Exhibit 10.22


 










	
   

  	
  [*]         designates
  portions of this document that have been omitted pursuant to a request for
  confidential treatment filed seperately with the Commission

  



 


PUBLIC HEALTH SERVICE


 


PATENT LICENSE AGREEMENT—EXCLUSIVE


 


 


COVER PAGE


 


For PHS internal use
only:


 


 


Patent
License Number: L-025-01/0


 


US Patent Numbers
5,821,081; 5,843,882; 5,962,653; 5,962,668; 5,998,587; 6,015,876; 6,245,737;
6,420,336; and 6,428,790; and US Patent Applications Numbers [*].


 


Licensee:
Biosyn, Inc.


 


Cooperative
Research and Development Agreement (CRADA) Number (if applicable): N/A


 


Additional
Remarks:


 


	
   

  
	
   

  
	
   

  



 


Public
Benefit(s): Microbicide to protect against infection by HIV


 


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 (Field of Use and Territory), Appendix C (Royalties), Appendix D
(Modifications), Appendix E (Benchmarks and Performance), Appendix F (Commercial
Development Plan) and Appendix G (Developing Countries).  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”.


 


CONFIDENTIAL


 


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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, 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 (a) first
shipment of Licensed Products to
an unrelated third party by or on behalf of Licensee
or its sublicensees, or (b) the first performance of a Licensed Process for an unrelated third
party by Licensee or its
sublicensees, in each case by or on behalf of Licensee
in exchange for cash (or some equivalent to which value can be assigned for the
purpose of determining Net Sales)
in excess of fully burdened manufacturing cost. 
Notwithstanding the foregoing, First
Commercial Sale shall not include transfers at or below cost by or
on behalf of Licensee or its
sublicensees of Licensed Products,
or the practice of Licensed Processes,
in connection with compassionate use, emergency use, treatment Investigational
New Drug Applications (IND’s), or the like authorized by the U.S. Food and Drug
Administration (FDA) or corresponding foreign agencies.


 


2.04                           “Government” means the Government of the United States of
America.


 


2.05                           “Licensed Biological Materials” means:


 


a)
Plasmid constructs encoding the wild type or mutant forms of the Cyanovirin-N
gene, and;


 


b) Polyclonal antibodies and hybridoma
cell lines producing monoclonal antibodies specific for wild type or mutant
forms of Cyanovirin-N.


 


2.06                           “Licensed Field of Use” means the field of use identified in
Appendix B.       


 


2.07                           “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 application(s) of a) above; and v) any reissues,
reexaminations, and extensions and reregistrations 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 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.


 


2.08                           “Licensed Process(es)” means processes which, in the course
of being practiced would be within the scope of one or more claims of the Licensed Patent Rights that have not been held unpatentable,
invalid or unenforceable by an unappealed or unappealable judgment of a court
of competent jurisdiction.


 


2.09                           “Licensed Product(s)” means tangible materials which, in the
course of manufacture, use, sale, or importation would be within the scope of
one or more claims of the Licensed Patent Rights
that have not been held unpatentable, invalid or unenforceable by an unappealed
or unappealable judgment of a court of competent jurisdiction.


 


2.10                           “Licensed Territory” means the geographical area identified
in Appendix B.


 


2.11                           “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.


 


In the
event PHS, on a country-by-country basis, is
receiving earned royalties under this Agreement from
any Licensed Product sold in a form
containing Licensed Product(s) and at least
one other ingredient, product or component having a specific pharmalogical
effect (i.e., an antiinfective or anti-inflammatory, but not a diluent,
carrier, perfume etc.) (a “Combination Product”)
which is sold separate and apart from the Licensed Product(s)
in the Combination Product, Net Sales for such Combination Product
will be calculated by multiplying the actual Net Sales of
the Combination Product by the fraction
A/(A+B), where A is the Net Sales price
per dose of the Licensed Product(s) if sold
separately and B is the Net Sales price
per dose of the other ingredient(s), product(s) or component(s) in the Combination Product, if sold separately. If the other
ingredient(s), product(s) or component(s) is not sold separately in a country, Net Sales for such Combination Product
will be calculated by multiplying the actual Net Sales of
the


 


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Combination
Product by the fraction A/C, where A is the Net Sales price per dose of the Licensed
Product(s), if sold separately in said country, and C is the Net Sales price per dose of the Combination
Product.  If neither the Licensed Product(s) nor the other ingredient(s), product(s)
or component(s) is sold separately in a country, then Net Sales for
the Combination Product shall be determined
by multiplying the Net Sales of
the Combination Product by X/(X+Y), where X
is the number of Licensed Products and Y the number
of other ingredients, products or components in the Combination
Product. 


 


Notwithstanding
the above determination of Net Sales of Combination Product, in no event shall the Net Sales used to calculate earned royalty due on a Combination Product be reduced by more than fifty (50%)
percent of the actual Net Sales of
the Combination Product.


 


2.12                           “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.


 


2.13                           “Research License” means a nontransferable, nonexclusive
license to make and to use the Licensed Products
or Licensed Processes as defined by the Licensed Patent Rights in the Licensed
Field of Use for purposes of research and not for purposes of
commercial manufacture, sale, distribution or for development for such
commercial purposes.


 


2.14                           “Developing Country” means countries
eligible for support from the Global Alliance for Vaccine Initiatives (GAVI) or
successor organization, or which at the effective date of this Agreement are
those countries with a Gross National Product of less than US $1,000 per capita
per year, and at the effective date of this Agreement
include those listed in Appendix G.


 


2.15                           “Public Sector” means the U.S. government
and/or the government of a Developing Country,
or any nonprofit entity empowered by the U.S. government and/or the government
of a Developing Country to act for
said government in matters applicable to this Agreement,
organizations within the United Nations system including the World Health
Organization and UNICEF, and other non-profit organizations when they purchase
drugs or vaccines for delivery, manufacture and/or sale in the
U.S. and Developing
Countries.


 


2.16                           “Private Sector” means all other parties other than the Public Sector.


 


3.                                       GRANT
OF RIGHTS


 


3.01                           PHS hereby grants and Licensee
accepts, subject to the terms and conditions of this Agreement,
an exclusive 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 Field of Use and to practice and have practiced any
Licensed Processes in the Licensed Field 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. 
PHS represents to Licensee that as of the Effective Date of
this Agreement, PHS is unaware of any other PHS patent rights that block or limit the Licensed Patent Rights.


 


3.03                           PHS grants Licensee the benefit of any patent term extensions and
reregistrations applicable to the Licensed
Patent Rights and any Orphan Drug Act registrations applicable to Licensed Products and Licensed Processes and any comparable
extensions and registrations in the Licensed
Territory.  PHS agrees to reasonably cooperate, such as
by submitting applications to appropriate


 


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governmental
agencies, at the request and sole expense of Licensee,
in connection with applying for and obtaining such extensions and
registrations.


 


3.04                           To
the extent permitted by law, governmental regulation, and PHS policy, and other agreements between PHS and third parties, and for purposes
only of seeking regulatory approval to commercialize Licensed Products and Licensed
Processes in the Licensed Field of
Use, PHS agrees to
consider in good faith any requests from Licensee
to make its preclinical and clinical data, if any, relating to Licensed Products and Licensed Processes available nonexclusively
to Licensee, such requests shall
be considered on an expedited basis and shall not be unreasonably denied and,
in particular, where access by Licensee
to such data may expedite obtaining approval from applicable regulatory
agencies.


 


3.05                           In
addition to the above-mentioned rights, PHS
grants to Licensee, subject to
royalties as described herein, the use of Licensed
Biological Materials required for use of the Licensed Patent Rights granted hereunder.


 


4.                                       SUBLICENSING


 


4.01                           Upon
written approval by PHS, which
approval will not be unreasonably withheld, Licensee
may enter into sublicensing agreements under the Licensed Patent Rights. 
Such sublicensing arrangements shall be deemed to have been accepted by PHS if PHS
does not object within Forty Five (45) days of Licensee’s written request for approval of a sublicense.


 


4.02                           Licensee agrees that any sublicenses granted by it shall
provide that the obligations to PHS of
Paragraphs 5.01-5.04, 8.01, 10.01, 10.02, 12.05, and 13.05-13.10 of this Agreement shall be binding upon the sublicensee as if it
were a party to this Agreement.  Licensee
further agrees to attach copies of these Paragraphs to all sublicense
agreements.  PHS acknowledges that some of the obligations in these
Paragraphs may not appropriately apply to sublicensees, and agrees to
reasonably consider limitations added by Licensee
to such Paragraphs in a sublicense agreement to the extent permitted by law.


 


4.03                           Any
sublicenses granted by Licensee shall
provide for the termination of the sublicense, or the conversion to a license
directly between such sublicensees and PHS, at the
option of the sublicensee, upon termination of this Agreement
under Article 13.  Such conversion
is subject to PHS approval, which approval shall
not be unreasonably withheld, and contingent upon acceptance by the sublicensee
of the remaining provisions of this Agreement.


 


4.04                           Licensee agrees to forward to PHS
a copy of each fully executed sublicense agreement postmarked within thirty
(30) days of the execution of such agreement. 
To the extent permitted by law, PHS agrees to
maintain each such sublicense agreement as commercial and financial information
obtained from a person and as privileged and confidential pursuant to the
provisions of Section 9.09 of this Agreement.


 


5.                                       STATUTORY
AND PHS REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS


 


5.01                           PHS reserves on behalf of the Government an irrevocable, nonexclusive, nontransferable,
royalty-free license for the practice of all inventions licensed under the Licensed Patent Rights throughout the world by or on behalf
of the Government and on behalf of
any foreign government or not-for-profit, public health international
organization pursuant to any existing or future treaty or agreement to which
the Government is a signatory.  Prior to First Commercial Sale and to the extent that Licensee has available material,  Licensee agrees to provide PHS, subject to appropriate Materials Transfer
Agreements, reasonable quantities of Licensed
Products or materials made through the Licensed
Processes for PHS research
use, at a cost no greater than Licensee’s fully
burdened cost; i.e., direct costs of manufacturing plus overhead costs. 


 


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5.02                           Licensee agrees that products used or sold in the United
States embodying Licensed Products or produced
through performance of Licensed Processes
shall be manufactured substantially in the United States, unless a written
waiver is obtained in advance from PHS.


 


5.03                           Licensee acknowledges that PHS
may enter into future Cooperative Research and Development Agreements (CRADAs)
under the Federal Technology Transfer Act of 1986 that relate to the subject
matter of this Agreement.  Licensee agrees
not to unreasonably deny requests for a Research License
from such future collaborators with PHS when
acquiring such rights is necessary in order to make a Cooperative Research and
Development Agreement (CRADA) project feasible. 
Licensee may request an opportunity to
join as a party to the proposed Cooperative Research and Development Agreement
(CRADA). PHS agrees to notify Licensee in writing as soon as practicable, and before
execution, that it is contemplating a CRADA with a research plan that overlaps
with the Licensed Field of Use of this Agreement.



 


5.04                           In
addition to the reserved license of Paragraph 5.01 above, PHS
reserves the right to grant nonexclusive Research Licenses
directly or to require Licensee to
grant nonexclusive Research Licenses
in the Licensed Field of Use, on reasonable
terms.  The purpose of this Research License is to encourage basic research, whether
conducted at an academic or corporate facility. 
In order to safeguard the Licensed Patent Rights,
however, PHS shall consult with Licensee before granting to commercial entities a Research License in the Licensed Field of Use or
providing to them research samples of materials made through the Licensed Processes for use in the Licensed
Field of Use, except that PHS
may not distribute such Licensed Products
or materials provided to PHS by Licensee pursuant to Section 5.01.


 


5.05                           In
the event that PHS makes any filings or
submissions such as an IND or NDA (or foreign equivalent) to the Food and Drug
Administration (or foreign equivalent) in order to conduct clinical trials or
seek regulatory approval of a Licensed Product in Licensed Fields of Use,
PHS agrees to provide Licensee with an automatic right of
reference to such filings, including all data, reports and documents submitted
in connection therewith.  PHS agrees to sign appropriate
documentation to permit such reference and to promptly notify Licensee upon making such filings.


 


6.                                       ROYALTIES
AND REIMBURSEMENT


 


6.01                           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 that this Agreement
becomes effective.


 


6.02                           Licensee agrees to pay to PHS
a nonrefundable minimum annual royalty as set forth in Appendix C. 


 


6.03                           Licensee agrees to pay PHS earned
royalties on Net Sales as set
forth in Appendix C.


 


6.04                           Licensee agrees to pay PHS benchmark
royalties as set forth in Appendix C.


 


6.05                           Licensee agrees to pay PHS
sublicensing royalties as set forth in Appendix C.


 


6.06                           A
patent or patent application licensed under this Agreement
shall cease to fall within the Licensed Patent Rights
for the purpose of computing earned royalty payments in any given country on
the earliest of the dates that a) the application has been abandoned and not
continued, b) the patent expires or irrevocably lapses, or c) the claim has
been held to be invalid or unenforceable by an unappealed or unappealable
decision of a court of competent jurisdiction or administrative agency.


 


6.07                           No
multiple royalties shall be payable because any Licensed
Products or Licensed Processes
are covered by more than one of the Licensed Patent Rights.


 










	
   

  	
  [*]         designates
  portions of this document that have been omitted pursuant to a request for
  confidential treatment filed seperately with the Commission

  



 


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6.08                           On
sales of Licensed Products by Licensee to sublicensees or on sales made in other than an
arm’s-length transaction, the value of the Net Sales
attributed under this Article 6 to such a transaction shall be that which
would have been received in an arm’s-length transaction, based on sales of like
quantity and quality products on or about the time of such transaction.


 


6.09                           With
regard to expenses associated with the preparation, filing, prosecution, and
maintenance of all patent applications and patents included within the Licensed Patent Rights incurred by PHS prior to the effective date of this Agreement, Licensee shall pay to PHS
[*] (which is [*] of total patent cost in Appendix A), as an additional
royalty, within thirty (30) days from the date that this Agreement becomes effective. In addition, Licensee shall pay to PHS another [*] within thirty (30) days
from the date that an NDA has been filed. 


 


6.10                           With
regard to expenses associated with the preparation, filing, prosecution, and
maintenance of all patent applications and patents included within the Licensed Patent Rights incurred by PHS
on or after the effective date of this Agreement, PHS, at its sole option, may require Licensee:


 


(a) To
pay PHS on an annual basis, within sixty
(60) days of PHS’s submission of a statement
and request for payment, a royalty amount equivalent to all such patent
expenses incurred during the previous calendar year(s) for the Licensed Patent Rights corresponding to those listed in
Appendix A, divided equally among all commercialization licensees of the Licensed Patent Rights corresponding to those listed in
Appendix A, as applicable, that are on record as of the date on which the
statement and request for payment are sent by PHS to
Licensee, and limited specifically to
those commercialization license(s) under which licensee(s) are responsible for
paying a share of patent expenses, and specifically excluding any license(s)
which are for internal research use and/or for research reagent sales; or


 


(b) To
pay such expenses directly to the law firm employed by PHS
to handle such functions.  However, in
such event, PHS and not Licensee
shall be the client of such law firm.


 


In no
instance shall the amount due from Licensee
be more than [*] as patent cost payment per year.


 


Under
exceptional circumstances, Licensee may be
given the right to assume responsibility for the preparation, filing,
prosecution, or maintenance of any patent application or patent included with
the Licensed Patent Rights.  In that event, Licensee
shall directly pay the attorneys or agents engaged to prepare, file, prosecute,
or maintain such patent applications or patents and shall provide to PHS copies of each invoice associated with such services as
well as documentation that such invoices have been paid.


 


6.11                           In
the event that PHS provides exclusive or
nonexclusive commercialization licenses to more than two (2) licensees
under the Licensed Patent Rights corresponding to
any specific patents and/or patent applications to any additional licensee(s),
limited specifically to those commercialization license(s) under which
licensee(s) are responsible for paying a share of patent expenses, and
specifically excluding any license(s) which are for internal research use
and/or for research reagent sales, Licensee shall
receive as a credit a proportional share of any and all patent expenses
previously paid or due by Licensee under
Paragraphs 6.09 and 6.10 of this Agreement for
those specific patents and/or patent applications, based upon a proportional
reallocation of patent expenses among all exclusive or nonexclusive
commercialization licensees as specified in this Paragraph 6.10.  PHS
will notify Licensee within ninety
(90) of grant of any additional licenses under the Licensed
Patent Rights, and the credit described in this Paragraph 6.11 shall
be applied against Licensee’s next invoice for its share of any current and/or future patent expenses payable
under Paragraphs 6.09 and 6.10, minimum annual royalties, and/or earned
royalties.


 


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6.12                           Licensee may elect to surrender its rights in any country of
the Licensed Territory under any Licensed Patent Rights upon ninety (90) days written notice
to PHS and owe no payment obligation under
Article 6.10 for patent-related expenses incurred in that country after
ninety (90) days of the effective date of such written notice.


 


7.                                       PATENT
FILING, PROSECUTION, AND MAINTENANCE


 


7.01                           PHS agrees to take responsibility for, but to consult with
the Licensee in the preparation, filing,
prosecution, and maintenance of any and all patent applications or patents
included in the Licensed Patent Rights and shall
furnish, upon execution of this Agreement and
on a continuous basis thereafter as long as the Agreement
is in effect, copies of relevant patent-related documents to Licensee, including all drafts of patent applications
filings, domestic and foreign, amendments thereto, related correspondence and
other related documents, sufficiently in advance to allow Licensee
to comment thereon prior to filing or submission and at least fourteen (14)
days in advance if possible.  During the
term of this Agreement, PHS
shall never allow other licensees to assume responsibility for the preparation,
filing prosecution and maintenance of the Licensed Patent Rights without consultation with and prior approval
of Licensee.


 


7.02                           Each
party shall promptly inform the other as to all matters that come to its
attention that may materially affect the preparation, filing, prosecution, or
maintenance of the Licensed Patent Rights
and PHS shall permit Licensee
to provide comments and suggestions with respect to the preparation, filing,
prosecution, and maintenance of Licensed Patent Rights
in both the United States and foreign countries, and PHS shall
consider all reasonable comments and suggestions of Licensee.


 


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 an annual inspection at
the expense of PHS by an
accountant or other designated auditor selected by PHS and reasonably acceptable to Licensee for the sole purpose of verifying reports and
payments hereunder.  The accountant or
auditor shall execute a reasonable confidentiality agreement with Licensee and 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 9.08 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.  If the
inspection shows an overpayment by Licensee,
then Licensee will credit the
overpayment to future royalty payments. 
However in no event shall royalties paid PHS be less than the minimum annual royalty.


 


8.02                           Licensee agrees to have an audit of Net Sales and royalties conducted by an
independent auditor at least every two (2) years if annual royalty-bearing
sales of the Licensed Product or Licensed Processes performed for third
parties are over [*].  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.  PHS
shall pay for the entire cost of the audit. 
If an inspection shows an underreporting or underpayment in excess of [*]
for any 12 month period, then Licensee
shall reimburse PHS for cost of the
audit at


 










	
   

  	
  [*]         designates
  portions of this document that have been omitted pursuant to a request for
  confidential treatment filed seperately with the Commission

  



 


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the
time Licensee pays the unreported royalties, including late charges as required
by Paragraph 9.08 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.  If the
inspection shows an overpayment by Licensee,
then Licensee will credit the
overpayment to future royalty payments, however in no event shall royalties
paid PHS be less than the minimum
annual royalty.


 


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 have
been determined and set forth 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 the Licensed Field of Use
within ninety (90) 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, sublicensing, 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 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 as defined
in 37 CFR 404.3(d).  Licensee
shall amend the Commercial Development Plan and Benchmarks at the request of PHS
to address any Licensed Field of Use not
specifically addressed in the plan originally submitted.


 


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                           Commencing
with the First Commercial Sale by Licensee or a sublicensee, Licensee shall submit to PHS
within ninety (90) days after each calendar half-year ending June 30 and December 31
a royalty report setting forth for the preceding half-year period the amount of
the Licensed Products sold or Licensed Processes practiced by or on behalf of Licensee in each country within the Licensed
Territory, the Net Sales, if
any, and payments from sublicensees on which a royalty payment is owed to PHS, if any, and the amount of royalty
accordingly due.  With each such royalty
report, Licensee shall submit payment of the
earned royalties due.  If no earned
royalties are due to PHS for any
reporting period, the written report shall so state.  The royalty report shall be certified as
correct by an authorized officer of Licensee and
shall include a detailed listing of all deductions made under Paragraph 2.10 to
determine Net Sales made under Article 6 to
determine royalties due.


 


9.05                           Licensee agrees to forward semi-annually to PHS a copy of such reports received by Licensee
from its sublicensees during the preceding half-year period as shall be
pertinent to a royalty accounting to PHS by Licensee for activities under the sublicense.


 


9





















 


9.06                           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, P.O. Box 360120, Pittsburgh, PA
15251-6120.   Any loss of exchange,
value, taxes, or other expenses incurred in the transfer or conversion to U.S.
dollars shall be borne or 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.


 


9.07                           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.


 


9.08                           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.


 


9.09                           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 commercially reasonable efforts to bring the Licensed
Products and Licensed Processes
to Practical Application.  “Commercially reasonable efforts” for the
purposes of this provision shall include adherence by Licensee
to the Commercial Development Plan at Appendix
F and performance of the Benchmarks at
Appendix E.  For purposes of this Article 10,
Licensee’s efforts shall be deemed to
include the efforts of its sublicensees.


 


10.02                     Upon the First
Commercial Sale, until the expiration of this Agreement,
Licensee shall use commercially
reasonable efforts to make Licensed Products
and Licensed Processes reasonably
accessible to the United States public. For the purposes of this Article 10,
Licensee’s efforts shall be deemed to
include the efforts of its sublicensees. 



 


11.                                 INFRINGEMENT
AND PATENT ENFORCEMENT


 


11.01                     PHS
and Licensee agree to notify each
other promptly of each infringement of the Licensed
Patent Rights in the Licensed
Field of Use; as well as any material facts which may affect the
validity, scope or enforceability of the Licensed
Patent Rights, in each case, of which either party becomes aware.


 


11.02                     Pursuant to this Agreement and the provisions of Chapter 29 of title 35,
United States Code, Licensee may,
not withstanding the existence of any other license grants by PHS under the Licensed Patent Rights:
a) bring suit in its own name, at its own expense, and on its own behalf for
infringement of the Licensed Patent Rights
in the Licensed Field of Use; b) in any such
suit, enjoin infringement and collect for its use, damages, profits, and awards
of whatever nature recoverable for such infringement; and c) settle any claim
or suit for infringement of the Licensed Patent Rights
provided, however, that PHS and
appropriate Government authorities shall have
the first right to take such actions at their own expense.  If Licensee
desires to initiate a suit for patent infringement, Licensee
shall notify PHS in writing.  If PHS does not
notify Licensee of its intent to pursue legal
action within ninety (90) days, Licensee will
be free to initiate suit.  PHS shall have a continuing right to intervene in such suit
at its own expense.  Licensee
shall take no


 


10





















 


action
to compel the Government either to initiate or
to join in any such suit for patent infringement.  However, in the event that Licensee is forced to take action in order
to maintain such suit, then any such action by Licensee shall not be considered to be a material breach of
this Agreement.  Should the Government
be made a party to any such suit by motion or any other action of Licensee, Licensee shall
reimburse the Government for any costs,
expenses, or fees which the Government
incurs as a result of such motion or other action, including any and all costs
incurred by the Government in opposing any such
motion or other action.  In all cases, Licensee agrees to keep PHS reasonably
apprised of the status and progress of any litigation.  Before Licensee
commences an infringement action, Licensee shall
notify PHS and give careful consideration to
the views of PHS and to any potential effects
of the litigation on the public health in deciding whether to bring suit.  PHS shall
advise all other licensees under the Licensed Patent Rights
of any litigation pursuant to this Paragraph and of Licensee’s
request that they join said litigation, at Licensee’s expense,
if necessary in order for the Licensee to
have standing to bring or to maintain such litigation. In the event that Licensee is not able to maintain a lawsuit
because the necessary parties do not participate, all royalty obligations under
this Agreement shall be reduced as described in Appendix C.


 


11.03                     In the event that a declaratory
judgment action alleging invalidity or non-infringement of any of the Licensed Patent Rights shall be brought against Licensee or raised by way of counterclaim or affirmative
defense in an infringement suit brought by Licensee under
Paragraph 11.02, pursuant to this Agreement and
the provisions of Chapter 29 of Title 35, United States Code or other statutes,
Licensee may, after consultation with
other exclusive licensees of Licensed Patent Rights:
a) defend the suit in its own name, at its own expense, and on its own behalf
for the Licensed Patent Rights; b) in any such
suit, ultimately to enjoin infringement and to collect for its use, damages,
profits, and awards of whatever nature recoverable for such infringement; and
c) settle any claim or suit for declaratory judgment involving the Licensed Patent Rights-provided, however, that PHS and appropriate Government
authorities shall have the first right to take such actions and shall have a
continuing right to intervene in such suit at their own expense.  If PHS does not
notify Licensee of its intent to respond to
the legal action within a reasonable time, Licensee will
be free to do so.  Licensee
shall take no action to compel the Government
either to initiate or to join in any such declaratory judgment action, however,
any such action by Licensee shall
not be considered to be a material breach of this Agreement.  Should the Government be made a party to any such suit by motion or any
other action of Licensee, Licensee
shall reimburse the Government for
any costs, expenses, or fees which the Government
incurs as a result of such motion or other action.  If Licensee elects
not to defend against such declaratory judgment action, PHS,
at its option, may do so at its own expense. 
In all cases, Licensee agrees
to keep PHS reasonably apprised of the status
and progress of any litigation.  Before Licensee commences an infringement action, Licensee shall notify PHS and give
careful consideration to the views of PHS and to any
potential effects of the litigation on the public health in deciding whether to
bring suit. PHS shall advise all other
licensees under the Licensed Patent Rights
of any litigation pursuant to this Paragraph and of Licensee’s
request that they join said litigation, at Licensee’s expense,
if necessary in order for the Licensee to
have standing to bring or to maintain such litigation.  Also, if PHS grants the
right to litigate under this Paragraph to any other licensee of Licensed Patent Rights, such license shall provide an
opportunity for Licensee to consult in advance
with PHS and such other licensee before suit
is brought and before any settlement is reached that might affect Licensee’s rights under this Agreement.



 


11.04                     In any action under Paragraphs
11.02 or 11.03, the expenses including costs, fees, attorney fees, and
disbursements, shall be paid by Licensee.  The value of any recovery made by Licensee through court judgment or settlement, after
deduction of said expenses, shall be treated as Net Sales
and subject to earned royalties.


 


11.05                     PHS
shall cooperate fully with Licensee in
connection with any action under Paragraphs 11.02 or 11.03.  PHS agrees
promptly to provide access to all necessary documents and to render reasonable
assistance in response to a request by Licensee.


 


11





















 


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.  However, PHS
represents that it has complied with the duty of disclosure at the U.S. Patent
and Trademark Office and that it is unaware of any facts or reasons why the Licensed Patent Rights would not be valid.


 


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 sublicensees, directors, employees, or third parties under contract to Licensee 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. Notwithstanding any
other provision to the contrary, Licensee
shall have no indemnification obligation in connection with or arising out
of:  (a) the use by or on behalf of
the indemnified parties identified above of any Licensed Product or Licensed
Process for experimental or research purposes, or (b) the
design, manufacture, distribution or use of any Licensed Product or Licensed
Process by or on behalf of such indemnified parties for experimental
or research purposes.


 


13.                                 TERM,
TERMINATION, AND MODIFICATION OF RIGHTS


 


13.01                     This Agreement
is effective when signed by all parties and shall extend on a country-by-country
basis to the expiration of the last to expire of the Licensed
Patent Rights in each country 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 of the commencement
of a bankruptcy proceeding by or against Licensee under
the Bankruptcy Code that is not dismissed within ninety (90) days after it is
filed, PHS may, at its option, terminate this Agreement.  In the
event of a bankruptcy of Licensee
(unless PHS has already terminated this Agreement), all rights to Licensed
Patent Rights granted to Licensee under
this Agreement to the extent same survive
prior to filing of such bankruptcy are, and shall be deemed to be, for purposes
of Section 365(n) of the United States Bankruptcy Code, as amended from
time to time (the “Bankruptcy code”), licenses of right to “intellectual
property” as defined under Section 101(35A) of the Bankruptcy Code.  The Parties agree that Licensee,
as a


 


12





















 


licensee
of such rights under this Agreement,
shall retain and may fully exercise all its rights and elections under the
Bankruptcy Code.


 


13.04                     Licensee
shall have a unilateral right to terminate this Agreement
and/or any licenses in any country or territory by giving PHS
sixty (60) days written notice to that effect.


 


13.05                     PHS
shall specifically have the right to terminate or modify, at its option, this Agreement, if PHS determines
that the Licensee: 1) is not executing the Commercial Development Plan submitted with its request for a
license and the Licensee cannot otherwise
demonstrate to PHS’s reasonable satisfaction that
the Licensee has taken, or can be expected
to take within a reasonable time, effective steps to achieve Practical Application of the Licensed
Products or Licensed Processes;
2) has not achieved the Benchmarks as
may be modified under Paragraph 9.02; 3) has willfully made a false statement
of, or willfully omitted, a material fact in the license application or in any
report required by the Agreement; 4)
has committed a material breach of a covenant or agreement contained in the Agreement; 5) is not keeping Licensed
Products or Licensed Processes
reasonably available to the public after commercial use commences; 6) cannot
reasonably satisfy unmet health and safety needs within the Licensed Field of Use or 7) cannot reasonably justify a
failure to comply with the domestic production requirement of Paragraph 5.02
unless waived.   In making this
determination, PHS will take into account the
normal course of such commercial development programs conducted with sound and
reasonable business practices and judgment and the annual reports submitted by Licensee under Paragraph 9.02.  Prior to invoking its rights under this
Paragraph 13.05 upon any of the triggers described in items 1) through 7)
above, PHS shall give written notice to Licensee providing Licensee
specific notice of, and a ninety (90) day opportunity to respond to, PHS’s concerns as to the previous items 1) through 7).  If Licensee fails
to alleviate PHS’s concerns as to the previous
items 1) through 7) during such 90-day period or fails to initiate corrective
action to PHS’s satisfaction during such 90-day
period, PHS may terminate this Agreement.


 


13.06                     When the public health and safety
so require, and after written notice to Licensee
providing Licensee a ninety (90) day opportunity
to respond, PHS shall have the right to
require Licensee to grant sublicenses to
responsible applicants, on reasonable terms, in the Licensed
Field of Use under the Licensed Patent Rights,
unless Licensee can reasonably demonstrate
that the granting of the sublicense would not materially increase the
availability to the public of the subject matter of the Licensed
Patent Rights.  PHS will not require the granting of a sublicense unless the
responsible applicant has first negotiated in good faith with Licensee. If Licensee is
required to grant sublicense(s) under this Paragraph 13.06, Licensee agrees to provide PHS
and said sublicensee(s) with all data, documents and materials generated or
produced by or on behalf of Licensee that
would be or could be used in regulatory filings with the Food and Drug
Administration (or foreign equivalent regulatory agency). Licensee
agrees that such data, documents and/or materials can be used by PHS or said sublicensee(s) to prepare regulatory filings
with the Food and Drug Administration (or equivalent foreign regulatory
agencies).  Licensee
may charge a fee to said sublicensee(s) that is equal to its direct costs only
(i.e., no overhead shall be compensated) for producing said data, documents and
materials that said sublicensee(s) actually use in their regulatory filings.


 


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


 


13.08                     Within thirty (30) days of receipt
of written notice of PHS’s
unilateral decision to modify or terminate this Agreement pursuant
to the express provisions in this Agreement, Licensee may, consistent with the provisions of 37 CFR
404.11, appeal the decision by written submission to the designated PHS official.  The
decision of the designated PHS official
shall be the final agency


 


13





















 


decision.  Licensee may
thereafter exercise any and all administrative or judicial remedies that may be
available.


 


13.09                     Within ninety (90) days of
expiration or termination of this Agreement under
this Article 13, a final report, as per Paragraphs 9.02, 9.04 and 9.05,
shall be submitted by Licensee.  Any royalty payments, including those
incurred but not yet paid (such as the full minimum annual royalty), and those
related to patent expense, due to PHS shall
become immediately due and payable upon termination or expiration.  If terminated under this Article 13,
sublicensees may elect to convert their sublicenses to direct licenses with PHS pursuant to Paragraph 4.03.  Unless otherwise specifically provided for
under this Agreement, upon termination or
expiration of this Agreement, Licensee shall return all Licensed
Products or other materials included within the Licensed
Patent Rights to PHS or provide PHS with certification of the destruction thereof.


 


13.10                     In the event Licensee
unilaterally terminates this Agreement under
Paragraph 13.04 or this Agreement is
terminated for cause by PHS under
Paragraphs 13.02, 13.03 or 13.05, Licensee agrees
to provide PHS with all data, documents and
materials generated or produced by or on behalf of Licensee
that would be or could be used in regulatory filings with the Food and Drug
Administration (or foreign equivalent regulatory agencies).  Licensee agrees
that such data, documents and/or materials can be used by PHS
or future third party licensee(s) of Licensed Patent Rights
to prepare regulatory filings with the Food and Drug Administration (or
equivalent foreign regulatory agencies). 


 


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 either
the Licensee or 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 either the Licensee
or the Government or excuse a similar
subsequent failure to perform any such term or condition by either party.


 


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 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.  


 


14





















 


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; b) as part of a sale or transfer
of substantially the entire business of Licensee
relating to operations which concern this Agreement; or
c) in connection with a merger, consolidation or reorganization.  Licensee shall
notify PHS within ten (10) days of any
assignment of this Agreement by Licensee.


 


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 mark 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 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. Licensee may
publicly identify the existence of this Agreement and
is not prohibited from using publicly available factual information regarding Licensed Patent Rights, Licensed Products,
and Licensed Processes, specifically
including, but not limited to, the names of the inventors as appearing on the Licensed Patent Rights and their associated NIH institutes,
without such consent. 


 


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 4.03, 8.01, 9.05-9.07,
12.01-12.05, 13.08, 13.09, and 14.12 of this Agreement
shall survive termination of this Agreement.


 


15





















 


SIGNATURES BEGIN ON NEXT PAGE


 


16





















 


PHS PATENT LICENSE AGREEMENT—EXCLUSIVE


 


SIGNATURE PAGE


 


For PHS:


 


	
   

  	
   

  	
   

  	
   

  
	
  Steven M.
  Ferguson, M.B.A.

  	
  Date

  



Acting 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


6011 Executive Boulevard,
Suite 325


Rockville, Maryland  20852-3804 
U.S.A.


 


 


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:


 


	
   

  	
   

  	
   

  	
   

  
	
  Signature of Authorized
  Official

  	
  Date

  



 


Anne-Marie Corner


Printed Name 


 


President and CEO


Title 


 


Official and Mailing
Address for Notices:


 


CEO


Biosyn, Inc.


1800 Byberry Road,
Building 13


Huntingdon Valley, PA 19006-3525


 


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).


 


17





















 










	
   

  	
  [*]         designates
  portions of this document that have been omitted pursuant to a request for
  confidential treatment filed seperately with the Commission

  



 


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


 


Patent(s)
or Patent Application(s):


 


1. U.S. Patent No. 5,843,882,
filed April 27, 1995 from USSN 08/429,965, issued December 1, 1998,
entitled: “Antiviral Proteins and Peptides, DNA, DNA-coding Sequences Therefor,
and Uses Thereof” (Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert H.
Shoemaker and James B. McMahon) (E-117-95/0)


 


2. U.S. Patent No. 5,821,
081, filed April 26, 1996 from USSN 08/638,610, issued October 13,
1998, entitled: “Nucleic Acids Encoding Antiviral Proteins and Peptides,
Vectors and Host Cells Comprising Same, and Methods of Producing the Antiviral
Proteins and Peptides” (Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert
H. Shoemaker and James B. McMahon) (E-117-95/1)


 


3. U.S. Patent No. 5,962,653,
filed Nov. 13, 1997, issued Oct. 05, 1999, from SN 08/969,584 (DIV of
SN 08/429,965 E-117-95/0), entitled: “Methods of Obtaining Antiviral Proteins
and Antiviral Peptides from Nostoc Ellipsosporum” (Inventors: Michael R. Boyd
and Kirk R. Gustafson) (E-117-95/2)


 


4. U.S. Patent No. 6,015,876,
filed November 13, 1997 from USSN 08/969,378, issued January 18,
2000, entitled: “Method of Using Cyanovirins” (Inventor: Michael R. Boyd) (E-117-95/3)


 


5. U.S. Patent No. 5,962,668,
filed Nov. 13, 1997, issued Oct. 05, 1999, from SN 08/970,179 (DIV of
SN 08/638,610, E-117-95/1), entitled: “ Nucleic Acid Encoding Antiviral
Proteins and Peptides Fused to Effector Proteins” (Inventors: Michael R. Boyd
and Robert H. Shoemaker) (E-117-95/4)


 


[*]


 


7.  U.S. Patent No. 5,998,587, filed November 13,
1997 from USSN 08/969,249, issued December 7, 1999, entitled: “Anti-cyanovirin
Antibody “ (Inventors: Michael R. Boyd, Kirk R. Gustafson, Robert H. Shoemaker
and James B. McMahon) (E-117-95/6)


 


8. U. S. Patent No. 6,245,737,
filed Aug. 19, 1998, issued Jun. 12, 2001,from SN 09/137,134 (CON of
SN 08/429,965, E-117-95/0), entitled: “ Conjugates of Antiviral Proteins or
Peptides and Virus or Viral Envelope Glycoportiens” (Inventors: Michael R.
Boyd, Kirk R. Gustafson, Robert H. Shoemaker and James B. McMahon) (E-117-95/7)


 


[*]


 


10.  U.S. Patent No. 6,428,790, filed October 12,
1999, entitled: “Cyanovirin Conjugates and Matrix-Anchored Cyanovirin and
Related Compositions and Methods of Use” (Inventor: Michael R. Boyd) (E-074-99/1)


 


[*]


 


12.  U.S. Patent Application 09/427,873, filed October 27,
1999, entitled: “Methods of Using Cyanovirins to Inhibit Viral Infection”
(Inventor: Michael R. Boyd) (E-074-99/3)


 


[*]


 


14.   U.S. Patent Application 09/815,079, filed March 22,
2001, entitled: “Glycosylation-Resistant Cyanovirins and Related Conjugates,
Compositions, Nucleic Acids, Vectors, Host Cells, Methods of Production and
methods of Using Nonglycosylated Cyanovirins” (Inventor: Michael R. Boyd) (E-074-99/7)


 


18





















 


APPENDIX B—Licensed Field of Use and Territory


 


 


Licensed
Fields of Use:  


 


Compositions, devices and methods for the prevention of
infection by HIV and other sexually transmitted pathogens, by topical, but not
systemic, administration, utilizing cyanovirin-N, anti-HIV mutants of
cyanovirin-N, including glycosylation-resistant mutants of cyanovirin-N, and
anti-HIV fragments of both, including conjugated forms of cyanovirin-N, mutants
of cyanovirin-N, and anti-HIV fragments of both, to increase the in vivo
half-life, but excluding pegylated cyanovirin-N, pegylated mutants of
cyanovirin-N, and pegylated anti-HIV fragments of both.  For the avoidance of doubt, such compositions
shall include sustained release formulations; devices shall include all drug
delivery systems, including but not limited to condoms, sponges, vaginal rings,
suppositories, IUDs and other solid matrices; and topical administration shall
include administration to mucosal membranes, including vaginal, anal and oral
membranes.


 


 


Licensed
Territory:


 


Worldwide


 


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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 nonrefundable minimum annual royalty in the amounts as follows: [*], starting
[*]; [*] starting [*] and [*] starting [*], after [*].


 


Licensee
agrees to pay PHS
earned royalties on Net Sales by
or on behalf of Licensee as
follows:  


 


1.     [*]:


 


[*]


 


[*]


 


[*]


 


2.    [*]


 


[*]


 


[*]


 


[*]


 


3.     [*]


 


[*]


 


[*] 


 


4.     [*]


 


[*]


 


[*] 


 


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Licensee
agrees to pay PHS the following
one-time only benchmark royalties:


 


1. [*]
payable within sixty (60) days of [*].


 


2. [*]
payable within sixty (60) days [*]. 


 


3. [*]
payable within ninety (90) days after [*] 


 


4. [*]
payable within ninety (90) days after [*].


 


Licensee
agrees to pay PHS sublicensing
royalties, within ninety (90) days of receipt by Licensee, as follows:


 


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1.                                       Licensee agrees to pay PHS earned royalties on Net Sales by sublicensee(s):


 


a)     [*]


 


[*]


 


[*]


 


[*]


 


b)    [*]


 


[*]


 


[*]


 


[*]


 


[*]


 


2.                                       Licensee agrees to pay PHS additional sublicensing royalties as
follows:


 


[*]


 


APPENDIX
D—Modifications


 


 


Modifications are
included in the main text of this License
Agreement.


 


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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.


 


1. [*]


 


2. [*]


 


3. [*]


 


4. [*]


 


5. [*]


 


6.
Developing World Access


 


It is Licensee’s intent to provide Licensed
Product(s) to the Public Sector
in the quantity desired by the


Public
Sector and at the price described below.  License
therefore agrees:


 


a) To
provide a written report to PHS, within six
months of a Licensed Product being approved
for marketing in the U.S. or Europe detailing the potential Public Sector requirement for Licensed
Product(s) to fulfill the public health need in Developing
Countries, said report shall include the effect of any approved
competing products being offered to the Public Sector.
The report shall describe how Licensee
intends to fulfill said Public Sector
requirement for Licensed Product(s).  A similar report shall be required
within six months of marketing approval of the [*] of Licensed
Product(s).  Licensee shall
amend the Commercial Development Plan and this
Benchmarks and Performance Appendix as appropriate.  


 


b) The
price at which each Licensed Product is
sold to the Public Sector shall be i)
preferential to the lowest Private Sector
price, and ii) set at the lowest possible level permitting a commercially
reasonable return on worldwide sales of each said Licensed
Product.


 


c) A Licensed Product shall be sold to the Public
Sector within two years of marketing approval of said Licensed Product in the U.S. or Europe, and thereafter Licensee agrees to use commercially reasonable efforts to
meet any delivery date and in the quantities required in any order placed for Licensed Product(s) placed by the Public
Sector.


 


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APPENDIX
F—Commercial Development Plan


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 










	
   

  	
  [*]         designates
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  confidential treatment filed seperately with the Commission

  



 


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[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


[*]


[*]


[*]


[*]


[*]


 


[*]


 


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


[*]


 


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  confidential treatment filed separately with the Commission.

  
	
   

  	
   

  
	
  [*]

  	
   

  



 


 


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APPENDIX G—Developing Countries


 


The
list of developing countries as the following:


 


	
  1 Afghanistan

  
	
  2 Albania

  
	
  3 Angola

  
	
  4 Armenia

  
	
  5 Azerbaijan

  
	
  6 Bahamas

  
	
  7 Belize

  
	
  8 Bangladesh

  
	
  9 Barbados

  
	
  10 Benin

  
	
  11 Bhutan

  
	
  12 Bolivia

  
	
  13 Bosnia & Herzegov

  
	
  14 Botswana

  
	
  15 Burkina Faso

  
	
  16 Burundi

  
	
  17 Cambodia

  
	
  18 Cameroon

  
	
  19 Central Afr Rep

  
	
  20 Chad

  
	
  21 China

  
	
  22 Comoros

  
	
  23 Congo, Dem Rep

  
	
  24 Congo, Rep

  
	
  25 Côte d’Ivoire

  
	
  26 Cuba

  
	
  27 Dominican Republic

  
	
  28 Djibouti

  
	
  29 Eritrea

  
	
  30 Ethiopia

  
	
  31 Gambia

  
	
  32 Georgia

  
	
  33 Ghana

  
	
  34 Guinea

  
	
  35 Guinea-Bissau

  
	
  36 Guatemala

  
	
  37 Guyana

  
	
  38 Haiti

  
	
  39 Honduras

  
	
  40 India

  
	
  41 Indonesia

  
	
  42 Kenya

  
	
  43 Korea, DPR

  
	
  44 Kyrgyz Republic

  
	
  45 Lao PDR

  
	
  46 Lesotho

  
	
  47 Liberia

  
	
  48 Madagascar

  
	
  49 Malawi

  



 


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  50 Mali

  
	
  51 Mauritania

  
	
  52 Moldova

  
	
  53 Mongolia

  
	
  54 Mozambique

  
	
  55 Myanmar

  
	
  56 Namibia

  
	
  57 Nepal

  
	
  58 Nicaragua

  
	
  59 Niger

  
	
  60 Nigeria

  
	
  61 Pakistan

  
	
  62 Panama

  
	
  63 Papua New Guinea

  
	
  64 Rwanda

  
	
  65 São Thomé

  
	
  66 Senegal

  
	
  67 Sierra Leone

  
	
  68 Solomon Islands

  
	
  69 Somalia

  
	
  70 South Africa

  
	
  71 Sri Lanka

  
	
  72 Sudan

  
	
  73 Suriname

  
	
  74 Swaziland

  
	
  75 Thailand

  
	
  76 Tajikistan

  
	
  77 Tanzania

  
	
  78 Togo

  
	
  79 Trinidad

  
	
  80 Tobago

  
	
  81 Turkmenistan

  
	
  82 Ukraine

  
	
  83 Uganda

  
	
  84 Uzbekistan

  
	
  85 Vietnam

  
	
  86 Yemen

  
	
  87 Zambia

  
	
  88 Zimbabwe

  



 


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