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Amendment No. 6 to the License Agreement

License Agreement

Amendment No. 6

to the

License Agreement 

 | Document Parties: BIOSANTE PHARMACEUTICALS INC | ANTARES PHARMA IPL AG You are currently viewing:
This License Agreement involves

BIOSANTE PHARMACEUTICALS INC | ANTARES PHARMA IPL AG

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Title: Amendment No. 6 to the License Agreement
Date: 3/27/2007
Industry: Biotechnology and Drugs    

Amendment No. 6

to the

License Agreement 

, Parties: biosante pharmaceuticals inc , antares pharma ipl ag
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Exhibit 10.27

[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. 6

to the

License Agreement
dated 13th of June 2000

by and between

Antares Pharma IPL AG, Zug, Switzerland as Licensor
(formerly known as Permatec Technologies AG)

and

BioSante Pharmaceuticals, Inc., Lincolnshire, IL, USA as Licensee

WHEREAS , Antares Pharma IPL AG, Zug, Switzerland (“Antares”) and BioSante Pharmaceuticals, Inc., Lincolnshire, Illinois, United States of America (“BioSante”) have previously entered into a License Agreement dated June 13, 2000 (“License Agreement”), as amended in a series of five amendments, as follows:  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 Amendment No. 5, dated December 30, 2002 (collectively the Amendments and with the License Agreement, the “Agreement”); and

NOW THEREFORE , Antares and BioSante agree pursuant to this Amendment No. 6 dated October 20, 2006 to the Agreement (“Amendment No. 6”) to amend the Agreement as follows:

1.              License Grant .  The licenses granted under the Agreement are hereby amended as follows:

(a)            Paragraph 1.10 of the Agreement is hereby amended and restated in its entirety as follows:

“Products” shall have the meaning set forth in Exhibit B of this License Agreement.”

(b)            Exhibit B of this Agreement is hereby amended and replaced in its entirety as follows:

“A.           Products shall include all estrogen gels, all testosterone gels, all E and T gels, and all E and P gels, whether or not if any of the above gel formulations contain lauryl alcohol, except as noted in Section B below.

 



[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.]

B.             BIOSANTE owns on an exclusive worldwide basis, free and clear of any claims by ANTARES, its product and formulation currently known as and referred to as Bio-T-Gel (XXXXXXXXXXXXXXXXXXXXXXX XXXXXXXXXX), and has no obligation to share information regarding Bio-T Gel with ANTARES, including data generated during development.

C.             Notwithstanding the above, AP-108l (gel containing norelgestromin and ethinyl estradiol and which is a competitor to Ortho Evra) shall not be included in Products.

D.             Notwithstanding the above, Nestorone (gel formulation made pursuant to Joint Development Agreement with The Population Council) shall not be included in Products.

E.              Notwithstanding the above, Antares shall retain its rights to testosterone gels for prevention or treatment of diseases in males in the Territory but only for products for which regulatory approval is sought and obtained by submission of (what in the United States would be known as) a full New Drug Application, and not an Abbreviated New Drug Application, “paper NDA” under section 505(b)(2) of the United States FD&C Act, or other form of application that relies on clinical studies conducted by others as to which the applicant does not have a right of reference.”

(c)            Paragraph I-1 of Amendment No. 4 to the License Agreement is no longer applicable and is deleted in its entirety.

(d)            Paragraph 2.1 of the Agreement is hereby amended and replaced in its entirety as follows:

“2.1.1       ANTARES hereby grants to BIOSANTE an exclusive license, with the right to grant sublicenses as provided in this License Agreement, to Develop the Products in the field of transdermal gel preparations (“Field”) in the Territory for purposes of obtaining Approvals, and upon receipt of the Approvals, to Market and sell the Products in the Field in the Territory, and to use the Patents and Know-How exclusively for that purpose, all in accordance with provisions contained in this Agreement.  It is the parties’ intention that any product characterized by its marketing approval, as opposed to Products, developed by BIOSANTE and based on PERMATECH’S Technology will be and remain the property of BIOSANTE but BIOSANTE will not be allowed to use or market the products in case this License Agreement between ANTARES and BIOSANTE is terminated.

2

 



2.1.2         ANTARES hereby grants to BIOSANTE a non-exclusive license, with the right to grant sublicenses as provided in this License Agreement, under the Patents and Know-How, to make and have made Bio-E-Gel in the Territory.

2.1.3         ANTARES additionally grants to BIOSANTE a non-exclusive license with the right to grant sublicenses as provided in this License Agreement, to conduct the following activities:  investigation, research, conduct clinical trials and perform market research in any country outside of the Territory.  For purposes of clarity the above license shall not include a license or right to apply or seek any regulatory approval/marketing authorization for any Product outside the Territory.”

(e)            Paragraph B(2) of Amendment No. 5 to the License Agreement is no longer applicable and is deleted in its entirety.

(f)             Paragraph 2.2 of the Agreement is hereby amended by the deletion of “(with only the commercial terms redacted)” from the last sentence therein.

(g)            Paragraph 2.2 of the Agreement is hereby further amended by the insertion of the following sentence after the end of the sentence beginning with “Furthermore, BIOSANTE undertakes . . .” with the following sentence:

“Additionally, BIOSANTE covenants that any and all sublicense agreements, in which Bio-E-Gel is sublicensed, shall provide that (i) all up-front, sublicense and milestone payments due from such sublicense agreement shall be paid into an interest bearing escrow account established for the benefit of both ANTARES and BIOSANTE and shall be the account designated by both ANTARES and BIOSANTE (“Escrow Account”) and (ii) that ANTARES is a third party beneficiary of such sublicense agreement solely with respect to subsection (i) above.  The parties agree that the terms of the Escrow Account shall provide that (a) ANTARES is responsible for all costs and fees to establish and maintain the Escrow Account, (b) seventy-five (75%) of funds deposited shall immediately be released to BIOSANTE, and (c) the remaining twenty-five (25%) of funds deposited plus any and all interest accrued shall be released to ANTARES upon thirty days from deposit.”

2.              Credit for Sublicense Payments for Bio-E-Gel .  In the event that BioSante (i) terminates a sublicense agreement for Bio-E-Gel (“Sublicense Agreement”) prior to February 15, 2007 and where such termination is based on BioSante failing to receive regulatory approval for Bio-E-Gel by the FDA (as defined below) and (ii) has to return all or a portion of the upfront consideration received pursuant to such Sublicense Agreement, then Antares will credit the pro rata portion of such upfront consideration that it received to future payments due by BioSante for Bio-E-Gel.

3.              Disclosure of Confidential Information .  Each party may disclose non-public confidential information of the other party to subcontractors or potential licensees who are under a binding obligation of confidentiality to such party, at least as strict as in the Agreement and so long as such party remains responsible for the potential licensees’ compliance.

3

 



[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.]

4.              Patent Prosecution and Maintenance .  From the effective date of this Amendment No. 6, Antares will, at its cost and expense, file, prosecute, and maintain the Patents, including, but not limited to, those listed on Appendix A hereto.  If Antares determines to abandon or not file any Patent, then Antares shall provide BioSante with written notice at least thirty (30) days or if less, as long as reasonably practicable, prior to the date such abandonment or failure to file would become effective for BioSante to act in its stead, provided, that BioSante has received from Antares any and all reasonable documentation and information it reasonably needs to make a decision and take the necessary action in reasonable sufficient time to avoid abandonment.  For purposes of clarity, discontinuance shall be elected on a country-by-country basis.  BioSante may elect at its sole discretion to continue prosecution or maintenance of any discontinued Patent at its sole expense.  BioSante shall then own any such Patent, and Antares shall execute such documents and perform such acts, at BioSante’s cost, as may be reasonably necessary for BioSante to continue prosecution or maintenance, including assigning and transferring ownership of such Patent to BioSante and directing its counsel to tr


 
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