1
EXHIBIT 10.4
[NOTE: CERTAIN PORTIONS OF THIS DOCUMENT HAVE BEEN MARKED TO INDICATE THAT
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR THIS CONFIDENTIAL INFORMATION.
THESE PORTIONS HAVE BEEN MARKED WITH THE CLAUSE "CONFIDENTIAL TREATMENT
REQUESTED" AND/OR TWO ASTERISKS ENCLOSED IN BRACKETS (i.e., [**]). THE
CONFIDENTIAL PORTIONS HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES
AND EXCHANGE COMMISSION.]
1
2
COLLABORATION AGREEMENT
THIS COLLABORATION AGREEMENT ("AGREEMENT") is made and entered
into effective as of June 12, 2001 (the "EFFECTIVE DATE"), by and between GENMAB
A/S, having principal offices at Xxxxxxxx 00X, 0xx xxxxx, XX 0000 Xxxxxxxxxx X,
Xxxxxxx ("GENMAB"), MEDAREX, INC., having principal offices at 000 Xxxxx Xxxx,
Xxxxx 000, Xxxxxxxxx, Xxx Xxxxxx 00000-0000, on behalf of itself and its wholly
owned subsidiary, GENPHARM INTERNATIONAL, INC., with principal offices at 000
Xxxxxxxxxx Xxxxx, Xxxxxxxx, Xxxxxxxxxx 00000 (collectively, "MEDAREX"), and
deCODE GENETICS EHF., having principal offices at Xxxxxxxxxxx 00, 000 Xxxxxxxxx,
Xxxxxxx ("DECODE"). Genmab, Medarex and deCODE each may be referred to herein
individually as a "PARTY," or collectively as the "PARTIES."
WHEREAS, The Parties desire to enter into a definitive agreement to
collaborate to produce fully human antibodies to antigen targets in order to
develop and commercialize genomics-derived, antibody-based products on the terms
set forth below;
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual promises and covenants contained herein and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
Parties, intending to be legally bound, do hereby agree as follows:
ARTICLE 1 -
SCOPE OF COLLABORATION; COLLABORATION ACTIVITIES
SECTION 1.1 SCOPE OF COLLABORATION. The Parties have entered into
this collaboration (such collective enterprise, the "COLLABORATION") to jointly
research, develop and commercialize Collaboration Products with respect to
Collaboration Targets throughout the Territory as set forth in this Agreement.
Any capitalized term used in this Agreement not otherwise defined herein shall
have the meaning set forth on Appendix A.
SECTION 1.2 RESEARCH ACTIVITIES.
1.2.1 GENERAL. Under the direction and supervision of the
Steering Committee, the Collaborators shall use Commercially Reasonable Efforts
to conduct their respective research activities in accordance with this
Agreement, each Project Plan and each Project Budget.
1.2.2 IDENTIFICATION OF COLLABORATION TARGETS. deCODE shall
use its Commercially Reasonable Efforts to identify and provide Collaboration
Targets to the Collaboration. The list of Antigens attached hereto as Appendix C
sets forth the initial list of Collaboration Targets. Such list may be amended
pursuant to Section 1.7 or 5.1.2, by the express written agreement of
Genmab/Medarex and deCODE or as follows:
(a) If, at any time prior to or during the Target Entry
Period (as defined in Section 1.2.2(g)), deCODE or any of its Affiliates
identify, or otherwise obtain
1
3
rights with respect to, Antigens (in addition to the Collaboration Targets
listed on Appendix C) which (x) deCODE reasonably believes show, or are likely
to show, scientific and commercial promise for the development of antibody-based
products; (y) are Controlled by deCODE or its Affiliates; and (z) are not
subject to a Pre-Existing Agreement entered into by deCODE or its Affiliates
prior to the earlier of the date of such identification and the date such rights
were obtained, then deCODE may provide such Antigen to the Collaboration. In the
event deCODE elects to provide an Antigen, it shall promptly develop Antigen
Evaluation Materials for such Antigen and furnish such Antigen Evaluation
Materials to Medarex and Genmab. The "ANTIGEN EVALUATION MATERIALS" shall
include:
(i) a written description of the applicable
Antigen, including DNA and amino acid sequences thereof, when available;
(ii) the human tissue and/or cell type
expression profile for such Antigen;
(iii) all available data reasonably necessary
for determining whether such Antigen is amenable to targeting by Antibodies;
(iv) all other scientific data in the
possession of deCODE or its Affiliates relating to such Antigen;
(v) all available information regarding the
proprietary status of such Antigen, the intellectual property rights Controlled
by deCODE and its Affiliates with respect to such Antigen, and any potential
restrictions (contractual, patent or otherwise) that would limit or otherwise
affect the Parties' right to fully Exploit any Collaboration Products with
respect thereto;
(vi) existing and available models for
preclinical validation of Antibody Products against such Antigen, to the extent
deCODE has taken steps to identify or determine such models;
(vii) a list of expected indications for
Antibody Products against such Antigen;
(viii) clinical trial designs applicable to
Antibody Products against such Antigen, to the extent known by deCODE;
(ix) any market analyses undertaken by or on
behalf of deCODE or its Affiliates with respect to the commercial potential of
Antibody Products against such Antigen;
(x) the commercial and scientific rationale for
why deCODE believes such Antigen is a promising target for the development of
antibody-based products; and
4
(xi) all other relevant information in deCODE's
or its Affiliates' possession with respect to such Antigen.
(b) In the event Genmab/Medarex receives Antigen
Evaluation Materials for a given Antigen pursuant to Section 1.2.2(a), but does
not believe such materials are reasonably adequate to enable Genmab/Medarex to
reasonably determine whether to accept or decline such Antigen pursuant to
Section 1.2.2(d), the Collaborators shall discuss in good faith additional
analyses to be performed by deCODE as necessary for such reasonable
determination and deCODE shall use Commercially Reasonable Efforts to perform
such reasonable additional analyses in a timely manner to enable Genmab/Medarex
to make such reasonable determination, provided that deCODE shall not be
required to provide additional materials or perform additional analyses other
than those contemplated by Section 1.2.2(a). Any additional materials provided
pursuant to this Section 1.2.2(b) shall be deemed to be Antigen Evaluation
Materials.
(c) Within thirty (30) days following receipt by
Genmab/Medarex of all Antigen Evaluation Materials (including those Antigen
Evaluation Materials provided pursuant to Section 1.2.2(b)) with respect to an
Antigen and Genmab/Medarex's determination that it has received complete Antigen
Evaluation Materials with respect thereto, such determination not to be
unreasonably withheld or delayed, the Steering Committee shall designate a set
of preliminary assays (each, an "ASSAY") for screening Assay Candidates against
such Antigen and preliminary criteria (the "ASSAY SUCCESS CRITERIA") for
determining, subject to Section 1.2.6, whether an Assay Candidate should become
a Collaboration Antibody. The Assays and Assay Success Criteria shall be
included in the Project Plan for such Collaboration Target.
(d) No later than fifteen (15) days following the
designation of the Assays and Assay Success Criteria for an Antigen pursuant to
Section 1.2.2(c), Genmab/Medarex shall provide deCODE with written notice of
whether Genmab/Medarex wishes to pursue such Antigen under the Collaboration. If
Genmab/Medarex accepts such Antigen into the Collaboration, such Antigen shall
become a Collaboration Target under this Agreement, and Appendix C shall be
amended accordingly. If Genmab/Medarex fails to provide deCODE with written
notice within forty five (45) days following receipt of all Antigen Evaluation
Materials with respect to such Antigen that it accepts such Antigen, or if
Genmab/Medarex earlier provides written notice that it declines such Antigen,
such Antigen shall not become a Collaboration Target and Genmab/Medarex shall
have no further rights with respect thereto under this Agreement and deCODE
shall have no further obligations with respect thereto under this Agreement. If
Genmab/Medarex declines an Antigen pursuant to this Section 1.2.2(d), Genmab and
Medarex shall, at deCODE's election, either return to deCODE or destroy all
Antigen Evaluation Materials with respect to such Antigen in their possession.
(e) Upon designation of an Antigen as a Collaboration
Target pursuant to Section 1.2.2(d), the Steering Committee shall use good faith
efforts to agree on a written description of such Antigen, which descriptions
shall be included on Appendix C.
5
(f) From time to time, as the Parties gain greater
understanding of each Collaboration Target and the potential utility of Antibody
Products thereto, the Steering Committee shall update the description of such
Collaboration Target on Appendix C to more accurately reflect what Antigens, or
portions thereof, are included in the Collaboration. The Parties acknowledge and
agree that the Assays and the Assay Success Criteria may be amended and updated
by the Steering Committee as the Parties gain greater understanding of the
Collaboration Targets.
(g) The "TARGET ENTRY PERIOD" shall commence on the
Effective Date and shall continue until the fifth (5th) anniversary thereof
unless (i) earlier terminated by (A) the unanimous agreement of the Parties, or
(B) a Party pursuant to Article 8; or (ii) extended by unanimous agreement of
the Parties. The termination or expiration of the Target Entry Period shall not
constitute a termination of this Agreement.
(h) During the Target Entry Period, deCODE shall use
Commercially Reasonable Efforts to provide at least five (5) Antigens to
Genmab/Medarex that are accepted into the Collaboration as Collaboration Targets
pursuant to the procedure set forth in Section 1.2.2(a); provided, however, in
the event deCODE exercises its right pursuant to Section 8.2 to convert a
Collaboration Product to a Unilateral Product of deCODE as a result of a
material breach by Genmab/Medarex hereunder with respect to such Collaboration
Product, then deCODE shall have no further obligation to offer Antigens to the
Collaboration, but may, in its sole discretion, offer additional Antigens to the
Collaboration according to the procedure set forth in Section 1.2.2(a), and
provided further in the event (i) deCODE undergoes a Change of Control, then
Genmab/Medarex shall have the right to decide, in its sole discretion, whether
deCODE has any further obligation to offer Antigens to the Collaboration
according to the procedure set forth in Section 1.2.2(a), or (ii) Genmab or
Medarex undergoes a Change of Control, then deCODE shall have no further
obligation to offer Antigens to the Collaboration, but may, in its sole
discretion, offer additional Antigens to the Collaboration according to the
procedure set forth in Section 1.2.2(a). In the event that Genmab/Medarex, in
its reasonable business judgment, declines an Antigen pursuant to Section
1.2.2(d) for any reason other than for bona fide adverse scientific,
intellectual property or commercialization considerations set forth in a written
letter addressed to deCODE articulating all such reasons, such Antigen shall be
counted against the five (5) Antigen threshold described above.
1.2.3 IDENTIFICATION OF APPLICABLE ASSAYS AND SUCCESS
CRITERIA. As part of the Project Plan for a given Collaboration Target, the
Steering Committee will:
(a) identify the immunogen(s) (each, an "IMMUNOGEN") to
be used to enable Genmab/Medarex to perform its activities pursuant to Section
1.2.5;
(b) determine which Party(ies) will be responsible for
delivering the Immunogen(s) to Genmab/Medarex; and
(c) determine which Party(ies) will be responsible for
delivering the Assays to the Collaboration.
6
The Steering Committee may elect to use a Third Party to provide one or more
Immunogen(s) to the Collaboration. In addition, the Steering Committee may elect
to have a Third Party develop and/or perform one or more of the Assays.
1.2.4 ALLOCATION OF COSTS. All costs associated with
identifying Collaboration Targets, preparing and furnishing to Genmab/Medarex
complete Antigen Evaluation Materials with respect thereto, creating and
delivering the Immunogen(s) to Genmab/Medarex and performing all other
activities listed on Appendix E under "deCODE Responsibilities" (the "DECODE
RESEARCH ACTIVITIES") shall be borne 100% by deCODE. All costs associated with
immunizing the HuMAb Mice, raising a panel of different Antibodies to the
applicable Collaboration Target pursuant to the last sentence of Section 1.2.5
and performing all other activities listed on Appendix E under "Genmab/Medarex
Responsibilities" (the "GENMAB/MEDAREX RESEARCH ACTIVITIES") shall be borne 100%
by Genmab/Medarex; provided, however, that the Genmab/Medarex Research
Activities shall not include the creation of transgenic animal models unless
Genmab/Medarex expressly agrees otherwise. All costs associated with performing
all activities listed on Appendix E under "Shared Responsibilities" and all
other activities not identified in the immediately preceding two sentences shall
be borne 50% by Genmab/Medarex and 50% by deCODE. The Collaborators acknowledge
and agree that the deCODE Research Activities and the Genmab/Medarex Research
Activities are deemed to be and are of equal value and neither Collaborator
shall have any right to reimbursement or credit from the other Collaborator for
the cost and expenses associated with such research activities.
1.2.5 RAISING OF ANTIBODIES BY GENMAB/MEDAREX. The
Collaborator designated under Section 1.2.3(b) shall use Commercially Reasonable
Efforts to provide Genmab/Medarex, within thirty (30) days of such designation,
sufficient Immunogen for each Collaboration Target to enable Genmab/Medarex to
perform its activities pursuant to this Section 1.2.5. However, the
Collaborators acknowledge that it may take as long as three (3) to six (6)
months to create sufficient quantities of such Immunogen. Within thirty (30)
days of the delivery of such Immunogen, Genmab/Medarex shall use Commercially
Reasonable Efforts to immunize the HuMAb Mice and thereafter shall use
Commercially Reasonable Efforts to raise a panel of different Antibodies to the
applicable Collaboration Target. The Collaborators acknowledge that it often
takes three (3) to six (6) months to raise Antibodies to an Antigen after
immunization of the HuMAb Mice and that this period can be significantly longer
for certain Antigens. If, notwithstanding the Commercially Reasonable Efforts of
Genmab/Medarex, no Antibodies have been raised to such Collaboration Target
within one (1) year after the delivery of such Immunogen to Genmab/Medarex, the
Collaborators shall meet and discuss in good faith how to proceed with respect
to such Collaboration Target.
1.2.6 SELECTION OF ASSAY CANDIDATES; ASSAY SCREENING;
SELECTION OF COLLABORATION ANTIBODIES.
(a) Genmab/Medarex shall select a subset of the
Antibodies raised pursuant to Section 1.2.5 to become "ASSAY CANDIDATES". As set
forth under the applicable Project Plan, the Parties shall run each Assay
Candidate through the applicable
7
Assays. deCODE may, in its discretion, participate in, observe, monitor and/or
review such screening; provided, however, in the event such screening is
performed at Medarex's places of business, such participation, observation,
monitoring or review by deCODE shall be subject to Medarex's prior approval .
Upon completion of the Assay screening for a given Assay Candidate, each Party
will be provided with the results of such screening (including the raw data
underlying such results). Within sixty (60) days of the Parties' receipt of such
results, or such longer period as the Steering Committee may agree, the Steering
Committee will determine whether the Assay Candidate has met the applicable
Assay Success Criteria. Subject to Section 1.2.6(b), each Assay Candidate that
meets the applicable Assay Success Criteria shall be deemed to be a
"COLLABORATION ANTIBODY"; provided, however, the Steering Committee may, in its
sole discretion, (i) decide that an Assay Candidate that meets the Assay Success
Criteria shall nonetheless not be deemed to be a Collaboration Antibody, or (ii)
decide that an Assay Candidate that does not meet the Assay Success Criteria
shall nonetheless be deemed to be a Collaboration Antibody.
(b) Notwithstanding Section 1.2.6(a), if either Medarex
or Genmab (i) is researching or developing, or has researched or developed,
either alone or in collaboration with the other or with a Third Party, such
Assay Candidate, or (ii) has previously granted a Third Party rights with
respect to such Assay Candidate, then such Assay Candidate shall not become a
Collaboration Antibody, and all amounts of such Assay Candidate produced
pursuant to this Agreement will be destroyed. The Collaborators acknowledge that
such determination is currently made based on analysis of the VH variable region
heavy chain sequence of an Antibody from and including FR1 to and including FR4.
1.2.7 EFFECT OF DESIGNATION OF COLLABORATION ANTIBODIES. Any
Antibody that is designated a Collaboration Antibody in accordance with Section
1.2.6 shall be exclusive to the Collaboration. Except as otherwise provided in
this Agreement, once an Antibody is designated a Collaboration Antibody, all
costs associated with the research, development, manufacturing and
commercialization of such Antibody shall be split 50% for deCODE and 50% for
Genmab/Medarex, as more fully described in Section 4.1.
1.2.8 LEAD COLLABORATION ANTIBODIES. Out of the pool of
Collaboration Antibodies against a given Collaboration Target, the Steering
Committee will select the Collaboration Antibody that it believes to be most
promising for development and commercialization and it will then move such
Collaboration Antibody into Production Process Development. Each Collaboration
Antibody that is put into Production Process Development shall be deemed to be a
"LEAD COLLABORATION ANTIBODY". It is understood that the Steering Committee may,
over time, select more than one Lead Collaboration Antibody against a given
Collaboration Target, or substitute one Lead Collaboration Antibody for another.
Upon designation of each Lead Collaboration Antibody, each of Genmab/Medarex and
deCODE shall commit to support fifty percent (50%) of the cost of Production
Process Development for such Lead Collaboration Antibody, which cost is
estimated to be two million dollars ($2,000,000) to three million dollars
($3,000,000) in the aggregate per Lead Collaboration Antibody, although such
cost may vary depending
8
on the particular characteristics of a given Lead Collaboration Antibody. With
respect to each Lead Collaboration Antibody, the Steering Committee shall
solicit bids from suppliers to perform the Production Process Development. Each
Party shall have the right to submit a bid on such terms as it desires. The
Steering Committee shall use its best efforts to negotiate a development
agreement on behalf of the Parties with the supplier that is best able to meet
the Parties' requirements, taking into consideration such factors as price,
quality, capacity, quantity, reliability and reputation. In the event the
Steering Committee selects a Party to perform Production Process Development
pursuant to this Section 1.2.8, and such Party agrees to do so, the price and
other terms and conditions of such Production Process Development shall be based
on arm's length negotiations with the Steering Committee.
1.2.9 IDENTIFICATION OF RESTRICTIONS ON EXPLOITATION OF
COLLABORATION PRODUCTS. Upon designation of a given Antigen as a Collaboration
Target pursuant to Section 1.2.2, the Collaboration shall solicit a formal
patent review and opinion regarding such Collaboration Target from an outside
law firm selected by the Steering Committee. The costs of such formal opinion
shall be shared 50% by deCODE and 50% by Genmab/Medarex. The Steering Committee
shall monitor, or cause to be monitored, the proprietary status of such
Collaboration Target and may update such review and opinion from time to time as
it deems appropriate.
SECTION 1.3 PROJECT PLAN AND PROJECT BUDGET. Upon designation of a
given Antigen as a Collaboration Target pursuant to Section 1.2.2,
Genmab/Medarex and deCODE shall jointly develop and implement a Project Plan
(each a "PROJECT PLAN") and Project Budget (each a "PROJECT BUDGET") for the
research, development, manufacture and commercialization of Collaboration
Antibodies against such Collaboration Target. Each initial Project Plan and
Project Budget shall include a preliminary timeline that sets forth the
anticipated schedule for the development of Collaboration Antibodies against
such Collaboration Target (the "ANTICIPATED TIMELINE"), which Anticipated
Timeline shall, to the extent possible, highlight possible contingencies that
might significantly affect such schedule; provided, however, that the Parties
acknowledge and agree that such Anticipated Timeline shall only be an
approximation and any failure to comply with such Anticipated Timeline, despite
the Parties' Commercially Reasonable Efforts, shall not be deemed to be a
default under, or breach of, this Agreement. Additionally, such initial Project
Plan shall include the Assays for screening Assay Candidates against such
Collaboration Target and the Assay Success Criteria for determining whether such
Assay Candidates shall become Collaboration Antibodies, each as identified by
the Steering Committee pursuant to Section 1.2.3. It is understood that the
components of each Project Plan and Project Budget will evolve as the applicable
Collaboration Antibodies move through the research, development, manufacture and
commercialization life cycle. Upon the completion of each phase of research and
development (e.g., toxicology studies in support of an IND, and phase I, phase
II or phase III studies) with respect to a given Collaboration Target, or more
often as the Steering Committee may agree, the Steering Committee shall, in
consultation with Medarex, review the Project Plan and Project Budget and shall
make such modifications or updates to such Project Plan and, with the prior
approval of Medarex, such Project Budget that it deems appropriate, including a
revised Anticipated Timeline for the next phase of research and development with
respect
9
to such Collaboration Target. Medarex shall not be obligated to perform any
activity with respect to a Collaboration Target, whether under a Project Plan or
otherwise, unless it has expressly agreed to do so. Notwithstanding the
foregoing, if Genmab agrees in a Project Plan to perform any activity with
respect to a Collaboration Target, then Genmab shall, subject to the terms and
conditions of this Agreement, be obligated to perform such activity even if
Medarex declines to participate in such activity.
SECTION 1.4 PERFORMANCE STANDARDS. Each Party shall perform, or
cause to be performed, its respective activities hereunder in good scientific
manner, and in compliance in all material respects with all Applicable Law and
shall use Commercially Reasonable Efforts to (a) research, develop, file for
Regulatory Approval and commercialize one or more Collaboration Products with
respect to each Lead Collaboration Antibody, and (b) achieve the objectives of
each Project Plan in accordance with each Project Budget and the applicable
Anticipated Timeline, in each case, efficiently and expeditiously by allocating
sufficient time, effort, equipment and skilled personnel to complete such
activities successfully and promptly. As between Medarex and Genmab, Genmab
shall be responsible for performing the Genmab/Medarex Research Activities,
unless Medarex expressly agrees otherwise.
SECTION 1.5 PRODUCT TRADEMARKS. The Collaborators shall develop
Product Trademarks for each Collaboration Product that will be commercialized.
Such Product Trademarks shall not be confusingly similar to, misleading or
deceptive with respect to, or dilute any of the Trademarks owned or Controlled
by any of the Parties, or any part of such Trademarks. No Party or any of its
Affiliates or sublicensees shall commercialize a Collaboration Product under any
Trademark other than the Product Trademarks. No Party or any of its Affiliates
or sublicensees shall use in its business any Trademark that is confusingly
similar to, misleading or deceptive with respect to, or dilutes any of the
Product Trademarks or any other Trademarks used to identify or distinguish a
Collaboration Product, or any part of the foregoing. The Steering Committee
shall oversee the filing, prosecution and maintenance of all Product Trademark
registrations. The Collaborators shall share equally (50%) in the costs and
expenses of such filing, prosecution and maintenance. Subject to Applicable Law,
the label of any Collaboration Products shall include, at deCODE's sole
discretion, the name of deCODE and, at Genmab/Medarex's sole discretion, the
name of either or both Medarex and Genmab.
SECTION 1.6 SUPPLY OF COLLABORATION PRODUCTS. With respect to
clinical and commercial supplies of Collaboration Products, the Steering
Committee shall solicit bids from suppliers to supply the Parties' requirements
thereof. Each Party shall have the right to submit a bid on such terms as it
desires. The Steering Committee shall use its best efforts to enter into a
supply agreement with the supplier that is best able to meet the Parties'
requirements, taking into consideration such factors as price, quality,
capacity, quantity, reliability and reputation. In the event the Steering
Committee selects a Party to produce clinical and/or commercial supplies
pursuant to this Section 1.6, and such Party agrees to do so, the price and
other terms and conditions of such supply shall be based on arm's length
negotiations with the Steering Committee.
10
SECTION 1.7 REVERSION OF COLLABORATION TARGETS. If (x) the
Collaborators mutually decide not to proceed with a Collaboration Target
pursuant to the last sentence of Section 1.2.5, or (y) notwithstanding the
Commercially Reasonable Efforts of the Collaborators, no Collaboration
Antibodies have been designated with respect to a Collaboration Target pursuant
to Section 1.2.6(a) within two (2) years, or such other period as the Parties
may agree, after the immunization of the HuMAb Mice with respect to such
Collaboration Target pursuant to Section 1.2.5, then (a) such Antigen shall
cease to be a Collaboration Target (such Antigen, a "REVERSION TARGET"), and
Appendix C shall be amended accordingly, (b) any Antibodies with respect thereto
shall not become Collaboration Antibodies, (c) any Antibody Products with
respect thereto shall not become Collaboration Products, and (d) any licenses
granted pursuant to Article 3, with respect to such Antigen, Antibody or
Antibody Product shall terminate. Promptly upon such designation, the Parties
shall destroy all Antibody Products and other Biological Materials created under
this Agreement with respect to such a Reversion Target. For the avoidance of
doubt, neither Medarex nor Genmab shall have any right under this Agreement to
use any deCODE Know-How, including any deCODE Genomics Data, to Exploit, either
alone or in collaboration with a Third Party, or in connection with a Research
and Commercialization Agreement, Antibody Products with respect to a Reversion
Target or an Antigen declined by Genmab/Medarex pursuant to Section 1.2.2(a).
ARTICLE 2 -
OPERATION OF THE COLLABORATION
SECTION 2.1 STEERING COMMITTEE.
2.1.1 FORMATION OF STEERING COMMITTEE. The Parties shall
establish a joint steering committee (the "STEERING Committee"), which shall
manage the overall Collaboration and oversee the research, development and
commercialization activities under this Agreement. Each of deCODE and Genmab
shall appoint an equal number of representatives with the requisite experience
and seniority to enable them to make decisions on behalf of the Collaborators
with respect to the Collaboration. Each Party shall initially appoint two (2)
representatives to the Steering Committee, one of whom will be a member of its
senior management and the other a scientist. It is anticipated that the
composition of the Steering Committee shall change over time as Collaboration
Antibodies move through the research, development, manufacture and
commercialization life cycle. From time to time, deCODE and Genmab each may
substitute any of its representatives to the Steering Committee or mutually
agree to increase the number of representatives to the Steering Committee.
deCODE and Genmab each may, in their sole discretion, invite other non-voting
representatives of such Party to attend Steering Committee meetings. Medarex
shall have the right to have one or more non-voting representatives participate
(whether in person or by telephone) in all meetings of the Steering Committee.
Such representative(s) of Medarex shall have access to all data and reports
provided to, or created by, the Steering Committee.
2.1.2 RESPONSIBILITIES. The Steering Committee shall, in
addition to its other responsibilities described in this Agreement: (a)
prioritize the research,
11
development, manufacturing and commercialization activities with respect to
Collaboration Targets, Collaboration Antibodies and Collaboration Products; (b)
subject to Section 1.3, allocate responsibility for such activities among
deCODE, Genmab and Medarex taking into consideration their relevant expertise
and available resources; (c) review and amend each Project Plan and, with the
approval of Medarex, each Project Budget in accordance with Section 1.3; (d)
develop and implement a strategy for researching, developing, manufacturing,
obtaining and maintaining Regulatory Approvals for, and commercializing, the
Collaboration Products; (e) establish such subcommittees as deemed appropriate
by the Steering Committee; and (f) take such other actions as are set forth in
this Article 2 or as the Collaborators may unanimously agree. The Steering
Committee shall consider in good faith any input offered by Medarex with respect
to its activities and each Project Plan and Project Budget. The Steering
Committee may evaluate additional technologies that may be necessary or
beneficial to the Collaboration and may recommend the acquisition or
in-licensing of these technologies to the Collaborators.
2.1.3 PROCEDURAL RULES FOR THE STEERING COMMITTEE.
(a) GENERALLY. Except as explicitly set forth in this
Section 2.1.3, the Steering Committee shall establish its own procedural rules
for its operation.
(b) VOTING. The Steering Committee shall take action by
unanimous consent of deCODE and Genmab/Medarex, with each such Collaborator
having a single vote, irrespective of the number of representatives actually in
attendance at a meeting, or by a written resolution signed by the designated
representatives of each of deCODE and Genmab/Medarex. As between Medarex and
Genmab, the decision-making procedures shall be set forth in the Genmab/Medarex
Applied Genomics Agreement.
(c) MEETINGS. The Steering Committee shall meet
semiannually, or as otherwise agreed to by the members, with the location of
such meetings and method by which such meetings will be conducted alternating
between locations and methods designated by deCODE and locations and methods
designated by Genmab. Such meetings may be designated to occur in person or by
video conferencing and/or teleconferencing provided that all representatives
attending such meeting can hear each other simultaneously. The Collaborator that
designates the location of a meeting shall prepare and circulate minutes of such
meeting, for the review and approval of the other Collaborator, in a timely
manner after such meeting, which the Collaborators anticipate will be within
fifteen (15) days after such meeting. The Collaborators anticipate that the
minutes of each meeting will be reviewed and approved by the Collaborators
within thirty (30) days of each such meeting. Each Party shall bear all costs
and expenses associated with its representatives' attendance at meetings of the
Steering Committee.
SECTION 2.2 PROGRESS REPORTS. Within thirty (30) days after the end
of each calendar year, or as otherwise required by the Steering Committee, each
Party shall provide to the other Parties a written progress report, which shall
(a) describe any research, development or commercialization activities with
respect to Collaboration
12
Targets or Collaboration Products and any other work relating to the
Collaboration Targets and Collaboration Products that it has performed, or
caused to be performed, since the last such report, (b) evaluate the work
performed in relation to the goals of this Agreement and the applicable Project
Plan, and (c) provide such other information as may be required by this
Agreement and the applicable Project Plan or reasonably requested by the other
Parties relating to such activities. In addition to the progress reports
provided hereunder, it is contemplated that the Parties will maintain informal
communications through the Steering Committee and their day-to-day activities
under this Agreement.
SECTION 2.3 DISPUTES; DISPUTE RESOLUTION.
2.3.1 DISPUTES. Any dispute that may arise relating to the
terms of this Agreement or the activities of the Collaborators hereunder shall
be brought to the attention of the Steering Committee, which shall attempt in
good faith to achieve a resolution. Any Party may convene a special meeting of
the Steering Committee for the purpose of resolving disputes. If the Steering
Committee is unable to resolve such a dispute within twenty (20) days of the
first presentation of such dispute to the Steering Committee, and with respect
to all other disputes, such dispute shall be referred to the Chief Executive
Officers of each of the Parties (or their respective designees) who shall use
their good faith efforts to mutually agree upon the proper course of action to
resolve the dispute. Any disputes arising with respect to Mice-Related
Technology shall be resolved conclusively by the Chief Executive Officer of
Medarex (or its designee), who shall give good faith consideration to the
comments of the Chief Executive Officers of deCODE and Genmab (or their
respective designees) in resolving such matter. Any disputes arising with
respect to (a) deCODE Genomics Data, or (b) any health institution, governmental
agency or authority in Iceland or any statutes, law, rules or regulations of
Iceland shall be resolved conclusively under Icelandic law by the Chief
Executive Officer of deCODE (or its designee), who shall give good faith
consideration to the comments of the Chief Executive Officers of Genmab and
Medarex (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 each
of Genmab and Medarex 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. If any dispute is not resolved by the Chief
Executive Officers (or their designees) within ten (10) business days after an
issue is referred to them, or such longer period as the Chief Executive Officers
(or their respective designees) may collectively agree, then any Party shall
have the right (x) if such dispute relates to Sections 1.2.3(a), (c) or (e),
1.2.6(a) (to the extent the dispute relates to the determination of whether an
Assay Candidate has met the applicable Assay Success Criteria), 1.2.8 (to the
extent the dispute relates to the selection of a Lead Collaboration Antibody),
or 1.3 (to the extent the dispute relates to the determination of the activities
to be undertaken pursuant to a Project Plan, but not with respect to a dispute
regarding which Party will perform any such activities), to refer such dispute
to an Expert for expedited arbitration as set forth in subparagraphs (a) through
(c) below, or (y) with respect to any other dispute, including with respect to a
Party's interpretation of, or any allegation of breach
13
of, this Agreement, to pursue arbitration in accordance with Section 11.5 or to
pursue such other dispute resolution mechanism as the Parties may agree.
(a) With respect to disputes under subparagraph (x)
above that are not resolved by the Chief Executive Officers of the Parties (or
their designees) pursuant to Section 2.3.1, upon written request by any Party to
the other Parties, the Parties shall promptly negotiate in good faith to appoint
a mutually acceptable disinterested, conflict-free individual not affiliated
with any Party, with scientific, technical and regulatory experience with
respect to the development of antibody-based products necessary to resolve such
dispute (an "EXPERT"). If the Parties are not able to agree within five (5) days
after the receipt by a Party of the written request in the immediately preceding
sentence, the CPR Institute for Dispute Resolution shall be responsible for
selecting an Expert within seven (7) days of being approached by a Party. The
fees and costs of the Expert and the CPR Institute for Dispute Resolution shall
be shared equally by the Parties.
(b) Within fifteen (15) days after the designation of
the Expert, the Parties shall each simultaneously submit to the Expert and one
another a written statement of their respective positions on such disagreement.
Each Party shall have five (5) days from receipt of any other Party's submission
to submit a written response thereto, which shall include any scientific and
technical information in support thereof. The Expert shall have the right to
meet with the Parties, either alone or together, as necessary to make a
determination.
(c) No later than thirty (30) days after the
designation of the Expert, the Expert shall make a determination by selecting
the resolution proposed by one of the Parties that as a whole is the most fair
and reasonable to the Parties in light of the totality of the circumstances and
shall provide the Parties with a written statement setting forth the basis of
the determination in connection therewith. The decision of the Expert shall be
final and conclusive, absent manifest error.
SECTION 2.4 SEPARATE AGREEMENT BETWEEN MEDAREX AND GENMAB. It is
understood that Medarex and Genmab have entered into the Genmab/Medarex Applied
Genomics Agreement, which allocates between Medarex and Genmab certain rights
and obligations with respect to this Agreement, as well as other applied
genomics agreements to which Medarex and Genmab are parties. deCODE hereby
acknowledges that it has received a copy of the Genmab/Medarex Applied Genomics
Agreement in effect as of the Effective Date. In the event that Medarex and
Genmab amend the Genmab/Medarex Applied Genomics Agreement so that the
allocation of rights and obligations between Medarex and Genmab with respect to
this Agreement materially changes, Medarex and Genmab will promptly provide a
copy of such amendment to deCODE; provided, however, that no such amendment
shall increase the financial obligations of deCODE under this Agreement without
its prior written consent.
ARTICLE 3 -
GRANT OF RIGHTS
14
SECTION 3.1 LICENSE GRANTS FOR COLLABORATION ACTIVITIES.
3.1.1 GENMAB GRANT. Subject to Section 3.3 and the other
terms and conditions of this Agreement, Genmab hereby grants to deCODE and its
Affiliates a co-exclusive (with Medarex, Genmab and their respective Affiliates)
fully-paid, royalty-free license, with the right to sublicense solely as
provided in Section 3.4, under the Genmab Technology (except to the extent
prohibited by the Cross License Agreement) and the Collaboration Technology, in
each case to (a) perform deCODE's activities under Section 1.2 and (b) jointly
Exploit the Collaboration Products in accordance with this Agreement.
3.1.2 MEDAREX GRANT. Subject to Section 3.3 and the other
terms and conditions of this Agreement, Medarex hereby grants to deCODE and its
Affiliates a co-exclusive (with Medarex, Genmab and their respective
Affiliates), fully-paid, royalty-free license, with the right to sublicense
solely as provided in Sections 3.3.5 and 3.4, under the Medarex Technology
(except to the extent prohibited by the Cross License Agreement) and the
Collaboration Technology, in each case to (a) perform deCODE's activities under
Section 1.2, and (b) jointly Exploit the Collaboration Products in accordance
with this Agreement.
3.1.3 deCODE GRANT. Subject to Section 3.3 and the other
terms and conditions of this Agreement, deCODE hereby grants to Medarex and
Genmab and their respective Affiliates a co-exclusive (with deCODE and its
Affiliates), fully-paid, royalty-free license, with the right to sublicense
solely as provided in Section 3.4, under the deCODE Technology and the
Collaboration Technology, in each case to (a) perform Genmab/Medarex's
activities under Section 1.2, and (b) jointly Exploit the Collaboration Products
in accordance with this Agreement.
SECTION 3.2 PRODUCT TRADEMARKS FOR COLLABORATION PRODUCTS.
3.2.1 GENMAB GRANT. Subject to the terms and conditions of
this Agreement, Genmab hereby grants to deCODE and its Affiliates a co-exclusive
(with Genmab, Medarex and their respective Affiliates), fully-paid, royalty-free
license, with the right to sublicense solely as provided in Section 3.4, to use
the Product Trademarks to Exploit the Collaboration Products in accordance with
this Agreement.
3.2.2 MEDAREX GRANT. Subject to the terms and conditions of
this Agreement, Medarex hereby grants to deCODE and its Affiliates a
co-exclusive (with Medarex, Genmab and their respective Affiliates), fully-paid,
royalty-free license, with the right to sublicense solely as provided in Section
3.4, to use the Product Trademarks to Exploit the Collaboration Products in
accordance with this Agreement.
3.2.3 deCODE GRANT. Subject to the terms and conditions of
this Agreement, deCODE hereby grants to Medarex and Genmab and their respective
Affiliates a co-exclusive (with deCODE and its Affiliates), fully-paid,
royalty-free license, with the right to sublicense solely as provided in Section
3.4, to use the Product Trademarks to Exploit the Collaboration Products in
accordance with this Agreement.
15
SECTION 3.3 EXCLUSIVITY, RESERVED RIGHTS AND PRE-EXISTING GRANTS.
3.3.1 ANTIGEN EXCLUSIVITY.
(a) Subject to Sections 3.3.2, 3.3.3 and 3.3.4, the
Parties acknowledge and agree that this Collaboration shall be exclusive with
respect to the Collaboration Targets and that no Party shall engage, directly or
indirectly, on behalf of itself or any other party, in the research,
development, commercialization or other Exploitation of antibody-based
prophylactic or therapeutic products with respect to any Collaboration Target
other than the Collaboration Products and Unilateral Products as provided in
this Agreement and any related agreements among the Parties. deCODE represents
that it has entered into that certain Term Sheet re: Diagnostic Products between
deCODE, a certain Third Party and Affiliates of such Third Party dated as of
March 1, 2001, and any further agreement between deCODE, such Third Party and/or
such Affiliates entered into pursuant thereto (the "PRE-EXISTING DIAGNOSTIC
AGREEMENT"). deCODE acknowledges and agrees that it has no right to use, outside
of the Collaboration, any Antibodies generated pursuant to this Agreement or a
Unilateral Development and Commercialization Agreement, except as expressly set
forth in the applicable Unilateral Development and Commercialization Agreement.
(b) deCODE shall use commercially reasonable efforts
(i) to develop and commercialize or cause to be developed and commercialized
Diagnostic Products with respect to each Collaboration Target to the extent
necessary or reasonably useful for the Exploitation of Collaboration Products
with respect to such Collaboration Target, (ii) provide or cause to be provided
such Diagnostic Products to the Collaborators at a commercially reasonable cost
for use in connection with the development of such Collaboration Products,
including to assist the Collaboration in selecting patients for clinical trials
involving such Collaboration Products, and (iii) use commercially reasonable
efforts, consistent with the Pre-Existing Diagnostic Agreement, to make such
Diagnostic Products generally available to the public on commercially reasonable
terms or cause to be so made to the extent necessary or reasonably useful to
Exploit such Collaboration Products.
(c) Notwithstanding clause (b) above, if at any time
deCODE obtains rights, pursuant to the Pre-Existing Diagnostic Agreement or
otherwise, to a Diagnostic Product with respect to a Collaboration Target, then
deCODE shall offer such Diagnostic Product to Genmab/Medarex to be Exploited
under the Collaboration as a Collaboration Product. If Genmab/Medarex accepts
such Diagnostic Product into the Collaboration within sixty (60) days of receipt
of such offer, then the definition of Collaboration Product shall be
automatically amended to include such Diagnostic Product for all purposes with
respect to such Collaboration Target, subject to deCODE's obligations under the
Pre-Existing Diagnostic Agreement.
3.3.2 RESEARCH AND COMMERCIALIZATION AGREEMENTS. Medarex
shall have the right to (a) grant licenses and other rights to other parties,
including Genmab or deCODE, under the Medarex Technology for such parties, to
Exploit Antibody Products (but not Collaboration Products) with respect to
Antigens, including Collaboration
16
Targets, (b) transfer Medarex Know-How to such parties in connection therewith,
including by providing instruction with respect to the use and immunization of
HuMAb Mice and assistance with respect to the Mice-Related Technology, (c)
develop production processes for, and manufacture, such Antibody Products, and
(d) receive license fees, milestone payments, royalties and other remuneration
in connection therewith, but, in connection with clause (a), (b), (c) or (d)
above, not to otherwise actively participate in the clinical development or
commercialization of such Antibody Products by such parties (each agreement with
respect to the foregoing, a "RESEARCH AND COMMERCIALIZATION AGREEMENT");
provided, however, that Medarex shall not, based on the deCODE Know-How,
including any deCODE Genomics Data, propose to a Third Party that they include a
Reversion Target or a Collaboration Target in a Research and Commercialization
Agreement, but Medarex shall have the right to enter into a Research and
Commercialization Agreement with respect thereto if such Third Party first
proposes to Medarex that they include such Reversion Target or Collaboration
Target in such Research and Commercialization Agreement.
3.3.3 RETAINED RIGHTS.
(a) OTHER ANTIGENS. Notwithstanding anything in this
Agreement to the contrary, Medarex and Genmab do each hereby retain the right to
(i) enter into collaborations with, and to grant licenses and other rights under
the Medarex Technology and Genmab Technology respectively to, Third Parties to
Exploit Antibody Products with respect to Antigens other than Collaboration
Targets, and/or (ii) independently Exploit Antibody Products with respect to
Antigens other than Collaboration Targets.
(b) NON-ANTIBODY PRODUCTS. Notwithstanding anything in
this Agreement to the contrary, each Party does hereby retain the right to (i)
enter into collaborations with, and to grant licenses and other rights under its
respective Technology (other than Collaboration Technology, which shall be
governed by Section 7.1.6) to, Third Parties to Exploit products other than
antibody-based products with respect to Collaboration Targets that such Party
has acquired rights to outside the Collaboration, and/or (ii) independently
Exploit products other than antibody-based products with respect to
Collaboration Targets that such Party has acquired rights to outside the
Collaboration. By way of clarification, the Parties acknowledge that deCODE has
not granted Genmab or Medarex any rights under deCODE Technology to Exploit
products that are not Collaboration Products under this Agreement.
3.3.4 EXISTING GRANTS. The Parties further acknowledge and
agree that (a) pursuant to the Cross-License Agreement, Medarex has granted a
non-exclusive license under certain Medarex Patents to Exploit Antibody
Products, including Collaboration Products, with respect to Antigens, including
the Collaboration Targets, in the Territory, and (b) Medarex has entered into a
Research and Commercialization Agreement with Genmab.
3.3.5 CROSS LICENSE AGREEMENT. The Cross-License Agreement
prohibits Medarex from granting commercialization rights to the same Antibody
Product, whether by license or sublicense, under certain Medarex Technology and,
to the extent
17
licensed from Medarex, Genmab Technology to more than one party in a territory.
The Parties shall structure their respective commercialization rights in each
country in the Territory, in accordance with this Section 3.3.5, so as to comply
with the requirements of the Cross-License Agreement and shall use good faith
efforts to ensure that any such structure preserves the intended economic
benefits of the Collaboration to the Parties.
(a) So long as the Cross-License Agreement is in
effect, if the Steering Committee desires to grant a sublicense with respect to
commercialization of a Collaboration Product pursuant to Section 3.4, then the
Steering Committee shall provide Medarex with written notice thereof, which
shall set forth in reasonable detail the terms and conditions of such
sublicense, the Medarex Technology, Genmab Technology and the Collaboration
Product involved, and the identity of the proposed sublicensee. Upon receipt of
such notice, Medarex shall make a good faith determination as to whether such
Medarex Technology or Genmab Technology, as applicable, is subject to the
sublicense restrictions contained in the Cross-License Agreement.
(b) To the extent that Medarex determines that such
Medarex Technology or Genmab Technology, as applicable, is not subject to the
sublicense restrictions contained in the Cross-License Agreement, Medarex shall
so notify the Steering Committee in writing and the Collaboration thereafter
shall have the right to grant such sublicense, subject to Section 3.4.
(c) To the extent that Medarex determines that all or
part of such Medarex Technology or Genmab Technology, as applicable, is subject
to the sublicense restrictions contained in the Cross-License Agreement, Medarex
shall so notify the Steering Committee in writing. The Parties shall then meet
to discuss in good faith how to proceed in order to optimize the
commercialization of the applicable Collaboration Product hereunder while
complying with the requirements of the Cross-License Agreement.
SECTION 3.4 SUBLICENSES. Subject to Section 3.3.5, each Party shall
have the right to grant sublicenses under the licenses granted in Sections 3.1
and 3.2 (a) to Affiliates without the approval of the applicable licensor,
provided that any such sublicensor shall remain jointly and severally liable for
the performance or non-performance of any such Affiliate sublicensee, and (b) to
Third Parties pursuant to Section 5.2 with the prior approval of each applicable
licensor, not to be unreasonably withheld or delayed, which approval shall be
deemed to be granted with respect to a sublicense if the licensor fails, within
twenty (20) business days of its receipt of a written notice from the
sublicensing Party setting forth in reasonable detail the nature of such
sublicense and the identity of the sublicensee, to notify such sublicensing
Party that it withholds its consent to such sublicense. Notwithstanding the
previous sentence, the grant of any such sublicense shall not relieve the
sublicensing Party of its obligations under this Agreement.
18
SECTION 3.5 LICENSE LIMITATIONS.
3.5.1 GENMAB TECHNOLOGY. deCODE hereby covenants to Genmab
that neither deCODE nor any of its Affiliates, licensees or sublicensees shall
use or practice the Genmab Technology, directly or indirectly, on behalf of
itself or any other party, for any purpose other than as permitted under Section
3.1 and in particular, but without limiting the generality of the foregoing, for
any research, development, commercialization or other Exploitation of an
Antibody Product or any other product or method, other than a Collaboration
Product as provided hereunder.
3.5.2 MEDAREX TECHNOLOGY. deCODE hereby covenants to Medarex
that neither deCODE nor any of its Affiliates, licensees or sublicensees shall
use or practice the Medarex Technology, directly or indirectly, on behalf of
itself or any other party, for any purpose other than as permitted under Section
3.1 and in particular, but without limiting the generality of the foregoing, for
any research, development, commercialization or other Exploitation of an
Antibody Product or any other product or method, other than a Collaboration
Product as provided hereunder.
3.5.3 deCODE TECHNOLOGY.
(a) Medarex hereby covenants to deCODE that neither
Medarex nor any of its Affiliates, licensees or sublicensees shall use or
practice the deCODE Technology, directly or indirectly, on behalf of itself or
any other party, for any purpose other than as permitted under Sections 3.1 and
in particular, but without limiting the generality of the foregoing, for any
research, development, commercialization or other Exploitation of an Antibody
Product or any other product or method, other than a Collaboration Product as
provided hereunder.
(b) Genmab hereby covenants to deCODE that neither
Genmab nor any of its Affiliates, licensee or sublicensees shall use or practice
the deCODE Technology, directly or indirectly, on behalf of itself or any other
party, for any purpose other than as permitted under Sections 3.1 and in
particular, but without limiting the generality of the foregoing, for any
research, development, commercialization or other Exploitation of an Antibody
Product or any other product or method, other than a Collaboration Product as
provided hereunder.
SECTION 3.6 NO OTHER RIGHTS. For the avoidance of doubt, Medarex,
Genmab and their respective Affiliates shall have no right, express or implied,
with respect to the deCODE Technology and deCODE and its Affiliates shall have
no right, express or implied, with respect to the Medarex Technology and the
Genmab Technology, in each case except as expressly provided in Section 3.1.
19
ARTICLE 4 -
FINANCIAL PROVISIONS
SECTION 4.1 PROFIT AND EXPENSE ALLOCATION WITH RESPECT TO
COLLABORATION PRODUCTS.
4.1.1 NET PROFITS AND NET LOSSES. Except as otherwise
provided in this Agreement, the Collaborators shall share equally (50%) in the
Net Profits and Net Losses, as applicable, with respect to the Collaboration
Products, as set forth in this Section. Within thirty (30) days after the end
of each calendar quarter in which Net Profits or Net Losses are recognized with
respect to a Collaboration Product, each Collaborator shall provide the other
Collaborator with a statement detailing its Net Profits or Net Losses for such
Collaboration Product for such calendar quarter on a country-by-country basis,
which statement shall set forth in reasonable detail any Net Sales by such
Collaborator or its Affiliates, any Commercialization Expenses and any Other
Operating (Income)/Expense, including a detailed breakdown of the components of
the foregoing, with respect to such Collaboration Product, provided that such
Commercialization Expenses (including the components thereof) may not exceed
(or be projected to exceed) the amount set forth in the applicable Project
Budget with respect to the commercialization activities set forth in the
applicable Project Plan by more than [**] without the approval of the Steering
Committee ("AUTHORIZED COMMERCIALIZATION EXPENSES"). Within forty-five (45)
days after the end of each calendar quarter, the Collaborators shall make
payments to one another so that each shall share equally (50%) in the Net
Profits or Net Losses, as applicable, for such calendar quarter for each
Collaboration Product.
4.1.2 RESEARCH AND DEVELOPMENT EXPENSES. Except as otherwise
provided in this Agreement, Genmab/Medarex, on the one hand, and deCODE, on the
other hand, shall share equally (50%) in the cost and expense of all Authorized
R&D Expenses (as defined below) incurred by or on behalf of the Collaborators in
connection with their activities other than the deCODE Research Activities and
the Genmab/Medarex Research Activities. Within thirty (30) days after the end of
each calendar quarter, each Party shall furnish the Steering Committee with a
statement (a) detailing the costs and expenses actually incurred in connection
with the research and development activities (including phase IV and any other
post-Regulatory Approval research and development activities) performed by or on
behalf of such Party during such calendar quarter, provided that such costs or
expenses may not exceed (or be projected to exceed) the amounts set forth in the
relevant Project Budget with respect to such research and development activities
by more than [**] without the approval of the Steering Committee (the
"AUTHORIZED R&D EXPENSES") and (b) comparing such expenses to date with the
projections set forth in the Project Budget. Within forty-five (45) days after
the end of each calendar quarter, Genmab/Medarex and deCODE shall make payments
to one another so that each shall bear fifty percent (50%) of the total
Authorized R&D Expenses for such calendar quarter.
SECTION 4.2 PAYMENT METHOD. All amounts due by one Collaborator
hereunder shall be paid in U.S. dollars by wire transfer in immediately
available funds to
20
an account designated by the receiving Collaborator. Any payments or portions
thereof due hereunder which are not paid on the date such payments are due under
this Agreement shall bear interest at a rate equal to the lesser of the prime
rate as published in The Wall Street Journal, Eastern Edition, on the first day
of each calendar quarter in which such payments are overdue, plus two (2)
percentage points, and the maximum rate permitted by law, calculated on the
number of days such payment is delinquent, compounded monthly.
SECTION 4.3 CURRENCY; FOREIGN PAYMENTS. If any currency conversion
shall be required in connection with any payment hereunder, such conversion
shall be made by using the exchange rate for the purchase of U.S. dollars as
published in The Wall Street Journal, Eastern Edition, on the last business day
of the calendar quarter to which such payments relate. If at any time legal
restrictions prevent the prompt remittance of any Net Profits with respect to
Net Sales in any jurisdiction, the applicable Collaborator may notify the other
and make such payments by depositing the amount thereof in local currency in a
bank account or other depository in such country in the name of the receiving
Collaborator or its designee, and such Collaborator shall have no further
obligations under this Agreement with respect thereto.
SECTION 4.4 TAXES. A Collaborator may deduct from any amounts it is
required to pay pursuant to this Agreement an amount equal to that withheld for
or due on account of any taxes (other than taxes imposed on or measured by net
income) or similar governmental charge imposed by a jurisdiction other than the
United States ("WITHHOLDING TAXES"). At the receiving Collaborator's request,
the paying Collaborator shall provide the receiving Collaborator a certificate
evidencing payment of any Withholding Taxes hereunder and shall reasonably
assist the receiving Collaborator, at the receiving Collaborator's expense, to
obtain the benefit of any applicable tax treaty.
SECTION 4.5 RECORDS RETENTION; AUDIT.
4.5.1 RECORD RETENTION. Each Party shall maintain (and shall
ensure that its Affiliates and sublicensees shall maintain) complete and
accurate books, records and accounts that fairly reflect their respective (a)
Authorized R&D Expenses, Authorized Commercialization Expenses, Other Operating
(Income)/Expenses, any costs and expenses reimbursable under Article 7, and any
other costs and expenses reimbursable or otherwise shared by the Parties
hereunder (collectively, the "COLLABORATION EXPENSES"), and (b) Net Sales of
Collaboration Products and Net Profits and Net Losses with respect to
Collaboration Products, in each case in sufficient detail to confirm the
accuracy of any payments required hereunder and in accordance with GAAP, which
books, records and accounts shall be retained by such party until the later of
(i) three (3) years after the end of the period to which such books, records and
accounts pertain, and (ii) the expiration of the applicable tax statute of
limitations (or any extensions thereof), or for such longer period as may be
required by Applicable Law.
4.5.2 AUDIT. Each Party shall have the right to have an
independent certified public accounting firm of nationally recognized standing,
reasonably acceptable to the audited Party, to have access during normal
business hours, and upon reasonable
21
prior written notice, to such of the records of the other Parties (and their
Affiliates and sublicensees) as may be reasonably necessary to verify the
accuracy of such Collaboration Expenses, Net Sales, or Net Profits or Net
Losses, as applicable, for any calendar quarter ending not more than thirty-six
(36) months prior to the date of such request; provided, however, that no Party
shall have the right to conduct more than one such audit in any twelve
(12)-month period. The accounting firm shall disclose to each Party whether such
Collaboration Expenses, Net Sales, or Net Profits or Net Losses, as applicable,
are correct or incorrect and the specific details concerning any discrepancies.
No other information shall be provided to the requesting Party. The requesting
Party shall bear the cost of such audit unless the audit reveals a variance of
more than five percent (5%) from the reported results, in which case the audited
Party shall bear the cost of the audit. The results of such accounting firm
shall be final, absent manifest error.
4.5.3 PAYMENT OF ADDITIONAL AMOUNTS. If, based on the results
of such audit, additional payments are owed by a Collaborator under this
Agreement, such Collaborator shall make such additional payments, with interest
from the date originally due at the rate of one and a half percent (1.5%) per
month, within sixty (60) days after the date on which such accounting firm's
written report is delivered to such Collaborator.
4.5.4 CONFIDENTIALITY. The auditing Party shall treat all
information subject to review under this Section 4.5 in accordance with the
confidentiality provisions of Article 6 and shall cause its accounting firm to
enter into a reasonably acceptable confidentiality agreement with the audited
Party obligating such firm to maintain all such financial information in
confidence pursuant to such confidentiality agreement.
ARTICLE 5 -
UNILATERAL AND THIRD PARTY DEVELOPMENT AND COMMERCIALIZATION
SECTION 5.1 UNILATERAL DEVELOPMENT AND COMMERCIALIZATION.
5.1.1 OPTING-OUT BY A COLLABORATOR. Each Collaborator (i.e.,
Genmab/Medarex, on the one hand, and deCODE, on the other hand) (the "OPTING-OUT
COLLABORATOR") shall have the right, on thirty (30) days' written notice to the
other (an "OPT-OUT NOTICE"), to elect not to proceed with the research,
development and commercialization ("OPT-OUT") of all Collaboration Antibodies
and Collaboration Products with respect to a given Collaboration Target at any
time after the completion of the deCODE Research Activities and the
Genmab/Medarex Research Activities with respect to such Collaboration Target,
provided that such Collaborator shall be responsible for all budgeted costs and
expenses associated with the research and development activities with respect to
such Collaboration Antibody(ies) and Collaboration Product(s) that such
Collaborator has committed to in the applicable Project Budget as necessary to
complete that phase of research and development (e.g., toxicology studies in
support of an IND or phase I, phase II or phase III studies) that was under way
when such Collaborator Opted-Out. By way of clarification, if a Collaborator
Opts-Out of a
22
Collaboration Antibody or Collaboration Product with respect to a Collaboration
Target, such Collaborator will be deemed to have Opted-Out with respect to all
Antibodies and Antibody Products with respect to the same Collaboration Target.
5.1.2 RIGHTS AND OBLIGATIONS OF COLLABORATORS WITH RESPECT TO
UNILATERAL PRODUCTS.
(a) UNILATERAL DEVELOPMENT AND COMMERCIALIZATION. Upon
receipt by a Collaborator of an Opt-Out Notice, the receiving Collaborator shall
have the right, on written notice to the Opting-Out Collaborator within thirty
(30) days following receipt of the Opt-Out Notice (an "ELECTION NOTICE"), to
proceed unilaterally with the research, development and commercialization of all
Collaboration Antibodies to the applicable Collaboration Target (each, a
"UNILATERAL PRODUCT") pursuant to the separate agreement with the Opting-Out
Collaborator attached hereto as Xxxxxxxx X-0 or Xxxxxxxx X-0, as applicable
(each, a "UNILATERAL DEVELOPMENT AND COMMERCIALIZATION AGREEMENT"). Upon receipt
by Genmab/Medarex of an Election Notice from deCODE with respect to a
Collaboration Target, the Unilateral Development and Commercialization Agreement
set forth in Xxxxxxxx X-0 shall be automatically amended to include such
Collaboration Target and any Antibodies and Antibody Products with respect
thereto. Upon receipt by deCODE of an Election Notice from Genmab/Medarex with
respect to a Collaboration Target, the Unilateral Development and
Commercialization Agreement set forth in Xxxxxxxx X-0 shall be automatically
amended to include such Collaboration Target and any Antibodies and Antibody
Products with respect thereto. Upon such amendment of a Unilateral Development
and Commercialization Agreement pursuant to this Section 5.1.2, the applicable
Antigen shall cease to be a Collaboration Target and Appendix C shall be amended
accordingly, and any licenses granted pursuant to Article 3, with respect to
such Antigen and any Antibodies and Antibody Products with respect thereto,
shall terminate. The Collaborators shall work together to ensure a smooth and
orderly transition of the Unilateral Products to the non-Opting-Out
Collaborator, including the assignment of any contracts with respect to the
Exploitation of such Unilateral Products to the non-Opting-Out Collaborator, and
the assumption by the non-Opting-Out Collaborator of any obligations thereunder.
Except for the obligations provided for in Section 5.1.1, the Opting-Out
Collaborator shall have (x) no further financial obligation to support or
otherwise fund any additional efforts in respect of such Unilateral Product, and
(y) no obligation, responsibility, or authority regarding such additional
efforts in respect of such Unilateral Product. In the event that neither
Collaborator elects to proceed with the research, development or
commercialization of any Collaboration Antibody or Collaboration Product with
respect to a Collaboration Target, the rights and obligations of the
Collaborators with respect to such Collaboration Target shall be governed by
Sections 5.2 and 5.3.
(b) OPT-OUT OF UNILATERAL PRODUCTS. If, at any time,
the non-Opting Out Collaborator elects to Opt-Out of all Unilateral Products
with respect to a Unilateral Target (as defined in the applicable Unilateral
Development and Commercialization Agreement) pursuant to such Unilateral
Development and Commercialization Agreement and the other Collaborator does not
elect to proceed
23
unilaterally with the research, development and commercialization of such
Unilateral Products, all such Unilateral Products shall become Dormant Products
pursuant to Section 5.3 and the non-Opting Out Collaborator shall, without any
additional consideration, assign fifty percent (50%) of its right, title and
interest in and to any Product Trademark and all Regulatory Documentation with
respect to such Unilateral Products, including any Regulatory Approvals and
applications therefor (but excluding any Regulatory Documentation comprising
Production Process Technology, including any drug master file), to the other
Collaborator.
5.1.3 OPTING-OUT BY MEDAREX OR GENMAB. As between Medarex and
Genmab, each shall have the right, at any time, to individually elect not to
proceed with the research, development and commercialization of all
Collaboration Antibodies and Collaboration Products with respect to a given
Collaboration Target. In the event that one, but not both, of Medarex and Genmab
elects not to proceed with the research, development and commercialization of
such Collaboration Antibodies and Collaboration Products, but the other Party
(i.e., Genmab or Medarex) elects to proceed jointly with deCODE with respect to
such Collaboration Antibodies and Collaboration Products, then such election
shall not be governed by Sections 5.1.1 and 5.1.2 and the rights and
responsibilities as between Medarex and Genmab shall be governed by this Section
5.1.3 and the Genmab/Medarex Applied Genomics Agreement. If Genmab elects to so
proceed with respect to a Collaboration Target, all references to Genmab/Medarex
under this Agreement shall be deemed to be references to Genmab with respect to
such Collaboration Target, and if Medarex elects to so proceed with respect to a
Collaboration Target, all references to Genmab/Medarex under this Agreement
shall be deemed to be references to Medarex with respect to such Collaboration
Target and Medarex, and not Genmab, shall have the right to participate on the
Steering Committee with respect thereto. Once an election is made pursuant to
this Section 5.1.3 not to proceed with the research, development or
commercialization of a Collaboration Antibody or Collaboration Product, such
election shall be final with respect to the non-pursuing Party (i.e., Medarex or
Genmab) and such Party shall not be able to participate in any further research,
development or commercialization of such Collaboration Antibody or Collaboration
Product; provided, however, in the event Genmab elects not to proceed with a
Collaboration Target pursuant to this Section 5.1.3, Genmab shall continue to
immunize the HuMAb Mice with respect to such Collaboration Target in accordance
with Section 1.2.5 at Medarex's sole cost and expense.
SECTION 5.2 THIRD-PARTY RESEARCH, DEVELOPMENT AND COMMERCIALIZATION
OF COLLABORATION PRODUCTS. The Steering Committee, in consultation with Medarex,
shall have the right, at any time with respect to a Collaboration Product, to
license to Third Parties rights with respect to the research, development,
manufacture or commercialization of such Collaboration Product on such terms and
conditions as the Steering Committee may agree; provided that (a) any such
sublicense with respect to (i) Genmab Technology, to the extent licensed from
Medarex, or Medarex Technology shall be governed by the procedures set forth in
Sections 3.3.5 and 3.4, and (ii) deCODE Technology and other Genmab Technology
shall be governed by the procedures set forth in Section 3.4; and (b) any
disputes between the Steering Committee members as to
24
whether or not to grant such a license shall not be subject to litigation or any
other Third Party dispute resolution mechanism.
SECTION 5.3 DORMANT PRODUCTS. If the Collaborators do not elect to
proceed with the research, development or commercialization of a particular
Collaboration Antibody or Collaboration Product with respect to a Collaboration
Target, and the Collaborators have not licensed rights to such Collaboration
Antibody or Collaboration Product to a Third Party pursuant to Section 5.2 that
would be inconsistent therewith, (each, a "DORMANT PRODUCT") either Collaborator
shall have the right at any time, subject to Section 3.3, to bring such Dormant
Product to the Steering Committee to discuss whether to initiate or reinitiate
the research, development or commercialization of such Dormant Product. The
initiating Collaborator shall specify the reasons for proposing to initiate or
reinitiate such research, development or commercialization. If, within thirty
(30) days after the receipt of such notice, the other Collaborator fails to
notify the interested Collaborator in writing that it wishes to participate in
the research, development or commercialization of such Dormant Product, then the
interested Collaborator shall have the right to pursue research, development or
commercialization of such Dormant Product as a Unilateral Product pursuant to
Section 5.1, provided that no Collaboration Antibody or Collaboration Product
with respect to the same Collaboration Target as such Dormant Product is being
Exploited under this Agreement or by the other Collaborator under a Unilateral
Development and Commercialization Agreement.
ARTICLE 6 -
CONFIDENTIALITY
SECTION 6.1 DEFINITION. "CONFIDENTIAL INFORMATION" of a Party shall
mean all information and know-how and any tangible embodiments thereof provided
by or on behalf of such Party to another Party either in connection with the
discussions and negotiations pertaining to this Agreement or in the course of
performing this Agreement, including data; knowledge; practices; processes;
ideas; research plans; engineering designs and drawings; research data;
manufacturing processes and techniques; scientific, manufacturing, marketing and
business plans; and financial and personnel matters relating to the disclosing
Party or to its present or future products, sales, suppliers, customers,
employees, investors or business. For purposes of this Agreement,
notwithstanding the Party that disclosed such information or know-how, all
deCODE Know-How and all information or know-how with respect thereto, shall be
Confidential Information of deCODE, all Genmab Know-How, and all information or
know-how with respect thereto, shall be Confidential Information of Genmab, and
all Medarex Know-How, including all Mice-Related Know-How, and all information
and know-how with respect thereto, shall be Confidential Information of Medarex.
SECTION 6.2 EXCLUSIONS. Notwithstanding the foregoing, information
or know-how of a Party shall not be deemed Confidential Information with respect
to a receiving Party for purposes of this Agreement if such information or
know-how:
25
(a) was already known to the receiving Party or its
Affiliates, other than under an obligation of confidentiality or non-use, at the
time of disclosure to, or, with respect to Know-How, discovery or development
by, such receiving Party;
(b) was generally available or known to parties
reasonably skilled in the field to which such information or know-how pertains,
or was otherwise part of the public domain, at the time of its disclosure to,
or, with respect to Know-How, discovery or development by, such receiving Party;
(c) became generally available or known to parties
reasonably skilled in the field to which such information or know-how pertains,
or otherwise became part of the public domain, after its disclosure to, or, with
respect to Know-How, discovery or development by, such receiving Party through
no fault of a Party other than the Party that Controls such information and
know-how;
(d) was disclosed to such receiving Party or its
Affiliates, other than under an obligation of confidentiality or non-use, by a
Third Party who had no obligation to the Party that Controls such information
and know-how not to disclose such information or know-how to others; or
(e) was independently discovered or developed by such
receiving Party or its Affiliates, as evidenced by their written records,
without the use of Confidential Information belonging to the Party that Controls
such information and know-how, except with respect to deCODE Know-How, Genmab
Know-How and Medarex Know-How, which shall be and remain Confidential
Information of deCODE, Genmab and Medarex, respectively.
Specific aspects or details of Confidential Information shall not be deemed to
be within the public domain or in the possession of a Party merely because the
Confidential Information is embraced by more general information in the public
domain or in the possession of such Party. Further, any combination of
Confidential Information shall not be considered in the public domain or in the
possession of a Party merely because individual elements of such Confidential
Information are in the public domain or in the possession of such Party unless
the combination and its principles are in the public domain or in the possession
of such Party.
SECTION 6.3 DISCLOSURE AND USE RESTRICTION. Except as expressly
provided herein, the Parties agree that, for the Term and for five (5) years
thereafter, each Party and its Affiliates and sublicensees shall keep completely
confidential and shall not publish or otherwise disclose and shall not use for
any purpose except for the purposes contemplated by this Agreement any
Confidential Information of the other Parties or their respective Affiliates or
sublicensees.
26
SECTION 6.4 AUTHORIZED DISCLOSURE. Each Party may disclose
Confidential Information of another Party to the extent that such disclosure is:
6.4.1 REQUIRED BY GOVERNMENTAL ORDER. Made in response to a
valid order of a court of competent jurisdiction or other supra-national,
federal, national, regional, state, provincial or local governmental or
regulatory body of competent jurisdiction; provided, however, that such Party
shall first have given notice to such other Party and given such other Party a
reasonable opportunity to quash such order and to obtain a protective order
requiring that the Confidential Information and documents that are the subject
of such order be held in confidence by such court or agency or, if disclosed, be
used only for the purposes for which the order was issued; and provided further
that if a disclosure order is not quashed or a protective order is not obtained,
the Confidential Information disclosed in response to such court or governmental
order shall be limited to that information which is legally required to be
disclosed in response to such court or governmental order;
6.4.2 REQUIRED BY LAW. Otherwise required by law; provided,
however, that the disclosing Party shall provide such other Party with notice of
such disclosure in advance thereof to the extent practicable;
6.4.3 REQUIRED BY REGULATORY AUTHORITY. Made by such Party to
the Regulatory Authorities as required in connection with any filing,
application or request for Regulatory Approval; provided, however, that
reasonable measures shall be taken to assure confidential treatment of such
information;
6.4.4 REQUIRED BY AGREEMENT. Made by such Party, in
connection with the performance of this Agreement, to Affiliates, permitted
sublicensees, research parties, employees, consultants, representatives or
agents, each of whom prior to disclosure must be bound by obligations of
confidentiality and non-use at least equivalent in scope to those set forth in
this Article 6; or
6.4.5 REQUIRED BY CERTAIN THIRD PARTIES. Made by such Party
to existing or potential acquirers or merger candidates; existing or potential
pharmaceutical collaborators (to the extent contemplated hereunder); investment
bankers; existing or potential investors, venture capital firms or other
financial institutions or investors for purposes of obtaining financing; or
Affiliates, each of whom prior to disclosure must be bound by obligations of
confidentiality and non-use at least equivalent in scope to those set forth in
this Article 6. Notwithstanding this Section 6.4.5, neither deCODE nor Genmab
shall disclose any item of Medarex's Confidential Information to any existing or
potential acquirer or merger partner that is substantially involved in the
Exploitation of Antibodies or Antibody Products without first providing Medarex
with reasonable advance written notice of each such disclosure.
SECTION 6.5 USE OF NAME. Each Party may use the name, insignia,
symbol, trademark, trade name or logotype of another Party only (a) in
connection with announcements and other permitted disclosures relating to this
Agreement and the
27
activities contemplated hereby, (b) as required by Applicable Law, and (c)
otherwise as agreed in writing by such other Party.
SECTION 6.6 PRESS RELEASES. Press releases or other similar public
communication by any Party relating to this Agreement, shall be approved in
advance by the other Parties, which approval shall not be unreasonably withheld
or delayed, except for those communications required by Applicable Law (which
shall be provided to the other Parties as soon as practicable after the release
or communication thereof), disclosures of information for which consent has
previously been obtained, and information of a similar nature to that which has
been previously disclosed publicly with respect to this Agreement, each of which
shall not require advance approval.
SECITON 6.7 PUBLICATIONS. The Parties acknowledge that scientific
lead-time is a key element of the value of the research and development
activities under this Agreement and further agree that scientific publications
must be strictly monitored to prevent any adverse effect from premature
publication of results of the research or development activities hereunder. At
least sixty (60) days prior to submission of any material related to the
research or development activities hereunder for publication or presentation,
the submitting Party shall provide to the other Parties a draft of such material
for its review and comment. The receiving Parties shall provide any comments to
the submitting Party within thirty (30) days of receipt of such materials. No
publication or presentation with respect to the research or development
activities hereunder shall be made by a Party unless and until the other
Parties' comments on the proposed publication or presentation have been
addressed, changes have been agreed upon, and any information determined by such
other Parties to be Confidential Information of such Parties has been removed.
If requested in writing by the other Parties, the submitting Party shall
withhold material from submission for publication or presentation for an
additional sixty (60) days to allow for the filing of a patent application or
the taking of such measures to establish and preserve proprietary rights in the
information in the material being submitted for publication or presentation. In
all cases, each Party agrees that such Party shall provide appropriate
representation and acknowledgement of the other Parties in any publication or
presentation for the respective contributions of the scientists employed by the
other Parties with regard to the subject matter of such publication or
presentation.
ARTICLE 7 -
INTELLECTUAL PROPERTY
SECTION 7.1 INTELLECTUAL PROPERTY OWNERSHIP.
7.1.1 OWNERSHIP OF GENMAB TECHNOLOGY. Subject to the license
grants to deCODE under Article 3, as between deCODE and Genmab, Genmab shall own
and retain all right, title and interest in and to any and all: (a) Information
and Inventions that are conceived, discovered, developed or otherwise made, as
necessary to establish authorship, inventorship or ownership under Applicable
Law, by or on behalf of Genmab (or its Affiliates or its licensees or
sublicensees (other than deCODE and its Affiliates)), whether or not patented or
patentable, and any and all Patent and other intellectual
28
property rights with respect thereto, except to the extent that any such
Information and Inventions, or any Patent or other intellectual property rights
with respect thereto, are Collaboration Technology; (b) other Information and
Inventions, and Patent and other intellectual property rights that are
Controlled (other than pursuant to the license grants set forth in Article 3) by
Genmab, its Affiliates or, to the extent permitted, its licensees or
sublicensees (other than deCODE and its Affiliates); and (c) other Genmab
Technology.
7.1.2 OWNERSHIP OF MEDAREX TECHNOLOGY. Subject to the license
grants to deCODE under Article 3, as between deCODE and Medarex, Medarex shall
own and retain all right, title and interest in and to any and all: (a)
Information and Inventions that are conceived, discovered, developed or
otherwise made, as necessary to establish authorship, inventorship or ownership
under Applicable Law, by or on behalf of Medarex (or its Affiliates or its
licensees or sublicensees (other than deCODE and its Affiliates)), whether or
not patented or patentable, and any and all Patent and other intellectual
property rights with respect thereto, except to the extent that any such
Information and Inventions, or any Patent or other intellectual property rights
with respect thereto, are Collaboration Technology; (b) other Information and
Inventions, and Patent and other intellectual property rights that are
Controlled (other than pursuant to the license grants set forth in Article 3) by
Medarex, its Affiliates or its licensees or sublicensees (other than deCODE and
its Affiliates); and (c) other Medarex Technology.
7.1.3 OWNERSHIP OF deCODE TECHNOLOGY. Subject to Section
7.1.4 and the license grants to Medarex and Genmab under Article 3, as among the
Parties, deCODE shall own and retain all right, title and interest in and to any
and all: (a) Information and Inventions that are conceived, discovered,
developed or otherwise made, as necessary to establish authorship, inventorship
or ownership under Applicable Law, by or on behalf of deCODE (or its Affiliates
or its licensees or sublicensees (other than Medarex and Genmab and their
respective Affiliates)), whether or not patented or patentable, and any and all
Patent and other intellectual property rights with respect thereto, except to
the extent that any such Information and Inventions, or any Patent or other
intellectual property rights with respect thereto, are Collaboration Technology
or Mice Materials or Mice-Related Technology; (b) other Information and
Inventions, and Patent and other intellectual property rights that are
Controlled (other than pursuant to the license grants set forth in Article 3) by
deCODE, its Affiliates or its licensees or sublicensees (other than Medarex and
Genmab and their respective Affiliates); and (c) other deCODE Technology.
7.1.4 OWNERSHIP OF MICE-RELATED TECHNOLOGY. Subject to the
license grants to deCODE under Article 3, as among the Parties, Medarex shall
own and retain all right, title and interest in and to all Mice Materials and
Mice-Related Technology, including any and all Information and Inventions with
respect to the Mice Materials or the Mice-Related Technology (including any
Improvements thereto) that are conceived, discovered, developed or otherwise
made, as necessary to establish authorship, inventorship or ownership under
Applicable Law, by or on behalf of deCODE, its Affiliates or its licensees or
sublicensees (other than Medarex, Genmab and their respective Affiliates),
whether or not patented or patentable, and any and all Patent and other
intellectual property rights with respect thereto. deCODE acknowledges and
agrees
29
that (a) the licenses granted to it pursuant to Article 3 permit deCODE to use
Mice Materials and Mice-Related Technology solely for the Exploitation of
Collaboration Products as provided in this Agreement, (b) deCODE has no right to
use the HuMAb Mice or to discover, develop or otherwise make Improvements with
respect to Mice Materials and Mice-Related Technology under such grants, and (c)
neither it, nor any of its Affiliates, licensees or sublicensees, will engage,
directly or indirectly, in activities designed to, or otherwise undertake or
attempt, either on behalf of itself or another, to discover, develop or make any
Information and Inventions that relate to the Mice Materials or the Mice-Related
Technology. Accordingly, deCODE shall promptly disclose to Medarex in writing,
the conception or reduction to practice, or the discovery, development or making
of any Mice Material or Mice-Related Technology and shall, and does hereby,
assign, and shall cause its Affiliates, licensees and sublicensees to so assign,
to Medarex, without additional compensation and at Medarex's expense (for
reasonable and direct out-of-pocket costs actually incurred), all of their
respective rights, titles and interests in and to any Mice Material or
Mice-Related Technology.
7.1.5 OWNERSHIP OF PRODUCTION PROCESS TECHNOLOGY. Each Party
shall own and retain all right, title and interest in and to its Production
Process Technology, including any and all Information and Inventions with
respect to such Production Process Technology (including any Improvements
thereto) that are conceived, discovered, developed or otherwise made, as
necessary to establish authorship, inventorship or ownership under Applicable
Law, by or on behalf of such Party, its Affiliates, its licensees or
sublicensees, whether or not patented or patentable, and any and all Patent and
other intellectual property rights with respect thereto. Except as the Parties
may otherwise expressly agree, including by separate written agreement pursuant
to Section 1.2.8 or Section 1.6, no Party shall have any rights, express or
implied, under this Agreement with respect to any Production Process Technology
of the other Parties and nothing in this Agreement is intended to or shall be
interpreted as granting a Party any license to such Production Process
Technology, whether subordinate or dominant to any other Technology.
7.1.6 OWNERSHIP OF COLLABORATION TECHNOLOGY. Subject to
Sections 7.1.3 and 7.1.4 and the license grants under Article 3, the Parties
shall each own an equal, undivided interest in any Collaboration Technology;
provided, however, that, except as otherwise expressly provided in this
Agreement, neither a Party nor any of its Affiliates, licensees or sublicensees
shall, directly or indirectly, Exploit any Collaboration Technology, or any
intellectual property rights with respect thereto, without the consent of the
other Parties, not to be unreasonably withheld or delayed, except that each
Party shall have the right to Exploit such Collaboration Technology for its
internal research and discovery purposes (as opposed to the development,
commercialization or other Exploitation of products or technology resulting
therefrom), without the consent of the other Parties; provided, however, that no
Party shall have the right to use, outside the Collaboration, any Antibodies
generated pursuant to this Agreement or a Unilateral Development and
Commercialization Agreement, except as expressly set forth in the applicable
Unilateral Development and Commercialization Agreement. Each Party shall
promptly disclose to the other Parties in writing, and shall cause its
Affiliates, licensees and sublicensees to so disclose, the development, making,
conception or reduction to
30
practice of any Collaboration Technology, and shall, and does hereby, assign,
and shall cause its Affiliates, licensees and sublicensees to so assign, to the
other Parties, without additional compensation, such right, title and interest
in and to any Collaboration Technology as well as any intellectual property
rights with respect thereto, as is necessary to fully effect the joint ownership
provided for in the foregoing sentence.
7.1.7 OWNERSHIP OF PRODUCT TRADEMARKS. Subject to the license
grants in Article 3, the Collaborators shall each own an equal, undivided
interest in each Product Trademark with respect to a Collaboration Product. In
the event that a Collaborator Opts-Out with respect to a Collaboration Product,
it shall, without any additional consideration, assign all of its right, title
and interest in and to any Product Trademark with respect to such Collaboration
Product or Unilateral Product to the non-Opting-Out Collaborator; provided,
however, that each Collaborator shall retain all of its right, title and
interest in and to any Product Trademarks with respect to Dormant Products.
7.1.8 OWNERSHIP OF REGULATORY DOCUMENTATION. Subject to the
license grants in Article 3, all Regulatory Approvals with respect to a
Collaboration Product shall be owned by one of the Collaborators, with such
ownership alternating between the Collaborators on a Collaboration
Target-by-Collaboration Target basis with respect to Collaboration Products,
unless otherwise agreed upon by the Steering Committee. With respect to the
first Collaboration Product and any other Collaboration Products with respect to
the same Collaboration Target, the Regulatory Approvals shall be owned by the
designee of Genmab/Medarex. With respect to the first Collaboration Product with
respect to the next Collaboration Target, and any other Collaboration Products
with respect to the same Collaboration Target, the Regulatory Approvals shall be
owned by deCODE or its designee. Subject to the license grants in Article 3,
each Collaborator shall, to the extent permitted by law, have an equal,
undivided interest in all other Regulatory Documentation. Subject to the
foregoing sentence, each Collaborator shall promptly (a) disclose to the other
Collaborator in writing, and shall cause its Affiliates, licensees and
sublicensees to so disclose, such other Regulatory Documentation, and (b)
assign, or cause its Affiliates, licensees or sublicensees to assign, to the
other Collaborator, without additional compensation, such right, title and
interest in and to such other Regulatory Documentation as is necessary to fully
effect the joint ownership provided for in the foregoing sentence. Each
non-Opting-Out Collaborator shall have the right to own all right, title and
interest in and to all Regulatory Approvals with respect to its Unilateral
Products. In the event that a Collaborator Opts-Out with respect to a
Collaboration Product, it shall assign all of its right, title and interest in
and to all Regulatory Documentation with respect to such Collaboration Product,
including any Regulatory Approvals and applications therefor, to the non-Opting
Out Collaborator (or its designee); provided, however, that each Collaborator
shall retain any of its right, title and interest in and to any Regulatory
Documentation with respect to a Dormant Product. Notwithstanding the ownership
of any Regulatory Approval or any other Regulatory Documentation, each
Collaborator shall have the right to use and reference any of the Regulatory
Documentation in connection with the Exploitation of Collaboration Products as
provided in this Agreement. Notwithstanding the foregoing, any Regulatory
Documentation containing Production Process Know-How of a Party shall be and
remain
31
the sole and exclusive property of such Party and such Party shall have the
right to submit any such Production Process Know-How directly to the Regulatory
Authorities using a drug master file, or any foreign equivalent that is designed
to protect such Party's Confidential Information, which filing shall be and
remain the sole and exclusive property of such Party.
SECTION 7.2 PROSECUTION OF PATENTS AND TRADEMARKS.
7.2.1 MEDAREX RIGHTS. As among the Parties, Medarex shall,
subject to Section 7.2.6, have the sole right, at its cost and expense, to
obtain, prosecute and maintain throughout the world the Medarex Patents,
including the Mice-Related Patents and its Production Process Patents.
7.2.2 GENMAB RIGHTS. As among the Parties, Genmab shall,
subject to Section 7.2.6, have the sole right, at its cost and expense, to
obtain, prosecute and maintain throughout the world the Genmab Patents,
including its Production Process Patents.
7.2.3 deCODE RIGHTS. As among the Parties, deCODE shall,
subject to Section 7.2.6, have the sole right, at its cost and expense, to
obtain, prosecute and maintain throughout the world the deCODE Patents,
including its Production Process Patents.
7.2.4 COLLABORATION TECHNOLOGY AND PRODUCT TRADEMARKS.
(a) FILINGS OF PATENTS. Subject to Section 7.2.7, the
Collaborators shall, and shall cause their respective Affiliates, licensees and
sublicensees, as applicable, to, cooperate with one another with respect to the
filing, prosecution and maintenance of all Collaboration Patents, including by
selecting outside counsel, reasonably acceptable to the Collaborators, to handle
such filing, prosecution and maintenance. The Collaborators shall share equally
in the expenses associated with the filing, prosecution (including any
interferences, reissue proceedings and reexaminations) and maintenance of all
Patents included in the Collaboration Technology.
(b) FILINGS OF PRODUCT TRADEMARKS. The Steering
Committee, with respect to a Collaboration Product, shall supervise and direct
the filing, prosecution and maintenance of the registrations of the Product
Trademarks for such Collaboration Product. The Steering Committee shall provide
each Party with (i) drafts of any new application to register a Product
Trademark prior to filing that application, allowing adequate time for review
and comment by the Parties if possible; provided, however, the Steering
Committee shall not be obligated to delay the filing of any application; and
(ii) copies of all correspondence from any and all Trademark offices concerning
Product Trademark registrations and an opportunity to comment on any proposed
responses, voluntary amendments and submissions of any kind to be made to any
and all such Trademark offices. Subject to Section 7.2.7, the Collaborators
shall share equally in the expenses associated with the filing, prosecution and
maintenance of such Product Trademark registrations.
32
7.2.5 COOPERATION. Each Party shall, and shall cause its
Affiliates, licensees and sublicensees, as applicable, to, cooperate fully in
the preparation, filing, prosecution, and maintenance of the other Parties'
Patents and the Product Trademarks. Such cooperation includes (a) promptly
executing all papers and instruments and requiring employees to execute such
papers and instruments as reasonable and appropriate so as to enable such other
Party or the Steering Committee, as applicable, to file, prosecute, and maintain
its Patents in any country; and (b) promptly informing such other Parties of
matters that may affect the preparation, filing, prosecution, or maintenance of
any such Patents.
7.2.6 PATENT FILINGS. deCODE covenants not to, and to cause
its Affiliates, licensees and sublicensees, as applicable, not to, file any
patent application disclosing or claiming any Information and Inventions
comprising any Medarex Technology or Genmab Technology or the Exploitation
thereof, without Medarex's or Genmab's, as applicable, prior written consent,
which consent shall not be unreasonably withheld or delayed. Medarex and Genmab
covenant not to, and to cause their respective Affiliates, licensees and
sublicensees, as applicable, not to, file any patent application disclosing or
claiming any Information and Inventions comprising any deCODE Technology or the
Exploitation thereof, without deCODE's prior written consent, which consent
shall not be unreasonably withheld or delayed.
7.2.7 ELECTION NOT TO PROSECUTE. If any Party elects not (a)
to pursue the filing, prosecution or maintenance of a Collaboration Patent in a
particular country, (b) to pursue the registration, prosecution or maintenance
of a Product Trademark in a particular country, or (c) to take any other action
with respect to Collaboration Technology or a Product Trademark in a particular
country that is necessary or reasonably useful to establish or preserve rights
thereto, then in each such case such Party shall so notify the other Parties
promptly in writing and in good time to enable such other Party(ies) to meet any
deadlines by which an action must be taken to establish or preserve any such
rights in such Collaboration Technology or Product Trademark, as applicable, in
such country. Upon receipt of each such notice by such other Parties or if, at
any time, such Party fails to initiate any such action within thirty (30) days
after a request by such other Party(ies) that it do so (or thereafter diligently
pursue such action), such other Party(ies) shall have the right, but not the
obligation, to pursue the filing or registration, or support the continued
prosecution or maintenance, of such Patent or Product Trademark, as applicable,
at its expense in such country. If such other Party(ies) elects to pursue such
filing or registration, as the case may be, or continue such support, then such
other Party(ies) shall notify such Party of such election and such Party(ies)
shall, and shall cause its Affiliates, licensees and sublicensees, as
applicable, to, (x) reasonably cooperate with such other Party in this regard,
and (y) subject to Article 3, promptly release or assign to such other
Party(ies), without compensation, all right, title and interest in and to such
Patent or Product Trademark, as applicable, in such country.
SECTION 7.3 ENFORCEMENT OF PATENTS AND TRADEMARKS.
7.3.1 RIGHTS AND PROCEDURES. If Medarex, Genmab or deCODE
determines that any Technology or Product Trademark is being infringed by a
Third
33
Party's activities and that such infringement could affect the exercise by the
Parties of their respective rights and obligations under this Agreement, it
shall promptly notify the other Parties in writing and provide them with any
evidence of such infringement that is reasonably available. Promptly after the
receipt of such written notice, the Parties shall meet and discuss in good faith
the removal of such infringement. The pursuing Party shall consider in good
faith any comments from the other Parties and shall keep the other Parties
reasonably informed of any steps taken to remove such infringement.
(a) COLLABORATION TECHNOLOGY AND PRODUCT TRADEMARKS.
With respect to Collaboration Technology and Product Trademarks, the Steering
Committee shall have the first right to remove such infringement using
commercially appropriate steps, including the filing of an infringement suit or
taking other similar action. Each Collaborator shall be responsible for half of
the reasonable and verifiable costs and expenses incurred in connection with
such action. In the event the Steering Committee fails to take commercially
appropriate steps to remove any infringement of any such Collaboration
Technology or Product Trademark within ninety (90) days following notice of such
infringement, or earlier notifies the Parties in writing of its intent not to
take such steps, and (i) such failure to act is due to the refusal of one
Collaborator's representatives on the Steering Committee to authorize action
over the objection of the other Collaborator's representatives, then the
Collaborator whose representatives wish to proceed shall have the right to do so
at its expense, or (ii) such failure to act is due to any reason other than as
set forth in clause (i) above, then any Collaborator shall have the right to
proceed at its expense; provided, however, that if the Steering Committee has
commenced negotiations with an alleged infringer for discontinuance of such
infringement within such ninety (90) day period, the Steering Committee shall
have an additional ninety (90) days to conclude its negotiations before a Party
unilaterally may bring suit for such infringement.
(b) OTHER TECHNOLOGY. With respect to Technology of a
Party, the owner of such Technology shall have the sole right, but not the
obligation, to remove such infringement; provided, however, that, with respect
to Medarex Technology or Genmab Technology, deCODE shall reimburse
Genmab/Medarex for fifty percent (50%)of the reasonable out-of-pocket costs
incurred by Genmab/Medarex with respect to the removal of any such infringement
with respect to any Collaboration Product, and with respect to deCODE
Technology, Genmab/Medarex shall reimburse deCODE for fifty percent (50%) of the
reasonable out-of-pocket costs incurred by deCODE with respect to the removal of
any such infringement with respect to any Collaboration Product.
7.3.2 COOPERATION. The Parties not enforcing the applicable
Technology or Product Trademark shall provide reasonable assistance to the other
Party, including providing access to relevant documents and other evidence,
making its employees available at reasonable business hours, and joining the
action to the extent necessary to allow the enforcing Party to maintain the
action.
7.3.3 RECOVERY. Any amounts recovered by any Party pursuant
to Section 7.3.1, whether by settlement or judgment, shall be used to reimburse
the Parties for their reasonable costs and expenses in making such recovery
(which amounts shall be
34
allocated pro rata if insufficient to cover the totality of such expenses), with
any remainder being retained by the Party that has exercised its right to bring
the enforcement action; provided, however, that to the extent that any award is
attributable to loss of sales of a Collaboration Product, the Parties shall
negotiate in good faith an appropriate allocation of such award to reflect the
economic interests of the Parties under this Agreement with respect to such
Collaboration Product.
SECTION 7.4 POTENTIAL THIRD PARTY RIGHTS.
7.4.1 THIRD PARTY LICENSES. If (a) in the Collective Opinion
of Counsel, a Collaborator, or any of its Affiliates, licensees or permitted
sublicensees, cannot Exploit a Collaboration Product in a country in the
Territory without infringing one or more Patents that have issued to a Third
Party in such country, or (b) as a result of any claim made against a Party, or
any of its Affiliates, licensees or permitted sublicensees, alleging that the
Exploitation of a Collaboration Product infringes or misappropriates any Patent
or any other intellectual property right of a Third Party in a country in the
Territory, a judgment is entered by a court of competent jurisdiction from which
no appeal is taken within the time permitted for appeal, such that a
Collaborator cannot Exploit such Collaboration Product in such country without
infringing the Patent or other proprietary rights of such Third Party, then, in
either case, the Collaborators shall use Commercially Reasonable Efforts to
obtain a license in the names of the Collaborators from such Third Party as
necessary for the Exploitation of any Collaboration Products hereunder in such
country; provided, however, that Medarex shall have the sole right to seek any
such license with respect to Mice-Related Technology, and shall use Commercially
Reasonable Efforts to obtain such a license in its own name from such Third
Party in such country, under which Medarex shall, to the extent permissible
under such license, grant a sublicense to deCODE and Genmab as necessary for
deCODE and Genmab, and any of their respective Affiliates and permitted
sublicensees, to Exploit the Collaboration Products as provided hereunder in
such country. The Collaborators shall each bear fifty percent (50%) of any
royalty or other obligations under such licenses, except with respect to the
Medarex Technology, Genmab Technology or the deCODE Technology, where the
Collaborators shall each be responsible for fifty percent (50%) of only those
royalty and other obligations with respect to the Exploitation of Collaboration
Products and the other activities of the Parties hereunder. For purposes of this
Section 7.4.1, "COLLECTIVE OPINION OF COUNSEL" shall mean the final joint
opinion of patent counsel selected by deCODE and patent counsel selected by
Genmab/Medarex, after review of all data and information reasonably available at
the time such opinion is rendered. If patent counsel for the Collaborators
cannot agree on a final joint opinion within twenty (20) days after submission
of the matter to such counsel, the patent counsel of the Collaborators shall
agree on a third patent counsel who shall offer an independent opinion on the
subject matter, which independent opinion shall be deemed the Collective Opinion
of Counsel.
7.4.2 THIRD PARTY LITIGATION. In the event that a Third Party
institutes a Patent, Trademark or other infringement suit (including any suit
alleging the invalidity or unenforceability of the Patents of a Party or its
Affiliates, or claiming confusion, deception or dilution of a Trademark by a
Product Trademark) against any Party or its
35
Affiliates, licensees or permitted sublicensees during the Term, alleging that
the Exploitation of the Collaboration Products in the Territory or any other
activities hereunder, infringes one or more Patent, Trademark or other
intellectual property rights held by such Third Party (an "INFRINGEMENT SUIT"),
the Parties shall cooperate with one another in defending such suit. Except with
respect to the Medarex Technology, Genmab Technology or the deCODE Technology,
the Collaborators shall jointly direct and control any Infringement Suit with
respect to Collaboration Products or any Collaboration Patents; provided,
however, that no Party shall cease to defend, settle or otherwise dispose of a
suit with respect to any intellectual property of another Party without the
prior written consent of such other Party. Each Party shall have the sole right
to direct and control (including the right to cease to defend, settle or
compromise) any Infringement Suit with respect to its Technology. The
Collaborators shall each bear fifty percent (50%) of any costs and expenses of
such defense, except with respect to the Medarex Technology, Genmab Technology
or the deCODE Technology, where the Collaborators shall each be responsible for
fifty percent (50%) of those costs and expenses only with respect to (i) the
Exploitation of Collaboration Products and the other activities of the Parties
hereunder, and (ii) Collaboration Targets for which a legal opinion was obtained
pursuant to Section 1.2.9.
7.4.3 RETAINED RIGHTS. Nothing in this Section 7.4 shall
prevent any Party, at its own expense, from obtaining any license or other
rights from Third Parties it deems appropriate in order to permit the full and
unhindered exercise of its rights under this Agreement.
SECTION 7.5 EXCHANGE OF KNOW-HOW.
7.5.1 INFORMATION DISCLOSURE. Each Party shall, and shall
cause its Affiliates, licensees and sublicensees, as applicable, to, without
additional compensation and at such Party's sole expense, disclose and make
available to the other Parties, in whatever form each such other Party may
reasonably request, all Regulatory Documentation, all of its other Know-How, all
Information and Inventions included in the Collaboration Technology and any
other Information and Inventions relating, directly or indirectly, to the
Exploitation of any Collaboration Products immediately after the Effective Date
and thereafter immediately upon the earlier of the conception or reduction to
practice, discovery, development or making of each such Regulatory
Documentation, Know-How, or other Information and Inventions.
7.5.2 COOPERATION. With respect to the research, development,
commercialization or other Exploitation of the Collaboration Products, each
Collaborator, shall cooperate with any and all reasonable requests for
assistance from the other Collaborator, including by making its employees,
consultants and other scientific staff available upon reasonable notice during
normal business hours at their respective places of business to consult with
such other Collaborator, as applicable, on issues arising during such research,
development, commercialization or Exploitation.
7.5.3 BIOLOGICAL MATERIALS. For purposes of facilitating the
conduct of the research and development activities under this Agreement,
Genmab/Medarex and
36
deCODE shall each provide to the other tissues, cells, cell lines, organisms,
blood samples, genetic material, and other biological substances and materials,
including the Mice Materials, the Collaboration Targets and other Antigens
(collectively, "BIOLOGICAL MATERIALS") specified from time to time in this
Agreement or the applicable Project Plan. Each Collaborator agrees to provide
all such Biological Materials to the other in accordance with this Agreement and
the applicable Project Plan, and under the supervision of the Steering
Committee. The Parties agree that: (a) all Biological Materials provided by one
Party to another Party and any Biological Material (including Collaboration
Products and other Mice Materials) produced against or with, or derived from,
such Biological Materials shall be used solely for the research and development
activities as provided in the Project Plan, and in material compliance with all
Applicable Law; (b) all such Biological Materials shall be provided without any
warranties, express or implied; (c) the Party providing such Biological
Materials shall obtain (or cause its Third Party collaborators to obtain or
certify that they have obtained) all appropriate and required consents from the
source of such Biological Materials; (d) Biological Materials provided by one
Party to another Party (other than Collaboration Products) shall not be made
available by such other Party to any Third Party except as expressly provided in
the Project Plan, unless the prior written consent of the Party providing such
Biological Materials is first obtained; and (e) subject to the license grants in
Article 3 and other provisions in this Agreement, all right, title and interest
in and to (i) the Mice Materials and the Mice-Related Technology shall be, and
remain, vested in Medarex, and (ii) the Collaboration Targets shall be, and
remain, vested in deCODE.
7.5.4 REGULATORY RECORDS. With respect to the subject matter
of this Agreement, each Party shall maintain, or cause to be maintained, records
of its respective research, development, manufacturing and commercialization
activities, including all Regulatory Documentation, in sufficient detail and in
good scientific manner appropriate for patent and regulatory purposes, which
shall be complete and accurate and shall fully and properly reflect all work
done and results achieved in the performance of such activities, and which shall
be retained during the term of this Agreement and for a period of five (5) years
thereafter, or for such longer period as may be required by Applicable Law. Each
Party shall have the right, during normal business hours and upon reasonable
notice, to inspect and copy any such records, except (a) with respect to
Medarex's records, to the extent that such records contain proprietary
information with respect to the HuMAb Mice, or (b) with respect to a Party's
records, to the extent that such records contain proprietary information with
respect to its Production Process Technology.
7.5.5 PRODUCTION PROCESS TECHNOLOGY. Notwithstanding anything
to the contrary in this Section 7.5 or elsewhere in this Agreement, no Party
shall be obligated to disclose or provide any of its Production Process
Technology, including Biological Materials, to any other Party or any Third
Party except as may be required or permitted under a separate written agreement
entered into by the Parties pursuant to Section 1.2.8 or Section 1.6.
ARTICLE 8 -
TERM AND TERMINATION
37
SECTION 8.1 TERM. The term of this Agreement (the "TERM") shall
commence upon the Effective Date and shall continue in effect until the later of
(a) the fourth (4th) anniversary of the expiration or earlier termination of the
Target Entry Period, or (b) such time as there is no longer any (i) Dormant
Product with respect to which the Collaborators have rights pursuant to Section
5.3, or (ii) Collaboration Product being Exploited hereunder, whether pursuant
to Section 1.7 or otherwise, or any Unilateral Product being Exploited under a
Unilateral Development and Commercialization Agreement, unless terminated at an
earlier date in accordance with the terms and conditions set forth in this
Article 8.
SECTION 8.2 TERMINATION FOR MATERIAL BREACH. Any material failure
by a Party to comply with any of its material obligations contained herein shall
entitle the Parties not in default to give to the Party in default written
notice specifying the nature of the default, requiring the defaulting Party to
make good or otherwise cure such default, and stating its intention if such
default is not cured to terminate or, at the option of the Party(ies) not in
default, to convert a Collaboration Product to which the material breach applies
to a Unilateral Product pursuant to Section 5.1. If such default is not cured
within thirty (30) days after the receipt of such notice (or, if such default
cannot be cured within such thirty (30)-day period, if the Party in default does
not commence actions to cure such default within such period and thereafter
diligently continue such actions or if such default is not otherwise cured
within one-hundred and twenty (120) days after the receipt of such notice),
except in the case of a payment default, as to which the defaulting Party shall
have only a thirty (30) day cure period, the Parties not in default shall be
entitled, on written notice to the other Party, without prejudice to any of its
other rights conferred on it by this Agreement, and in addition to any other
remedies available to it by law or in equity, to (a) terminate this Agreement in
its entirety, or (b) convert such Collaboration Product to a Unilateral Product
pursuant to Section 5.1, whereupon the defaulting Party shall be deemed the
Opting-Out Party with respect to such Unilateral Product for all purposes
hereunder and the notice provided under this provision shall be deemed
equivalent to an Election Notice as provided in Section 5.1.
SECTION 8.3 TERMINATION UPON INSOLVENCY. Subject to the applicable
United States bankruptcy laws or equivalent foreign laws, any Party may
terminate this Agreement if, at any time, any other Party shall file in any
court or agency pursuant to any statute or regulation of any state, country or
jurisdiction, a petition in bankruptcy or insolvency or for reorganization or
for an arrangement or for the appointment of a receiver or trustee of that Party
or of its assets, or if such other Party proposes a written agreement of
composition or extension of its debts, or if such other Party shall be served
with an involuntary petition against it, filed in any insolvency proceeding, and
such petition shall not be dismissed within sixty (60) days after the filing
thereof, or if such other Party shall propose or be a party to any dissolution
or liquidation, or if such other Party shall make an assignment for the benefit
of its creditors; provided, however, that in the event such bankrupt or
insolvent Party is Medarex or Genmab, the other such Party (whether Medarex or
Genmab) shall have the right to assume all of the obligations of the bankrupt or
insolvent Party under this Agreement, and upon such assumption, such other Party
shall be entitled to all of the rights and benefits hereunder of such bankrupt
or insolvent Party and deCODE shall have no right to terminate pursuant to this
Section 8.4.
38
SECTION 8.4 RIGHTS IN BANKRUPTCY. All rights and licenses granted
under or pursuant to this Agreement by Medarex, Genmab or deCODE are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of the United States
Bankruptcy Code, licenses of rights to "intellectual property" as defined under
Section 101 of the United States Bankruptcy Code. The Parties agree that the
Parties, as licensees of such rights under this Agreement, shall retain and may
fully exercise all of their rights and elections under the United States
Bankruptcy Code and equivalent provisions under applicable foreign law. The
Parties further agree that, in the event of the commencement of a bankruptcy
proceeding by or against any Party under the United States Bankruptcy Code, the
Parties hereto that are not a Party to such proceeding shall be entitled to a
complete duplicate of (or complete access to, as appropriate) any such
intellectual property and all embodiments of such intellectual property, which,
if not already in the non-subject Party's(ies') possession, shall be promptly
delivered to it (a) upon any such commencement of a bankruptcy proceeding upon
the non-subject Party's(ies') written request therefor, unless the Party subject
to such proceeding continues to perform all of its obligations under this
Agreement or (b) if not delivered under clause (a) above, following the
rejection of this Agreement by or on behalf of the Party subject to such
proceeding upon written request therefor by the non-subject Party(ies).
SECTION 8.5 CONSEQUENCES OF EXPIRATION OR TERMINATION.
8.5.1 LICENSES. Upon expiration of the full term of this
Agreement in accordance with Section 8.1 and payment of all amounts owed
pursuant to Section 4.1, the licenses granted by Medarex and Genmab to deCODE,
and by deCODE to Medarex and Genmab, hereunder shall become fully-paid up.
8.5.2 RETURN OF INFORMATION AND MATERIALS. Upon expiration of
this Agreement pursuant to Section 8.1 or upon termination of this Agreement in
its entirety by any Party pursuant to this Article 8, each Party, at the request
of another Party, shall return Biological Materials of such other Parties and
all data, files, records and other materials in its possession or control
relating to such other Party's Technology, or containing or comprising such
other Party's Information and Inventions or other Confidential Information (as
defined in Article 6) and, in each case, to which the returning Party does not
retain rights hereunder (except one copy of which (other than Biological
Materials) may be retained solely for archival purposes).
SECTION 8.6 ACCRUED RIGHTS; SURVIVING OBLIGATIONS.
8.6.1 ACCRUED RIGHTS. Termination or expiration of this
Agreement for any reason shall be without prejudice to any rights that shall
have accrued to the benefit of a Party prior to such termination or expiration.
Such termination or expiration shall not relieve a Party from obligations that
are expressly indicated to survive the termination or expiration of this
Agreement.
8.6.2 SURVIVAL. Articles 4 (with respect to obligations
arising prior to expiration or termination), 6 and 9, and Sections 2.3, 3.3.5,
3.4, 7.1, 7.2, 7.5.3, 7.5.4,
39
7.5.5, 8.5, 11.5 and 11.6 of this Agreement and this Section 8.6.2 shall survive
expiration or termination of this Agreement for any reason.
ARTICLE 9 -
INDEMNIFICATION AND INSURANCE
SECTION 9.1 INDEMNIFICATION OF MEDAREX AND GENMAB. deCODE shall
indemnify Medarex, Genmab and their respective Affiliates, directors, officers,
employees and agents, and defend and save each of them harmless, from and
against any and all losses, damages, liabilities, costs and expenses (including
reasonable attorneys' fees and expenses) in connection with any and all
liability suits, investigations, claims or demands (collectively, "LOSSES")
arising from or occurring as a result of or in connection with (a) any breach by
deCODE of this Agreement, or (b) the gross negligence, recklessness or willful
misconduct on the part of deCODE or its Affiliates, licensees or sublicensees in
performing any activity contemplated by this Agreement, except for those Losses
for which Medarex or Genmab has an obligation to indemnify deCODE pursuant to
Section 9.2, as to which Losses each of Medarex and Genmab shall indemnify the
other to the extent of their respective liability for the Losses.
SECTION 9.2 INDEMNIFICATION OF deCODE.
9.2.1 BY MEDAREX. Medarex shall indemnify deCODE, its
Affiliates and their respective directors, officers, employees and agents, and
defend and save each of them harmless, from and against any and all Losses
arising from or occurring as a result of or in connection with (a) any breach by
Medarex of this Agreement, or (b) the gross negligence, recklessness or willful
misconduct on the part of Medarex or its Affiliates, licensees or sublicensees
in performing any activity contemplated by this Agreement, except for those
Losses for which deCODE has an obligation to indemnify Medarex and its
Affiliates pursuant to Section 9.1, as to which Losses each Party shall
indemnify the other to the extent of their respective liability for the Losses.
9.2.2 BY GENMAB. Genmab shall indemnify deCODE, its
Affiliates and their respective directors, officers, employees and agents, and
defend and save each of them harmless, from and against any and all Losses
arising from or occurring as a result of or in connection with (a) any breach by
Genmab of this Agreement, or (b) the gross negligence, recklessness or willful
misconduct on the part of Genmab or its Affiliates, licensees or sublicensees in
performing any activity contemplated by this Agreement, except for those Losses
for which deCODE has an obligation to indemnify Genmab and its Affiliates
pursuant to Section 9.1, as to which Losses each Party shall indemnify the other
to the extent of their respective liability for the Losses
SECTION 9.3 INDEMNIFICATION PROCEDURE.
9.3.1 NOTICE OF CLAIM. The indemnified Party shall give the
indemnifying Party prompt written notice (an "INDEMNIFICATION CLAIM NOTICE") of
any Losses or discovery of fact upon which such indemnified Party intends to
base a request for indemnification under Section 9.1 or Section 9.2, but in no
event shall the
40
indemnifying Party be liable for any Losses that result from any delay in
providing such notice. Each Indemnification Claim Notice must contain a
description of the claim and the nature and amount of such Loss (to the extent
that the nature and amount of such Loss are known at such time). The indemnified
Party shall furnish promptly to the indemnifying Party copies of all papers and
official documents received in respect of any Losses. All indemnification claims
in respect of a Party, its Affiliates or their respective directors, officers,
employees and agents (collectively, the "INDEMNITEES" and each an "INDEMNITEE")
shall be made solely by such Party to this Agreement (the "INDEMNIFIED PARTY").
9.3.2 THIRD PARTY CLAIMS. The obligations of an indemnifying
Party under this Article 9 with respect to Losses arising from claims of any
Third Party that are subject to indemnification as provided for in Section 9.1
or 9.2 (a "THIRD PARTY Claim") shall be governed by and be contingent upon the
following additional terms and conditions:
(a) CONTROL OF DEFENSE. At its option, the
indemnifying Party may assume the defense of any Third Party Claim by giving
written notice to the Indemnified Party within thirty (30) days after the
indemnifying Party's receipt of an Indemnification Claim Notice. The assumption
of the defense of a Third Party Claim by the indemnifying Party shall not be
construed as an acknowledgment that the indemnifying Party is liable to
indemnify any Indemnitee in respect of the Third Party Claim, nor shall it
constitute a waiver by the indemnifying Party of any defenses it may assert
against any Indemnitee's claim for indemnification. Upon assuming the defense of
a Third Party Claim, the indemnifying Party may appoint as lead counsel in the
defense of the Third Party Claim any legal counsel selected by the indemnifying
Party. In the event the indemnifying Party assumes the defense of a Third Party
Claim, the Indemnified Party shall immediately deliver to the indemnifying Party
all original notices and documents (including court papers) received by any
Indemnitee in connection with the Third Party Claim. Should the indemnifying
Party assume the defense of a Third Party Claim, the indemnifying Party shall
not be liable to the Indemnified Party or any other Indemnitee for any legal
expenses subsequently incurred by such Indemnified Party or other Indemnitee in
connection with the analysis, defense or settlement of the Third Party Claim. In
the event that it is ultimately determined that the indemnifying Party is not
obligated to indemnify, defend or hold harmless an Indemnitee from and against
the Third Party Claim, the Indemnified Party shall reimburse the indemnifying
Party for any and all costs and expenses (including attorneys' fees and costs of
suit) and any Losses incurred by the indemnifying Party in its defense of the
Third Party Claim with respect to such Indemnitee.
(b) RIGHT TO PARTICIPATE IN DEFENSE. Without limiting
Section 9.3.2(a), any Indemnitee shall be entitled to participate in, but not
control, the defense of such Third Party Claim and to employ counsel of its
choice for such purpose; provided, however, that such employment shall be at the
Indemnitee's own expense unless (i) the employment thereof has been specifically
authorized by the indemnifying Party in writing, or (ii) the indemnifying Party
has failed to assume the defense and employ
41
counsel in accordance with Section 9.3.2(a) (in which case the Indemnified Party
shall control the defense).
(c) SETTLEMENT. With respect to any Losses relating
solely to the payment of money damages in connection with a Third Party Claim
and that will not result in the Indemnitee's becoming subject to injunctive or
other relief or otherwise adversely affect the business of the Indemnitee in any
manner, and as to which the indemnifying Party shall have acknowledged in
writing the obligation to indemnify the Indemnitee hereunder, the indemnifying
Party shall have the sole right to consent to the entry of any judgment, enter
into any settlement or otherwise dispose of such Loss, on such terms as the
indemnifying Party, in its sole discretion, shall deem appropriate. With respect
to all other Losses in connection with Third Party Claims, where the
indemnifying Party has assumed the defense of the Third Party Claim in
accordance with Section 9.3.2(a), the indemnifying Party shall have authority to
consent to the entry of any judgment, enter into any settlement or otherwise
dispose of such Loss provided it obtains the prior written consent of the
Indemnified Party (which consent shall not be unreasonably withheld or delayed).
The indemnifying Party shall not be liable for any settlement or other
disposition of a Loss by an Indemnitee that is reached without the written
consent of the indemnifying Party. Regardless of whether the indemnifying Party
chooses to defend or prosecute any Third Party Claim, no Indemnitee shall admit
any liability with respect to, or settle, compromise or discharge, any Third
Party Claim without the prior written consent of the indemnifying Party.
(d) COOPERATION. Regardless of whether the indemnifying
Party chooses to defend or prosecute any Third Party Claim, the Indemnified
Party shall, and shall cause each other Indemnitee to, cooperate in the defense
or prosecution thereof and shall furnish such records, information and
testimony, provide such witnesses and attend such conferences, discovery
proceedings, hearings, trials and appeals as may be reasonably requested in
connection therewith. Such cooperation shall include access during normal
business hours afforded to the indemnifying Party to, and reasonable retention
by the Indemnified Party of, records and information that are reasonably
relevant to such Third Party Claim, and making Indemnitees and other employees
and agents available on a mutually convenient basis to provide additional
information and explanation of any material provided hereunder, and the
indemnifying Party shall reimburse the Indemnified Party for all its reasonable
out-of-pocket expenses in connection therewith.
(e) EXPENSES. Except as provided above, the reasonable
and verifiable costs and expenses, including fees and disbursements of counsel,
incurred by the Indemnified Party in connection with any claim shall be
reimbursed on a calendar quarter basis by the indemnifying Party, without
prejudice to the indemnifying Party's right to contest the Indemnified Party's
right to indemnification and subject to refund in the event the indemnifying
Party is ultimately held not to be obligated to indemnify the Indemnified Party.
SECTION 9.4 INSURANCE. Each Party shall have and maintain such
types and amounts of liability insurance as is normal and customary in the
industry generally for
42
parties similarly situated, and shall upon request provide the other Parties
with a copy of its policies of insurance in that regard, along with any
amendments and revisions thereto.
ARTICLE 10 -
REPRESENTATIONS, WARRANTIES AND COVENANTS
SECTION 10.1 REPRESENTATIONS, WARRANTIES AND COVENANTS. Each Party
hereby represents, warrants and covenants to the other Parties as of the
Effective Date as follows:
10.1.1 CORPORATE AUTHORITY. Such Party (a) has the power and
authority and the legal right to enter into this Agreement and perform its
obligations hereunder, and (b) has taken all necessary action on its part
required to authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder. This Agreement has been duly executed
and delivered on behalf of such Party and constitutes a legal, valid and binding
obligation of such Party and is enforceable against it in accordance with its
terms subject to the effects of bankruptcy, insolvency or other laws of general
application affecting the enforcement of creditor rights and judicial principles
affecting the availability of specific performance and general principles of
equity, whether enforceability is considered a proceeding at law or equity.
10.1.2 LITIGATION. Such Party is not aware of any pending or
threatened litigation (and has not received any communication) that alleges that
such Party's activities related to this Agreement have violated, or that by
conducting the activities as contemplated herein such Party would violate, any
of the intellectual property rights of any other party.
10.1.3 CONSENTS, APPROVALS, ETC. All necessary consents,
approvals and authorizations of all Regulatory Authorities and other parties
required to be obtained by such Party in connection with the execution and
delivery of this Agreement and the performance of its obligations hereunder have
been obtained.
10.1.4 CONFLICTS. The execution and delivery of this Agreement
and the performance of such Party's obligations hereunder (a) do not conflict
with or violate any requirement of Applicable Law or any provision of the
articles of incorporation, bylaws or any similar instrument of such Party, as
applicable, in any material way, and (b) do not conflict with, violate, or
breach or constitute a default or require any consent under, any contractual
obligation or court or administrative order by which such Party is bound.
10.1.5 DEBARMENT. No such Party nor any of its Affiliates has
been debarred or is subject to debarment and neither such Party nor any of its
Affiliates will use in any capacity, in connection with the services to be
performed under this Agreement, any party who has been debarred pursuant to
Section 306 of the Federal Food, Drug, and Cosmetic Act, as amended, or who is
the subject of a conviction described in such section. Each Party will inform
the other Parties in writing immediately if it or any party who is performing
services hereunder is debarred or is the subject of a conviction described in
Section 306, or if any action, suit, claim,
43
investigation or legal or administrative proceeding is pending or, to such
Party's knowledge, is threatened, relating to the debarment or conviction of
such Party or any party performing services hereunder.
SECTION 10.2 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF MEDAREX.
Medarex represents and warrants to deCODE that Medarex is a corporation duly
organized, validly existing and in good standing under the laws of the State of
New Jersey, and has full corporate power and authority and the legal right to
own and operate its property and assets and to carry on its business as it is
now being conducted and as it is contemplated to be conducted by this Agreement.
To the knowledge of the officers of Medarex and without a duty to conduct any
investigation, as of the Effective Date, Medarex is the owner or (sub)licensee
(with the right to grant sublicenses, subject to the terms of the Cross License
Agreement) of the Medarex Technology.
SECTION 10.3 ADDITIONAL REPRESENTATIONS AND WARRANTIES OF GENMAB.
Genmab represents and warrants to deCODE that Genmab is a corporation duly
organized, validly existing and in good standing under the laws of Denmark, and
has full corporate power and authority and the legal right to own and operate
its property and assets and to carry on its business as it is now being
conducted and as it is contemplated to be conducted by this Agreement. To the
knowledge of the officers of Genmab and without a duty to conduct any
investigation, as of the Effective Date, Genmab is the owner or (sub)licensee
(with the right to grant sublicenses, subject to the terms of the Cross License
Agreement) of the Genmab Technology.
SECTION 10.4 ADDITIONAL REPRESENTATIONS, WARRANTIES AND COVENANT OF
DECODE. deCODE represents and warrants to Medarex and Genmab that deCODE is a
private limited company duly organized, validly existing and in good standing
under the laws of Iceland, and has full corporate power and authority and the
legal right to own and operate its property and assets and to carry on its
business as it is now being conducted and as it is contemplated to be conducted
by this Agreement. deCODE shall comply with all of the applicable terms and
conditions of the MRC Agreement. To the knowledge of the officers of deCODE and
without a duty to conduct any investigation, as of the Effective Date, deCODE is
the owner or (sub)licensee (with the right to grant sublicenses) of the deCODE
Technology.
SECTION 10.5 KNOWLEDGE. For purposes of Sections 10.2, 10.3 and 10.4,
(a) "knowledge of" a Party shall mean such Party's good faith understanding of
the facts and information in its possession without any duty to conduct any
investigation with respect to such facts and information, and (b) "officers" of
a Party shall mean persons in the positions of vice president, senior vice
president, executive vice president, president and chief executive officer.
SECTION 10.6 DISCLAIMER OF WARRANTY. EXCEPT FOR THE EXPRESS
WARRANTIES SET FORTH IN SECTIONS 10.1, 10.2, 10.3 AND 10.4, deCODE, GENMAB AND
MEDAREX MAKE NO REPRESENTATIONS AND GRANT NO WARRANTIES, EXPRESS OR IMPLIED,
EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR OTHERWISE, AND deCODE,
XXXXXX
00
AND MEDAREX EACH SPECIFICALLY DISCLAIM ANY OTHER WARRANTIES, WHETHER WRITTEN OR
ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF QUALITY, MERCHANTABILITY
OR FITNESS FOR A PARTICULAR USE OR PURPOSE OR ANY WARRANTY AS TO THE VALIDITY OR
ANY PATENTS OR THE NON-INFRINGEMENT OF ANY INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES.
ARTICLE 11 -
MISCELLANEOUS
SECTION 11.1 FORCE MAJEURE. No Party shall be held liable or
responsible to the other Parties or be deemed to have defaulted under or
breached this Agreement for failure or delay in fulfilling or performing any
term of this Agreement when such failure or delay is caused by or results from
events beyond the reasonable control of the non-performing Party, including
fires, floods, embargoes, shortages, epidemics, quarantines, war, acts of war
(whether war be declared or not), insurrections, riots, civil commotion,
strikes, lockouts or other labor disturbances, acts of God or acts, omissions or
delays in acting by any governmental authority. The non-performing Party shall
notify the other Parties of such force majeure within ten (10) days after such
occurrence by giving written notice to the other Parties stating the nature of
the event, its anticipated duration, and any action being taken to avoid or
minimize its effect. The suspension of performance shall be of no greater scope
and no longer duration than is necessary and the non-performing Party shall use
Commercially Reasonable Efforts to remedy its inability to perform; provided,
however, that in the event the suspension of performance continues for
one-hundred and eighty (180) days after the date of the occurrence, the Parties
shall meet to discuss in good faith how to proceed in order to accomplish the
goals of the Collaboration outlined in this Agreement.
SECTION 11.2 SUBCONTRACTORS. Each Party shall have the right,
subject to the prior written consent of the Steering Committee, such consent not
to be unreasonably withheld or delayed, to subcontract any of its research,
development, manufacture and/or commercialization activities to a Third Party,
provided that it furnishes the other Parties with advanced written notice
thereof, which notice shall specify the work to be subcontracted, and obtains a
written undertaking from the subcontractor that it shall be subject to the
applicable terms and conditions of this Agreement, including the provisions of
Article 6. If a Party wishes to subcontract any of its research, development,
manufacturing or commercialization activities to a Third Party and the Steering
Committee consents, another Party may submit a bid to the subcontracting Party
to perform such work. The subcontracting Party shall use Commercially Reasonable
Efforts to enter into an agreement with the bidder that is best able to meet the
Collaboration's requirements, taking into consideration such factors as price,
quality, capacity, quantity, reliability and reputation, provided that such
bidder is reasonably acceptable to the Steering Committee. Unless the Project
Plan provides, or the Steering Committee agrees otherwise, the Collaborators
shall share equally (50%) in the costs and expenses associated with the use of a
subcontractor to conduct research, development, manufacture and
commercialization activities, but, unless the Collaborators agree otherwise, the
subcontracting Collaborator shall remain solely liable for the performance of
its research,
45
development, manufacture or commercialization activities by its subcontractor;
provided, however, that deCODE and Genmab/Medarex each shall remain solely
responsible for all costs and expenses associated with its use of
subcontractor(s) with respect to the deCODE Research Activities and the
Genmab/Medarex Research Activities, respectively.
SECTION 11.3 ASSIGNMENT. Without the prior written consent of the
other Parties hereto, no Party shall sell, transfer, assign, delegate, pledge or
otherwise dispose of, whether voluntarily, involuntarily, by operation of law or
otherwise, this Agreement or any of its rights or duties hereunder; provided,
however, that any Party hereto may assign or transfer this Agreement or any of
its rights or obligations hereunder without the consent of the other Parties (a)
to any Affiliate of such Party, respectively; or (b) subject to Section
1.2.2(h), to any Third Party with which it may merge or consolidate, or to which
it may transfer all or substantially all of its assets to which this Agreement
relates if in any such event (i) the assigning Party (provided that it is not
the surviving entity) remains jointly and severally liable with the relevant
deCODE Affiliate, Genmab Affiliate, Medarex Affiliate or Third Party assignee
under this Agreement, and (ii) the relevant deCODE Affiliate assignee, Genmab
Affiliate assignee or Medarex Affiliate assignee, Third Party assignee or
surviving entity assumes in writing all of the assigning Party's obligations
under this Agreement. Any purported assignment or transfer in violation of this
Section shall be void ab initio and of no force or effect.
SECTION 11.4 SEVERABILITY. If any provision of this Agreement is
held to be illegal, invalid or unenforceable under any present or future law,
and if the rights or obligations of any Party under this Agreement will not be
materially and adversely affected thereby, (a) such provision shall be fully
severable, (b) this Agreement shall be construed and enforced as if such
illegal, invalid or unenforceable provision had never comprised a part hereof,
(c) the remaining provisions of this Agreement shall remain in full force and
effect and shall not be affected by the illegal, invalid or unenforceable
provision or by its severance herefrom, and (d) in lieu of such illegal, invalid
or unenforceable provision, there shall be added automatically as a part of this
Agreement a legal, valid and enforceable provision as similar in terms to such
illegal, invalid or unenforceable provision as may be possible and reasonably
acceptable to the Parties herein. To the fullest extent permitted by applicable
law, each Party hereby waives any provision of law that would render any
provision prohibited or unenforceable in any respect.
SECTION 11.5 GOVERNING LAW, JURISDICTION, VENUE AND SERVICE. This
Agreement shall be governed by and construed in accordance with the laws of the
State of New Jersey, applicable to contracts made and wholly performed within
such jurisdiction by residents of such jurisdiction. Subject to Section 2.3, the
Parties hereby irrevocably and unconditionally consent to the exclusive
jurisdiction of the courts of London, England for any action, suit or proceeding
arising out of or relating to this Agreement, and agree not to commence any
action, suit or proceeding related thereto except in such courts. The Parties
further hereby irrevocably and unconditionally waive any objection to the laying
of venue of any action, suit or proceeding arising out of or relating to this
Agreement in the courts of London, England, and hereby further irrevocably and
unconditionally waive and agree not to plead or claim in any such court
46
that any such action, suit or proceeding brought in any such court has been
brought in an inconvenient forum. Each Party hereto further agrees that service
of any process, summons, notice or document by registered mail to its address
set forth below shall be effective service of process for any action, suit or
proceeding brought against it under this Agreement in any such court.
SECTION 11.6 NOTICES. All notices or other communications that are
required or permitted hereunder shall be in writing and delivered personally,
sent by facsimile (and promptly confirmed by personal delivery, registered or
certified mail or overnight courier as provided herein), sent by
nationally-recognized overnight courier or sent by registered or certified mail,
postage prepaid, return receipt requested, addressed as follows:
If to deCODE, to:
deCODE genetics ehf
Hlioarsmari 15
200 Kopavogur, Iceland
Attention: Chief Executive Officer
Facsimile: 000-000-0000
Telephone: 000-000-0000
with a copies to:
deCODE genetics ehf
Hlioarsmari 15
200 Kopavogur, Iceland
Attention: Legal Department
Facsimile: 000-000-0000
Telephone: 000-000-0000
Xxxx Xxxxx LLP
Princeton Xxxxxxxxx Village
000 Xxxx Xxxxxx, Xxxxx 000
Xxxxxxxxx, Xxx Xxxxxx 00000
Attention: Xxxxx X. Xxxxxxx, Esq.
Facsimile: (000) 000-0000
If to Genmab, to:
Genmab A/S
Xxxxxxxx 00, 0xx Xxxxx
0000 Xxxxxxxxxx
Xxxxxxx
Attention: President
Facsimile: 45 7020 2729
47
If to Medarex, to:
Medarex, Inc.
000 Xxxxx Xxxx, Xxxxx 000
Xxxxxxxxx, Xxx Xxxxxx 00000-0000
Attention: President
Facsimile: (000) 000-0000
with copies to:
Medarex, Inc.
000 Xxxxx Xxxx, Xxxxx 000
Xxxxxxxxx, Xxx Xxxxxx 00000-0000
Attention: General Counsel
Facsimile: (000) 000-0000
Xxxxxxxxx & Xxxxxxx
0000 Xxxxxxxxxxxx Xxx., X.X.
Xxxxxxxxxx, X.X. 00000
Attention: Xxxx X. Xxxxxxx, Esq.
Facsimile: (000) 000-0000
or to such other address as the Party to whom notice is to be given may have
furnished to the other Parties in writing in accordance herewith. Any such
communication shall be deemed to have been given (i) when delivered, if
personally delivered or sent by facsimile on a business day, (ii) on the
business day after dispatch, if sent by nationally-recognized overnight courier,
and (iii) on the third business day following the date of mailing, if sent by
mail. It is understood and agreed that this Section 11.6 is not intended to
govern the day-to-day business communications necessary among the Parties in
performing their duties, in due course, under the terms of this Agreement.
SECTION 11.7 ENTIRE AGREEMENT; MODIFICATIONS. This Agreement sets
forth and constitutes the entire agreement and understanding among the Parties
with respect to the subject matter hereof and all prior agreements,
understanding, promises and representations, whether written or oral, with
respect thereto are superseded hereby. Each Party confirms that it is not
relying on any representations or warranties of the other Parties except as
specifically set forth herein. No amendment, modification, release or discharge
shall be binding upon the Parties unless in writing and duly executed by
authorized representatives of all Parties.
SECTION 11.8 RELATIONSHIP OF THE PARTIES. It is expressly agreed that
the Parties shall be independent contractors of one another and that the
relationship among the Parties shall not constitute a partnership, joint venture
or agency. Neither deCODE, on the one hand, nor Genmab/Medarex, on the other
hand, shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding on the
other, without the prior written consent of the other to do so. All
48
persons employed by a Party shall be employees of such Party and not of the
other Parties and all costs and obligations incurred by reason of any such
employment shall be for the account and expense of such Party.
SECTION 11.9 EQUITABLE RELIEF. Each Party acknowledges and agrees
that the restrictions set forth in Articles 6 and 7 of this Agreement are
reasonable and necessary to protect the legitimate interests of the other
Party(ies) and that such other Party(ies) would not have entered into this
Agreement in the absence of such restrictions, and that any violation or
threatened violation of any provision of Article 6 or 7 will result in
irreparable injury to such other Party(ies). Each Party also acknowledges and
agrees that in the event of a violation or threatened violation of any provision
of Article 6 or 7, the other Party(ies) shall be entitled to preliminary and
permanent injunctive relief, without the necessity of proving irreparable injury
or actual damages and without the necessity of having to post a bond, as well as
to an equitable accounting of all earnings, profits and other benefits arising
from any such violation. The rights provided in the immediately preceding
sentence shall be cumulative and in addition to any other rights or remedies
that may be available to such other Party(ies). Nothing in this Section 11.9 is
intended, or should be construed, to limit such other Party(ies)'s right to
preliminary and permanent injunctive relief or any other remedy for a breach of
any other provision of this Agreement.
SECTION 11.10 WAIVER. Any term or condition of this Agreement may be
waived at any time by the Party that is entitled to the benefit thereof, but no
such waiver shall be effective unless set forth in a written instrument duly
executed by or on behalf of the Party waiving such term or condition. The waiver
by any Party hereto of any right hereunder or of the failure to perform or of a
breach by the other Party or Parties shall not be deemed a waiver of any other
right hereunder or of any other breach or failure by said other Party whether of
a similar nature or otherwise.
SECTION 11.11 COUNTERPARTS. This Agreement may be executed in two (2)
or more counterparts, each of which shall be deemed an original, but all of
which together shall constitute one and the same instrument. This Agreement may
be executed by facsimile signatures and such signatures shall be deemed to bind
each Party hereto as if they were original signatures.
SECTION 11.12 NO BENEFIT TO THIRD PARTIES. The representations,
warranties, covenants and agreements set forth in this Agreement are for the
sole benefit of the Parties hereto and their successors and permitted assigns,
and they shall not be construed as conferring any rights on any other parties.
SECTION 11.13 FURTHER ASSURANCE. Each Party shall duly execute and
deliver, or cause to be duly executed and delivered, such further instruments
and do and cause to be done such further acts and things, including the filing
of such assignments, agreements, documents and instruments, as may be necessary
or as the other Party(ies) may reasonably request in connection with this
Agreement or to carry out more effectively the provisions and purposes, or to
better assure and confirm unto such other Party(ies) its rights and remedies
under this Agreement.
49
SECTION 11.14 ENGLISH LANGUAGE. This Agreement has been written and
executed in the English language. Any translation into any other language shall
not be an official version thereof, and in the event of any conflict in
interpretation between the English version and such translation, the English
version shall control.
SECTION 11.15 REFERENCES. Unless otherwise specified, (a) references
in this Agreement to any Article, Section, Schedule or Exhibit shall mean
references to such Article, Section, Schedule or Exhibit of this Agreement, (b)
references in any section to any clause are references to such clause of such
section, and (c) references to any agreement, instrument or other document in
this Agreement refer to such agreement, instrument or other document as
originally executed or, if subsequently varied, replaced or supplemented from
time to time, as so varied, replaced or supplemented and in effect at the
relevant time of reference thereto.
SECTION 11.16 CONSTRUCTION. Except where the context otherwise
requires, wherever used, the singular shall include the plural, the plural the
singular, the use of any gender shall be applicable to all genders and the word
"or" is used in the inclusive sense (and/or). The captions of this Agreement are
for convenience of reference only and in no way define, describe, extend or
limit the scope or intent of this Agreement or the intent of any provision
contained in this Agreement. The term "including" as used herein shall mean
including, without limiting the generality of any description preceding such
term. The language of this Agreement shall be deemed to be the language mutually
chosen by the Parties and no rule of strict construction shall be applied
against any Party hereto.
[The remainder of this page has been intentionally left blank.]
50
IN WITNESS WHEREOF, the Parties hereto have caused this
Agreement to be executed by their duly authorized representatives as of the date
first above written.
MEDAREX, INC. deCODE GENETICS EHF
By: /s/ Xxxxxxx X. Appelbaum_______ By: /s/ Dr. Kari Stefansson________
Name: Xxxxxxx X. Xxxxxxxxx Name: Dr. Xxxx Xxxxxxxxxx
Title: Executive Vice-President Title: Managing Director
GENMAB A/S
By: /s/ Xx. Xxxx X. Xxxxxxxx ______
Name: Xx. Xxxx X. Xxxxxxxx
Title: Chief Executive Officer
By:_/s/ Xxxxxxx Xxxxx Jensen______
Name: Xxxxxxx Xxxxx Xxxxxx
Title: Chief Financial Officer & Head of Legal Department
51
APPENDIX A
DEFINITIONS
This Appendix to the Collaboration Agreement ("AGREEMENT") effective as
of June 12, 2001, by and between MEDAREX, INC., on behalf of itself and its
wholly owned subsidiary, GENPHARM INTERNATIONAL, INC., (collectively,
"MEDAREX"), GENMAB A/S ("GENMAB") and deCODE GENETICS EHF. ("deCODE") provides
agreed upon definitions applicable to the Collaborators for purposes of the
Agreement. All capitalized terms used herein without definition shall have the
meanings ascribed thereto in the Agreement, unless otherwise expressly provided
herein.
The contents of this Appendix A are hereby incorporated into the
Agreement and are governed by the terms and conditions of the Agreement,
including the confidentiality provisions set forth therein.
"AFFILIATE" of a party shall mean any other party that, directly or
indirectly, through one or more intermediaries, controls, is controlled by, or
is under common control with such first party. For purposes of this definition
only, "control" and, with correlative meanings, the terms "controlled by" and
"under common control with" shall mean (a) the possession, directly or
indirectly, of the power to direct the management or policies of a party,
whether through the ownership of voting securities or by contract relating to
voting rights or corporate governance, or (b) the ownership, directly or
indirectly, of more than fifty percent (50%) of the voting securities or other
ownership interest of a party; provided that, if local law restricts foreign
ownership, control will be established by direct or indirect ownership of the
maximum ownership percentage that may, under such local law, be owned by foreign
interests. For the avoidance of doubt, none of Medarex, Genmab or deCODE shall
be deemed to be Affiliates of one another for purposes of this Agreement.
"ANTIBODY" shall mean any fully human antibody, or fragment thereof,
with a unique amino acid sequence that has a therapeutically meaningful binding
affinity for an Antigen. References in the Agreement to an "Antibody" shall
include (a) cells expressing or secreting such Antibody or containing nucleotide
sequences (whether coding or non-coding) with respect to the expression of such
Antibody, and (b) nucleotide sequences (whether coding or non-coding) with
respect to the expression of such Antibody (or a fragment of such entire
Antibody containing that portion of such Antibody conferring binding specificity
for an Antigen). By way of clarification, Antibodies with different amino acid
sequences shall be deemed to be different Antibodies, irrespective of whether
they bind to the same Antigen.
"ANTIBODY PRODUCT" shall mean any composition or formulation containing
or comprising one or more Antibodies, including, by way of clarification, (a)
cells expressing or secreting one or more of such Antibodies or containing
nucleotide sequences (whether coding or non-coding) with respect to the
expression of such Antibodies, and (b) nucleotide sequences (whether coding or
non-coding) with respect to the expression of such Antibodies (or a fragment of
such entire Antibody containing that
A-1
52
portion of such Antibody conferring binding specificity for an Antigen), for the
diagnosis, prophylaxis or treatment of human diseases or conditions.
"ANTIGEN" shall mean any protein (including any glyco- or
lipo-protein), carbohydrate, compound or other composition, and any fragment,
peptide or epitope thereof, that stimulates the production of antibodies.
"APPLICABLE LAW" shall mean the applicable laws, rules, and
regulations, including any rules, regulations, guidelines, or other requirements
of the Regulatory Authorities, that may be in effect from time to time in the
Territory.
"BIOSITE AGREEMENT" shall mean that certain Collaboration Agreement,
dated as of June 1, 2000, between Medarex and Biosite Diagnostics Incorporated,
a Delaware corporation.
"BLA" or "BIOLOGICS LICENSE APPLICATION" shall mean a Biologics License
Application, as defined in the U.S. Federal Food, Drug, and Cosmetics Act, as
amended, and the regulations promulgated thereunder, and any corresponding
foreign or domestic marketing authorization application, registration or
certification, necessary or reasonably useful to market a Collaboration Product
in the Territory, but not including pricing and reimbursement approvals.
"CHANGE OF CONTROL" shall mean (a) a merger or consolidation of a Party
that results in the voting securities of such Party outstanding immediately
prior thereto ceasing to represent at least fifty percent (50%) of the combined
voting power of the surviving entity immediately after such merger or
consolidation; (b) the sale of all or substantially all of the assets of a
Party; or (c) any Person, together with any "affiliates" or "associates" of such
Person (as such terms are defined in the Securities Exchange Act of 1934, as
amended), becoming the beneficial owner of fifty percent (50%) or more of the
combined voting power of the outstanding securities of a Party (other than such
Party, any trustee or other fiduciary holding securities under an employee
benefit plan of such Party or any corporation owned directly or indirectly by
the stockholders of such Party in substantially the same proportion as their
ownership of stock of such Party).
"COLLABORATION PRODUCT" shall mean any Antibody Product for the
prophylaxis or treatment of human diseases or conditions that contains a
Collaboration Antibody and any Diagnostic Products that are offered by deCODE
and accepted by Genmab/Medarex pursuant to Section 3.3.1(c).
"COLLABORATION TARGET" shall mean any Antigen listed on Appendix C, as
such appendix may be amended pursuant to this Agreement.
"COLLABORATION TECHNOLOGY" shall mean any and all (a) Information and
Inventions, conceived, discovered, developed or otherwise made, as necessary to
establish authorship, inventorship or ownership under Applicable Law, by or on
behalf of a Party (or its Affiliates or, to the extent permitted, its
sublicensees), whether solely or jointly, in connection with the work conducted
under or in connection with this Agreement, whether or not patented or
patentable, but excluding any Mice Materials, Mice-Related Technology or
Production Process Technology; and (b) Patents and other intellectual property
rights with respect thereto. (collectively, "COLLABORATION PATENTS").
A-2
53
"COLLABORATOR" shall mean either Genmab/Medarex, on the one hand, or
deCODE, on the other hand. "COLLABORATORS" shall mean Genmab/Medarex and deCODE
collectively.
"COMMERCIALLY REASONABLE EFFORTS" shall mean, with respect to the
research, development, manufacture or commercialization of a Collaboration
Target or a resulting Collaboration Product, efforts and resources commonly used
in the biotechnology industry for an antibody of similar commercial potential at
a similar stage in its lifecycle, taking into consideration its safety and
efficacy, its cost to develop, the competitiveness of alternative products, its
proprietary position, the likelihood of regulatory approval, its profitability,
and all other relevant factors. Commercially Reasonable Efforts shall be
determined on a market-by-market basis for each Collaboration Target and
Collaboration Product, as applicable.
"CONTROL" shall mean, with respect to any Information and Invention,
Patent or other intellectual property right, possession of the right, whether
directly or indirectly, and whether by ownership, license or otherwise, to
assign, or grant a license, sublicense or other right to or under, such
Information and Invention, Patent or right as provided for herein without
violating the terms of any agreement or other arrangement with any Third Party.
"CROSS-LICENSE AGREEMENT" shall mean that certain Cross-License
Agreement entered into by and among Abgenix, Inc., Cell Genesys, Inc., Japan
Tobacco Inc., Xenotech L.P., and GenPharm International, Inc., effective as of
March 26, 1997, as amended from time to time.
"deCODE GENOMICS DATA" shall mean (a) the information stored in the
Icelandic Health Sector Database and deCODE's genealogical and genotypic
databases and such other databases as may be created or developed by deCODE from
time to time during the term of this Agreement, 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 databases, including proprietary
methods, procedures and techniques, procedure manuals, personal and scientific
data, computer technical expertise and software, in each case that has been
independently developed by deCODE and such software useful for the analysis of
the information included in such databases; provided, however, that deCODE
Genomics Data shall not include Information and Inventions with respect to any
Collaboration Products or Unilateral Products.
"deCODE KNOW-HOW" shall mean all Information and Inventions in the
Control of deCODE or its Affiliates as of the Effective Date or at any time
during the Term that are necessary or reasonably useful for the Exploitation of
the Collaboration Products, including the discovery, identification or
characterization of Collaboration Targets, or for the exercise of the deCODE
Patents, in each case that are not generally known, including the deCODE
Genomics Data, but excluding (x) any Information and Inventions included in the
Collaboration Technology, (y) any Information and Inventions to the extent
covered or claimed by the deCODE Patents and (z) any Production Process
Know-How. deCODE Know-How shall include all: (a) biological, chemical,
pharmacological, toxicological, pharmaceutical, physical and analytical,
clinical and safety data and
A-3
54
information related to the Collaboration Targets and the Collaboration Products,
and (b) data and information with respect to, and resulting from, assays and
biological methodologies necessary or reasonably useful for the Exploitation of
the Collaboration Targets and the Collaboration Products.
"deCODE PATENTS" shall mean all of the Patents that deCODE and its
Affiliates Control as of the Effective Date and at any time during the Term,
that claim or cover any invention necessary or reasonably useful for the
Exploitation of the Collaboration Products, including any Patents that claim or
cover any Collaboration Target or any method for the discovery, identification
or characterization of Collaboration Targets, but excluding any Collaboration
Patents and any Production Process Patents.
"deCODE TECHNOLOGY" shall mean the deCODE Know-How and deCODE Patents.
"DIAGNOSTIC PRODUCT" shall mean any composition or formulation
containing or comprising one or more antibodies, including, by way of
clarification, (a) cells expressing or secreting one or more of such antibodies
or containing nucleotide sequences (whether coding or non-coding) with respect
to the expression of such antibodies, and (b) nucleotide sequences (whether
coding or non-coding) with respect to the expression of such antibodies (or a
fragment of such entire antibody containing that portion of such antibody
conferring binding specificity for an Antigen), for use in vitro solely in
connection with the diagnosis of human diseases or conditions.
"EXPLOIT" or "EXPLOITATION" shall mean to make, have made, import, use,
sell, offer for sale, or otherwise dispose of, including all discovery,
research, development, registration, modification, enhancement, improvement,
manufacture, storage, formulation, exportation, transportation, distribution,
promotion and marketing activities related thereto.
"FDA" shall mean the United States Food and Drug Administration and any
successor agency thereto.
"GAAP" shall mean United States generally accepted accounting
principles consistently applied.
"GENMAB KNOW-HOW" shall mean all Information and Inventions in the
Control of Genmab or its Affiliates as of the Effective Date or at any time
during the Term that are necessary or reasonably useful for the Exploitation of
the Collaboration Products or for the exercise of the Genmab Patents, in each
case that are not generally known, but excluding (w) any Third Party Know-How or
Medarex Know-How, (x) any Information and Inventions included in the
Collaboration Technology, (y) any Production Process Know-How and (z) any
Information and Inventions to the extent covered or claimed by the Genmab
Patents or the Medarex Patents. Genmab Know-How shall include all: (a)
biological, chemical, pharmacological, toxicological, pharmaceutical, physical
and analytical, clinical and safety data and information related to the
Collaboration Targets and the Collaboration Products, and (b) data and
information with respect to, and resulting from, assays and biological
methodologies necessary or reasonably useful for the Exploitation of the
Collaboration Targets and the Collaboration Products. By way of clarification,
deCODE shall not have any rights with respect to Third-Party Know-How
A-4
55
under this Agreement unless the Parties enter into a separate written agreement
with respect thereto.
"GENMAB PATENTS" shall mean all of the Patents that Genmab or its
Affiliates Control as of the Effective Date and at any time during the Term,
that cover or claim any invention necessary or reasonably useful for the
Exploitation of the Collaboration Products, but excluding any Third Party
Patents, any Collaboration Patents and any Production Process Patents. By way of
clarification, deCODE shall not have any rights with respect to any Third-Party
Patents under this Agreement unless the Parties enter into a separate written
agreement with respect thereto.
"GENMAB TECHNOLOGY" shall mean the Genmab Know-How and Genmab Patents.
"GENMAB/MEDAREX" shall mean Genmab and Medarex collectively or, as
agreed by Genmab and Medarex, either Genmab or Medarex.
"GENMAB/MEDAREX APPLIED GENOMICS AGREEMENT" shall mean that certain
First Amended and Restated Binding Memorandum of Understanding for an Applied
Genomics Collaboration between Medarex and Genmab dated as of September 8, 2000,
and any further agreement between Medarex and Genmab entered into pursuant
thereto.
"HUMAB MICE" shall mean any immunizable transgenic mice containing
unrearranged human immunoglobulin transgenes inserted into mouse chromosomes,
but not containing any human chromosomes or fragments thereof, that are
Controlled by Medarex or its Affiliates as of the Effective Date or at any time
during the term of this Agreement, but excluding any immunizable mice capable of
producing human antibodies that are in-licensed or otherwise acquired by Medarex
or its Affiliates after the Effective Date.
"IMPROVEMENT" shall mean any modification to an antibody, compound,
product or technology or any discovery, device, process or formulation related
to such antibody, compound, product or technology, whether or not patented or
patentable, including any enhancement in the efficiency, operation, manufacture,
ingredients, preparation, presentation, formulation, means of delivery,
packaging or dosage of an antibody, compound, product or technology, any
discovery or development of any new or expanded indications or applications for
an antibody, compound, product or technology, or any discovery or development
that improves the stability, safety or efficacy of an antibody, compound,
product or technology.
"IND" shall mean an investigational new drug application filed with the
FDA for authorization to commence human clinical trials, and its equivalent in
other countries or regulatory jurisdictions.
"INFORMATION AND INVENTIONS" shall mean all technical, scientific and
other know-how and information, trade secrets, knowledge, technology, means,
methods, processes, practices, formulas, instructions, skills, techniques,
procedures, experiences, ideas, technical assistance, designs, drawings,
assembly procedures, computer programs, apparatuses, specifications, data,
results and other material, including high-throughput screening, gene
expression, genomics, proteomics and other drug discovery and development
technology, pre-clinical and clinical trial results, manufacturing procedures,
A-5
56
test procedures and purification and isolation techniques, (whether or not
confidential, proprietary, patented or patentable) in written, electronic or any
other form now known or hereafter developed, and all Improvements, whether to
the foregoing or otherwise, and other discoveries, developments, inventions and
other intellectual property (whether or not confidential, proprietary, patented
or patentable).
"KIRIN AGREEMENT" shall mean that certain Agreement on Essential Terms
for Collaboration between Kirin Brewery Co, Ltd. ("KIRIN") and Genmab/Medarex
dated as of December 27, 1999, and any further agreement between Kirin and
Genmab/Medarex entered into pursuant thereto.
"KNOW-HOW" shall mean the Medarex Know-How, Genmab Know-How (including
the Mice-Related Know-How), the deCODE Know-How and/or the Collaboration
Know-How, as applicable.
"LEAD COLLABORATION ANTIBODY" shall have the meaning set forth in
Section 1.2.8. For the avoidance of doubt, a Collaboration Antibody that has
been designated a Lead Collaboration Antibody shall continue to be a
Collaboration Antibody for purposes of this Agreement.
"MEDAREX KNOW-HOW" shall mean all Information and Inventions in the
Control of Medarex or its Affiliates as of the Effective Date or at any time
during the Term that are necessary or reasonably useful for the Exploitation of
the Collaboration Products or for the exercise of the Medarex Patents, in each
case that are not generally known, but excluding (w) any Third Party Know-How,
(x) any Information and Inventions included in the Collaboration Technology, (y)
any Production Process Know-How, and (z) any Information and Inventions to the
extent covered or claimed by the Medarex Patents. Medarex Know-How shall include
all: (a) biological, chemical, pharmacological, toxicological, pharmaceutical,
physical and analytical, clinical and safety data and information related to the
Collaboration Targets and the Collaboration Products, and (b) data and
information with respect to, and resulting from, assays and biological
methodologies necessary or reasonably useful for the Exploitation of the
Collaboration Targets and the Collaboration Products. By way of clarification,
deCODE shall not have any rights with respect to Third-Party Know-How under this
Agreement unless the Parties enter into a separate written agreement with
respect thereto.
"MEDAREX PATENTS" shall mean all of the Patents that Medarex or its
Affiliates Control as of the Effective Date and at any time during the Term,
that cover or claim any invention necessary or reasonably useful for the
Exploitation of the Collaboration Products, but excluding any Third Party
Patents, any Collaboration Patents, and any Production Process Patents. By way
of clarification, deCODE shall not have any rights with respect to any
Third-Party Patents under this Agreement unless the Parties enter into a
separate written agreement with respect thereto.
"MEDAREX TECHNOLOGY" shall mean the Medarex Know-How and Medarex
Patents, including all Mice-Related Technology.
"MICE MATERIALS" shall mean the HuMAb Mice, any parts or derivatives of
the HuMAb Mice, including hybridomas, cells, genetic material (including
nucleotide sequences (e.g., DNA, RNA, and complementary and reverse
complementary nucleotide
A-6
57
sequences thereto, whether coding or non-coding) with respect to the expression
of an Antibody or fragment thereof, and any replicates or modifications thereof
or Improvements thereto (e.g., additions, deletions or substitutions of
nucleotides therein)) or other biological materials derived directly or
indirectly from the HuMAb Mice, but excluding any Collaboration Products.
"MICE-RELATED KNOW-HOW" shall mean (a) any Information and Inventions
with respect to any Mice Materials or other biological materials derived
directly or indirectly from the HuMAb Mice, but excluding any Collaboration
Products and any Information and Inventions with respect to Exploitation of
Collaboration Products, and (b) any Information and Inventions with respect to
the HuMAb Mice and the Exploitation thereof, but in each case excluding any
Information and Inventions to the extent covered or claimed by the Mice-Related
Patents.
"MICE-RELATED PATENTS" shall mean any Patents that claim or cover (a)
Mice Materials or other biological materials derived directly or indirectly from
the HuMAb Mice, and any Information and Inventions with respect to the
foregoing, but excluding any claims with respect to Collaboration Products or
any Information and Inventions with respect to the Exploitation of the
Collaboration Products, and (b) the HuMAb Mice and the Exploitation thereof.
"MICE-RELATED TECHNOLOGY" shall mean the Mice-Related Know-How and the
Mice-Related Patents.
"MRC AGREEMENT" shall mean that certain License Agreement entered into
by the Medical Research Council Institute of Animal Physiology and Genetics
Research of Babraham Hall and Xxxxxxxx Xxxxxxxxxx and GenPharm International,
Inc., effective October 1, 1993, as amended on August 12, 1994.
"PATENTS" shall mean (x) all patents and patent applications, (y) any
substitutions, divisions, continuations, continuations-in-part, reissues,
renewals, registrations, confirmations, re-examinations, extensions,
supplementary protection certificates and the like, and any provisional
applications, of any such patents or patent applications, and (z) any foreign or
international equivalent of any of the foregoing.
"PRE-EXISTING AGREEMENT" shall mean, with respect to an Antigen, any
agreement with a Third Party that would preclude such Antigen from becoming a
Collaboration Target hereunder.
"PRODUCT TRADEMARKS" shall mean the trademarks developed for the
Collaboration Products by the Steering Committee, all packaging designs and
other trade dress used in connection with the Collaboration Products and such
other Trademarks relating thereto and any registrations thereof or any pending
applications relating thereto.
"PRODUCTION PROCESS DEVELOPMENT" shall mean the development of
processes and technology to facilitate production, purification, evaluation,
characterization, stability assessment, vialing and distribution, and release of
a Collaboration Antibody.
"PRODUCTION PROCESS KNOW-HOW" shall mean any Information and Inventions
of a Party with respect to the Production Process Development or the manufacture
of Antibody Products, but excluding any Information and Inventions to the extent
covered or claimed by the Production Process Patents.
A-7
58
"PRODUCTION PROCESS PATENTS" shall mean any Patents of a Party that
claim or cover the Production Process Development or the manufacture of Antibody
Products.
"PRODUCTION PROCESS TECHNOLOGY" shall mean any Production Process
Know-How and Production Process Patents.
"REGULATORY APPROVAL" shall mean any and all approvals (including
pricing and reimbursement approvals), licenses, registrations or authorizations
of any Regulatory Authority, necessary for the Exploitation of a Collaboration
Product in a country, including any (a) approval for a Collaboration Product
(including any INDs, BLAs and supplements and amendments thereto); (b) pre- and
post-approval marketing authorizations (including any prerequisite manufacturing
approval or authorization related thereto); (c) labeling approval; and (d)
technical, medical and scientific licenses.
"REGULATORY AUTHORITY" shall mean any applicable government entities
regulating or otherwise exercising authority with respect to the Exploitation of
the Collaboration Targets or the Collaboration Products in the Territory.
"REGULATORY DOCUMENTATION" shall mean all applications, registrations,
licenses, authorizations and approvals (including all Regulatory Approvals), all
correspondence submitted to or received from Regulatory Authorities (including
minutes and official contact reports relating to any communications with any
Regulatory Authority), all supporting documents and all clinical studies and
tests, relating to any Collaboration Antibody, Collaboration Target or any
Collaboration Products, and all data contained in any of the foregoing,
including all regulatory drug lists, advertising and promotion documents,
adverse event files and complaint files.
"TECHNOLOGY" shall mean Medarex Technology, Genmab Technology, the
deCODE Technology and/or the Collaboration Technology, as applicable.
"TERRITORY" shall mean the entire world.
"THIRD PARTY" shall mean any party other than Medarex, Genmab, deCODE
or their respective Affiliates.
"THIRD-PARTY KNOW-HOW" shall mean any and all Information and
Inventions that Medarex, Genmab or any of their respective Affiliates Control
pursuant to the Biosite Agreement, the Kirin Agreement or any other agreement
with a Third Party that is entered into after the Effective Date, but excluding
any Information and Inventions that are claimed or covered by the Third-Party
Patents.
"THIRD-PARTY PATENT" shall mean any Patents that Medarex, Genmab or any
of their respective Affiliates Control pursuant to the Biosite Agreement, the
Kirin Agreement or any other agreement with a Third Party that is entered into
after the Effective Date.
"TRADEMARK" shall include any word, name, symbol, color, designation
or device or any combination thereof, including any trademark, trade dress,
service xxxx, service name, brand xxxx, trade name, brand name, logo or business
symbol.
A-8
59
TERMS DEFINED ELSEWHERE IN THIS AGREEMENT. The following terms are
defined in the applicable Sections of this Agreement:
DEFINED TERM SECTION
Anticipated Timeline Section 1.3
Antigen Evaluation Materials Section 1.2.2(a)
Assay Section 1.2.2(c)
Assay Candidate Section 1.2.6(a)
Assay Success Criteria Section 1.2.2(c)
Authorized Commercialization Expenses Section 4.1.1
Authorized R&D Expenses Section 4.1.2
Biological Materials Section 7.5.3
Collaboration Section 1.1
Collaboration Antibody Section 1.2.6(a)
Collaboration Expenses Section 4.5.1
Collective Opinion of Counsel Section 7.4.1
Commercialization Expenses Appendix B
Confidential Information Section 6.1
deCODE Research Activities Section 1.2.4
Dormant Product Section 5.3
Effective Date Preamble
Election Notice Section 5.1.2
Expert Section 2.3.1(a)
Genmab/Medarex Research Activities Section 1.2.4
Immunogen Section 1.2.3(a)
Indemnification Claim Notice Section 9.3.1
Indemnified Party Section 9.3.1
Indemnitee Section 9.3.1
Infringement Suit Section 7.4.2
Lead Collaboration Antibody Section 1.2.8
Losses Section 9.1
Net Profits, Net Losses Appendix B
Net Sales Appendix B
Opt-Out Section 5.1.1
Opt-Out Notice Section 5.1.1
Opting-Out Collaborator Section 5.1.1
Other Operating (Income)/Expense Appendix B
Pre-Existing Diagnostic Agreement Section 3.3.1(a)
Project Budget Section 1.3
Project Plan Section 1.3
Research and Commercialization Agreement Section 3.3.2
Reversion Target Section 1.7
Steering Committee Section 2.1.1
Target Entry Period Section 1.2.2(g)
Term Section 8.1
A-9
60
DEFINED TERM SECTION
Third Party Claim Section 9.3.2
Third Party Payments Appendix B
Unilateral Development and Commercialization Agreement Section 5.1.2
Unilateral Product Section 5.1.2
Withholding Taxes Section 4.4
X-00
00
XXXXXXXX X
FINANCIAL DEFINITIONS
This Appendix to the Collaboration Agreement ("AGREEMENT")
effective as of June 12, 2001, by and between GENMAB A/S ("GENMAB"), MEDAREX,
INC., on behalf of itself and its wholly owned subsidiary, GENPHARM
INTERNATIONAL, INC., (collectively, "MEDAREX"), and deCODE GENETICS EHF.
("deCODE") provides agreed upon definitions of financial terms applicable to the
Collaborators for purposes of the Agreement. All capitalized terms used herein
without definition shall have the meanings ascribed thereto in the Agreement,
unless otherwise expressly provided herein.
The contents of this Appendix B are hereby incorporated into
the Agreement and are governed by the terms and conditions of the Agreement,
including the confidentiality provisions set forth therein.
It is the intention of the Parties that the interpretation of
these definitions will be in accordance with GAAP.
1. "NET SALES" shall mean, for any period, the gross amount
invoiced by the Parties and their Affiliates for the sale of Collaboration
Product(s) to Third Parties, less deductions for: (a) normal and customary
trade, quantity and cash discounts and sales returns and allowances (other than
allowances for doubtful accounts), including (i) those granted on account of
price adjustments, billing errors, rejected goods, damaged goods, returns and
rebates, (ii) administrative and other fees and reimbursements and similar
payments directly related to the sale or delivery of Collaboration Product(s)
paid to wholesalers and other distributors, buying groups, pharmacy benefit
management organizations, health care insurance carriers and other institutions,
(iii) allowances, rebates and fees directly related to the sale or delivery of
Collaboration Product(s) paid to distributors and (iv) chargebacks; (b) freight,
postage, shipping and insurance costs to the extent that such items are included
in the gross amount invoiced; (c) customs and excise duties and other duties
related to the sales to the extent that such items are included in the gross
amount invoiced; (d) rebates and similar payments made with respect to sales
paid for or reimbursed by any governmental or regulatory authority such as, by
way of illustration and not in limitation of the Parties' rights hereunder,
Federal or state Medicaid, Medicare or similar state program or equivalent
foreign governmental program; (e) sales and other taxes and duties directly
related to the sale or delivery of Collaboration Product(s) (but not including
taxes assessed against the income derived from such sale); (f) distribution
costs and expenses to the extent that such items are included in the gross
amount invoiced; and (g) any such invoiced amounts that are not collected by the
Parties or their Affiliates; provided, however, that an amount shall be deducted
only once regardless of how many categories may apply to it. Any of the
deductions listed above that involves a payment by a Party or its Affiliates
shall be taken as a deduction in the calendar quarter in which the payment is
accrued by such entity. Deductions pursuant to subsection (g) above shall be
taken in the calendar quarter in
B-1
62
which such sales are no longer recorded as a receivable. For purposes of
determining Net Sales, the Collaboration Product(s) shall be deemed to be sold
when invoiced and a "sale" shall not include transfers or dispositions for
charitable, promotional, pre-clinical, clinical, regulatory or governmental
purposes.
For purposes of calculating Net Sales of Collaboration
Products, sales between or among the Parties or their Affiliates shall be
excluded from the computation of Net Sales, but sales by a Party or its
Affiliates to sublicensees or Third Parties shall be included in the computation
of Net Sales.
2. "NET PROFITS" and, with correlative meaning, "NET LOSSES",
shall mean, with respect to a Collaboration Product, Net Sales of such
Collaboration Product less Authorized Commercialization Expenses (to the extent
not already deducted from Net Sales) and Other Operating (Income)/Expense with
respect to such Collaboration Product, all for a given period.
3. "COMMERCIALIZATION EXPENSES" shall mean all Cost of Sales,
Distribution Costs, Marketing Costs, Sales Costs, General and Administrative
Costs (in each case, to the extent not deducted from Net Sales under Section 1
hereof) of the Parties and their Affiliates with respect to the Collaboration
Products.
3.1 "COST OF SALES" shall mean (a) the supply price, and
any other direct costs and expense of acquiring, including costs of
transport, customs, clearance and storage of product (if necessary),
freight, customs, duty, and insurance borne by the Parties (to the
extent not included in such supply price), with respect to Net Sales of
a Collaboration Product, and (b) any Third Party Payments with respect
to such Net Sales, to the extent not included in such supply price or
reimbursed by a Third Party.
3.1.1 "THIRD PARTY PAYMENTS" shall mean
intellectual property and technology acquisition and license
costs and expenses (including royalties, license fees,
milestone payments and other payment obligations) paid to
Third Parties with respect to a Collaboration Product,
including any payments made pursuant to the MRC Agreement.
3.2 "DISTRIBUTION COSTS" shall mean the costs and
expenses specifically identifiable to the distribution of a
Collaboration Product by a Party including customer services,
collection of data about sales to hospitals and other end users, order
entry, billing, shipping, credit and collection and other such
activities, but in any case, not including any costs or expenses which
are reimbursed by any Third Party.
3.3 "MARKETING COSTS" shall mean, with respect to a
Collaboration Product, the direct costs and expenses of marketing,
promotion, advertising, promotional materials, professional education,
product-related public relations, relationships with opinion leaders
and professional societies, market research (before and after
Regulatory Approval of a Collaboration Product), healthcare
B-2
63
economics studies, post-marketing studies required to maintain or
expand Regulatory Approvals of such Collaboration Product (to the
extent not included in Authorized R&D Expenses) and other similar
activities related to such Collaboration Product and approved by the
Steering Committee. Such costs and expenses will include both internal
costs (e.g., salaries, benefits, supplies and materials, etc.) and
costs of outside services and expenses (e.g., consultants, agency fees,
meeting costs, etc.). Marketing Costs shall also include costs and
expenses directly related to obtaining reimbursement from payers and
the cost of obtaining sales and marketing data (to the extent not
included in the Distribution Costs). Notwithstanding anything to the
contrary in the foregoing, Marketing Costs shall specifically exclude
the cost and expense of activities that promote a Party's business as a
whole without being specific to a Collaboration Product (e.g.,
corporate image advertising).
3.4 "SALES COSTS" shall mean, with respect to a
Collaboration Product, costs and expenses approved by the Steering
Committee in the annual budget for the commercialization of such
Collaboration Product, incurred by any Party or for its account and
specifically identifiable to the sales efforts for such Collaboration
Product in all markets in the Territory including the managed care
market. Sales Costs shall include costs and expenses associated with
sales representatives for a Collaboration Product, including the cost
of compensation, benefits, travel, supervision, training, sales
meetings, and other sales expenses for such sales representatives.
Notwithstanding anything to the contrary in the foregoing, Sales Costs
shall exclude costs and expenses associated with the start-up of a
Party's sales force, including recruiting, relocation and other similar
costs and expenses.
3.5 "GENERAL AND ADMINISTRATIVE COSTS" shall mean, with
respect to a Collaboration Product, costs equal to ten percent (10%) of
the sum of the Distribution Costs, Marketing Costs and Sales Costs
related to such Collaboration Product in any country, of the Parties,
in the aggregate, but only to the extent these costs are chargeable
under the Agreement. Each Party shall have the right to charge General
and Administrative Costs with respect to its Distribution Costs,
Marketing Costs and Sales Costs chargeable under the Agreement.
4. "OTHER OPERATING (INCOME)/EXPENSE" shall mean (a) payments and
other consideration received from Third Parties, including sublicensees, with
respect to the commercialization of a Collaboration Product, including any
license fees, milestone payments, royalties or other payments (including the
fair market value of any consideration received) in connection with the license,
sublicense, assignment or transfer of rights with respect to such Collaboration
Product (to the extent not included in Net Sales), and (b) any other operating
income received from or expense owed to Third Parties, including sublicensees,
in connection with an activity that is not part of the primary business activity
of a Party under the Agreement but is considered and approved by the Parties as
income or expense for purposes of the Agreement, which may include: (i) actual
inventory write-offs of any Collaboration Product; (ii) the cost and expense of
prosecuting, maintaining and enforcing patent, trademark and other intellectual
property
B-3
64
rights and defending against claims of infringement; and (iii) product liability
insurance to the extent the Collaborators obtain a joint policy.
B-4
65
APPENDIX C
COLLABORATION TARGETS
This Appendix to the Collaboration Agreement ("AGREEMENT") effective as
of June 12, 2001, by and between GENMAB A/S ("GENMAB"), MEDAREX, INC., on behalf
of itself and its wholly owned subsidiary, GENPHARM INTERNATIONAL, INC.,
(collectively, "MEDAREX"), and deCODE GENETICS EHF., INC. ("deCODE") sets forth
the Collaboration Targets.
The contents of this Appendix C are hereby incorporated into the
Agreement and are governed by the terms and conditions of the Agreement,
including the confidentiality provisions set forth therein.
X-0
00
XXXXXXXX X-0
UNILATERAL DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This Appendix to the Collaboration Agreement ("AGREEMENT") effective as
of June 12, 2001, by and between GENMAB A/S ("GENMAB"), MEDAREX, INC., on behalf
of itself and its wholly owned subsidiary, GENPHARM INTERNATIONAL, INC.,
(collectively, "MEDAREX"), and deCODE GENETICS EHF. ("deCODE") sets forth the
Unilateral Development and Commercialization Agreement between the
Collaborators. All capitalized terms used herein without definition shall have
the meanings ascribed thereto in the Agreement, unless otherwise expressly
provided herein.
The contents of this Xxxxxxxx X-0 are hereby incorporated into the
Agreement and are governed by the terms and conditions of the Agreement,
including the confidentiality provisions set forth therein.
67
APPENDIX D-1
UNILATERAL DEVELOPMENT
AND COMMERCIALIZATION AGREEMENT
THIS UNILATERAL DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
("AGREEMENT") is made and entered into effective as of June 12, 2001 (the
"EFFECTIVE DATE"), by and between GENMAB A/S, having principal offices at
Xxxxxxxx 00X, 0xx xxxxx, XX 0000 Xxxxxxxxxx X, Xxxxxxx ("GENMAB"), MEDAREX,
INC., having principal offices at 000 Xxxxx Xxxx, Xxxxx 000, Xxxxxxxxx, Xxx
Xxxxxx 00000-0000, on behalf of itself and its wholly owned subsidiary, GENPHARM
INTERNATIONAL, INC., with principal offices at 000 Xxxxxxxxxx Xxxxx, Xxxxxxxx,
Xxxxxxxxxx 00000 (collectively, "MEDAREX"), and deCODE GENETICS EHF., having
principal offices at Xxxxxxxxxxx 00, 000 Xxxxxxxxx, Xxxxxxx ("DECODE"). Genmab,
Medarex and deCODE each may be referred to herein individually as a "PARTY," or
collectively as the "PARTIES."
WHEREAS, the Parties have entered into that certain Collaboration
Agreement, dated as of the date hereof (the "COLLABORATION AGREEMENT");
WHEREAS, the Parties have agreed that in the event Genmab/Medarex elects
not to proceed with the development and commercialization of certain
Collaboration Targets and deCODE notifies Genmab/Medarex of its election to
proceed unilaterally with such development and commercialization in accordance
with Section 5.1.2 of the Collaboration Agreement, that deCODE shall have the
right to do so in accordance with the terms set forth below; and
WHEREAS, the Parties have agreed that in the event Genmab/Medarex fails
to comply with any of its material obligations contained in the Collaboration
Agreement with respect to a Collaboration Product, deCODE shall have the right
to convert such Collaboration Product into a Unilateral Product in accordance
with Section 8.2 of the Collaboration Agreement and proceed unilaterally with
the development and commercialization of such Unilateral Product in accordance
with the terms set forth below;
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual promises and covenants contained herein and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
Collaborators, intending to be legally bound, do hereby agree as follows:
ARTICLE 1 -
UNILATERAL DEVELOPMENT AND COMMERCIALIZATION
SECTION 1.1 DEFINITIONS. Any capitalized term used in this Agreement
not otherwise defined herein shall have the meaning set forth in the
Collaboration Agreement.
1
68
SECTION 1.2 UNILATERAL TARGETS, ANTIBODIES AND PRODUCTS. In the event
that deCODE provides Genmab/Medarex with (a) an Election Notice with respect to
a Collaboration Target pursuant to Section 5.1.2 of the Collaboration Agreement,
or (b) written notice of Genmab/Medarex's failure to cure a default in any of
its material obligations with respect to a Collaboration Product with respect to
a Collaboration Target pursuant to Section 8.2 of the Collaboration Agreement,
Appendix A hereto shall be amended to include such Collaboration Target and any
Collaboration Antibodies with respect thereto, which Collaboration Targets and
Collaboration Antibodies shall be referred to herein as "UNILATERAL TARGETS" and
"UNILATERAL ANTIBODIES," respectively. deCODE shall have the exclusive right to
Exploit any and all Antibody Products with respect to the Unilateral Targets
(each such Antibody Product, a "UNILATERAL PRODUCT"), including any
Collaboration Products with respect to such Unilateral Targets developed or
commercialized pursuant to the Collaboration Agreement or any other Antibody
Products containing or comprising Unilateral Antibodies.
SECTION 1.3 RIGHTS AND OBLIGATIONS OF THE COLLABORATORS WITH RESPECT TO
UNILATERAL PRODUCTS. Except as otherwise expressly provided herein, deCODE shall
be solely responsible for all costs and expenses in connection with the
development and commercialization of the Unilateral Products; provided, however,
that Genmab/Medarex shall be responsible for all budgeted costs and expenses
associated with the research and development activities with respect to the
Unilateral Products that Genmab/Medarex has committed to in the applicable
Project Budget as necessary to complete that phase (e.g., the Genmab/Medarex
Research Activities, toxicology studies in support of an IND or Phase I, Phase
II or Phase III) of research and development that was under way when
Genmab/Medarex Opted-Out of such Unilateral Products. By way of clarification,
deCODE shall be responsible, at its sole cost, for all milestone and royalty
payments, license fees and other payments owed to Third Parties, whether by
deCODE, Genmab, Medarex or their respective Affiliates, in connection with the
development and commercialization of Unilateral Products, including any payments
owed by Medarex and its Affiliates under the Biosite Agreement or the MRC
Agreement. The Collaborators shall work together to ensure a smooth and orderly
transition of the Unilateral Products to deCODE, including the assignment of any
contracts with respect to the Exploitation of such Unilateral Products to
deCODE, and the assumption by deCODE of any obligations thereunder. Except for
the obligations provided for in this Section 1.3, Genmab/Medarex shall have (a)
no further financial obligation to support or otherwise fund any additional
efforts in respect of such Unilateral Products, and (b) no obligation,
responsibility, or authority regarding such additional efforts in respect of
such Unilateral Products.
SECTION 1.4 PERFORMANCE OF DECODE. deCODE shall use Commercially
Reasonable Efforts to develop and commercialize one or more Unilateral Products
with respect to each Unilateral Target. Such activities shall be performed in
good scientific manner, and in compliance in all material respects with all
Applicable Law, including current good laboratory practices and good clinical
practices (including compliance with such practices and guidelines necessary to
allow the results of such activities to support INDs, BLAs and other Regulatory
Approvals), as applicable. deCODE shall have the right, subject to the
obligations set forth in this Section 1.4, to license to Third Parties rights
with respect to the development or commercialization of a Unilateral Product in
its
2
69
sole discretion; provided that any such Third Party enters into a written
agreement with deCODE to indemnify Genmab, Medarex and their respective
Affiliates to the extent provided in Article 7, and to comply with the
applicable provisions of Articles 4 and 5 and Section 1.3; provided, however,
that any sublicense with respect to the Medarex Technology or the Genmab
Technology shall be governed by the procedures set forth in Sections 2.2.5 and
2.3.
SECTION 1.5 deCODE REPORTS. deCODE shall provide an annual written
progress report to Genmab/Medarex describing the development and
commercialization activities with respect to each of its Unilateral Products in
sufficient detail to enable Genmab/Medarex to determine whether deCODE is using
Commercially Reasonable Efforts with respect thereto.
SECTION 1.6 COMMUNICATIONS AND FILINGS WITH REGULATORY AUTHORITIES.
deCODE shall be responsible for all communications and filings with the
Regulatory Authorities with respect to each of its Unilateral Products.
SECTION 1.7 OPT-OUT BY DECODE. If, at any time, deCODE decides to cease
development or commercialization of all Unilateral Products with respect to a
Unilateral Target, either alone or in collaboration with or through a Third
Party, it shall give prompt written notice thereof to Genmab/Medarex, which
notice shall describe in reasonable detail the reasons for such decision. deCODE
shall, for a period of thirty (30) days after notice to Genmab/Medarex with
respect thereto, furnish Genmab/Medarex with such information and materials as
Genmab/Medarex may reasonably request so as to determine whether it wishes to
proceed with the unilateral development and commercialization of such Unilateral
Products. Upon its receipt of all of such information and materials,
Genmab/Medarex shall, for a period of thirty (30) days, have the right to elect
to proceed unilaterally with the development and commercialization of such
Unilateral Products. Upon such election, Appendix A shall be amended to delete
such Unilateral Target and any Unilateral Antibodies with respect thereto, and
the Unilateral Development and Commercialization Agreement set forth in Appendix
D-2 to the Collaboration Agreement shall be automatically amended to include
such Unilateral Target and such Unilateral Antibodies. By way of clarification,
deCODE shall have the right to pursue one or more Unilateral Products with
respect to a Unilateral Target and any decision to cease Exploiting one in favor
of another shall not be subject to this Section 1.7 for so long as deCODE is
using Commercially Reasonable Efforts to develop and commercialize at least one
Unilateral Product with respect to such Unilateral Target.
ARTICLE 2 -
LICENSE GRANTS
SECTION 2.1 LICENSE GRANTS FOR UNILATERAL ACTIVITIES.
2.1.1 MEDAREX GRANT. Subject to Section 2.2 and the other terms and
conditions of this Agreement, Medarex hereby grants to deCODE and its
Affiliates, with respect to each Unilateral Product, an exclusive (even as to
Medarex and its Affiliates), royalty-bearing license, with the right to
sublicense solely as provided in Section 2.3,
3
70
under the Medarex Technology, the Collaboration Technology and the Joint
Technology to Exploit such Unilateral Products in the Territory in accordance
with this Agreement.
2.1.2 GENMAB GRANT. Subject to Section 2.2 and the other terms and
conditions of this Agreement, Genmab hereby grants to deCODE and its Affiliates,
with respect to each Unilateral Product, an exclusive (even as to Genmab and its
Affiliates), royalty-bearing license, with the right to sublicense solely as
provided in Section 2.3, under the Genmab Technology, the Collaboration
Technology and the Joint Technology to Exploit such Unilateral Products in the
Territory in accordance with this Agreement.
SECTION 2.2 EXCLUSIVITY, RESERVED RIGHTS AND PRE-EXISTING GRANTS.
2.2.1 ANTIGEN EXCLUSIVITY.
(a) Subject to Sections 2.2.2, 2.2.3 and 2.2.4, the Parties
acknowledge and agree that no Party shall engage, directly or indirectly, on
behalf of itself or any other party, in the research, development,
commercialization or other Exploitation of antibody-based prophylactic or
therapeutic products with respect to any Unilateral Target listed on Appendix A
other than the Unilateral Products as provided in this Agreement. deCODE
represents that it has entered into that certain Term Sheet re: Diagnostic
Products between deCODE, a certain Third Party and Affiliates of such Third
Party dated as of March 1, 2001, and any further agreement between deCODE, such
Third Party and/or such Affiliates entered into pursuant thereto (the
"PRE-EXISTING DIAGNOSTIC AGREEMENT"). deCODE acknowledges and agrees that it has
no right to use any Antibodies generated pursuant this Agreement or the
Collaboration Agreement except as expressly set forth herein or therein.
(b) deCODE shall use commercially reasonable efforts to (i)
develop and commercialize or cause to be developed and commercialized Diagnostic
Products with respect to each Unilateral Target to the extent necessary or
reasonably useful for the Exploitation of Unilateral Products with respect to
such Unilateral Target, and (ii) consistent with the Pre-Existing Diagnostic
Agreement, make such Diagnostic Products generally available to the public on
commercially reasonable terms or cause to be so made to the extent necessary or
reasonably useful to Exploit such Unilateral Products.
2.2.2 RESEARCH AND COMMERCIALIZATION AGREEMENTS. Medarex shall have the
right to (a) grant licenses and other rights to other parties, including Genmab
or deCODE, under the Medarex Technology for such parties to Exploit Antibody
Products (but not Collaboration Products or Unilateral Products) with respect to
Antigens, including Unilateral Targets, (b) transfer Medarex Know-How to such
parties in connection therewith, including by providing instruction with respect
to the use and immunization of HuMAb Mice and assistance with respect to the
Mice-Related Technology, (c) develop production processes for, and manufacture,
such Antibody Products, and (d) receive license fees, milestone payments,
royalties and other remuneration in connection therewith, but, in connection
with clause (a), (b), (c) or (d) above, not to otherwise actively participate in
the clinical development or
4
71
commercialization of such Antibody Products by such parties (each agreement with
respect to the foregoing, a "RESEARCH AND COMMERCIALIZATION AGREEMENT");
provided, however, that Medarex shall not, based on the deCODE Know-How,
including any deCODE Genomics Data, propose to a Third Party that they include a
Unilateral Target, Reversion Target or Collaboration Target in a Research and
Commercialization Agreement, but Medarex shall have the right to enter into a
Research and Commercialization Agreement with respect thereto if such Third
Party first proposes to Medarex that they include such Unilateral Target,
Reversion Target or Collaboration Target in such Research and Commercialization
Agreement.
2.2.3 RETAINED RIGHTS.
(a) OTHER ANTIGENS. Notwithstanding anything in this Agreement
to the contrary, Medarex and Genmab do each retain the right to (i) enter into
collaborations with, and to grant licenses and other rights under the Medarex
Technology and Genmab Technology respectively to, Third Parties to Exploit
Antibody Products with respect to Antigens other than Unilateral Targets, and/or
(ii) independently Exploit Antibody Products with respect to Antigens other than
Unilateral Targets.
(b) NON-ANTIBODY PRODUCTS. Notwithstanding anything in this
Agreement to the contrary, each Party shall have and retain the right to (i)
enter into collaborations with, and to grant licenses and other rights under its
respective Technology (other than Joint Technology and Collaboration Technology,
which shall be governed by Section 5.1.3 and the Collaboration Agreement,
respectively) to, Third Parties to Exploit products other than antibody-based
products with respect to Unilateral Targets, and/or (ii) independently Exploit
products other than antibody-based products with respect to Unilateral Targets.
By way of clarification, the Parties acknowledge that deCODE has not granted
Genmab or Medarex any rights under its Technology to Exploit products that are
not antibody-based products under this Agreement.
2.2.4 EXISTING GRANTS. The Parties further acknowledge and agree that
(a) pursuant to the Cross-License Agreement, Medarex has granted a non-exclusive
license under certain Medarex Patents to Exploit Antibody Products with respect
to Antigens, including the Unilateral Targets, in the Territory, and (b) Medarex
has entered into a Research and Commercialization Agreement with Genmab.
2.2.5 CROSS LICENSE AGREEMENT. The Cross-License Agreement prohibits
Medarex from granting commercialization rights to the same Antibody Product,
whether by license or sublicense, under certain Medarex Technology and, to the
extent licensed from Medarex, Genmab Technology to more than one party in a
territory. So long as the Cross-License Agreement is in effect, if deCODE
desires to grant a sublicense with respect to commercialization of a Unilateral
Product pursuant to Section 2.3, then deCODE shall provide Medarex with written
notice thereof, which shall set forth in reasonable detail the terms and
conditions of such sublicense, the Medarex Technology, Genmab Technology and
Unilateral Product involved, and the identity of the proposed sublicensee. Upon
receipt of such notice, Medarex shall make a good faith determination
5
72
as to whether such Medarex Technology or Genmab Technology, as applicable, is
subject to the sublicense restrictions contained in the Cross-License Agreement.
(a) To the extent that Medarex determines that such Medarex
Technology or Genmab Technology, as applicable, is not subject to the sublicense
restrictions contained in the Cross-License Agreement, Medarex shall so notify
deCODE in writing and deCODE thereafter shall have the right to grant such
sublicense, subject to Section 2.3.
(b) To the extent that Medarex determines that all or part of
such Medarex Technology or Genmab Technology, as applicable, is subject to the
sublicense restrictions contained in the Cross-License Agreement, Medarex shall
so notify deCODE in writing. The Parties shall then meet to discuss in good
faith how to proceed in order to optimize the commercialization of the
applicable Unilateral Product hereunder while complying with the requirements of
the Cross-License Agreement.
SECTION 2.3 SUBLICENSES. Subject to Section 2.2.5, deCODE shall have
the right to grant sublicenses under the licenses granted in Section 2.1 (a) to
Affiliates without the approval of the applicable licensor, provided that deCODE
shall remain jointly and severally liable for the performance or non-performance
of any such Affiliate sublicensee, and (b) to Third Parties pursuant to Section
1.4, with the prior approval of the applicable licensor, not to be unreasonably
withheld or delayed, which approval shall be deemed to be granted with respect
to a sublicense if the licensor fails, within twenty (20) business days of its
receipt of a written notice from deCODE setting forth in reasonable detail the
nature of such sublicense and the identity of the sublicensee, to notify deCODE
that it withholds its consent to such sublicense. Notwithstanding the previous
sentence, the grant of any such sublicense shall not relieve deCODE of its
obligations under this Agreement.
SECTION 2.4 LICENSE LIMITATIONS.
2.4.1 MEDAREX TECHNOLOGY. deCODE hereby covenants to Medarex that
neither deCODE nor any of its Affiliates, licensees or sublicensees shall use or
practice the Medarex Technology, directly or indirectly, on behalf of itself or
any other party, for any purpose other than as permitted under Section 2.1.1 and
in particular, but without limiting the generality of the foregoing, for any
research, development, commercialization or other Exploitation of an Antibody
Product or any other product or method, other than a Unilateral Product as
provided hereunder or a Collaboration Product as provided in the Collaboration
Agreement.
2.4.2 GENMAB TECHNOLOGY. deCODE hereby covenants to Genmab that neither
deCODE nor any of its Affiliates, licensees or sublicensees shall use or
practice the Genmab Technology, directly or indirectly, on behalf of itself or
any other party, for any purpose other than as permitted under Section 2.1.2 and
in particular, but without limiting the generality of the foregoing, for any
research, development, commercialization or other Exploitation of an Antibody
Product or any other product or
6
73
method, other than a Unilateral Product as provided hereunder or a Collaboration
Product as provided in the Collaboration Agreement.
SECTION 2.5 NO OTHER RIGHTS. For the avoidance of doubt, deCODE and its
Affiliates shall have no right, express or implied, with respect to the Medarex
Technology and the Genmab Technology, in each case except as expressly provided
in Section 2.1 of this Agreement and Section 3.1 of the Collaboration Agreement.
ARTICLE 3 -
FINANCIAL PROVISIONS
SECTION 3.1 MILESTONE PAYMENTS. Within thirty (30) days of the
achievement of the following milestones, on a Unilateral Target-by-Unilateral
Target basis, for Unilateral Products with respect to each Unilateral Target,
deCODE shall pay to Genmab/Medarex the specified milestone payments, each of
which shall be nonrefundable:
MILESTONES 1ST UNILATERAL 2ND UNILATERAL EACH ADDITIONAL
PRODUCT WITH PRODUCT WITH UNILATERAL PRODUCT
RESPECT TO A RESPECT TO A WITH RESPECT TO A
UNILATERAL TARGET UNILATERAL TARGET UNILATERAL TARGET
[CONFIDENTIAL TREATMENT REQUESTED]
SECTION 3.2 ROYALTIES.
3.2.1 OBLIGATION. With respect to each Unilateral Target, deCODE shall
pay Genmab/Medarex royalties based upon the annual worldwide Net Sales (on a
calendar year basis) for all Unilateral Products with respect to such Unilateral
Target. For purposes of this Agreement, Net Sales shall be deemed to include Net
Sales of Unilateral Products by sublicensees. The royalty rates shall be
determined on a Unilateral Target-by-Unilateral Target basis based on the
aggregate Net Sales of all Unilateral Products with respect to such Unilateral
Target.
7
74
3.2.2 RATES. The royalty rates for each Unilateral Product (a) for
which Genmab/Medarex Opted-Out pursuant to Section 5.1.1 of the Collaboration
Agreement, or (b) which was converted from a Collaboration Product pursuant to
Section 8.2 of the Collaboration Agreement upon Genmab/Medarex's default in any
of its material obligations shall be as follows:
[CONFIDENTIAL TREATMENT REQUESTED]
3.2.3 DEFINITIONS. For purposes of this Agreement, the following
definitions shall apply:
(a) "MAJOR MARKET" shall mean each of Japan, the United
States, the United Kingdom, France, Germany and the European Union as a whole.
(b) "PHASE I" shall mean a human clinical trial, the principal
purpose of which is a preliminary determination of safety in healthy individuals
or patients as required in 21 C.F.R. Section 312, or a similar clinical study
prescribed by the Regulatory Authorities in a Major Market other than the United
States.
(c) "PHASE II" shall mean a human clinical trial, for which a
primary endpoint is a preliminary determination of efficacy or dose ranges in
patients with the disease target being studied as required in 21 C.F.R. Section
312, or a similar clinical study prescribed by the Regulatory Authorities in a
Major Market other than the United States. Any well-controlled study intended to
provide the substantial evidence of efficacy necessary to support the filing of
an approvable BLA (such as a combined Phase II/Phase III study, or any Phase III
study in lieu of a Phase II study) (a "PIVOTAL STUDY") shall automatically be
deemed to have reached Phase II status. A Phase II study shall be deemed to have
commenced when the first subject in such study has been enrolled.
(d) "PHASE III" shall mean a human clinical trial, the
principal purpose of which is to establish safety and efficacy in patients with
the disease target being studied as required in 21 C.F.R. Section 312, or
similar clinical study prescribed by the Regulatory Authorities in a Major
Market other than the United States. A Phase III study shall also include any
other human clinical trial intended as a Pivotal Study, whether or not such
study is a traditional Phase III study. A Phase III study shall be deemed to
have commenced when the first patient has been enrolled in a Pivotal Study.
SECTION 3.3 ROYALTY TERM. deCODE's royalty obligations under Section
3.2.2 shall terminate, on a country-by-country basis, with respect to each
Unilateral Product with respect to a Unilateral Target, on the later to occur of
(a) the thirteenth (13th) anniversary of the first sale for use or consumption
by the general public of such Unilateral Product in a country after Regulatory
Approval has been obtained for such Unilateral Product in such country (the
"FIRST COMMERCIAL SALE"), and (b) the expiration date in such country of the
last to expire of any issued Joint Patents, Medarex Patents or Genmab Patents
that include, with respect to a particular country, at least one claim in such
country that (x) has not been revoked or held unenforceable or invalid by a
decision of a court or governmental agency of competent jurisdiction from which
no appeal can be
8
75
taken or has been taken within the time allowed for appeal; (y) has not been
abandoned, disclaimed, denied or admitted to be invalid or unenforceable through
reissue or disclaimer or otherwise in such country; and (z) provides exclusive
and enforceable rights with respect to the Exploitation of a Unilateral Product
in such country, covering the Exploitation of such Unilateral Product in such
country. Upon termination of the royalty obligations of deCODE under this
Section 3.3 in a country, the license grants to deCODE in Section 2.1 shall
become fully-paid up with respect to such country.
SECTION 3.4 ROYALTY PAYMENTS. Running royalties shall be payable on a
quarterly basis, within sixty (60) days after the end of each calendar quarter,
based upon the Net Sales during such calendar quarter, commencing with the
calendar quarter in which the First Commercial Sale of a Unilateral Product is
made. Royalties shall be calculated in accordance with GAAP and with the terms
of this Article 3. Only one royalty payment will be due on Net Sales of a given
Unilateral Product even though the manufacture, sale or use of such Unilateral
Product may be covered by more than one intellectual property right in a
country.
SECTION 3.5 ROYALTY STATEMENTS. deCODE shall deliver to Genmab/Medarex
within sixty (60) days after the end of each calendar quarter in which
Unilateral Products, for which deCODE owes a royalty hereunder, are sold, a
detailed statement showing (a) Net Sales of each such Unilateral Product, (b)
the number of units of each such Unilateral Product sold on a country-by-country
basis during the applicable calendar quarter, and (c) the amount and calculation
of royalties due on such Net Sales.
SECTION 3.6 PAYMENT METHOD. All amounts due by deCODE hereunder shall
be paid in U.S. dollars by wire transfer in immediately available funds to an
account designated by Genmab/Medarex. Any payments or portions thereof due
hereunder which are not paid on the date such payments are due under this
Agreement shall bear interest at a rate equal to the lesser of the prime rate as
published in The Wall Street Journal, Eastern Edition, on the first day of each
calendar quarter in which such payments are overdue, plus two (2) percentage
points, and the maximum rate permitted by law, calculated on the number of days
such payment is delinquent, compounded monthly.
SECTION 3.7 CURRENCY; FOREIGN PAYMENTS. If any currency conversion
shall be required in connection with any payment hereunder, such conversion
shall be made by using the exchange rate for the purchase of U.S. dollars as
published in The Wall Street Journal, Eastern Edition, on the last business day
of the calendar quarter to which such payments relate. If at any time legal
restrictions prevent the prompt remittance of any royalties with respect to Net
Sales in any jurisdiction, deCODE may notify Genmab/Medarex and make such
payments by depositing the amount thereof in local currency in a bank account or
other depository in such country in the name of Genmab/Medarex or its designee,
and deCODE shall have no further obligations under this Agreement with respect
thereto.
SECTION 3.8 TAXES. deCODE may deduct from any royalty amounts it is
required to pay pursuant to this Agreement any Withholding Taxes. At
Genmab/Medarex's request, deCODE shall provide Genmab/Medarex a certificate
9
76
evidencing payment of any Withholding Taxes hereunder and shall reasonably
assist Genmab/Medarex, at Genmab/Medarex's expense, to obtain the benefit of any
applicable tax treaty.
SECTION 3.9 RECORDS RETENTION; AUDIT.
3.9.1 RECORD RETENTION. deCODE shall maintain (and shall ensure that
its Affiliates and sublicensees shall maintain) complete and accurate books,
records and accounts that fairly reflect their respective Net Sales of
Unilateral Products in sufficient detail to confirm the accuracy of any payments
required hereunder and in accordance with GAAP, which books, records and
accounts shall be retained by deCODE until the later of (a) three (3) years
after the end of the period to which such books, records and accounts pertain,
and (b) the expiration of the applicable tax statute of limitations (or any
extensions thereof), or for such longer period as may be required by Applicable
Law.
3.9.2 AUDIT. Each of Genmab and Medarex shall have the right to have an
independent certified public accounting firm of nationally recognized standing,
reasonably acceptable to deCODE, to have access during normal business hours,
and upon reasonable prior written notice, to such of the records of deCODE (and
its Affiliates and sublicensees) as may be reasonably necessary to verify the
accuracy of such Net Sales for any calendar quarter ending not more than
thirty-six (36) months prior to the date of such request; provided, however,
that Genmab/Medarex shall not have the right to conduct more than one such audit
in any twelve (12)-month period. The accounting firm shall disclose to each
Party whether such Net Sales are correct or incorrect and the specific details
concerning any discrepancies. No other information shall be provided to Genmab
or Medarex. Genmab or Medarex, as applicable, shall bear the cost of such audit
unless the audit reveals a variance of more than five percent (5%) from the
reported results, in which case deCODE shall bear the cost of the audit. The
results of such accounting firm shall be final, absent manifest error.
3.9.3 PAYMENT OF ADDITIONAL ROYALTIES. If, based on the results of such
audit, additional payments are owed by deCODE under this Agreement, deCODE shall
make such additional payments, with interest from the date originally due as
provided in Section 3.6, within forty-five (45) days after the date on which
such accounting firm's written report is delivered to deCODE.
SECTION 3.10 CONFIDENTIALITY. Genmab and Medarex shall treat all
information subject to review under Section 3.9 in accordance with the
confidentiality provisions of Article 4 and shall cause its accounting firm to
enter into a reasonably acceptable confidentiality agreement with deCODE
obligating such firm to maintain all such financial information in confidence
pursuant to such confidentiality agreement.
ARTICLE 4 -
CONFIDENTIALITY
SECTION 4.1 CONFIDENTIAL INFORMATION. The confidentiality and use
restrictions set forth in Sections 6.1 through 6.4 of the Collaboration
Agreement shall
10
77
apply to all Confidential Information during the Term of this Agreement and for
a period of five (5) years thereafter, provided, however, that Medarex and
Genmab recognize that by reason of deCODE's status as an exclusive licensee
pursuant to the grant under Section 2.1, deCODE has an interest in Medarex's and
Genmab's retention in confidence of certain information of Medarex and Genmab,
respectively. Accordingly, Medarex and Genmab shall, and shall cause their
respective officers, directors, employees and agents to, keep completely
confidential, and not publish or otherwise disclose, and not use directly or
indirectly for any purpose, any information relating solely to the Unilateral
Products, except to the extent (a) such information is in the public domain
through no fault of Medarex or Genmab, their respective Affiliates or any of
their respective officers, directors, employees and agents, (b) such disclosure
or use would be permitted under Section 6.4 of the Collaboration Agreement, or
(c) such disclosure or use is otherwise expressly permitted by the terms of this
Agreement or is reasonably necessary for the performance of this Agreement. For
clarification, the disclosure by Medarex or Genmab to deCODE or by deCODE to
Medarex or Genmab of certain information of Medarex or Genmab relating solely to
the Unilateral Products shall not cause such information to cease to be subject
to the confidentiality provisions of Sections 6.1 through 6.4 of the
Collaboration Agreement.
SECTION 4.2 USE OF NAME. Each Party may use the name, insignia, symbol,
trademark, trade name or logotype of another Party only (a) in connection with
announcements and other permitted disclosures relating to this Agreement and the
activities contemplated hereby, (b) as required by Applicable Law, and (c)
otherwise as agreed in writing by such other Party.
SECTION 4.3 PRESS RELEASES. Press releases or other similar public
communication by any Party relating to this Agreement, shall be approved in
advance by the other Parties, which approval shall not be unreasonably withheld
or delayed, except for those communications required by Applicable Law (which
shall be provided to the other Parties as soon as practicable after the release
or communication thereof), disclosures of information for which consent has
previously been obtained, and information of a similar nature to that which has
been previously disclosed publicly with respect to this Agreement, each of which
shall not require advance approval.
SECTION 4.4 PUBLICATIONS. At least sixty (60) days prior to submission
for publication, presentation or other public disclosure by deCODE or any of its
Affiliates of any material pertaining to or resulting from the Medarex
Technology or Genmab Technology, deCODE shall provide to Medarex or Genmab, as
applicable, a draft of such material for its review and comment. No publication
or presentation with respect to the Medarex Technology or Genmab Technology
shall be made unless and until Medarex's or Genmab's comments, as applicable, on
the proposed publication or presentation have been addressed and changes have
been agreed upon and any information determined by Medarex or Genmab, as
applicable, to be Confidential Information has been removed. If requested in
writing by Medarex or Genmab, as applicable, deCODE shall withhold material from
submission for publication or presentation for an additional sixty (60) days to
allow for the filing of a patent application or the taking of such measures to
establish
11
78
and preserve proprietary rights in the information in the material being
submitted for publication or presentation.
ARTICLE 5 -
INTELLECTUAL PROPERTY
SECTION 5.1 INTELLECTUAL PROPERTY OWNERSHIP.
5.1.1 OWNERSHIP OF TECHNOLOGY. Subject to Section 5.1.2 and the license
grants to deCODE under Article 2, as among the Parties, each Party shall own and
retain all right, title and interest in and to any and all: (a) Information and
Inventions that are conceived, discovered, developed or otherwise made, as
necessary to establish authorship, inventorship or ownership under Applicable
Law, by or on behalf of such Party (or its Affiliates or its licensees or
sublicensees (other than the other Parties and their respective Affiliates)),
whether or not patented or patentable, and any and all Patent and other
intellectual property rights with respect thereto, except to the extent that any
such Information and Inventions, or any Patent or other intellectual property
rights with respect thereto, are Collaboration Technology or Joint Technology;
(b) other Information and Inventions, and Patent and other intellectual property
rights that are Controlled (other than pursuant to the license grants set forth
in Article 2) by such Party, its Affiliates or its licensees or sublicensees
(other than such other Parties); and (c) other Technology of such Party.
5.1.2 OWNERSHIP OF MICE-RELATED TECHNOLOGY. Subject to the license
grants to deCODE under Article 2, as among the Parties, Medarex shall own and
retain all right, title and interest in and to all Mice Materials and
Mice-Related Technology, including any and all Information and Inventions with
respect to the Mice Materials or the Mice-Related Technology (including any
Improvements thereto) that are conceived, discovered, developed or otherwise
made, as necessary to establish authorship, inventorship or ownership under
Applicable Law, by or on behalf of deCODE, its Affiliates or its licensees or
sublicensees (other than Medarex, Genmab and their respective Affiliates),
whether or not patented or patentable, and any and all Patent and other
intellectual property rights with respect thereto. deCODE acknowledges and
agrees that (a) the licenses granted to it pursuant to Section 2.1 permit deCODE
to use Mice Materials and Mice-Related Technology solely for the Exploitation of
Unilateral Products as provided in this Agreement, (b) deCODE has no right to
use the HuMAb Mice or to discover, develop or otherwise make Improvements with
respect to Mice Materials and Mice-Related Technology under such grants, and (c)
neither it, nor any of its Affiliates, licensees or sublicensees, will engage,
directly or indirectly, in activities designed to, or otherwise undertake or
attempt, either on behalf of itself or another, to discover, develop or make any
Information and Inventions that relate to the Mice Materials or the Mice-Related
Technology. Accordingly, deCODE shall promptly disclose to Medarex in writing,
the conception or reduction to practice, or the discovery, development or making
of any Mice Material or Mice-Related Technology and shall, and does hereby,
assign, and shall cause its Affiliates, licensees and sublicensees to so assign,
to Medarex, without additional compensation and at Medarex's expenses (for
reasonable and direct out-of-
12
79
pocket costs actually incurred, all of their respective rights, titles and
interests in and to any Mice Material or Mice-Related Technology.
5.1.3 OWNERSHIP OF JOINT TECHNOLOGY. Subject to Section 5.1.2 and the
license grants under Article 2, deCODE and at least one of Medarex and Genmab
(the "JOINT INVENTORS") shall each own an equal, undivided interest in any and
all (i) Information and Inventions, conceived, discovered, developed or
otherwise made, as necessary to establish authorship, inventorship or ownership
under Applicable Law, jointly by or on behalf of such Joint Inventors (or, with
respect to each Joint Inventor, its Affiliates or, to the extent permitted, its
sublicensees), in connection with the work conducted under or in connection with
this Agreement, whether or not patented or patentable, but excluding any Mice
Materials or Mice-Related Technology; and (ii) Patents (the "JOINT PATENTS") and
other intellectual property rights with respect thereto (collectively, the
"JOINT TECHNOLOGY"); provided, however, that neither a Joint Inventor nor any of
its Affiliates, licensees or sublicensees shall, directly or indirectly, Exploit
any Joint Technology or other such intellectual property rights without the
consent of the other Joint Inventor(s), not to be unreasonably withheld or
delayed, except that each Party shall have the right to Exploit such Joint
Technology for internal research and discovery purposes (as opposed to the
development, commercialization or other Exploitation of products or technology
resulting therefrom) without the consent of the other Party; provided, however,
that neither Party shall have the right to use Antibodies with respect to the
Unilateral Targets except as set forth hereunder. Each Joint Inventor shall
promptly disclose to the other Joint Inventor(s) in writing, and shall cause its
Affiliates, licensees and sublicensees to so disclose, the development, making,
conception or reduction to practice of any Joint Technology.
5.1.4 OWNERSHIP OF PRODUCT TRADEMARKS. deCODE shall own all right,
title and interest in and to each Product Trademark with respect to a Unilateral
Product. Genmab/Medarex hereby assigns all of its right, title and interest in
and to any Product Trademark to deCODE to the extent that such Product Trademark
relates solely to the Unilateral Products.
5.1.5 OWNERSHIP OF REGULATORY DOCUMENTATION. deCODE shall own all
right, title and interest in and to all Regulatory Documentation that relates
solely to the Unilateral Products. Genmab/Medarex hereby assigns to deCODE such
of its right, title and interest in and to such Regulatory Documentation as is
necessary to vest ownership of such Regulatory Documentation in deCODE as
provided in the immediately preceding sentence. Notwithstanding the ownership of
any Regulatory Documentation, each Collaborator shall have the right to use and
reference any of the Regulatory Documentation in connection with the
Exploitation of Unilateral Products as provided in this Agreement and
Collaboration Products as provided in the Collaboration Agreement.
Notwithstanding the foregoing, any Regulatory Documentation containing
Production Process Know-How of a Party shall be and remain the sole and
exclusive property of such Party and such Party shall have the right to submit
any such Production Process Know-How directly to the Regulatory Authorities
using a drug master file, or any foreign equivalent that is designed to protect
such Party's Confidential Information, which filing shall be and remain the sole
and exclusive property of such Party.
13
80
5.1.6 NOTICES. To the extent that deCODE has the right to (a) assign,
transfer, convey or otherwise encumber any right, title or interest in or to any
Medarex Technology, Genmab Technology, Joint Technology or Collaboration
Technology, (b) grant any license or other right, title or interest in or to any
Medarex Technology, Genmab Technology, Joint Technology or Collaboration
Technology, or (c) agree to or otherwise become bound by any covenant not to xxx
for any infringement, misuse or other action or inaction with respect to any
Medarex Technology, Genmab Technology, Joint Technology or Collaboration
Technology, in each case deCODE shall not do so, directly or indirectly,
expressly or by implication, by action or omission or otherwise without
providing Genmab/Medarex with at least sixty (60) days advance written notice
thereof.
SECTION 5.2 PROSECUTION OF PATENTS AND TRADEMARKS.
5.2.1 MEDAREX PATENTS. As among the Parties, Medarex shall have the
sole right, at its cost and expense, to obtain, prosecute and maintain
throughout the world the Medarex Patents; provided, however, that deCODE shall
reimburse Medarex for one hundred percent (100%) of the reasonable out-of-pocket
costs incurred by Medarex for filing, prosecuting and maintaining such Patents
(other than Mice-Related Patents) to the extent that they claim or cover (x) as
a composition of matter, a Unilateral Product or any active ingredient in such
Unilateral Product or (y) the use of any such Unilateral Product or ingredient;
and provided further that deCODE shall reimburse Medarex for one hundred percent
(100%) of the reasonable out-of-pocket costs incurred by Medarex for filing,
prosecuting and maintaining Mice-Related Patents only if such Patents (a) have
no application outside a Unilateral Product, and (b) solely claim or cover (i)
as a composition of matter, a Unilateral Product or any active ingredient in
such Unilateral Product or (ii) the use of any such Unilateral Product or
ingredient. deCODE shall, and shall cause its Affiliates, licensees and
sublicensees, as applicable, to, cooperate fully with Medarex in the
preparation, filing, prosecution, and maintenance of Medarex's Patents, provided
that deCODE shall not be responsible for such preparation, filing, prosecution
or maintenance except as set forth in this Section 5.2.1. Such cooperation
includes (a) promptly executing all papers and instruments and requiring
employees to execute such papers and instruments as reasonable and appropriate
so as to enable Medarex to file, prosecute, and maintain its Patents in any
country; and (b) promptly informing Medarex of matters that may affect the
preparation, filing, prosecution, or maintenance of any such Patents.
5.2.2 GENMAB PATENTS. As among the Parties, Genmab shall have the sole
right, at its cost and expense, to obtain, prosecute and maintain throughout the
world the Genmab Patents; provided, however, that deCODE shall reimburse Genmab
for one hundred percent (100%) of the reasonable out-of-pocket costs incurred by
Genmab for filing, prosecuting and maintaining such Patents to the extent that
they claim or cover (x) as a composition of matter, a Unilateral Product or any
active ingredient in such Unilateral Product or (y) the use of any such
Unilateral Product or ingredient. deCODE shall, and shall cause its Affiliates,
licensees and sublicensees, as applicable, to, cooperate fully with Genmab in
the preparation, filing, prosecution, and maintenance of Genmab's Patents,
provided that deCODE shall not be responsible for such preparation,
14
81
filing, prosecution or maintenance except as set forth in this Section 5.2.1.
Such cooperation includes (a) promptly executing all papers and instruments and
requiring employees to execute such papers and instruments as reasonable and
appropriate so as to enable Genmab to file, prosecute, and maintain its Patents
in any country; and (b) promptly informing Genmab of matters that may affect the
preparation, filing, prosecution, or maintenance of any such Patents.
5.2.3 JOINT PATENTS. The Joint Inventors shall, and shall cause their
respective Affiliates, licensees and sublicensees, as applicable, to cooperate
with one another with respect to the filing, prosecution and maintenance of all
Joint Patents, including by selecting outside counsel, reasonably acceptable to
the Joint Inventors, to handle such filing, prosecution and maintenance. The
Joint Inventors shall share equally in the expenses associated with the filing,
prosecution (including any interferences, reissue proceedings and
reexaminations) and maintenance of all Joint Patents. If a Joint Inventor elects
not to pursue the filing, prosecution or maintenance of a Joint Patent in a
particular country, or to take any other action with respect to its Joint
Technology in a particular country that is necessary or reasonably useful to
establish or preserve rights thereto, then in each such case such Joint Inventor
shall so notify the other Joint Inventor(s) promptly in writing and in good time
to enable such other Joint Inventor(s) to meet any deadlines by which an action
must be taken to establish or preserve any such rights in such Joint Patent or
Joint Technology in such country. Upon receipt of each such notice by such other
Joint Inventor(s) or if, at any time, such Joint Inventor fails to initiate any
such action within thirty (30) days after a request by such other Joint
Inventor(s) that it do so (or thereafter diligently pursue such action), such
other Joint Inventor(s) shall have the right, but not the obligation, to pursue
the filing or registration, or support the continued prosecution or maintenance,
of such Patent at its expense in such country. If such other Joint Inventor(s)
elects to pursue such filing or registration, as the case may be, or continue
such support, then such other Joint Inventor(s) shall notify such Joint Inventor
of such election and such Joint Inventor shall, and shall cause its Affiliates,
licensees and sublicensees, as applicable, to, (x) reasonably cooperate with
such other Joint Inventor(s) in this regard, and (y) subject to Article 2,
promptly release or assign to such other Joint Inventor(s), without
compensation, all right, title and interest in and to such Patent in such
country.
5.2.4 PATENT FILINGS. deCODE covenants not to, and to cause its
Affiliates, licensees and sublicensees, as applicable, not to, file any patent
application disclosing or claiming any Information and Inventions comprising any
Medarex Technology or Genmab Technology or the Exploitation thereof, without
Medarex's or Genmab's, as applicable, prior written consent, which consent shall
not be unreasonably withheld or delayed.
SECTION 5.3 ENFORCEMENT OF PATENTS AND TRADEMARKS.
5.3.1 RIGHTS AND PROCEDURES. If Medarex, Genmab or deCODE determines
that any Technology (which for purposes of this Agreement shall be deemed to
include Joint Technology) of another Party(ies) is being infringed by a Third
Party's activities and that such infringement could affect the exercise by the
Parties of their
15
82
respective rights and obligations under this Agreement, it shall promptly notify
the other Party(ies) in writing and provide such other Party(ies) with any
evidence of such infringement that is reasonably available. Promptly after the
receipt of such written notice, the Parties shall meet and discuss in good faith
the removal of such infringement. The pursuing Party shall consider in good
faith any comments from the other Parties and shall keep the other Parties
reasonably informed of any steps taken to remove such infringement.
(a) JOINT TECHNOLOGY. With respect to Joint Technology, the
Joint Inventors shall have the first right to jointly remove such infringement
using commercially appropriate steps, including the filing of an infringement
suit or taking other similar action. Each such Joint Inventor shall be
responsible for half of the reasonable and verifiable costs and expenses
incurred in connection with such action. In the event the Joint Inventors fail
to jointly take commercially appropriate steps to remove any infringement of any
Joint Technology within ninety (90) days following notice of such infringement,
or a Joint Inventor earlier notifies such other Joint Inventor(s) in writing of
its intent not to take such steps, the Joint Inventor pursuing the filing,
prosecution or maintenance of a Patent comprising such Joint Technology (the
"PROSECUTING PARTY") shall have the right to do so at its own expense, or, in
the event such Party declines, such other Joint Inventor(s) shall have the right
to do so at its own expense; provided, however, that if the Joint Inventors have
jointly commenced negotiations with an alleged infringer for discontinuance of
such infringement within such ninety (90) day period, the Joint Inventors shall
have an additional ninety (90) days to conclude their negotiations before a
Joint Inventor unilaterally may bring suit for such infringement.
(b) MEDAREX TECHNOLOGY. With respect to Medarex Technology
that is not Mice-Related Technology, Medarex shall have the first right, but not
the obligation, to remove such infringement at its sole cost and expense. In the
event Medarex fails to take commercially appropriate steps to remove any
infringement of such Technology within ninety (90) days following notice of such
infringement, or earlier notifies deCODE in writing of its intent not to take
such steps, deCODE shall have the right to do so at its sole cost and expense;
provided, however, that if Medarex has commenced negotiations with an alleged
infringer for discontinuance of such infringement within such ninety (90) day
period, Medarex shall have an additional ninety (90) days to conclude its
negotiations before deCODE may bring suit for such infringement; and provided
further that deCODE shall reimburse Medarex for one hundred percent (100%) of
the reasonable out-of-pocket costs incurred by Medarex with respect to the
removal of any such infringement with respect to any Unilateral Product.
(c) GENMAB TECHNOLOGY. With respect to Genmab Technology,
Genmab shall have the first right, but not the obligation, to remove such
infringement at its sole cost and expense. In the event Genmab fails to take
commercially appropriate steps to remove any infringement of such Technology
within ninety (90) days following notice of such infringement, or earlier
notifies deCODE in writing of its intent not to take such steps, deCODE shall
have the right to do so at its sole cost and expense; provided, however, that if
Genmab has commenced negotiations with an alleged infringer for
16
83
discontinuance of such infringement within such ninety (90) day period, Genmab
shall have an additional ninety (90) days to conclude its negotiations before
deCODE may bring suit for such infringement; and provided further that deCODE
shall reimburse Genmab for one hundred percent (100%) of the reasonable
out-of-pocket costs incurred by Genmab with respect to the removal of any such
infringement with respect to any Unilateral Product.
(d) MICE-RELATED TECHNOLOGY. With respect to Medarex's
Mice-Related Technology, Medarex shall have the sole right, but not the
obligation, to remove such infringement at its sole cost and expense; provided,
however, that deCODE shall reimburse Medarex for one hundred percent (100%) of
the reasonable out-of-pocket costs incurred by Medarex with respect to the
removal of any such infringement with respect to any Unilateral Product.
5.3.2 COOPERATION. The Parties not enforcing the applicable Technology
shall provide reasonable assistance to the other Party, including providing
access to relevant documents and other evidence, making its employees available
at reasonable business hours, and joining the action to the extent necessary to
allow the enforcing Party to maintain the action.
5.3.3 RECOVERY. Any amounts recovered by any Party pursuant to Section
5.3.1, whether by settlement or judgment, shall be used to reimburse the Parties
for their reasonable costs and expenses in making such recovery (which amounts
shall be allocated pro rata if insufficient to cover the totality of such
expenses), with any remainder being retained by the Party that has exercised its
right to bring the enforcement action; provided, however, that to the extent
that any award is attributable to loss of sales of a Unilateral Product, the
Parties shall negotiate in good faith an appropriate allocation of such award to
reflect the economic interests of the Parties under this Agreement with respect
to such Unilateral Product.
SECTION 5.4 POTENTIAL THIRD PARTY RIGHTS.
5.4.1 THIRD PARTY LICENSES. If (a) in the opinion of outside patent
counsel to deCODE, deCODE, or any of its Affiliates, licensees or permitted
sublicensees, cannot Exploit a Unilateral Product in a country in the Territory
without infringing one or more Patents that have issued to a Third Party in such
country, or (b) as a result of any claim made against a Party, or any of its
Affiliates, licensees or permitted sublicensees, alleging that the Exploitation
of a Unilateral Product infringes or misappropriates any Patent or any other
intellectual property right of a Third Party in a country in the Territory, a
judgment is entered by a court of competent jurisdiction from which no appeal is
taken within the time permitted for appeal, such that deCODE cannot Exploit such
Unilateral Product in such country without infringing the Patent or other
proprietary rights of such Third Party, then, in either case, deCODE shall have
the first right, but not the obligation to negotiate and to obtain a license
from such Third Party as necessary for the Exploitation of any Unilateral
Products hereunder in such country; provided, however, that Medarex shall have
the sole right to seek any such license with respect to Mice-Related Technology
and shall use Commercially Reasonable Efforts to
17
84
obtain such a license in its own name from such Third Party in such country,
under which Medarex shall, to the extent permissible under such license, grant a
sublicense to deCODE as necessary for deCODE and any of its Affiliates and
permitted sublicensees, to Exploit the Unilateral Products as provided hereunder
in such country. deCODE shall be solely responsible for one hundred percent
(100%) of all royalty and other obligations with respect to the Exploitation of
Unilateral Products.
5.4.2 THIRD PARTY LITIGATION. In the event that a Third Party
institutes a Patent, Trademark or other infringement suit (including any suit
alleging the invalidity or unenforceability of the Patents of a Party or its
Affiliates, or claiming confusion, deception or dilution of a Trademark by a
Product Trademark) against any Party or its Affiliates, licensees or permitted
sublicensees during the Term, alleging that the Exploitation of the Unilateral
Products in the Territory or any other activities hereunder, infringes one or
more Patent, Trademark or other intellectual property rights held by such Third
Party (an "INFRINGEMENT SUIT"), the Parties shall cooperate with one another in
defending such suit. deCODE shall direct and control, at its sole cost and
expense, any Infringement Suit with respect to the Unilateral Products
(excluding any Infringement Suit with respect to the Mice-Related Technology as
to which Medarex shall retain the exclusive right to direct and control);
provided, however, that deCODE shall not cease to defend, settle or otherwise
dispose of a suit with respect to any intellectual property of Medarex or Genmab
without Medarex's or Genmab's, respectively, prior written consent. With respect
to the Collaboration Patents, the Collaborators shall each bear fifty percent
(50%) of any costs and expenses of such defense; provided, with respect to the
Exploitation of Unilateral Products, deCODE shall bear one hundred percent
(100%) of those costs and expenses. With respect to the Joint Patents, the
Collaborators shall each bear fifty percent (50%) of any costs and expenses of
such defense; provided, with respect to the Exploitation of Unilateral Products,
deCODE shall bear one hundred percent (100%) of those costs and expenses.
5.4.3 RETAINED RIGHTS. Nothing in this Section 5.4 shall prevent
deCODE, at its own expense, from obtaining any license or other rights from
Third Parties it deems appropriate in order to permit the full and unhindered
exercise of its rights under this Agreement.
SECTION 5.5 EXCHANGE OF KNOW-HOW.
5.5.1 INFORMATION DISCLOSURE. Medarex and Genmab shall, and shall cause
their respective Affiliates, licensees and sublicensees, as applicable, to,
without additional compensation and at their sole expense, disclose and make
available to deCODE, in whatever form deCODE may reasonably request, all
Regulatory Documentation, all of its other Know-How, all Information and
Inventions included in the Collaboration Technology and the Joint Technology and
any other Information and Inventions that are reasonably necessary to Exploit
Antibody Products with respect to each Unilateral Target immediately after such
Unilateral Target is first designated as such and thereafter immediately upon
the earlier of the conception or reduction to practice, discovery, development
or making of each such Regulatory Documentation, Know-How, or other Information
and Inventions.
18
85
5.5.2 COOPERATION. Medarex and Genmab shall cooperate with any and all
reasonable requests for assistance from deCODE, at deCODE's sole cost and
expense, including by making their respective employees, consultants and other
scientific staff, as applicable, available upon reasonable notice during normal
business hours at Medarex's or Genmab's, as applicable, place of business to
consult with deCODE on issues arising with respect to the Medarex Technology or
Genmab Technology in connection with the research, development,
commercialization or other Exploitation of Unilateral Products.
5.5.3 BIOLOGICAL MATERIALS. For purposes of facilitating the conduct of
the development activities with respect to the Unilateral Products,
Genmab/Medarex shall provide to deCODE the Biological Materials necessary to
perform such activities. The Parties agree that: (a) all such Biological
Materials provided by Genmab/Medarex to deCODE and any Biological Material
produced against or with, or derived from, such Biological Materials shall be
used solely for the development and commercialization of Unilateral Products,
and in material compliance with all Applicable Law; (b) all such Biological
Materials shall be provided without any warranties, express or implied; (c)
Genmab/Medarex shall obtain (or cause its Third Party collaborators to obtain or
certify that they have obtained) all appropriate and required consents from the
source of such Biological Materials; (d) Biological Materials provided by
Genmab/Medarex to deCODE shall not be made available by deCODE to any Third
Party, unless the prior written consent of Genmab/Medarex is first obtained; and
(e) subject to the license grants in Article 2 and other provisions in this
Agreement, all right, title and interest in and to the Mice Materials and the
Mice-Related Technology shall be, and remain, vested in Medarex.
5.5.4 REGULATORY RECORDS. deCODE shall maintain, or cause to be
maintained, records of its respective research, development, manufacturing and
commercialization activities for the Unilateral Products, including all
Regulatory Documentation, in sufficient detail and in good scientific manner
appropriate for patent and regulatory purposes, which shall be complete and
accurate and shall fully and properly reflect all work done and results achieved
in the performance of such activities, and which shall be retained during the
term of this Agreement and for a period of five (5) years thereafter, or for
such longer period as may be required by Applicable Law. Genmab and Medarex
shall have the right, during normal business hours and upon reasonable notice,
to inspect and copy any such records, except to the extent that such records
contain proprietary information with respect to deCODE's Production Process
Technology. Genmab and Medarex shall have an irrevocable, perpetual right to use
and reference such Regulatory Documentation for all purposes.
5.5.4 PRODUCTION PROCESS TECHNOLOGY. Notwithstanding anything to the
contrary in this Section 5.5 or elsewhere in this Agreement, Medarex or Genmab
shall not be obligated to disclose or provide any of their respective Production
Process Technology, including Biological Materials, to deCODE or any Third Party
except as may be required or permitted under a separate written agreement
entered into by the Parties pursuant to Section 1.2.8 or Section 1.6 of the
Collaboration Agreement.
19
86
ARTICLE 6 -
TERM AND TERMINATION
SECTION 6.1 TERM. The term of this Agreement (the "TERM") shall
commence upon the Effective Date and shall continue in effect until such time as
there is no longer any Unilateral Product being Exploited hereunder, unless
terminated at an earlier date in accordance with the terms and conditions set
forth in this Article 6.
SECTION 6.2 TERMINATION FOR MATERIAL BREACH. Any material failure by a
Collaborator to comply with any of its material obligations contained herein
shall entitle the Collaborator not in default to give to the Collaborator in
default written notice specifying the nature of the default, requiring the
defaulting Collaborator to make good or otherwise cure such default, and stating
its intention if such default is not cured to terminate or, if deCODE is the
defaulting Collaborator, at the option of Genmab/Medarex, to convert such
Unilateral Product to which the material breach applies to a Unilateral Product
of Genmab/Medarex under the Unilateral Development and Commercialization
Agreement attached to the Collaboration Agreement as Appendix D-2. If such
default is not cured within thirty (30) days after the receipt of such notice
(or, if such default cannot be cured within such thirty (30)-day period, if the
Collaborator in default does not commence actions to cure such default within
such period and thereafter diligently continue such actions or if such default
is not otherwise cured within one-hundred and eighty (180) days after the
receipt of such notice), except in the case of a payment default, as to which
the defaulting Collaborator shall have only a thirty (30) day cure period, the
Collaborator not in default shall be entitled, on written notice to the other
Collaborator, without prejudice to any of its other rights conferred on it by
this Agreement, and in addition to any other remedies available to it by law or
in equity, to (a) terminate this Agreement in its entirety, or (b) if deCODE is
the defaulting Collaborator, to convert such Unilateral Product to a Unilateral
Product of Genmab/Medarex, whereupon each shall be subject to their respective
rights and obligations under the Unilateral Development and Commercialization
Agreement attached to the Collaboration Agreement as Xxxxxxxx X-0, including the
royalty obligations set forth therein and the indemnification obligations.
SECTION 6.3 TERMINATION UPON INSOLVENCY. Any Party may terminate this
Agreement if, at any time, any other Party shall file in any court or agency
pursuant to any statute or regulation of any state, country or jurisdiction, a
petition in bankruptcy or insolvency or for reorganization or for an arrangement
or for the appointment of a receiver or trustee of that Party or of its assets,
or if such other Party proposes a written agreement of composition or extension
of its debts, or if such other Party shall be served with an involuntary
petition against it, filed in any insolvency proceeding, and such petition shall
not be dismissed within sixty (60) days after the filing thereof, or if such
other Party shall propose or be a party to any dissolution or liquidation, or if
such other Party shall make an assignment for the benefit of its creditors;
provided, however, that in the event such bankrupt or insolvent Party is Medarex
or Genmab, the other such Party (whether Medarex or Genmab) shall have the right
to assume all of the obligations of the bankrupt or insolvent Party under this
Agreement, and upon such assumption, such other
20
87
Party shall be entitled to all of the rights and benefits hereunder of such
bankrupt or insolvent Party and deCODE shall have no right to terminate pursuant
to this Section 6.4.
SECTION 6.4 RIGHTS IN BANKRUPTCY. All rights and licenses granted under
or pursuant to this Agreement by Medarex, Genmab or deCODE are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of the United States
Bankruptcy Code, licenses of rights to "intellectual property" as defined under
Section 101 of the United States Bankruptcy Code. The Parties agree that the
Parties, as licensees of such rights under this Agreement, shall retain and may
fully exercise all of their rights and elections under the United States
Bankruptcy Code. The Parties further agree that, in the event of the
commencement of a bankruptcy proceeding by or against any Party under the United
States Bankruptcy Code, the Parties hereto are not a Party to such proceeding
shall be entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property and all embodiments of such
intellectual property, which, if not already in the non-subject Party's(ies')
possession, shall be promptly delivered to it (a) upon any such commencement of
a bankruptcy proceeding upon the non-subject Party's(ies') written request
therefor, unless the Party subject to such proceeding continues to perform all
of its obligations under this Agreement or (b) if not delivered under clause (a)
above, following the rejection of this Agreement by or on behalf of the Party
subject to such proceeding upon written request therefor by the non-subject
Party(ies).
SECTION 6.5 CONSEQUENCES OF EXPIRATION OR TERMINATION.
6.5.1 LICENSES. Upon expiration of the full term of this Agreement in
accordance with Section 6.1 and the payment of all amounts due under Section
3.1, the licenses granted by Medarex and Genmab to deCODE hereunder shall be
deemed fully-paid up.
6.5.2 RETURN OF INFORMATION. Upon expiration of this Agreement pursuant
to Section 6.1 or upon termination of this Agreement in its entirety by any
Party pursuant to this Article 6, deCODE, at the request of Medarex or Genmab,
shall return all data, files, records and other materials in its possession or
control relating to Medarex's Technology or Genmab's Technology, as applicable,
or containing or comprising Medarex's or Genmab's Information and Inventions, as
applicable or other Confidential Information and to which deCODE does not retain
rights hereunder (except one copy of which may be retained for archival
purposes).
SECTION 6.6 ACCRUED RIGHTS; SURVIVING OBLIGATIONS.
6.6.1 ACCRUED RIGHTS. Termination or expiration of this Agreement for
any reason shall be without prejudice to any rights that shall have accrued to
the benefit of a Party prior to such termination or expiration. Such termination
or expiration shall not relieve a Party from obligations that are expressly
indicated to survive the termination or expiration of this Agreement.
21
88
6.6.2 SURVIVAL. Articles 3 (with respect to obligations arising prior
to expiration or termination), 4 and 7, and Sections 2.2.5, 2.3, 5.1, 5.2,
5.5.3, 5.5.4, 5.5.5, 6.4, 6.5, 9.4, 9.5 and 9.6 of this Agreement and this
Section 6.6 shall survive expiration or termination of this Agreement for any
reason.
ARTICLE 7 -
INDEMNIFICATION AND INSURANCE
SECTION 7.1 INDEMNIFICATION OF deCODE.
7.1.1 BY MEDAREX. Medarex shall indemnify deCODE, its Affiliates and
their respective directors, officers, employees and agents, and defend and save
each of them harmless, from and against any and all losses, damages,
liabilities, costs and expenses (including reasonable attorneys' fees and
expenses) in connection with any and all liability suits, investigations, claims
or demands (collectively, "LOSSES") arising from or occurring as a result of or
in connection with any breach by Medarex of this Agreement, except for those
Losses for which deCODE has an obligation to indemnify Medarex and its
Affiliates pursuant to Section 7.2, as to which Losses each Party shall
indemnify the other to the extent of their respective liability for the Losses.
7.1.2 BY GENMAB. Genmab shall indemnify deCODE, its Affiliates and
their respective directors, officers, employees and agents, and defend and save
each of them harmless, from and against any and all Losses arising from or
occurring as a result of or in connection with any breach by Genmab of this
Agreement, except for those Losses for which deCODE has an obligation to
indemnify Genmab and its Affiliates pursuant to Section 7.2, as to which Losses
each Party shall indemnify the other to the extent of their respective liability
for the Losses.
SECTION 7.2 INDEMNIFICATION OF MEDAREX AND GENMAB. deCODE shall
indemnify Medarex, Genmab and their respective Affiliates, directors, officers,
employees and agents, and defend and save each of them harmless, from and
against any and all Losses arising from or occurring as a result of or in
connection with (a) any breach by deCODE of this Agreement, (b) the development,
manufacture or commercialization of a Unilateral Product by or on behalf of
deCODE or its Affiliates or sublicensees, or (c) the gross negligence,
recklessness or willful misconduct on the part of deCODE or its Affiliates,
licensees or sublicensees in performing any activity contemplated by this
Agreement, except for those Losses for which Medarex or Genmab has an obligation
to indemnify deCODE pursuant to Section 7.1, as to which Losses each of Medarex
and Genmab shall indemnify the other to the extent of their respective liability
for the Losses.
SECTION 7.3 INDEMNIFICATION PROCEDURE.
7.3.1 NOTICE OF CLAIM. The indemnified Party shall give the
indemnifying Party prompt written notice (an "INDEMNIFICATION CLAIM NOTICE") of
any Losses or discovery of fact upon which such indemnified Party intends to
base a request for indemnification under Section 7.1 or Section 7.2, but in no
event shall the
22
89
indemnifying Party be liable for any Losses that result from any delay in
providing such notice. Each Indemnification Claim Notice must contain a
description of the claim and the nature and amount of such Loss (to the extent
that the nature and amount of such Loss are known at such time). The indemnified
Party shall furnish promptly to the indemnifying Party copies of all papers and
official documents received in respect of any Losses. All indemnification claims
in respect of a Party, its Affiliates or their respective directors, officers,
employees and agents (collectively, the "INDEMNITEES" and each an "INDEMNITEE")
shall be made solely by such Party to this Agreement (the "INDEMNIFIED PARTY").
7.3.2 THIRD PARTY CLAIMS. Subject to Section 5.4, the obligations of an
indemnifying Party under this Article 7 with respect to Losses arising from
claims of any Third Party that are subject to indemnification as provided for in
Section 7.1 or 7.2 (a "THIRD PARTY CLAIM") shall be governed by and be
contingent upon the following additional terms and conditions:
(a) CONTROL OF DEFENSE. At its option, the indemnifying Party
may assume the defense of any Third Party Claim by giving written notice to the
Indemnified Party within thirty (30) days after the indemnifying Party's receipt
of an Indemnification Claim Notice. The assumption of the defense of a Third
Party Claim by the indemnifying Party shall not be construed as an
acknowledgment that the indemnifying Party is liable to indemnify any Indemnitee
in respect of the Third Party Claim, nor shall it constitute a waiver by the
indemnifying Party of any defenses it may assert against any Indemnitee's claim
for indemnification. Upon assuming the defense of a Third Party Claim, the
indemnifying Party may appoint as lead counsel in the defense of the Third Party
Claim any legal counsel selected by the indemnifying Party. In the event the
indemnifying Party assumes the defense of a Third Party Claim, the Indemnified
Party shall immediately deliver to the indemnifying Party all original notices
and documents (including court papers) received by any Indemnitee in connection
with the Third Party Claim. Should the indemnifying Party assume the defense of
a Third Party Claim, the indemnifying Party shall not be liable to the
Indemnified Party or any other Indemnitee for any legal expenses subsequently
incurred by such Indemnified Party or other Indemnitee in connection with the
analysis, defense or settlement of the Third Party Claim. In the event that it
is ultimately determined that the indemnifying Party is not obligated to
indemnify, defend or hold harmless an Indemnitee from and against the Third
Party Claim, the Indemnified Party shall reimburse the indemnifying Party for
any and all costs and expenses (including attorneys' fees and costs of suit) and
any Losses incurred by the indemnifying Party in its defense of the Third Party
Claim with respect to such Indemnitee.
(b) RIGHT TO PARTICIPATE IN DEFENSE. Without limiting Section
7.3.2(a), any Indemnitee shall be entitled to participate in, but not control,
the defense of such Third Party Claim and to employ counsel of its choice for
such purpose; provided, however, that such employment shall be at the
Indemnitee's own expense unless (i) the employment thereof has been specifically
authorized by the indemnifying Party in writing, or (ii) the indemnifying Party
has failed to assume the defense and employ
23
90
counsel in accordance with Section 7.3.2(a) (in which case the Indemnified Party
shall control the defense).
(c) SETTLEMENT. With respect to any Losses relating solely to
the payment of money damages in connection with a Third Party Claim and that
will not result in the Indemnitee's becoming subject to injunctive or other
relief or otherwise adversely affect the business of the Indemnitee in any
manner, and as to which the indemnifying Party shall have acknowledged in
writing the obligation to indemnify the Indemnitee hereunder, the indemnifying
Party shall have the sole right to consent to the entry of any judgment, enter
into any settlement or otherwise dispose of such Loss, on such terms as the
indemnifying Party, in its sole discretion, shall deem appropriate. With respect
to all other Losses in connection with Third Party Claims, where the
indemnifying Party has assumed the defense of the Third Party Claim in
accordance with Section 7.3.2(a), the indemnifying Party shall have authority to
consent to the entry of any judgment, enter into any settlement or otherwise
dispose of such Loss provided it obtains the prior written consent of the
Indemnified Party (which consent shall not be unreasonably withheld or delayed).
The indemnifying Party shall not be liable for any settlement or other
disposition of a Loss by an Indemnitee that is reached without the written
consent of the indemnifying Party. Regardless of whether the indemnifying Party
chooses to defend or prosecute any Third Party Claim, no Indemnitee shall admit
any liability with respect to, or settle, compromise or discharge, any Third
Party Claim without the prior written consent of the indemnifying Party.
(d) COOPERATION. Regardless of whether the indemnifying Party
chooses to defend or prosecute any Third Party Claim, the Indemnified Party
shall, and shall cause each other Indemnitee to, cooperate in the defense or
prosecution thereof and shall furnish such records, information and testimony,
provide such witnesses and attend such conferences, discovery proceedings,
hearings, trials and appeals as may be reasonably requested in connection
therewith. Such cooperation shall include access during normal business hours
afforded to indemnifying Party to, and reasonable retention by the Indemnified
Party of, records and information that are reasonably relevant to such Third
Party Claim, and making Indemnitees and other employees and agents available on
a mutually convenient basis to provide additional information and explanation of
any material provided hereunder, and the indemnifying Party shall reimburse the
Indemnified Party for all its reasonable out-of-pocket expenses in connection
therewith.
(e) EXPENSES. Except as provided above, the costs and
expenses, including fees and disbursements of counsel, incurred by the
Indemnified Party in connection with any claim shall be reimbursed on a calendar
quarter basis by the indemnifying Party, without prejudice to the indemnifying
Party's right to contest the Indemnified Party's right to indemnification and
subject to refund in the event the indemnifying Party is ultimately held not to
be obligated to indemnify the Indemnified Party.
SECTION 7.4 INSURANCE. deCODE shall have and maintain such types and
amounts of liability insurance as is normal and customary in the industry
generally for
24
91
parties similarly situated, and shall upon request provide the other Party with
a copy of its policies of insurance in that regard, along with any amendments
and revisions thereto.
ARTICLE 8 -
REPRESENTATIONS, WARRANTIES AND COVENANTS
SECTION 8.1 REPRESENTATIONS, WARRANTIES AND COVENANTS. Each Party is
entering into this Agreement in reliance upon the representations, warranties
and covenants of the other Parties set forth in Sections 10.1, 10.2, 10.3 and
10.4 of the Collaboration Agreement.
SECTION 8.2 DISCLAIMER OF WARRANTY. EXCEPT FOR THE EXPRESS WARRANTIES
SET FORTH IN SECTIONS 10.1, 10.2, 10.3 AND 10.4 OF THE COLLABORATION AGREEMENT,
deCODE, MEDAREX AND GENMAB MAKE NO REPRESENTATIONS AND GRANT NO WARRANTIES,
EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR
OTHERWISE, AND deCODE, MEDAREX AND GENMAB EACH SPECIFICALLY DISCLAIM ANY OTHER
WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE
OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY
INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
ARTICLE 9 -
MISCELLANEOUS
SECTION 9.1 FORCE MAJEURE. No Party shall be held liable or responsible
to the other Parties or be deemed to have defaulted under or breached this
Agreement for failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or results from events beyond
the reasonable control of the non-performing Party, including fires, floods,
embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be
declared or not), insurrections, riots, civil commotion, strikes, lockouts or
other labor disturbances, acts of God or acts, omissions or delays in acting by
any governmental authority. The non-performing Party shall notify the other
Parties of such force majeure within ten (10) days after such occurrence by
giving written notice to the other Parties stating the nature of the event, its
anticipated duration, and any action being taken to avoid or minimize its
effect. The suspension of performance shall be of no greater scope and no longer
duration than is necessary and the non-performing Party shall use Commercially
Reasonable Efforts to remedy its inability to perform; provided, however, that
in the event the suspension of performance continues for one-hundred and eighty
(180) days after the date of the occurrence, the Parties shall meet to discuss
in good faith how to proceed in order to accomplish the goals of the
Collaboration outlined in this Agreement.
SECTION 9.2 ASSIGNMENT. Without the prior written consent of the other
Parties hereto, no Party shall sell, transfer, assign, delegate, pledge or
otherwise dispose of,
25
92
whether voluntarily, involuntarily, by operation of law or otherwise, this
Agreement or any of its rights or duties hereunder; provided, however, that any
Party hereto may assign or transfer this Agreement or any of its rights or
obligations hereunder without the consent of the other Parties (a) to any
Affiliate of such Party, respectively; or (b) to any Third Party with which it
may merge or consolidate, or to which it may transfer all or substantially all
of its assets to which this Agreement relates if in any such event (i) the
assigning Party (provided that it is not the surviving entity) remains jointly
and severally liable with the relevant deCODE Affiliate, Medarex Affiliate or
Genmab Affiliate, or Third Party assignee under this Agreement, and (ii) the
relevant deCODE Affiliate assignee, Medarex Affiliate assignee or Genmab
Affiliate assignee, Third Party assignee or surviving entity assumes in writing
all of the assigning Party's obligations under this Agreement. Any purported
assignment or transfer in violation of this Section shall be void ab initio and
of no force or effect.
SECTION 9.3 SEVERABILITY. If any provision of this Agreement is held to
be illegal, invalid or unenforceable under any present or future law, and if the
rights or obligations of any Party under this Agreement will not be materially
and adversely affected thereby, (a) such provision shall be fully severable, (b)
this Agreement shall be construed and enforced as if such illegal, invalid or
unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Agreement shall remain in full force and effect and shall not
be affected by the illegal, invalid or unenforceable provision or by its
severance herefrom, and (d) in lieu of such illegal, invalid or unenforceable
provision, there shall be added automatically as a part of this Agreement a
legal, valid and enforceable provision as similar in terms to such illegal,
invalid or unenforceable provision as may be possible and reasonably acceptable
to the Parties herein. To the fullest extent permitted by applicable law, each
Party hereby waives any provision of law that would render any provision
prohibited or unenforceable in any respect.
SECTION 9.4 DISPUTES. Any dispute that may arise relating to this
Agreement shall be referred to the Chief Executive Officers of each of the
Parties (or their respective designees) who shall use their good faith efforts
to mutually agree upon the proper course of action to resolve the dispute. If
any dispute is not resolved by the Chief Executive Officers of the Parties (or
their designees) within ten (10) business days after such dispute is referred to
them, then any Party shall have the right to arbitrate such dispute in
accordance with Section 9.5 or to pursue such other dispute resolution mechanism
as the Parties may agree.
SECTION 9.5 GOVERNING LAW, JURISDICTION, VENUE AND SERVICE. This
Agreement shall be governed by and construed in accordance with the laws of the
State of New Jersey, applicable to contracts made and wholly performed within
such jurisdiction by residents of such jurisdiction. Subject to Section 9.4, the
Parties hereby irrevocably and unconditionally consent to the exclusive
jurisdiction of the courts of London, England for any action, suit or proceeding
arising out of or relating to this Agreement, and agree not to commence any
action, suit or proceeding related thereto except in such courts. The Parties
further hereby irrevocably and unconditionally waive any objection to the laying
of venue of any action, suit or proceeding arising out of or
26
93
relating to this Agreement in the courts of London, England, and hereby further
irrevocably and unconditionally waive and agree not to plead or claim in any
such court that any such action, suit or proceeding brought in any such court
has been brought in an inconvenient forum. Each Party hereto further agrees that
service of any process, summons, notice or document by registered mail to its
address set forth below shall be effective service of process for any action,
suit or proceeding brought against it under this Agreement in any such court.
SECTION 9.6 NOTICES. All notices or other communications that are
required or permitted hereunder shall be in writing and delivered personally,
sent by facsimile (and promptly confirmed by personal delivery, registered or
certified mail or overnight courier as provided herein), sent by
nationally-recognized overnight courier or sent by registered or certified mail,
postage prepaid, return receipt requested, addressed as follows:
If to deCODE, to:
deCODE genetics ehf
Hlioarsmari 15
200 Kopavogur, Iceland
Attention: Chief Executive Officer
Facsimile: 000-000-0000
Telephone: 000-000-0000
with a copies to:
deCODE genetics ehf
Hlioarsmari 15
200 Kopavogur, Iceland
Attention: Legal Department
Facsimile: 000-000-0000
Telephone: 000-000-0000
Xxxx Xxxxx LLP
Princeton Xxxxxxxxx Village
000 Xxxx Xxxxxx, Xxxxx 000
Xxxxxxxxx, Xxx Xxxxxx 00000
Attention: Xxxxx X. Xxxxxxx, Esq.
Facsimile: (000) 000-0000
27
94
If to Genmab, to:
Genmab A/S
Xxxxxxxx 00, 0xx Xxxxx
0000 Xxxxxxxxxx
Xxxxxxx
Attention: President
Facsimile: 45 7020 2729
If to Medarex, to:
Medarex, Inc.
000 Xxxxx Xxxx, Xxxxx 000
Xxxxxxxxx, Xxx Xxxxxx 00000-0000
Attention: President
Facsimile: (000) 000-0000
with copies to:
Medarex, Inc.
000 Xxxxx Xxxx, Xxxxx 000
Xxxxxxxxx, Xxx Xxxxxx 00000-0000
Attention: General Counsel
Facsimile: (000) 000-0000
Xxxxxxxxx & Xxxxxxx
0000 Xxxxxxxxxxxx Xxx., X.X.
Xxxxxxxxxx, X.X. 00000
Attention: Xxxx X. Xxxxxxx, Esq.
Facsimile: (000) 000-0000
or to such other address as the Party to whom notice is to be given may have
furnished to the other Parties in writing in accordance herewith. Any such
communication shall be deemed to have been given (i) when delivered, if
personally delivered or sent by facsimile on a business day, (ii) on the
business day after dispatch, if sent by nationally-recognized overnight courier,
and (iii) on the third business day following the date of mailing, if sent by
mail. It is understood and agreed that this Section 9.6 is not intended to
govern the day-to-day business communications necessary between the Parties in
performing their duties, in due course, under the terms of this Agreement.
SECTION 9.7 ENTIRE AGREEMENT; MODIFICATIONS. This Agreement, together
with the Collaboration Agreement, sets forth and constitutes the entire
agreement and understanding among the Parties with respect to the subject matter
hereof and thereof and all prior agreements, understanding, promises and
representations, whether written or oral, with respect thereto are superseded
hereby and thereby. Each Party confirms that it
28
95
is not relying on any representations or warranties of the other Parties except
as specifically set forth herein or therein. No amendment, modification, release
or discharge shall be binding upon the Parties unless in writing and duly
executed by authorized representatives of all Parties.
SECTION 9.8 RELATIONSHIP OF THE PARTIES. It is expressly agreed that
the Parties shall be independent contractors of one another and that the
relationship among the Parties shall not constitute a partnership, joint venture
or agency. Neither deCODE, on the one hand, nor Genmab/Medarex on the other
hand, shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding on the
other, without the prior written consent of the other to do so. All persons
employed by a Party shall be employees of such Party and not of the other
Parties and all costs and obligations incurred by reason of any such employment
shall be for the account and expense of such Party.
SECTION 9.9 EQUITABLE RELIEF. Each Party acknowledges and agrees that
the restrictions set forth in Articles 4 and 5 of this Agreement are reasonable
and necessary to protect the legitimate interests of the other Parties and that
such other Parties would not have entered into this Agreement in the absence of
such restrictions, and that any violation or threatened violation of any
provision of Article 4 or 5 will result in irreparable injury to such other
Parties. Each Party also acknowledges and agrees that in the event of a
violation or threatened violation of any provision of Article 4 or 5, the other
Parties shall be entitled to preliminary and permanent injunctive relief,
without the necessity of proving irreparable injury or actual damages and
without the necessity of having to post a bond, as well as to an equitable
accounting of all earnings, profits and other benefits arising from any such
violation. The rights provided in the immediately preceding sentence shall be
cumulative and in addition to any other rights or remedies that may be available
to such other Parties. Nothing in this Section 9.9 is intended, or should be
construed, to limit such other Parties' right to preliminary and permanent
injunctive relief or any other remedy for breach of any other provision of this
Agreement.
SECTION 9.10 WAIVER. Any term or condition of this Agreement may be
waived at any time by the Party that is entitled to the benefit thereof, but no
such waiver shall be effective unless set forth in a written instrument duly
executed by or on behalf of the Party waiving such term or condition. The waiver
by any Party hereto of any right hereunder or of the failure to perform or of a
breach by the other Party or Parties shall not be deemed a waiver of any other
right hereunder or of any other breach or failure by said other Party whether of
a similar nature or otherwise.
SECTION 9.11 COUNTERPARTS. This Agreement may be executed in two (2) or
more counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. This Agreement may be
executed by facsimile signatures and such signatures shall be deemed to bind
each Party hereto as if they were original signatures.
SECTION 9.12 NO BENEFIT TO THIRD PARTIES. The representations,
warranties, covenants and agreements set forth in this Agreement are for the
sole benefit of the
29
96
Parties hereto and their successors and permitted assigns, and they shall not be
construed as conferring any rights on any other parties.
SECTION 9.13 FURTHER ASSURANCE. Each Party shall duly execute and
deliver, or cause to be duly executed and delivered, such further instruments
and do and cause to be done such further acts and things, including the filing
of such assignments, agreements, documents and instruments, as may be necessary
or as the other Party(ies) may reasonably request in connection with this
Agreement or to carry out more effectively the provisions and purposes, or to
better assure and confirm unto such other Party(ies) its rights and remedies
under this Agreement.
SECTION 9.14 ENGLISH LANGUAGE. This Agreement has been written and
executed in the English language. Any translation into any other language shall
not be an official version thereof, and in the event of any conflict in
interpretation between the English version and such translation, the English
version shall control.
SECTION 9.15 REFERENCES. Unless otherwise specified, (a) references in
this Agreement to any Article, Section, Schedule or Exhibit shall mean
references to such Article, Section, Schedule or Exhibit of this Agreement, (b)
references in any section to any clause are references to such clause of such
section, and (c) references to any agreement, instrument or other document in
this Agreement refer to such agreement, instrument or other document as
originally executed or, if subsequently varied, replaced or supplemented from
time to time, as so varied, replaced or supplemented and in effect at the
relevant time of reference thereto.
SECTION 9.16 CONSTRUCTION. Except where the context otherwise requires,
wherever used, the singular shall include the plural, the plural the singular,
the use of any gender shall be applicable to all genders and the word "or" is
used in the inclusive sense (and/or). The captions of this Agreement are for
convenience of reference only and in no way define, describe, extend or limit
the scope or intent of this Agreement or the intent of any provision contained
in this Agreement. The term "including" as used herein shall mean including,
without limiting the generality of any description preceding such term. The
language of this Agreement shall be deemed to be the language mutually chosen by
the Parties and no rule of strict construction shall be applied against any
Party hereto.
[The remainder of this page has been intentionally left blank.]
30
97
' IN WITNESS WHEREOF, the Parties hereto have caused this Agreement
to be executed by their duly authorized representatives as of the date first
above written.
MEDAREX, INC. deCODE GENETICS EHF
By: /s/ Xxxxxxx X. Xxxxxxxxx By: /s/ Dr. Xxxx Xxxxxxxxxx
Name: Xxxxxxx X. Xxxxxxxxx Name: Dr. Xxxx Xxxxxxxxxx
Title: Executive Vice-President Title: Managing Director
GENMAB A/S
By: /s/ Xx. Xxxx X. Xxxxxxxx
Name: Xx. Xxxx X. Xxxxxxxx
Title: Chief Executive Officer
By: /s/ Xxxxxxx Xxxxx Xxxxxx
Name: Xxxxxxx Xxxxx Xxxxxx
Title: Chief Financial Officer & Head of Legal Department
31
98
APPENDIX A
COLLABORATION ANTIBODIES AND COLLABORATION PRODUCTS
This Appendix to the UNILATERAL DEVELOPMENT AND COMMERCIALIZATION
AGREEMENT ("AGREEMENT") effective as of June 12, 2001, by and between GENMAB A/S
("GENMAB"), MEDAREX, INC., on behalf of itself and its wholly owned subsidiary,
GENPHARM INTERNATIONAL, INC. (collectively, "MEDAREX"), and deCODE, INC.
("deCODE"), sets forth the Collaboration Antibodies with respect to the
applicable Collaboration Targets.
The contents of this Appendix A are hereby incorporated into the
Agreement and are governed by the terms and conditions of the Agreement,
including the confidentiality provisions set forth therein.
1
99
APPENDIX D-2
UNILATERAL DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
This Appendix to the Collaboration Agreement ("AGREEMENT") effective as
of June 12, 2001, by and between GENMAB A/S ("GENMAB"), MEDAREX, INC., on behalf
of itself and its wholly owned subsidiary, GENPHARM INTERNATIONAL, INC.,
(collectively, "MEDAREX"), and deCODE GENETICS EHF. ("deCODE") sets forth the
Unilateral Development and Commercialization Agreement between the
Collaborators. All capitalized terms used herein without definition shall have
the meanings ascribed thereto in the Agreement, unless otherwise expressly
provided herein.
The contents of this Xxxxxxxx X-0 are hereby incorporated into the
Agreement and are governed by the terms and conditions of the Agreement,
including the confidentiality provisions set forth therein.
100
APPENDIX D-2
UNILATERAL DEVELOPMENT
AND COMMERCIALIZATION AGREEMENT
THIS UNILATERAL DEVELOPMENT AND COMMERCIALIZATION AGREEMENT
("AGREEMENT") is made and entered into effective as of June 12, 2001 (the
"EFFECTIVE DATE"), by and between GENMAB A/S, having principal offices at
Xxxxxxxx 00X, 0xx xxxxx, XX 0000 Xxxxxxxxxx X, Xxxxxxx ("GENMAB"), MEDAREX,
INC., having principal offices at 000 Xxxxx Xxxx, Xxxxx 000, Xxxxxxxxx, Xxx
Xxxxxx 00000-0000, on behalf of itself and its wholly owned subsidiary, GENPHARM
INTERNATIONAL, INC., with principal offices at 000 Xxxxxxxxxx Xxxxx, Xxxxxxxx,
Xxxxxxxxxx 00000 (collectively, "MEDAREX"), and deCODE GENETICS EHF., having
principal offices at Xxxxxxxxxxx 00, 000 Xxxxxxxxx, Xxxxxxx ("deCODE"). deCODE,
Genmab and Medarex each may be referred to herein individually as a "PARTY," or
collectively as the "PARTIES."
WHEREAS, the Parties have entered into that certain Collaboration
Agreement, dated as of the date hereof (the "COLLABORATION AGREEMENT");
WHEREAS, the Parties have agreed that in the event deCODE elects not to
proceed with the development and commercialization of certain Collaboration
Targets and Genmab/Medarex notifies deCODE of its election to proceed
unilaterally with such development and commercialization in accordance with
Section 5.1.2 of the Collaboration Agreement, that Genmab/Medarex shall have the
right to do so in accordance with the terms set forth below; and
WHEREAS, the Parties have agreed that in the event deCODE fails to
comply with any of its material obligations contained in the Collaboration
Agreement with respect to a Collaboration Product, Genmab/Medarex shall have the
right to convert such Collaboration Product into a Unilateral Product in
accordance with Section 8.2 of the Collaboration Agreement and proceed
unilaterally with the development and commercialization of such Unilateral
Product in accordance with the terms set forth below;
NOW, THEREFORE, in consideration of the foregoing premises and the
mutual promises and covenants contained herein and other good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, the
Collaborators, intending to be legally bound, do hereby agree as follows:
ARTICLE 1 -
UNILATERAL DEVELOPMENT AND COMMERCIALIZATION
SECTION 1.1 DEFINITIONS. Any capitalized term used in this Agreement
not otherwise defined herein shall have the meaning set forth in the
Collaboration Agreement.
1
101
SECTION 1.2 UNILATERAL TARGETS, ANTIBODIES AND PRODUCTS. In the event
that Genmab/Medarex provides deCODE with (a) an Election Notice with respect to
a Collaboration Target pursuant to Section 5.1.2 of the Collaboration Agreement,
or (b) written notice of deCODE's failure to cure a default in any of its
material obligations with respect to a Collaboration Product with respect to a
Collaboration Target pursuant to Section 8.2 of the Collaboration Agreement,
Appendix A hereto shall be amended to include such Collaboration Target and any
Collaboration Antibodies with respect thereto, which Collaboration Targets and
Collaboration Antibodies shall be referred to herein as "Unilateral Targets" and
"Unilateral Antibodies," respectively. Genmab/Medarex shall have the exclusive
right to Exploit any and all Antibody Products with respect to the Unilateral
Targets (each such Antibody Product, a "UNILATERAL PRODUCT"), including any
Collaboration Products with respect to such Unilateral Targets developed or
commercialized pursuant to the Collaboration Agreement or any other Antibody
Products containing or comprising Unilateral Antibodies.
SECTION 1.3 RIGHTS AND OBLIGATIONS OF THE COLLABORATORS WITH RESPECT TO
UNILATERAL PRODUCTS. Except as otherwise expressly provided herein,
Genmab/Medarex shall be solely responsible for all costs and expenses in
connection with the development and commercialization of the Unilateral
Products; provided, however, that deCODE shall be responsible for all budgeted
costs and expenses associated with the research and development activities with
respect to the Unilateral Products that deCODE has committed to in the
applicable Project Budget as necessary to complete that phase (e.g., the deCODE
Research Activities, toxicology studies in support of an IND or Phase I, Phase
II or Phase III) of research and development that was under way when deCODE
Opted-Out of such Unilateral Products. By way of clarification, Genmab/Medarex
shall be responsible, at its sole cost, for all milestone and royalty payments,
license fees and other payments owed to Third Parties, whether by Genmab,
Medarex, deCODE or their respective Affiliates, in connection with the
development and commercialization of Unilateral Products, including any payments
owed by Medarex and its Affiliates under the Biosite Agreement or the MRC
Agreement. The Collaborators shall work together to ensure a smooth and orderly
transition of the Unilateral Products to Genmab/Medarex, including the
assignment of any contracts with respect to the Exploitation of such Unilateral
Products to Genmab/Medarex, and the assumption by Genmab/Medarex of any
obligations thereunder. Except for the obligations provided for in this Section
1.3, deCODE shall have (a) no further financial obligation to support or
otherwise fund any additional efforts in respect of such Unilateral Products,
and (b) no obligation, responsibility, or authority regarding such additional
efforts in respect of such Unilateral Products.
SECTION 1.4 PERFORMANCE OF GENMAB/MEDAREX. Genmab/Medarex shall use
Commercially Reasonable Efforts to develop and commercialize one or more
Unilateral Products with respect to each Unilateral Target. Such activities
shall be performed in good scientific manner, and in compliance in all material
respects with all Applicable Law, including current good laboratory practices
and good clinical practices (including compliance with such practices and
guidelines necessary to allow the results of such activities to support INDs,
BLAs and other Regulatory Approvals), as applicable. Genmab/Medarex shall have
the right, subject to the obligations set forth in this Section
2
102
1.4, to license to Third Parties rights with respect to the development or
commercialization of a Unilateral Product in its sole discretion; provided that
any such Third Party enters into a written agreement with Genmab/Medarex to
indemnify deCODE and its Affiliates to the extent provided in Article 7, and to
comply with the applicable provisions of Articles 4 and 5 and Section 1.3;
provided, however, that any sublicense with respect to the deCODE Technology
shall be governed by the procedures set forth in Section 2.3.
SECTION 1.5 GENMAB/MEDAREX REPORTS. Genmab/Medarex shall provide an
annual written progress report to deCODE describing the development and
commercialization activities with respect to each of its Unilateral Products in
sufficient detail to enable deCODE to determine whether Genmab/Medarex is using
Commercially Reasonable Efforts with respect thereto.
SECTION 1.6 COMMUNICATIONS AND FILINGS WITH REGULATORY AUTHORITIES.
Genmab/Medarex shall be responsible for all communications and filings with the
Regulatory Authorities with respect to each of its Unilateral Products.
SECTION 1.7 OPT-OUT BY GENMAB/MEDAREX. If, at any time, Genmab/Medarex
decides to cease development or commercialization of all Unilateral Products
with respect to a Unilateral Target, either alone or in collaboration with or
through a Third Party, it shall give prompt written notice thereof to deCODE,
which notice shall describe in reasonable detail the reasons for such decision.
Genmab/Medarex shall, for a period of thirty (30) days after notice to deCODE
with respect thereto, furnish deCODE with such information and materials as
deCODE may reasonably request so as to determine whether it wishes to proceed
with the unilateral development and commercialization of such Unilateral
Products. Upon its receipt of all of such information and materials, deCODE
shall, for a period of thirty (30) days, have the right to elect to proceed
unilaterally with the development and commercialization of such Unilateral
Products. Upon such election, Appendix A shall be amended to delete such
Unilateral Target and any Unilateral Antibodies with respect thereto, and the
Unilateral Development and Commercialization Agreement set forth in Appendix D-1
to the Collaboration Agreement shall be automatically amended to include such
Unilateral Target and such Unilateral Antibodies. By way of clarification,
Genmab/Medarex shall have the right to pursue one or more Unilateral Products
with respect to a Unilateral Target and any decision to cease Exploiting one in
favor of another shall not be subject to this Section 1.7 for so long as
Genmab/Medarex is using Commercially Reasonable Efforts to develop and
commercialize at least one Unilateral Product with respect to such Unilateral
Target.
SECTION 1.8 OPT-OUT BY GENMAB OR MEDAREX. As between Medarex and
Genmab, each shall have the right, at any time, to individually elect not to
proceed with the research, development and commercialization of all Unilateral
Products with respect to a given Unilateral Target. In the event that one, but
not both, of Medarex and Genmab elects not to proceed with the research,
development and commercialization of such Unilateral Products, but the other
Party (i.e., Genmab or Medarex) elects to proceed unilaterally with respect to
such Unilateral Products, then such election shall not be
3
103
governed by Section 1.7 and the rights and responsibilities as between Medarex
and Genmab shall be governed by this Section 1.8 and the Genmab/Medarex Applied
Genomics Agreement. If Genmab elects to so proceed with respect to a Unilateral
Target, all references to Genmab/Medarex under this Agreement shall be deemed to
be references to Genmab with respect to such Unilateral Target, and if Medarex
elects to so proceed with respect to a Unilateral Target, all references to
Genmab/Medarex under this Agreement shall be deemed to be references to Medarex
with respect to such Unilateral Target.
ARTICLE 2 -
LICENSE GRANTS
SECTION 2.1 deCODE GRANT. Subject to Section 2.2 and the other terms
and conditions of this Agreement, deCODE hereby grants to Genmab/Medarex and its
Affiliates, with respect to each Unilateral Product, an exclusive (even as to
deCODE and its Affiliates), royalty-bearing license, with the right to
sublicense solely as provided in Section 2.3, under the deCODE Technology, the
Collaboration Technology and the Joint Technology to Exploit such Unilateral
Products in the Territory in accordance with this Agreement.
SECTION 2.2 EXCLUSIVITY, RESERVED RIGHTS AND PRE-EXISTING GRANTS.
2.2.1 ANTIGEN EXCLUSIVITY.
(a) Subject to Sections 2.2.2, 2.2.3 and 2.2.4, the Parties
acknowledge and agree that no Party shall engage, directly or indirectly, on
behalf of itself or any other party, in the research, development,
commercialization or other Exploitation of antibody-based prophylactic or
therapeutic products with respect to any Unilateral Target listed on Appendix A
other than the Unilateral Products as provided in this Agreement. deCODE
represents that it has entered into that certain Term Sheet re: Diagnostic
Products between deCODE, a certain Third Party and Affiliates of such Third
Party dated as of March 1, 2001, and any further agreement between deCODE, such
Third Party and/or such Affiliates entered into pursuant thereto (the
"PRE-EXISTING DIAGNOSTIC AGREEMENT"). deCODE acknowledges and agrees that it has
no right to use any Antibodies generated pursuant to this Agreement or the
Collaboration Agreement except as expressly set forth in the Collaboration
Agreement or the Unilateral Development and Commercialization Agreement set
forth in Appendix D-1 of the Collaboration Agreement.
(b) deCODE shall use commercially reasonable efforts (i) to
develop and commercialize or cause to be developed and commercialized Diagnostic
Products with respect to each Unilateral Target to the extent necessary or
reasonably useful for the Exploitation of Unilateral Products with respect to
such Unilateral Target, (ii) to provide or cause to be provided such Diagnostic
Products to Genmab/Medarex at a commercially reasonable cost for use in
connection with the development of such Unilateral Products, and (iii)
consistent with the Pre-Existing Diagnostic Agreement, to make such Diagnostic
Products generally available to the public on commercially
4
104
reasonable terms or cause to be so made to the extent necessary or reasonably
useful to Exploit such Unilateral Products.
(c) Notwithstanding clause (b) above, if at any time deCODE
obtains rights, pursuant to the Pre-Existing Diagnostic Agreement or otherwise,
to a Diagnostic Product with respect to a Unilateral Target, then deCODE shall
offer such Diagnostic Product to Genmab/Medarex to be Exploited under this
Agreement as a Unilateral Product. If Genmab/Medarex accepts such Diagnostic
Product within sixty (60) days of receipt of such offer, then the definition of
Unilateral Product shall be automatically amended to include such Diagnostic
Product for all purposes with respect to such Unilateral Target, subject to
deCODE's obligations under the Pre-Existing Diagnostic Agreement.
2.2.2 RESEARCH AND COMMERCIALIZATION AGREEMENTS. Medarex shall
have the right to (a) grant licenses and other rights to other parties
including Genmab or deCODE, under the Medarex Technology for such
parties to Exploit Antibody Products (but not Collaboration Products or
Unilateral Products containing or comprising Unilateral Antibodies)
with respect to Antigens, including Unilateral Targets, (b) transfer
Medarex Know-How to such parties in connection therewith, including by
providing instruction with respect to the use and immunization of HuMAb
Mice and assistance with respect to the Mice-Related Technology, (c)
develop production processes for, and manufacture, such Antibody
Products, and (d) receive license fees, milestone payments, royalties
and other remuneration in connection therewith, but, in connection with
clause (a), (b), (c) or (d) above, not to otherwise actively
participate in the clinical development or commercialization of such
Antibody Products by such parties (each agreement with respect to the
foregoing, a "RESEARCH AND COMMERCIALIZATION AGREEMENT"); provided,
however, that Medarex shall not, based on the deCODE Know-How,
including any deCODE Genomics Data, propose to a Third Party that they
include a Unilateral Target, Reversion Target or Collaboration Target
in a Research and Commercialization Agreement, but Medarex shall have
the right to enter into a Research and Commercialization Agreement with
respect thereto if such Third Party first proposes to Medarex that they
include such Unilateral Target, Reversion Target or Collaboration
Target in such Research and Commercialization Agreement.
2.2.3 RETAINED RIGHTS.
(a) OTHER ANTIGENS. Notwithstanding anything in this Agreement
to the contrary, Medarex and Genmab do each retain the right to (i) enter into
collaborations with, and to grant licenses and other rights under the Medarex
Technology and Genmab Technology respectively to, Third Parties to Exploit
Antibody Products with respect to Antigens other than Unilateral Targets, and/or
(ii) independently Exploit Antibody Products with respect to Antigens other than
Unilateral Targets.
(b) NON-ANTIBODY PRODUCTS. Notwithstanding anything in this
Agreement to the contrary, each Party shall have and retain the right to (i)
enter into collaborations with, and to grant licenses and other rights under its
respective Technology (other than Joint Technology and Collaboration Technology,
which shall be governed by
5
105
Section 5.1.3 and the Collaboration Agreement, respectively) to, Third Parties
to Exploit products other than antibody-based products with respect to
Unilateral Targets, and/or (ii) independently Exploit products other than
antibody-based products with respect to Unilateral Targets. By way of
clarification, the Parties acknowledge that deCODE has not granted Genmab or
Medarex any rights under its Technology to Exploit products that are not
antibody-based products under this Agreement.
SECTION 2.3 SUBLICENSES. Subject to Section 2.2.5, Genmab and Medarex
shall have the right to grant sublicenses under the licenses granted in Section
2.1 (a) to Affiliates without the approval of deCODE, provided that any such
sublicensor shall remain jointly and severally liable for the performance or
non-performance of any such Affiliate sublicensee, and (b) to Third Parties
pursuant to Section 1.4, with the prior approval of deCODE, not to be
unreasonably withheld or delayed, which approval shall be deemed to be granted
with respect to a sublicense if deCODE fails, within twenty (20) business days
of its receipt of a written notice from the sublicensing Party setting forth in
reasonable detail the nature of such sublicense and the identity of the
sublicensee, to notify such sublicensing Party that it withholds its consent to
such sublicense. Notwithstanding the previous sentence, the grant of any such
sublicense shall not relieve the sublicensing Party of its obligations under
this Agreement.
SECTION 2.4 LICENSE LIMITATIONS. Genmab/Medarex hereby covenants to
deCODE that neither Genmab/Medarex nor any of its Affiliates, licensees or
sublicensees shall use or practice the deCODE Technology, directly or
indirectly, on behalf of itself or any other party, for any purpose other than
as permitted under Section 2.1 and in particular, but without limiting the
generality of the foregoing, for any research, development, commercialization or
other Exploitation of an Antibody Product or any other product or method, other
than a Unilateral Product as provided hereunder or a Collaboration Product as
provided in the Collaboration Agreement.
SECTION 2.5 NO OTHER RIGHTS. For the avoidance of doubt, Genmab/Medarex
and its Affiliates shall have no right, express or implied, with respect to the
deCODE Technology, in each case except as expressly provided in Section 2.1 of
this Agreement and Section 3.1 of the Collaboration Agreement.
ARTICLE 3 -
FINANCIAL PROVISIONS
SECTION 3.1 MILESTONE PAYMENTS. Within thirty (30) days of the
achievement of the following milestones, on a Unilateral Target-by-Unilateral
Target basis, for Unilateral Products with respect to each Unilateral Target,
Genmab/Medarex shall pay to deCODE the specified milestone payments, each of
which shall be nonrefundable:
MILESTONES 1ST UNILATERAL 2ND UNILATERAL EACH ADDITIONAL
PRODUCT WITH PRODUCT WITH UNILATERAL PRODUCT
RESPECT TO A RESPECT TO A WITH RESPECT TO A
UNILATERAL TARGET UNILATERAL TARGET UNILATERAL TARGET
[CONFIDENTIAL TREATMENT REQUESTED]
6
106
SECTION 3.2 ROYALTIES.
3.2.1 OBLIGATION. With respect to each Unilateral Target,
Genmab/Medarex shall pay deCODE royalties based upon the annual worldwide Net
Sales (on a calendar year basis) for all Unilateral Products with respect to
such Unilateral Target. For purposes of this Agreement, Net Sales shall be
deemed to include Net Sales of Unilateral Products by sublicensees. The royalty
rates shall be determined on a Unilateral Target-by-Unilateral Target basis
based on the aggregate Net Sales of all Unilateral Products with respect to such
Unilateral Target.
3.2.2 RATES. The royalty rates for each Unilateral Product (a) for
which deCODE Opted-Out pursuant to Section 5.1.1 of the Collaboration Agreement,
or (b) which was converted from a Collaboration Product pursuant to Section 8.2
of the Collaboration Agreement upon deCODE's default in any of its material
obligations shall be as follows:
[CONFIDENTIAL TREATMENT REQUESTED].
3.2.3 DEFINITIONS. For purposes of this Agreement, the following
definitions shall apply:
(a) "MAJOR MARKET" shall mean each of Japan, the United
States, the United Kingdom, France, Germany and the European Union as a whole.
(b) "PHASE I" shall mean a human clinical trial, the principal
purpose of which is a preliminary determination of safety in healthy individuals
or
7
107
patients as required in 21 C.F.R. Section 312, or a similar clinical study
prescribed by the Regulatory Authorities in a Major Market other than the United
States.
(c) "PHASE II" shall mean a human clinical trial, for which a
primary endpoint is a preliminary determination of efficacy or dose ranges in
patients with the disease target being studied as required in 21 C.F.R. Section
312, or a similar clinical study prescribed by the Regulatory Authorities in a
Major Market other than the United States. Any well-controlled study intended to
provide the substantial evidence of efficacy necessary to support the filing of
an approvable BLA (such as a combined Phase II/Phase III study, or any Phase III
study in lieu of a Phase II study) (a "PIVOTAL STUDY") shall automatically be
deemed to have reached Phase II status. A Phase II study shall be deemed to have
commenced when the first subject in such study has been enrolled.
(d) "PHASE III" shall mean a human clinical trial, the
principal purpose of which is to establish safety and efficacy in patients with
the disease target being studied as required in 21 C.F.R. Section 312, or
similar clinical study prescribed by the Regulatory Authorities in a Major
Market other than the United States. A Phase III study shall also include any
other human clinical trial intended as a Pivotal Study, whether or not such
study is a traditional Phase III study. A Phase III study shall be deemed to
have commenced when the first patient has been enrolled in a Pivotal Study.
SECTION 3.3 ROYALTY TERM. Genmab/Medarex's royalty obligations under
Section 3.2.2 shall terminate, on a country-by-country basis, with respect to
each Unilateral Product with respect to a Unilateral Target, on the later to
occur of (a) the thirteenth (13th) anniversary of the first sale for use or
consumption by the general public of such Unilateral Product in a country after
Regulatory Approval has been obtained for such Unilateral Product in such
country (the "FIRST COMMERCIAL SALE"), and (b) the expiration date in such
country of the last to expire of any issued Joint Patents or deCODE Patents that
include, with respect to a particular country, at least one claim in such
country that (x) has not been revoked or held unenforceable or invalid by a
decision of a court or governmental agency of competent jurisdiction from which
no appeal can be taken or has been taken within the time allowed for appeal; (y)
has not been abandoned, disclaimed, denied or admitted to be invalid or
unenforceable through reissue or disclaimer or otherwise in such country; and
(z) provides exclusive and enforceable rights with respect to the Exploitation
of a Unilateral Product in such country, covering the Exploitation of such
Unilateral Product in such country. Upon termination of the royalty obligations
of Genmab/Medarex under this Section 3.3 in a country, the license grants to
Genmab/Medarex in Section 2.1 shall become fully-paid up with respect to such
country.
SECTION 3.4 ROYALTY PAYMENTS. Running royalties shall be payable on a
quarterly basis, within sixty (60) days after the end of each calendar quarter,
based upon the Net Sales during such calendar quarter, commencing with the
calendar quarter in which the First Commercial Sale of a Unilateral Product is
made. Royalties shall be calculated in accordance with GAAP and with the terms
of this Article 3. Only one royalty payment will be due on Net Sales of a given
Unilateral Product even though the manufacture, sale or use of such Unilateral
Product may be covered by more than one intellectual property right in a
country.
8
108
SECTION 3.5 ROYALTY STATEMENTS. Genmab/Medarex shall deliver to deCODE
within sixty (60) days after the end of each calendar quarter in which
Unilateral Products, for which Genmab/Medarex owes a royalty hereunder, are
sold, a detailed statement showing (a) Net Sales of each such Unilateral
Product, (b) the number of units of each such Unilateral Product sold on a
country-by-country basis during the applicable calendar quarter, and (c) the
amount and calculation of royalties due on such Net Sales.
SECTION 3.6 PAYMENT METHOD. All amounts due by Genmab/Medarex hereunder
shall be paid in U.S. dollars by wire transfer in immediately available funds to
an account designated by deCODE. Any payments or portions thereof due hereunder
which are not paid on the date such payments are due under this Agreement shall
bear interest at a rate equal to the lesser of the prime rate as published in
The Wall Street Journal, Eastern Edition, on the first day of each calendar
quarter in which such payments are overdue, plus two (2) percentage points, and
the maximum rate permitted by law, calculated on the number of days such payment
is delinquent, compounded monthly.
SECTION 3.7 CURRENCY; FOREIGN PAYMENTS. If any currency conversion
shall be required in connection with any payment hereunder, such conversion
shall be made by using the exchange rate for the purchase of U.S. dollars as
published in The Wall Street Journal, Eastern Edition, on the last business day
of the calendar quarter to which such royalty payments relate. If at any time
legal restrictions prevent the prompt remittance of any royalties with respect
to Net Sales in any jurisdiction, Genmab/Medarex may notify deCODE and make such
payments by depositing the amount thereof in local currency in a bank account or
other depository in such country in the name of deCODE or its designee, and
Genmab/Medarex shall have no further obligations under this Agreement with
respect thereto.
SECTION 3.8 TAXES. Genmab/Medarex may deduct from any royalty amounts
it is required to pay pursuant to this Agreement any Withholding Taxes. At
deCODE's request, Genmab/Medarex shall provide deCODE a certificate evidencing
payment of any Withholding Taxes hereunder and shall reasonably assist deCODE,
at deCODE's expense, to obtain the benefit of any applicable tax treaty.
SECTION 3.9 RECORDS RETENTION; AUDIT.
3.9.1 RECORD RETENTION. Genmab/Medarex shall maintain (and shall ensure
that its Affiliates and sublicensees shall maintain) complete and accurate
books, records and accounts that fairly reflect their respective Net Sales of
Unilateral Products in sufficient detail to confirm the accuracy of any payments
required hereunder and in accordance with GAAP, which books, records and
accounts shall be retained by Genmab/Medarex until the later of (a) three (3)
years after the end of the period to which such books, records and accounts
pertain, and (b) the expiration of the applicable tax statute of limitations (or
any extensions thereof), or for such longer period as may be required by
Applicable Law.
9
109
3.9.2 AUDIT. deCODE shall have the right to have an independent
certified public accounting firm of nationally recognized standing, reasonably
acceptable to Genmab/Medarex, to have access during normal business hours, and
upon reasonable prior written notice, to such of the records of Medarex or
Genmab (and their respective Affiliates and sublicensees) as may be reasonably
necessary to verify the accuracy of such Net Sales for any calendar quarter
ending not more than thirty-six (36) months prior to the date of such request;
provided, however, that deCODE shall not have the right to conduct more than one
such audit in any twelve (12)-month period. The accounting firm shall disclose
to each Party whether such Net Sales are correct or incorrect and the specific
details concerning any discrepancies. No other information shall be provided to
deCODE. deCODE shall bear the cost of such audit unless the audit reveals a
variance of more than five percent (5%) from the reported results, in which case
Genmab/Medarex shall bear the cost of the audit. The results of such accounting
firm shall be final, absent manifest error.
3.9.3 PAYMENT OF ADDITIONAL ROYALTIES. If, based on the results of such
audit, additional payments are owed by Genmab/Medarex under this Agreement,
Genmab/Medarex shall make such additional payments, with interest from the date
originally due as provided in Section 3.6, within forty-five (45) days after the
date on which such accounting firm's written report is delivered to
Genmab/Medarex.
SECTION 3.10 CONFIDENTIALITY. deCODE shall treat all information
subject to review under Section 3.9 in accordance with the confidentiality
provisions of Article 4 and shall cause its accounting firm to enter into a
reasonably acceptable confidentiality agreement with Genmab/Medarex obligating
such firm to maintain all such financial information in confidence pursuant to
such confidentiality agreement.
ARTICLE 4 -
CONFIDENTIALITY
SECTION 4.1 CONFIDENTIAL INFORMATION. The confidentiality and use
restrictions set forth in Sections 6.1 through 6.4 of the Collaboration
Agreement shall apply to all Confidential Information during the Term of this
Agreement and for a period of five (5) years thereafter, provided, however, that
deCODE recognizes that by reason of Genmab/Medarex's status as an exclusive
licensee pursuant to the grant under Section 2.1, Genmab/Medarex has an interest
in deCODE's retention in confidence of certain information of deCODE.
Accordingly, deCODE shall, and shall cause its officers, directors, employees
and agents to, keep completely confidential, and not publish or otherwise
disclose, and not use directly or indirectly for any purpose, any information
relating solely to the Unilateral Products, except to the extent (a) such
information is in the public domain through no fault of deCODE, its Affiliates
or any of their respective officers, directors, employees and agents, (b) such
disclosure or use would be permitted under Section 6.4 of the Collaboration
Agreement, or (c) such disclosure or use is otherwise expressly permitted by the
terms of this Agreement or is reasonably necessary for the performance of this
Agreement. For clarification, the disclosure by deCODE to Medarex or Genmab or
by Medarex or Genmab to deCODE of certain information of deCODE relating solely
to the Unilateral Products shall not cause such information to
10
110
cease to be subject to the confidentiality provisions of Sections 6.1 through
6.4 of the Collaboration Agreement.
SECTION 4.2 USE OF NAME. Each Party may use the name, insignia, symbol,
trademark, trade name or logotype of another Party only (a) in connection with
announcements and other permitted disclosures relating to this Agreement and the
activities contemplated hereby, (b) as required by Applicable Law, and (c)
otherwise as agreed in writing by such other Party.
SECTION 4.3 PRESS RELEASES. Press releases or other similar public
communication by any Party relating to this Agreement, shall be approved in
advance by the other Parties, which approval shall not be unreasonably withheld
or delayed, except for those communications required by Applicable Law (which
shall be provided to the other Parties as soon as practicable after the release
or communication thereof), disclosures of information for which consent has
previously been obtained, and information of a similar nature to that which has
been previously disclosed publicly with respect to this Agreement, each of which
shall not require advance approval.
SECTION 4.4 PUBLICATIONS. At least sixty (60) days prior to submission
for publication, presentation or other public disclosure by Genmab/Medarex or
any of its Affiliates of any material pertaining to or resulting from the deCODE
Technology, Genmab/Medarex shall provide to deCODE a draft of such material for
its review and comment. No publication or presentation with respect to the
deCODE Technology shall be made unless and until deCODE's comments on the
proposed publication or presentation have been addressed and changes have been
agreed upon and any information determined by deCODE to be Confidential
Information has been removed. If requested in writing by deCODE, Genmab/Medarex
shall withhold material from submission for publication or presentation for an
additional sixty (60) days to allow for the filing of a patent application or
the taking of such measures to establish and preserve proprietary rights in the
information in the material being submitted for publication or presentation.
ARTICLE 5 -
INTELLECTUAL PROPERTY
SECTION 5.1 INTELLECTUAL PROPERTY OWNERSHIP.
5.1.1 OWNERSHIP OF TECHNOLOGY. Subject to Section 5.1.2 and the license
grants to Genmab/Medarex under Article 2, as among the Parties, each Party shall
own and retain all right, title and interest in and to any and all: (a)
Information and Inventions that are conceived, discovered, developed or
otherwise made, as necessary to establish authorship, inventorship or ownership
under Applicable Law, by or on behalf of such Party (or its Affiliates or its
licensees or sublicensees (other than the other Parties and their respective
Affiliates)), whether or not patented or patentable, and any and all Patent and
other intellectual property rights with respect thereto, except to the extent
that any such Information and Inventions, or any Patent or other intellectual
property rights with respect thereto, are Collaboration Technology or Joint
Technology; (b) other
11
111
Information and Inventions, and Patent and other intellectual property rights
that are Controlled (other than pursuant to the license grants set forth in
Article 2) by such Party, its Affiliates or its licensees or sublicensees (other
than such other Parties); and (c) other Technology of such Party.
5.1.2 OWNERSHIP OF MICE-RELATED TECHNOLOGY. As among the Parties,
Medarex shall own and retain all right, title and interest in and to all Mice
Materials and Mice-Related Technology, including any and all Information and
Inventions with respect to the Mice Materials or the Mice-Related Technology
(including any Improvements thereto) that are conceived, discovered, developed
or otherwise made, as necessary to establish authorship, inventorship or
ownership under Applicable Law, by or on behalf of deCODE, its Affiliates or its
licensees or sublicensees (other than Medarex, Genmab and their respective
Affiliates), whether or not patented or patentable, and any and all Patent and
other intellectual property rights with respect thereto. deCODE acknowledges and
agrees that (a) there are no licenses granted to deCODE under this Agreement
with respect to the Mice Materials and Mice-Related Technology and deCODE has no
right to use the HuMAb Mice or to discover, develop or otherwise make
Improvements with respect to Mice Materials and Mice-Related Technology, and (c)
neither it, nor any of its Affiliates, licensees or sublicensees, will engage,
directly or indirectly, in activities designed to, or otherwise undertake or
attempt, either on behalf of itself or another, to discover, develop or make any
Information and Inventions that relate to the Mice Materials or the Mice-Related
Technology. Accordingly, deCODE shall promptly disclose to Medarex in writing,
the conception or reduction to practice, or the discovery, development or making
of any Mice Material or Mice-Related Technology and shall, and does hereby,
assign, and shall cause its Affiliates, licensees and sublicensees to so assign,
to Medarex, without additional compensation and at Medarex's expenses (for
reasonable and direct out-of-pocket costs actually incurred), all of their
respective rights, titles and interests in and to any Mice Material or
Mice-Related Technology.
5.1.3 OWNERSHIP OF JOINT TECHNOLOGY. Subject to Section 5.1.2 and the
license grants under Article 2, deCODE and at least one of Medarex and Genmab
(the "JOINT INVENTORS") shall each own an equal, undivided interest in any and
all (i) Information and Inventions, conceived, discovered, developed or
otherwise made, as necessary to establish authorship, inventorship or ownership
under Applicable Law, jointly by or on behalf of such Joint Inventors (or, with
respect to each Joint Inventor, its Affiliates or, to the extent permitted, its
sublicensees), in connection with the work conducted under or in connection with
this Agreement, whether or not patented or patentable, but excluding any Mice
Materials or Mice-Related Technology; and (ii) Patents (the "JOINT PATENTS") and
other intellectual property rights with respect thereto (collectively, the
"JOINT TECHNOLOGY"); provided, however, that neither a Joint Inventor nor any of
its Affiliates, licensees or sublicensees shall, directly or indirectly, Exploit
any Joint Technology or other such intellectual property rights without the
consent of the other Joint Inventor(s), not to be unreasonably withheld or
delayed, except that each Party shall have the right to Exploit such Joint
Technology for internal research and discovery purposes (as opposed to the
development, commercialization or other Exploitation of products or technology
resulting therefrom) without the consent of the other Party; provided, however,
that neither Party shall have the right to use Antibodies
12
112
with respect to the Unilateral Targets except as set forth hereunder. Each Joint
Inventor shall promptly disclose to the other Joint Inventor(s) in writing, and
shall cause its Affiliates, licensees and sublicensees to so disclose, the
development, making, conception or reduction to practice of any Joint
Technology.
5.1.4 OWNERSHIP OF PRODUCT TRADEMARKS. Genmab/Medarex shall own all
right, title and interest in and to each Product Trademark with respect to a
Unilateral Product. deCODE hereby assigns all of its right, title and interest
in and to any Product Trademark to Genmab/Medarex to the extent that such
Product Trademark relates solely to the Unilateral Products.
5.1.5 OWNERSHIP OF REGULATORY DOCUMENTATION. Genmab/Medarex shall own
all right, title and interest in and to all Regulatory Documentation that
relates solely to the Unilateral Products. deCODE hereby assigns to
Genmab/Medarex such of its right, title and interest in and to such Regulatory
Documentation as is necessary to vest ownership of such Regulatory Documentation
in Genmab/Medarex as provided in the immediately preceding sentence.
Notwithstanding the ownership of any Regulatory Documentation, each Collaborator
shall have the right to use and reference any of the Regulatory Documentation in
connection with the Exploitation of Unilateral Products as provided in this
Agreement and Collaboration Products as provided in the Collaboration Agreement.
Notwithstanding the foregoing, any Regulatory Documentation containing
Production Process Know-How of a Party shall be and remain the sole and
exclusive property of such Party and such Party shall have the right to submit
any such Production Process Know-How directly to the Regulatory Authorities
using a drug master file, or any foreign equivalent that is designed to protect
such Party's Confidential Information, which filing shall be and remain the sole
and exclusive property of such Party.
5.1.6 NOTICES. To the extent that Genmab/Medarex has the right to (a)
assign, transfer, convey or otherwise encumber any right, title or interest in
or to any deCODE Technology, Joint Technology or Collaboration Technology, (b)
grant any license or other right, title or interest in or to any deCODE
Technology, Joint Technology or Collaboration Technology, or (c) agree to or
otherwise become bound by any covenant not to xxx for any infringement, misuse
or other action or inaction with respect to any deCODE Technology, Joint
Technology or Collaboration Technology, in each case Genmab/Medarex shall not do
so, directly or indirectly, expressly or by implication, by action or omission
or otherwise without providing deCODE with at least sixty (60) days advance
written notice thereof.
SECTION 5.2 PROSECUTION OF PATENTS AND TRADEMARKS.
5.2.1 deCODE PATENTS. As among the Parties, deCODE shall have the sole
right, at its cost and expense, to obtain, prosecute and maintain throughout the
world the deCODE Patents; provided, however, that Genmab/Medarex shall reimburse
deCODE for one hundred percent (100%) of the reasonable out-of-pocket costs
incurred by deCODE for filing, prosecuting and maintaining such Patents to the
extent that they claim or cover (x) as a composition of matter, a Unilateral
Product or any active ingredient in such Unilateral Product or (y) the use of
any such Unilateral
13
113
ingredient. Genmab/Medarex shall, and shall cause its Affiliates, licensees and
sublicensees, as applicable, to, cooperate fully with deCODE in the preparation,
filing, prosecution, and maintenance of deCODE's Patents, provided that
Genmab/Medarex shall not be responsible for such preparation, filing,
prosecution or maintenance except as set forth in this Section 5.2.1. Such
cooperation includes (a) promptly executing all papers and instruments and
requiring employees to execute such papers and instruments as reasonable and
appropriate so as to enable deCODE to file, prosecute, and maintain its Patents
in any country; and (b) promptly informing deCODE of matters that may affect the
preparation, filing, prosecution, or maintenance of any such Patents.
5.2.2 JOINT PATENTS. The Joint Inventors shall, and shall cause their
respective Affiliates, licensees and sublicensees, as applicable, to cooperate
with one another with respect to the filing, prosecution and maintenance of all
Joint Patents, including by selecting outside counsel, reasonably acceptable to
the Joint Inventors, to handle such filing, prosecution and maintenance. The
Joint Inventors shall share equally in the expenses associated with the filing,
prosecution (including any interferences, reissue proceedings and
reexaminations) and maintenance of all Joint Patents. If a Joint Inventor elects
not to pursue the filing, prosecution or maintenance of a Joint Patent in a
particular country, or to take any other action with respect to its Joint
Technology in a particular country that is necessary or reasonably useful to
establish or preserve rights thereto, then in each such case such Joint Inventor
shall so notify the other Joint Inventor(s) promptly in writing and in good time
to enable such other Joint Inventor(s) to meet any deadlines by which an action
must be taken to establish or preserve any such rights in such Joint Patent or
Joint Technology in such country. Upon receipt of each such notice by such other
Joint Inventor(s) or if, at any time, such Joint Inventor fails to initiate any
such action within thirty (30) days after a request by such other Joint
Inventor(s) that it do so (or thereafter diligently pursue such action), such
other Joint Inventor(s) shall have the right, but not the obligation, to pursue
the filing or registration, or support the continued prosecution or maintenance,
of such Patent at its expense in such country. If such other Joint Inventor(s)
elects to pursue such filing or registration, as the case may be, or continue
such support, then such other Joint Inventor(s) shall notify such Joint Inventor
of such election and such Joint Inventor shall, and shall cause its Affiliates,
licensees and sublicensees, as applicable, to, (x) reasonably cooperate with
such other Joint Inventor(s) in this regard, and (y) subject to Article 2,
promptly release or assign to such other Joint Inventor(s), without
compensation, all right, title and interest in and to such Patent in such
country.
5.2.3 PATENT FILINGS. Medarex and Genmab covenant not to, and to cause
their respective Affiliates, licensees and sublicensees, as applicable, not to,
file any patent application disclosing or claiming any Information and
Inventions comprising any deCODE Technology or the Exploitation thereof, without
deCODE's prior written consent, which consent shall not be unreasonably withheld
or delayed.
SECTION 5.3 ENFORCEMENT OF PATENTS AND TRADEMARKS.
5.3.1 RIGHTS AND PROCEDURES. If Medarex, Genmab or deCODE determines
that any Technology (which for purposes of this Agreement shall be deemed
14
114
to include Joint Technology) of another Party(ies) is being infringed by a Third
Party's activities and that such infringement could affect the exercise by the
Parties of their respective rights and obligations under this Agreement, it
shall promptly notify the other Party(ies) in writing and provide such other
Party(ies) with any evidence of such infringement that is reasonably available.
Promptly after the receipt of such written notice, the Parties shall meet and
discuss in good faith the removal of such infringement. The pursuing Party shall
consider in good faith any comments from the other Parties and shall keep the
other Parties reasonably informed of any steps taken to remove such
infringement.
(a) JOINT TECHNOLOGY. With respect to Joint Technology, the
Joint Inventors shall have the first right to jointly remove such infringement
using commercially appropriate steps, including the filing of an infringement
suit or taking other similar action. Each such Joint Inventor shall be
responsible for half of the reasonable and verifiable costs and expenses
incurred in connection with such action. In the event the Joint Inventors fail
to jointly take commercially appropriate steps to remove any infringement of any
Joint Technology within ninety (90) days following notice of such infringement,
or a Joint Inventor earlier notifies such other Joint Inventor(s) in writing of
its intent not to take such steps, the Joint Inventor pursuing the filing,
prosecution or maintenance of a Patent comprising such Joint Technology (the
"PROSECUTING PARTY") shall have the right to do so at its own expense, or, in
the event such Party declines, such other Joint Inventor(s) shall have the right
to do so at its own expense; provided, however, that if the Joint Inventors have
jointly commenced negotiations with an alleged infringer for discontinuance of
such infringement within such ninety (90) day period, the Joint Inventors shall
have an additional ninety (90) days to conclude their negotiations before a
Joint Inventor unilaterally may bring suit for such infringement.
(b) deCODE TECHNOLOGY. With respect to deCODE Technology,
deCODE shall have the first right, but not the obligation, to remove such
infringement at its sole cost and expense. In the event deCODE fails to take
commercially appropriate steps to remove any infringement of such Technology
within ninety (90) days following notice of such infringement, or earlier
notifies Genmab/Medarex in writing of its intent not to take such steps,
Genmab/Medarex shall have the right to do so at its sole cost and expense;
provided, however, that if deCODE has commenced negotiations with an alleged
infringer for discontinuance of such infringement within such ninety (90) day
period, deCODE shall have an additional ninety (90) days to conclude its
negotiations before Genmab/Medarex may bring suit for such infringement; and
provided further that Genmab/Medarex shall reimburse deCODE for one hundred
percent (100%) of the reasonable out-of-pocket costs incurred by deCODE with
respect to the removal of any such infringement with respect to any Unilateral
Product.
5.3.2 COOPERATION. The Parties not enforcing the applicable Technology
shall provide reasonable assistance to the other Party, including providing
access to relevant documents and other evidence, making its employees available
at reasonable business hours, and joining the action to the extent necessary to
allow the enforcing Party to maintain the action.
15
115
5.3.3 RECOVERY. Any amounts recovered by any Party pursuant to Section
5.3.1, whether by settlement or judgment, shall be used to reimburse the Parties
for their reasonable costs and expenses in making such recovery (which amounts
shall be allocated pro rata if insufficient to cover the totality of such
expenses), with any remainder being retained by the Party that has exercised its
right to bring the enforcement action; provided, however, that to the extent
that any award is attributable to loss of sales of a Unilateral Product, the
Parties shall negotiate in good faith an appropriate allocation of such award to
reflect the economic interests of the Parties under this Agreement with respect
to such Unilateral Product.
SECTION 5.4 POTENTIAL THIRD PARTY RIGHTS.
5.4.1 THIRD PARTY LICENSES. If (a) in the opinion of outside patent
counsel to Genmab/Medarex, Genmab/Medarex, or any of its Affiliates, licensees
or permitted sublicensees, cannot Exploit a Unilateral Product in a country in
the Territory without infringing one or more Patents that have issued to a Third
Party in such country, or (b) as a result of any claim made against a Party, or
any of its Affiliates, licensees or permitted sublicensees, alleging that the
Exploitation of a Unilateral Product infringes or misappropriates any Patent or
any other intellectual property right of a Third Party in a country in the
Territory, a judgment is entered by a court of competent jurisdiction from which
no appeal is taken within the time permitted for appeal, such that
Genmab/Medarex cannot Exploit such Unilateral Product in such country without
infringing the Patent or other proprietary rights of such Third Party, then, in
either case, Genmab/Medarex shall have the first right, but not the obligation
to negotiate and to obtain a license from such Third Party as necessary for the
Exploitation of any Unilateral Products hereunder in such country.
Genmab/Medarex shall be solely responsible for one hundred percent (100%) of all
royalty and other obligations with respect to the Exploitation of Unilateral
Products.
5.4.2 THIRD PARTY LITIGATION. In the event that a Third Party
institutes a Patent, Trademark or other infringement suit (including any suit
alleging the invalidity or unenforceability of the Patents of a Party or its
Affiliates, or claiming confusion, deception or dilution of a Trademark by a
Product Trademark) against any Party or its respective Affiliates, licensees or
permitted sublicensees during the Term, alleging that the Exploitation of the
Unilateral Products in the Territory or any other activities hereunder,
infringes one or more Patent, Trademark or other intellectual property rights
held by such Third Party (an "INFRINGEMENT SUIT"), the Parties shall cooperate
with one another in defending such suit. Genmab/Medarex shall direct and
control, at its sole cost and expense, any Infringement Suit with respect to the
Unilateral Products; provided, however, that Genmab/Medarex shall not cease to
defend, settle or otherwise dispose of a suit with respect to any intellectual
property of deCODE without deCODE's prior written consent. With respect to the
Collaboration Patents, the Collaborators shall each bear fifty percent (50%) of
any costs and expenses of such defense; provided, with respect to the
Exploitation of Unilateral Products, Genmab/Medarex shall bear one hundred
percent (100%) of those costs and expenses. With respect to Joint Patents, the
Collaborators shall each bear fifty percent (50%) of any costs and expenses of
such defense; provided, with
16
116
respect to the Exploitation of Unilateral Products, Genmab/Medarex shall bear
one hundred percent (100%) of those costs and expenses.
5.4.3 RETAINED RIGHTS. Nothing in this Section 5.4 shall prevent
Genmab/Medarex, at its own expense, from obtaining any license or other rights
from Third Parties it deems appropriate in order to permit the full and
unhindered exercise of its rights under this Agreement.
SECTION 5.5 EXCHANGE OF KNOW-HOW.
5.5.1 INFORMATION DISCLOSURE. deCODE shall, and shall cause its
Affiliates to, without additional compensation and at its sole expense, disclose
and make available to Genmab/Medarex, in whatever form Genmab/Medarex may
reasonably request, all Regulatory Documentation, all of its other Know-How, all
Information and Inventions included in the Collaboration Technology and the
Joint Technology and any other Information and Inventions that are reasonably
necessary to Exploit Antibody Products with respect to each Unilateral Target
immediately after such Unilateral Target is first designated as such and
thereafter immediately upon the earlier of the conception or reduction to
practice, discovery, development or making of each such Regulatory
Documentation, Know-How, or other Information and Inventions.
5.5.2 COOPERATION. deCODE shall cooperate with any and all reasonable
requests for assistance from Genmab/Medarex, at Genmab/Medarex's sole cost and
expense, including by making its employees, consultants and other scientific
staff available upon reasonable notice during normal business hours at deCODE's
place of business to consult with Genmab/Medarex on issues arising with respect
to the deCODE Technology in connection with the research, development,
commercialization or other Exploitation of Unilateral Products.
5.5.3 BIOLOGICAL MATERIALS. For purposes of facilitating the conduct of
the development activities with respect to the Unilateral Products, deCODE shall
provide to Genmab/Medarex the Biological Materials necessary to perform such
activities in material compliance with all Applicable Law. The Parties agree
that: (a) all such Biological Materials provided by deCODE to Genmab/Medarex and
any Biological Material produced against or with, or derived from, such
Biological Materials shall be used solely for the development and
commercialization of Unilateral Products, and in material compliance with all
Applicable Law; (b) all such Biological Materials shall be provided without any
warranties, express or implied; (c) deCODE shall obtain (or cause its Third
Party collaborators to obtain or certify that they have obtained) all
appropriate and required consents from the source of such Biological Materials;
and (d) Biological Materials provided by deCODE to Genmab/Medarex shall not be
made available by Genmab/Medarex to any Third Party, unless the prior written
consent of deCODE is first obtained.
5.5.4 REGULATORY RECORDS. Genmab/Medarex shall maintain, or cause to be
maintained, records of its respective research, development, manufacturing and
commercialization activities for the Unilateral Products, including all
Regulatory
17
117
Documentation, in sufficient detail and in good scientific manner appropriate
for patent and regulatory purposes, which shall be complete and accurate and
shall fully and properly reflect all work done and results achieved in the
performance of such activities, and which shall be retained during the term of
this Agreement and for a period of five (5) years thereafter, or for such longer
period as may be required by Applicable Law. deCODE shall have the right, during
normal business hours and upon reasonable notice, to inspect and copy any such
records, except to the extent that such records contain proprietary information
with respect to the HuMAb Mice or Medarex's Production Process Technology or
Genmab's Production Process Technology, as applicable. deCODE shall have an
irrevocable, perpetual right to use and reference such Regulatory Documentation
for all purposes.
5.5.5 PRODUCTION PROCESS TECHNOLOGY. Notwithstanding anything to the
contrary in this Section 5.5 or elsewhere in this Agreement, deCODE shall not be
obligated to disclose or provide any of its Production Process Technology,
including Biological Materials, to Genmab/Medarex or any Third Party except as
may be required or permitted under a separate written agreement entered into by
the Parties pursuant to Section 1.2.8 or Section 1.6 of the Collaboration
Agreement.
ARTICLE 6 -
TERM AND TERMINATION
SECTION 6.1 TERM. The term of this Agreement (the "TERM") shall
commence upon the Effective Date and shall continue in effect until such time as
there is no longer any Unilateral Product being Exploited hereunder, unless
terminated at an earlier date in accordance with the terms and conditions set
forth in this Article 6.
SECTION 6.2 TERMINATION FOR MATERIAL BREACH. Any material failure by a
Collaborator to comply with any of its material obligations contained herein
shall entitle the Collaborator not in default to give to the Collaborator in
default written notice specifying the nature of the default, requiring the
defaulting Collaborator to make good or otherwise cure such default, and stating
its intention if such default is not cured to terminate or, if Genmab/Medarex is
the defaulting Collaborator, at the option of deCODE, to convert such Unilateral
Product to which the material breach applies to a Unilateral Product of deCODE
under the Unilateral Development and Commercialization Agreement attached to the
Collaboration Agreement as Appendix D-1. If such default is not cured within
thirty (30) days after the receipt of such notice (or, if such default cannot be
cured within such thirty (30)-day period, if the Collaborator in default does
not commence actions to cure such default within such period and thereafter
diligently continue such actions or if such default is not otherwise cured
within one-hundred and eighty (180) days after the receipt of such notice),
except in the case of a payment default, as to which the defaulting Collaborator
shall have only a thirty (30) day cure period, the Collaborator not in default
shall be entitled, on written notice to the other Collaborator, without
prejudice to any of its other rights conferred on it by this Agreement, and in
addition to any other remedies available to it by law or in equity, to (a)
terminate this Agreement in its entirety, or (b) if Genmab/Medarex is the
defaulting Collaborator, to convert such Unilateral Product to a Unilateral
Product of deCODE,
18
118
whereupon each shall be subject to their respective rights and obligations under
the Unilateral Development and Commercialization Agreement attached to the
Collaboration Agreement as Xxxxxxxx X-0, including the royalty obligations set
forth therein and the indemnification obligations.
SECTION 6.3 TERMINATION UPON INSOLVENCY. Any Party may terminate this
Agreement if, at any time, any other Party shall file in any court or agency
pursuant to any statute or regulation of any state, country or jurisdiction, a
petition in bankruptcy or insolvency or for reorganization or for an arrangement
or for the appointment of a receiver or trustee of that Party or of its assets,
or if such other Party proposes a written agreement of composition or extension
of its debts, or if such other Party shall be served with an involuntary
petition against it, filed in any insolvency proceeding, and such petition shall
not be dismissed within sixty (60) days after the filing thereof, or if such
other Party shall propose or be a party to any dissolution or liquidation, or if
such other Party shall make an assignment for the benefit of its creditors;
provided, however, that in the event such bankrupt or insolvent Party is Medarex
or Genmab, the other such Party (whether Medarex or Genmab) shall have the right
to assume all of the obligations of the bankrupt or insolvent Party under this
Agreement, and upon such assumption, such other Party shall be entitled to all
of the rights and benefits hereunder of such bankrupt or insolvent Party and
deCODE shall have no right to terminate pursuant to this Section 6.4.
SECTION 6.4 RIGHTS IN BANKRUPTCY. All rights and licenses granted under
or pursuant to this Agreement by deCODE, Medarex or Genmab are, and shall
otherwise be deemed to be, for purposes of Section 365(n) of the United States
Bankruptcy Code, licenses of rights to "intellectual property" as defined under
Section 101 of the United States Bankruptcy Code. The Parties agree that the
Parties, as licensees of such rights under this Agreement, shall retain and may
fully exercise all of their rights and elections under the United States
Bankruptcy Code. The Parties further agree that, in the event of the
commencement of a bankruptcy proceeding by or against a Party under the United
States Bankruptcy Code, the Party hereto that is not a Party to such proceeding
shall be entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property and all embodiments of such
intellectual property, which, if not already in the non-subject Party's(ies')
possession, shall be promptly delivered to it (a) upon any such commencement of
a bankruptcy proceeding upon the non-subject Party's(ies') written request
therefor, unless the Party subject to such proceeding continues to perform all
of its obligations under this Agreement or (b) if not delivered under clause (a)
above, following the rejection of this Agreement by or on behalf of the Party
subject to such proceeding upon written request therefor by the non-subject
Party(ies).
SECTION 6.5 CONSEQUENCES OF EXPIRATION OR TERMINATION.
6.5.1 LICENSES. Upon expiration of the full term of this Agreement in
accordance with Section 6.1 and the payment of all amounts due under Section
3.1, the licenses granted by deCODE to Genmab/Medarex hereunder shall be deemed
fully-paid up.
19
119
6.5.2 RETURN OF INFORMATION. Upon expiration of this Agreement pursuant
to Section 6.1 or upon termination of this Agreement in its entirety by either
Party pursuant to this Article 6, Genmab/Medarex, at the request of deCODE,
shall return all data, files, records and other materials in its possession or
control relating to deCODE's Technology, or containing or comprising deCODE's
Information and Inventions or other Confidential Information and to which
Genmab/Medarex does not retain rights hereunder (except one copy of which may be
retained for archival purposes).
SECTION 6.6 ACCRUED RIGHTS; SURVIVING OBLIGATIONS.
6.6.1 ACCRUED RIGHTS. Termination or expiration of this Agreement for
any reason shall be without prejudice to any rights that shall have accrued to
the benefit of a Party prior to such termination or expiration. Such termination
or expiration shall not relieve a Party from obligations that are expressly
indicated to survive the termination or expiration of this Agreement.
6.6.2 SURVIVAL. Articles 3 (with respect to obligations arising prior
to expiration or termination), 4 and 7, and Sections 2.3, 5.1, 5.2, 5.5.3,
5.5.4, 5.5.5, 6.4, 6.5, 9.4, 9.5 and 9.6 of this Agreement and this Section 6.6
shall survive expiration or termination of this Agreement for any reason.
ARTICLE 7 -
INDEMNIFICATION AND INSURANCE
SECTION 7.1 INDEMNIFICATION OF MEDAREX AND GENMAB. deCODE shall
indemnify Medarex and Genmab and their respective Affiliates and their
respective directors, officers, employees and agents, and defend and save each
of them harmless, from and against any and all losses, damages, liabilities,
costs and expenses (including reasonable attorneys' fees and expenses) in
connection with any and all liability suits, investigations, claims or demands
(collectively, "LOSSES") arising from or occurring as a result of or in
connection with any breach by deCODE of this Agreement, except for those Losses
for which Medarex or Genmab has an obligation to indemnify deCODE and its
Affiliates pursuant to Section 7.2, as to which Losses each of Medarex and
Genmab shall indemnify the other to the extent of their respective liability for
the Losses.
SECTION 7.2 INDEMNIFICATION OF deCODE.
7.2.1 BY MEDAREX. Medarex shall indemnify deCODE and its Affiliates,
directors, officers, employees and agents, and defend and save each of them
harmless, from and against any and all Losses arising from or occurring as a
result of or in connection with (a) any breach by Medarex of this Agreement, (b)
the development, manufacture or commercialization of a Unilateral Product by or
on behalf of Medarex or its Affiliates or sublicensees, or (c) the gross
negligence, recklessness or willful misconduct on the part of Medarex or its
Affiliates, licensees or sublicensees in performing any activity contemplated by
this Agreement, except for those Losses for which deCODE has an obligation to
indemnify Medarex and its respective Affiliates
20
120
pursuant to Section 7.1, as to which Losses each Party shall indemnify the other
to the extent of their respective liability for the Losses.
7.2.2 BY GENMAB. Genmab shall indemnify deCODE and its Affiliates,
directors, officers, employees and agents, and defend and save each of them
harmless, from and against any and all Losses arising from or occurring as a
result of or in connection with (a) any breach by Genmab of this Agreement, (b)
the development, manufacture or commercialization of a Unilateral Product by or
on behalf of Genmab or its Affiliates or sublicensees, or (c) the gross
negligence, recklessness or willful misconduct on the part of Genmab or its
Affiliates, licensees or sublicensees in performing any activity contemplated by
this Agreement, except for those Losses for which deCODE has an obligation to
indemnify Genmab and its respective Affiliates pursuant to Section 7.1, as to
which Losses each Party shall indemnify the other to the extent of their
respective liability for the Losses.
SECTION 7.3 INDEMNIFICATION PROCEDURE.
7.3.1 NOTICE OF CLAIM. The indemnified Party shall give the
indemnifying Party prompt written notice (an "INDEMNIFICATION CLAIM NOTICE") of
any Losses or discovery of fact upon which such indemnified Party intends to
base a request for indemnification under Section 7.1 or Section 7.2, but in no
event shall the indemnifying Party be liable for any Losses that result from any
delay in providing such notice. Each Indemnification Claim Notice must contain a
description of the claim and the nature and amount of such Loss (to the extent
that the nature and amount of such Loss are known at such time). The indemnified
Party shall furnish promptly to the indemnifying Party copies of all papers and
official documents received in respect of any Losses. All indemnification claims
in respect of a Party, its Affiliates or their respective directors, officers,
employees and agents (collectively, the "INDEMNITEES" and each an "INDEMNITEE")
shall be made solely by such Party to this Agreement (the "INDEMNIFIED PARTY").
7.3.2 THIRD PARTY CLAIMS. Subject to Section 5.4, the obligations of an
indemnifying Party under this Article 7 with respect to Losses arising from
claims of any Third Party that are subject to indemnification as provided for in
Section 7.1 or 7.2 (a "THIRD PARTY CLAIM") shall be governed by and be
contingent upon the following additional terms and conditions:
(a) CONTROL OF DEFENSE. At its option, the indemnifying Party
may assume the defense of any Third Party Claim by giving written notice to the
Indemnified Party within thirty (30) days after the indemnifying Party's receipt
of an Indemnification Claim Notice. The assumption of the defense of a Third
Party Claim by the indemnifying Party shall not be construed as an
acknowledgment that the indemnifying Party is liable to indemnify any Indemnitee
in respect of the Third Party Claim, nor shall it constitute a waiver by the
indemnifying Party of any defenses it may assert against any Indemnitee's claim
for indemnification. Upon assuming the defense of a Third Party Claim, the
indemnifying Party may appoint as lead counsel in the defense of the Third Party
Claim any legal counsel selected by the indemnifying Party. In the event the
indemnifying
21
121
Party assumes the defense of a Third Party Claim, the Indemnified Party shall
immediately deliver to the indemnifying Party all original notices and documents
(including court papers) received by any Indemnitee in connection with the Third
Party Claim. Should the indemnifying Party assume the defense of a Third Party
Claim, the indemnifying Party shall not be liable to the Indemnified Party or
any other Indemnitee for any legal expenses subsequently incurred by such
Indemnified Party or other Indemnitee in connection with the analysis, defense
or settlement of the Third Party Claim. In the event that it is ultimately
determined that the indemnifying Party is not obligated to indemnify, defend or
hold harmless an Indemnitee from and against the Third Party Claim, the
Indemnified Party shall reimburse the indemnifying Party for any and all costs
and expenses (including attorneys' fees and costs of suit) and any Losses
incurred by the indemnifying Party in its defense of the Third Party Claim with
respect to such Indemnitee.
(b) RIGHT TO PARTICIPATE IN DEFENSE. Without limiting
Section 7.3.2(a), any Indemnitee shall be entitled to participate in, but not
control, the defense of such Third Party Claim and to employ counsel of its
choice for such purpose; provided, however, that such employment shall be at the
Indemnitee's own expense unless (i) the employment thereof has been specifically
authorized by the indemnifying Party in writing, or (ii) the indemnifying Party
has failed to assume the defense and employ counsel in accordance with Section
7.3.2(a) (in which case the Indemnified Party shall control the defense).
(c) SETTLEMENT. With respect to any Losses relating
solely to the payment of money damages in connection with a Third Party Claim
and that will not result in the Indemnitee's becoming subject to injunctive or
other relief or otherwise adversely affect the business of the Indemnitee in any
manner, and as to which the indemnifying Party shall have acknowledged in
writing the obligation to indemnify the Indemnitee hereunder, the indemnifying
Party shall have the sole right to consent to the entry of any judgment, enter
into any settlement or otherwise dispose of such Loss, on such terms as the
indemnifying Party, in its sole discretion, shall deem appropriate. With respect
to all other Losses in connection with Third Party Claims, where the
indemnifying Party has assumed the defense of the Third Party Claim in
accordance with Section 7.3.2(a), the indemnifying Party shall have authority to
consent to the entry of any judgment, enter into any settlement or otherwise
dispose of such Loss provided it obtains the prior written consent of the
Indemnified Party (which consent shall not be unreasonably withheld or delayed).
The indemnifying Party shall not be liable for any settlement or other
disposition of a Loss by an Indemnitee that is reached without the written
consent of the indemnifying Party. Regardless of whether the indemnifying Party
chooses to defend or prosecute any Third Party Claim, no Indemnitee shall admit
any liability with respect to, or settle, compromise or discharge, any Third
Party Claim without the prior written consent of the indemnifying Party.
(d) COOPERATION. Regardless of whether the
indemnifying Party chooses to defend or prosecute any Third Party Claim, the
Indemnified Party shall, and shall cause each other Indemnitee to, cooperate in
the defense or prosecution thereof and shall furnish such records, information
and testimony, provide such witnesses and attend
22
122
such conferences, discovery proceedings, hearings, trials and appeals as may be
reasonably requested in connection therewith. Such cooperation shall include
access during normal business hours afforded to indemnifying Party to, and
reasonable retention by the Indemnified Party of, records and information that
are reasonably relevant to such Third Party Claim, and making Indemnitees and
other employees and agents available on a mutually convenient basis to provide
additional information and explanation of any material provided hereunder, and
the indemnifying Party shall reimburse the Indemnified Party for all its
reasonable out-of-pocket expenses in connection therewith.
(e) EXPENSES. Except as provided above, the costs and
expenses, including fees and disbursements of counsel, incurred by the
Indemnified Party in connection with any claim shall be reimbursed on a calendar
quarter basis by the indemnifying Party, without prejudice to the indemnifying
Party's right to contest the Indemnified Party's right to indemnification and
subject to refund in the event the indemnifying Party is ultimately held not to
be obligated to indemnify the Indemnified Party.
SECTION 7.4 INSURANCE. Genmab/Medarex shall have and maintain such
types and amounts of liability insurance as is normal and customary in the
industry generally for parties similarly situated, and shall upon request
provide the other Party with a copy of its policies of insurance in that regard,
along with any amendments and revisions thereto.
ARTICLE 8 -
REPRESENTATIONS, WARRANTIES AND COVENANTS
SECTION 8.1 REPRESENTATIONS, WARRANTIES AND COVENANTS. Each Party is
entering into this Agreement in reliance upon the representations, warranties
and covenants of the other Party set forth in Sections 10.1, 10.2, 10.3 and 10.4
of the Collaboration Agreement.
SECTION 8.2 DISCLAIMER OF WARRANTY. EXCEPT FOR THE EXPRESS WARRANTIES
SET FORTH IN SECTIONS 10.1, 10.2, 10.3 AND 10.4 OF THE COLLABORATION AGREEMENT,
MEDAREX, GENMAB AND deCODE MAKE NO REPRESENTATIONS AND GRANT NO WARRANTIES,
EXPRESS OR IMPLIED, EITHER IN FACT OR BY OPERATION OF LAW, BY STATUTE OR
OTHERWISE, AND GENMAB/MEDAREX AND deCODE EACH SPECIFICALLY DISCLAIM ANY OTHER
WARRANTIES, WHETHER WRITTEN OR ORAL, OR EXPRESS OR IMPLIED, INCLUDING ANY
WARRANTY OF QUALITY, MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE OR PURPOSE
OR ANY WARRANTY AS TO THE VALIDITY OF ANY PATENTS OR THE NON-INFRINGEMENT OF ANY
INTELLECTUAL PROPERTY RIGHTS OF THIRD PARTIES.
ARTICLE 9 -
MISCELLANEOUS
23
123
SECTION 9.1 FORCE MAJEURE. No Party shall be held liable or responsible
to the other Parties or be deemed to have defaulted under or breached this
Agreement for failure or delay in fulfilling or performing any term of this
Agreement when such failure or delay is caused by or results from events beyond
the reasonable control of the non-performing Party, including fires, floods,
embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be
declared or not), insurrections, riots, civil commotion, strikes, lockouts or
other labor disturbances, acts of God or acts, omissions or delays in acting by
any governmental authority. The non-performing Party shall notify the other
Parties of such force majeure within ten (10) days after such occurrence by
giving written notice to the other Parties stating the nature of the event, its
anticipated duration, and any action being taken to avoid or minimize its
effect. The suspension of performance shall be of no greater scope and no longer
duration than is necessary and the non-performing Party shall use Commercially
Reasonable Efforts to remedy its inability to perform; provided, however, that
in the event the suspension of performance continues for one-hundred and eighty
(180) days after the date of the occurrence, the Parties shall meet to discuss
in good faith how to proceed in order to accomplish the goals of the
Collaboration outlined in this Agreement.
SECTION 9.2 ASSIGNMENT. Without the prior written consent of the other
Parties hereto, no Party shall sell, transfer, assign, delegate, pledge or
otherwise dispose of, whether voluntarily, involuntarily, by operation of law or
otherwise, this Agreement or any of its rights or duties hereunder; provided,
however, that any Party hereto may assign or transfer this Agreement or any of
its rights or obligations hereunder without the consent of the other Parties (a)
to any Affiliate of such Party; or (b) to any Third Party with which it may
merge or consolidate, or to which it may transfer all or substantially all of
its assets to which this Agreement relates if in any such event (i) the
assigning Party (provided that it is not the surviving entity) remains jointly
and severally liable with the relevant Medarex Affiliate, Genmab Affiliate,
deCODE Affiliate or Third Party assignee under this Agreement, and (ii) the
relevant Medarex Affiliate assignee, Genmab Affiliate assignee, deCODE Affiliate
assignee, Third Party assignee or surviving entity assumes in writing all of the
assigning Party's obligations under this Agreement. Any purported assignment or
transfer in violation of this Section shall be void ab initio and of no force or
effect.
SECTION 9.3 SEVERABILITY. If any provision of this Agreement is held to
be illegal, invalid or unenforceable under any present or future law, and if the
rights or obligations of any Party under this Agreement will not be materially
and adversely affected thereby, (a) such provision shall be fully severable, (b)
this Agreement shall be construed and enforced as if such illegal, invalid or
unenforceable provision had never comprised a part hereof, (c) the remaining
provisions of this Agreement shall remain in full force and effect and shall not
be affected by the illegal, invalid or unenforceable provision or by its
severance herefrom, and (d) in lieu of such illegal, invalid or unenforceable
provision, there shall be added automatically as a part of this Agreement a
legal, valid and enforceable provision as similar in terms to such illegal,
invalid or unenforceable provision as may be possible and reasonably acceptable
to the Parties herein. To the fullest extent permitted by applicable law, each
Party hereby waives any
24
124
provision of law that would render any provision prohibited or unenforceable in
any respect.
SECTION 9.4 DISPUTES. Any dispute that may arise relating to this
Agreement shall be referred to the Chief Executive Officers of each of the
Parties (or their respective designees) who shall use their good faith efforts
to mutually agree upon the proper course of action to resolve the dispute. If
any dispute is not resolved by the Chief Executive Officers of the Parties (or
their designees) within ten (10) business days after such dispute is referred to
them, then any Party shall have the right to arbitrate such dispute in
accordance with Section 9.5 or to pursue such other dispute resolution mechanism
as the Parties may agree.
SECTION 9.5 GOVERNING LAW, JURISDICTION, VENUE AND SERVICE. This
Agreement shall be governed by and construed in accordance with the laws of the
State of New Jersey, applicable to contracts made and wholly performed within
such jurisdiction by residents of such jurisdiction. Subject to Section 9.4, the
Parties hereby irrevocably and unconditionally consent to the exclusive
jurisdiction of the courts of London, England for any action, suit or proceeding
arising out of or relating to this Agreement, and agree not to commence any
action, suit or proceeding related thereto except in such courts. The Parties
further hereby irrevocably and unconditionally waive any objection to the laying
of venue of any action, suit or proceeding arising out of or relating to this
Agreement in the courts of London, England, and hereby further irrevocably and
unconditionally waive and agree not to plead or claim in any such court that any
such action, suit or proceeding brought in any such court has been brought in an
inconvenient forum. Each Party hereto further agrees that service of any
process, summons, notice or document by registered mail to its address set forth
below shall be effective service of process for any action, suit or proceeding
brought against it under this Agreement in any such court.
SECTION 9.6 NOTICES. All notices or other communications that are
required or permitted hereunder shall be in writing and delivered personally,
sent by facsimile (and promptly confirmed by personal delivery, registered or
certified mail or overnight courier as provided herein), sent by
nationally-recognized overnight courier or sent by registered or certified mail,
postage prepaid, return receipt requested, addressed as follows:
If to deCODE, to:
deCODE genetics ehf
Hlioarsmari 15
200 Kopavogur, Iceland
Attention: Chief Executive Officer
Facsimile: 000-000-0000
Telephone: 000-000-0000
with a copies to:
25
125
deCODE genetics ehf
Hlioarsmari 15
200 Kopavogur, Iceland
Attention: Legal Department
Facsimile: 000-000-0000
Telephone: 000-000-0000
Xxxx Xxxxx LLP
Princeton Xxxxxxxxx Village
000 Xxxx Xxxxxx, Xxxxx 000
Xxxxxxxxx, Xxx Xxxxxx 00000
Attention: Xxxxx X. Xxxxxxx, Esq.
Facsimile: (000) 000-0000
If to Genmab, to:
Genmab A/S
Xxxxxxxx 00, 0xx Xxxxx
0000 Xxxxxxxxxx
Xxxxxxx
Attention: President
Facsimile: 45 7020 2729
If to Medarex, to:
Medarex, Inc.
000 Xxxxx Xxxx, Xxxxx 000
Xxxxxxxxx, Xxx Xxxxxx 00000-0000
Attention: President
Facsimile: (000) 000-0000
with copies to:
Medarex, Inc.
000 Xxxxx Xxxx, Xxxxx 000
Xxxxxxxxx, Xxx Xxxxxx 00000-0000
Attention: General Counsel
Facsimile: (000) 000-0000
Xxxxxxxxx & Xxxxxxx
0000 Xxxxxxxxxxxx Xxx., X.X.
Xxxxxxxxxx, X.X. 00000
Attention: Xxxx X. Xxxxxxx, Esq.
Facsimile: (000) 000-0000
26
126
or to such other address as the Party to whom notice is to be given may have
furnished to the other Parties in writing in accordance herewith. Any such
communication shall be deemed to have been given (i) when delivered, if
personally delivered or sent by facsimile on a business day, (ii) on the
business day after dispatch, if sent by nationally-recognized overnight courier,
and (iii) on the third business day following the date of mailing, if sent by
mail. It is understood and agreed that this Section 9.6 is not intended to
govern the day-to-day business communications necessary between the Parties in
performing their duties, in due course, under the terms of this Agreement.
SECTION 9.7 ENTIRE AGREEMENT; MODIFICATIONS. This Agreement, together
with the Collaboration Agreement, sets forth and constitutes the entire
agreement and understanding among the Parties with respect to the subject matter
hereof and thereof and all prior agreements, understanding, promises and
representations, whether written or oral, with respect thereto are superseded
hereby and thereby. Each Party confirms that it is not relying on any
representations or warranties of the other Parties except as specifically set
forth herein or therein. No amendment, modification, release or discharge shall
be binding upon the Parties unless in writing and duly executed by authorized
representatives of all Parties.
SECTION 9.8 RELATIONSHIP OF THE PARTIES. It is expressly agreed that
the Parties shall be independent contractors of one another and that the
relationship among the Parties shall not constitute a partnership, joint venture
or agency. Neither deCODE, on the one hand, nor Genmab/Medarex on the other
hand, shall have the authority to make any statements, representations or
commitments of any kind, or to take any action, which shall be binding on the
other, without the prior written consent of the other to do so. All persons
employed by a Party shall be employees of such Party and not of the other
Parties and all costs and obligations incurred by reason of any such employment
shall be for the account and expense of such Party.
SECTION 9.9 EQUITABLE RELIEF. Each Party acknowledges and agrees that
the restrictions set forth in Articles 4 and 5 of this Agreement are reasonable
and necessary to protect the legitimate interests of the other Parties and that
such other Parties would not have entered into this Agreement in the absence of
such restrictions, and that any violation or threatened violation of any
provision of Article 4 or 5 will result in irreparable injury to such other
Parties. Each Party also acknowledges and agrees that in the event of a
violation or threatened violation of any provision of Article 4 or 5, the other
Parties shall be entitled to preliminary and permanent injunctive relief,
without the necessity of proving irreparable injury or actual damages and
without the necessity of having to post a bond, as well as to an equitable
accounting of all earnings, profits and other benefits arising from any such
violation. The rights provided in the immediately preceding sentence shall be
cumulative and in addition to any other rights or remedies that may be available
to such other Parties. Nothing in this Section 9.9 is intended, or should be
construed, to limit such other Parties' right to preliminary and permanent
injunctive relief or any other remedy for breach of any other provision of this
Agreement.
SECTION 9.10 WAIVER. Any term or condition of this Agreement may be
waived at any time by the Party that is entitled to the benefit thereof, but no
such waiver shall be
27
127
effective unless set forth in a written instrument duly executed by or on behalf
of the Party waiving such term or condition. The waiver by any Party hereto of
any right hereunder or of the failure to perform or of a breach by the other
Party or Parties shall not be deemed a waiver of any other right hereunder or of
any other breach or failure by said other Party whether of a similar nature or
otherwise.
SECTION 9.11 COUNTERPARTS. This Agreement may be executed in two (2) or
more counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument. This Agreement may be
executed by facsimile signatures and such signatures shall be deemed to bind
each Party hereto as if they were original signatures.
SECTION 9.12 NO BENEFIT TO THIRD PARTIES. The representations,
warranties, covenants and agreements set forth in this Agreement are for the
sole benefit of the Parties hereto and their successors and permitted assigns,
and they shall not be construed as conferring any rights on any other parties.
SECTION 9.13 FURTHER ASSURANCE. Each Party shall duly execute and
deliver, or cause to be duly executed and delivered, such further instruments
and do and cause to be done such further acts and things, including the filing
of such assignments, agreements, documents and instruments, as may be necessary
or as the other Party(ies) may reasonably request in connection with this
Agreement or to carry out more effectively the provisions and purposes, or to
better assure and confirm unto such other Party(ies) its rights and remedies
under this Agreement.
SECTION 9.14 ENGLISH LANGUAGE. This Agreement has been written and
executed in the English language. Any translation into any other language shall
not be an official version thereof, and in the event of any conflict in
interpretation between the English version and such translation, the English
version shall control.
SECTION 9.15 REFERENCES. Unless otherwise specified, (a) references in
this Agreement to any Article, Section, Schedule or Exhibit shall mean
references to such Article, Section, Schedule or Exhibit of this Agreement, (b)
references in any section to any clause are references to such clause of such
section, and (c) references to any agreement, instrument or other document in
this Agreement refer to such agreement, instrument or other document as
originally executed or, if subsequently varied, replaced or supplemented from
time to time, as so varied, replaced or supplemented and in effect at the
relevant time of reference thereto.
SECTION 9.16 CONSTRUCTION. Except where the context otherwise requires,
wherever used, the singular shall include the plural, the plural the singular,
the use of any gender shall be applicable to all genders and the word "or" is
used in the inclusive sense (and/or). The captions of this Agreement are for
convenience of reference only and in no way define, describe, extend or limit
the scope or intent of this Agreement or the intent of any provision contained
in this Agreement. The term "including" as used herein shall mean including,
without limiting the generality of any description preceding such term.
29
128
The language of this Agreement shall be deemed to be the language mutually
chosen by the Parties and no rule of strict construction shall be applied
against any Party hereto.
[The remainder of this page has been intentionally left blank.]
29
129
IN WITNESS WHEREOF, the Parties hereto have caused this Agreement
to be executed by their duly authorized representatives as of the date first
above written.
MEDAREX, INC. deCODE GENETICS EHF
By: /s/ Xxxxxxx X. Xxxxxxxxx By: /s/ Dr. Xxxx Xxxxxxxxxx
Name: Xxxxxxx X. Xxxxxxxxx Name: Dr. Xxxx Xxxxxxxxxx
Title: Executive Vice-President Title: Managing Director
GENMAB A/S
By: /s/ Xx. Xxxx X. Xxxxxxxx
Name: Xx. Xxxx X. Xxxxxxxx
Title: Chief Executive Officer
By:/s/ Xxxxxxx Xxxxx Xxxxxx
Name: Xxxxxxx Xxxxx Xxxxxx
Title: Chief Financial Officer & Head of Legal Department
30
130
APPENDIX A
COLLABORATION ANTIBODIES AND COLLABORATION PRODUCTS
This Appendix to the UNILATERAL DEVELOPMENT AND COMMERCIALIZATION
Agreement ("AGREEMENT") effective as of June 12, 2001, by and between GENMAB A/S
("GENMAB"), MEDAREX, INC., on behalf of itself and its wholly owned subsidiary,
GENPHARM INTERNATIONAL, INC. (collectively, "MEDAREX"), and deCODE, INC.
("deCODE"), sets forth the Collaboration Antibodies with respect to the
applicable Collaboration Targets.
The contents of this Appendix A are hereby incorporated into the
Agreement and are governed by the terms and conditions of the Agreement,
including the confidentiality provisions set forth therein.
1
000
XXXXXXXX X
deCODE - GENMAB/MEDAREX EARLY STAGE PROJECT RESPONSIBILITIES
This Appendix to the Collaboration Agreement ("AGREEMENT") effective as
of June 12, 2001, by and between GENMAB A/S ("GENMAB"), MEDAREX, INC., on behalf
of itself and its wholly owned subsidiary, GENPHARM INTERNATIONAL, INC.,
(collectively, "MEDAREX"), and deCODE GENETICS EHF. ("deCODE") sets forth the
Collaborator's Early Stage Project Responsibilities. All capitalized terms used
herein without definition shall have the meanings ascribed thereto in the
Agreement, unless otherwise expressly provided herein.
The contents of this Appendix E are hereby incorporated into the
Agreement and are governed by the terms and conditions of the Agreement,
including the confidentiality provisions set forth therein.
--------------------------------------------------------------------------------
deCODE - GENMAB/MEDAREX
-----------------------
EARLY STAGE PROJECT RESPONSIBILITIES
------------------------------------
--------------------------------------------------------------------------------
deCODE RESPONSIBILITIES
--------------------------------------------------------------------------------
[CONFIDENTIAL TREATMENT REQUESTED]
1
