Contract
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, Xxxxxxxxxxxxx 00, 0000 Xxx, Xxxxxxxxxxx as
Licensor (formerly known as Permatec Technologie AG) as Licensor
and
BioSante Pharmaceuticals, Inc., Lincolnshire, IL, U.S.A. as Licensee
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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
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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)
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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.]
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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 Xx. 0, Xxxxxxxxx Xx. 0 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.
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ANTARES Pharma IPL AG |
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Allschwie August 28, 2001 |
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/s/ Xxxxx Xxxxxxx |
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Place and Date |
By: |
Xx. Xxxxx Xxxxxxx |
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Its: |
Managing Director, Swiss Operations |
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BioSante Pharmaceuticals, Inc. |
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Lincolnshire, IL August 30, 2001 |
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/s/ Xxxxxxx X. Xxxxx |
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Place and Date |
By: |
Xxxxxxx X. Xxxxx |
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Its: |
President and CEO |
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