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KNOW-HOW LICENSE AGREEMENT BY & BETWEEN REGISTRANT & NOVEXEL SA

License Agreement

KNOW-HOW LICENSE AGREEMENT BY & BETWEEN REGISTRANT & NOVEXEL SA | Document Parties: Aventis Pharma SA | INDEVUS PHARMACEUTICALS, INC | NOVEXEL SA You are currently viewing:
This License Agreement involves

Aventis Pharma SA | INDEVUS PHARMACEUTICALS, INC | NOVEXEL SA

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Title: KNOW-HOW LICENSE AGREEMENT BY & BETWEEN REGISTRANT & NOVEXEL SA
Governing Law: United States Of America     Date: 12/7/2006
Industry: Biotechnology and Drugs     Sector: Healthcare

KNOW-HOW LICENSE AGREEMENT BY & BETWEEN REGISTRANT & NOVEXEL SA, Parties: aventis pharma sa , indevus pharmaceuticals  inc , novexel sa
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EXHIBIT 10.161

CONFIDENTIAL TREATMENT REQUESTED. CONFIDENTIAL PORTIONS OF THIS DOCUMENT HAVE BEEN REDACTED AND HAVE BEEN FILED SEPARATELY WITH THE U.S. SECURITIES AND EXCHANGE COMMISSION

Execution Copy

KNOW-HOW LICENSE AGREEMENT

by and between

INDEVUS PHARMACEUTICALS, INC.

and

NOVEXEL SA

THIS KNOW-HOW LICENSE AGREEMENT (" Agreement ") is effective as of December 4 th , 2006 (" Effective Date "), by and between INDEVUS PHARMACEUTICALS, INC. , a corporation organized and existing under the laws of the State of Delaware and having its principal office at 33 Hayden Avenue, Lexington, Massachusetts 02421, United States (" Indevus "), and NOVEXEL SA, a corporation organized and existing under the laws of France and having its principal office at Parc Biocitech, 102, route de Noisy, F-93230 Romainville France (" Novexel "). Indevus and Novexel are collectively referred to herein as the " Parties ", and individually, as a " Party ".

W I T N E S S E T H:

WHEREAS, effective April 18, 2003, Indevus entered into that certain License Agreement with Aventis Pharma SA (" Aventis ") (as amended, the " 2003 License ") under which, among other things, Indevus was granted an exclusive license under AVENTIS Intellectual Property (as defined in the 2003 License) to develop and commercialize Compound and Product (each as defined below);

WHEREAS, pursuant to the Assignment Agreement (as defined below) effective as of December 1, 2004, Aventis assigned to Novexel all of Aventis’s right, title and interest in and to all intellectual property rights relating to Compound and Product;

WHEREAS, pursuant to the Assignment Agreement, effective as of December 1, 2004, Aventis also assigned to Novexel the 2003 License and Aventis’s rights and obligations thereunder (except for the right to manufacture and supply Nucleus (as defined below) that was retained by Aventis) and Novexel assumed all such rights and obligations thereunder;

WHEREAS, under the 2003 License, Indevus, through its efforts to develop Product, has generated the Indevus Know-how (as defined below);

WHEREAS, Indevus has made a strategic corporate decision to search for a partner to pursue development and commercialization of Compound and Product and Novexel wishes to have an exclusive right to pursue such activities, Indevus and Novexel have agreed, and mutually desire, to simultaneously execute three agreements which will, together, allow Novexel to exclusively pursue development and commercialization of Compound and Product; and

WHEREAS the three agreements Indevus and Novexel have agreed to simultaneously execute include (i) a Termination Agreement terminating the 2003 License, (ii) this Know-How License Agreement under which Indevus will grant Novexel an exclusive license to Indevus Know-How (the "Know-How License"), and (iii) a letter agreement assigning Indevus’ rights and obligations relative to Aventis in the manufacture and supply of Nucleus to Novexel, to which Aventis is also a party (the "Side Agreement").

NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:

 

Page 1

ARTICLE I

DEFINITIONS

Unless specifically set forth to the contrary herein, the following terms, where used in the singular or plural, shall have the respective meanings set forth below:

 

 

1.1

" Affiliate " means (i) any corporation or business entity of which more than fifty percent (50%) of the securities or other ownership interests representing the equity, the voting stock or general partnership interest are owned, controlled or held, directly or indirectly, by a Party or (ii) any corporation or business entity which, directly or indirectly, owns, controls or holds more than fifty percent (50%) (or the maximum ownership interest permitted by law) of the securities or other ownership interests representing the equity, the voting stock or, if applicable, the general partnership interest, of a Party.

 

 

1.2

" Assignment Agreement " means the Subscription Agreement in relation to Novexel SA dated as of 25 October 2004 by and among Aventis, Novexel and the other parties listed on the signature page thereto, a redacted form of which has been previously provided to Indevus.

 

 

1.3

" Aventis " means Sanofi-aventis, the successor to Aventis Pharma SA.

 

 

1.4

" Business Day(s) " means any day that is not a Saturday or a Sunday or a day on which the New York Stock Exchange is closed or a day that is a bank holiday in France (which days are set forth on Schedule 1.4 ).

 

 

1.5

" Calendar Quarter " means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31.

 

 

1.6

" Calendar Year " means each successive period of twelve (12) months commencing on January 1 and ending on December 31.

 

 

1.7

" Centralized Procedure " means the European Union Centralized Procedure for marketing authorization in accordance with Council Regulation n° 2309/93 of July 22, 1993 or any successor regulations.

 

 

1.8

" Compound " means the chemical compound known under the International Non-proprietary name aminocandin and the code name HMR-3270 and diagrammed on Schedule 1.8 , and any other compounds disclosed or covered or included in the Novexel Patent Assets or any compound that is part of the aminocandin family of compounds or any derivative, homolog, or analog of any of the foregoing, and any isomer, salt, hydrate, solvate, amide, ester, metabolite, or prodrug of any of the foregoing

 

 

1.9

" Dominating Patent " shall mean an unexpired patent which has not been invalidated by a court or other governmental agency of competent jurisdiction which is owned by a Third Party and which Novexel or its sublicensees reasonably believe they have no

 

Page 2

 

alternative to obtaining a royalty-bearing license under such patent in order to commercialize a Product under this Agreement without infringing such patent. Any Third Party patent that (i)  [*] and (ii) becomes subject to the preceding sentence after the Effective Date, shall be deemed a Dominating Patent.

 

 

1.10

" EMEA " means the European Agency for the Evaluation of Medicinal Products based in London (UK), as established by Council Regulation n° 2309/93 of July 22, 1993, as subsequently amended by Commission Regulation 649/98 of March 23, 1998, and any successor thereto having substantially the same functions.

 

 

1.11

" FDA " means the United States Food and Drug Administration and any successor agency having substantially the same functions.

 

 

1.12

" First Commercial Sale " means the date of the first commercial sale of Product in the Territory by Novexel or its Affiliates, or their sublicensee(s) after all required Regulatory Approvals in the country of sale have been obtained.

 

 

1.13

" Indevus Know-How" means any and all information and materials, including but not limited to, discoveries, Inventory, information, processes, formulae, data, inventions (whether patentable or not), invention disclosures, know-how and trade secrets, patentable or otherwise, that relate to Compound or Product, including without limitation, all chemical, pharmaceutical, toxicological, biochemical, and biological, technical and non technical data, and information relating to the results of tests, assays, methods, and processes, and specifications and/or other documents containing information and related data, and any preclinical, clinical, assay control, manufacturing, regulatory, and any other data or information used or useful for the development, manufacturing, regulatory filing or application and/or regulatory approval of Compound or Product that are immediately prior to the Effective Date, owned or controlled by Indevus. A list of the principal components of the Indevus Know-How is attached as Schedule 1.13 .

 

 

1.14

" Inventory " means the materials set forth on Schedule 1.14 attached hereto and incorporated by reference herein that as of the Effective Date are stored and held by or on behalf of Indevus.

 

 

1.15

" Losses " means any and all damages, awards, deficiencies, settlement amounts, defaults, assessments, fines, dues, penalties (including penalties imposed by any governmental authority), costs, fees, liabilities, obligations, taxes, liens, losses, and expenses (including court costs, interest and reasonable fees of attorneys, accountants and other experts) awarded or otherwise paid or payable to Third Parties.

 

 

1.16

" Material Adverse Change " means a serious adverse condition or event relating to the clinical safety, efficacy, toxicity or side effects of Compound or Product that (i) was not included in the Indevus Know-How; (ii) was in the Indevus Know-How or was known to Novexel, but after the Effective date and reasonably diligent efforts by Novexel is determined by Novexel to be a condition or event that cannot be reasonably overcome; (iii) was not, as of the Effective Date, known to Novexel, including any action by any Regulatory Authority significantly limiting the development or commercialization of Compound or Product.

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

Page 3

 

1.17

" NDA " means a new drug application or other submission filed with the applicable Regulatory Authority in any regulatory jurisdiction in the Territory to obtain Regulatory Approval of a Product in such regulatory jurisdiction, and any amendments and supplements thereto.

 

 

1.18

" Net Sales " means the actual gross amount invoiced by Novexel, its Affiliates or its sublicensees for the commercial sale of all Products in the Territory to a Third Party, commencing upon the date of First Commercial Sale, after deducting the following:

        • (a) trade, cash, quantity or ordinary discounts;

          (b) allowances for product returns, including allowances or credits for rejected Product, or spoilage or recalled Product;

          (c) rebates, credits, reimbursements and charge backs;

          (d) sales or excise taxes, VAT or other taxes, and transportation and insurance charges and additional special transportation, custom duties, and other governmental charges;

          (e) rebates or similar payments paid in connection with sales of Product to any governmental or regulatory authority in respect of any state or federal programs similar to Medicare or Medicaid in the United States in any country of the Territory;

          (f) retroactive price reductions; and

          (g) write-offs or allowances for bad debt, not to exceed two percent (2%) of Net Sales.

        If Novexel or its Affiliates or sublicensees sells Product together with other products to Third Parties in a particular country and the price attributable to the Product is less than the average price of "arms length" sales of the Product alone in the particular country for the reporting period in which sales occur (such sales to be excluded from the calculation of the average price of "arms length" sales), Net Sales for any such sales shall be the average price of "arms length" sales by Novexel or its Affiliates or sublicensees of the Product alone and in the country during the reporting period in which such sales occur. If the average price of "arms length" sale of the Product cannot be determined in any given country, Net Sales will be determined by the value of the Product sold to similar customers in countries with similar pricing and reimbursement structures and for similar quantities. Any dispute as to the determination of value shall be resolved under the dispute procedure in accordance with the provisions of Section 10.6.

        If a Product contains one or more therapeutically active ingredients in addition to Compound ("Combination Product"), the Net Sales from the Combination Product, for

 

Page 4

      • the purposes of determining royalty payments, shall be determined by multiplying the Net Sales of the Combination Product during the applicable royalty reporting period, by the fraction, A/A+B, where A is the weighted average per unit sale price of Product when sold in finished form with the Compound as the only active ingredient in the country in which the Combination Product is sold, and B is the weighted average per unit sale price of an active ingredient other than Compound (it being understood that if there are multiple other active ingredients they shall be designated as B-1, B-2, etc.) contained in the Combination Product when sold separately in finished form in the country in which the Combination Product is sold multiplied by the number of units of such active ingredient(s) in the Combination Product, in each case during the applicable royalty reporting period or, if sales of the Product alone did not occur in such period, then in the most recent royalty reporting period in which arm’s length fair market sales of such Product occurred. In the event that such weighted average sale price cannot be determined for either the Product or all other product(s) included in the Combination Product, Net Sales for the purpose of determining royalty payments due on a Combination Product shall be mutually agreed upon by the Parties based on the relative value contributed by each component, such agreement not to be unreasonably withheld, conditioned or delayed.

        Use of Products for promotional or sampling purposes or for use in clinical trials contemplated under this Agreement shall not be considered in determining Net Sales. In the case of any sale of a Product between Novexel and its Affiliates or sublicensees for resale, Net Sales shall be calculated as above only on the first arm’s length sale thereafter to a Third Party.

 

 

1.19

" Novexel Know-How " means any and all information and materials, including but not limited to, discoveries, improvements, information, processes, formulae, data, inventions (whether patentable or not), invention disclosures, know-how and trade secrets, patentable or otherwise, that relate to Compound or Product, including without limitation, all chemical, pharmaceutical, toxicological, biochemical, and biological, technical and non technical data, and information relating to the results of tests, assays, methods, and processes, and specifications and/or other documents containing information and related data, and any preclinical, clinical, assay control, manufacturing, regulatory, and any other data or information used or useful for the development, manufacturing, regulatory filing or application and/or regulatory approval of Compound or Product that are as of the Effective Date or at any time during the Term of this Agreement become, owned or controlled by Novexel (other than pursuant to the license granted by Indevus under this Agreement) and as to which Novexel has the right to license or sublicense.

 

 

1.20

" Novexel Patent Assets " means the United States patents and patent applications and any foreign counterparts thereof listed on Schedule 1.20 or which as of the Effective Date are, or at any time during the Term of this Agreement become, owned or controlled by Novexel, and relate to Compound or Product or any improvement, including all certificates of invention and applications for certificates of invention and substitutions, divisions, continuations, continuations-in-part, patents issuing thereon or reissues or reexaminations thereof, supplementary protection certificates or the like of any such patents and patent applications.

 

Page 5

 

1.21

" Nucleus " means deacylmulundocandin, the starting material for the manufacture of the Compound, obtained by biochemistry through a biosynthesis from an Aspergillus strain, the first step of which leads to deoxymulundocandin and the second step of which leads to deacylmulundocandin.

 

 

1.22

" Product " means any product in final form (or where the context so indicates, the product being tested) which contains Compound as at least one of the therapeutically active ingredients.

 

 

1.23

" Proprietary Information " means any and all scientific, clinical, regulatory, marketing, financial and commercial information or data, whether communicated in writing, orally or by any other means, which is owned and under the protection of one Party and is being provided by that Party to the other Party in connection with this Agreement. For purposes of the confidentiality and non-use provisions of this Agreement, Novexel Know-How and Reports are deemed Novexel Proprietary Information and Indevus Know-How is deemed Indevus Proprietary Information.

 

 

1.24

"Regulatory Approval " means all authorizations and approvals (including pricing and reimbursement approvals where required for marketing), of all regional, federal, state or local agencies, departments, bureaus or other governmental entities, necessary for the manufacture, use, storage, import, export, transport and sale of Product in a jurisdiction.

 

 

1.25

" Regulatory Authority " means the FDA in the United States and any body in the European Union and any health regulatory authority(ies) in any country(ies) in the Territory that is equivalent to the FDA and holds responsibility for granting Regulatory Approval for a Product in such country(ies), and any successor(s) thereto having substantially the same functions.

 

 

1.26

" Royalty Year " means, (i) for the year in which the First Commercial Sale occurs, the period commencing with the first day of the Calendar Quarter in which the First Commercial Sale occurs and expiring on the last day of the Calendar Year in which the First Commercial Sale occurs and (ii) for each subsequent year, each successive Calendar Year.

 

 

1.27

" SEC " means the US Securities and Exchange Commission or any successor agency.

 

 

1.28

" Side Agreement " means the agreement entered into by and among Novexel, Indevus and Aventis on even date herewith and attached as Exhibit A which provides inter alia , for Indevus’ rights and obligations under Sections 3.1.2 and 3.8 of the 2003 License to be assigned to Novexel, and that in the event of a termination of this agreement where Indevus will reacquire the rights consistent with the 2003 License, the rights and obligations under Sections 3.1.2 and 3.8 shall be reassigned back to Indevus.

 

Page 6

 

1.29

" Termination Agreement " means the agreement entered into between the Parties on even date herewith, and attached as Exhibit B, which provides, inter alia , for the termination of the 2003 License in consideration of the Parties entering into this Agreement and Novexel, Indevus and Aventis entering into the Side Agreement.

 

 

1.30

" Territory " means all of the countries in the world.

 

 

1.31

" Third Party(ies) " means a person or entity who or which is neither a Party nor an Affiliate of a Party.

ARTICLE II

LICENSE; SUBLICENSES

 

 

2.1

License Grant . Indevus hereby grants to Novexel an exclusive license, with the right to sublicense in accordance with the terms of this Agreement (with the right of sublicensees to further sublicense), to use and practice the Indevus Know-How for any purpose in connection with Compound and/or Product, including to develop, make, have made, use, import, offer for sale, sell, market, promote, commercialize, distribute, or otherwise dispose of Compound and Product for any and all uses in the Territory.

 

 

2.2

Delivery of Indevus Know-How . Within thirty (30) days after the Effective Date, Indevus shall deliver to Novexel, at Indevus’s expense, all tangible items (except Inventory) within the Indevus Know-How in a form(s) to be agreed upon and to a place designated in writing by Novexel. The Parties shall agree on a mutual place and time within thirty (30) days after the Effective Date, to arrange for a delivery to Novexel’s personnel, at Indevus’s expense, all of the Indevus Know-How not available in tangible form. Such transfer shall be made by qualified Indevus personnel who understand, have used and are familiar with such Indevus Know-How.

 

 

2.3

Sublicenses . Subject to the terms and conditions of this Agreement, Novexel shall have the right to grant sublicenses of any of the rights granted to Novexel under Section 2.1 to Affiliates or any Third Party, provided, however , that any sublicense shall be consistent with Novexel’s obligations under this Agreement, including under Section 9.4. Novexel shall remain responsible for the performance by the sublicensee of such obligations. Novexel shall notify Indevus of any sublicense granted in the US, Japan and/or Europe.

 

 

2.4

Inventory . Effective as of the Effective Date, Indevus hereby assigns and transfers to Novexel all of Indevus’s right, title and interest in the Inventory. The Inventory shall be delivered for the account of Novexel, at Novexel’s expense, in accordance with and as soon as reasonably practicable after receipt by Indevus of written instructions from Novexel, provided , however , that prior to any such delivery, the Inventory shall be held from and after the Effective Date, for the account of Novexel and, from and after the Effective Date, Novexel shall bear all risk of partial or total deterioration or loss of any Inventory through no fault of Indevus, without any recourse against Indevus in relation thereto. To the best of Indevus’ knowledge, the Inventory at all times while held for the account of Indevus has been stored in accordance with cGMPs and all other applicable laws and regulations.

 

Page 7

 

2.5

Non-Use/Non-Disclosure . From and after the Effective Date, Indevus agrees and covenants to Novexel that Indevus shall not disclose any Indevus Know-How to any Third Party without the prior written consent of Novexel. From and after the Effective Date (except if the provisions of Section 9.4.3 or 9.4.4 become applicable), Indevus agrees and covenants to Novexel that Indevus shall not use any Indevus Know-How for any purpose whatsoever. To implement the provision of this Section 2.5, Indevus shall make reasonable efforts to notify all of its employees who have used or have access to Indevus Know-How of the provisions of this Section 2.5, and in accordance with Indevus’ standard procedures, collect all documents and things containing Indevus Know-How and maintain them in a locked file.

 

 

2.6

Technical Assistance .

      • 2.6.1 Access to Indevus’s Records . Upon Novexel’s request, within the six (6) month period after the Effective Date, Novexel personnel shall be permitted access to Indevus’s facility where the original documents and things within Indevus Know-How are maintained to inspect and copy, if desired, such original documents and things. Any such access shall be during normal business hours and upon at least five (5) Business Days advance notice.

        2.6.2 Assistance. Within the one (1) year period after the Effective Date, Indevus shall make available to Novexel at Novexel’s designated facility, Indevus’ qualified personnel familiar with the Indevus Know-How to provide reasonable training and assistance to Novexel with its use of the Indevus Know-How, upon Novexel’s reasonable written request and at such times and for such periods as may be mutually agreed to in good faith, subject to the terms of this Section 2.6.2. Novexel shall bear all out of pocket expenses associated with such assistance. Such assistance shall be limited to [*]. Thereafter, if Novexel requests additional training or assistance, and Indevus agrees to provide such assistance, Novexel shall pay Indevus at the rate of [*] and bear all out of pocket expenses in the manner set forth above. Any such additional assistance shall be limited to [*].

 

 

2.7

Regulatory Filings . Within thirty (30) days after the Effective Date, Indevus, at its expense, shall transfer ownership to Novexel of any and all regulatory applications, filings and submissions with respect to Compound and Product so that Novexel can continue clinical development of Compound and Product in its own name, and in accordance with Section 3.2.

ARTICLE III

DEVELOPMENT AND COMMERCIALIZATION

 

 

3.1

Development and Commercialization . Novexel shall control and shall be solely responsible for development, manufacture and commercialization of Compound and

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

Page 8

 

the Products conducted or performed after the Effective Date. Novexel shall comply with all applicable laws and regulations in the development and commercialization of Product. A summary of Novexel’s progress and results of such development and commercialization will be reported to Indevus at least on an annual basis. Such progress reports and the information, data and results contained therein (" Reports ") shall be deemed Proprietary Information of Novexel and shall remain the property of Novexel. Only those employees of Indevus who administer this Agreement shall have access to such Reports.

 

 

3.2

Regulatory Matters . Novexel shall own, control and retain primary legal and financial responsibility for the preparation, filing, prosecution and maintenance of all filings and regulatory applications required to obtain and maintain authorization to develop, manufacture, sell and use Product in the Territory. Novexel shall notify Indevus of the dates of First Commercial Sale in each country in the Territory. Novexel shall be solely responsible for filing all reports required to be filed in order to maintain Regulatory Approvals for Product in the Territory, and for all interactions with Regulatory Authorities in the Territory regarding such Regulatory Approvals. Novexel shall have sole responsibility for, bear all costs and expenses associated with and make all decisions with respect to any recall, withdrawal or seizure of the Product. Novexel shall notify Indevus with respect to any material changes or material problems that may arise in connection with its Regulatory Approvals in any country in the Territory.

 

 

3.3

Diligence; Development and Commercialization . Novexel shall use commercially reasonable efforts to develop and commercialize Product. As used herein, "commercially reasonable efforts" shall mean efforts and resources normally used by Novexel for a product owned by it or to which it has exclusive rights, which is of similar market potential at a similar stage in its development or product life, taking into account issues of safety and efficacy, product profile, the competitiveness of the marketplace, the proprietary position of the compound or product, the regulatory and reimbursement structure involved, the profitability of the concerned products, and other relevant factors if any.

 

 

3.4

Trademark . Novexel shall have the right to select, own and maintain trademarks for Product in the Territory.

 

 

3.5

Agreements . Schedule 3.5 sets forth a list of all contracts, agreements and other arrangements in effect as of the Effective Date between Indevus and any Third Parties relating to the research, development or storage of the Compound and Product. Indevus shall use commercially reasonable efforts to assign to Novexel, and Novexel shall assume all of Indevus’s obligations under, the contracts and agreements listed on Schedule 3.5 which Novexel shall specifically request, and Indevus shall terminate any such other contracts, agreements or other arrangements. From and after the Effective Date, Indevus shall have no obligations under any of the contracts or agreements assigned to Novexel except for payment obligations that accrued prior to the Effective Date.

 

Page 9

 

3.6

Manufacturing and Supply. During the Term of this Agreement, and subject to the following sentence, Novexel shall have all rights and responsibility relating to chemistry, manufacturing and control for clinical and commercial use of Compound or Product. The Parties hereby acknowledge that pursuant to the 2003 License, Aventis retained the right to manufacture and supply or have manufactured or have supplied, the Nucleus under the terms and conditions set forth therein and that as of the Effective Date, Indevus and Aventis have not entered into the manufacturing and supply agreement referred to therein, but have extended the time period for entering into such an agreement through July 1, 2007, as established by the correspondence between Indevus and Aventis included in Exhibit C , which shall also include any amendments to the 2003 License.

ARTICLE IV

PAYMENTS AND REPORTS

 

 

4.1

License and Transfer Fees . In partial consideration of the rights granted by Indevus hereunder, Novexel shall pay Indevus the following non-refundable and non-creditable license fees by wire transfer of immediately available funds to a bank account or bank accounts designated by Indevus:

      • 4.1.1 one million five hundred thousand dollars (US$1,500,000) payable within five (5) Business days after the Effective Date ; and

        4.1.2 two hundred fifty thousand dollars (US$250,000) on a quarterly basis, commencing twenty-four (24) months from the Effective Date, provided that such obligation shall expire on the commencement of the first Phase 2 clinical trial (first dosing of first patient) and payment of the milestone referred to in Section 4.2.1. Such payments may be temporarily suspended in the event of, and for the duration of, a Material Adverse Change, provided, that Novexel shall have provided Indevus with written notice and evidence of such Material Adverse Change prior to the date any quarterly payment required by this Section 4.1.2 would otherwise have been payable.

 

 

4.2

Milestone Payments . In further consideration of the rights granted by Indevus hereunder, Novexel shall pay Indevus the following non-refundable and non-creditable milestone payments, contingent upon occurrence of the specified event, with each milestone payment to be made no more than once with respect to the achievement of such milestone and no amounts payable for any subsequent or repeated achievement of such milestones, regardless of the number of Products for which such milestone may be achieved (but payable the first time such milestone is achieved):

      • 4.2.1 For the first IV formulation of the first Product :

 

 

(a)

US $2,000,000 upon commencement (first dosing of the first patient) of first Phase 2 clinical trial;

 

 

(b)

US $750,000 upon the commencement (first dosing of the first patient) of the first Phase 3 clinical trial;

 

Page 10

 

(c)

US $1,500,000 upon the FDA’s acceptance for filing of the first NDA;

 

 

(d)

US $750,000 upon the first acceptance for filing of an NDA with the EMEA;

 

 

(e)

US $750,000 upon the first acceptance for filing of an NDA in Japan;

 

 

(f)

US $3,500,000 upon receipt of first written Regulatory Approval in the United States by the FDA;

 

 

(g)

US $2,000,000 upon receipt of written Regulatory Approval by the EMEA;

 

 

(h)

US $2,000,000 upon receipt of written Regulatory Approval by the Regulatory Authority in Japan;

 

 

(i)

US $750,000 upon the achievement of cumulative Net Sales of US $100,000,000 ;

 

 

(j)

US $750,000 upon the achievement of cumulative Net Sales of US $200,000,000;

 

 

(k)

US $750,000 upon the achievement of cumulative Net Sales of US $300,000,000; and

 

 

(l)

US $750,000 upon the achievement of cumulative Net Sales of US $400,000,000.

      • 4.2.2 For the first oral formulation of the first Product :

 

 

(a)

US $2,250,000 upon the commencement (first dosing of the first patient) of the first Phase 3 Clinical Trial;

 

 

(b)

US $2,625,000 upon the FDA’s acceptance for filing of the first NDA;

 

 

(c)

US $1,875,000 upon the first acceptance for filing of an NDA by the EMEA;

 

 

(d)

US $1,500,000 upon the first acceptance for filing of an NDA in Japan;

 

 

(e)

US $5,000,000 upon receipt of first written Regulatory Approval in the United States by the FDA;

 

 

(f)

US $4,000,000 upon receipt of written Regulatory Approval by the EMEA;

 

 

(g)

US $2,000,000 upon receipt of written Regulatory Approval by the Regulatory Authority in Japan;

 

Page 11

 

(h)

US $1,500,000 upon the achievement of cumulative Net Sales of US $200,000,000;

 

 

(i)

US $1,500,000 upon the achievement of cumulative Net Sales of US $400,000,000;

 

 

(j)

US $1,500,000 upon the achievement of cumulative Net Sales of US $600,000,000;

 

 

(k)

US $1,500,000 upon the achievement of cumulative Net Sales of US $800,000,000; and

 

 

(l)

US $1,500,000 upon the achievement of cumulative Net Sales of US $1,000,000,000.

          • Novexel shall notify Indevus in writing within fifteen (15) Business Days after the achievement of each milestone (thirty (30) days for the milestones set forth in Section 4.2.1 (i), (j), (k) and (l), and Section 4.2 (h), (i), (j), (k) and (l)), and payment shall be made concurrent with such notice by wire transfer of immediately available funds to a bank account or bank accounts designated by Indevus.

 

 

4.3

Royalties .

      • 4.3.1 In further consideration of the rights granted by Indevus hereunder, Novexel shall pay to Indevus in each Royalty Year royalties on Net Sales in the Territory at the following rates:

 

 

       

Annual Net Sales in all countries in the Territory:

  

Royalty Rate

 

  • Less than US$500,000,000

  

5

%

  • Greater than or equal to US$500,000,000 and less than US$1,000,000,000

  

6

%

  • Greater than or equal to US$ 1,000,000,000

  

7.5

%



      • 4.3.2 Royalties shall accrue as of the date of First Commercial Sale of Product in the Territory and shall continue and accrue on Net Sales in each country in the Territory until the later of in any such country, (a) the expiration of the last to expire Novexel Patent Asset that exists as of the Effective Date in such country and is listed on Schedule 1.20 , or (b) [*] from the date of First Commercial Sale of Product in such country. After the expiration of the applicable royalty term in any country, Novexel shall be relieved of any royalty payment in that country.

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

Page 12

      • 4.3.3 The payment of royalties hereunder shall be subject to the following:

 

 

(a)

No royalties shall accrue on the disposition of Product by Novexel, Affiliates or sublicensees as samples or as donations (for example, to non-profit institutions or government agencies);

 

 

(b)

In the event Novexel, a Novexel Affiliate or sublicensee sells Compound or bulk drug product rather than Product in finished packaged form to a Third Party, other than a sublicensee, and is unable to determine Net Sales as defined in this Agreement, then the royalty obligations shall apply to the Compound or bulk drug product sold; and

 

 

(c)

Novexel shall be responsible for any royalties or other amounts payable to Third Parties in order to make, have made, use, sell or import Compound or Product in any country in the Territory, including pursuant to any license agreement with any Third Party. Notwithstanding the foregoing, except with respect to any payments required to be made in connection with the Nucleus, including the manufacture or rights to manufacture the Nucleus, if Novexel, its Affiliates, sublicensees or their co-promotion partners would be prevented from developing, making, having made, using, selling or importing Product in any country of the Territory on the grounds that by doing so they would infringe a Dominating Patent or other patent rights held by a Third Party in said country, and any of them enter into an agreement with a Third Party pursuant to which an actual royalty on Compound or Product is paid to such Third Party, then Novexel shall be entitled to a credit against future royalties otherwise payable to Indevus hereunder in an amount equal to [*] of the amount of such royalty payments paid to such Third Parties; provided that the credit for any given year will not exceed [*] of the royalties payable to Indevus for such year; and provided further that in such event Indevus has been informed of the Dominating Patent or other patent rights and has had an opportunity to provide input on any related discussion.

      • 4.3.4 In the event that Novexel or any Novexel Affiliate or sublicensee determines to commercialize Product as an Over-the-Counter Product, the Parties shall negotiate in good faith a royalty payable to Indevus on Net Sales of Over-the-Counter Products in countries where the manufacture, use or sale of such Over-the-Counter Product wouldinfringe any of the Novexel Patent Assets in such country.

        4.3.5 Upon the expiration of the obligation of Novexel to make the royalty payments required by Section 4.3.1 in any country in the Territory, Novexel shall have a fully paid-up, royalty free, transferable license in such country to use the Indevus Know-How for any purpose whatsoever.

 

 

4.4

Reports; Payment of Royalties. Novexel shall furnish to Indevus by not later than twenty (20) days following the end of each Calendar Quarter a written report for such Calendar quarter showing: (i) gross sales and Net Sales of Product or Compound

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

Page 13

 

during such Calendar Quarter (including a detailing of all deductions taken in the calculation of Net Sales and, where available, the number of units sold) in each country’s currency, (ii) the formulas used in the calculation of the royalties owed thereon, (iii) the applicable exchange rate to convert from each country’s currency to United States Dollars, and (iv) the royalties payable to Indevus. Royalty payments shall first be calculated in the currency in which sales took place and then converted to United States Dollars using the arithmetic averages of the closing conversion rates on the first and last Business Day of such Calendar Quarter, as published by The Wall Street Journal, Eastern edition (if available), or any other publication as agreed to by the Parties. The royalties shown to have accrued by each report, if any, shall be due and payable on the date such report is due. Novexel shall keep, and shall require its Affiliates and sublicensees to keep, complete and accurate records in sufficient detail to enable the royalties payable hereunder to be determined.

 

 

4.5

In order for Indevus to receive compensation on a quarterly basis, Novexel shall pay to Indevus, on a quarterly basis, royalties based on the cumulative Net Sales for the applicable Royalty Year to date, less royalties previously paid to Indevus on account of Net Sales for the previous Calendar Quarters in such Royalty Year. Any change in the amount that would have been payable from Novexel to Indevus under this Agreement which results from any restatements to a prior period’s financial results due to errors, omissions, or any other misstatements, shall be added to or deducted from, as applicable, the amount of the next payment due under this Agreement.

 

 

4.6

Financial Audits . Upon the written request of Indevus and not more than once in each Calendar Year, Novexel shall permit an independent certified public accounting firm selected by Indevus and reasonably acceptable to Novexel to have access during normal business hours, upon ten-days notice to Novexel, to such of the records of Novexel, its Affiliates and sublicensees, as applicable, as may be reasonably necessary to verify the accuracy of the reports under Section 4.4 for any Royalty Year ending not more than [*]prior to the date of such request. The accounting firm shall disclose to Indevus only whether the reports are correct or incorrect and the specific details concerning any discrepancies.

      • 4.6.1 If such accounting firm concludes that additional amounts were owed by Novexel for such Royalty Year, Novexel shall pay the additional amounts within thirty (30) days of the date Indevus delivers to Novexel such accounting firm’s written report so concluding. In the event such accounting firm concludes that amounts were overpaid by Novexel during such period, Indevus shall repay Novexel the amount of such overpayment within thirty (30) days of the date Indevus delivers to Novexel such accounting firm’s written report so concluding. The fees charged by such accounting firm shall be paid by Indevus; provided , however , that if an error in favor of Indevus of more than the greater of (i) [*] or (ii) [*] of the amounts due hereunder for the period being reviewed is discovered, then the fees and expenses of the accounting firm shall be paid by Novexel.

        4.6.2 Upon the expiration of thirty-six (36) months following the end of any Royalty Year the calculation of royalties or other payments payable with respect to such

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

Page 14

      • Royalty Year shall be binding and conclusive upon Indevus, and Novexel shall be released from any liability or accountability with respect to royalties for such Royalty Year.

        4.6.3 Indevus shall treat all financial information subject to review under this Section 4.6 in accordance with the confidentiality provisions of this Agreement and shall cause its accounting firm to enter into a reasonable and mutually satisfactory confidentiality agreement with Novexel obligating it to retain all such financial information in confidence pursuant to such confidentiality agreement.

 

 

4.7

Payments . All payments to Indevus under this Agreement shall be made in United States dollars.

 

 

4.8

Late Payment . In case of any late payment due hereunder by Novexel, Novexel shall pay to Indevus interest on the unpaid amount until such payment is paid in full, at the LIBOR Rate (as defined below), [*] but in no event in excess of the maximum rate permitted by applicable law. "LIBOR Rate" means an interest rate per annum equal to the rate of interest per annum at which deposits in United States dollars are offered by the principal office of Citibank, N.A. in London, England, to prime banks in the London interbank market at 11:00 a.m. (London time) on the Business Day immediately preceding the commencement of such interest period.

 

 

4.9

Tax Withholding If withholding taxes are payable with respect to any payments to Indevus hereunder, Novexel shall pay such withholding taxes and deduct the amount thereof from the amounts otherwise due to Indevus hereunder. Novexel shall provide Indevus with a certificate evidencing payment of any withholding taxes hereunder, together with a written statement of any such taxes paid with respect to Indevus’s tax liability. Novexel shall provide Indevus with both a written statement of any such withholding taxes and a certificate evidencing payment of such taxes. Novexel will use commercially reasonable efforts consistent with its usual business practices and reasonably cooperate with Indevus to ensure that any withholding taxes imposed are reduced as far as possible under the provisions of the current or any future taxation treaties or agreements between foreign countries. In the event that Novexel is legally required to file such forms for the benefit of Indevus, Indevus shall provide fully completed forms for verification and subsequent filing by Novexel.

 

 

4.10

Restrictions on Payment . If by law, regulations or fiscal policy of a particular country, remittance of royalties in United States Dollars is restricted or forbidden, notice thereof will be promptly given to Indevus, and payment of the royalties shall be made by the deposit thereof in local currency to the credit of Indevus in a recognized banking institution designated by Indevus. When in any country the law or regulations prohibit both the transmittal and deposit of royalties on sales in such a country, royalty payments shall be suspended for as long as such prohibition is in effect and as soon as such prohibition ceases to be in effect, all royalties that Novexel would have been under obligation to transmit or deposit but for the prohibition, shall forthwith be deposited or transmitted promptly to the extent allowable.

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

Page 15

ARTICLE V

CONFIDENTIALITY AND PUBLICITY

 

 

5.1

Non-Disclosure and Non-Use Obligations . All Proprietary Information disclosed by one Party to the other Party hereunder shall be maintained in confidence and shall not be disclosed to any Third Party or used for any purpose except as expressly permitted herein without the prior written consent of the Party that disclosed the Proprietary Information to the other Party during the Term of this Agreement and for a period of five years thereafter, except that with respect to the Indevus Know-How, Indevus’s obligation hereunder shall continue throughout the Term of this Agreement. The foregoing non-disclosure and non-use obligations shall not apply to the extent that such Proprietary Information:

      • 5.1.1 is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by business records;

        5.1.2 is or becomes properly in the public domain or knowledge, but not by any action of the receiving Party;

        5.1.3 is subsequently disclosed to a receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or

        5.1.4 is developed by the receiving Party independently of Proprietary Information received from the other Party, as documented by research and development records.

 

 

5.2

Permitted Disclosure of Proprietary Information . Notwithstanding Section 5.1,

      • 5.2.1 Novexel may disclose Indevus Proprietary Information:

 

 

(a)

to governmental or other regulatory agencies in order to obtain patents, or to gain approval to conduct clinical trials or to market Product, but such disclosure may be only to the extent reasonably necessary to obtain such patents or authorizations;

 

 

(b)

to its respective agents, consultants, Affiliates, sublicensees and/or other Third Parties for the development and/or marketing of Product (or for such parties to determine their interests in performing such activities) on the condition that such Third Parties agree to be bound by the confidentiality obligations consistent with this Agreement; or

 

 

(c)

if required to be disclosed by law or court order, provided that notice is promptly delivered to the non-disclosing Party in order to provide an opportunity to challenge or limit the disclosure obligations; and

      • 5.2.2 Indevus may disclose Novexel Proprietary Information if required to be disclosed by law or court order, provided that notice is promptly delivered to the non-disclosing Party in order to provide an opportunity to challenge or limit the disclosure obligations.

 

Page 16

 

5.3

Return of Proprietary Information . Upon termination of this Agreement, the Party to which Proprietary Information has been disclosed pursuant to this Agreement shall, upon request, promptly return within thirty (30) days all such information, including any copies thereof, and cease its use or, at the request of the Party transmitting such Proprietary Information, shall promptly destroy the same and certify such destruction to the transmitting party; except for a single copy thereof which may be retained for the sole purpose of determining the scope of the obligations incurred under this Agreement. Upon termination of this Agreement, Novexel shall return to Indevus or destroy, as provided in Section 9.4, the Indevus Know-How, including any unused Inventory.

 

 

5.4

Public Disclosure . Notwithstanding the provisions of this Article V, it is understood that the Parties may make disclosure of this Agreement and the terms hereof in any filings required by the SEC, other governmental authority or securities exchange, may file this Agreement as an exhibit to any filing with the SEC, other governmental authority or securities exchange, and may distribute any such filing in the ordinary course of its business. Except as set forth in this Agreement or as required by law, neither Party shall make any press release or other public announcement or other disclosure to a Third Party concerning the existence of or terms of this Agreement without the prior written consent of the other Party, which consent shall not be unreasonably withheld or delayed. Each Party agrees to provide to the other Party a copy of any public announcement as soon as reasonably practicable under the circumstances prior to its scheduled release. Each party shall have the right to expeditiously (but in any event within one Business Day of receipt) review any press release or announcement regarding this Agreement or the subject matter of this Agreement; provided , however , that such right of review shall only apply for the first time that specific information is to be disclosed, and shall not apply to the subsequent disclosure of substantially similar information that has previously been disclosed unless there have been material changes in the disclosure since the date of the previous disclosure.

ARTICLE VI

REPRESENTATIONS AND WARRANTIES

 

 

6.1

General Representations . Each Party hereby represents and warrants to the other Party as of the Effective Date as follows:

      • 6.1.1 Such Party is a corporation duly organized, validly existing and in good standing under the laws of the jurisdiction in which it is incorporated;

        6.1.2 Such Party has the corporate power and authority and the legal right to enter into this Agreement, the Termination and the Side Agreement and to perform its obligations hereunder and thereunder and the execution, delivery and performance by such party of this Agreement, the Termination and the Side Agreement has been duly authorized by all necessary corporate action;

 

Page 17

      • 6.1.3 Each of this Agreement, the Termination and the Side Agreement has been duly executed and delivered on behalf of such party, and each constitutes a legal, valid, binding obligation, enforceable against such Party in accordance with its terms except as enforceability may be limited by (a) any applicable bankruptcy, insolvency, reorganization, moratorium or similar law affecting creditor’s rights generally, or (b) general principles of equity, whether considered in a proceeding in equity or at law;

        6.1.4 All necessary consents, approvals and authorizations of all governmental authorities and other persons required to be obtained by such Party in connection with this Agreement, the Termination and the Side Agreement have been obtained; and

        6.1.5 The execution and delivery of this Agreement, the Termination and the Side Agreement and the performance of such Party’s obligations hereunder and thereunder does not conflict with or violate any requirement of applicable laws or regulations or any judgment, injunction, decree, determination or award presently in effect having applicability to it.

 

 

6.2

Indevus Representations and Warranties . Indevus represents and warrants to Novexel that as of the Effective Date:

      • 6.2.1 Indevus has not received any written notice alleging that the practice of the subject matter of the Indevus Know-How or the making, using or selling of Compound or Product in the Territory would infringe any Third Party patents and Indevus is not aware of any facts or circumstances that would support a claim of infringement;

        6.2.2 there are no claims, judgments or settlements against or owed by Indevus relating to the Indevus Know-How;

        6.2.3 Indevus has not previously assigned, transferred, conveyed or otherwise encumbered any right, title and interest in the Indevus Know-How, or entered into any agreement with any Third Party which is in conflict with the rights granted to Novexel pursuant to this Agreement;

        6.2.4 No Third Party has claimed or threatened to claim ownership, control or the right to use Indevus Know-How and Indevus is not aware of any facts or circumstances that would support such a claim;

        6.2.5 Indevus has not filed, and shall not file during the Term of this Agreement, any application for patent, copyright, trademark or other form of intellectual property right disclosing or claiming any Indevus Know-How;

        6.2.6 Indevus does not own, control or otherwise possess any information or technology related to Compound or Product that is not included in Indevus Know-How; and

 

Page 18

      • 6.2.7 All of the information concerning Inventory set forth in Schedule 1.14 , including the amount of each material listed, is true and accurate in all material respects; Indevus does not own or control any additional such materials; from and after the time such Inventory has been held for the account of Indevus, to the best of Indevus’ knowledge, the Inventory has been held and stored in accordance with cGMPs and all applicable laws and regulations.

 

 

6.3

Novexel Representations and Warranties. Novexel represents and warrants to Indevus that:

      • 6.3.1 in accordance with the Assignment Agreement, effective as of December 1, 2004 , the 2003 License, and all of Aventis’ rights thereunder, other than with respect to the Nucleus, have been assigned by Aventis to Novexel, and Novexel has assumed all of Aventis’ obligations thereunder; the Assignment Agreement is in full force and effect and no party thereto is in breach or default thereof; and

        6.3.2 as of the Effective Date, Novexel owns all right, title and interest in and to the Novexel Patent Assets, all of which are listed on Schedule 1.20 , and has not assigned, transferred, conveyed or otherwise encumbered its right, title or interest in the Novexel Patent Assets;

 

 

6.4

THE LIMITED WARRANTIES SET FORTH IN THIS SECTION 6 ARE IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY, WARRANTY OF NON-INFRINGEMENT AND ANY WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE. EXCEPT FOR THE WARRANTIES EXPRESSED IN THIS SECTION 6, NEITHER PARTY MAKES ANY OTHER WARRANTY, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE COMPOUND OR THE PRODUCT.

ARTICLE VII

INDEMNIFICATION AND INSURANCE

 

 

7.1

Indemnification by Indevus . Indevus will indemnify, defend and hold harmless Novexel, its Affiliates, directors, officers, employees, agents, successors, and assigns (each, a " Novexel Indemnitee ") from and against any and all Losses arising out of, attributable to or resulting from any claim, suit, action or proceedings (collectively, "Claims"), that are brought by a Third Party against a Novexel Indemnitee that are attributable to a breach by Indevus of any of its representations, warranties or covenants under this Agreement; provided , however , that Indevus shall not be obligated under this Section 7.1 to the extent any Losses (A) arose out of the negligence or wrongdoing on the part of Novexel; (B) arose out of any breach by Novexel of any of its representations, warranties and/or covenants hereunder; or (C) are Losses subject to indemnification by Novexel under Section 7.2.

 

 

7.2

Indemnification by Novexel . Novexel shall indemnify, defend and hold harmless Indevus and its Affiliates, directors, officers, employees, agents, successors and

 

Page 19

 

assigns (each a " Indevus Indemnitee ") from and against any and all Losses arising out of, attributable to or resulting from any Claims that are brought by a Third Party against an Indevus Indemnitee that are attributable to (i) the development, manufacture, use, marketing, promotion or sale of Compound or Product; (ii) Novexel’s negligence, recklessness or willful misconduct in exercising or performing any of its rights or obligations under this Agreement; or (iii) a breach by Novexel of any of its representations, warranties or covenants under this Agreement; provided , however , that Novexel shall not be obligated under this Section 7.2 to the extent any Losses (A) arose out of any breach by Indevus of any of its representations, warranties and/or covenants hereunder; or (B) are Losses subject to indemnification by Indevus under Section 7.1.

 

 

7.3

Procedure . In the event that any Indemnitee intends to claim indemnification under this Article VII it shall promptly notify the other Party (the " Indemnitor ") in writing of such Claim. Failure to provide prompt notice shall not relieve any Party of the duty to defend or indemnify unless such failure materially prejudices the defense of any matter. The Indemnitor shall have the sole right to control the defense and settlement thereof provided , however , that an Indemnitor shall not, without the written consent of the other Party, as part of any settlement or compromise (i) admit to liability on the part of the other Party; (ii) agree to an injunction against the other Party; or (iii) settle any matter in a manner that separately apportions fault to the other Party. The Parties shall have a reasonable opportunity to participate in decision-making with respect to the strategy of such defense, and shall reasonably cooperate with each other in connection with the implementation thereof. An Indemnitee shall not, except at its own cost, voluntarily make any payment or incur any expense with respect to any Claim without the prior written consent of the Indemnitor, which the Indemnitor shall not be required to give.

 

 

7.4

Insurance . Novexel shall maintain, during the Term of this Agreement and for a period of three (3) years after any expiration of termination of this Agreement, a Commercial General Liability Insurance policy or policies (including coverage for Product Liability, Contractual Liability, Bodily Injury, Property Damage and Personal Injury), with minimum limits per occurrence and in the aggregate customary for the stage of development and commercial activity of the aminocandin program, but in any event shall not be less than [*] total per year. Such insurance shall insure against liability arising out of the manufacture, use, sale, or marketing of Product in the Territory as appropriate for the stage and extent of development and commercial activity of the aminocandin program. During the Term, Novexel shall not permit such insurance to be reduced, expired or canceled without reasonable prior written notice to Indevus. Upon request Novexel shall provide Certificates of Insurance to Indevus evidencing the coverage specified herein.

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

Page 20

ARTICLE VIII

PATENT MATTERS

 

 

8.1

Novexel shall be responsible in its sole discretion for all filing, prosecution, maintenance, enforcement and defense (including interference and opposition proceedings) of the Novexel Patent Assets. Notwithstanding the foregoing, Novexel shall prosecute, maintain, enforce and defend the Novexel Patent Assets in the US, Europe and Japan covering Compound.

ARTICLE IX

TERM AND TERMINATION

 

 

9.1

Term and Expiration . This Agreement shall be effective as of the Effective Date and unless terminated earlier under Section 9.2, the term of this Agreement shall extend for a period (the " Term ") which shall expire and terminate, on a country-by country basis, on the expiration of all royalty obligations with respect to such country under Section 4.3.

 

 

9.2

Termination .

      • 9.2.1 By Notice . Novexel shall have the right to terminate this Agreement (a) at any time upon [*] advance written notice to Indevus upon the occurrence of a Material Adverse Change, or (b) after the earlier of (i) the commencement of the first Phase 2 clinical trial, or (ii) [*] after the Effective Date, for any or no reason, upon [*] advance written notice to Indevus.

        In the event of any termination under this Section 9.2.1, the provisions of Section 9.4.3 shall be applicable, provided, that any amounts payable pursuant to Section 4.1.2 that become due during the period commencing from the date of the termination notice until the effective date of termination shall not be payable.

        9.2.2 Termination of Agreement for Cause . Either Party may terminate this Agreement by notice to the other Party at any time during the Term as follows:

 

 

(a)

if the other Party is in breach of any material obligation hereunder by causes and reasons within its control, or has breached, in any material respect, any representations or warranties set forth herein, and has not cured such breach within (i) [*] Business Days in case the breach is a non payment of any amount due under this Agreement, and (ii) within [*] for other cases of breach, after notice requesting cure of the breach, provided , however , that if a breach other than a non payment is not capable of being cured within [*] of such written notice, the Agreement may not be terminated sooner than [*] of such written notice so long as the breaching Party commences and is taking commercially reasonable actions to cure such breach as promptly as practicable; or

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

Page 21

 

(b)

upon the filing or institution of bankruptcy, reorganization, liquidation or receivership proceedings, or upon an assignment of a substantial portion of the assets for the benefit of creditors by the other Party; provided , however , in the case of any involuntary bankruptcy, reorganization, liquidation, receivership or assignment proceeding such right to terminate shall only become effective if the Party consents to the involuntary proceeding or such proceeding is not dismissed within [*] after the filing thereof.

 

 

9.3

Rights not Affected . All rights and licenses granted pursuant to this Agreement are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the Bankruptcy Code licenses of rights to "intellectual property" as defined under Section 101(35A) of the Bankruptcy Code. The Parties agree that Novexel and Indevus shall retain and may fully exercise all of their respective rights, remedies and elections under the Bankruptcy Code. The Parties further agree that, in the event of the commencement of a bankruptcy or reorganization case by or against a Party under the Bankruptcy Code, the other Party shall be entitled to all applicable rights under Section 365 (including 365(n)) of the Bankruptcy Code. Upon rejection of this Agreement by a Party or a trustee in bankruptcy for such Party, pursuant to Section 365(n), the other Party may elect (i) to treat this Agreement as terminated by such rejection or (ii) to retain its rights (including any right to enforce any exclusivity provision of this Agreement) to intellectual property (including any embodiment of such intellectual property) under this Agreement and under any agreement supplementary to this Agreement for the duration of this Agreement and any period for which this Agreement could have been extended by such other Party, subject, however, to the continued payment of all amounts owing under this Agreement, all of which amounts shall be deemed to be royalties for purposes of Section 365(n) of the Bankruptcy Code. Upon written request to the trustee in bankruptcy or bankrupt Party, the trustee or Party, as applicable, shall (i) provide to the other Party any intellectual property (including such embodiment) held by the trustee or the bankrupt Party and shall provide to the other Party a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property and (ii) not interfere with the rights of the other Party to such intellectual property as provided in this Agreement or any agreement supplementary to this Agreement, including any right to obtain such intellectual property (or such embodiment or duplicates thereof) from a Third Party.

 

 

9.4

Effect of Expiration or Termination . Upon termination of this Agreement, all rights and licenses granted to Novexel hereunder shall terminate upon the effective date of such termination and the Parties shall arrange for an orderly return to Indevus (or, at Indevus’ request, destruction by Novexel) of any Indevus Know-How in Novexel’s possession including any remaining Inventory. Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination.

      • 9.4.1 Outstanding Payment . Payments of amounts owing to Indevus under this Agreement as of its expiration or termination shall be due and payable within the later of (i) to the extent such amounts can be calculated and a fixed sum determined at the time of

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

Page 22

      • expiration or termination of this Agreement, thirty (30) after the date of such expiration or termination, or (ii) ten (10) days after the date in which such amounts can be calculated and a fixed sum determined.

        9.4.2 Sale of Remaining Product . Upon termination of this Agreement (but not its expiration), Novexel shall notify Indevus of the amount of Product Novexel, its Affiliates and their sublicensees then have on hand or have committed to purchase or sell. For a period ending upon the earlier of: (i) Novexel, its Affiliates and their sublicensees sale of all Product in their possession on the date of termination of this Agreement, or (ii) the end of the six (6) month period following such termination (the " Trailing Period "), Novexel, its Affiliates and their sublicensees shall be permitted to sell such Product and Indevus hereby grants Novexel a non-exclusive license reasonably necessary to sell such Product, subject to the payment of royalties at the same rates and on the same terms and conditions as the royalties set forth in Section 4.3, on any Net Sales of such Product during the Trailing Period.

        9.4.3 Termination by Novexel by Notice . If Novexel terminates this Agreement pursuant to Section 9.2.1, the following shall be applicable:

 

 

(a)

Indevus shall have a [*] period to determine whether it wishes to obtain a license under the Novexel Patent Assets and Novexel Know-How. Upon Indevus’ written request and expense, Novexel shall reasonably cooperate to facilitate Indevus decision-making, including providing Indevus with reasonable access to the Novexel Patent Assets and Novexel Know-How. If Indevus decides to license the Novexel Patent Assets and the Novexel Know-How, it shall so notify Novexel in writing and the Parties shall then immediately execute a license (the " Automatic License ") identical, except for the following changes, to the 2003 License: (i) Aventis shall be replaced by Novexel as the licensor and in all other aspects (except with respect to those provisions specifically not assigned to Novexel by Aventis, in particular the commitment to supply Nucleus or Nucleus intellectual property, which is addressed in subsection (iv) below; (ii) any milestone events set forth in the 2003 License already achieved as of the effective date of the termination of this Agreement shall be deleted; (iii) the License Fee in Section 5.1 of the 2003 Agreement shall be replaced by a payment equal to the amount of all patent costs on the Novexel Patent Assets paid by Novexel during the period commencing on the Effective Date and expiring on the effective date of the termination of this Agreement, as evidenced by appropriate back-up documentation, up to a maximum [*] per year during such period; (iv) Novexel’s rights under the Side Agreement shall be assigned to Indevus on and subject to the same terms and conditions as set forth in the Side Agreement or any supply agreement between Aventis and Novexel with respect to the Nucleus then in effect; and (v) in the event Indevus advises that it desires to include in the Automatic License any Novexel Patent Asset that was acquired by Novexel from a Third Party after the Effective Date (other than in connection with a royalty-bearing license) (a " New Novexel Patent

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

Page 23

 

Asset "), the Parties shall negotiate in good faith any additional consideration to be payable by Indevus to Novexel for the rights to such New Novexel Patent Asset. If Indevus advises Novexel in writing that it does not wish to obtain the Automatic License under the Novexel Patent Assets and Novexel Know-How, then Indevus shall have no further rights with respect to the Novexel Patent Assets and Novexel Know-How, and Novexel shall have no further obligation to Indevus with respect to the Novexel Patent Assets and Novexel Know-How; and

 

 

(b)

In the event Indevus elects to license the Novexel Patent Assets and Novexel Know-How in accordance with Section 9.4.3(a), (i) Novexel will, if requested by Indevus, cooperate with Indevus or Indevus’ designee to transfer to Indevus or Indevus’ designee the supervision of any ongoing clinical trial in such a way that no delay incurs in such clinical trial, if the termination of such trial would materially adversely affect the development of Product and Indevus has advised Novexel that it intends to continue development of Product; (ii) Novexel will promptly upon having sent such notice transfer to Indevus or Indevus’ designee all data, files, INDs, Regulatory Approvals, if any, and information, data, Novexel Know-how, etc in the possession of Novexel and related to Compound or Product; (iii) Indevus will be entitled to start negotiations with Third Parties in relation to Compound or Product immediately upon receipt of such notice; and (iv) Novexel will provide Indevus with reasonable assistance that Indevus may request in responding to due diligence requests by Third Parties that Indevus is negotiating with as potential licensees for Compound or Product, provided that Novexel shall not be required to disclose to such Third Parties Novexel Proprietary Information that does not relate to Compound or Product.

      • 9.4.4 Termination by Indevus for Cause. If Indevus terminates this Agreement pursuant to Section 9.2.2(a), the provisions of Section 9.4.3 shall be applicable except that in the event that Indevus advises that it desires to include in the Automatic License any Novexel Know-How that was developed by Novexel after the Effective Date (other than Novexel Know-How included in a New Novexel Patent Asset), the Parties shall negotiate in good faith any additional consideration to be payable by Indevus to Novexel for the rights to such new Novexel Know-How, provided, however , that the nature of the breach by Novexel shall be a principal component in determining the amount of any such additional consideration.

        9.4.5 Termination by Novexel for Cause . If Novexel terminates this Agreement pursuant to Section 9.2.2, effective as of the effective date of such termination, if requested by Novexel, the Parties shall immediately enter into a new, mutually agreeable agreement granting Novexel the same rights and obligations that were granted by Indevus to and assumed by Novexel under this Agreement, and providing for compensation to Indevus which will be negotiated in good faith between the Parties.

 

Page 24

      • 9.4.6 Survival . In addition to any other provisions of this Agreement which by their terms continue after the expiration of this Agreement, the provisions of Article VII shall survive the expiration or termination of this Agreement and shall continue in effect for five (5) years from the date of expiration or termination (subject to the changes thereto as set forth in the Automatic License). In addition, any other provision required to interpret and enforce the Parties’ rights and obligations under this Agreement shall also survive, but only to the extent required for the full observation and performance of this Agreement.

        9.4.7 Non-Exclusive Right . Except as expressly set forth herein, the rights to terminate as set forth herein shall be in addition to all other rights and remedies available under this Agreement, at law, or in equity, or otherwise.

ARTICLE X

MISCELLANEOUS

 

 

10.1

Force Majeure . Neither Party shall be held liable or responsible to the other Party nor be deemed to have defaulted under or breached the Agreement for failure or delay in fulfilling or performing any term of the Agreement during the period of time when such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party including, but not limited to, fire, flood, embargo, war, acts of war (whether war be declared or not), terrorism, insurrection, riot, civil commotion, strike, lockout or other labor disturbance, factory shutdowns, failure of public utilities or common carriers, act of God or act, omission or delay in acting by any governmental authority or the other Party. The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practicable.

 

 

10.2

Assignment . The Agreement may not be assigned or otherwise transferred without the prior written consent of the other Party; provided , however , that either Party may assign this Agreement to an Affiliate or in connection with the transfer or sale of its business or all or substantially all of its assets to which this Agreement relates or in the event of a merger, consolidation, change in control or similar corporate transaction. Any permitted assignee shall assume in writing all obligations of its assignor under this Agreement.

 

 

10.3

Severability . In the event that any of the provisions contained in this Agreement are held invalid, illegal or unenforceable in any respect, the validity, legality and enforceability of the remaining provisions contained herein shall not in any way be affected or impaired thereby, unless the invalid provisions are of such essential importance for this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without the invalid provisions. In such event, the Parties shall substitute such invalid provisions by valid ones, which in their economic effect come so close to the invalid provisions that it can be reasonably assumed that the Parties would have entered into this Agreement also with those substituted provisions.

 

Page 25

 

10.4

Notices . All notices or other communications which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:

        • if to Novexel to:

          Novexel SA

          Parc Biocitech

          102, route de Noisy

          F-93230 Romainville France

          Attention: Chief Executive Officer

          Fax No: +33 1 48 46 39 26

          if to Indevus to:

          Indevus Pharmaceuticals, Inc.

          33 Hayden Avenue

          Lexington, MA 02421

          Attention: Chief Executive Officer

          Fax No.: 781-862-3859

        or to such other address as the Party to whom notice is to be given may have furnished to the other Parties in writing in accordance herewith. Any such communication shall be deemed to have been given when delivered if personally delivered or sent by facsimile on a Business Day, upon confirmed delivery by nationally-recognized overnight courier if so delivered and on the third Business Day following the date of mailing if sent by registered or certified mail.

 

 

10.5

Applicable Law . The Agreement shall be governed by and construed in accordance with the laws of the United States of America and State of New York without reference to any rules of conflict of laws, except matters of intellectual property law, which shall be determined in accordance with the national intellectual property laws relevant to the intellectual property in question.

 

 

10.6

Dispute Resolution .

      • 10.6.1 Except if a Party reasonably determines that it must seek a preliminary injunction, temporary restraining order or other provisional relief, the Parties shall resolve all claims, disputes, or controversies arising under, out of, or in connection with this Agreement (a " Dispute ") in accordance with the following procedure. The Parties agree to attempt initially to solve Disputes by conducting good faith negotiations. Any Disputes which cannot be resolved by good faith negotiation within [*] Business Days, shall be referred, by written notice from either Party to the other, to the Chief Executive Officer of each Party. Such Chief Executive Officers shall negotiate in good faith to achieve a resolution of the Dispute referred to them within [*] Business Days after such notice is received by the Party to whom the notice was sent. If the Chief Executive

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

Page 26

      • Officers are unable to settle the Dispute between them within [*] Business Days, they shall so report to the Parties in writing. The Dispute shall then be referred to mediation as set forth in the following subsection 10.6.2.

        10.6.2 Upon the Parties receiving the Chief Executive Officers’ report that the Dispute referred to them pursuant to subsection 10.6.1 has not been resolved, the Dispute shall be referred to mediation by written notice from either Party to the other. The mediation shall be conducted pursuant to the LCIA Mediation Procedure. In the event Indevus is the claimant, the mediation shall be held in London, England; in the event Novexel is the claimant, the mediation shall be held in Geneva, Switzerland. If the Parties have not reached a settlement within twenty (20) Business Days of the date of the notice of mediation, the Dispute shall be referred to arbitration pursuant to subsection 10.6.3.

        10.6.3 If after the procedures set forth in subsections 10.6.1 and 10.6.2, the Dispute has not been resolved, a Party shall decide to institute arbitration proceedings, it shall give written notice to that effect to the other Party. The Parties shall refrain from instituting the arbitration proceedings for a period of sixty (60) days following such notice. During such period, the Parties shall continue to make good faith efforts to amicably resolve the dispute without arbitration. If the Parties have not reached a settlement during that period the arbitration proceedings shall go forward and be governed by the LCIA Arbitration Rules then in force. Each such arbitration shall be conducted by a panel of three arbitrators with appropriate experience in the biotechnology or pharmaceutical industry: one arbitrator shall be appointed by each of Novexel and Indevus and the third arbitrator, who shall be the Chairman of the tribunal, shall be appointed by the two Party-appointed arbitrators. In the event Indevus is the claimant, the arbitration shall be held in London, England; in the event Novexel is the claimant, the arbitration shall be held in Geneva, Switzerland. The arbitrators shall have the authority to grant specific performance. Judgment upon the award so rendered may be entered in any court having jurisdiction or application may be made to such court for judicial acceptance of any award and an order of enforcement, as the case may be. In no event shall a demand for arbitration be made after the date when institution of a legal or equitable proceeding based on such claim, dispute or other matter in question would be barred by the applicable statute of limitations. Each Party shall bear its own costs and expenses incurred in connection with any arbitration proceeding and the Parties shall equally share the cost of the mediation and arbitration levied by the LCIA. Any mediation or arbitration proceeding entered into pursuant to this Section 10.6 shall be conducted in the English language.

 

 

10.7

Entire Agreement . This Agreement, together with the Schedules and Exhibits hereto, contains the entire understanding of the Parties with respect to the subject matter hereof. All express or implied agreements and understandings, either oral or written, heretofore made are expressly merged in and made a part of this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by all Parties hereto.

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

Page 27

 

10.8

Independent Contractors . It is expressly agreed that the Parties shall be independent contractors and that the relationship between the Parties shall not constitute a partnership, joint venture or agency. Neither Party shall have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on the other Party, without the prior consent of such other Party.

 

 

10.9

Waiver . The waiver by a Party hereto of any right hereunder or the failure to perform or of a breach by another Party shall not be deemed a waiver of any other right hereunder or of any other breach or failure by said other Party whether of a similar nature or otherwise.

 

 

10.10

Headings . The captions to the several Articles and Sections hereof are not a part of the Agreement, but are merely guides or labels to assist in locating and reading the several Articles and Sections hereof.

 

 

10.11

Counterparts . The Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.

 

 

10.12

Use of Names . Except as otherwise provided in this Agreement, neither Party shall use the name of the other Party in relation to this transaction in any public announcement, press release or other public document without the consent of such other Party, which consent shall not be unreasonably withheld or delayed; provided , however , that either Party may use the name of the other Party in any document required to comply with applicable laws, rules or regulations.

 

 

10.13

Interpretation.

      • 10.13.1 Whenever any provision of this Agreement uses the term "including" (or "includes"), such term shall be deemed to mean "including without limitation" and "including but not limited to" (or "includes without limitations" and "includes but is not limited to") regardless of whether the words "without limitation" or "but not limited to" actually follow the term "including" (or "includes");

        10.13.2 "Herein", "hereby", "hereunder", "hereof" and other equivalent words shall refer to this Agreement in its entirety and not solely to the particular portion of this Agreement in which any such word is used;

        10.13.3 All definitions set forth herein shall be deemed applicable whether the words defined are used herein in the singular or the plural;

        10.13.4 Wherever used herein, any pronoun or pronouns shall be deemed to include both the singular and plural and to cover all genders;

        10.13.5 The recitals set forth at the start of this Agreement, along with the Exhibits and Schedules to this Agreement, and the terms and conditions incorporated in such recitals, Exhibits and Schedules shall be deemed integral parts of this Agreement and all

 

Page 28

      • references in this Agreement to this Agreement shall encompass such recitals, Exhibits and Schedules and the terms and conditions incorporated in such recitals, Exhibits and Schedules, provided, that in the event of any conflict between the terms and conditions of this Agreement and any terms and conditions set forth in the Exhibits and Schedules, the terms of this Agreement shall control;

        10.13.6 In the event of any conflict between the terms and conditions of this Agreement and any terms and conditions that may be set forth on any order, invoice, verbal agreement or otherwise, the terms and conditions of this Agreement shall govern;

        10.13.7 The Agreement shall be construed as if both Parties drafted it jointly, and shall not be construed against either Party as principal drafter;

        10.13.8 Unless otherwise provided, all references to Sections, Schedules and Exhibits in this Agreement are to Sections, Schedules and Exhibits of and to this Agreement;

        10.13.9 All references to days, months, quarters or years are references to calendar days, calendar months, calendar quarters or calendar years unless otherwise expressly provided;

        10.13.10 Any reference to any federal, national, state, local or foreign statute or law shall be deemed to also refer to all rules and regulations promulgated thereunder, unless the context requires otherwise;

        10.13.11 Any requirements of notice or notification by one Party to another shall be construed to mean written notice in accordance with Section 10.4; and

        10.13.12 Wherever used, the word "shall" and the word "will" are each understood to be imperative or mandatory in nature and are interchangeable with one another.

[remainder of page intentionally left blank]

 

Page 29

IN WITNESS WHEREOF, the Parties have executed this Agreement as of the date first set forth above.

 

 

     

INDEVUS PHARMACEUTICALS, INC.

By:

 

/s/ Glenn L. Cooper, M.D.

Name:

 

Glenn L. Cooper, M.D.

Title:

 

Chairman and Chief Executive Officer

NOVEXEL SA

By:

 

/s/ Iain Buchanan

Name:

 

Iain Buchanan

itle:

 

Chief Executive Officer



 

Page 30

SCHEDULE 1.4

BANK HOLIDAYS-FRANCE

 

 

         

Wednesday

  

January 1 (*)

  

New Year Day

Monday

  

April 9 (**)

  

Easter Monday

Thursday

  

May 1 (*)

  

Labour Day

Thursday

  

May 8 (*)

  

End of World War II

Thursday

  

May 17 (**)

  

Ascension

Monday

  

May 28 (**)

  

Whit Monday

Monday

  

July 14 (*)

  

National Day

Friday

  

August 15 (**)

  

Assumption

Saturday

  

November 1 (*)

  

All Saints’ Day

Tuesday

  

November 11 (*)

  

End of World War I

Thursday

  

December 25 (*)

  

Christmas



(*)

Every year on same date

(**)

Dates are for 2007 , but for following years, since they are catholic religious feasts , they are worldwide identical dates.

SCHEDULE 1.8

COMPOUND

[*]

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

SCHEDULE 1.13

INDEVUS KNOW-HOW

 

 

1.

Complete reports of all clinical trials undertaken including all adverse events identified by clinical investigators

 

 

a.

Phase-I single dose study

 

 

b.

Phase I multi-dose study (terminated due to injection site irritation issues)

 

 

c.

Phase I multi-dose study with modified administration (terminated due to injection site irritation issues)

 

 

2.

Complete reports and data from all formulation work including animal studies

 

 

3.

All records (including batch records and GMP certifications) relating to synthesis, storage and transport of Inventory listed in Schedule 1.14

 

 

4.

All correspondence with regulatory agencies relating to Compound

 

 

5.

All correspondence with ethics committees and clinical investigators relating to Compound

 

 

6.

Copies of all publications relating to Compound

SCHEDULE 1.14

INVENTORY

[*]

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

SCHEDULE 1.20

NOVEXEL PATENT ASSETS

[*]

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

SCHEDULE 3.5

AGREEMENTS

 

 

         

Facility and Address

  

Task/Agreement Type

  

Dates



[*]

 

[*]

CONFIDENTIAL TREATMENT REQUESTED

 

- 2 -

EXHIBIT A

SIDE AGREEMENT

[SEE ATTACHED]

 

- 3 -

NOVEXEL

novel therapies for infectious disease

AVENTIS PHARMA SA

20 avenue Raymond Aron

92165 Antony

France

TO WHOM IT MAY CONCERN

This letter is to inform you that Novexel is finalizing an agreement with Indevus whereby the rights to aminocandins licensed to Indevus by Aventis Pharma SA ("Aventis") under the 18 April 2003 License Agreement will be transferred to Novexel. As you are aware, the rights and obligations of Aventis under this License Agreement were transferred to Novexel as of December 1, 2004. However, the part of the License Agreement that dealt with supply of Nucleus remained with Aventis.

Novexel requests that the rights and obligations of Indevus under the License Agreement in Sections 3.1.2 and 3.8 now be assigned to Novexel. In the event the aforesaid agreement between Indevus and Novexel is terminated and Indevus reacquires the rights consistent with the License Agreement, these rights and obligations under Sections 3.1.2 and 3.8 shall be reassigned back to Indevus, upon joint notification by Novexel and Indevus to Aventis, thereto. The text of these Sections is reproduced below.

 

 

3.1.2

As long as AVENTIS manufactures and supplies or, in accordance with the provisions of Section 3.8 (a) hereof, AVENTIS’ permitted assignee manufactures and supplies, INDEVUS with Nucleus, in each case in accordance with the supply agreement contemplated by Section 3.8 (a) hereof, AVENTIS shall not be required to disclose or transfer to INDEVUS that portion of the AVENTIS Intellectual Property specifically covering the manufacturing process for the Nucleus, provided, however, that such information and AVENTIS Intellectual Property shall at all times be included in the Drug Master File relating to Compound and/or Product and AVENTIS hereby grants INDEVUS all rights of reference thereto. In the event that (i) AVENTIS and INDEVUS have not entered into such supply agreement relating to the manufacture and supply of the Nucleus by AVENTIS in the time period set forth in Section 3.8 hereto, or (ii) the Parties have entered into such supply agreement but for any reason AVENTIS or AVENTIS’ permitted assignee of such manufacturing right decides not to, or for any other reason, does not manufacture and supply INDEVUS with the Nucleus, AVENTIS shall promptly transfer to INDEVUS all AVENTIS Intellectual Property relating to the manufacturing process for the Nucleus and shall provide to INDEVUS in establishing a Third Party manufacturer of the Nucleus such reasonable assistance as can be expected to be needed by a manufacturer having a reasonably high level of knowledge and experience in the manufacturing of comparable products. Such assistance will be provided free of charge to the extent

 

- 4 -

 

that information has to be supplied, and on the basis of cost reimbursement if any employee of AVENTIS has to come on the concerned manufacturing premise, which in any case should be for a limited period of time, to be specified in the aforesaid supply agreement.

3.8 Manufacturing and Supply . INDEVUS shall have all rights and responsibility relating to chemistry, manufacturing and control for clinical and commercial use of Compound or Product such as but not limited to process development, scale up and manufacturing of Compound and Product, subject to the following:

(a) Manufacture of Nucleus. AVENTIS shall retain the right to manufacture and supply or, subject to the provisions of this Section 3.8 (a), have manufactured or have supplied the Nucleus for additional clinical trials and for commercial use by INDEVUS, provided that (i) AVENTIS can manufacture and supply, or any Third Party manufacturer that is a permitted assignee of AVENTIS’ rights under this Section 3.8 (a) can manufacture and supply, the Nucleus in accordance with cGMP and other regulatory requirements; and (ii) AVENTIS shall not have the right to assign its rights under this Section 3.8 (a) to a Third Party manufacturer or supplier of the Nucleus, without INDEVUS’ prior written consent, except with a sale or other divesture of the manufacturing site where the Nucleus is manufactured; and (iii) any such manufacture and supply is in accordance with the terms of the agreement referred to in the next sentence. INDEVUS and AVENTIS shall negotiate in good faith to enter into a manufacturing and supply agreement between the Parties containing mutually acceptable terms within ninety (90) days after the Effective Date, which shall set forth the terms and conditions of the manufacturing and supply of the Nucleus.

(b) Other Manufacturing. In connection with any other manufacturing and supply of Compound and/or Product, INDEVUS will consider AVENTIS in priority to any Third Party, as such manufacturer and supplier.

If you are in agreement with these changes, please acknowledge by having this letter signed by an authorized member of your company.

 

- 5 -

Best regards,

 

                 

For Novexel S.A.

 

 

 

For Indevus Pharmaceuticals Inc.


 
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