Document:

Amendment No

Exhibit 10.19

 

[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.  A copy of this

Exhibit with all sections intact has been filed separately with the Securities

and Exchange Commission.]

 

AMENDMENT NO. 2

to the

License Agreement dated 13th

of June, 2000

as amended by Amendment

No. 1 to that License Agreement dated May 20, 2001 by and

between

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

Licensor (formerly

known as Permatec Technologie AG)

and

BioSante Pharmaceuticals, Inc., 175 Olde Half Day Road, Lincolnshire, IL.,

60069 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 13th of June,

2000 (the “Agreement”), regarding the grant of a license with the right to

sublicense products as defined in the Agreement, and have entered into a May

20, 2001 amendment to that Agreement entitled in part “Amendment No. 1 to the

License Agreement dated 13th of June 2000” (“Amendment No. 1”)

WHEREAS, ANTARES has granted BIOSANTE an option regarding the licensing of

XXXX Combi-Gel in 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.  A copy of this

Agreement with this section intact has been filed separately with the Securities

and Exchange Commission.]

WHEREAS, ANTARES has offered within the “offering period” and BIOSANTE has an

interest in licensing XXXX Combi-Gel.  [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.  A copy of this Agreement with this section

intact has been filed separately with the Securities and Exchange Commission.]

WHEREAS, the parties acknowledge that the prerequisites provided for in 10.3.1

of the Agreement have been met;

NOW, THEREFORE, the Parties hereby agree according to this Amendment

No. 2 to the License Agreement dated 13th of June 2000 (the

“Agreement”) (“Amendment No. 2”) to amend the Agreement as follows:

 

 

 

	

  1.

  	

  BIOSANTE hereby agrees to accept an exclusive license of the XXXX

  Combi-Gel pursuant to the terms and conditions set forth in the Agreement as

  amended by Amendment No. 1.  [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.  A copy of this Agreement with this section

  intact has been filed separately with the Securities and Exchange

  Commission.]

  
	

   

  	

   

  
	

  2.

  	

  The

  Parties hereby reaffirm their agreement to the terms and conditions under

  10.3.2 and 10.3.3 of the Agreement, and reaffirm that the payment obligations

  in 10.3.3.1 of the Agreement have been fully eliminated pursuant to 4.1(c) of

  Amendment No. 1.

  
	

   

  	

   

  
	

  3.

  	

  Except

  for the amendments and changes to the Agreement as set forth in Amendment No.

  1 and in this Amendment No. 2, which shall upon execution hereof become an

  integral part of the Agreement, any and all terms and conditions contained in

  the Agreement as agreed upon by the Parties shall remain in full force and

  effect and shall not be changed, amended or altered by this Amendment.

  
	

   

  	

   

  
	

  4.

  	

  Any

  and all capitalized terms used herein but not defined shall have the meaning

  ascribed to such terms in the Agreement.

  
	

   

  	

   

  
	

  5.

  	

  The

  parties further agree that in the event that any further amendment, change or

  alteration of the language or wording etc. 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.

  

 

IN WITNESSETH WHEREOF, the Parties have duly executed this Amendment

effective as of the 5th day of July, 2001.

 

	

   

  	

  Antares Pharma IPL AG

  
	

   

  	

   

  
	

  Allschwie     June 27, 2001

  	

   

  	

  /s/ Dario Carrara

  	

   

  
	

  Place and Date

  	

  By:

  	

  Dario Carrara

  
	

   

  	

  Its:

  	

  Executive Director

  
	

   

  	

   

  
	

   

  	

   

  
	

   

  	

  BioSante Pharmaceuticals, Inc. 

  

  
	

   

  	

   

  
	

  Lincolnshire, IL     July 5, 2001 

  	

   

  	

  /s/ Stephen M. Simes

  	

   

  
	

  Place and Date

  	

  By:

  	

  Stephen M. Simes

  
	

   

  	

  Its:

  	

  President and CEO

  
					

 

 

2Amendment No

Exhibit

10.20

 

[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.  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.  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

XXXXXXXXXXXXXX (“E2-XXXX Combi Gel”). 

The commission on royalties for the said product will be XXX for sales

amounting up to XXXXXXXX (XXXXXXXXXX) and XXX for sales over XXXXXXXXX

(XXXXXXXXXX).  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-XXXX Combi Gel.  [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.  A copy of this Agreement with this section

intact has been filed separately with the Securities and Exchange Commission.]

 

(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-XXXX 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 XXXXXXXX (XXXX) in

an average three (3) month period, then the Royalty payable by BIOSANTE to

ANTARES for E2-XXXX Combi-Gel after such reasonable notice in that country of

the Territory will be XXXXXXXXXXX (XXXX) up to total sales of XXXXXXXXXX

(XXXXXXX) and XXXXXXXX (XXX) for sales over XXXXXXXXXXXX (XXXXXXXX), for as

long as (1) such competing product is on sale, and (2) BIOSANTE’s Royalty

obligation exists under this 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.  A copy of this

Agreement with this section intact has been filed separately with the

Securities and Exchange Commission.]

 

(c)                                  Books and records

 

2

 

Pertaining to

E2-XXXX 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.  [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.  A copy of this

Agreement with this section intact has been filed separately with the

Securities and Exchange Commission.]

 

(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 public accountants, acceptable to ANTARES, BIOSANTE and SOLVAY, upon

request by ANTARES, to examine all books and records relating to the sales of

E2-XXXX 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.  [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.  A copy of this

Agreement with this section intact has been filed separately with the

Securities and Exchange Commission.]

 

2.                                       Reallocation of XXXXXXX

As consideration for the

successful sub-license of the E2-XXXX Combi Gel (see 3), hereinafter, ANTARES

reallocates as follows the XXXXXXX (XXXXXXXXXXXX) obligation (as per section

4.1.2 of the Agreement) corresponding to E2-XXXX Combi Gel formulation and

production costs: XXXXXXX (XXXXXXXXXXX) for “Estradiol single gel” and

additional XXXXXXX (XXXXXXXXXXX) 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 XXXXXXX (XXXXXXXXXXX)  [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.  A copy of this

Agreement with this section intact has been filed separately with the

Securities and Exchange Commission.]

 

3.                                       Manufacturing rights (Sublicense)

 

3

ANTARES grants to

BIOSANTE the right to grant manufacturing of E2-XXXX 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.  [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.  A copy of this Agreement with this section

intact has been filed separately with the Securities and Exchange Commission.]

 

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-XXXX Combi Gel, the

Manufacturing Assistance Agreement shall: 

(1) Replace the Supply Agreement for E2-XXXX Combi-Gel;

(2) Eliminate any and all ANTARES obligations contained in the Supply

Agreement for E2-XXXX Combi-Gel; and (3) Govern all manufacturing aspects

related to E2-XXXX Combi Gel.  [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.  A copy of this Agreement with this section

intact has been filed separately with the Securities and Exchange Commission.]

 

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 XXXX (XXXXXXXXXXXXX) XXXXXXX 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 ANTARES within a reasonable time in response to

requests in connection with BIOSANTE’s or the sublicensee’s efforts to manufacture

the product.  [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.  A copy of this Agreement with this section intact has been filed

separately with the Securities and Exchange Commission.]

 

5.                                       Discount of XXXXXXX

ANTARES grants a XXXXXXX

to BIOSANTE of XXXXXXX (XXXXXXXXXX) 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.  [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. 

A copy of this Agreement with this section intact has been filed

separately with the Securities and Exchange Commission.]

4

6.            No Further Funding for E2-XXXX 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-XXXX Combi Gel as outlined in the

Agreement and the Supply Agreement except for those obligations contained in

this Amendment 3.  [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. 

A copy of this Agreement with this section intact has been filed

separately with the Securities and Exchange Commission.]

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.

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

  
					

 

 

5

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