Exhibit 10.4
***Text Omitted and Filed
Separately
with the Securities and Exchange
Commission.
Confidential Treatment Requested
Under 17 C.F.R. Sections
200.80(b)(4)
and 240.24b-2.
COLLABORATION
AGREEMENT
This Collaboration Agreement
(hereinafter called the “Agreement”) made and entered
into this 28 th day of February 2005 (the
“Effective Date”), by and between
Neurogenetics, Inc., a corporation organized and existing
under the laws of Delaware (“Neurogenetics”), with
principal place of business at 11085 North Torrey Pines Road, La
Jolla, CA 92037, the United States of America, and Eisai Co., Ltd.,
a corporation organized and existing under the laws of Japan
(“Eisai”), with its registered office at 6-10
Koishikawa 4-chome, Bunkyo-ku, Tokyo 112-8088, Japan.
WITNESSETH THAT:
WHEREAS , Neurogenetics is engaged in a certain project
for the discovery of Compounds (as defined below) in the field of
Alzheimer’s disease in humans; and
WHEREAS, Eisai wishes to participate in such project in
the manner and to the extent described below, to obtain the first
negotiation right with respect to any and all intellectual property
of Neurogenetics claiming, disclosing or covering any Validated
Compounds (as defined below), or the manufacture, use, sale, offer
for sale or import of any Validated Compounds, arising out of or
resulting from such project and to obtain a right of first refusal
with respect to any Term Sheet (as defined below), on the terms set
forth in this Agreement.
NOW, THEREFORE
, for good and valuable
consideration, the receipt and sufficiency of which is
acknowledged, the Parties hereto agree as follows:
ARTICLE 1
DEFINITIONS
As used in this Agreement, the
following terms shall have the following respective meanings, and
except as explicitly noted, each definition shall apply
appropriately to the plural
form of the word as well as to the
singular:
1.1
“Affiliate” shall mean any corporation, firm, association,
joint venture, partnership or other entity which directly or
indirectly Owns, is Owned by or is under common Ownership with
either Party. The terms “Owns”, “Owned” and
“Ownership” for purpose of determining status as an
Affiliate shall mean ownership of at least fifty percent (50%) of
the voting equity or other ownership interest conferring on the
entity who holds it the power directly or indirectly to control or
direct the affairs of such corporation, firm, association, joint
venture, partnership, or other entity (or such lesser percentage in
a particular jurisdiction that provides such control).
1.2
“Adverse
Ruling” shall have
the meaning set forth in Section 6.2
1.3
“ADR”
shall have the meaning set forth in
Exhibit B hereto.
1.4
“Compound”
shall be a chemical entity that
lowers amyloid beta 42 peptide without significantly affecting
Notch processing. For clarification, the definition of
“Compounds” excludes Neurogenetics’ muscarinic
receptor agonist compounds, including, without limitation, NGX267
and NGX292.
1.5
“Dispute”
shall have the meaning set forth in
Section 8.3.
1.6
“Effective
Date” shall mean
the date first set forth above.
1.7
“Eisai’s
Counsel” shall mean
Eisai’s designated outside counsel, who is identified in
Exhibit C.
1.8
“Eisai’s Proprietary
Information” shall
mean any and all scientific and technical information and data,
know-how and concepts which have been developed prior to the
Effective Date or hereafter developed during the term of this
Agreement by or on behalf of Eisai.
1.9
“Extension
Term” shall have
the meaning set forth in Section 6.1.
1.10
“FTE”
shall mean the equivalent of work
performed during a twelve (12)-month period on a full time basis by
a scientist or other professional (whether an employee or
independent contractor of Neurogenetics) possessing skills and
experience necessary for Neurogenetics to carry out the
Project.
1.11
“Indication of
Interest” shall
have the meaning set forth in Section 3.2(c).
1.12
“Negotiation
Period” shall have
the meaning set forth in Section 3.2(d).
1.13
“Neurogenetics’
Property” shall
mean any and all intellectual property (including, without
limitation, all patents, patent applications, trade secrets and
know-how) claiming, disclosing or covering any Validated Compound
resulting from the Project and any and all Neurogenetics’
Proprietary Information with respect to any such Validated
Compound.
1.14
“Neurogenetics’
Proprietary Information” shall mean any and all scientific and technical
information and data, know-how and concepts which have been
developed prior to the Effective Date by or on behalf of
Neurogenetics in the course of its project for the discovery of
Compounds in the field of treatment or prevention of
Alzheimer’s disease in humans, or are hereafter developed
during the term of this Agreement by or on behalf of Neurogenetics
in the course of the Project.
1.15
“Neutral”
shall have the meaning set forth in
Exhibit B hereto.
1.16
“Party”
and “Parties”
shall mean Eisai or Neurogenetics or both, as
applicable.
1.17
“Project”
shall mean the project for the
discovery of Compounds in the field of treatment or prevention of
Alzheimer’s disease in humans, which Neurogenetics is
performing and will carry out during the Term, as specified in the
Project Plan.
1.18
“Project
Plan” shall mean
the plan attached as Exhibit A hereto and incorporated
herein.
1.19
“Recipient” shall have the meaning set forth in
Section 7.1.
1.20
“Response
Period” shall have
the meaning set forth in Section 3.2(f).
1.21
“Term”
shall have the meaning set forth in
Section 6.1.
1.22
“Term
Sheet” shall have
the meaning set forth in Section 3.2(f).
1.23
“Validated
Compound” shall
mean (a) any Compound discovered or identified by or on behalf
of Neurogenetics prior to the Effective Date or in the course of
the Project, which is designated by Neurogenetics as validated in
accordance with the Validation Criteria in effect at the time the
applicable quarterly report detailing such Compound is submitted to
Eisai’s Counsel where such designation is confirmed by Eisai
pursuant to Section 3.2(a), and (b) hydrates, solvates,
salts, stereoisomers, prodrugs and polymorphs of such
Compound.
1.24
“Validation
Criteria” shall
mean the biochemical, toxicological and/or pharmacological criteria
for validating a Compound identified in the course of the Project
that are attached hereto as Exhibit D and incorporated by
reference herein, as they may be amended upon written
agreement of the Parties.
ARTICLE 2
COLLABORATION AND
GOVERNANCE
2.1
Neurogenetics shall use all
reasonable efforts to conduct the Project during the Term in
accordance with the Project Plan. However, it is agreed and
acknowledged that, so long as it conducts the Project in accordance
with the Project Plan, Neurogenetics shall be solely responsible
for conducting the Project, and shall, in its sole discretion,
select the research tools and methods that are used in the course
of the Project. Eisai shall not control the Project. Neurogenetics
shall devote such personnel and other resources to the Project
during each year of
the Term as is appropriate to perform or
support the work to be conducted under the Project in accordance
with the Project Plan.
2.2
Neurogenetics acknowledges that
Eisai has developed and possesses its own proprietary chemical
entities resulting from its own project whose purpose is to
discover lead compounds that selectively lower amyloid beta peptide
without significantly affecting Notch processing and that Eisai
will continue to develop its own chemical entities in an effort to
obtain pharmaceutical compounds which will be suitable for clinical
development in the field of Alzheimer’s disease. In this
respect, the Parties agree to establish mutually acceptable
procedures to prevent the disclosure of Eisai’s Proprietary
Information to Neurogenetics and, except as provided herein, to
prevent the disclosure of Neurogenetics’ Proprietary
Information to Eisai.
ARTICLE 3
FIRST NEGOTIATION RIGHT AND RIGHT
OF FIRST REFUSAL
3.1
Neurogenetics hereby grants to
Eisai, during the Term and the Extension Term, as applicable, the
exclusive right to be the first to negotiate terms and conditions
to license, collaborate, form alliances, joint ventures and/or
partnerships or other similar business arrangements with respect to
a Validated Compound and Neurogenetics’ Property claiming,
disclosing or covering such Validated Compound or its manufacture,
use, sale, offer for sale or import in accordance with
Section 3.2. Neurogenetics also grants to Eisai a right of
first refusal on any Term Sheet (as defined below) in accordance
with Section 3.2.
3.2
The Parties agree and acknowledge
that Eisai’s exclusive right, set forth in Section 3.1,
to be the first to negotiate and Eisai’s right of first
refusal on any Term Sheet shall be realized and implemented through
the following procedures:
(a)
Neurogenetics shall submit to Eisai
and Eisai’s Counsel a report promptly following the end of
each calendar quarter during the Term, which provides true and
accurate information regarding the following: (i) a
statement whether, as to each Compound referenced in the
report, the Compound is believed by Neurogenetics to satisfy
Validation Criteria, together with a detailed explanation of the
performance and characteristics of the Compound as compared to
each of the Validation Criteria; and (ii) a summary of
research activities under the Project during the applicable period,
provided that Neurogenetics shall not disclose to Eisai, but will
disclose to Eisai’s Counsel, the identity and
structure of each Compound referenced in the report. Upon
receipt of the report, Eisai may ask questions regarding such
Compounds and other matters referenced in the report directly or
through Eisai’s Counsel to Neurogenetics, who shall respond
in good faith to such questions promptly. In the event that Eisai
does not designate as a Validated Compound a Compound which is
referenced in the report, which Neurogenetics states it believes
satisfies the Validation Criteria, and for which information
relating to the Validation Criteria is provided in that report,
within [***]) days after the date of such report or [***] days
after receipt of Neurogenetics’ good faith responses to such
questions asked by Eisai, then such Compound will be deemed not to
be a Validated Compound. If Eisai reasonably believes that
additional experiments are required before it can determine whether
a Compound is a Validated Compound, Eisai informs Neurogenetics of
such additional experiments and then Neurogenetics shall
perform the experiments in a timely manner. The results of any
such additional experiments on such Compound will be described in a
report provided in accordance with this Section 3.2(a). The
contents of reports provided to Eisai and Eisai’s Counsel
hereunder shall be treated by them as confidential information of
Neurogenetics, within the meaning of and subject to the terms and
obligations of Article 7 hereof and the agreement between
Eisai’s Counsel and
*** Confidential Treatment
Requested
Neurogenetics, which is attached hereto as
Exhibit E, respectively. Except as provided in
Section 3.2(e), Neurogenetics will not disclose to third
parties any information described in the quarterly report or
summaries without prior written consent of Eisai during the Term,
except that (i) Neurogenetics may disclose information
described in the quarterly report or summaries to potential third
party financial investors in Neurogenetics (provided that
Neurogenetics shall not disclose chemical structure of the
Compounds to any such third party financial investor and any such
third party financial investor agrees to maintain the
confidentiality of any such information of Neurogenetics provided
to such third party financial investor by Neurogenetics), and
(ii) Neurogenetics may issue press releases and make
scientific presentations and publications in the ordinary course of
its business that generally describe the status of its research and
development activities, provided that such press releases or
scientific presentations do not disclose any Validated Compounds to
which Eisai continues to have rights under this Section 3.2 or
any Compounds discovered or identified in the course of the Project
that Eisai has not completed yet their review to determine whether
or not they are Validated Compounds. It is agreed and acknowledged
that the particular compounds disclosed by Neurogenetics to
Eisai’s Counsel on February 14, 2005 shall be governed
by this Agreement.
(b)
Neurogenetics shall allow
Eisai’s Counsel or their agents to visit research facilities
of Neurogenetics during the Term and the Extension Term, as
applicable, with reasonable prior notice and at reasonable times
and for a reasonable length of stay in order to enable
Eisai’s Counsel or their agent to understand the status of
the Project. Eisai’s Counsel or their agents shall be subject
to Neurogenetics’ standard policies regarding visitors to its
facilities and shall be obligated to hold any confidential
information of Neurogenetics in confidence in accordance with the
letter between Eisai’s Counsel and Neurogenetics, and neither
Eisai nor
Eisai’s Counsel or their agents shall use
any such confidential information of Neurogenetics for any purpose
other than as contemplated by this Agreement in accordance with the
provisions of Article 7. In addition, Neurogenetics and Eisai
or Eisai’s Counsel, as applicable, will have regular
communication by video, telephone and e-mail as reasonably
necessary during the Term regarding the status of the
Project.
(c)
During the Term and the Extension
Term, as applicable, Eisai may express its interest in
negotiating the terms and conditions of a license, collaboration,
alliance, joint venture, partnership or other similar business
arrangement with respect to one (1) or more specific Validated
Compounds within the Neurogenetics’ Property by providing
written notice to Neurogenetics specifying the applicable Validated
Compounds of interest (an “Indication of Interest”).
Eisai must provide an Indication of Interest with respect to a
Validated Compound within [***] days after the date that Eisai
designates such Validated Compound. If Eisai does not provide an
Indication of Interest with respect to a Validated Compound within
such period, then the right of first negotiation with respect to
such Validated Compound shall expire at the end of such period, and
Eisai shall have no further rights with respect to such Validated
Compound.
(d)
For a period of [***] days following
the date of an Indication of Interest (the “Negotiation
Period”), the Parties shall negotiate in good faith regarding
a proposal for a license, collaboration, alliance, joint venture,
partnership or other similar business arrangement with respect to
the Validated Compound specified in such Indication of Interest and
the Neurogenetics’ Property claiming, disclosing or covering
such Validated Compound or its manufacture, use, sale, offer for
sale or import. The Negotiation Period may be extended upon
written mutual agreement of the Parties for an additional [***]
days, and such additional [***]
*** Confidential Treatment
Requested
day period shall be included in the defined term
“Negotiation Period.” The terms and subject
matter of such negotiations shall be treated by the Parties as
confidential information of both Parties, within the meaning of,
and subject to the terms and obligations of, Article 7 of this
Agreement. During the Negotiation Period, Neurogenetics will
provide to Eisai current information, and will respond to
Eisai’s reasonable inquiries, regarding any Validated
Compound as to which Eisai has provided an Indication of
Interest.
(e)
In the event that, by the end of
such Negotiation Period, the Parties reach an agreement with
respect to the terms and conditions of a license, collaboration,
alliance, joint venture, partnership, or other similar business
arrangement with respect to the Validated Compound specified in the
applicable Indication of Interest and the Neurogenetics’
Property claiming, disclosing or covering such Validated Compound
or its manufacture, use, sale, offer for sale or import, then the
Parties will enter into a definitive agreement reflecting the terms
and conditions mutually agreed to by the Parties. In the event
that, by the end of such Negotiation Period, the Parties do not
reach an agreement with respect to the terms and conditions of a
license, collaboration, alliance, joint venture, partnership or
other business arrangement with respect to the Validated Compound
specified in such Indication of Interest and the
Neurogenetics’ Property claiming, disclosing or covering such
Validated Compound or its manufacture, use, sale, offer for sale or
import, then, except as set forth in Section 3.2(f) with
respect to the right of first refusal, Eisai shall have no rights
with respect to the Validated Compound specified in such Indication
of Interest or any Neurogenetics’ Property claiming,
disclosing or covering such Validated Compound or its manufacture,
use, sale, offer for sale or import, and Neurogenetics shall be
free to discuss and, subject to compliance with
Section 3.2(f), as applicable, enter into with a third party
the terms and conditions of a license, collaboration,
alliance, joint venture, partnership or other
similar business arrangement with respect to the Validated Compound
specified in such Indication of Interest and the
Neurogenetics’ Property claiming, disclosing or covering such
Validated Compound or its manufacture, use, sale, offer for sale or
import, and to disclose such Neurogenetics’ Property,
including, without limitation, information described in the
relevant quarterly report and summaries as necessary to facilitate
such actions.
(f)
For a period of [***] months
following the end of such Negotiation Period, Neurogenetics
may not enter into an agreement with respect to the terms and
conditions of a license, collaboration, alliance, joint venture,
partnership, transfer or other similar business arrangement with
respect to the Validated Compound that was the subject of an
Indication of Interest and the Neurogenetics’ Property
claiming, disclosing or covering such Validated Compound or its
manufacture, use, sale, offer for sale or import (for
clarification, excluding any Proposed Transaction, which shall be
addressed in Section 3.2(i)) unless (i) Neurogenetics
first provides to Eisai the Term Sheet (as defined below) for such
agreement, and (ii) Eisai does not make a proposal to
Neurogenetics in writing that is equivalent or superior to the Term
Sheet within the Response Period (as defined below). As used
herein, “Term Sheet” means the term sheet (or if there
is no term sheet, a written summary of the terms) agreed to by
Neurogenetics and a third party in connection with negotiations
with such third party, which describes the material terms and
conditions of a definitive agreement for a transaction described
above regarding specific Neurogenetics’ Property relating to
a Validated Compound that was previously identified in such
Indication of Interest. As used herein, “Response
Period” means the [***] day period immediately following the
date that Neurogenetics first provided the Term Sheet to Eisai;
provided that, if such Term Sheet is amended or modified in any
material respect
*** Confidential Treatment
Requested
prior to the end of such [***] day period, such
Response Period shall be extended, if necessary, so that such
Response Period ends no earlier than [***] business days after the
date that Neurogenetics provided the Term Sheet as so amended or
modified to Eisai. If the Term Sheet is amended or modified in any
material respect prior to the end of the Response Period,
Neurogenetics shall provide to Eisai the Term Sheet as amended or
modified, and references to such Term Sheet in this
Section 3.2(f) shall thereafter refer to the Term Sheet
as amended or modified. During the Response Period, Neurogenetics
will provide to Eisai current information, and will respond to
Eisai’s inquiries, regarding any Validated Compound as to
which is subject of the Term Sheet. For avoidance of doubt, in the
event that Eisai makes a proposal to Neurogenetics in writing that
is equivalent or more favorable to Neurogenetics than the Term
Sheet within the Response Period, Eisai and Neurogenetics shall
enter into good faith negotiations for a definitive agreement with
respect to that proposal. In that event, Neurogenetics shall not
enter into discussions about a definitive agreement with the third
party regarding a transaction described in this
Section 3.2(f) for a period of [***] days after such
proposal is provided by Eisai to Neurogenetics. If Neurogenetics
consummates such a transaction with a third party in compliance
with this Section 3.2(f), then Eisai shall have no rights with
respect to the Validated Compound and the Neurogenetics’
Property relating to the Validated Compound specified in such
Indication of Interest.
(g)
At the end of the Term or the
Extension Term, as applicable, Eisai shall have no rights with
respect to any Neurogenetics’ Property, except
(i) rights granted under any license, collaboration, alliance,
joint venture, partnership or other similar business arrangement
with respect to the Validated Compound specified in an Indication
of Interest and the Neurogenetics’ Property claiming,
disclosing or covering such Validated Compound or its
*** Confidential Treatment
Requested
manufacture, use, sale, offer for sale or import
entered into by the Parties in accordance with the procedures
described in this Section 3.2, and (ii) solely during the
applicable Negotiation Period, the right of first negotiation
granted under this Section 3.2, and, if applicable, solely for
the [***] month period following the end of such Negotiation
Period, the right of first refusal granted under this
Section 3.2, with respect to the Validated Compound specified
in any Indication of Interest dated prior to the end of the Term or
the Extension Term, as applicable, and the Neurogenetics’
Property claiming, disclosing or covering such Validated Compound
or its manufacture, use, sale, offer for sale or import.
(h)
For clarification, the Parties
acknowledge and agree that the right of first negotiation in this
Section 3.2 shall apply only to the Validated Compound
specified in an Indication of Interest and the Neurogenetics’
Property claiming, disclosing or covering such Validated Compound
or its manufacture, use, , sale, offer for sale or import, and the
right of first refusal granted in this Section 3.2 shall apply
only to a transaction described in Section 3.2(f) with
respect to a Validated Compound specified in an Indication of
Interest and the Neurogenetics’ Property claiming, disclosing
or covering such Validated Compound or its manufacture, use, sale,
offer for sale or import, and shall not otherwise apply to any
other intellectual property of Neurogenetics.
(i)
If, during the Term or the Extension
Term, as applicable, the Board of Directors of Neurogenetics
determines to consider the sale of all of its business, or any
portion of its business that includes the Neurogenetics Property,
through a merger, sale of assets or similar transaction (a
“Proposed Transaction”), then before Neurogenetics
agrees to the principal terms of a Proposed Transaction with any
third party, Neurogenetics will first advise Eisai in writing that
Neurogenetics is considering a Proposed Transaction. If Eisai does
not provide written
*** Confidential Treatment
Requested
notice to Neurogenetics within [***] days after
the date of the written notice provided by Neurogenetics to Eisai
regarding a Proposed Transaction that Eisai is interested in
discussing a Proposed Transaction between the Parties, then
Neurogenetics may proceed with a Proposed Transaction with any
third party without further obligation to Eisai under this
Section 3.2(i). If Eisai provides written notice to
Neurogenetics within [***] days after the date of the written
notice provided by Neurogenetics to Eisai regarding a Proposed
Transaction that Eisai is interested in discussing a Proposed
Transaction between the Parties, then, for a period of [***] days
following the date of such written notice from Eisai (the
“Discussion Period”), the Parties shall negotiate in
good faith regarding a Proposed Transaction between Neurogenetics
and Eisai. The Discussion Period may be extended upon written
mutual agreement of the Parties for an additional[***] days, and
such additional [***] day period shall be included in the defined
term “Discussion Period.” The terms and subject
matter of such negotiations shall be treated by the Parties as
confidential information of both Parties, within the meaning of,
and subject to the terms and obligations of, Article 7 of this
Agreement. In the event that, by the end of such
Discussion