Document:

Exhibit 10.28

 

[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 “XXXX.”  A copy of this Exhibit with all sections intact has been filed separately with the Securities and Exchange Commission.]

 

Amendment No. 1

 

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

 

Recitals:

 

WHEREAS, Permatec Technologie AG has changed its corporate name into Antares Pharma IPL AG (“ANTARES”); and

 

WHEREAS, “ANTARES” has secured a third party being interested in a license package which package would — inter alia — include the rights to certain Products (all capitalized terms used herein but not defined shall have such meaning as ascribed to such terms in the Agreement) in specified countries of the Territory as licensed to BioSante Pharmaceuticals, Inc. (“BIOSANTE”) under the Agreement; and

 

WHEREAS, BIOSANTE is prepared to return such rights to certain Products in specified countries included in the license under the Agreement for the consideration described and under the terms and conditions set forth herein below.

 

NOW THEREFORE, the Parties hereby agree pursuant to this Amendment No. 1 to the License Agreement dated 13th of June 2000 (the “Agreement”) (“Amendment No. 1”) to amend the Agreement as follows:

 

1.                                      Change of Corporate Name

 

Following the change of corporate name from Permatec Technologie AG into Antares Pharma IPL AG effective as of 15th February 2001, the Agreement is hereby amended as follows for clarification and to make the Agreement consistent with this Amendment No. 1.

 

 

(a)                                  all references in the Agreement to Permatec Technologie AG shall be substituted by Antares Pharma IPL AG; and

 

(b)                                 all references in the Agreement to PERMATEC shall be substituted by ANTARES.

 

2.                                      Return of Rights

 

2.1                                 BIOSANTE hereby returns its rights granted under the Agreement as part of the license (including without limitation rights to Develop, apply and receive Approval as applicant, Market, use and sell) to ANTARES with respect to:

 

(a)                                  all rights to the Product Patch E2 (where estradiol is the sole active ingredient and where the patch is applied to the skin) for all countries of the Territory; and

 

(b)                                 the rights to the Product Gel E2 (where estradiol is the sole active ingredient and where the gel is applied to the skin), for the countries Australia and Malaysia; and

 

(c)                                  the rights to the Product Gel Testosterone (where testosterone is the sole active ingredient and where the gel is applied to the skin), for the countries Australia and Malaysia.

 

All such rights returned to ANTARES as described in this Section 2.1 shall be collectively referred to hereinafter as the “Returned Rights”).

 

2.2                                 In order to give effect to the waiver and return of the Returned Rights, the parties agree to amend the Agreement as follows:

 

(a)                                  the Product Patch E2 (where estradiol is the sole active ingredient and where the patch is applied to the skin) is deleted from the list of Products attached to the Agreement as Exhibit B, and all references to Patch E2 in the Agreement are deleted and eliminated without substitution; and

 

(b)                                 the definition of the term “Territory” in Section 1.14 of the Agreement is deleted in its entirety and substituted by the following definition:

 

1.14         “Territory” shall mean the United States of America and those of its territories and possessions over which the FDS has regulatory authority (the “USA”); Canada; Australia; New Zealand; South Africa; Israel; Mexico; The People’s Republic of China (including Hong Kong) (“China”); Malaysia; and Indonesia, except for the Products Gel E2 and Gel Testosterone, for which Products the term “Territory” shall mean the United States of America and those of its territories and possessions over which the FDS has regulatory authority (the “USA”); Canada; New Zealand; South Africa; Israel; Mexico; The People’s Republic of China

 

 

(including Hong Kong) (“China”); and Indonesia.  The countries are classified according to Exhibit C in three tiers.

 

3.                                      Data Sharing

 

3.1                                 In order to secure the mutual exchange and sharing of data relating to the Products in the Territory (as amended hereby) by BIOSANTE and its sub-licensees, and outside the Territory (as amended hereby) by ANTARES and/or its third party licensees, the parties hereby agree that Section 5.2 of the Agreement shall in particular also include the use of any data and results generated in the Territory by BIOSANTE or any of its sub-licensees (if any) for use by ANTARES or any licensee with respect to the Returned Rights outside the Territory, and any data and results generated by ANTARES or any licensee with respect to the Returned Rights for use by BIOSANTE or its sub-licensees in the Territory.

 

3.2                                 ANTARES undertakes to include a respective obligation giving effect to such data sharing also with respect to the Returned Rights in any eventual license agreement with a third party on the Returned Rights (or any part thereof).

 

4.                                      Changes in Payment Obligations

 

4.1                                 As consideration for the Returned Rights by BIOSANTE, the parties agree to eliminate certain payment obligation of BIOSANTE under the Agreement as specified herein below:

 

(a)                                  the payment obligation of BIOSANTE under Section 3.3.1 of the Agreement in the amount of USD 125,000 upon start of manufacturing of the first batch of GMP-compliant finished Product for use in a clinical trial of the first Product to be subjected to such clinical trial (which is either the Product GEL E2 or GEL Testosterone) shall be eliminated from the Agreement; and

 

(b)                                 the payment obligation of BIOSANTE under Section 3.3.2 of the Agreement in the amount of USD 125,000 upon start of manufacturing of the first batch of GMP-compliant finished Product for use in a clinical trial of the second Product to be subjected to such clinical trial (which is either the Product GEL E2 or GEL Testosterone) shall be eliminated from the Agreement; and

 

(c)                                  the milestone payment obligation of BIOSANTE under Section10.3.3.1 of the Agreement in the amount of XXXXXXXXXXXXXXXXXXX XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX, shall be eliminated from the Agreement.  [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 “XXXX.”  A copy of this Agreement with this section intact has been filed separately with the Securities and Exchange Commission.]

 

 

4.2                                 As further consideration for the Returned Rights by BIOSANTE, ANTARES agrees that its obligation under Section 4.1.3 of the Agreement is not diminished by this Amendment No. 1, such that ANTARES remains obligated to expend funds for the formulation and production of the Products remaining under the Agreement, up to a potential maximum of Six Hundred Thousand Dollars ($600,000), and such that the funds it was to have expended on the Product Patch E2, up to One Hundred Fifty Thousand Dollars ($150,000), will be allocated as additional formulation and production expenditures for Product Gel E2 and Product Gel Testosterone.

 

4.3                                 The parties hereby confirm that the consideration described above is sufficient and adequate for the Returned Rights.

 

5.                                      No Further Changes

 

5.1                                 The parties hereby agreed and acknowledge that the Agreement shall, except for and in due incorporation of the changes agreed upon in this Amendment No. 1, remain in full force and effect and, subject to Section 5.2 below, not be otherwise changed, altered or amended.

 

5.2                                 The parties further agree that in the event that any further amendment, change or alteration of the language or wording of any Section of the Agreement would be required to give full effect to any of the changes agreed upon in this Amendment, then such further amendment, change or alteration of the language or wording shall be made upon reasonable request of either party.

 

5.3                                 This Amendment is agreed to be subject to the provisions of the Agreement of 11.1. (Governing Law) and 11.2 (Dispute Resolution) by reference.

 

IN WITNESS WHEREOF, the parties hereto have caused this instrument to be executed by their duly authorized officers with effect as of the 20th day of May, 2001.

 

 

	
Antares   Pharma IPL AG
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
/s/   Dario Carrara
    	
 
    	
 
    
	
By:   
    	
Dario   Carrara
    	
 
    	
By:   
    
	
Its:   
    	
Executive   Director
    	
 
    	
Its:
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
BIOSANTE   PHARMACEUTICALS, INC.
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
/s/   Stephen M. Simes
    	
 
    	
 
    
	
By:   
    	
Stephen   M. Simes
    	
 
    	
 
    
	
Its:   
    	
President   and CEO
    	
 
    	
 
    

 

 

EXHIBIT C

 

COUNTRY CLASSIFICATION

 

First Tier:                                               USA

 

Second Tier:                                          Canada; China

 

Third Tier:                                             All other countries of the TerritoryExhibit 10.30

 

[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 “XXXX.” A copy of this Exhibit with all sections intact has been filed separately with the Securities and Exchange Commission.]

 

AMENDMENT NO. 3

 

to the

 

License Agreement dated 13th of June, 2000 (the “Agreement”)

 

by and between

 

ANTARES Pharma IPL AG, Zug, Baarerstrasse 95, 6301 Zug, Switzerland as

Licensor (formerly known as Permatec Technologie AG) as Licensor

 

and

 

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

 

Recitals:

 

WHEREAS, ANTARES Pharma IPL AG (“ANTARES”) and BioSante Pharmaceuticals, Inc. (“BIOSANTE”) have entered into that certain License Agreement dated of June 13, 2000 (the “Agreement”), regarding the grant of a license with the right to sublicense products as defined in the Agreement;

 

WHEREAS, ANTARES Pharma IPL AG (“ANTARES”) and BioSante Pharmaceuticals, Inc. (“BIOSANTE”) have entered into a Supply Agreement dated of June 13, 2000 (the “Supply Agreement”) regarding the manufacturing and the supply of products (according to Exhibit D of the Supply Agreement);

 

WHEREAS, ANTARES and BIOSANTE have concluded some alterations to the Agreement in Amendment No. 1 of May 20, 2001 (“Amendment No. 1”);

 

WHEREAS, ANTARES has granted BIOSANTE the licensing of XXXX Combi-Gel which is set out in Amendment No. 2 of July 5, 2001 (“Amendment No. 2”)  [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 “XXXX.”  A copy of this Agreement with this section intact has been filed separately with the Securities and Exchange Commission.]

 

WHEREAS, the parties have negotiated this third set of terms and conditions in alteration of the Agreement;

 

NOW, THEREFORE, the Parties agree according to this Amendment No. 3 (“Amendment No. 3”) to amend the Agreement as follows:

 

 

1.                                       Royalties

 

(a)                                  Royalty payment

 

BIOSANTE will receive from ANTARES in modification of section 3.2 of the “Agreement” a commission on royalty for the sale of the combination product “Estradiol plus Norethindrone Acetate (“E2-NETA Combi Gel”).  The commission on royalties for the said product will be 5% for sales amounting up to USD 75,000,000 (Seventy five million US-dollars) and 7% for sales over USD 75,000,000 (Seventy five million US-dollars).  This modification comes into effect as per the date of signature (effective date) of this Amendment No. 3.  However, this modification of the royalties does not apply for the products “Estradiol single gel”, “Testosterone single gel” and the combination product “Estradiol plus Testosterone” but only and exclusive for E2-NETA Combi Gel.

 

(b)                                 Reduction in Royalty Payments

 

Consistent with the principles in the BIOSANTE-SOLVAY agreement, in the instance in which an A/B rated generic equivalent or substitute of E2-NETA Combi Gel (“Product”) is reasonably notified by BIOANTE, SOLVAY or ANTARES to infringe a patent available for such product in the United States or Canada, and SOLVAY may give evidence that the marketing of such competitive product has led to a reduction in sales of the product in either such country of more than fifteen percent (15%) in an average three (3) month period, then the Royalty payable by BIOSANTE to ANTARES for E2-NETA Combi-Gel after such reasonable notice in that country of the Territory will be three and one half percent (3 1⁄2%) up to total sales of Seventy Five Million Dollars (USD 75,000,000) and five percent (5%) for sales over Seventy Five Million Dollars (USD 75,000,000), for as long as (1) such competing product is on sale, and (2) BIOSANTE’s Royalty obligation exists under this Agreement.

 

(c)                                  Books and records

 

Pertaining to E2-NETA Combi Gel BIOSANTE shall keep full, true and accurate books of accounting containing all particulars and reasonable supporting documentation which may be necessary for the purpose of the accurate determination of the Net Sales achieved by SOLVAY.  The inspection of the books and records will be carried out according to the terms and conditions of the Agreement.

 

(d)                                 Audits

 

ANTARES has the right to notify BIOSANTE that it would like to audit the books and records of SOLVAY to inspect the accuracy of SOLVAY Net Sales reported to BIOSANTE, in which instance BIOSANTE will in turn notify SOLVAY that it would like to exercise its right to audit pursuant to the agreement between BIOSANTE and SOLVAY.  SOLVAY shall permit a firm of certified

 

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public accountants, acceptable to ANTARES, BIOSANTE and SOLVAY, upon request by ANTARES, to examine all books and records relating to the sales of E2-NETA Combi Gel, at all reasonable times and upon reasonable notice, to verify BIOSANTE’s reports and accountings determining the correctness of the sublicense royalties.  The expenses for such audit will be borne by ANTARES as per the BIOSANTE-SOLVAY agreement.

 

2.                                       Reallocation of USD 150,000

 

As consideration for the successful sub-license of the E2-NETA Combi Gel (see 3), hereinafter, ANTARES reallocates as follows the USD 150,000 (One hundred fifty thousand US-Dollars) obligation (as per section 4.1.2 of the Agreement) corresponding to E2-NETA Combi Gel formulation and production costs: USD 75,000 (Seventy five thousand US-dollars) for “Estradiol single gel” and additional USD 75,000 (Seventy five thousand US-dollars) for “Testosterone single gel”.  The reallocation will take effect as per the date of signature (effective date) of this Amendment No. 3.  This reallocation is in addition to the reallocation stipulated in section 4.2 of Amendment No. 1.  The net effect of these reallocations is that ANTARES is obliged to expend funds for the formulation and production of Product Gel E2 (“Estradiol single gel”) and of Product Gel Testosterone (“Testosterone single gel”) up to a potential maximum of USD 600,000 (Six hundred thousand US Dollars).

 

3.                                       Manufacturing rights (Sublicense)

 

ANTARES grants to BIOSANTE the right to grant manufacturing of E2-NETA Combi Gel exclusively to Solvay Pharmaceuticals, B.V. (“SOLVAY”).  In the event of termination of the Agreement between ANTARES and BIOSANTE, BIOSANTE’s rights under the BIOSANTE-SOLVAY Agreement will be assigned to ANTARES, except that BIOSANTE will continue to receive its share of milestone and royalty payments paid by SOLVAY pursuant to the terms of the BIOSANTE-SOLVAY Agreement.

 

4.                                       Assistance of ANTARES

 

The parties agree to draft and sign a separate Manufacturing Assistance Agreement within a period of 60 days after the signing of this Amendment No. 3.  As pertains E2-NETA Combi Gel, the Manufacturing Assistance Agreement shall:  (1) Replace the Supply Agreement for E2-NETA Combi-Gel; (2) Eliminate any and all ANTARES obligations contained in the Supply Agreement for E2-NETA Combi-Gel; and (3) Govern all manufacturing aspects related to E2-NETA Combi Gel.

 

The Manufacturing Assistance Agreement shall inter alia contain the following points:

 

ANTARES agrees during the term of the Manufacturing Assistance Agreement to provide technical and scientific assistance to BIOSANTE or its sublicensee against reimbursement applying a rate of USD 150 (One hundred fifty US-Dollars) per man-hour spent by ANTARES personnel.  BIOSANTE further undertakes and agrees to reimburse any and all reasonable out-of-pocket expenses incurred by ANTARES and agreed to in advance in writing by BIOSANTE in connection with any such assistance to BIOSANTE.  Such assistance shall be provided by

 

3

 

ANTARES within a reasonable time in response to requests in connection with BIOSANTE’s or the sublicensee’s efforts to manufacture the product.

 

5.                                       Discount of USD 125,000

 

ANTARES grants a discount to BIOSANTE of USD 125,000 (One hundred twenty five thousand US-Dollars) for its development work already performed on “Estradiol single gel” and “Testosterone single gel”.  This discount may be implemented by reduction of the invoice of ANTARES to BIOSANTE dated June 30, 2001.  Nothing herein shall prevent the parties from negotiating or entering into further agreements on adjustments to the June 30, 2001 invoice.

 

6.                                       No Further Funding for E2-NETA Combi-Gel

 

After the execution of this Amendment 3 including the execution of the Manufacturing Assistance Agreement, ANTARES has no further obligation to financially fund, develop, market, assist or otherwise support E2-NETA Combi Gel as outlined in the Agreement and the Supply Agreement except for those obligations contained in this Amendment 3.

 

7.                                       No Further Changes

 

The parties hereby agree and acknowledge that the Agreement shall, except for and in due incorporation of the changes agreed upon in Amendment No. 1, Amendment No. 2 and this Amendment No. 3, remain in full force and effect and, subject to the following, not be otherwise altered or amended.

 

The amendments and changes to the Agreement as set forth in this Amendment No. 3 shall upon execution become an integral part of the Agreement.

 

The parties further agree that in the event that any further amendment, change or alteration of the language or wording of any Section of the Agreement would be required to give full effect to any of the changes agreed upon in this Amendment, then such further amendment, change or alteration of the language or wording shall be made upon reasonable request of either party.

 

8.                                       Governing Law

 

This Amendment No. 3 is construed under and governed by Illinois Law.

 

4

 

IN WITNESSETH WHEREOF, the Parties have duly executed this Amendment effective as of the          day of                   , 2001.

 

 

	
 
    	
 
    	
ANTARES   Pharma IPL AG
    
	
 
    	
 
    	
 
    
	
Allschwie    August 28, 2001
    	
 
    	
/s/   Dario Carrara
    
	
Place   and Date
    	
 
    	
By:   
    	
Dr. Dario   Carrara
    
	
 
    	
 
    	
Its:   
    	
Managing   Director, Swiss Operations
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
 
    
	
 
    	
 
    	
BioSante   Pharmaceuticals, Inc. 
    
	
 
    	
 
    	
 
    
	
Lincolnshire, IL    August 30, 2001
    	
 
    	
/s/   Stephen M. Simes
    
	
Place   and Date
    	
 
    	
By:   
    	
Stephen   M. Simes
    
	
 
    	
 
    	
Its:   
    	
President   and CEO
    

 

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