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LICENSE AGREEMENT

License Agreement

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SPECTRUM PHARMACEUTICALS INC

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Title: LICENSE AGREEMENT
Governing Law: California     Date: 11/9/2007
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AGREEMENT, Parties: spectrum pharmaceuticals inc
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Pursuant to 17 CTR 240.24b-2, confidential information has been omitted in places marked “[***]"
and has been filed separately with the Securities and Exchange Commission pursuant to a
Confidential Treatment Application filed with the Commission.
EXHIBIT 10.4
LICENSE AGREEMENT
by and between
INDENA SPA
and
SPECTRUM PHARMACEUTICALS, INC.

 


 
TABLE OF CONTENTS
         
 
  Page
1. DEFINITIONS
    1  
 
       
1.1 Affiliate
    1  
1.2 cGMP
    2  
1.3 Confidential Information
    2  
1.4 Controlled
    2  
1.5 DMF
    2  
1.6 EMEA
    3  
1.7 Event of Default
    3  
1.8 FDA
    3  
1.9 First Commercial Sale
    3  
1.10 GAAP
    3  
1.11 IDN 5109
    3  
1.12 Improvements
    3  
1.13 IND
    3  
1.14 Joint Inventions
    3  
1.15 Joint Patent
    3  
1.16 Know-How
    3  
1.17 License
    4  
1.18 Licensed Compound or “API”
    4  
1.19 Licensed Field
    4  
1.20 MAA
    4  
1.21 MHLW
    4  
1.22 Milestone Payments
    4  
1.23 NDA
    4  
1.24 Net Sales
    4  
1.25 Patent
    5  
1.26 Patent Rights
    5  
1.27 Product
    5  
1.28 Regulatory Approval
    5  
1.29 Regulatory Authority
    5  
1.30 Regulatory Filings
    5  
1.31 Royalty Term
    5  
1.32 Technology
    6  
1.33 Term
    6  
1.34 Territory
    6  
1.35 Third Party
    6  
1.36 Valid Claim
    6  
 
       
2. LICENSE
    6  
 
       
2.1 License
    6  
2.2 Sublicenses
    6  
2.3 Technology and Material Transfer
    6  
2.4 Exceptions to Exclusivity
    6  
2.5 Regulatory Filings
    7  
 
       
3. FINANCIAL TERMS AND CONDITIONS
    7  
 
       
3.1 Upfront and Milestone Payments
    7  
3.2 Product Royalties
    9  
3.3 Payments
    10  


 
         
 
  Page
3.4 Records
    10  
3.5 Income or Other Tax Withholding
    10  
3.6 Audit
    11  
3.7 Late Payments
    11  
 
       
4. OWNERSHIP AND PATENT MATTERS
    11  
 
       
4.1 Ownership
    11  
4.2 Prosecution and Maintenance of Patent Rights
    12  
4.3 Infringement Actions
    13  
 
       
5. OBLIGATIONS RELATED TO SUPPLY, DEVELOPMENT, MARKETING AND COMMERCIALIZATION
    14  
 
       
5.1 Spectrum’s Diligence Obligations
    15  
5.2 Research and Development
    15  
5.3 Governmental Approvals
    15  
5.4 Supply of API
    15  
 
       
6. INDEMNITY
    16  
 
       
6.1 Spectrum Indemnification
    16  
6.2 Indena Indemnification
    16  
6.3 Indemnity Procedure
    17  
 
       
7. REPRESENTATIONS AND WARRANTIES
    18  
 
       
7.1 By Indena
    18  
7.2 By Spectrum
    20  
 
       
8. ADDITIONAL COVENANTS
    21  
 
       
8.1 Preservation of Title
    21  
8.2 No Conflicts
    21  
 
       
9. CONFIDENTIALITY AND PUBLICATION
    21  
 
       
9.1 Treatment of Confidential Information
    21  
9.2 Public Statements
    22  
 
       
10. TERM, DEFAULT AND TERMINATION
    23  
 
       
10.1 Term of Agreement
    23  
10.2 Unilateral Termination — Spectrum
    23  
10.3 Default
    23  
10.4 Insolvency
    24  
10.5 Effects of Expiration or Termination
    24  
10.6 Work-in-Progress
    27  
 
       
11. DISPUTE RESOLUTION
    27  
 
       
11.1 Arbitration
    27  
11.2 Administration
    28  
11.3 Waivers
    28  
11.4 Non-Arbitrable Disputes
    28  

ii 


 
         
12. GENERAL PROVISIONS
    28  
 
       
12.1 Further Assurances
    28  
12.2 Independent Contractors
    28  
12.3 Entire Agreement; Modification
    29  
12.4 Force Majeure
    29  
12.5 Limitation of Liability
    29  
12.6 Assignment
    29  
12.7 Governing Law
    29  
12.8 Headings
    29  
12.9 Interpretation
    29  
12.10 Severability
    30  
12.11 No Waiver
    30  
12.12 Notices
    30  
12.13 Compliance with Laws
    31  
12.14 Counterparts
    31  

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LICENSE AGREEMENT
      This License Agreement (this “Agreement” ) is entered into as of July 17, 2007 (the “Effective Date” ), by and between SPECTRUM PHARMACEUTICALS, INC. ( “Spectrum” ), a Delaware corporation having offices at 157 Technology Drive, Irvine, CA 92618 and INDENA SPA ( “Indena” ), an Italian company having offices at Viale Ortles 12, 20139 Milano, Italy. Indena and Spectrum may each be referred to herein individually as a “Party” and collectively as the “Parties.”
RECITALS
     A. WHEREAS, Indena owns the rights to a compound known as IDN 5109 used in treating cancer in humans and has acquired and developed certain know-how concerning such compound.
     B. WHEREAS, IDN 5109 is the subject of patents in the United States, the European Union and Japan.
     C. WHEREAS, Spectrum is engaged in the development and marketing, sale and licensing of pharmaceutical products and desires to have access to the IDN 5109 and Indena’s know how relating to IDN 5109.
     D. WHEREAS, the Parties desire to enter into a license agreement whereby Spectrum shall obtain the exclusive right to develop and commercialize IDN 5109 as the active ingredient in products for all uses worldwide.
     NOW, THEREFORE, in consideration of the mutual covenants and conditions set forth herein, Indena and Spectrum hereby agree as follows:
AGREEMENT
1. DEFINITIONS. In addition to terms defined elsewhere in this Agreement, whenever used herein the following capitalized terms shall have the meaning set forth below.
      1.1 Affiliate. The term “Affiliate” shall mean any entity which directly or indirectly controls, is controlled by, or is under common control with Spectrum or Indena, as applicable. The term “control” as used in this definition means having (i) more than fifty percent (50%) ownership of the assets, profit interest or outstanding voting securities or (ii) the power to direct or cause the direction of the management and the policies of an entity, whether by contract or otherwise.

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      1.2 cGMP. The term “cGMP” means all applicable standards relating to manufacturing practices for fine chemicals, intermediates, bulk products or finished pharmaceutical products including (i) ICH Q7a, U.S. cGMP 21CFR Parts 210 & 211, The Rules Governing Medicinal Products in the European Community, Volume IV Good Manufacturing Practice for Medicinal Products, and the principles detailed in the Japanese Pharmaceutical Affairs Law and Japanese Ministerial Ordinance 136, as each may be amended from time to time and (ii) statutes, rules, regulations or guidance documents (including but not limited to advisory opinions, compliance policy guides and guidelines) promulgated by any Regulatory Authority having jurisdiction over the manufacture of the Licensed Compound and the Products.
      1.3 Confidential Information. The term “Confidential Information” shall mean all know-how, trade secrets and other proprietary or confidential information of a disclosing Party or held by the disclosing Party, which may be disclosed from one Party to the other Party at any time and from time to time during the term of this Agreement. “Confidential Information” shall include the terms of this Agreement as well as any proprietary or confidential information that is jointly owned by the Parties. Information shall not be considered Confidential Information to the extent such information:
          (a) 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;
          (b) is properly in the public domain;
          (c) is subsequently disclosed to the receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or
          (d) is developed by the receiving party independently of Confidential Information received from the disclosing Party, as documented by research and development records.
Nothing in this definition shall preclude a Party from use or disclosure of any proprietary or Confidential Information owned by that Party where the other Party has no rights of ownership.
      1.4 Controlled. The term “Controlled” shall mean possessing the ability to grant a license or sublicense without violating (i) any applicable law or governmental regulation or (ii) the terms of an agreement with a Third Party that has an effective date which predates the Effective Date hereof.
      1.5 DMF. The term “DMF” shall mean the documentation submitted to a Regulatory Authority that is used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of API for pharmaceutical use.

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      1.6 EMEA. The term “EMEA” shall mean the European Agency for the Evaluation of Medicinal Products (European Medicines Agency), any successor agency thereto or any equivalent replacement agency having substantially the same functions.
      1.7 Event of Default. The term “Event of Default” shall have the meaning set forth in Section 10.3.1 of this Agreement.
      1.8 FDA. The term “FDA” shall mean the United States Food and Drug Administration, or any successor agency thereto.
      1.9 First Commercial Sale. The term “First Commercial Sale” shall mean, with respect to any Product, the first sale for end use or consumption of such Product in a country after all required approvals, including marketing and pricing approvals, have been granted by the governing Regulatory Authority of such country.
      1.10 GAAP. The term “GAAP” shall mean generally accepted accounting principles in the United States, in each case as consistently applied by Spectrum or its Affiliates in their respective financial statements, audited if applicable.
      1.11 IDN 5109. The term IDN 5109 shall mean the compound described in Exhibit A hereto.
      1.12 Improvements. The term “Improvements” shall mean all inventions, discoveries, enhancements, improvements or modifications, whether or not patented or patentable, related to the Licensed Compound, a Product or the Technology, including but not limited to the manufacture, structure, formulation, conjugation, preparation, dosage, administration or packaging of the Licensed Compound, a Product or the Technology.
      1.13 IND. The term “IND” shall mean (i) an Investigational New Drug application as defined in the United States Food, Drug & Cosmetic Act and applicable regulations promulgated thereunder, as amended from time to time or (ii) an equivalent application or filing with the applicable Regulatory Authority in any country other than the United States allowing the commencement of human clinical trials.
      1.14 Joint Inventions. The term “Joint Inventions” shall have the meaning set forth in Section 4.1 of this Agreement.
      1.15 Joint Patent. The term “Joint Patent” shall mean any Patent filed with respect to a Joint Invention.
      1.16 Know-How. The term “Know-How” shall mean any discoveries, methods, processes, techniques, data and technical information that relate to the Licensed Compound, Patent Rights or the

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Regulatory Filings, now or in the future owned or Controlled by Indena, whether or not: (i) the same is eligible for protection under the patent laws of the United States or elsewhere; (ii) enforceable as a trade secret; or (iii) the copying of which would be enjoined or restrained by a court as constituting unfair competition.
      1.17 License. The term “License” shall have the meaning set forth in Section 2.1.
      1.18 Licensed Compound or “API”. The terms “Licensed Compound” or “API” shall mean the compound known as IDN 5109 (also known as Ortataxel) and any polymorph, analog or derivative thereof.
      1.19 Licensed Field. The term “Licensed Field” shall mean all uses (human or otherwise), including all therapeutic, prophylactic, palliative and diagnostic uses.
      1.20 MAA. The term “MAA” shall mean a Marketing Authorization Application or similar application filed with the EMEA after completion of human clinical trials to obtain marketing approval for a Product in the European Union.
      1.21 MHLW. The term “MHLW” shall mean the Ministry of Health, Labour and Welfare in Japan or any successor agency thereto or any equivalent replacement agency having substantially the same functions.
      1.22 Milestone Payments. The term “Milestone Payments” shall mean the payments from Spectrum to Indena under Section 3.1.
      1.23 NDA. The term “NDA” shall mean a New Drug Application, as defined in the United States Food, Drug & Cosmetic Act and applicable regulations promulgated thereunder, as amended from time to time, to obtain approval from the FDA for commercial sale of a Product, or an equivalent application or filing with the applicable Regulatory Authority in any country other than the United States.
      1.24 Net Sales. The term “Net Sales” shall mean the amount received by Spectrum, its Affiliates or its sublicensees on account of sales of a Product to Third Parties in the Territory, less the following deductions to the extent actually allowed or specifically allocated to the Product by the selling party using GAAP and not separately invoiced: (i) sales and excise taxes and duties paid or allowed by the selling party and any other governmental charges imposed upon the production, importation, use or sale of such Product; (ii) customary trade, quantity and cash discounts allowed on the Product; (iii) allowances or credits to customers on account of rejection or return of Product or on account of retroactive price reductions affecting such Product; (iv) freight and insurance costs; (v) rebates, chargebacks and other amounts paid on sale or dispensing of the Product; (vi) sales commissions paid to

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distributors and/or selling agents; (vii) the booked cost of devices or systems used for delivering a Product into the patient where the Product when sold is a combination of the active pharmaceutical ingredient and the device or system; and (viii) amounts not actually received due to bad debt or returned checks. For the avoidance of doubt, for each Product the Net Sales shall be calculated only once for the first sale of such Product by Spectrum, its Affiliate or its sublicensee, as the case may be, to a Third Party which is neither an Affiliate nor sublicensee of Spectrum. A sale of Products by Spectrum, its Affiliate or its sublicensee to a wholesaler shall be regarded as the first sale of the Product for the purpose of calculating Net Sales. Net Sales shall not include the amount received on account of sales of a Product or of sales of a Product in a particular country for which the Term of this Agreement has expired.
      1.25 Patent. The term “Patent” shall mean any and all unexpired patents, patent applications, provisional patent applications and any patent issuing therefrom worldwide, together with any extensions, registrations, confirmations, reissues, continuations, divisions, continuations-in-part, reexamination certificates, confirmations, registrations, revalidations, additions, supplementary protection certificates, substitutions or renewals thereof and any patents anywhere in the world, claiming the priority date of any of the foregoing.
      1.26 Patent Rights. The term “Patent Rights” shall mean: the Patents set forth on Exhibit B , all rights (including all U.S. and foreign Patents) arising out of or resulting from each such Patent, and any other U.S. and foreign Patents, now or in the future owned or Controlled by Indena having claims covering or directed to the Licensed Compound or the Know-How. The term “Class A Patents Rights” shall include any and all Patent Rights claiming a Licensed Compound. The term “Class B Patent Rights” shall include any and all Patent Rights claiming the process to make a Licensed Compound.
      1.27 Product. The term “Product” shall mean any finished formulation containing the Licensed Compound as an active ingredient.
      1.28 Regulatory Approval. The term “Regulatory Approval” shall mean the approval, as amended or modified from time to time, from a Regulatory Authority approving the development, manufacture, sale or price, as applicable, of Products in a given country.
      1.29 Regulatory Authority. The term “Regulatory Authority” shall mean the principal governmental organization or agency that has the right to approve the development, manufacture, sale or, if applicable, the price of Products in a given country, including the FDA, the EMEA and the MHLW.
      1.30 Regulatory Filings. The term “Regulatory Filings” shall mean all filings with Regulatory Authorities that relate to the Licensed Compound or a Product, including Regulatory Approvals.
      1.31 Royalty Term. The term “Royalty Term” shall have the meaning set forth in Section 3.2.2.

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      1.32 Technology. The term “Technology” shall mean the Patent Rights, Know-How and Regulatory Filings, together with Indena’s interest in any Joint Inventions and any Improvements owned or Controlled by Indena.
      1.33 Term. The term “Term” shall have the meaning set forth in Section 10.1.
      1.34 Territory. The term “Territory” shall mean all of the countries in the world (including their territories and possessions).
      1.35 Third Party. The term “Third Party” shall mean any person or entity other than a Party hereto or an Affiliate.
      1.36 Valid Claim. The term “Valid Claim” shall mean a claim in any unexpired, issued patent within the Patent Rights which has not been held invalid and/or unenforceable in a decision by a court or other body of competent jurisdiction from which there is no appeal or, if appealable, from which no appeal has been taken.
2. LICENSE.
      2.1 License. Indena hereby grants to Spectrum an exclusive (even as to Indena, except as provided in Section 2.4), right and license under Indena’s rights in and to the Technology to research, develop, make, have made, use, offer for sale, sell, have sold, distribute, import, and export the Licensed Compound and/or the Products in the Licensed Field in the Territory (the “ License ”).
      2.2 Sublicenses. Spectrum shall have the right, but not the obligation, to grant sublicenses under the License to its Affiliates and Third Parties. Each sublicense shall be consistent with the terms of this Agreement. Spectrum shall remain responsible for the performance of its sublicensees. Spectrum shall notify Indena of each sublicense granted hereunder.
      2.3 Technology and Material Transfer. On the Effective Date, Indena shall disclose, and as applicable, provide copies of, all Know-How to Spectrum.
      2.4 Exceptions to Exclusivity. Notwithstanding Section 2.1, Indena retains: (i) the right under the Technology to manufacture and sell the Licensed Compound and/or the Products exclusively to Spectrum or Spectrum’s designee in accordance with this Agreement; and (ii) the limited right to use and license the Patent Rights and Know-How for the manufacture and sale of compounds which do not contain the Licensed Compound and which are not in competition with the Licensed Compound. Indena shall keep Spectrum informed of its development efforts with regard to such compounds.

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      2.5 Regulatory Filings. As soon as practicable after the Effective Date, Indena shall assign and transfer ownership, or have Bayer Corporation (“Bayer”), i.e. Indena’s former licensee whose license has been terminated to assign and transfer ownership, to Spectrum of any and all Regulatory Filings. Spectrum shall own all of the Regulatory Filings in perpetuity provided that this Agreement is not terminated by Spectrum pursuant to Section 10.2 or by Indena pursuant to Sections 10.3 or 10.4, in which case, upon request by Indena, Spectrum shall assign and transfer back to Indena ownership to all regulatory filings assigned and transferred by Indena (or Bayer) to Spectrum, on a Product-by-Product and/or country-by-country basis. Spectrum shall have the right to reference any and all of the data submitted in support of the Regulatory Filings. This right of reference shall survive expiration or termination of this Agreement for any reason other than for the same reasons set forth in the preceding sentence. As soon as practicable after the Effective Date, Indena shall provide copies to Spectrum of all Regulatory Filings, including all correspondence with appropriate Regulatory Authorities. The upfront payment indicated in Section 3.1 below shall be paid by Spectrum to Indena promptly upon receiving written confirmation that Indena has performed its obligations under this Section 2.5 relating to the transfer of ownership of any and all Regulatory Filings and the delivery of copies of all Regulatory Filings.
3. FINANCIAL TERMS AND CONDITIONS.
      3.1 Upfront and Milestone Payments. (a) In consideration of the License and the obligations assumed by Indena hereunder, Indena shall be entitled to receive from Spectrum the following amounts:
          (a) [***] Euro ( [***]) for the license under Class A Patent Rights and the right to refer to Indena’s DMF;
          (b) [***] Euro ( [***]) for: (i) the license under Class B Patent Rights; (ii) the right to use any and all toxicological, pharmacological and clinical data developed by Indena and/or Bayer relating to the Licensed Compound; and (iii) the transfer of the IND for the Licensed Compound from Indena or Bayer to Spectrum;
and thus in total the sum of [***] Euros ( [***]) which shall become due and payable by Spectrum in installments upon achievement of the following milestones:
         
    Payment
    (Euros)
 
Upfront    
As per Section 2.5
  (i)   1,000,000 pursuant to Section 3.1(a); and
 
       
 
  (ii)   1,000,000 pursuant to Section 3.1(b)

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    Payment
    (Euros)
Milestones
       
 
       
[***] months after the date both of the following have been achieved: (i) [***] (consistent with the terms of [***] of this Agreement) [***], in [***] reasonable opinion, [***]:
      [***] pursuant to Section 3.1(b)
 
       
At the time the 10th patient is dosed in a Phase 3 clinical trial:
  (i)   [***] pursuant to Section 3.1(a); and
 
       
 
  (ii)   [***] pursuant to Section 3.1(b)
 
       
Acceptance of the NDA filing by the FDA in the United States:
      [***] pursuant to Section 3.1(b)
 
       
Approval of the NDA by FDA in the United States:
  (i)   [***] pursuant to Section 3.1(a); and
 
       
 
  (ii)   [***] pursuant to Section 3.1(b)
 
       
Acceptance of the MAA filing by the EMEA:
  (i)   [***] pursuant to Section 3.1(a); and
 
       
 
  (ii)   [***] pursuant to Section 3.1(b)
 
       
Approval of the MAA filing by the EMEA:
  (i)   [***] pursuant to Section 3.1(a); and
 
       
 
  (ii)   [***] pursuant to Section 3.1(b)
 
       
Acceptance of the NDA filing by the MHLW in Japan:
  (i)   [***] pursuant to Section 3.1(a); and
 
       
 
  (ii)   [***] pursuant to Section 3.1(b)
 
       
Approval of the NDA by the MHLW in Japan:
  (i)   [***] pursuant to Section 3.1(a); and
 
       
 
  (ii)   [***] pursuant to Section 3.1(b)

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    Payment
    (Euros)
Annual Net Sales exceed [***]:
  (i)   [***] pursuant to Section 3.1(a); and
 
       
 
  (ii)   [***] pursuant to Section 3.1(b)
 
       
Annual Net Sales exceed [***]:
  (i)   [***] pursuant to Section 3.1(a); and
 
       
 
  (ii)   [***] pursuant to Section 3.1(b)
Spectrum shall pay Indena the above payments within thirty (30) days of achieving the milestone (or thirty (30) days after the Effective Date with regard to the upfront payment). Each of the foregoing payments shall be paid only one time. Sections 3.1 (a) and (b) are not meant in any way to limit the License granted by Indena to Spectrum pursuant to Section 2.1
      3.2 Product Royalties.
           3.2.1 Patent Royalties During the Royalty Term, Spectrum shall pay Indena a royalty rate as set forth in the chart below on the aggregate annual Net Sales of each Product sold by Spectrum, its Affiliates and any sublicensees during each calendar year.
     
Annual Net Sales   Royalty Rate
[***]
  [***]%
More than [***] but less than or equal to [***]
  [***]%
More than [***]
  [***]%
           3.2.2 Royalty Term The “ Royalty Term ” shall begin on the First Commercial Sale of a particular Product in a particular country and expire on the earlier of (i) the expiration of the last Valid Claim covering such Product in that country, as determined on a Product-by-Product basis and a country-by-country basis or (ii) the regulatory approval of a generic version of a Product in that country, as determined on a Product-by-Product basis and a country-by-country basis.
           3.2.3 Royalty Offsets In the event that royalty payments are owed by Spectrum to Third Parties with respect to licenses necessary to use, develop, manufacture or import the Licensed

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Compound, the royalties owed to Indena under Section 3.2.1 shall be reduced by [***] Percent ([***]) of the amount of the royalty payments actually paid by Spectrum to such Third Parties provided that such reductions shall not reduce the royalty paid to Indena in such country below [***] Percent ([***]%).
     In the event that royalty payments are owed by Spectrum to Third Parties with respect to licenses necessary to use, develop, manufacture, import or sell a finished formulation of the Licensed Compound, the royalties owed to Indena under Section 3.2.1 shall be reduced by [***] Percent ([***]) of the amount of the royalty payments actually paid by Spectrum to such Third Parties provided that such reductions shall not reduce the royalty paid to Indena in such country by more than [***] Percent ([***]%) in the aggregate.
           3.2.4 Quarterly Royalty Payments 3.2.5 Royalties owed to Indena pursuant to this Article 3 shall be payable by Spectrum within ninety (90) days after the end of each calendar quarter (i.e., ninety (90) days after March 31, June 30, September 30 and December 31) based upon the Net Sales of each Product during such quarter. Any underpayment or overpayment of the quarterly royalty payments shall be reconciled and added or deducted to the royalty payment due in the calendar quarter in which such underpayment or overpayment is discovered.
           3.2.5 Reports Spectrum shall furnish to Indena at the same time as each royalty payment is made by Spectrum, a written report of Net Sales of the Products on a Product-by-Product basis and the royalty due and payable thereon, for the quarterly period upon which the royalty payment is based. Such reports shall be derived from Spectrum’s consolidated financial statements.
      3.3 Payments. All payments will be made in immediately available funds in Euros by bank wire transfer to such bank account designated in writing by Indena from time to time.
      3.4 Records. Spectrum shall keep full, complete and proper records and accounts of all sales of Products by Spectrum and its Affiliates in accordance with GAAP. All such records, statements, reports and accounts referred to in this Section 3.4 shall be retained for a period of three (3) years after the end of the period to which they apply.
      3.5 Income or Other Tax Withholding. If laws, rules or regulations require withholding of income or other taxes imposed upon payments set forth in this Article 3, Spectrum may make such withholding payments as required and subtract such withholding payments from the payments set forth in this Article 3. Spectrum shall submit appropriate proof of payment of the withholding rates to Indena within a reasonable period of time. Spectrum shall use efforts consistent with its usual business practices to ensure that any withholding taxes imposed are reduced as far as possible under the provisions of the current or any future double taxation treaties or agreements between foreign countries, and the Parties

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shall cooperate with each other with respect thereto, with the appropriate Party under the circumstances providing the documentation required under such treaty or agreement to claim benefits thereunder.
      3.6 Audit. If Indena disagrees with a royalty report provided by Spectrum, with reasonable justification for such disagreement, Indena, at its own expense, shall have the right, upon reasonable prior notice during regular business hours, to meet with Spectrum’s independent auditor to inspect and discuss the books and accounts of Spectrum or its Affiliates, related to the payment and calculation of royalties arising under this Agreement. After this inspection, if Indena still disagrees with the report provided by Spectrum, with reasonable justification for such disagreement, Indena, at its own expense, shall have the right, upon reasonable prior notice during regular business hours, to appoint independent auditors reasonably acceptable to Spectrum and have them during normal business hours, inspect and audit the books and accounts of Spectrum or its Affiliates, related to the payment and calculation of royalties arising under this Agreement. Spectrum shall cooperate and cause Spectrum’s Affiliates, to cooperate with such auditors. The auditors performing the audit shall disclose to Indena only information relating to the accuracy of records kept and the payments made, and shall be under a duty to keep confidential any other information obtained from such records. If any such audit establishes that Spectrum has underpaid or overpaid the amount due, Spectrum shall promptly pay any remaining amounts due as established by such audit or Indena shall promptly refund any over payment. If the underpayment is more than [***] percent ([***]%) of the aggregate Net Sales for all countries during any calendar year, Spectrum shall reimburse Indena for its out-of-pocket expense of such audit, together with interest at the rate specified in Section 3.7 below for late payments on any such overdue payment from the date due until paid.
      3.7 Late Payments. Any payments due to Indena under this Agreement that are not paid on the due date shall accrue interest at the rate of [***] Euro [***].
4. OWNERSHIP AND PATENT MATTERS.
      4.1 Ownership. As between the parties, all Technology provided hereunder by Indena shall be owned by Indena. Improvements made by an employee, agent or consultant of Spectrum, solely or jointly with a Third Party, shall be owned by Spectrum. Any Improvements, that are made jointly by employees, agents or consultants of Spectrum and employees, agents or consultants of Indena (“ Joint Inventions ”) shall be jointly owned by Spectrum and Indena and treated as joint inventions under U.S. laws applicable to joint inventions. Improvements made by an employee, agent or consultant of Indena, solely or jointly with a Third Party, shall be owned by Indena. Indena hereby grants to Spectrum, effective after the Agreement expires pursuant to Section 10.1 or Spectrum terminates the Agreement pursuant to Section 10.3 or 10.4, a perpetual, royalty-free right and license to all Improvements owned or Controlled by Indena and all information, know-how and other data owned or Controlled by Indena pertaining to all

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Improvements or the Joint Inventions. For the avoidance of doubt, the previous sentences shall in no way be read to modify Sections 2.1 and 5.2 regarding Spectrum’s exclusive (even as to Indena) license to the Technology. Spectrum shall own any trademarks associated with the Products.
      4.2 Prosecution and Maintenance of Patent Rights.
           4.2.1 Patent Prosecution and Maintenance Spectrum, at its own expense, shall direct and control the preparation, filing, prosecution and maintenance of all United States and foreign Patents within the Patent Rights and all Joint Patents, including any interferences and oppositions. Notwithstanding the foregoing, Indena shall be responsible, at its own expense, for the re-issue of United States Patent Number 6,906,101 in all countries of the Territory, as applicable. Indena shall keep Spectrum informed of the re-issue process for this patent.
           4.2.2 Participation and Assistance If requested by Indena, Spectrum shall consult with Indena with regard to the preparation, filing, prosecution and/or maintenance of the Patents within the Patent Rights and any Joint Patents. Notwithstanding the preceding sentence, however, Spectrum shall in all events have final decision-making authority as relates to the preparation, filing, prosecution and/or maintenance of the Patents within the Patent Rights and any Joint Patents, and the scope of claims contained therein. Indena shall cooperate fully with Spectrum, at Spectrum’s request, in all matters relating to the preparation, filing, prosecution and/or maintenance of the Patents within the Patent Rights and any Joint Patents, including signing any necessary or appropriate documents, providing written and testimonial evidence, and doing such other acts as Spectrum may reasonably require.
           4.2.3 Patent Abandonment In the event Spectrum elects not to prosecute or to discontinue or abandon the prosecution and/or maintenance of any patent or patent application within the Patent Rights, any such patent or patent application shall at that time be excluded from the definition of Patent Rights and from the scope of the licenses granted under this Agreement. Spectrum shall give Indena at least sixty (60) days’ prior written notice of its election to discontinue or abandon any such patent or patent application within the Patent Rights during which time Indena may elect, in its sole discretion, to prosecute, file, continue and maintain such patent or patent application at its sole cost and expense and for its sole benefit by delivery of written notice to Spectrum. If Indena does not notify Spectrum in writing during such sixty (60) day period that it is exercising such rights, the patent or patent application shall be deemed abandoned and neither Indena nor Spectrum shall have any further responsibility for any such abandoned patent applications or patents. However, if Indena does not elect to prosecute, file, continue and maintain such patent or patent application, Spectrum may later elect to continue to prosecute and maintain such patent or patent application, in which case, the patent or patent application shall remain within the Patent Rights and License hereunder.

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           4.2.4 Execution of Documents Each Party shall promptly execute or have executed by its employees, agents and consultants all documents necessary to vest ownership of inventions and related intellectual property rights relating to Joint Patents in Indena and Spectrum and to enable Spectrum to file, prosecute and maintain the Patents within the Patent Rights and Joint Patents. If Spectrum is unable, after reasonable effort, to secure the signature of Indena or any employee, agent or independent contractor of Indena on any document needed to apply for, prosecute or defend any patent or other intellectual property right or protection relating to the Patent Rights or the Joint Patents, Indena hereby designates and appoints Spectrum and its duly authorized officers and agents as its agent and attorney in fact to execute, verify and file applications, and to do all other lawfully permitted acts necessary to protect Spectrum’s rights in Joint Patents and to enable Spectrum to file, prosecute and maintain Patent Rights and Joint Patents with the same legal force and effect as if executed by Indena.
      4.3 Infringement Actions.
           4.3.1 Prosecution of Infringement
         

 
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