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Exhibit 10.44 RESEARCH AND LICENSE
AGREEMENT BETWEEN EYETECH PHARMACEUTICALS, INC.
AND ARCHEMIX CORP. Dated April 8, 2004
Confidential Portions of this Exhibit were omitted and have
been filed separately with the Secretary of the Commission pursuant
to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
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ARTICLE 1 DEFINITIONS
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2
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ARTICLE 2 RESEARCH PROGRAM
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21
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ARTICLE 3 LICENSE OPTION
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28
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ARTICLE 4 LICENSES; DEVELOPMENT AND COMMERCIALIZATION
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35
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ARTICLE 5 PAYMENTS
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49
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ARTICLE 6 CONFIDENTIALITY
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58
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ARTICLE 7 INDEMNIFICATION
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60
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ARTICLE 8 INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND
RELATED MATTERS
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64
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ARTICLE 9 TERM AND TERMINATION
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75
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ARTICLE 10 REPRESENTATIONS AND WARRANTIES
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80
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ARTICLE 11 MISCELLANEOUS PROVISIONS
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82
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Confidential Portions of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment
under Rule 406 of the Securities Act.
i
RESEARCH AND LICENSE AGREEMENT
This Research and License Agreement
(the "Agreement") is made and entered into as of this 8th day of
April 2004 (the "Effective Date") between Archemix Corp., a
Delaware corporation with offices at One Hampshire Street,
Cambridge, MA 02139 ("ARCHEMIX"), and Eyetech Pharmaceuticals,
Inc., a Delaware corporation with offices at 500 Seventh Avenue,
18th Floor, New York, New York 10018 ("EYETECH"). WITNESSETH:
WHEREAS, ARCHEMIX has developed
expertise to undertake the identification and optimization of
Aptamers using the SELEX Process and owns or holds licenses
covering the use of Aptamers other than the Aptamer known as NX1838
for treating, preventing or delaying human diseases or conditions;
WHEREAS, EYETECH is engaged in the
research and development of pharmaceutical compounds that are safe
and effective in treating, preventing or delaying the progress of
ophthalmologic diseases and conditions;
WHEREAS, both Parties desire to enter
into a research program the objective of which will be for ARCHEMIX
to identify and optimize Aptamers against Targets that fulfil
certain criteria in order to be developed and marketed by EYETECH
for the prevention and treatment of ophthalmologic diseases or
conditions; WHEREAS, ARCHEMIX would
like to license to EYETECH Aptamers so identified by ARCHEMIX, and
to provide EYETECH with samples of such Aptamers, and EYETECH would
like to accept and receive such licenses and samples for purposes
of pre-clinical and clinical testing and (if appropriate)
commercial use, all under the terms and conditions of this
Agreement. WHEREAS, EYETECH desires
the right to obtain licenses to Aptamers so identified by ARCHEMIX.
Confidential Portions of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment
under Rule 406 of the Securities Act.
1
WHEREAS, the Parties each are
parties to agreements with Gilead under which they have certain
rights or are subject to certain restrictions concerning Aptamers
against VEGF and wish to individually negotiate, or jointly if
mutually agreed upon, certain changes in such agreements with
Gilead with respect to VEGF and to grant each other certain
licenses with respect to Aptamers against VEGF, all under the terms
and conditions of this Agreement. NOW
THEREFORE, in consideration of the mutual covenants set forth in
this Agreement, the Parties agree as follows: ARTICLE 1
DEFINITIONS For the purpose of
this Agreement, the following terms, whether used in singular or
plural form, shall have the respective meanings set forth below:
1.1
"Affiliate" . Affiliate shall mean, with respect to any
Person, any other Person, which directly or indirectly, by itself
or through one or more intermediaries, controls, or is controlled
by, or is under direct or indirect common control with, such
Person. As used in this Section 1.1 only, the term "control"
means the possession, direct or indirect, of the power to direct or
cause the direction of the management and policies of a Person,
whether through the ownership of voting securities, by contract or
otherwise. Control will be presumed if one Person owns, either of
record or beneficially, more than 50% of the voting stock or other
equity interest of any other Person.
1.2
"Annual Research Plan" . Annual Research Plan shall mean the
research and development plan for the Research Program to be
developed and approved by the JRC for each Contract Year.
1.3
"Aptamer" . Aptamer shall mean an oligonucleotide identified
through the SELEX Process.
1.4
"Aptamer Equivalent" . Aptamer Equivalent shall mean any
structural variations, modifications, derivatives, homologs,
analogs, or mimetics of an Aptamer having a different chemical
composition than the original Aptamer, including without limitation
changes in the Confidential Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
2
base sequence composition or backbone and conjugations that
affect pharmacokinetics. The Parties acknowledge that the required
difference in chemical composition for an Aptamer to become an
Aptamer Equivalent is intended to avoid a finding by the FDA or
other Regulatory Authority that an Aptamer and its Aptamer
Equivalent constitute the same drug for regulatory purposes. Each
Party shall consider such intention at the time it commences
activities to develop or commercialize an Aptamer Equivalent to an
Aptamer being developed or commercialized by the other Party. If a
Party in good faith determines that an Aptamer is an Aptamer
Equivalent with respect to the original Aptamer, then such Aptamer
shall constitute an Aptamer Equivalent with respect to the original
Aptamer even if the FDA or other Regulatory Authority subsequently
finds that such Aptamer Equivalent and the original Aptamer
constitute the same drug for regulatory purposes; provided that the
Aptamer Equivalent meets the criteria set forth in the first
sentence of this Section with respect to the original Aptamer.
1.5
"ARCHEMIX Additional Compound" . ARCHEMIX Additional
Compound shall have the meaning set forth in Section 3.2.
1.6
"ARCHEMIX Early Decision Initial Compound" . ARCHEMIX Early
Decision Initial Compound shall have the meaning set forth in
Section 3.2.
1.7
"ARCHEMIX Initial Compound" . ARCHEMIX Initial Compound
shall have the meaning set forth in Section 3.2.
1.8
"ARCHEMIX Know-How" . ARCHEMIX Know-How shall mean all
Know-How Controlled by ARCHEMIX, whether disclosed in a pending
patent application or not, as of the Effective Date or during the
Research Term relating to a Compound or the use thereof, ARCHEMIX
Proprietary Targets or the use thereof or the SELEX Process,
excluding ARCHEMIX Program Technology and ARCHEMIX’s interest
in Joint Program Technology.
1.9
"ARCHEMIX Patents" . ARCHEMIX Patents shall mean any Patents
Controlled by ARCHEMIX as of the Effective Date or during the
Collaboration Term, claiming a Compound or the use thereof,
ARCHEMIX Proprietary Targets, or the SELEX Process, excluding
ARCHEMIX Program Patents and ARCHEMIX’s interest in Joint
Program Patents. Confidential Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
3
Provided, however, that ARCHEMIX Patents shall not include
Patents claiming ARCHEMIX Proprietary Targets discovered, reduced
to practise or obtained after the Research Term.
1.10
"ARCHEMIX Program Patents" . ARCHEMIX Program Patents shall
mean Patents claiming ARCHEMIX Program Technology.
1.11
"ARCHEMIX Program Technology" . ARCHEMIX Program Technology
shall mean all Program Technology other than formulations and
methods of use relating (A) solely to ARCHEMIX Technology or
ARCHEMIX Proprietary Targets; or (B) solely to Aptamers,
Aptamer Equivalents, or the SELEX Process.
1.12
"ARCHEMIX Proprietary Target" . ARCHEMIX Proprietary Target
shall mean a Target the use of which to select an Aptamer, or the
use of which as a target for therapeutic and preventive
intervention, is covered by an ARCHEMIX Valid Claim or pending
patent application.
1.13
"ARCHEMIX Technology" . ARCHEMIX Technology shall mean all
ARCHEMIX Patents and ARCHEMIX Know-How.
1.14
"ARCHEMIX Valid Claim" . ARCHEMIX Valid Claim shall mean a
claim of an issued and unexpired ARCHEMIX Patent, ARCHEMIX Program
Patent or Joint Program Patent, which has not been revoked or held
permanently unenforceable or invalid by a decision of a court or
other governmental agency of competent jurisdiction, which decision
is unappealable or unappealed within the time allowed for appeal,
and which has not been admitted to be invalid or unenforceable
through re-issue or disclaimer or otherwise.
1.15
"Back-Up" . Back-Up shall have the meaning set forth in
Section 3.5.1 hereof.
1.16
"Bankruptcy Code". Bankruptcy Code shall have the meaning
set forth in Section 4.9.1.
1.17
"Collaboration Term". Collaboration Term shall mean the Term
of this Agreement that commences on the Effective Date and
continues until the end of the Royalty Term as defined in
Section 9.2. Confidential Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
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1.18
"Collaborator". Collaborator shall mean any third party who
has been granted a sublicense by ARCHEMIX under Section 4.3.2
of this Agreement for the development and/or commercialization of
Refused Candidates and Aptamer Equivalents of Compounds outside the
Field and Aptamers against VEGF outside the Field and the Local
Delivery Field.
1.19
"Commercialization" or "Commercialize". Commercialization or
Commercialize shall mean any and all activities directed to
commercial scale manufacturing (including assays and validation,
testing development and manufacturing scale-up), marketing,
promoting, distributing, importing and selling a product.
1.20
"Compound" . Compound shall mean any ARCHEMIX Initial
Compound, Program Compound, ARCHEMIX Additional Compound or
Back-Up, it being understood that all the aforementioned categories
of Compounds can include compounds against VEGF, so long as the
Parties obtain any necessary rights covering VEGF from Gilead,
unless and until it becomes a Refused Candidate pursuant to
Section 3.7, 4.5, or 4.8.1 hereof.
1.21
"Compound Candidate". Compound Candidate shall mean a
Program Compound that (A) fulfils the Early Selection Criteria for
such Program Compound with respect to a Target or (B) which is
selected by EYETECH, through written notice to ARCHEMIX, to be a
Compound Candidate pursuant to Section 3.4.
1.22
"Compound Product" . Compound Product shall mean a finished
form of product that comprises, contains or is a Compound and which
(i) the manufacture, use or sale of which would infringe any
ARCHEMIX Valid Claim; and/or (ii) embodies ARCHEMIX Know How
or ARCHEMIX Program Technology.
1.23
"Confidential Information" . Confidential Information shall
mean all Know-How or other information, including, without
limitation, proprietary information and materials (whether or not
patentable) regarding a Party’s technology, products,
business information or objectives, which is designated as
confidential in writing by the disclosing Party, whether by letter
or by the use of an appropriate stamp or legend, prior to or at the
time any such material, trade secret or other information is
disclosed by the disclosing Party to the other Party.
Notwithstanding anything in the foregoing to the contrary,
materials, know-how or other Confidential Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
5
information which is orally, electronically or visually
disclosed by a Party, or is disclosed in writing without an
appropriate letter, stamp or legend, shall constitute Confidential
Information of a Party if the disclosing Party, within [***]
business days after such disclosure, delivers to the other Party a
written document or documents describing the materials, know-how or
other information and referencing the place and date of such oral,
visual, electronic or written disclosure and the names of the
persons to whom such disclosure was made. Notwithstanding the
foregoing, EYETECH Know-How or ARCHEMIX Know-How, as the case may
be, that is disclosed to the other Party in the course of the
Research Program shall constitute Confidential Information of a
Party whether or not designated as confidential in writing.
1.24
"Contract Year" . Contract Year shall mean the period
beginning on the Effective Date and ending on December 31,
2004 (the "First Contract Year"), and each succeeding twelve (12)
month period thereafter during the Research Term (referred to as
the "Second Contract Year," "Third Contract Year," etc.).
1.25
"Controlled" . Controlled shall mean the legal authority or
right of a Party hereto or an Affiliate of a Party to grant a
license or sublicense of intellectual property rights to the other
Party hereto which is consistent with the terms of this Agreement,
or to otherwise disclose proprietary or trade secret information to
such other Party, without breaching the terms of any agreement with
a Third Party.
1.26
"Damages" . Damages shall mean any and all costs, losses,
claims, liabilities, fines, penalties, damages and expenses, court
costs, and reasonable fees and disbursements of counsel,
consultants and expert witnesses incurred by a Gilead Indemnitee
(as defined in Section 7.2(b)) (including any interest payments
which may be imposed in connection therewith).
1.27
"Development" or "Develop" . Development or Develop shall
mean any activity with respect to a Lead Compound, including
without limitation, preclinical and clinical drug development
activities, including test method development and stability
testing, toxicology, formulation, quality assurance/quality control
development, statistical analysis, clinical studies and regulatory
affairs, product approval and registration. Confidential Portions
of this Exhibit were omitted and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
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1.28
"Development Compound" . Development Compound shall mean a
Lead Compound for which EYETECH has completed all the activities
described in Appendix 3 hereof, as such appendix may be
amended or updated by JRC or by the provisions of the Annual
Research Plan.
1.29
"Development Information". Development Information shall
have the meaning set forth in Section 3.2(d).
1.30
"Diligent Efforts" . Diligent Efforts shall mean efforts at
least equal to those normally used by a Party for a compound or
product owned by it or to which it has rights, which is of similar
market potential, at a similar stage in its product life, taking
into account the competitiveness of the marketplace, the regulatory
structure involved, the profitability of the applicable products
and other relative factors.
1.31
"Early Selection Criteria" or "ESC" . Early Selection
Criteria or ESC shall mean guideline selection criteria for
identifying Compounds which are sufficiently promising to warrant
Development set forth in Appendix 1 hereof, as such
Appendix shall be adjusted by mutual agreement of the Parties with
respect to each individual Target to be included in the Research
Program before any activities with respect to such Target are
initiated. The specific ESC for each Target must be consistent with
the guidelines in Appendix 1 and be adopted by the formal
written resolution of the JRC duly signed by the Program Director
of each Party.
1.32
"Excluded Aptamers" . Excluded Aptamers shall mean (a)
[***], (b) [***] , and (c) any Aptamer or Aptamer Equivalent
directed to any of the following targets:
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i.
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[***];
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ii.
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[***];
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iii.
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[***];
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iv.
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[***];
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v.
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[***];
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Confidential Portions of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment
under Rule 406 of the Securities Act.
7
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vi.
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[***];
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vii.
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[***] ;
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viii.
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[***];
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ix.
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[***];
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x.
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[***];
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xi.
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[***]; or
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xii.
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[***].
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1.33
"Executive Officers" . Executive Officers shall mean the
Chief Executive Officer of EYETECH (or an executive officer of
EYETECH designated by such Chief Executive Officer and the Chief
Executive Officer of ARCHEMIX (or an executive officer of ARCHEMIX
designated by such Chief Executive Officer).
1.34
"Exercise Notice" . Exercise Notice shall have the meaning
set forth in Section 3.4.
1.35
"EYETECH Development Program" . EYETECH Development Program
shall mean the product development program to be undertaken by
EYETECH during or after the Research Term to develop Lead Compounds
into Compound Products.
1.36
"EYETECH Development Program Technology" . EYETECH
Development Program Technology shall mean all Know-How conceived,
reduced to practice or developed by EYETECH during and in the
conduct of the EYETECH Development Program specifically relating to
any Compound, ARCHEMIX Proprietary Target or EYETECH Proprietary
Target or methods of use of any Compound, ARCHEMIX Proprietary
Target or EYETECH Proprietary Target.
1.37
"EYETECH Development Program Patents" . EYETECH Development
Program Patents shall mean Patents claiming EYETECH Development
Program Technology. Confidential Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
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1.38
"EYETECH Diligence Goal" . EYETECH Diligence Goal shall have
the meaning set forth in Section 2.4(b)(iii).
1.39
"EYETECH Know-How" . EYETECH Know-How shall mean all
Know-How Controlled by EYETECH, whether disclosed in a pending
patent application or not, as of the Effective Date or during the
Research Term relating to a Compound or the use thereof or an
EYETECH Proprietary Target or the use thereof, excluding EYETECH
Program Technology and EYETECH’s interest in Joint Program
Technology.
1.40
"EYETECH Patents" . EYETECH Patents shall mean any Patents
Controlled by EYETECH as of the Effective Date or during the
Research Term, claiming a Compound or the use thereof or a Target
or the use thereof, excluding EYETECH Program Patents and
EYETECH’s interest in Joint Program Patents.
1.41
"EYETECH Program Patents". EYETECH Program Patents shall
mean Patents claiming EYETECH Program Technology.
1.42
"EYETECH Program Technology" . EYETECH Program Technology
shall mean all Program Technology relating (A) solely to
EYETECH Proprietary Targets or EYETECH Technology, and/or (B)
solely to formulations or methods of use of any Compound.
Notwithstanding anything to the contrary herein, any methods of use
of any Compound discovered or reduced to practise during the course
of the Research Term shall be deemed to be EYETECH Program
Technology.
1.43
"EYETECH Proprietary Target" . EYETECH Proprietary Target
shall mean a Target the use of which to select an Aptamer, or the
use of which as a target for therapeutic intervention, is covered
by an EYETECH Valid Claim or pending patent application.
1.44
"EYETECH Technology" . EYETECH Technology shall mean all
EYETECH Patents and EYETECH Know-How.
1.45
"EYETECH Valid Claim" . EYETECH Valid Claim shall mean a
claim of an issued and unexpired EYETECH Patent, EYETECH Program
Patent or Joint Program Patent Confidential Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
9
which has not been revoked or held permanently unenforceable or
invalid by a decision of a court or other governmental agency of
competent jurisdiction, which decision is unappealable or
unappealed within the time allowed for appeal, and which has not
been admitted to be invalid or unenforceable through re-issue or
disclaimer or otherwise.
1.46
"FDA" . FDA shall mean the United States Food and Drug
Administration.
1.47
"Field" . Field shall mean the treatment, prevention and/or
delay of any and all opthamological diseases and conditions in
humans, including, without limitation, diseases and conditions of
the eye and/or the ocular adnexa (orbit and its contents, eyelids
and lacrimal system).
1.48
"First Commercial Sale" . First Commercial Sale shall mean,
for each Compound Product or VEGF Product, the first commercial
sale in a country as part of a nationwide introduction by EYETECH
or its Affiliates, or for a VEGF Product by ARCHEMIX or its
Affiliates. Sales for test marketing, clinical trial purposes or
compassionate or similar use shall not be considered to constitute
a First Commercial Sale.
1.49
"Force Majeure" . Force Majeure shall have the meaning set
forth in Section 11.9 hereof.
1.50
"FTE" . FTE shall mean a full time (meaning a total of at
least [***] hours per year) equivalent employee (which may consist
of hours spent by more than one person) dedicated to scientific,
technical or managerial work on or directly related to the Research
Program with a Bachelor of Science or greater qualifications, as
contemplated in Section 2.4(a)(i) hereof; provided that, in no
event shall such FTEs be responsible for any overhead, laboratory
operational or other non-scientific functions unrelated to the
Research Program.
1.51
"FTE Rate" . FTE Rate shall mean an annual rate of $[***]
during the first Contract Year, and thereafter will mean such rate
increased at the beginning of each subsequent Contract Year to
reflect any increase in the Consumer Price Index for Boston,
Massachusetts during the prior Contract Year. Confidential Portions
of this Exhibit were omitted and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
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1.52
"Gilead" . Gilead shall mean Gilead Sciences, Inc.
1.53
"Gilead-Archemix License" . Gilead-Archemix License shall
mean that certain license agreement dated October 23, 2001, as
amended, between ARCHEMIX and Gilead.
1.54
"Gilead-Eyetech License" . Gilead-Eyetech License shall mean
that certain license agreement dated March 30, 2000, as
amended, between EYETECH and Gilead.
1.55
"Gilead-Eyetech Patent Portfolio" . Gilead-Eyetech Patent
Portfolio shall mean those patent applications and patents licensed
to EYETECH under the Gilead-Eyetech License, including without
limitation those listed on Appendix 5 attached hereto.
1.56
"IND" . IND shall mean an application submitted to a
Regulatory Authority to initiate human clinical trials, including
(a) an Investigational New Drug application or any successor
application or procedure filed with the FDA of the United States,
(b) except where otherwise specifically provided in this
Agreement, any foreign equivalent of a U.S. Investigational New
Drug application, and (c) all supplements and amendments that
may be filed with respect to the foregoing.
1.57
"Indication" . Indication shall mean any human indication,
disease or condition (i) in the Field with respect to Compound
Products, (ii) in the Field and/or the Local Delivery Field
for Aptamers against VEGF developed or commercialized for or by
EYETECH, and (iii) outside the Field and the Local Delivery
Field for Aptamers against VEGF developed or commercialized for or
by ARCHEMIX which can be treated, prevented, cured or the
progression of which can be delayed.
1.58
"Invalidity Claim" . Invalidity Claim shall have the meaning
set forth in Section 8.5 hereof.
1.59
"In Vitro Diagnostics" . In Vitro Diagnostics shall mean the
use of Aptamers or Aptamer Equivalents in the assay, testing or
determination outside of a living organism, of a substance in a
test material. Confidential Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
11
1.60
"In Vivo Diagnostic Agent" . In Vivo Diagnostic Agent shall
mean any product containing one or more Aptamers or Aptamer
Equivalents that is used for any human in vivo diagnostic purpose
related to, inter alia, the identification, quantification or
monitoring of the propensity toward, or actual existence of, any
disease state.
1.61
"Joint Program Patents" . Joint Program Patents shall mean
Patents claiming Joint Program Technology.
1.62
"Joint Program Technology" . Joint Program Technology shall
mean all Program Technology conceived, reduced to practice or
developed jointly by employees, agents, consultants or
subcontractors of both Parties during, and in the conduct of, the
Research Program that is neither ARCHEMIX Program Technology nor
EYETECH Program Technology.
1.63
"JRC" . JRC shall have the meaning set forth in
Section 2.1 hereof.
1.64
"Know-How" . Know-How shall mean all proprietary material
and information, including data, technical information, know-how,
experience, inventions, discoveries, trade secrets, compositions of
matter and methods, whether existing at the Effective Date or
developed or obtained during the Research Term and whether or not
patentable or confidential, that are Controlled by a Party to this
Agreement and that relate to the discovery, development,
utilization, manufacture or use of any Compound, Compound Product,
SELEX Process or Target, including but not limited to processes,
techniques, methods, products, materials and compositions.
1.65
"Lead Compound". Lead Compound shall mean a Compound for
which EYETECH has exercised the License Option as set forth in
Section 3.4 hereof.
1.66
"Lead Compound Equivalent ". Lead Compound Equivalent shall
mean any Aptamer directed to the same Target or Target Binding
Partner as a Lead Compound.
1.67
"License Option ". License Option shall have the meaning set
forth in Section 3.1 hereof. Confidential Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
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1.68
"Local Delivery Field ". Local Delivery Field shall mean any
delivery of an Aptamer whose intended mode of action is solely to
treat tissue in the proximity of the delivery site of such Aptamer,
for example by topical application to treat the skin at the point
of application, or injection into or in proximity of a joint or
tumor to treat only that joint or tumor.
1.69
"Loss". Loss shall have the meaning set forth in
Section 7.1 hereof.
1.70
"NDA". NDA shall mean an application submitted to a
Regulatory Authority for marketing approval of a product, including
(a) a New Drug Application, Product License Application (as
defined in Title 21 of the United States Code of Federal
Regulations, as amended from time to time) or Biologics License
Application (as defined in Title 21 of the United States Code of
Federal Regulations, as amended from time to time) filed with the
FDA or any successor applications or procedures, (b) except
where otherwise specifically provided in this Agreement, any
foreign equivalent of a U.S. New Drug Application, Product License
Application or Biologics License Application, and (c) all
supplements and amendments that may be filed with respect to the
foregoing.
1.71
"Net Sales" . Net Sales shall mean the gross amount received
by a Party, its Affiliates and/or its Sublicensees on Sales of
Compound Products or VEGF Products in the case of EYETECH or VEGF
Products only in the case of ARCHEMIX less the following
deductions:
(a) Trade,
cash and/or quantity discounts actually allowed and taken with
respect to such sales to wholesalers, hospitals or other buying
institutions, as reflected in the amount invoiced;
(b) Excises,
sales taxes, value-added taxes or other taxes imposed upon and paid
directly with respect to the production, sale, delivery or use of
the Compound Product or VEGF Product (excluding national, state or
local taxes based on such Party’s or its Affiliates’
income), as reflected in the amount invoiced;
(c) Import
and export duties paid by a Party or its Affiliates or
Sublicensees; Confidential Portions of this Exhibit were omitted
and have been filed separately with the Secretary of the Commission
pursuant to the Company’s application requesting confidential
treatment under Rule 406 of the Securities Act.
13
(d) Amounts
repaid or credited by reason of rejections, defects, recalls or
returns or because of governmental charges, chargebacks, refunds,
rebates or retroactive price reductions; and
(e) Freight,
insurance and other transportation charges incurred in shipping
Compound Product or VEGF Product to Third Parties, as reflected in
the amount invoiced. Such amounts shall be determined from the
books and records of the relevant Party, its Affiliates, and/or its
Sublicensees maintained in accordance with U.S. generally accepted
accounting principles, consistently applied. In the case of any
sale of Compound Products or VEGF Products for consideration other
than cash, such as barter or counter-trade, Net Sales shall be
calculated on the fair market value of the consideration received.
In the event the Compound Product or VEGF Product is sold as part
of a Combination Product (as defined below), the Net Sales from the
Combination Product or VEGF Product, for the purposes of
determining royalty payments, shall be determined by multiplying
the Net Sales of the Combination Product, during the applicable
royalty reporting period, by the fraction, [***], where [***] is
the [***] of the Compound Product or VEGF Product when sold [***]
in finished form and [***] is the [***] of the other product(s)
having independent and/or synergistic efficacy in the Indication
for which the product is sold included in the Combination Product
when sold [***] in finished form, in each case in the same country
as the Combination Product during the applicable royalty reporting
period or, if sales of both the Compound Product or VEGF Product
and such other product(s) did not occur in the same country as the
Combination Product in such period, then in the most recent royalty
reporting period in which sales of both occurred in the same
country as the Combination Product. In the event that such average
sale price cannot be determined for both the Compound Product or
VEGF Product and all such other products(s) included in the
Combination Product, Net Sales for the purposes of determining
royalty payments shall be calculated by multiplying the Net Sales
of the Combination Product by the fraction, [***], where [***] is
the [***] of the Compound Product or VEGF Product and [***] is the
[***] of all other pharmaceutical product(s) having independent
and/or synergistic efficacy in the Indication for which the product
is sold included in the Combination Product. In such event, the
Party not selling the product shall in good faith make a
determination of the Confidential Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
14
respective [***] of the Compound Product or VEGF Product and all
other such pharmaceutical products included in the Combination
Product, and shall notify the other Party of such determination and
provide the other Party with data to support such determination.
The other Party shall have the right to review such determination
and supporting data, and to notify the Party not selling the
product if it disagrees with such determination. If the other Party
does not agree with such determination and if the Parties are
unable to agree in good faith as to such respective [***], then
such matter shall be referred to the Executive Officers for
determination. As used above, the term "Combination Product" means
any pharmaceutical product, which consists of a Compound Product or
VEGF Product and other active compounds and/or active ingredients
having independent efficacy and/or synergistic benefit in the
Indication for which the product is sold together in one package.
For avoidance of doubt, if a Combination Product is comprised of a
Compound Product and a VEGF Product the royalties shall be
calculated separately for the Compound Product and the VEGF Product
each pursuant to the formula set forth above and the royalty rates
set forth in Sections 5.2.1 and 5.2.2.
1.72
"Option Period". Option Period shall have meaning set forth
in Section 3.3.1.
1.73
"NX1838" . NX1838 shall mean the anti-VEGF aptamer known as
NX1838, together with all anti-VEGF Aptamers comprising a sequence
identity greater than [***]% over the entire length of NX1838,
whether or not such Aptamers incorporate [***], or have [***],
including without limitation [***] to alter the pharmacokinetic
properties of the molecule.
1.74
"Party". Party shall mean either ARCHEMIX or EYETECH, as
applicable, and "Parties" shall mean both ARCHEMIX and EYETECH.
1.75
"Patent Prosecution ". Patent Prosecution shall mean the
filing, prosecution, maintenance or extension of a Patent,
including without limitation, interferences, nullity suits and
re-examinations.
1.76
"Patents ". Patents shall mean all patents and patent
applications existing at the Effective Date and all patent
applications hereafter filed during the Term, including any
continuation, continuation-in-part, division, provisional or any
substitute applications, any patent Confidential Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
15
issued with respect to any such patent applications, any
reissue, re-examination, black box application, renewal or
extension (including any supplementary protection certificate) of
any such patent, and any confirmation patent or registration patent
or patent of addition based on any such patent, and all foreign
counterparts of any of the foregoing.
1.77
"Person". Person shall mean any individual, corporation,
partnership, limited liability company, association, joint-stock
company, trust, unincorporated organization, other business entity
or government or political subdivision thereof.
1.78
"Phase 1 Clinical Study". Phase 1 Clinical Study shall mean
a study of a Compound in human volunteers or patients with the
endpoint of determining initial tolerance, safety and/or
pharmacokinetic information in a single dose, single ascending
dose, multiple dose and/or multiple ascending dose regimen.
1.79
"Phase 2 Clinical Study". Phase 2 Clinical Study shall mean
a study of a Compound in patients to determine additional safety
information and initial efficacy and dose range finding.
1.80
"Phase 3 Clinical Study". Phase 3 Clinical Study shall mean
a clinical study in patients, conducted in accordance with a
protocol designed to ascertain efficacy and safety of a Compound
for the purpose of preparing and submitting an NDA to the competent
Regulatory Authorities in the Territory.
1.81
"Program Compound". Program Compound shall mean any Aptamer
(other than Excluded Aptamers), including, without limitation, an
Aptamer which has not yet met the Early Selection Criteria, that
has been demonstrated to have an affinity for, to bind to, inhibit
or otherwise modulate the activity of any Target that is being
investigated in the Research Program.
1.82
"Program Director". Program Director shall mean a research
executive appointed by each Party to serve as such Party’s
principal coordinator and liaison for the Research Program. The
Program Director appointed by EYETECH is referred to as the EYETECH
Program Director, and the Program Director appointed by ARCHEMIX is
referred to as the ARCHEMIX Program Director. Confidential Portions
of this Exhibit were omitted and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
16
1.83
"Program Patent Rights". Program Patent Rights shall mean
ARCHEMIX Program Patents, EYETECH Program Patents or Joint Program
Patents.
1.84
"Program Technology". Program Technology shall mean all
Know-How (whether or not patentable and whether or not
copyrightable) conceived, reduced to practice or developed by a
Party or jointly by the Parties during, and in the conduct of, the
Research Program.
1.85
"Radio Therapeutic ". Radio Therapeutic shall mean any
product for human therapeutic use that contains one or more
Aptamers or Aptamer Equivalents that target specifically any
diseased tissue, cells or disease-specific molecules or any tissue
or cells which are affected by a disease or located in the close
neighborhood of a disease process and is linked to or incorporates
(a) radio nucleotides or (b) any structure or elements
which develop therapeutic effects similar to the effect of linking
or incorporating radio nucleotides after submission of any kind of
radiation.
1.86
"Refused Candidate ". Refused Candidate shall have the
meaning set forth in Sections , 3.7, 4.5, and 4.8.1 hereof.;
provided that notwithstanding anything to the contrary in the
aforesaid Sections, Compounds that ARCHEMIX has not disclosed to
EYETECH pursuant to Section 3.2 and compounds which ARCHEMIX
discovers following termination or expiration of this Agreement
shall not constitute, or be deemed to be Refused Candidates for any
purposes under this Agreement, including without limitation for
purposes of Section 8.7.6.
1.87
"Refused Target ". Refused Target shall mean any Target or
proposed Target that becomes a Refused Target as set forth in
Section 2.5, 3.7, 4.2.5.3, 4.5, or 4.8.1 other than VEGF and
its two (2) Target Binding Partners (FLT1 and KDR).
1.88
"Regulatory Approval ". Regulatory Approval shall mean, with
respect to any country, all authorizations by the appropriate
governmental entity or entities necessary for commercial sale of a
Compound Product or VEGF Product in that country (or in the case of
the European Union, group of countries) including, without
limitation and where applicable, approval of labelling, and
manufacturing. "Regulatory Approval" in the United States shall
mean final approval of an NDA pursuant to United States Code as
published at 21 USC 355 and Confidential Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
17
corresponding regulations at 21 CFR Part 314, permitting
marketing of the applicable Compound Product or VEGF Product in
interstate commerce in the United States. "Regulatory Approval" in
the European Union shall mean marketing authorization for the
applicable Compound Product or VEGF Product pursuant to Council
Directive 2001/83/EC, as amended, or Council
Regulation 2309/93/EEC, as amended.
1.89
"Regulatory Authority ". Regulatory Authority shall mean any
federal, national, supranational, state, provincial or local
regulatory agency, department, bureau or other governmental entity
with authority over the testing, manufacture, use, storage, import,
promotion, marketing and sale of a therapeutic product in a country
or countries, including, but not limited to, the FDA.
1.90
"Regulatory Filings". Regulatory Filings shall have the
meaning set forth in Section 9.7 hereof.
1.91
"Research Program". Research Program shall mean all research
and discovery activities undertaken by the Parties under this
Agreement according to an Annual Research Plan, associated with the
identification and design of Compounds, Compound Candidates for
Indications as provided herein, including Compounds directed
against VEGF in the Field and/or the Local Delivery Field;
including but not limited to identification and initial testing of
Program Compounds; selection of Compound Candidates from Compounds
and preparation for preclinical assessment of such Compounds. For
purposes of clarity, the Research Program does not include any
Development activities performed in the course of the EYETECH
Development Program.
1.92
"Research Program Data". Research Program Data shall mean
all data and information pertaining to Compounds, Compound
Candidates, Back-Ups, Lead Compounds, Development Compounds,
including Compounds directed against VEGF in the Field or the Local
Delivery Field obtained by the Parties in the course of the
Research Program.
1.93
"Research Term ". Research Term shall have the meaning set
forth in Section 9.1 hereof. Confidential Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
18
1.94
"Royalty Term ". Royalty Term shall have the meaning set
forth in Section 9.2 hereof.
1.95
"Sales". Sales shall mean with respect to a Compound Product
or a VEGF Product, the gross amounts invoiced by either Party or
its Affiliates or sublicensees (including, but not limited to,
transfers to wholesale distributors but excluding subsequent sales
by such distributors) on account of sales or use of such Compound
Product or a VEGF Product.
1.96
"Sales Report" . Sales Report shall mean a written report or
written reports showing each of (i) the Net Sales of each
Compound Product or VEGF Product in each country in the Territory
during the reporting period by EYETECH or ARCHEMIX and each of
their respective Affiliates and Sublicensees; (ii) the
royalties, payable in US Dollars, which shall have accrued under
Section 5.2 hereof in respect of such sales and the basis of
calculating those royalties; (iii) withholding taxes, if any,
required by law to be deducted in respect of any such sales;
(iv) the exchange rates used in converting into US Dollars,
from the currencies in which sales were made, any payments due
which are based on Net Sales; and (v) dispositions of Compound
Products or VEGF Products other than pursuant to sale to a Third
Party exclusively for cash.
1.97
"SELEX Portfolio" . SELEX Portfolio shall mean those patent
applications and patents licensed by Gilead to ARCHEMIX pursuant to
the Gilead-Archemix License, including without limitation those set
forth in Appendix _5___attached hereto.
1.98
"SELEX Process" . SELEX Process shall mean any process for
identification or use of a nucleic acid, which process is disclosed
in or falls within the claimed scope of U.S. Patent Nos. [***] or
[***], including any continuations, divisionals
continuations-in-part, or any substitute applications, any patent
issued with respect to any such patent applications, any reissue,
re-examination, black box application, renewal or extension
(including any supplementary protection certificate) or foreign
equivalents.
1.99
"Service Providers" . Service Provider shall mean Third
Parties who execute a confidentiality agreement with a Party that
is at least as restrictive as the provisions hereof and who provide
assistance, consultation, advice, guidance, recommendation, and
training to a Party Confidential Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
19
for the purpose of improving or enhancing the Party’s
ability to meet the objectives of this Agreement.
1.100
"Sublicensee". Sublicensee shall mean a Third Party to whom
EYETECH or ARCHEMIX grants a sublicense of any or all of the rights
granted hereunder to it by the other Party or from Gilead in
respect of VEGF.
1.101
"Target". Target shall mean any non-intracellular enzyme,
receptor, transducer, transcription factor or other molecule
approved by the JRC or proposed by EYETECH unless the JRC
determines that there is a compelling scientific reason for
refusing the Target proposed by EYETECH, for use in identifying
Compounds meeting the ESC for use in the Field under the Research
Program. For avoidance of doubt, Target shall not include any
intracellular target, but shall include extra-cellular and
membrane-bound targets.
1.102
"Target Binding Partner". Target Binding Partner shall mean
the primary natural ligand that binds to a Target, as designated
pursuant to Section 2.5. However, the Parties acknowledge that
in some cases the Target Binding Partner will be comprised of two
primary ligands (for example with respect to VEGF the primary
natural ligands are FLT1 and KDR).
1.103
"Target Criteria ". Target Criteria shall mean the criteria
set forth on Appendix 4 hereto.
1.104
"Term". Term shall have the meaning set forth in
Section 9.3 hereof.
1.105
"Territory". Territory shall mean worldwide.
1.106
"Third Party". Third Party shall mean any person or entity,
which is not a Party or an Affiliate of any Party.
1.107
"USD" or "US Dollars ". USD or US Dollars shall mean the
legal tender in the United States of America. Confidential Portions
of this Exhibit were omitted and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
20
1.108
"URC License Agreement". URC License Agreement shall mean
the Restated Assignment and License Agreement, dated July 17,
1991, by and between University Research Corporation and Gilead, as
successor in interest to NeXstar (as defined therein).
1.109
"UTC". UTC shall mean the University Technology Corporation,
the successor to the University Research Corporation (as defined
there).
1.110
"VEGF". VEGF shall mean vascular endothelial growth factor.
1.111
"VEGF Product ". VEGF Product shall mean a finished dosage
form usable for administration to a patient as a pharmaceutical
containing, as an active ingredient, an Aptamer against VEGF that
is not NX1838. ARTICLE 2 RESEARCH PROGRAM
2.1
Joint Research Committee (JRC).
(a)
Composition; Responsibilities . The Parties shall establish
a joint research committee (the "JRC"), comprised of [***]
representatives of ARCHEMIX (including the ARCHEMIX Program
Director) and [***] representatives of EYETECH (including the
EYETECH Program Director). Each Party shall make its designation of
its representatives prior to the Effective Date. The JRC shall meet
within [***] days after the Effective Date and, thereafter, at
least [***] during the Research Term to (i) subject to
Section 2.5, select Targets and develop the ESC for each such
Target and the activities to be set forth in Appendix 3 which
will establish that an Aptamer against such Target is a Development
Compound, (ii) review the efforts of the Parties in the
conduct of the Research Program, (iii) review and approve
amendments to the Annual Research Plan, (iv) address such
other matters as either Party may bring before the JRC,
(v) perform such other tasks and undertake such other
responsibilities as may be set forth in this Agreement, and (vi)
attempt to resolve any disputes relating to this Agreement that may
arise between the Parties. For purposes of clarity, (i) the
JRC shall not review, oversee or have any jurisdiction with respect
to Development of Lead Compounds and the EYETECH Development
Program and (ii) the JRC may request but shall not have the
right to require ARCHEMIX to perform any work on an Aptamer after
it becomes a Lead Compound. Confidential Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
21
(b)
Administrative Matters . The JRC shall appoint [***]
co-chairpersons, [***] from among the representatives of EYETECH
and [***] from among the representatives of ARCHEMIX (the
"Chairpersons"). The Chairpersons shall be responsible for calling
meetings of the JRC and for leading the meetings at their
respective facilities. A JRC member of the Party hosting a meeting
of the JRC shall serve as secretary of that meeting. The secretary
of the meeting shall prepare and distribute to all members of the
JRC minutes of the meeting within [***] days following the meeting
to allow adequate review and comment. Such minutes shall provide a
description in reasonable detail of the discussions held at the
meeting and a list of any actions, decisions or determinations
approved by the JRC. Minutes of each JRC meeting shall be approved
or disapproved, and revised as necessary, at the next meeting.
(c) The
location of meetings of the JRC shall alternate between
ARCHEMIX’s principal place of business and EYETECH’s
principal place of business, or as otherwise agreed by the Parties.
The JRC may also meet by means of a telephone conference call or
videoconference. Each Party may change any one or more of its
representatives to the JRC at any time upon notice to the other
Party. Each Party shall use reasonable efforts to cause its
representatives to attend the meetings of the JRC. If a
representative of a Party is unable to attend a meeting, such Party
may designate an alternate to attend such meeting in place of the
absent representative. In addition, each Party may, at its
discretion, invite non-voting employees, and, with the consent of
the other Party, consultants or scientific advisors, to attend the
meetings of the JRC to, among other things, review and discuss the
Research Program and its results. Either Party may convene a
special meeting of the JRC for the purpose of resolving disputes.
(d)
Decision Making . Until the time a Compound becomes a Lead
Compound, the goal of all decision making as to such Compound shall
be to achieve consensus, recognizing ARCHEMIX’s expertise in
the identification and optimization of Aptamers and EYETECH’s
right to select Targets for consideration by the JRC. Prior to the
Lead Compound designation each Party (acting through its designated
members) shall have one vote on the JRC to be cast by its
Co-Chairperson and unanimous agreement shall be required for any
action, except as set forth in Section 2.5.
(e)
Term . The JRC shall function during the Research Term.
Confidential Portions of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment
under Rule 406 of the Securities Act.
22
2.2
Management of Research Program.
(a)
Program Directors . ARCHEMIX and EYETECH shall each appoint
a Program Director prior to the Effective Date. Each Party shall
have the right, after consultation with the other Party, to
designate a different Program Director. The Program Directors shall
jointly oversee the conduct of the Research Program, shall report
to the JRC and shall be responsible for recommending to the JRC any
changes to the Annual Research Plan.
(b)
Project Teams . The Program Directors shall appoint one or
more appropriate Project Teams, in each case consisting of
representatives from ARCHEMIX and EYETECH, to facilitate the
conduct of elements of the Research Program in (i) the areas
set forth in the Annual Research Plan and (ii) such other
areas as may be agreed upon by the Program Directors.
(c)
Dispute Resolution . The Program Directors shall decide
matters appropriate to the scope of their responsibilities on a
consensus basis. In the event that the Program Directors are unable
to reach agreement on any matter within [***] business days after
the matter is first considered by them, the issue may be referred
to the JRC by either Program Director for resolution thereby.
2.3
Annual Research Plan.
(a)
Annual Research Plan . The JRC shall prepare and approve the
Annual Research Plan for first Contract Year within [***] days of
the Effective Date. Thereafter the JRC shall prepare and approve
the Annual Research Plan for each Contract Year during the Research
Term (other than the First Contract Year) at least [***] days prior
to the commencement of such Contract Year. At EYETECH’s
request, the JRC shall include in the Annual Research Plan a plan
to discover and develop Compounds against the Targets PDGF and
VEGF, so long as the Parties obtain any necessary rights covering
VEGF from Gilead. In the event the JRC fails to approve an Annual
Research Plan due to a dispute over the contents of such Annual
Research Plan, each Party shall have the right to refer such
dispute to resolution pursuant to Section 11.2. Confidential
Portions of this Exhibit were omitted and have been filed
separately with the Secretary of the Commission pursuant to the
Company’s application requesting confidential treatment under
Rule 406 of the Securities Act.
23
(b)
Updates and Amendments . The JRC shall review and approve
updates and amendments, as appropriate, to the current Annual
Research Plan during the course of the applicable Contract Year.
(c)
Content . Each Annual Research Plan shall be consistent with
the other terms and conditions of this Agreement. Each Annual
Research Plan shall specify, among other things, (i) specific
research objectives and priorities, (ii) specific activities
to be performed, (iii) the Party responsible for performance
of an activity, (iv) the number and types of FTEs expected to
be assigned to specific activities by each Party,
(v) timelines for performance and (vi) specific
deliverables. The Annual Research Plan shall not require ARCHEMIX
to perform any research other than the identification and
optimization of Aptamers using the SELEX Process but ARCHEMIX
agrees to reasonably consider requests to perform such other work
related to the identification of Lead Compounds as may be requested
by EYETECH. The number of FTEs to be provided by ARCHEMIX may not
be increased without at least [***] months prior notice to ARCHEMIX
and may never be reduced below [***] and for any reduction ARCHEMIX
must be given at least [***] months prior written notice.
(d)
Implementation . The Parties shall undertake the Research
Program in accordance with the Annual Research Plan.
2.4
Obligations under the Research Program
(a)
ARCHEMIX Obligations and Restrictions . Subject to the
oversight of the JRC, during the Research Term, ARCHEMIX agrees
that:
(i) with
respect to the Annual Research Plan, (A) ARCHEMIX shall
undertake the responsibilities assigned to it, as set forth in the
Annual Research Plan, and (B) ARCHEMIX shall make available
for the conduct of the Research Program, as needed, those resources
to be provided by ARCHEMIX as set forth in the Annual Research
Plan;
(ii) as
of the Effective Date, ARCHEMIX shall have disclosed to EYETECH all
ARCHEMIX Initial Compounds; and Confidential Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
24
(iii) during
the Research Term ARCHEMIX shall use Diligent Efforts to perform
the activities assigned to ARCHEMIX in the Annual Research Plan in
a professional and timely manner(the "ARCHEMIX Diligence Goal"). In
the event ARCHEMIX fails to meet the ARCHEMIX Diligence Goal within
a [***] month period, EYETECH shall have no obligation to meet its
Diligence Goal pursuant to Section 2.4 (b) (iii) within
such period.
(b)
EYETECH Obligations . Subject to the oversight of the JRC,
EYETECH agrees that:
(i) during
the Research Term, to pay the FTE Rate per FTE per annum, quarterly
in advance based on the number of FTEs set forth in the Annual
Research Plan for the quarter;
(ii) with
respect to the Annual Research Plan, EYETECH shall undertake the
responsibilities assigned to it in the Annual Research Plan,
including, but not limited to, the dedication of resources to such
efforts as set forth in the Annual Research Plan; and
(iii) during
the Research Term, EYETECH shall use Diligent Efforts to meet the
EYETECH Diligence Goal. The "EYETECH Diligence Goal" shall be to
(A) approve at least [***] Lead Compound (in accordance with
Section 3.4) which is ARC127 in its pegylated or non-pegylated
form, a Compound against VEGF, a Program Compound that was not
originally an ARCHEMIX Initial Compound or an ARCHEMIX Additional
Compound or a Program Compound that was originally an ARCHEMIX
Initial Compound or an ARCHEMIX Additional Compound but which was
designated as a Program Compound prior to achieving the ESC in each
[***] month period, (B) move at least one such Lead Compound
to Development Compound status in each [***] month period and
(C) commence at least [***] IND for a Development Compound
which is ARC127, a Compound against VEGF, a Program Compound that
was not originally an ARCHEMIX Initial Compound or an ARCHEMIX
Additional Compound or a Program Compound that was originally an
ARCHEMIX Initial Compound or an ARCHEMIX Additional Compound but
which was designated as a Program Compound Prior to achieving the
ESC in each [***] year period, except, without limitation in each
of (A), (B) and Confidential Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
25
(C), for any delays caused by ARCHEMIX’s failure to meet
the ARCHEMIX Diligence Goal, an inconsequential delay by EYETECH or
Force Majeure. In addition, in the event of a deadlock of the JRC
continuing for more than [***] months with respect to inclusion of
a target in the Research Program, and the dispute is resolved in
EYETECH’s favour, then EYETECH’s diligence requirement
in (A) shall be extended by the duration of the deadlock and
dispute resolution.
(c)
Failure to meet Diligence Goals . ARCHEMIX may terminate the
Research Program, but not this Agreement and the licenses granted
hereunder, if EYETECH fails to achieve any aspect of the EYETECH
Diligence Goal, provided, that such failure is not caused by
ARCHEMIX’ failure to meet the ARCHEMIX Diligence Goal;
provided, however, that (i) EYETECH Diligence Goal "A" shall
be waived for any [***]-month period in which EYETECH has paid for
[***] FTEs per year at ARCHEMIX; (ii) EYETECH Diligence Goal "B"
shall be waived for any [***]-month period in which EYETECH has
paid for [***] FTEs per year at ARCHEMIX during the entire period;
and (iii) EYETECH Diligence Goal "C" shall be waived for any
[***] year period for which EYETECH has paid for [***] FTEs per
year at ARCHEMIX during the entire period.
2.5
Target Selection . The JRC shall determine which Targets
shall be utilized for identification of Compounds under the
Research Program ; provided that in no event will any of the
targets listed in Section 1.32 be utilized as a Target under
this Agreement except as set forth in Section 8.7.2. ARCHEMIX
and EYETECH each may propose Targets to be used for identification
of Compounds under the Research Program. If any Target is presented
by either Party, the JRC will consider such Target and such Target
may be included in the Research Program, or deferred for later
consideration until the Parties agree in writing that such Target
shall become a Refused Target; provided, however that Targets
proposed by EYETECH shall be included in the Research Program
unless there is a compelling scientific reason to exclude such
Target. In the event the JRC refuses to accept, or can not reach
consensus on the acceptance of a proposed Target for inclusion into
the Research Program and EYETECH believes there exists no
compelling scientific reason for excluding such Target from
inclusion into the Research Program, then EYETECH shall have the
right to refer such matter to dispute resolution pursuant
Confidential Portions of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment
under Rule 406 of the Securities Act.
26
to Section 11.2. If the JRC determines that such Target
does not have potential utility in the Field, such Target shall be
a Refused Target. Once a Target is selected, (i) the JRC will
promptly develop the ESC for such Target and the activities which
will establish that an Aptamer against such Target is a Development
Compound to be set forth in Appendix 3, and (ii) EYETECH
will propose a molecule to be designated as the Target Binding
Partner for such Target and will present to the JRC the data
supporting such designation and the JRC will determine the Target
Binding Partner for such Target. For the avoidance of doubt,
nothing in this Agreement shall give ARCHEMIX any right to utilize
any EYETECH Proprietary Target, (excluding any Target that is
within the definition of EYETECH Proprietary Target solely because
it is covered by claims in a Joint Program Patent), for any purpose
other than in the performance of its obligations or the exercise of
its rights under this Agreement and nothing in this Agreement shall
give EYETECH any right to utilize any ARCHEMIX Proprietary Target,
(excluding any Target that is within the definition of ARCHEMIX
Proprietary Target solely because it is covered by claims in a
Joint Program Patent), for any purpose other than in the
performance of its obligations or the exercise of its rights under
this Agreement.
2.6
Compliance with Laws . Each Party agrees to use commercially
reasonable efforts to carry out all work assigned to such Party in
the Annual Research Plan in material compliance with all applicable
federal, supranational, state or local laws, regulations and
guidelines governing the conduct of such work, including, without
limitation, all applicable export and import control laws.
2.7
Product Labelling . All Compound Products and all VEGF
Products sold by a Party shall carry that Party’s name and
logo. A Party shall have no rights to have its name and logo
incorporated on the label or otherwise associated with the other
Party’s Compound Products or VEGF Products (as applicable).
2.8
Progress Reports . Within [***] business days after the end
of each calendar quarter, each Party shall provide to the other
Party a written report summarizing the activities undertaken by the
reporting Party during the preceding calendar quarter in connection
with the Research Program. ARCHEMIX’s report shall include
details on the number of FTEs dedicated Confidential Portions of
this Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
27
to and actually working on the Research Program, and ARCHEMIX
shall maintain adequate records to verify such work.
2.9
Research Records . ARCHEMIX shall maintain complete and
accurate records, in sufficient detail and in good scientific
manner appropriate for patent and regulatory purposes, that fully
and properly reflect in all material respects all work done and
results achieved in the performance of the Research Program. Such
records shall include, but not be limited to, as appropriate in the
particular circumstances, all books, reports, research notes,
charts, graphs, comments, computations, analyses, recordings,
photographs, computer programs, databases, and documentation
thereof, samples of materials and other graphic, written or
tangible data or material generated in connection with the Research
Program, including any data required to be maintained pursuant to
all requirements of applicable laws and regulations, and records of
the number, qualifications and job responsibilities of FTEs working
on the Research Program. All of such books and records related to
the Research Program shall be subject to audit by EYETECH. EYETECH
shall have the right, during normal business hours and with
reasonable notice, to inspect and copy all such records of
ARCHEMIX. Notwithstanding the foregoing, EYETECH shall not have the
right to audit or copy any materials that relate to Aptamers that
do not, or have been determined not to, have utility in the Field
or that become Refused Candidates or are ARCHEMIX Initial Compounds
or ARCHEMIX Additional Compounds that have not been designated as
Program Compounds. ARTICLE 3 LICENSE OPTION
3.1
Exclusive Option. During the Option Period, EYETECH shall
have the exclusive right and option to select for further
Development and Commercialization hereunder (the "License Option")
(i) Program Compounds based on its own analysis of information
provided by ARCHEMIX hereunder, and/or (ii) Compound
Candidates.
3.2
Process for Determining Compound Candidate .
(a)
ARCHEMIX Initial Compounds . As of the Effective Date,
ARCHEMIX shall have disclosed in writing to EYETECH and the JRC all
Aptamers (other than Excluded Aptamers) Controlled by ARCHEMIX
including without limitation, ARC 127 in its Confidential Portions
of this Exhibit were omitted and have been filed separately with
the Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
28
pegylated and non-pegylated variations ("ARCHEMIX Initial
Compounds"). Of the ARCHEMIX Initial Compounds, ARCHEMIX will
identify up to [***] ARCHEMIX Initial Compounds against up to [***]
targets for immediate consideration by the JRC ("ARCHEMIX Early
Decision Initial Compounds"). If the JRC elects to have any such
Aptamer included in the Research Program, which the JRC cannot
refuse to do for ARCHEMIX Initial Compounds selected by EYETECH for
up to [***] Initial Compounds per target, unless there exists a
compelling scientific basis for such refusal, the JRC will modify
the Annual Research Plan accordingly and will establish the ESC and
activities to be set forth in Appendix 3 for such Aptamer, and
such Aptamer shall thereafter be a Program Compound hereunder. If
the JRC does not select an ARCHEMIX Initial Compound for inclusion
in the Research Program within [***] days, or an ARCHEMIX Early
Decision Initial Compound on or before April 26, 2004, such
Aptamer will not be a Program Compound, but ARCHEMIX may request
the JRC to establish ESC for no more than [***] ARCHEMIX Initial
Compounds per [***] and the JRC will do so within [***] days. At
any time during the Research Term upon EYETECH’S request,
ARCHEMIX shall provide updates to EYETECH with respect to the
development status of the ARCHEMIX Initial Compounds which have not
become Program Compounds, and EYETECH and ARCHEMIX may, at
ARCHEMIX’s sole option, agree through the JRC to include into
the Program such ARCHEMIX Initial Compounds. In addition at any
time during the Research Term, EYETECH shall have the right to
request the JRC to include into the Research Program an effort to
discover Aptamer Equivalents of ARCHEMIX Initial Compounds that
have not become Program Compounds, and the JRC shall approve the
inclusion of such Aptamer Equivalents which then becomes a Program
Compound unless there exists a compelling scientific reason to
refuse such approval.
(b)
Program Compounds . Within [***] business days of the end of
each calendar quarter (ending each March 31, June 30,
September 30 and December 31) during the Research Term
ARCHEMIX will notify EYETECH and the JRC of each Program Compound
identified in such calendar quarter.
(c)
Archemix Additional Compounds. In addition, ARCHEMIX may, in
its sole discretion, notify EYETECH of any Aptamer identified by
ARCHEMIX outside the Confidential Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
29
Research Program believed by ARCHEMIX to have potential
application in the Field and for Aptamers against VEGF in the Field
("ARCHEMIX Additional Compounds"). If the JRC elects to have any
ARCHEMIX Additional Compound included in the Research Program, the
JRC will modify the Annual Research Plan accordingly and will
establish the ESC and activities to be set forth in Appendix 3
for such Aptamer and such Aptamer shall thereafter be a Program
Compound hereunder. If the JRC does not elect to have an ARCHEMIX
Additional Compound included in the Research Program within [***]
days after disclosure thereof, such Aptamer will not be a Program
Compound, but ARCHEMIX may then request the JRC to establish ESC
for such Aptamer and the JRC will do so within [***] days. The JRC
shall not be obligated to consider more than [***] ARCHEMIX
Additional Compounds for inclusion in the Research Program per
calendar quarter.
(d)
Development Information . ARCHEMIX will provide EYETECH and
the JRC on a quarterly basis during the Research Term, with notice
of all material information applicable to the Field known to
ARCHEMIX about any Program Compound (the "Development
Information"), including analysis results and raw data which the
JRC should reasonably require to assess whether a given Program
Compound meets the Early Selection Criteria or which EYETECH should
reasonably require in order for EYETECH (i) to exercise its
rights under this Agreement, and (ii) to decide, in
EYETECH’s sole discretion, whether to exercise the License
Option with respect to such Program Compound or Compound Candidate,
as applicable. The Development Information shall also include any
previously undisclosed information with respect to ARCHEMIX
Technology, which is important for a scientific and commercial
evaluation of the Program Compound. EYETECH expects to utilize
evaluation criteria such as those set forth on
Appendix 1 , without limitation, in its assessment of
whether to license Program Compounds or Compound Candidates.
(e) In
addition to the Development Information, at the request of EYETECH
given within [***] days of the notice under Section 3.2(b)
hereof, ARCHEMIX shall supply EYETECH with up to [***] of the
Program Compound or Compound Candidate (the "Material") at
ARCHEMIX’s direct manufacturing cost of production (which
includes (i) direct and indirect labor (salaries, wages and
employee benefits) and (ii) direct and indirect materials)
Confidential Portions of this Exhibit were omitted and have been
filed separately with the Secretary of the Commission pursuant to
the Company’s application requesting confidential treatment
under Rule 406 of the Securities Act.
30
thereof for EYETECH’s use in connection with determining
whether to exercise the License Option with respect to such Program
Compound or Compound Candidate (the "Evaluation"). ARCHEMIX will
use commercially reasonable efforts to deliver the Material to
EYETECH no later than [***] days following EYETECH’s request
and shall be accompanied by a document setting forth the sequence
of the Program Compound or Compound Candidate and any analytic
information with respect thereto which ARCHEMIX has available.
ARCHEMIX shall make no warranty. At the request of EYETECH,
ARCHEMIX will provide additional quantities of the Material at
ARCHEMIX’s fully loaded cost of production thereof.
EYETECH’s use of the Material shall be subject to the
following provisions:
(i) EYETECH
agrees to use the Material only for non-commercial internal
research in the conduct of the Evaluation. EYETECH shall not
(i) provide access to or distribute the Material to any third
party other than employees of EYETECH who are working on the
Evaluation and who are bound by the requirements of this Agreement,
(ii) otherwise use such Material in research outside of the
Evaluation, nor (iii) modify or change in any way the
Material, in any case without the express prior written consent of
ARCHEMIX. Any Material delivered pursuant to this Agreement
(x) is understood to be experimental in nature and may have
hazardous properties (and EYETECH agrees to handle the Material
accordingly), (y) is supplied solely for use in animals used
exclusively for testing and/or in vitro testing, and
(z) is not to be used for in vivo testing in humans. If
the relevant License Option is not exercised in accordance with its
terms, then upon expiration thereof, EYETECH shall at the
instruction of ARCHEMIX either destroy or return any unused
Material;
(ii) EYETECH
shall use the Material only in compliance with all applicable
Federal, state, and local laws, regulations and guidelines; and
(iii) EYETECH
acknowledges and agrees that, subject to EYETECH’s rights
following exercise of the relevant License Option, all Material is
and shall be owned by ARCHEMIX and EYETECH has no right to
ownership of the Material and ARCHEMIX reserves all intellectual
property rights therein and thereto. Confidential Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
31
(f) If
ARCHEMIX reasonably believes any Program Compound, or any ARCHEMIX
Additional Compound or ARCHEMIX Initial Compound that has been
presented by ARCHEMIX but has not become a Program Compound has met
the ESC and thus should be designated as a Compound Candidate,
ARCHEMIX shall notify the JRC and EYETECH in writing (the "Compound
Candidate Notice"), and shall provide to the JRC the data and
information demonstrating that the Program Compound, ARCHEMIX
Initial Compound or ARCHEMIX Additional Compound satisfies the
relevant ESC. At the request of the JRC, ARCHEMIX shall provide the
JRC with such additional data as the JRC shall reasonably request.
Within [***] days after its receipt of the Compound Candidate
Notice, or (as applicable) its receipt of the requested additional
data, the JRC shall (i) review the data and information using
the relevant ESC, (ii) determine whether such Program Compound,
ARCHEMIX Initial Compound or ARCHEMIX Additional Compound satisfies
such ESC and (iii) notify the Parties in writing of such
determination. If the determination is positive, such Program
Compound, ARCHEMIX Initial Compound or ARCHEMIX Additional Compound
shall be deemed to have been so designated as a Compound Candidate
as of the date of the Compound Candidate determination. Any
negative determination shall be accompanied by a detailed
explanation of the reasons therefor.
In the
Event that the JRC fails to determine if the Program Compound,
ARCHEMIX Initial Compound or ARCHEMIX Additional Compound is a
Compound Candidate within such [***] day period, the matter will be
resolved in accordance with Section 11.2.1 hereof.
If it
is determined by the JRC or under Section 11.2.1 hereof that
the Program Compound, ARCHEMIX Initial Compound or ARCHEMIX
Additional Compound does not meet the ESC, the JRC may amend the
Annual Research Plan to add performance by ARCHEMIX, as a part of
the Research Program and using the resources set forth in the
Annual Research Plan, any activities, identified by the JRC as
necessary and reasonable to determine if the Program Compound,
ARCHEMIX Initial Compound or ARCHEMIX Additional Compound fulfils
the ESC, that are susceptible of being performed and resubmit the
resulting information to the JRC, whereupon the procedure set forth
above shall again apply. Confidential Portions of this Exhibit were
omitted and have been filed separately with the Secretary of the
Commission pursuant to the Company’s application requesting
confidential treatment under Rule 406 of the Securities
Act.
32
3.3 Option and Review
Periods.
3.3.1
Option Period . The option period (the "Option Period") for
each Compound Candidate and its Back-Up, as applicable, commences
when it is determined that the Compound is a Compound Candidate and
ends, on a Compound Candidate -by-Compound Candidate basis, upon
the later of (i) [***] days in the case of a Program Compound
identified in the Research Program, and [***] days in the case of a
Program Compound that was initially an ARCHEMIX Initial Compound or
an ARCHEMIX Additional Compound, after the date of the relevant
Compound Candidate determination or the determination pursuant to
Section 11.2.1 hereof that a Program Compound meets the ESC
and (ii) [***] days after the date of receipt by EYETECH of the
initial quantity of Material and all of the Development Information
that has been developed as of the date of delivery of the initial
quantity of Material for that Compound Candidate or Back-Up, as
applicable, contemplated in Section 3.2 above.
3.4 Exercise of Option .
EYETECH may exercise a License Option and accept a Program Compound
for further Development and Commercialization, either for itself or
on behalf of any of its Affiliates, by delivery to ARCHEMIX, within
the relevant Option Period for such License Option, of a written
notice of exercise (an "Exercise Notice"), specifying the Program
Compound as to which such License Option is being exercised and by
paying (i) the entire payment for Milestone (A) set forth
in Section 5.3.1 for each Exercise Notice; it being understood
that for VEGF Products the Milestones and Payments set forth in
Section 5.4.1 shall apply. In addition, EYETECH may designate
a Program Compound as a Compound Candidate at any time and may
exercise its License Option with respect to an ARCHEMIX Initial
Compound that has become a Program Compound, Program Compound, or
ARCHEMIX Additional Compound that has become a Program Compound at
any time before the Option Period begins, regardless of whether the
Compound meets the ESC, unless it has become a Refused Candidate or
is directed to a Refused Target. 3.5
Back-Ups.
3.5.1
Delivery of a Back-Up for each Compound Candidate . As
directed by the JRC, for each Compound Candidate provided to
EYETECH by ARCHEMIX, ARCHEMIX will Confidential Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
33
use diligent and commercially reasonable efforts, consistent
with those customary in the industry, to deliver to EYETECH an
Aptamer in addition to the Compound Candidate as a follow-up
Aptamer against the Target, which is distinct in chemical structure
from the Compound Candidate ("Back-Up"). ARCHEMIX’s
activities to identify a Back-Up shall be performed as a part of
the Research Program using the resources set forth therein and the
Annual Research Plan shall be amended accordingly. The rights and
obligations of the Parties relating to a Back-Up shall be identical
to those applicable to the accompanying Compound Candidate, except
as otherwise expressly provided herein.
3.6
Back-Up Notices . EYETECH shall notify ARCHEMIX in writing
in the event EYETECH chooses to replace a Compound Candidate, Lead
Compound or Development Compound with the applicable Back-Up or to
develop the Back-Up in addition to the Compound Candidate, Lead
Compound or Development Compound. Subsequent to such notice, as
applicable, any reference to the Compound Candidate, Lead Compound
or Development Compound shall be deemed to include or to be made to
the Back-Up for the purposes of this Agreement.
3.7
Refused Candidate . If EYETECH does not exercise its License
Option with respect to a particular Compound Candidate or its
Back-Up within the Option Period for such Compound Candidate, then
the applicable License Option shall expire and such Compound
Candidate and its Back-Up shall be a Refused Candidate, and
ARCHEMIX will thereafter, subject to its obligations under
Sections 4.2.3 and 4.2.5.1, be free to exercise all of its
rights with respect to the Refused Candidate at is own costs and
expense; provided, however, that nothing contained in this Section
3.7 shall be deemed to constitute a license under any EYETECH
Technology or EYETECH Program Technology. In addition, if there are
no other Program Compounds directed to the Target against which the
Refused Candidate is directed and Aptamers against such Target are
not the subject of activities in the Research Program or the
EYETECH Development Program, then the Target against which the
Refused Candidate is directed shall be a Refused Target without
further action by the Parties. However, Refused Candidates directed
against VEGF can only be used by Archemix outside of the Field and
the Local Delivery Field. Confidential Portions of this Exhibit
were omitted and have been filed separately with the Secretary of
the Commission pursuant to the Company’s application
requesting confidential treatment under Rule 406 of the
Securities Act.
34
Nothing in this Agreement shall provide Archemix with the right,
and ARCHEMIX hereby covenants not to use Aptamers directed against
VEGF in the Field or in the Local Delivery Field. ARTICLE 4
LICENSES; DEVELOPMENT AND COMMERCIALIZATION
4.1 Evaluation License to
EYETECH . Solely for the purpose of evaluating the efficacy of
Compounds for Indications, during the Research Term, ARCHEMIX
hereby grants to EYETECH a non-exclusive, royalty-free license,
sublicensable only to its Affiliates and Service Providers, in the
Territory under the ARCHEMIX Technology, ARCHEMIX Program
Technology, ARCHEMIX Program Patents, ARCHEMIX’s interest in
the Joint Program Technology and Joint Program Patents, and any
ARCHEMIX Valid Claim covering an ARCHEMIX Proprietary Target to
which such Compounds are directed, to use and practice the ARCHEMIX
Technology, ARCHEMIX Program Technology, Joint Program Technology,
ARCHEMIX Proprietary Target and manufacture or have manufactured
such Compounds,; provided , however , that no license
is granted to EYETECH (i) under any ARCHEMIX Valid Claim
relating to any ARCHEMIX Proprietary Target, except as expressly
provided in this Section 4.1 or (ii) to use or practice
the SELEX Process. 4.2 Development
and Commercialization License Grants to EYETECH; Exclusivity .
4.2.1 License . Effective upon each exercise of a License
Option by EYETECH for a Program Compound or Compound Candidate
hereunder, ARCHEMIX hereby grants to EYETECH an exclusive,
royalty-bearing (during the applicable Royalty Term only) license
in the Territory, with the right to grant sublicenses as set forth
in Section 4.2.2 below, under the ARCHEMIX Technology,
ARCHEMIX Program Technology, ARCHEMIX Program Patents and
ARCHEMIX’s interest in the Joint Program Technology and Joint
Program Patents, and under any ARCHEMIX Valid Claim covering an
ARCHEMIX Proprietary Target to which such Lead Compound is
directed, to Develop, modify, manufacture, have manufactured,
export, import, use, sell and offer to sell, Compound Products in
the Field incorporating such Lead Compound and all Back Ups
relating to such Lead Compound; provided, however, that no license
is granted to EYETECH under any claim of any ARCHEMIX Patent or
ARCHEMIX Program Patent (i) under any ARCHEMIX Valid Claim
relating to any ARCHEMIX Proprietary Confidential Portions of this
Exhibit were omitted and have been filed separately with the
Secretary of the Commission pursuant to the Company’s
application requesting confidential treatment under Rule 406
of the Securities Act.
35
Target, except as expressly provided in this Section 4.2.1
or (ii) to use or practice the SELEX Process. The foregoing
license is granted for an unlimited number of Lead Compounds for
which the License Option is duly exercised and an unlimited number
of instances during the Term. Upon each exercise of a License
Option by EYETECH, ARCHEMIX will provide a complete list of all
patents it controls that, but for the grant of the license, would
be infringed by the manufacture, use, sale, offer for sale or
import of the anticipated Compound Products in the Field to which
such Lead Compound is directed. ARCHEMIX shall provide updates to
such list as requested by EYETECH.
4.2.2
Sublicense Rights . Subject to the terms of this Agreement,
EYETECH shall have the right to grant sublicenses solely under the
license granted pursuant to Section 4.2.1 above and
Section 4.13.1 below. EYETECH shall give ARCHEMIX prompt
written notice of each sublicense under this Agreement along with a
true, correct and complete copy of such sublicense promptly
following execution thereof by the parties thereto with financial
and other information redacted that is not required to enable
ARCHEMIX to fulfill its reporting obligations to Gilead under the
Gilead-Archemix License. Any such sublicense shall contain
provisions for the assignment to ARCHEMIX of EYETECH’s
interest therein upon termination of this Agreement, subject to the
last sentence of this Section 4.2.2, unless the termination of
this Agreement arises out of the action or inaction of such
Sublicensee or the Sublicensee is then in breach of its obligations
under such sublicense, in which case ARCHEMIX, at its option, may
terminate such sublicense. Each sublicense shall also contain
provisions which obligate such Sublicensee to comply with terms,
conditions, agreements and obligations that are consistent with the
terms, conditions, agreements and obligations to which EYETECH is
subject under this Agreement. ARCHEMIX hereby agrees to accept such
assignment and that such sublicense, as assigned, will remain in
full force and effect, provided that ARCHEMIX shall have no
obligation thereunder except to maintain the continued
effectiveness of the sublicense.
4.2.3
Exclusivity for Compounds . ARCHEMIX hereby agrees that
(A) neither ARCHEMIX nor its Affiliates will use, make, have
made, offer to sell, sell
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