  	
   

  	
  SOUTH AFRICA

  	
   

  	
  3/11/2004

  	
   

  	
  3/11/2024

  
	
  USES AND FORMULATIONS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS

  	
   

  	
  ISRAEL

  	
   

  	
  3/11/2004

  	
   

  	
  3/11/2024

  
	
  USES AND FORMULATIONS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS

  	
   

  	
  INDIA

  	
   

  	
  3/11/2004

  	
   

  	
  3/11/2024

  
	
  USES AND FORMULATIONS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS

  	
   

  	
  SOUTH KOREA

  	
   

  	
  3/11/2004

  	
   

  	
  3/11/2024

  
	
  USES AND FORMULATIONS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF ACTIVE AGENTS

  	
   

  	
  INDONESIA

  	
   

  	
  3/11/2004

  	
   

  	
  3/11/2024

  
	
  NOVEL COMPOSITIONS FOR TRANSDERMAL AND/OR
  MUCOSAL ADMINISTRATION OF ACTIVE COMPOUNDS THAT ENSURES ADEQUATE THERAPEUTIC
  LEVELS

  	
   

  	
  UNITED STATES

  	
   

  	
  05/19/2004

  	
   

  	
  08/03/2021

  
	
  METHODS OF TREATING HOT FLASHES WITH
  FORMULATIONS FOR TRANSDERMAL OR TRANSMUCOSAL APPLICATION

  	
   

  	
  UNITED STATES

  	
   

  	
  04/21/2006

  	
   

  	
  04/21/2007

  



 

















 


	
  Title

  	
   

  	
  Country

  	
   

  	
  Filing

  Date

  	
   

  	
  Expiration

  Date

  
	
  FORMULATIONS FOR TRANSDERMAL OR TRANSMUCOSAL
  APPLICATION OF ACTIVE AGENTS

  	
   

  	
  UNITED STATES

  	
   

  	
  03/10/2004

  	
   

  	
  08/03/2021

  
	
  PERMEATION ENHANCER COMRISING GENUS CURCUMA OR
  GERMACRONE FOR TRANSDERMAL AND TOPICAL ADMINISTRATION OF ACTIVE AGENTS

  	
   

  	
  UNITED STATES

  	
   

  	
  04/26/2005

  	
   

  	
  04/26/2025

  
	
  PERMEATION ENHANCER COMRISING GENUS CURCUMA FOR
  TRANSDERMAL AND TOPICAL ADMINISTRATION OF ACTIVE AGENTS

  	
   

  	
  WIPO

  	
   

  	
  04/28/2005

  	
   

  	
   

  
	
  METHODS AND APPARATUS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF TESTOSTERONE

  	
   

  	
  UNITED STATES

  	
   

  	
  05/24/2006

  	
   

  	
  05/24/2026

  
	
  METHOD AND APPARATUS FOR TRANSDERMAL OR
  TRANSMUCOSAL APPLICATION OF TESTOSTERONE

  	
   

  	
  SOUTH AFRICA

  	
   

  	
   

  	
   

  	
   

  
	
  EUTECTIC COMPOSITION FOR ENHANCED TRANSDERMAL
  DRUG DELIVERY AND METHOD OF MAKING SAME

  	
   

  	
  UNITED STATES

  	
   

  	
  08/17/2006

  	
   

  	
  08/17/2026

  
	
  LOW-FRIABILITY, PATENT-FRIENDLY ORALLY
  DISINTEGRATING FORMATULATIONS OBTAINED BY DIRECT COMPRESSION

  	
   

  	
  UNITED STATES

  	
   

  	
  02/17/2006

  	
   

  	
  02/17/2007

  
	
  TRANSDERMAL COMPOSITIONS OF PRAMIPEXOLE HAVING
  ENHANCED PERMEATION PROPERTIES

  	
   

  	
  UNITED STATES

  	
   

  	
  06/29/2006

  	
   

  	
  06/29/2007

  
	
  TRANSDERMAL COMPOSITIONS HAVING ENHANCED COLOR
  STABILITY

  	
   

  	
  UNITED STATES

  	
   

  	
  06/29/2006

  	
   

  	
  06/29/2007

  



 


 


Trademarks


 


Antares Pharma


Medi-Jector


Medi-Jector Choice


Medi-Jector visions


 


Copyrights


 


None.


 

















 


Schedule 10(f) to License Agreement

(Form of Notice)


 


[Azur Pharma International II Limited Letterhead]


 


[President and
CEO]


Antares Pharma IPL
AG


[Baarerstrasse 95


6301] Zug


Switzerland


 


COPY to:


President and CEO


BioSante
Pharmnaceutica1s, Inc.


111 Barclay
Boulevard


Lincolnshire,
IL  60069


USA


 


[*] November 2008


 


Antares / BioSante License Agreement

Acceptance of Third Party Beneficiary Rights


 


Dear [*]


 


We refer to the License Agreement dated as of June 13, 2000 between
Antares Pharma IPL AG as successor in interest to Permatec Technologie, AG (“Antares”) and BioSante Pharmaceuticals, Inc. (“BioSante”), 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 (“Amendment No. 6”) with three
clarifying letters dated October 27, 2006, November 6, 2006, and November 7,
2006 (“Clarification Letters”).  The said agreement as amended and clarified,
is referred to in this letter as the “License Agreement”.


 


Under the License Agreement, certain rights are extended to sub-licensees
and in specified circumstances Antares is to assume certain rights and
obligations with respect to a sub-licensee.


 

















 


As you are aware, having been notified by BioSante, BioSante Azur Pharma
International II Limited (“Azur”.) has
entered into a License Agreement dated as of November [*], 2008 (“Azur  License”).  Inter alia, the Azur License grants to Azur
exclusive sub-license rights in the United States under the rights licensed to
BioSante in the License Agreement.


 


Azur hereby accepts as a third party beneficiary all rights under the
License Agreement which may properly be extended to Azur as sub-licensee,
together with all obligations which Antares has or may have to such a
sub-licensee.  In particular and without
prejudice to the generality of the foregoing:


 


1.                                       Pursuant to Section 6 of Amendment No. 6,
Azur accepts those rights possessed by BioSante as set forth in Section 8.2.2
and 8.2.4 of the License Agreement.


 


2.                                       Pursuant to Section 12 of Amendment No. 6,
as clarified by the Clarification Letters, Azur accepts that in the event of a
termination of the License Agreement due to BioSante’s breach or bankruptcy
that is not caused by Azur, Azur’s rights will not terminate and that the Azur
License, and all future payments and performance under the Azur License, will
continue between Antares and Azur.


 


Sincerely,


 


 


	
   

  	
   

  
	
  Duly authorized for and on behalf of

  	
   

  
	
  Azur Pharma International II Limited

  	
   

  
	
   

  	
   

  
	
  Name:

  	
   

  	
   

  
			



 
















 


Schedule l1(a) to License Agreement

(Disclosure Schedules)


 

















 


Schedule l1(x) to License Agreement

(Consents from Third Parties)


 


None


 

















 


Schedule l1(xiii) to License Agreement

(IP Filings)


 


Trademarks


Pending U.S.
Trademark application for ELESTRIN Serial No. 77053313


 


Domain
Names


Elestrin.com


 


Patents


See Schedule l(aa)


 

















 


Schedule l1(xv) to License Agreement

(NDAs)


 


NDA #21-813


SNDA #001


 

















 


Exhibit A1 (Initial Press Release by BPA)


 


BioSante Pharmaceuticals Signs ElestrinTM
Marketing Agreement with Azur Pharma


 


Payments could reach $144.5 million plus royalties


 


LINCOLNSHIRE,
Illinois (December 1, 2008) — BioSante Pharmaceuticals, Inc. (NASDAQ:
BPAX) today announced that it has signed an exclusive agreement with Azur
Pharma International II Limited for the marketing of Elestrin (estradiol gel)
to treat moderate-to-severe hot flashes in menopausal women in the United
States.  Upon execution of the agreement,
BioSante received $3.325 million comprised of a $0.5 million product licensing
fee and $2.825 million for transfer of the Elestrin trademark and inventories,
among other items.  BioSante also is
entitled to receive additional payments of up to an aggregate of $144.5 million
if certain sales-based milestones are achieved. 
In addition Azur has agreed to pay to BioSante royalties on sales of
Elestrin ranging from 10 percent to 20 percent depending on the annual sales
level.


 


Azur
has agreed to market Elestrin using its women’s health and urology sales force
of approximately 50 sales people that target estrogen prescribing physicians in
the U.S. comprised mostly of gynecologists. 
In addition, Azur has agreed to minimum marketing expenditures in the
first two years of the agreement.


 


“We
are excited to sign this agreement with Azur,” said Mr. Stephen Simes,
president & CEO of BioSante.  “We
believe Azur has excellent, established relationships with the leading U.S.
gynecological practitioners who write the majority of estrogen prescriptions
and is in an excellent position to capture an important share of the U.S.
estrogen therapy market, which is currently estimated at approximately $1.4
billion in annual sales, of which the transdermal segment, mostly patches, is
about $260 million.  We look forward to
working with Azur on the successful marketing of Elestrin.”


 


Dave
Domzalski, vice president of sales of Azur said, “We are impressed with the
potential for Elestrin in the United States and we believe Elestrin and its
approved low dose regimen will be an attractive alternative for physicians who
treat and for women who suffer from menopause symptoms.”  Mr. Domzalski is the former vice
president of sales for Warner Whilcott Limited (NASDAQ: WCRX).


 


About ElestrinTM


Elestrin
is a fast-drying gel formulation of estradiol, the same estrogen produced
naturally in women.  Elestrin is absorbed
through the skin after topical application on the upper arm, and delivers
estradiol to the bloodstream evenly over time in a non-irritating, painless
manner.  Elestrin is administered using a
metered dose applicator that delivers 12.5 micrograms of estradiol, one of the
two lowest estradiol doses and 67 percent lower than the lowest dose estrogen
patch approved by the FDA for the treatment of hot flashes.  The gel dried quickly in one to two minutes.


 


About BioSante Pharmaceuticals, Inc.


BioSante
is a specialty pharmaceutical company focused on developing products for female
sexual 


 

















 


health,
menopause, contraception and male hypogonadism. 
BioSante’s lead products include LibiGel® (transdermal
testosterone gel) in Phase III clinical development by BioSante under a U.S.
Food and Drug Administration (FDA) SPA (Special Protocol Assessment) for the
treatment of female sexual dysfunction (FSD), and ElestrinTM (estradiol gel)
developed through FDA approval by BioSante, indicated for the treatment of
moderate-to-severe vasomotor symptoms associated with menopause, currently
marketed in the U.S.  Under BioSante’s
license agreement with Antares Pharma, BioSante is required to pay Antares 25
percent of license and milestone payments received for products covered by that
agreement in the U.S.  Also in
development are Bio-T-GelTM, a testosterone gel for male hypogonadism, and an
oral contraceptive in Phase II/III clinical development using BioSante patented
technology.  The current market in the
U.S. for estrogen and testosterone products is approximately $2.5 billion and
for oral contraceptives approximately $3 billion.  The company also is developing its calcium
phosphate technology (CaP) for novel vaccines, drug delivery and aesthetic
medicine (BioLookTM).  Additional
information is available online at: 
www.biosantepharma.com.


 


About Azur Pharma


Azur
is a privately held pharmaceutical company dedicated to enhancing patients’
lives by developing and marketing pharmaceutical products in specialist therapeutic
areas.  Azur’s strategy is to identify,
evaluate, selectively acquire and enhance the value of late stage development
and approved pharmaceutical products. 
(Website:  www.azurpharma.com)


 


This news
release contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. 
The statements regarding BioSante contained in this news release that
are not historical in nature, particularly those that utilize terminology such
as “will,” “potential”, “could,” “can,” “believe,” “intends,” “continue,” “plans,”
“expects,” “estimates” or comparable terminology, are forward-looking
statements.  Forward-looking statements
are based on current expectations and assumptions, and entail various risks and
uncertainties that could cause actual results to differ materially from those
expressed in such forward-looking statements. 
Important factors known to BioSante that could cause actual results to
differ materially from those expressed in such forward-looking statements
include the difficulty of developing pharmaceutical products, obtaining
regulatory and other approvals and achieving market acceptance; the marketing
success of BioSante’s licensees or sublicensees; the success of clinical
testing,  BioSante’s potential cash needs
and other factors identified and discussed from time to time in BioSante’s
filings with the Securities and Exchange Commission, including those factors
discussed in BioSante’s most recent annual report on Form 10-K and
subsequent quarterly report on Form 10-Q, which discussions also are
incorporated herein by reference.  All
forward-looking statements speak only as of the date of this news release.
BioSante undertakes no obligation to update or revise any forward-looking
statement, whether as a result of new information, future events or otherwise.


 


For
more information, please contact:


McKinney/Chicago


Alan
Zachary


(312)
944-6784 ext. 316;


Investor
Relations:  The Investor Relations Group


Media:  Laura Colontrelle /Janet Vasquez 212-825-3210


Investors:  Adam S. Holdsworth / Christine Berni
212-825-3210


 

















 


Exhibit A2 (Initial Press Release by Azur)


 


Azur Pharma Announces the
Acquisition of ElestrinTM


 


DUBLIN,
Ireland, November [], 2008 — Azur Pharma Limited (“Azur”) today announced
that it has entered into a definitive agreement with BioSante Pharmaceuticals,
Inc (“BioSante”) (Nasdaq: BPAX) to acquire U.S. rights to ElestrinTM.  Elestrin is a fast drying gel formulation of
estradiol which is indicated for the treatment of moderate to severe vasomotor
symptoms associated with menopause. 
Elestrin is patented through June 2022.


 


Under
the terms of the agreement, Azur Pharma paid BioSante $3.3 million comprised of
a product licensing fee of $0.5 million and $2.8 million for the transfer of
the trademark and inventories, amongst other items.  In addition, Azur Pharma will pay BioSante
royalties and contingent milestones based on net sales of Elestrin.


 


Azur
will market Elestrin to estrogen prescribing physicians in the U.S., comprised
mostly of gynecologists, with its women’s health and urology sales force.  Mr. Seamus Mulligan, Chairman and CEO of
Azur, commented, “We are impressed with the potential for Elestrin in the
United States given its approved ultra-low dose regimen.  The product is an important addition to our
women’s health product portfolio and we look forward to launching our Elestrin
efforts in early 2009.”


 


“We
are excited to sign this agreement with Azur”, said Mr. Stephen Simes,
president and CEO of BioSante.  “We
believe Azur has excellent, established relationships with the leading U.S.
gynecological practitioners who write the majority of estrogen prescriptions
and is in an excellent position to capture an important share of the U.S.
estrogen therapy market, which currently is estimated at approximately $1.4
billion in annual sales, of which the transdermal segment, mostly patches, is
about $260 million.  We look forward to
working with Azur on the successful marketing of Elestrin.”


 


About ElestrinTM


 


Elestrin
is a fast-drying gel formulation of estradiol, the same estrogen produced
naturally in women.  Elestrin is absorbed
through the skin after topical application on the upper arm, and delivers
estradiol to the bloodstream evenly over time in a non-irritating, painless
manner.  Elestrin is administered using a
metered dose applicator that delivers 12.5 micrograms of estradiol, one of the
two lowest dose approved by the FDA for the treatment of hot flashes.  The gel dried quickly in one to two minutes.


 


About Azur Pharma


 


Azur
is a privately held pharmaceutical company dedicated to enhancing patients’
lives by developing and marketing pharmaceutical products in specialist
therapeutic areas.  Azur’s strategy is to
identify, evaluate, selectively acquire and enhance the value of late stage
development and 


 

















 


approved
pharmaceutical products.  (Website:  www.azurpharma.com)


 


About BioSante Pharmaceuticals, Inc.


 


BioSante
is a specialty pharmaceutical company focused on developing products for female
sexual health, menopause, contraception and male hypogonadism.  BioSante’s lead products include LibiGel® (transdermal testosterone gel) in Phase III
clinical development by BioSante under a U.S. Food and Drug Administration
(FDA) SPA (Special Protocol Assessment) for the treatment of female sexual
dysfunction (FSD), and ElestrinTM (estradiol gel) developed through FDA approval
by BioSante, indicated for the treatment of moderate-to-severe vasomotor
symptoms associated with menopause, currently marketed in the U.S.  Also in development are Bio-T-GelTM, a
testosterone gel for male hypogonadism, and an oral contraceptive in Phase
II/III clinical development using BioSante patented technology.  The current market in the U.S. for estrogen
and testosterone products is approximately $2.5 billion and for oral
contraceptives approximately $3 billion. 
The company also is developing its calcium phosphate technology (CaP)
for novel vaccines, drug delivery and aesthetic medicine (BioLookTM).  Additional information is available online
at:  www.biosantepharma.com.


 


Media Contact


Mr. Ray
Gordon, MRPA Kinman Communications


Telephone:
+353-1-7038619/+353-87-2417373


Email:  ray@mrpakinman.ie


 

















 


Exhibit B (form of letter to DPT)


[Azur
Letterhead]


 


DPT
Laboratories, Ltd.

4040 Broadway, Suite 401

San Antonio, TX 78209


 


Re:  Elestrin and BioSante


 


Gentlemen:


 


This company has acquired from BioSante Pharmaceuticals, Inc. (“BioSante”)
the NDA for Elestrin.  We look forward to
a productive commercial relationship with DPT for Elestrin’s manufacture.


 


Under our agreement with BioSante, BioSante retains ex-US
commercialization rights and as such retains the right to communicate with DPT,
and freely receive information from DPT, concerning the manufacture of Elestrin
(the “Purpose”).  Accordingly, please
respond to any such request for information from BioSante in the same manner as
which you would respond to requests from us as it relates to the Purpose.


 


We would be obliged if you would keep us copied on your correspondence
with BioSante, who have agreed to this.


 


While we and BioSante intend to work cooperatively with each other to
further the sale of Elestrin, neither company is the agent of the other.  Accordingly, while we request that you share
information as stated above, BioSante does not have authority to make
agreements on behalf of us, and we do not have authority to make agreements on
behalf of BioSante.  Nothing in this
letter should amend or impact the contractual arrangements between DPT and
Azur.


 


Very
truly yours,


 

















 


Exhibit C


 


The
following agreements have previously been filed with the Securities and
Exchange Commission (“SEC”) and are hereby incorporated by reference into this Exhibit C:


 


·                  License Agreement, dated June 13, 2000, between
Permatec Technologie, AG (now known as Antares Pharma) and BioSante
Pharmaceuticals, Inc., incorporated by reference to Exhibit 10.1 to
BioSante’s Current Report on Form 8-K as filed with the SEC on July 11,
2000 (File No. 0-28637). 
Confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended, has been granted with respect to designated portions
of Exhibit 10.1.


 


·                  Amendment No. 1 to the License Agreement, dated May 20,
2001, between Antares Pharma IPL AG and BioSante Pharmaceuticals, Inc.,
incorporated by reference to Exhibit 10.18 to BioSante’s Annual Report on Form 10-KSB
for the fiscal year ended December 31, 2001 as filed with the SEC on March 28,
2002 (File No. 0-28637). 
Confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended, has been granted with respect to designated portions
of Exhibit 10.18.


 


·                  Amendment No. 2 to the License Agreement, dated July 5,
2001, between Antares Pharma IPL AG and BioSante Pharmaceuticals, Inc.,
incorporated by reference to Exhibit 10.19 to BioSante’s Annual Report on Form 10-KSB
for the fiscal year ended December 31, 2001 as filed with the SEC on March 28,
2002 (File No. 0-28637). 
Confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended, has been granted with respect to designated portions
of Exhibit 10.19.


 


·                  Amendment No. 3 to the License Agreement, dated
August 30, 2001, between Antares Pharma IPL AG and BioSante
Pharmaceuticals, Inc., incorporated by reference to Exhibit 10.20 to
BioSante’s Annual Report on Form 10-KSB for the fiscal year ended December 31,
2001 as filed with the SEC on March 28, 2002 (File No. 0-28637) and
Exhibit D to the Supply Agreement between Antares Pharma IPL AG and
BioSante Pharmaceuticals, Inc., incorporated by reference to Exhibit 10.2
to BioSante’s Current Report on Form 8-K as filed with the SEC on July 11,
2000 (File No. 0-28637).  Confidential
treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as
amended, has been granted with respect to designated portions of Exhibits 10.20
and 10.2.


 


·                  Amendment No. 4 to the License Agreement, dated August 8,
2002, between Antares Pharma IPL AG and BioSante Pharmaceuticals, Inc.,
incorporated by reference to Exhibit 10.20 to BioSante’s Registration
Statement on Form SB-2, as amended, as filed with the Securities and
Exchange Commission on August 22, 2002 (File No. 333-87542).  Confidential treatment under Rule 406 of
the Securities Act of 1933, as amended, has been granted with respect to
designated portions of Exhibit 10.20.


 


·                  Amendment No. 5 to the License Agreement, dated December 30,
2002, between Antares Pharma IPL AG and BioSante Pharmaceuticals, Inc.,
incorporated by reference to Exhibit 10.25 to BioSante’s Annual Report on Form 10-KSB
for the fiscal year ended December 31, 2002 as filed with the SEC on March 31,
2003 (File No. 0-28637). 
Confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended, has been granted with respect to designated portions
of Exhibit 10.25.


 

















 


·                  Amendment No. 6 to the License Agreement, dated October 20,
2006, between Antares Pharma IPL AG and BioSante Pharmaceuticals, Inc.,
incorporated by reference to Exhibit 10.27 to BioSante’s Annual Report on Form 10-K
for the fiscal year ended December 31, 2006 as filed with the SEC on March 27,
2007 (File No. 001-31812). 
Confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended, has been granted with respect to designated portions
of Exhibit 10.27.