Exhibit 10.37
CONFIDENTIAL TREATMENT REQUESTED.
CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN
SEPARATELY FILED WITH THE SECURITIES AND EXCHANGE COMMISSION.
AMENDMENT NO. 3
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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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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 **** Combi-Gel which is
set out in Amendment No. 2 of July 5, 2001; ("Amendment No. 2");
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
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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 ****** ("E2-****** Combi-Gel"). The commission on royalties
for the said product will be **% for sales amounting up to USD ******
(****** US-dollars) and **% for sales over USD ****** (****** 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
1
***** - Denotes portions omitted pursuant to a request for confidentiality under
Rule 24b-2 of the Securities Exchange Act of 1934. A copy of this agreement with
the omitted information intact has been filed separately with the Securities and
Exchange Commission.
the products "Estradiol single gel", "Testosterone single gel" and the
combination product "Estradiol plus Testosterone" but only and exclusively
for **** 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-****
Combi Gel ("Product") is reasonably notified by BIOSANTE, 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 ****** percent (**%) in an average three (3) month
period, then the Royalty payable by BIOSANTE to ANTARES for E2-****
Combi-Gel after such reasonable notice in that country of the Territory
will be ***** percent (**%) up to total sales of ****** Dollars (USD
******) and ***** percent (**%) for sales over ****** Dollars (USD ******)
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-**** 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 public
accountants, acceptable to ANTARES, BIOSANTE and SOLVAY, upon request by
ANTARES, to examine all books and records relating to the sales of E2-****
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 ******
--------------------------
As consideration for the successful sub-license of the E2-**** Combi Gel
(see 3), hereinafter, ANTARES reallocates as follows the USD ****** (******
US-Dollars) obligation (as per section 4.1.2 of the Agreement)
corresponding to E2-**** Combi Gel formulation and production costs: USD
****** (****** US-dollars) for "Estradiol single gel" and additional USD
****** (******US-dollars) for Testosterone single gel". The reallocation
will take effect as per the date of signature (effective date) of this
2
***** - Denotes portions omitted pursuant to a request for confidentiality under
Rule 24b-2 of the Securities Exchange Act of 1934. A copy of this agreement with
the omitted information intact has been filed separately with the Securities and
Exchange Commission.
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 ****** (******US Dollars).
3. Manufacturing rights (Sublicense)
---------------------------------
ANTARES grants to BIOSANTE the right to grant manufacturing of E2-****
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-**** Combi Gel, the Manufacturing Assistance Agreement
shall: (1) Replace the Supply Agreement for E2-**** Combi-Gel; (2)
Eliminate any and all ANTARES obligations contained in the Supply Agreement
for E2-**** Combi-Gel; and (3) Govern all manufacturing aspects related to
E2-**** 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 ***** (***** 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 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 ******
----------------------
ANTARES grants a ***** to BIOSANTE at USD ****** (****** 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.
3
***** - Denotes portions omitted pursuant to a request for confidentiality under
Rule 24b-2 of the Securities Exchange Act of 1934. A copy of this agreement with
the omitted information intact has been filed separately with the Securities and
Exchange Commission.
6. No Further Funding for E2-**** 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-****
Combi Gel as outlined in the Agreement and the Supply Agreement except for
those obligations contained in this Amendment 3.
7. No Further Changes
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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 changed 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
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This Amendment No. 3 is construed under and governed by Illinois Law.
IN WITNESSETH WHEREOF, the Parties have duly executed this Amendment effective
this 28th day of August,2001.
ANTARES Pharma IPL AG
Allschwil, August 28, 2001 /s/ Xxxxx Xxxxxxx
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Place and Date By: Xxxxx Xxxxxxx
Its: Managing Director, Swiss Operations
BioSante Pharmaceuticals, Inc.
Lincolnshire, IL, August 30, 2001 /s/ Xxxxxxx X. Xxxxx
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Place and Date By: Xxxxxxx X. Xxxxx
Its: President and CEO
4
***** - Denotes portions omitted pursuant to a request for confidentiality under
Rule 24b-2 of the Securities Exchange Act of 1934. A copy of this agreement with
the omitted information intact has been filed separately with the Securities and
Exchange Commission.
