Exhibit 10.13
XXXXXXXXX-XXXXXX (15 USC 3710)
COOPERATIVE RESEARCH AND DEVELOPMENT
AGREEMENT (hereinafter CRADA) No. 04-CR-09
BETWEEN
Xxxxxxx BWXT Idaho, LLC
under its U.S. Department of Energy Contract
No. DE-AC07-00XX00000 (hereinafter Contractor)
AND
Applied DNA Sciences, Inc. (hereinafter Participant), both being hereinafter
referred singularly as "Party" and jointly as "Parties"
ARTICLE I: DEFINITIONS
----------------------
A. "Government" means the Federal Government of the United States (U.S.) of
America and agencies thereof.
B. "DOE" means the Department of Energy, an agency of the Federal Government.
C. "Contracting Officer" means the DOE employee administering the Contractor's
DOE contract.
D. "Generated Information" means information produced in the performance of
this CRADA.
E. "Proprietary Information" means information which embodies (i) trade
secrets or (ii) commercial or financial information which is privileged or
confidential under the Freedom of Information Act (5 USC 552 (b) (4)),
either of which is developed at private expense outside of this CRADA and
which is marked as Proprietary Information.
F. "Protected CRADA Information" means Generated Information which is marked
as being Protected CRADA Information by a Party to this CRADA and which
would have been Proprietary Information had it been obtained from a
non-Federal entity.
G. "Subject Invention" means any invention of the Contractor or Participant
conceived or first actually reduced to practice in the performance of work
under this CRADA.
H. "Intellectual Property" means Patents, Trademarks, Copyrights, Mask Works,
Protected CRADA Information, and other forms of comparable property rights
protected by Federal Law and foreign counterparts, except trade secrets.
I. "Trademark" means a distinctive xxxx, symbol, or emblem used in commerce by
a producer or manufacturer to identify and distinguish its goods or
services from those of others.
J. "Service Xxxx" means a distinctive word, slogan, design, picture, symbol,
or any combination thereof, used in commerce by a person to identify and
distinguish its services from those of others.
K. "Mask Work" means a series of related images, however fixed or encoded,
having or representing the predetermined, three-dimensional pattern of
metallic, insulating, or semiconductor material present or removed from the
layers of a semiconductor chip product and in which series the relation of
the images to one another is that each image has the pattern of the surface
of one form of the semiconductor chip product.
L. "Background Intellectual Property" means the Intellectual Property
identified by the Parties in Appendix B, Background Intellectual Property,
which was in existence prior to or is first produced outside of this CRADA,
except that in the case of inventions in those identified items, the
inventions must have been conceived outside of this CRADA and not first
actually reduced to practice under this CRADA to qualify as Background
Intellectual Property.
ARTICLE II: STATEMENT OF WORK
-----------------------------
Appendix A, Statement of Work, is an integral part of this CRADA, and is hereby
incorporated by reference into this CRADA.
ARTICLE III: FUNDING AND COSTS
------------------------------
A. The effective date of this CRADA shall be the latter date of (1) the date
on which it is signed by the last of the Parties, (2) the date on which it
is approved by DOE, or (3) the date on which the advance funding referred
to in Article III.E is received by the Contractor. The work to be performed
under this CRADA shall be complete within two (2) years from the effective
date.
B. Participant's estimated contribution is $50,000 funds-in and $0 in-kind for
FY-04 and $200,000 funds-in and $0 in-kind for FY-05. There is no
Government funding associated with this CRADA.
C. Neither Party shall have an obligation to continue or complete performance
of its work at a contribution in excess of its estimated contribution as
contained in Article III B, above, including any subsequent amendment.
D. Each Party agrees to provide at least thirty (30) days notice to the other
Party if the actual cost to complete performance will exceed its estimated
contribution.
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F. Participant shall provide Contractor sufficient advance funds to maintain
approximately a 90-day advance of funds during the entire period of work.
No work will begin before the receipt of a cash advance. Failure of
Participant to provide the necessary advance funding is cause for
termination of this CRADA.
ARTICLE V: DISCLAIMER
---------------------
THE GOVERNMENT, PARTICIPANT, AND CONTRACTOR MAKE NO EXPRESS OR IMPLIED WARRANTY
AS TO THE CONDITIONS OF THE RESEARCH OR ANY INTELLECTUAL PROPERTY, GENERATED
INFORMATION, OR PRODUCT MADE OR DEVELOPED UNDER THIS CRADA, OR THE OWNERSHIP,
MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE RESEARCH OR
RESULTING PRODUCT. NEITHER THE GOVERNMENT, PARTICIPANT, NOR CONTRACTOR SHALL BE
LIABLE FOR SPECIAL, CONSEQUENTIAL, OR INCIDENTAL DAMAGES ATTRIBUTED TO SUCH
RESEARCH OR RESULTING PRODUCT, INTELLECTUAL PROPERTY, GENERATED INFORMATION, OR
PRODUCT MADE OR DEVELOPED UNDER THIS CRADA.
ARTICLE VI: LIABILITY
---------------------
Except to the extent of any liability resulting from willful misconduct or
negligent acts or omissions of Contractor, the Participant indemnifies the
Government and Contractor for all damages, costs and expenses, including
attorney's fees, arising from personal injury or property damage occurring as a
result of the making, using, or selling of a product, process, or service by or
on behalf of Participant, its assignees, or licensees, which was derived from
the work performed under this CRADA. In respect to this Article, neither the
Government nor Contractor shall be considered assignees or licensees of the
Participant, as a result of reserved Government and Contractor rights. The
indemnity set forth in this paragraph shall apply only if Participant shall have
been informed as soon and as completely as practical by the Contractor and/or
the Government of the action alleging such claim and shall have been given an
opportunity, to the maximum extent afforded by applicable laws, rules, or
regulations, to participate in and control its defense, and the Contractor
and/or the Government shall have provided all reasonably available information
and reasonable assistance requested by Participant. No settlement for which the
Participant would be responsible shall be made without Participant's consent
unless required by final decree of a court of competent jurisdiction.
Other liability. Except to the extent of any liability resulting from willful
misconduct or negligent acts or omissions of the Contractor, Participant
indemnities the Government and Contractor for all damages, costs and
expenditures, including attorneys' fees, arising from any other claims or
actions to which Contractor is subjected which result from any willful
misconduct or negligent acts or omissions of the Participant in the performance
of this CRADA. Contractor agrees to give prompt written notice to Participant
regarding any claim or action initiated against Contractor which Contractor has
reason to believe is likely to give rise to a claim for indemnity hereunder.
Upon such notice, Participant may provide and control an appropriate defense or
settle such claim or action through counsel of its choice or, at its election,
indemnify the costs of such actions under the direction and control of
Contractor. To the extent that such claims or actions arise from the willful
misconduct or negligent acts or omissions of any party other than Participant,
Participant shall have no duty or obligation to Contractor.
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To the extent necessary to effectuate the indemnity provisions heron, the
Participant hereby waives any immunity it may have under any applicable worker
compensation law.
ARTICLE VII: OBLIGATIONS AS TO PROPRIETARY INFORMATION
------------------------------------------------------
A. Each Party agrees to not disclose Proprietary Information provided by
another Party to anyone other than the CRADA Participant and Contractor
without written approval of the providing Party, except to Government
employees who are subject to the statutory provisions against disclosure of
confidential information set forth in the Trade Secrets Act (18 USC 1905).
B. If Proprietary Information is orally disclosed to a Party, it shall be
identified as such, orally, at the time of disclosure and confirmed in a
written summary thereof, appropriately marked by the disclosing Party,
within thirty (30) days as being Proprietary Information.
C. Proprietary Information in tangible form shall be returned to the
disclosing Party or destroyed with a certificate of destruction submitted
to the disclosing Party upon termination or expiration of this CRADA, or
during the term of this CRADA upon request by the disclosing Party.
D. All information marked as Proprietary Information shall be protected by the
recipient as Proprietary Information for a period of three (3) years from
the date of disclosure, unless, as shown by the recipient, such Proprietary
Information is in the public domain or thereafter becomes publicly known
without the fault of the recipient, comes into recipient's possession from
a third party without an obligation of confidentiality on the recipient, is
independently developed by recipient's employees who did not have access to
such Proprietary Information, is released by the disclosing Party to a
third party without restriction, or is released for disclosure with the
written consent of the disclosing Party.
E. Notwithstanding anything contained herein to the contrary, a recipient of
Proprietary Information may disclose Proprietary Information of any
disclosing Party to the extent required by law, regulation or valid court
order. Immediately upon receipt of such a court order, the recipient shall
notify the disclosing Party of such order to afford the disclosing Party
maximum opportunity to seek relief from such court order. In the case of
disclosure required by law or regulation, the recipient shall notify the
disclosing Party of the requirement of law or regulation immediately upon
learning of such requirement to afford the disclosing party maximum
opportunity to exercise its alternatives.
ARTICLE VIII: OBLIGATIONS AS TO PROTECTED CRADA INFORMATION
-----------------------------------------------------------
A. Each Party may designate as Protected CRADA Information any Generated
Information produced by its employees which meets the definition of Article
I.F and, with the agreement of the other Party, so designate any Generated
Information produced by the other Party's employees which meets the
definition of Article I.F. All such designated Protected CRADA Information
shall be appropriately marked.
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B. For a period of five (5) years from the date Protected CRADA Information is
produced, pursuant to 15 U.S.C. 3710 a(c)(7)(B), the Parties agree not to
further disclose such information and to use the same degree of care and
discretion, but no less than reasonable care and discretion, to avoid
disclosure, publication, or dissemination of such information to a third
party, as the Party employs for similar protection of its own information
which it does not desire to disclose, publish, or disseminate except:
(1) as necessary to perform this CRADA;
(2) as provided in Article XI [REPORTS AND ABSTRACTS];
(3) as requested by the DOE Contracting Officer to be provided to
other DOE facilities for use only at those DOE facilities with
the same protection in place;
(4) to existing or potential licensees, affiliates, customers, or
suppliers of the Parties in support of commercialization of the
technology with the same protection in place. Disclosure of the
Participant's Protected CRADA Information under this subparagraph
shall only be done with Participant's consent; or
(5) as mutually agreed by the Parties in advance.
C. The obligations of paragraph B above shall end sooner for any Protected
CRADA Information which shall become publicly known without fault of either
Party, shall come into a Party's possession without breach by that Party of
the obligations of paragraph B above, or shall be independently developed
by a Party's employees who did not have access to the Protected CRADA
Information.
ARTICLE IX: RIGHTS IN GENERATED INFORMATION
-------------------------------------------
The Parties agree that they shall have no obligations of nondisclosure or
limitations on their use of, and the Government shall have unlimited rights in,
all Generated Information produced and information provided by the Parties under
this CRADA, except for (a) information which is marked as being Copyrighted
(subject to Article XIII) or as Protected CRADA Information (subject to Article
VIII) or as Proprietary Information (subject to Article VII), or (b) information
that discloses an invention which may later be the subject of a U.S. or foreign
Patent application.
ARTICLE X: EXPORT CONTROL
-------------------------
THE PARTIES UNDERSTAND THAT MATERIALS AND INFORMATION RESULTING FROM THE
PERFORMANCE OF THIS CRADA MAY BE SUBJECT TO EXPORT CONTROL LAWS AND THAT EACH
PARTY IS RESPONSIBLE FOR ITS OWN COMPLIANCE WITH SUCH LAWS.
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ARTICLE XI: REPORTS AND ABSTRACTS
---------------------------------
A. The Parties agree to produce the following deliverables:
(1) an initial abstract suitable for public release at the time the
CRADA is approved by DOE;
(2) other abstracts (final when work is complete, and others as
substantial changes in scope and dollars occur);
(3) a final report, upon completion or termination of this CRADA, to
include a list of Subject Inventions;
(4) reserved;
(5) other topical/periodic reports, when the nature of research and
magnitude of dollars justify; and
(6) computer software in source and executable object code format as
defined within the Statement of Work or elsewhere within the
CRADA documentation.
B. The Parties acknowledge that the Contractor has the responsibility to
provide the above information at the time of its completion to the DOE
Office of Scientific and Technical Information.
C. Participant agrees to provide the above information to Contractor to enable
full compliance with paragraph B of this article.
D. The Parties acknowledge that the Contractor and DOE have a need to document
the long-term economic benefit of the cooperative research to be conducted
under this CRADA. Therefore, Participant shall respond to the Contractor's
reasonable requests for pertinent information, during the term of this
CRADA and for a period of five (5) years thereafter.
ARTICLE XII: PRE-PUBLICATION REVIEW
-----------------------------------
A. The Parties agree to secure pre-publication approval from each other, which
shall not be unreasonably withheld or denied beyond thirty (30) days, in
accordance with the following procedures:
(1) Each Party (hereinafter Submitter) shall submit to the other
Party (hereinafter Recipient), in advance, proposed written and
oral publications pertaining to work under the CRADA. Proposed
oral publications shall be submitted to the Recipient in the form
of a written presentation synopsis and a written abstract.
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(2) Recipient shall provide a written response to the Submitter
within thirty (30) days, either objecting or not objecting to the
proposed publication. The Submitter shall consider all objections
of the Recipient and shall not unreasonably refuse to incorporate
the suggestions and meet the objections of the Recipient. The
proposed publication shall be deemed not objectionable, unless
the proposed publication contains Proprietary Information,
Protected CRADA Information, export controlled information or
material that would create potential statutory bars to filing the
U.S. or corresponding foreign Patent applications, in which case
express written permission shall be required for publication.
B. The Parties agree that neither will use the name of the other Party or its
employees in any promotional activity, such as advertisements, with
reference to any product or service resulting from this CRADA, without
prior written approval of the other Party.
ARTICLE XIII: COPYRIGHTS
------------------------
A. The Parties may assert Copyright in any of their Generated Information.
Assertion of Copyright generally means to enforce or give an indication of
an intent or right to enforce such as by marking or securing Federal
registration.
B. Allocation of rights to Copyrights in Generated Information will be
negotiated by the Parties.
C. For Generated Information, the Parties acknowledge that the Government has
for itself and others acting on its behalf, a royalty-free,
nontransferrable, nonexclusive, irrevocable worldwide Copyright license to
reproduce, prepare derivative works, distribute copies to the public, and
perform publicly and display publicly, by or on behalf of the Government,
all Copyrightable works produced in the performance of this CRADA, subject
to the restrictions this CRADA places on publication of Proprietary
Information and Protected CRADA Information.
D. For all Copyrighted computer software produced in the performance of this
CRADA, the Party owning the Copyright will provide the source code, an
expanded abstract as described in Appendix A, the executable object code
and the minimum support documentation needed by a competent user to
understand and use the software to DOE's Energy Science and Technology
Software Center, X.X. Xxx 0000, Xxx Xxxxx, XX 00000. The expanded abstract
will be treated in the same manner as Generated Information in paragraph C
of this article.
E. Contractor and Participant agree that, with respect to any Copyrighted
computer software produced in the performance of this CRADA, DOE has the
right, at the end of the period set forth in paragraph B of Article VIII
hereof and at the end of each two-year interval thereafter, to request
Contractor and Participant and any assignee or exclusive licensee of the
Copyrighted software to grant a nonexclusive, partially exclusive, or
exclusive license to a responsible applicant upon terms that are reasonable
under the circumstances, provided such grant does not cause a termination
of any licensee's right to use the Copyrighted computer software. If
Contractor, Participant, any assignee, or exclusive licensee refuses such
request, Contractor and Participant agree that DOE has the right to grant
the license if DOE determines that Contractor, Participant, assignee, or
licensee has not made a satisfactory demonstration that it is actively
pursuing commercialization of the Copyrighted computer software.
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Before requiring licensing under this paragraph E, DOE shall furnish the
Contractor/Participant written notice of its intentions to require the
Contractor/Participant to grant the stated license, and the
Contractor/Participant shall be allowed thirty (30) days (or such longer
period as may be authorized by the cognizant DOE Contracting Officer for
good cause shown in writing by the Contractor/Participant) after such
notice to show cause why the license should not be required to be granted.
Contractor/Participant shall have the right to appeal the decision by DOE
to the grant of the stated license to the Invention Licensing Appeal Board
as set forth in paragraphs (b)-(g) of 10 CFR 781.65, "Appeals."
F. The Parties agree to place copyright and other notices, as appropriate for
the protection of copyright, in human readable form onto all physical
media, and in digitally encoded form in the header of machine readable
information recorded on such media such that the notice will appear in
human readable form when the digital data are off loaded or the data are
accessed for display or printout,
ARTICLE XIV: REPORTING INVENTIONS
---------------------------------
A. The Parties agree to disclose to each other each Subject Invention which
may be patentable or otherwise protectable under the Patent Act. The
Parties agree that Contractor and Participant will disclose their
respective Subject Inventions to DOE and each other within two (2) months
after the inventor first discloses the Subject Invention in writing to the
person(s) responsible for Patent matters of the disclosing Party.
B. These disclosures should be in sufficiently complete technical detail to
convey a clear understanding, to the extent known at the time of
disclosure, of the nature, purpose, and operation of the Subject Invention.
The disclosure shall also identify any known actual or potential statutory
bars, i.e., printed publications describing the Subject Invention or the
public use or "on sale" of the Subject Invention in this country. The
Parties further agree to disclose to each other any subsequent known actual
or potential statutory bar that occurs for a Subject Invention disclosed
but for which a Patent application has not been filed. All Subject
Invention disclosures shall be marked as confidential under 35 U.S.C. 205.
ARTICLE XV: TITLE TO INVENTIONS
-------------------------------
Wherein DOE has granted Participant and Contractor the right to elect to retain
title to their respective Subject Inventions, and wherein Participant has the
option to choose an exclusive license, for reasonable compensation, for a
pre-negotiated field of use to Contractor's Subject Inventions,
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A. Each Party shall have the first option to elect to retain title to any
Subject Invention made by its employees and that election shall be made:
(1) for the Participant, within twelve (12) months of disclosure of the
Subject Invention to DOE or (2) for the Contractor, within twelve (12)
months of disclosure of the Subject Invention to DOE. If a Party elects not
to retain title to any Subject Invention of its employees, the other Party
shall have the second option to elect to retain title to such Subject
Invention. DOE shall retain title to any Subject Invention which is not
retained by any Party.
For Subject Inventions conceived or first actually reduced to practice
under this CRADA, which are joint Subject Inventions made by Contractor and
Participant, title to such Subject Inventions shall be jointly owned by
Contractor and Participant.
B. The Parties acknowledge that DOE may obtain title to each Subject Invention
reported under Article XIV for which a Patent application or applications
are not filed pursuant to Article XVI and for which any issued Patents are
not maintained by any Party to this CRADA.
C. The Parties acknowledge that the Government retains a non-exclusive,
nontransferrable, irrevocable, paid-up license to practice or to have
practiced for or on behalf of the U. S. every Subject Invention under this
CRADA throughout the world. The Parties agree to execute a Confirmatory
License to affirm the Government's retained license.
D. During the term of this CRADA and for a period of six (6) months after the
termination or completion of this CRADA, Participant shall have the
opportunity, pursuant to 15 U.S.C. 37l0a, to obtain a license to Contractor
Subject Inventions. In particular, Participant shall have the option to
obtain, up to and including, an exclusive license to Contractor Subject
Inventions within a defined field of use on mutually agreed- upon
reasonable terms and conditions, including the payment of negotiated
license fees and royalties.
ARTICLE XVI: FILING PATENT APPLICATIONS
---------------------------------------
A. The Parties agree that the Party initially indicated as having an ownership
interest in any Subject Invention (hereinafter Inventing Party) shall have
the first opportunity to file U.S. and foreign Patent applications. If
Participant does not file such applications within one (1) year after
election, or if Contractor does not file such applications within the
filing time specified in its prime contract, the other Party to this CRADA
exercising an option pursuant to Article XV may file Patent applications on
such Subject Inventions. If a Patent application is filed by the other
Party (hereinafter Filing Party), the Inventing Party shall reasonably
cooperate and assist the Filing Party, at the Filing Party's expense, in
executing a written assignment of the Subject Invention to the Filing Party
and in otherwise perfecting the Patent application, and the Piling Party
shall have the right to control the prosecution of the Patent application.
The Parties shall agree between themselves as to who will file Patent
applications on any joint Subject Invention.
B. The Parties agree that DOE has the right to file patent applications in any
country if neither Party desires to file a patent application for any
Subject Invention. Notification of negative intent shall be made in writing
to the DOE Contracting Officer within three (3) months of the decision of
the non-Inventing Party to not file a patent application for the Subject
Invention pursuant to Article XV or not later than sixty (60) days prior to
the time when any statutory bar might foreclose filing of a U.S. patent
application.
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C. The Parties agree to include within the beginning of the specification of
any U.S. Patent application and any patent issuing thereon (including
foreign Patents) covering a Subject Invention, the following statement:
"This invention was made under a Cooperative Research and Development
Agreement 04-CR-09 between Applied DNA Sciences, Inc. and Xxxxxxx BWXT
Idaho, LLC under Xxxxxxxx Xx. XX-XX00-00XX00000, awarded by the United
States Department of Energy. The United States Government has certain
rights in the invention."
D. A Party electing title or filing a Patent application in the U.S. or in any
foreign country shall advise the other Party and DOE if it no longer
desires to continue prosecution, pay maintenance fees, or retain title in
the U.S. or any foreign country. The other Party and then DOE will be
afforded the opportunity to take title and retain the Patent rights in the
U.S. or in any such foreign country.
ARTICLE XVII: TRADEMARKS
------------------------
The Parties may seek to obtain Trademark/Service Xxxx protection on products or
services generated under this CRADA in the U.S. or foreign countries. The
ownership and other rights relating to Trademarks shall be as mutually agreed to
in writing by the Parties. The Parties hereby acknowledge that the Government
shall have the right to indicate on any similar goods or services produced by or
for the Government that such goods or services were derived from and are a DOE
version of the goods or services protected by such Trademark/Service Xxxx with
the Trademark and the owner thereof being specifically identified. In addition,
the Government shall have the right to use such Trademark/Service Xxxx in print
or communications media.
ARTICLE XVIII: MASK WORKS
-------------------------
Reserved
ARTICLE XIX: COST OF INTELLECTUAL PROPERTY PROTECTION
-----------------------------------------------------
Each Party shall be responsible for payment of all costs relating to Copyright,
Trademark, and Mask Work filing; U.S. and foreign patent application filing and
prosecution; and all costs relating to maintenance fees for U.S. and foreign
Patents hereunder which are solely owned by that Party. Government/DOE
laboratory funds contributed as DOE's cost share to a CRADA cannot be given to
Participant for payment of Participants costs of filing and maintaining patents
or filing for Copyrights, Trademarks, and Mask Works. With respect to jointly
owned Intellectual Property, the costs associated in protecting such jointly
owned Intellectual Property xxxx be shared by the Parties as mutually agreed.
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ARTICLE XX: REPORTS OF INTELLECTUAL PROPERTY USE
------------------------------------------------
Participant agrees to submit, for a period of three (3) years from the date of
termination or completion of this CRADA and upon request of DOE, a
nonproprietary report no more frequently than annually on Participant's efforts
to utilize any Intellectual Property arising under the CRADA.
ARTICLE XXI: DOE MARCH-IN RIGHTS
--------------------------------
The Parties acknowledge that DOE has certain march-in rights to any Subject
Inventions in accordance with 48 CFR 27.304-1(g) and 15 U.S.C. 3710 a (b)(1)(B)
and (C).
ARTICLE XXII: U.S. COMPETITIVENESS
----------------------------------
The Parties agree that a purpose of this CRADA is to provide substantial benefit
to the U.S. economy.
A. In exchange for the benefits received under this CRADA, Participant
therefore agrees to the following:
(1) Products embodying Intellectual Property developed under this CRADA
shall be substantially manufactured in the U. S., and
(2) Processes, services, and improvements thereof which are covered by
Intellectual Property developed under this CRADA shall be incorporated
into Participant's manufacturing facilities in the U.S. either prior
to or simultaneously with implementation outside the U.S. Such
processes, services, and improvements, when implemented outside the U.
S. shall not result in reduction of the use of the same processes,
services, or improvements in the U.S.
B. Contractor agrees to a U.S. Industrial Competitiveness clause in accordance
with its prime contract with respect to any licensing and assignments of
its Intellectual Property arising from this CRADA, except that any
licensing or assignment of its Intellectual Property rights to Participant
shall be in accordance with the terms of paragraph A of this article.
ARTICLE XXIII: ASSIGNMENT OF PERSONNEL
--------------------------------------
A. Each Party may assign personnel to the other Party's facility as part of
this CRADA to participate in or observe the research to be performed under
this CRADA. Such personnel assigned by the assigning Party shall not during
the period of such assignments be considered employees of the receiving
Party for any purpose.
B. The receiving Party shall have the right to exercise routine administrative
and technical supervisory control of the occupational activities of such
personnel during the assignment period and shall have the right to approve
the assignment of such personnel and/or to later request their removal by
the assigning Party.
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C. The assigning Party shall bear any and all costs and expenses with regard
to its personnel assigned to the receiving Party's facilities under this
CRADA. The receiving Party shall bear facility costs of such assignments.
ARTICLE XXIV: FORCE MA.IEURE
----------------------------
No failure or omission by Contractor or Participant in the performance of any
obligation under this CRADA shall be deemed a breach of this CRADA or create any
liability if the same shall arise from any cause or causes beyond the control of
Contractor or Participant, including but not limited to the following, which,
for the purpose of this CRADA, shall be regarded as beyond the control of the
Party in question: Acts of God, acts or omissions of any government or agency
thereof, compliance with requirements, rules, regulations, or orders of any
governmental authority or any office, department, agency, or instrumentality
thereof, fire, storm, flood, earthquake, accident, acts of the public enemy,
war, rebellion, insurrection, riot, sabotage, invasion, quarantine, restriction,
transportation embargoes, or failures or delays in transportation.
ARTICLE XXV: ADMINISTRATION OF CRADA
------------------------------------
Contractor enters into this CRADA under the authority of its prime contract with
DOE. Contractor is authorized to and will administer this CRADA in all respects
unless otherwise specifically provided for herein. Administration of this CRADA
may be transferred from Contractor to DOE or its designee with notice of such
transfer to Participant, and Contractor shall have no further responsibilities
except for the confidentiality, use, and/or non-disclosure obligations of this
CRADA.
ARTICLE XXVI: RECORDS AND ACCOUNTING FOR GOVERNMENT PROPERTY
------------------------------------------------------------
Participant shall maintain records of receipts, expenditures, and the
disposition of all Government property in its custody related to this CRADA.
ARTICLE XX VII: NOTICES
-----------------------
A. Any communications required by this CRADA, if given by postage prepaid
first class U.S. Mail or other verifiable means addressed to the Party to
receive the communication, shall be deemed made as of the day of receipt of
such communication by the addressee, or on the date given if by verified
facsimile. Address changes shall be given in accordance with this Article
and shall be effective thereafter. All such communications, to be
considered effective, shall include the number of this CRADA.
B. The addresses, telephone numbers and facsimile numbers for the Parties are
as follows:
For Contractor: For Participant:
Agreements Administrator Chief Technology Officer
Technology Outreach Applied DNA Sciences, Inc.
Xxxxxxx BWXT Idaho, LLC 0000 X. Xxxxxx Xxxx., Xxx. 000
0000 X. Xxxxxxx Xxx. Xxx Xxxxxxx, XX 00000
X.X. Xxx 0000, M.S. 3805 Phone: (000) 000-0000
Xxxxx Xxxxx, XX 00000-0000 Fax: (000) 000-0000
E-mail: xxxxxxxx@xxxx.xxx
Phone: (000) 000-0000
Fax: (000) 000-0000
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ARTICLE XXVIII: DISPUTES
------------------------
The Parties shall attempt to jointly resolve all disputes arising from this
CRADA. If the Parties are unable to jointly resolve a dispute within a
reasonable period of time, the dispute shall be decided by the DOE Contracting
Officer, who shall reduce his/her decision to writing within sixty (60) days of
receiving in writing the request for a decision by either Party to this CRADA.
The DOE Contracting Officer shall mail or otherwise furnish a copy of the
decision to the Parties. The decision of the DOE Contracting Officer is final
unless, within 120 days, Participant brings an action for adjudication in a
court of competent jurisdiction in the State of Idaho. To the extent that there
is no applicable U.S. Federal law, this CRADA and performance thereunder shall
be governed by the law of the State of Idaho.
ARTICLE XXIX: ENTIRE CRADA AND MODIFICATIONS
--------------------------------------------
A. Except for a nondisclosure agreement between the Parties, if any, this
CRADA with its appendixes contains the entire agreement between the Parties
with respect to the subject matter hereof, and all other prior
representations or agreements relating hereto have been merged into this
document and are thus superseded in totality by this CRADA. This CRADA
shall not be effective until approved by DOE and signed by the Parties.
B. Any agreement to materially change any terms or conditions of this CRADA or
the appendices shall be valid only if the change is made in writing,
executed by the Parties hereto, and approved by DOE.
ARTICLE XXX: TERMINATION
------------------------
This CRADA may be terminated by either Party upon ninety (90) days written
notice to the other Party. This CRADA may also be terminated by the Contractor
in the event of failure by the Participant to provide the necessary advance
funding, as agreed in Article III.
In the event of termination by either Party, each Party shall be responsible for
its share of the costs incurred through the effective date of termination, as
well as its share of the costs incurred after the effective date of termination,
and which are related to the termination.
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The confidentiality, use, and/or non-disclosure obligations of this CRADA shall
survive any termination of this CRADA.
FOR XXXXXXX BWXT IDAHO, LLC FOR APPLIED DNA SCIENCES, INC.
BY: /S/ A. XXX XXXXXX BY: /s/ XXXX X. XXXX
----------------- ----------------
A. Xxx Xxxxxx Xxxx X. Xxxx
Director, Technology Outreach Chief Technology Officer
DATE: September 2, 2004 DATE: September 2, 2004
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APPENDIX A
STATEMENT OF WORK
ENHANCED DEVELOPMENT OF DNA-EMBEDDED SECURITY
TECHNOLOGY
CRADA NO. 04-04-09
A. Scope of Work
Participant has proprietary DNA-embedded security technology based on
combinations of and assay methods for unique plant DNA security sequences. This
technology can verify authenticity and protect corporate and government agencies
from counterfeiting, fraud, piracy, product diversion, identify theft and
unauthorized intrusion. Under this CRADA, Participant and Contractor will work
together to adapt Participant and Contractor DNA-embedded security technology to
a wide range of applications relevant to DOE and Homeland Security needs.
Collaborative research and development (R&D) that utilizes the Contractor's
biology, chemistry and sensing capabilities have been identified and will be
used to carry out the scope of work for this CRADA. Contractor will contribute
to the characterization of the DNA security technology and its adaptation
leading to a more rapid detection assays and sensor systems.
The scope of work will be carried out by BBWI in three phases and may be
continued based on the outcome of the second and/or third phase.
(1) Phase I ($50K funds-in)
The physical characteristics of the materials associated with the DNA
tag will be characterized. For example, the matrix's functional groups
with potential for linking rapid assay tagging molecules will be
analyzed. The outcome of this analysis will provide the background
information needed to select the appropriate path forward. Phase I
will define the physical and chemical properties that are critical for
selecting development paths that best complement the existing
DNA-embedded security technology. Our objective is to use this
information to identify, prioritize and define specific technical
paths that can most readily lead to the deployment of rapid detection
methods and systems.
(2) Phase II ($100K funds-in)
Using the baseline data derived from Phase I, develop a strategy and
define methods for increasing the rapidity with which materials can be
collected, extracted and rapidly assayed. Given the physical and
chemical characteristics of the matrix material, determine the most
effective method of applying antigens to the base matrix material and
rapidly detecting them. In an analogous way, assess the viability of
alternative tagging agents and/or coatings or additives for optical
recognition. Refine and begin implementing the Research & Development
strategy for Phase III.
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(3) Phase III ($100K funds-in)
Develop and test rapid detection methods and sensors defined by Phases
I and II. In addition, develop alternatives and improvements for
forensic testing equipment specific to the DNA marker product. Because
the DNA marker embody similar botanical genotypes and share in their
encapsulation chemistry, a simplified sample preparation method will
be sought as well as improvements to the front-end protocols for DNA
extraction and isolation which improve speed and efficiency of PCR
technology.
Further develop and refine the selected applications.
Timeline:
------------------------------------------------------ --------------- --------------- ----------------------------- ---------------
1st Month 2nd Month 3rd, 4th and 5th Months Follow-on work
------------------------------------------------------ --------------- --------------- ----------------------------- ---------------
FUNDING $50K $100K $100K TBD
-------
------------------------------------------------------ --------------- --------------- ----------------------------- ---------------
Task I: Characterize the physical and functional [-----------] TBD
properties of matrix material and prioritize
opportunities.
------------------------------------------------------ --------------- --------------- ----------------------------- ---------------
Task II: Define path forward and begin implementing [-----------] TBD
the rapid detection strategy.
------------------------------------------------------ --------------- --------------- ----------------------------- ---------------
Task III: Setup and demonstrate rapid detection [--------------------------] TBD
proof-of-principle.
------------------------------------------------------ --------------- --------------- ----------------------------- ---------------
00
XXXXXXXX X
BACKGROUND INTELLECTUAL PROPERTY
ENHANCED DEVELOPMENT OF DNA-EMBEDDED SECURITY
TECHNOLOGY
CRADA NO. 04-CR-09
A. Contractor Background Intellectual Property
BBWI Invention Disclosure Record No.B-441, Tagging Currency Through
Automated Teller Machines (ATMs), submitted July 30, 2003.
B. Participant Background Intellectual Property
(1) U.S. Provisional Patent Application No. 60-463,215 "A System and
Method for Marking Textiles Using DNA" filed April 16, 2003.
(2) U.S. Utility Patent Application No. 10/825,968 and International
Application No. PCT/US2004/12031 "System and Method for Marking
Textiles with Nucleic Acid," both filed April 15, 2004.
(3) U.S. Provisional Patent Application No. 60/538,490 `System and Method
for Authenticating Clients on a Local Area Network Using Nucleic
Acids" Filed January 21, 2004.
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