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.

 

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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  

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  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 

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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  

iii 

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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.

1

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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.

2

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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

3

--------------------------------------------------------------------------------

 

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

4

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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.

5

--------------------------------------------------------------------------------

 

     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.

6

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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)

7

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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)

8

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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

9

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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 Payments3.2.5 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
               (a) The Parties shall promptly notify one another in writing of
any and all actual or threatened infringements by Third Parties of any Patents
within the Technology that relate to a Product in the Licensed Field that is
known to them, and in any event within thirty (30) days of learning of such
infringement.
               (b) With respect to actual or threatened infringements of Patents
within the Technology with respect to the Products, Spectrum shall have the
first right, but not the obligation, to file suit or take other action to
prevent such infringements of any such Patents. To the extent Spectrum takes
such action, Spectrum shall control any such action and may enter into
settlements, stipulated judgments or other arrangements respecting such
infringement, at its own expense; provided, however, that such proposed
settlements, judgments or arrangements shall be subject to Indena’s consent, not
to be unreasonably withheld. In the event that Spectrum takes such action,
Spectrum shall indemnify, defend and hold Indena harmless from any costs,
expenses and liabilities respecting the action for such claimed infringement.
Indena shall permit an action to be brought by Spectrum in Indena’s name if
required by law. Indena agrees to provide all assistance that Spectrum may
reasonably require in any litigation, including providing written evidence,
deposition and trial testimony, for which Spectrum shall pay to Indena a
reasonable and customary hourly rate of compensation. Spectrum shall keep Indena
informed of developments in any such action, including, to the extent
permissible by law, the status of any settlement negotiations and the terms of
any offer related thereto. Indena shall have the right at its own expense to be
represented by counsel in any such action. Any damages or other recovery from an
infringement action undertaken by Spectrum pursuant to this Section 4.3.1(b)
shall [***].

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               (c) Spectrum shall promptly notify Indena in writing of its
intention with regard to any such infringement. In the event that Spectrum
elects not to take action against an actual or threatened infringement, Indena
shall have the right to take action against such infringement, in which case
Indena shall (i) pay any and all costs and expenses incurred in such action,
(ii) indemnify, defend and hold Spectrum harmless from any costs, expenses or
liability respecting all such action, and (iii) retain any and all recovery from
such action. Spectrum agrees to provide all assistance that Indena may
reasonably require in any litigation, including providing written evidence,
deposition and trial testimony, for which Indena shall pay to Spectrum a
reasonable hourly rate of compensation.
          4.3.2 Defense of Infringement Claims
               (a) If a Third Party makes or threatens against Spectrum, its
Affiliates or sublicensees any claim of infringement of a Patent right based
upon the use of, or arising as a result of the exercise of the rights and
licenses granted hereunder to the Technology (each an “Alleged Infringement”),
Spectrum shall have the right to respond to and defend any and all such Alleged
Infringements at its own cost and expense, and in its sole discretion. Indena
agrees to provide any necessary assistance that Spectrum may reasonably require
in any such defense action for which Spectrum shall pay to Indena a reasonable
hourly rate of compensation. Indena shall have the right, at its own expense, to
retain counsel of its choice to represent it in any such defense action.
               (b) Spectrum shall promptly notify Indena in writing and provide
a copy of (i) any claim of Alleged Infringement filed with a court or
governmental authority or (ii) any written notice of an Alleged Infringement
from an attorney or law firm. Within a reasonable period of time in advance of
any responsive deadline required by law or otherwise set forth in the claim or
notice of Alleged Infringement, Spectrum shall notify Indena in writing as to
whether or not Spectrum intends to respond to such Alleged Infringement. In the
event that Spectrum does not intend to respond to any such claim or notice or,
notwithstanding Section 4.3.2(a), and notifies Indena in accordance with this
Section, Indena shall have the right, in its sole discretion, to respond to such
Alleged Infringement, in which case Indena shall pay any and all future costs
and expenses incurred by Spectrum in such action, and shall indemnify, defend
and hold Spectrum harmless from any future costs, expenses or liability
respecting all such actions undertaken by Indena.
5. OBLIGATIONS RELATED TO SUPPLY, DEVELOPMENT, MARKETING AND COMMERCIALIZATION.

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     5.1 Spectrum’s Diligence Obligations. Spectrum, its Affiliates and/or
sublicensees, as applicable, shall use commercially reasonable efforts to
(i) complete, file and pursue Regulatory Approval for one or more Products in
the Territory and (ii) promote and market the Product or Products in the
Territory. Such development, marketing and commercialization shall be pursued at
such party’s sole cost and expense. Spectrum, its Affiliates and/or
sublicensees, as applicable, shall have sole responsibility for making all
decisions regarding the development, marketing and commercialization of the
Products.
     5.2 Research and Development. Indena shall not conduct or sponsor any
research or development with respect to the Licensed Compound without the prior
written consent of Spectrum.
     5.3 Governmental Approvals. Spectrum, its Affiliates and/or sublicensees,
as applicable, shall be solely responsible for obtaining all necessary approvals
from Regulatory Authorities for the use, development, production, distribution,
sale and import or export of any Products, at such parties expense, including
preclinical and clinical trials and Regulatory Filings. Spectrum, its Affiliates
and/or sublicensees, as applicable, shall have sole responsibility for any
warning labels, packaging and instructions as to the use of Products. Spectrum,
its Affiliates and/or sublicensees shall own all Regulatory Filings made with
the applicable Regulatory Authorities with respect to the Products and all
regulatory approvals.
     5.4 Supply of API. Subject to the provisions set out below in this
Section 5.4, Indena shall [***] supply and Spectrum shall purchase [***] from
Indena [***] Spectrum’s, its Affiliates’ and/or sublicensees’, [***] API [***]
the Product at a price of € [***] per gram subject to adjustment for the reasons
specified in this Section 5.4. The Parties shall in good faith negotiate the
terms of a supply agreement and a quality agreement for [***] supply of the API.
The provisions of such agreements shall be consistent with the provisions set
forth in this Section 5.4 and the term of such agreements shall survive the
termination or expiration of this Agreement, subject to standard termination
provisions, including a unilateral right to terminate by Spectrum.
     Each shipment of API shall be accompanied by a Certificate of Analysis and
Compliance in a form mutually agreed by the Parties, signed by Indena’s
designated quality manager, that sets forth the analytical test results against
the specifications for a lot of API and that certifies that such lot was
produced and tested in compliance with the specifications, cGMPs, and all
applicable Regulatory Approvals. [***].

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     If Spectrum, its Affiliates and/or sublicensees, as applicable, engage a
Third Party to manufacture the API, upon written request by Spectrum, Indena
will provide technical assistance to the manufacturer engaged by Spectrum, its
Affiliates and/or sublicensees, as applicable. The [***] of technical assistance
shall be provided at [***] (other than for [***] from an Indena facility at
Spectrum’s request) and any additional technical assistance shall be provided at
€ [***].
     If Spectrum, its Affiliates and/or sublicensees, as applicable, receive a
bona fide offer from a qualified Third Party to supply API at a price lower than
€ [***] per gram and upon terms comparable to those applicable to current
supplies by Indena, then the Parties shall take the steps provided for in the
supply agreement between the Parties.
     Upon request by Spectrum, Indena shall supply to Spectrum, to a location
Spectrum designates, an amount of API, as reasonably determined by Spectrum,
necessary for Spectrum to conduct Phase 2 clinical trials.
6. INDEMNITY.
     6.1 Spectrum Indemnification. Spectrum (the “Indemnifying Party” under this
Section 6.1) hereby agrees to indemnify, defend and hold Indena, its Affiliates,
and its directors, employees and agents (the “Indemnified Party(ies)” under this
Section 6.1) harmless from and against any and all suits, claims, actions,
demands, liabilities, expenses and/or loss, including reasonable legal expenses
and attorneys’ fees (collectively, “Losses”), to which one or more Indemnified
Parties may become subject as a result of any (a) claim, demand, action or other
proceeding for personal injury, wrongful death or product defect by any Third
Party relating to the research, development, manufacture, use or sale of
Products by Indemnifying Party and/or its Affiliates and/or their respective
employees or agents, except to the extent that such Losses result from the gross
negligence, wrongful intentional acts or willful omissions of Indemnified
Party(ies), (b) claim, demand, action or other proceeding by any Third Party to
the extent such Losses result from Spectrum’s material breach of any,
obligation, representation, warranty or covenant contained in this Agreement or
(c) any failure by Spectrum or its Affiliates or its sublicensees to comply with
applicable law. In no event shall Spectrum be liable for any lost opportunities,
profits or special, incidental, consequential or indirect damages of the
Indemnified Party(ies) under this Section 6.1, except, however, as the result of
any breach by Spectrum of the covenants in Article 8 below.
     6.2 Indena Indemnification. Indena (the “Indemnifying Party” under this
Section 6.2) hereby agrees to indemnify, defend and hold Spectrum and its
Affiliates and their directors, officers, employees, and agents (the
“Indemnified Party(ies)” under this Section 6.2) harmless from and against any
Losses

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to which one or more Indemnified Parties may become subject as a result of any
(a) claim, demand, action or other proceeding by any Third Party to the extent
such Losses result from Indena’s breach of any material obligation,
representation, warranty or covenant contained in this Agreement or (b) failure
by Indena to comply with applicable law. In no event shall Indena be liable for
any lost opportunities, profits or special, incidental, consequential or
indirect damages of the Indemnified Party(ies) under this Section 6.2., except,
however, as the result of any breach by Indena of any of the covenants in
Article 8 below.
     6.3 Indemnity Procedure.
               (a) The Indemnified Party(ies) agrees to give the Indemnifying
Party(ies) written notice, as soon as is practicable, but in any event within
thirty (30) days if possible, of any claim, suit, loss or the discovery of facts
upon which such Indemnified Party(ies) intends to base a request for
indemnification under Section 6.1 or Section 6.2 (collectively, a “Claim”).
               (b) The Indemnified Party(ies) shall furnish promptly to the
Indemnifying Party(ies) copies of all papers and official documents received in
respect of any Claim. The Indemnified Party(ies) shall cooperate with the
Indemnifying Party(ies), at the Indemnifying Party(ies)’s expense, in providing
witnesses and records necessary in the defense against any Claim.
               (c) With respect to any Claim relating solely to the payment of
money damages that will not (i) result in the Indemnified Party(ies)’s becoming
subject to injunctive or other relief, (ii) require an admission of guilt or
other responsibility or liability, or (iii) otherwise adversely affect the
business interests or rights of the Indemnified Party(ies) in any manner, and as
to which the Indemnifying Party(ies) shall have acknowledged in writing the
obligation to indemnify the Indemnified Party(ies) hereunder, the Indemnifying
Party(ies) shall have the sole right to defend, settle, or otherwise dispose of
such claim, on such terms as the Indemnifying Party(ies), in its sole discretion
(subject to the limitations of this Section), shall deem appropriate.
               (d) With respect to all other Claims the Indemnifying Party(ies)
shall obtain the written consent of the Indemnified Party(ies), which shall not
be unreasonably withheld, prior to ceasing to defend, settling, or otherwise
disposing thereof.
               (e) The Indemnifying Party(ies) shall not be liable for any
settlement or other disposition of a Claim by the Indemnified Party(ies) that is
reached without the written consent of the Indemnifying Party(ies).
               (f) Except as provided above, the costs and expenses, including
fees and disbursements of counsel, incurred by any Indemnified Party(ies) in
connection with any claim shall be

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paid by the Indemnifying Party(ies), without prejudice to the Indemnifying
Party(ies)’s right to contest the Indemnified Party(ies)’s right to
indemnification and subject to refund in the event the Indemnifying Party(ies)
is ultimately held not to be obligated to indemnify the Indemnified Party(ies).
               (g) The Indemnified Party(ies) shall always have the right to
retain counsel and participate in the defense, negotiation or settlement of any
Claim at its/their own cost and expense.
7. REPRESENTATIONS AND WARRANTIES.
     7.1 By Indena.
     Indena hereby represents and warrants that as of the Effective Date:
               (a) It is a financially solvent company duly organized, validly
existing and in good standing under the laws of its jurisdiction of formation.
               (b) This Agreement is a legal and valid obligation of Indena,
binding upon Indena and enforceable against Indena in accordance with the terms
of this Agreement, except as such enforceability may be affected by laws
affecting creditors’ rights generally and general equitable principles. The
execution, delivery and performance of this Agreement by Indena does not
conflict with any agreement, instrument or understanding, oral or written, to
which Indena is a party or by which Indena may be bound, or violate any law or
regulation of any court, governmental body or administrative or other agency
having authority over Indena. All consents, approvals and authorizations from
all governmental authorities or other Third Parties required to be obtained by
Indena in connection with the execution, delivery and performance of this
Agreement have been obtained.
               (c) (A) it has all necessary right and authority to execute,
deliver and perform all of its obligations under this Agreement, which actions
have been duly and validly authorized and approved by all necessary corporate
action of Indena; (B) it has the right to grant the licenses and other rights
granted herein; (C) it has not previously granted any right, license or interest
in or to the Technology, or any portion thereof, inconsistent with the rights
granted to Spectrum herein; and (D) to the best of its knowledge, there are no
material adverse proceedings, claims or actions pending or threatened relating
to the Technology which would materially interfere with Indena’s performance of
its obligations or power to make the grants and covenants hereunder, or
Spectrum’s unfettered use of the Technology.
               (d) Indena is the owner of all right, title and interest in and
to all of the Technology. The Technology is free and clear of any and all
encumbrances, covenants, conditions and restrictions or, other adverse claims or
interests of any kind or nature, including but not limited to, financial and
technical, and Indena has not received any oral or written notice or claim
challenging its complete

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and exclusive rights to the Technology or suggesting that any other person has
any claim of legal or beneficial ownership with respect thereto, and there is no
agreement, decree, arbitral award or other provision or contingency in effect in
which Indena has granted licenses in the Technology or in which Indena is
obligated to grant licenses in the Technology.
               (e) To Indena’s best knowledge, it owns or possesses sufficient
rights to use all of the Technology necessary to develop, make, have made, use,
sell, offer for sale, have sold, import and export and commercialize the
Licensed Compound in the Licensed Field in the Territory.
               (f) The license agreement with Bayer has been terminated in its
entirety and Bayer has no rights in any way to the Technology.
               (g) It has provided copies to Spectrum of all Know-How, as
applicable, and all Regulatory Filings, including all correspondence with
appropriate Regulatory Authorities.
               (h) No litigation is now pending and no notice or other claim has
been received by Indena, (A) alleging that Indena has engaged in any activity or
conduct that infringes upon, violates or constitutes the unauthorized use of any
Patents of any Third Party, or (B) challenging the ownership, use, validity or
enforceability of any of the Patents Rights. In addition, Indena is not aware of
any unasserted claim or demand which it believes can be enforced by a Third
Party against any the Patent Rights.
               (i) The Technology was not obtained by Indena in violation of any
contractual or fiduciary obligation to which Indena or any of its respective
employees are or were bound, or by the misappropriation of the trade secrets of
any Third Party.
               (j) To the best of Indena’s knowledge and belief, all of the data
and information that Indena has provided to Spectrum prior to the Effective Date
relating to the Technology, and to IDN 5109 in general, are reasonably accurate,
and Indena has not omitted therefrom any material data or information in
Indena’s possession or control reasonably in advance of the Effective Date
concerning the same.
               (k) The Patent Rights are in full force and effect and are in
compliance with all legal requirements regarding the filing, examination, and
maintenance fees. Indena has not taken any action or, failed to take any action
(including a failure to disclose material prior art in connection with the
prosecution of any patent), or used or enforced or, failed to use or enforce any
of the Patents Rights in a manner that would result in the abandonment or
unenforceability of any of the Patents Rights.
               (l) No Patent Rights have been or are now involved in any
interference, reissue, reexamination or opposing proceeding in any jurisdiction
within the Territory. To Indena’s best

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knowledge, no such action has been threatened. There is no patent of any person
that claims the same subject matter as the Patent Rights, and Indena is not
aware of any prior art that invalidates any claim within the Patent Rights.
               (m) To Indena’s best knowledge, the use of the Patents Rights to
develop, make, have made, use, sell, offer for sale, have sold, import and
export and commercialize the Licensed Compound in the Licensed Field in the
Territory, would not infringe upon, violate or constitute the unauthorized use
of any rights owned or controlled by any Third Party, including any Patent of
any Third Party.
               (n) To Indena’s best knowledge, no Third Party is
misappropriating, infringing, diluting or violating any of the Patent Rights,
and no claims for any of the foregoing have been brought against any Third Party
by Indena. Indena has taken reasonable steps in accordance with normal industry
practice to protect its Patent Rights.
               (o) The chemical structure described in Exhibit A is the correct
chemical structure of IDN 5109.
     7.2 By Spectrum.
     Spectrum hereby represents and warrants that as of the Effective Date:
               (a) (A) it is a financially solvent corporation duly organized,
validly existing and in good standing under the laws of the State of Delaware;
(B) it has the full right, authority and power to enter into this Agreement and
to perform its obligations hereunder, which actions have been duly and validly
authorized and approved by all necessary corporate action of Spectrum; (C) the
execution, delivery and performance of this Agreement have been duly authorized
by all necessary corporate action on the part of Spectrum; and (D) to the best
of its knowledge there are no material adverse proceedings, claims or actions
pending or threatened against it which would materially interfere with the
performance of its obligations hereunder.
               (b) This Agreement is a legal and valid obligation of Spectrum,
binding upon Spectrum and enforceable against Spectrum in accordance with the
terms of this Agreement, except as such enforceability may be affected by laws
affecting creditors’ rights generally and general equitable principles. The
execution, delivery and performance of this Agreement by Spectrum does not
conflict with any agreement, instrument or understanding, oral or written, to
which Spectrum is a party or by which Spectrum may be bound, or violate any law
or regulation of any court, governmental body or administrative or other agency
having authority over Spectrum. All consents, approvals and authorizations from
all governmental authorities or other Third Parties required to be obtained by

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Spectrum in connection with the execution, delivery and performance of this
Agreement have been obtained.
8. ADDITIONAL COVENANTS.
     8.1 Preservation of Title. Indena shall use its best efforts to preserve
and maintain its ownership and title to all Technology licensed hereunder.
     8.2 No Conflicts. Neither Party shall grant any right, license or interest
in or to the Technology, or any portion thereof, inconsistent with the rights
granted to Spectrum herein. Without the other Party’s prior written consent,
neither Party shall enter into any agreement that creates additional obligations
upon the other Party or limits the exercise of the other Party’s rights
hereunder or diminishes the other Party’s rights hereunder.
9. CONFIDENTIALITY AND PUBLICATION.
     9.1 Treatment of Confidential Information. The Parties agree that during
the term of this Agreement, and for a period of seven (7) years after this
Agreement terminates or expires, a Party receiving Confidential Information of
the other Party will (i) maintain in confidence such Confidential Information to
the same extent such Party maintains the confidentiality of its own Confidential
Information, (ii) not disclose such Confidential Information to any Third Party
without the prior written consent of the disclosing Party and (iii) not use such
Confidential Information for any purpose other than the exercise of a Party’s
rights or performance of a Party’s obligations under this Agreement; provided
however, that the provisions of this Section 9.1 shall not prevent a Party from
disclosing Confidential Information if such disclosure:
               (a) is made to its employees, directors, accountants, attorneys,
contractors or consultants who reasonably require such disclosure on a need to
know basis and who are bound to it by obligations of confidentiality and non-use
no less stringent than the obligations between Spectrum and Indena hereunder;
               (b) is made to collaborators for the purpose of performing the
obligations or exercising the rights of a Party hereunder and who are bound to
that Party by obligations of confidentiality and non-use no less stringent than
the obligations between Spectrum and Indena hereunder;
               (c) is in response to a valid order of an United States court or
otherwise required by law or regulation, provided however that receiving Party
shall first have given notice to the disclosing Party and shall have made a
reasonable effort to obtain a protective order by: (i) seeking protection of
Confidential Information not relevant to the court’s inquiry from a general
disclosure (e.g., without

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limitation, requesting limited and in-camera review by such court and/or seeking
that such information be treated under seal); (ii) seeking to redact any
Confidential Information; and (iii) in any event requiring that, to the extent
ordered to be disclosed, that such disclosure of Confidential Information be
used only for the purposes for which the order was issued; or
               (d) is necessary to: (i) file or prosecute Patents in accordance
with this Agreement; (ii) submit regulatory filings with respect to Products in
accordance with this Agreement; (iii) prosecute or defend litigation; (iv) make
required governmental securities filings and other such similar and required
disclosures by law, subject to appropriate redactions and requests for
confidential treatment as permitted by law; (v) make disclosures required by the
principal stock exchange on which the Party’s stock is traded, subject to
appropriate redactions and requests for confidential treatment as permitted by
law and the rules of such exchange; (vi) conduct pre-clinical or clinical trials
of Products in accordance with this Agreement, provided any Affiliates or Third
Parties conducting pre-clinical trials agree to be bound by terms of
confidentiality and non-use at least equivalent in scope to those set forth in
this Section 9.1 and any Affiliates or Third Parties conducting clinical trials
agree to be bound by terms of confidentiality and non-use that are customarily
obtained in connection with such clinical trials; or (viii) enable Affiliates or
bona fide potential or actual sublicensees to evaluate and/or exercise their
rights under a sublicense that would be or has been issued in accordance with
this Agreement, provided such Affiliates and Third Parties agree to be bound by
similar terms of confidentiality and non-use at least equivalent in scope to
those set forth in this Section 9.1.
     9.2 Public Statements.
          9.2.1 Publications Indena or Spectrum, as the case may be, may publish
or present information derived from the performance of this Agreement, provided
that: the publishing Party first provides the non-publishing Party with a copy
of a proposed manuscript for comment and input at least twenty (20) days prior
to any submission to the publisher and a copy of an abstract for comment and
input at least ten (10) days before submission to the Third Party organization.
In addition, at the non-publishing Party’s request, the publishing party will
further delay the presentation or publication for an additional ten (10) days so
as to allow the non-publishing party time to file for patent protection or other
intellectual property protection. If a publication by Spectrum results from work
relating to the Technology, Spectrum agrees to acknowledge Indena and give
credit to Indena’s scientists, as scientifically appropriate, based on any
contribution they may have made to the work. Likewise, if a publication by
Indena results from work performed by Spectrum, Indena agrees to acknowledge
Spectrum and give credit to Spectrum’ scientists, as scientifically appropriate,
based on any contribution they may have made to the work.
          9.2.2 Other Public Statements Except as provided in Section 9.2.1, or
as otherwise required by law or the rules of the principal stock exchange on
which the Party’s stock is traded, no Party

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shall originate any public statement, news release or other written public
announcement, whether in the public press, stockholders’ reports, or otherwise,
relating to this Agreement or to any sublicense hereunder, or to the performance
hereunder or any such agreements, or use a Party’s name for any purpose,
including in connection with the advertising or sale of Products, without the
prior written approval of the other Party, such consent not to be unreasonably
withheld. The Parties each agree to respond to each such request within five
(5) business days of receipt of a request (unless a shorter period of time is
necessary to comply with law). Notwithstanding anything to the contrary in this
Agreement, each party shall be permitted to publicly disclose (i) the existence
of this Agreement, (ii) that Indena and Spectrum are the parties to this
Agreement, and (iii) the Technology covered by this Agreement. In the case of
unintentional public disclosure concerning this Agreement, any Product or any
other subject matter hereof, the disclosing Party shall promptly inform the
other Party of such disclosure and the other Party shall be entitled to make a
public announcement regarding the subject matter of the disclosure. The other
Party shall notify the disclosing Party of their intention to make such an
announcement. Following a Party’s consent to or approval of the public
announcement of any information pursuant to this Section 9.2.2, both Parties
shall be entitled to make subsequent public announcements of such information
without renewed compliance with this Section 9.2.2, unless the scope and/or
duration of such consent or approval is expressly limited. Upon conclusion of
this Agreement, the Parties will publish a press release on their future
cooperation.
10. TERM, DEFAULT AND TERMINATION.
     10.1 Term of Agreement. The term of this Agreement shall commence on the
Effective Date and, unless terminated early in accordance with the provisions of
this Agreement, shall continue on a Product-by-Product and country-by-country
basis until the expiration of the obligation to pay royalties under Section 3.2
above applicable to such Product in such country (the “Term”). This Agreement
shall expire in its entirety after the date that Spectrum no longer owes any
royalties to Indena under Section 3.2.
     10.2 Unilateral Termination – Spectrum. Spectrum shall have the unilateral
right to terminate this Agreement, in its entirety or on a Product-by-Product
and/or country-by-country basis, at any time for any reason.
     10.3 Default.
          10.3.1 The following event shall constitute an “Event of Default”
hereunder: a material breach of a material provision of this Agreement by a
Party, and the failure of the Party in breach to cure such material breach
within ninety (90) days after receipt of notice from the other Party specifying
in reasonable detail the nature of such breach (the “Termination Notice”). For
purposes of this Agreement,

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it is not a “material breach” of this Agreement by Spectrum if the development
of a Product is delayed due to the following: (i) reasonable scientific, medical
or technical reasons; (ii) circumstances that are beyond the control of
Spectrum; or (iii) the fault of Indena. In addition, in the event of a Dispute
(as defined in Section 11.1) between the Parties as to whether a payment is owed
hereunder, then such Dispute shall be resolved in accordance with Article 11 and
the applicable cure period shall be tolled (even if such period has already
expired) during the pendency of such resolution.
          10.3.2 Upon the occurrence of any Event of Default by a Party, the
non-defaulting Party may deliver to the defaulting Party a Termination Notice
and without need of a further notice, such termination to be effective ninety
(90) days after the date of receipt of the Termination Notice, unless the Party
in breach cures the breach to the reasonable satisfaction of the terminating
Party during said ninety (90) days period. Such termination rights shall be in
addition to and not in substitution for any other remedies that may be available
to the non-defaulting Party. Termination pursuant to this Section 10.3.2 shall
not be treated as an election of remedies and shall not relieve the defaulting
Party from liability and damages to the other Party for breach of this
Agreement. Waiver by either Party of a single breach or a succession of breaches
shall not deprive such Party of any right to terminate this Agreement arising by
reason of any subsequent breach.
     10.4 Insolvency. In addition to the termination rights provided for in this
Section, each Party shall have the right to terminate this Agreement,
immediately by giving written notice of termination to the other Party, if the
other Party files a voluntary petition, or if an involuntary petition is granted
in respect of the other Party and appeal proceedings are not commenced within a
period of fifteen (15) days from the date of such petition under the bankruptcy
provisions of applicable law, or the other Party is declared insolvent,
undergoes voluntary or involuntary dissolution, or makes an assignment for the
benefit of its creditors, or fails or is unable to pay its debts as they come
due, or suffers the appointment of a receiver or trustee over all, or
substantially all, of its assets or properties. All rights and licenses granted
under or pursuant to this Agreement by Indena are, for the purposes of Section
365(n) of the U.S. Bankruptcy Code, licenses of rights to “intellectual
property” as defined under Section 101 of the U.S. Bankruptcy Code. The Parties
agree that Spectrum shall retain and may fully exercise all of its rights and
elections under the U.S. Bankruptcy Code.
     10.5 Effects of Expiration or Termination
               (a) Rights Upon Expiration. Following the expiration of this
Agreement with respect to a Product in a country in the Territory pursuant to
Section 10.1, Spectrum shall have and retain a perpetual, royalty-free, fully
paid up License for such Product in such country, however, Spectrum’s
obligations under this Agreement with respect to such Product in such country in
the Territory shall terminate. Following the expiration of the term of this
Agreement in its entirety pursuant to Section 10.1,

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Spectrum shall have and retain a perpetual, royalty-free, fully paid up License
for the Licensed Compound in all countries in the Territory, however, Spectrum’s
obligations under this Agreement shall terminate. In addition, Spectrum shall
retain all rights and interest in all materials, inventions, discoveries and
know-how (whether or not patentable or patented) solely generated by Spectrum in
the course of performing research and development activities under the licenses
granted in this Agreement. Other than rights intended to survive expiration, or
as otherwise provided under Section 10.5(e), neither Party shall have any
further rights or obligations upon the expiration of this Agreement in its
entirety.
               (b) Rights Upon Termination by Indena Under Sections 10.3 or 10.4
or by Spectrum Under Section 10.2. Upon any termination of this Agreement by
Indena under Section 10.3 or 10.4 or by Spectrum under Section 10.2, all rights
and licenses granted by Indena to Spectrum shall terminate and revert to Indena
and, subject to clause (e) below, Spectrum’s obligations under this Agreement
shall terminate. The foregoing provisions shall also apply to the partial
termination of this Agreement by Spectrum on a Product-by-Product and/or
country-by-country basis in accordance with Section 10.2, provided, however,
that in such event only those rights that solely pertain to the Product and/or
country being terminated would revert back to Indena and Spectrum’s obligations
under this Agreement only with respect to such Product in such country shall
terminate. In addition, Spectrum shall provide to Indena all CMC data,
preclinical testing and stability data and results and clinical trial data and
results relating to the development of Products and a technology transfer
package for all processes, formulations, and protocols for the manufacture of
Products. If Spectrum has licensed any technology from Third Parties relating to
the Technology or any Product, Spectrum shall use commercially reasonable
efforts to transfer such rights to Indena at no cost to Indena. Notwithstanding
the foregoing, Spectrum shall retain its right, title and interest under
Section 4.1 in any Improvements made solely by Spectrum and in any Joint
Inventions and hereby grants to Indena effective upon termination of this
Agreement by Spectrum pursuant to Section 10.2 a non-exclusive, perpetual,
royalty-free right and license to any Improvements made solely by Spectrum and
to any Joint Inventions.
               (c) Rights Upon Termination by Spectrum under Sections 10.3 or
10.4. Upon any termination of this Agreement by Spectrum under Sections 10.3 or
10.4, the license rights granted by Indena to Spectrum contained in this
Agreement shall continue in full force and effect, provided however, that,
subject to clause (e) below, Spectrum’s obligations under this Agreement shall
terminate. Notwithstanding the foregoing, Indena shall retain its right, title
and interest under Section 4.1 in any Joint Inventions and in any Improvements
made by Indena solely or jointly with a Third Party.
               (d) Payments. Not later than ninety (90) days after the
expiration or termination date of this Agreement in its entirety, each Party
shall pay to the other Party any amounts that are then due and payable,
including any final period royalty report and payment.

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               (e) Accrued Rights; Surviving Obligations. Termination (partially
or completely) or expiration of this Agreement for any reason shall be without
prejudice to any rights which shall have accrued to the benefit of either Party
prior to such termination or expiration, and shall not relieve either Party from
its obligations which are expressly indicated to survive expiration or
termination of this Agreement, including those under Articles 1, 6, 9, 11 and 12
and Sections 4.1, 4.2, 5.4, 10.5 and 10.6 which shall survive any expiration or
termination of this Agreement. Spectrum shall have no liability for financial
obligations that accrue after the date of termination or expiration of this
Agreement, including but not limited to the milestone payments payable pursuant
to Section 3.1. For the avoidance of doubt, if Spectrum terminates this
Agreement pursuant to Section 10.2 [***].

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     10.6 Work-in-Progress. Notwithstanding anything in this Agreement to the
contrary, upon any such early termination of the license granted hereunder in
accordance with this Agreement, Spectrum shall be entitled to finish any
work-in-progress and to sell any completed inventory of a Product which remain
on hand as of the date of the termination, so long as Spectrum pays to Indena
the royalties applicable to said subsequent sales in accordance with the terms
and conditions as set forth in this Agreement, provided that no such sales shall
be permitted after the expiration of [***] after the date of termination.
11. DISPUTE RESOLUTION.
     11.1 Arbitration. Without prejudice to the provisions of Section 11.4
below, any claim, dispute, or controversy of any nature arising out of or
relating to this Agreement, including any action or claim based on tort,
contract or statute, or concerning the interpretation, effect, termination,
validity, performance and/or breach of this Agreement (each, a “Dispute”)
between the Parties shall be finally settled by binding arbitration conducted in
the English language in accordance with the Rules of the International Chamber
of Commerce (“ICC”). The arbitration shall be held in Paris, France, if the
demand for arbitration is filed by Spectrum, and New York, New York, if the
demand for arbitration is filed by Indena, and shall be conducted by three (3)
arbitrators who are knowledgeable in the subject matter at issue in the dispute.
One (1) arbitrator will be selected by Indena, one (1) arbitrator will be
selected by Spectrum, and the third arbitrator will be selected by mutual
agreement of the two (2) arbitrators selected by the Parties, provided that if a
Party fails to select an arbitrator within thirty (30) days of the request for
arbitration, the arbitrator that was to be selected by such Party shall be
appointed in accordance with the rules of the ICC. The arbitrators may proceed
to an award, notwithstanding the failure of either Party to participate in the
proceedings. The arbitrators shall issue a written award and statement of
decision describing the essential findings and conclusions on which the award is
based, including the calculation of any damages awarded. The arbitrators shall
be authorized to award compensatory damages, but shall NOT be authorized to
(i) award non-economic or punitive damages (except to the extent expressly
permitted by this Agreement), or (ii) reform, modify or materially change this
Agreement or any other agreements contemplated hereunder; provided, however,
that the damage limitations described in part (i) of this sentence will not
apply if such damages are statutorily imposed. The arbitrators also shall be
authorized to grant any temporary, preliminary or permanent equitable remedy or
relief that the arbitrators deem just and equitable and within the scope of this
Agreement, including an injunction or order for specific performance. The award
of the arbitrators shall be the sole and exclusive remedy of the Parties.
Judgment on the award rendered by the arbitrators may be enforced in any court
having competent jurisdiction thereof, subject only to revocation on grounds of
fraud or clear bias on the part of the arbitrators.

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     11.2 Administration. Each Party shall bear its own attorneys’ fees, costs,
and disbursements arising out of the arbitration, and shall pay an equal share
of the fees and costs of the arbitrators; provided, however, that the
arbitrators shall be authorized to determine whether a Party is the prevailing
party, and if so, to award to that prevailing party reimbursement for its
reasonable attorneys’ fees, costs and disbursements (including, for example,
expert witness fees and expenses, photocopy charges and travel expenses), and/or
the fees and costs of the arbitrators. Absent the filing of an application to
correct or vacate the arbitration award (if permitted by ICC rules), each Party
shall fully perform and satisfy the arbitration award within fifteen (15) days
of the service of the award.
     11.3 Waivers. By agreeing to the binding arbitration provision in
Section 11.1, the Parties understand that they are waiving certain rights and
protections which may otherwise be available if a Dispute between the Parties
were determined by litigation in court, including the right to seek or obtain
certain types of damages precluded by this provision, the right to a jury trial,
certain rights of appeal, and a right to invoke formal rules of procedure and
evidence.
     11.4 Non-Arbitrable Disputes. Section 11.1 shall not apply to any dispute,
controversy or claim that concerns (A) the validity, enforceability or
infringement of a Patent, trademark or copyright; or (B) any antitrust,
anti-monopoly or competition law or regulation, whether or not statutory. All
such disputes, controversies or claims, and all judicial actions brought in
order to enforce the instituting Party’s rights hereunder through specific
performance, injunction or similar equitable relief, shall be brought before any
court having jurisdiction.
12. GENERAL PROVISIONS.
     12.1 Further Assurances. At any time or from time to time on and after the
Effective Date, each Party, at the request of the other Party, shall (i) deliver
to the other Party such records, data or other documents consistent with the
provisions of this Agreement, (ii) execute, and deliver or cause to be
delivered, all such assignments, consents, documents or further instruments of
transfer or license, and (iii) take or cause to be taken all such other actions,
as the other Party may reasonably deem necessary or desirable in order for such
other Party to obtain the full benefits of this Agreement and the transactions
contemplated hereby.
     12.2 Independent Contractors. The relationship between Indena and Spectrum
is that of principal to principal. Indena and Spectrum are not joint venturers,
partners, principal and agent, master and servant, employer or employee, and
have no other relationship other than independent contracting Parties. Indena
and Spectrum shall have no power to bind or obligate each other in any manner,
other than as is expressly set forth in this Agreement.

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     12.3 Entire Agreement; Modification. This Agreement sets forth the entire
agreement and understanding between the Parties as to the subject matter hereof.
There shall be no amendments or modifications to this Agreement, except by a
written document which is signed by both Parties.
     12.4 Force Majeure. Neither Party shall be liable for any delay or failure
of performance to the extent such delay or failure is caused by circumstances
beyond its reasonable control and that by the exercise of due diligence it is
unable to prevent, provided that the Party claiming excuse uses its commercially
reasonable efforts to overcome the same.
     12.5 Limitation of Liability. EXCEPT FOR LIABILITY FOR BREACH OF
CONFIDENTIALITY OR FOR INFRINGEMENT OR MISAPPROPRIATION, NEITHER PARTY SHALL BE
LIABLE TO THE OTHER FOR INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR
EXEMPLARY DAMAGES, INCLUDING BUT NOT LIMITED TO LOST PROFITS (EXCEPT, HOWEVER,
ANY LOST PROFITS OF SPECTRUM AS THE RESULT OF ANY BREACH BY INDENA OF ANY OF THE
REPRESENTATIONS IN SECTION 7.1 AND/OR THE COVENANTS IN ARTICLE 8), ARISING FROM
OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF THE
POSSIBILITY OF SUCH DAMAGES.
     12.6 Assignment. Except for sublicensing rights as set forth in
Section 2.2, this Agreement nor any rights granted hereunder may be assigned or
transferred by either Party without the prior written consent of the
non-assigning Party. Notwithstanding the foregoing, either Party may assign this
Agreement to (i) an Affiliate or (ii) a Third Party in connection with the
transfer or sale of all or substantially all of the business of such Party to
which this agreement relates whether by a merger, consolidation, sale of stock,
acquisition, sale of assets or otherwise. Subject to the limitations on
assignment herein, this Agreement shall be binding upon and inure to the benefit
of any successors in interest and permitted assigns of Indena and Spectrum. Any
such successor or permitted assignee shall expressly assume in writing the
performance of all terms and conditions of this Agreement to be performed by the
assigning Party.
     12.7 Governing Law. This Agreement shall be construed and enforced in
accordance with the laws of the State of California, without regard to the
conflicts of laws principles thereof.
     12.8 Headings. The headings for each article and section in this Agreement
have been inserted for convenience of reference only and are not intended to
limit or expand on the meaning of the language contained in the particular
article or section.
     12.9 Interpretation. The following provisions apply to this entire
Agreement unless a particular provision clearly specifies otherwise:

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               (a) All references to monetary amounts are to the Euro, the
official currency of the Eurozone.
               (b) The use of words in the singular or plural, or with a
particular gender, shall not limit the scope or exclude the application of any
provision of this Agreement to such person or persons or circumstances as the
context otherwise permits.
               (c) The words “include” and “including” have the inclusive
meaning “including without limitation” and “including but not limited to.”
               (d) The word “day” shall mean a calendar day and the words
“business day” shall mean a day other than a Saturday, a Sunday, or any day that
is a public holiday for employees of the U.S. Federal government (as established
by 5 U.S.C. 6103 or any statute that supersedes it).
               (e) Time periods within or following which any payment is to be
made or act is to be done shall be calculated by excluding the day on which the
period commences and including the day on which the period ends and by extending
the period to the next business day following if the last day of the period is
not a business day in the jurisdiction of the Party to make such payment or do
such act.
               (f) Any reference to this Agreement or any other agreement,
document or filing shall refer to that item as amended from time to time.
               (g) Any reference to an Article, Section, Exhibit or Schedule
shall be to the applicable Article, Section, Exhibit or Schedule to this
Agreement and not to or of any other document.
     12.10 Severability. Should any one or more of the provisions of this
Agreement be held invalid or unenforceable by a court of competent jurisdiction,
it shall be considered severed from this Agreement and shall not serve to
invalidate the remaining provisions thereof. The Parties shall make a good faith
effort to replace any invalid or unenforceable provision with a valid and
enforceable one such that the objectives contemplated by them when entering this
Agreement may be realized.
     12.11 No Waiver. Any delay in enforcing a Party’s rights under this
Agreement or any waiver as to a particular default or other matter shall not
constitute a waiver of such Party’s rights to the future enforcement of its
rights under this Agreement, excepting only as to an express written and signed
waiver as to a particular matter for a particular period of time.
     12.12 Notices. Any notices required by this Agreement shall be in writing,
shall specifically refer to this Agreement and shall be sent by registered or
certified airmail, postage prepaid, or by e-mail or telefax, confirmed by
registered mail, or by telex or cable, charges prepaid, or by overnight courier,

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charges prepaid, and shall be delivered to the respective addresses set forth
below unless subsequently changed by written notice to the other Party:

     
For Indena:
  Indena SpA
 
  Viale Ortles, 12
 
  20139 Milano, Italy
 
  Facsimile: (+39) 02 57496236
 
  E-Mail: [***]
 
  Attention: Gian Paolo Forni
 
   
For Spectrum:
  Spectrum Pharmaceuticals, Inc.
 
  157 Technology Drive
 
  Irvine, CA 92618
 
  Facsimile: (949) 788-6706
 
  E-Mail: [***]
 
  Attention: Rajesh C. Shrotriya, M.D.

Notice shall be deemed delivered upon the earlier of (i) when actually received,
(ii) the date notice is sent via e-mail, telefax, telex or cable, and confirmed
by written receipt or (iii) the day immediately following delivery to overnight
courier, except that notices received on Sundays or holidays will be deemed
received the following business day.
     12.13 Compliance with Laws. Nothing contained in this Agreement shall
require or permit Indena or Spectrum to do any act inconsistent with the
requirements of any Italian or United States law, regulation or executive order
as the same may be in effect from time to time.
     12.14 Counterparts. This Agreement may be executed simultaneously in one or
more counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
     IN WITNESS WHEREOF, the Parties have executed this Agreement by their duly
authorized representatives as of the date first set forth above.

              INDENA SPA   SPECTRUM PHARMACEUTICALS, INC.
 
           
By:
  /s/ Dario Bonacorsi   By:   /s/ Rajesh C. Shrotriya, M.D.
 
            Name: Dario Bonacorsi   Name: Rajesh C. Shrotriya, M.D. Title:
President and CEO   Title: Chairman, CEO and President

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EXHIBIT A
IDN 5109
[***]

 

--------------------------------------------------------------------------------

 

EXHIBIT B
LIST OF PATENTS
[***]

 

[Exhibit B, 11 pages, has been omitted in its entirety and filed separately with
the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted pages.]