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
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1.
DEFINITIONS
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1.1
Affiliate
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1.2 cGMP
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1.3 Confidential
Information
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1.4
Controlled
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1.5 DMF
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1.6 EMEA
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1.7 Event of
Default
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1.8 FDA
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1.9 First
Commercial Sale
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1.10 GAAP
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1.11 IDN
5109
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1.12
Improvements
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1.13 IND
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1.14 Joint
Inventions
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1.15 Joint
Patent
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1.16
Know-How
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1.17 License
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1.18 Licensed
Compound or “API”
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1.19 Licensed
Field
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1.20 MAA
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1.21 MHLW
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1.22 Milestone
Payments
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1.23 NDA
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1.24 Net
Sales
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1.25 Patent
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1.26 Patent
Rights
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1.27 Product
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1.28 Regulatory
Approval
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1.29 Regulatory
Authority
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1.30 Regulatory
Filings
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1.31 Royalty
Term
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1.32
Technology
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1.33 Term
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1.34
Territory
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1.35 Third
Party
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1.36 Valid
Claim
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2. LICENSE
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2.1 License
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2.2
Sublicenses
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2.3 Technology and
Material Transfer
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2.4 Exceptions to
Exclusivity
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2.5 Regulatory
Filings
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3. FINANCIAL TERMS
AND CONDITIONS
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3.1 Upfront and
Milestone Payments
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3.2 Product
Royalties
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3.3 Payments
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3.4 Records
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3.5 Income or
Other Tax Withholding
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3.6 Audit
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3.7 Late
Payments
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4. OWNERSHIP AND
PATENT MATTERS
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4.1
Ownership
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4.2 Prosecution
and Maintenance of Patent Rights
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4.3 Infringement
Actions
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5. OBLIGATIONS
RELATED TO SUPPLY, DEVELOPMENT, MARKETING AND
COMMERCIALIZATION
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5.1
Spectrum’s Diligence Obligations
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5.2 Research and
Development
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5.3 Governmental
Approvals
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5.4 Supply of
API
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6. INDEMNITY
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6.1 Spectrum
Indemnification
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6.2 Indena
Indemnification
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6.3 Indemnity
Procedure
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7. REPRESENTATIONS
AND WARRANTIES
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7.1 By
Indena
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7.2 By
Spectrum
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8. ADDITIONAL
COVENANTS
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8.1 Preservation
of Title
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8.2 No
Conflicts
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9. CONFIDENTIALITY
AND PUBLICATION
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9.1 Treatment of
Confidential Information
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9.2 Public
Statements
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10. TERM, DEFAULT
AND TERMINATION
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10.1 Term of
Agreement
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10.2 Unilateral
Termination — Spectrum
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10.3 Default
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10.4
Insolvency
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10.5 Effects of
Expiration or Termination
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10.6
Work-in-Progress
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11. DISPUTE
RESOLUTION
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11.1
Arbitration
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11.2
Administration
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11.3 Waivers
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11.4
Non-Arbitrable Disputes
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12. GENERAL
PROVISIONS
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12.1 Further
Assurances
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12.2 Independent
Contractors
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12.3 Entire
Agreement; Modification
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12.4 Force
Majeure
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12.5 Limitation of
Liability
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12.6
Assignment
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12.7 Governing
Law
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12.8
Headings
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12.9
Interpretation
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12.10
Severability
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12.11 No
Waiver
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12.12
Notices
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12.13 Compliance
with Laws
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12.14
Counterparts
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iii
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
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
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
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
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:
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Upfront |
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As per
Section 2.5
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€ 1,000,000 pursuant to Section 3.1(a); and |
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(ii) |
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€ 1,000,000 pursuant to Section 3.1(b) |
7
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Payment |
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(Euros) |
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Milestones
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[***] months after
the date both of the following have been achieved: (i) [***]
(consistent with the terms of [***] of this Agreement) [***], in
[***] reasonable opinion, [***]:
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€ [***] pursuant to Section 3.1(b) |
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At the time the 10th
patient is dosed in a Phase 3 clinical trial:
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(i) |
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€ [***] pursuant to Section 3.1(a); and |
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(ii) |
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€ [***] pursuant to Section 3.1(b) |
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Acceptance of the
NDA filing by the FDA in the United States:
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€ [***] pursuant to Section 3.1(b) |
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Approval of the NDA
by FDA in the United States:
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(i) |
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€ [***] pursuant to Section 3.1(a); and |
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(ii) |
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€ [***] pursuant to Section 3.1(b) |
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Acceptance of the
MAA filing by the EMEA:
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(i) |
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€ [***] pursuant to Section 3.1(a); and |
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(ii) |
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€ [***] pursuant to Section 3.1(b) |
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Approval of the MAA
filing by the EMEA:
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(i) |
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€ [***] pursuant to Section 3.1(a); and |
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(ii) |
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€ [***] pursuant to Section 3.1(b) |
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Acceptance of the
NDA filing by the MHLW in Japan:
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(i) |
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€ [***] pursuant to Section 3.1(a); and |
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(ii) |
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€ [***] pursuant to Section 3.1(b) |
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Approval of the NDA
by the MHLW in Japan:
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(i) |
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€ [***] pursuant to Section 3.1(a); and |
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(ii) |
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€ [***] pursuant to Section 3.1(b) |
8
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Payment |
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(Euros) |
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Annual Net Sales
exceed € [***]:
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(i) |
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€ [***] pursuant to Section 3.1(a); and |
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(ii) |
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€ [***] pursuant to Section 3.1(b) |
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Annual Net Sales
exceed € [***]:
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(i) |
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€ [***] pursuant to Section 3.1(a); and |
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(ii) |
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€ [***] 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.
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Annual Net Sales |
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Royalty Rate |
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€ [***]
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[***]% |
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More than
€ [***] but less than or
equal to € [***]
|
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[***]% |
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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
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
10
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
11
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.
12
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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