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Confidential Materials omitted and
provided separately with the
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Exhibit 10.30
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Securities and Exchange
Commission. Asterisks denote omissions.
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EXECUTION COPY
ELAN PHARMA INTERNATIONAL
LIMITED
AND
NITROMED, INC.
LICENSE
AGREEMENT
INDEX
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1.
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Definitions and Interpretation
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2.
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The License
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3.
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Intellectual Property
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4.
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Non-Competition
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5.
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Registration, Marketing and the Promotion of
the Product
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6.
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Production License
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7.
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Financial Provisions
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8.
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Payments, Reports and Audits
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9.
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Duration and Termination
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10.
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Consequences of Termination
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11.
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Warranties, Indemnification and
Liability
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12.
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Confidentiality
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13.
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Miscellaneous Provisions
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Schedule 1
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Technological Competitors of
Elan
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Schedule 2
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Key Terms for Supply Agreement
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Schedule 3
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Product Manufacturing Costs
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THIS AGREEMENT is dated 9 February,
2007.
PARTIES:
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(1)
ELAN PHARMA INTERNATIONAL LIMITED , a public
limited company incorporated under the laws of Ireland, having its
registered office at Monksland Industrial Estate, Athlone, County
Westmeath Ireland (" Elan "); and
(2)
NITROMED, INC. , a Delaware corporation,
having its principal place of business at 125 Spring Street,
Lexington MA 02421-7801 (" NitroMed ").
BACKGROUND:
(A)
Elan possesses certain proprietary technology and
confidential information used or useful in the manufacture and use
of pharmaceutical products displaying a sustained or modified
release profile, as described more fully below.
(B)
NitroMed is developing pharmaceutical formulations
containing the Compound, as defined below.
(C)
NitroMed wishes to enter into this Agreement to
obtain the right to utilize the Elan Intellectual Property (as
defined below) to import, use, offer for sale and sell the Product
in the Field in the Territory, on the terms and conditions set out
below.
(D)
Simultaneously with this Agreement, Elan’s
Affiliate EDDI (as defined below) and NitroMed have entered into a
Development Agreement whereby EDDI is to develop the Product (the "
Development Agreement ").
TERMS:
The parties agree as follows:
1.
DEFINITIONS AND INTERPRETATION
" Affiliate " means any corporation or entity
controlling, controlled or under common control with Elan or
NitroMed, as the case may be. For the purposes of this
Agreement, "control" means the direct or indirect ownership of more
than 50% of the issued voting shares or other voting rights of the
subject entity to elect directors, or if not meeting the preceding
criteria, any entity owned or controlled by or owning or
controlling at the maximum control or ownership right permitted in
the country where such entity exists.
" Agreement " means this license agreement (which
expression shall be deemed to include its Recitals and
Schedules).
" BiDil " means the existing immediate release product
containing the Compound that is currently marketed in the United
States by NitroMed.
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" Business Days " means Monday to Friday
inclusive, excluding any days on which the clearing banks are
generally closed in Dublin and/or New York.
" Claims " means all and any claims (whether successful
or otherwise), loss, liability, damages and expenses, including
reasonable attorneys’ fees and expenses and legal costs.
" CMC Section " means the chemistry, manufacturing, and
controls section of the Regulatory Application in the USA as
defined in 21 C.F.R. Section 314.50 (1) relating to the Product, as
may be amended from time to time, and/or its equivalent in other
Regulatory Applications.
" Competitive Product " means any pharmaceutical product
(other than the Product itself) that has received final regulatory
approval (including marketing, pricing, reimbursement and any other
applicable approval) from the applicable Governmental Authority in
a country in the Territory for use solely for the treatment of
heart failure as an adjunct to current standard therapy in
self-identified black patients to improve survival.
" Compound " means the combination of the active drug
substances isosorbide dinitrate and hydralazine HCl and/or other
salts, bases and isomeric forms of each.
" Compound Data " means data relating to the Compound
generated by NitroMed or EDDI pursuant to the R&D Program.
" DMF " means the Drug Master File, as defined in the 21
C.F.R., Section 314.420 and/or its equivalent in the other
countries of the Territory, which Elan (or an Affiliate) may file
in respect of the Elan Technology and the application of the Elan
Technology as regards the Product.
" EDDI " means Elan Drug Delivery Inc., a Delaware
corporation, having its principal place of business at 3000 Horizon
Drive, King of Prussia, PA 19406
" EEA " means the Member States of the European Economic
Area, as same may change from time to time in terms of Member
States.
" EHI " means Elan Holdings, Inc a Delaware corporation
having its principal place of business at 1300 Gould Drive,
Gainesville, GA 30504, USA.
" Effective Date " means the date of this Agreement as
first set forth above.
" Elan Improvements " means any and all improvements to
the Elan Patents, the Elan Know-How, the Elan Technology and/or the
Product Patents that have been conceived, created, developed and/or
otherwise invented by Elan and/or NitroMed under the R&D
Program, or otherwise pursuant to this Agreement.
" Elan Intellectual Property " means the Elan Know-How,
the Elan Patents, the Elan Improvements and the Product
Patents.
" Elan Know-How " means any and all rights owned,
licensed or controlled by Elan as of the Effective Date to any
scientific, pharmaceutical or technical information, data,
discovery, invention (whether patentable or not), know-how,
substances, techniques, processes, systems, formulations, designs
and expertise relating to the Elan Technology which is not
generally known to the public.
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" Elan Patents " means any and all Patent
Rights now existing, currently pending or hereafter filed by Elan
relating to the Elan Technology.
" Elan Technology " means the SODAS â oral controlled
release formulation technology that comprises the formation of
0.5-5mm beads containing an active agent and excipients which can
be coated with a product-specific modified release polymer and then
formulated into a final formulation such as a sprinkle, a tablet or
a capsule, as applied in the Elan Know-How.
" Elan Trademark " means SODAS ® or such other trade marks as
Elan may from time to time reasonably specify.
" EXW " (ex works) has the same meaning as in the ICC
Incoterms 2000, International Rules for the Interpretation of Trade
Terms, ICC Publication No. 560.
" FDA " means the United States Food and Drug
Administration or any other successor agency whose approval is
necessary to market the Product in the United States of
America.
" Field " means the use as a prescription or
over-the-counter pharmaceutical product in humans.
" Force Majeure " means any cause or condition beyond the
reasonable control of the party obliged to perform, including acts
of God, acts of government (in particular with respect to the
refusal to issue necessary import or export licenses), fire, flood,
earthquake, war, acts of terrorism, riots or embargoes, strikes or
other labour difficulties affecting a party.
" Governmental Authority " means all governmental and
regulatory bodies, agencies, departments or entities, whether or
not located in the Territory, which regulate, direct or control
commercial and other related activities in or with the
Territory.
" In Market " means the sale of the Product in the
Territory by NitroMed, or where applicable, by a permitted
sub-licensee, to an unaffiliated third party, such as a wholesaler,
distributor, managed care organisation, hospital or pharmacy, and
shall exclude the transfer pricing of the Product by one NitroMed
Affiliate to another NitroMed Affiliate or a permitted
sub-licensee.
" Major Market(s) " means the United States, the United
Kingdom, France, Germany, Spain and Italy and such additional
countries as may be agreed by the parties from time to time.
" Major Territories " means the United States, the United
Kingdom, France, Germany, Spain, Italy, Canada, Australia, New
Zealand, Japan, South Korea and Brazil.
" Net Sales " shall, subject to the provisions of Clause
7.4, mean in the case of Product sold by NitroMed, or by a
permitted sub-licensee, the aggregate gross In Market sales
proceeds billed for the Product by NitroMed, or by a permitted
sub-licensee, as the case may be, in accordance with generally
accepted accounting principles, less the following:
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(i)
trade, cash or quantity discounts, allowances,
adjustments and rejections;
(ii)
rebates, recalls (other than where the Product is
replaced without charge) and returns;
(iii)
price reductions or rebates imposed by Governmental
Authorities;
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(iv)
debts arising from failure to collect on customer
accounts (such debts not to exceed 1% of gross In Market
sales);
(v)
sales, excise, turnover, inventory, value-added and
similar taxes assessed on the royalty-bearing sale of such Product,
but not including any taxes on income paid by or assessed against
NitroMed or a permitted sub-licensee;
(vi)
transportation, importation, shipping, insurance and
other handling expenses directly chargeable to the royalty-bearing
sale of the Product, but only to the extent that such expenses are
separately delineated in the applicable invoices; and
(vii)
chargebacks granted to drug wholesalers or their
customers in cases where there are not direct shipments to such
customers by NitroMed or its permitted sublicense.
Any discretionary rebates, discounts or adjustments shall be
commercially reasonable and consistent with standard industry
practices.
" NitroMed Improvements " means any and all improvements
to the NitroMed Patents, the NitroMed Know-How and/or the Compound
that have been conceived, created, developed and/or otherwise
invented by NitroMed and/or Elan under the R&D Program, or
otherwise pursuant to this Agreement.
" NitroMed Intellectual Property " means the NitroMed
Know-How, the NitroMed Patents and the NitroMed Improvements.
" NitroMed Know-How " means any and all rights owned,
licensed or controlled by NitroMed (otherwise than pursuant to the
Elan License) to any scientific, pharmaceutical or technical
information, data, discovery, invention (whether patentable or
not), know-how, substances, techniques, processes, systems,
formulations and designs and expertise relating to the Compound
which is not generally known to the public.
" NitroMed Patents " means any and all Patent Rights now
existing, currently pending or hereafter filed, or acquired or
licensed by NitroMed relating to the Compound.
" NitroMed Trademark " means NitroMed’s rights to
use the trademark(s) NitroMed ®
, BiDil ® , NitRx ® , the NitroMed "N" logo and such
other trademarks as NitroMed may from time to time reasonably
specify.
" Patent Rights " means any and all rights under any and
all patent applications and/or issued or granted patents, now
existing, currently pending or hereafter filed, including, but not
limited to, provisional applications, substitutions, divisionals,
continuations, continuations-in-part, renewals and any foreign
counterparts thereof or equivalents thereto, including the right to
claim priority from any of the foregoing under the Paris
Convention, and all patents issuing or granted on any of the
foregoing, and any foreign counterparts thereof, together with all
registrations, reissues, re-examinations, supplemental protection
certificates, or extensions thereof, and any foreign counterparts
thereof, or any other government-issued rights substantially
equivalent to the foregoing.
" Product " means the once or twice-daily oral tablet or
oral capsule formulation(s) incorporating the Elan Technology and
containing the Compound as its sole active combination of
ingredients, being developed pursuant to the R&D Program.
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" Product Patents " means Patent Rights
specifically exemplifying or claiming the Product. For the
avoidance of doubt, Product Patents do not include the NitroMed
Patents or the Elan Patents.
" Prosecute " means in relation to a class of
intellectual property:
(a)
to secure the grant of any patent application within
such class;
(b)
to file and prosecute patent applications on
patentable inventions and discoveries relating to that
class;
(c)
to defend all such applications against third party
oppositions; and
(d)
to maintain in force any issued letters patent
relating to the same
and " Prosecution " has a corresponding meaning.
" R&D Program " means the research and development
program set forth in the Development Agreement.
" Regulatory Application " means any regulatory
application or any other application for marketing approval for the
Product, which NitroMed may file in the Territory, including any
supplements or amendments thereto which NitroMed may file.
" Regulatory Approval " means the final approval to
market the Product in any country of the Territory, including all
approvals which are required to launch the Product in the normal
course of business.
" Supply Agreement " means the manufacturing and supply
agreement to be negotiated in good faith between Elan and NitroMed
whereby Elan will supply substantially all of NitroMed’s
commercial requirements of the Product, subject to the terms herein
and therein, and which shall incorporate the key terms set out in
Schedule 2.
" Technical Failure " means the inability to achieve a
pharmacokinetic profile for Product (assessing Cmax (maximum
concentration) and AUC (area under the curve) criteria within
80-125% of mean data) consistent with that of BiDil administered
three times daily (at 6 hour intervals).
" Technological Competitor " means a person or entity
listed in Schedule 1, and divisions, subsidiaries and successors
thereof, and such other corporate entities that, other than as a de
minimis activity, develop oral drug delivery technology displaying
a sustained release or modified release profile and/or manufacture
products displaying a sustained or modified release profile that
Elan may request to add to Schedule 1 from time to time, subject to
the consent of NitroMed, which consent may not be unreasonably
withheld or delayed.
" Term " means the term of this Agreement, as set out in
Clause 9.
" Territory " means all of the countries of the
world.
" $ " and " US$ " mean United States Dollars.
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Definition
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Clause
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"Alternate Source"
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6.1
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"Bankruptcy Code"
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2.3
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"Confidential Information"
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12.1
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"Development Agreement"
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Recital (D)
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"Disclosing Party"
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12.12
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"Due Date"
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8.8
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"Elan License"
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2.1
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"Estimated Statement"
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8.1
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"Final Statement"
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8.1
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"Firm"
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3.5.5
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"Infringement Claim"
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3.4.1
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"Initial Term"
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9.1
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"License Milestone Payments"
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7.1
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"Manufacturer"
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6.1.2
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"Second Source"
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6.1
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"Tech Transfer Program"
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6.2
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"Notice"
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13.11.1
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"Notified Party"
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3.5.1
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"Notifying Party"
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3.5.1
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2.
THE LICENSE
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2.1.
Elan License to NitroMed . Subject
to the terms of this Agreement, Elan hereby grants to NitroMed for
the Term an exclusive license (the " Elan License ") to the
Elan Intellectual Property to import, use, offer for sale and sell
the Product in the Field in the Territory. For the avoidance of
doubt, the Elan License does not include the right to perform any
formulation and/or process development activities for the
Product.
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licensees and shall not disclose any information
from the CMC Section to a any third party, including a permitted
sub-licensee, without the prior written consent of Elan, which
consent shall not be unreasonably withheld or delayed, other than
as contemplated pursuant to the terms of Clause 2.2.1.
2.3.
Section 365(n) of the Bankruptcy Code
. The licenses granted under this Agreement shall be treated
as licenses of rights to "intellectual property" (as defined in
Section 101(56) of Title 11 of the United States Code, as amended
(the " Bankruptcy Code ")) for purposes of Section 365(n) of
the Bankruptcy Code. The parties agree that each party may
elect to retain and may fully exercise all of its rights and
elections under the Bankruptcy Code; provided that the
electing party complies with the terms of this Agreement.
3.
INTELLECTUAL PROPERTY
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intellectual property rights of a third party and
that such infringement arises from or relates to use of the Elan
Technology in the Product, that party (the " Notifying Party
") shall so inform the other party (the " Notified Party ")
by written notice, which shall include documents supporting the
Notifying Party’s position. If the Notifying Party
believes a license from such third party is necessary or advisable
to exercise its rights and obligations under this Agreement,
including without limitation to sell the Product and/or mitigate
any potential liability arising therefrom (a " Third Party
License "), the notice shall include reference to such Third
Party License.
3.5.2
Counter-Notice . The Notified Party
shall have fifteen (15) working days to review the notice issued
pursuant to Clause 3.5.1 from the Notifying Party and to agree or
disagree with the Notifying Party’s belief by written
counter-notice. If the Notified Party disagrees with the
Notifying Party’s belief, then the Notified Party shall
provide the Notifying Party with documents supporting the Notified
Party’s position. The Notifying Party shall have
fifteen (15) working days from the date of receipt to review the
documents from the Notified Party. Failure to respond to the
other party’s notice shall be taken for the purposes of the
decision as to whether to obtain a license under this Clause 3.5.2
(but for the avoidance of doubt, not for any other purpose
whatsoever) as accession to the position of the other party.
The parties agree that the time periods as set forth in this Clause
3.5.2 may be reasonably extended by the mutual written agreement of
the parties.
3.5.3
Use of Documents . All documents
exchanged by the parties shall be maintained in confidence and
shall not be used for any other purpose than the resolution of the
scope of a third party’s intellectual property rights as it
pertains to the importation, use, offer for sale or sale of the
Product as set forth in this Agreement.
3.5.4
Resolution . If the Notified Party
disagrees with the Notifying Party’s position pursuant to the
terms as set forth in Clause 3.5.2 herein and if the Notifying
Party maintains its original position after such review period,
then the matter shall be referred first to the officers of Elan and
NitroMed having responsibility for the subject matter of the
dispute, or their designees. Such officers, or their
designees, as the case may be, shall negotiate in good faith to
resolve such dispute in a mutually satisfactory manner. If
such efforts do not result in a mutually satisfactory resolution of
the dispute within fifteen (15) working days of such referral, the
matter shall be referred to the chief executive officer of each
party, or their respective designees.
3.5.5
Final Resolution . If the
parties’ chief executive officers or their designees do not
resolve the dispute within fifteen (15) working days of the matter
being referred to them (or such longer time periods as may be
mutually agreed in writing by the parties), an independent mutually
acceptable Third Party law firm with suitable expertise in the
field of intellectual property in pharmaceuticals (the "
Firm ") shall be appointed to determine whether, in its
opinion, the sale of the Product would infringe such third party
intellectual property. The Firm’s opinion shall be binding on
both parties. An appropriate community of interest agreement
shall be entered into so that the benefit of the Firm’s
opinion shall inure to both parties. Once appointed, the Firm
shall not be used by either party for matters pertaining to the
Elan Intellectual Property or the NitroMed Intellectual Property,
other than subsequent disputes under this Clause 3.5. The
costs of the Firm shall be borne by the party with whom the Firm
disagrees.
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3.5.6
Disputes Not To Be Reopened . The
procedure in Clauses 3.5.1 to 3.5.5 shall not be used more than
once in relation to any particular third party intellectual
property allegedly infringed, absent new and relevant
facts.
3.5.7
Negotiation . If the parties or the
Firm determine that a license should be obtained, Elan shall have
the initial right to negotiate such license. Elan shall not
agree to or settle any license negotiations for an amount that
exceeds its obligation to pay pursuant to Section 3.4 without
NitroMed’s prior written approval. To the extent Elan
violates the foregoing, Elan shall be fully liable for the monetary
obligation arising from the agreement and/or settlement as a result
thereof. In the event that Elan is unsuccessful in obtaining
such a license within [**] days of the determination to seek a
license from such third party, then NitroMed shall have the right
to negotiate such license. In the event that NitroMed obtains
the right to negotiate a third party license pursuant to this
Clause 3.5.7, and chooses to exercise such right, NitroMed shall
not, without Elan’s prior written approval, propose nor agree
to the grant of any right whatsoever under the Elan Intellectual
Property as a part of those negotiations or as a part of any
settlement arising from such negotiations.
3.5.8
Terms . The party attempting to
negotiate the license shall:
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3.5.8.1
use all commercially reasonable efforts to achieve
commercially reasonable terms;
3.5.8.2
keep the other party reasonably informed of such
negotiations;
3.5.8.3
submit to the other party any draft terms for
approval;
3.5.8.4
reasonably take into account any comments the other
party may have; and
3.5.8.5
without prejudice to the generality of the
foregoing, use all commercially reasonable efforts to ensure that
the license is sub-licensable to NitroMed (in the case of Elan) or
sub-licensable and freely transferable to Elan (in the case of
NitroMed).
3.5.9
Third Party Royalties. Regardless as to
whether Elan or NitroMed is responsible for negotiating any Third
Party License pursuant to this Clause 3.5 the costs of obtaining
such Third Party License shall be apportioned as follows:
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3.5.9.1
Elan shall be responsible for [**] of all such
costs, including license fees, milestone payments and royalties up
to a maximum aggregate responsibility under all Third Party
Licenses (" Third Party Royalties ") in any given calendar
quarter up to [**] of the royalties otherwise payable to Elan under
this Agreement in that quarter, subject to the provisions of Clause
3.4;
3.5.9.2
NitroMed shall be responsible for any Third Party
Royalties in any calendar quarter of the Term in excess in excess
of the limits set forth in Clause 3.5.9.1; and
3.5.9.3
Notwithstanding the foregoing, any amounts payable
by NitroMed under Clause 3.5.9.2 may be carried forward to
subsequent calendar quarters of
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3.6.
Notwithstanding any provision to the contrary in
this Agreement and for clarity, Elan’s maximum aggregate
liability for Third Party Royalties and Infringement Claim Fees
shall be limited to a maximum of [**] of the royalties otherwise
payable to Elan under this Agreement, except as otherwise provided
in Clause 3.4, but NitroMed shall be entitled to recover any Third
Party Royalties or Infringement Claim Fees for which (in each case)
Elan is responsible in excess of such quarterly limit as a credit
against any royalties due to Elan in subsequent quarters of
the Term up to [**] of the royalties otherwise payable to Elan
under this Agreement in such quarter, except as otherwise provided
in Clause 3.4.
3.7.
Trademarks .
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