1)
The National Institutes of Health ("NIH"), the Centers for
Disease Control and Prevention ("CDC"), or the Food and Drug Administration
("FDA"), hereinafter singly or collectively referred to as "PHS", agencies of
the United States Public Health Service within the Department of Health and
Human Services ("DHHS"); and
2)
The person, corporation, or institution identified above and/or
on the Signature Page, having offices at the address indicated on the Signature
Page, hereinafter referred to as "Licensee".
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PHS PATENT LICENSE AGREEMENT - EXCLUSIVE
PHS and Licensee agree as follows:
1.
BACKGROUND
1.01
IN THE COURSE OF CONDUCTING BIOMEDICAL AND BEHAVIORAL RESEARCH, PUS
INVESTIGATORS MADE INVENTIONS THAT MAY HAVE COMMERCIAL APPLICABILITY.
1.02
BY ASSIGNMENT OF RIGHTS FROM PHS EMPLOYEES AND OTHER INVENTORS,
DHHS, ON BEHALF OF THE UNITED STATES GOVERNMENT, OWNS INTELLECTUAL PROPERTY
RIGHTS CLAIMED IN ANY UNITED STATES AND/OR FOREIGN PATENT APPLICATIONS OR
PATENTS CORRESPONDING TO THE ASSIGNED INVENTIONS. ALL RIGHTS, TITLES AND
INTERESTS IN THE LICENSED PATENT RIGHTS HAVE BEEN TRANSFERRED TO PUS. DHHS ALSO
OWNS ANY TANGIBLE EMBODIMENTS OF THESE INVENTIONS ACTUALLY REDUCED TO PRACTICE
BY PUS.
1.03
THE SECRETARY OF DHHS HAS DELEGATED TO PUS THE AUTHORITY TO MITER
INTO THIS AGREEMENT FOR THE LICENSING OF RIGHTS TO THESE INVENTIONS UNDER 35
U.S.C. §§200 212, THE FEDERAL TECHNOLOGY TRANSFER ACT OF 1986, 15 U.S.C. §3710A,
AND/OR REGULATIONS GOVERNING THE LICENSING OF GOVERNMENT OWNED INVENTIONS, 37
CFR PART 404.
1.04
PUS DESIRES TO TRANSFER THESE INVENTIONS TO THE PRIVATE SECTOR
THROUGH COMMERCIALIZATION LICENSES TO FACILITATE THE COMMERCIAL DEVELOPMENT OF
PRODUCTS AND PROCESSES FOR PUBLIC USE AND BENEFIT.
1.05
LICENSEE DESIRES TO ACQUIRE RIGHTS TO CERTAIN OF THESE INVENTIONS
IN ORDER TO DEVELOP PROCESSES, METHODS, AND/OR MARKETABLE PRODUCTS FOR PUBLIC
USE AND BENEFIT.
2.
DEFINITIONS
2.01
"BENCHMARKS" MEAN THE PERFORMANCE MILESTONES THAT ARE SET FORTH IN
APPENDIX E.
2.02
"COMMERCIAL DEVELOPMENT PLAN" MEANS THE WRITTEN COMMERCIALIZATION
PLAN ATTACHED AS APPENDIX F.
2.03
"FIRST COMMERCIAL SALE" MEANS THE INITIAL TRANSFER BY OR ON BEHALF
OF LICENSEE OR ITS SUBLICENSEES OF LICENSED PRODUCT(S) OR THE INITIAL PRACTICE
OF A LICENSED PROCESS(ES) BY OR ON BEHALF OF LICENSEE OR ITS SUBLICENSEES IN
EXCHANGE FOR CASH OR SOME EQUIVALENT TO WHICH VALUE CAN BE ASSIGNED FOR THE
PURPOSE OF DETERMINING NET SALES.
2.04
"GOVERNMENT" MEANS THE GOVERNMENT OF THE UNITED STATES OF AMERICA.
2.05
"LICENSED FIELDS OF USE" MEANS THE FIELDS OF USE IDENTIFIED IN
APPENDIX B.
2.06
"LICENSED PATENT RIGHTS" SHALL MEAN:
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A)
PATENT APPLICATIONS (INCLUDING PROVISIONAL PATENT APPLICATIONS
AND PCT PATENT APPLICATIONS) AND/OR PATENTS LISTED IN APPENDIX A, ALL DIVISIONS
AND CONTINUATIONS OF THESE APPLICATIONS, ALL PATENTS ISSUING FROM SUCH
APPLICATIONS, DIVISIONS, AND CONTINUATIONS, AND ANY REISSUES, REEXAMINATIONS,
AND EXTENSIONS OF ALL SUCH PATENTS;
B)
TO THE EXTENT THAT THE FOLLOWING CONTAIN ONE OR MORE CLAIMS
DIRECTED TO THE INVENTION OR INVENTIONS DISCLOSED IN A) ABOVE: I)
CONTINUATIONS-IN-PART OF A) ABOVE; II) ALL DIVISIONS AND CONTINUATIONS OF THESE
CONTINUATIONS IN PART; III) ALL PATENTS ISSUING FROM SUCH CONTINUATIONS IN PART,
DIVISIONS, AND CONTINUATIONS; IV) PRIORITY PATENT APPLICATIONS) OF