PUBLIC HEALTH SERVICE
BIOLOGICAL MATERIALS LICENSE AGREEMENT
This Agreement is entered into between the Public
Health Service ("PHS"), through theTechnology
Transfer Office, the Centers for Disease Control and
Prevention, 4770 Buford Hwy, Mailstop K79, Atlanta,
GA 30341, U.S.A. and
__________________________________
("LICENSEE"), a corporation of
_________________________, having an office
at_____________________________________________________________________________
.
1. Definitions
a. "Materials" means the following biological
materials including all progeny, subclones, and
derivatives thereof:
____________________________________________________________,
as described in
_________________________________________________________________________
and developed in the laboratory of
___________________________________________________________.
b. "Licensed Products" means
_________________________________.
c. "Net Sales" means the total gross receipts
by LICENSEE for sales of Licensed Products, or for
income from leasing, renting or otherwise making Licensed
Products available to others without sale
or other disposition transferring title, whether invoiced
or not, less returns and allowances actually
granted, packing costs, insurance costs, freight out,
taxes or excise duties imposed on the transaction
(if separately invoiced), and wholesaler and cash
discounts in amounts customary in the trade. No
deductions shall be made for commissions paid to
individuals, whether they be with independent
sales agencies or regularly employed by LICENSEE, or for
the cost of collections.
2. LICENSEE wishes to obtain a license from PHS to use
the Materials provided under this
Agreement in its commercial research or product
development and marketing activities. LICENSEE
represents that it has the facilities, personnel and
expertise to use the Materials for commercial
purposes and agrees to expend reasonable efforts and
resources to develop the Materials for
commercial use and/or commercial research.
3. PHS hereby grants to LICENSEE a worldwide,
non-exclusive license to make, have made and
use the Materials and to make, have made, use and sell
Licensed Products in the field of use of
________________________________________________________________________.
4. PHS agrees to provide LICENSEE with samples of the
Materials, excluding progeny, subclones
and derivatives thereof, ("Supplied Materials"),
as available, and at reasonable cost to replace the
Supplied Materials, as available, in the event of their
unintentional destruction.
5. In consideration of the grant in Paragraph 3 above,
LICENSEE hereby agrees to make the
following payments to PHS:
a. Within 30 days of its execution of this Agreement, a
noncreditable, nonrefundable license issue
royalty of __________ Dollars ($_______).
b. A nonrefundable minimum annual royalty of _________
Dollars ($_________) which shall be
due and payable on January 1 of each calendar and may be
credited against earned royalties for due
for sales made in that year. The minimum annual royalty
for the first calendar year of this Agreement
is due and payable within thirty (30) days from the
effective date of this Agreement and may be
prorated according to the fraction of the calendar year
remaining between the effective date of this
Agreement and the next subsequent January 1.
c. An earned royalty of ______________ percent (___%)
of Net Sales, which shall be due and
payable within sixty days of the end of each calendar
year.
All payments required under this Agreement shall be in
U.S. Dollars, net of all non-U.S. taxes, and
shall be made by check or bank draft drawn on a United
States bank and made payable to
"CDC/Technology Transfer" and shall reference
the agreement number assigned by CDC. All
payments required by thisAgreement shall be mailed to the
following address: CDC, Technology
Transfer Office, 1600 Clifton Road, NE, Mailstop E-67,
Atlanta, GA 30333. Late charges will be
applied to any overdue payments as required by the U.S.
Department of Treasury in the Treasury
Fiscal Requirements Manual, Section 8025.40. The payment
of such late charges shall not prevent
PHS from exercising any other rights it may have as a
consequence of the lateness of any payment.
6. LICENSEE agrees to make written reports to PHS
within sixty (60) days after the end of each
calendar year. This report shall state the number,
description, and aggregate Net Sales of Licensed
Products made, sold, or otherwise disposed of, and the
total gross income received by LICENSEE
from leasing, renting, or otherwise making Licensed
Products available to others without sale or
other disposition transferring title, during such
completed calendar year, and resulting calculation
pursuant to Paragraph 5 of payment due. LICENSEE shall
submit each such report along with
payment due PHS for the calendar year covered by the
report to PHS at the address listed in
Paragraph 5 above and shall also send a copy of the report
to PHS at the Mailing Address for
Notices indicated on the Signature Page of this Agreement.
Late charges will be applied to any
overdue payments as required by the U.S. Department of
Treasury in the Treasury Fiscal
Requirements Manual, Section 8025.40. The payment of such
late charges shall not prevent PHS
from exercising any other rights it may have as a
consequence of the lateness of any payment.
LICENSEE shall be solely responsible for determinng if any tax on
royalty income is owed outside the United States and shall pay any such
tax and be responsible for all filings with appropriate agencies of
foreign governments.
7. LICENSEE agrees to supply the laboratory of Dr.
_____________ (PHS) at no charge
reasonable quantities of Materials and Licensed Products
that LICENSEE offers for sale or
otherwise makes available for public use.
8.This Agreement shall become effective on the date
when the last party to sign has executed this
Agreement and shall terminate __________________ ( ) years
from this effective date, unless
previously terminated under the terms of Paragraphs 16 or
17 below.
9. As part of LICENSEE's performance under this
Agreement, LICENSEE agrees to
___________________
________________________________________________________________________.
10. LICENSEE agrees to retain control over the
Materials, and not to distribute them to third parties
without the prior written consent of PHS except as
provided in Paragraph 3.
11. LICENSEE agrees that this Agreement does not
preclude PHS from distributing the Materials to
third parties for research or commercial purposes.
12. By this Agreement, PHS grants no patent rights
expressly or by implication to any anticipated or
pending PHS patent applications or issued patents.
13. NO WARRANTIES, EXPRESS OR IMPLIED, ARE OFFERED AS
TO THE
MERCHANTABILITY OR FITNESS FOR ANY PURPOSE OF THE
MATERIALS
PROVIDED TO LICENSEE UNDER THIS AGREEMENT, OR THAT THE
MATERIALS OR
LICENSED PRODUCTS MAY BE EXPLOITED WITHOUT INFRINGING THE
PATENT
RIGHTS OF ANY THIRD PARTIES. LICENSEE accepts license
rights to the Materials and
Licensed Products "as is", and PHS does not
offer any guarantee of any kind.
14. LICENSEE agrees to indemnify and hold harmless the
United States government from any
claims, costs, damages or losses that may arise from or
through LICENSEE's use of the Materials or
Licensed Products. LICENSEE further agrees that it will
not by its action bring the United States
government into any lawsuit involving the Materials or
Licensed Products.
15. LICENSEE agrees in its use of any PHS-supplied
materials to comply with all applicable
statutes, regulations and guidelines, including Public
Health Service and PHS regulations and
guidelines. LICENSEE agrees not to use the Materials for
research involving human subjects or
clinical trials in the United States without complying
with 21 CFR Part 50 and 45 CFR Part 46.
LICENSEE agrees not to use the Materials for research
involving human subjects or clinical trials
outside of the United States without notifying PHS, in
writing, of such research or trials and
complying with the applicable regulations of the
appropriate national control authorities. Written
notification to PHS of research involving human subjects
or clinical trials outside of the United States
shall be given no later than sixty (60) days prior to
commencement of such research or trials.
16. LICENSEE may terminate this Agreement upon sixty
(60) days written notice to PHS.
17. PHS may terminate this Agreement if LICENSEE is in
default in the performance of any material
obligation under this Agreement, and if the default has
not been remedied within ninety (90) days
after the date of written notice by PHS of such
default.
18. Upon termination of this Agreement, LICENSEE agrees
to return all Materials and Licensed
Products to PHS, or provide PHS with certification of
their destruction.
19. Within ninety (90) days of termination of this
Agreement, LICENSEE agrees to submit a final
report to PHS, and to submit payment of any royalties
due.
20. LICENSEE is encouraged to publish the results of
its research projects using the Materials or
Licensed Products. In all oral presentations or written
publications concerning the Materials or
Licensed Products, LICENSEE will acknowledge the
contribution of Dr. ____________________
and the PHS agency supplying the Materials, unless
requested otherwise by PHS or Dr.
________________________.
21. This Agreement shall be construed in accordance
with the laws of the United States as
interpreted and applied by the Federal courts in the
District of Columbia.
22. This Agreement constitutes the entire understanding
of PHS and LICENSEE and supersedes all
prior agreements and understandings with respect to the
Materials.
23. The provisions of this Agreement are severable, and
in the event that any provision of this
Agreement shall be determined to be invalid or
unenforceable under any controlling body of law,
such invalidity or unenforceability shall not in any way
affect the validity or enforceability of the
remaining provisions of this Agreement.
24. Paragraphs 9, 13, 14, and 20 of this Agreement
shall survive termination of this Agreement.
SIGNATURES BEGIN ON NEXT PAGE
PHS BIOLOGICAL MATERIALS LICENSE AGREEMENT SIGNATURE
PAGE
In Witness Whereof, the parties have executed this
agreement on the dates set forth below. Any
communication or notice to be given shall be forwarded to
the respective addresses listed below.
FOR PHS:
__________________________________________
_____________
.
Director Date
Centers for Disease Control and Prevention
Mailing Address for Notices: Technology Transfer
Office
Centers for Disease Control and Prevention
4770 Buford Hwy
Mailstop K79
Atlanta, GA 30341
FOR LICENSEE (Upon information and belief, the
undersigned expressly certifies or affirms that
the contents of any statements of LICENSEE made or
referred to in this Agreement are truthful and
accurate.)
__________________________________________
_____________
Signature Date
__________________________________________
Printed Name
__________________________________________
Title
Mailing Address for Notices:
__________________________________________
__________________________________________
__________________________________________
__________________________________________
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