**Exhibit 10.26**

 

**AMENDMENT NO. 4 TO LICENSE AGREEMENT**

 

THISAMENDMENT NO. 4 TO LICENSE AGREEMENT is made as of the 25th day of March,2004 by and between BENTLEY PHARMACEUTICALS, INC., a Delaware corporation,with offices at Bentley Park, 2 Holland Way, Exeter, New Hampshire 03833(hereinafter, “BENTLEY” or “Licensor”), and AUXILIUM PHARMACEUTICALS, INC.(formerly Auxilium A2, Inc.), a Delaware corporation having a principalplace of business at 160 W. Germantown Pike, Norristown, Pennsylvania 19401(hereinafter, “AUXILIUM” or “Licensee”). BENTLEY and AUXILIUM may bereferred to as a “Party” or, collectively, as “Parties.”

 

RECITALS

 

WHEREASthe parties have entered into that certain License Agreement, dated May 31,2000, relating to the grant by BENTLEY to AUXILIUM of a license of certaintechnology (the “License Agreement”);

 

WHEREASthe parties clarified certain aspects of the License Agreement by entering intoAmendment Nos. 1, 2 and 3 to the License Agreement, dated October 31,2000, May 31, 2001 and September 6, 2002, respectively (“PreviousAmendments”); and

 

WHEREAS,BENTLEY would like to provide incentives to AUXILIUM to enter into sub-licensesfor the Products in territories outside the United States; and

 

WHEREASthe Parties wish to further amend the License Agreement to clarify certainsections of the License Agreement;

 

NOW,THEREFORE, in consideration of the promises and mutual covenants containedherein, and INTENDING TO BE LEGALLY BOUND HEREBY, the Parties further amend theLicense Agreement as follows:

 

ARTICLE I

DEFINITIONS

 

1.1Except as amended below, the terms defined in the License Agreement, as amendedby the Previous Amendments, shall remain unchanged. Unless otherwise defined inthis Amendment, all capitalized terms in this Amendment shall have the meaningsascribed to them in the License Agreement, as amended by the PreviousAmendments.

 

“NetSales Price” means, with respect to the Product, the gross amount invoiced byLicensee for such Product, less deductions for:

 

(i) returnedgoods; (ii) trade and quantity discounts; (iii) rebates, includingthose in respect of any governmental subsidized program, rebate payments givento wholesalers, buying groups, healthcare insurance carriers or otherinstitutions; (iv) sales or other taxes actually paid by Licensee or itssublicensee or distributor, not including taxes assessed on the incomeresulting from such sales; and (v) freight allowances, insurance andcustoms duties, to the extent any of the foregoing are identified on theinvoice for the Product. If Product is sold for consideration other than cash,the fair market value of such other consideration shall be included in NetSales. If a Product is sold in a package or kit containing another product

 

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whichis not a Product, the Net Sales price for purposes of calculating the royaltyunder Section 3.2 hereof shall be calculated by multiplying the Net SalesPrice of the combination product by the fraction of A/A+B, where “A” is the NetSales Price of Product when sold separately “B” is the Net Sales Price of theother product or products when sold separately. If either the Product or theother product is not sold separately, the Net Sales Price of the Product shallbe negotiated in good faith by the Parties.

 

“CommercialSale” means the sale of Product (as indicated by shipment of Product) to anunaffiliated third-party of the Licensee, or of its sublicensee or distributionpartner, such as a wholesaler, managed care organization, hospital or pharmacyand shall exclude (i) any transfer of Product by Licensee to itssublicensee, distribution partner or Affiliate and (ii) any distributionof Product for use in research, development, pre-clinical and clinical trials.

 

ARTICLE II

PAYMENTS IN CONSIDERATION FOR LICENSE

 

2.1Except as amended below, all payments set forth in Article III of theLicense Agreement shall remain unchanged.

 

2.2Section 3.2 of the License Agreement is hereby amended to include thefollowing additional paragraph (d):

 

“(d) Notwithstandingany contrary provisions in this Section 3.2, the royalty payments dueunder Sections 3.2 (a), (b) or (c) above shall be paid on acountry-by-country basis only until the later of (i) the termination ofBentley Patent rights in such country or (ii) ten years from the date offirst Commercial Sale of Product in such country.

 

ARTICLE III

CERTAIN OBLIGATIONS OF LICENSEE

 

3.1A new Section 4.4 shall be added to the License Agreement as follows:

 

4.4Drug Master File. Licensee shall make certain data generated during theresearch and development of Testim accessible to Licensor through thepreparation and filing of one or more Drug Master Files (“DMF”). Such DMF shall(a) be filed by or on behalf of the Licensee with the United States Foodand Drug Administration (“FDA”) on or before June 30, 2004 and (b) shallcontain the data listed on the index attached as Exhibit A to thisAmendment 4 to the License Agreement (the “Data Index”). Licensee willdesignate Licensor, or its licensee if requested in writing by Licensor, ashaving a right of reference with the FDA to the DMF (the “Right of Reference”).Licensor shall treat the Data Index as confidential information of Licensee andmay disclose the Data Index only to those persons or third parties whohave agreed in writing to maintain its confidentiality and to use the DataIndex solely for purposes of evaluation of a potential business opportunitywith Licensor.

 

ARTICLE IV

PATENTS, TRADEMARKS AND INFRINGEMENT

 

4.1Section 9.2(a) of the License Agreement shall be deleted in itsentirety and replaced with the 

 

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following:

 

(a) Inthe event of Licensor wishing to abandon any BENTLEY Patents, Licensor willoffer to assign to Licensee or a sublicense of Licensee, at Licensee’s option,free of charge, any such Patent prior to effectuating the abandonment. Licenseewill bear the costs connected to any assignment hereunder.

 

4.2A new Section 9.6 shall be added to the License Agreement as follows:

 

9.6Bentley Trademark. In cooperation with Licensee, Licensor shall register inthe United States Patent and Trademark Office and such other countries of theworld where the trademark is registrable, a trademark to be used to describethe unique qualities of the technology contained in the Bentley Patents (the “NewTrademark”). Licensee shall have a perpetual, royalty free, worldwide, sole andexclusive license with the right to sublicense, to use the New Trademark inconnection with the Product or any other product, patents, technology orsimilar rights licensed from Licensor now or in the future which contain theingredient pentadecalactone. Nothing in this Section 9.6 shall preventLicensee from using or registering any trademark of its own in connection withthe Product or any characteristic of or ingredient in the Product.

 

ARTICLE V

TERM AND TERMINATION

 

5.1Except as amended below, all provisions of Article XI Term and Terminationof the License Agreement shall remain unchanged.

 

5.2Section 11.1 of the License Agreement shall be deleted in its entirety andreplaced with the following:

 

11.1Term. This Agreement and the licenses granted herein shall commence on theEffective Date and shall continue until all royalty obligations of Licenseeunder Section 3.2 of this Agreement are ended, subject to earliertermination under Section 11.2 hereof. Once all such royalty obligationsof Licensee have ended Licensee shall have a fully paid up license under thisAgreement.

 

5.3Section 11.2 (a) of the License Agreement shall be deleted in itsentirety and replaced with the following:

 

(a) Uponthe occurrence of any of the events set forth below (“Events of Default”), theLicensor shall have the right to terminate this Agreement by giving writtennotice of termination, such termination effective with the giving of suchnotice:

 

(i) Inthe event of nonpayment of any material amount payable to the Licensor aftercompletion of an audit provided for under Section 3.5 hereof, whichnonpayment is continuing thirty (30) calendar days after the Licensor givesLicensee written notice of such non-payment.

 

(ii) Inthe event that Licensee fails to initiate clinical trials within two (2) yearsof availability of final formulation in quantities adequate for clinicaltesting and associated documentation for clinical trials, unless such failureis outside of the control of Licensee. See Auxilium Development Plan attachedas Schedule C hereto.

 

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(iii) Inthe event that Licensee does not submit an application for marketing approvalin a major market within a five (5) year period after the Effective Dateunless such failure to submit is outside of the control of Licensee.

 

(iv) Inthe event that Licensee becomes subject to a Bankruptcy Event provided, however,that so long as Licensor continues to receive royalty payments from Licenseeunder this Agreement, such Bankruptcy Event shall not be a basis fortermination of this Agreement by Licensor.

 

ARTICLE VI

ADDITIONAL PROVISION

 

6.1Section 13.5 of the License Agreement shall be deleted in its entirety andreplaced with the following:

 

13.5Notices. Any notice under this Agreement shall be sufficiently given ifsent in writing by overnight courier, prepaid, first class, certified orregistered mail, return receipt requested, addressed as follows:

 

Ifto the Licensor, to:

 

BENTLEYPHARMACEUTICALS, INC.

BentleyPark

2Holland Way

Exeter,New Hampshire 03833

Attention:President

 

Ifto the Licensee, to:

 

AUXILIUMPHARMACEUTICALS, INC.

160W. Germantown Pike

Norristown,PA 19401

Attention:President

Copyto General Counsel

 

orto such other addresses as may be designated from time to time by noticegiven in accordance with the terms of this Section.

 

INWITNESS WHEREOF, the parties hereto have duly executed this Amendment No. 4to License Agreement as of the date first above written.

 

 
| BENTLEY  PHARMACEUTICALS, INC. | AUXILIUM  PHARMACEUTICALS, INC.        |
|-------------------------------------|---------------------------------------------|
|                                |                                        |   |   |
| By:                                 | /s/    James  R. Murphy |   | By: | /s/    Geraldine  A Henwood |   |
|                                |                                        |   |   |
|                                | James  R. Murphy                            |   | Geraldine  A. Henwood  |
|                                | Chief  Executive Officer                    |   | Chief  Executive Officer |
|                                     |                                             |  |  |  |  |

 

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