Exhibit 10.4
MATERIAL TRANSFER
AGREEMENT
By and Between
CORAUTUS GENETICS INC.,
A Delaware Corporation,
And
CARITAS ST. ELIZABETH’S MEDICAL CENTER OF
BOSTON, INC.,
A Massachusetts Not For Profit
Corporation
August 10, 2005
effective as of August 1, 2004
MATERIAL TRANSFER
AGREEMENT
THIS MATERIAL TRANSFER
AGREEMENT is entered
into, effective as of the 1 st day of August 2004, by and between
CORAUTUS GENETICS INC., a Delaware Corporation
(“Corautus”), and CARITAS ST. ELIZABETH’S MEDICAL
CENTER OF BOSTON, INC., a Massachusetts Not For Profit Corporation
(“Recipient”).
W
I T N
E S S E T H
:
WHEREAS , Corautus licenses intellectual property rights
to the vascular endothelial growth factor-2 gene, referred to as
VEGF-2, and has produced proprietary naked plasmid DNA encoding for
VEGF-2, including plasmid DNA sometimes referred to as phVEGF-2 or
pVGI.1(VEGF2);
WHEREAS, Recipient desires to use the VEGF-2 gene and/or
plasmid DNA material and related documentation for the limited
purpose of the Research Study as hereinafter defined;
WHEREAS, Corautus has agreed to transfer to Recipient,
and Recipient has agreed to receive from Corautus, certain
quantities of Original Biological Materials, as defined below, and
related documentation for such limited purposes pursuant to the
terms and conditions set forth in this Agreement; and
NOW, THEREFORE,
in consideration of the premises
and the mutual covenants herein contained and other good and
valuable consideration, the receipt and sufficiency of which are
hereby acknowledged, the Parties agree as follows:
ARTICLE I
DEFINITIONS AND
INTERPRETATION
1.01 Definitions . For purposes of this Agreement, the following
capitalized terms shall have the following respective
means:
(a) “ Act ” means
the United States Food, Drug and Cosmetic Act, as may be amended
from time to time, to the extent applicable.
(b) “ AE ” means,
with respect to use of the Biological Material, any adverse event
within the meaning of applicable FDA regulations, and including,
without limitation, any unfavorable and unintended sign (including,
without limitation, an abnormal laboratory finding), exacerbation
of a pre-existing condition, intercurrrent illness, drug
interaction, significant worsening of a disease under investigation
or treatment, significant failure of expected pharmacological or
biological action, or symptom or disease temporally associated with
the use of such Biological Material, which event is associated with
the use of the Biological Material in the Research
Study.
CONFIDENTIAL AND
PROPRIETARY
Contains Confidential and/or Proprietary
Information.
May not be disclosed except as provided in this
Agreement.
(c) “ Agreement ”
means this Material Transfer Agreement, together with all Exhibits
attached hereto and all amendments hereto executed by all
Parties.
(d) “ Biological
Materials ” means the vascular endothelial growth
factor-2 gene referred to as “VEGF-2” and proprietary
naked plasmid DNA encoding for VEGF-2, including the plasmid DNA
sometimes referred to as “phVEGF-2” or
“pVGI.1(VEGF2),” together with any Progeny, Derivatives
and Modifications therefrom.
(e) “ Corautus Confidential
Information ” shall mean all Documentation and any other
data or information that is of value to Corautus and is not
generally known to competitors of Corautus. To the extent
consistent with the foregoing, Confidential Information includes
information or data that (i) concerns the operations,
facilities, manufacturing, clinical trials, pre-clinical studies,
regulatory affairs and compliance, protocols, bench work, assay
development, methodology, pricing, plans, affairs and businesses of
Corautus and the financial affairs of Corautus,
(ii) constitutes trade secrets under applicable law, or
(iii) is marked confidential, restricted, proprietary or with
a similar designation. Confidential Information also includes any
information of the type described in this paragraph that Corautus
obtains from another Person that Corautus or such other Person
treats as proprietary or designates as confidential information,
whether or not owned or developed by Corautus or such other Person.
Notwithstanding the foregoing, such term shall not include any
materials or information of the types specified above to the extent
that such materials or information: (i) are or become
generally utilized by other Persons engaged in the same business or
activities in which Corautus utilized, developed or otherwise
acquired such information or publicly known; (ii) are known to
Recipient prior to receipt thereof and without any restrictions on
disclosure in favor of Corautus; or (iii) are furnished to
other Persons by Corautus with no restriction on
disclosure.
(f) “ Corautus Field of
Use ” means the use of Biological Materials for treating
a peripheral neuropathy, including, without limitation, diabetic
neuropathy.
(g) “ Corautus Trials
” means Corautus clinical trials under IND 7961 and
8205.
(h) “ Derivative
” means a substance which constitutes an unmodified
functional sub-unit or product expressed by the Biological
Materials, including, but not limited to, genes and regulatory
sequences and proteins expressed by DNA or RNA.
(i) “ Documentation
” means the documents and information transferred by Corautus
to Recipient for purposes of the Research Study described
herein.
(j) “ FDA ” means
the United States Food and Drug Administration.
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CONFIDENTIAL AND
PROPRIETARY
Contains Confidential and/or Proprietary
Information.
May not be disclosed except as provided in this
Agreement.
(k) “ Intellectual
Property ” means all intellectual property rights,
including (i) United States and other national patents and
patent applications, divisions, continuations,
continuations-in-part, reissues, renewals, reexaminations, requests
for continued examination, supplemental registrations or extensions
thereof, (ii) trademarks, whether registered or unregistered
and applications for registration thereof, (iii) copyrights,
whether registered or unregistered and applications for
registration thereof, and (iv) trade secrets, know-how,
technology, proprietary information and data, including formulae,
procedures, plans, methods, processes, specifications, models,
protocols, techniques and experimentation, and design, testing and
manufacturing data, and products, compositions, and
procedures.
(l) “ Inventions
” means findings, discoveries, inventions, additions,
modifications, formulations, variations, enhancements, refinements
or derivative works.
(m) “ Joint Invention
” means any Invention except a Recipient Invention or a VEGF
Invention, whether patentable or not, first conceived and/or
reduced to practice under the Research Study which could be
described in a patent application, if one were to be filed, naming
one or more employees and/or agents of Recipient and one or more
employees and/or agents of Corautus as joint inventors as
determined under U.S. patent laws
(n) “ Law ” means
the Act and any other United States or non-United States federal,
national, supranational, state, provincial, local or similar
statute, law, ordinance, regulation, rule, code, order, rule of law
or requirement, to the extent applicable.
(o) “ Modification
” means any material substantially based on, containing or
incorporating a substantial element of the Biological Material, or
any materials which are not new or not obviously distinct from the
Biological Material.
(p) “ Original Biological
Materials ” means the Biological Materials provided to
Recipient under this Agreement, together with any Progeny,
Derivatives and Modifications therefrom.
(q) “ Party ” or
“ Parties ” means individually and collectively,
respectively, Corautus and Recipient.
(r) “ Person ”
means any natural person, corporation, limited liability company,
partnership, limited partnership, joint venture, association,
trust, firm, organization, governmental authority or other entity
of any kind or nature.
(s) “ Progeny ”
means any unmodified descendant from the Biological Material,
including cell from cell, or organism from organism.
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CONFIDENTIAL AND
PROPRIETARY
Contains Confidential and/or Proprietary
Information.
May not be disclosed except as provided in this
Agreement.
(t) “ Recipient
Confidential Information ” shall mean all Documentation
and any other data or information that is of value to Recipient and
is not generally known to competitors of Recipient. To the extent
consistent with the foregoing, Confidential Information includes
information or data that (i) concerns the operations,
facilities, manufacturing, clinical trials, pre-clinical studies,
regulatory affairs and compliance, protocols, bench work, assay
development, methodology, pricing, plans, affairs and businesses of
Recipient and the financial affairs of Recipient,
(ii) constitutes trade secrets under applicable law, or
(iii) is marked confidential, restricted, proprietary or with
a similar designation. Confidential Information also includes any
information of the type described in this paragraph that Recipient
obtains from another Person that Recipient or such other Person
treats as proprietary or designates as confidential information,
whether or not owned or developed by Recipient or such other
Person. Notwithstanding the foregoing, such term shall not include
any materials or information of the types specified above to the
extent that such materials or information: (i) are or become
generally utilized by other Persons engaged in the same business or
activities in which Recipient utilized, developed or otherwise
acquired such information or publicly known; (ii) are known to
Recipient prior to receipt thereof and without any restrictions on
disclosure in favor of Recipient; or (iii) are furnished to
other Persons by Recipient with no restriction on
disclosure.
(u) “ Recipient Patents
” means those United States or foreign patents and/or
applications listed on Exhibit B hereto as amended and modified
from time to time by Recipient which such Exhibit is hereby
incorporated herein by reference, the inventions disclosed therein,
and any divisions, reissues, continuations, continuations in part
or extensions relating or corresponding thereto, and disclosed in
foreign patent application corresponding thereto.
(v) “ Recipient
Invention ” means Inventions relating solely to the use
of vascular endothelial growth factors for the treatment of
diabetic neuropathy conceived and/or reduced to practice during the
Research Study by use of the Original Biological Material, to the
extent any patent applications or patents directed to such
Inventions are not a Recipient Patent.
(w) “ Research Study
” means the Phase 1 clinical trial under IND 11572 entitled
pVGI.1 (VEGF-2) Gene Transfer for Diabetic Neuropathy funded, in
part, by a grant received by Recipient from the National Institutes
of Health, and is pursuant to NIH Protocol No. 0402-632. The
Research Study will be conducted at the facility of Recipient and
through a subinvestigator at the New England Medical Center,
Boston, Massachusetts.
(x) “ VEGF Invention
” means Inventions relating solely to the Original Biological
Materials, including but not limited to manufacturing, use or
techniques thereof. Specifically excluded from this definition are
Recipient Inventions.
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CONFIDENTIAL AND
PROPRIETARY
Contains Confidential and/or Proprietary
Information.
May not be disclosed except as provided in this
Agreement.
1.02 Interpretation and
Construction.
(a) References . Whenever
reference is made in this Agreement to any Article, Section or
Exhibit, such reference shall be deemed to apply to the specified
Article or Section of, or the specified Exhibit to, this Agreement.
The words “hereof,” “herein,”
“hereby,” “hereinafter,”
“hereunder” and words of similar import shall refer to
material set forth in this Agreement as a whole and not to any
particular subdivision unless expressly so limited.
(b) Headings. Article,
Section and other headings contained in this Agreement are inserted
for convenience only and shall not be construed to define,
interpret, describe or limit the scope, extent or intent of this
Agreement or any provision hereof.
(c) Gender and Number. Where
the context requires, the use of a pronoun of one gender or the
neuter is to be deemed to include a pronoun of the appropriate
gender, singular words are to be deemed to include the plural, and
vice versa.
(d) Including . Words of
inclusion shall not be construed as terms of limitation herein, so
that references to “included” matters shall be regarded
as non-exclusive, non-characterizing illustrations.
ARTICLE II
SUPPLY OF MATERIALS AND SCOPE OF
USE
2.01 Supply of Original Biological Materials and
Documentation . Corautus
shall supply to Recipient the Original Biological Materials and the
Documentation in such quantity and from such sources as are
identified in Exhibit A attached hereto for the limited
purposes stated herein; provided, however, that Corautus in its
sole discretion may substitute Original Biological Materials from
other sources.
2.02 Scope of Use . Recipient may use the Original Biological
Materials and Documentation only at its facilities and at the
facilities of the New England Medical Center, Boston, Massachusetts
for the sole purpose of conducting the Research Study described
herein. Except as expressly permitted hereby, Recipient shall not
use any Original Biological Materials or Documentation in human
subjects in any manner or for commercial purposes, including the
use of such Original Biological Materials or Documentation to
produce or manufacture products for sale. No Original Biological
Materials or Documentation may be exported or otherwise transferred
outside of the United States. Recipient may use the Original
Biological Materials solely for the purpose of injecting in the
limbs of patients as part of the Research Study and may not modify
or alter the Original Biological Materials in any way or conduct
any research with the Original Biological Materials other than the
Research Study.
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CONFIDENTIAL AND
PROPRIETARY
Contains Confidential and/or Proprietary
Information.
May not be disclosed except as provided in this
Agreement.
2.03 Control and Use of Original Biological
Materials . The principal
investigator named in the Research Study shall administer the
Original Biological Materials only to patients under his personal
supervision or under the supervision of an investigator responsible
to him.
2.04 Compliance with
Laws .
(a) Original Biological
Materials. Recipient shall use, handle, store and dispose of
the Original Biological Materials in a safe manner consistent with
the Handling Instructions set forth in Exhibit C-1 and in
compliance with all Laws, including, without limitation, all
requirements and guidelines of the National Institutes of Health
and the FDA and all requirements relating to human and animal
subjects and recombinant DNA. Recipient shall also comply with all
Laws relating to the delivery of Original Biological Materials
provided hereunder.
(b) Research Study. Recipient
shall fully and timely discharge all obligations under all Laws or
requirements of the FDA or National Institutes of Health with
respect to the Research Study.
2.05 Records
.
(a) Study Records . The
Recipient and the principal investigator shall, and shall cause all
investigators to, prepare and maintain Original Biological
Materials records in accordance with the protocol approved for the
Research Study and applicable Law. Properly organized Research
Study records must be maintained and assistance provided for
routine inspections and audits of such records by Corautus’
authorized representatives at mutually agreed upon reasonable
times, including portions of pertinent records for all patients in
the Research Study. Without limiting the generality of the
foregoing, Recipient shall maintain a clinical trial material
accountability log to maintain records of the Original Biological
Materials. The cost of these inspections shall be borne by
Corautus.
(b) Access and Reference .
Recipient agrees that Corautus may reference and access the data in
the Research Study to the extent requested by Corautus to support
the Corautus Trials under IND 7961 and 8205, and Recipient will
advise the FDA in writing of such rights of reference and access
when requested by Corautus. Corautus must
