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Exhibit 10.33
[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT
HAVE BEEN MARKED TO INDICATE THAT
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED
FOR CONFIDENTIAL INFORMATION CONTAINED
IN THIS DOCUMENT. THE CONFIDENTIAL PORTIONS
HAVE BEEN OMITTED AND FILED
SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.]
LICENSE AND RESEARCH COLLABORATION AGREEMENT
BETWEEN
MERCK & CO., INC.
AND
DECODE GENETICS, EHF.
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LICENSE AND RESEARCH COLLABORATION AGREEMENT
THIS RESEARCH COLLABORATION AND LICENSE AGREEMENT (this
"Agreement"),
which shall be effective as of February 25,
2004 (the "Effective Date"), is
entered into by and between deCODE
genetics, Ehf., a corporation organized under
the laws of Iceland ("deCODE") and Merck
& Co., Inc., a corporation organized
under the laws of the State of New Jersey,
having an office located at One Merck
Drive, Whitehouse Station, New Jersey 08889
("MERCK").
PRELIMINARY STATEMENTS
A.
deCODE has expertise in conducting research in the field of
human
genetics and genomics and in the conduct of
clinical trials.
B.
MERCK has certain expertise in drug development and in the design
and
conduct of clinical trials to demonstrate
the safety and efficacy of its
pharmaceutical products.
C.
deCODE and MERCK wish to collaborate on the design and conduct
of
Information Rich Clinical Trials (terms
with initial capitals as hereafter
defined) on selected MERCK compounds in
specified Disease Areas in accordance
with the attached Work Plan.
D.
deCODE Parent (as
hereinafter defined) and MERCK are simultaneously
entering into a separate Stock and Warrant
Purchase Agreement whereby MERCK
shall purchase shares of stock of deCODE
Parent pursuant to the terms and
conditions set forth in that agreement.
NOW, THEREFORE, in consideration of the
foregoing Preliminary Statements and the
mutual agreements and covenants set forth
herein, the Parties hereby agree as
follows:
1.
DEFINITIONS
Unless specifically set forth to the contrary herein, the
following
terms, whether used in the singular or
plural, shall have the respective
meanings set forth below:
1.1
"AFFILIATE" shall mean as to deCODE or MERCK, as the case may be
(i)
any corporation or business entity of which fifty percent (50%) or
more
of the securities or other ownership interests representing the
equity,
the voting stock or general partnership interest are owned,
controlled
or held, directly or indirectly, by MERCK or deCODE; or (ii)
any
corporation or business entity which, directly or indirectly,
owns,
controls or holds fifty percent (50%) (or the maximum ownership
interest permitted by law) or more of the securities or other
ownership
interests representing the equity, the voting stock or, if
applicable,
the general partnership interest, of MERCK or deCODE.
1.2
"ASSOCIATED INFORMATION" shall mean information about
[CONFIDENTIAL
TREATMENT REQUESTED] in an IRCT performed as part of the
Research
Program which [CONFIDENTIAL TREATMENT REQUESTED] in an
Exclusive
Disease Area or a Non-exclusive Disease Area where the
[CONFIDENTIAL
TREATMENT REQUESTED] is associated with the [CONFIDENTIAL
TREATMENT
REQUESTED] within the Disease Area being studied in that IRCT.
1.3 "BUDGET"
shall mean the projected expenditures for the upcoming year
set out in Schedule 2.6
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and more fully described in Section 2.6.
1.4 "CALENDAR
QUARTER" shall mean the respective periods of three (3)
consecutive calendar months ending on March 31, June 30, September
30
and December 31.
1.5 "CALENDAR
YEAR" shall mean each successive period of twelve (12) months
commencing on January 1 and ending on December 31.
1.6 A "CHANGE
IN CONTROL" shall mean the occurrence of any of the
following:
(a) An acquisition of any voting securities of deCODE Parent
(the
"Voting
Securities") by any "Person" (as the term "person" is used for
purposes of Section 13(d) or 14(d) of the Securities Exchange Act
of
1934, as amended (the "Exchange Act")), immediately after which
such
Person has "Beneficial Ownership" (within the meaning of Rule
13d-3
promulgated under the Exchange Act) of more than fifty percent
(50%) of
(1) the then-outstanding shares of common stock of deCODE Parent
(or
any other securities into which such shares of common stock are
changed
or for which such shares of common stock are exchanged) (the
"Shares")
or (2) the combined voting power of deCODE Parent's
then-outstanding
Voting Securities;
(b) The individuals who, as of Effective Date, are members of the
board
of directors of deCODE Parent (the "Incumbent Board"), following
a
Merger (as hereinafter defined), do not for any reason constitute
at
least a majority of the members of the board of directors of (x)
the
corporation resulting from such Merger (the "Surviving
Corporation"),
if fifty percent (50%) or more of the combined voting power of
the
then-outstanding voting securities of the Surviving Corporation is
not
Beneficially Owned, directly or indirectly, by another Person
(a
"Parent Corporation") or (y) if there is one or more than one
Parent
Corporation, the ultimate Parent Corporation; PROVIDED, HOWEVER,
that,
any individual becoming a director subsequent to the date hereof
whose
election, or nomination for election by such company's
shareholders,
was approved by a vote of at least a majority of the directors
then
comprising the Incumbent Board shall be considered as though
such
individual were a member of the Incumbent Board, but excluding,
for
this purpose, any such individual whose initial assumption of
office
occurs as a result of an actual or threatened election contest
with
respect to the election or removal of directors or other actual
or
threatened solicitation of proxies or consents by or on behalf of
a
Person other than the board of directors of deCODE Parent (a
"Proxy
Contest"), including by reason of any agreement intended to avoid
or
settle any Proxy Contest;
(c) At least eighty (80%) percent of voting securities of deCODE
are no
longer owned directly or indirectly by deCODE Parent; or
(d) The consummation of:
(i) A merger,
consolidation or reorganization (1) with or
into deCODE Parent or a direct or indirect subsidiary of deCODE
Parent
or (2) in which securities of deCODE Parent are issued (both
1.5(c)(i)(1) and (2) are defined as a "Merger"), unless such Merger
is
a "Non-Control Transaction." A "Non-Control Transaction" shall mean
a
Merger in which:
(A) the stockholders of deCODE Parent immediately
before such Merger own directly or indirectly immediately
following
such Merger at least fifty percent (50%) of the combined voting
power
of the outstanding voting securities of (x) the Surviving
Corporation,
if there is no Parent Corporation or (y) if there is one or more
than
one Parent Corporation, the
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ultimate Parent Corporation;
(B) the individuals who were members of the
Incumbent Board immediately prior to the execution of the
agreement
providing for such Merger constitute at least a majority of the
members
of the board of directors of (x) the Surviving Corporation, if
there is
no Parent Corporation, or (y) if there is one or more than one
Parent
Corporation, the ultimate Parent Corporation; and
(C) no Person other than (1) deCODE Parent, or
(2) any Person who, immediately prior to the Merger had
Beneficial
Ownership of fifty percent (50%) or more of the then outstanding
Shares
or Voting Securities, has Beneficial Ownership, directly or
indirectly,
of fifty percent (50%) or more of the combined voting power of
the
outstanding voting securities or common stock of (x) the
Surviving
Corporation, if fifty percent (50%) or more of the combined
voting
power of the then outstanding voting securities of the
Surviving
Corporation is not Beneficially Owned, directly or indirectly by
a
Parent Corporation, or (y) if there is one or more than one
Parent
Corporation, the ultimate Parent Corporation; PROVIDED, HOWEVER,
that
any Person described in clause (2) of this subsection (C) may
not,
immediately following the Merger, Beneficially Own more than
thirty
percent (30%) of the combined voting power of the outstanding
voting
securities of the Surviving Corporation or the Parent Corporation,
as
applicable, for the Merger to constitute a Non-Control
Transaction.
(ii) A complete liquidation or dissolution of
deCODE Parent; or
(iii) The sale or other disposition of all or
substantially all of the assets of deCODE Parent and its
Subsidiaries
taken as a whole to any Person (other than (x) a transfer under
conditions that would constitute a Non-Control Transaction, with
the
disposition of assets being regarded as a Merger for this purpose
or
(y) the distribution to deCODE Parent's stockholders of any
other
assets).
Notwithstanding the foregoing, a Change in Control shall not be
deemed
to occur solely because any Person (the "Subject Person")
acquired
Beneficial Ownership of more than the permitted amount of the
then
outstanding Shares or Voting Securities as a result of the
acquisition
of Shares or Voting Securities by deCODE Parent which, by reducing
the
number of Shares or Voting Securities then outstanding, increases
the
proportional number of shares Beneficially Owned by the Subject
Persons; provided that if a Change in Control would occur (but for
the
operation of this sentence) as a result of the acquisition of
Shares or
Voting Securities by deCODE Parent and, after such share
acquisition by
deCODE Parent, the Subject Person becomes the Beneficial Owner of
any
additional Shares or Voting Securities and such Beneficial
Ownership
increases the percentage of the then outstanding Shares or
Voting
Securities Beneficially Owned by the Subject Person, then a Change
in
Control shall occur.
1.7
"COLLABORATION DATE" shall be February 25, 2004.
1.8
"COLLABORATION INFORMATION AND INVENTION" shall mean any
discoveries,
Improvements, processes, methods, protocols, formulas, data,
inventions, know-how and trade secrets, patentable or otherwise,
that
arise from the Research Program.
1.9
"COLLABORATION PATENTS" shall mean any and all patents and
patent
applications in the Territory (which for the purposes of this
Agreement
shall be deemed to include certificates of invention
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and applications for certificates of invention) that a Party or
its
Affiliates owns, Controls or through license or otherwise
acquires
rights during the term of this Agreement which claim, cover or
relate
to Collaboration Information and Inventions or are divisions,
continuations, continuations-in-part, reissues, renewals,
extensions,
supplementary protection certificates, utility, models and the like
of
any such patents and patent applications and foreign
equivalents
thereof.
1.10 "COMBINATION
PRODUCT" shall mean a Product which includes one or more
active ingredients other than IRCT Compound or Related IRCT
Compound in
combination with IRCT Compound or Related IRCT Compound. All
references
to Product in this Agreement shall be deemed to include
Combination
Product.
1.11 "COMPETITIVE
PRODUCT" shall mean a product containing the IRCT Compound
or Related IRCT Compound which has or attains on a Calendar Year
basis
a market share of [CONFIDENTIAL TREATMENT REQUESTED] or more in
a
country of sale as measured by prescriptions or other similar
information in the country of sale.
1.12 "COMPETITOR"
shall mean a company in the pharmaceutical business sector
with reported annual gross revenues from the sale of
pharmaceuticals in
excess [CONFIDENTIAL TREATMENT REQUESTED] for each of its
[CONFIDENTIAL
TREATMENT REQUESTED].
1.13 "CONTROL",
"CONTROLS" OR "CONTROLLED BY" shall mean either (a) being an
Affiliate of either MERCK or deCODE; or (b) with respect to any
item of
or right under Collaboration Patents, Patents or Know-How, the
possession of (whether by ownership or license, other than pursuant
to
this Agreement) or the ability of a Party to grant access to, or
a
license or sublicense of, such items or right as provided for
herein
without violating the terms of any agreement or other arrangement
with
any Third Party existing at the time such Party would be
required
hereunder to grant the other Party such access or license or
sublicense.
1.14 "deCODE
INFORMATION AND INVENTIONS" shall mean all Collaboration
Information and Inventions developed or invented solely by
employees of
deCODE or other persons not employed by MERCK acting on behalf
of
deCODE.
1.15 "deCODE
KNOW-HOW" shall mean all secret, substantial and identified
information and materials, including, but not limited to,
discoveries,
Improvements, processes, formulas, data, inventions(including
without
limitation
deCODE's Information and Inventions and deCODE's rights in
Joint Information and Inventions), know-how and trade secrets,
patentable or otherwise, which arise from the Research Program
and
during the term of this Agreement (i) are in deCODE's possession
or
control, (ii) are not generally known and (iii) are necessary or
useful
to MERCK in connection with the Research Program or the
research,
development, manufacture, marketing, use or sale of IRCT
Compound,
Related IRCT Compound, Tests or Product in the
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Territory.
1.16 "deCODE
COLLABORATION PATENTS" shall mean Collaboration Patents that
claim, cover or relate to deCODE Information and Inventions
excluding
deCODE Information and Inventions relating to deCODE
Generalized
Technology.
1.17 "deCODE
COMPOUNDS" shall mean compounds[CONFIDENTIAL TREATMENT
REQUESTED].
1.18 "deCODE
GENERALIZED TECHNOLOGY" shall mean any Technical Information
relating to generalized methods for conducting genomics research
and
characterizing the function of genes or any raw data useful in
generalized genomics research tools which at any time is owned
or
controlled by deCODE or its Affiliates (provided deCODE or its
Affiliates have the right to license or otherwise make available
such
Technical Information to MERCK).
1.19 "deCODE GENOMICS
DATA" shall mean (a) [CONFIDENTIAL TREATMENT
REQUESTED] as may be created, developed or acquired by deCODE from
time
to time during the term of this Agreement or as may be existing or
have
been created as of the Effective Date, and (b) deCODE's
proprietary
inventions, processes and other assets directly relating to the
use,
creation, maintenance, development, operation, access,
analysis,
reporting, storage, protection, and/or transmission of such
proprietary
databases, including proprietary methods, procedures and
techniques,
procedure manuals, personal and scientific data, computer
technical
expertise and software, in each case independently developed by or
on
behalf of deCODE and such software useful for the analysis of
the
information included in such databases.
1.20 "deCODE PARENT"
shall mean deCODE genetics, Inc., a corporation
organized and existing under the laws of the State of Delaware.
1.21 "deCODE PATENTS"
shall mean Patents, that deCODE or its Affiliates
Control prior to the Effective Date or during the term of this
Agreement, including but not limited to those listed on Schedule
1.21,
that are necessary or useful to MERCK in connection with the
Research
Program or the research, development, manufacture, marketing, use
or
sale of IRCT Compound, Tests or Product in the Territory
including
Patents claiming deCODE Genomics Data but excluding any part of
Patents
claiming deCODE Generalized Technology.
1.22 "deCODE PRIOR
KNOW-HOW" shall mean all secret, substantial and
identified information and materials, including, but not limited
to,
discoveries, Improvements, processes, formulas, data,
inventions,
know-how and trade secrets, patentable or otherwise, which
existed
prior to the Effective Date and during the term of this Agreement
(i)
are in deCODE's possession or control, (ii) are not generally known
and
(iii) are necessary or useful to MERCK in connection with the
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Research Program or the research, development, manufacture,
marketing,
use or sale of IRCT Compound, Tests or Product in the Territory
including deCODE Genomics Data but excluding deCODE Generalized
Technology and deCODE Know-How.
1.23 "DISEASE AREAS"
shall mean Exclusive Disease Areas and Non-exclusive
Disease Areas.
1.24 "EXCLUSIVE
DISEASE AREAS" shall mean at least one of the following:
[CONFIDENTIAL TREATMENT REQUESTED].
1.25 [CONFIDENTIAL
TREATMENT REQUESTED]
1.26 [CONFIDENTIAL
TREATMENT REQUESTED]
1.27 [CONFIDENTIAL
TREATMENT REQUESTED]
1.28 "NON-EXCLUSIVE
DISEASE AREAS" shall mean [CONFIDENTIAL TREATMENT
REQUESTED].
1.29 [CONFIDENTIAL
TREATMENT REQUESTED]
1.30 "ELECTED
DISEASE" shall have the meaning set out in Section 3.1(d).
1.31 "EXCLUSIVE
LICENSE FEE" shall have the meaning set out in Section
3.1(d).
1.32 "EXECUTIVE
COMMITTEE" shall mean the committee made up of one senior
executive of each Party as more fully described in Section
2.5.1.
1.33 "FILING" of an
NDA shall mean the acceptance by a Regulatory Authority
of an NDA for filing.
1.34 "FIRST
COMMERCIAL SALE" shall mean, with respect to any Product or
Test, the first sale for end use or consumption of such Product or
Test
in a country after all required approvals, including Marketing
Authorization, have been granted by the Regulatory Authority of
such
country.
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1.35 "FULL TIME
EQUIVALENT" or "FTE" shall mean the equivalent of a
full-time scientist's work time over a twelve-month period
(including
normal vacations, sick days and holidays). The portion of an FTE
year
devoted by a scientist to the Research Program shall be determined
by
dividing the number of full days during any twelve-month period
devoted
by such employee to the Research Program by the total number of
working
days during such twelve-month period.
1.36 "IMPROVEMENT"
shall mean any enhancement, whether or not patentable, in
the manufacture, formulation, ingredients, preparation,
presentation,
means of delivery, dosage or packaging of IRCT Compound, Related
IRCT
Compound, Tests or Product.
1.37 "INFORMATION"
shall mean any and all information and data, including
without limitation all MERCK Know-How, deCODE Know-How, and all
other
scientific, pre-clinical, clinical, regulatory, manufacturing,
marketing, financial and commercial information or data,
whether
communicated in writing or orally or by any other method, which
is
provided by one Party to the other Party in connection with
this
Agreement.
1.38 "INFORMATION
RICH CLINICAL TRIAL OR IRCT" shall mean a clinical trial
which includes the following, as specified in the protocol for
such
clinical trial: [CONFIDENTIAL TREATMENT REQUESTED]
1.39 "INVENTION"
means any process, method, composition of matter, article
of manufacture, discovery or finding that is conceived and reduced
to
practice.
1.40 "IRCT COMPOUND"
shall mean a Selected Compound that has [CONFIDENTIAL
TREATMENT REQUESTED] in accordance with the Agreement.
1.41 "JOINT
INFORMATION AND INVENTIONS" shall mean all discoveries,
Improvements, processes, methods, protocols, formulas, data,
Inventions, know-how and trade secrets, patentable or
otherwise,
arising from the Research Program developed or invented jointly
by
employees of MERCK and deCODE or others acting on behalf of MERCK
and
deCODE.
1.42 "JOINT
COLLABORATION PATENTS" shall mean Collaboration Patents that
claim, cover or relate to Joint Information and Inventions.
1.43 "MARKETING
AUTHORIZATION" shall mean any approval (including without
limitation all applicable pricing and governmental
reimbursement
approvals) necessary to receive permission from the relevant
Regulatory
Authority to market and sell a Product or Test in any country.
1.44 "MERCK COMPOUND
OPTION" shall have the meaning set out in Section
3.1(e) (i).
1.45 "MERCK COMPOUND
PATENT" shall mean any Patent that claims, covers or
relates to an IRCT Compound, Related IRCT Compound, Test or
Product
Controlled by MERCK.
1.46 "MERCK EXERCISE
NOTICE" shall have the meaning set out in Section
3.1(e) (iii).
1.47 "MERCK
INFORMATION AND INVENTIONS" shall mean all discoveries,
Improvements, processes,
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methods, protocols, formulas, data, Inventions, know-how and
trade
secrets, patentable or otherwise, arising from the Research
Program
developed or invented solely by employees of MERCK or other persons
not
employed by deCODE acting on behalf of MERCK.
1.48 "MERCK KNOW-HOW"
shall mean any information and materials, including
but not limited to, discoveries, Improvements, processes,
methods,
protocols, formulas, data, inventions (including without
limitation
MERCK's Information and Inventions and MERCK's rights in Joint
Information and Inventions), know-how and trade secrets, patentable
or
otherwise, which arise from the Research Program and during the
term of
this Agreement, (i) are in MERCK's possession or control, (ii) are
not
generally known and (iii) are in MERCK's opinion necessary to
deCODE in
the performance of its obligations under the Research Program.
1.49 "MERCK
COLLABORATION PATENTS" shall mean Collaboration Patents that
claim, cover or relate to MERCK Information and Inventions.
1.50 "MERCK PATENTS"
shall mean Patents Controlled by MERCK prior to the
Effective Date or during the term of this Agreement (provided MERCK
has
the right to license or otherwise make available such Patents
to
deCODE) and are necessary or useful to deCODE in connection with
the
Research Program.
1.51 "MERCK PRIOR
KNOW-HOW" shall mean any information and materials,
including but not limited to, discoveries, Improvements,
processes,
methods, protocols, formulas, data, inventions, know-how and
trade
secrets, patentable or otherwise, which existed prior to the
Effective
Date and during the term of this Agreement, (i) are in MERCK's
possession or control, (ii) are not generally known and (iii) are
in
MERCK's opinion necessary to deCODE in the performance of its
obligations under the Research Program excluding MERCK
Know-How.
1.52 "MERCK SHARE"
[CONFIDENTIAL TREATMENT REQUESTED].
1.53 "NET SALES"
shall mean the gross invoice price of Product or Tests sold
by MERCK or its Related Parties to the first Third Party after
deducting, if not previously deducted, from the amount invoiced
or
received:
(a)
trade and quantity discounts other than early pay cash
discounts;
(b)
returns, rebates, chargebacks and other allowances;
(c)
retroactive price reductions that are actually allowed or
granted;
(d)
sales commissions paid to Third Party distributors and/or
selling agents;
(e) a fixed amount equal
to [CONFIDENTIAL TREATMENT REQUESTED] of
the amount invoiced to cover bad debt, sales or excise taxes,
early
payment cash discounts, transportation and insurance, custom
duties,
and other governmental charges; and
(f)
the standard inventory cost of devices or delivery systems used
for dispensing or administering Product or Tests, as applicable.
With
respect to sales of Combination Products, Net Sales shall be
calculated
on the basis of
the gross invoice price of Product(s) containing the
same strength of IRCT Compound or Related IRCT Compound sold
without
other active ingredients. In the event that Product is sold only as
a
Combination Product, Net Sales shall be calculated on the basis of
the
gross invoice price of the
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Combination Product multiplied by a fraction, the numerator of
which
shall be the inventory cost of IRCT Compound or Related IRCT
Compound
in the Product and the denominator of which shall be the inventory
cost
of all of the active ingredients in the Combination Product.
Inventory
cost shall be determined in accordance with MERCK's regular
accounting
methods, consistently applied. The deductions set forth in
paragraphs
(a) through (f) above will be applied in calculating Net Sales for
a
Combination Product. In the event that Product is sold only as
a
Combination Product and either Party reasonably believes that
the
calculation set forth in this Paragraph does not fairly reflect
the
value of the Product relative to the other active ingredients in
the
Combination Product, the Parties shall negotiate, in good faith,
other
means of calculating Net Sales with respect to Combination
Products.
1.54 "PARTY OR
PARTIES" shall mean either MERCK or deCODE or both as the
context requires.
1.55 "PATENT RIGHTS"
shall mean deCODE Collaboration Patents, and deCODE's
interest in Joint Collaboration Patents.
1.56 "PATENTS" shall
mean any and all patents and patent applications in the
Territory (which for the purposes of this Agreement shall be deemed
to
include certificates of invention and applications for certificates
of
invention) that a Party owns, Controls or through license or
otherwise
acquires rights prior to the Effective Date or during the term of
this
Agreement which: (i) claim, cover or relate to a Selected
Compound,
Test and/or Product; or (ii) claim, cover or relate to Inventions;
or
(iii) are divisions, continuations, continuations-in-part,
reissues,
renewals, extensions, supplementary protection certificates,
utility,
models and the like of any such patents and patent applications
and
foreign equivalents thereof.
1.57 "PRODUCT(s)"
shall mean any therapeutic preparation in final form
containing (a)
an IRCT Compound for sale by prescription,
over-the-counter or any other method for any and all uses that
arise
from the [CONFIDENTIAL TREATMENT REQUESTED] in the Disease Area or
(b)
a Related IRCT Compound, including without limitation in the case
of
either 1.57(a) or (b) any Combination Product.
1.58 "RELATED
PARTIES" shall mean a Party's Affiliates or sublicensees, but
shall not mean a Party's distributors.
1.59 "REGULATORY
AUTHORITY" shall mean any applicable government regulatory
authority involved in granting approvals for the manufacturing,
marketing, reimbursement and/or pricing of a Product or Test,
as
applicable, in the Territory, including, in the United States,
the
United States Food and Drug Administration and any successor
governmental authority having substantially the same function.
1.60 "RELATED IRCT
COMPOUND" shall mean a compound Controlled by MERCK that
[CONFIDENTIAL TREATMENT REQUESTED].
1.61 "RESEARCH
PROGRAM TERM" shall mean the duration of the Research Program
and "Extended Research Program Term" shall mean any period of
the
Research Program as it may be extended by mutual agreement of
the
Parties, as described more fully in Section 2.10.
1.62 "RESEARCH
PROGRAM" shall mean the research activities undertaken by the
Parties hereto as set forth in Article 2 and Attachment 2.1.
1.63 "SELECTED
COMPOUND" shall mean any compound proposed by MERCK and
accepted by the
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Operating Committee to be evaluated in Information Rich
Clinical
Trials.
1.64 "OPERATING
COMMITTEE" shall mean the joint research committee
established to facilitate the Research Program as more fully
described
in Section 2.5.1.
1.65 "SUCCESSFUL
CLINICAL RESULT" shall mean result(s) [CONFIDENTIAL
TREATMENT REQUESTED].
1.66 "TECHNICAL
INFORMATION" shall mean information, data or know-how
(whether patentable or unpatentable), including without
limitation,
formulas, manufacturing methods, procedures, designs, compositions
of
matter, plans, applications, specifications, drawings,
techniques,
materials (including without limitation biological materials such
as
tissue samples, plasma samples, cell lines, RNA, DNA, DNA
fragments,
organisms, proteins, polypeptides, plasmids, vectors and the
like),
compounds, samples, inventions, discoveries, and the like, as well
as
improvements related thereto.
1.67 "TERRITORY"
shall mean all of the countries in the world, and their
territories and possessions.
1.68 "THERAPEUTIC
FIELD" shall mean any and all application of technology to
[CONFIDENTIAL TREATMENT REQUESTED].
1.69 "TESTS" shall
mean pharmacogenomic tests aimed at predicting the
response or non-response and side-effects to an IRCT Compound that
are
developed, discovered or identified through the Research
Program.
1.70 "THIRD PARTY"
shall mean an entity other than MERCK and its Affiliates,
and deCODE and its Affiliates.
1.71 "VALID PATENT
CLAIM" shall mean a claim of an issued and unexpired
patent included within the MERCK Compound Patent which claims
IRCT
Compound, Related IRCT Compound, Tests or Product as a composition
of
matter, which has not been revoked or held unenforceable or invalid
by
a decision of a court or other governmental agency of competent
jurisdiction, and which is not appealable or has not been
appealed
within the time allowed for appeal, and which has not been
disclaimed,
denied or admitted to be invalid or unenforceable through
reissue,
re-examination or disclaimer or otherwise.
1.72 "WORK PLAN"
shall mean Schedule 2.1-X describing the tasks to be
performed by each of the Parties in furtherance of the Research
Program. It is anticipated that there will be separate work
plans
relating to each IRCT conducted by the Parties which shall be
appended
to the Agreement in sequential order.
2.
RESEARCH PROGRAM
2.1
GENERAL
deCODE and MERCK shall engage in the Research Program upon the
terms
and conditions set forth in this Agreement. The activities to
be
undertaken in the course of each IRCT pursuant to the Research
Program
will be set forth in a Work Plan (Schedule 2.1-X) wherein X shall
begin
with 1 continue in succession. Prior to the initiation of any
IRCT
herein the Parties shall agree in writing signed by members of
the
Executive Committee or their designees on what is a Successful
Clinical
Result and the signed writing shall become part of the
corresponding
Work
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Plan for that IRCT. The Work Plan may be amended from time to time
upon
the mutual
written agreement by authorized representatives of the
Parties. All Work Plans including Schedule 2.1-0 attached hereto
are
part of the Agreement. Notwithstanding any provision of the
Agreement
to the contrary, neither Party shall be obligated to conduct
any
activities which it reasonably believes would be in violation of
any
statute, regulation, law, or terms of any ongoing deCODE project in
a
Non-exclusive Disease Area.
2.2 CONDUCT OF
RESEARCH
deCODE and MERCK each shall conduct the Research Program in
good
scientific manner, and in compliance in all material respects with
all
requirements of applicable laws, rules and regulations and all
applicable good laboratory practices to attempt to achieve
their
objectives efficiently and expeditiously. deCODE and MERCK each
shall
proceed diligently with the work set out in the Work Plan by
using
their respective good faith efforts to allocate sufficient
time,
effort, equipment and facilities to the Research Program and to
use
personnel with sufficient skills and experience as are required
to
accomplish the Research Program in accordance with the terms of
this
Agreement and Work Plan.
deCODE and MERCK shall be entitled to utilize the services of
their
Affiliates to perform their respective Research Program
activities.
Each Party shall also be entitled to utilized the services of
Third
Parties to perform their respective Research Program activities
only
upon the prior written consent of the other Party or as
specifically
set forth in Work Plan. Notwithstanding any such consent, both
Parties
shall
remain at all times fully liable for its respective
responsibilities under the Research Program.
2.3
INFORMATION RICH CLINICAL TRIALS
Each IRCT shall be conducted in accordance with the Work Plan and
a
detailed protocol. A proposed protocol and a draft proposal for
what a
Successful Clinical Result will be, shall be prepared initially by
the
Operating Committee. These draft proposals shall be further
reviewed
internally by the appropriate committees within MERCK and deCODE.
The
draft proposals, with any changes or revisions made by MERCK or
deCODE,
shall then be considered and revised by the Operating Committee
for
submission to the Executive Committee. deCODE shall be obligated
to
provide support needed to conduct no more than five (5) IRCTs
concurrently at any time during the Research Program. Each IRCT
shall
be conducted under the direction and control of the Operating
Committee
in accordance
with the terms and conditions set forth in Schedule 2.3
and a Study Protocol for that Selected Compound. In any given IRCT
that
is conducted under this Agreement the Parties may modify and/or
supplement the terms and conditions set forth in Schedule 2.3
in
accordance with Section 10.7 herein. All data and results
pertaining to
any Selected Compound may be used by MERCK in filings with
Regulatory
Authorities and all other rights to any intellectual property that
are
embodied by those data and results shall be governed by Article
3.
2.4 COMPOUND
SELECTION
MERCK shall nominate MERCK compounds during the Research Program
for
which Information Rich Clinical Trials shall be conducted by
the
Parties according to the Work Plan. deCODE shall be given the
opportunity to review each proposed compound to confirm that
deCODE's
conduct of one or more IRCTs on such compound under this
Agreement
would not
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conflict with any other ongoing deCODE project(s). The
Operating
Committee shall select which MERCK nominated compounds will
become
Selected Compounds; PROVIDED, HOWEVER, that solely with respect
to
compounds in the Non-exclusive Disease Area, deCODE shall not
be
obligated to perform development efforts with respect to any
such
compounds if it reasonably believes that the performance of
such
efforts will conflict with any ongoing deCODE project(s).
2.5 GOVERNANCE
OF THE COLLABORATION.
The Parties hereby establish process to govern the conduct of
the
Research Program and each party's contribution to the Research
Program
as follows:
2.5.1 MANAGERIAL
OVERSIGHT.
There will be two levels of managerial oversight of the
Research
Program. There will be an Executive Committee and an Operating
Committee. In addition each Party shall designate Project Leaders
for
the Research Program.
(a) EXECUTIVE
COMMITTEE
The Executive Committee shall consist of one senior executive
from each of MERCK and deCODE. The Executive Committee shall
have the ultimate authority for decisions regarding the
Research Program. The matters that require approval by the
Executive Committee shall include approval of financial
statements such
as the Budget and approval of the Work Plan.
(i) Any
disputes where the Executive Committee cannot
reach a mutually acceptable decision within thirty (30)
days after the matter was referred to them shall be
decided by the President of MERCK Research Laboratories
and the final determination of the issue that shall be
binding on the Parties and the Research Program;
PROVIDED, HOWEVER, as set forth below in Section 2.5.1
(a)(ii) regarding implementation of such decisions and in
all cases that to the extent such disputes materially
affect the rights or obligations of the Parties under
this Agreement, MERCK shall consult with deCODE and the
Parties shall agree on a course of action to lawfully
avoid or minimize such effects upon the rights or
obligations of the Parties, to the extent practicable.
(ii) Any
disputes arising with respect to the manner in
which decisions of the Operating Committee, the Executive
Committee or the President of Merck Research Laboratories
will be implemented that will affect relations with
patients participating in the Research Program, research
sites, consultants, investigators or vendors all of which
are in Iceland, or any governmental authority in Iceland
("Implementation Disputes"), shall be decided by the
Chief Executive Officer of deCODE (or his designee) and
the final determination of the issue that shall be
binding on the Parties and the Research Program, who
shall give good faith consideration to the comments of
MERCK's Executive Committee member (or their respective
designees) in resolving such matter; PROVIDED, HOWEVER,
that to the extent such disputes materially affect the
rights or obligations of the Parties under this
Agreement, deCODE shall consult with MERCK and the
Parties shall agree on a course of action to lawfully
avoid or minimize such effects upon the rights or
obligations of the Parties, to the extent practicable.
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(b) OPERATING
COMMITTEE
The Operating
Committee shall be based in Iceland and
composed of MERCK representatives and deCODE
representatives and shall exist for [**] after
termination or expiration of the Research Program Term.
The Operating Committee shall perform the following
functions (i) approve and, as the need arises, determine
the necessity to remove personnel working on the Research
Program, (ii) prepare the Budget, (iii) formulate and
adjust Work Plans, (iv) select Compounds; (v) oversee
progress of the Research Program and exchange of data
between the Parties; and (vi) appoint sub-committees of
equal representation to fulfill any of the enumerated
tasks set forth in this Section 2.5.1(b). Each Party
shall have 1 vote. Each Party shall appoint its
representatives to the Operating Committee from time to
time, and may substitute one or more of its
representatives, in its sole discretion, effective upon
notice to the other Party of such change. These
representatives shall have, individually or collectively,
appropriate technical credentials, experience and
knowledge, and ongoing familiarity with the Research
Program. Additional representatives or consultants may
from time to time, by mutual consent of the Parties, be
invited to attend Operating Committee meetings, in the
case of consultants subject to such consultant's written
agreement to comply with the requirements of Section 4.1.
Any member of the Operating Committee may designate a
substitute to attend and perform the functions of that
member at any meeting of the Operating Committee. A
chairperson and secretary of the Operating Committee
shall serve co-terminus one (1) year terms, commencing on
the Collaboration Date or an anniversary thereof, as the
case may be. deCODE shall have the right to name the
chairperson and MERCK shall have the right to name the
secretary of the Operating Committee. Decisions of the
Operating Committee shall be made unanimously by the
members. In the event that the Operating Committee cannot
or does not, after good faith efforts, reach agreement on
an issue, the resolution and/or course of conduct shall
be referred to the Executive Committee. Each Party shall
bear its own expenses related to the attendance of such
meetings by its representatives and invitees.
2.5.2 MEETINGS AND
MINUTES.
Meetings of the Operating Committee require the participation of
at
least one member of the Operating Committee from each Party. During
the
Research Program Term, the Operating Committee shall meet in person
at
least once during every Calendar Year. From time to time, a Party
may
give the other Party reasonable notice of its desire to hold a
meeting
of the Operating Committee. Unless otherwise agreed by the
Parties,
meetings of the Operating Committee shall be held in person and
shall
alternate between the offices of the Parties, or meet in such
other
place as agreed by the Parties. Instead of meeting in person,
the
members of the Operating Committee may, for purposes of holding
a
Operating Committee meeting, convene or be polled or consulted
from
time to time by means of telecommunications, video conferences,
electronic mail or correspondence, as deemed necessary or
appropriate
by the Parties.
With the sole exception of specific items of the meeting minutes
to
which the chairperson and the secretary cannot agree and which
are
escalated as provided below, definitive minutes of all
Operating
Committee meetings shall be finalized promptly after the meeting
to
which the minutes pertain, as follows:
Promptly after each Operating Committee meeting, the secretary
shall
prepare and distribute to all members of the Operating Committee
draft
minutes of the meeting. Such minutes shall provide a description,
in
reasonable detail, of the discussions at the meeting and a list of
any
actions,
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decisions or determinations approved by the Operating Committee and
a
list of any issues to be resolved by the Executive Officers.
The chairperson shall then promptly after receiving such draft
minutes
collect comments thereon from the members of his or her Party
and
provide them to the secretary.
The chairperson and the secretary of the Operating Committee shall
then
discuss each other's comments and finalize the minutes. The
secretary
and chairperson shall each sign and date the final minutes. The
signature of the chairperson and the secretary upon the final
minutes
shall indicate each Party's assent to the minutes.
If at any time during the preparation and finalization of the
Operating
Committee meeting minutes, the secretary and the chairperson do
not
agree on any issue with respect to the minutes, such issue shall
be
resolved by the decision making process as provided in Section
2.5.1(a). The decision resulting from the decision making process
shall
be recorded by the secretary in amended finalized minutes for
said
meeting.
2.5.3 PROJECT LEADERS.
MERCK and deCODE each shall appoint a person (a "Project Leader")
from
the Operating Committee to coordinate its part of the Research
Program.
The Project Leaders shall be the primary contact between the
Parties
and the Operating Committee with respect to the Research Program.
Each
Party shall notify the other within thirty (30) days of the date of
the
Agreement of the appointment of its Project Leader and shall notify
the
other Party as soon as practicable upon changing this
appointment.
2.6 ANNUAL
BUDGET .
All costs in personnel time, expenses, goods and Third Party
services
shall be
estimated in advance for the subsequent Calendar Year
according to the Budget to be set forth in Schedule 2.6. The
Budget
shall be prepared by the Project Leaders under the direction
and
control of the Operating Committee by September 30th of the
year
preceding the Calendar Year of the Budget.
2.7 RECORDS
AND REPORTS
2.7.1 RECORDS.
Each Party shall maintain records, in sufficient detail and in
good
scientific manner appropriate for patent and regulatory purposes,
which
shall fully and properly reflect all work done and results achieved
in
the performance of the Research Program by that Party.
2.7.2 COPIES AND INSPECTION
OF RECORDS.
(a) MERCK shall have the right, during normal business hours and
upon
reasonable notice, to inspect and copy all such records of
deCODE
referred to in Section 2.7.1. MERCK shall maintain such records and
the
information disclosed therein in confidence in accordance with
Section
4.1. MERCK shall have the right to arrange for its employees
and/or
consultants involved in the activities contemplated hereunder to
visit
the offices and laboratories of deCODE and any of its Third
Party
contractors as permitted under Section 2.2 during normal business
hours
and upon reasonable notice, and to discuss the Research Program
work
and its results in
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detail with the technical personnel and consultants of deCODE.
Upon
request, deCODE shall provide copies of the records described
in
Section 2.7.1 above.
(b) At least once per Calendar Year during the term of the
Agreement,
MERCK
shall provide deCODE with information about the status of any
IRCT Compounds in development at MERCK including a review of
any
significant developmental milestones achieved or setbacks
encountered
since the previous year's review and such other information as may
be
reasonably requested by deCODE so as to enable deCODE to monitor
or
confirm MERCK's compliance with the provisions of Section 3.4
hereof.
deCODE shall have the right, during normal business hours and
upon
reasonable notice, to inspect and copy all such records of
MERCK
referred to in Section 2.7.1 that are necessary to deCODE to
perform
its obligations under this Agreement. deCODE shall maintain
such
records and the
information disclosed therein in confidence in
accordance with Section 4.1.
2.8
COMPLIANCE
deCODE shall conduct the Research in accordance with all
applicable
laws, rules and regulations, including, without limitation, all
current
governmental regulatory requirements concerning Good Laboratory
Practices. In addition, if animals are used in research
hereunder,
deCODE will comply with the Animal Welfare Act or any other
applicable
local, state, national and international laws or regulations
relating
to the care and use of laboratory animals. MERCK encourages deCODE
to
use the highest standards, such as those set forth in the Guide for
the
Care and Use of Laboratory Animals (NRC, 1996), for the humane
handling, care and treatment of such research animals. Any
animals
which are used in the course of the Research, or products derived
from
those animals, such as eggs or milk, will not be used for food
purposes, nor will these animals be used for commercial
breeding
purposes. deCODE shall notify MERCK in writing of any deviations
from
applicable regulatory or legal requirements. deCODE hereby
certifies
that it will not and has not employed or otherwise used in any
capacity
the services of any person debarred under Section 21 USC 335a
in
performing any services hereunder.
2.9 RESEARCH
PROGRAM TERM
Except as otherwise provided herein, the term of the Research
Program
shall commence on the Collaboration Date and continue for a period
of
seven (7) years. Following the initial seven (7) year term, the
Research Program will renew annually for successive one (1) year
terms
("Extended Research Term") unless either Party sends a written
notice
of termination at any time to the other Party PROVIDED, HOWEVER,
that
MERCK may send such written notice of termination at any time
beginning
five (5) years after the Collaboration Date. Such notice of
termination
shall be sent at least [**] prior to the date of termination. In
the
event that deCODE exercises its right to terminate under this
Section
2.9, such termination shall not affect any ongoing IRCTs which
shall be
completed at MERCK's discretion, PROVIDED HOWEVER that deCODE shall
not
be obligated to begin any new IRCT which has been approved by
the
Operating Committee but not yet begun. From time-to-time, the
Parties
shall amend the Work Plan as applicable. In the event of a Change
of
Control pursuant to which a Competitor Controls deCODE, MERCK
shall
have the right to terminate the Research Program at any time on
written
notice to deCODE. In the event that the term of the Research
Program
expires or the Research Program is terminated during the pendency
of an
IRCT or in the event that the Parties elect to abandon or terminate
any
IRCT during the course of the Research Program, the Parties
shall
arrange for orderly completion or
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early termination of such IRCT over a reasonable period of at least
90
days, including making provision for payment for all
non-cancelable
expenses associated therewith.
2.10 EXCLUSIVE
EFFORTS
(a) During the Research Program Term, deCODE shall work
exclusively
with MERCK in efforts to conduct IRCT [CONFIDENTIAL TREATMENT
REQUESTED] and shall not otherwise facilitate or assist any Third
Party
to conduct IRCT [CONFIDENTIAL TREATMENT REQUESTED] by providing
rights
to, either through license or any agreement to forgo enforcement
of,
deCODE Patents or deCODE Prior Know-How. This Agreement does
not
prohibit deCODE from (i) conducting IRCT [CONFIDENTIAL
TREATMENT
REQUESTED]; or (ii) conducting clinical trials [CONFIDENTIAL
TREATMENT
REQUESTED]. In the event that MERCK and deCODE begin an IRCT with
a
Selected Compound in a Non-exclusive Disease Area, deCODE shall
not
commence any IRCT with [CONFIDENTIAL TREATMENT REQUESTED].
(b) Beginning after the first anniversary of the Effective Date,
if
during any [**] period the Parties do not commence or continue an
IRCT
in any one of the Exclusive Disease Areas, and if during such
two-year
period the Operating Committee neither plans nor conducts at least
five
concurrent IRCT's during at least [**] of such [**] period, then
such
specific Disease Area shall thereafter become a Non-Exclusive
Disease
Area for all purposes under this Agreement. Notwithstanding the
preceding sentence, the Parties may agree to create exceptions to,
or
the tolling of, the foregoing for special circumstances.
2.11 EXCHANGE OF
INFORMATION
During the Research Term, deCODE promptly shall disclose on an
ongoing
basis to MERCK in English and in writing all deCODE Know-How.
MERCK
shall promptly disclose to deCODE during the Research Program Term
all
MERCK Know-How.
2.12 USE OF HUMAN
MATERIALS
With respect to any human cell lines, tissue, human clinical
isolates
or similar human-derived materials that have been or are to be
collected and/or used in the Research Program ("Human Materials"),
each
Party represents and warrants (i) that it has complied, or
shall
comply, with all applicable laws, guidelines and regulations
relating
to the collection and/or use of the Human Materials and (ii) that
it
has obtained, or shall obtain, all necessary approvals and
appropriate
informed consents, in writing, for the collection and/or use of
such
Human Materials. deCODE shall provide documentation of such
approvals
and consents upon MERCK's request. Each Party further represents
and
warrants that such Human Materials may be used as contemplated in
this
Agreement without any obligations to the individuals or
entities
("Providers") who contributed the Human Materials, including,
without
limitation, any obligations of compensation to such Providers or
any
other Third Party for the intellectual property associated with,
or
commercial use of, the Human Materials for any purposes.
2.13 PHARMACOGENOMICS
TESTS.
(a) TESTS FOR USE IN CLINICAL TRIALS. MERCK shall have the sole
and
exclusive right to direct and control the development and
commercialization of Tests for use with Selected Compounds.
deCODE
shall have the first right to perform the work needed to develop
such
Tests for use in the
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conduct of IRCT's under this Agreement as set forth below. MERCK
shall
identify and prioritize the Tests it wishes to have developed and
Merck
shall have the right
to solicit bids from Third Parties including
deadlines for the achievement of defined events in the development
of
suc