Exhibit 10.51
CERTAIN INFORMATION IN THIS EXHIBIT HAS BEEN OMITTED
AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT
HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS.
PUBLIC HEALTH SERVICE
PATENT LICENSE AGREEMENT--NONEXCLUSIVE
COVER PAGE
For PHS internal use only:
Patent License Number: L-108-99/0
Serial Number(s) of Licensed Patent(s) and/or Patent Application(s):
06/602,945; 06/602946; 06/643,729; 06/785,638; 07/117,937
Licensee: Calypte Biomedical, Inc.
Cooperative Research and Development Agreement (CRADA) Number (if
applicable): N/A
Additional Remarks: None
Public Benefit(s): N/A
This Patent License Agreement, hereinafter referred to as the "AGREEMENT",
consists of this Cover Page, an attached AGREEMENT, a Signature Page, Appendix A
(List of Patent(s) and/or Patent Application(s)), Appendix B (Fields of Use and
Territory), Appendix C (Royalties), Appendix D (Modifications), Appendix E
(Benchmarks), and Appendix F (Commercial Development Plan). The Parties to this
AGREEMENT are:
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".
THE SYMBOL '[**]' IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
PHS PATENT LICENSE AGREEMENT--NONEXCLUSIVE
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/or 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 Secretary of DHHS has delegated to PHS the authority to enter
into this AGREEMENT for the licensing of rights to these
inventions.
1.04 PHS 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 commercialization 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 PRODUCTS or the
initial practice of a LICENSED PROCESS 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:
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 application(s) of a) above; and v) 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 disclosed in a) above: all
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
counterpart foreign and U.S. patent
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 disclosed in a)
above.
2.07 "LICENSED PROCESS(es)" means processes 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 judgment of a court of competent jurisdiction.
2.08 "LICENSED PRODUCT(s)" means tangible materials which, in the
course of manufacture, use, sale, or importation 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 judgment of a court
of competent jurisdiction.
2.09 "LICENSED TERRITORY" means the geographical area identified in
Appendix B.
2.10 "NET SALES" means the total gross receipts for sales of LICENSED
PRODUCTS or practice of LICENSED PROCESSES by or on behalf of
LICENSEE or its sublicensees, and from leasing, renting, or
otherwise making LICENSED PRODUCTS available to others without
sale or other dispositions, whether invoiced or not, less returns
and allowances, 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 to the extent actually granted. No deductions shall
be made for commissions paid to individuals, whether they be with
independent sales agencies or regularly employed by LICENSEE, or
sublicensees, and on its payroll, or for the cost of collections.
2.11 "PRACTICAL APPLICATION" means to manufacture in the case of a
composition or product, to practice in the case of a process or
method, or to operate in the case of a machine or system; and in
each case, under such conditions as to establish that the
invention is being utilized and that its benefits are to the
extent permitted by law or GOVERNMENT regulations available to the
public on reasonable terms.
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 have
made, to use and have used, to sell and have sold, to offer to
sell, and to import any LICENSED PRODUCTS in the LICENSED FIELDS
OF USE and to practice and have practiced any LICENSED PROCESSES
in the LICENSED FIELDS OF USE.
3.02 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.
4. SUBLICENSING
4.01 LICENSEE has no right to sublicense.
5. STATUTORY AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS
5.01 Prior to the FIRST COMMERCIAL SALE, LICENSEE agrees to provide PHS
reasonable quantities of LICENSED PRODUCTS or materials made
through the LICENSED PROCESSES for PHS research use.
5.02 LICENSEE agrees that products used or sold in the United States
embodying LICENSED PRODUCTS or produced through use of LICENSED
PROCESSES shall be manufactured substantially in the United
States, unless a written waiver is obtained in advance from
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
PHS.
6. ROYALTIES AND REIMBURSEMENT
6.01 [**]
6.02 [**]
6.03 [**]
6.04 [**]
6.05 [**]
6.06 [**]
6.07 [**]
6.08 [**]
6.09 [**]
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
6.10 [**]
7. PATENT FILING, PROSECUTION, AND MAINTENANCE
7.01 PHS agrees to take responsibility for the preparation, filing,
prosecution, and maintenance of any and all patent applications or
patents included in the LICENSED PATENT RIGHTS.
8. RECORD KEEPING
8.01 LICENSEE agrees to keep accurate and correct records of LICENSED
PRODUCTS made, used, sold, or imported and LICENSED PROCESSES
practiced under this AGREEMENT appropriate to determine the amount
of royalties due PHS. Such records shall be retained for at least
five (5) years following a given reporting period and shall be
available during normal business hours for inspection at the
expense of PHS by an accountant or other designated auditor
selected by PHS for the sole purpose of verifying reports and
payments hereunder. The accountant or auditor shall only disclose
to PHS information relating to the accuracy of reports and
payments made under this AGREEMENT. If an inspection shows an
underreporting or underpayment in excess of five percent (5%) for
any twelve (12) month period, then LICENSEE shall reimburse PHS
for the cost of the inspection at the time LICENSEE pays the
unreported royalties, including any late charges as required by
Paragraph 9.07 of this AGREEMENT. All payments required under
this Paragraph shall be due within thirty (30) days of the date
PHS provides LICENSEE notice of the payment due.
8.02 LICENSEE agrees to have an audit of sales and royalties conducted
by an independent auditor at least every two (2) years if annual
sales of the LICENSED PRODUCT or LICENSED PROCESSES are over two
(2) million dollars. The audit shall address, at a minimum, the
amount of gross sales by or on behalf of LICENSEE during the audit
period, terms of the license as to percentage or fixed royalty to
be remitted to the GOVERNMENT, the amount of royalty funds owed to
the GOVERNMENT under this AGREEMENT, and whether the royalty
amount owed has been paid to the GOVERNMENT and is reflected in
the records of the LICENSEE. The audit shall also indicate the
PHS license number, product, and the time period being audited. A
report certified by the auditor shall be submitted promptly by the
auditor directly to PHS on completion. LICENSEE shall pay for the
entire cost of the audit.
9. REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS
9.01 Prior to signing this AGREEMENT, LICENSEE has provided to PHS the
COMMERCIAL DEVELOPMENT PLAN at Appendix F, under which LICENSEE
intends to bring the subject matter of the LICENSED PATENT RIGHTS
to the point of PRACTICAL APPLICATION. This COMMERCIAL
DEVELOPMENT PLAN is hereby incorporated by reference into this
AGREEMENT. Based on this plan, performance BENCHMARKS are
determined as specified in Appendix E.
9.02 LICENSEE shall provide written annual reports on its product
development progress or efforts to commercialize under the
COMMERCIAL DEVELOPMENT PLAN for each of the LICENSED FIELDS OF USE
within sixty (60) days after December 31 of each calendar year.
These progress reports shall include, but not be limited to:
progress on research and development, status of applications for
regulatory approvals, manufacturing, marketing, importing, and
sales during the preceding calendar year, as well as plans for the
present calendar year. PHS also encourages these reports to
include information on any of LICENSEE's public service activities
that relate to the LICENSED PATENT RIGHTS. If reported progress
differs from that projected in the COMMERCIAL DEVELOPMENT PLAN and
BENCHMARKS, LICENSEE shall explain the reasons for such
differences. In any such annual report, LICENSEE may propose
amendments to the COMMERCIAL DEVELOPMENT PLAN, acceptance of which
by PHS may not be denied unreasonably. LICENSEE agrees to
THE SYMBOL '[**]' IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
provide any additional information reasonably required by PHS to
evaluate LICENSEE's performance under this AGREEMENT. LICENSEE
may amend the BENCHMARKS at any time upon written consent by PHS.
PHS shall not unreasonably withhold approval of any request of
LICENSEE to extend the time periods of this schedule if such
request is supported by a reasonable showing by LICENSEE of
diligence in its performance under the COMMERCIAL DEVELOPMENT PLAN
and toward bringing the LICENSED PRODUCTS to the point of
PRACTICAL APPLICATION.
9.03 LICENSEE shall report to PHS the dates for achieving BENCHMARKS
specified in Appendix E and the FIRST COMMERCIAL SALE in each
country in the LICENSED TERRITORY within thirty (30) days of such
occurrences.
9.04 [**]
9.05 Royalties due under Article 6 shall be paid in U.S. dollars. 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. All
checks and bank drafts shall be drawn on United States banks and
shall be payable, as appropriate, to "NIH/Patent Licensing." All
such payments shall be sent to the following address: NIH,
X.X. Xxx 000000, Xxxxxxxxxx, XX 00000-0000. 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.
The royalty report required by Paragraph 9.04 of this AGREEMENT
shall accompany each such payment, and a copy of such report shall
also be mailed to PHS at its address for notices indicated on the
Signature Page of this AGREEMENT.
9.06 LICENSEE shall be solely responsible for determining 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.
9.07 Interest and penalties may be assessed by PHS on any overdue
payments in accordance with the Federal Debt Collection Act. 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.
9.08 All plans and reports required by this Article 9 and marked
"confidential" by LICENSEE shall, to the extent permitted by law,
be treated by PHS as commercial and financial information obtained
from a person and as privileged and confidential, and any proposed
disclosure of such records by the PHS under the Freedom of
Information Act (FOIA), 5 U.S.C. ' 552 shall be subject to the
predisclosure notification requirements of 45 CFR ' 5.65(d).
10. PERFORMANCE
10.01 LICENSEE shall use its reasonable best efforts to bring the
LICENSED PRODUCTS and LICENSED PROCESSES to PRACTICAL APPLICATION.
"Reasonable best efforts" for the purposes of this provision shall
include adherence to the COMMERCIAL DEVELOPMENT PLAN at Appendix F
and performance of the BENCHMARKS at Appendix E.
10.02 Upon the FIRST COMMERCIAL SALE, until the expiration of this
AGREEMENT, LICENSEE shall use its reasonable best efforts to make
LICENSED PRODUCTS and LICENSED PROCESSES reasonably accessible to
the United States public.
THE SYMBOL '[**]' IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
11. INFRINGEMENT AND PATENT ENFORCEMENT
11.01 PHS and LICENSEE agree to notify each other promptly of each
infringement or possible infringement of the LICENSED PATENT
RIGHTS, as well as any facts which may affect the validity, scope,
or enforceability of the LICENSED PATENT RIGHTS of which either
Party becomes aware.
11.02 [**]
12. NEGATION OF WARRANTIES AND INDEMNIFICATION
12.01 PHS offers no warranties other than those specified in Article 1.
12.02 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.
12.03 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 TANGIBLE MATERIALS
RELATED THERETO.
12.04 PHS does not represent that it will commence legal actions against
third parties infringing the LICENSED PATENT RIGHTS.
12.05 LICENSEE shall indemnify and hold PHS, 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 or on behalf
of LICENSEE, its directors, employees, or third parties of any
LICENSED PATENT RIGHTS; or b) the design, manufacture,
distribution, or use of any LICENSED PRODUCTS, LICENSED PROCESSES
or materials by LICENSEE, 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.
13. TERM, TERMINATION, AND MODIFICATION OF RIGHTS
13.01 This AGREEMENT is effective when signed by all parties and shall
extend to the expiration of the last to expire of the LICENSED
PATENT RIGHTS unless sooner terminated as provided in this Article
13.
13.02 In the event that LICENSEE is in default in the performance of any
material obligations under this AGREEMENT, including but not
limited to the obligations listed in Article 13.05, 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 and pursue outstanding amounts owed
through procedures provided by the Federal Debt Collection Act.
13.03 In the event that LICENSEE becomes insolvent, files a petition in
bankruptcy, has such a
THE SYMBOL '[**]' IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
petition filed against it, determines to file a petition in
bankruptcy, or receives notice of a third party's intention to
file an involuntary petition in bankruptcy, LICENSEE shall
immediately notify PHS in writing. Furthermore, PHS shall have
the right to terminate this AGREEMENT immediately upon
LICENSEE's receipt of written notice.
13.04 LICENSEE shall have a unilateral right to terminate this AGREEMENT
in any country or territory by giving PHS sixty (60) days written
notice to that effect.
13.05 [**]
13.06 [**]
13.07 [**]
13.08 [**]
14. GENERAL PROVISIONS
14.01 Neither Party may waive or release any of its rights or interests
in this AGREEMENT except in writing. The failure of the
GOVERNMENT to assert a right hereunder or to insist upon
compliance with any term or condition of this AGREEMENT shall not
constitute a waiver of that right by the GOVERNMENT or excuse a
similar subsequent failure to perform any such term or condition
by LICENSEE.
14.02 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
THE SYMBOL '[**]' IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
expressed by this AGREEMENT.
14.03 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.
14.04 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.
14.05 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.
14.06 All notices required or permitted by this AGREEMENT shall be given
by prepaid, first class, registered or certified mail or by an
express/overnight delivery service provided by a commercial
carrier, 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.
Notices shall be considered timely if such notices are received on
or before the established deadline date or sent on or before the
deadline date as verifiable by U.S. Postal Service postmark or
dated receipt from a commercial carrier. Parties should request a
legibly dated U.S. Postal Service postmark or obtain a dated
receipt from a commercial carrier or the U.S. Postal Service.
Private metered postmarks shall not be acceptable as proof of
timely mailing.
14.07 This AGREEMENT shall not be assigned by LICENSEE except: a) with
the prior written consent of PHS, such consent not to be withheld
unreasonably; or b) as part of a sale or transfer of substantially
the entire business of LICENSEE relating to operations which
concern this AGREEMENT. LICENSEE shall notify PHS within ten (10)
days of any assignment of this AGREEMENT by LICENSEE, and LICENSEE
shall pay PHS, as an additional royalty, one percent (1%) of the
fair market value of any consideration received for any assignment
of this AGREEMENT within thirty (30) days of such assignment.
14.08 LICENSEE agrees in its use of any PHS-supplied materials to comply
with all applicable statutes, regulations, and guidelines,
including PHS and DHHS 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.
14.09 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.
14.10 LICENSEE agrees to xxxx the LICENSED PRODUCTS or their packaging
sold in the United States with all applicable U.S. patent numbers
and similarly to indicate "Patent Pending" status. All LICENSED
PRODUCTS manufactured in, shipped to, or sold in other countries
shall be marked in such a manner as to preserve PHS patent rights
in such countries.
14.11 By entering into this AGREEMENT, PHS does not directly or
indirectly endorse any product
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
or service provided, or to be provided, by LICENSEE whether
directly or indirectly related to this AGREEMENT. LICENSEE
shall not state or imply that this AGREEMENT is an endorsement
by the GOVERNMENT, PHS, any other GOVERNMENT organizational
unit, or any GOVERNMENT employee. Additionally, LICENSEE shall
not use the names of NIH, CDC, PHS, or DHHS or the GOVERNMENT
or their employees in any advertising, promotional, or sales
literature without the prior written consent of PHS.
14.12 The Parties agree to attempt to settle amicably any controversy or
claim arising under this AGREEMENT or a breach of this AGREEMENT,
except for appeals of modifications or termination decisions
provided for in Article 13. LICENSEE agrees first to appeal any
such unsettled claims or controversies to the designated PHS
official, or designee, whose decision shall be considered the
final agency decision. Thereafter, LICENSEE may exercise any
administrative or judicial remedies that may be available.
14.13 Nothing relating to the grant of a license, nor the grant itself,
shall be construed to confer upon any person any immunity from or
defenses under the antitrust laws or from a charge of patent
misuse, and the acquisition and use of rights pursuant to 37 CFR
Part 404 shall not be immunized from the operation of state or
Federal law by reason of the source of the grant.
14.14 Paragraphs 8.01, 9.06-9.08, 12.01-12.05, 13.07, 13.08, and 14.12
of this AGREEMENT shall survive termination of this AGREEMENT.
SIGNATURES BEGIN ON NEXT PAGE
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OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
PHS PATENT LICENSE AGREEMENT--NONEXCLUSIVE
SIGNATURE PAGE
For PHS:
/s/ Xxxx Xxxxxxx 6/30/99
--------------------------------------------- ---------------
Xxxx Xxxxxxx, Ph.D. Date
Director, Division of Technology Development and Transfer
Office of Technology Transfer
National Institutes of Health
Mailing Address for Notices:
Office of Technology Transfer
National Institutes of Health
0000 Xxxxxxxxx Xxxxxxxxx, Xxxxx 000
Xxxxxxxxx, Xxxxxxxx 00000-0000 X.X.X.
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.):
by:
/s/ Xxxxxxx X. Xxxxxx 6/23/99
--------------------------------------------- ---------------
Signature of Authorized Official Date
Xxxxxxx X. Xxxxxx
---------------------------------------------
Printed Name
CEO
---------------------------------------------
Title
Official and Mailing Address for Notices:
Xxxxxxx X. Xxxxxx
President and CEO
Calypte Biomedical
0000 Xxxxxx Xxx Xxxx.
Xxxxxxx, XX 00000
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
imprisonment).
THE SYMBOL '[**]' IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
APPENDIX A--PATENT(s) OR PATENT APPLICATION(s)
PATENT(s) OR PATENT APPLICATION(s):
USPA SN 06/602,945, filed April 23, 1984, (USPN 4,520,113, issued May 28,
1985) "Serological Detection of Antibodies to HTLV-III in Sera of
Patients with AIDS and Pre-AIDS Conditions"
USPA SN 06/602,946, filed April 23, 1984, (USPN 4,647,773, issued March
3, 1987) "Method of Continuous Production of Retrovirus (HTLV-III) from
Patients with AIDS and Pre-AIDS"
USPA SN 06/643,729, filed August 24, 1984, (USPN 4,652,599, issued March
24, 1987) "Method of Continuous Production of Retrovirus (HTLV-III) from
Patients with AIDS and Pre-AIDS Using Permissive Cells"
USPA SN 06/785,638, filed October 8, 1985, (USPN 4,708,818, issued
November 24, 1987) "Human Immunodeficiency Viruses Associated with
Acquired Immune Deficiency Syndrome (AIDS), A Diagnostic Method for AIDS
and Pre-AIDS and a Kit Therefor"
USPA SN 07/117,937, filed November 5, 1987, (USPN 5,135,684, issued
August 4, 1992) "Human Immunodeficiency Viruses Associated with Acquired
Immune Deficiency Syndrome (AIDS), A Diagnostic Method for AIDS and
Pre-AIDS and a Kit Therefor"
THE SYMBOL '[**]' IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
APPENDIX B--LICENSED FIELDS OF USE AND TERRITORY
[**]
THE SYMBOL '[**]' IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
APPENDIX C--ROYALTIES
[**]
THE SYMBOL '[**]' IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
APPENDIX D--MODIFICATIONS
PHS and LICENSEE agree to the following modifications to the Articles and
Paragraphs of this AGREEMENT:
(Amended)
6.02 [**]
(Amended)
13.01 This AGREEMENT is effective AUGUST 6, 1996 when signed by all
parties and shall extend to the expiration of the last to expire
of the LICENSED PATENT RIGHTS unless sooner terminated as provided
in this Article 13.
THE SYMBOL '[**]' IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
APPENDIX E--BENCHMARKS AND PERFORMANCE
LICENSEE agrees to the following BENCHMARKS for its performance under this
AGREEMENT and, within thirty (30) days of achieving a BENCHMARK, shall notify
PHS that the BENCHMARK has been achieved.
None.
THE SYMBOL '[**]' IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
APPENDIX F--COMMERCIAL DEVELOPMENT PLAN
The COMMERCIAL DEVELOPMENT PLAN shall be as described in the license
application.
THE SYMBOL '[**]' IS USED TO INDICATE THAT A PORTION OF THE EXHIBIT HAS BEEN
OMITTED AND FILED SEPARATELY WITH THE COMMISSION.
