This Agreement is based on the model
Commercial Evaluation - Biological Material License Agreement adopted
by the U.S. Public Health Service (“PHS”) Technology
Transfer Policy Board for use by components of the National
Institutes of Health (“NIH”), the Centers for Disease
Control and Prevention (“CDC”), and the Food and Drug
Administration (“FDA”), which are agencies of the PHS
within the Department of Health and Human Services (“HHS”).
This Cover Page identifies the Parties to this
The U.S. Department of Health and Human Services,
as represented by
[Insert the full
name of the IC]
an Institute or Center (hereinafter referred to as
the “IC”) of the
appropriate: NIH, CDC, or FDA]
hereinafter referred to as the “Licensee”,
having offices at [Insert
created and operating
under the laws of [Insert State of
“Benchmark Royalty” means a royalty due upon the six (6)
month anniversary of the Effective Date. The Benchmark
Royalty will be payable upon the six (6) month anniversary of
the Effective Date unless Licensee provides notice of
termination of this Agreement at least thirty (30) days
prior to the due date of the Benchmark Royalty.
“Effective Date” means the date when the last party to
sign has executed this Agreement.
“FDA” means the Food and Drug Administration.
“Government” means the government of the United States
“Licensed Field of Use” means the use of Licensed
Products for internal research purposes only. The Licensed
Field of Use specifically excludes the sale or other
distribution of the Materials or the Licensed Products
for any purpose, including the use of the Materials or the
Licensed Products in a fee-for-service assay.
“Licensed Products” means the ___________________
produced by the Materials and compositions incorporating the
__________________ produced by the Materials.
“Materials” means the following biological materials,
including all progeny, subclones, or unmodified derivatives
and developed in the laboratory of
“Materials Royalty” means a royalty due upon the six (6)
month anniversary of the Effective Date when additional
Materials are required.
Licensee desires to obtain:
a license from IC to use the Materials provided under
this Agreement to evaluate the Licensed Products for
a period of up to six (6) months from the Effective Date;
a license from IC to use the Materials or the
Licensed Products in its commercial research or product
development and marketing activities upon the payment of the
to conduct laboratory experiments under this Agreement to
evaluate the suitability of the Licensed Products in the
LicensedField of Use; and
to continue to use the Materials or the Licensed Products
in the LicensedField of Use onlyupon payment
of the Benchmark Royalty.
Licensee represents that it has the facilities, personnel,
and expertise to use the Materials and the Licensed
Products, and agrees to expend reasonable efforts and resources
on research and development of the Licensed Products unless
this Agreement is otherwise terminated or expired.
IC hereby grants to Licensee a non-exclusive license,
within its research facilities, to make, have made and use, but
not to sell, the Materials or the Licensed Products
within the Licensed Field of Use. Licensee agrees
that the continued use of the Materials or the Licensed
Products after the six (6) month anniversary of the Effective
Date will occur only pursuant to the payment of the Benchmark
Royalty. The continued use of the Materials or the
Licensed Products after the six (6) month anniversary of the
Effective Date without payment of the Benchmark Royalty
will be considered a material breach of this Agreement.
Licensee hereby agrees to pay IC:
A non-creditable, non-refundable license issue royalty of ________
dollars ($X) no later than sixty (60) days following the Effective
A non-creditable, non-refundable Benchmark Royalty of
__________ dollars ($X) no later than six (6) months after the
Effective Date. This Benchmark Royalty is due unless
Licensee indicates to IC that it will terminate the
Agreement in writing and at least thirty (30) days prior to
the due date of the Benchmark Royalty.
(only if additional Materials are required)
A non-creditable, non-refundable Materials Royalty of
__________ dollars ($X) if additional Materials are required
at the six (6) month anniversary of the Effective Date. The
Materials Royalty is due only if IC has been
requested to send the additional Materials.
A non-refundable annual royalty of _________ dollars ($X), as
The first annual royalty is due and payable no later than the six
(6) month anniversary of the Effective Date and may be
prorated according to the fraction of the calendar year remaining
between the six (6) month anniversary of the Effective Date
and the next subsequent January 1.
Each subsequent annual royalty shall be due and payable on January
1 of each calendar year.
Each annual royalty is due unless Licensee indicates to IC
that it will terminate the Agreement in writing and at
least thirty (30) days prior to its due date.
All payments required under this Agreement shall be paid in
U.S. dollars and payment options are listed in Appendix B. For
conversion of foreign currency to U.S. dollars, the conversion rate
shall be the New York foreign exchange rate quoted in The Wall
Street Journal on the day that the payment is due.
Any loss of exchange, value, taxes, or other expenses incurred in
the transfer or conversion to U.S. dollars shall be paid entirely
by Licensee; and
Additional royalties may be assessed by IC on any payment
that is more than ninety (90) days overdue at the rate of one
percent (1%) per month. This one percent (1%) per month rate may
be applied retroactively from the original due date until the date
of receipt by IC of the overdue payment and additional
royalties. The payment of any additional royalties shall not
prevent IC from exercising any other rights it may have as
a consequence of the lateness of any payment.
IC agrees, upon receipt and verification of the license issue
royalty, as required by Paragraph 6(a), to provide Licensee
with XXX (please enter quantity) of the Materials, as
available, and to replace the Materials, as available and at
reasonable cost, in the event of their unintentional destruction.
[If additional Materials are required upon
the six (6) month anniversary of the Effective Date,
IC agrees, after receipt and verification of
the Materials Royalty, as required by Paragraph
6(c), to provide Licensee with an additional
XXX (please enter quantity) of the Materials,
as available, and to replace the Materials, as
available and at reasonable cost, in the event of their
unintentional destruction (only if necessary)]. IC
shall provide the Materials to Licensee at Licensee’s
expense and as specified in Appendix A.
This Agreement shall become effective on the Effective
Date unless the provisions of Paragraph 26 are not fulfilled,
and shall expire exactly ____ (X) years after the Effective Date.
Within thirty (30) days of the termination or expiration of this
Agreement, Licensee shall return all Materials
and Licensed Products to IC or provide IC with
written certification of their destruction.
Licensee agrees to retain control over the Materials
and the Licensed Products, and not to distribute them to
third parties without the prior written consent of IC.
This Agreement does not preclude IC or the FDA from
distributing the Materials or the Licensed Products to
third parties for research or commercial purposes. Licensee
acknowledges that third parties also may be evaluating the Licensed
Products or the Materials for a variety of commercial
By this Agreement, IC grants no patent rights
expressly or by implication to any anticipated or pending IC
or FDA patent applications or issued patents.
NO WARRANTIES, EXPRESS OR IMPLIED, ARE OFFERED AS TO THE
MERCHANTABILITY OR FITNESS FOR ANY PURPOSE OF THE MATERIALS
OR THE LICENSED PRODUCTS 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
Licensed Products and the Materials “as is” and IC
does not offer any guarantee of any kind.
Licensee agrees to indemnify and hold harmless IC and
the Government from any claims, costs, damages, or losses
that may arise from or through Licensee's use of the
Materials or the Licensed Products. Licensee
further agrees that it shall not by its action bring the Government
into any lawsuit involving the Materials or the Licensed
Licensee agrees in its use of the Materials or the
Licensed Products to comply with all applicable statutes,
regulations, and guidelines, including NIH and HHS
regulations and guidelines. Licensee agrees not to use the
Materials or the Licensed Products for research
involving human subjects or clinical trials in the United States
without complying with 21
C.F.R. Part 50 and 45
C.F.R. Part 46. Licensee agrees not to use the Materials
or the Licensed Products for research involving human
subjects or clinical trials outside of the United States without
notifying IC, in writing, of such research or trials and
complying with the applicable regulations of the appropriate
national control authorities. Written notification to IC 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.
The Licensee may terminate this Agreement upon thirty
(30) days written notice to the IC, but only after sixty (60)
days from the Effective Date.
The IC may terminate this Agreement if the 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 the IC
of the default.
Within ninety (90) days of termination, expiration or term extension
of this Agreement, the Licensee agrees to submit a
report to the IC, and to submit to the IC payment of
any royalties due.
The report shall include, but not be limited to, progress on the
research and development involving the Materials or the
Licensed Products and use of the Materials or the
Licensed Products. The Licensee shall send the report
to the IC at the Mailing Address for Agreement
notices indicated on the Signature Page;
If the term of the Agreement is extended at the Licensee’s
request, then the IC and the Licensee will negotiate
in good faith regarding the schedule for reports regarding the
information required in 18(a);
If the term of this Agreement is longer than ten (10) years,
then the IC may request a status update report after the
fifth (5th) year of the Agreement; and
The Licensee may not be granted additional IC
licenses if this reporting requirement is not fulfilled.
All plans and reports required by this Agreement shall be
treated by the IC as commercial and financial information
obtained from a person and as privileged and confidential and, to
the extent permitted by law, not subject to disclosure under the
Freedom of Information Act, 5
The Licensee is encouraged to publish the results of its
research projects using the Materials or the Licensed
Products. In all oral presentations or written publications
concerning the Materials or the Licensed Products, the
Licensee shall acknowledge the contribution of Dr.
____________________ and the HHS agency supplying the
Materials, unless requested otherwise by the IC or the
FDA or Dr. ________________________.
Licensee agrees to supply the laboratory of Dr.
_____________, at IC, at no charge, reasonable quantities of
Materials or the Licensed Products that Licensee
makes or uses, provided that either IC or Dr. _____________
makes a request for said Materials or Licensed Products.
This Agreement shall be construed in accordance with U.S.
Federal law, as interpreted and applied by the U.S. Federal courts
in the District of Columbia. Federal law and regulations shall
preempt any conflicting or inconsistent provisions in this
Agreement. Licensee agrees to be subject to the
jurisdiction of U.S. courts.
This Agreement constitutes the entire understanding of IC
and Licensee and supersedes all prior agreements and
understandings with respect to the Materials and the Licensed
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, the invalidity or unenforceability of any provision of this
Agreement, shall not in any way affect the validity or
enforceability of the remaining provisions of this Agreement.
Paragraphs 6, 9, 13, 14, 18, 19, 20 and 25 of this Agreement
shall survive termination or expiration of this Agreement.
The terms and conditions of this Agreement shall, at IC’s
sole option, be considered by IC to be withdrawnfrom
Licensee’s consideration and the terms and
conditions of this Agreement,and the Agreement
itself to be null and void,unless this Agreement
is executedby the Licensee and a fully executed
original is received by IC within sixty (60) days from the
date of IC signature found at the Signature Page.
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 document are truthful and accurate.):
Official and Mailing Address for Agreement notices:
Official and Mailing Address for Financial notices (The Licensee’s
contact person for royalty payments)
Any false or
misleading statements made, presented, or submitted to the
Government, including any relevant omissions, under this
Agreement and during the course of negotiation of this
Agreement are subject to all applicable civil and criminal
statutes including Federal statutes 31
U.S.C. §§3801-3812 (civil liability) and 18
U.S.C. §1001 (criminal liability including fine(s) and/or
APPENDIX A – SHIPPING INFORMATION
The Licensee’s Shipping Contact: information or
questions regarding shipping should be directed to the Licensee’s
Shipping Contact at:
Contact’s Name Title
() Fax: () E-mail:
Shipping Address: Name & Address to which
Materials should be shipped (please be specific):
Company Name & Department
shipping carrier and account number to be used for shipping purposes:
Clearing House (ACH) for payments through U.S. banks only
encourages its licensees to submit electronic funds transfer payments
through the Automated Clearing House (ACH). Submit your ACH payment
through the U.S. Treasury web site located at:
Please note that the IC "only" accepts ACH payments through
this U.S. Treasury web site.
Funds Wire Transfers:The
following account information is provided for wire payments. In
order to process payment via Electronic Funds Wire Transfer sender
MUST supply the following information within the transmission:
Drawn on a U.S. bank account via
Please provide the following
instructions to your Financial Institution for the remittance of
Fedwire payments to the NIH ROYALTY FUND.
ABA routing number*
ABA short name
Identifier (account number)
12 digit gateway account #)
agency name associated with the Beneficiary Identifier)
/ NIH (75080031)
the name of the originator of the payment)
to Beneficiary Information – Line 1
information to identify the purpose of the payment)
to Beneficiary Information – Line 2
information to identify the purpose of the payment)
to Beneficiary Information – Line 3
information to identify the purpose of the payment)
to Beneficiary Information – Line 4
information to identify the purpose of the payment)
*The financial institution address for Treasury’s routing
number is 33 Liberty Street, New York, NY 10045.