Cancer Therapy Evaluation Program Intellectual Property Option to Collaborator, 17412-17414 [2010-7743]
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17412
Federal Register / Vol. 75, No. 65 / Tuesday, April 6, 2010 / Notices
history update forms will provide
essential data for outcomes assessment
for this population of aging women.
Frequency of Response: Annually.
Affected Public: Individuals and
physicians. Type of Respondents:
Women, next-of-kin, and physician’s
office staff. The annual reporting burden
is as follows:
ESTIMATE OF ANNUAL HOUR BURDEN
Number of
respondents
Type of response
Frequency of
response
Average hours
per response
Annual hour
burden
Observational Study Participants ..................................................................
Next of Kin1 ....................................................................................................
Health Care Providers1 ..................................................................................
42,550
941
8
1.12
1
1
.4155
.083
.085
19,801
78
Total ........................................................................................................
43,499
........................
........................
19,880
.68
1 Annual
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burden is placed on health care providers and respondent relatives/informants through requests for information which will help in the
compilation of the number and nature of new fatal and nonfatal events.
The annualized cost burden to
respondents is estimated at $397,617.
There are no Capital Costs, Operating
Costs and/or Maintenance Costs to
report.
Request for Comments: Written
comments and/or suggestions from the
public and affected agencies should
address one or more of the following
points: (1) Evaluate whether the
proposed collection is necessary for the
proper performance of the function of
the agency, including whether the
information will have practical utility;
(2) Evaluate the accuracy of the agency’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) Enhance the
quality, utility, and clarity of the
information to be collected; and (4)
Minimize the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plan and instruments, contact: Shari
Eason Ludlam, Project Officer, Women’s
Health Initiative Program Office, 6701
Rockledge Drive, 2 Rockledge Centre,
Room 9188, MSC 7913, Bethesda, MD
20892–7936, or call non-toll-free
number (301) 402–2900 or E-mail your
request, including your address to:
ludlams@mail.nih.gov.
Comments Due Date: Comments
regarding this information collection are
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best assured of having their full effect if
received within 30 days of the date of
this publication.
[FR Doc. 2010–7741 Filed 4–5–10; 8:45 am]
option, set forth below. Comments
should be addressed to: CTEP IP Option
Project, nciipoption@mail.nih.gov.
FOR FURTHER INFORMATION CONTACT:
Jason Vittorio Cristofaro, J.D., PhD,
Intellectual Property Advisor, National
Cancer Institute/NIH/DHHS, Division of
Cancer Treatment and Diagnosis, 31
Center Drive, Room 3A44, Bethesda, MD
20892–2580, telephone 301–594–5318,
fax 301–496–0826, e-mail
cristofaroj@mail.nih.gov.
BILLING CODE 4140–01–P
SUPPLEMENTARY INFORMATION:
Dated: March 23, 2010.
Michael S. Lauer,
Director, Division of Cardiovascular Science,
NHLBI, National Institutes of Health.
Dated: March 24, 2010.
Suzanne Freeman,
Chief, FOIA, NHLBI, National Institutes of
Health.
I. Background
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Cancer Therapy Evaluation Program
Intellectual Property Option to
Collaborator
AGENCY: National Cancer Institute (NCI),
National Institutes of Health (NIH),
DHHS.
ACTION: Notice; request for comments.
SUMMARY: The National Cancer Institute,
Division of Cancer Treatment and
Diagnosis, is seeking comments on a
proposed revision to its policy on
intellectual property agreements with
certain funding recipients, entitled the
Cancer Therapy Evaluation Program
(CTEP) INTELLECTUAL PROPERTY
OPTION. The proposed policy, if
finalized, would establish that potential
applicants for CTEP funding should
include an assurance of agreement with
the recommended Intellectual Property
Option and Institution Notification if
they wish to be considered for funding
support to carry out any CTEPsponsored clinical trial for which CTEP
holds the investigational new drug
(IND) application.
DATES: Comments must be received by
NIH on or before May 6, 2010.
ADDRESSES: The NIH welcomes public
comment on the full text of the CTEP IP
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The Cancer Therapy Evaluation
Program (CTEP) of the National Cancer
Institute’s (NCI) Division of Cancer
Treatment and Diagnosis (DCTD)
obtains proprietary ‘‘Agents’’ from
biotechnology and pharmaceutical
companies (hereinafter ‘‘Collaborators’’)
for use in NCI CTEP-supported clinical
trials under funding agreements. As part
of the arrangement with these
Collaborators to use their proprietary
Agents and to make funding clinical
research possible, Collaborators will
often require, as a condition of
collaboration, that the NCI CTEP
funding recipients receiving the Agent
(‘‘Institutions’’) agree to certain
conditions, including the willingness to
provide notice of and grant options to
certain intellectual property rights
arising from research involving the
Agent under the scope of an NCI CTEP
funding agreement.
The current IP option language is
silent as to the disposition of
intellectual property developed from
data and Agent-treated samples. As a
result, both Collaborators and
Institutions have claimed an ownership
interest in inventions generated from
these data and materials. This lack of
clarity has become a major impediment
in NCI CTEP’s ability to obtain
proprietary Agents from collaborators
for use in CTEP-sponsored clinical
studies, which has resulted in delays
E:\FR\FM\06APN1.SGM
06APN1
Federal Register / Vol. 75, No. 65 / Tuesday, April 6, 2010 / Notices
and threatens the continuing ability of
CTEP to provide proprietary Agents to
CTEP-funded investigators. The lack of
Agents for these clinical studies would
jeopardize NCI CTEP’s ability to support
these research activities. The proposed
revised CTEP IP Option and Institution
Notification is intended to offer
appropriate incentives and assurance for
both Collaborators and Institutions to
participate in CTEP-sponsored clinical
studies.
This proposed policy was developed
with input from a variety of sources
including the CTEP-sponsored
cooperative groups, other CTEPsponsored investigators performing
early clinical trials, industry
representatives who partner with CTEP
and the Council on Government
Relations (COGR).
sroberts on DSKD5P82C1PROD with NOTICES
II. Proposed Revision to CTEP
Intellectual Property Option
The Cancer Therapy Evaluation
Program (CTEP) of the National Cancer
Institute’s (NCI) Division of Cancer
Treatment and Diagnosis (DCTD)
obtains ‘‘Agents’’ from biotechnology
and pharmaceutical companies
(hereinafter ‘‘Collaborators’’) through
Cooperative Research and Development
Agreements (‘‘CRADAs’’) and other
means, for use in NCI-funded research
conducted via extramural funding
agreements. As part of the arrangement
with these Collaborators to use their
Agents and to make the collaborative
research possible, NCI CTEP would
agree not to provide Agents to
Institutions unless they provide
Collaborators with the IP Options and
Institution Notifications described
below. The specific terms of the IP
Options depend on the types of
inventions that arise out of the NCI
CTEP funded research (Section A
Inventions, Section B Inventions, or
Unauthorized Inventions). NCI CTEP is
requesting that applicants include
assurances of agreement with the terms
of the IP Options and Institutional
Notification described below in their
funding applications to NCI CTEP.
References to ‘‘Institution’’ mean the
funding recipient conducting the
research described herein. The
Intellectual Property Options (IP
Options) and Institution Notification
described below will apply to
inventions arising from research
involving the Agent(s) under the scope
of an NCI CTEP funding agreement.
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A. The IP Option Described in This
Section A Would Apply to Inventions
That Use or Incorporate the Agent(s)
and That are Conceived or First
Actually Reduced to Practice Pursuant
to NCI CTEP–Funded Clinical or NonClinical Studies Utilizing the Agent(s)
(‘‘Section A Inventions’’)
Institution agrees to grant to
Collaborator(s): (i) A royalty-free,
worldwide, nonexclusive license for
commercial purposes; and (ii) a time
limited first option to negotiate an
exclusive, or co-exclusive, if applicable,
worldwide, royalty bearing license for
commercial purposes, including the
right to grant sub licenses, subject to any
rights of the Government of the United
States of America, on terms to be
negotiated in good faith by the
Collaborator(s) and Institution. If
Collaborator accepts the nonexclusive
commercial license, the Collaborator
agrees to pay all out of pocket patent
prosecution and maintenance costs
which will be pro-rated and divided
equally among all licensees. If
Collaborator obtains an exclusive
commercial license, in addition to any
other agreed upon licensing
arrangements such as royalties and due
diligence requirements, the Collaborator
agrees to pay all out of pocket patent
prosecution and maintenance costs.
Collaborator(s) will notify Institution, in
writing, if it is interested in obtaining a
commercial license to any Section A
Invention within three (3) months of
Collaborator’s receipt of a patent
application or six (6) months of receipt
of an invention report notification of
such Section A Invention. In the event
that Collaborator fails to so notify
Institution, or elects not to obtain an
exclusive license, then Collaborator’s
option expires with respect to that
Section A Invention, and Institution
will be free to dispose of its interests in
accordance with its policies. If
Institution and Collaborator fail to reach
agreement within ninety (90) days, (or
such additional period as Collaborator
and Institution may agree) on the terms
for an exclusive license for a particular
Section A Invention, then for a period
of three (3) months thereafter Institution
agrees not to offer to license the Section
A Invention to any third party on
materially better terms than those last
offered to Collaborator without first
offering such terms to Collaborator, in
which case Collaborator will have a
period of thirty (30) days in which to
accept or reject the offer. If Collaborator
elects to negotiate an exclusive
commercial license to a Section A
Invention, then Institution agrees to file
and prosecute patent application(s)
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17413
diligently and in a timely manner and
to give Collaborator an opportunity to
comment on the preparation and filing
of any such patent application(s).
Notwithstanding the above, Institution
is under no obligation to file or maintain
patent prosecution for any Section A
Invention.
For all Section A Inventions,
regardless of Collaborator’s decision to
seek a commercial license, Institution
agrees to grant Collaborator a paid-up,
nonexclusive, royalty-free, world-wide
license for research purposes only.
Institution retains the right to make and
use any Section A Invention for all nonprofit research, including for
educational purposes and to permit
other educational and non-profit
institutions to do so.
B. The IP Option Described in This
Section B Would Apply to Inventions
That Do Not Use or Incorporate the
Agent(s) but That Are Conceived or First
Actually Reduced To Practice Pursuant
to NCI CTEP Clinical or Non-Clinical
Studies Utilizing the Agent(s). It Also
Applies to Inventions That Are
Conceived or First Actually Reduced To
Practice Pursuant to NCI CTEP Studies
Utilizing Clinical Data or Specimens
From Patients Treated With the Agent
(Including Specimens Obtained From
NCI CTEP-Funded Tissue Banks)
(‘‘Section B Inventions’’)
Institution agrees to grant to
Collaborator(s): (i) A paid-up
nonexclusive, nontransferable, royaltyfree, world-wide license to all Section B
Inventions for research purposes only;
(ii) a time-limited first option to
negotiate a nonexclusive, exclusive, or
co-exclusive, if applicable, world-wide
royalty-bearing license for commercial
purposes, including the right to grant
sub-licenses, subject to any rights of the
Government of the United States of
America, on terms to be negotiated in
good faith by the Collaborator(s) and
Institution and (iii) a nonexclusive,
royalty-free, world-wide license either
to (a.) disclose Section B Inventions to
a regulatory authority when seeking
marketing authorization of the Agent, or
(b.) disclose Section B Inventions on a
product insert or other promotional
material regarding the Agent after
having obtained marketing
authorization from a regulatory
authority. Collaborator will notify
Institution, in writing, of its interest in
obtaining an exclusive commercial
license to any Section B Invention
within one year of Collaborator’s receipt
of a patent application or eighteen
months of receipt of an invention report
notifying Collaborator of such Section B
Invention(s). In the event that
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Collaborator fails to so notify
Institution, or elects not to obtain an
exclusive license, then Collaborator’s
option expires with respect to that
Section B Invention, and Institution will
be free to dispose of its interests in such
Section B Invention in accordance with
Institution’s policies. If Institution and
Collaborator fail to reach agreement
within ninety (90) days (or such
additional period as Collaborator and
Institution may agree) on the terms for
an exclusive license for a particular
Subject B Invention, then for a period of
six (6) months thereafter Institution
agrees not to offer to license the Section
B Invention to any third party on
materially better terms than those last
offered to Collaborator without first
offering such terms to Collaborator, in
which case Collaborator will have a
period of thirty (30) days in which to
accept or reject the offer. Institution
retains the right to make and use any
Section B Inventions for all non-profit
research, including for educational
purposes and to permit other
educational and non-profit institutions
to do so. If Collaborator elects to
negotiate an exclusive commercial
license to a Section B Invention, then
Institution agrees to file and prosecute
patent application(s) diligently and in a
timely manner and to give Collaborator
an opportunity to comment on the
preparation and filing of any such
patent application(s). Notwithstanding
the above, Institution is under no
obligation to file or maintain patent
prosecution for any Section B Invention.
Inventions arising more than five
years after the release of data on the
primary end point of the NCI CTEP
clinical trial that generated the clinical
data and/or specimens will not be
subject to the Section B (ii) IP Option.
C. The IP Option Described in This
Section C Would Apply to Inventions
Made by Institution’s Investigator(s) or
Any Other Employees or Agents of
Institution, Which Are or May Be
Patentable or Otherwise Protectable, as
a Result of Research Utilizing the
Agent(s) Outside the Scope of the NCI
CTEP Funding Agreement
(Unauthorized Inventions)
Institution agrees, at Collaborator’s
request and expense, to grant to
Collaborator a royalty-free exclusive or
co-exclusive license to Unauthorized
Inventions.
D. Institution Notification
Institution agrees to promptly notify
NCI CTEP (NCICTEPpubs@mail.nih.gov)
and Collaborator(s) in writing of any
Section A Inventions, Section B
Inventions, and Unauthorized
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Inventions upon the earlier of: (i) Any
submission of any invention disclosure
to Institution of a Section A, Section B,
or Unauthorized Invention, or (ii) the
filing of any patent applications of a
Section A, Section B, or Unauthorized
Invention. Institution agrees to provide
a copy of either the invention disclosure
or the patent application to the
Collaborator and to NCI CTEP which
will treat it in accordance with 37 CFR
part 401. These requirements do not
replace any applicable reporting
requirements under the Bayh-Dole Act,
35 U.S.C. 200–212, and implementing
regulations at 37 CFR part 401.
III. Request for Comments
NCI CTEP is seeking comment not
only from NCI CTEP funding recipients,
but from the full range of academic, notfor-profit, government, and private
sector participants in biomedical
research and development. Widespread
comment and participation by varied
stakeholders in the biomedical research
and development enterprise is critical if
this language is to be effective in
guiding the interactions of NIH funding
recipients with external Collaborators in
CTEP-funded studies.
Dated: March 30, 2010.
Jeffrey Abrams,
Associate Director, Cancer Therapy
Evaluation Program, Division of Cancer
Treatment and Diagnosis, NCI, National
Institutes of Health.
[FR Doc. 2010–7743 Filed 4–5–10; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–E–0079]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TOVIAZ
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) has determined
the regulatory review period for
TOVIAZ and is publishing this notice of
that determination as required by law.
FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit written comments
and petitions to the Division of Dockets
Management (HFA–305), Food and Drug
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Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6222, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Public Law 98–
417) and the Generic Animal Drug and
Patent Term Restoration Act (Public
Law 100–670) generally provide that a
patent may be extended for a period of
up to 5 years so long as the patented
item (human drug product, animal drug
product, medical device, food additive,
or color additive) was subject to
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of Patents and Trademarks may
award (for example, half the testing
phase must be subtracted as well as any
time that may have occurred before the
patent was issued), FDA’s determination
of the length of a regulatory review
period for a human drug product will
include all of the testing phase and
approval phase as specified in 35 U.S.C.
156(g)(1)(B).
FDA recently approved for marketing
the human drug product TOVIAZ
(fesoterodine fumarate). TOVIAZ is
indicated for treatment of overactive
bladder with symptoms of urge urinary
incontinence, urgency, and frequency.
Subsequent to this approval, the Patent
and Trademark Office received a patent
term restoration application for TOVIAZ
(U.S. Patent No. 6,858,650) from
Schwarz Pharma AG, and the Patent and
Trademark Office requested FDA’s
assistance in determining this patent’s
eligibility for patent term restoration. In
a letter dated September 29, 2009, FDA
advised the Patent and Trademark
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]]>Agencies
[Federal Register Volume 75, Number 65 (Tuesday, April 6, 2010)]
[Notices]
[Pages 17412-17414]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-7743]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Cancer Therapy Evaluation Program Intellectual Property Option to
Collaborator
AGENCY: National Cancer Institute (NCI), National Institutes of Health
(NIH), DHHS.
ACTION: Notice; request for comments.
-----------------------------------------------------------------------
SUMMARY: The National Cancer Institute, Division of Cancer Treatment
and Diagnosis, is seeking comments on a proposed revision to its policy
on intellectual property agreements with certain funding recipients,
entitled the Cancer Therapy Evaluation Program (CTEP) INTELLECTUAL
PROPERTY OPTION. The proposed policy, if finalized, would establish
that potential applicants for CTEP funding should include an assurance
of agreement with the recommended Intellectual Property Option and
Institution Notification if they wish to be considered for funding
support to carry out any CTEP-sponsored clinical trial for which CTEP
holds the investigational new drug (IND) application.
DATES: Comments must be received by NIH on or before May 6, 2010.
ADDRESSES: The NIH welcomes public comment on the full text of the CTEP
IP option, set forth below. Comments should be addressed to: CTEP IP
Option Project, nciipoption@mail.nih.gov.
FOR FURTHER INFORMATION CONTACT: Jason Vittorio Cristofaro, J.D., PhD,
Intellectual Property Advisor, National Cancer Institute/NIH/DHHS,
Division of Cancer Treatment and Diagnosis, 31 Center Drive, Room 3A44,
Bethesda, MD 20892-2580, telephone 301-594-5318, fax 301-496-0826, e-
mail cristofaroj@mail.nih.gov.
SUPPLEMENTARY INFORMATION:
I. Background
The Cancer Therapy Evaluation Program (CTEP) of the National Cancer
Institute's (NCI) Division of Cancer Treatment and Diagnosis (DCTD)
obtains proprietary ``Agents'' from biotechnology and pharmaceutical
companies (hereinafter ``Collaborators'') for use in NCI CTEP-supported
clinical trials under funding agreements. As part of the arrangement
with these Collaborators to use their proprietary Agents and to make
funding clinical research possible, Collaborators will often require,
as a condition of collaboration, that the NCI CTEP funding recipients
receiving the Agent (``Institutions'') agree to certain conditions,
including the willingness to provide notice of and grant options to
certain intellectual property rights arising from research involving
the Agent under the scope of an NCI CTEP funding agreement.
The current IP option language is silent as to the disposition of
intellectual property developed from data and Agent-treated samples. As
a result, both Collaborators and Institutions have claimed an ownership
interest in inventions generated from these data and materials. This
lack of clarity has become a major impediment in NCI CTEP's ability to
obtain proprietary Agents from collaborators for use in CTEP-sponsored
clinical studies, which has resulted in delays
[[Page 17413]]
and threatens the continuing ability of CTEP to provide proprietary
Agents to CTEP-funded investigators. The lack of Agents for these
clinical studies would jeopardize NCI CTEP's ability to support these
research activities. The proposed revised CTEP IP Option and
Institution Notification is intended to offer appropriate incentives
and assurance for both Collaborators and Institutions to participate in
CTEP-sponsored clinical studies.
This proposed policy was developed with input from a variety of
sources including the CTEP-sponsored cooperative groups, other CTEP-
sponsored investigators performing early clinical trials, industry
representatives who partner with CTEP and the Council on Government
Relations (COGR).
II. Proposed Revision to CTEP Intellectual Property Option
The Cancer Therapy Evaluation Program (CTEP) of the National Cancer
Institute's (NCI) Division of Cancer Treatment and Diagnosis (DCTD)
obtains ``Agents'' from biotechnology and pharmaceutical companies
(hereinafter ``Collaborators'') through Cooperative Research and
Development Agreements (``CRADAs'') and other means, for use in NCI-
funded research conducted via extramural funding agreements. As part of
the arrangement with these Collaborators to use their Agents and to
make the collaborative research possible, NCI CTEP would agree not to
provide Agents to Institutions unless they provide Collaborators with
the IP Options and Institution Notifications described below. The
specific terms of the IP Options depend on the types of inventions that
arise out of the NCI CTEP funded research (Section A Inventions,
Section B Inventions, or Unauthorized Inventions). NCI CTEP is
requesting that applicants include assurances of agreement with the
terms of the IP Options and Institutional Notification described below
in their funding applications to NCI CTEP.
References to ``Institution'' mean the funding recipient conducting
the research described herein. The Intellectual Property Options (IP
Options) and Institution Notification described below will apply to
inventions arising from research involving the Agent(s) under the scope
of an NCI CTEP funding agreement.
A. The IP Option Described in This Section A Would Apply to Inventions
That Use or Incorporate the Agent(s) and That are Conceived or First
Actually Reduced to Practice Pursuant to NCI CTEP-Funded Clinical or
Non-Clinical Studies Utilizing the Agent(s) (``Section A Inventions'')
Institution agrees to grant to Collaborator(s): (i) A royalty-free,
worldwide, nonexclusive license for commercial purposes; and (ii) a
time limited first option to negotiate an exclusive, or co-exclusive,
if applicable, worldwide, royalty bearing license for commercial
purposes, including the right to grant sub licenses, subject to any
rights of the Government of the United States of America, on terms to
be negotiated in good faith by the Collaborator(s) and Institution. If
Collaborator accepts the nonexclusive commercial license, the
Collaborator agrees to pay all out of pocket patent prosecution and
maintenance costs which will be pro-rated and divided equally among all
licensees. If Collaborator obtains an exclusive commercial license, in
addition to any other agreed upon licensing arrangements such as
royalties and due diligence requirements, the Collaborator agrees to
pay all out of pocket patent prosecution and maintenance costs.
Collaborator(s) will notify Institution, in writing, if it is
interested in obtaining a commercial license to any Section A Invention
within three (3) months of Collaborator's receipt of a patent
application or six (6) months of receipt of an invention report
notification of such Section A Invention. In the event that
Collaborator fails to so notify Institution, or elects not to obtain an
exclusive license, then Collaborator's option expires with respect to
that Section A Invention, and Institution will be free to dispose of
its interests in accordance with its policies. If Institution and
Collaborator fail to reach agreement within ninety (90) days, (or such
additional period as Collaborator and Institution may agree) on the
terms for an exclusive license for a particular Section A Invention,
then for a period of three (3) months thereafter Institution agrees not
to offer to license the Section A Invention to any third party on
materially better terms than those last offered to Collaborator without
first offering such terms to Collaborator, in which case Collaborator
will have a period of thirty (30) days in which to accept or reject the
offer. If Collaborator elects to negotiate an exclusive commercial
license to a Section A Invention, then Institution agrees to file and
prosecute patent application(s) diligently and in a timely manner and
to give Collaborator an opportunity to comment on the preparation and
filing of any such patent application(s). Notwithstanding the above,
Institution is under no obligation to file or maintain patent
prosecution for any Section A Invention.
For all Section A Inventions, regardless of Collaborator's decision
to seek a commercial license, Institution agrees to grant Collaborator
a paid-up, nonexclusive, royalty-free, world-wide license for research
purposes only. Institution retains the right to make and use any
Section A Invention for all non-profit research, including for
educational purposes and to permit other educational and non-profit
institutions to do so.
B. The IP Option Described in This Section B Would Apply to Inventions
That Do Not Use or Incorporate the Agent(s) but That Are Conceived or
First Actually Reduced To Practice Pursuant to NCI CTEP Clinical or
Non-Clinical Studies Utilizing the Agent(s). It Also Applies to
Inventions That Are Conceived or First Actually Reduced To Practice
Pursuant to NCI CTEP Studies Utilizing Clinical Data or Specimens From
Patients Treated With the Agent (Including Specimens Obtained From NCI
CTEP-Funded Tissue Banks) (``Section B Inventions'')
Institution agrees to grant to Collaborator(s): (i) A paid-up
nonexclusive, nontransferable, royalty-free, world-wide license to all
Section B Inventions for research purposes only; (ii) a time-limited
first option to negotiate a nonexclusive, exclusive, or co-exclusive,
if applicable, world-wide royalty-bearing license for commercial
purposes, including the right to grant sub-licenses, subject to any
rights of the Government of the United States of America, on terms to
be negotiated in good faith by the Collaborator(s) and Institution and
(iii) a nonexclusive, royalty-free, world-wide license either to (a.)
disclose Section B Inventions to a regulatory authority when seeking
marketing authorization of the Agent, or (b.) disclose Section B
Inventions on a product insert or other promotional material regarding
the Agent after having obtained marketing authorization from a
regulatory authority. Collaborator will notify Institution, in writing,
of its interest in obtaining an exclusive commercial license to any
Section B Invention within one year of Collaborator's receipt of a
patent application or eighteen months of receipt of an invention report
notifying Collaborator of such Section B Invention(s). In the event
that
[[Page 17414]]
Collaborator fails to so notify Institution, or elects not to obtain an
exclusive license, then Collaborator's option expires with respect to
that Section B Invention, and Institution will be free to dispose of
its interests in such Section B Invention in accordance with
Institution's policies. If Institution and Collaborator fail to reach
agreement within ninety (90) days (or such additional period as
Collaborator and Institution may agree) on the terms for an exclusive
license for a particular Subject B Invention, then for a period of six
(6) months thereafter Institution agrees not to offer to license the
Section B Invention to any third party on materially better terms than
those last offered to Collaborator without first offering such terms to
Collaborator, in which case Collaborator will have a period of thirty
(30) days in which to accept or reject the offer. Institution retains
the right to make and use any Section B Inventions for all non-profit
research, including for educational purposes and to permit other
educational and non-profit institutions to do so. If Collaborator
elects to negotiate an exclusive commercial license to a Section B
Invention, then Institution agrees to file and prosecute patent
application(s) diligently and in a timely manner and to give
Collaborator an opportunity to comment on the preparation and filing of
any such patent application(s). Notwithstanding the above, Institution
is under no obligation to file or maintain patent prosecution for any
Section B Invention.
Inventions arising more than five years after the release of data
on the primary end point of the NCI CTEP clinical trial that generated
the clinical data and/or specimens will not be subject to the Section B
(ii) IP Option.
C. The IP Option Described in This Section C Would Apply to Inventions
Made by Institution's Investigator(s) or Any Other Employees or Agents
of Institution, Which Are or May Be Patentable or Otherwise
Protectable, as a Result of Research Utilizing the Agent(s) Outside the
Scope of the NCI CTEP Funding Agreement (Unauthorized Inventions)
Institution agrees, at Collaborator's request and expense, to grant
to Collaborator a royalty-free exclusive or co-exclusive license to
Unauthorized Inventions.
D. Institution Notification
Institution agrees to promptly notify NCI CTEP
(NCICTEPpubs@mail.nih.gov) and Collaborator(s) in writing of any
Section A Inventions, Section B Inventions, and Unauthorized Inventions
upon the earlier of: (i) Any submission of any invention disclosure to
Institution of a Section A, Section B, or Unauthorized Invention, or
(ii) the filing of any patent applications of a Section A, Section B,
or Unauthorized Invention. Institution agrees to provide a copy of
either the invention disclosure or the patent application to the
Collaborator and to NCI CTEP which will treat it in accordance with 37
CFR part 401. These requirements do not replace any applicable
reporting requirements under the Bayh-Dole Act, 35 U.S.C. 200-212, and
implementing regulations at 37 CFR part 401.
III. Request for Comments
NCI CTEP is seeking comment not only from NCI CTEP funding
recipients, but from the full range of academic, not-for-profit,
government, and private sector participants in biomedical research and
development. Widespread comment and participation by varied
stakeholders in the biomedical research and development enterprise is
critical if this language is to be effective in guiding the
interactions of NIH funding recipients with external Collaborators in
CTEP-funded studies.
Dated: March 30, 2010.
Jeffrey Abrams,
Associate Director, Cancer Therapy Evaluation Program, Division of
Cancer Treatment and Diagnosis, NCI, National Institutes of Health.
[FR Doc. 2010-7743 Filed 4-5-10; 8:45 am]
BILLING CODE 4140-01-P
