Exhibit 10.2


 


[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.]


 


AMENDMENT NO. 1 TO LICENSE
AGREEMENT


AND ASSET PURCHASE AGREEMENT


 


This AGREEMENT (“Amendment”),
dated November 30, 2009 (the “Amendment Effective Date”)
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 and Company are parties to that certain
License Agreement dated as of December 3, 2008 (as amended by the
Amendment, the “License Agreement”).


 


WHEREAS, BPA and Company wish to amend certain
provisions of the License Agreement as set forth below.


 


WHEREAS, BPA and Company are parties to that certain
Asset Purchase Agreement dated as of December 3, 2008 (as amended by the
Amendment, the “Asset Purchase Agreement”).


 


WHEREAS, BPA and Company wish to amend certain
provisions of the Asset Purchase Agreement as set forth below.


 


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


 


1.                                       Definitions. 
Except as otherwise set forth in this Amendment, capitalized terms shall
have the definitions set forth in the License Agreement or Asset Purchase
Agreement, as the case may be.


 


2.                                       Royalties and Milestone Payments;
Amendment to License Agreement.


 


(a)                                  Within seven (7) days of the
Amendment Effective Date, Company shall pay BPA $1,000,000.00 (“Payment One”).


 


(b)                                 Company may in its sole and absolute
discretion pay BPA an additional amount of either $525,000.00 (“Payment Two”) or $1,050,000 (“Payment Two A”) no later than January 11, 2010.  For clarity, the benefits to Company under
this Amendment for making Payment Two shall also apply if Company makes Payment
Two A.


 


1

















 


(c)                                  If Company has made Payment Two A, then
Company may in its sole and absolute discretion pay BPA an additional amount of
either $550,000.00 (“Payment Three”)
or $1,100,000.00 (“Payment Three A”)
no later than February 22, 2010. 
For clarity, the benefits to Company under this Amendment for making
Payment Three shall also apply if Company makes Payment Three A.


 


(d)                                 In consideration of the above payments,
and depending on what payments are made, the royalty required by Section 3(a)(ii) of
the License Agreement and the milestones required by Sections 3(a)(iii)(1),
3(a)(iii)(2), 3(a)(iii)(4), and 3(a)(iii)(5) of the License Agreement
shall modified from the current rates and amounts to the rates and amounts
shown in the attached Table 1.  After
Payment One, the royalties will be reduced to the rates under the heading “After
Payment One.”  If Payment Two is made,
such royalties shall be reduced to the rates shown in the Table 1 below under
the heading “After Payment Two.”  If
Payment Two A is made, such royalties and such milestones shall be reduced to
the rates and amounts under the heading “After Payment Two A.”  If Payment Three is made, then such royalties
shall be reduced to the rates under the heading “After Payment Three.”  If Payment Three A is made, such royalties
and such milestones shall be reduced to the rates and amounts under the heading
“After Payment Three A.”


 


For clarity, the milestones
required by Sections 3(a)(iii)(3), (6), and (7) of the License Agreement
are not modified by this Amendment and will still be required in accordance
with the terms of the License Agreement if the specified Net Sales of those
subsections are achieved.


 


(e)                                  If Company pays BPA Payment Two, the
second Section 3(a)(ii)(2) of the License Agreement (beginning “In the
event that one of more generic versions. . . .”) is deleted in its entirety and
replaced with the following:


 


“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 from the royalties shown in Table 1 under the heading “After Payment
Two” by the same percent reduction as occurs under the Antares License
Agreement as the result of such generic entry.”


 


(f)                                    If Company pays BPA both Payment Two and
Payment Three, the second Section 3(a)(ii)(2) of the License
Agreement (beginning “In the event that one of more generic versions. . . .”)
is deleted in its entirety and replaced with the following:


 


“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 such
amount below 4.5% of Net Sales as the royalty payable by BPA to Antares is
reduced.”


 


(g)                                 In each case, the royalties
and milestones set forth in Table 1 shall take effect as of the first day of
the calendar month following the month in which the payment is made.


 


2

















 


(h)                                 Section 3 of the
License Agreement is amended by adding a new Section 3(b) as follows:


 


“Notwithstanding
anything in this Agreement to the contrary, (i) the royalties hereunder
shall never be less than the royalties required by the Antares License
Agreement, which are 4.5% of Net Sales with a reduction to 3.5% of Net Sales in
the case of generic competition and (ii) if Company has made Payment Three
or Payment Three A, the royalties hereunder shall never be greater than the
royalties required by the Antares License Agreement (which as stated above is
4.5% of Net Sales with a reduction to 3.5% of Net Sales in the case of generic
competition).  Further, when Company
sends royalty reports to BPA it shall at the same time send a copy of those royalty
reports to Antares.  Additionally, if
Company makes Payment Three or Payment Three A then it shall going forward
remit royalty payments and send royalty reports directly to Antares (with a
copy of the reports and check or payment advice to BPA), and BPA agrees that
with respect to Company’s royalty obligations to BPA under this License
Agreement the receipt of those payments by Antares shall be deemed equivalent
to their receipt by BPA.”


 


3.                                       Additional Modifications to License
Agreement in the Event of Payment Three.


 


If Company pays BPA both Payment Two and Payment
Three, then the License Agreement shall be further amended as follows upon
receipt of Payment Three:


 


(a)                                  Section 7 of the License Agreement
is amended as follows:  Sections 7(a) and
7(b) are retained without modification. 
Sections 7(c), 7(d), and 7(e) are deleted in their entirety and
replaced with the following:


 


“(c)                            Company shall provide BPA an annual
summary report of its commercialization of the Product, including copies of the
Company’s sales and marketing plans and one copy of each
advertising, detailing or promotional material used during the year.


 


(d)                                  With each annual
summary required by Section 7(c) above, Company shall also provide BPA with copies of all
material correspondence and documents to and from FDA and all notices received
from FDA concerning the Product. 
However, any such materials concerning safety or adverse events, or
matters that may interrupt manufacture or require any recall, shall promptly be
provided by Company to BPA and not delayed until the annual submission.”


 


(b)                                 Section 16(b)(iii)(a) to (c) of
the License Agreement shall be deleted in its entirety and replaced with the
following:


 


“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 


 


3

















 


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


 


(c)                                      if upon, expiration of the twenty-one
(21) day period, Company elects at its discretion 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.  Any recovery realized as a
result of any infringement action described in this Section 16(b)(iii) (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).”


 


(c)                                  Section 16(e) of the License
Agreement shall be deleted in its entirety and replaced with the following:


 


“(e)(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 


 


4

















 


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).


 


(e)(ii)                    BPA shall at Company’s request consult with Company on
the response to an Infringement Claim, and shall at Company’s request cooperate
with Company (at Company’s expense) in Company’s response and defense of such
claim, but shall otherwise have no obligation in respect to an Infringement
Claim.


 


(e)(iii)                 Company shall have sole discretion as to the manner in
which it will defend an Infringement Claim, including with regard to any
actions 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 ceasing to manufacture and supply Company with
Product, Company ceasing to supply BPA with Product (for use outside the
Territory) and/or the Company electing to modify the Product.”


 


(d)                                 Section 16(f) of the License
Agreement shall be deleted in its entirety and replaced with the following:


 


“Any licenses from Third
Parties that may be required for Company’s activities under this License
Agreement shall be the sole responsibility of Company in its sole discretion
and at its sole expense.  BPA shall at
Company’s request consult with Company with respect to any such potential
license.”


 


(e)                                  Section 9(d) of the License
Agreement shall be deleted in its entirety and replaced with the following:


 


“Subject to
compliance with all applicable laws and regulatory requirements, Company agrees
to supply BPA with Product at cost plus 7.5% for use in Israel and Canada and BPA shall have
the right to place orders for reasonable quantities of Product for sale by BPA
or BPA’s licensees in Israel and Canada 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) 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 


 


5

















 


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 that 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)).”


 


(f)                                    Section 9 of the License Agreement
is amended by adding a new Section 9(f) as follows:


 


“For countries outside
the Territory other than Israel and Canada, Company may at its sole discretion
agree that it shall supply
BPA with Product for use in such countries on such terms as may be agreed
including (i) to the extent applicable, the provisions set out in Section 9(d),
(ii) Company
shall be permitted to allocate limited manufacturing capacity or limited supply
of Product to itself and its own customers ahead of any orders for Product
placed by BPA for such countries, and (iii) the Parties shall in such
event confer in an effort to arrange to fill BPA’s orders for such countries in
a way that will not disrupt manufacturing or supply for Company.”


 


4.                                       Modification to Asset Purchase Agreement
in the Event Company Makes Payment 3 Three A.


 


If Company pays BPA both Payment Two A and Payment
Three A, then the Asset Purchase Agreement shall be amended as follows upon
receipt of Payment Three:


 


(a)                                  Section 13 of the Asset Purchase
Agreement shall be deleted in its entirety and replaced with the following:


 


“In the event that the
License Agreement between BPA and the Company is terminated for material breach
by Company, or Company knowingly takes any action (or refuses or omits to take
any action) that would cause a breach of the Antares License Agreement likely
to result in the termination of the Antares License Agreement by Antares on
account of such breach,  Company
assigns all right, title and interest in and to the NDA, the Trademark
(together with all goodwill associated therewith), and the Domain Names to BPA,
shall promptly transfer all documentation related to such NDA, Trademark, and
Domain Names to BPA, and agrees to take all such further action and promptly
execute such 


 


6

















 


further documents as may
be reasonably necessary or desirable to give full effect to such assignment,
including without limitation submitting a letter to the FDA requesting transfer
and any related documents with the FDA to effect such transfer, providing an
assignment of the Trademark in recordable form, and providing an assignment to
transfer ownership of the Domain Name with the registrar.  After such transfer of the NDA to BPA, Company
agrees to cooperate with BPA, at Company’s own expense other than its
reasonable out of pocket expenses, which shall be reimbursed by BPA upon
request, for a reasonable transition period not to exceed six (6) months,
regarding (i) FDA regulatory obligations for the Product, including
without limitation the preparation and submission of annual reports, the
reporting of adverse events, and cooperating with governmental regulatory
agencies; (ii) communication with Third Parties regarding the Product, including
without limitation responding to complaints and medical inquiries; (iii) investigating
all complaints and adverse drug experiences related to the Product; and (iv) giving
such notice as BPA may request to the FDA and to DPT or any other contract manufacturer
of Product.”


 


5.                                                                                       Agreements otherwise remain in effect. 
All provisions of the License Agreement and Asset Purchase Agreement
that are not amended in this Agreement remain in effect, except to the extent
that any provisions may have lapsed, been satisfied, or become moot without
regard to this Agreement.


 


[signature page follows]


 


7

















 


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

  



 


8

















 


TABLE 1


 


	
  Event

  	
   

  	
  Current

  	
   

  	
  After

  Payment One

  	
   

  	
  After

  Payment Two

  	
   

  	
  After

  Payment Two A

  	
   

  	
  After

  Payment Three

  	
   

  	
  After

  Payment Three A

  	
   

  
	
  Net Sales of the Product in the Territory
  in a calendar year under $10,000,000 or over $17,500,000

  	
   

  	
  Royalty 10%

  	
   

  	
  Royalty 7.25%

  	
   

  	
  Royalty 5.875%

  	
   

  	
  Royalty 5.875%

  	
   

  	
  Royalty 4.5%

  	
   

  	
  Royalty 4.5%

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Net Sales of the Product in the Territory
  in a calendar year Sales between $10,000,000 and $17,500,000

  	
   

  	
  Royalty 20%

  	
   

  	
  Royalty 12.75%

  	
   

  	
  Royalty 8.625%

  	
   

  	
  Royalty 8.625%

  	
   

  	
  Royalty 4.5%

  	
   

  	
  Royalty 4.5%

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Milestone at $XXXXXXX in Net Sales of the
  Product in the Territory in a calendar year

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Milestone at $XXXXXXX in Net Sales of the
  Product in the Territory in a calendar year

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Milestone at $XXXXXXX in Net Sales of the
  Product in the Territory in a calendar year

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Milestone at $XXXXXXX in Net Sales of the
  Product in the Territory in a calendar year

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  	
  $XXXXXXXX

  	
   

  



 


[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 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.]


 


9