Document:

Exhibit 10.31

 

[Portions of this Exhibit have been omitted pursuant to a request for confidentiality under Rule 406 of the Securities Act of 1933, as amended.  The confidential portions of this Exhibit that have been omitted are marked with “XXXX.” A copy of this Exhibit with all sections intact has been filed separately with the Securities and Exchange Commission.]

 

Amendment No. 4

to the

License Agreement

dated 13th of June 2000 (the “Agreement”) by and between

Antares Pharma IPL AG, Zug, Switzerland as Licensor

(formerly known as Permatec Technologie AG)

and

BioSante Pharmaceuticals, Inc., Lincolnshire, IL, U.S.A. as Licensee

 

WHEREAS, Antares Pharma IPL AG, Zug, Switzerland (“Antares”) and BioSante Pharmaceuticals, Inc. (“BioSante”) have previously entered into a License Agreement dated June 13, 2000 (“Agreement”), regarding the grant of a license with the right to sublicense specified products, as well as a Supply Agreement of the same date; and

 

WHEREAS, Antares and BioSante have also entered into a series of three amendatory agreements subsequent to June 13, 2000, each of which has made specified amendments to the terms of the Agreement, as follows:  Amendment No. 1, dated May 20, 2001; Amendment No. 2, dated July 5, 2001; and Amendment No. 3, dated August 30, 2001; and

 

WHEREAS, Antares and BioSante each acknowledge that the other is, as of this date, in material compliance with all aspects of the License Agreement and Supply Agreement, but that Antares and BioSante have identified issues involving interpretation of the Agreement and the amendments regarding which they disagree, including issues relating to the Products covered by the Agreement, and desire to resolve those differences and continue their business relationship subject to some altered terms; and

 

WHEREAS, in order to effectuate these purposes, Antares and BioSante desire to enter into an agreement that will effectuate a fourth set of amendments to the Agreement, with the terms set forth below;

 

NOW THEREFORE, the Parties hereby agree pursuant to this Amendment No.4 to the License Agreement dated 13th of June 2000 (“Amendment No. 4”) to amend the Agreement as follows:

 

I.              Amendments to Agreement

 

[I-1]         Covered Products

 

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Paragraph 2.1 License, as amended by Amendment No. 1, is further modified to provide that BioSante is granted a license, with the right to grant sublicenses, to Develop the Products and any improvements or modifications thereof created, developed or devised by BioSante or Antares.  It therefore follows that:

 

A.            The Products include all estrogen gels, all testosterone gels, all E+T gels, and all E+P gels, whether or not their formulations contain lauryl alcohol, except as noted in B below;

 

B.            BioSante owns, on an exclusive worldwide basis all rights to Bio-T-Gel, XXXXXXXXXXXXXXXXXXXXXXXXXXXX  XXXXX, and has no obligation to share any information regarding Bio-T-Gel with Antares, including data generated during development; [A portion of this section has been omitted pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended.  The confidential portions of this section that have been omitted are marked with “XXXX.”  A copy of this section with the portion intact has been filed separately with the Securities and Exchange Commission]

 

[I-2]         Assistance

 

I-2-1        Paragraph 2.3 Assistance:  Paragraph 2.3 Assistance of the Agreement is amended by the addition of an alternative means for Antares to provide assistance,  as follows:  if and when requested by BioSante in its sole discretion, provision of assistance will be negotiated on a project basis with an agreed-upon budget before the work commences.  The final charges will be based on this budget only and will be invoiced at +/- 10% of the agreed upon budget.  No additional work beyond the agreed project will commence, nor charges reimbursed, without the written agreement of Antares and BioSante.

 

I-2-2        Manufacturing Assistance Agreement:  The parties acknowledge and agree that the Manufacturing Assistance Agreement between the parties creation of which was provided for by Amendment No.3 has not been created, and that, as a result of different agreements of the parties embodied in this Amendment no.4, the parties no longer desire that such a Manufacturing Assistance Agreement should be created or entered into between them.

 

[I-3]         Royalty

 

Paragraph 3.2 Roya1ty Payments of the Agreement, as amended by Amendment No. 3, is further amended to provide that BioSante’s obligation to pay a royalty is amended from XXXXXX (XXXX) to XXXXXX (XXXX) in the case of licensed Products, and BioSante will pay to Antares a royalty of XXXX of the royalty received by BioSante, up to a maximum of XXXX of net sales, in the case of sub-licensed Products.  [A portion of this section has been omitted pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended.  The confidential portions of this Exhibit that have been omitted are marked with “XXXX.”  A copy of this section with the portion intact has been filed separately with the Securities and Exchange Commission]

 

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[I-4]         Sub-licensee up-front, sublicense or milestone payments

 

Paragraph 3.4 of the Agreement is amended to provide that:

 

A.            Upon sub-license by BioSante of any Product covered in this Agreement or Amendments Nos. 1, 2, or 3 (other than E/Neta), BioSante will pay to Antares the proportion of such upfront payments defined in C below or Milestone Payments defined in paragraph 3.3 actually received, as follows:  a) where the payments received by BioSante are XXXXXXXXXXXX from BioSante to Antares then XXXXXXXXXX will be due to Antares, b) where the payments to BioSante are XXXXXXXXXXXXXXX above the commitment to Antares, the additional amount payable to Antares will be XXX of this excess, and c) where payments received by BioSante are XXXXXXXXXXX the amounts due to Antares, then BioSante will pay Antares XXX of this excess.  (For example, if a Milestone Payment of XXXXXX is due from BioSante to Antares, and a sub-licensee pays BioSante a Milestone Payment upon the same milestone of XXXXXX, BioSante will pay Antares XXX of the amount from XXXXXX to XXXXXX (that is, XXXXXX) and BioSante will pay Antares XXX of the XXXXXX excess over XXXXXXXXXXX the XXXXXX Milestone Payment, or XXXXXX) for a total of XXXXXX;  [A portion of this section has been omitted pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended.  The confidential portions of this Exhibit that have been omitted are marked with “XXXX.”  A copy of this section with the portion intact has been filed separately with the Securities and Exchange Commission]

 

B.            In the case of E/Neta, BioSante will pay to Antares XXX of all sums received from sub-licensees for the same Milestone in excess of the Milestone Payment payable under paragraph 3.3;  [A portion of this section has been omitted pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended.  The confidential portions of this Exhibit that have been omitted are marked with “XXXX.”  A copy of this section with the portion intact has been filed separately with the Securities and Exchange Commission]

 

C.            For purposes of calculating the appropriate amount of upfront payments, Antares and BioSante agree that the $1.0 million BioSante paid upfront to Antares is deemed to be attributed XXXXXXX to each of Bio-E-Gel, LibiGel and E/Neta (XXXXXXXX);  [A portion of this section has been omitted pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended.  The confidential portions of this Exhibit that have been omitted are marked with “XXXX.”  A copy of this section with the portion intact has been filed separately with the Securities and Exchange Commission]

 

D.            BioSante has no obligation to pay to Antares any portion of payments made to it for equity investments by sub-licensees, except to the extent that such equity investment incorporates payment of a per-share premium over the then-current market price, in which case BioSante shall pay Antares XXX of such premiums received.  [A portion of this section has been omitted pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended.  The confidential portions of this Exhibit that have been omitted are marked with “XXXX.” A copy of this section with the portion intact has been filed separately with the Securities and Exchange Commission]

 

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[I-5]         BioSante’s Development and Marketing obligations/United States and Non-US

 

Paragraphs 5.3 BioSante’s Development and Marketing obligations/United States and 5.4 BioSante’s Development and Marketing obligations/Non-US are amplified by the agreement that at its risk, BioSante will make final decisions as to data requirements for US submissions.

 

[I.6]         Reduction in Royalty

 

Paragraph 8.2.3 Reduction in Royalty is amended to provide that in the instance in which arise the triggering circumstances described in that Paragraph 8.2.3, relating to the existence an A/B rated generic equivalent, the royalty owing is to be reduced from XXXXXXX  XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX.  [A portion of this section has been omitted pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended.  The confidential portions of this Exhibit that have been omitted are marked with “XXXX.”   copy of this section with the portion intact has been filed separately with the Securities and Exchange Commission]

 

[I-7]         Terms

 

Paragraph 10.3.2 Terms, regarding XXX Combi Gel is amended to provide that

 

A.            the license fee totals XXXXXXXXXXXXXXXXXXXXXXXXXX (XXXXXX);  and

 

B.            XXXXXXXXXXXXXXXXXXXXXXXX (XXXXXX) of the license fee has been satisfied by Amendment No. 1, and royalty to XXXXX from XXXXX.

 

[A portion of these sections have been omitted pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended.  The confidential portions of this Exhibit that have been omitted are marked with “XXXX.”  A copy of these sections with the portion intact has been filed separately with the Securities and Exchange Commission]

 

[I-8]         Payments

 

I-8-1        10.3.3.2 Manufacturing of clinical batches:  The provisions of sub-paragraph 10.3.3.2 of the Agreement are entirely deleted, extinguished and eliminated.

 

I-8-2        10.3.3.3 Filing of the product:  The provisions of sub-paragraph 10.3.3.3 are amended to provide that the maximum milestone payment owed by BioSante upon filing of the product is XXXXXXXXXXXXXXXXXXXXX (XXXXXX).  [A portion of this section has been omitted pursuant to a request for confidential treatment under Rule 406 under the Securities Act of 1933, as amended.  The confidential portions of this Exhibit that have been omitted are marked with “XXXX.”  A copy of this section with the portion intact has been filed separately with the Securities and Exchange Commission]

 

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II.            Supply Agreement

 

[II-1]       Supply Agreement Termination

 

The Supply Agreement between Antares (formerly known as Permatec Technologie, AG) and BioSante dated June 13, 2000, by agreement of Antares and BioSante, is hereby terminated, extinguished an eliminated in its entirety pursuant to Article 18 (Modification) of the Supply Agreement.  Antares and BioSante acknowledge that all manufacturing is being transferred to a U.S. based GMP manufacturer and that Antares has no similar capacity.  Any assistance in manufacturing will be governed by Paragraph 2.3 as amended above.  Antares and BioSante each acknowledge that (a) neither has accrued any rights to its benefit under the Supply Agreement prior to this date, and that (b) neither has any obligations under the Supply Agreement that survive this termination

 

[II-2]       Antares to Involve BioSante in Manufacturing Communications

 

In order to maintain efficiency and accuracy in manufacturing, which will benefit both Antares and BioSante, Antares agrees to assure that BioSante will be fully involved and informed in conversations and communications with DPT regarding BioSante products, Bio-E-Gel, LibiGel, LibiGel E/T and any other product that may be developed.

 

III.           General

 

[III- 1]     Package Development

 

In the event that another Antares licensee uses a package or labeling developed by BioSante, BioSante will be reimbursed by Antares for development expenses in an amount to be negotiated by the parties in good faith.  In the event another Antares licensee uses packaging for which BioSante provides dies, tooling, and similar equipment, BioSante will be reimbursed by Antares for the expense of such equipment.

 

[III-2]      Governance

 

In addition to and preceding the mechanisms in 11.2 Dispute Resolution of the Agreement, the parties agree that Steering Committee, made up of Dario Cararra, Roger Harrison, Stephen Simes and Leah Lehman or replacements to be named by the respective companies.  The Operational Committee will be Holger, Doris and Lisa or replacements to be named by the respective companies.

 

[III-3]      Continued effect

 

The parties agree that the Agreement shall, except for and in due incorporation of the amendments agreed upon in Amendment No. 1, dated May 20,2001; Amendment No. 2 dated July 5,2001;  and Amendment No.3, dated August 30, 2001, and this Amendment No. 4, remains in full force and effect and are not otherwise changed, altered or amended.  The parties further agree that in the event that any further amendment, change or alteration to the language or wording if any section of the Agreement or this Amendment No.4 is determined by the parties to

 

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be required to give full effect to any of the changes agreed upon in this Amendment No. 4, then the parties agree to execute in writing any such further amendment, change or alteration.

 

IN WITNESSETH WHEREOF, the Parties have duly executed this Amendment effective as of the 8th day of August, 2002.

 

 

	
Antares   Pharma IPL AG  
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
/s/   Roger G. Harrison
    
	
Place   and Date
    	
 
    	
By:   
    	
Roger   G. Harrison
    
	
 
    	
 
    	
Its:   
    	
CEO   and President
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
BioSante Pharmaceuticals, Inc.
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Lincolnshire, IL                       8/8/02
    	
 
    	
/s/   Stephen M. Simes
    
	
Place   and Date
    	
 
    	
By:   
    	
Stephen   M. Simes
    
	
 
    	
 
    	
Its:   
    	
President   and CEO
    

 

6Exhibit 10.32

 

Amendment No. 5

to the

License Agreement dated 13th of June 2000 (the

“Agreement”)

by and between

 

Antares Pharma IPL AG

Zug, Switzerland

as Licensor

(formerly known as Permatec Technologie AG)

 

and

 

BioSante Pharmaceuticals, Inc.

Lincolnshire, IL, U.S.A.

as Licensee

 

 

WHEREAS, Antares Pharma IPL AG, Zug, Switzerland (“Antares”) and BioSante Pharmaceuticals, Inc., Lincolnshire, Illinois (“BioSante”) have previously entered into a License Agreement dated June 13, 2000 (“Agreement”), regarding the grant of a license with the right to sublicense specified products, as well as a Supply Agreement of the same date;

 

WHEREAS, Antares and BioSante have also entered into a series of four amendatory agreements subsequent to June 13, 2000, each of which has made specified amendments to the terms of the Agreement, as follows: Amendment No. 1, dated May 20, 2001; Amendment No. 2, dated July 5, 2001; Amendment No. 3, dated August 30, 2001; and Amendment No. 4, August 8, 2002;

 

WHEREAS, Antares and BioSante each acknowledge that Antares and BioSante have identified issues involving interpretation of the Agreement and the amendatory agreements regarding which they disagree, specifically as to the appropriate timing of the milestone payment provided for in paragraph 3.3.3 of the Agreement, as modified by section 1-4(B) of Amendment No. 4, and the agreed geographical location of product development activities; and

 

WHEREAS, Antares and BioSante each desire to resolve their differences without acknowledging the accuracy or validity of the assertions of the other, except as may be set forth herein, and desire to continue their business relationship subject to some altered terms;

 

NOW THEREFORE, Antares and BioSante hereby agree pursuant to this Amendment No. 5 to the License Agreement dated 13th of June 2000 (“Amendment No. 5”) to amend the Agreement as follows:

 

1

 

A.            MILESTONE

 

In order to perform its obligations under paragraph 3.3.3 of the Agreement, as modified by paragraph 1-4(B) of Amendment No. 4, Antares and BioSante agree that BioSante shall pay

 

(1)           the sum of Two Hundred Thousand Dollars (USD 200,000), upon execution of this Amendment No. 5; and

 

(2)           an additional Three Hundred Thousand Dollars (USD 300,000) upon the start of a clinical trial of E2-Neta Combi Gel in the USA or upon filing of a New Drug Application with the US Food and Drug Administration for E2-NETA Combi Gel by Solvay Pharmaceuticals, whichever occurs first.

 

The Parties agree and acknowledge that the above sums are in full and complete performance of the obligations in paragraph 3.3.3 of the Agreement, as modified by paragraph 1-4(B) of Amendment No. 4, and in full and complete settlement and resolution of their differences with respect to such paragraphs, and that payment of such sums are in addition to and different than payment of any other sums provided for in the Agreement and any of the four prior amendments to it.

 

B.            GEOGRAPHY OF DEVELOPMENT ACTIVITIES

 

In order to resolve the Parties’ disagreement regarding the proper geographical location of development activities for defined Products:

 

(1)           BioSante hereby acknowledges and agrees that its license from Antares regarding E2-Neta Combi Gel includes marketing rights only in the United States and Canada, and regarding other Products, only in countries specifically enumerated in the Agreement and/or one or more of the amendments to it, and hereby reaffirms that it has no intention of undertaking or sublicensing development activities for any purposes other than achieving regulatory approval and making subsequent sales and undertaking related support activities in the countries with respect to which it has received such licenses from Antares; and

 

(2)           Antares and BioSante hereby acknowledge and agree that, under the terms of the Agreement and the five amendments to it, activities constituting Development of any Product may be undertaken in any geographical location inside or outside the agreed and defined Territory for such Product, whether undertaken by BioSante or its sublicensee Solvay Pharmaceuticals regarding E2-Neta Combi Gel, or any other sublicensee regarding any other Product, or any future sublicensee, assignee or designee.  The choices of location of such activities are in the sole discretion of BioSante, Solvay or its assignee or designee, and such entities will not, by virtue of their choice of location alone, be considered to be in breach of the Agreement or any amendment to it.  As in section B(1) above, it is acknowledged that all such activity will be directed toward achieving regulatory approval and making subsequent sales and undertaking related support activities in the territories in which BioSante, its current or future sub licensees, or any

 

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future sub licensees, designees or assignees have rights to the Products as specified in the Agreement and all amendments.

 

C.            MISCELLANEOUS

 

The parties agree that the Agreement shall, except for and in due incorporation of the amendments agreed upon in Amendment No. 1, dated May 20, 2001; Amendment No. 2, dated July 5, 2001; Amendment No. 3, dated August 30, 2001; Amendment No. 4, dated August 8, 2002, and this Amendment No. 5, remain in full force and effect and is not otherwise changed, altered or amended.

 

IN WITNESSETH WHEREOF, the Parties have duly executed this Amendment effective as of the 30th day of December, 2002.

 

	
Antares Pharma IPL AG
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
PA 
    	
12/30/02
    	
 
    	
/s/   Roger G. Harrison
    
	
Place and Date
    	
 
    	
By:   
    	
Roger   G. Harrison
    
	
 
    	
 
    	
Its:
    	
President   and CEO
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
BioSante   Pharmaceuticals, Inc.
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
Lincolnshire, IL 
    	
12/27/02
    	
 
    	
/s/   Stephen M. Simes
    
	
Place and Date
    	
 
    	
By:
    	
Stephen   M. Simes
    
	
 
    	
 
    	
Its:   
    	
President   and CEO
    

 

3

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