Document:

Exhibit 10.27

 

Paycheck Protection Program Term Note

 

	$72,100.00	May 04, 2020

 

FOR VALUE RECEIVED, VIRPAX PHARMACEUTICALS,
INC. (the “Borrower”), with an address at 1238 WATERFORD ROAD, WEST CHESTER, PENNSYLVANIA 19380-5847, promises
to pay to the order of PNC BANK, NATIONAL ASSOCIATION (the “Bank”), in lawful money of the United States
of America in immediately available funds at its offices located at 222 Delaware Avenue, Wilmington, Delaware 19801, Attn: Business
Banking, or at such other location as the Bank may designate from time to time, the principal sum of $72,100.00 (the “Facility”),
together with interest accruing on the outstanding principal balance from the date hereof, all as provided below. This Note is
being issued pursuant to the Coronavirus Aid, Relief, and Economic Security Act’s (the “CARES Act”) (P.L.
116-136) Paycheck Protection Program (the “Program”).

 

1.
Rate of Interest. Amounts outstanding under this Note will bear interest at a rate per annum (“Fixed
Rate”) which is at all times equal to 1.00%. Interest will be calculated based on the actual number of days that principal
is outstanding over a year of 360 days. In no event will the rate of interest hereunder exceed the maximum rate allowed by law.

 

2.
Structure; Payment Terms. During the period (the “Deferral Period”) beginning on the
date of this Note and ending on the 6 month anniversary of the date of this Note (the “Deferral Expiration Date”),
interest on the outstanding principal balance will accrue at the Fixed Rate, but neither principal nor interest shall be due and
payable during the Deferral Period. On the Deferral Expiration Date, the outstanding principal of the Facility that is not forgiven
under the Program (the “Conversion Balance”) shall convert to an amortizing term loan payable as set forth
below.

 

On the 1 5th day of the 7” month
following the date of this Note (the “First Payment Date”), all accrued interest that is not forgiven under
the Program shall be due and payable. Additionally, on the First Payment Date, and continuing on the 15th day of each month thereafter
until the 2” anniversary of the date of this Note (the “Maturity Date”), equal installments of principal
shall be due and payable, each in an amount determined by dividing the Conversion Balance by 18 (the “Monthly Principal
Amount”). Interest shall be payable at the same times as the Monthly Principal Amount. Any outstanding principal and
accrued interest shall be due and payable in full on the Maturity Date.

 

If any payment under this Note shall become
due on a day other than a Business Day, such payment shall be made on the next succeeding Business Day and such extension of time
shall be included in computing interest in connection with such payment. “Business Day” shall mean any day other
than a Saturday or Sunday or a legal holiday on which commercial banks are authorized or required by law to be closed for business
in the State of Delaware. The Borrower hereby authorizes the Bank to charge the Borrower’s deposit account at the Bank for
any payment when due. Payments received will be applied to charges, fees and expenses (including attorneys’ fees), accrued
interest and principal in any order the Bank may choose, in its sole discretion.

 

     

     

    

 

3.
Forgiveness of the Facility. All or a portion of this Facility may be forgiven in accordance with the
Program requirements. The amount of forgiveness shall be calculated (and may be reduced) in accordance with the requirements of
the Program, including the provisions of Section 1106 of the CARES Act. Not more than 25% of the amount forgiven can be attributable
to non-payroll costs.

 

4.
Late Payments; Default Rate. If the Borrower fails to make any payment of principal, interest or other
amount coming due pursuant to the provisions of this Note within fifteen (15) calendar days of the date due and payable, the Borrower
also shall pay to the Bank a late charge equal to the lesser of five percent (5%) of the amount of such payment or $100.00 (the
“Late Charge”). Such fifteen (15) day period shall not be construed in any way to extend the due date of any
such payment. Upon maturity, whether by acceleration, demand or otherwise, and at the Bank’s option upon the occurrence
of any Event of Default (as hereinafter defined) and during the continuance thereof, each advance outstanding under this Note
shall bear interest at a rate per annum (based on the actual number of days that principal is outstanding over a year of 360 days)
which shall be five percentage points (5.00%) in excess of the interest rate in effect from time to time under this Note but not
more than the maximum rate allowed by law (the “Default Rate”). The Default Rate shall continue to apply whether
or not judgment shall be entered on this Note. Both the Late Charge and the Default Rate are imposed as liquidated damages for
the purpose of defraying the Bank’s expenses incident to the handling of delinquent payments, but are in addition to, and
not in lieu of, the Bank’s exercise of any rights and remedies hereunder, under the other Loan Documents (as defined below)
or under applicable law, and any fees and expenses of any agents or attorneys which the Bank may employ. In addition, the Default
Rate reflects the increased credit risk to the Bank of carrying a loan that is in default. The Borrower agrees that the Late Charge
and Default Rate are reasonable forecasts of just compensation for anticipated and actual harm incurred by the Bank, and that
the actual harm incurred by the Bank cannot be estimated with certainty and without difficulty. As used in this Note, “Loan
Documents” means, individually and collectively, this Note, together with all other agreements and documents executed and/or
delivered in connection with this Note or referred to in this Note, as amended, modified or renewed from time to time.

 

5.
Prepayment. The Borrower shall have the right to prepay any amounts outstanding under this Note at any
time and from time to time, in whole or in part, without penalty.

 

6.
Increased Costs; Yield Protection. On written demand, together with written evidence of the justification
therefor, the Borrower agrees to pay the Bank all direct costs incurred, any losses suffered or payments made by the Bank as a
result of any Change in Law (hereinafter defined), imposing any reserve, deposit, allocation of capital or similar requirement
(including without limitation, Regulation D of the Board of Governors of the Federal Reserve System) on the Bank, its holding
company or any of their respective assets relative to the Facility. “Change in Law” means the occurrence, after
the date of this Note, of any of the following: (a) the adoption or taking effect of any law, rule, regulation or treaty, (b)
any change in any law, rule, regulation or treaty or in the administration, interpretation, implementation or application thereof
by any governmental authority or (c) the making or issuance of any request, rule, guideline or directive (whether or not having
the force of law) by any governmental authority; provided that notwithstanding anything herein to the contrary, (x) the Dodd-Frank
Wall Street Reform and Consumer Protection Act and all requests, rules, guidelines or directives thereunder or issued in connection
therewith and (y) all requests, rules, guidelines or directives promulgated by the Bank for International Settlements, the Basel
Committee on Banking Supervision (or any successor or similar authority) or the United States or foreign regulatory authorities,
in each case pursuant to Basel III, shall in each case be deemed to be a “Change in Law”, regardless of the date enacted,
adopted or issued.

 

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7. Representations,
Warranties and Covenants.

 

(a) The
Borrower hereby represents and warrants that, if not a natural person, the Borrower is duly organized, validly existing and in
good standing under the laws of the state of its incorporation or organization and has the power and authority to own and operate
its assets and to conduct its business as now or proposed to be carried on, and is duly qualified, licensed and in good standing
to do business in all jurisdictions where its ownership of property or the nature of its business requires such qualification or
licensing.

 

(b) The
Borrower certifies, acknowledges and agrees that the certifications contained in the Paycheck Protection Program Certification
and the Program application delivered to the Bank are true and correct, which certifications are hereby incorporated herein by
this reference as if set forth herein.

 

(c) The
Borrower covenants and agrees that the Borrower will do all things necessary to (i) if not a natural person, (A) maintain, renew
and keep in full force and effect its organizational existence and all rights, permits and franchises necessary to enable it to
continue its business as currently conducted; and (B) continue in operation in substantially the same manner as at present, to
the extent permitted by applicable law (including without limitation any statute, ordinance, rule or regulation relating to employment
practices, pension benefits or environmental, occupational and health standards and controls); and (ii) comply with all laws applicable
to the Borrower and to the operation of its business (including without limitation any statute, ordinance, rule or regulation relating
to employment practices, pension benefits or environmental, occupational and health standards and controls).

 

(d) The
Borrower represents and warrants that (i) the Borrower has full power, authority and capacity to enter into the transactions provided
for in this Note and the other Loan Documents; (ii) if not a natural person, all necessary action to authorize the execution and
delivery of this Note and the other Loan Documents has been properly taken; (iii) this Note and the other Loan Documents, when
executed and delivered by the Borrower, will constitute the legal, valid and binding obligations of the Borrower enforceable in
accordance with their terms; (iv) if not a natural person, the Borrower is and will continue to be duly authorized to perform all
of the terms and provisions of this Note and the other Loan Documents; (v) there does not exist, either before or after giving
effect to the terms of this Note, any default or violation by the Borrower of or under any of the terms, conditions or obligations
of any of its governing documents; and (vi) the Borrower does not require the consent of any party with respect to this Note, the
other Loan Documents or the Facility except for such consents that have been obtained.

 

(e) The
Borrower covenants and agrees to take all such additional actions and promptly provide to the Bank all additional documents, statements
and information as the Bank may require from time to time, in its discretion, in connection with the SBA’s requirements or
requests under or in respect of the Program or the general standard operating procedures of the SBA.

 

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(f) The
Borrower authorizes and directs the Bank to disburse the proceeds of the Facility and to direct payments due under the Facility
in accordance with the Disbursement and Payment Authorization Instructions attached to this Note as Exhibit A.

 

8.
Other Loan Documents. Notwithstanding any provision to the contrary in any Loan Document or any other
collateral security documents that may have been or may in the future be executed and delivered to the Bank, or an agent acting
on behalf of the Bank, to secure any obligations of the Borrower to the Bank, this Note is not intended to be secured by real
property, and the applicability of any lien on such real property to secure this Note is expressly disclaimed by the Bank.

 

9.
Events of Default. The occurrence of any of the following events will be deemed to be an “Event
of Default” under this Note: (i) the nonpayment of any principal, interest or other indebtedness under this Note when
due; (ii) the occurrence of any event of default or any default and the lapse of any notice or cure period, or the Borrower’s
failure to observe or perform any covenant or other agreement, under or contained in any Loan Document; (iii) the filing by or
against the Borrower of any proceeding in bankruptcy, receivership, insolvency, reorganization, liquidation, conservatorship or
similar proceeding (and, in the case of any such proceeding instituted against the Borrower, such proceeding is not dismissed
or stayed within 30 days of the commencement thereof, provided that the Bank shall not be obligated to advance additional funds
hereunder during such period); (iv) any assignment by the Borrower for the benefit of creditors, or any levy, garnishment, attachment
or similar proceeding is instituted against any property of the Borrower held by or deposited with the Bank; (v) the commencement
of any foreclosure or forfeiture proceeding, execution or attachment against any collateral securing the obligations of the Borrower
to the Bank; (vi) the entry of a final judgment against the Borrower and the failure of the Borrower to discharge the judgment
within ten (10) days of the entry thereof; (vii) any change in the Borrower’s equity ownership (if not a public company),
or any merger, consolidation, division or other reorganization of, with or by the Borrower, or the sale or other transfer of all
or any substantial part of the Borrower’s property or assets, except as otherwise permitted by the Bank; (viii) any change
in the Borrower’s business, assets, operations, financial condition or results of operations that has or could reasonably
be expected to have any material adverse effect on the Borrower; (ix) the Borrower ceases doing business as a going concern; (x)
any representation or warranty made by the Borrower to the Bank in any Loan Document or any other documents now or in the future
evidencing or securing the obligations of the Borrower to the Bank, is false, erroneous or misleading in any material respect;
(xi) the death, incarceration, indictment or legal incompetency of any individual Borrower or, if the Borrower is a partnership
or limited liability company, the death, incarceration, indictment or legal incompetency of any individual general partner or
member; or (xii) failure of the Borrower to notify the Bank within ten (10) days of any change of the Borrower’s address.

 

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Upon the occurrence of an Event of Default:
(a) the Bank shall be under no further obligation to make advances hereunder; (b) if an Event of Default specified in clause (iii)
or (iv) above shall occur, the outstanding principal balance and accrued interest hereunder together with any additional amounts
payable hereunder shall be immediately due and payable without demand or notice of any kind; (c) if any other Event of Default
shall occur, the outstanding principal balance and accrued interest hereunder together with any additional amounts payable hereunder,
at the Bank’s option and without demand or notice of any kind, may be accelerated and become immediately due and payable;
(d) at the Bank’s option, this Note will bear interest at the Default Rate from the date of the occurrence of the Event of
Default; and (e) the Bank may exercise from time to time any of the rights and remedies available under the Loan Documents or under
applicable law. The Borrower acknowledges that upon the occurrence of an Event of Default, SBA, as defined below, may be required
to pay the Lender under the SBA guarantee, and SBA may then seek recovery on the Facility (to the extent any balance remains after
loan forgiveness).

 

10.
Right of Setoff. In addition to all rights of setoff against the Borrower’s money, securities or
other property given to the Bank by law, the Bank shall have, with respect to the Borrower’s obligations to the Bank under
this Note and to the extent permitted by law, a contractual right of setoff against all of the Borrower’s deposits, moneys,
securities and other property now or hereafter in the possession of or on deposit with, or in transit to, the Bank or any other
direct or indirect subsidiary of The PNC Financial Services Group, Inc., whether held in a general or special account or deposit,
whether held jointly with someone else, or whether held for safekeeping or otherwise, excluding, however, all IRA, Keogh, and
trust accounts. Every such right of setoff may be exercised without demand upon or notice to the Borrower upon the occurrence
of an Event of Default. Every such right of setoff shall be deemed to have been exercised immediately upon the occurrence of an
Event of Default hereunder without any action of the Bank, although the Bank may enter such setoff on its books and records at
a later time.

 

11.
Financial and Other Information. Within forty five (45) days after the Bank’s request, the Borrower
agrees to deliver any financial and other business and ownership information concerning the Borrower that the Bank may request
from time to time, such as annual and interim financial statements (all of which shall be prepared in accordance with generally
accepted accounting principles), federal income tax returns. The Borrower also agrees to deliver to the Bank, promptly upon the
Bank’s request, certification(s) of beneficial owners in the form requested by the Bank (as executed and delivered to the
Bank on or prior to the date of this Note and updated from time to time, the “Certification of Beneficial Owners”).
If the Borrower was required to execute and deliver to the Bank a Certification of Beneficial Owners, (a) the Borrower represents
and warrants, as of the date of this Note and as of the date each updated Certification of Beneficial Owners is provided to the
Bank, that the information in the Certification of Beneficial Owners is true, complete and correct, and (b) the Borrower agrees
to provide confirmation of the accuracy of the information set forth in the Certification of Beneficial Owners, or deliver a new
Certification of Beneficial Owners in form and substance acceptable to the Bank, as and when requested by the Bank and/or when
any individual identified on the most recent Certification of Beneficial Owners provided to the Bank as a controlling party and/or
a direct or indirect individual owner has changed. The Borrower further agrees to provide such other information and documentation
as may reasonably be requested by the Bank from time to time for purposes of compliance by the Bank with applicable laws (including
without limitation the USA PATRIOT Act and other “know your customer” and anti-money laundering rules and regulations),
and any policy or procedure implemented by the Bank to comply therewith. Additionally, the Borrower will keep books and records
in a manner satisfactory to the Bank and allow the Bank and SBA to inspect and audit books, records and papers relating to the
Borrower’s financial or business condition.

 

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12.
Anti-Money Laundering/International Trade Law Compliance. The Borrower represents and warrants to the
Bank, as of the date of this Note, the date of each advance of proceeds under the Facility, the date of any renewal, extension
or modification of the Facility, and at all times until the Facility has been terminated and all amounts thereunder have been
indefeasibly paid in full, that: (a) no Covered Entity (i) is a Sanctioned Person; (ii) has any of its assets in a Sanctioned
Country or in the possession, custody or control of a Sanctioned Person; or (iii) does business in or with, or derives any of
its operating income from investments in or transactions with, any Sanctioned Country or Sanctioned Person in violation of any
law, regulation, order or directive enforced by any Compliance Authority; (b) the proceeds of the Facility will not be used to
fund any operations in, finance any investments or activities in, or, make any payments to, a Sanctioned Country or Sanctioned
Person in violation of any law, regulation, order or directive enforced by any Compliance Authority; (c) the funds used to repay
the Facility are not derived from any unlawful activity; and (d) each Covered Entity is in compliance with, and no Covered Entity
engages in any dealings or transactions prohibited by, any laws of the United States, including but not limited to any Anti-Terrorism
Laws. Borrower covenants and agrees that it shall immediately notify the Bank in writing upon the occurrence of a Reportable Compliance
Event.

 

As used herein: “Anti-Terrorism
Laws” means any laws relating to terrorism, trade sanctions programs and embargoes, import/export licensing, money laundering,
or bribery, all as amended, supplemented or replaced from time to time; “Compliance Authority” means each and
all of the (a) U.S. Treasury Department/Office of Foreign Assets Control, (b) U.S. Treasury Department/Financial Crimes Enforcement
Network, (c) U.S. State Department/Directorate of Defense Trade Controls, (d) U.S. Commerce Department/Bureau of Industry and Security,
(e) U.S. Internal Revenue Service, (f) U.S. Justice Department, and (g) U.S. Securities and Exchange Commission; “Covered
Entity” means the Borrower, its affiliates and subsidiaries, all guarantors, pledgors of collateral, all owners of the
foregoing, and all brokers or other agents of the Borrower acting in any capacity in connection with the Facility; “Reportable
Compliance Event” means that any Covered Entity becomes a Sanctioned Person, or is indicted, arraigned, investigated
or custodially detained, or receives an inquiry from regulatory or law enforcement officials, in connection with any Anti-Terrorism
Law or any predicate crime to any Anti-Terrorism Law, or self-discovers facts or circumstances implicating any aspect of its operations
with the actual or possible violation of any Anti-Terrorism Law; “Sanctioned Country” means a country subject
to a sanctions program maintained by any Compliance Authority; and “Sanctioned Person” means any individual
person, group, regime, entity or thing listed or otherwise recognized as a specially designated, prohibited, sanctioned or debarred
person or entity, or subject to any limitations or prohibitions (including but not limited to the blocking of property or rejection
of transactions), under any order or directive of any Compliance Authority or otherwise subject to, or specially designated under,
any sanctions program maintained by any Compliance Authority.

 

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13.
Release and Indemnity. The Borrower agrees to indemnify each of the Bank, each legal entity, if any,
who controls, is controlled by or is under common control with the Bank, and each of their respective directors, officers and
employees (the “Indemnified Parties”), and to defend and hold each Indemnified Party harmless from and against any
and all claims, damages, losses, liabilities and expenses (including all fees and charges of internal or external counsel with
whom any Indemnified Party may consult and all expenses of litigation and preparation therefor) which any Indemnified Party may
incur or which may be asserted against any Indemnified Party by any person, entity or governmental authority (including the Borrower
or any person or entity claiming derivatively on behalf of the Borrower), in connection with or arising out of the Program or
relating to the matters referred to in this Note or in the other Loan Documents or the use of any advance hereunder, whether (a)
arising from or incurred in connection with any breach of a representation, warranty or covenant by the Borrower, or (b) arising
out of or resulting from any suit, action, claim, proceeding or governmental investigation, pending or threatened, whether based
on statute, regulation or order, or tort, or contract or otherwise, before any court or governmental authority; provided,
however, that the foregoing indemnity shall not apply to any claims, damages, losses, liabilities and expenses solely attributable
to an Indemnified Party’s gross negligence or willful misconduct. The release and indemnity agreements contained in this
paragraph shall survive the termination of this Note, payment of any advance hereunder and the assignment of any rights hereunder.
The Borrower may participate at its expense in the defense of any such action or claim.

 

14.
Miscellaneous. All notices, demands, requests, consents, approvals and other communications required
or permitted hereunder (“Notices”) must be in writing (except as may be agreed otherwise above with respect
to borrowing requests or as otherwise provided in this Note) and will be effective upon receipt. Notices may be given in any manner
to which the parties may agree. Without limiting the foregoing, first-class mail, postage prepaid, facsimile transmission and
commercial courier service are hereby agreed to as acceptable methods for giving Notices. In addition, the parties agree that
Notices may be sent electronically to any electronic address provided by a party from time to time. Notices may be sent to a party’s
address as set forth above or to such other address as any party may give to the other for such purpose in accordance with this
paragraph. No delay or omission on the Bank’s part to exercise any right or power arising hereunder will impair any such
right or power or be considered a waiver of any such right or power, nor will the Bank’s action or inaction impair any such
right or power. The Bank’s rights and remedies hereunder are cumulative and not exclusive of any other rights or remedies
which the Bank may have under other agreements, at law or in equity. No modification, amendment or waiver of, or consent to any
departure by the Borrower from, any provision of this Note will be effective unless made in a writing signed by the Bank, and
then such waiver or consent shall be effective only in the specific instance and for the purpose for which given. Notwithstanding
the foregoing, the Bank may modify this Note for the purposes of completing missing content or correcting erroneous content, without
the need for a written amendment, provided that the Bank shall send a copy of any such modification to the Borrower (which notice
may be given by electronic mail). The Borrower agrees to pay on demand, to the extent permitted by law, all costs and expenses
incurred by the Bank in the enforcement of its rights in this Note and in any security therefor, including without limitation
reasonable fees and expenses of the Bank’s counsel. If any provision of this Note is found to be invalid, illegal or unenforceable
in any respect by a court, all the other provisions of this Note will remain in full force and effect. The Borrower and all other
makers and indorsers of this Note hereby forever waive presentment, protest, notice of dishonor and notice of non-payment. The
Borrower also waives all defenses based on suretyship or impairment of collateral. If this Note is executed by more than one Borrower,
the obligations of such persons or entities hereunder will be joint and several. This Note shall bind the Borrower and its heirs,
executors, administrators, successors and assigns, and the benefits hereof shall inure to the benefit of the Bank and its successors
and assigns; provided, however, that the Borrower may not assign this Note in whole or in part without the Bank’s written
consent and the Bank at any time may assign this Note in whole or in part.

 

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This Note has been delivered to and accepted
by the Bank and will be deemed to be made in the State of Delaware. THIS NOTE WILL BE INTERPRETED AND THE RIGHTS AND LIABILITIES
OF THE BANK AND THE BORROWER DETERMINED IN ACCORDANCE WITH (I) FEDERAL REGULATIONS, AND (II) TO THE EXTENT NOT PREEMPTED BY FEDERAL
LAWS OR REGULATIONS, THE LAWS OF THE STATE OF DELAWARE, EXCLUDING ITS CONFLICT OF LAWS RULES, INCLUDING WITHOUT LIMITATION THE
ELECTRONIC TRANSACTIONS ACT (OR EQUIVALENT) IN EFFECT IN THE STATE OF DELAWARE (OR, TO THE EXTENT CONTROLLING, THE LAWS OF THE
UNITED STATES OF AMERICA, INCLUDING WITHOUT LIMITATION THE ELECTRONIC SIGNATURES IN GLOBAL AND NATIONAL COMMERCE ACT). The
Borrower hereby irrevocably consents to the exclusive jurisdiction of any state or federal court in the State of Delaware; provided
that nothing contained in this Note will prevent the Bank from bringing any action, enforcing any award or judgment or exercising
any rights against the Borrower individually, against any security or against any property of the Borrower within any other county,
state or other foreign or domestic jurisdiction. The Borrower acknowledges and agrees that the venue provided above is the most
convenient forum for both the Bank and the Borrower. The Borrower waives any objection to venue and any objection based on a more
convenient forum in any action instituted under this Note.

 

15.
Commercial Purpose. The Borrower represents that the indebtedness evidenced by this Note is being incurred
by the Borrower solely for the purpose of acquiring or carrying on a business, professional or commercial activity, and not for
personal, family or household purposes.

 

16.
USA PATRIOT Act Notice. To help the government fight the funding of terrorism and money laundering activities,
Federal law requires all financial institutions to obtain, verify and record information that identifies each Borrower that opens
an account. What this means: when the Borrower opens an account, the Bank will ask for the business name, business address, taxpayer
identifying number and other information that will allow the Bank to identify the Borrower, such as organizational documents.
For some businesses and organizations, the Bank may also need to ask for identifying information and documentation relating to
certain individuals associated with the business or organization.

 

17.
Authorization to Obtain Credit Reports. By signing below, each person, who is signing in his or her individual
capacity, requests and provides written authorization to the Bank or its designee (and any assignee or potential assignee hereof)
to obtain such individual’s personal credit profile from one or more national credit bureaus. This authorization extends
to obtaining a credit profile in (i) considering an application for credit that is evidenced, guaranteed or secured by this document,
(ii) assessing creditworthiness and (iii) considering extensions of credit, including on an ongoing basis, as necessary for the
purposes of (a) update, renewal or extension of such credit or additional credit, (b) reviewing, administering or collecting the
resulting account and (c) reporting on the repayment and satisfaction of such credit obligations. By signing below, such individual
further ratifies and confirms his or her prior requests and authorizations with respect to the matters set forth herein. For the
avoidance of doubt, this provision does not apply to persons signing below in their capacities as officers or other authorized
representatives of entities, organizations or governmental bodies.

 

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18.
Electronic Signatures and Records. Notwithstanding any other provision herein, the Borrower agrees that
this Note, the Loan Documents, any amendments thereto, and any other information, notice, signature card, agreement or authorization
related thereto (each, a “Communication”) may, at the Bank’s option, be in the form of an electronic
record. Any Communication may, at the Bank’s option, be signed or executed using electronic signatures. For the avoidance
of doubt, the authorization under this paragraph may include, without limitation, use or acceptance by the Bank of a manually
signed paper Communication which has been converted into electronic form (such as scanned into PDF format) for transmission, delivery
and/or retention.

 

19.
Depository. Unless the Bank otherwise agrees, the Borrower will establish and maintain with the Bank
the Borrower’s primary depository accounts.

 

20.
Federal Law. When the U.S. Small Business Administration (“SBA”) is the holder, this Note
will be interpreted and enforced under federal law, including SBA regulations. The Bank or SBA may use state or local procedures
for filing papers, recording documents, giving notice, foreclosing liens, and other purposes. By using such procedures, SBA does
not waive any federal immunity from state or local control, penalty, tax, or liability. As to this Note, the Borrower may not
claim or assert against SBA any local or state law to deny any obligation, defeat any claim of SBA, or preempt federal law.

 

21. DISPUTE
RESOLUTION.

 

(a) WAIVER
OF JURY TRIAL. FOR ANY DISPUTE THAT IS NOT ARBITRATED, AND TO THE EXTENT PERMITTED BY APPLICABLE LAW, THE BORROWER AND THE BANK
IRREVOCABLY WAIVES ANY AND ALL RIGHTS THE BORROWER OR THE BANK MAY HAVE TO A TRIAL BY JURY IN ANY ACTION, PROCEEDING OR CLAIM OF
ANY NATURE RELATING TO THIS NOTE, ANY DOCUMENTS EXECUTED IN CONNECTION WITH THIS NOTE OR ANY TRANSACTION CONTEMPLATED IN ANY OF
SUCH DOCUMENTS. THE BORROWER ACKNOWLEDGES THAT THE FOREGOING WAIVER IS KNOWING AND VOLUNTARY.

 

(b) ARBITRATION
OF DISPUTES. The Borrower or the Bank may elect to submit any and all disputes arising out of or relating to the Loan Documents
or any breach thereof (a “Dispute”) to binding arbitration

 

(i) Arbitration.
Any arbitration shall be conducted pursuant to and in accordance with the AAA Commercial Arbitration Rules and, where applicable,
the Supplementary Rules for Large, Complex Commercial Disputes, and judgment upon the award rendered by the arbitrator may be entered
in any court having jurisdiction thereof. Such arbitration shall be conducted in a mutually acceptable location. Except as expressly
set forth below, the procedures specified herein shall be the sole and exclusive procedures for the resolution of Disputes; provided,
however, that the Borrower or the Bank may seek provisional or ancillary remedies, such as preliminary injunctive relief, from
a court having jurisdiction, before, during or after the pendency of any arbitration proceeding. The institution and maintenance
of any action for such judicial relief, or pursuit of provisional or ancillary remedies, shall not constitute a waiver of the right
or obligation of any party to submit any claim or dispute to arbitration. Nothing herein shall in any way limit or modify any remedies
available to the Bank under the Loan Documents or otherwise at law or in equity.

 

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(ii) Motion
Practice. In any arbitration hereunder, the arbitrator(s) shall decide any pre-hearing motions which are substantially similar
to pre-hearing motions to dismiss for failure to state a claim or motions for summary adjudication.

 

(iii) Discovery.
Discovery shall be limited to the pre-hearing exchange of all documents which the Borrower and the Bank intend to introduce at
the hearing and any expert reports prepared by any expert who will testify at the hearing.

 

(iv) Sequential
Hearing Days. At the administrative conference conducted by the AAA, the Borrower and the Bank and the AAA shall determine
how to ensure that the hearing is started and completed on sequential hearing days. Potential arbitrators shall be informed of
the anticipated length of the hearing and they shall not be subject to appointment unless they agree to abide by the parties’
intent that, absent exigent circumstances, the hearing shall be conducted on sequential days.

 

(v) Award.
The award of the arbitrator(s) shall be accompanied by a statement of the reasons upon which such award is based.

 

(vi) Fees
and Expenses. The Borrower and the Bank shall each bear equally all fees and costs and expenses of the arbitration, and each
shall bear its own legal fees and expenses and the costs of its experts and witnesses; provided, however, that if the arbitration
panel shall award to a party substantially all relief sought by such party, then, notwithstanding any applicable governing law
provisions, the other party shall pay all costs, fees and expenses incurred by the prevailing party and such costs, fees and expenses
shall be included in such award.

 

(vii) Confidentiality
of Disputes. The entire procedure shall be confidential and none of the parties nor arbitrator(s) may disclose the existence,
content, or results of any arbitration hereunder without the written consent of all parties to the Dispute, except (i) to the extent
disclosure is required to enforce any applicable arbitration award or may otherwise be required by law and (ii) that either party
may make such disclosures to its regulators, auditors, accountants, attorneys and insurance representatives. No conduct, statements,
promises, offers, views, or opinions of any party involved in an arbitration hereunder shall be discoverable or admissible for
any purposes in litigation or other proceedings involving the parties to the Dispute and shall not be disclosed to anyone not an
agent, employee, expert, witness, or representative for any of such parties.

 

    -10- 

     

    

  

(viii) CLASS
ACTION WAIVER. THE BORROWER HEREBY WAIVES, WITH RESPECT TO ANY DISPUTE: (I) THE RIGHT TO PARTICIPATE IN A CLASS ACTION, PRIVATE
ATTORNEY GENERAL ACTION OR OTHER REPRESENTATIVE ACTION IN COURT OR IN ARBITRATION, EITHER AS A CLASS REPRESENTATIVE OR CLASS MEMBER;
AND (II) THE RIGHT TO JOIN OR CONSOLIDATE CLAIMS WITH CLAIMS OF ANY OTHER PERSON. The foregoing waiver is referred to herein
as the “class action waiver”. The Bank and the Borrower agree that no arbitrator shall have authority to conduct any
arbitration in violation of the class action waiver or to issue any relief that applies to any person or entity other than the
Borrower and/or the Bank individually. The parties acknowledge that this class action waiver is material and essential to the arbitration
of any claims and is non-severable from this Dispute Resolution section. If the class action waiver is voided, found unenforceable,
or limited with respect to any claim for which the Borrower seeks class-wide relief, then this Dispute Resolution section (except
for this sentence) shall be null and void with respect to such claim, subject to the right to appeal the limitation or invalidation
of the class action waiver. However, this Dispute Resolution section shall remain valid with respect to all other claims and Disputes.
The parties acknowledge and agree that under no circumstances will a class action be arbitrated.

 

(ix) Applicability
of Federal Arbitration Act. This Note evidences transaction(s) in interstate commerce, and thus the Federal Arbitration Act
governs the interpretation and enforcement of this Dispute Resolution section.

 

REMAINDER OF PAGE INTENTIONALLY LEFT
BLANK

 

    -11- 

     

    

 

If the Borrower is a legal entity, the
undersigned certifies to the Bank that the undersigned (individually and collectively if more than one, the “Authorized Representative”)
is and was authorized and directed to (1) execute and deliver, including to electronically execute and deliver, in the name of
and on behalf of the Borrower, this Note and any other documents executed in connection with this Note or the Facility, all in
such form as may be requested by the Bank or required under the Program and any of which may contain a provision waiving the right
to trial by jury; (ii) execute and deliver to or in favor of, including to electronically execute and deliver to or in favor of,
the Bank any amendments, modifications, renewals or supplements of or to any of the foregoing agreements, documents or instruments;
(iii) take any other action requested, required or deemed advisable by the Bank in order to effectuate the foregoing; and (iv)
delegate the foregoing duties to other representatives of the Borrower. The undersigned further certifies that the Authorized Representative
holds the office, title or status with the Borrower specified below the Authorized Representative’s signature.

 

The Borrower acknowledges that it has
read and understands all the provisions of this Note, including the waiver of jury trial, arbitration and class action waiver,
and has been advised by counsel as necessary or appropriate, or has elected not to seek the advice of counsel.

 

WITNESS the due execution hereof
as a document under seal, as of the date first written above, with the intent to be legally bound hereby.

 

	 	VIRPAX PHARMACEUTICALS, INC.
	 	 	 
	 	By:	E-signed by Anthony Mack
	 	 	On 05-08-2020  14:38:59 EDT
	 	 	(SEAL)
	 	 	 
	 	Anthony Mack, President

 

    -12- 

     

    

 

EXHIBIT A

TO PAYCHECK PROTECTION PROGRAM TERM
NOTE

 

DISBURSEMENT AND PAYMENT AUTHORIZATION
INSTRUCTIONS

 

Loan Disbursement Authorization:

 

Borrower authorizes and directs the Bank
to disburse the proceeds of the Facility as directed below. Each authorized representative of the Borrower is authorized to make
this request, the Bank is entitled to rely conclusively on the below instructions to make disbursements in the amount and manner
specified.

 

Disbursements

 

Disburse the proceeds of the Facility into
the Borrower’s demand deposit account with PNC Bank, Account No. 8401880041.

 

Automatic Payment Authorization Under
Facility:

 

The Borrower irrevocably authorizes and
directs the Bank to charge any deposit account identified above and maintained at the Bank (or such other account at the Bank as
the undersigned may designate to the Bank in writing from time to time) for all payments of principal and interest due or fees
on the Facility, and to debit such account for the amount of such payments on the date each payment is due. The Borrower acknowledges
and agrees that, to the extent there are insufficient funds in any such account to pay the required amounts when due, the Borrower
shall immediately pay to the Bank all sums remaining unpaid. This authorization supplements, and does not limit, the Bank’s
rights under the promissory note(s) and other documents evidencing or securing the Facility. The Bank is entitled to rely conclusively
on this authorization until this authorization is terminated by the Bank or the Borrower, and the Bank has had a reasonable time
to act thereon.

 

    -13- 

     

    

 

 

Paycheck Protection Program Certification

 

May 04, 2020

 

VIRPAX PHARMACEUTICALS, INC. (the “Borrower”)
has applied to PNC Bank, National Association (the “Bank”) for a Small Business Association (“SBA”)
7(a) Paycheck Protection Program loan (the “PPP Loan”).

 

The below signer understands that the statements
made in this certification are part of the agreement with the Bank and that the Bank will rely on these statements when deciding
whether or not to make the PPP Loan.

 

I certify, acknowledge and agree that (a)
if the Borrower is not a natural person, I am an authorized officer of the Borrower and am authorized on behalf of the Borrower
to certify to the statements provided below, and (b) if the Borrower is a natural person, the undersigned certifies to the statements
below, and (c) in either case, the following are true and correct statements:

 

		1.	The Borrower was in operation on February 15, 2020 and, if Borrower is not a self-employed worker
or independent contractor, had employees for whom it paid salaries and payroll taxes.

 

		2.	The uncertainty of current economic conditions makes necessary the PPP Loan request to support
the ongoing operations of the Borrower.

 

		3.	The proceeds of the PPP Loan will be used to retain workers and maintain payroll or make mortgage
interest payments, lease payments, and utility payments; and at least 75 percent of the proceeds of the PPP Loan will be used for
payroll expenses. If the funds are knowingly used for unauthorized purposes, the federal government may hold the undersigned and
the Borrower legally liable such as for charges of fraud.

 

		4.	Documentation verifying the number of full-time equivalent employees on the Borrower’s payroll
as well as the dollar amounts of payroll costs, covered mortgage interest payments, covered rent payments, and covered utilities
for the eight week period following the disbursement of the PPP Loan will be provided to the Bank.

 

		5.	The Borrower understands and agrees that loan forgiveness may be provided if the Borrower uses
all of the loan proceeds for documented payroll costs, covered mortgage interest payments, covered rent payments, and covered utilities.
The actual amount forgiven will be determined in accordance with the requirements of the Program, including the provisions of Section
1106 of the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) (P.L. 116-136), and in no event may more than 25 percent
of the forgiven amount be attributable to non-payroll costs.

 

    -1-

     

    

 

		6.	The Borrower does not have any other PPP Loan applications pending and will not apply for another
PPP Loan. During the period beginning on February 15, 2020 and ending on December 31, 2020 Borrower has not received and will not
receive another PPP Loan.

 

		7.	The Borrower shall notify the Bank if the Borrower received an SBA Economic Injury Disaster Loan
(“EIDL”) between January 31, 2020 and April 3, 2020 and the proceeds of such EIDL were or are used to retain
workers and maintain payroll; in such circumstances the proceeds of the PPP Loan must be used to refinance any such EIDL.

 

		8.	The information provided in the PPP Loan application and the information provided in all supporting
documents and forms is true and accurate in all material respects. Each of the undersigned understands that knowingly making a
false statement to obtain a guaranteed loan from SBA is punishable under the law, including under 18 USC 1001 and 3571 by imprisonment
of not more than five years and/or a fine of up to $250,000; under 15 USC 645 by imprisonment of not more than two years and/or
a fine of not more than $5,000; and, if submitted to a federally insured institution, under 18 USC 1014 by imprisonment of not
more than thirty years and/or a fine of not more than $1,000,000.

 

		9.	The Borrower acknowledges that the Bank will confirm the eligible PPP Loan amount using the Borrower’s
information that it has submitted, including without limitation, tax returns and tax transcripts (collectively, the “Tax
Information”). The Borrower affirms that the Tax Information is identical to that submitted to the Internal Revenue Service.
The Borrower also understands, acknowledges, and agrees that the Bank can share the Borrower’s Tax Information with (i) the
SBA’s authorized representatives, including authorized representatives of the SBA Office of Inspector General, (ii) the Bank’s
affiliates, and its and their respective directors, officers, employees, agents and advisors (the “Representatives”),
and (iii) any actual or potential owners of a credit facility extended by the Bank or its Representatives to the Borrower, any
acquirers of any beneficial or other interest in such credit facility, guarantor, servicers or service providers for such parties,
and their successors and/or assigns (the “Other Loan Participants”) for the purpose of (w) compliance with SBA
loan program requirements and all SBA reviews, (x) originating, maintaining, managing, monitoring, servicing, selling, insuring,
and securitizing a credit facility; (y) enforcing any of its rights or remedies under the loan documents applicable to such credit
facility (including, without limitation, in connection with any collection action related thereto) or (z) as otherwise permitted
by applicable laws, including state and federal privacy and data security laws, or if required to do so by legal process, regulation
or law, or in defense of any claims or causes of action against the Bank or any of its Representatives.

 

	 	VIRPAX PHARMACEUTICALS, INC.
	 	 	 
	 	By:	E-signed by Anthony Mack
	 	 	On 05-08-2020  14:39:12 EDT
	 	 	(SEAL)
	 	 	 
	 	Anthony Mack, President

 

 

-2-Exhibit
10.28

 

PUBLIC
HEALTH SERVICE

 

COOPERATIVE
RESEARCH AND DEVELOPMENT AGREEMENT

 

This
Agreement is based on the model Cooperative Research and Development Agreement (“CRADA”) 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 CRADA:

 

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

National Center for Advancing Translational Sciences (NCATS) an Institute or Center (hereinafter referred to as the “IC”)
of the

NIH

and

 

VIRPAX
Pharmaceuticals Inc.,

hereinafter referred to as the “Collaborator”,

having
offices at 1554 Paoli Pike, #279 | West Chester, PA 19380,

created and operating under the laws of Delaware.

 

     

     

    

 

COOPERATIVE
RESEARCH AND DEVELOPMENT AGREEMENT

 

Article
1. Introduction

 

This
CRADA between IC and Collaborator will be effective when signed by the Parties, which are identified on both the Cover Page and
the Signature Page. The official contacts for the Parties are identified on the Contacts Information Page. Publicly available
information regarding this CRADA appears on the Summary Page. The research and development activities that will be undertaken
by IC and Collaborator in the course of this CRADA are detailed in the Research Plan, attached as Appendix A. The staffing, funding,
and materials contributions of the Parties are set forth in Appendix B. Any changes to the model CRADA are set forth in Appendix
C.

 

NCATS
personnel will be working diligently to characterize the agents provided to them with the goal of making them viable clinical
candidates. In the course of that work it is likely that NCATS personnel may make patentable inventions based on the agents or
their method of use. The parties agree and understand that the NCATS/NIH as a U.S. Federal Government lab will own a sole interest
in sole inventions and a joint interest in joint inventions, where inventorship will be determined by U.S. patent law, regardless
of the collaborator’s ownership interest in the agent itself or patents directed to it.

 

Article
2. Definitions

 

The
terms listed in this Article will carry the meanings indicated throughout the CRADA. To the extent a definition of a term as provided
in this Article is inconsistent with a corresponding definition in the applicable sections of either the United States Code (U.S.C.)
or the Code of Federal Regulations (C.F.R.), the definition in the U.S.C. or C.F.R. will control.

 

		2.1	“Affiliate”
                                         means any corporation or other business entity controlled by, controlling, or under common
                                         control with Collaborator at any time during the term of the CRADA. For this purpose,
                                         “control” means direct or indirect beneficial ownership of at least fifty
                                         percent (50%) of the voting stock or at least fifty percent (50%) interest in the income
                                         of the corporation or other business entity.

 

		2.2	“Background
                                         Invention” means an Invention conceived and first actually reduced to practice
                                         before the Effective Date.

 

		2.2.1	“Background
                                         Data and Information” means all data and information owned by or in the possession
                                         of the CRADA Collaborator that is related to the CRADA Research Plan. This may include,
                                         but is not limited to, safety, toxicity, ADME, and/or animal data.

 

		2.3	“Collaborator
                                         Materials” means all tangible materials not first produced in the performance
                                         of this CRADA that are owned or controlled by Collaborator and used in the performance
                                         of the Research Plan.

 

    	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 2 of 26	Confidential	Revised August 1, 2012

     

    

 

		2.4	“Confidential
                                         Information” means confidential scientific, business, or financial information
                                         provided that the information does not include:

 

		(a)	information
                                         that is publicly known or that is available from public sources;

 

		(b)	information
                                         that has been made available by its owner to others without a confidentiality obligation;

 

		(c)	information
                                         that is already known by the receiving Party, or information that is independently created
                                         or compiled by the receiving Party without reference to or use of the provided information;
                                         or

 

		(d)	information
                                         that relates to potential hazards or cautionary warnings associated with the production,
                                         handling, or use of the subject matter of the Research Plan.

 

		2.5	“Cooperative
                                         Research and Development Agreement” or “CRADA” means this
                                         Agreement, entered into pursuant to the Federal Technology Transfer Act of 1986, as amended(15
                                         U.S.C. §§ 3710a et seq.), and Executive Order 12591 of April 10, 1987.

 

		2.6	“CRADA
                                         Data” means all recorded information first produced in the performance of the
                                         Research Plan.

 

		2.7	“CRADA
                                         Materials” means all tangible materials first produced in the performance of
                                         the Research Plan other than CRADA Data.

 

		2.8	“CRADA
                                         Subject Invention” means any Invention of either or both Parties, conceived
                                         or first actually reduced to practice in the performance of the Research Plan.

 

		2.9	“Effective
                                         Date” means May 06, 2020, the effective date of the Letter of Intent, which
                                         was signed by the Parties.

 

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

 

		2.11	“IC
                                         Materials” means all tangible materials not first produced in the performance
                                         of this CRADA that are owned or controlled by IC and used in the performance of the Research
                                         Plan.

 

		2.12	“Invention”
                                         means any invention or discovery that is or may be patentable or otherwise protected
                                         under Title 35 of the United States Code, or any novel variety of plant which is or may
                                         be protectable under the Plant Variety Protection Act, 7 U.S.C. §§ 2321 et
                                         seq.

 

		2.13	“Patent
                                         Application” means an application for patent protection for a CRADA Subject
                                         Invention with the United States Patent and Trademark Office (“U.S.P.T.O.”)
                                         or the corresponding patent-issuing authority of another nation.

 

		2.14	“Patent”
                                         means any issued United States patent, any international counterpart(s), and any corresponding
                                         grant(s) by a non-U.S. government in place of a patent.

 

		2.15	“Principal
                                         Investigator(s)” or “PI(s)” means the person(s) designated
                                         by the Parties who will be responsible for the scientific and technical conduct of the
                                         Research Plan.

 

    	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 3 of 26	Confidential	Revised August 1, 2012

     

    

 

		2.16	“Research
                                         Plan” means the statement in Appendix A of the respective research and development
                                         commitments of the Parties.

 

Article
3. Cooperative Research and Development

 

		3.1	Performance
                                         of Research and Development. The research and development activities to be carried
                                         out under this CRADA will be performed solely by the Parties identified on the Cover
                                         Page unless specifically stated elsewhere in this Agreement. The PIs will be responsible
                                         for the scientific and technical conduct of this project on behalf of their employers.
                                         Any Collaborator employees who will work at IC facilities will be required to sign an
                                         agreement appropriately modified in view of the terms of this CRADA.

 

All
Parties acknowledge and agree that IC may share Collaborator Materials and Collaborator Confidential Information with the NCATS
Therapeutic Development Branch’s (TDB) prime contractor or its subcontractors in fulfillment of the CRADA Research Plan.
The TDB prime contractor is subject to a Determination of Exceptional Circumstances (35 U.S.C. § 202(a)(ii)) under the Bayh-Dole
Act, which obligates it to assign inventions made by its employees to the United States Government. To the extent that subcontractors
of the NCATS TDB prime contractor use Collaborator Materials, or Collaborator Background Information and/or Data or any materials
or information which is proprietary to the CRADA Collaborator in fulfillment of the CRADA Research Plan, the subcontractor is
thereby subject to a Determination of Exceptional Circumstances (35 U.S.C. § 202(a)(ii)) under the Bayh-Dole Act. Accordingly
the said subcontractor is obligated to assign inventions made by its employees arising from such use of materials or information
which is proprietary to the CRADA Collaborator, Collaborator Materials, Collaboration Background Information and/or Data to the
United States Government. For the purposes of this Agreement, such inventions will be considered jointly developed “CRADA
Subject Inventions” and will be jointly owned by Collaborator and IC.

 

		3.2	Research
                                         Plan. The Parties recognize that the Research Plan describes the collaborative research
                                         and development activities they will undertake and that interim research goals set forth
                                         in the Research Plan are good faith guidelines. Should events occur that require modification
                                         of these goals, then by mutual agreement the Parties can modify them through an amendment,
                                         according to Paragraph 13.6.

 

		3.3	Use
                                         and Disposition of Collaborator Materials and IC Materials. The Parties agree to
                                         use Collaborator Materials and IC Materials only in accordance with the Research Plan,
                                         not to transfer these materials to third parties except in accordance with the Research
                                         Plan or as approved by the owning or providing Party, and, upon expiration or termination
                                         of the CRADA, to dispose of these materials as directed by the owning or providing Party.

 

		3.4	Third-Party
                                         Rights in Collaborator’s CRADA Subject Inventions. If Collaborator has received
                                         (or will receive) support of any kind from a third party in exchange for rights in any
                                         of Collaborator’s CRADA Subject Inventions, Collaborator agrees to ensure that
                                         its obligations to the third party are both consistent with Articles 6 through 8 and
                                         subordinate to Article 7 of this CRADA.

 

    	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 4 of 26	Confidential	Revised August 1, 2012

     

    

 

		3.5	Disclosures
                                         to IC. Prior to execution of this CRADA, Collaborator agrees to disclose to IC all
                                         instances in which outstanding royalties are due under a PHS license agreement, and in
                                         which Collaborator had a PHS license terminated in accordance with 37 C.F.R. § 404.10.
                                         These disclosures will be treated as Confidential Information upon request by Collaborator
                                         in accordance with Paragraphs 2.4, 8.3, and 8.4.

 

Article
4. Reports

 

		4.1	Interim
                                         Research and Development Reports. The PIs should exchange information quarterly,
                                         in writing. This exchange may be accomplished through meeting minutes, annual reports,
                                         detailed correspondence (including e-mail), and circulation of draft manuscripts. Additionally,
                                         quarterly meeting of the PI’s will be held for the purpose of identifying new CRADA
                                         Subject Inventions and putative inventors that may have arisen from the work being conducted
                                         under the Research Plan.

 

		4.2	Final
                                         Research and Development Reports. The Parties will exchange final reports of their
                                         results within forty-five (45) days after the expiration or termination of this CRADA.
                                         These reports will set forth the technical progress made; any publications arising from
                                         the research; and the existence of invention disclosures of potential CRADA Subject Inventions
                                         and/or any corresponding Patent Applications.

 

		4.3	Additional
                                         Reports. The Collaborator will be expected to report to the ICD certain FDA milestones
                                         it achieves (such as IND filing, Phase 1, 2 and 3 Trials, etc.) and other major business
                                         related events. Other major business related events, may include but are not limited
                                         to, third party alliances to co-develop the lead compound, change in the development
                                         of indication stated in the CRADA Research Plan.

 

		4.4	Fiscal
                                         Reports. If Collaborator has agreed to provide funding to IC under this CRADA and
                                         upon the request of Collaborator, then concurrent with the exchange of final research
                                         and development reports according to Paragraph 4.2, IC will submit to Collaborator a
                                         statement of all costs incurred by IC for the CRADA. If the CRADA has been terminated,
                                         IC will specify any costs incurred before the date of termination for which IC has not
                                         received funds from Collaborator, as well as for all reasonable termination costs including
                                         the cost of returning Collaborator property or removal of abandoned Collaborator property,
                                         for which Collaborator will be responsible.

 

Article
5. Staffing, Financial, and Materials Obligations

 

		5.1	IC
                                         and Collaborator Contributions. The contributions of any staff, funds, materials,
                                         and equipment by the Parties are set forth in Appendix B. The Federal Technology Transfer
                                         Act of 1986, 15 U.S.C. § 3710a(d)(1) prohibits IC from providing funds to Collaborator
                                         for any research and development activities under this CRADA.

 

		5.2	IC
                                         Staffing. No IC employees will devote 100% of their effort or time to the research
                                         and development activities under this CRADA. IC will not use funds provided by Collaborator
                                         under this CRADA for IC personnel to pay the salary of any permanent IC employee. Although
                                         personnel hired by IC using CRADA funds will focus principally on CRADA research and
                                         development activities, Collaborator acknowledges that these personnel may nonetheless
                                         make contributions to other research and development activities, and the activities will
                                         be outside the scope of this CRADA.

 

    	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 5 of 26	Confidential	Revised August 1, 2012

     

    

 

		5.3	Collaborator
                                         Funding. Collaborator acknowledges that Government funds received by Collaborator
                                         from an agency of the Department of Health and Human Services may not be used to fund
                                         IC under this CRADA. If Collaborator has agreed to provide funds to IC then the payment
                                         schedule appears in Appendix B and Collaborator will make payments according to that
                                         schedule. If Collaborator fails to make any scheduled payment, IC will not be obligated
                                         to perform any of the research and development activities specified herein or to take
                                         any other action required by this CRADA until the funds are received. IC will use these
                                         funds exclusively for the purposes of this CRADA. Each Party will maintain separate and
                                         distinct current accounts, records, and other evidence supporting its financial obligations
                                         under this CRADA and, upon written request, will provide the other Party a Fiscal Report
                                         according to Paragraph 4.3, which delineates all payments made and all obligated expenses,
                                         along with the Final Research Report described in Paragraph 4.2.

 

		5.4	Capital
                                         Equipment. Collaborator’s commitment, if any, to provide IC with capital equipment
                                         to enable the research and development activities under the Research Plan appears in
                                         Appendix B. If Collaborator transfers to IC the capital equipment or provides funds for
                                         IC to purchase it, then IC will own the equipment. If Collaborator loans capital equipment
                                         to IC for use during the CRADA, Collaborator will be responsible for paying all costs
                                         and fees associated with the transport, installation, maintenance, repair, removal, or
                                         disposal of the equipment, and IC will not be liable for any damage to the equipment.

 

Article
6. Intellectual Property

 

		6.1	Ownership
                                         of CRADA Subject Inventions, CRADA Data, and CRADA Materials. Subject to the Government
                                         license described in Paragraph 7.5, the sharing requirements of Paragraph 8.1, and the
                                         regulatory filing requirements of Paragraph 8.2, the producing Party will retain sole
                                         ownership of and title to all CRADA Subject Inventions, all copies of CRADA Data, and
                                         all CRADA Materials produced solely by its employee(s). The Parties will own jointly
                                         all CRADA Subject Inventions invented jointly and all copies of CRADA Data and all CRADA
                                         Materials developed jointly.

 

		6.2	Reporting.
                                         The Parties will promptly report to each other in writing each CRADA Subject Invention
                                         reported by their respective personnel, and any Patent Applications filed thereon, resulting
                                         from the research and development activities conducted under this CRADA. Each Party will
                                         report all CRADA Subject Inventions to the other Party in sufficient detail to determine
                                         inventorship, which will be determined in accordance with U.S. patent law. These reports
                                         will be treated as Confidential Information in accordance with Article 8. Formal reports
                                         will be made by and to the Patenting and Licensing Offices identified on the Contacts
                                         Information Page herein.

 

    	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 6 of 26	Confidential	Revised August 1, 2012

     

    

 

		6.3	Filing
                                         of Patent Applications. Each Party will make timely decisions regarding the filing
                                         of Patent Applications on the CRADA Subject Inventions made solely by its employee(s),
                                         and will notify the other Party in advance of filing. Collaborator will have the first
                                         opportunity to file a Patent Application on joint CRADA Subject Inventions and will notify
                                         PHS of its decision within sixty (60) days of an Invention being reported or at least
                                         thirty (30) days before any patent filing deadline, whichever occurs sooner. If Collaborator
                                         fails to notify PHS of its decision within that time period or notifies PHS of its decision
                                         not to file a Patent Application, then PHS has the right to file a Patent Application
                                         on the joint CRADA Subject Invention. Neither Party will be obligated to file a Patent
                                         Application. Collaborator will place the following statement in any Patent Application
                                         it files on a CRADA Subject Invention: “This invention was created in the performance
                                         of a Cooperative Research and Development Agreement with the [INSERT into Agency’s
                                         model as appropriate: National Institutes of Health, Food and Drug Administration, Centers
                                         for Disease Control and Prevention], an Agency of the Department of Health and Human
                                         Services. The Government of the United States has certain rights in this invention.”
                                         If either Party files a Patent Application on a joint CRADA Subject Invention, then the
                                         filing Party will include a statement within the Patent Application that clearly identifies
                                         the Parties and states that the joint CRADA Subject Invention was made under this CRADA.

 

		6.4	Patent
                                         Expenses. Unless agreed otherwise, the Party filing a Patent Application will pay
                                         all preparation and filing expenses, prosecution fees, issuance fees, post issuance fees,
                                         patent maintenance fees, annuities, interference expenses, and attorneys’ fees
                                         for that Patent Application and any resulting Patent(s). If a license to any CRADA Subject
                                         Invention is granted to Collaborator, then Collaborator will be responsible for all expenses
                                         and fees, past and future, in connection with the preparation, filing, prosecution, and
                                         maintenance of any Patent Applications and Patents claiming exclusively-licensed CRADA
                                         Subject Inventions and will be responsible for a pro-rated share, divided equally among
                                         all licensees, of those expenses and fees for non-exclusively licensed CRADA Subject
                                         Inventions. Collaborator may waive its exclusive option rights at any time, and incur
                                         no subsequent financial obligation for those Patent Application(s) or Patent(s).

 

		6.5	Prosecution
                                         of Patent Applications. The Party filing a Patent Application will provide the non-filing
                                         Party with a copy of any official communication relating to prosecution of the Patent
                                         Application within thirty (30) days of transmission of the communication. Each Party
                                         will also provide the other Party with the power to inspect and make copies of all documents
                                         retained in the applicable Patent Application or Patent file. The Parties agree to consult
                                         with each other regarding the prosecution of Patent Applications directed to joint CRADA
                                         Subject Inventions. If Collaborator elects to file and prosecute Patent Applications
                                         on joint CRADA Subject Inventions, then Collaborator agrees to use the U.S.P.T.O. Customer
                                         Number Practice and/or grant PHS a power(s) of attorney (or equivalent) necessary to
                                         assure PHS access to its intellectual property rights in these Patent Applications. PHS
                                         and Collaborator will cooperate with each other to obtain necessary signatures on Patent
                                         Applications, assignments, or other documents.

 

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Article
7. Licensing

 

		7.1	Background
                                         Inventions. Other than as specifically stated in this Article 7, nothing in this
                                         CRADA will be construed to grant any rights in one Party’s Background Invention(s)
                                         to the other Party, except to the extent necessary for the Parties to conduct the research
                                         and development activities described in the Research Plan.

 

		7.2	Collaborator’s
                                         License Option to CRADA Subject Inventions. With respect to Government rights to
                                         any CRADA Subject Invention made solely by an IC employee(s) or made jointly by an IC
                                         employee(s) and a Collaborator employee(s) for which a Patent Application was filed,
                                         PHS hereby grants to Collaborator an exclusive option to elect an exclusive or nonexclusive
                                         commercialization license. The license will be substantially in the form of the appropriate
                                         model PHS license agreement and will fairly reflect the nature of the CRADA Subject Invention,
                                         the relative contributions of the Parties to the CRADA Subject Invention and the CRADA,
                                         a plan for the development and marketing of the CRADA Subject Invention, the risks incurred
                                         by Collaborator, and the costs of subsequent research and development needed to bring
                                         the CRADA Subject Invention to the marketplace. The field of use of the license will
                                         not exceed the scope of the Research Plan.

 

		7.3	Exercise
                                         of Collaborator’s License Option. To exercise the option of Paragraph 7.2 Collaborator
                                         must submit a written notice to the PHS Patenting and Licensing Contact identified on
                                         the Contacts Information Page (and provide a copy to the IC Contact for CRADA Notices)
                                         within three (3) months after either (i) Collaborator receives written notice from PHS
                                         that the Patent Application has been filed or (ii) the date on which Collaborator files
                                         the Patent Application. The written notice exercising this option will include a completed
                                         “Application for License to Public Health Service Inventions” and will initiate
                                         a negotiation period that expires nine (9) months after the exercise of the option. If
                                         PHS has not responded in writing to the last proposal by Collaborator within this nine
                                         (9) month period, the negotiation period will be extended to expire one (1) month after
                                         PHS so responds, during which month Collaborator may accept in writing the final license
                                         proposal of PHS. In the absence of Collaborator’s exercise of the option, or upon
                                         election of a nonexclusive license, PHS will be free to license the CRADA Subject Invention
                                         to others. These time periods may be extended at the sole discretion of PHS upon good
                                         cause shown in writing by Collaborator.

 

		7.4	Government
                                         License in IC Sole CRADA Subject Inventions and Joint CRADA Subject Inventions. Pursuant
                                         to 15 U.S.C. § 3710a(b)(1)(A), for CRADA Subject Inventions owned solely by IC or
                                         jointly by IC and Collaborator, and licensed pursuant to the option of Paragraph 7.2,
                                         Collaborator grants to the Government a nonexclusive, nontransferable, irrevocable, paid-up
                                         license to practice the CRADA Subject Invention or have the CRADA Subject Invention practiced
                                         throughout the world by or on behalf of the Government. In the exercise of this license,
                                         the Government will not publicly disclose trade secrets or commercial or financial information
                                         that is privileged or confidential within the meaning of 5 U.S.C. § 552(b)(4) or
                                         which would be considered privileged or confidential if it had been obtained from a non-federal
                                         party.

 

		7.5	Government
                                         License in Collaborator Sole CRADA Subject Inventions. Pursuant to 15 U.S.C. §
                                         3710a(b)(2), for CRADA Subject Inventions made solely by an employee of Collaborator,
                                         Collaborator grants to the Government a nonexclusive, nontransferable, irrevocable, paid-up
                                         license to practice the CRADA Subject Invention or have the CRADA Subject Invention practiced
                                         throughout the world by or on behalf of the Government for research or other Government
                                         purposes.

 

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		7.6	Third
                                         Party License. Pursuant to 15 U.S.C. § 3710a(b)(1)(B), if PHS grants an exclusive
                                         license to a CRADA Subject Invention made solely by an IC employee or jointly with a
                                         Collaborator employee, the Government will retain the right to require Collaborator to
                                         grant to a responsible applicant a nonexclusive, partially exclusive, or exclusive sublicense
                                         to use the CRADA Subject Invention in Collaborator’s licensed field of use on terms
                                         that are reasonable under the circumstances; or, if Collaborator fails to grant a license,
                                         to grant the license itself. The exercise of these rights by the Government will only
                                         be in exceptional circumstances and only if the Government determines (i) the action
                                         is necessary to meet health or safety needs that are not reasonably satisfied by Collaborator,
                                         (ii) the action is necessary to meet requirements for public use specified by federal
                                         regulations, and such requirements are not reasonably satisfied by Collaborator; or (iii)
                                         Collaborator has failed to comply with an agreement containing provisions described in
                                         15 U.S.C. § 3710a(c)(4)(B). The determination made by the Government under this
                                         Paragraph is subject to administrative appeal and judicial review under 35 U.S.C. §
                                         203(b).

 

		7.7	Third-Party
                                         Rights In IC Sole CRADA Subject Inventions. For a CRADA Subject Invention conceived
                                         prior to the Effective Date solely by an IC employee that is first actually reduced to
                                         practice after the Effective Date in the performance of the Research Plan, the option
                                         offered to Collaborator in Paragraph 7.2 may be restricted if, before the Effective Date,
                                         PHS had filed a Patent Application and has either offered or granted a license or has
                                         executed a license in the CRADA Subject Invention to a third party. Collaborator nonetheless
                                         retains the right to apply for a license to any such CRADA Subject Invention in accordance
                                         with the terms and procedures of 35 U.S.C. § 209 and 37 C.F.R. Part 404.

 

Article
8. Rights of Access and Publication

 

		8.1	Right
                                         of Access to CRADA Data and CRADA Materials. IC and Collaborator agree to exchange
                                         all CRADA Data and to share all CRADA Materials. If the CRADA is terminated, both Parties
                                         agree to provide CRADA Materials in quantities needed to complete the Research Plan.
                                         Such provision will occur before the termination date of the CRADA or sooner, if required
                                         by the Research Plan.

 

		8.2	Use
                                         of CRADA Data and CRADA Materials. The Parties will be free to utilize CRADA Data
                                         and CRADA Materials internally for their own purposes, consistent with their obligations
                                         under this CRADA. The Collaborator agrees to share all CRADA Background Information and
                                         Data in its possession with IC. The Parties may share CRADA Data or CRADA Materials with
                                         their Affiliates, agents or contractors provided the obligations of this Article 8.2
                                         are simultaneously conveyed.

 

		(a)	CRADA
                                         Data.

 

Collaborator
and IC will use reasonable efforts to keep CRADA Data confidential until published or until corresponding Patent Applications
are filed. To the extent permitted by law, each Party will have the right to use any and all CRADA Data in and for any regulatory
filing by or on behalf of the Party. All CRADA Data will be managed and disseminated in accordance with the NIH HEAL Data Policy
https://heal.nih.gov/about/public-access-data

 

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		(b)	CRADA
                                         Materials.

 

Collaborator
and IC will use reasonable efforts to keep descriptions of CRADA Materials confidential until published or until corresponding
Patent Applications are filed. Collaborator acknowledges that the basic research mission of PHS includes sharing with third parties
for further research those research resources made in whole or in part with NIH funding. Consistent with this mission and the
tenets articulated in “Sharing of Biomedical Research Resources: Principles and Guidelines for Recipients of NIH Research
Grants and Contracts”, December 1999, available at http://www.ott.nih.gov/policy/research_tool.aspx, following publication
either Party may make available to third parties for further research those CRADA Materials made jointly by both PHS and Collaborator.
Notwithstanding the above, if those joint CRADA Materials are the subject of a pending Patent Application or a Patent, the Parties
may agree to restrict distribution or freely distribute them. Either Party may distribute those CRADA Materials made solely by
the other Party only upon written consent from that other Party or that other Party’s designee.

 

		8.3	Confidential
                                         Information. Each Party agrees to limit its disclosure of Confidential Information
                                         to the amount necessary to carry out the Research Plan, and will place a confidentiality
                                         notice on all such information. A Party orally disclosing Confidential Information to
                                         the other Party will summarize the disclosure in writing and provide it to the other
                                         Party within fifteen (15) days of the disclosure. Each Party receiving Confidential Information
                                         agrees to use it only for the purposes described in the Research Plan. Either Party may
                                         object to the designation of information as Confidential Information by the other Party.

 

		8.4	Protection
                                         of Confidential Information. Confidential Information will not be disclosed, copied,
                                         reproduced or otherwise made available to any other person or entity without the consent
                                         of the owning or providing Party except as required by a court or administrative body
                                         of competent jurisdiction, or federal law or regulation. Each Party agrees to use reasonable
                                         efforts to maintain the confidentiality of Confidential Information, which will in no
                                         instance be less effort than the Party uses to protect its own Confidential Information.
                                         Each Party agrees that a Party receiving Confidential Information will not be liable
                                         for the disclosure of that portion of the Confidential Information which, after notice
                                         to and consultation with the disclosing Party, the receiving Party determines may not
                                         be lawfully withheld, provided the disclosing Party has been given a reasonable opportunity
                                         to seek a court order to enjoin disclosure.

 

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		8.5	Protection
                                         of Human Subjects’ Information. The research and development activities to
                                         be conducted under this CRADA are not intended to involve human subjects or human tissues
                                         within the meaning of 45 C.F.R. Part 46 and 21 C.F.R. Part 50. Should it become necessary
                                         to utilize human subjects or human tissues, or to provide a Party with access to information
                                         about identifiable human subjects, the Parties agree to amend this CRADA in accordance
                                         with Paragraph 13.6 to ensure that the research and development activities conducted
                                         hereunder will conform to the appropriate federal laws and regulations, including but
                                         not limited to all applicable FDA regulations and HHS regulations relating to the protection
                                         of human subjects.

 

		8.6	Duration
                                         of Confidentiality Obligation. The obligation to maintain the confidentiality of
                                         Confidential Information will expire at the earlier of the date when the information
                                         is no longer Confidential Information as defined in Paragraph 2.4 or three (3) years
                                         after the expiration or termination date of this CRADA. Collaborator may request an extension
                                         to this term when necessary to protect Confidential Information relating to products
                                         not yet commercialized.

 

		8.7	Publication.
The Parties are encouraged to make publicly available the results of their research and development activities. Authorship and
other matters relating to publications shall be as set forth in the Uniform Requirements for Manuscripts Submitted to Biomedical
Journals of the International Committee of Major Journal Editors (http://www.icmje.org/). Before either Party submits a
paper or abstract for publication or otherwise intends to publicly disclose information about a CRADA Subject Invention, CRADA
Data or CRADA Materials, the other Party will have thirty (30) days to review the proposed publication or disclosure to assure
that Confidential Information is protected. Either Party may request in writing that the proposed publication or other disclosure
be delayed for up to thirty (30) additional days as necessary to file a Patent Application. Any public disclosures in relation
to this agreement must acknowledge the support and funding of the NIH HEAL Initiative.

 

Article
9. Representations and Warranties

 

		9.1	Representations
                                         of IC. IC hereby represents to Collaborator that:

 

		(a)	IC
                                         has the requisite power and authority to enter into this CRADA and to perform according
                                         to its terms, and that IC’s official signing this CRADA has authority to do so.

 

		(b)	To
                                         the best of its knowledge and belief, neither IC nor any of its personnel involved in
                                         this CRADA is presently subject to debarment or suspension by any agency of the Government
                                         which would directly affect its performance of the CRADA. Should IC or any of its personnel
                                         involved in this CRADA be debarred or suspended during the term of this CRADA, IC will
                                         notify Collaborator within thirty (30) days of receipt of final notice.

 

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		9.2	Representations
                                         and Warranties of Collaborator. Collaborator hereby represents and warrants to IC
                                         that:

 

		(a)	Collaborator
                                         has the requisite power and authority to enter into this CRADA and to perform according
                                         to its terms, and that Collaborator’s official signing this CRADA has authority
                                         to do so.

 

		(b)	Neither
                                         Collaborator nor any of its personnel involved in this CRADA, including Affiliates, agents,
                                         and contractors are presently subject to debarment or suspension by any agency of the
                                         Government. Should Collaborator or any of its personnel involved in this CRADA be debarred
                                         or suspended during the term of this CRADA, Collaborator will notify IC within thirty
                                         (30) days of receipt of final notice.

 

		(c)	Subject
                                         to Paragraph 12.3, and if and to the extent Collaborator has agreed to provide funding
                                         under Appendix B, Collaborator is financially able to satisfy these obligations in a
                                         timely manner.

 

Article
10. Expiration and Termination

 

		10.1	Expiration.
                                         This CRADA will expire on the last date of the term set forth on the Summary Page. In
                                         no case will the term of this CRADA extend beyond the term indicated on the Summary Page
                                         unless it is extended in writing in accordance with Paragraph 13.6.

 

		10.2	Termination
                                         by Mutual Consent. IC and Collaborator may terminate this CRADA at any time by mutual
                                         written consent.

 

		10.3	Unilateral
                                         Termination. Either IC or Collaborator may unilaterally terminate this CRADA at any
                                         time by providing written notice at least sixty (60) days before the desired termination
                                         date. IC may, at its option, retain funds transferred to IC before unilateral termination
                                         by Collaborator for use in completing the Research Plan. Reasons for unilateral termination
                                         may include but are not limited to failure to meet or complete project milestones, failure
                                         to disclose all safety and toxicity data related to the project.

 

		10.4	Funding
                                         for IC Personnel. If Collaborator has agreed to provide funding for IC personnel
                                         and this CRADA is mutually or unilaterally terminated by Collaborator before its expiration,
                                         then Collaborator agrees that funds for that purpose will be available to IC for a period
                                         of six (6) months after the termination date or until the expiration date of the CRADA,
                                         whichever occurs sooner. If there are insufficient funds to cover this expense, Collaborator
                                         agrees to pay the difference.

 

		10.5	New
                                         Commitments. Neither Party will incur new expenses related to this CRADA after expiration,
                                         mutual termination, or a notice of a unilateral termination and will, to the extent feasible,
                                         cancel all outstanding commitments and contracts by the termination date. Collaborator
                                         acknowledges that IC will have the authority to retain and expend any funds for up to
                                         one (1) year subsequent to the expiration or termination date to cover any unpaid costs
                                         obligated during the term of the CRADA in undertaking the research and development activities
                                         set forth in the Research Plan.

 

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Article
11. Disputes

 

		11.1	Settlement.
                                         Any dispute arising under this CRADA which is not disposed of by agreement of the Principal
                                         Investigators will be submitted jointly to the signatories of this CRADA. If the signatories,
                                         or their designees, are unable to jointly resolve the dispute within thirty (30) days
                                         after notification thereof, the Assistant Secretary for Health (or his/her designee or
                                         successor) will propose a resolution. Nothing in this Paragraph will prevent any Party
                                         from pursuing any additional administrative remedies that may be available and, after
                                         exhaustion of such administrative remedies, pursuing all available judicial remedies.

 

		11.2	Continuation
                                         of Work. Pending the resolution of any dispute or claim pursuant to this Article
                                         11, the Parties agree that performance of all obligations will be pursued diligently.

 

Article
12. Liability

 

		12.1	NO
                                         WARRANTIES. EXCEPT AS SPECIFICALLY STATED IN ARTICLE 9, THE PARTIES MAKE NO EXPRESS
                                         OR IMPLIED WARRANTY AS TO ANY MATTER WHATSOEVER, INCLUDING THE CONDITIONS OF THE RESEARCH
                                         OR ANY INVENTION OR MATERIAL, WHETHER TANGIBLE OR INTANGIBLE, MADE OR DEVELOPED UNDER
                                         OR OUTSIDE THE SCOPE OF THIS CRADA, OR THE OWNERSHIP, MERCHANTABILITY, OR FITNESS FOR
                                         A PARTICULAR PURPOSE OF THE RESEARCH OR ANY INVENTION OR MATERIAL, OR THAT A TECHNOLOGY
                                         UTILIZED BY A PARTY IN THE PERFORMANCE OF THE RESEARCH PLAN DOES NOT INFRINGE ANY THIRD-PARTY
                                         PATENT RIGHTS.

 

		12.2	Indemnification
                                         and Liability. Collaborator agrees to hold the Government harmless and to indemnify
                                         the Government for all liabilities, demands, damages, expenses and losses arising out
                                         of the use by Collaborator for any purpose of the CRADA Data, CRADA Materials or CRADA
                                         Subject Inventions produced in whole or part by IC employees under this CRADA, unless
                                         due to the negligence or willful misconduct of IC, its employees, or agents. The Government
                                         has no statutory authority to indemnify Collaborator. Each Party otherwise will be liable
                                         for any claims or damages it incurs in connection with this CRADA, except that IC, as
                                         an agency of the Government, assumes liability only to the extent provided under the
                                         Federal Tort Claims Act, 28 U.S.C. Chapter 171.

 

		12.3	Force
                                         Majeure. Neither Party will be liable for any unforeseeable event beyond its reasonable
                                         control and not caused by its own fault or negligence, which causes the Party to be unable
                                         to perform its obligations under this CRADA, and which it has been unable to overcome
                                         by the exercise of due diligence. If a force majeure event occurs, the Party unable
                                         to perform will promptly notify the other Party. It will use its best efforts to resume
                                         performance as quickly as possible and will suspend performance only for such period
                                         of time as is necessary as a result of the force majeure event.

 

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Article
13. Miscellaneous

 

		13.1	Governing
                                         Law. The construction, validity, performance and effect of this CRADA will be governed
                                         by U.S. federal law, as applied by the federal courts in the District of Columbia. If
                                         any provision in this CRADA conflicts with or is inconsistent with any U.S. federal law
                                         or regulation, then the U.S. federal law or regulation will preempt that provision.

 

		13.2	Compliance
                                         with Law. IC and Collaborator agree that they will comply with, and advise their
                                         contractors and agents to comply with, all applicable statutes, Executive Orders, HHS
                                         regulations, and all FDA, CDC, and NIH policies relating to research on human subjects
                                         (45 C.F.R. Part 46, 21 C.F.R. Parts 50 and 56) and relating to the appropriate care and
                                         use of laboratory animals (7 U.S.C. §§ 2131 et seq.; 9 C.F.R. Part 1,
                                         Subchapter A). Additional information on these subjects is available from the HHS Office
                                         for Human Research Protections or from the NIH Office of Laboratory Animal Welfare. Collaborator
                                         agrees to ensure that employees, contractors, and agents of Collaborator who might have
                                         access to a “select agent or toxin” (as that term is defined in 42 C.F.R.
                                         §§ 73.4-73.5) transferred from IC is properly licensed to receive the “select
                                         agent or toxin”.

 

		13.3	Waivers.
                                         None of the provisions of this CRADA will be considered waived by any Party unless a
                                         waiver is given in writing to the other Party. The failure of a Party to insist upon
                                         strict performance of any of the terms and conditions hereof, or failure or delay to
                                         exercise any rights provided herein or by law, will not be deemed a waiver of any rights
                                         of any Party.

 

		13.4	Headings.
                                         Titles and headings of the articles and paragraphs of this CRADA are for convenient reference
                                         only, do not form a part of this CRADA, and will in no way affect its interpretation.

 

		13.5	Severability.
                                         The illegality or invalidity of any provisions of this CRADA will not impair, affect,
                                         or invalidate the other provisions of this CRADA.

 

		13.6	Amendments.
                                         Minor modifications to the Research Plan may be made by the mutual written consent of
                                         the Principal Investigators. Substantial changes to the CRADA, extensions of the term,
                                         or any changes to Appendix C will become effective only upon a written amendment signed
                                         by the signatories to this CRADA or by their representatives duly authorized to execute
                                         an amendment. A change will be considered substantial if it directly expands the range
                                         of the potential CRADA Subject Inventions, alters the scope or field of any license option
                                         governed by Article 7, or requires a significant increase in the contribution of resources
                                         by either Party.

 

		13.7	Assignment.
                                         Neither this CRADA nor any rights or obligations of any Party hereunder shall be assigned
                                         or otherwise transferred by either Party without the prior written consent of the other
                                         Party. The Collaborator acknowledges the applicability of 41 U.S.C. § 15, the Anti
                                         Assignment Act, to this Agreement. The Parties agree that the identity of the Collaborator
                                         is material to the performance of this CRADA and that the duties under this CRADA are
                                         nondelegable.

 

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		13.8	Notices.
                                         All notices pertaining to or required by this CRADA will be in writing, signed by an
                                         authorized representative of the notifying Party, and delivered by first class, registered,
                                         or certified mail, or by an express/overnight commercial delivery service, prepaid and
                                         properly addressed to the other Party at the address designated on the Contacts Information
                                         Page, or to any other address designated in writing by the other Party. Notices will
                                         be considered timely if 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. Notices regarding the exercise of license options will be
                                         made pursuant to Paragraph 7.3. Either Party may change its address by notice given to
                                         the other Party in the manner set forth above.

 

		13.9	Independent
                                         Contractors. The relationship of the Parties to this CRADA is that of independent
                                         contractors and not agents of each other or joint venturers or partners. Each Party will
                                         maintain sole and exclusive control over its personnel and operations.

 

		13.10	Use
                                         of Name; Press Releases. By entering into this CRADA, the Government does not directly
                                         or indirectly endorse any product or service that is or will be provided, whether directly
                                         or indirectly related to either this CRADA or to any patent or other intellectual-property
                                         license or agreement that implements this CRADA by Collaborator, its successors, assignees,
                                         or licensees. Collaborator will not in any way state or imply that the Government or
                                         any of its organizational units or employees endorses any product or service. Each Party
                                         agrees to provide proposed press releases that reference or rely upon the work under
                                         this CRADA to the other Party for review and comment at least seven (7) days prior to
                                         publication. Either Party may disclose the Summary Page to the public without the approval
                                         of the other Party.

 

		13.11	Reasonable
                                         Consent. Whenever a Party’s consent or permission is required under this CRADA,
                                         its consent or permission will not be unreasonably withheld.

 

		13.12	Export
                                         Controls. Collaborator agrees to comply with U.S. export law and regulations. If
                                         Collaborator has a need to transfer any CRADA Materials made in whole or in part by IC,
                                         or IC Materials, or IC’s Confidential Information, to a person located in a country
                                         other than the United States, to an Affiliate organized under the laws of a country other
                                         than the United States, or to an employee of Collaborator in the United States who is
                                         not a citizen or permanent resident of the United States, Collaborator will acquire any
                                         and all necessary export licenses and other appropriate authorizations.

 

		13.13	Entire
                                         Agreement. This CRADA constitutes the entire agreement between the Parties concerning
                                         the subject matter of this CRADA and supersedes any prior understanding or written or
                                         oral agreement.

 

		13.14	Survivability.
                                         The provisions of Paragraphs 3.3, 3.4, 4.2, 4.3, 5.3, 5.4, 6.1-9.2, 10.3-10.5, 11.1,
                                         12.1-12.3, 13.1-13.3, 13.10 and 13.14 will survive the expiration or early termination
                                         of this CRADA.

 

SIGNATURES
BEGIN ON THE NEXT PAGE

 

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Public
Health Service

Cooperative
Research and Development Agreement

 

SIGNATURE
PAGE

 

ACCEPTED
AND AGREED

 

By
executing this agreement, each Party represents that all statements made herein are true, complete, and accurate to the best of
its knowledge. Collaborator acknowledges that it may be subject to criminal, civil, or administrative penalties for knowingly
making a false, fictitious, or fraudulent statement or claim.

 

	FOR IC:	 	 
	 	 	 
	 	 	 
	Signature	 	Date
	 	 	 
	 	 	 
	Typed Name	 	 
	 	 	 
	 	 	 
	Title	 	 
	 	 	 
	FOR COLLABORTOR:	 	 
	 	 	 
	 	 	 
	Signature	 	Date
	 	 	 
	 	 	 
	Typed Name	 	 
	 	 	 
	 	 	 
	Title	 	 

 

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Public
Health Service

Cooperative
Research and Development Agreement

 

CONTACTS
INFORMATION PAGE

 

CRADA
Notices

 

	For IC:	For Collaborator:
	 	 
	Lili Portilla, MPA	Shana Panzarella Director of Strategic
	Alliances, NCATS	Chief of Staff
	9800 Medical Center Drive, Room 3042B	1554 Paoli Pike, PMB 279
	 	West Chester, PA 19380
	Tel:  301-827-7170	Tel/Fax:  484-880-4588
	Email: lilip@nih.gov	Email: spanzarella@virpaxpharma.com

 

Patenting
and Licensing

 

	For IC:	For Collaborator (if separate from above):
	 	 
	Tel: 301-827-4301	Tel: 484-880-4588
	Email: kenxeo@aol.com	 

 

Delivery
of Materials Identified In Appendix B (if any)

 

	For IC:	For Collaborator:
	 	 
	Junfeng Huang, PhDp	Anthony Mack, Chairman & CEO
	NCATS, NIH	1554 Paoli Pike, PMB 279
	9800 Medical Center Drive, 224W	West Chester, PA 19380
	Rockville, MD 20892-3370	 
	Tel:  301.827.7162 (JH); 301.827.0980 (SH)	Tel/Fax: 484-880-4588
	Email: Junfeng.Huang@nih.gov;	Email: amack@virpaxpharma.com
	sharie.haugabook@nih.gov	 

 

    	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 17 of 26	Confidential	Revised August 1, 2012

     

    

 

Public
Health Service

Cooperative
Research and Development Agreement

 

SUMMARY
PAGE

 

EITHER
PARTY MAY, WITHOUT FURTHER CONSULTATION OR PERMISSION, RELEASE THIS SUMMARY PAGE TO THE PUBLIC.

 

TITLE
OF CRADA: Fast, Centrally-Acting, Non-Addicting Novel Analgesic for Chronic Non-Cancer Pain

 

	PHS [IC] Component:	NCATS
	IC Principal Investigator:	Donald Lo, Ph.D.
	 	 
	Collaborator:	Virpax Pharmaceuticals, Inc
	Collaborator Principal Investigator:  	Jeffrey Gudin, MD
	TERM OF CRADA:	Four (4) years from the Effective Date.

 

ABSTRACT
OF THE RESEARCH PLAN:

 

Americans
are faced with a dual crisis of chronic pain and an opioid abuse epidemic. The development of an effective analgesic with rapid
onset for the treatment of pain that is devoid of the common side effects that are often associated with the use of the highly
prescribed mu-opioid receptor agonists is a priority for our healthcare system. Having such an analgesic with this product profile
has the potential to alleviate suffering and reduce dependence on mu-opioid based analgesics which contribute to misuse, abuse,
and overdose related deaths due to severe respiratory depression. Another endogenous opioid system, the enkephalins, preferentially
bind to delta-opioid receptors and are able to produce analgesic benefit without the associated respiratory depression typically
noted from mu-opioid receptor binding, and as an additional benefit, is also thought to play an important role in emotional reactivity
and mood disturbance which often accompanies chronic painful disorders. Unfortunately, systemically administered enkephalins are
prevented from reaching the brain by both rapid enzymatic degradation and the blood-brain-barrier, even with the use of various
penetration enhancers, preventing their development as patient-available pain therapy. This CRADA between the NIH/NCATS and Virpax
Pharmaceuticals focuses on the characterization of NES100, a fast, centrally acting, non-addicting analgesic. In the NES100 formulation,
the active pharmaceutical ingredient is the endogenous peptide Leu Enkephalin (L-ENK) whose molecules are encapsulated utilizing
a proprietary nanoparticle “molecular envelope technology” or MET. The polymer used to make the nanoparticles confers
a positive surface charge to the nanoparticles which allows it to stick to and integrate into mucosal surfaces present in the
nasal cavity upon intranasal administration. This “mucointegration” is expected to enhance the residence time of the
nanoparticulate peptide in the nares, enabling the prolonged delivery of L-ENK. The polymer nanoparticles encapsulating L-ENK
is then able to transport L-ENK exclusively to the brain via the intranasal route with essentially no peripheral exposure. The
scope of this project plan includes studies that are focused on the pre-clinical characterization of NES100 as a novel analgesic
for acute and chronic non-cancer pain.

 

    	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 18 of 26	Confidential	Revised August 1, 2012

     

    

 

Public
Health Service

Cooperative
Research and Development Agreement

 

APPENDIX
A

 

RESEARCH
PLAN

 

I. Abstract
of the Research Project – for Public Release

 

Either
party may, without further consultation or permission, release this ABSTRACT to the public.

 

Americans
are faced with a dual crisis of chronic pain and an opioid abuse epidemic. The development of an effective analgesic with rapid
onset for the treatment of pain that is devoid of the common side effects that are often associated with the use of the highly
prescribed mu-opioid receptor agonists is a priority for our healthcare system. Having such an analgesic with this product profile
has the potential to alleviate suffering and reduce dependence on mu-opioid based analgesics which contribute to misuse, abuse,
and overdose related deaths due to severe respiratory depression. Another endogenous opioid system, the enkephalins, preferentially
bind to delta-opioid receptors and are able to produce analgesic benefit without the associated respiratory depression typically
noted from mu-opioid receptor binding, and as an additional benefit, is also thought to play an important role in emotional reactivity
and mood disturbance which often accompanies chronic painful disorders. Unfortunately, systemically administered enkephalins are
prevented from reaching the brain by both rapid enzymatic degradation and the blood-brain-barrier, even with the use of various
penetration enhancers, preventing their development as patient-available pain therapy. This CRADA between the NIH/NCATS and Virpax
Pharmaceuticals focuses on the characterization of NES100, a fast, centrally acting, non-addicting analgesic. In the NES100 formulation,
the active pharmaceutical ingredient is the endogenous peptide Leu Enkephalin (L-ENK) whose molecules are encapsulated utilizing
a proprietary nanoparticle “molecular envelope technology” or MET. The polymer used to make the nanoparticles confers
a positive surface charge to the nanoparticles which allows it to stick to and integrate into mucosal surfaces present in the
nasal cavity upon intranasal administration. This “mucointegration” is expected to enhance the residence time of the
nanoparticulate peptide in the nares, enabling the prolonged delivery of L-ENK. The polymer nanoparticles encapsulating L-ENK
is then able to transport L-ENK exclusively to the brain via the intranasal route with essentially no peripheral exposure. The
scope of this project plan includes studies that are focused on the pre-clinical characterization of NES100 as a novel analgesic
for acute and chronic non-cancer pain.

 

    	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 19 of 26	Confidential	Revised August 1, 2012

     

    

 

Public
Health Service

Cooperative
Research and Development Agreement

 

II. Goal(s)
of Project

 

Goals
of the project include:

		●	Project
                                         Planning / Initiation / CRADA execution

		●	Non-cGMP
                                         and cGMP manufacture of NES100 (medicinal product and device) and API stability studies

		●	Formulation
                                         development, fill / finish, and stability studies

		●	Development
                                         or optimization & qualification and/or validation of new or existing assays and associated
                                         analytical methods required for characterization of NES100

		●	Bioanalytical
                                         assay development and qualification and/or validation

		●	Pre-clinical
                                         PK studies in species planned for use in efficacy and safety evaluations

		●	PK/PD
                                         studies in efficacy models in Sprague Dawley rats

		●	IND
                                         enabling Toxicology and Safety Pharmacology studies

 

For
avoidance of doubt, the scope of the CRADA Research Plan is limited to tasks / studies that are focused on the pre-clinical development
of NES100 for the management of acute and chronic, non-cancer pain.

 

III. Background

 

Chronic
pain is among the most common reasons for seeking medical attention and is reported by 20 - 50%of patients seen in primary care.
While the CDC in their 2016 Guidelines (Dowell et al., 2016) recommends initial treatment of non-cancer chronic pain with acetaminophen
and NSAIDs, these agents feature black box warnings for serious cardiovascular and gastrointestinal adverse events, and acetaminophen
has known hepatotoxicity. Most notably, both classes of analgesics have documented limited efficacy. Opioids are effective, but
their associated tolerance, dependence and euphoria has contributed to the current abuse epidemic, and their respiratory depressant
actions contribute to significant abuse-related mortality. Development of a fast-acting, highly effective analgesic for the treatment
of non-cancer chronic pain that is devoid of the common, well- recognized side effects of opioids which act predominantly at mu
(μ)-opioid receptors, is therefore a priority to break the cycle of pain-prescription-dependence-overdose.

 

Naturally
occurring endorphins bind to μ-opioid receptors and act as a key molecular switch, triggering brain reward systems and potentially
initiating addictive behaviors. Another endogenous opioid system, i.e. the enkephalins, preferentially bind to delta (δ)-opioid
receptors (Toll et al., 1998) to produce analgesic benefits without the associated respiratory depression typically noted from
μ-opioid receptor binding. In addition, δ-opioid receptor is thought to play an important role in emotional reactivity
and mood disturbance which often accompanies chronic painful disorders. Unfortunately, systemically administered enkephalins are
prevented from reaching the brain by both rapid enzymatic degradation and the blood- brain-barrier (BBB) (Lalatsa et al., 2014),
even with the use of various penetration enhancers (Lalatsa et al., 2012), preventing their development as patient-available pain
therapy. Therefore, new methods of enkephalin delivery must be developed and investigated to devise novel, non-addictive pain-relieving
therapies.

 

    	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 20 of 26	Confidential	Revised August 1, 2012

     

    

 

Public
Health Service

Cooperative
Research and Development Agreement

 

NES100
is a microparticulate dosage form of leucine-5- enkephalin (L-ENK) prepared by the encapsulation of L-ENK in an IP-protected molecular
envelope technology (MET), aka GCPQ (N-palmitoyl-N-monomethyl-N, N-dimethyl-N, N, N-trimethyl-6-O-glycolchitosan), which is a
modified amphiphilic chitosan derivative polymer that self-assembles in aqueous media. The polymer used to make the nanoparticles
confers a positive surface charge to the nanoparticles and the particles stick to and integrate into mucosal surfaces present
in the nasal cavity. This “mucointegration” is believed to enhance the residence time of the nanoparticulate peptide
in the nares, enabling the prolonged delivery of L-ENK. The polymer nanoparticles encapsulating L-ENK is then able to transport
L-ENK exclusively to the brain via the intranasal route with essentially no peripheral exposure.

 

Efficacy
studies have shown that NES100 is active in several animal models of acute and chronic pain. The collaboration is focused on investigational
new drug (IND) studies and the output of this project will be a data package suitable for an IND application to the US FDA.

 

IV. Respective
Contributions of the Parties

 

Virpax’s
Responsibilities

 

Protocols
/ Reagents for TRND:

		1.	MET
                                         GLP toxicology reports

		2.	NES100
                                         (medicinal product and device) manufacturing protocol

		3.	MET,
                                         LENK & MET L-ENK (NES100) for method development / validation, efficacy, and PK/TK
                                         studies

 

Preclinical
IND Enabling Tasks/Studies:

		1.	pIND
                                         meeting minutes

		2.	Archive
                                         preclinical data and biological samples

 

Other
Related Tasks/Studies:

		1.	Preparation
                                         of Investigator’s Brochure

		2.	Preparation
                                         of First-in-Human (i.e. SAD/MAD) clinical protocol and associated model ICF

		3.	Preparation
                                         of IND application for filing and submission

 

    	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 21 of 26	Confidential	Revised August 1, 2012

     

    

 

Public
Health Service

Cooperative
Research and Development Agreement

 

NCATS
’Responsibilities

 

Preclinical
IND Enabling Tasks/Studies:

		1.	Acute
                                         and/or chronic pain efficacy study in rats

		2.	In
                                         vitro Safety screen panel for GPCRs and ion channels

		3.	Qualified
                                         Bio A method transfer for plasma (tox species) and method development for human plasma

		4.	ADA
                                         assay development in tox species and human plasma

		5.	In
                                         vitro ADME studies

		6.	GMP
                                         manufacture of MET and LENK

		7.	Formulations:
                                         Dosage form optimization /manufacturing and stability studies of NES100 and MET for intranasal
                                         administration.

		8.	GLP
                                         Toxicology / Safety Pharmacology studies of NES100 and a single arm of MET

 

Other
Related Tasks/Studies:

		1.	N/A

 

Joint
Collaborator’s NCATS’ Responsibilities

 

All
Parties will mutually agree on the CRADA Research Plan strategy for the preclinical development of NES100 as an intranasally administered
treatment for chronic, non-cancer pain.

 

The
Parties will also review and interpret the results of any in vitro and in vivo studies, biomarker research, and
mechanistic studies of these therapeutic molecules

 

V. Material
Contributed by NCATS

 

		1.	N/A

 

VI. Material
Contributed by Collaborator

 

		1.	MET,
                                         LENK & MET L-ENK (NES100) for method development / validation, efficacy, and PK/TK

 

    	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 22 of 26	Confidential	Revised August 1, 2012

     

    

 

Public
                                         Health Service

Cooperative
Research and Development Agreement

 

VII. Experimental
Plan

 

		1.	Project
Planning / Initiation

	Project Award	04/16/2020
	Gap Analysis / Project Plan Draft	Q2 2020
	Project Plan Execution/CRADA Agreement	Q3 2020

 

		2.	In
vitro Potency

	In vitro safety screen for GPCRs & ion channels on up to 125 targets	Q3 2020

 

		3.	PD-Efficacy
/ Biomarker

	PD-Efficacy studies in Sprague Dawley rats	Q3/4 2020

 

GO/No
GO Decision

No
GO: Lack of efficacy in all animal pain models.

 

		4.	Bioanalytical
Method Development (Human)

	Reagent generation	Q3 2020
	ADA Assay Development (human)	Q4 2020
	Bioanalytical method dev for LENK for human plasma	Q2 2021

 

GO/No
GO Decision

No
GO: No reliable and sensitive bioanalytical method can be developed.

 

		5.	CMC-
Process

GMP
manufacture of LENK:

	Contracting cGMP batch LENK (1 Kg) (est. 3 month	Q2 2020
	Process development, 20 g demo-batch, and qualification of analytical methods for lot release and stability studies (est.2 month)	Q4 2020
	cGMP run and delivery of 1.0 Kg LENK including Certificate of Analysis, MSDS for toxicology studies and Phase I clinical study (est. 3 month)	Q1 2021
	Initiation of stability study (3-year)	Q2 2021
	Technology Transfer for all CMC elements	Q2 2021

 

GMP
manufacture of MET (GCPQ):

	Contracting cGMP batch MET (1.5 Kg) (est. 5-months)	Q4 2020
	Tech transfer and familiarization (est. 2-months)	Q4 2020
	Process development, 50g Demo Batch, and qualification of analytical methods for lot release and stability (est. 3-months)	Q4 2020/Q1 2021
	cGMP run and delivery 1.5 Kg MET including Certificate of Analysis, MSDS for toxicology studies and Phase I clinical study, and initiation of stability study (est. 2-months)	Q2 2021
	Initiation of stability study (3-year)	Q2 2021
	Technology Transfer for all CMC elements	Q3 2021

 

GO/No
GO Decision

No
GO: Manufacturing failure due to inherent process scalability issues.

 

    	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 23 of 26	Confidential	Revised August 1, 2012

     

    

 

Public
Health Service

Cooperative
Research and Development Agreement

 

		6.	Toxicology
/ Safety Pharmacology (IND-Enabling)

 

	BioA method transfer/val. (LENK) & MET & ADA method dev	Q3 2020
	Non GLP ADME assays	Q1/2 2021
	Non-GLP 14-day intranasal (NES100) toxicology study in adult rats	Q1/2 2021
	Non-GLP 14-day intranasal (NES100) toxicology study in adult dogs	Q1/2 2021
	GLP in-vitro genetic toxicity studies (NES100) (Ames & Chromosome aberration)	Q4 2021
	GLP 28-day repeat dose intranasal (NES100) toxicology study with a MET arm in adult rats (including Micronucleus and FOB CNS safety pharm)	Q4 2021
	GLP 28-day repeat dose (NES100) intranasal toxicology study with a MET arm in adult dogs	Q4 2021
	GLP intranasal single dose (NES100) pulmonary and cardiovascular safety pharm in adult dogs	Q4 2021
	GLP 28-day repeat dose intravenous toxicology study (NES100) in adult rats (as needed)	Q4 2021

 

GO/No
GO Decision

GO:
Acceptable toxicity profile and adequate margin of safety based on the completed work package above would help determine path
forward for the further development of NES100 for the treatment of pain.

No
GO: Unacceptable toxicity or safety profile to enable clinical dosing.

 

		7.	CMC-
Formulation

	Analytical method transfer and validation on NES-100	Q4 2020
	Process development, 50g demonstration run	Q1/2 2021
	GMP Manufacture of the NES100 intranasal dosage forms (drug product – device combination)	Q2/3 2021
	Initiation of ICH stability study on NES100 in device up to 24 months	Q3 2021

 

GO/No
GO Decision

No
GO: Inability to manufacture the NES100 dosage form.

 

		8.	Regulatory

 

	*IND Filing	Q4 2022
	*Dependent upon the successful completion of all IND-enabling studies and assumes that preclinical planning for the IND-enabling studies begins in Q2 2020.	 

 

 

    	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 24 of 26	Confidential	Revised August 1, 2012

     

    

 

Public
Health Service

Cooperative
Research and Development Agreement

 

APPENDIX
B

 

STAFFING,
FUNDING, AND MATERIALS/EQUIPMENT CONTRIBUTIONS

OF THE PARTIES

 

Staffing
Contributions: Not Applicable

 

Funding
Contributions: No Funds are being exchanged

 

Not
applicable

 

CRADA
Travel Payments: No travel Payments are being contributed by Collaborator

 

Materials/Equipment
Contributions:

 

IC
will provide to Collaborator the following IC Materials for use under this CRADA: None

 

Collaborator
will provide to IC the following Collaborator Materials and/or capital equipment for use under this CRADA:

 

Collaborator
Materials: MET, LENK & MET L-ENK (NES100) for method development / validation, efficacy, and PK/TK.

 

Capital
Equipment: Not Applicable

 

If
either Party decides to provide additional Materials for use under this CRADA, those Materials will be transferred under a cover
letter that identifies them and states that they are being provided under the terms of the CRADA.

 

    	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 25 of 26	Confidential	Revised August 1, 2012

     

    

 

Public
Health Service

Cooperative
Research and Development Agreement

 

APPENDIX
C

 

MODIFICATIONS
TO THE MODEL CRADA

 

 

	PHS CRADA	Agreement Ref. No. 2020-12	MODEL ADOPTED June 18, 2009
	Page 26 of 26	Confidential	Revised August 1, 2012

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