This Agreement is entered into between the Public Health Service ("PHS"), through the Technology
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_____________________________________________________________________________
. 

PHS and Licensee agree as follows: 

1. Background 

1.01 In the course of conducting biomedical and behavioral research, PHS 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 foreign
patent applications or patents corresponding to the assigned inventions. DHHS also owns any
tangible embodiments of these inventions actually reduced to practice by PHS. 

1.03 The Assistant Secretary for Health of DHHS has delegated to PHS the authority to enter into
this Agreement for the licensing of rights to these inventions under 35 U.S.C. 200212, the Federal
Technology Transfer Act of 1986, 15 U.S.C. 3710a, and the regulations governing the licensing of
Government-owned inventions, 37 CFR Part 404. 

1.04 PHS desires to transfer these inventions to the private sector through commercial research
licenses to facilitate the commercial development of products and processes for public use and
benefit. 

1.05 Licensee desires to acquire the rights to use certain of these inventions in order to develop
processes, methods, or marketable products for public use and benefit. 

2. Definitions 

2.01 "Licensed Patent Rights" shall mean: 

a) U.S. patent applications and 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
claimed in a) above: i) continuationsinpart of a) above; ii) all divisions and continuations of these
continuationsin-part; iii) all patents issuing from such continuationsinpart, divisions, and continuations;
and iv) any reissues, reexaminations, and extensions of all such patents; 

c) to the extent that the following contain one or more claims directed to the invention or inventions
claimed in a) above: all counterpart foreign applications and patents to a) and b) above, including
those listed in Appendix A. 

Licensed Patent Rights shall not include b) or c) above to the extent that they contain one or more
claims directed to new matter which is not the subject matter of a claim in a) above. 

2.02 "Licensed Product(s)" means tangible materials, identified in Appendix B, which, in the course
of manufacture, use, or sale would, in the absence of this Agreement, infringe one or more claims of
the Licensed Patent Rights that have not been held invalid or unenforceable by an unappealed or
unappealable judgement of a court of competent jurisdiction. 

2.03 "Licensed Process(es)" means processes, identified in Appendix B, which, in the course of
being practiced would, in the absence of this Agreement, infringe one or more claims of the
Licensed Patent Rights that have not been held invalid or unenforceable by an unappealed or
unappealable judgement of a court of competent jurisdiction. 

2.04 "Licensed Territory" means the geographical area identified in Appendix B. 

2.05 "Government" means the government of the United States of America. 

2.06 "Licensed Fields of Use" means internal commercial use and/or product development. 

3. Grant of Rights 

3.01 PHS hereby grants and Licensee accepts, subject to the terms and conditions of this
Agreement, a Nonexclusive License under the Licensed Patent Rights in the Licensed
Territory to make and to use, but not to sell the Licensed Products and Licensed Processes in
the Licensed Fields of Use only. 

3.02 Licensee has no right to grant sublicenses. 

3.03 This Agreement confers no license or rights by implication, estoppel, or otherwise under any
patent applications or patents of PHS other than Licensed Patent Rights regardless of whether
such patents are dominant or subordinate to Licensed Patent Rights. 

3.04 PHS acknowledges that information related to the Licensed Patent Rights may be of
assistance to Licensee in its commercialization efforts. Accordingly, PHS will consider reasonable
requests by Licensee for access to the inventors of the Licensed Patent Rights. 

4. Royalties 

4.01 Licensee agrees to pay to PHS a noncreditable, nonrefundable license issue royalty as set
forth in Appendix C within thirty (30) days from the date this Agreement becomes effective. 

4.02 Licensee agrees to pay to PHS a nonrefundable annual royalty as set forth in Appendix C.
The annual royalty is due and payable on the anniversary date of the effective date of this agreement
of each calendar year. The first annual royalty is due and payable within thirty (30) days from the
date this Agreement becomes effective. 

4.03 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 this Agreement 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. 

5. Performance 

5.01 PHS agrees, if Licensed Products are available to PHS, to provide Licensee with samples of
the Licensed Products and, at reasonable cost to Licensee, to replace them in the event of their
unintentional destruction. Licensee agrees to retain control over the Licensed Products and shall
not distribute or release them to others without the prior written consent of PHS. 

5.02 Licensee shall expend reasonable efforts and resources to carry out the research development
plan submitted with Licensee's application for a license and shall begin research within six (6)
months of the effective date of this Agreement. 

5.03 Licensee agrees in its use of any PHS-supplied materials to comply with all applicable
statutes, regulations, and guidelines, including Public Health Service and National Institutes of Health
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. 

5.04 Licensee shall provide written annual reports within sixty (60) days of the end of each
calendar year detailing the current status of on-going research using Licensed Products. 

5.05 All plans and reports required by this Article 5 shall be treated by PHS 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 U.S.C. 552. 

6. Negation of Warranties and Indemnification 

6.01 PHS offers no warranties other than those expressly specified in this Agreement. 

6.02 PHS does not warrant the validity of the Licensed Patent Rights and makes no
representations whatsoever with regard to the scope of the Licensed Patent Rights, or that the
Licensed Patent Rights may be exploited without infringing other patents or other intellectual
property rights of third parties. 

6.03 PHS MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE of any subject matter
defined by the claims of the Licensed Patent Rights or of any material provided to Licensee
under Paragraph 5.01. 

6.04 PHS does not represent that it will commence legal actions against third parties infringing the
Licensed Patent Rights. 

6.05 Licensee shall indemnify and hold PHS and its employees, students, fellows, agents, and
consultants harmless from and against all liability, demands, damages, expenses, and losses, including
but not limited to death, personal injury, illness, or property damage in connection with or arising out
of a) the use by Licensee, its directors, employees, or third parties of any Licensed Patent
Rights, or b) the design, manufacture, distribution, or use of any Licensed Products or materials
provided under Article 5.01, or other products or processes developed in connection with or arising
out of the Licensed Patent Rights. Licensee agrees to maintain a liability insurance program
consistent with sound business practice. 

7. Termination and Modification of Rights 

7.01 This Agreement is effective when signed by all parties and shall terminate at the time specified
in Appendix B, unless previously terminated under the terms of Article 7 below. 

7.02 In the event that Licensee is in default in the performance of any material obligations under this
Agreement, and if the default has not been remedied within ninety (90) days after the date of notice
in writing of such default, PHS may terminate this Agreement by written notice. 

7.03 PHS shall specifically have the right to terminate this Agreement by written notice if Licensee:
1) has not demonstrated that it is executing the research plan submitted with its application for a
license or that it has taken or can be expected to take, within a reasonable time, effective steps to
achieve the practical application of the Licensed Patent Rights as contemplated by this
Agreement; or 2) has willfully made a false statement of or willfully omitted a material fact in its
application for a license or in any report required by this Agreement. 

7.04 PHS reserves the right according to 35 U.S.C. 209(f)(4) to terminate this Agreement if its is
determined that such action is necessary to meet requirements for public use specified by Federal
regulations issued after the date of the license and such requirements are not reasonably satisfied by
Licensee. 

7.05 Licensee shall have a unilateral right to terminate this Agreement by giving PHS sixty (60)
days' written notice to that effect. 

7.06 Within thirty (30) days of receipt of written notice of PHS's unilateral decision to terminate this
Agreement, Licensee may, consistent with the provisions of 37 CFR 404.11, appeal the decision
by written submission to the Director of NIH or designee. The decision of the NIH Director or
designee shall be the final agency decision. Licensee may thereafter exercise any and all
administrative or judicial remedies that may be available. 

7.07 If either Party desires a modification to this Agreement, the Parties shall, upon reasonable
notice of the proposed modification by the Party desiring the change, confer in good faith to
determine the desirability of such modification. No modification will be effective until a written
amendment is signed by the signatories to this Agreement or their designees. 

7.08 Within thirty (30) days of the termination of this Agreement under this Article 7 or expiration
under Paragraph 7.01, Licensee shall submit payment of any royalties due and shall return all
Licensed Products or other materials included within the Licensed Patent Rights to PHS or
provide PHS with certification of their destruction. 

7.09 Paragraphs 4.03, 5.05, 6.01, 6.02, 6.03, 6.04, 6.05, 7.06, and 7.08 of this Agreement shall
survive termination of this Agreement. 

8.General Provisions 

8.01 This Agreement constitutes the entire agreement between the parties relating to the subject
matter of the Licensed Patent Rights, and all prior negotiations, representations, agreements, and
understandings are merged into, extinguished by, and completely expressed by this Agreement. 

8.02 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 determination shall not in any way affect the validity or enforceability of the remaining provisions
of this Agreement. 

8.03 The construction, validity, performance, and effect of this Agreement shall be governed by
Federal law as applied by the Federal courts in the District of Columbia. 

8.04 All notices required or permitted by this Agreement shall be given by prepaid, first class,
registered or certified mail properly addressed to the other Party at the address designated on the
following Signature Page, or to such other address as may be designated in writing by such other
Party, and shall be effective as of the date of the postmark of such notice. 

8.05 This Agreement shall not be assigned by Licensee except a) with the prior written consent of
PHS; or b) as part of a sale or transfer of substantially the entire business of Licensee relating to
operations which concern this Agreement. 

8.06 Licensee acknowledges that it is subject to and agrees to abide by the United States laws and
regulations (including the Export Administration Act of 1979 and Arms Export Control Act)
controlling the export of technical data, computer software, laboratory prototypes, biological
material and other commodities. The transfer of such items may require a license from the cognizant
agency of the U.S. Government or written assurances by Licensee that it shall not export such items
to certain foreign countries without prior approval of such agency. PHS neither represents that a
license is or is not required or that, if required, it shall be issued. 

8.07 The Parties agree to attempt to settle amicably any controversy or claim arising under this
Agreement or a breach of the Agreement, except for appeals of modification or termination
decisions provided for in Article 7. Licensee agrees first to appeal any such unsettled claims or
controversies to the Director of NIH or designee, whose decision shall be considered the final
agency decision. Thereafter, Licensee may exercise any administrative or judicial remedies that may
be available. 

SIGNATURES BEGIN ON NEXT PAGE 

PHS NONEXCLUSIVE PATENT LICENSE AGREEMENT FOR COMMERCIAL
RESEARCH 

FOR PHS: 

by:___________________________________________________ ________________ 

.  
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 document are truthful and
accurate.): 

______________________________________________________ 

Licensee 

by:___________________________________________________ ________________ 

Signature of Authorized Official Date 

__________________________________________ 

Printed Name 

__________________________________________ 

Title 

Mailing Address for
Notices:_______________________________________________________ 

_______________________________________________________ 

_______________________________________________________ 

_______________________________________________________ 

APPENDIX A—Patent(s) or Patent Application(s) 

Patent(s) or Patent Application(s): 

APPENDIX B—Licensed Product(s), Process(es), and Territory 

Licensed Product(s): 

Licensed Process(es): 

Licensed Territory: 

Termination: 

This Agreement shall terminate ________ (___) years from the effective date as defined in
Paragraph 7.01. 

APPENDIX C—Royalties 

Royalties: 

Licensee agrees to pay to PHS a noncreditable, nonrefundable license issue royalty in the amount
of
__________________________________________________________________________________.

Licensee agrees to pay to PHS a noncreditable, nonrefundable annual royalty in the amount of
__________________________________________________________________________________________.

APPENDIX D—Modifications 

PHS and Licensee agree to the following modifications to the Articles and Paragraphs of this
Agreement: