PUBLIC HEALTH SERVICE COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
Exhibit
10.1
PUBLIC
HEALTH SERVICE
COOPERATIVE
RESEARCH AND DEVELOPMENT AGREEMENT
This
Agreement is based on the model Cooperative Research and Development Agreement
(“CRADA “) adopted by the U.S. Public Health Service (“PHS”) Technology Transfer
Policy Board for use by components of the National Institutes of Health (“NIH”),
the Centers for Disease Control and Prevention (“CDC”), and the Food and Drug
Administration (“FDA “), which are agencies of the PHS within the Department of
Health and Human Services (“HHS”).
This
Cover Page identifies the Parties to this CRADA:
The
U.S.
Department of Health and Human Services, as represented by
National
Institute of Neurological Disorders and Stroke
an
Institute, Center, or Division (hereinafter referred to as the “ICD”)
of
the
the
National Institutes of Health
and
Lixte,
Inc.
hereinafter
referred to as the “Collaborator”,
having
offices at 0 Xxxxxx Xxxx, Xxxx Xxxxxxxxx, Xxx Xxxx 00000
created
and operating under the laws of Delaware.
COOPERATIVE
RESEARCH AND DEVELOPMENT AGREEMENT
Article
1. Introduction
This
CRADA between ICD and Collaborator will be effective when signed by the Parties,
which are identified on both the Cover Page and the Signature Page (page 16).
The official contacts for the Parties are identified on the Contacts Information
Page (page 17). Publicly available information regarding this CRADA appears
on
the Summary Page (page 18). The research and development activities that will
be
undertaken by ICD and Collaborator in the course of this CRADA are detailed
in
the Research Plan, attached as Appendix A. The staffing, funding, and materials
contributions of the Parties are set forth in Appendix B. Any changes to the
model CRADA are set forth in Appendix C.
Article
2. Definitions
The
terms
listed in this Article will carry the meanings indicated throughout the CRADA.
To the extent a definition of a term as provided in this Article is inconsistent
with a corresponding definition in the applicable sections of either the United
States Code (U.S.C.) or the Code of Federal Regulations (C.F.R.), the definition
in the U.S.C. or C.F.R. will control.
| 2.1 |
“Affiliate”
means any corporation or other business entity controlled by, controlling,
or under common control with Collaborator at any time during the
term of
the CRADA. For this purpose, “control” means direct or indirect beneficial
ownership of at least fifty percent (50%) of the voting stock or
at least
fifty percent (50%) interest in the income of the corporation or
other
business entity.
|
| 2.2 |
“Background
Invention”
means an Invention conceived and first actually reduced to practice
before
the Effective Date.
|
| 2.3 |
“Collaborator
Materials”
means all tangible materials not first produced in the performance
of this
CRADA that are owned or controlled by Collaborator and used in the
performance of the Research Plan.
|
| 2.4 |
“Confidential
Information”
means confidential scientific, business, or financial information
provided
that the information does not include:
|
| (a) |
information
that is publicly known or that is available from public sources;
|
| (b) |
information
that has been made available by its owner to others without a
confidentiality obligation;
|
| (c) |
information
that is already known by the receiving Party, or information that
is
independently created or compiled by the receiving Party without
reference
to or use of the provided information; or
|
2
| (d) |
information
that relates to potential hazards or cautionary warnings associated
with
the production, handling, or use of the subject matter of the Research
Plan.
|
| 2.5 |
| 2.6 |
“CRADA
Data”
means all recorded information first produced in the performance
of the
Research Plan.
|
| 2.7 |
“CRADA
Materials”
means all tangible materials first produced in the performance of
the
Research Plan other than CRADA Data.
|
| 2.8 |
“CRADA
Subject Invention”
means any Invention of either or both Parties, conceived or first
actually
reduced to practice in the performance of the Research Plan.
|
| 2.9 |
“Effective
Date”
means the date of the last signature of the Parties executing this
Agreement.
|
| 2.10 |
“Government”
means the Government of the United States of America.
|
| 2.11 |
“ICD
Materials”
means all tangible materials not first produced in the performance
of this
CRADA that are owned or controlled by ICD and used in the performance
of
the Research Plan.
|
| 2.12 |
“Invention”
means any invention or discovery that is or may be patentable or
otherwise
protected under Title 35 of the United States Code, or any novel
variety
of plant which is or may be protectable under the Plant Variety Protection
Act, 7 U.S.C. §§ 2321 et
seq.
|
| 2.13 |
“Patent
Application”
means an application for patent protection for a CRADA Subject Invention
with the United States Patent and Trademark Office (“U.S.P.T.O.”) or the
corresponding patent-issuing authority of another nation.
|
| 2.14 |
“Patent”
means any issued United States patent, any international counterpart(s),
and any corresponding grant(s) by a non-U.S. government in place
of a
patent.
|
| 2.15 |
“Principal
Investigator(s)”
or “PI(s)”
means the person(s) designated by the Parties who will be responsible
for
the scientific and technical conduct of the Research Plan. .
|
| 2.16 |
“Research
Plan”
means the statement in Appendix A of the respective research and
development commitments of the Parties.
|
Article
3. Cooperative
Research and Development
| 3.1 |
Performance
of Research and Development.
The research and development activities to be carried out under this
CRADA
will be performed solely by the Parties identified on the Cover Page
unless specifically stated elsewhere in this Agreement. The PIs will
be
responsible for the scientific and technical conduct of this project
on
behalf of their employers. Any Collaborator employees who will work
at ICD
facilities will be required to sign a Guest Researcher or Special
Volunteer Agreement appropriately modified in view of the terms of
this
CRADA.
|
3
| 3.2 |
Research
Plan.
The Parties recognize that the Research Plan describes the collaborative
research and development activities they will undertake and that
interim
research goals set forth in the Research Plan are good faith guidelines.
Should events occur that require modification of these goals, then
by
mutual agreement the Parties can modify them through an amendment,
according to Paragraph 13.6.
|
| 3.3 |
Use
and Disposition of Collaborator Materials and ICD
Materials.
The Parties agree to use Collaborator Materials and ICD Materials
only in
accordance with the Research Plan, not to transfer these materials
to
third parties except in accordance with the Research Plan or as approved
by the owning or providing Party, and, upon expiration or termination
of
the CRADA, to dispose of these materials as directed by the owning
or
providing Party.
|
| 3.4 |
Third-Party
Rights in Collaborator’s CRADA Subject Inventions.
If Collaborator has received (or will receive) support of any kind
from a
third party in exchange for rights in any of Collaborator’s CRADA Subject
Inventions, Collaborator agrees to ensure that its obligations to
the
third party are both consistent with Articles 6 through 8 and subordinate
to Article 7 of this CRADA.
|
| 3.5 |
Disclosures
to ICD.
Prior to execution of this CRADA, Collaborator agrees to disclose
to ICD
all instances in which outstanding royalties are due under a PHS
license
agreement, and in which Collaborator had a PHS license terminated
in
accordance with 37 C.F .R. § 404.10. These disclosures will be treated as
Confidential Information upon request by Collaborator in accordance
with
Paragraphs 2.4, 8.3, and 8.4.
|
Article
4. Reports
| 4.1 |
Interim
Research and Development Reports.
The PIs should exchange information regularly, in writing. This exchange
may be accomplished through meeting minutes, annual reports, detailed
correspondence, and circulation of draft manuscripts.
|
| 4.2 |
Final
Research and Development Reports.
The Parties will exchange final reports of their results within four
(4)
months after the expiration or termination of this CRADA. These reports
will set forth the technical progress made; any publications arising
from
the research; and the existence of invention disclosures of potential
CRADA Subject Inventions and/or any corresponding Patent Applications.
|
| 4.3 |
Fiscal
Reports.
If Collaborator has agreed to provide funding to ICD under this CRADA
and
upon the request of Collaborator, then concurrent with the exchange
of
final research and development reports according to Paragraph 4.2,
ICD
will submit to Collaborator a statement of all costs incurred by
ICD for
the CRADA. If the CRADA has been terminated, ICD will specify any
costs
incurred before the date of termination for which ICD has not received
funds from Collaborator, as well as for all reasonable termination
costs
including the cost of returning Collaborator property or removal
of
abandoned Collaborator property, for which Collaborator will be
responsible.
|
4
Article
5. Staffing,
Financial, and Materials Obligations
| 5.1 |
ICD
and Collaborator Contributions.
The contributions of any staff, funds, materials, and equipment by
the
Parties are set forth in Appendix B. The Federal Technology Transfer
Act
of 1986, l5 U.S.C. § 37l0a(d)(1) prohibits ICD from providing funds to
Collaborator for any research and development activities under this
CRADA.
|
| 5.2 |
ICD
Staffing.
No ICD employees will devote 100% of their effort or time to the
research
and development activities under this CRADA. ICD will not use funds
provided by Collaborator under this CRADA for ICD personnel to pay
the
salary of, any permanent ICD employee. Although personnel hired by
ICD
using CRADA funds will focus principally on CRADA research and development
activities, Collaborator acknowledges that these personnel may nonetheless
make contributions to other research and development activities,
and the
activities will be outside the scope of this CRADA.
|
| 5.3 |
Collaborator
Funding.
Collaborator acknowledges that Government funds received by Collaborator
from an agency of the Department of Health and Human Services may
not be
used to fund ICD under this CRADA. If Collaborator has agreed to
provide
funds to ICD then the payment schedule appears in Appendix B and
Collaborator will make payments according to that schedule. If
Collaborator fails to make any scheduled payment, ICD will not be
obligated to perform any of the research and development activities
specified herein or to take any other action required by this CRADA
until
the funds are received. ICD will use these funds exclusively for
the
purposes of this CRADA. Each Party will maintain separate and distinct
current accounts, records, and other evidence supporting its financial
obligations under this CRADA and, upon written request, will provide
the
other Party a Fiscal Report according to Paragraph 4.3, which delineates
all payments made and all obligated expenses, along with the Final
Research Report described in Paragraph 4.2.
|
| 5.4 |
Capital
Equipment.
Collaborator’s commitment, if any, to provide ICD with capital equipment
to enable the research and development activities under the Research
Plan
appears in Appendix B. If Collaborator transfers to ICD the capital
equipment or provides funds for ICD to purchase it, then ICD will
own the
equipment. If Collaborator loans capital equipment to ICD for use
during
the CRADA, Collaborator will be responsible for paying all costs
and fees
associated with the transport, installation, maintenance, repair,
removal,
or disposal of the equipment, and ICD will not be liable for any
damage to
the equipment.
|
Article
6. Intellectual
Property
| 6.1 |
Ownership
of CRADA Subject Inventions, CRADA Data, and CRADA
Materials.
Subject to the Government license described in Paragraph 7.5, the
sharing
requirements of Paragraph 8.1, and the regulatory filing requirements
of
Paragraph 8.2, the producing Party will retain sole ownership of
and title
to all CRADA Subject Inventions, all copies of CRADA Data, and all
CRADA
Materials produced solely by its employee(s). The Parties will own
jointly
all CRADA Subject Inventions invented jointly and all copies of CRADA
Data
and all CRADA Materials developed jointly.
|
5
| 6.2 |
Reporting.
The Parties will promptly report to each other in writing each CRADA
Subject Invention reported by their respective personnel, and any
Patent
Applications filed thereon, resulting from the research and development
activities conducted under this CRADA. Each Party will report all
CRADA
Subject Inventions to the other Party in sufficient detail to determine
inventorship, which will be determined in accordance with U.S. patent
law.
These reports will be treated as Confidential Information in accordance
with Article 8. Formal reports will be made by and to the Patenting
and
Licensing Offices identified on the Contacts Information Page herein.
|
| 6.3 |
Filing
of Patent Applications.
Each Party will make timely decisions regarding the filing of Patent
Applications on the CRADA Subject Inventions made solely by its
employee(s), and will notify the other Party in advance of filing.
Collaborator will have the first opportunity to file a Patent Application
on joint CRADA Subject Inventions and will notify PHS of its decision
within sixty (60) days of an Invention being reported or at least
thirty
(30) days before any patent filing deadline, whichever occurs sooner.
If
Collaborator fails to notify PHS of its decision within that time
period
or notifies PHS of its decision not to file a Patent Application,
then PHS
has the right to file a Patent Application on the joint CRADA Subject
Invention. Neither Party will be obligated to file a Patent Application.
Collaborator will place the following statement in any Patent Application
it files on a CRADA Subject Invention: “This invention was created in the
performance of a Cooperative Research and Development Agreement with
the
National Institutes of Health, an Agency of the Department of Health
and
Human Services. The Government of the United States has certain rights
in
this invention.” If either Party files a Patent Application on a joint
CRADA Subject Invention, then the filing Party will include a statement
within the Patent Application that clearly identifies the Parties
and
states that the joint CRADA Subject Invention was made under this
CRADA.
|
| 6.4 |
Patent
Expenses.
Unless agreed otherwise, the Party filing a Patent Application will
pay
all preparation and filing expenses, prosecution fees, issuance fees,
post
issuance fees, patent maintenance fees, annuities, interference expenses,
and attorneys’ fees for that Patent Application and any resulting
Patent(s). If a license to any CRADA Subject Invention is granted
to
Collaborator, then Collaborator will be responsible for all expenses
and
fees, past and future, in connection with the preparation, filing,
prosecution, and maintenance of any Patent Applications and Patents
claiming exclusively-licensed CRADA Subject Inventions and will be
responsible for a pro-rated share, divided equally among
all licensees, of those expenses and fees for non-exclusively licensed
CRADA Subject Inventions. Collaborator may waive its exclusive option
rights at any time, and incur no subsequent financial obligation
for those
Patent Application(s) or Patent(s)
|
6
| 6.5 |
Prosecution
of Patent Applications.
The Party filing a Patent Application will provide the non-filing
Party
with a copy of any official communication relating to prosecution
of the
Patent Application within thirty (30) days of transmission of the
communication. Each Party will also provide the other Party with
the power
to inspect and make copies of all documents retained in the applicable
Patent Application or Patent file. The Parties agree to consult with
each
other regarding the prosecution of Patent Applications directed to
joint
CRADA Subject Inventions. If Collaborator elects to file and prosecute
Patent Applications on joint CRADA Subject Inventions, then Collaborator
agrees to use the U.S.P.T.O. Customer Number Practice and/or grant
PHS a
power(s) of attorney (or equivalent) necessary to assure PHS access
to its
intellectual property rights in these Patent Applications. PHS and
Collaborator will cooperate with each other to obtain necessary signatures
on Patent Applications, assignments, or other documents.
|
Article
7. Licensing
| 7.1 |
Background
Inventions.
Other than as specifically stated in this Article 7, nothing in this
CRADA
will be construed to grant any rights in one Party’s Background
Invention(s) to the other Party, except to the extent necessary for
the
Parties to conduct the research and development activities described
in
the Research Plan.
|
| 7.2 |
Collaborator’s
License Option to CRADA Subject Inventions.
With respect to Government rights to any CRADA Subject Invention
made
solely by an ICD employee(s) or made jointly by an ICD employee(s)
and a
Collaborator employee(s) for which a Patent Application was filed,
PHS
hereby grants to Collaborator an exclusive option to elect an exclusive
or
nonexclusive commercialization license. The license will be substantially
in the form of the appropriate model PHS license agreement and will
fairly
reflect the nature of the CRADA Subject Invention, the relative
contributions of the Parties to the CRADA Subject Invention and the
CRADA,
a plan for the development and marketing of the CRADA Subject Invention,
the risks incurred by Collaborator, and the costs of subsequent research
and development needed to bring the CRADA Subject Invention to the
marketplace. The field of use of the license will not exceed the
scope of
the Research Plan.
|
| 7.3 |
Exercise
of Collaborator’s License Option.
To exercise the option of Paragraph 7.2 Collaborator must submit
a written
notice to the PHS Patenting and Licensing Contact identified on the
Contacts Information Page (and provide a copy to the ICD Contact
for CRADA
Notices) within three (3) months after either (i) Collaborator receives
written notice from PHS that the Patent Application has been filed
or (ii)
the date on which Collaborator files the Patent Application. The
written
notice exercising this option will include a completed “Application for
License to Public Health Service Inventions” and will initiate a
negotiation period that expires nine (9) months after the exercise
of the
option. If PHS has not responded in writing to the last proposal
by
Collaborator within this nine (9) month period, the negotiation period
will be extended to expire one (1) month after PHS so responds, during
which month Collaborator may accept in writing the final license
proposal
of PHS. In the absence of Collaborator’s exercise of the option, or upon
election of a nonexclusive license, PHS will be free to license the
CRADA
Subject Invention to others. These time periods may be extended at
the
sole discretion of PHS upon good cause shown in writing by Collaborator.
|
7
| 7.4 |
Government
License in ICD Sole CRADA Subject Inventions and Joint CRADA Subject
Inventions.
Pursuant to 15 U.S.C. § 3710a(b)(1)(A), for CRADA Subject Inventions owned
solely by ICD or jointly by ICD and Collaborator, and licensed pursuant
to
the option of Paragraph 7.2, Collaborator grants to the Government
a
nonexclusive, nontransferable, irrevocable, paid-up license to practice
the CRADA Subject Invention or have the CRADA Subject Invention practiced
throughout the world by or on behalf of the Government. In the exercise
of
this license, the Government will not publicly disclose trade secrets
or
commercial or financial information that is privileged or confidential
within the meaning of 5 U.S.C. § 552(b)(4) or which would be considered
privileged or confidential if it had been obtained from a non-federal
party.
|
| 7.5 |
Government
License in Collaborator Sole CRADA Subject Inventions.
Pursuant to 15 U.S.C. § 3710a(b)(2), for CRADA Subject Inventions made
solely by an employee of Collaborator, Collaborator grants to the
Government a nonexclusive, nontransferable, irrevocable, paid-up
license
to practice the CRADA Subject Invention or have the CRADA Subject
Invention practiced throughout the world by or on behalf of the Government
for research or other Government purposes.
|
| 7.6 |
Third
Party License.
Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants an exclusive license
to a CRADA Subject Invention made solely by an ICD employee or jointly
with a Collaborator employee, the Government will retain the right
to
require Collaborator to grant to a responsible applicant a nonexclusive,
partially exclusive, or exclusive sublicense to use the CRADA Subject
Invention in Collaborator’s licensed field of use on terms that are
reasonable under the circumstances; or, if Collaborator fails to
grant a
license, to grant the license itself. The exercise of these rights
by the
Government will only be in exceptional circumstances and only if
the
Government determines (i) the action is necessary to meet health
or safety
needs that are not reasonably satisfied by Collaborator, (ii) the
action
is necessary to meet requirements for public use specified by federal
regulations, and such requirements are not reasonably satisfied by
Collaborator; or (iii) Collaborator has failed to comply with an
agreement
containing provisions described in 15 U.S.C. § 3710a(c)(4)(B). The
determination made by the Government under this Paragraph is subject
to
administrative appeal and judicial review under 35 U.S.C. § 203(2).
|
| 7.7 |
Third-Party
Rights In ICD Sole CRADA Subject Inventions.
For a CRADA Subject Invention conceived prior to the Effective Date
solely
by an ICD employee that is first actually reduced to practice after
the
Effective Date in the performance of the Research Plan, the option
offered
to Collaborator in Paragraph 7.2 may be restricted if, before the
Effective Date, PHS had filed a Patent Application and has either
offered
or granted a license or has executed a license in the CRADA Subject
Invention to a third party. Collaborator nonetheless retains the
right to
apply for a license to any such CRADA Subject Invention in accordance
with
the terms and procedures of 35 U.S.C. § 209 and 37 C.F.R. Part 404.
|
8
| 7.8 |
Joint
CRADA Subject Inventions Not Exclusively Licensed by
Collaborator.
If Collaborator does not acquire an exclusive commercialization license
in
a joint CRADA Subject Invention in all fields of use then, for those
fields of use not exclusively licensed to Collaborator, each Party
will
have the right to use the joint CRADA Subject Invention and to license
its
use to others, and each Party will cooperate with the other, as necessary,
to fulfill international licensing requirements. The Parties may
agree to
a joint licensing approach for any remaining fields of use.
|
Article
8. Rights
of Access and Publication
| 8.1 |
Right
of Access to CRADA Data and CRADA Materials.
ICD and Collaborator agree to exchange all CRADA Data and to share
all
CRADA Materials. If the CRADA is terminated, both Parties agree to
provide
CRADA Materials in quantities needed to complete the Research Plan.
Such
provision will occur before the termination date of the CRADA or
sooner,
if required by the Research Plan.
|
| 8.2 |
Use
of CRADA Data and CRADA Materials.
The Parties will be free to utilize CRADA Data and CRADA Materials
internally for their own purposes, consistent with their obligations
under
this CRADA. The Parties may share CRADA Data or CRADA Materials with
their
Affiliates, agents or contractors provided the obligations of this
Article
8.2 are simultaneously conveyed.
|
| (a) |
CRADA
Data.
|
| Collaborator and ICD will use reasonable efforts to keep CRADA Data confidential until published or until corresponding Patent Applications are filed. To the extent permitted by law, each Party will have the right to use any and all CRADA Data in and for any regulatory filing by or on behalf of the Party. |
| (b) |
CRADA
Materials.
|
Collaborator
and ICD will use reasonable efforts to keep descriptions of CRADA Materials
confidential until published or until corresponding Patent Applications are
filed. Collaborator acknowledges that the basic research mission of PHS includes
sharing with third parties for further research those research resources made
in
whole or in part with NIH funding. Consistent with this mission and the tenets
articulated in “Sharing of Biomedical Research Resources: Principles and
Guidelines for Recipients of NIH Research Grants and Contracts”, December 1999,
available at xxxx://xxx.xx.xxx.xxx/XxxXxxxx/XXxxxxx_xxxxx.xxxx, following
publication either Party may make available to third parties for further
research those CRADA Materials made jointly by both PHS and Collaborator.
Notwithstanding the above, if those joint CRADA Materials are the subject of
a
pending Patent Application or a Patent, the Parties may agree to restrict
distribution or freely distribute them. Either Party may distribute those CRADA
Materials made solely by the other Party only upon written consent from that
other Party or that other Party’s designee.
9
| 8.3 |
Confidential
Information.
Each Party agrees to limit its disclosure of Confidential Information
to
the amount necessary to carry out the Research Plan, and will place
a
confidentiality notice on all such information. A Party orally disclosing
Confidential Information to the other Party will summarize the disclosure
in writing and provide it to the other Party within fifteen (15)
days of
the disclosure. Each Party receiving Confidential Information agrees
to
use it only for the purposes described in the Research Plan. Either
Party
may object to the designation of information as Confidential Information
by the other Party.
|
| 8.4 |
Protection
of Confidential Information.
Confidential Information will not be disclosed, copied, reproduced
or
otherwise made available to any other person or entity without the
consent
of the owning or providing Party except as required by a court or
administrative body of competent jurisdiction, or federal law or
regulation. Each Party agrees to use reasonable efforts to maintain
the
confidentiality of Confidential Information, which will in no instance
be
less effort than the Party uses to protect its own Confidential
Information. Each Party agrees that a Party receiving Confidential
Information will not be liable for the disclosure of that portion
of the
Confidential Information which, after notice to and consultation
with the
disclosing Party, the receiving Party determines may not be lawfully
withheld, provided the disclosing Party has been given a reasonable
opportunity to seek a court order to enjoin disclosure.
|
| 8.5 |
Protection
of Human Subjects’ Information.
The research and development activities to be conducted under this
CRADA
are not intended to involve human subjects or human tissues within
the
meaning of 45 C.F .R. Part 46 and 21 C.F.R. Part 50. Should it become
necessary to utilize human subjects or human tissues, or to provide
a
Party with access to information about identifiable human subjects,
the
Parties agree to amend this CRADA in accordance with Paragraph 13.6
to
ensure that the research and development activities conducted hereunder
will conform to the appropriate federal laws and regulations, including
but not limited to all applicable FDA regulations and HHS regulations
relating to the protection of human subjects.
|
| 8.6 |
Duration
of Confidentiality Obligation.
The obligation to maintain the confidentiality of Confidential Information
will expire at the earlier of the date when the information is no
longer
Confidential Information as defined in Paragraph 2.4 or three (3)
years
after the expiration or termination date of this CRADA. Collaborator
may
request an extension to this term when necessary to protect Confidential
Information relating to products not yet commercialized.
|
| 8.7 |
Publication.
The Parties are encouraged to make publicly available the results
of their
research and development activities. Before either Party submits
a paper
or abstract for publication or otherwise intends to publicly disclose
information about a CRADA Subject Invention, CRADA Data or CRADA
Materials, the other Party will have thirty (30) days to review the
proposed publication or disclosure to assure that Confidential Information
is protected. Either Party may request in writing that the proposed
publication or other disclosure be delayed for up to thirty (30)
additional days as necessary to file a Patent Application.
|
10
Article
9. Representations
and Warranties
| 9.1 |
Representations
of ICD.
ICD hereby represents to Collaborator that:
|
| (a) |
ICD
has the requisite power and authority to enter into this CRADA and
to
perform according to its terms, and that ICD’s official signing this CRADA
has authority to do so.
|
| (b) |
To
the best of its knowledge and belief, neither ICD nor any of its
personnel
involved in this CRADA is presently subject to debarment or suspension
by
any agency of the Government which would directly affect its performance
of the CRADA. Should ICD or any of its personnel involved in this
CRADA be
debarred or suspended during the term of this CRADA, ICD will notify
Collaborator within thirty (30) days of receipt of final notice.
|
| 9.2 |
Representations
and Warranties of Collaborator.
Collaborator hereby represents and warrants to ICD that:
|
| (a) |
Collaborator
has the requisite power and authority to enter into this CRADA and
to
perform according to its terms, and that Collaborator’s official signing
this CRADA has authority to do so.
|
| (b) |
Neither
Collaborator nor any of its personnel involved in this CRADA, including
Affiliates, agents, and contractors are presently subject to debarment
or
suspension by any agency of the Government. Should Collaborator or
any of
its personnel involved in this CRADA be debarred or suspended during
the
term of this CRADA, Collaborator will notify ICD within thirty (30)
days
of receipt of final notice.
|
| (c) |
Subject
to Paragraph 12.3, and if and to the extent Collaborator has agreed
to
provide funding under Appendix B, Collaborator is financially able
to
satisfy these obligations in a timely manner.
|
Article
10. Expiration
and Termination
| 10.1 |
Expiration.
This CRADA will expire on the last date of the term set forth on
the
Summary Page. In no case will the term of this CRADA extend beyond
the
term indicated on the Summary Page unless it is extended in writing
in
accordance with Paragraph 13.6.
|
| 10.2 |
Termination
by Mutual Consent.
ICD and Collaborator may terminate this CRADA at any time by mutual
written consent.
|
| 10.3 |
Unilateral
Termination.
Either ICD or Collaborator may unilaterally terminate this CRADA
at any
time by providing written notice at least sixty (60) days before
the
desired termination date. ICD may, at its option, retain funds transferred
to ICD before unilateral termination by Collaborator for use in completing
the Research Plan.
|
11
| 10.4 |
Funding
for ICD Personnel.
If Collaborator has agreed to provide funding for ICD personnel and
this
CRADA is mutually or unilaterally terminated by Collaborator before
its
expiration, then Collaborator agrees that funds for that purpose
will be
available to ICD for a period of six (6) months after the termination
date
or until the expiration date of the CRADA, whichever occurs sooner.
If
there are insufficient funds to cover this expense, Collaborator
agrees to
pay the difference.
|
| 10.5 |
New
Commitments.
Neither Party will incur new expenses related to this CRADA after
expiration, mutual termination, or a notice of a unilateral termination
and will, to the extent feasible, cancel all outstanding commitments
and
contracts by the termination date. Collaborator acknowledges that
ICD will
have the authority to retain and expend any funds for up to one (1)
year
subsequent to the expiration or termination date to cover any unpaid
costs
obligated during the term of the CRADA in undertaking the research
and
development activities set forth in the Research Plan.
|
Article
11. Disputes
| 11.1 |
Settlement.
Any dispute arising under this CRADA which is not disposed of by
agreement
of the Principal Investigators will be submitted jointly to the
signatories of this CRADA. If the signatories, or their designees,
are
unable to jointly resolve the dispute within thirty (30) days after
notification thereof, the Assistant Secretary for Health (or his/her
designee or successor) will propose a resolution. Nothing in this
Paragraph will prevent any Party from pursuing any additional
administrative remedies that may be available and, after exhaustion
of
such administrative remedies, pursuing all available judicial remedies.
|
| 11.2 |
Continuation
of Work.
Pending the resolution of any dispute or claim pursuant to this Article
11, the Parties agree that performance of all obligations will be
pursued
diligently.
|
Article
12. Liability
| 12.1 |
NO
WARRANTIES.
EXCEPT AS SPECIFICALLY STATED IN ARTICLE 9, THE PARTIES MAKE NO EXPRESS
OR
IMPLIED WARRANTY AS TO ANY MATTER WHATSOEVER, INCLUDING THE CONDITIONS
OF
THE RESEARCH OR ANY INVENTION OR MATERIAL, WHETHER TANGIBLE OR INTANGIBLE,
MADE OR DEVELOPED UNDER OR OUTSIDE THE SCOPE OF THIS CRADA, OR THE
OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF
THE
RESEARCH OR ANY INVENTION OR MATERIAL, OR THAT A TECHNOLOGY UTILIZED
BY A
PARTY IN THE PERFORMANCE OF THE RESEARCH PLAN DOES NOT INFRINGE ANY
THIRD-PARTY PATENT RIGHTS.
|
| 12.2 |
Indemnification
and Liability.
Collaborator agrees to hold the Government harmless and to indemnify
the
Government for all liabilities, demands, damages, expenses and losses
arising out of the use by Collaborator for any purpose of the CRADA
Data,
CRADA Materials or CRADA Subject Inventions produced in whole or
part by
ICD employees under this CRADA, unless due to the negligence or willful
misconduct of ICD, its employees, or agents. The Government has no
statutory authority to indemnify Collaborator. Each Party otherwise
will
be liable for any claims or damages it incurs in connection with
this
CRADA, except that ICD, as an agency of the Government, assumes liability
only to the extent provided under the Federal Tort Claims Act, 28
U.S.C.
Chapter 171.
|
12
| 12.3 |
Force
Majeure.
Neither Party will be liable for any unforeseeable event beyond its
reasonable control and not caused by its own fault or negligence.
which
causes the Party to be unable to perform its obligations under this
CRADA,
and which it has been unable to overcome by the exercise of due diligence.
If a force
majeure
event occurs, the Party unable to perform will promptly notify the
other
Party. It will use its best efforts to resume performance as quickly
as
possible and will suspend performance only for such period of time
as is
necessary as a result of the force
majeure
event.
|
Article
13. Miscellaneous
| 13.1 |
Governing
Law.
The construction, validity, performance and effect of this CRADA
will be
governed by U.S. federal law, as applied by the federal courts in
the
District of Columbia. If any provision in this CRADA conflicts with
or is
inconsistent with any U.S. federal law or regulation, then the U.S.
federal law or regulation will preempt that provision.
|
| 13.2 |
Compliance
with Law.
ICD and Collaborator agree that they will comply with, and advise
their
contractors and agents to comply with, all applicable statutes, Executive
Orders, HHS regulations, and all FDA, CDC, and NIH policies relating
to
research on human subjects (45 C.F.R. Part 46, 21 C.F.R. Parts 50
and 56)
and relating to the appropriate care and use of laboratory animals
(7
U.S.C. §§ 2131 et
seq.;
9 C.F.R. Part 1, Subchapter A). Additional information on these subjects
is available from the HHS Office for Human Research Protections or
from
the NIH Office of Laboratory Animal Welfare. Collaborator agrees
to ensure
that employees, contractors, and agents of Collaborator who might
have
access to a “select agent or toxin” (as that term is defined in 42 C.F .R.
§§ 73.4-73.5) transferred from ICD is properly licensed to receive the
“select agent or toxin”.
|
| 13.3 |
Waivers.
None of the provisions of this CRADA will be considered waived by
any
Party unless a waiver is given in writing to the other Party. The
failure
of a Party to insist upon strict performance of any of the terms
and
conditions hereof, or failure or delay to exercise any rights provided
herein or by law, will not be deemed a waiver of any rights of any
Party.
|
| 13.4 |
Headings.
Titles and headings of the articles and paragraphs of this CRADA
are for
convenient reference only, do not form a part of this CRADA, and
will in
no way affect its interpretation.
|
| 13.5 |
Severability.
The illegality or invalidity of any provisions of this CRADA will
not
impair, affect, or invalidate the other provisions of this CRADA.
|
13
| 13.6 |
Amendments.
Minor modifications to the Research Plan may be made by the mutual
written
consent of the Principal Investigators. Substantial changes to the
CRADA,
extensions of the term, or any changes to Appendix C will become
effective
only upon a written amendment signed by the signatories to this CRADA
or
by their representatives duly authorized to execute an amendment.
A change
will be considered substantial if it directly expands the range of
the
potential CRADA Subject Inventions, alters the scope or field of
any
license option governed by Article 7, or requires a significant increase
in the contribution of resources by either Party.
|
| 13.7 |
Assignment.
Neither this CRADA nor any rights or obligations of any Party hereunder
will be assigned or otherwise transferred by either Party without
the
prior written consent of the other Party.
|
| 13.8 |
Notices.
All notices pertaining to or required by this CRADA will be in writing,
signed by an authorized representative of the notifying Party, and
delivered by first class, registered, or certified mail, or by an
express/overnight commercial delivery service, prepaid and properly
addressed to the other Party at the address designated on the Contacts
Information Page, or to any other address designated in writing by
the
other Party. Notices will be considered timely if received on or
before
the established deadline date or sent on or before the deadline date
as
verifiable by U.S. Postal Service postmark or dated receipt from
a
commercial carrier. Notices regarding the exercise of license options
will
be made pursuant to Paragraph 7.3. Either Party may change its address
by
notice given to the other Party in the manner set forth above.
|
| 13.9 |
Independent
Contractors.
The relationship of the Parties to this CRADA is that of independent
contractors and not agents of each other or joint venturers or partners.
Each Party will maintain sole and exclusive control over its personnel
and
operations.
|
| 13.10 |
Use
of Name; Press Releases.
By entering into this CRADA, the Government does not directly or
indirectly endorse any product or service that is or will be provided,
whether directly or indirectly related to either this CRADA or to
any
patent or other intellectual-property license or agreement that implements
this CRADA by Collaborator, its successors, assignees, or licensees.
Collaborator will not in any way state or imply that the Government
or any
of its organizational units or employees endorses any product or
service.
Each Party agrees to provide proposed press releases that reference
or
rely upon the work under this CRADA to the other Party for review
and
comment at least seven (7) days prior to publication. Either Party
may
disclose the Summary Page to the public without the approval of the
other
Party.
|
| 13.11 |
Reasonable
Consent.
Whenever a Party’s consent or permission is required under this CRADA, its
consent or permission will not be unreasonably withheld.
|
| 13.12 |
Export
Controls.
Collaborator agrees to comply with U.S. export law and regulations.
If
Collaborator has a need to transfer any CRADA Materials made in whole
or
in part by ICD, or ICD Materials, or ICD’s Confidential Information, to a
person located in a country other than the United States, to an Affiliate
organized under the laws of a country other than the United States,
or to
an employee of Collaborator in the United States who is not a citizen
or
permanent resident of the United States, Collaborator will acquire
any and
all necessary export licenses and other appropriate authorizations.
|
14
| 13.13 |
Entire
Agreement.
This CRADA constitutes the entire agreement between the Parties concerning
the subject matter of this CRADA and supersedes any prior understanding
or
written or oral agreement.
|
| 13.14 |
Survivability.
The provisions of Paragraphs 3.3, 3.4, 4.2, 4.3, 5.3, 5.4, 6.l-9.2,
l0.3,
10.5, 11.1, 12.1-12.3, 13.1-13.3, 13.10 and 13.14 will survive the
expiration or early termination of this CRADA.
|
SIGNATURES
BEGIN ON THE NEXT PAGE
15
SIGNATUREPAGE
ACCEPTED
AND AGREED
BY
EXECUTING THIS AGREEMENT, EACH PARTY REPRESENTS THAT ALL STATEMENTS MADE HEREIN
ARE TRUE, COMPLETE, AND ACCURATE TO THE BEST OF ITS KNOWLEDGE. COLLABORATOR
ACKNOWLEDGES THAT IT MAY BE SUBJECT TO CRIMINAL, CIVIL, OR ADMINISTRATIVE
PENALTIES FOR KNOWINGLY MAKING A FALSE, FICTITIOUS, OR FRAUDULENT STATEMENT
OR
CLAIM.
| FOR NINDS: | ||||
| /s/ Story Xxxxxx |
3/20/06
|
|||
|
Story
Xxxxxx, Ph.D.
|
Date
|
|||
|
Director,
National Institute of Neurological Disorders and Stroke
|
| FOR COLLABORATOR: | ||||
| /s/ Xxxx X. Xxxxxx |
3/22/06
|
|||
|
Xx.
Xxxx X. Xxxxxx
|
Date
|
|||
|
President,
Lixte, Inc.
|
16
CONTACTS
INFORMATION PAGE
|
CRADA
Notices
|
||
|
For
ICD:
|
For
Collaborator:
|
|
|
Xx.
Xxxxxx Xxxxx
|
Xx.
Xxxx X. Xxxxxx
|
|
|
0000
Xxxxxxxxx Xxxx
|
0
Xxxxxx Xxxx
|
|
|
Xxxxx
000
|
Xxxx
Xxxxxxxxx, XX 00000
|
|
|
Xxxxxxxxx,
XX 00000
|
||
|
Patenting
and Licensing
|
||
|
For
ICD:
|
For
Collaborator (if separate from above):
|
|
|
Division
Director, Division of Technology
|
Same
as above
|
|
|
Development
and Transfer
|
||
|
NIH
Office of Technology Transfer
|
||
|
0000
Xxxxxxxxx Xxxxxxxxx, Xxxxx 000
|
||
|
Xxxxxxxxx,
Xxxxxxxx 00000-0000
|
||
|
Tel:
000-000-0000
|
||
|
Fax:
000-000-0000
|
||
|
Delivery
of Materials Identified In Appendix B (if any)
|
||
|
For
ICD:
|
For
Collaborator:
|
|
|
Xx.
Xxxxxxxxx Xxxxxx
|
N.A.
|
|
|
Xxxx
00 Xxxx 0X000
|
||
|
00
Xxxxxx Xxxxx
|
||
|
Xxxxxxxx,
XX 00000
|
||
17
SUMMARY
PAGE
EITHER
PARTY MAY, WITHOUT FURTHER CONSULTATION OR PERMISSION.
RELEASE
THIS SUMMARY PAGE TO THE PUBLIC.
TITLE
OF
CRADA: Identification of agents regulating Nuclear Receptor Corepressor (N-CoR)
pathway for glioma tumor cell differentiation
|
PHS[ICD]
Component:
|
National
Institute of Neurological Disorders and Stroke
|
|
|
ICD
Principal Investigator:
|
Xx.
Xxxxxx Xxxxxxxx
|
|
|
ICD
Co-Principal Investigator:
|
Xx.
Xxxxxxxxx Xxxxxx
|
|
|
Collaborator:
|
Lixte,
Inc.
|
|
|
Collaborator
Principal Investigator:
|
Xx.
Xxxx X.Xxxxxx
|
|
|
TERM
OF CRADA:
|
2
(Two) years from the Effective Date
|
18
SIGNATURE
PAGE
ACCEPTED
AND AGREED TO
| FOR NINDS: | ||||
| /s/ Story Xxxxxx |
10/19/06
|
|||
|
Story
Xxxxxx, Ph.D.
|
Date
|
|||
|
Director,
National Institute of Neurological Disorders and
Stroke
|
| FOR COLLABORATOR: | ||||
| /s/ Xxxx X. Xxxxxx |
10/26/06
|
|||
|
Xx.
Xxxx X. Xxxxxx
|
Date
|
|||
|
President,
Lixte Biotechnology, Inc.
|
A
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