FUNDS-IN AGREEMENT
REGENTS OF THE UNIVERSITY OF CALIFORNIA
LOS ALAMOS NATIONAL LABORATORY
Operating Under Prime Contract No. W-74-5-ENG-36 for the U.S. Department of
Energy And Sponsor Identified Below
Section I
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1. SPONSOR NAME 2. FUNDS-IN AGREEMENT NUMBER
E. coli Measurement Systems, Inc. FIA-98-053
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3. ESTIMATED PERFORMANCE 4. PROJECT TITLE/DESCRIPTION
PERIOD (IN MONTHS)
24 Months Prototype System for Detection
of Bacterial Contamination
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5. FINANCIAL 6. LOS ALAMOS NATIONAL
a. Estimated Cost LABORATORY
(1) LANL Cost $410,000 a. Technical Representative:
(2) Total Cost to ▇▇▇▇▇▇ ▇▇▇▇▇▇
Sponsor $410,000 Los Alamos National
Laboratory
P.O. Box 1663, P-21, MS D434
b. Incremental Funding Los Alamos, NM 87545
Approved Yes Telephone: (▇▇▇) ▇▇▇-▇▇▇▇
c. Amount Advanced Fax: (▇▇▇) ▇▇▇-▇▇▇▇
This Action $70,000 E-Mail: ▇▇▇@▇▇▇▇.▇▇▇
See Attached Invoice for Advance Payment Instructions
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7. AGREEMENT TERMS AND CONDITIONS
This Agreement consists of this form with Terms and Conditions plus the
following:
a. Appendix A - Statement of Work c. Appendix C - Rights in Technical
Facilities Data - Use of
b. Appendix B - Patent Rights
- Use of Facilities (Unlimited)
d. Other:
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8. FOR E.COLI MEASUREMENT 9. FOR THE REGENTS OF THE
SYSTEMS, INC. UNIVERSITY OF CALIFORNIA
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Name: ▇▇. ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ Name: ▇▇. ▇▇▇▇▇ ▇. ▇▇▇▇▇
Title: President Title: Program Manager
Address:▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ Address:Los Alamos National Laboratory
Plant City FL 33566 Civilian and Industrial
Technology Programs
Partnership Agreements Office
P.O. Box 1663, MS C334
Los Alamos, NM 87545
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Telephone: (▇▇▇) ▇▇▇-▇▇▇▇ Telephone: (▇▇▇) ▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇ Fax: (▇▇▇) ▇▇▇-▇▇▇▇
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Signature Date Signature Date
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TERMS AND CONDITIONS
Section II
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1. Parties to the Agreement. The U.S. Department of Energy Contractor, The
Regents of the University of California, hereinafter referred to as the
"University", has been requested by the Sponsor referred to in Section I.1.,
hereinafter referred to as the "Sponsor", to perform the work set forth in the
Statement of Work, attached hereto as Appendix A. It is understood by the
Parties that the University is obligated to comply with the terms and conditions
of its Management and Operations (M&O) contract with the United States
Government (hereinafter called the "government") represented by the United
States Department of Energy (hereinafter called the "Department" or "DOE") when
providing goods, services, products, processes, materials, or information to the
Sponsor under this Agreement.
2. Term of the Agreement. This Agreement shall be effective as of the latter
date of (1) the date on which it is signed by the last of the Parties thereto,
or (2) the date on which the University receives advance funding from the
sponsor, and shall continue for the estimated period stated in Section I.3. The
term of this Agreement may be extended by mutual, written agreement of the
Parties when the extension does not affect the cost, statement of work or terms
and conditions, which require a formal amendment to this Agreement.
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Sequentially numbered page 99
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3. Costs. The University has no obligation to continue or complete performance
of the work at a cost stated in Section l.5.(2) in excess of its estimated cost,
including any subsequent amendment. The University agrees to provide at least
thirty (30) days notice to the Sponsor if it is anticipated that the actual cost
to complete performance will exceed its estimated cost.
4. Funding and Payment. The University is required by DOE to receive advance
funding before beginning work. The Sponsor shall provide sufficient funds in
advance to reimburse the University for costs to be incurred in performance of
the work described in this Agreement, and the University shall have no
obligation to perform in the absence of adequate advance funds. If the estimated
period of performance exceeds ninety (90) days or the estimated cost exceeds
$25,000, the Sponsor may, with the University's approval, advance funds
incrementally In such a case, the University may initially invoice the Sponsor
in an amount sufficient to permit the work to proceed for one hundred twenty
(120) days, and thereafter invoice the Sponsor monthly so as to maintain
approximately a ninety (90) day period that is funded in advance, Payment shall
be made directly to the University. Upon termination or completion, excess funds
shalt be refunded by the University to the Sponsor, in accordance with the
University's closeout procedures.
5. Source of Funds. If the Sponsor is receiving funding from another Government
source, this Agreement does not serve to release the Sponsor from any
obligations it has under the Agreement with the Government providing the
funding.
6. Property. Upon termination of this Agreement, property or equipment having a
value greater than $25,000 produced or acquired in conducting the work under
this Agreement shall be owned as follows:
Property valued over $25,000 disposed of as directed by the Sponsor, with
property under $25,000 to remain at Los Alamos National Laboratory, and to
become property of the Government, unless otherwise specified in the Statement
of Work. No Federal funds will be used to purchase property or equipment for
this Agreement. Property or equipment produced or acquired as part of this
Agreement will be accounted for and maintained during the term of this Agreement
in the same manner as Department property or equipment. Any property which
becomes integrated into the Facility becomes the property of the Government.
7. Pre-Publication Review. The publishing Party shall provide the other Party a
sixty (60) day period in which to review and comment on proposed publications,
including news releases and advertisements, that either disclose technical
developments and/or research findings generated in the course of this Agreement,
or identify Proprietary Information. The publishing Party shall not publish or
otherwise disclose Proprietary Information or Protected Generated Information
identified by the other Party, except as provided by law.
8. Legal Notice. Any technical paper, article publication, or announcement of
advances generated in connection with the work done under this Agreement, during
the period of performance of this Agreement or in the future shall give credit
to the Sponsor as a sponsor of the work and shall contain the following notice:
THIS REPORT WAS PREPARED AS AN ACCOUNT OF WORK UNDER A SPONSORED AGREEMENT AND
PURSUANT TO CONTRACT BETWEEN THE UNIVERSITY AND THE UNITED STATES GOVERNMENT.
NEITHER THE UNITED STATES GOVERNMENT, THE UNITED STATES DEPARTMENT OF ENERGY,
NOR THE REGENTS OF THE UNIVERSITY OF CALIFORNIA, NOR ANY OF THEIR EMPLOYEES
MAKES ANY WARRANTY, EXPRESSED OR IMPLIED, OR ASSUMES ANY LEGAL LIABILITY OR
RESPONSIBILITY FOR THE ACCURACY, COMPLETENESS, OR USEFULNESS OF ANY
INFOIIMIATION, APPARATUS, PRODUCT, OR PROCESS DISCLOSED, OR REPRESENTS THAT ITS
USE WOULD NOT INFRINGE PRIVATELY OWNED RIGHTS. REFERENCE HEREIN TO ANY SPECIFIC
COMMERCIAL PRODUCT, PROCESS, OR SERVICE BY TRADE NAME, MARK, MANUFACTURER, OR
OTHERWISE, DOES NOT NECESSARILY CONSTITUTE OR IMPLY ITS ENDORSEMENT,
RECOMMENDAT[ON, OR FAVORING BY THE UNITED STATES GOVERNMENT OR ANY AGENCY OR
CONTRACTOR THEREOF. THE VIEWS AND OPINIONS OF AUTHORS EXPRESSED HEREIN DO NOT
NECESSARILY STATE OR REFLECT THOSE OF THE UNITED STATES GOVERNMENT OR ANY AGENCY
OR CONTRACTOR THEREOF.
Sequentially numbered page 100
9. Disclaimer. THE GOVERNMENT, AND THE UNIVERSITY 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 AGREEMENT, OR
THE OWNERSHIP, MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF THE
RESEARCH OR RESULTING PRODUCT. NEITHER THE GOVERNMENT, NOR THE UNIVERSITY 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 AGREEMENT.
10.a Product Liability Indemnity. The Sponsor hereby agrees to indemnify and
hold harmless the University, and the Government, their officers, agents, and
employees, from any and all liability, claims or damages, including attorney
fees and cost whatsoever, for injury to or death of persons, or damage to or
destruction of property, as a result of or arising out of the making, using, or
selling of a product, process, or service which was derived from the work
performed under this Agreement by or on behalf of the Sponsor, its assignees or
licensees, provided, however, that neither the Government nor the University
shall be considered assignees or licensees of the Sponsor as a result of
reserved Government and University rights.
10.b General Indemnity. Except for any liability resulting from any negligent
acts or omissions of the University, the Sponsor hereby agrees to indemnif~ and
hold harmless the University and the Government, their officers, agents, and
employees from any and all liability, claims or damages, including attorney fees
and cost whatsoever, for injury to or death of persons, or damage to or
destruction of property arising out of the performance of the work under this
agreement.
11. Intellectual Property Indemnity - Limited. The Sponsor shah indemnify the
Government and the University, and their officers, agents, and employees against
liability, including attorney's fees and costs, for infringement of any United
States patent, copyright, or other intellectual property arising out of any acts
required or directed by the Sponsor to be performed under this Agreement, to the
extent such acts are not already performed at the Facility. Such indemnity shall
not apply to a claimed infringement that is settled without the consent of the
Sponsor unless required by a court of competent jurisdiction.
12. Notice and Assistance Regarding patent and Copyright Infringement. The
Sponsor shall report to the Department and the University promptly, and in
reasonable written detail, each claim of patent or copyright infringement based
on the performance of this Agreement of which the Sponsor has knowledge. The
Sponsor shall furnish to the Department and the University, when requested by
the Department or the University, all evidence and information in the possession
of the Sponsor pertaining to such claim.
13. Patents and Technical Data Rights. Terms and Conditions regarding Patents
and Technical Data Rights are set forth in the attached here as Appendix B and
Appendix C, respectively.
14. Assignment. Neither this Agreement, nor any interest therein, or claim
thereunder shall be assigned or transferred by either Party, except as
authorized in writing by the other Party to this Agreement, provided the
University may transfer it to the Department, or its designee, with notice of
such transfer to the Sponsor, and the University shall have no further
responsibilities except for the confidentiality, use, and/or non-disclosure
obligations of this Agreement.
15. Similar or Identical Services. The Government and/or University shall have
the right to perform similar or identical services in the Statement of Work
(SOW) for other Sponsors, as long as neither Sponsor's Proprietary Information
nor Protected Information during the term of its protection is utilized.
16. Non Competition. The Sponsor states that, to the best of the Sponsor's
knowledge, the University is not in competition with the domestic private
sector.
17. Export Control. Each party is responsible for its own compliance with laws
and regulations governing export controls.
Sequentially numbered page 101
18. Termination. Performance of work under this Agreement may be terminated at
any time by either Party, without liability, upon giving a thirty (30) day
written notice to the other Party. The University shall terminate this Agreement
only when the University determines, after direction from DOE, that such
termination is in the best interest of the Government, provided however, that
the University shall have the right to terminate if the Sponsor shall have
failed to advance the funds required by article 4., Funding and Payment. In the
event of termination the Sponsor shall be responsible for the University's costs
(including closeout costs), through the effective date of termination, but in no
event shall the Sponsor's cost responsibility exceed the total cost to the
Sponsor as described in Section I. (5) Financial.
19. Entire Agreement and Amendments to the Agreement. It is expressly understood
and agreed that this Agreement with its Appendices contains the entire Agreement
between the Parties. Any agreement to change any terms and conditions of this
Agreement or the Appendices shall be valid only if the change is made in writing
and executed by the Parties to this Agreement.
20. Force Majeure. No failure or omission by the University or Sponsor in the
performance of any obligation under this Agreement shall be deemed a breach of
this Agreement or create any liability if the same shall arise from any cause or
causes beyond the control of the University or Sponsor, including but not
limited to the following, which, for the purpose of this Agreement, 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.
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APPENDIX A
Statement of Work
FIA-98-053
E. coli Measurement Systems, Inc.
Prototype System for Detection of Bacterial Contamination
I. Description of Services
1.0 Objective
It is widely accepted that current methods for the analysis of
bacterial contamination in food products are inadequate. These
traditional methods rely on enrichment regimes and isolation on
diagnostic plates followed by biochemical tests, sometimes with further
characterization by serology/diagnostic media. These methods can take
many days to give results, which is an unacceptable amount of time,
particularly when dealing with perishable items like foods. Thus,
corrective action to combat any safety or spoilage problems cannot be
implemented immediately. The methods are also labor intensive and hence
costly, and the quality of the information provided is often
questionable. These methods are also incapable of detecting the
so-called "viable but not-culturable cells" whose significance for
quality control of food products is as yet uncertain. New methods need
to be developed which should ideally be able to:
a) Give results in a short period of time (< 1 hr).
b) Be highly sensitive, reproducible and repeatable, and be
non-hazardous (i.e., radio-isotopes are not acceptable in the food
handling environment).
c) Not interfered with by the presence of other organisms.
d) Give accurate and reliable information about the identity of the
pathogen.
e) Be applicable to a wide range of organisms.
f) Have a low per-assay cost.
g) Be amenable to automation.
We propose to develop methods and instrumentation for the detection and
quantitation of bacterial contaminants present in food products
according to the criteria outlined above. This new technique makes use
of newly devised molecular biology protocols for the direct and highly
specific detection of characteristic nucleic acid sequences of
pathogens present in food samples. A highly sensitive fluorescence
detector based on our demonstrated technique of single-molecule
detection will be developed to identify the presence of low-level
nucleic acids. The new method described here promises to combine the
advantages of flow-based analytical Systems (system automation, speed,
reproducibility) with the unsurpassed sensitivity of single-molecule
detection. The sensitivity of this method allows for the direct
detection of specific pathogenic nucleic acids without the need for
using amplification methods such as PCR and exhibits advantages over
current methodologies in terms of sensitivity, specificity, speed, and
per-assay-cost.
2.0 Scope
This project will be divide in two phases. The initial phase consists
of developing the necessary molecular biology protocols for the
detection of specific nucleic acid sequences with high sensitivity and
specificity. The method consists of synthesizing a highly fluorescent
nucleic acid reporter molecule using a sequence of the target as a
template. This synthesis is accomplished by using a short
oligonucleotide primer that is complementary to the target. A suitable
polymerize and free nucleotides are added to the sample. One of these
oligonucleotides is -at least partially- labeled with a fluorophore. If
the target is present in the sample, the primer binds to it, and the
polymerase will incorporate the labeled and unlabeled nucleotides
reconstructing the target's complementary sequence. If the labeled
nucleotide concentration is kept below that of the unlabeled
nucleotides, most of it will be incorporated into the reporter DNA
molecule. Detection of the reporter signifies the presence of the
target being sought. The fluorescent signal from the reporter molecule
is expected to be much larger than that of the background originating
from free labeled nucleotides, since the reaction is allowed to proceed
until the reporter molecule is hundreds or thousands of bases long.
Initially, lambda DNA will be used as a model system for all
experiments. Once the protocols are fully developed, they will be
optimized for the detection of E. coli. The second phase of the project
consists of designing and constructing an ultra sensitive fluorescence
detector prototype. This instrument will be based on our
single-molecule detection technology, and will allow the detection of
reporter molecules described above with high specificity and
single-molecule sensitivity. The total project duration is 24 months.
Sequentially numbered page 103
3.0 Applicable Documents
S-89, 696 --> ▇▇▇▇▇▇, METHOD FOR THE DETECTION OF SPECIFIC NUCLEIC ACID
SEQUENCES BY POLYMERASE NUCLEOTIDE INCORPORATION. UC filed a
provisional patent application 12/18/98 and elected title in the name
of UC. Foreign filing rights may be applied for on this technology. The
technology has not yet been reduced to practice. The technology is not
encumbered at this time, so it is presently available for licensing.
4.0 Technical Tasks
Phase Task Description Start Duration
Month (Months)
I Development of molecular biology protocols.
1 Nucleic acid probe design. Optimal E. coli and lambda 1 1
nucleic acid sequences will be determined for maximum
specificity.
2 Optimization of protocols for labeled nucleotide 2 6
incorporation by polymerize target extension. Labeled
oligonucleotides complementary to nucleic acid targets
will be synthesized by enzymatic extension reactions.
Optimal conditions for fluorescent report synthesis
will be determined.
3 Optimization of sample preparation protocols. 8 3
Experiments will be performed to determine the optimal
conditions for sample preparation. Various parameters
such as buffer composition, extraction procedures, and
hybridization conditions will be evaluated. Targets will
consist of low levels of E. coli genomic DNA. Effects of
interferants usually present in food samples will be
evaluated.
4 Demonstration of the detection of specific sequences of 11 2
bacterial contaminants. The detection system currently
in operation at LANL will be modified to perform
experiments on the detection of specific sequences of
bacterial contaminants. Increasingly diluted samples
of E. coli genomic DNA will be analyzed. Limits of
detection are expected to lie in the femtomolar (10-15
M) range.
II Design and construction of a prototype instrument for the 13
detection of low levels of E. coli.
1 Prototype design. This instrument will be composed of 13 1
various subsystems: optical, sample delivery,
electronics, data acquisition and automated control. At
this stage , these subsystems will be designed in
accordance to the molecular biology protocols
developed in Phase I. Each component will be specified.
2 Constuction of optical subsystem. The 14 3
high-collection-efficiency fluorescence detection optical
subsystem will be constructed. This subsystem consists
of excitation componenets (laser, focusing optics),
fluorescence collection optical components, spectral and
spatial discrimination components, and single-photom
detection components, in accordance to established single-
molecule detection technology.
Sequentially numbered page 104
4.0 Technical Tasks (continued)
3 Construction of sample delivery subsystem. The automated 17 2
internal sample injection subsystem will be constructed.
It consists of a fluorescence micro-cell and sample
injection components.
4 Construction of electronics subsystem. This subsystem 19 1
comprises the signal amplification and
conditioning electronics, scaling electronics,
computer interface electronics, and power
supplies for various electronic components.
5 Implementation of data acquisition and automated 20 3
control subsystem. In this stage, the data acquisition
and automated control software will be written in the
LabVIEW programming environment.
6 Final system integration and test. The electronics and 23 2
optical subsystems will be incorporated into an
instrument chassis at this point. The limits of detection
of the instrument will be determined by detecting
increasingly smaller quantities of E. coli genomic DNA.
II. Reports Data and Other Deliverables
A prototype instrument for the detection of food pathogens will be delivered
to the company.
III. Special Considerations
None.
IV. Designated Signature Authorities/Representatives
E. coli Measurement Systems, Inc. Los Alamos National Laboratory
Attn.:▇▇. ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇ Attn.: ▇▇. ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇
President Civilian and Industrial Technology
▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇ ▇▇ ▇▇▇▇▇ Partnership Agreements Office
Los Alamos National Laboratory
P.O. Box 1663, MS C334
Tel: (8l3) 654-6l13 Los Alamos, NM 87545
Fax: (▇▇▇) ▇▇▇-▇▇▇▇ Tel: (▇▇▇) ▇▇▇-▇▇▇▇
Fax: (▇▇▇) ▇▇▇-▇▇▇▇
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APPENDIX B
PATENTS RIGIITS - USE OF FACILITIES
1. Definitions.
A. "Invention" means any invention or discovery which is or may be
patentable or otherwise protectable under Title 35 of the United
States Code or any novel variety of plant that is or may be
protectable under the Plant Variety Protection Action (7 U.S.C. 232 et
seq.).
B. "Sponsor Invention" means any invention, to the extent that the
Sponsor is performing any work under this Agreement, of the Sponsor,
conceived or first actually reduced to practice in the course of work
under this Agreement.
C. "Patent Counsel" means the DOE Patent Counsel assisting the procuring
activity which has the administrative responsibility for the facility
where the work under this Agreement is to be performed.
2. University Inventions.
The Government and the University shall have rights in any Invention
conceived in the performance of work under this Agreement by employees of
the University in accordance with the provision of Department of Energy's
(DOE) Management and Operating (M&O) contract with the University, subject
to the Sponsor obtaining upon notice to the DOE Patent Counsel, a
nonexclusive, nontransferable, irrevocable, paid-up license to practice
said Invention throughout the world. Sponsor further has the first option
to negotiate with the University for an exclusive license in a
pre-negotiated field of use on reasonable terms and conditions. This Option
shall expire six (6) months after the conclusion of the work under the
Statement of Work.
3. Sponsor's Election to Retain Rights.
Subject to the provisions of 4.B. (Terms and Conditions of Waived Rights),
with respect to any Sponsor Invention reported and elected in accordance
with paragraph 5. (Invention Identification, Disclosures, and Reports) of
this clause, the Sponsor may elect to obtain the entire right, title, and
interest in any patent application filed in any country on a Sponsor
Invention, and in any resulting patent secured by the Sponsor. Where
appropriate, the filing of patent application by the Sponsor is subject to
DOE security regulations and requirements.
4. Rights of University and Government
A. Assignment to either the University or Government The Sponsor agrees
to assign to either the University or the Government, as requested by
the University, the entire right, title, and interest in any country
to each Sponsor Invention where the Sponsor:
(1) does not elect pursuant to this article to retain such rights; or
(2) elects to obtain title to a Sponsor Invention pursuant to
paragraph 3 (Sponsor's Election to Retain Rights) but fails to
have a patent application filed in that country on the Sponsor
Invention, or decides not to continue prosecution, or not to pay
any maintenance fees covering the invention; or
(3) elects to retain title to a Sponsor Invention but at any time, no
longer desires to retain title.
B. Terms and Conditions of Waived Rights.
(1) To preserve the University's and the Government's residual rights
to Sponsor Inventions, and in patent applications, and patents on
Sponsor Inventions, the Sponsor shall take all actions in
reporting, electing, filing on, prosecuting, and maintaining
invention rights promptly, but in any event, in sufficient time
to satisfy domestic and foreign statutory and regulatory time
requirements, or, if the Sponsor decides not to take appropriate
steps to protect the invention rights, it shall notiiy the
University or the Goverrunent in sufficient time to permit either
the University or the Government to file, prosecute, and maintain
patent applications, and any resulting patents prior to the end
of such domestic or foreign statutory or regulatory time
requirements.
(2) The Sponsor shall convey or ensure the conveyance of any executed
instruments necessary to vest in either the University or the
Government the rights set forth in this article.
Sequentially numbered page 106
(3) With respect to any Sponsor Invention in which the Sponsor
obtains title, the Sponsor hereby grants to the Government a
non-exclusive, nontransferable, irrevocable, paid-up license to
practice or have practiced by or on behalf of the United States,
the Sponsor Invention throughout the world.
(4) The Sponsor shall provide the Government a copy of any patent
applications filed on a Sponsor Invention within six (6) months
after such application is filed, including its serial number and
filing date.
(5) Preference for U.S. Industry. Notwithstanding any other provision
of this article, the Sponsor agrees that any products or
processes embodying the Subject Invention for use or sale in the
United States, shall be substantially manufactured in the United
States, and that neither it nor any assignee will grant to any
person the exclusive right to use or sell any Sponsor Invention
in the United States, unless such person agrees that any products
embodying the Sponsor Invention, or produced through the use of
the Sponsor Invention, will be manufactured substantially in the
United States. However, in individual cases, the requirement for
such an agreement may be waived by DOE upon a showing by the
Sponsor or its assignee that reasonable but unsuccessful efforts
have been made to grant licenses on similar terms to potential
licensees that would be likely to manufacture substantially in
the United States, or that under the circumstances, domestic
manufacture is not commercially feasible.
(6) March-in Rights. The Sponsor agrees that with respect to any
Sponsor Invention, the DOE shall retain the right to require the
Sponsor to grant to a responsible applicant, a non-exclusive,
partially exclusive, or exclusive license to use the Sponsor
Invention in any field of use, on terms that are reasonable under
the circumstances, or if the Sponsor fails to grant such a
license, to grant the license itself. DOE may exercise this right
only in exceptional circumstances, and only if DOE determines
that:
(a) the action is necessary to meet health or safety needs
that are not reasonably satisfied by the Sponsor, or
(b) the action is necessary to meet the requirements for
public use specified by Federal regulations, and such
requirements are not reasonably satisfied by the
Sponsor; or
(c) such action is necessary because a licensee of the
exclusive right to use or sell any Subject Invention in
the United States is in breach of this Agreement
required by paragraph 4.B.(5) (Preference for U.S.
Industry).
(7) The Sponsor agrees to refund any amounts received as royalty
charges on any Sponsor Invention in procurements by or on behalf
of the Government, and to provide for that refund in any
instrument transferring rights to any party in the invention.
(8) The Sponsor agrees to include, within the specification of any
United States patent applications, and any patent issuing thereon
covering a Sponsor Invention, the following statement. "The
Government has rights in this invention pursuant to "FIA-98-O53."
5. Invention Identification, Disclosures, and Reports.
A. The Sponsor shall furnish the Patent Counsel, and the University, a
written report containing full and complete technical information
concerning each Sponsor Invention it makes within six (6) months after
conception or ftrst actual reduction to practice, whichever occurs
first, in the course of or under this Agreement, but in any event
prior to any on sale, public use, or public disclosure of such
invention known to the Sponsor. The report shall identify the contract
and inventor, and shall be sufficiently complete in technical detail,
and appropriately illustrated by sketch or diagram to convey to one
skilled in the art to which the invention pertains a clear
understanding to the extent known at the time of disclosure, of the
nature, purpose, operation, and to the extent known, the physical,
chemical, biological, or electrical characteristics of the invention.
The report should also include any election of invention rights under
this article. When an invention is reported under this paragraph 5.A.,
it shall be presumed to have been made in the manner specified in
Section (a)(l) and (2) of 42 USC 59O8.
Sequentially numbered page 107
B. The University shall report University Inventions it makes in
accordance with the procedures set forth in its Management and
Operating Contract with DOE. In addition, the University shall
disclose to the Sponsor, at the same time as disclosure to the
Department, any University Inventions made by the University under
this Agreement.
6. Limitation of Rights
Nothing contained in this patent rights article shall be deemed to give the
Government any rights with respect to any invention other than a University
or Sponsor Invention, except as set forth in the Facilities License of
paragraph 7.
7. Facilities License.
In addition to the rights of the Parties with respect to inventions or
discoveries conceived or first actually reduced to practice in the course
of or under this Agreement, the Sponsor agrees to, and does hereby grant to
the Government, an irrevocable, non-exclusive, paid-up license in and to
any inventions or discoveries regardless of when conceived or first
actually reduced to practice, or acquired by the Sponsor, which at any
time, through completion of this Agreement, are owned or controlled by the
Sponsor, and are incorporated in the Facility as a result of this
Agreement, to such an extent that the Facility is not restored to the
condition existing prior to this Agreement (1) to practice or to have
practiced by or for the Government at the Facility, and (2) to transfer
such license with the transfer of the Facility. The acceptance or exercise
by the Government of the aforesaid rights and license shall not prevent the
Government at any time from contesting the enforceability, validity, or
scope of, or title to any rights or patents herein licensed.
8. Early Termination of Agreement.
The terms and conditions of this article shall survive this Agreement, even
in the event that this Agreement is terminated before completion of the
Statement of Work.
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APPENDIX C
RIGHTS IN TECHNICAL DATA - USE OF FACILITIES (UNLIMITED)
The Sponsor, University, and the Government, shall have the right to use,
disclose, and duplicate for any purpose whatsoever, and have others do so, all
technical data first produced or used in the performance of work under this
Agreement, (Technical data is defined as set forth in 48 CFR 27.401).
Any Sponsor furnished, properly marked Proprietary Information necessary for, or
pertaining to work under this Agreement, will not be disclosed outside the
Government or University, and will be returned to the Sponsor by or before
termination of this Agreement.
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LANL Document Control No. ▇▇-▇▇-▇▇▇▇▇
APPENDIX D
MILESTONES
1. Licensee will enter into a research and development agreement with the
Univesity that will lead to the reduction to practice of the invention
described in U.S. Provisional Patent Application AN 60/113,139 (PATENT
RIGHTS) and to the delivery to the Licensee of a prototype instrument
embodying this invention at the end of that agreement.
2. Complete survey to identify strategic partners for manufacturing and
distribution and deliver a report to the University within 120 days of
delivery of the prototype instrument.
3. Complete a draft marketing plan and deliver to the University within six
(6) months of delivery of the prototype instrument.
4. Complete alpha testing of the prototype instrument and deliver a report to
the University within twelve (12) months of delivery of the prototype
instrument.
5. Complete beta testing of the prototype instrument and deliver a report to
the University within eighteen (18) months of delivery of the prototype
instrument.
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APPENDIX E
REPORT FORMAT
Date of Report:
Reporting Period:
Corporate Fiscal Year Is:
1. DEVELOPMENT:
-Progress towards commercialization
-Problems encountered
-Pre-commercialization marketing efforts
-Any shift in time-line from original business plan
-Expected launch date
-Any improvements, new patents, derivative works, etc. arising from the
work
2. COMMERCIALIZATION:
-First commercial sale
-Sales, production or other royalty-generating activity
-Royalty calculations and royalties due
3. CONTINUING:
-Continued efforts in evolving the product/service -Improvements
-Sublicenses -Foreign registrations, licenses, commercialization, etc.
-Any problems which would potentially effect the License Agreement -Any
infringements of intellectual property (as provided in the License
Agreement)
-Any potential litigation involving the licensed intellectual property
4. OF GENERAL INTEREST:
-Promotional material, news releases, etc. -Company annual reports
-Testing activity, scientific publications -Any feedback, positive or
negative -Suggestions
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APPENDIX F
FINANCIAL REPORT FORMAT
Date of Report:
Reporting Period:
Corporate Fiscal Year is:
Domestic Sales
------------------- ---------------------- ------------- ----------------- --------------- --------------- --------------------
Description of Unit Price (sale Gross sales
Licensed lease, and/or use) Units sold Units leased in U.S. Net Sales in Royalties due in $
Product(s) U.S. U.S.
------------------- ---------------------- ------------- ----------------- --------------- --------------- --------------------
------------------- ---------------------- ------------- ----------------- --------------- --------------- --------------------
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Foreign Sales By Country
--------------- -------------- --------------- ---------- ------------ ----------- ------------ --------------- ---------------
Country Description Unit Price Gross Monetary
of (sale, lease, Units Units sales in Net Sales exchange rate Royalties due
Licensed and/or use) Sold leased U.S. in U.S. in $ U.S.
Product(s)
--------------- -------------- --------------- ---------- ------------ ----------- ------------ --------------- ---------------
--------------- -------------- --------------- ---------- ------------ ----------- ------------ --------------- ---------------
U.S. Government Sales
---------------------- --------------------- -------------- --------------------- ------------------ --------------------------
Description of Unit Price (sale, Gross sales to
Licensed Product(s) lease, and/or use) Units Sold Units leased to U.S. Govt. Net Sales to U.S. Govt.
to U.S. Govt. U.S. Govt.
---------------------- --------------------- -------------- --------------------- ------------------ --------------------------
---------------------- --------------------- -------------- --------------------- ------------------ --------------------------
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APPENDIX G
DESIGNATION OF THE LICENSING TEAM
Negotiating Team:
▇▇▇▇ ▇. ▇▇▇▇, Licensing Executive
Civilian & Industrial Technology Program Office
Pay ▇. ▇▇▇▇▇▇, Patent Attorney
Business & Patent Law
▇▇▇▇▇▇ ▇▇▇▇, Bioscience Program Manager
Civilian & Industrial Technology Program Office
Technical Advisors:
▇▇▇▇▇▇ ▇▇▇▇▇▇, Technical Staff Member, P-21
▇▇▇▇▇ ▇▇▇▇, Group Leader, P-21
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