EXHIBIT 10.1

 

 

Patent and Biological Materials License Agreement with the

National Institute of Allergy and Infectious Diseases, dated October 22, 2020

 

 

 

Certain information as identified herein has been omitted from this exhibit
because it is

both (i) not material and (ii) would be competitively harmful if publicly
disclosed.

 

 

 

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PUBLIC HEALTH SERVICE

 

PATENT LICENSE AGREEMENT NONEXCLUSIVE

 

and

 

BIOLOGICAL MATERIALS LICENSE AGREEMENT

 

This Agreement is based on the model Patent License Non-Exclusive Agreement
adopted by the U.S. Public Health Service (“PHS”) Technology Transfer Policy
Board for use by components of the National Institutes of Health (“NIH”), the
Centers for Disease Control and Prevention (“CDC”), and the Food and Drug
Administration (“FDA”), which are agencies of the PHS within the Department of
Health and Human Services (“HHS”).

 

 

This Cover Page identifies the Parties to this Agreement:

 

 

The U.S. Department of Health and Human Services, as represented by

 

National Institute of Allergy and Infectious Diseases an Institute or Center
(hereinafter referred to as the “IC”) of the

 

NIH

 

 

and

 

 

GeoVax, Inc.,

 

hereinafter referred to as the “Licensee”,

 

having offices at

 

1900 Lake Park Dr., Ste. 380

 

Smyrna, Georgia 30080 

 

created and operating under the laws of Georgia, United States.

 

Tax ID No.: 58-2646816

 

 

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For the IC’s internal use only:

 

License Number: L-257-2020-0

 

License Application Number: A-409-2020

 

Serial Number(s) of Licensed Patent(s) or Patent Application(s): see Appendix A

 

 

Licensee: GeoVax, Inc.

 

 

Cooperative Research and Development Agreement (CRADA) Number (if a subject
invention): N/A

 

 

Additional Remarks: n/a

 

 

 

Public Benefit(s): Preventive Modified Vaccinia Ankara Virus-Virus Like Particle
(MVA-VLP) vaccine primes and/or boosters against -“SARS-CoV-2.”.

 

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) or Patent Application(s)), Appendix B (tangible materials,
Licensed Fields of Use and Licensed Territory), Appendix C (Royalties), Appendix
D ((Benchmarks and Performance), Appendix E (Commercial Development Plan),
Appendix F (Royalty Reporting), and Appendix G (Royalty Payment Options).

 

 

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The IC and the Licensee agree as follows:

 

1.

BACKGROUND

 

 

1.1

In the course of conducting biomedical and behavioral research, the IC
investigators made inventions, including intellectual properties and tangible
materials, that may have commercial applicability.

 

 

1.2

By assignment of rights from the IC employees and other inventors, HHS, on
behalf of the Government, owns intellectual property rights claimed in any
United States or foreign patent applications or patents corresponding to the
assigned inventions. HHS also owns any tangible embodiments of these inventions
actually reduced to practice by the IC, regardless of whether patents or patent
applications claiming the Materials exist.

 

 

1.3

The Secretary of HHS has delegated to the IC the authority to enter into this
Agreement for the licensing of rights to these inventions under 35 U.S.C.
§§200-212, the Federal Technology Transfer Act of 1986, 15 U.S.C. §3710(a), and
the regulations governing the licensing of Government-owned inventions, 37 CFR
Part 404.

 

 

1.4

The IC 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.

 

 

1.5

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

 

2.

DEFINITIONS

 

 

2.1

“Affiliate(s)” means any corporation or other business entity in which Licensee
owns or controls, directly or indirectly, at least fifty percent (50%) of the
voting rights or other ownership interest or is entitled to elect more than
fifty percent (50%) of directors. In any country where the local law does not
permit foreign equity participation of at least fifty percent (50%), then
“Affiliate” means any company in which Licensee owns or controls, directly or
indirectly, the maximum percentage of outstanding stock or voting rights that is
permitted by local law.

 

 

2.2

“Benchmarks” mean the performance milestones that are set forth in Appendix D.

 

 

2.3

“Commercial Development Plan” means the written commercialization plan attached
as Appendix E.

 

 

2.4

“First Commercial Sale” means the initial transfer by or on behalf of the
Licensee of Licensed Products or the initial practice of a Licensed Process by
or on behalf of the Licensee in exchange for cash or some equivalent to which
value can be assigned for the purpose of determining Net Sales.

 

 

2.5

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

 

 

2.6

“Licensed Fields of Use” means the fields of use identified in Appendix B.

 

 

2.7

“Licensed Patent Rights” shall mean:

 

 

(a)

Patent applications (including provisional patent applications and PCT patent
applications) or patents listed in Appendix A, all divisions and continuations
of these applications, all patents issuing from these applications, divisions,
and continuations, and any reissues, reexaminations, and extensions of all these
patents;

 

 

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(b)

to the extent that the following contain one or more claims directed to the
invention or inventions disclosed in 2.7(a):

 

 

(i)

continuations-in-part of 2.7(a);

 

 

(ii)

all divisions and continuations of these continuations-in-part;

 

 

(iii)

all patents issuing from these continuations-in-part, divisions, and
continuations;

 

 

(iv)

priority patent application(s) of 2.7(a); and

 

 

(v)

any reissues, reexaminations, and extensions of all these patents;

 

 

(c)

to the extent that the following contain one or more claims directed to the
invention or inventions disclosed in 2.7(a): all counterpart foreign and U.S.
patent applications and patents to 2.7(a) and 2.7(b), including those listed in
Appendix A; and

 

 

(d)

Licensed Patent Rights shall not include 2.7(b) or 2.7(c) to the extent that
they contain one or more claims directed to new matter which is not the subject
matter disclosed in 2.7(a).

 

 

2.8

“Licensed Processes” 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.

 

 

2.9

“Licensed Products” 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. For the sake of clarity, vaccine primes and/or boosters
incorporating Materials (or functional components of such) described in Appendix
B are considered Licensed Products.

 

 

2.10

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

 

 

2.11

“Materials” means

 

 

(a)

tangible materials, identified in Appendix B, including progeny, subclones,
unmodified derivatives, fractions, or components isolated therefrom, whether or
not within the scope of the claims of the Licensed Patent Rights;

 

 

(b)

other 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;

 

 

(c)

modifications created by Licensee that contain or incorporate any of the
tangible materials identified in Paragraph 2.11(a) and 2.11(b) above.

 

 

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2.12

“Net Sales” means the total gross amounts invoiced or otherwise charged (whether
consisting of cash or any other form of consideration) for the Final Sale of
Licensed Products to Customers by or on behalf of the Licensee or any Affiliate,
less the following deductions (to the extent included in and not already
deducted from the gross amount invoiced or otherwise charged) to the extent
reasonable and customary and if separately invoiced: (a) wholesaler or trade
quantity discounts actually granted to Customers; and (b) credits to Customers
because of rejections or returns (specifically excluding any allowances for bad
debt). Without prior approval of IC, total deductions for the calculation of Net
Sales shall not exceed four (4) percent of the total gross amounts invoiced or
otherwise charged. Where Licensee or any Affiliate is the Customer, the Net
Sales shall be based on the gross amount normally invoiced or otherwise charged
to other Customers in an arms-length transaction for such Licensed Products. For
the avoidance of doubt, if Licensee or any Affiliate supplies (directly or
indirectly) a product that constitutes of Licensed Product to any Affiliate, and
such Affiliate includes such product in another product, then Net Sales shall be
based on the total gross amount invoiced or otherwise charged for such other
product in its entirety. No deductions shall be made for commissions paid to
individuals, whether they are with independent sales agencies or regularly
employed by the Licensee, or any Affiliate and on its payroll, or for the cost
of collections.

 

 

2.13

“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 these 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.

 

 

2.14

“Customer” means any individual or entity that receives Licensed Product(s),
provided however, that Licensee, or any Affiliate shall be deemed a Customer
only if it receives Licensed Product(s) for its own end-use and not resale.

 

 

2.15

“Effective Date” means the first date when both IC and Licensee have signed this
Agreement.

 

 

2.16

“Fair Value” means the price that would be received to sell an asset or paid to
transfer a liability in an orderly transaction between market participants at
the measurement date; for the calculation of assignment royalty, the measurement
date for Fair Value shall be the date when all parties to the assignment have
signed the assignment.

 

 

2.17

“Final Sale” means any sale, transfer, lease, exchange or other disposition or
provision of a Licensed Product to a Customer. A Final Sale shall be deemed to
have occurred upon the earliest to occur of the following (as applicable): (a)
the transfer of title to such Licensed Product to a Customer; (b) the shipment
of such Licensed Product to a Customer; (c) the provision of an invoice for such
License Product to a Customer; or (d) payment by the Customer for Licensed
Product(s).

 

 

2.18

“First Commercial Sale” means the initial transfer by or on behalf of the
Licensee of Licensed Products by or on behalf of the Licensee in exchange for
cash or some equivalent to which value can be assigned for the purpose of
determining Net Sales.

 

 

2.19

“Third Party” or “Third Parties” means a party or parties other than IC, on the
one hand, or Licensee or its Affiliate(s), on the other hand.

 

 

2.20

“Average Price” means, on a Licensed Product-by-Licensed Product and
country-by-country basis, the total gross sales of a particular Licensed Product
in a particular country during a particular calendar year divided by the total
doses of such Licensed Product sold in such country during such calendar year.

 

 

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2.21

“Valid Claim” means a claim of an issued and unexpired patent that is in force
included within the Licensed Patent Rights which has not been revoked or held
unenforceable or invalid by a decision of a court or other governmental agency
of competent jurisdiction (which decision is not appealable or has not been
appealed within the time allowed for appeal), and which claim has not been
disclaimed, denied or admitted to be invalid or unenforceable through reissue,
re-examination or disclaimer or otherwise.

 

 

2.22

“Pro Rata Share” means one of the following:

 

 

(a)

in instances where the Additional Coronavirus-Spike License(s) granted by NIAID
recover a predetermined percentage of patent costs, Pro Rata Share will mean one
hundred percent (100%) of patent prosecution costs minus the percentage of
patent prosecution costs recovered by the Additional Coronavirus-Spike
License(s) which recover a pre-determined percentage of patent costs. For
example, if NIAID has granted an Additional Coronavirus-Spike License which
recovers twenty percent (20%) of patent prosecution costs, then the Pro Rata
Share would be one hundred percent (100%) minus twenty percent (20%), or eighty
percent (80%);

 

 

(b)

in instances where the Additional Coronavirus-Spike License(s) granted by NIAID
recover a full Pro Rata Share of patent prosecution costs, Pro Rata Share will
mean one (1) minus the value derived from the number of Additional
Coronavirus-Spike License(s) granted by NIAID which recover a full Pro Rata
Share of patent prosecution costs divided by the total number of licenses
granted by NIAID which recover a full Pro Rata Share of patent prosecution
costs. For example, if NIAID has granted four (4) Additional Coronavirus-Spike
Licenses which recover a full Pro Rata Share of patent prosecution costs, then
the Pro Rata Share would be, one (1) minus [four (4) divided by five (5)], or
one fifth (1/5); or

 

 

(c)

instances where the Additional Coronavirus-Spike License(s) are granted
according to the definition of both 2.22a) and 2.22(b), the Pro Rata Share paid
by Licensee will be the value derived from the Pro Rata Share as determined
under paragraph 2.22(a) multiplied by the value derived from the Pro Rata Share
as determined under paragraph 2.22(b). For example, if two (2) Additional
Coronavirus-Spike Licenses are granted wherein one (1) Additional
Coronavirus-Spike License recovers twenty percent (20%) of patent prosecution
costs and one (1) Additional Coronavirus-Spike License recovers a full Pro Rata
Share of patent prosecution costs, the Pro Rata Share would be (one hundred
percent (100%) minus twenty percent (20%)) multiplied by (one (1) minus (one (1)
divided by two (2)), or eighty percent (80%) multiplied by one-half (1/2),
equaling forty percent (40%).

 

 

2.23

“Additional Coronavirus-Spike License” means an exclusive or nonexclusive
license that includes the Licensed Patent Rights associated with the E-234-2016
and E-086-2020 technologies as described in Appendix A of this Agreement (the
“Coronavirus-Spike Rights”) and is granted to a Third Party who is responsible
for paying a share of patent expenses, and wherein the exclusive or nonexclusive
license has a Licensed Field of Use directed to therapeutic applications.
Additional Coronavirus-Spike License specifically excludes license directed
solely to evaluation, internal research use or commercialization of research
agents.

 

 

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3.

GRANT OF RIGHTS

 

 

3.1

The IC hereby grants and the 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. For the sake of clarity, the Licensee has no
right to sell, transfer or otherwise distribute Materials that are not
incorporated as a component of a vaccine prime and/or booster Licensed Product
in combination with Licensee’s proprietary technology.

 

 

3.2

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

 

 

3.3

Materials have been previously provided to Licensee under transfers separate
from this Agreement. Upon request, and upon 1) receipt by IC of the license
issue royalty and the pro-rated first year minimum annual royalty, 2)
verification of these royalty payments, and 3) confirmation of Licensee’s
shipping carrier and account number to be used for shipping purposes, IC agrees
to replace these Materials, as available, at reasonable cost, in the event of
the unintentional destruction of such Materials. IC shall provide any such
Materials to Licensee at Licensee’s expense.

 

4.

SUBLICENSING

 

 

4.1

The Licensee has no right to sublicense.

 

5.

STATUTORY AND NIH REQUIREMENTS AND RESERVED GOVERNMENT RIGHTS

 

 

5.1

Prior to the First Commercial Sale, the Licensee agrees to provide the IC with
reasonable quantities of Licensed Products or materials made through the
Licensed Processes for the IC’s research use.

 

 

5.2

The 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 the IC.

 

6.

ROYALTIES AND REIMBURSEMENT

 

 

6.1

The Licensee agrees to pay the IC a noncreditable, nonrefundable license issue
royalty as set forth in Appendix C.

 

 

6.2

The Licensee agrees to pay the IC a minimum annual royalty as set forth in
Appendix C.

 

 

6.3

The Licensee agrees to pay the IC earned royalties as set forth in Appendix C.

 

 

6.4

The Licensee agrees to pay the IC Benchmark royalties as set forth in Appendix
C.

 

 

6.5

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 patent has been held to be invalid or unenforceable by an unappealed or
unappealable decision of a court of competent jurisdiction or administrative
agency.

 

 

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6.6

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

 

 

6.7

With regard to unreimbursed expenses associated with the preparation, filing,
prosecution, and maintenance of all patent applications and patents included
within the Licensed Patent Rights and paid by the IC prior to the effective date
of this Agreement, the Licensee shall pay the IC, as additional royalties,
within sixty (60) calendar days of the IC’s submission of a statement and
request for payment to the Licensee, an amount of royalties as set forth in
Appendix C of this Agreement.

 

 

6.8

The IC agrees, upon written request, to provide the Licensee with summaries of
patent prosecution invoices for which the IC has requested payment from the
Licensee under Paragraph 6.7. The Licensee agrees that all information provided
by the IC related to patent prosecution costs shall be treated as confidential
commercial information and shall not be released to a third party except as
required by law or a court of competent jurisdiction.

 

 

6.9

The Licensee may elect to surrender its rights in any country of the Licensed
Territory under any of the Licensed Patent Rights upon sixty (60) days written
notice to the IC and owe no payment obligation under Paragraph 6.7 for
patent-related expenses paid in that country after the effective date of the
written notice.

 

 

6.10

NO ROYALTIES SHALL BE PAID WITH FUNDS STEMMING FROM ANY FEDERAL CONTRACT, GRANT,
OR COOPERATIVE AGREEMENT.

 

7.

PATENT FILING, PROSECUTION, AND MAINTENANCE

 

 

7.1

The IC 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

 

 

8.1

The 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 to the IC. These
records shall be retained for the term of this Agreement and for at least five
(5) years from the last day of the final reporting period and shall be available
during normal business hours for inspection, at the expense of the IC, by an
accountant or other designated auditor selected by the IC for the sole purpose
of verifying reports and royalty payments hereunder.

 

 

8.2

If an inspection shows an underreporting or underpayment of royalties due to the
IC in excess of five percent (5%) for any twelve (12) month period, then the
Licensee shall reimburse the IC for the cost of the inspection at the time the
Licensee pays the unreported royalties, including any additional royalties as
required by Paragraph 9.6. All royalty payments required under this Paragraph
shall be due within sixty (60) calendar days of the date the IC provides notice
to the Licensee of the payment due.

 

 

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8.3

Licensee agrees to conduct, or to arrange and pay for the cost of, an
independent self-audit of sales and royalties at least every two (2) years if
annual sales of Licensed Product are over Five Million Dollars ($5,000,000). The
audit will address, at a minimum, the amount of gross sales by or on behalf of
Licensee or any Affiliate during the audit period, the amount of funds owed to
IC under this Agreement, and whether the amount owed has been paid to IC and is
reflected in the records of Licensee. Licensee will submit the auditor’s report
promptly to IC upon completion. Licensee will pay for the entire cost of the
audit.

 

9.

REPORTS ON PROGRESS, BENCHMARKS, SALES, AND PAYMENTS

 

 

9.1

Annual Reporting. Prior to signing this Agreement, the Licensee has provided the
IC with the Commercial Development Plan in Appendix E, under which the Licensee
intends to bring the subject matter of the Licensed Patent Rights and Materials
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 D.

 

 

(a)

The Licensee shall provide to IC written annual progress 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)
calendar days after December 31 of each calendar year. These progress reports
shall be signed by an officer of Licensee and shall include, but not be limited
to, at least the following topics:

 

 

(i)

summary of work completed;

 

 

(ii)

key scientific discoveries;

 

 

(iii)

summary of work in-progress on research and development, status of applications
for regulatory approvals, manufacture;

 

 

(iv)

current schedule of anticipated events or Benchmarks;

 

 

(v)

market plans for introduction of Licensed Product(s); and

 

 

(vi)

status of marketing, importing, and total Net Sales during the preceding
calendar year as well as, plans for the present calendar year.

 

 

(b)

The IC also encourages Licensee to include in progress reports information on
any of the Licensee’s public service activities that relate to the Licensed
Patent Rights and Licensed Products. If reported progress differs from that
projected in the Commercial Development Plan and Benchmarks, the Licensee shall
explain the reasons for such differences. Licensee agrees to provide any
additional information reasonably required by the IC to evaluate Licensee’s
performance under this Agreement.

 

 

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(c)

Commercial Development Plan Amendments. In any annual report, the Licensee may
propose amendments to the Commercial Development Plan and Benchmarks. The IC
shall not unreasonably withhold approval of any request of the Licensee to amend
the Commercial Development Plan or Benchmarks if Licensee’s request is supported
by a reasonable showing by the Licensee of diligence in its performance under
the Commercial Development Plan and toward bringing the Licensed Products to the
point of Practical Application. At IC’s discretion, amendments to change the
Commercial Development Plan or Benchmarks (or both) may include amendment
royalties. In determining whether or not to impose an amendment royalty, IC
shall consider in good faith any information provided by Licensee demonstrating
that a performance delay is due to inaction or delayed action by a regulatory
agency and not by inaction or intentional or avoidable action by Licensee.

 

 

9.2

The Licensee shall report to the IC the date of achievement of each Benchmark
specified in Appendix D and the First Commercial Sale in each country in the
Licensed Territory within thirty (30) calendar days of such occurrence.

 

 

9.3

Semi-annual Sales Reports. Following the date of the First Commercial Sale,
Licensee must submit to the IC, within sixty (60) calendar days after each
calendar half-year ending June 30 and December 31, a written sales report, as
described in the example in Appendix F, setting forth for the preceding
half-year period the amount of the Licensed Products sold by or on behalf of the
Licensee in each country within the Licensed Territory, the Net Sales, and the
amount of royalty accordingly due. With each sales report, the Licensee shall
submit payment of earned royalties due for that reporting period. If no earned
royalties are due to the IC for any reporting period, the written report shall
so state. The sales report shall be certified as correct by an authorized
officer of the Licensee and shall include the information identified in Appendix
F and shall make clear the following information:

 

 

(a)

gross receipts from Final Sales of Licensed Products for which an earned royalty
is payable under Paragraph 6.3;

 

 

(b)

any deductions from gross receipts used to arrive at Net Sales; and

 

 

(c)

Licensee’s computation of the aggregate earned royalties payable to IC. Licensee
agrees to provide a copy of sales report information in electronic spreadsheet
format (e.g., Microsoft Excel) when submitting sales reports by electronic mail.

 

 

9.4

Royalties due under Article 6 shall be paid in U.S. dollars and payment options
are listed in Appendix G. 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. Licensee shall pay any
loss of exchange, value, taxes, bank charge, or other expense incurred in the
transfer of or conversion to U.S. dollars. The royalty reports required by
Paragraph 9.3 shall be mailed to the IC at its address for Agreement Notices
indicated on the Signature Page.

 

 

9.5

The Licensee shall be solely responsible for determining if any tax on royalty
income is owed outside the United States and shall promptly pay this tax and be
responsible for all filings with appropriate agencies of foreign governments.
Licensee will use its best efforts to furnish IC with proof of payment of any
tax. IC shall cooperate in good faith with Licensee for the purposes of tax
obligations and filing of exemption and credit recovery paperwork.

 

 

9.6

For each royalty payment not received by IC when due, Licensee must pay to IC as
an additional royalty, if assessed by the IC, a compound interest charge of one
percent (1%) per month, to be calculated from the date payment was due until the
date payment is actually received by IC. The payment of any additional royalties
incurred under this Paragraph 9.6 shall not prevent the IC from exercising any
other rights it may have as a consequence of the lateness of any payment.

 

 

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9.7

All plans and reports required by this Article 9 and marked “confidential” by
the Licensee shall, to the extent permitted by law, be treated by the IC as
commercial and financial information obtained from a person and as privileged
and confidential, and any proposed disclosure of these records by the IC 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).

 

 

9.8

With each report submitted to IC under this Article 9, Licensee shall provide
the name, mailing address, telephone number and email address of Licensee’s
current Official for financial notices and for Agreement notices, if such
individual is not the person listed on the Signature Page.

 

10.

PERFORMANCE AND DILIGENCE OBLIGATIONS

 

 

10.1

The Licensee shall use its reasonable commercial efforts to bring the Licensed
Products and Licensed Processes to Practical Application. “Reasonable commercial
efforts” for the purposes of this provision shall include adherence to the
Commercial Development Plan in Appendix E and performance of the Benchmarks in
Appendix D.

 

 

10.2

The Licensee agrees, after its First Commercial Sale, to make reasonable
quantities of Licensed Products available to patient assistance programs in the
Licensed Territory, to the extent commercially reasonable and without otherwise
harming the business interests or viability of Licensee.

 

 

10.3

The Licensee agrees, after its First Commercial Sale and as part of its
marketing and product promotion, to develop educational materials (e.g.,
brochures, website, etc.) directed to patients and physicians detailing the
Licensed Products.

 

 

10.4

The Licensee agrees to supply, to the Office of Technology Transfer, NIH and
Technology Transfer and Intellectual Property Office (TTIPO), NIAID with inert
samples of the Licensed Products or Licensed Processes or their packaging for
educational and display purposes only.

 

11.

INFRINGEMENT AND PATENT ENFORCEMENT

 

 

11.1

The IC and the 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.

 

 

11.2

In the event that a declaratory judgment action alleging invalidity of any of
the Licensed Patent Rights shall be brought against the IC, the IC agrees to
notify the Licensee that an action alleging invalidity has been brought. The IC
agrees to discuss in good faith with the Licensee regarding defending any such
declaratory judgement action, and the cost of such defense, but for the sake of
clarity the IC does not represent that it shall commence legal action to defend
against a declaratory action alleging invalidity nor shall any discussion bind
the IC to commence legal action. The Licensee shall take no action to compel the
Government either to initiate or to join in any declaratory judgment action.
Should the Government be made a party to any suit by motion or any other action
of the Licensee, the Licensee shall reimburse the Government for any costs,
expenses, or fees, which the Government incurs as a result of the motion or
other action. Upon the Licensee's payment of all costs incurred by the
Government as a result of the Licensee's joinder motion or other action, these
actions by the Licensee shall not be considered a default in the performance of
any material obligation under this Agreement.

 

12.

NEGATION OF WARRANTIES AND INDEMNIFICATION

 

 

12.1

The IC offers no warranties other than those specified in Article 1.

 

 

--------------------------------------------------------------------------------

 

 

 

12.2

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

 

 

12.3

THE IC MAKES NO WARRANTIES, EXPRESSED OR IMPLIED, OF MERCHANTABILITY OR FITNESS
FOR A PARTICULAR PURPOSE OF ANY MATERIALS OR SUBJECT MATTER DEFINED BY THE
CLAIMS OF THE LICENSED PATENT RIGHTS OR TANGIBLE MATERIALS RELATED THERETO.

 

 

12.4

The IC does not represent that it shall commence legal actions against third
parties infringing the Licensed Patent Rights.

 

 

12.5

The Licensee shall indemnify and hold the IC, 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 the Licensee, any Affiliate(s), its directors,
employees, or third parties of any Licensed Patent Rights, Licensed Products or
Materials; or

 

 

(b)

the design, manufacture, distribution, or use of any Licensed Products, Licensed
Processes or Materials by the Licensee, or other products or processes developed
in connection with or arising out of the Licensed Patent Rights.

 

 

12.6

The Licensee agrees to maintain a liability insurance program consistent with
sound business practice.

 

13.

TERM, TERMINATION, AND MODIFICATION OF RIGHTS

 

 

13.1

This Agreement is effective when signed by all parties, unless the provisions of
Paragraph 14.14 are not fulfilled, and shall extend on a country-by-country
basis to the later of (a) twenty (20) years from the First Commercial Sale where
no Licensed Patent Rights exist or have ceased to exist, or (b) to the
expiration of the last to expire of the Licensed Patent Rights unless sooner
terminated as provided in this Article 13.

 

 

13.2

In the event that the Licensee (or its Affiliate(s)) is in default in the
performance of any material obligations under this Agreement, including but not
limited to the obligations listed in Paragraph 13.5, and if the default has not
been remedied within ninety (90) calendar days after the date of notice in
writing of the default, the IC may terminate this Agreement by written notice
and pursue outstanding royalties owed through procedures provided by the Federal
Debt Collection Act.

 

 

13.3

In the event that the Licensee becomes insolvent, files a petition in
bankruptcy, has such a 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, the Licensee shall immediately notify the IC
in writing.

 

 

13.4

The Licensee shall have a unilateral right to terminate this Agreement
completely or in any country of the Licensed Territory by giving the IC sixty
(60) days written notice to that effect.

 

 

13.5

The IC shall specifically have the unilateral right to terminate or modify, at
its option, this Agreement, if the IC determines that the Licensee (or its
Affiliate(s)):

 

 

--------------------------------------------------------------------------------

 

 

 

(a)

is not executing the Commercial Development Plan submitted with its request for
a license and the Licensee cannot otherwise demonstrate to the IC’s 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;

 

 

(b)

has not achieved the Benchmarks as may be modified under Paragraph 9.1;

 

 

(c)

has willfully made a false statement of, or willfully omitted, a material fact
in the license application, negotiation of this Agreement, or in any report
required by this Agreement;

 

has committed a material breach of a covenant or agreement contained in this
Agreement;

 

(d)

 

 

 

(e)

is not keeping Licensed Products or Licensed Processes reasonably available to
the public after commercial use commences;

 

 

(f)

cannot reasonably satisfy unmet health and safety needs;

 

 

(g)

cannot reasonably justify a failure to comply with the domestic production
requirement of Paragraph 5.2, unless waived;

 

 

(h)

has not provided timely annual progress or semi-annual royalty reports to IC
under Article 9; or

 

 

(i)

has not made timely royalty payments to IC under Article 6.

 

 

13.6

In making the determination referenced in Paragraph 13.5, the IC shall 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 the Licensee under Paragraph 9.3. Prior to invoking termination or
modification of this Agreement under Paragraph 13.5, the IC shall give written
notice to the Licensee providing the Licensee specific notice of, and a ninety
(90) day opportunity to respond to, the IC’s concerns as to the items referenced
in 13.5(a)-13.5(g). If the Licensee fails to alleviate the IC’s concerns as to
the items referenced in 13.5(a)-13.5(g) or fails to initiate corrective action
to the IC’s satisfaction, the IC may terminate this Agreement.

 

 

13.7

The IC reserves the right according to 35 U.S.C. §209(d)(3) to terminate or
modify this Agreement if it is determined that the action is necessary to meet
the requirements for public use specified by federal regulations issued after
the date of the license and these requirements are not reasonably satisfied by
the Licensee.

 

 

13.8

Within thirty (30) calendar days of receipt of written notice of the IC’s
unilateral decision to modify or terminate this Agreement, the Licensee may,
consistent with the provisions of 37 CFR §404.11, appeal the decision by written
submission to the designated the IC official. The decision of the designated IC
official shall be the final agency decision. The Licensee may thereafter
exercise any and all administrative or judicial remedies that may be available.

 

 

13.9

Within ninety (90) calendar days of expiration or termination of this Agreement
under this Article 13, a final report shall be submitted by the 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 the IC
shall become immediately due and payable upon termination or expiration.

 

 

--------------------------------------------------------------------------------

 

 

 

13.10

Unless otherwise specifically provided for under this Agreement, within thirty
(30) calendar days of termination, cancellation or expiration of this Agreement,
the Licensee shall return all Materials, Licensed Products or other materials
included within the Licensed Patent Rights to the IC or provide the IC with
written certification of the destruction thereof. The Licensee may not be
granted additional HHS licenses if the final reporting requirement is not
fulfilled.

 

14.

GENERAL PROVISIONS

 

 

14.1

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 of these terms or conditions
by the Licensee.

 

 

14.2

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

 

 

14.3

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

 

 

14.4

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 the modification.
No modification shall be effective until a written amendment is signed by the
signatories to this Agreement or their designees.

 

 

14.5

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.

 

 

14.6

All Agreement notices required or permitted by this Agreement shall be given by
prepaid, first class, registered or certified mail or by an express or overnight
delivery service provided by a commercial carrier, properly addressed to the
other party at the address designated on the Signature Page, or to any other
address as may be designated in writing by such other party. Agreement 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.

 

 

--------------------------------------------------------------------------------

 

 

 

14.7

This Agreement shall not be assigned or otherwise transferred (including any
transfer by legal process or by operation of law, and any transfer in bankruptcy
or insolvency, or in any other compulsory procedure or order of court) except to
the Licensee’s Affiliate(s) without the prior written consent of the IC. The
parties agree that the identity of the parties is material to the formation of
this Agreement and that the obligations under this Agreement are nondelegable.
In the event, that the IC approves a proposed assignment, the Licensee shall pay
the IC, as an additional royalty within sixty calendar (60) days of the
assignment execution, one percent (1%) of the Fair Value of any consideration
received for any assignment of this Agreement. Licensee shall provide IC with a
copy of any executed assignment agreement. The Licensee agrees in its use of any
IC-supplied materials to comply with all applicable statutes, regulations, and
guidelines, including the NIH and the HHS regulations and guidelines. The
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. The Licensee agrees not to use the materials for research
involving human subjects or clinical trials outside of the United States without
notifying the IC, in writing, of the research or trials and complying with the
applicable regulations of the appropriate national control authorities. Written
notification to the IC of research involving human subjects or clinical trials
outside of the United States shall be given no later than sixty (60) days prior
to commencement of the research or trials.

 

 

14.8

The 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 materials, and other
commodities. The transfer of these items may require a license from the
appropriate agency of the Government or written assurances by the Licensee that
it shall not export these items to certain foreign countries without prior
approval of the agency. The IC neither represents that a license is or is not
required or that, if required, it shall be issued.

 

 

14.9

The 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 a manner to preserve the IC patent
rights in those countries.

 

 

14.10

By entering into this Agreement, the IC does not directly or indirectly endorse
any product or service provided, or to be provided, by the Licensee whether
directly or indirectly related to this Agreement. The Licensee shall not state
or imply that this Agreement is an endorsement by the Government, the IC, any
other Government organizational unit, or any Government employee. Additionally,
the Licensee shall not use the names of the IC, NIH, FDA or HHS or the
Government or their employees in any advertising, promotional, or sales
literature without the prior written approval of the IC.

 

 

14.11

Licensee and IC 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. The
Licensee agrees first to appeal any unsettled claims or controversies to the
designated the IC official, or designee, whose decision shall be considered the
final agency decision. Thereafter, the Licensee may exercise any administrative
or judicial remedies that may be available.

 

 

14.12

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.

 

 

14.13

Paragraphs 6.5, 6.10, 8.1, 8.2, 9.5-9.7, 12.1-12.5, 13.2, 13.8, 13.9, 13.10,
14.11, 14.12, 14.13 and 14.14 of this Agreement shall survive termination of
this Agreement.

 

 

14.14

The terms and conditions of this Agreement shall, at the IC’s sole option, be
considered by the IC to be withdrawn from the Licensee’s consideration and the
terms and conditions of this Agreement, and the Agreement itself to be null and
void, unless this Agreement is executed by the Licensee and a fully executed
original is received by the IC within sixty (60) calendar days from the date of
the IC signature found at the Signature Page.

 

SIGNATURES BEGIN ON NEXT PAGE

 

 

--------------------------------------------------------------------------------

 

 

NIH PATENT LICENSE AGREEMENT NONEXCLUSIVE and BML

 

SIGNATURE PAGE

 

For the IC:

 

________ __________________________                              Michael R.
Mowatt, Ph.D. Date

Director

Technology Transfer and Intellectual Property Office

National Institute of Allergy and Infectious Diseases

National Institutes of Health

 

Mailing Address or E-mail Address for Agreement notices and reports:

 

License Compliance and Administration 

Monitoring & Enforcement

Office of Technology Transfer

National Institutes of Health

6011 Executive Boulevard, Suite 325

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

 

 

E-mail: LicenseNotices_Reports@mail.nih.gov

 

 

For the Licensee (Upon, information and belief, the undersigned expressly
certifies or affirms that the contents of any statements of the Licensee made or
referred to in this document are truthful and accurate.):

 

by:

 

__________________________________                             Mr. David A.
Dodd   Date

Chairman and CEO

GeoVax, Inc.

1900 Lake Park Drive

Suite 380

Smyrna, GA 30080

ddodd@geovax.com

 

 

--------------------------------------------------------------------------------

 

 

__________________________________

Mr. David A. Dodd

 

__________________________________

Chairman and CEO

 

 

I.

Official and Mailing Address for Agreement notices:

          Mr. David A.
Dodd                                                                  Name      
    Chairman and CEO                                     
                            Title           Mailing Address           1900 Lake
Park Drive                                                              Suite
380                                                                             
    Smyrna, GA 30080                                                  
                           Email Address:     ddodd@geovax.com          
Phone:     678-384-7222 (office); 864-290-9114 (mobile)                 
Fax:     N/A                                                                    
         

 

 

--------------------------------------------------------------------------------

 

 

 

II.

Official and Mailing Address for Financial notices (the Licensee’s contact
person for royalty payments)           Mr. David A.
Dodd                                                                  Name      
    Chairman and CEO                                     
                            Title           Mailing Address           GeoVax,
Inc.                                                                           
      1900 Lake Park Dr. Suite 380                                             
          Smyrna, Georgia 30080                                           
                     Email Address:     ddodd@geovax.com          
Phone:     678-384-7222 (office); 864-290-9114 (mobile)           Fax:     N/A

 

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).

 

 

--------------------------------------------------------------------------------

 

 

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

 

Patent(s) or Patent Application(s):

 

I.

E-552-1982 technology:

 

HHS Ref. No.

Territory

Application No.

Patent No.

E-552-1982-2-US-03

United States

07/987,546

7045313

E-552-1982-2-US-04

United States

08/470,357

7015024

E-552-1982-2-US-06

United States

08/470,360

6998252

E-552-1982-2-US-05

United States

08/470,359

7045136

 

 

II.

E-018-2010 technology:

 

HHS Ref. No.

Territory

Application No.

Patent No.

E-018-2010-0-AU-03

Australia

2010306559

2010306559

E-018-2010-0-CA-04

Canada

2777744

2777744

E-018-2010-0-EP-05

European Patent

10771611

2488649, validated in DE, DK, FR, GB, NL

E-018-2010-0-IN-06

India

4311/DELNP/2012

*presently pending

E-018-2010-0-JP-07

Japan

2012-534414

5789263

E-018-2010-0-US-08

United States

13/502,205

9,133,480

E-018-2010-0-ZA-09

South Africa

2012/03551

2012/03551

E-018-2010-0-US-10

United States

14/837,382

9,879,231

E-018-2010-0-PCT-02

PCT

PCT/US2010/052929

expired

E-018-2010-0-US-01

United States

61/252,326

converted

 

 

III.

E-248-2006 technology:

 

HHS Ref. No.

Territory

Application No.

Patent No.

E-248-2006-0-EP-03

European Patent

07874019.8

07874019.8, validated in BE, CH, DE, DK, ES, FR, GB, IE, IT, NL

E-248-2006-0-IN-04

India

1535/DELNP/2009

281791

E-248-2006-0-US-05

United States

12/377,847

9,133,478

E-248-2006-0-CN-06

China

200780035385.3

200780035385.3

E-248-2006-0-EP-07

European Patent

11183527.8

11183527.8, validated in DE, DK, ES, FR, GB, NL

E-248-2006-0-CN-18

China

2013100549071

2013100549071

E-248-2006-0-US-19

United States

14/833,913

10,421,978

E-248-2006-0-CN-20

China

201610183481.3

*presently pending

E-248-2006-0-US-26

United States

16/579,276

*presently pending

E-248-2006-1-PCT-02

PCT

PCT/US2007/076829

expired

E-248-2006-0-PCT-02

PCT

PCT/IB2007/004575

expired

E-248-2006-1-US-01

United States

60/840,755

converted

E-248-2006-0-US-01

United States

60/840,093

converted

 

 

--------------------------------------------------------------------------------

 

 

IV.

E-234-2016 technology:

 

HHS Ref. No.

Territory

Application No.

Patent No.

E-234-2016-1-EP-02

European Patent

17800655.7

*presently pending

E-234-2016-1-US-03

United States

16/344,774

*presently pending

E-234-2016-1-PCT-01

PCT

17800655.7

expired

E-234-2016-0-US-01

United States

62/412,703

converted

 

 

V.

E-086-2020 technology:

 

HHS Ref. No.

Territory

Application No.

Patent No.

E-086-2020-0-US-01

United States

62/972,886

*presently pending

 

 

--------------------------------------------------------------------------------

 

 

APPENDIX B – TANGIBLE MATERIALS, Licensed Fields of Use and Territory

 

I.

Tangible Materials:

 

 

(a)

plasmid shuttle vector pLW-76 (as described by HHS reference number
E-018-2010/0).

 

 

(b)

plasmid shuttle vector pLW-73 (as described by HHS reference number
E-248-2006/0).

 

 

II.

Licensed Fields of Use:

 

 

(a)

development and use of Licensed Patent Rights and Materials in combination with
Licensee’s proprietary technology for the creation of a preventive Modified
Vaccinia Ankara Virus-Virus Like Particle (MVA-VLP) vaccine primes and/or
boosters against -“SARS-CoV-2.”

 

III.

Licensed Territory:

 

 

(a)

Worldwide.

 

 

--------------------------------------------------------------------------------

 

 

APPENDIX C – Royalties

 

 

 

[This appendix has been redacted in its entirety]

 

 

--------------------------------------------------------------------------------

 

 

APPENDIX D – Benchmarks and Performance

 

 

 

[This appendix has been redacted in its entirety]

 

 

--------------------------------------------------------------------------------

 

 

APPENDIX E – Commercial Development Plan

 

Commercial Market and Commercialization Plans

 

 

The anticipated relevant commercial market consists primarily of government
agencies and health organizations purchasing for at risk worldwide populations
of contracting COVID-19, which at this time is nearly universal due to the fluid
epidemiological nature of this virus.

 

GeoVax anticipates that there will be multiple COVID-19 vaccines successfully
developed and licensed for use. Depending on the eventual epidemiology of
COVID-19, there may be need for ongoing Product supply and support or the
dynamics may dictate more of a public health stockpile/replenishment business
model. Regardless, GeoVax management is highly experienced in successful
management of Product acceptance and supply in either situation.

 

Eventual market acceptance, penetration and competitive market share will be a
function of the attributes of the Product (e.g., single-dose; durability;
efficacy; stability; cost, etc.) that is demonstrated via the product
development process. In addition, order of market entry will be a factor in
market use and market share attained. GeoVax is focused on rapidly developing
the Product, advancing into animal testing as soon as possible, then into
clinical development, advancing to regulatory licensure. Upon regulatory
licensure, GeoVax anticipates Product commercialization within three months,
having minimized the interim commercial-planning period between regulatory
submission decision and licensure.

 

Following successful completion of Phase 2 clinical development, GeoVax will
establish secure commercial distribution and supply chain
agreements/relationships to enable eventual commercialization and Product supply
across global territories. GeoVax management has extensive experience in
establishing and successfully managing a combination of internal and such
external commercial/distribution relations throughout Europe, Africa, South
America and the Asia/Pacific region.

 

Eventual sales derived from the Product commercialization will result from
several factors, including those previously noted: Product
differentiation/performance attributes; order of market entry; COVID-19
epidemiology and dynamics; manufacturing costs; and, Product pricing. All such
commercial-related factors will be evaluated, along with other factors that may
be specific to differing governmental territories, healthcare systems, etc.,
during the Product development process. Current information suggests that a
COVID-19 vaccine will be utilized throughout the world, but critical
epidemiologic dynamics remain uncertain.

 

GeoVax will focus priority effort on ensuring broad access to the COVID-19
vaccine, following a model of achieving marginal profit, recognizing the
critical need to ensure widespread access and benefit from the anticipated
COVID-19 vaccine. Further commercial and market-related information will
continue to evolve, providing an ongoing basis to refine the specific market
parameters such as (a) number of relevant patients (US and worldwide), (b)
utilization of Product (ongoing or episodic), (c) differentiation of Product
versus competitive products (re market acceptance and penetration) and other
critical commercial parameters.

 

  

 

Clinical Development and Regulatory Plans

 

 

Toxicology:

 

Toxicology testing is absent from our project plan. We had an Initial Targeted
Engagement for Regulatory Advice on CBER products (INTERACT) meeting on May 15,
2020 with the FDA in which we discussed our overall development plan and our
proposal to omit animal toxicity testing in light of the proven safety profile
of MVA as a vaccine platform. Acknowledging the previous safety experience
available for MVA-based vaccine platforms, the FDA concurred that no additional
non-clinical and toxicology studies will be required, provided that the immune
response to the ultimately chosen GeoVax vaccine construct is adequately
assessed in appropriate animal models.

 

 

--------------------------------------------------------------------------------

 

 

Clinical:

 

As described below under Regulatory Path, our development program is geared
toward Emergency Use Authorization (EUA) readiness. To generate the human safety
and immunogenicity data required for an EUA, we will propose a Phase 1a/1b trial
to FDA. The final design of the clinical trial will be determined in discussions
with FDA, most importantly the Pre-IND meeting. Our draft design for this study,
which can be completed in approximately four months (excluding follow-up phase),
calls for a Phase 1a dose-ranging study in approximately 40 volunteers (three
vaccine groups and one placebo group; 10 participants per group). Assuming that
safety endpoints are met, we will choose a single dose from the dose-ranging
study and test it in Phase 1b in approximately 150 volunteers (100 in vaccine
group, 50 in placebo group). With this Phase 1a/1b trial, we expect to obtain
adequate data to enable use of the vaccine under an EUA.

 

In the Phase 1a/1b Clinical Trial, we will obtain safety and immunogenicity data
in healthy normal volunteers. An abbreviated synopsis for this clinical trial is
provided in the table below. Our trial is designed to provide initial data on
safety, tolerability, and immunogenicity and to identify an optimal regimen in
Phase 1a and then to obtain additional data in a larger, more diverse population
in Phase 1b to enable use of our vaccine under an EUA.

 

 

Abbreviated Clinical Trial Synopsis

Group

N

Vaccine (target virus)

Dose (TCID50)

Regimen

Phase 1a (Single Site, Healthy Normal Volunteers)

1

15

GEO-SARS-CoV2

1 × 107

Single dose (day 0)

2

15

GEO-SARS-CoV2

3 × 107

Single dose (day 0)

3

15

GEO-SARS-CoV2

1 × 108

Single dose (day 0)

4

15

GEO-SARS-CoV2

1 × 108

Prime-boost (days 0 & 28)

6

15

Placebo

-

Prime-boost (days 0 & 28)

Phase 1b (Multiple Sites, Healthy Normal Volunteers)

7

150

GEO-SARS-CoV2

Determined based on results of Phase 1a

8

50

Placebo

Determined based on results of Phase 1a

Measurements

Standard safety and tolerability assessments, binding antibody, neutralizing
antibody, T-cell responses

 

 

The Phase 1a/1b strategy is our preferred strategy, but we will present plans
for Phase 1 and Phase 2 studies to be implemented if FDA does not accept Phase
1a/1b as adequate to enable an EUA. Planning for the Phase 1 study will commence
during Q4 2020, working in conjunction with clinical advisors and seeking input
from the FDA. Management of the clinical development program and requisite
regulatory support will be performed by TRI (Technical Resources International),
a highly experienced Contract Research Organization with experience supporting
~800 vaccine studies, extensive knowledge of clinical trial management and
regulatory relative to vaccine development and registration.

 

The Phase 1 study is anticipated to include between 30-50 patients across 3-5
sites within the U.S. The Phase 2 and Phase 3 clinical programs will be designed
in conjunction with input from the FDA, assistance from TRI and input from
internal clinical advisors and staff. Planning for the Phase 2 program is
anticipated to begin during Q4 2021, although informal planning and design of
the study will begin earlier. The Phase 2 study is anticipated to include
approximately 100-200 patients utilizing 10-20 sites in the U.S., however,
depending on which of the GeoVax COVID-19 vaccines advances to clinical
development, the protocol will be appropriately modified and designed to support
the Phase 2 study relative to that respective vaccine.

 

Upon successful completion of the Phase 2 program, FDA will be consulted
relative to clinical protocol design requirement for the Phase 3 program.
Typically, a Phase 3 study for an infectious disease vaccine includes a minimum
of ~5,000 participants, but can include as high as 30,000+. Should the Phase 3
COVID-19 candidate vaccine be the design relative to very high-risk,
immunocompromised populations, the study design would include fewer patients,
using a stratified cohort design. The first dosing of a patient in the Phase 3
program is expected to occur by December 1, 2023 with submission of the BLA
targeted by June 1, 2025. Regulatory approval is anticipated to occur by June 1,
2026, with anticipated commercialization and market entry scheduled to occur
within three months of regulatory approval. Throughout the clinical development
program, including the design and planning periods, interaction and input from
FDA will be sought, as well as ongoing involvement of highly recognized clinical
experts within the infectious disease vaccine industry.

 

 

--------------------------------------------------------------------------------

 

 

Regulatory Path:

 

It is unclear whether 2019-nCoV will persist as a pathogen, like influenza, or
will be contained, like SARS. Anticipating the former, our focus is on bringing
the vaccine to the point of readiness for use under an EUA, the regulatory
process by which the FDA Commissioner may allow unapproved medical products or
unapproved uses of approved medical products to be used in an emergency to
diagnose, treat, or prevent serious or life-threatening diseases or conditions
caused by CBRN threat agents when there are no adequate, approved, and available
alternatives.

 

To minimize the time required to obtain an EUA, we will engage with FDA early
and often in the development process for our vaccine. We had an Initial Targeted
Engagement for Regulatory Advice on CBER products (INTERACT) meeting on May 15,
2020 with the FDA in which discussed our overall development plan and our
proposal to omit animal toxicity testing in light of the proven safety profile
of MVA as a vaccine platform. Acknowledging the previous safety experience
available for MVA-based vaccine platforms, the FDA concurred that no additional
non-clinical and toxicology studies will be required, provided that the immune
response to the ultimately chosen GeoVax vaccine construct is adequately
assessed in appropriate animal models.

 

As soon as process development and animal studies have generated clear data on
the performance of the vaccine, we will present our plans for first-in-human
clinical testing to FDA in a Pre-IND meeting. When our Phase 1 clinical trial
material has been produced and all IND-enabling studies have been completed, we
will file an IND to enable initiation of clinical trials. During our clinical
trials and in consultation with FDA, we will produce vaccine suitable for use
under an EUA. Upon completion of the initial clinical trial and production of
the EUA lots (which will occur almost simultaneously, assuming that a Phase
1a/1b trial is adequate), we will achieve EUA readiness in approximately 14
months.

 

 

--------------------------------------------------------------------------------

 

 

APPENDIX F –Royalty ReportING

 

Required royalty report information includes:

 

●

License reference number (L-XXX-200X/0)

●

Reporting period

●

Catalog number and units sold of each Licensed Product (domestic and foreign)

●

Gross Sales per catalog number per country

●

Total Gross Sales

●

Itemized deductions from Gross Sales

●

Total Net Sales

●

Earned Royalty Rate and associated calculations

●

Gross Earned Royalty

●

Adjustments for Minimum Annual Royalty (MAR) and other creditable payments made

●

Net Earned Royalty due

 

Example

Catalog Number

Product Name

Country

Units Sold

Gross Sales (US$)

1

A

US

250

62,500

1

A

UK

32

16,500

1

A

France

25

15,625

2

B

US

0

0

3

C

US

57

57,125

4

D

US

12

1,500

 

Total Gross Sales

153,250

   

Less Deductions:

     

Freight

3,000

   

Returns

7,000

   

Total Net Sales

143,250

           

Royalty Rate

8%

   

Royalty Due

11,460

   

Less Creditable Payments

10,000

   

Net Royalty Due

1,460

 

 

 

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Appendix G – Royalty Payment Options

New Payment Options Effective March 2018

 

The License Number MUST appear on payments, reports and correspondence.

 

Credit and Debit Card Payments: Credit and debit card payments can be submitted
for amounts up to $24,999. Submit your payment through the U.S. Treasury web
site located at: https://www.pay.gov/public/form/start/28680443.

 

Automated Clearing House (ACH) for payments through U.S. banks only

 

The IC encourages its licensees to submit electronic funds transfer payments
through the Automated Clearing House (ACH). Submit your ACH payment through the
U.S. Treasury web site located at:
https://www.pay.gov/public/form/startJ28680443. Please note that the IC "only"
accepts ACH payments through this U.S. Treasury web site.

 

Electronic Funds Wire Transfers: The following account information is provided
for wire payments. In order to process payment via Electronic Funds Wire
Transfer sender MUST supply the following information within the transmission:

 

Drawn on a U.S. bank account via FEDWIRE:

 

Please provide the following instructions to your Financial Institution for the
remittance of Fedwire payments to the NIH ROYALTY FUND.

 

Fedwire Field Tag

Fedwire Field Name

Required Information

 

{1510}

Type/Subtype

1000

{2000}

Amount

(enter payment amount)

{3400}

Receiver ABA routing number*

021030004

{3400}

Receiver ABA short name

TREAS NYC

{3600}

Business Function Code

CTR (or CTP)

{4200}

Beneficiary Identifier (account number)

(enter 12 digit gateway account #)

875080031006

{4200}

Beneficiary Name

(enter agency name associated with the Beneficiary Identifier)

DHHS / NIH (75080031)

{5000}

Originator

(enter the name of the originator of the payment)

COMPANY NAME

{6000}

Originator to Beneficiary Information – Line 1

(enter information to identify the purpose of the payment)

ROYALTY

{6000}

Originator to Beneficiary Information – Line 2

(enter information to identify the purpose of the payment)

LICENSE NUMBER

{6000}

Originator to Beneficiary Information – Line 3

(enter information to identify the purpose of the payment)

INVOICE NUMBER

{6000}

Originator to Beneficiary Information – Line 4

(enter information to identify the purpose of the payment)

Notes:
*The financial institution address for Treasury’s routing number is 33 Liberty
Street, New York, NY 10045.

 

 

--------------------------------------------------------------------------------

 

 

Agency Contacts: Office of Technology Transfer (OTT) (301) 496-7057
OTT-Royalties@mail.nih.gov

 

Drawn on a foreign bank account via FEDWIRE:

 

The following instructions pertain to the Fedwire Network. Deposits made in US
Dollars (USD).

 

Should your remitter utilize a correspondent US domestic bank in transferring
electronic funds, the following Fedwire instructions are applicable.

 

Fedwire Field Tag

Fedwire Field Name

Required Information

 

{1510}

Type/Subtype

1000

{2000}

Amount

(enter payment amount)

{3100}

Sender Bank ABA routing number

(enter the US correspondent bank’s ABA routing number)

{3400}

Receiver ABA routing number*

021030004

{3400}

Receiver ABA short name

TREAS NYC

{3600}

Business Function Code

CTR (or CTP)

{4200}

Beneficiary Identifier (account number)**

(enter 12 digit gateway account #)

875080031006

{4200}

Beneficiary Name

(enter agency name associated with the Beneficiary Identifier)

DHHS / NIH (75080031)

{5000}

Originator

(enter the name of the originator of the payment)

COMPANY’S NAME

{6000}

Originator to Beneficiary Information – Line 1

(enter information to identify the purpose of the payment)

ROYALTY

{6000}

Originator to Beneficiary Information – Line 2

(enter information to identify the purpose of the payment)

LICENSE NUMBER

{6000}

Originator to Beneficiary Information – Line 3

(enter information to identify the purpose of the payment)

INVOICE NUMBER

{6000}

Originator to Beneficiary Information – Line 4

(enter information to identify the purpose of the payment)

Notes:
*The financial institution address for Treasury’s routing number is 33 Liberty
Street, New York, NY 10045.

**Anything other than the 12 digit gateway account # will cause the Fedwire to
be returned – SWIFT CODE: FRNYUS33

 

 

--------------------------------------------------------------------------------

 

 

Agency Contacts:

 

Office of Technology Transfer (OTT)     (301)
496-7057     OTT-Royalties@mail.nih.gov

 

Checks

 

All checks should be made payable to “NIH Patent Licensing”

 

Checks drawn on a U.S. bank account and sent by US Postal Service should be sent
directly to the following address:

 

National Institutes of Health

P.O. Box 979071

St. Louis, MO 63197-9000

 

Checks drawn on a U.S. bank account and sent by overnight or courier should be
sent to the following address:

 

US Bank

Government Lockbox SL-MO-C2GL

1005 Convention Plaza

St. Louis, MO 63101

Phone: 314-418-4087

 

Checks drawn on a foreign bank account should be sent directly to the following
address:

 

National Institutes of Health

Office of Technology Transfer

License Compliance and Administration

Royalty Administration

6011 Executive Boulevard

Suite 325, MSC 7660

Rockville, Maryland 20852