Exhibit 10.17
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT
ARTICLE 1. INTRODUCTION
This Cooperative Research and Development Agreement (CRADA) between the
Centers for Disease Control and Prevention (CDC) and the Collaborator will be
effective when signed by all parties. By signing this CRADA, the Collaborator
acknowledges that it has received and read a copy of the Policy Statement on
Cooperative Research and Development Agreements and Intellectual Property
Licensing which is attached as Appendix A. The Research and Development
project(s) which will be undertaken by each of the Parties in the course of
this CRADA is detailed in the Research Plan (RP) which is attached as
Appendix B. The funding and staffing commitments of the Parties are set forth
in Appendix C. Any exceptions or changes to the CRADA are set forth in
Appendix D.
ARTICLE 2. DEFINITIONS
As used in this CRADA, the following terms shall have the indicated meanings:
2.1 "COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT" or "CRADA" means this
Agreement, entered into by CDC pursuant to the Federal Technology Transfer
Act of 1986 and Executive Order 12591 of October 10, 1987.
2.2 "PROPRIETARY INFORMATION" means confidential scientific, business or
financial information provided that such information:
2.2.1 Is not publicly known or available from other sources who are
not under a confidentiality obligation to the source of the
information;
2.2.2 Has not been made available by its owners to others without a
confidentiality obligation;
2.2.3 Is not already available to the receiving Party without a
confidentiality obligation; and
2.2.4 Does not relate to potential hazards or cautionary warnings
associated with the production, handling or use of the subject
matter of the Research Plan of this CRADA.
2.3 "SUBJECT DATA" means all recorded information first produced in the
performance of this CRADA.
2.4 "RESEARCH RESULTS" means all tangible materials other than Subject Data
first produced in the performance of this CRADA.
2.5 "SUBJECT INVENTION" means any invention conceived and reduced to
practice in the performance of research under this CRADA that may be
patentable under 35 U.S.C. Section 101 or Section 161, protectable under
7 U.S.C. Section 2321, or otherwise protectable by other types of U. S.
or foreign Intellectual Property (IP) fight.
2.6 "GOVERNMENT" means the U. S. Government and any of its agencies.
2.7 "RESEARCH PLAN" or "RP" means the statement in Appendix B of the
respective research and development commitments of the Parties to this
CRADA.
2.8 "PRINCIPAL INVESTIGATOR" or "PI" means each of the persons designated
respectively by the Parties to this CRADA who will be responsible for
the scientific and technical conduct of the RP.
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ARTICLE 3. COOPERATIVE RESEARCH
3.1 RESEARCH TEAM. The Parties agree to establish a joint research and
development team (hereinafter referred to as the "Team") comprising at
least the Principal Investigators designated pursuant to Article 3.3 to
conduct and monitor the research in accordance with the RP. Although
members of the Team shall be considered as having been delegated to the
Team, they shall continue to remain employed by their respective
employers under their respective terms of employment.
3.2 REVIEW OF WORK. Periodic conferences shall be held by the Team to
review work progress; it is understood that the nature of this
cooperative research precludes guarantee of its completion within
the specified period of performance or limits of allocated financial or
staffing support. Accordingly, research under this CRADA is to be
performed on a best efforts basis.
3.3 PRINCIPAL INVESTIGATORS. CDC research work under this CRADA will be
performed by the Laboratory identified in the RP, and the CDC Principal
Investigator (PI) designated in the RP will be responsible for the
scientific and technical conduct of this project on behalf of CDC. Also
designated in the RP is the Collaborator PI who will be responsible for
the scientific and technical conduct of this project on behalf of the
Collaborator.
3.4 RESEARCH PLAN CHANGE. The RP may be modified by mutual written consent of
the Principal Investigators. Substantial changes in the scope of the RP
will be treated as amendments under Article 14.6
ARTICLE 4. REPORTS
4.1 INTERIM REPORTS. The Parties shall exchange formal written interim
progress reports on a schedule agreed to by the PIs, but at least within
six (6) months after this CRADA becomes effective and at least within
every six (6) months thereafter. Such reports shall set forth the
technical progress made, identifying such problems as may have been
encountered and establishing goals and objectives requiring further
effort.
4.2 FINAL REPORTS. The Parties shall exchange final reports of their results
within four (4) months after completing the projects described in the RP
or after the termination of this CRADA.
ARTICLE 5. FINANCIAL AND STAFFING OBLIGATIONS
5.1 CDC AND COLLABORATOR CONTRIBUTIONS. The CDC contribution to the RP in
the form of personnel, services and property is designated in Appendix C.
The Collaborator contribution to the RP in the form of personnel,
services, property, support for staffing and/or funding is designated in
Appendix C. Payment schedules, if applicable, are also indicated in
Appendix C.
5.2 INSUFFICIENT AND EXCESS FUNDS. CDC shall not be obligated to perform any
of the research specified herein or to take any other action required by
this CRADA if the funding is not provided as set forth in Appendix C.
CDC shall return excess funds to the Collaborator when it sends its
final fiscal report pursuant to Article 5.3, except for staffing support
pursuant to Article 11.3.
5.3 ACCOUNTING RECORDS. CDC shall maintain separate and distinct current
accounts, records, and other evidence supporting all its obligations
under this CRADA, and shall provide the Collaborator with an annual
report reflecting the use of the Collaborator's funds and a final fiscal
report at the time that final reports are exchanged pursuant to
Article 4.2.
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ARTICLE 6. TITLE TO PROPERTY
6.1 CAPITAL EQUIPMENT. The purchase or use of capital equipment to carry
out this CRADA does not affect the ownership rights that would otherwise
apply. Equipment purchased by CDC with funds provided by the
collaborator shall be the property of CDC. All capital equipment
provided under this CRADA by one party for the use of another Party
remains the property of the providing Party unless other disposition is
mutually agreed upon in writing by the collaborating parties. If title
to this equipment remains with the providing Party, that Party is
responsible for maintenance of the equipment and the costs of its
transportation to and from the site where it will be used.
ARTICLE 7. INTELLECTUAL PROPERTY RIGHTS AND APPLICATIONS
7.1 REPORTING. The Parties shall promptly report to each other in writing
each Subject Invention resulting from the research conducted under this
CRADA that is reported to them by their respective employees. Such
reports shall be treated in confidence by the receiving Party until
such time as a patent or other Intellectual Property (IP) application,
as appropriate, claiming that Subject Invention has been filed.
Because of the royalty sharing provisions for Government inventors in
the Federal Technology Transfer Act of 1986, and in view of Article 8.4
of this CRADA which grants the Government a research license on
inventions made solely by the Collaborator, the Collaborator
acknowledges a special duty to report all Subject Inventions to CDC so
that CDC may determine whether or not inventors properly includes CDC
investigators.
7.2 COLLABORATOR EMPLOYEE INVENTIONS. The Collaborator may elect to retain
IP rights to any Subject Invention made solely by a Collaborator
employee. The Collaborator shall notify CDC promptly upon making this
election. If the Collaborator does not elect to retain its IP rights,
the Collaborator shall offer to assign these IP rights to the Subject
Invention to CDC pursuant to Article 7.5. If CDC declines such
assignment, the Collaborator may release its IP rights to its employee
inventors pursuant to Article 7.6.
7.3 CDC EMPLOYEE INVENTION. CDC, on behalf of the U.S. Government, may elect
to retain IP fights to each Subject Invention made solely by CDC
employees. If CDC does not elect to retain IP rights, CDC shall offer to
assign these IP rights to such Subject Invention to the Collaborator
pursuant to Article 7.5. If the Collaborator declines such assignment,
CDC may release IP rights in such Subject Invention to its employee
inventors pursuant to Article 7.6.
7.4 JOINT INVENTIONS. Each Subject Invention made jointly by CDC and
Collaborator employees shall be jointly owned by CDC and the
Collaborator. The Collaborator may elect to file the joint patent or
other IP application(s) thereon and shall notify CDC promptly upon making
this election. If the Collaborator decides to file such applications, it
shall do so in a timely manner and at its own expense. If the
Collaborator does not elect to file such application(s), CDC on behalf of
the U.S. Government, shall have the right to file the joint applications
in a timely manner and at its own expense. If either Party decides not
to retain its IP rights to a jointly owned Subject Invention, it shall
offer to assign such rights to the other Party pursuant to Article 7.5.
If the other Party declines such assignment, the offering Party may
release its IP rights to employee inventors pursuant to Article 7.6.
7.5 FILING OF PATENT APPLICATIONS. With respect to Subject Inventions made
by the Collaborator as described in Article 7.2 or by CDC as described
in Article 7.3, a Party exercising its right to elect to retain IP rights
to a Subject Invention agrees to file patent or other IP applications in
a timely manner and at its own expense. The Party may elect not to file
a patent or other IP application thereon in any particular country or
countries provided it so advises the other Party ninety (90) days prior
to the expiration of any applicable filing deadline, priority period or
statutory bar date, and hereby agrees to assign its IP rights, title
and interest in such country or countries to the Subject Invention to
the other Party and to cooperate
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in the preparation and filing of a patent or other IP applications.
In any countries in which title to patent or other IP fights is
transferred from CDC to the Collaborator, the Collaborator agrees that
CDC inventors will share in any royalty distribution that the
Collaborator pays to its own inventors.
7.6 RELEASE TO INVENTORS. In the event neither of the Parties to this CRADA
elects to file a patent or other IP application on a Subject Invention,
either or both (if a joint invention) may release their IP rights to
their respective employee inventor(s) with a nonexclusive,
non-transferrable, royalty-free license being retained by each Party.
7.7 PATENT EXPENSES. The expenses attendant to the filing of patent or
other IP applications generally shall be paid by the Party filing such
application. If an exclusive license to any Subject Invention is granted
to the Collaborator by CDC, the Collaborator shall reimburse CDC for the
reasonable past and ongoing funds expended worldwide for filing
prosecuting and maintaining any applications. The Collaborator may waive
its exclusive license fights on any application, patent or other IP
grant at any time, and incur no subsequent compensation obligation for
that application, patent or IP grant.
7.8 PROSECUTION OF INTELLECTUAL PROPERTY APPLICATIONS. Each Party shall
provide the other Party with copies of the applications it files on any
Subject Invention along with the power to inspect and make copies of all
documents retained in the patent or other IP application files by the
applicable patent or other IP office. The Parties agree to consult with
each other with respect to the prosecution of Subject Inventions
described in Article 7.3 and joint Subject Inventions described in
Article 7.4. If the Collaborator elects to file and prosecute IP
applications on joint Subject Inventions pursuant to Article 7.4, CDC
will be granted an associate power of attorney (or its equivalent) on
such IP applications.
ARTICLE 8. LICENSING
8.1 OPTION FOR EXCLUSIVE COMMERCIALIZATION LICENSE. With respect to
Government IP rights to any Subject Invention not made solely by the
Collaborator's employees for which a patent or other IP application is
filed, CDC grants to the Collaborator an option to negotiate, in good
faith, the terms of an exclusive or nonexclusive commercialization
license that fairly reflects the relative contributions of the Parties
to the invention and the CRADA, the risks incurred by the Collaborator,
and the costs of subsequent research and development needed to bring
the invention to the marketplace. The license will specify the licensed
fields of use, breadth of exclusivity and royalties. Royalty rates will
be based on product sales and the rates conventionally granted in the
field identified in the RP for inventions with reasonably similar
commercial potential Royalty rates generally will not exceed a rate
within the range of [***] for extensive commercialization licenses.
Contingent royalty schemes based on, e.g., patent issuance or
nonissuance, and provisions treating the stacking of royalties or
packaging of other licensed inventions developed under this CRADA may be
provided. Extensive licensees will be expected to reimburse CDC for IP
expenses related to each licensed intellectual property, and may be
permitted to offset such reimbursement against future product royalties.
8.2 EXERCISE OF LICENSE OPTION. The option of Article 8.1 must be exercised
by written notice mailed within three (3) months after the patent or
other IP application is filed to:
CDC Technology Transfer Coordinator
Centers for Disease Control
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[***] Confidential Treatment Requested
Exercise of this option by the Collaborator initiates a negotiation
period that expires nine (9) months after the patent or other IP
application filing date. If the last proposal by the Collaborator has
not been responded to in writing by CDC within this nine (9) month
period, the negotiation period shall be extended to expire one (1) month
after CDC so responds, during which month the Collaborator may accept in
writing the final license proposal of CDC. After that time, CDC will be
free to license such IP rights to others.
8.3 PRICING. CDC has a concern that there be a reasonable relationship
between the pricing of a licensed product, the public investment in that
product, and the health and safety needs of the public. Accordingly,
extensive commercialization licenses granted for CDC intellectual
property rights may require that this relationship be supported by
reasonable evidence.
8.4 GOVERNMENT INTELLECTUAL PROPERTY RIGHTS. For inventions developed wholly
by CDC investigators or jointly with a Collaborator under this CRADA,
CDC is required by the Federal Technology Transfer Act of 1986, 15 U.S.C.
at Section 3710a(b)(2), to retain at least a nonexclusive, irrevocable,
paid-up license to practice the invention or to have the invention
practiced throughout the world by or on behalf of the U.S. Government.
For inventions developed wholly by the Collaborator under this CRADA,
the Collaborator agrees to grant a research license as described in
Article 8.5 to the Government.
8.5 RESEARCH LICENSES. CDC reserves the right under any IP license granted
by CDC to the Collaborator under this CRADA to grant nonexclusive
licenses to third parties to make and to use the licensed invention for
purposes of research involving the invention ifself, and not for
purposes of commercial manufacture or in lieu of purchase as a commercial
product for use in other research. CDC intends to consult with their
exclusive commercialization licensee(s) before granting research licenses
to commercial entities.
8.6 JOINT INVENTIONS NOT EXCLUSIVELY LICENSED. In the event that the
Collaborator does not choose to acquire an exclusive commercialization
license to IP rights in joint Subject Inventions described in Article
7.4, then each Party shall have the right to use the joint Subject
Invention and to license its use to others. The Parties may agree to a
joint licensing approach for such IP rights.
ARTICLE 9. PROPRIETARY RIGHTS AND PUBLICATION
9.1 RIGHT OF ACCESS. CDC and the Collaborator agree to exchange all Subject
Data and Research Results produced in the course of research under this
CRADA, whether developed solely by CDC, jointly with the Collaborator, or
solely by the Collaborator. Tangible research products developed under a
CRADA will be shared equally by the Parties to the CRADA unless other
disposition is agreed to by the Principal Investigators. All Parties to
this CRADA will be free to utilize Subject data and Research Results for
their own purposes, consistent with their obligations under this CRADA.
9.2 OWNERSHIP OF SUBJECT DATA IN RESEARCH RESULTS. Subject to the sharing
requirements of Article 9.1, the producing Party will retain ownership
of and title to all Subject Inventions, all Subject Data and all
Research Results produced solely by their investigators. Jointly
developed Subject Inventions, Subject Data and Research Results will be
jointly owned. However, except as may be afforded through IP rights that
require public disclosure of the protected subject matter (e.g.,
patents), CDC does not have statutory authority to limit (or agree with
the Collaborator to limit) dissemination of Subject Data or Research
Results developed solely by CDC investigators or jointly with the
Collaborator. Accordingly, CDC may not agree to exclude others from
utilizing or commercializing such Subject Data or Research Results.
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9.3 PROPRIETARY AND CONFIDENTIAL INFORMATION. Each Party agrees to limit its
disclosure of Proprietary Information to the amount necessary to carry
out the Research Plan of this CRADA, and shall place a confidentiality
notice on all such information. Research materials required for the RP
may also be designated as Proprietary Information.
Each Party receiving Proprietary Information agrees that any information
so designated shall be used by it only for the purposes described in the
attached Research Plan. Any Party may object to the designation of
information as Proprietary Information by another Party and may decline
to accept such information. Data and research products developed solely
by the Collaborator may be designated as Proprietary Information when
they are wholly separable from the data and research product categories
as set forth in the RP. The exchange of confidential information should
be similarly limited and treated. Unless disclosure is otherwise
mutually agreed upon, all Parties to this CRADA agree to keep CRADA
Subject Data and Research Results confidential, to the extent permitted
by law, until they arc published or corresponding patent or other IP
application(s) have been filed.
9.4 PROTECTION OF PROPRIETARY INFORMATION. Proprietary Information shall not
be disclosed, copied, reproduced or otherwise made available to any
other person or entity without the consent of the owning Party except as
may be required under court order or the Freedom of Information Act (5
U.S.C. Section 552). Each Party agrees to use its best efforts to main-
tain the confidentiality of Proprietary Information. Each Party agrees
that another Party is not liable for the disclosure of Proprietary
Information which, after notice to and consultation with the concerned
Party, another Party in possession of the Proprietary Information
determines the information may not lawfully bc withheld, provided the
concerned Party has been given an opportunity to obtain a court order to
enjoin disclosure.
9.5 DURATION OF CONFIDENTIALITY OBLIGATION. The obligation to maintain the
confidentiality of Proprietary Information shall expire at the earlier of
the date when the information is no longer Proprietary Information as
defined in Article 2.2 or three (3) years after the expiration or
termination date of this CRADA. The Collaborator may request an extension
to this term when necessary to protect Proprietary Information relating
to products not yet commercialized.
9.6 PUBLICATION. The Parties are encouraged to make publicly available the
results of their research. Before either Party submits a paper or
abstract for publication or otherwise intends to publicly disclose
information about a Subject Invention, Subject Data or Research Results,
the other Party shall be provided thirty (30) days to review the
proposed publication or disclosure to assure that Proprietary
Information is protected. The publication or other disclosure shall be
delayed for up to (thirty) 30 additional days upon written request by
any Party as necessary to preserve U.S. or foreign patent or other IP
rights.
ARTICLE 10. REPRESENTATIONS AND WARRANTIES
10.1 REPRESENTATIONS AND WARRANTIES OF CDC. CDC hereby represents and warrants
to the Collaborator that the Official signing this CRADA has authority to
do so.
10.2 REPRESENTATIONS AND WARRANTIES OF THE COLLABORATOR. The Collaborator
hereby represents and warrants to CDC that the Collaborator has the
requisite power and authority to enter into this CRADA and to perform
according to its terms, and that the Collaborator's Official signing
this CRADA has authority to do so. The Collaborator further represents
that it is financially able to satisfy any funding commitments made in
Appendix C.
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ARTICLE 11. TERMINATION
11.1 TERMINATION BY MUTUAL CONSENT. The CDC and the Collaborator may terminate
this CRADA, or portions thereof, at any time by mutual written consent.
In such event the Parties shall specify the disposition of all property,
inventions, patents and other IP applications and other results of work
accomplished or in progress, arising from or performed under this CRADA.
11.2 UNILATERAL TERMINATION. Either CDC or the Collaborator may unilaterally
terminate this entire CRADA at any time by giving the written notice at
least thirty (30) days prior to the desired termination date, and any
rights accrued in property, patents or other IP shall be disposed of as
in 11.1.
11.3 STAFFING. If this CRADA is mutually or unilaterally terminated prior to
its expiration, funds will nevertheless remain available to CDC for
continuing any staffing commitment made by the Collaborator pursuant
to Article 5.1 above and Appendix C, ff applicable, for a period of six
(6) months after such termination. If there are insufficient funds to
cover this expense, the Collaborator agrees to pay the difference.
11.4 NEW COMMITMENTS. No party shall make new commitments related to this
CRADA after a mutual or unilateral termination and shall, to the extent
feasible, cancel all outstanding commitments and contracts by the
termination date.
11.5 TERMINATION COSTS. Concurrently with the exchange of final reports
pursuant to Articles 4.2 and 5.3, CDC shall submit to the Collaborator
for payment a statement of all costs incurred prior to the date of
termination and for all reasonable termination costs including the cost
of returning Collaborator property or removal of abandoned property.
ARTICLE 12. DISPUTES
12.1 SETTLEMENT. Any dispute arising under the CRADA which is not disposed of
by agreement of the Principal Investigators shall bc submitted jointly
to the signatories of this CRADA. If the signatories are unable to
jointly resolve the dispute within thirty (30) days after notification
thereof, the Assistant Secretary of Health (or his/her designee) shall
propose a resolution. Nothing in this section shall prevent any Party
from pursuing any and all administrative and/or judicial remedies which
may be available.
12.2 CONTINUATION OF WORK. Pending the resolution of any dispute or claim
pursuant to this Article, the Parties agree that performance of all
obligations shall be pursued diligently in accordance with the direction
of the CDC signatory.
ARTICLE 13. LIABILITY
13.1 PROPERTY. The U.S. Government shall not be responsible for damages to any
property of the Collaborator provided to CDC or acquired by CDC pursuant
to this CRADA.
13.2 NO WARRANTY. Except as specifically stated in Article 10, the Parties
make no express or implied warranty as to any matter whatsoever,
including the conditions of the research or any invention or product,
whether tangible or intangible, made, or developed under this CRADA, or
the ownership, merchantability, or fitness for a particular purpose of
the research or any invention or product.
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13.3 INDEMNIFICATION. The Collaborator agrees to hold the U.S. Government
harmless and to indemnify the Government for all liabilities, demands,
damages, expenses and losses arising out of the use by the Collaborator
for any purpose of the Subject Data, Research results and/or Subject
Inventions produced in whole or part by CDC employees under this CRADA,
unless due to the negligence of CDC, its employees or agents. The
Collaborator shall be liable for any claims or damages it incurs in
connection with this CRADA. CDC has no authority to indemnify the
Collaborator.
13.4 FORCE MAJEURE. Neither party shall be liable for any unforeseeable event
beyond its reasonable control not caused by the fault or negligence of
such Party, which causes such 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. In the event of the occurrence of such a
force majeure event, the Party unable to perform shall promptly notify
the other Party. It shall further use its best efforts to resume
performance as quickly as possible and shall suspend performance only
for such period of time as necessary as a result of the force majeure
event.
ARTICLE 14. MISCELLANEOUS
14.1 GOVERNING LAW. The construction, validity, performance and effect of
this CRADA shall be governed by Federal Law, as applied by the Federal
Courts. Federal law and regulations will preempt any conflicting or
inconsistent provisions in this CRADA.
14.2 ENTIRE AGREEMENT. This CRADA constitutes the entire agreement between
the Parties concerning the subject matter of this CRADA and supersedes
any prior understanding of written or oral agreement.
14.3 HEADINGS. Titles and headings of the sections and subsections of this
CRADA are for the convenience of references only and do not form a
part of this CRADA and shall in no way affect its interpretation.
14.4 WAIVERS. None of the provisions of this CRADA shall be considered waived
by any Party unless such 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, shall not be deemed a waiver of any rights of
any Party.
14.5 SEVERABILITY. The illegality or invalidity of any provisions of this
CRADA shall not impair, affect or invalidate the other provisions of
this CRADA.
14.6 AMENDMENTS. If either party desires a modification to this CRADA, the
Parties shall, upon reasonable notice of the proposed modification or
extension by the Party desiring the change, confer in good faith to
determine the desirability of such modification or extension. Such
modification shall not be effective until a written amendment is signed
by the signatories to this CRADA or by their representatives duly
authorized to execute such amendment.
14.7 ASSIGNMENT. Neither this CRADA nor any rights or obligations of any
Party hereunder shall be assigned or otherwise transferred by either
Party without the prior written consent of the other Party.
14.8 NOTICES. All notices pertaining to or required by this CRADA shall be
in writing and shall be signed by an authorized representative and shall
be delivered by hand or sent by certified mail, return receipt requested,
with postage prepaid, to addresses indicated on the signature page for
each Party. Notices regarding the exercise of license options shall be
made pursuant to Article 8.2. Any Party may change such address by notice
given to the other Party in the manner set forth above.
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14.9 INDEPENDENT CONTRACTORS. The relationship of the Parties to this CRADA is
that of independent contractors and not as agents of each other or as
joint venturers or partners. Each Party shall maintain sole and exclusive
control over its personnel and operations. Collaborator employees who
will be working at CDC facilities may be asked to sign a Guest Researcher
or Special Volunteer Agreement appropriately modified in view of the
terms of this CRADA.
14.10 USE OF NAME OR ENDORSEMENTS. By entering into this Agreement, CDC does
not directly or indirectly endorse any product or service provided, or
to be provided, whether directly or indirectly related to either this
CRADA or to any patent license or other IP license or agreement which
implements this CRADA by its successors, assignees, or licensees. The
Collaborator shall not in any way state or imply that this CRADA is an
endorsement of any such product or service by the U.S. Government or any
of its organizational units or employees.
14.11 EXCEPTIONS TO THIS CRADA. Any exceptions or modifications to this CRADA
that are agreed to by the Parties prior to their execution of this CRADA
are set forth in Appendix D.
14.12 REASONABLE CONSENT. Whenever a Party's consent or permission is required
under this CRADA, such consent or permission shall not be unreasonably
withheld.
ARTICLE 15. DURATION OF AGREEMENT
15.1 DURATION. It is mutually recommended that this project cannot be rigidly
defined in advance and that the contemplated time periods for various
phases of the RP are only good faith guidelines subject to adjustment
by mutual agreement to fit circumstances as the RP proceeds. In no case
will the term of this CRADA extend beyond the term indicated in the RP
unless it is revised in accordance with Article 14.6.
15.2 SURVIVABILITY. The provisions of Articles 4.2, 5.2, 5.3, 6.1, Articles
7-9, 11.3, 11.5, 12.1, 13.3 and 14.10 shall survive the termination of
this CRADA.
CRADA #: CID-93-045-00
FOR THE CDC: FOR THE COLLABORATOR:
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SIGNATURE DATE SIGNATURE DATE
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TYPED NAME TYPED NAME
Associate Director for Laboratory Chairman and CEO
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TITLE TITLE
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APPENDIX A
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC)
AND THE
AGENCY FOR TOXIC SUBSTANCES AND DISEASE REGISTRY
POLICY STATEMENT ON
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENTS
AND INTELLECTUAL PROPERTY LICENSING
This Statement sets forth the policies of the Centers for Disease Control and
Prevention (CDC) and the Agency for Toxic Substances and Disease Registry
(ATSDR) on various aspects of cooperative research and intellectual property
licensing. These policies apply to the negotiation of CDC and ATSDR
Cooperative Research and Development Agreements (CRADAs). License agreements
for intellectual property rights to inventions developed under a CRADA or
through the CDC and ATSDR intramural research programs, whether negotiated by
CDC and ATSDR or by the National Technical Information Service on its
behalf, will also incorporate these policies. This statement may be revised
as appropriate.
The Federal Technology Transfer Act of 1986 (FTTA, 15 U.S.C. at Section
3710), Executive Order 12591 of April 10, 1987, orders Federal laboratories
to assist universities and the private sector in broadening our national
technology base by moving new knowledge from the research laboratory into the
development of new products and processes. While Federal patent law (35
U.S.C. at Sections 200-212) authorizes the licensing of Government-owned
patent rights, the FTTA seeks to facilitate technological collaboration at an
earlier stage. Thus the FTTA authorizes Federal laboratories to enter into
CRADAs and to agree to grant intellectual property rights in advance to
collaborators for inventions made in whole or part by Federal employees under
the CRADA. Besides assisting in the transfer of commercially useful
technologies from Federal laboratories to the marketplace, CRADAs make
outside resources more accessible to Federal investigators.
The CDC and ATSDR, agencies of the U.S. Public Health Service (PHS) within
the Department of Health and Human Services (HHS), are lead Federal agencies
for prevention and control of disease and disability in the U.S. and
throughout the world. The CDC and ATSDR primary goals are to prevent
disease, illness, injuries, and disability before they occur, and to promote
health. Under the FTTA, 15 U.S.C. at Section 3710(a)2, technology transfer,
consistent with mission responsibilities, is also a responsibility of each
laboratory science and engineering professional. To achieve its goals, CDC
and ATSDR have developed an interdisciplinary research environment and
service program that promotes and encourages the free exchange of ideas and
information.
In order to safeguard the collegiality and integrity of, as well as public
confidence in, the CDC/ATSDR research programs, the following research and
technology transfer policies have been adopted.
1. RESEARCH FREEDOM
The CDC and ATSDR investigators generally are free to choose the subject
matter of their research, consistent with the mission of their
Center/Institute/Office (CIO) and the research programs of their
laboratories. No CRADA or license agreement may contravene this freedom.
2. RESEARCH POLICY
The CDC and ATSDR research results generally are disseminated freely through
publication in the scientific literature and presentations at public fora.
Brief delays in the dissemination of research results may be permitted under
a CRADA as necessary in order to file corresponding patent or other
intellectual property applications. The CDC and ATSDR consider the filing of
such applications to be an important component of its research efforts.
3. COOPERATIVE RESEARCH AND DEVELOPMENT UNDER A CRADA
As defined by the FTTA, 15 U.S.C. at Section 3710(d)(1), a CRADA means any
agreement between one or more Federal laboratories and one or more
non-Federal parties, under which the Government provides personnel, services,
facilities, equipment or other resources (but not funds), and the non-Federal
parties provide funds, personnel, services, facilities, equipment or other
resources toward the conduct of specified research or development efforts.
Cooperative research and development activities are intended to facilitate
the transfer of federally funded research and development for use by State
and local governments, universities, and the private sector, particularly
small business.
4. CDC AND ATSDR CRADAS FOR COOPERATIVE RESEARCH
As adopted by CDC and ATSDR, a CRADA is a standardized agreement intended to
provide an appropriate legal framework for, and to expedite the approval of,
cooperative research and development projects. The use of CRADAs is
encouraged for cooperative efforts because they permit CDC and ATSDR to
accept, retain, and use funds, personnel, services, and property from
collaborating parties and to provide personnel, services, and property to
collaborating parties. The CDC and ATSDR may permit its investigator to
enter into CRADAs with collaborators who will make significant intellectual
contributions to the research project undertaken or who will contribute
essential research materials not otherwise reasonably available. While CDC
and ATSDR welcome contributions to its gift funds for research purposes, it
does not view CRADAs as a general funding source or a mechanism for sponsored
research. This approach to implementing the FTTA has been chosen in order to
maintain the public's confidence in CDC and ATSDR through maintaining an
independence from reliance on industry funding.
5. SELECTION OF COLLABORATORS UNDER A CRADA
Collaborators under a CRADA may be suggested by potential collaborators or by
CDC and ATSDR investigators. Generally, the decision to initiate the
approval process for a CRADA is made by the involved CDC or ATSDR
investigator and laboratory chief with the approval of Division and CIO
directors. Approval is based on scientific considerations and the desire for
the public to benefit from the application by the private sector of
particular CDC and ATSDR research. For some cooperative projects, where the
development and commercialization potential is more immediate relative to the
basic research aspects, CDC and ATSDR may seek a collaborator(s) which has
both scientific expertise and commercialization capabilities. In certain
areas of research, e.g. where the Government has the intellectual lead or
where both scientific and commercialization capabilities are deemed essential
at the outset, CDC and ATSDR may competitively seek a collaborator(s) through
Federal Register notification. The PHS has also developed policy guidelines
for ensuring fairness of access to PHS laboratories such as CDC in the
process of initiating and developing CRADAs. Additionally, from time to
time, CDC and ATSDR may sponsor industry collaboration fora to publicize
opportunities for collaboration to a wide audience.
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6. PROPRIETARY OR CONFIDENTIAL INFORMATION AND MATERIALS
The CDC and ATSDR recognize that an effective collaborative research program
may require the disclosure of proprietary information to CDC and ATSDR
investigators. Although agreements to maintain confidentiality are permitted
under a CRADA, collaborators should limit their disclosure of proprietary
information to the amount necessary to carry out the research plan of the
CRADA. The mutual exchange of confidential information, e.g. patient
identification data, should be similarly limited. The CDC and ATSDR also
recognize that cooperative research may require the exchange of proprietary
research materials. Such materials may be used only for the purposes
specified in the research plan set forth in the CRADA. All parties to the
CRADA will agree to keep CRADA research results confidential until they are
published or presented at a scientific meeting.
7. TREATMENT OF DATA AND RESEARCH PRODUCTS PRODUCED UNDER A CRADA
The CDC and ATSDR investigator and the collaborator will agree to exchange
all data and research products developed in the course of research under a
CRADA whether developed solely by CDC and ATSDR, jointly with the
collaborator, or solely by the collaborator. In general, tangible research
products developed under a CRADA will be shared equally by the parties to the
CRADA. All parties to a CRADA will be free to utilize such data and research
products for their own purposes. Data and research products developed solely
by the collaborator may be designated as proprietary by the collaborator
when they are wholly separable from the data and research products developed
jointly with CDC and ATSDR investigators. However, except as may be afforded
through intellectual property rights that require public disclosure of the
protected subject matter (e.g. patents), the CDC and ATSDR will not agree to
exclude others from utilizing or commercializing the data or research
products developed solely by CDC and ATSDR investigators or jointly with the
collaborator under a CRADA. Thus, intellectual property which is not
patented is not to be afforded trade secret status.
8. OWNERSHIP OF AND LICENSING OF CDC INTELLECTUAL PROPERTY RIGHTS
Pursuant to the FTTA, 15 U.S.C. at Section 3710(b)(2), a Federal laboratory
is authorized to own and license patent rights to inventions made in whole or
part by its employees under a CRADA. The term "invention" is defined at
Section 3703(9) to mean any invention or discovery which is or may be
patentable or otherwise protected under Title 35 or any novel variety of
plant which is or may be protectable under the Plant Variety Protection Act
(PVPA), 7 U.S.C. Section 2321 et seq. The patent law, 35 U.S.C. Section 207,
authorizes the ownership and licensing of intramural inventions. Executive
Order 12591 at Section 1(b)(1)(B) further authorizes the transfer of
Government intellectual property rights. Although the FTTA speaks broadly of
the transfer of "technology", CDC and ATSDR do not have statutory authority
to license (or to agree to limit dissemination) of technology developed in
whole or part by their investigators under a CRADA unless a patent, PVPA
certificate or other intellectual property application has been filed for
that technology. The CDC and ATSDR will retain the Government ownership
interest in, but license rights to, all intellectual property rights to
inventions developed solely by their investigators through intramural
research or developed in whole or in part under a CRADA.
9. GENERAL LICENSING POLICY
The CDC and ATSDR recognize that under the FTTA and the patent licensing law
to which it refers, Congress and the President have chosen to utilize the
patent system as the primary mechanism for transferring Government inventions
to the private sector. The importance of patents to commercialization in the
biomedical field is further reflected by the Drug Price Competition and
Patent Term Restoration Act of 1984 (Pub. L. 98-417). A fundamental
principle of the patent system is that the owner of a patent has a
time-limited "right to exclude others from making, using, or selling the
[patented] invention." The reason for such a period of exclusivity is to
encourage industry to invest the resources necessary to bring an invention
from the discovery stage through subsequent development, clinical trials,
regulatory approvals, and ultimately into commercial production. The CDC and
ATSDR accordingly are willing to grant exclusive commercialization licenses
under their patent or other intellectual property rights in cases where
substantial additional risks, time, and costs must be
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undertaken by a licensee prior to commercialization. Under a CRADA, CDC and
ATSDR are also willing to agree to grant exclusive commercialization licenses
in advance to collaborators. The CDC and ATSDR will attempt, however, to
license their intramural inventions nonexclusively in cases where an
invention reflects a relatively more advance stage in its commercial
development, e.g. when a CDC and ATSDR investigator invents a patentable new
therapeutic use for a known and FDA approved compound.
Federal laboratories are authorized to negotiate license agreements for
Government-owned patent rights in intramural inventions pursuant to 35 U.S.C.
Section 207. Although Section 207 does not apply to intellectual property
license agreements authorized by the FTTA for inventions made under a CRADA,
CDC and ATSDR have adopted the following approach of Section 207 for all
license agreements:
Each Federal Agency [may] ... grant nonexclusive, exclusive or
partially exclusive licenses under federally owned patent applications,
patents, or other forms of protection ... on such terms and conditions
... as determined appropriate in the public interest.
The CDC and ATSDR have determined it to be appropriate and in the public
interest to grant nonexclusive research licenses and either exclusive or
nonexclusive commercialization licenses to HHS owned intellectual property
rights according to the plan discussed below.
10. GOVERNMENT INVENTION RIGHTS
For inventions developed wholly by CDC and ATSDR investigators or jointly
with a collaborator under a CRADA, CDC and ATSDR are required by the FTTA at
15 U.S.C. Section 3710(a)(b)(2) to retain at least a nonexclusive,
irrevocable, paid-up license to practice the invention or to have the
invention practiced throughout the world by or on behalf of the U.S.
Government. When granting exclusive or partially exclusive licenses to CDC
and ATSDR intramural inventions, 35 U.S.C. Section 208, as implemented by 37
C.F.R. Section 404.7(2)(i), required the reservation of similar Government
rights. The CDC and ATSDR will not assert an ownership right in inventions
made solely by a collaborator under a CRADA, but will require the grant of a
research license, as described below, to the Government for inventions made
wholly by collaborator under a CRADA.
11. RESEARCH LICENSES
The CDC and ATSDR will reserve the right under any CRADA and intellectual
property license to grant nonexclusive licenses to make and to use such
property, for purposes of research involving the invention itself and not for
purposes of commercial manufacture or in lieu of purchase as a commercial
product for use in other research. The purpose of the research license is to
facilitate basic academic research. The CDC and ATSDR intends to consult
with any involved commercialization licensee(s) before granting research
licenses to commercial entities. The grant of any research license hereunder
does not permit CDC and ATSDR to grant any license to third parties to use
the invention for any commercial purpose.
12. COMMERCIALIZATION LICENSES
The CDC and ATSDR are willing to consider requests for nonexclusive or
exclusive commercialization licenses to intellectual property rights to
inventions developed under a CRADA or in the course of intramural research
pursuant to applicable statutes and regulations. Under a CRADA, CDC and ATSDR
generally will grant a time-limited option to negotiate, in good faith, the
terms of a license that fairly reflects the relative contributions of the
parties, the risks incurred by the collaborator and the costs of subsequent
research and development needed to bring the results of CRADA research to the
marketplace. The CDC and ATSDR consider the drafting of a model invention
license to serve as the starting point for license negotiations. It is
contemplated further that such a model will reduce negotiations essentially
to matters of execution fees, royalty rates, and minimum annual royalties.
Royalty rates will be based on product sales and the rates conventionally
granted in the field identified in the CRADA's research plan for inventions
with reasonably similar commercial
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potential. Royalty rates generally will not exceed a rate [***]
for exclusive commercialization licenses. Contingent royalty
schemes based on, e.g. patent issuance or nonissuance, and clauses treating
the stacking of royalties or packaging of other inventions developed under
the CRADA may be provided. Exclusive licensees will be expected to reimburse
CDC and ATSDR for intellectual property related expenses and may be permitted
to offset such reimbursement against future product royalties.
13. NONEXCLUSIVE COMMERCIALIZATION LICENSES
Unless a request for exclusive commercialization license is made under a
CRADA or submitted for an intramural invention, CDC and ATSDR will attempt to
license their inventions nonexclusively. Such nonexclusive licenses
generally will follow the guidelines of 37 C.F.R. Part 404.
14. EXCLUSIVE COMMERCIALIZATION LICENSES
The CDC and ATSDR exclusive commercialization requires the submission by a
prospective licensee of an acceptable development and commercialization plan
as described by 35 U.S.C. Section 209(a) and subsequent, periodic reports on
utilization of the invention as described by Section 209(f)(1). All such
plans and reports will be treated in confidence and as privileged from
disclosure under the Freedom of Information Act. Modification provisions as
described by Section 209(f)(2-4) may apply. In appropriate cases, CDC and
ATSDR may also reserve the right to grant separate exclusive
commercialization licenses in various fields of use. The remaining
provisions of 35 U.S.C. Section 200-212 will also apply to licenses to CDC
and ATSDR intramural inventions.
The CDC and ATSDR also consider the following provisions for exclusive
commercialization licenses to be necessary and appropriate in the public
interest:
(i) the exclusive licensee must pledge its reasonable best efforts to
commercialize a licensed invention and the development and
commercialization plan mentioned above may serve as the measure of such
efforts;
(ii) the CDC and ATSDR shall have the right, after notice and
opportunity to cure, to terminate or render nonexclusive any license
granted: (1) if the licensee is not reasonably engaged in research,
development, clinical trials, manufacturing, marketing, sublicensing,
or other activities reasonably necessary to the expeditious commercial
dissemination of the licensed invention; or (2) when the licensee
cannot reasonably satisfy unmet health and safety needs;
(iii) in order to maximize the commercialization of the licensed
invention in other fields of use not utilized by the exclusive licensee
through ongoing development, manufacturing, or sublicensing, CDC and
ATSDR reserve the right to require the licensee to grant sublicenses to
responsible applicants, on reasonable terms, in such other fields of
use unless the licensee can reasonably demonstrate that such a
sublicense would be contrary to sound and reasonable business practice
and the granting of the sublicense would not materially increase the
availability to the public of the licensed invention; and
(iv) exclusive licensees to HHS inventions, whether developed under a
CRADA or through intramural research, must agree to not unreasonably
deny requests for sublicense or cross license rights from future CRADA
collaborators when the possibility of acquiring such derivative rights
is necessary in order to permit a proposed cooperative research project
with CDC and ATSDR to go forward, and the exclusive licensee has been
given a reasonable opportunity to join as a party to the proposed
CRADA. The grant of any sublicense or cross license rights hereunder
does not grant future CRADA collaborators a license to use or CDC and
ATSDR the right to grant to future CRADA collaborators a license to use
any inventions of the instant CRADA for any commercial purpose.
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15. COMPLIANCE UNDER CRADAS WITH OTHER POLICIES
For research conducted pursuant to a CRADA, collaborators must agree to
comply with PHS, CDC, and ATSDR policies and guidelines concerning, e.g.
human subjects research, the use of research animals, recombinant DNA and
other policy statements as may be promulgated from time to time.
16. PRICING
HHS has the responsibility for funding basic biomedical research, for funding
medical treatment through programs such as medicare and medicaid, for
providing direct medical care, and more generally, for protecting the health
and safety of the public. Because of these responsibilities, and the public
investment in the research that contributes to a product licensed under a
CRADA, HHS has a concern that there be a reasonable relationship between the
pricing of a licensed product, the public investment in the product, and the
health and safety needs of the public.
17. WAIVERS
The CDC and ATSDR will consider requests to modify any of the foregoing
policies in special cases where public health exigencies or commercial
situations warrant such a modification. Modifications dealing with business
terms such as royalties are not decided by the CDC and ATSDR investigators
and should be discussed with the appropriate CDC and ATSDR technology
management personnel.
18. SPECIAL CONSIDERATION AND PREFERENCE UNDER A CRADA
The CDC and ATSDR will give special consideration to entering into CRADAs with
small business firms and consortia involving small business firms; and will
give preference to business units located in the United States which agree to
manufacture substantially in the United States products which embody
inventions developed in the course of research under CRADAs.
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CRADA #: CID-93-045-00
Appendix B
Research Plan
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