TRADEMARK LICENSE AGREEMENT

Exhibit 10.9

 

TRADEMARK LICENSE AGREEMENT

 

between

 

PIERRE FABRE MEDICAMENT S.A.

 

and

 

NOVACEA, Inc.

 

Dated

 

July 19, 2005

TABLE OF CONTENTS

 

 

i

 

ii

SCHEDULES

 

 

iii

TRADEMARK LICENSE AGREEMENT

 

THIS TRADEMARK LICENSE AGREEMENT (the “Agreement”) is executed on July 19, 2005 (the “Effective Date”) by and between P IERRE F ABRE M EDICAMENT S.A., a corporation organized under the laws of France with headquarters at 45, place Abel-Gance, 92100 B OULOGNE , F RANCE (“P IERRE F ABRE ”), and N OVACEA , I NC ., a Delaware corporation with a principal place of business at 601 Gateway Boulevard, Suite 800, S OUTH S AN F RANCISCO , California 94080, U.S.A. (“N OVACEA ”).

 

RECITALS

 

WHEREAS , concurrently with the execution of this Agreement, P IERRE F ABRE and N OVACEA are entering into a Patent and Know-How License Agreement and a Supply Agreement with respect to the development, marketing and sale of a Vinca Alkaloid derivative known as “V INORELBINE ” (INN), formulated in softgel capsules and already registered, marketed and sold by P IERRE F ABRE or its Affiliates in various countries, and

 

WHEREAS , in connection with the rights and licenses granted to N OVACEA under such Patent and Know-How License Agreement, P IERRE F ABRE agrees to further grant to N OVACEA a license to use the Trademark [*], including if necessary or desirable, an alternative trademark that would also be owned by P IERRE F ABRE , to market and sell the Licensed Product in the N OVACEA Territory.

 

NOW , THEREFORE , in consideration of the premises and the mutual covenants and agreements herein contained, the Parties agree as follows:

 

ARTICLE 1 – DEFINITIONS

 

For purposes of this Agreement, the capitalized terms not defined herein shall have the meanings set forth in Schedule 1 attached hereto and incorporated herein by reference.

 

ARTICLE 2 – TRADEMARK LICENSE

 

2.1.	License Grant by P IERRE F ABRE to N OVACEA .

 

2.1.1. License Grant by P IERRE F ABRE to N OVACEA . P IERRE F ABRE hereby grants to N OVACEA , and N OVACEA accepts, an exclusive right and license to identify the Licensed Product by means of the Trademark in the N OVACEA Territory and to promote, market and sell such Licensed Product in the N OVACEA Territory under the Trademark (the “Trademark License”).

 

2.1.2. Obligation to use Trademark . During the Royalty Term of this Agreement, N OVACEA agrees to use the Trademark in each country of the N OVACEA Territory to identify, promote, market and sell the Licensed Product. No later than twelve (12) months prior to the end of the Royalty Term, N OVACEA shall notify P IERRE F ABRE in writing of its decision whether

 

[*] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

or not to continue using the Trademark after expiration of the Royalty Term. If N OVACEA decides to use the Trademark after expiration of the Royalty Term, this Agreement shall remain in effect and N OVACEA shall continue to use the Trademark until it otherwise notifies P IERRE F ABRE pursuant to Section 9.1. If N OVACEA decides not to use the Trademark after expiration of the Royalty Term, N OVACEA ’s right to use the Trademark shall be of no further force and effect after expiration of the Royalty Term. If N OVACEA fails to deliver timely notice pursuant to this Section 2.1.2, it shall be deemed to have elected to continue to use the Trademark after the expiration of the Royalty Term.

 

2.1.3. Use of Substitute Trademark after End of Royalty Term . If N OVACEA elects not to use the Trademark after expiration of the Royalty Term, N OVACEA may adopt a substitute trademark for use on the Licensed Product after expiration of the Royalty Term (the “Substitute Trademark”). All right, title and interest in and to any such Substitute Trademark shall belong to N OVACEA and said Substitute Trademark shall not be regarded as a Trademark within the scope of this Agreement. P IERRE F ABRE shall provide all reasonably requested assistance to N OVACEA in the transition from use of the Trademark to use of N OVACEA ’s Substitute Trademark and N OVACEA shall reimburse P IERRE F ABRE for all reasonable out-of-pocket expenses incurred in connection with such assistance.

 

2.1.4. Restriction on P IERRE F ABRE use of Substitute Trademark . Recognizing that the goodwill in any Substitute Trademark will be the result of efforts by N OVACEA , P IERRE F ABRE agrees not to use such Substitute Trademark, or any trademark confusingly similar thereto, on any product or service.

 

2.2.	Alternative Trademark.

 

2.2.1. Choice of Alternative Trademark . If within one hundred and eighty (180) days after the Effective Date, N OVACEA determines that [*] should not be used to identify the Licensed Product and that an alternative trademark is preferable, then N OVACEA shall have the right to propose an alternative trademark to P IERRE F ABRE (for P IERRE F ABRE ’ S approval, not to be unreasonably withheld if such alternative trademark is consistent with the Global Commercialization Strategy) for identifying, promoting, marketing and selling the Licensed Product in the N OVACEA Territory (the “Alternative Trademark”). N OVACEA will undertake the obligation and expense of conducting a comprehensive trademark search of any Alternative Trademark for use in each country in the N OVACEA Territory, and P IERRE F ABRE will undertake the obligation and expense of filing applications to register said Alternative Trademark in each such country. When (i) the Alternative Trademark is approved by the Parties, (ii) trademark applications for the Alternative Trademark have proceeded to the stage where they are no longer subject to opposition in the United States and Canada, and (iii) such Alternative Trademark receives regulatory approval, then all terms and conditions of this Agreement shall apply, mutatis mutandis , to the use and registration of such Alternative Trademark and, thereafter the term “Trademark” shall include such Alternative Trademark. In the event that an Alternative Trademark approved by the Parties is not registrable in the United States or Canada, N OVACEA may propose another Alternative Trademark and the provisions of this Section 2.2 shall be applicable thereto.

 

[*] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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2.2.2. Use of Alternative Trademark by P IERRE F ABRE . P IERRE F ABRE shall have the right to use any Alternative Trademark chosen by N OVACEA pursuant to Section 2.2.1 (i) in the P IERRE F ABRE Territory during and after the Royalty Term and (ii) in each country of the N OVACEA Territory with respect to which Termination (as defined in Section 9.3 below) has occurred.

 

2.3.	Trademark Ownership, Trade Names and Logos.

 

2.3.1. Trademark Ownership . N OVACEA agrees to accurately reflect P IERRE F ABRE ’s identity as manufacturer and licensor of the Licensed Product and owner of the Trademark on packaging, package inserts, Licensed Product literature, promotional materials and advertising literature in accordance with applicable Legal Requirements.

 

2.3.2. P IERRE F ABRE Trade Names and Logos . So long as N OVACEA uses the Trademark in the N OVACEA Territory, P IERRE F ABRE hereby grants to N OVACEA a limited non-exclusive right to the use in the N OVACEA Territory of certain of its trade names and logos to be specifically selected by the JCC in connection with the development and commercialization activities provided for in the Patent and Know-How License Agreement subject to the applicable terms of this Agreement and any of the Related Agreements. Except as provided above in this Section 2.3.2, N OVACEA ’s rights and obligations with respect to the use of such names and logos shall be subject to the same terms as its use of the Trademark under this Agreement.

 

2.3.3. N OVACEA Trade Name and Logo . N OVACEA shall have the right to adopt and use, in its labeling and advertising for the Licensed Product, its own trade name and/or logo. Each Party shall retain all right, title and interest in and to its respective trade names and logos.

 

2.4.	Right to Sublicense.

 

2.4.1. N OVACEA Right to Sublicense Affiliates . N OVACEA shall have the right to grant sublicenses to its Affiliates under the Trademark License in the N OVACEA Territory without any P IERRE F ABRE consent required.

 

2.4.2. Sublicense to Third Parties . N OVACEA shall have the right to grant sublicenses under the Trademark License to Third Parties in Canada in conjunction with any sublicense of those N OVACEA Licenses granted to it by P IERRE F ABRE under the Softgel Patents and the P IERRE F ABRE Know-How to use and sell a Licensed Product containing such Trademark in Canada, where the sublicense of such N OVACEA Licenses is permitted pursuant to the terms and conditions of Section 2.4.2 of the Patent and Know-How License Agreement.

 

2.4.3. Responsibilities of N OVACEA . N OVACEA shall be responsible for performing all of its obligations set forth in this Agreement, without regard to whether it has granted any sublicense under this Section 2.4. Without limitation of the foregoing in this Section 2.4, N OVACEA shall be responsible for reporting to P IERRE F ABRE the sales of Licensed Product by any sublicensee or designee and paying the Trademark Royalties on Net Sales as set forth in Section 5.1, in each case as though such sales were made by N OVACEA itself. N OVACEA shall have no right to grant sublicenses to Third Parties in the USA under the Trademark License without the prior written consent of P IERRE F ABRE , which may be given or withheld in its sole discretion.

 

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2.5.	Reasonable Assistance.

 

N OVACEA will, upon request, supply P IERRE F ABRE or its authorized representative with any information as to its use of the Trademark which P IERRE F ABRE may reasonably require and will render any assistance reasonably required by P IERRE F ABRE in securing and maintaining the registration(s) of the Trademark in the N OVACEA Territory.

 

2.6. Goodwill.

 

Any accretion of goodwill derived by N OVACEA , its Affiliates or permitted sublicensees from the use of the Trademark in combination with or apart from P IERRE F ABRE ’s trade names and logos shall accrue to P IERRE F ABRE and P IERRE F ABRE may call for a confirmatory assignment thereof.

 

2.7.	Effectiveness of License.

 

Notwithstanding anything to the contrary set forth in this Article 2, the grant to N OVACEA of the license and rights contemplated in this Agreement, shall be of no force and effect until the Effective Date.

 

Article 3 – MAINTENANCE OF THE TRADEMARK

 

3.1.	Registration of the Trademark.

 

P IERRE F ABRE shall, at its own cost and expense, file in the N OVACEA Territory and endeavor in good faith to obtain the registration of the Trademark in the N OVACEA Territory and, when registered, thereafter shall maintain the applicable Trademark in the N OVACEA Territory at its own expense for the Royalty Term of this Agreement and thereafter as long as N OVACEA uses the Trademark in conjunction with the Licensed Product in the N OVACEA Territory.

 

3.2.	Rights as Between Parties.

 

N OVACEA acknowledges, as between the Parties, the exclusive right, title and interest of P IERRE F ABRE in and to (i) the Trademark including any Alternative Trademark proposed to be used as provided in Section 2.2 hereof and (ii) certain trade names and logos of P IERRE F ABRE as contemplated by Section 2.3.2 hereof; and N OVACEA will not do or cause to be done any act or thing contesting or, in any way, impairing or tending to impair any part of said right, title and interest for the duration of this Agreement and after its expiration. N OVACEA will not make any representations or do any act which may be taken to indicate that it has any right, title or interest in or to the ownership or use of the Trademark except under the terms of this Agreement and acknowledges that nothing contained in this Agreement shall give N OVACEA any right, title or interest in or to the Trademark save as granted hereby.

 

3.3.	Infringement.

 

3.3.1. Infringement by Third Parties . P IERRE F ABRE and N OVACEA shall promptly notify the other in writing of any actual or threatened infringement by a Third Party or any challenge by a Third Party to the validity of the Trademark, or to P IERRE F ABRE ’ S ownership

 

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thereof or to N OVACEA ’s, its Affiliate’s or its permitted sublicensees’ right to use the Trademark. Both Parties shall use their Diligent Efforts in cooperating with each other to terminate or avert such infringement or to resolve such challenge without litigation. P IERRE F ABRE shall have the sole right to bring and control any action or proceeding with respect to infringement of the Trademark at its own expense and by counsel of its own choice. N OVACEA shall cooperate fully with P IERRE F ABRE and all reasonable out-of-pocket expenses, including attorneys’ fees, incurred by N OVACEA shall be reimbursed by P IERRE F ABRE . If P IERRE F ABRE fails to bring an action or proceeding within (a) sixty (60) days following the notification of actual or threatened infringement or (b) ten (10) business days before the time limit, if any, set forth in the appropriate laws and regulations for the filing of such actions or proceedings, whichever comes first, N OVACEA shall have the right to bring and control any such action or proceeding at its own expense and by counsel of its own choice. In any such action or proceeding brought by N OVACEA , P IERRE F ABRE shall have the right, at its own expense, to join and be represented by counsel of its own choice; if P IERRE F ABRE does not desire to join in such action or proceeding but joinder is required in order to maintain the action or proceeding, P IERRE F ABRE shall join and be reimbursed for reasonable out-of-pocket expenses. Neither Party shall have the right to settle any infringement litigation under this Section 3.3.1 relating to the Trademark without the prior written consent of the other Party. Except as otherwise agreed to by the Parties as part of a cost sharing arrangement, any recovery realized as a result of such litigation, after reimbursement of any litigation expenses of P IERRE F ABRE and N OVACEA , shall be divided evenly by the Parties to the extent the recovery relates to the N OVACEA Territory and shall be retained solely by P IERRE F ABRE to the extent recovery relates to the P IERRE F ABRE Territory.

 

3.3.2. Infringement of Third Party Rights . Each Party shall promptly notify the other in writing of any allegation made by a Third Party that the activity of either of the Parties pursuant to this Agreement, including without limitation use of the Trademark by N OVACEA , infringes or may infringe the intellectual property rights of such Third Party in the N OVACEA Territory. P IERRE F ABRE shall initially have the sole right to control the defense to any such allegation, at its own expense and by counsel of its own choice, and N OVACEA shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. If P IERRE F ABRE fails to proceed in a timely fashion with regard to such defense, N OVACEA shall have the right to control the defense of such allegation at its own expense and by counsel of its own choice; P IERRE F ABRE shall have the right, at its own expense, to be represented in any such action by counsel of its own choice. Neither Party shall have the right to settle any trademark infringement litigation under this Section 3.3.2 relating to the use of the Trademark in the N OVACEA Territory without the prior written consent of such other Party. Subject to Section 5.6, P IERRE F ABRE will indemnify, defend, and hold N OVACEA , its Affiliates and permitted sublicensees harmless from and against any and all liabilities, damages, losses, costs or expenses, including reasonable attorneys’ fees and other reasonable out-of-pocket expenses incurred in connection with such litigation or with dispute resolution (each, a “Liability”), to which any of them may become subject in connection with a claim, demand, suit or proceeding (“Action”) for trademark infringement arising out of the use by N OVACEA in the N OVACEA Territory of the [*] Trademark in accordance with this Agreement, provided that N OVACEA gives prompt notice to

 

[*] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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P IERRE F ABRE of any such Action and provides good faith cooperation in the defense of such Action. With respect to a Trademark other than [*], the provisions of the foregoing sentence are applicable, except that reimbursement to N OVACEA for Liabilities shall be fifty percent (50%).

 

ARTICLE 4 – QUALITY CONTROL

 

4.1.	Quality Standards.

 

The nature and quality of the Licensed Product identified, promoted, marketed or sold by N OVACEA , its Affiliates and permitted sublicensees, on which the Trademark appears shall conform to quality standards and Licensed Product Specifications for packaging and quality control of the Licensed Product approved by the Regulatory Authorities of the N OVACEA Territory.

 

4.2.	Inspections by P IERRE F ABRE .

 

During the Royalty Term and thereafter, N OVACEA agrees to cooperate with P IERRE F ABRE to enable P IERRE F ABRE to control the nature and quality of the Licensed Product and the manner of use of the Trademark so that P IERRE F ABRE may verify that the use of the Trademark is consistent with the agreed quality standards and Licensed Product Specifications. All facilities of N OVACEA , its Affiliates and permitted sublicensees used in the manufacture, packaging and storage of Licensed Product shall be open for inspection by representatives of P IERRE F ABRE on reasonable notice during normal business hours.

 

4.3.	Licensed Product Specimens.

 

To the extent N OVACEA or its subcontractor(s) manufactures and/or packages the Licensed Product, then, from time to time upon request from P IERRE F ABRE , N OVACEA shall submit to P IERRE F ABRE regular licensed production specimens of the Licensed Product to be sold by N OVACEA , its Affiliates and/or its permitted sublicensees under this Agreement.

 

ARTICLE 5 – EARNED ROYALTIES – PAYMENTS

 

5.1.	Earned Royalties.

 

5.1.1. Royalty Rate . In consideration of the right and license hereby granted, and subject to the terms of this Agreement, N OVACEA shall pay P IERRE F ABRE a royalty (“Trademark Royalty”) at the rate of [*] percent ([*]%) on the Net Sales of the Licensed Product made by N OVACEA , its Affiliates and its permitted sublicensees in each country of the N OVACEA Territory subject to Section 5.1.2. Such Trademark Royalty shall accrue starting on the Date of Launch of the Licensed Product in each country of the N OVACEA Territory for the Royalty Term of this Agreement and thereafter, so long as N OVACEA , its Affiliates and/or permitted sublicensees continue to use the Trademark to promote, market and sell a Licensed Product under the Trademark in the N OVACEA Territory pursuant to Section 2.1.2 hereof.

 

[*] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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5.1.2. Generic Competition and Competing Products

 

(a)

The Parties acknowledge that the sale by N OVACEA of Licensed Product during the Royalty Term may be affected by competition from Third Parties that, for whatever reason, have chosen to compete notwithstanding the P IERRE F ABRE Patents. In the event that there are lawful sales of a Generic Product in any Quarter during the Royalty Term, the Trademark Royalty applicable to Net Sales during such Quarter shall be indicated by W in the [*], in which “W” is the applicable percentage, “Y” is 1.0 and “Z” is the percentage points of Market Share (calculated as provided in Section 11.3.1 of the Patent and Know-How License Agreement), rounded to the nearest whole percentage point, captured by such Generic Product during such Quarter; provided, however, that in no event shall the applicable Trademark Royalty be less than [*] percent ([*]%). (As an example of how the applicable percentage W is calculated, assume that a Generic Product captures a Market Share of [*]%. The term (Y-Z) in the formula will be [*]. The applicable percentage of Net Sales payable to P IERRE F ABRE will be [*] or [*] percent ([*]%).

 

(b)

With respect to sales of a Competing Product other than lawful sales of a Generic Product, when such Competing Product captures a Market Share in excess of [*] percent ([*]%) for any Quarter in a country of the N OVACEA Territory, the applicable Trademark Royalty for made in such country shall be reduced to [*] percent ([*]%).

 

5.2.	Royalty Due Dates.

 

Commencing with the first Date of Launch of the Licensed Product in a first country of the N OVACEA Territory, Trademark Royalty payments accrued as of the end of each Commercial Half Year, as herein provided, shall be paid by N OVACEA to P IERRE F ABRE within sixty (60) days after the end of each Commercial Half Year (i.e., payment is due on or about the last day of each February and August following the first Date of Launch). In the event N OVACEA fails to pay any accrued Trademark Royalty within sixty (60) days after the end of each Commercial Half Year, P IERRE F ABRE may charge a monthly late payment fee equal to [*] percent ([*]%).

 

5.3.

Reports.

 

5.3.1. Content of Report . Each Trademark Royalty payment shall be accompanied by a written report, showing (a) the Net Sales of each dosage form of the Licensed Product on which the Trademark is used that is sold by N OVACEA , its Affiliates and its permitted sublicensees and the level of inventory (in units) in each country of the N OVACEA Territory during the reporting period; (b) the Trademark Royalties, payable in Dollars, which shall have accrued hereunder in respect of such Net Sales; (c) withholding taxes, if any, required by Legal Requirements to be deducted in respect of such Net Sales; and (d) the exchange rates used in determining the amount of Dollars. With respect to sales of a Licensed Product invoiced in

 

[*] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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Dollars, the Net Sales and Trademark Royalty payable shall be expressed in Dollars. With respect to sales of a Licensed Product invoiced in a currency other than Dollars, the Net Sales and Trademark Royalty payable hereunder shall be expressed in the domestic currency of the party making the sale together with the Dollar equivalent of the Trademark Royalty payable, calculated using the simple average of the exchange rates published in the Wall Street Journal on the last day of each month of the Commercial Year. N OVACEA , shall, upon written request, furnish to P IERRE F ABRE appropriate evidence of payment of any tax or other amount deducted from any Trademark Royalty payment. In case no Trademark Royalty is due for any Trademark Royalty period hereunder, N OVACEA shall so report. A sample of a Trademark Royalty report (without any withholding taxes) required to be delivered by N OVACEA pursuant to this Section 5.3 is attached as Schedule 5.3 hereto.

 

5.3.2. Annual Summary . In addition, unless otherwise provided pursuant to the Patent and Know-How License Agreement, within sixty (60) days of the end of each Commercial Year, N OVACEA shall provide to P IERRE F ABRE a written report, summarizing the gross sales and Net Sales of each dosage form of the Licensed Product sold by N OVACEA , its Affiliates and permitted sublicensees in all countries of the N OVACEA Territory during such Commercial Year.

 

5.4.	Royalty Payments.

 

Except as provided in this Section 5.4, Trademark Royalties shall be payable in Dollars and shall be paid by N OVACEA on its account and on account of its Affiliates and permitted sublicensees by wire transfer to P IERRE F ABRE ’ S bank account opened at SOCIETE GENERALE in France or at such other financial institution as P IERRE F ABRE may designate in writing from time to time, the specific wiring instructions with respect to which shall be provided by P IERRE F ABRE to N OVACEA from time to time. If at any time legal restrictions prevent the prompt remittance of part or all Trademark Royalties with respect to any country of the N OVACEA Territory where the Licensed Product is sold, N OVACEA shall have the right and option to make such payments by depositing the amount thereof in local currency to P IERRE F ABRE ’s account in a bank or other depository in such country.

 

5.5.	Accrual of Royalties.

 

No Trademark Royalty shall be payable on a Licensed Product used in the N OVACEA Territory for development purposes, meaning use of Finished Product by N OVACEA (i) in Phase 1, 2 and 3 Clinical Trials, (ii) in Phase 4 Clinical Trials to be conducted by N OVACEA in the N OVACEA Territory upon Regulatory Authorities’ request and (iii) to obtain Compendia Listings; provided, however, that in all cases, Finished Product is supplied by N OVACEA free of charge to the investigators. No Trademark Royalty shall be payable on sales among N OVACEA , its Affiliates and its permitted sublicensees, but Trademark Royalty shall be payable on subsequent sales by N OVACEA , its Affiliates and its sublicensees to a Third Party.

 

5.6.	Third Party Royalties.

 

If, based on the written advice of reputable, independent outside counsel selected by the Parties, copies of which shall be promptly provided to the Parties, N OVACEA shall deem it

 

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necessary in respect of sales of the Licensed Product to obtain a license from any Third Party in order for N OVACEA , its Affiliates or its permitted sublicensees to exercise their rights pursuant to Section 2.1.1 of this Agreement, and (i) the Licensed Product is being commercialized under the [*] Trademark, P IERRE F ABRE shall bear the full cost of any license fees, milestones, royalties or similar amounts (“License Payments”) payable to such Third Party to the extent such License Payments are allocable to the sale and use of a Licensed Product in the N OVACEA Territory, or (ii) the Licensed Product is not being commercialized under the [*] Trademark, each Party shall bear [*] percent ([*]%) of any License Payments payable to such Third Party to the extent any such License Payments are allocable to the sale and use of a Licensed Product in the N OVACEA Territory; provided, however, that in no event shall P IERRE F ABRE pay an aggregate amount of License Payments that at any time exceeds the aggregate Trademark Royalty paid to P IERRE F ABRE from and after the effective date of any such license with a Third Party with respect to Net Sales in the country(ies) that are the subject of the Third Party’s allegations. N OVACEA may credit its share of its obligation under clause (ii) above against any Trademark Royalty due to P IERRE F ABRE with respect to the Licensed Product (and shall so reflect any such credit in the next report to be delivered pursuant to Section 5.3 hereof).

 

5.7.	Records and Audits.

 

With respect to each Commercial Year, N OVACEA shall keep complete and accurate records of all sales of Licensed Product for at least sixty (60) months after such Commercial Year, provided, however that, in the event of any claim by P IERRE F ABRE asserted against N OVACEA during the sixty (60) month period, then N OVACEA shall preserve all relevant records until the resolution of the claim. Upon the expiration of sixty (60) months following the end of any Commercial Year, the calculation of Trademark Royalties payable with respect thereto shall be binding and conclusive on P IERRE F ABRE and N OVACEA , its Affiliates and its permitted sublicensees shall be released from any liability or accountability with respect to Trademark Royalties for such Commercial Year. P IERRE F ABRE shall have the right to cause an independent, certified public accountant reasonably acceptable to N OVACEA (and who has executed an appropriate confidentiality agreement reasonably acceptable to N OVACEA that requires the auditor to keep any information learned by it confidential except as needed to report its audit conclusions to P IERRE F ABRE ) to audit relevant records to confirm Net Sales and Trademark Royalty payments due hereunder for a period covering not more than the preceding sixty (60) months. Such audits may be exercised during normal business hours upon reasonable prior written notice to N OVACEA . A copy of the auditing firm’s conclusions of its audit shall be furnished to N OVACEA at least ten (10) days prior to disclosure to P IERRE F ABRE to allow N OVACEA an opportunity to review the accuracy of the auditing firm’s conclusions. Prompt adjustments shall be made by the Parties to reflect the results of such audit. P IERRE F ABRE shall bear the full cost of such audit unless such audit discloses a variance of more than five percent (5%) from the amount of the Net Sales or payments due under this Agreement. In such case, N OVACEA shall bear the full cost of such audit. In the event of underpayment, N OVACEA shall promptly remit to P IERRE F ABRE the amount of any underpayment. In the event of overpayment, P IERRE F ABRE shall promptly remit to N OVACEA the amount of any such overpayment.

 

[*] Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

 

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5.8.	Language of Reports.

 

All reports to be provided by N OVACEA hereunder shall be in the English language.

 

5.9.	Confidentiality of Reports.

 

P IERRE F ABRE agrees that all information subject to review under this Article 5 is confidential and that it shall retain, and shall cause its accountant to retain, such information in confidence in accordance with Article 7 of this Agreement.

 

5.10.

Withholding Taxes.

 

All payments to be made by one Party to the other Party under this Agreement shall be for the amounts specified therein less any withholding taxes, if any, required by Legal Requirements, including any applicable international tax treaty, to be deducted in respect of such payments. To the extent a Party withholds taxes as aforesaid, it shall promptly provide the other Party with all necessary information and documents to allow such other Party to apply for a corresponding tax credit or otherwise reflect the amount of taxes withheld.

 

ARTICLE 6 – PHARMACOVIGILANCE

 

The Parties acknowledge that, after the expiration of the Royalty Term, as long as N OVACEA uses the Trademark and purchases Finished Product from P IERRE F ABRE , they shall exchange pharmacovigilance data with each other pursuant to the Data Exchange Agreement (as defined in the Patent and Know-How License Agreement) which is hereby incorporated by reference or as otherwise provided in the Patent and Know-How License Agreement.

 

ARTICLE 7 – CONFIDENTIALITY

 

The Parties agree that Article 14 of the Patent and Know-How License Agreement shall govern the treatment of Information and other information, data and materials received by either Party (or by a person or entity acting on either Party’s behalf) from the other Party (or by a person or entity acting on the other Party’s behalf) pursuant to this Agreement (including, without limitation, the reports to be delivered pursuant to Section 5.3 hereof), as well as all Information developed during the course of the performance of this Agreement that is not publicly available, as though such provision, mutatis mutandis , was set forth in this Agreement.

 

ARTICLE 8 – ASSIGNMENT OF AGREEMENT

 

8.1.

General.

 

Except as otherwise permitted in this Article 8, neither this Agreement nor any rights granted hereunder may be assigned or otherwise transferred by either Party, nor shall they inure to the benefit of any trustee in bankruptcy, receiver or other successor of either Party, whether by operation of law or otherwise, without the written consent of the other Party, such consent not to be unreasonably withheld or delayed.

 

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8.2.	Assignment by Pierre Fabre.

 

P IERRE F ABRE may, without N OVACEA ’s consent, assign this Agreement to an Affiliate or to a Third Party in the following circumstances:

 

(a)

in the event of the transfer or sale by P IERRE F ABRE or any corporation directly or indirectly controlling P IERRE F ABRE to a Third Party of (i) stock representing more than fifty percent (50%) of P IERRE F ABRE or such corporation’s voting control, or (ii) all or substantially all of its assets; or

 

(b)

in the event of the merger or consolidation of P IERRE F ABRE , or of any corporation directly or indirectly controlling P IERRE F ABRE , with a Third Party in each case if such merger or consolidation results in the shareholders of P IERRE F ABRE (as existing at the Effective Date) or of any such corporation directly or indirectly controlling P IERRE F ABRE immediately prior to such merger or consolidation owning less than fifty percent (50%) of the voting control of the entity that survives such merger or consolidation, provided, however that, any such assignee shall agree in writing to assume the rights and obligations of P IERRE F ABRE under this Agreement, and P IERRE F ABRE shall promptly deliver a copy of such written assumption to N OVACEA .

 

8.3.	Assignment by Novacea.

 

N OVACEA may, without P IERRE F ABRE ’s consent, assign this Agreement in the following circumstances:

 

(a)

in the event of the transfer or sale by N OVACEA or any corporation directly or indirectly controlling N OVACEA to a Third Party of (i) stock representing more than fifty percent (50%) of N OVACEA ’s or such corporation’s voting control, or (ii) all or substantially all of its assets; or

 

(b)

in the event of the merger or consolidation of N OVACEA , or of any corporation directly or indirectly controlling N OVACEA , with a Third Party in each case if such merger or consolidation results in the shareholders of N OVACEA (as existing at the Effective Date) or of any such corporation directly or indirectly controlling N OVACEA immediately prior to such merger or consolidation, owning less than fifty percent (50%) of the voting control of the entity that survives such merger or consolidation, provided, however that:

 

(i)

any such assignee shall agree in writing to assume the rights and obligations of N OVACEA under this Agreement, and N OVACEA shall promptly deliver a copy of such written assumption to P IERRE F ABRE ; and

 

(ii)

in the event that during the Royalty Term, the Third Party referred to in (a) and (b) above is a company, that either (x) markets a Competing Product in the N OVACEA Territory or (y) is currently developing a Competing Pr