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5.3.2. The Recipient shall send an email notice to the BARDA PM and upload the BARDA PM approval as
an attachment upon submission of an invoice in WAWF (this can be done from within WAWF).
5.3.3. Payments shall be made by the Defense Finance and Accounting Services (DFAS) office indicatedbelow within thirty (30) calendar days of an accepted invoice in WAWF:
Defense Finance and Accounting Service (DFAS)DFAS COLUMBUS- North Entitlement Operations
1-800-756-4571
5.3.4. WAWF Provision:(a) Definitions. As used in this clause-Department of Defense Activity Address Code (DoDAAC) is a six position code that uniquely identifies a unit,
activity, or organization.
Document type means the type of payment request or receiving report available for creation in Wide Area Work
Flow (WAWF).
Local processing office (LPO) is the office responsible for payment certification when payment certification isdone external to the entitlement system.
(b) Electronic invoicing. The WAWF system is the method to electronically process vendor payment requests
and receiving reports, as authorized by DFARS 252.232- 7003, Electronic Submission of Payment Requests andReceiving Reports(c) WAWF access. To access WAWF, the Recipient shall (i) have a designated electronic business point ofcontact in the System for Award Management at https://www.acquisition.gov; and (ii) be registered to use
WAWF at https://wawf.eb.mil/ following the step-by-step procedures for self registration available at thiswebsite.
(d) WAWF training. The Recipient should follow the training instructions of the WAWF Web-Based Training
Course and use the Practice Training Site before submitting payment requests through WAWF. Both can beaccessed by selecting the "Web Based Training" link on the WAWF home page at https://wawf.eb.mil/.
(e) WAWF methods of document submission. Document submissions may be via Web entry, Electronic Data
Interchange, or File Transfer Protocol.
(f) WAWF payment instructions. The Recipient must use the following information when submitting
payment requests and receiving reports in WAWF for this contract/order:(1) Document type. The Recipient shall use the following document type:
Non-Procurement Instruments (NPI) Voucher(2) Document routing. The Recipient shall use the information in the Routing Data Table below only to fillin applicable fields in WAWF when creating payment requests and receiving reports in the system.
Routing Data Table
Pay Official DoDAAC HQ0337
Issue By DoDAAC
W911NF
Admin DoDAAC
S2206A
Inspect By DoDAAC
W911NF

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Ship To Code
W911NF
Ship From Code N/AMark For Code N/A
Service Approver DoDAAC S2206A
Service Acceptor DoDAAC W911NF
Accept at Other DoDAAC N/ALPO DoDAAC N/A
DCAA Auditor DoDAAC N/AOther DoDAAC(s) N/A(4) Payment request and supporting documentation. The Recipient shall ensure a payment request includes
appropriate contract line item and subline item descriptions of the work performed or supplies delivered, unit
price/cost per unit, fee (if applicable), and all relevant back-up documentation in support of each payment
request.
(5) WAWF email notifications. The Recipient shall enter the email address identified below in the "Send Additional
Email Notifications" field of WAWF once a document is submitted in the system.

(b) (6)(g) WAWF point of contact.
(1) The Recipient may obtain clarification regarding invoicing in WAWF from the following contracting activity's
WAWF point of contact.
(2) For technical WAWF help, contact the WAWF helpdesk at 866-618-5988
6. Accounting & Audit
6.1 Accounting System
6.1.1. The Recipient’s systems must demonstrate effective control of all funds. Control systems must be adequate toensure that costs charged to Federal funds and those counted as the Recipient’s cost share or match are consistent
with requirements for cost reasonableness, allowability, and allocability as set forth in 32 CFR §37.625(b) and in
the terms and conditions of the award. The Recipient must be able to provide accurate, current and complete records
that document for work funded wholly or in part with Federal funds the source and application of the Federal funds
and the Recipient has required cost share or match.
6.1.2. The Recipient’s cost accounting system shall be in compliance with Generally Accepted Accounting
Principles (GAAP) in accordance with 32 CFR §37.615. The system must effectively control all Project funds,
including Federal funds and any required cost share. The system must have complete, accurate, and current
records that document the sources of funds and the purposes for which they are disbursed. It also must haveprocedures for ensuring that Project funds are used only for purposes permitted by the agreement (§ 37.625).
6.1.3. Program income derived during the initial Period of Performance from Government funding shall beallocated to finance the non-Federal share of the Project (including the amounts described in Section 8.1) inaccordance with 32 CFR §34.14(d)(2). Pursuant to 32 CFR §34.14(c) costs incident to the generation of program
income may be deducted from gross income to determine program income, provided these costs have not been
charged to the award. As contemplated by 32 CFR §34.14(b)(2), Recipient will have no obligation to theGovernment for program income generated after the end of the Period of Performance, and no recovery of funds iscontemplated under 32 CFR §37.580.
6.2 Annual Audit Requirement
The Recipient shall have an annual audit performed by an independent auditor, in accordance with 32 CFR §37.650.
The Recipient shall provide a copy of the auditor's report to the Agreements Officer within 60 days after audit.
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12.2 Marking of Data: The Recipient is responsible for affixing appropriate markings indicating the rights of theRecipient on all data and technical data delivered under this Agreement. Any rights that a Party may have in datadelivered under this Agreement, whether arising under this Agreement or otherwise, will not be affected by a
Party’s failure to mark data pursuant to this Article. Any distribution markings shall be established by the GPM
and incorporated prior to distribution.
12.3 Any Software (as that term is defined in DFARS 252.227-7014) developed under this Agreement shall beowned by the Recipient subject to “Restricted Rights” (as that term is defined in DFARS 252.227-7014(a)(15))
held by the Government, noting that no Software is expected to be developed under this Agreement. The Recipient
shall deliver source and object code for each instance of Software developed under the Agreement in accordancewith the requirements of the other deliverables under this Agreement. Use of any open source code in any
Software required to be delivered to the Government shall be subject to approval of the Government.
Notwithstanding the foregoing, alternatively for any Software that meets the definition of commercial computer
software as that term is defined in FAR 2.101, the Recipient may elect in its sole discretion to grant, and theGovernment shall be subject to the licenses customarily provided to the public by the Recipient in the Software
unless such licenses are inconsistent with Federal procurement law or do not otherwise satisfy the Government’s
needs. The Recipient shall only be required to delivery object code for any commercial computer software.
13. FDA Regulatory Compliance13.1 GMP Compliance. To the extent required under the Federal Food, Drug, and Cosmetic Act (FFDCA), theRecipient will ensure that the manufacturing capability established under this Agreement complies with current
good manufacturing practices (cGMPs) under 21 CFR 210 and 211. The Recipient will notify the Governmentof any written cGMP inspection findings from the U.S. Food and Drug Administration (FDA) pertinent to the
manufacturing capability established under this Agreement. Notwithstanding the foregoing, the Government
acknowledges that the FFDCA does not require Recipient to manufacture its products to cGMP.
13.2 FDA Communications. The Recipient will provide the Government with summaries of any Recipient formal
meetings with the FDA and future correspondence between Recipient and the FDA regarding the manufacturingcontemplated under this Agreement and ensure that Government representatives are invited to participate in any
Recipient formal meetings with the FDA regarding topics that are material to Recipient’s compliance with theterms of this Agreement. FDA meetings initiated by an MCM Partner to which Recipient’s representatives may be
invited, or correspondence exchanged between such MCM Partners and FDA which may be provided to Recipient,
are outside the scope of this provision.
13.3 Regulatory Filings. The Recipient shall file, maintain, and update one or more confidential Type III drug
master files with the FDA necessary to the performance of this Agreement (collectively, “DMF”). Each DMF shall
include the information necessary to support MCM Partner regulatory submissions. At the MCM Partner’s request,
Recipient shall provide relevant MCM Partners with a Letter of Authorization to use in referencing Recipient’s
DMF(s) as part of the MCM Partners’ regulatory submissions to FDA. Notwithstanding the foregoing, theGovernment acknowledges that a DMF is not applicable to Recipient’s performance under this Agreement and will
not be filed with FDA.
14. Termination
Termination and Enforcement procedures are in accordance with 32 CFR §34.51 through §34.52.
15. Disputes
15.1 ADR. For any disagreement, claim, or dispute arising under this Agreement, the Parties shall communicate
with one another in good faith and in a timely and cooperative manner. Whenever disputes, disagreements, ormisunderstandings arise, the Parties shall attempt to resolve the issue by discussion and mutual agreement as soon
as practicable. Failing resolution by mutual agreement, the aggrieved party shall request a resolution in writingfrom the Agreements Officer. Alternately, the Parties may agree to explore and establish an Alternate Disputes
Resolution procedure to resolve this dispute.

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18.8.3. Exclusive right to use or sell the technology in the United States must, unless the Government grants
a waiver, require that products embodying the technology or produced through the use of the technology will
be manufactured substantially in the United States (37.875).
18.9 Performance by Affiliates.
The Government acknowledges and agrees that Recipient may perform its obligations under this Agreement
through one or more of its affiliates, provided that Recipient will be responsible for the full and timely
performance as and when due under, and observance of, all the covenants, terms, conditions and agreements set
forth in this Agreement by its affiliates. It is acknowledged that certain costs relating to the project and covered bythis Agreement may be incurred by the Recipient’s US affiliate (b) (4).
18.10 Enforcement
This Agreement may only be enforced by the parties hereto.

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Appendix 4 Clause for all other Other Transaction Authority
Agreements(b) (4)

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Key Personnel
Any key personnel specified in this Agreement are considered to be essential to work performance. At least thirty(30) calendar days prior to the Recipient voluntarily diverting any of the specified individuals to other programs orcontracts the Recipient shall notify the Agreements Officer and shall submit a justification for the diversion or
replacement and a request to replace the individual. The request must identify the proposed replacement and provide
an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of thecontract (including, when applicable, Human Subjects Testing requirements). If the employee of the Recipient isterminated for cause or separates from the Recipient voluntarily with less than thirty (30) calendar-day notice, theW911NF2130001
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Recipient shall provide the maximum notice practicable under the circumstances. The Recipient shall not divert,
replace, or announce any such change to key personnel without the written consent of the Agreement Officer. The
agreement will be modified to add or delete key personnel as necessary to reflect the agreement of the parties. The
individuals, as shown in the Recipient’s proposal, are determined to be key personnel.
Substitution of Key Personnel
The Recipient agrees to assign to the agreement those persons whose resumes/CVs were submitted with the proposal
who are necessary to fill the requirements of the agreement. No substitutions shall be made except in accordancewith this clause.
All requests for substitution must provide a detailed explanation of the circumstance necessitating the proposed
substitution, a complete resume for the proposed substitute and any other information requested by the contracting
officer to approve or disapprove the proposed substitution. All proposed substitutes must have qualifications that are
equal to or higher than the qualifications of the person to be replaced. The agreements officer or authorized
representative will evaluate such requests and promptly notify the recipient of his approval or disapproval thereof.
The recipient further agrees to include the substance of this clause in any subaward, which may be awarded under
this agreement.
Disclosure of Information
Performance under this agreement may require the Recipient to access non-public data and information proprietary
to a Government agency, another Government Contractor/Recipient or of such nature that its dissemination or use
other than as specified in the work statement would be adverse to the interests of the Government or others. Neither
the Recipient, nor Recipient personnel, shall divulge nor release data nor information developed or obtained underperformance of this agreement, except authorized by Government personnel or upon written approval of the AO in
accordance with OWS or other Government policies and/or guidance. The Recipient shall not use, disclose, or
reproduce proprietary data that bears a restrictive legend, other than as specified in this agreement, or any
information at all regarding this agency.
The Recipient shall comply with all Government requirements for protection of non-public information.
Unauthorized disclosure of nonpublic information is prohibited by the Government’s rules. Unauthorized disclosure
may result in termination of the agreement, replacement of a Recipient employee, or other appropriate redress.
Neither the Recipient nor the Recipient‘s employees shall disclose or cause to be disseminated, any information
concerning the operations of the activity, which could result in, or increase the likelihood of, the possibility of abreach of the activity‘s security or interrupt the continuity of its operations.
No information related to data obtained under this agreement shall be released or publicized without the priorwritten consent of the AOR, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided
that no such consent is required to comply with any law, rule, regulation, court ruling or similar order; forsubmission to any government entity’ for submission to any securities exchange on which the Recipient’s (or its
parent corporation’s) securities may be listed for trading; or to third parties relating to securing, seeking, establishingor maintaining regulatory or other legal approvals or compliance, financing and capital raising activities, or mergers,
acquisitions, or other business transactions.
Publications and Publicity
The Recipient shall not release any reports, manuscripts, press releases, or abstracts about the work being performed
under this agreement without written notice in advance to the Government.
(a) Unless otherwise specified in this agreement, the recipient may publish the results of its work under thisagreement. The Recipient shall promptly send a copy of each submission to the AOR for security review prior to
submission. The recipient shall also inform the AOR when the abstract article or other publication is published, andfurnish a copy of it as finally published.
(b) Unless authorized in writing by the AO, the Recipient shall not display Government logos including Operating
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Page 28 of 34(c) The Recipient shall not reference the products(s) or services(s) awarded under this agreement in commercial
advertising, as defined in FAR 31.205-1, in any manner which states or implies Government approval orendorsement of the product(s) or service(s) provided.
(d) The Recipient shall include this clause, including this section (d) in all subawards where the subawardee may
propose publishing the results of its work under the subaward. The Recipient shall acknowledge the support of theGovernment whenever publicizing the work under this agreement in any media by including an acknowledgement
substantially as follows:"This project has been funded in whole or in part by the U.S. Government under Agreement No. W911NF2030007.
The US Government is authorized to reproduce and distribute reprints for Governmental purposes notwithstanding
any copyright notation thereon.”
Confidentiality of Informationa. Confidential information, as used in this article, means information or data of a personal nature about anindividual, or proprietary information or data submitted by or pertaining to an institution or organization.
b. The Agreements Officer and the Recipient may, by mutual consent, identify elsewhere in this agreement
specific information and/or categories of information which the Government will furnish to the Recipient or that the
Recipient is expected to generate which is confidential. Similarly, the Agreement Officer and the Recipient may, by
mutual consent, identify such confidential information from time to time during the performance of the agreement.
Failure to agree will be settled pursuant to the "Disputes" clause.
c. If it is established elsewhere in this contract that information to be utilized under this contract, or a portion
thereof, is subject to the Privacy Act, the Recipient will follow the rules and procedures of disclosure set forth in the
Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations and policies, with respect to systems of records
determined to be subject to the Privacy Act.
d. Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without the priorwritten consent of the individual, institution, or organization.
e. Whenever the Recipient is uncertain with regard to the proper handling of material under the agreement, or if
the material in question is subject to the Privacy Act or is confidential information subject to the provisions of thisarticle, the Recipient shall obtain a written determination from the Agreement Officer prior to any release,
disclosure, dissemination, or publication.
f. Agreement Officer Determinations will reflect the result of internal coordination with appropriate program andlegal officials.
g. The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other
Federal, State or local laws.
All above requirements MUST be passed to all Sub-awardees.
Organizational Conflicts of Interest
Performance under this contract may create an actual or potential organizational conflict of interest such as arecontemplated by FAR Part 9.505-General Rules. The Recipient shall not engage in any other contractual or otheractivities which could create an organizational conflict of interest (OCI). This provision shall apply to the prime
Recipient and all sub-recipients. This provision shall have effect throughout the period of performance of thiscontract, any extensions thereto by change order or supplemental agreement, and for two (2) years thereafter. The
Government may pursue such remedies as may be permitted by law or this contract, upon determination that an OCI
has occurred.

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The work performed under this agreement may create a significant potential for certain conflicts of interest, as set
forth in FAR Parts 9.505-1, 9.505-2, 9.505-3, and 9.505-4. It is the intention of the parties hereto to prevent both thepotential for bias in connection with the Recipient‘s performance of this contract, as well as the creation of any
unfair competitive advantage as a result of knowledge gained through access to any non-public data or third party
proprietary information.
The Recipient shall notify the Agreement Officer immediately whenever it becomes aware that such access orparticipation may result in any actual or potential OCI. Furthermore, the Recipient shall promptly submit a plan to
the Agreement Officer to either avoid or mitigate any such OCI. The Agreement Officer will have sole discretion in
accepting the Recipient‘s mitigation plan. In the event the Agreement Officer unilaterally determines that any such
OCI cannot be satisfactorily avoided or mitigated, other remedies may be taken to prohibit the Recipient fromparticipating in agreement requirements related to OCI.
Whenever performance of this agreement provides access to another Contractor‘s proprietary information, theRecipient shall enter into a written agreement with the other entities involved, as appropriate, in order to protect
such proprietary information from unauthorized use or disclosure for as long as it remains proprietary; and refrainfrom using such proprietary information other than as agreed to, for example to provide assistance during technicalevaluation of other Contractors’ offers or products under this agreement. An executed copy of all proprietary
information agreements by individual personnel or on a corporate basis shall be furnished to the AO within fifteen(15) calendar days of execution.
Institutional Responsibility Regarding Investigator Conflicts of Interest
The Institution (includes any Recipient, public or private, excluding a Federal agency) shall comply with therequirements of 45 CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by
establishing standards to ensure that Investigators (defined as the project director or principal Investigator and anyother person, regardless of title or position, who is responsible for the design, conduct, or reporting of research
funded under Government contracts, or proposed for such funding, which may include, for example, collaborators or
consultants) will not be biased by any Investigator financial conflicts of interest. 45 CFR Part 94 is available at thefollowing Web site: http://www.ecfr.gov/cgibin/textidx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=
As required by 45 CFR Part 94, the Institution shall, at a minimum:
a. Maintain an up-to-date, written, enforceable policy on financial conflicts of interest that complies with 45 CFRPart 94, inform each Investigator of the policy, the Investigator's reporting responsibilities regarding disclosure ofsignificant financial interests, and the applicable regulation, and make such policy available via a publicly accessible
Web site, or if none currently exist, available to any requestor within five business days of a request. A significant
financial interest means a financial interest consisting of one or more of the following interests of the Investigator(and those of the Investigator's spouse and dependent children) that reasonably appears to be related to theInvestigator's institutional responsibilities:
1. With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration
received from the entity in the twelve months preceding the disclosure and the value of any equity interest in theentity as of the date of disclosure, when aggregated, exceeds $5,000. Included are payments and equity interests;
2. With regard to any non-publicly traded entity, a significant financial interest exists if the value of any
remuneration received from the entity in the twelve months preceding the disclosure, when aggregated,exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity
interest; or
3. Intellectual property rights and interests, upon receipt of income related to such rights and interest.
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1. Income from seminars, lectures, or teaching, and service on advisory or review panels for Government agencies,
Institutions of higher education, academic teaching hospitals, medical centers, or research institutes with an
Institution of higher learning; and2. Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator
does not directly control the investment decisions made in these vehicles.
b. Require each Investigator to complete training regarding the Institution's financial conflicts of interest policy
prior to engaging in research related to any Government funded contract and at least every four years. The
Institution must take reasonable steps [see Part 94.4(c)] to ensure that investigators working as collaborators,
consultants or subcontractors comply with the regulations.
c. Designate an official(s) to solicit and review disclosures of significant financial interests from each Investigator
who is planning to participate in, or is participating in, the Government funded research.
d. Require that each Investigator who is planning to participate in the Government funded research disclose to theInstitution's designated official(s) the Investigator's significant financial interest (and those of the Investigator's
spouse and dependent children) no later than the date of submission of the Institution's proposal for Government
funded research. Require that each Investigator who is participating in the Government funded research to submit an
updated disclosure of significant financial interests at least annually, in accordance with the specific time period
prescribed by the Institution during the period of the award as well as within thirty days of discovering or acquiring
a new significant financial interest.
e. Provide guidelines consistent with the regulations for the designated official(s) to determine whether an
Investigator's significant financial interest is related to Government funded research and, if so related, whether thesignificant financial interest is a financial conflict of interest. An Investigator's significant financial interest is related
to Government funded research when the Institution, thorough its designated official(s), reasonably determines thatthe significant financial interest: Could be affected by the Government funded research; or is in an entity whose
financial interest could be affected by the research. A financial conflict of interest exists when the Institution,
through its designated official(s), reasonably determines that the significant financial interest could directly andsignificantly affect the design, conduct, or reporting of the Government funded research.
f. Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a
subcontractor Investigator. Management of an identified financial conflict of interest requires development andimplementation of a management plan and, if necessary, a retrospective review and mitigation report pursuant toPart 94.5(a).
g.

Provide initial and ongoing FCOI reports to the Contracting Officer pursuant to Part 94.5(b).

h. Maintain records relating to all Investigator disclosures of financial interests and the Institution's review of, andresponse to, such disclosures, and all actions under the Institution's policy or retrospective review, if applicable, forat least 3 years from the date of final payment or, where applicable, for the other time periods specified in 48 CFRPart 4, subpart 4.7, Contract Records Retention.
i. Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions
to ensure Investigator compliance as appropriate.
j. Complete the certification in Section K - Representations, Certifications, and Other Statements of Contractors
titled "Certification of Institutional Policy on Financial Conflicts of Interest".
If the failure of an Institution to comply with an Institution's financial conflicts of interest policy or a financial
conflict of interest management plan appears to have biased the design, conduct, or reporting of the Government
funded research, the Institution must promptly notify the Agreement Officer of the corrective action taken or to betaken. The Agreement Officer will consider the situation and, as necessary, take appropriate action or refer thematter to the Institution for further action, which may include directions to the Institution on how to maintainappropriate objectivity in the Government funded research project.

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The Agreement Officer and/or Government may inquire at any time before, during, or after award into any
Investigator disclosure of financial interests, and the Institution's review of, and response to, such disclosure,regardless of whether the disclosure resulted in the Institution's determination of a financial conflict of interests. The
Agreement Officer may require submission of the records or review them on site. On the basis of this review ofrecords or other information that may be available, the Agreement Officer may decide that a particular financial
conflict of interest will bias the objectivity of the Government funded research to such an extent that further
corrective action is needed or that the Institution has not managed the financial conflict of interest in accordancewith Part 94.6(b). The issuance of a Stop Work Order by the Agreement Officer may be necessary until the matter isresolved.
If the Agreement Officer determines that Government funded clinical research, whose purpose is to evaluate thesafety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by an
Investigator with a financial conflict of interest that was not managed or reported by the Institution, the Institution
shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of theresults of the research and to request an addendum to previously published presentations.

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Accounting and Appropriation
Summary for the Payment Office
As a result of this modification, the total funded amount for this document was increased by $384,623.00 from
$32,190,000.00 to $32,574,623.00.
SUBCLIN 000601:
Funding on SUBCLIN 000601 is initiated as follows:
ACRN: AB
CIN: GFEBS001167985200001
Acctng Data: 0212021202220400000664643255
Increase: $384,623.00
Total: $384,623.00
Cost Code: A5XAH(End of Summary of Changes)

S.0074658.5.64

6100.9000021001