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ELAN PHARMA INTERNATIONAL LIMITED AND ENTREMED, INC. LICENSE AGREEMENT
License Agreement
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ENTREMED INC | ELAN PHARMA INTERNATIONAL LIMITED
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Title: ELAN PHARMA INTERNATIONAL LIMITED AND ENTREMED, INC. LICENSE AGREEMENT Date: 5/10/2006 Industry: Biotechnology and Drugs
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Exhibit
10.1
EXECUTION
COPY
ELAN PHARMA INTERNATIONAL
LIMITED
AND
ENTREMED, INC.
LICENSE AGREEMENT
INDEX
1.
Definitions
and Interpretation
1
2.
The
License
7
3.
Intellectual
Property
8
4.
Non-Competition
15
5.
Registration, Marketing and the Promotion of the
Product
15
6.
Financial
Provisions
15
7.
Manufacture
and Supply
18
8.
Payments,
Reports and Audits
19
9.
Duration and
Termination
19
10.
Consequences
of Termination
21
11.
Warranties,
Indemnification and Liability
22
12.
Confidentiality
25
13.
Miscellaneous Provisions
26
Schedule 1
EPIL
Patents
31
Schedule 2
EntreMed
Patents
39
Schedule 3
Technological Competitors
40
Schedule 4
Commercial
Unit Dose Cost of Goods Pricing
41
Schedule 5
Key Terms
for Manufacturing and Supply Agreement
42
i
THIS LICENSE
AGREEMENTis dated
January 9, 2006
PARTIES:
(1)
ELAN PHARMA INTERNATIONAL
LIMITED, a
company incorporated under the laws of Ireland, having its
registered office at Monksland, Athlone, Co Westmeath, Ireland
(“ EPIL ”); and
(2)
ENTREMED, INC., a Delaware
corporation, having its principal place of business at 9640 Medical
Center Drive, Rockville, MD 20850 (“ EntreMed
”).
BACKGROUND:
(A)
EPIL possesses certain proprietary
technology as well as proprietary know-how and confidential
information used or useful in the manufacture and use of
pharmaceutical products containing nanoparticles.
(B)
EntreMed possesses certain rights to
intellectual property rights covering the Compound (as defined
below).
(C)
EntreMed wishes to obtain the right
to utilize certain EPIL Intellectual Property to commercialize the
Product in the Field in the Territory in accordance with the terms
and conditions set out below.
(D)
Simultaneously with or shortly after
the execution of this Agreement, EntreMed intends to enter into a
Services Agreement with EDDI, an EPIL Affiliate, that will contain
a Development Plan for further research and development of the
Product and that will grant EDDI the exclusive right to supply the
Product to EntreMed for preclinical, clinical and regulatory
purposes.
(E)
Following the execution of this
Agreement and the Services Agreement, EPIL and EntreMed intend to
enter into a Manufacturing and Supply Agreement that will establish
the terms by which EPIL or an Affiliate will manufacture and supply
to EntreMed its entire requirement of the Product for commercial
supply in the Territory.
TERMS:
The Parties
agree as follows:
1.
DEFINITIONS AND
INTERPRETATION
1.1.
Definitions. In this Agreement:
“ Affiliate ”
means any corporation or entity controlling, controlled or under
common control with EPIL or EntreMed, 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.
*
The marked
portions have been omitted pursuant to a request for confidential
treatment and filed separately with the Securities Exchange
Commission.
Page 1
“ Agreement ”
means this license agreement (which expression shall be deemed to
include its Recitals and Schedules).
“ API ” means
active pharmaceutical ingredient.
“ Business Days ”
means Monday to Friday inclusive, excluding any days on which the
clearing banks are generally closed in Dublin and/or New
York.
“ cGMP ” means
the then current regulations set forth in 21 C.F.R. Parts 210-211,
820 or 21 C.F.R. Subchapter C (drugs) quality system
regulations and the requirements thereunder imposed by the FDA and,
as applicable, the equivalent regulations and requirements imposed
by other RHAs in the Territory.
“ Claims ” means
all and any claims (whether successful or otherwise), demands,
settlement amounts, losses, liabilities, damages, costs and
expenses, including reasonable attorneys’ fees and expenses
and legal costs.
“ Commercially Reasonable
Efforts ” means those efforts of a party which are
consistent with those utilised by such party for its own internally
developed or in-licensed pharmaceutical products, taking into
account all factors that impact the manufacturing, development,
marketing and sales of such products, as applicable.
“ Compound ”
means EntreMed’s proprietary compound 2-methoxyestradiol
(2ME2) having the following chemical formula: