10 USC 2373 AGREEMENTBETWEEN
Ology Bioservices, Inc. (Awardee or Contractor)
13200 NW Nano Court
Alachua, FL 32615
And
NATICK CONTRACTING DIVISION (Government)
110 Thomas Johnson Dr.
Frederick, MD 21702
Effective Date:  )HE Agreement No.: W911QY-20-9-0003
Total Amount of the Agreement: (b) (4)Government (b) (6)Ology Bioservices, Inc.
(b) (6)Signature

Signature(b) (6)(b) (6)

Printed Name

Printed Name
Agreements Officer
Title(b) (6)Title )HEUXDU\ Date )HE 

Date

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ARTICLE 1. Scope.
A. This 10 U.S.C. § 2373 Agreement (the “Agreement”) is entered into between the
Government and the Awardee on the Effective Date set forth above. For the avoidance of
doubt, this Agreement is entered into pursuant to 10 U.S.C. § 2373 and is not a
procurement contract governed by the Federal Acquisition Regulation (FAR), a grant,cooperative agreement, or 10 U.S.C. § 2371(b) other transaction agreement. The FAR andthe Defense Federal Acquisition Regulation Supplement (DFARS) apply only as
specifically referenced herein. This Agreement is not intended to be, nor will it beconstrued as, forming, by implication or otherwise, a partnership, a corporation, or otherbusiness organization. This Agreement is not subject to the Bayh-Dole Act, 35 U.S.C.
§§ 200-212.
B. The 2018 National Defense Authorization Act (NDAA) amended 10 U.S.C. § 2358 to
add 10 U.S.C. § 2373 as “authorized means” of Defense contracting for research anddevelopment projects (Pub. L. 115–91, div. A, title VIII, § 862, Dec. 12, 2017, 131 Stat.
1495) and expressed a preference for use of 10 U.S.C. § 2373 for certain contracting
actions: “In the execution of science and technology and prototyping programs” (Pub. L.
115–91, div. A, title VIII, § 867, Dec. 12, 2017, codified at 10 U.S.C. § 2371 note).
C. This Agreement meets all criteria necessary for 10 U.S.C. § 2373 contracting actions.
Consistent with the stated purpose of the statute, the Parties agree that scope and theultimate purpose of this Agreement is to acquire chemical activity and medical supplies
and designs thereof necessary for experimental or test purposes in the development of thebest supplies needed for national defense. Examples of supplies for purposes of thisAgreement include manufacturing platforms, compounds, drug product, drug substance,
conformance lots, optimized products, shakedown/engineering/ development runs,
equipment, and materials. All supplies purchased for testing and experimental purposes
under this Agreement are necessary to develop the best supplies for national defense, suchas Food and Drug Administration (FDA) licensed vaccines and therapeutics.
D. This Agreement will facilitate multiple projects for development of specific supplies
required by the Government within the scope of the Agreement as described herein, each ofwhich will be described in a Statement of Work (SOW).
E. Each project facilitated by this Agreement, will produce quantities of supplies that arenecessary for experimentation and technical evaluation of those supplies only. Any projectwith multiple SOWs shall not, in the aggregate, exceed the quantity necessary forexperimentation and technical evaluation. All SOWs executed under this Agreement shallbe within the scope of the Agreement as described herein. The Parties agree that thisAgreement is not intended to, and does not authorize purchase of chemical activity andmedical supplies and designs thereof in quantities greater than those necessary forexperimental or test purposes in the development of the best supplies needed for national
defense. Accordingly, the requirements of 10 USC Chapter 137 are not applicable to thisAgreement or any SOW issued hereunder.

2Agreement is formally revised by the AO and made part of this Agreement. Any
modification to this Agreement to account for recommended changes in the SOW or
Payable Milestones will be considered a supplemental agreement.
C. Review of Recommendations: The AO will be responsible for the review andverification of any recommendations to revise or otherwise modify the Agreement, theSOW, or other proposed changes to the terms and conditions of this Agreement.
D. Government Changes. The Government may issue unilateral, within scope changes to thework called for under this Agreement, which the Awardee shall perform pending finalizationof the Agreement’s modification reflecting the change and associated costs. The Awardee will
be reimbursed for costs incurred that are reasonable, allowable and allocable to the work
performed as required by the Government’s mandated change. In addition, the Government
may unilaterally make minor or administrative no-cost agreement modifications (e.g., changes
in the paying office or appropriation data, changes to Contractor personnel proposed byContractor, etc.).
E. Amending the Agreement: The Government will be responsible for effecting all
modifications to this Agreement, with the concurrence of the Awardee for modifications
that are not minor or administrative. Administrative and material matters under thisAgreement will be referred to the AO.
F. Modification Communications: No other communications, whether oral or in writing,that purport to change this Agreement are valid.
G. Government Property: If applicable, terms and conditions applicable to Government
Property shall be incorporated through Appendix C.
H. Disputes: For any disagreement, claim, or dispute arising under this Agreement, theparties shall communicate with one another in good faith and in a timely and cooperative
manner. Whenever disputes, disagreements, or misunderstandings arise, the parties shallattempt 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 inwriting from the AO. The AO will review the matter and render a decision in writing. Anysuch decision is final and binding. In the event of a decision, within (60) calendar days of
the referral for review (or such other period as agreed upon by the parties), either party
may pursue any right or remedy provided by law in a court of competent jurisdiction as
authorized by 28 U.S.C. 1491. Alternately, the parties may agree to explore and establish
and Alternate Disputes Resolution procedure to resolve this dispute.
I. Quality Agreement. A Quality Agreement will be developed separately for each Order
exercised under this Agreement.
ARTICLE 6. INSPECTION/ACCEPTANCE
A. Inspection: The Government has the right to inspect and test all work called for by theapplicable SOW during the period of performance. The Government or its designee, including
7

employees and contractors of the FDA, may inspect the areas of premises of the Awardee or
any subawardee that are specifically designated to the performance of the work under theapplicable SOW. Inspections and testing will be requested and scheduled between the
Government Project Manager (or its designee) and Awardee Project Manager. The
Government shall perform inspections and tests in a manner that will not unduly delay thework, and during an agreeable time and date for both the Government and Awardee(subawardee). If the Government performs any required inspection or test on the premises of
the Awardee or a subawardee, the Awardee shall furnish and shall require subawardees tofurnish, at no increase in price, all reasonable facilities and assistance for the safe andconvenient performance of these duties. Except as otherwise provided in the Agreement, theGovernment shall bear the expense of Government inspections or tests made at other than theAwardee’s or subawardee’s premises.
B. The Government shall inspect/accept or reject the work after completion/delivery, unlessotherwise specified in the Agreement. Work is nonconforming when it is defective in material
or workmanship or is otherwise not in conformity with Agreement requirements. The
Government has the right to reject nonconforming work. Inspection/Acceptance of thedeliverable(s) performed at Awardee's facility shall not exceed 120 days after completion The
Government waives the right to reject nonconforming work should it fail to notify theAwardee within the 120 days of delivery, unless otherwise specified in the applicable SOW.
Acceptance of the work shall be conclusive. The Government shall notify the Awardee, andseparately negotiate storage of a deliverable, if storage of the work is anticipated to exceed 120
days.
ARTICLE 7. Financial Matters
This is an expenditure-based agreement. The payments provided under this Agreement are
intended to compensate the Awardee on a cost basis for performance under thisAgreement. The Awardee shall provide its best efforts to complete a project based on theestimated cost.
A. Payment. Payments are based on amounts generated from the Awardee’s financial or
cost records. The Awardee shall be reimbursed for each element identified in the awarded
cost proposal as set forth in Appendix B. The schedule is predicated upon the
Government’s fiscal year, which begins on October 1 of each calendar year, and ends on
September 30 of the subsequent calendar year.
B. Obligation. Under no circumstances shall the Government's financial obligation exceed
the amount obligated in this Agreement or by amendment to the Agreement. The
Government may incrementally fund this agreement. The amount of Government funds
obligated by this Agreement and available for payment is set forth in the Line of
Accounting and Appropriation, or subsequent amendments providing incremental funding.
C. The Government is not obligated to provide payment to the Awardee for amounts inexcess of the amount of obligated funds allotted by the Government.
D. The Government shall pay the Awardee, upon submission of proper invoices, the prices
stipulated in this Agreement for work delivered or rendered and accepted, less any
8deductions provided in this Agreement. Unless otherwise specified, payment shall bemade upon acceptance of any portion of the work delivered or rendered for which a priceis separately stated in the Agreement. Payments processed in WAWF and should be madewithin thirty (30) calendar days of receipt of a request for payment.
E. WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS(a) Definitions.
Department of Defense Activity Address Code (DoDAAC) is a six-positioncode 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 WorkFlow (WAWF).
Local processing office (LPO) is the office responsible for payment certification
when payment certification is done 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 252.2327003, Electronic Submission of Payment Requests and Receiving Reports.
(c) WAWF access. To access WAWF, the Awardee shall (i) have a designatedelectronic business point of contact 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 this website.
(d) WAWF training. The Awardee 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 be accessed 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 Awardee must use the following information
when submitting payment requests and receiving reports in WAWF for thiscontract/order:(1) Document type. The Awardee shall use the following document type:
Invoice and Receiving Report (Combo)(2) Inspection/acceptance location. The Awardee shall select the following
inspection/acceptance location(s) in WAWF, as specified by the contracting
officer.

9(3) Document routing. The Awardee shall use the information in the Routing
Data Table below only to fill in applicable fields in WAWF when creating
payment requests and receiving reports in the system.
Routing Data Table*
Field Name in WAWF

Data to be entered in WAWF

Pay Official DoDAAC

HQ0490Issue By DoDAAC
Admin DoDAAC
Inspect By DoDAAC
Ship To Code

W911QY
W911QYW56XNHW56XNH(4) Payment request and supporting documentation. The Awardee shall ensure apayment request includes appropriate contract line item and subline item
descriptions of the work performed or supplies delivered, unit price/cost perunit, fee (if applicable), and all relevant back-up documentation in support ofeach payment request.
(5) WAWF email notifications. The Awardee 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)(b) (6)(g) WAWF point of contact.
(1) The Awardee may obtain clarification regarding invoicing in WAWF fromthe following contracting activity's WAWF point of contact.
(2) For technical WAWF help, contact the WAWF helpdesk at
866-618-5988.
F. Comptroller General Access to Records. To the extent that the total Government
payments under this Agreement exceed $5,000,000, the Comptroller General, at its
discretion, shall have access to and the right to examine records of any Party to theAgreement or any entity that participates in the performance of this Agreement that
directly pertain to, and involve transactions relating to, the Agreement for a period of three(3) years after final payment is made. This requirement shall not apply with respect to any
Party to this Agreement or any entity that participates in the performance of theAgreement, or any subordinate element of such Party or entity, that has not entered into
any other agreement (contract, grant, cooperative agreement, or “other transaction”) that10

provides for audit access by a government entity in the year prior to the date of thisAgreement. This paragraph only applies to any record that is created or maintained in theordinary course of business or pursuant to a provision of law. The terms of this paragraphshall be included in all sub-agreements to the Agreement other than sub-agreements with acomponent of the U.S. Government. The Comptroller General may not examine records
pursuant to a clause included in an agreement more than three years after the final
payment is made by the United States under the agreement.
ARTICLE 8. Reserved
ARTICLE 9. Intellectual Property Rights
The Parties agree that the terms in this Article apply generally to this Agreement, and thatthe terms may be modified in any SOW issued under this Agreement by mutual agreementof the Parties. If a SOW does not address intellectual property rights, the terms of this
Article will govern intellectual property rights related to that SOW. To the extent there isany conflict between this Article and the intellectual property rights provision contained in
a SOW, the terms of the SOW shall control.
A. Background Intellectual Property and Materials. The Awardee and the Government
each retain any intellectual property (IP) rights to their own materials, data, technology,
information, documents, or know-how—or potential rights, such as issued patents, patentapplications, invention disclosures, or other written documentation—that exist prior to
execution of this Agreement or are developed outside the scope of this Agreement(“Background IP”). Additionally, no party to this Agreement will enter into an agreementwith any manufacturer or other third party whereby the third party will obtain rights inAgreement Inventions or Study Data, as those terms are defined in this Agreement, absent
the mutual consent of the parties to the awarded contract.
B. Definitions. For purposes of this agreement, an “Agreement Invention” is any
invention, regardless of whether it is not patentable, or is patentable under U.S. patent law
that is conceived or first reduced to practice under this Agreement.
C. Awardee’s Background IP. Prior to the issuance of any SOW, Awardee shall disclose
Background IP which contain claims that are related to research contemplated under the
SOW, and shall provide identifying information to the Government. No license(s) to any
patent applications, issued patents, or Background IP shall be granted under thisAgreement, and are specifically excluded from the definitions of "Agreement Invention"
contained in this Agreement.
D. Patent indemnity. The Awardee shall indemnify the Government and its officers,
employees and agents against liability, including costs, for actual or alleged direct orcontributory infringement of, or inducement to infringe, any United States or foreign
patent, trademark or copyright, arising out of this Agreement, provided the Awardee isnotified of such claims and proceedings as soon as practicable by the Government of thesuit or action alleging such infringement and shall have been given such opportunity as is11

afforded by applicable laws, rules, or regulations to participate in its defense. Further, thisindemnity shall not apply toAn infringement resulting from compliance with specific written instructions of the AO
directing a change in the supplies to be delivered or in the materials or equipment to be
used, or directing a manner of performance of the contract not normally used by theContractor; An infringement resulting from addition to or change in supplies orcomponents furnished subsequent to delivery or performance; or a claimed infringementthat is unreasonably settled without the consent of the Contractor, unless required by final
decree of a court of competent jurisdiction.
E. Patent Prosecution. Awardee agrees to take responsibility for the preparation, filing,prosecution, and maintenance of any and all patents and patent applications listed asAwardee Background IP that are relevant to work performed under this Agreement.
Awardee shall keep the Government reasonably advised on the status of Awardee
Background IP by providing an annual report on the status of Awardee Background IP.
Prior to acting on a decision by Awardee to abandon or not file in any country a patent or
patent application covering an Agreement Invention, which is defined below, Awardee
shall so inform the Government in a timely manner to allow Awardee to thoughtfully
consider the Government's comments regarding such a proposed decision. Nothing in this
Article 10 shall restrict the Government in its preparation, filing, prosecution andmaintenance of a patent or patent application covering an Agreement Invention.
F. Patent Enforcement. Awardee will have the first option to enforce any patent rights
covering an Agreement Invention owned jointly by the Parties or solely by Awardee, atAwardee’s expense. If Awardee chooses not to exercise this option, the Government may
enforce patent rights covering a joint Agreement Invention only with Awardee’s priorwritten approval.
G. Ownership. Ownership of any invention, regardless of whether it is not patentable, oris patentable under U.S. patent law that is conceived or first reduced to practice under thisAgreement (Agreement Invention) will follow inventorship in accordance with U.S. patentlaw. The Bayh-Dole Act, 35 U.S.C. §§ 200-212 does not apply to this Agreement and, assuch, title to Agreement Inventions will accrue to the inventor or inventor-organization.
The Parties represent and warrant that each inventor will assign his or her rights in any
such inventions to his or her employing organization. If either an Awardee employee or a
Government employee makes a sole Agreement Invention, the entire rights to that
Agreement Invention will be respectively assigned to the Awardee or the Government. If
an Awardee employee and a Government employee jointly make an Agreement Invention,
it will be owned jointly by the Awardee and the Government. Ownership of Agreement
Inventions made in whole or in part with subawardee employees, including employees ofother components of the Government, will be determined solely pursuant to an agreement
between the Awardee and the applicable subawardee.
H. Patent Applications. The Parties will respectively have the option to file a patentapplication claiming any Agreement Invention made solely by their respective employees.
The Parties will consult with each other regarding the options for filing a patentapplication claiming a joint Agreement Invention. Within thirty (30) calendar days of
being notified of the discovery of an Agreement Invention or filing a patent application
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material or data to the extent that such material or data was produced outside the scope of
this Agreement.
Notwithstanding the above, as a result of this Agreement, the Government shall obtain"Unlimited rights," as this term is defined in DFARS 252.227-7013(a)(16) specific to any
Study Data generated under, and as a result of this Agreement.
B. The Awardee agrees to retain and maintain in good condition until five (5) years after
completion or termination of this Agreement, all Study Data generated under thisAgreement. In the event of exercise of the Government's rights as potentially granted
under paragraph 2.C, the Awardee agrees to deliver at no additional cost to theGovernment, all Study Data, in Awardee's possession and developed under thisAgreement, necessary to deliver the supplies identified on the particular SOW within sixty(60) calendar days from the date of the written request.
C. Marking of Data: The Awardee will mark any Study Data delivered under thisAgreement with the following legend:"Use, duplication, or disclosure is subject to the restrictions as stated (b) (4)between the Government and the Awardee."
Any rights that the Awardee or the Government may have in Study Data delivered under
this Agreement, whether arising under this Agreement or otherwise, will not be affectedby Awardee's failure to mark data pursuant to this Article.
D. All Technical Data and Software (each term as defined under DFARS 252.227-7013)
which shall be delivered under this Agreement with less than unlimited rights shall beidentified with reasonable specificity and particular rights granted (Government Purpose,
Limited or Restricted (all as defined in DFARS 252.227-7013)) in a data rights assertions
list supplied to the Government, for review and evaluation, prior to entering into theagreement for the applicable SOW. All other Technical Data and Software developed
under funding of this Agreement shall be delivered with unlimited rights as provided forwithin this Article.
ARTICLE 11. Regulatory Rights.
The Parties agree that the terms in this Article 11 apply generally to this Agreement, andthat the terms may be modified in any SOW issued under this Agreement by mutual
agreement of the Parties. If a SOW does not address regulatory rights, the terms of this
Article 11 will govern regulatory rights related to that SOW. To the extent there is any
conflict between this Article 11 and the data rights provision contained in a SOW, theterms of the SOW shall control.
This Agreement may include research with one or more investigational drug, biologic or medical
device that is regulated by the U.S. Food and Drug Administration (FDA) and requires FDA
pre-market approval or clearance before commercial marketing may begin. Subject to further
negotiation between the parties and set forth in the SOW, the Contractor may serve as the14

Sponsor of the Regulatory Application (an Investigational New Drug Application (IND),
Investigational Device Exemption (IDE), New Drug Application (NDA), Biologics License
Application (BLA), Premarket Approval Application (PMA), or 510(k) Pre-Market Notification
Filing (510(k)) or another regulatory filing submitted to FDA) that controls research under thisagreement. The Sponsor of the Regulatory Application to FDA (as the terms “sponsor” and“applicant” are defined or used in at 21 CFR §§3.2(c), 312.5, 600.3(t), 812.2(b), 812 Subpart C,
or 814.20) has certain standing before the FDA that entitles it to exclusive communications
related to the Regulatory Application.
With respect to any products regulated by the FDA, the Contractor agrees to the following:a. The Contractor shall provide to the Government all data, including top-line summaries
and key conclusions from all studies, supporting the regulatory filing and commercial
approval to the extent that such data, summaries, and conclusions are funded under thisAgreement. In addition, the Contractor will offer the Government the opportunity toreview and provide comments on a final draft of regulatory submissions which include
data funded under this Agreement. The Government will review any such submissions
promptly upon receipt. The Contractor shall reasonably consider any comments
provided by the Government, and prior to submission shall provide notification to theGovernment of any additional edits or revisions. The Contractor shall keep theGovernment reasonably apprised of planned FDA meetings and post-meeting outcomes
relating to activities funded under this Agreement.
b. Communications. The Contractor shall provide the Government with allcommunications and summaries thereof, both formal and informal, to or from FDA
regarding the regulatory submissions subject to this Agreement and ensure that theGovernment representatives are invited to participate in any formal Sponsor meetings
with the FDA. The Contractor shall use its best efforts to ensure that the Government
representatives are invited to participate in any informal Sponsor meetings with the
FDA so long as the Contractor has 48 hour advance notice of such Sponsor meetingfrom the FDA prior to the scheduled meeting time.
c. Non-compliance with section (b) may result in termination of the agreement.
d. Product Development Failure. Certain product development failures may trigger certain
remedies in Section “e.” below for the Government advanced developer funding thedevelopment of the work contemplated in the applicable SOW. This remedy is notavailable to the Government for any cause outside of the following:(i) if this agreement is terminated for nonperformance; or(ii) the Contractor gives notice, required to be submitted to the Government no later
than 30 business days, of any formal management decision to terminate thisproduct development effort pre-market or to file for Federal bankruptcy
protection.
e. If any of the product development failures listed in section “d” occur, the Contractor,
upon the request of the Government:(i) shall transfer possession, ownership and sponsorship or holdership of any
Regulatory Application (including any associated expedited review designation,priority review voucher, or marketing exclusivity eligibility or award), regulatory
correspondence, and supporting regulatory information related to the Technology
to the Government or its designee;
15

(ii) shall inform FDA of the transfer of sponsorship or holdership of the Regulatory
Application transferred under section (e)(i) above; and(iii) shall negotiate in good faith a non-exclusive license, at customary industry rates
and under reasonable terms and conditions, to any patent, copyright or otherintellectual property owned or controlled by the Contractor, developed prior to or
outside the scope of this agreement, or any technical data that is necessary for theGovernment to pursue commercialization of this technology with a third party forsale to the Government or otherwise.
f. This clause will survive the acquisition or merger of the Contractor by or with a third
party. This clause will also be included in any subcontracts/sub agreements relating to
the development of the Technology. This clause will survive the expiration of thisagreement.
ARTICLE 12. Foreign Access to Data.
Export Compliance: The Parties will comply with any applicable U.S. export control
statutes or regulations in performing this Agreement.
ARTICLE 13. Scientific Publications and Press Releases.
A. The Parties shall jointly agree on a publication plan for the data derived from studies
executed under this Agreement (such data to be considered New Data). This publication
plan will identify key New Data to be disclosed or presented and the target date forfinalizing any related scientific abstract or manuscript. As part of its Monthly Progress
Reports, the Awardee will share the publication plan with the Government.
B. The Parties will jointly develop each abstract or manuscript and agree on the authorshipand the content of the final draft to be submitted; provided that authorship for each
abstract and manuscript will be determined based on whether a particular individual madea significant contribution to the conceptualization, design, execution, or interpretation of a
research study, as authorship is defined in the fifth edition of the Guidelines and Policies
for the Conduct of Research in the Intramural Research Program at NIH, available at:https://oir.nih.gov/sites/default/files/uploads/sourcebook/documents/ethical_conduct/guidelines-conduct_research.pdf.
C. Prior to submission for publication, the Parties shall provide drafts of proposed
publications to the authors of such publications for review and comment, and shall provide
copies to non-authors for viewing purposes. Review periods are (b) (4)for
abstracts, or (b) (4)days if agreed by Project Managers and in order tomeet publication submission deadlines. Review periods are (b) (4)calendar days formanuscripts. Contributing parties shall be appropriately accredited in any publication.
D. The Parties will jointly agree on whether to issue one or more press releases related to
the resulting New Data. If all Parties agree that one or both Parties will issue a press
release, each Party will also have the right to review and agree on the content in advanceof its publication. Other parties, if any, contributing to the studies, will have review rights
and will be appropriately accredited in the press release. For data generated in studies
16executed by Awardee outside the scope of this Agreement, the Awardee, at its sole
discretion, may issue a press release related to such data.
ARTICLE 14. Miscellaneous Clauses.
A. No Consent. Nothing in the terms of this Agreement constitutes express or implied
Government authorization and consent for Awardee or its subawardee(s) to utilize,
manufacture or practice inventions covered by United States or foreign patents in theperformance of work under this Agreement.
B. Patent Infringement. Each Party will advise the other Party promptly and in reasonable
written detail, of each claim or lawsuit of patent infringement based on the performance of
this Agreement. When requested by either Party, all evidence and information inpossession of the Party pertaining to such claim or lawsuit will be provided to the other at
no cost to the requesting Party.
C. Limitation of Liability. In no event will either Party be liable to the other Party or any
third party claiming through such Party for any indirect, incidental, consequential or
punitive damages, or claims for lost profits, arising under or relating to this Agreement,
whether based in contract, tort or otherwise, even if the other Party has been advised of thepossibility of such damages.
D. Disclosure of Information. Subject to Articles 10 and 11, the Awardee shall not releaseto anyone outside the Awardee’s organization any unclassified information, regardless of
medium (e.g., film, tape, document), pertaining to any part of this Agreement or any
program related to this Agreement, unless (i) the Agreements Officer has given priorwritten approval or (ii) the information is otherwise in the public domain before the dateof release.
E. Force Majeure. Neither Party will be liable to the other Party for failure or delay inperforming its obligations hereunder if such failure or delay arises from circumstances
beyond the control and without the fault or negligence of the Party (a Force Majeure
event). Examples of such circumstances are: authorized acts of the government in either
its sovereign or contractual capacity, war, insurrection, freight embargos, fire, flood, or
strikes. The Party asserting Force Majeure as an excuse must take reasonable steps tominimize delay or damages caused by unforeseeable events.
F. Severability. If any provision of this Agreement, or the application of any suchprovision to any person or set of circumstances, is determined to be invalid, unlawful, voidor unenforceable to any extent, the remainder of this Agreement, and the application ofsuch provision to persons or circumstances other than those as to which it is determined to
be invalid, unlawful, void or unenforceable, will not be impaired or otherwise affected andwill continue to be valid and enforceable to the fullest extent permitted by law.
G. Priority Access.
1) Defense Priority and Allocations Requirements. This Agreement, and each Order placed
under this Agreement may be a rated order certified for national defense and emergency
17

precedence in descending order as follows: (i) each SOW as included in Appendix A, (ii)the Articles of this Agreement, and (iii) other Appendices to the Agreement.

19

3.1.2.2.5

3.1.2.2.6

potential solutions, problems solved during the course of
the year, and the solutions to the solved problems.
3.1.2.2.43
The Final Report shall demonstrate how the
manufacturing platform was developed and advanced.
The Awardee shall perform, record and report physical inventory
results of all Contractor Acquired Property in the contractor's
possession, if the Awardee purchases material or equipment using USG
funds, as approved by the Government Project Manager (GPM)
during performance of the project.
Incident Reporting
3.1.2.2.6.1
The Awardee shall report any incident to the USG that
could result in more than a one-month delay in schedulefrom the most recent IMS critical path delivered to the
USG in an incident report.
3.1.2.2.6.2
The Awardee shall telephonically contact the program
manager for the USG within one day of incident.
3.1.2.2.6.3
The Awardee shall submit a written summary report
within three business days of an incident, to include what
happened, the impact, the availability of any available
corrective actions, and a timeline for any corrective
actions to be in place.

3.2 Task 2: Establishment of Rapid Response Communications Paradigm, Designating
Defined Levels of Urgency, and Rapidly Initiating Work (Ology Bio)
Assumptions:

The final deliverable will be a policy document outlining Urgency Levels and describing
the risk, schedule and cost implications under all scenarios.
3.2.1 Based on lessons learned from previous projects, such as (b) (4), the Awardee shall develop a protocol that correspond tolevels of response urgency so that the USG and the Awardee have a clear and aligned
understanding of impacts from each level of urgency to product delivery schedule,
cost and ongoing DoD ADM Facility operations.
3.2.2 In collaboration with the USG, the Awardee shall define the Urgency Levels.
3.2.3 The Awardee shall host a one-day workshop at the DoD ADM in coordination with
the DoD to define Urgency Levels with emphasis on risk tolerance (e.g., how muchrisk can be assumed with urgency level 1 vs. 2, 3) in each area of operations and whatneeds to be in place to respond to each of the different urgency levels (e.g.,
prepositioned supply chain, equipment, personnel, resources, operational
efficiencies, novel technologies).
3.2.4 The Awardee shall prepare an Urgency Level Policy Document with definitions foreach Urgency Level, modifications to the rapid response approach based on risk andhigh- level schedule and budget information for each Urgency Level.

Page 4 of 11

Ology Bio’s Background IP and Materials shall remain the property of Ology Bio. No license(s) to
Ology Bio’s Background IP and Materials shall be granted under this SOW or Agreement, and the
Background IP above are specifically excluded from the definition of "Agreement Invention"
contained in Article 9 Section B of the 2373 Agreement.
6.0 SHIPPING PROVISIONS
Controlled, temperature-monitored domestic shipments shall be conducted with World Courier orFederal Express. The manufacturing platform will be delivered to the USG per instructions provided
by the project Agreement’s Officer Representative (AOR) identified in CLIN 0001 of theAgreement. Data deliverables will be provided in electronic format and coordinated with the project
AOR, as required.
7.0 Reporting and Data Requirements
7.1 Progress Reports
7.1.1 Monthly. A Monthly Progress Report (MPR) shall be submitted by the 15th ofeach month. The MPR will contain the technical progress made during the previous. The
schedule update will include the explanation for any changes in the schedule, drivers forthe change, as applicable. The report will also address any concerns that would impact
the performance, schedule, or cost planned for the effort. Updated project risks andmitigation activities will also be included.
7.1.2 Final. A Final Report shall be submitted at the end of this project’s performance
inclusive of the base period activities as well as any exercised options. The report will narrate
a complete summary of the project execution and results obtained. The narration will include
outstanding problems and their potential solutions, problems solved during the project, thesolutions to the solved problems, and how the product was advanced.
7.2 Regulatory and Technical Data Package
The Contractor shall be responsible for submitting all documentation required to support
regulatory filings with the FDA related to deliverables under this project, as specified in thisSOW. The Contractor shall provide the Government with copies of all technical data generated
by the Contractor during performance of contract necessary to pursue FDA approval and notify
the Government of FDA decisions as these take place. All written communications to and/orfrom the FDA generated during the performance of this SOW and received from the FDA by theContractor will be provided to the Government. All documentation shall be prepared for thesubmission to the FDA and provided to the Government in the format required by the sponsor.
Any pre-existing technical data that is required to support government funded activities will beon terms mutually agreed to via negotiation prior to award through an assertion process that
identifies such pre-existing technical data and its potential relationship to this SOW hereunder.
7.3 Meetings
7.3.1 Kick-Off Meeting. The Awardee will schedule a post-award kick-off meeting (b) (4)following the award date of this SOW with all key SOW stakeholders. This
one-day meeting is conducted to establish a common purpose among stakeholders and toprovide for a clear understanding of the scope of the project, the schedule for key
activities/milestones, the team roster and individual responsibilities, appropriate
Page 8 of 11(b) (4)Page 11 of 11

Appendix B
Project Schedule Payment Schedule
The Government shall pay the Contractor, upon the submission of proper invoices or vouchers
Expenditures shall be submitted based on the awarded budget. Federal funds are to be used only
for costs that a reasonable and prudent person would incur in carrying out the work. The
Awardee must maintain a financial system capable of identifying costs applicable to thisAgreement, compliant with Cost Principles (48 CFR Part 31). An invoice will be submitted
through Wide Area Work Flow (WAWF) in accordance with agreement requirements. Finalpayment of the Agreement shall be determined upon mutual agreement and settlement of any
outstanding indirect costs.
The Awardee shall proceed with the performance in accordance with the terms and conditions of thisAgreement and its Appendices. However, the Government may require the Awardee to cease
performance at any time prior to the commencement of any milestone or task. Such notice to cease
performance must be from the AO and be in writing, of which email is an acceptable form.

Page 1 of 1

inventory results, audits and self-assessments, corrective actions, and other property related
reports as directed by the AO.
Upon conclusion or termination of the Agreement, the Awardee shall submit a request in writing
to the AO, for disposition/disposal instructions and shall store Government Property not toexceed 120 days pending receipt of such instructions. Storage shall be at no additional cost to theGovernment unless otherwise noted in the Agreement. The Government, upon written notice to
the Awardee, may abandon any Government Property in place, at which time all obligations of
the Government regarding such Government Property shall cease.
Awardee Liability for Government Property. “Loss of Government Property” means
the loss, damage or destruction to Government Property reducing the Government’s
expected economic benefits of the property and includes loss of accountability but does
not include planned and purposeful destructive testing, obsolescence, normal wear andtear or manufacturing defects. THE AWARDEE SHALL BE LIABLE FOR LOSS OF
GOVERNMENT PROPERTY IN AWARDEE’S POSSESSION, EXCEPT WHENANY ONE OF THE FOLLOWING APPLIES: (I) AO GRANTS RELIEF OFRESPONSIBILITY AND LIABILITY FOR LOSS OF THE PARTICULARGOVERNMENT PROPERTY; (II) GOVERNMENT PROPERTY IS DELIVEREDOR SHIPPED UNDER THE GOVERNMENT’S INSTRUCTIONS; OR (III)GOVERNMENT PROPERTY IS DISPOSED OF IN ACCORDANCE WITH THE
GOVERNMENT’S DIRECTIONS.

Page 2 of 2

AWARD/CONTRACT
2. CONTRACT (Proc. Inst. Ident.) NO.
W911QY2090003

1. THIS CONTRACT IS A RATED ORDER
UNDER DPAS (15 CFR 700)
3. EFFECTIVE DATE
22 Feb 2020

CODE W911QY

5. ISSUED BYW6QK ACC-APG NATICKCONTRACT NG DIVISIONBLDG 1 GENERAL GREENE AVENUE
NATICK MA 01760-5011

7. NAME AND ADDRESS OF CONTRACTORRATING
PAGE OF PAGES
DO-N6
1
8
4. REQUISITION/PURCHASE REQUEST/PROJECT NO.
0011438990

CODE W911QY

6. ADMINISTERED BY (If other than Item 5)
W6QK ACC-APG NATICK
110 THOMAS JOHNSON DR SUITE #240
FREDERICK MD 21702

8. DELIVERY[ ] FOB ORIGIN(No., street, city, county, state and zip code)

OLOGY BIOSERVICES, NC
NANOTHERAPEUTICS
13200 NW NANO COURT
ALACHUA FL 32615-8726[ X ] OTHER(See below)

9 DISCOUNT FOR PROMPT PAYMENT

10 SUBMIT INVOICES

ITEM(4 copies unless otherwise specified)

CODE 3GQS9
11. SHIP TO/MARK FOR

TO THE ADDRESSSHOWN IN:

FACILITY CODE
CODE W56XNHCODE HQ0490

12. PAYMENT WILL BE MADE BY

DEFENSE F NANCE AND ACCOUNT NG SERVICEDFAS- NDY VP GFEBS
8899 E 56TH STREETNDIANAPOLIS IN 46249-3800

JPM MCSJPM CBRN MEDICALFT. DETRICK, MD VA 21702

13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN
COMPETITION:] 41 U.S.C. 253(c)()[] 10 U.S.C. 2304(c)() [14. ACCOUNTING AND APPROPRIATION DATA

15A. ITEM NO.

15C. QUANTITY

15B. SUPPLIES/ SERVICES

See Schedule
15D. UNIT

15E. UNIT PRICE

15F. AMOUNTSEE SCHEDULE

15G. TO TAL AMO UNT O F CO NTRACT$3,275,778.21
16. TABLE OF CONTENTS(X) SEC.
DESCRIPTION
PAGE(S)DESCRIPTION
PAGE(S) (X) SEC.
PART I - THE SCHEDULE
PART II - CO NTRACT CLAUSESXA SOLICITATION/ CONTRACT FORM
1
I CONTRACT CLAUSESXB SUPPLIES OR SERVICES AND PRICES/ COSTS
2-3
PART III – LIST O F DO CUMENTS, EXHIBITS AND O THER ATTACH.
C DESCRIPTION/ SPECS./ WORK STATEMENTJ LIST OF ATTACHMENTS
D PACKAGING AND MARKINGPART IV - REPRESENTATIO NS AND INSTRUCTIO NSE INSPECTION AND ACCEPTANCEREPRESENTATIONS, CERTIFICATIONS ANDK
OTHER STATEMENTS OF OFFERORSXF DELIVERIES OR PERFORMANCE
4X
G CONTRACT ADMINISTRATION DATA
5-8
L INSTRS., CONDS., AND NOTICES TO OFFERORSH SPECIAL CONTRACT REQUIREMENTS
M EVALUATION FACTORS FOR AWARDCONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT) OR 18 (SEALED-BID PROCUREMENT) AS APPLICABLE
17 [ ] CONTRACTOR'S NEGOTIATED AGREEMENT
Contractor is required to sign thisdocument and returncopies to issuing office )Contractor agrees to furnish and deliver all
items or perform all the services set forth or otherwise identified above and on any continuation
sheets for the consideration stated herein The rights and obligations of the parties to thiscontract shall be subject to and governed by the following documents: (a) this award/contract,(b) the solicitation, if any , and (c) such provisions, representations, certifications, and specifications,as are attached or incorporated by reference herein(Attachments are listed herein )19A. NAME AND TITLE OF SIGNER ( Type or print)

18 [] SEALED-BID AWARD (Contractor is not required to sign this document )Your bid on Solicitation Number
including the additions or changes made by y ou which additions or changes are set forth in full above, is hereby accepted as
to the terms listed above and on any continuation sheets This award consummates the contract which consists of thefollowing documents: (a) the Government's solicitation and y our bid, and (b) this award/contract No further contractual
document is necessary (Block 18 should be checked only when awarding a sealed-bid contract )20A. NAME OF CONTRACTING OFFICER(b) (6)

19B. NAME OF CONTRACTOR

19C. DATE SIGNED 20B. UNITED STATES OF AMERICA
B

BY(Signature of person authorized to sign)
AUTHORIZED FOR LOCAL REPRODUCTION
Previous edition is NOT usable(b) (6)

20C. DATE SIGNED
22-Feb-2020(Signature of Contracting Officer)
STANDARD FORM 26 (REV 5/2011)
Prescribed by GSA – FAR (48 CFR) 53 214(a)W911QY2090003
Page 3 of 8

INSPECTION AND ACCEPTANCE TERMS
Supplies/services will be inspected/accepted at:
CLIN INSPECT AT
0001
Destination
000101 N/A

INSPECT BY
Government
N/A

ACCEPT AT
Destination
N/A

ACCEPT BY
Government
N/A

W911QY2090003
Page 4 of 8
Section F - Deliveries or Performance

DELIVERY INFORMATION
CLIN

DELIVERY DATE

0001

21-NOV-2020

000101 N/A

QUANTITYN/A

SHIP TO ADDRESSDODAAC /CAGE

JPM MCSJPM CBRN MEDICALFT. DETRICK, MD VA 21702
FOB: Destination

W56XNH

N/A

N/A

W911QY2090003
Page 6 of 8

ACCOUNTING AND APPROPRIATION DATA
AA: 09720202021040000026010006060255
COST CODE: A5XAHAMOUNT (b) (4)A.0011316.3.1.1

6100.9000021001

ACRN

CLIN/SLINCINAMOUNTAA

000101

GFEBS001143899000001(b) (4)

CLAUSES INCORPORATED BY REFERENCE
52.232-22

Limitation Of Funds

APR 1984

CLAUSES INCORPORATED BY FULL TEXT
252.204-7006 BILLING INSTRUCTIONS (OCT 2005)
When submitting a request for payment, the Contractor shall-(a) Identify the contract line item(s) on the payment request that reasonably reflect contract work performance; and(b) Separately identify a payment amount for each contract line item included in the payment request.
(End of clause)

252.232-7006 WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (DEC 2018)(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
WorkFlow (WAWF).
“Local processing office (LPO)” is the office responsible for payment certification when payment certification isdone external to the entitlement system.
“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission ofPayment Requests and Receiving Reports.

W911QY2090003
Page 7 of 8(b) Electronic invoicing. The WAWF system provides the method to electronically process vendor payment requests
and receiving reports, as authorized by Defense Federal Acquisition Regulation Supplement (DFARS) 252.2327003, Electronic Submission of Payment Requests and Receiving Reports.
(c) WAWF access. To access WAWF, the Contractor shall—(1) Have a designated electronic business point of contact in the System for Award Management at
https://www.sam.gov; and(2) Be registered to use WAWF at https://wawf.eb mil/ following the step-by-step procedures for self-registration
available at this web site.
(d) WAWF training. The Contractor 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 Contractor shall use the following information when submitting payment
requests and receiving reports in WAWF for this contract or task or delivery order:(1) Document type. The Contractor shall submit payment requests using the following document type(s):(i) For cost-type line items, including labor-hour or time-and-materials, submit a cost voucher.
(ii) For fixed price line items—(A) That require shipment of a deliverable, submit the invoice and receiving report specified by the Contracting
Officer.
____________________________________________________________(Contracting Officer: Insert applicable invoice and receiving report document type(s) for fixed price line items that
require shipment of a deliverable.)(B) For services that do not require shipment of a deliverable, submit either the Invoice 2in1, which meets therequirements for the invoice and receiving report, or the applicable invoice and receiving report, as specified by theContracting Officer.
__2-in-1___________________________________________________(Contracting Officer: Insert either “Invoice 2in1” or the applicable invoice and receiving report document type(s) for
fixed price line items for services.)(iii) For customary progress payments based on costs incurred, submit a progress payment request.
(iv) For performance based payments, submit a performance based payment request.
(v) For commercial item financing, submit a commercial item financing request.
(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in thecontract.

W911QY2090003(b) (6)
Page 4 of 6
SUBCLIN 000101
ITEM NO
000101

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

FUNDING TO CLIN 0001
CPFF
PURCHASE REQUEST NUMBER: 0011438990
ESTIMATED COST
FIXED FEE

$0.00
$0.00
$0.00

TOTAL EST COST + FEE
ACRN AA
CIN: GFEBS001143899000001(b) (4)SUBCLIN 000102
ITEM NO
000102

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

Funding to CLN 0001
CPFF
ACRN AA
PURCHASE REQUEST NUMBER: 0011438990-0006
ESTIMATED COST
FIXED FEE

$0.00
$0.00
$0.00

TOTAL EST COST + FEE
ACRN AA
CIN: GFEBS001143899000002

CLIN 0002 is added as follows:(b) (4)

W911QY2090003(b) (6))
Page 6 of 6

SECTION F - DELIVERIES OR PERFORMANCE
The following Delivery Schedule for CLIN 0002 has been added:
DELIVERY DATEQUANTITY

28-MAR-2022

SHIP TO ADDRESSDODAAC /CAGE

JPM MCSJPM CBRN MEDICALFT. DETRICK, MD VA 21702
FOB: Destination

W56XNHSECTION G - CONTRACT ADMINISTRATION DATA
Accounting and Appropriation
Summary for the Payment Office
As a result of this modification, the total funded amount for this document was increased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 000201:
Funding on SUBCLIN 000201 is initiated as follows:
ACRN: AB
CIN: GFEBS001147420300001
Acctng Data: 09720202021013000018170446463252
Increase: (b) (4)Total: (b) (4)Cost Code: AHPII(End of Summary of Changes)

S.0025760.7.5.1

6100.9000021001

W911QY2090003
P00003
Page 2 of 4
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00003

A. The purpose of this amendment is as follows:a. The SOW for Project 20-03, Procurement, Commissioning and Qualification of (b) (4)at the DoD ADM Facility, Appendix A-3, is hereby incorporated(b) (4)
into the agreement under CLIN 0003.
b. The total cost of the agreement is hereby increased by (b) (4), fromto (b) (4).
(b) (4)c. CLIN 000301 is hereby added to the agreement into incorporate incremental funding in
the amount of (b) (4)under ACRN (b) (4)B. The parties hereby agree that changes effected by this amendment constitute both theconsideration and the equitable adjustment due under any Article in this agreement resulting
from the incorporation of Project 20-03.
C. All other terms and conditions remain the same and in full force and effect.

SECTION A - SOLICITATION/CONTRACT FORM

The total cost of this contract was increased by (b) (4)(b) (4)

SECTION B - SUPPLIES OR SERVICES AND PRICES
CLIN 0003 is added as follows:from (b) (4)toW911QY2090003
P00003
Page 3 of 4
ITEM NO
0003

SUPPLIES/SERVICESQUANTITYUNIT
Job

UNIT PRICEAMOUNT(b) (4)

PROJECT 20-03: (b) (4)CPFF
Project 20-03: Procurement, Commissioning and Qualification of (b) (4)at the DoD ADM Facility labor, materials, equipment(b) (4)and associated allowable costs delineated the in Statment of Work entitled,"Procurement, Commissioning and Qualification of (b) (4)(b) (4)at the DoD ADM Facility," hereby incorporated into the Agreement
under Appendix A.
The project level Agreements Officer Representative shall be the Government's
representative on technical matters related solely to this project.
The project level AOR does not supersede the roles and duties of the Agreement
AOR. The Project AOR's contact Information is below:(b) (6)
FOB: Destination
PSC CD: AN14
ESTIMATED COST
FIXED FEETOTAL EST COST + FEE(b) (4)(b) (4)(b) (4)SUBCLIN 000301 is added as follows:
ITEM NO
000301

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

GFY 2020 Funding
CPFF
Project 20-03
PURCHASE REQUEST NUMBER: 0011473355
ESTIMATED COST
FIXED FEE

$0.00
$0.00
$0.00

TOTAL EST COST + FEE
ACRN AC
CIN: GFEBS001147335500001(b) (4)

SECTION E - INSPECTION AND ACCEPTANCE
The following Acceptance/Inspection Schedule was added for CLIN 0003:
INSPECT AT
INSPECT BY
ACCEPT AT
Destination
Government
Destination

The following Acceptance/Inspection Schedule was added for SUBCLIN 000301:

ACCEPT BY
Government

W911QY2090003
P00003
Page 4 of 4
INSPECT AT
N/A

INSPECT BY
N/A

ACCEPT AT
N/AACCEPT BY
N/A

SECTION F - DELIVERIES OR PERFORMANCE
The following Delivery Schedule for CLIN 0003 has been added:
DELIVERY DATEQUANTITY

30-SEP-2020

SHIP TO ADDRESSDODAAC /CAGEMCSJPL EB
1564 FREEDMAN DRIVE
FORT DETRICK MD 21702
FOB: Destination

W56XNHSECTION G - CONTRACT ADMINISTRATION DATA
Accounting and Appropriation
Summary for the Payment Office
As a result of this modification, the total funded amount for this document was increased by (b) (4)to (b) (4)(b) (4)SUBCLIN 000301:
Funding on SUBCLIN 000301 is initiated as follows:
ACRN: AC
CIN: GFEBS001147335500001
Acctng Data: 09720202021040000026010006060255
Increase:(b) (4)Total: (b) (4)Cost Code: A5XAH(End of Summary of Changes)

A.0011316.3.1.2

6100.9000021001

fromW911QY2090003
P00004
Page 2 of 3
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00004The purpose of this amendment is to incorporate additional funding under CLIN 0003. All other terms andconditions remain the same and in full force and effect.

SECTION B - SUPPLIES OR SERVICES AND PRICESSUBCLIN 000302 is added as follows:
ITEM NO
000302

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

Funding FY 20CPFF
PURCHASE REQUEST NUMBER: 0011476080
ESTIMATED COST
FIXED FEE

$0.00
$0.00
$0.00

TOTAL EST COST + FEE
ACRN AB
CIN: GFEBS001147608000001(b) (4)

SECTION E - INSPECTION AND ACCEPTANCE
The following Acceptance/Inspection Schedule was added for SUBCLIN 000302:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

SECTION G - CONTRACT ADMINISTRATION DATA
Accounting and Appropriation
Summary for the Payment Office
As a result of this modification, the total funded amount for this document was increased by (b) (4)to (b) (4)(b) (4)fromW911QY2090003
P00004
Page 3 of 3
SUBCLIN 000302:
Funding on SUBCLIN 000302 is initiated as follows:
ACRN: AB
CIN: GFEBS001147608000001
Acctng Data: 09720202021013000018170446463252
Increase: $715,265.00
Total (b) (4)Cost Code: AHPII(End of Summary of Changes)

S.0025760.7.5.1

6100.9000021001

1. CONTRACT ID CODEAMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

PAGE OF P AGES

1
2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

P00005

4. REQUISITION/PURCHASE REQ. NO.
SEE SCHEDULE

22-Mar-2020

6. ISSUED BY

CODE

5

5. P ROJECT NO.(If applicable)

7. ADMINISTERED BY (If other than item 6)

W911QY

W911QYCODE

W6QK ACC-APG NATICK
110 THOMAS JOHNSON DR SUITE #240
FREDERICK MD 21702

W6QK ACC-APG NATICKCONTRACTING DIVISIONBLDG 1 GENERAL GREENE AVENUE
NATICK MA 01760-5011

9A. AMENDMENT OF SOLICIT AT ION NO.

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)OLOGY BIOSERVICES, INC
NANOTHERAPEUTICS
13200 NW NANO COURT
ALACHUA FL 32615-8726

9B. DATED (SEE IT EM 11)
MOD. OF CONTRACT/ORDER NO.
X 10A.
W911QY2090003

CODE

10B. DAT ED (SEE ITEM 13)
X 22-Feb-2020
FACILIT Y CODE
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICIT AT IONS

3GQS9The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer

is extended,

is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:(a) By completing Items 8 and 15, and returning
copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN
REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter,
provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNT ING AND APPROPRIATION DATA (If required)
See Schedule
13. T HIS IT EM APPLIES ONLY TO MODIFICATIONS OF CONT RACT S/ORDERS.
IT MODIFIES T HE CONT RACT /ORDER NO. AS DESCRIBED IN ITEM 14.
A. THIS CHANGE ORDER IS ISSUED PURSUANT T O: (Specify authority) THE CHANGES SET FORT H IN ITEM 14 ARE MADE IN T HE
CONT RACT ORDER NO. IN ITEM 10A.
B. THE ABOVE NUMBERED CONT RACT /ORDER IS MODIFIED TO REFLECT T HE ADMINISTRAT IVE CHANGES (such as changes in paying
office, appropriation date, etc.) SET FORT H IN IT EM 14, PURSUANT T O T HE AUT HORIT Y OF FAR 43.103(B).
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUT HORIT Y OF:
X D. OT HER (Specify type of modification and authority)
In accordance w ith Article 5 of the Agreement
E. IMPORT ANT: Contractor

is not,X

is required to sign this document and return1

copies to the issuing office.

14. DESCRIPT ION OF AMENDMENT /MODIFICAT ION (Organized by UCF section headings, including solicitation/contract subject matter
where feasible.)
Modification Control Number: (b) (6)The purpose of this amendment is to incorporate Project 20-04 under CL N 0004, incorporate incremental funding, and revise Article 14.G. Allother terms and conditions remain the same and in full force and effect.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND T ITLE OF CONTRACTING OFFICER (Type or print)(b) (6)

TEL: (b) (6)15B. CONT RACT OR/OFFEROR

15C. DATE SIGNED

16B. UNIT ED ST AT ES OF AMERICA
BY(Signature of person authorized to sign)
EXCEPTION T O SF 30
APPROVED BY OIRM 11-84(b) (6)EMAIL: (b) (6)16C. DAT E SIGNED
22-Mar-2020(Signature of Contracting Officer)
30-105-04

ST ANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243

W911QY2090003
P00005
Page 2 of 5
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00005

A. The purpose of this amendment is as follows:a. Paragraph A.1 of modification P00002 is hereby changed from:
1. (b) (4)To:
1. (b) (4)b. (b) (4)c. The total cost of the agreement is hereby increased by (b) (4)to (b) (4).
(b) (4)fromd. (b) (4)e. Article 14.G is hereby replace in its entirety with “Any project order incorporated into
this agreement may be DO C-9 rated order certified for national defense, emergency
preparedness, and energy program use under the Defense Priorities and Allocations
System (DPAS) (15 CFR700), and the Awardee will be required to follow all of therequirements of this regulation.
f. (b) (4)B. (b) (4)C. All other terms and conditions remain the same and in full force and effect.

W911QY2090003
P00005
Page 3 of 5

The following have been modified:
P00004

ITEM NO
000301

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

GFY 2020 Funding
CPFF
Project 20-03
PURCHASE REQUEST NUMBER: 0011473355
ESTIMATED COST
FIXED FEE

$0.00
$0.00
$0.00

TOTAL EST COST + FEE
ACRN AC
CIN: GFEBS001147335500001(b) (4)

SECTION A - SOLICITATION/CONTRACT FORM

The total cost of this contract was increased by (b) (4)(b) (4)

SECTION B - SUPPLIES OR SERVICES AND PRICES
CLIN 0004 is added as follows:from (b) (4)toW911QY2090003
P00005
Page 4 of 5
ITEM NO
0004

SUPPLIES/SERVICESQUANTITYUNIT
Job

UNIT PRICE

UNIT

UNIT PRICEAMOUNT(b) (4)(b) (4), (b) (6)SUBCLIN 000401 is added as follows:
ITEM NO
000401

SUPPLIES/SERVICESQUANTITYAMOUNT$0.00

FY 20 Funding
CPFF
PURCHASE REQUEST NUMBER: 0011474201
ESTIMATED COST
FIXED FEE

$0.00
$0.00
$0.00

TOTAL EST COST + FEE
ACRN AB
CIN: GFEBS001147420100001(b) (4)

SECTION E - INSPECTION AND ACCEPTANCE
The following Acceptance/Inspection Schedule was added for CLIN 0004:
INSPECT AT
INSPECT BY
ACCEPT AT
Destination
Government
Destination

ACCEPT BY
Government

The following Acceptance/Inspection Schedule was added for SUBCLIN 000401:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/AW911QY2090003
P00005
Page 5 of 5

SECTION F - DELIVERIES OR PERFORMANCE
The following Delivery Schedule for CLIN 0004 has been added:
DELIVERY DATEQUANTITY

31-MAR-2022

SHIP TO ADDRESSDODAAC /CAGE

N/A
FOB: Destination

SECTION G - CONTRACT ADMINISTRATION DATA
Accounting and Appropriation
Summary for the Payment Office
As a result of this modification, the total funded amount for this document was increased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 000401:
Funding on SUBCLIN 000401 is initiated as follows:
ACRN: AB
CIN: GFEBS001147420100001
Acctng Data: 09720202021013000018170446463252
Increase: (b) (4)Total: (b) (4)Cost Code: AHPII(End of Summary of Changes)

S.0025760.7.5.1

6100.9000021001

Charter, Communication Plan, IMS, Work Breakdown Structure (WBS), Cost
Management/Spend Plan and List of Deliverables.
2.1.2 Execution
2.1.2.1 Meetings
2.1.2.1.1 The Awardee shall conduct IPT meetings no less than twice permonth. The Awardee shall provide the agendas and IPT slide
decks within 24 hours in advance of the IPT. Finalized meeting
minutes shall be submitted to the USG within five business days
following each teleconference.
2.1.2.1.2 The Awardee shall conduct ad hoc meetings as necessary, uponteam member or USG request, to discuss issues as they arise.
Minutes from these meetings shall be provided to the USG within
five business days following the meeting.
2.1.2.2 Reports
2.1.2.2.1 The Awardee shall deliver a Monthly IMS and spend plan for thelife cycle of the project. The Awardee shall submit each Monthly
IMS and spend plan within 20 calendar days after the end of eachmonth of performance. The USG will have 10 calendar days torespond to the report with any comments, and the Awardee will
have an additional five calendar days to revise the deliverable or
respond to those comments.
2.1.2.2.2 The Awardee shall provide Quarterly and Annual Progress
Reports. The reports shall provide a technical summary of
progress over the associated time period, as well as a summary
analysis of any risks, issues and/or opportunities. Delivery dates
for Quarterly and Annual Progress reports will be based on award
date and not the calendar year.
2.1.2.2.3 The Awardee shall submit a Quarterly Financial Status Report nolater than 20 calendar days after the end of each quarter of
performance. The USG will have 30 calendar days to respond to
the report with any comments, and the awardee will have anadditional 10 calendar days to revise the deliverable or respondto those comments. Reports will cover work performed every
three months for the duration of the period of performance.
2.1.2.2.4 The Awardee shall perform, record and report physical inventory
results of all Contractor Acquired Property in the contractor's
possession, if the Awardee purchases material or equipment using
USG funds, as approved by the Agreement Officer’s
Representative (AOR) during performance of the project.
2.1.2.2.5 Incident Reporting
2.1.2.2.5.1 The Awardee shall report any incident to the USG that
could result in more than a one-month delay in schedulefrom the most recent IMS critical path delivered to the
USG in an incident report. In addition, the Awardee shallprovide advance notice of critical path schedule changes
resulting in more than a 15 calendar-day shift that are not2.9.7.1
2.9.7.2
2.9.7.3
2.9.7.4
2.9.7.5
2.9.7.6

Engineering Run Report
Finalized CGMP Batch Record templates
Finalized CGMP specifications
Final BOM
Engineering non-CGMP DS CoTEngineering non-CGMP DS MSDS

2.10 Task 10: CGMP DS Run (b) (4)2.10.1 The Awardee shall update the TTP and MBRs as needed.
2.10.2 The Awardee shall perform all CGMP manufacturing campaigns in accordance with
CGMP per U.S. Code of Federal Regulations and all applicable regulatory guidance.
2.10.3 The Awardee shall execute (b) (4) run for the CGMP DS using MBRs and (b) (4).
2.10.3.1 The Awardee shall conduct the in-process and release testing outlined inTable 2 and Table 3.
2.10.3.2 The Awardee shall provide the final QA review of the PBR and QC data andrelease of the CGMP DS with a COA and MSDS, ensuring that it meets alltechnical specifications and is acceptable for subsequent CGMP formulationand fill.
2.10.3.3 The Awardee shall write a CGMP DS Campaign Summary Report including
Batch Production Documents, Process Flow Diagrams, final BOM, COA andMSDS.
2.10.4 The Awardee shall provide:
2.10.4.1 QA-Approved Executed DS Batch Production Records
2.10.4.2 QA-Approved DS COA
2.10.4.3 QA-Approved DS MSDS
2.11 Task 11: Optional: CGMP DP Fill/Finish (b) (4)2.11.1 The Awardee shall determine the final dose and vial configuration in conjunction with
the USG (b) (4) .
2.11.2 The Awardee shall perform all CGMP manufacturing campaigns in accordance with
CGMP per U.S. Code of Federal Regulations and all applicable regulatory guidance.
2.11.3 The Awardee shall perform liquid fill operations using the CGMP DS from Task 10.
(b) (4)2.11.4 The Awardee shall fill (b) (4)multi-dose vials of CGMP DP suitable for use in a
Phase 1 clinical trial at a concentration TBD in collaboration with the client. This
includes formulation, fill, inspection, labeling, packaging and QA review.
2.11.5 The Awardee shall conduct sampling and lot release testing.
2.11.6 The Awardee shall provide controlled and temperature-monitored transport of analyticalsamples and final released lot.
2.11.7 The Awardee shall provide a CGMP DP Campaign Summary Report, raw material
COA(s), analytical testing summary and analytical report, and executed CGMP batchrecords, and CoA and MSDS for CGMP DP.
2.12 Task 12: Optional: CGMP DS Runs (b) (4) (Additional runs)

2.12.1 The Awardee shall perform all CGMP manufacturing campaigns in accordance with
CGMP per U.S. Code of Federal Regulations and all applicable regulatory guidance.
2.12.2 The Awardee shall execute (b) (4) runs for the CGMP DS using MBRs; the numberof runs will be based on the discretion of the USG and suggestions from (b) (4) .
2.12.2.1 The Awardee shall conduct the in-process and release testing outlined inTable 2 and Table 3.
2.12.2.2 The Awardee shall provide the final QA review of the PBR and QC data andrelease of the CGMP DS with a COA and MSDS, ensuring that it meets alltechnical specifications and is acceptable for subsequent CGMP formulationand fill.
2.12.2.3 The Awardee shall write a CGMP DS Campaign Summary Report including
Batch Production Documents, Process Flow Diagrams, final BOM, COA andMSDS.
2.12.3 The Awardee shall provide:
2.12.3.1 QA-Approved Executed DS Batch Production Records
2.12.3.2 QA-Approved DS COA
2.12.3.3 QA-Approved DS MSDS
2.13 Task 13: Optional: CGMP DP Fill/Finish (b) (4)2.13.1 The Awardee shall perform all CGMP manufacturing campaigns in accordance with
CGMP per U.S. Code of Federal Regulations and all applicable regulatory guidance.
2.13.2 The Awardee shall perform liquid fill operations using the CGMP DS from Task 12.
(b) (4)2.13.3 The Awardee shall fill (b) (4)of CGMP DP suitable for use in a
Phase 1 clinical trial at a concentration TBD in collaboration with the client. This
includes formulation, fill, inspection, labeling, packaging and QA review.
2.13.4 The Awardee shall conduct sampling and lot release testing.
2.13.5 The Awardee shall provide controlled and temperature-monitored transport of analyticalsamples and final released lot.
2.13.6 The Awardee shall provide a CGMP DP Campaign Summary Report, raw material
COA(s), analytical testing summary and analytical report, and executed CGMP batchrecords, and COA and MSDS for CGMP DP.
2.14 Task 14: Stability Testing of DS and DP (b) (4)2.14.1 Engineering DS
2.14.1.1 The Awardee shall provide a Stability Protocol for the Engineering DS,
including (b) (4) real-time stability studies and accelerated and stressed
temperature stability studies, to be determined in collaboration with the USG
prior to the start of stability.
2.14.1.2 The Awardee shall execute the stability study using the Engineering Run DS.
2.14.1.3 The Awardee shall provide a Stability Report.
2.14.2 CGMP DS
2.14.2.1 The Awardee shall provide a Stability Protocol for the CGMP DS, including(b) (4) real-time stability studies and accelerated and stressed temperaturestability studies, to be determined in collaboration with the USG prior to thestart of stability.

W911QY‐20‐9‐0003

Appendix A‐2 Rev 1

results of all Contractor Acquired Property in the contractor's
possession, if the Awardee purchases material or equipment using
USG funds, as approved by the AOR during performance of the
project.
2.1.2.2.5 Incident Reporting
2.1.2.2.5.1 The Awardee shall report any incident to the USG that
could result in more than a one-month delay in schedulefrom the most recent IMS critical path delivered to the
USG in an incident report. In addition, the Awardee shallprovide advanced notice of critical path schedule changes
resulting in more than a 15-day calendar shift that are nothandled as Incident Reports. The Ology Bio PM will
provide written notification (via email) to the AOR.
2.1.2.2.5.2 The Awardee shall telephonically contact the program
manager for the USG no later than 24 hours after theincident is identified.
2.1.2.2.5.3 The Awardee shall submit a written summary report
within three business days of an incident, to include what
happened, the impact, the availability of any available
corrective actions, and a timeline for any corrective
actions to be in place. If additional time is required for the
Root Cause Analysis, the Ology Bio PM will work with
the AOR to agree on timing of the written summary
report.
2.1.2.2.6 The Project Agreement Holder (PAH) shall provide the draft
Quality Agreement within ten calendar days of project award.
The draft Quality Agreement will be submitted via e-mail to the
USG technical representatives. The USG shall respond withcomments or acceptance ten calendar days following receipt ofthe draft Quality Agreement. The final agreement withincorporated changes shall be submitted five calendar days after
receipt of USG comments. The USG will provide written
acceptance.
2.1.2.2.7 The Awardee shall support USG quality audits of the Awardee’ssystems and procedures as outlined in the Quality Agreement,
insofar as they relate to the service and control of the USG’s
product. These audits may be performed at times mutually agreed
upon by the Awardee and the USG. The Awardee shall provide
the USG with monthly follow-ups on the status of audit
observation commitments found in the USG annual audit orregulatory inspection, as they apply to the USG’s product.
2.2 Task 2: Technology Transfer and Plasmid Generation
Assumptions: The mAb sequences for (b) (4)mAbs from which the (b) (4) mAb candidates will
be selected, will be provided by the USG Performer.

W911QY2090003(b) (6)
Page 4 of 9.
SUBCLIN 000202 is added as follows:
ITEM NO
000202

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00(b) (4)FFP(b) (4)

PURCHASE REQUEST NUMBER: 0011495606

NET AMT
ACRN AG
CIN: GFEBS001149560600001$0.00(b) (4)SUBCLIN 000402 is added as follows:
ITEM NO
000402

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

Optimization/Production of a DNA vaccine
FFP
Optimization/Production of a DNA vaccine
PURCHASE REQUEST NUMBER: 0011495607

NET AMT
ACRN AH
CIN: GFEBS001149560700001

CLIN 0007 is added as follows:$0.00(b) (4)

W911QY2090003(b) (6))
Page 7 of 9
INSPECT AT
N/A

INSPECT BY
N/A

ACCEPT AT
N/AACCEPT BY
N/A

The following Acceptance/Inspection Schedule was added for CLIN 0007:
INSPECT AT
INSPECT BY
ACCEPT AT
Destination
Government
Destination

ACCEPT BY
Government

The following Acceptance/Inspection Schedule was added for SUBCLIN 000701:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

The following Acceptance/Inspection Schedule was added for CLIN 0008:
INSPECT AT
INSPECT BY
ACCEPT AT
Destination
Government
Destination

ACCEPT BY
Government

The following Acceptance/Inspection Schedule was added for SUBCLIN 000801:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

SECTION F - DELIVERIES OR PERFORMANCE
The following Delivery Schedule for CLIN
DELIVERY DATE

has been added:

QUANTITY

23-AUG-2023

SHIP TO ADDRESSDODAAC /CAGE

MCS
110 THOMAS JOHNSON DR.
FREDERICK MD 21702(b) (6)
FOB: Destination

W56XNHThe following Delivery Schedule for CLIN 0008 has been added:
DELIVERY DATE
23-MAR-2023

QUANTITYSHIP TO ADDRESSDODAAC /CAGE

MCS
110 THOMAS JOHNSON DR.
FREDERICK MD 21702(b) (6)
FOB: Destination

W56XNHSECTION G - CONTRACT ADMINISTRATION DATA
Accounting and Appropriation

W911QY2090003(b) (6)
Page 8 of 9
Summary for the Payment Office
As a result of this modification, the total funded amount for this document was increased by (b) (4)from (b) (4)to $50,318,531.37.
SUBCLIN 000202:
Funding on SUBCLIN 000202 is initiated as follows:
ACRN: AG
CIN: GFEBS001149560600001
Acctng Data: 09720202021013000018170551519252

S.0025760.7.5.4.1

6100.9000021001

S.0025760.7.5.4.2

6100.9000021001

Increase: $17,336,141.00
Total: (b) (4)Cost Code: AHPIISUBCLIN 000402:
Funding on SUBCLIN 000402 is initiated as follows:
ACRN: AH
CIN: GFEBS001149560700001
Acctng Data: 09720202021013000018170551519252
Increase: (b) (6)Total: (b) (6)Cost Code: AHPIISUBCLIN 000701:
Funding on SUBCLIN 000701 is initiated as follows:
ACRN: AF
CIN: GFEBS001149253400003
Acctng Data:^^^097^2020^2021^^0400^000^^255^D^0603384BP^^^^^2600^00008522^044315^DTRA^RCM,VACCINES/TH^0603384BP_TM3_CPM_R
Increase: (b) (6)Total: (b) (4)Cost Code: A
SUBCLIN 000801:
Funding on SUBCLIN 000801 is initiated as follows:W911QY2090003(b) (6))
Page 9 of 9
ACRN: AF
CIN: GFEBS001149253400002
Acctng Data:^^^097^2020^2021^^0400^000^^255^D^0603384BP^^^^^2600^00008522^044315^DTRA^RCM,VACCINES/TH^0603384BP_TM3_CPM_R
Increase: (b) (6)Total: (b) (4)0

Cost Code: A(End of Summary of Changes)

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

1. CONTRACT ID CODE

PAGE OF P AGES

1
2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

P000094. REQUISITION/PURCHASE REQ. NO.
SEE SCHEDULE

07-May-2020

6. ISSUED BY

CODE

2

5. P ROJECT NO.(If applicable)

7. ADMINISTERED BY (If other than item 6)

W911QY

W911QYCODE

W6QK ACC-APG NATICK
110 THOMAS JOHNSON DR SUITE #240
FREDERICK MD 21702

W6QK ACC-APG NATICKCONTRACTING DIVISIONBLDG 1 GENERAL GREENE AVENUE
NATICK MA 01760-5011

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)OLOGY BIOSERVICES, INC
NANOTHERAPEUTICS
13200 NW NANO COURT
ALACHUA FL 32615-8726

9A. AMENDMENT OF SOLICIT AT ION NO.
9B. DATED (SEE IT EM 11)
MOD. OF CONTRACT/ORDER NO.
X 10A.
W911QY2090003

CODE

10B. DAT ED (SEE ITEM 13)
X 22-Feb-2020
FACILIT Y CODE
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICIT AT IONS

3GQS9The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer

is extended,

is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:(a) By completing Items 8 and 15, and returning
copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN
REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter,
provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNT ING AND APPROPRIATION DATA (If required)
13. T HIS IT EM APPLIES ONLY TO MODIFICATIONS OF CONT RACT S/ORDERS.
IT MODIFIES T HE CONT RACT /ORDER NO. AS DESCRIBED IN ITEM 14.
A. THIS CHANGE ORDER IS ISSUED PURSUANT T O: (Specify authority) THE CHANGES SET FORT H IN ITEM 14 ARE MADE IN T HE
CONT RACT ORDER NO. IN ITEM 10A.
B. THE ABOVE NUMBERED CONT RACT /ORDER IS MODIFIED TO REFLECT T HE ADMINISTRAT IVE CHANGES (such as changes in paying
office, appropriation date, etc.) SET FORT H IN IT EM 14, PURSUANT T O T HE AUT HORIT Y OF FAR 43.103(B).
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUT HORIT Y OF:
X D. OT HER (Specify type of modification and authority)
In accordance w ith Article 4 of the agreement.
E. IMPORT ANT: ContractorX

is not,is required to sign this document and returncopies to the issuing office.

14. DESCRIPT ION OF AMENDMENT /MODIFICAT ION (Organized by UCF section headings, including solicitation/contract subject matter
where feasible.)
Modification Control Number: (b) (6)The purpose of this modification is to authorize purchases under project 20-09. All other terms and conditions remain the same and in fullforce and effect.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND T ITLE OF CONTRACTING OFFICER (Type or print)(b) (6)TEL:(b) (6)
15B. CONT RACT OR/OFFEROR(Signature of person authorized to sign)
EXCEPTION T O SF 30
APPROVED BY OIRM 11-84

15C. DATE SIGNED

16B

16C. DAT E SIGNED

B

07-May-2020(b) (6)30-105-04

ST ANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243

W911QY2090003
P00009Page 2 of 2
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00009

A. This unpriced change order is being issued to authorize the Awardee to proceed withefforts delineated in notification, dated 7 May 2020, entitled (b) (4), hereby effecting the following changes:
1. Ology is hereby authorized to proceed with the (b) (4)fermentors and (b) (4)bioreactors.
2. Funding for the above efforts is available under ACRN AB for CLIN 0002.
B. Prior to definitization, reimbursement of costs resulting from this change order shall not
exceed (b) (4). Application of fee is subject to negotiation and will be finalized uponaward of the supplemental modification.
C. Appendix A of the Agreement shall be revised to incorporate the identified efforts, andshall be finalized upon supplemental agreement. Negotiations shall be conducted inaccordance with the terms of the Agreement.
D. All other terms and conditions remain unchanged and in full force and effect.

(End of Summary of Changes)

1. CONTRACT ID CODEAMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

PAGE OF P AGES

1
2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

P000104. REQUISITION/PURCHASE REQ. NO.
SEE SCHEDULE

14-May-2020

6. ISSUED BY

CODE

4

5. P ROJECT NO.(If applicable)

7. ADMINISTERED BY (If other than item 6)

W911QY

W911QYCODE

W6QK ACC-APG NATICK
110 THOMAS JOHNSON DR SUITE #240
FREDERICK MD 21702

W6QK ACC-APG NATICKCONTRACTING DIVISIONBLDG 1 GENERAL GREENE AVENUE
NATICK MA 01760-5011

9A. AMENDMENT OF SOLICIT AT ION NO.

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)OLOGY BIOSERVICES, INC
NANOTHERAPEUTICS
13200 NW NANO COURT
ALACHUA FL 32615-8726

9B. DATED (SEE IT EM 11)
MOD. OF CONTRACT/ORDER NO.
X 10A.
W911QY2090003

CODE

10B. DAT ED (SEE ITEM 13)
X 22-Feb-2020
FACILIT Y CODE
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICIT AT IONS

3GQS9The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer

is extended,

is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:(a) By completing Items 8 and 15, and returning
copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN
REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter,
provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNT ING AND APPROPRIATION DATA (If required)
See Schedule
13. T HIS IT EM APPLIES ONLY TO MODIFICATIONS OF CONT RACT S/ORDERS.
IT MODIFIES T HE CONT RACT /ORDER NO. AS DESCRIBED IN ITEM 14.
A. THIS CHANGE ORDER IS ISSUED PURSUANT T O: (Specify authority) THE CHANGES SET FORT H IN ITEM 14 ARE MADE IN T HE
CONT RACT ORDER NO. IN ITEM 10A.
B. THE ABOVE NUMBERED CONT RACT /ORDER IS MODIFIED TO REFLECT T HE ADMINISTRAT IVE CHANGES (such as changes in paying
office, appropriation date, etc.) SET FORT H IN IT EM 14, PURSUANT T O T HE AUT HORIT Y OF FAR 43.103(B).
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUT HORIT Y OF:
X D. OT HER (Specify type of modification and authority)
In accordance w ith Article 4 of the agreement.
E. IMPORT ANT: ContractorX

is not,is required to sign this document and returncopies to the issuing office.

14. DESCRIPT ION OF AMENDMENT /MODIFICAT ION (Organized by UCF section headings, including solicitation/contract subject matter
where feasible.)
Modification Control Number: (b) (6)The purpose of this change order is to incorporate additional costs specific to Project 20-09 under CL N 0009, and incorporate incremental
funding. All other terms and conditions remain the same and in full force and effect.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND T ITLE OF CONTRACTING OFFICER (Type or print)
CONTRACTING OFFICER(b) (6)

TEL: (b) (6)15B. CONT RACT OR/OFFEROR

15C. DATE SIGNED

16B. UNIT ED ST AT ES OF AMERICA
B(Signature of person authorized to sign)
EXCEPTION T O SF 30
APPROVED BY OIRM 11-84(b) (6)EMAIL: (b) (6)16C. DAT E SIGNED
14-May-2020(Signature of Contracting Officer)

30-105-04

ST ANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243

W911QY2090003
P00010Page 2 of 4
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00010A. Change order P00009 is hereby rescinded and replaced as follows:
1.The Awardee is hereby authorized to proceed with efforts delineated in notification,
dated 8 May 2020 titled ”Quotes for (b) (4)” and 14 May 2020 titled“Request for ATP to order long lead-time equipment (b) (4)”.
2. Ology is hereby authorized to proceed with the purchase of the supplies identified in
the requests identified in paragraph A.
3. CLIN 0009 in the amount of (b) (4)is hereby added.

4. CLIN 000901 is hereby added to incorporate incremental funding in the amount of.
(b) (4)
B. Prior to definitization, reimbursement of costs resulting from this change order shall not
exceed (b) (4). Application of fee is subject to negotiation and will be finalized uponaward of the supplemental modification. Definitization of costs and schedule is expected prior to
21 May 2020.
C. Appendix A of the Agreement shall be revised to incorporate the identified efforts, andshall be finalized upon supplemental agreement. Negotiations shall be conducted inaccordance with the terms of the Agreement.
D. All other terms and conditions remain unchanged and in full force and effect.

SECTION A - SOLICITATION/CONTRACT FORM

The total cost of this contract was increased by (b) (4)(b) (4)

SECTION B - SUPPLIES OR SERVICES AND PRICES
CLIN 0009 is added as follows:from (b) (4)toW911QY2090003
P00010Page 3 of 4

ITEM NO
0009

SUPPLIES/SERVICESQUANTITYUNIT
Job

UNIT PRICEAMOUNT(b) (4)

PROJECT 20-09: Helios/Asimov Equipment
CPFF
Project 20-09: Equipment/supplies in support of (b) (4)inclusive of labor,materials, equipment and associated allowable costs delineated the request for
Authorization to Proceed, dated 14 May 2014. The Project Level Agreements
Officer Representitive shall be the Government's representative on technicalmatters related solely to this project. The project level AOR does not supersede
the roles and duties of the Agreement AOR. The Project AOR's contact
Information is below:(b) (6)
FOB: Destination
PSC CD: AN14
ESTIMATED COST
FIXED FEETOTAL EST COST + FEE(b) (4)(b) (4)(b) (4)SUBCLIN 000901 is added as follows:
ITEM NO
000901

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

FY 2020 Funding
CPFF
PURCHASE REQUEST NUMBER: 0011499801
ESTIMATED COST
FIXED FEE

$0.00
$0.00
$0.00

TOTAL EST COST + FEE
ACRN AJ
CIN: GFEBS001149980100001(b) (4)

SECTION E - INSPECTION AND ACCEPTANCE
The following Acceptance/Inspection Schedule was added for CLIN 0009:
INSPECT AT
INSPECT BY
ACCEPT AT
Destination
Government
Destination

ACCEPT BY
Government

The following Acceptance/Inspection Schedule was added for SUBCLIN 000901:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/AW911QY2090003
P00010Page 4 of 4

SECTION F - DELIVERIES OR PERFORMANCE
The following Delivery Schedule for CLIN 0009 has been added:
DELIVERY DATEQUANTITY

23-MAR-2023

SHIP TO ADDRESSDODAAC /CAGE

MCS
110 THOMAS JOHNSON DR.
FREDERICK MD 21702(b) (6)
FOB: Destination

W56XNHSECTION G - CONTRACT ADMINISTRATION DATA
Accounting and Appropriation
Summary for the Payment Office
As a result of this modification, the total funded amount for this document was increased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 000901:
Funding on SUBCLIN 000901 is initiated as follows:
ACRN: AJ
CIN: GFEBS001149980100001
Acctng Data: 09720202021013000018170551519252
Increase: (b) (4)Total: (b) (4)Cost Code: AHPII(End of Summary of Changes)

S.0025760.7.5.4.4

6100.9000021001

W911QY2090003(b) (6))
Page 2 of 5
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00013

A. The purpose of this Amendmenet is as follows:a. Appendix AͲ4 Rev. 1 is hereby incorporated into the Agreement. This revision
supersedes the previously incorporated Appendix AͲ4 in full.
b. The value of CLIN 0004 is hereby increased to retroactively apply Awardee’s recently
approved indirect rates from DCAA.
c. The value of CLIN 0004 is hereby increased by (b) (4)from (b) (4)to(b) (4)d. SubCLIN 000403 is hereby added to the Agreement to incorporate incremental funding
in the amount of (b) (4)under ACRN AK.
e. SubCLIN 000404 is hereby added to the Agreement to incorporate incremental funding
in the amount of $(b) (4)under ACRN AK.
B. The total value of this Agreement is increased by (b) (4)from (b) (4)to(b) (4)

C. Total funding for this Agreement is increased by (b) (4)from (b) (4)to(b) (4)

D. The parties hereby agree that changes affected by this Amendment constitute both theconsideration and equitable adjustment due under any Article in this Agreement resulting fromincorporation of Appendix AͲ4 Rev. 1 and Awardee’s newly approved indirect rates.
E. All other terms and conditions remain the same and in full force and effect.

SECTION A - SOLICITATION/CONTRACT FORM(b) (4)

The total cost of this contract was increased by (b) (4).

from (b) (4)to

SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0004
The CLIN extended description has changed from:
Project 20-04: Rapid COVID-19 Plasmid Manufacturing for Phase 1 Clinical Programs labor, materials, equipment
and associated allowable costs delineated the in Statment of Work entitled, "Procurement, Commissioning and
Qualification of (b) (4) (b) (4)at the DoD ADM Facility," hereby incorporated into theW911QY2090003(b) (6)
Page 5 of 5
SUBCLIN 000404:
Funding on SUBCLIN 000404 is initiated as follows:
ACRN: AK
CIN: GFEBS001150684000001
Acctng Data: 09720202021013000018170552520252
Increase: (b) (4)Total: (b) (4)Cost Code: AHPDD(End of Summary of Changes)

S.0074658.1.1.2

6100.9000021001

after the end of each month identifying task progress, percent
completion and schedule slippage.
2.1.1.3 The Awardee shall provide a PMP that will contain, at a minimum, a Project
Charter, Communication Plan, IMS, Work Breakdown Structure (WBS), Cost
Management/Spend Plan and List of Deliverables.
2.1.2 Execution
2.1.2.1 Meetings
2.1.2.1.1 The Awardee shall conduct IPT meetings no less than twice permonth. The Awardee shall provide the agendas and IPT slide
decks within 24 hours in advance of the IPT. Finalized meeting
minutes shall be submitted to the USG within five business days
following each teleconference.
2.1.2.1.2 The Awardee shall conduct ad hoc meetings as necessary, uponteam member or USG request, to discuss issues as they arise.
Minutes from these meetings shall be provided to the USG within
five business days following the meeting.
2.1.2.2 Reports
2.1.2.2.1 The Awardee shall deliver a Monthly IMS and spend plan for thelife cycle of the project. The Awardee shall submit each Monthly
IMS and spend plan within 20 calendar days after the end of eachmonth of performance. The USG will have 10 calendar days torespond to the report with any comments, and the Awardee will
have an additional five calendar days to revise the deliverable or
respond to those comments.
2.1.2.2.2 The Awardee shall provide Quarterly and Annual Progress
Reports. The reports shall provide a technical summary of
progress over the associated time period, as well as a summary
analysis of any risks, issues and/or opportunities. Delivery dates
for Quarterly and Annual Progress reports will be based on award
date and not the calendar year.
2.1.2.2.3 The Awardee shall submit a Quarterly Financial Status Report nolater than 20 calendar days after the end of each quarter of
performance. The USG will have 30 calendar days to respond to
the report with any comments, and the awardee will have anadditional 10 calendar days to revise the deliverable or respondto those comments. Reports will cover work performed every
three months for the duration of the period of performance.
2.1.2.2.4 The Awardee shall perform, record and report physical inventory
results of all Contractor Acquired Property in the contractor's
possession, if the Awardee purchases material or equipment using
USG funds, as approved by the Agreement Officer’s
Representative (AOR) during performance of the project.
2.1.2.2.5 Incident Reporting
2.1.2.2.5.1 The Awardee shall report any incident to the USG that
could result in more than a one-month delay in schedulefrom the most recent IMS critical path delivered to the(b) (4)

2.1.32.1.4

USG in an incident report. In addition, the Awardee shallprovide advance notice of critical path schedule changes
resulting in more than a 15 calendar-day shift that are nothandled as Incident Reports. The Ology Bio PM shallprovide written notification (via email) to the AOR.
2.1.2.2.5.2 The Awardee shall telephonically contact the program
manager for the USG no later than 24 hours after theincident is identified.
2.1.2.2.5.3 The Awardee shall submit a written summary report
within three business days of an incident, to include what
happened, the impact, the availability of any available
corrective actions, and a timeline for any corrective
actions to be in place. If additional time is required for the
Root Cause Analysis, the Ology Bio PM will work with
the AOR to agree on timing of the written summary
report.
2.1.2.2.6 The Project Agreement Holder (PAH) shall establish a Quality
Agreement with the USG. The PAH shall provide the draft
Quality Agreement within ten calendar days of project award.
The draft Quality Agreement will be submitted via e-mail to the
USG technical representatives. The USG shall respond withcomments or acceptance ten calendar days following receipt ofthe draft Quality Agreement. The final agreement withincorporated changes shall be submitted five calendar days after
receipt of USG comments. The USG will provide written
acceptance.
2.1.2.2.7 The PAH shall also develop a Quality Agreement with Inovio thatdefines the roles and responsibilities of both parties. The Quality
Agreement with Inovio will be provided to the USG for
informational purposes rather than review and approval.
2.1.2.2.8 The Awardee shall support USG quality audits of the Awardee’ssystems and procedures, insofar as they relate to the service andcontrol of the USG’s product. These audits may be performed attimes mutually agreed upon by the Awardee and the USG. The
Awardee shall provide the USG with monthly follow-ups on thestatus of audit observation commitments found in the USG
annual audit or regulatory inspection, as they apply to the USG’s
product.
Regulatory/CMC Support
2.1.3.1 The Awardee shall provide support to the product sponsor to enabling
updating of their CMC sections with manufacturing data and technicalinformation.
Equipment Maintenance and Service
2.1.4.1 The Awardee shall maintain and service equipment purchased underContract W911QY2090003, (b) (4)and used for this Project 20-04.

2.5.4
2.5.5
2.5.6

Facility.
The Awardee shall use resins and filters dedicated for this project. The Awardee shalluse the same columns/resins for both the Engineering and CGMP Runs.
The Awardee shall conduct in-process and release testing on Engineering DS based on theanalytical tests from Task 4 and (b) (4) provided specifications for purity and impurity
levels.
The Awardee shall provide:
2.5.6.1 Engineering Run Report
2.5.6.2 Finalized CGMP Batch Record templates
2.5.6.3 Finalized CGMP specifications
2.5.6.4 Final BOM
2.5.6.5 Engineering non-CGMP DS CoT
2.5.6.6 Engineering non-CGMP DS MSDS

2.6 Task 6: CGMP DS Runs (b) (4)
2.6.1
2.6.2
2.6.3

2.6.4

2.6.5

The Awardee shall update the Technology Transfer Protocol (TTP) and MBRs as needed.
The Awardee shall perform all CGMP manufacturing campaigns in accordance with
CGMP per U.S. Code of Federal Regulations and all applicable regulatory guidance.
The Awardee shall execute (b) (4)runs for the CGMP DS using MBRs, with
the number of runs based on the discretion of the USG and suggestions from Ology Bio.
2.6.3.1 The Awardee shall conduct the CGMP Run using the Ology Bio-manufactured
WCB.
2.6.3.2 The Awardee shall conduct the in-process and release testing outlined in Table
1 and
2.6.3.3 Table 2.
2.6.3.4 The Awardee shall store the DS frozen pending DP fill/finish. All DS lots will
be at the disposition of the USG and storage will be at the ADM Facility.
2.6.3.5 The Awardee shall provide the final QA review of the PBR and QC data andrelease of the CGMP DS with a COA and MSDS, ensuring that it meets alltechnical specifications and is acceptable for subsequent CGMP formulationand fill.
2.6.3.6 The Awardee shall write a CGMP DS Campaign Summary Report including
Batch Production Documents, Process Flow Diagrams, final BOM, COA andMSDS.
The Awardee shall provide manufacturing and testing information (e.g., raw data orsummary reports as required) related to Ology Bio-produced DS (b) (4) for
incorporation into their submission to their IND or Master File to support clinicaldevelopment.
The Awardee shall provide the following for each CGMP DS Lot:
2.6.5.1 QA-Approved DS Executed Batch Production Records
2.6.5.2 QA-Approved DS COA
2.6.5.3 QA-Approved DS MSDS
2.6.5.4 CGMP DS Campaign Summary Reportprior to the start of stability.
2.14.2.2 The Awardee shall execute the stability study using the CGMP DS.
2.14.2.3 The Awardee shall provide a Stability Report.
2.14.3 CGMP DP
2.14.3.1 The Awardee shall provide a Stability Protocol for the CGMP DP from Task
7, including (b) (4) real-time stability studies and accelerated and stressed
temperature stability studies, to be determined in collaboration with the USG
prior to the start of stability.
2.14.3.2 The Awardee shall execute the stability study using the CGMP DP.
2.14.3.3 The Awardee shall provide Stability Reports.
2.15 Task 15: Stability Testing of DS and DP (b) (4)2.15.1 CGMP DS
2.15.1.1 The Awardee shall provide a Stability Protocol for the CGMP DS, including(b) (4) real-time stability studies and accelerated and stressed temperaturestability studies, to be determined in collaboration with the USG prior to thestart of stability.
2.15.1.2 The Awardee shall execute the stability study using the CGMP DS.
2.15.1.3 The Awardee shall provide a Stability Report.
2.15.2 CGMP DP
2.15.2.1 The Awardee shall provide a Stability Protocol for the CGMP DP, to be
determined in collaboration with the Client, including (b) (4) real-timestability studies and accelerated and stressed temperature stability studies, tobe determined in collaboration with the USG prior to the start of stability.
2.15.2.2 The Awardee shall execute the stability study using the CGMP DP.
2.15.2.3 The Awardee shall provide Stability Reports.
2.16 Task 16: Emergency Use Authorization Preparation
2.16.1 Preparation
2.16.1.1 The Awardee shall evaluate current procedures and processes to align withrequirements for CGMP Phase 3 in preparation for anticipated EUA or
Expanded Access prior to product approval.
2.16.1.2 The Awardee shall revise necessary procedures from identified gaps to ensurecompliance with applicable regulations.
2.16.1.3 The Awardee shall provide all necessary information and data to the IND
holder.
2.16.2 Execution
2.16.2.1 The Awardee shall conduct an in-depth audit for this scope of work to
represent an FDA inspection consistent with CGMP Phase 3 for EUA. Thismay be conducted by Awardee, qualified subcontractor(s) or a combination
thereof as identified in coordination with the USG. USG shall have the optionof sending a representative to participate in or observe the audit.
2.16.2.2 The Awardee shall develop and provide a comprehensive audit reportdetailing the audit activities and findings for the areas inspected.
2.16.2.3 The Awardee shall host and manage any applicable necessary regulatoryinspection (e.g. FDA EUA) to support the requirements within this Scope ofWork.

3.3 Acceptance of Deliverables
The USG will provide review of all data deliverables within (b) (4) of delivery. The USG will
acknowledge receipt of all supply deliverables within (b) (4) of delivery.

W911QY2090003
P00014
Page 2 of 5
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00014

A. The purpose of this Amendment is as follows:a. Appendix A-2 Rev 2 is hereby incorporated into the Agreement. This revision supersedes
the previously incorporated Appendix A-2 Rev 1 in full.
b. (b) (4)c. The total cost of CLIN 0002 is increased by (b) (4)from (b) (4)to(b) (4)d. (b) (4)e. The total cost of this agreement is increased by (b) (4)from (b) (4)to(b) (4)f.

SubCLIN 000203 is hereby added to the agreement to incorporate incremental funding in
the amount of (b) (4)under ACRN AL.

g. (b) (4)h. Total funding for this agreement is increased by (b) (4)from (b) (4)to(b) (4)

B. The Parties hereby agree that changes effected by this Amendment constitute both theconsideration and equitable adjustment due under any Article in this agreement resulting from theincorporation of Appendix A-2 Rev 2 (b) (4)C. All other terms and conditions remain the same and in full force and effect.

SECTION A - SOLICITATION/CONTRACT FORM

The total cost of this contract was increased by (b) (4)to (b) (4)SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0002
The CLIN extended description has changed from:from (b) (4)W911QY2090003
P00014
Page 3 of 5

Project 20-05: Rapid mAB COVID 19 labor, materials, equipment and associated costs delineated the in Statementof Work entitled, "Rapid Production of Monoclonal Antibodies as Medical Countermeasures against COVID-19",
hereby incorporated into the Agreement as Appendix A-2 Rev 1.
The project level Agreements Officer Representative shall be the Government's representative on technical mattersrelated solely to this project. The project level AOR does not supersede the roles and duties of the Agreement AOR.
The Project AOR's contact Information is below:Name: (b) (4)To:
Project 20-05: Rapid mAB COVID 19 labor, materials, equipment and associated costs delineated the in Statementof Work entitled, "Rapid Production of Monoclonal Antibodies as Medical Countermeasures against COVID-19",
hereby incorporated into the Agreement as Appendix A-2 Rev 2.
The project level Agreements Officer Representative shall be the Government's representative on technical mattersrelated solely to this project. The project level AOR does not supersede the roles and duties of the Agreement AOR.
The Project AOR's contact Information is below:Name: (b) (4).
The estimated/max cost has increased by (b) (4)from (b) (4)The fixed fee has increased by (b) (4)from (b) (4)to (b) (4)The total cost of this line item has increased by (b) (4)from (b) (4)(b) (4)SUBCLIN 000203 is added as follows:to $(b) (4)to (b) (4).

W911QY2090003
P00014
Page 4 of 5
ITEM NO
000203

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

Ology mABS Scale up & Manufacturing
FFP
Ology mABS Scale up & Manufacturing
PURCHASE REQUEST NUMBER: 0011506795

NET AMT
ACRN AL
CIN: GFEBS001150679500001$0.00(b) (4)SUBCLIN 000902 is added as follows:
ITEM NO
000902

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

Equipment for mABS & DNA Suites @ Ology
FFP
Equipment for mABS & DNA Suites @ Ology
PURCHASE REQUEST NUMBER: 0011505679

NET AMT
ACRN AM
CIN: GFEBS001150567900001$0.00(b) (4)

SECTION E - INSPECTION AND ACCEPTANCE
The following Acceptance/Inspection Schedule was added for SUBCLIN 000203:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

The following Acceptance/Inspection Schedule was added for SUBCLIN 000902:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

SECTION G - CONTRACT ADMINISTRATION DATA
Accounting and Appropriation
Summary for the Payment OfficeW911QY2090003
P00014
Page 5 of 5

As a result of this modification, the total funded amount for this document was increased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 000203:
Funding on SUBCLIN 000203 is initiated as follows:
ACRN: AL
CIN: GFEBS001150679500001
Acctng Data: 09720202021013000018170552520252

S.0074658.1.1.6

6100.9000021001

S.0074658.1.1.1

6100.9000021001

Increase: (b) (4)Total: (b) (4)Cost Code: AHPDDSUBCLIN 000902:
Funding on SUBCLIN 000902 is initiated as follows:
ACRN: AM
CIN: GFEBS001150567900001
Acctng Data: 09720202021013000018170552520252
Increase: (b) (4)Total: (b) (4)Cost Code: AHPDD(End of Summary of Changes)calendar days after the end of each month identifying task progress, percent
completion and schedule slippage.
2.1.1.3 The Awardee shall provide a PMP that will contain, at a minimum, a Project
Charter, Communication Plan, IMS, Work Breakdown Structure (WBS), Cost
Management/Spend Plan and List of Deliverables.
2.1.2 Execution
2.1.2.1 Meetings
2.1.2.1.1 The Awardee shall conduct IPT meetings (b) (4)The Awardee shall provide the agendas and IPT slide
decks within 24 hours in advance of the IPT. Finalized meeting
minutes shall be submitted to the USG within five business days
following each teleconference.
2.1.2.1.2 The Awardee shall conduct ad hoc meetings as necessary, uponteam member or USG request, to discuss issues as they arise.
Minutes from these meetings shall be provided to the USG within
five business days following the meeting.
2.1.2.2 Reports
2.1.2.2.1 The Awardee shall deliver a Monthly IMS and spend plan for thelife cycle of the project. The Awardee shall submit each Monthly
IMS and spend plan within 20 calendar days after the end of eachmonth of performance. The USG will have 10 calendar days torespond to the report with any comments, and the Awardee will
have an additional five calendar days to revise the deliverable or
respond to those comments.
2.1.2.2.2 The Awardee shall provide Quarterly and Annual Progress
Reports. The reports shall provide a technical summary of
progress over the associated time period, as well as a summary
analysis of any risks, issues and/or opportunities. Delivery dates
for Quarterly and Annual Progress reports will be based on award
date and not the calendar year.
2.1.2.2.3 The Awardee shall submit a Quarterly Financial Status Report nolater than 20 calendar days after the end of each quarter of
performance. The USG will have 30 calendar days to respond to
the report with any comments, and the awardee will have anadditional 10 calendar days to revise the deliverable or respondto those comments. Reports will cover work performed every
three months for the duration of the period of performance.
2.1.2.2.4 The Awardee shall perform, record and report physical inventory
results of all Contractor Acquired Property in the contractor's
possession, if the Awardee purchases material or equipment using
USG funds, as approved by the Agreement Officer’s
Representative (AOR) during performance of the project.
2.1.2.2.5 Incident Reporting
2.1.2.2.5.1 The Awardee shall report any incident to the USG that
could result in more than a one-month delay in schedulefrom the most recent IMS critical path delivered to the2.1.32.1.4

USG in an incident report. In addition, the Awardee shallprovide advance notice of critical path schedule changes
resulting in more than a 15 calendar-day shift that are nothandled as Incident Reports. The Ology Bio PM shallprovide written notification (via email) to the AOR.
2.1.2.2.5.2 The Awardee shall telephonically contact the program
manager for the USG no later than 24 hours after theincident is identified.
2.1.2.2.5.3 The Awardee shall submit a written summary report
within three business days of an incident, to include what
happened, the impact, the availability of any available
corrective actions, and a timeline for any corrective
actions to be in place. If additional time is required for the
Root Cause Analysis, the Ology Bio PM will work with
the AOR to agree on timing of the written summary
report.
2.1.2.2.6 The Project Agreement Holder (PAH) shall establish a Quality
Agreement with the USG. The PAH shall provide the draft
Quality Agreement within ten calendar days of project award.
The draft Quality Agreement will be submitted via e-mail to the
USG technical representatives. The USG shall respond withcomments or acceptance ten calendar days following receipt ofthe draft Quality Agreement. The final agreement withincorporated changes shall be submitted five calendar days after
receipt of USG comments. The USG will provide written
acceptance.
2.1.2.2.7 The PAH shall also develop a Quality Agreement with Inovio thatdefines the roles and responsibilities of both parties. The Quality
Agreement with Inovio will be provided to the USG for
informational purposes rather than review and approval.
2.1.2.2.8 The Awardee shall support USG quality audits of the Awardee’ssystems and procedures, insofar as they relate to the service andcontrol of the USG’s product. These audits may be performed attimes mutually agreed upon by the Awardee and the USG. The
Awardee shall provide the USG with monthly follow-ups on thestatus of audit observation commitments found in the USG
annual audit or regulatory inspection, as they apply to the USG’s
product.
Regulatory/CMC Support
2.1.3.1 The Awardee shall provide support to the product sponsor to enabling
updating of their CMC sections with manufacturing data and technicalinformation.
Equipment Maintenance and Service
2.1.4.1 The Awardee shall maintain and service equipment purchased underContract W911QY2090003, (b) (4)inspection (e.g. FDA EUA) to support the requirements within this Scope ofWork.

W911QY2090003(b) (6)
Page 2 of 6
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00017

A. The purpose of this Amendment is as follows:a. Appendix AͲ9 Rev. 1 is hereby incorporated into the Agreement. This revision
supersedes the previously incorporated Appendix AͲ9 in full.
b. (b) (4).
c. The value of CLIN 0003 is hereby increased to reflect actual expenditures.
d. The value of CLIN 0003 is hereby increased by (b) (4)from (b) (4)to(b) (4)e.

(b) (4)

g. SUBCLIN 000303 is hereby added to the Agreement to incorporate funding in theamount of (b) (4)under ACRN AM.
B. The total value of this Agreement is increased by (b) (4)from (b) (4)to(b) (4).
from (b) (4)toC. Total funding for this agreement is increased by (b) (4)(b) (4)

D. The parties hereby agree that changes effected by this Amendment constitute both theconsideration and equitable adjustment due under any Article in this Agreement resulting fromincorporation of Appendix AͲ9 Rev 1.
E. All other terms and conditions remain the same and in full force and effect.

SECTION A - SOLICITATION/CONTRACT FORM(b) (4)

The total cost of this contract was increased by (b) (4)from (b) (4)SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0003
The estimated/max cost has increased by (b) (4)from (b) (4)to (b) (4)toW911QY2090003((b) (6)Page 4 of 6
ITEM NO
000903

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

SoloVPE Equipment
FFP
SoloVPE Equipment
PURCHASE REQUEST NUMBER: 0011505679-0002

NET AMT
ACRN AM
CIN: GFEBS001150567900002$0.00(b) (6)SUBCLIN 000904 is added as follows:
ITEM NO
000904

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT$0.00

Mixer Equipment
FFP
Mixer Equipment
PURCHASE REQUEST NUMBER: 0011505679-0002

NET AMT
ACRN AM
CIN: GFEBS001150567900004$0.00(b) (4)

SECTION E - INSPECTION AND ACCEPTANCE
The following Acceptance/Inspection Schedule was added for SUBCLIN 000303:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

The following Acceptance/Inspection Schedule was added for SUBCLIN 000903:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/A

The following Acceptance/Inspection Schedule was added for SUBCLIN 000904:
INSPECT AT
INSPECT BY
ACCEPT AT
N/A
N/A
N/A

ACCEPT BY
N/AW911QY2090003(b) (6)
Page 5 of 6
SECTION G - CONTRACT ADMINISTRATION DATA
Accounting and Appropriation
Summary for the Payment Office
As a result of this modification, the total funded amount for this document was increased by (b) (4)from (b) (4)to(b) (4)SUBCLIN 000303:
Funding on SUBCLIN 000303 is initiated as follows:
ACRN: AM
CIN: GFEBS001150567900003
Acctng Data: 09720202021013000018170552520252

S.0074658.1.1.1

6100.9000021001

S.0074658.1.1.1

6100.9000021001

S.0074658.1.1.1

6100.9000021001

Increase: (b) (4)Total: (b) (4)Cost Code: AHPDDSUBCLIN 000903:
Funding on SUBCLIN 000903 is initiated as follows:
ACRN: AM
CIN: GFEBS001150567900002
Acctng Data: 09720202021013000018170552520252
Increase: (b) (4)Total: (b) (4)Cost Code: AHPDDSUBCLIN 000904:
Funding on SUBCLIN 000904 is initiated as follows:
ACRN: AM
CIN: GFEBS001150567900004
Acctng Data: 09720202021013000018170552520252
Increase: (b) (4)Total: (b) (4)Cost Code: AHPDD(End of Summary of Changes)

W911QY2090003(b) (6))
Page 6 of 6

W911QY2090003(b) (6)
Page 2 of 4
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00023

A. The purpose of this Amendment is to incorporate Appendix AͲ10.
a. The SOW for Project 21Ͳ01, Rapid Monoclonal Antibodies Manufacturing System using
COVID mAbs, Appendix AͲ10, is hereby incorporated into the Agreement under CLIN
0010.
b. New CPFF CLIN 0010 is hereby initiated with a value of (b) (4).
c. The total cost of this contract was increased by (b) (4)from (b) (4)to(b) (4)d. SubCLIN 001001 is hereby added to the agreement ot incorporate incremental funding
in the amount of(b) (4)under ACRN AP.
e. Total funding for this agreement is increased by (b) (4)from(b) (4)
(b)
(4)
to
B. The parties hereby agree that changes effected by this Amendment constitute both theconsideration and equitable adjustment due under any Article in this agreement resulting fromincorporation of Appendix AͲ10.
C. All other terms and conditions remain the same and in full force and effect.

SECTION A - SOLICITATION/CONTRACT FORM

to (b) (4)The total cost of this contract was increased by (b) (4)SECTION B - SUPPLIES OR SERVICES AND PRICES
CLIN 0010 is added as follows:from (b) (4)W911QY2090003(b) (6)
Page 4 of 4
N/A

N/A

N/A

N/A

SECTION F - DELIVERIES OR PERFORMANCE
The following Delivery Schedule for CLIN 0010 has been added:
DELIVERY DATEQUANTITY

31-JAN-2022

SHIP TO ADDRESSDODAAC /CAGEJPL CBRND ENABLING
BIOTECHNOLOGIES.
110 THOMAS JOHNSON DR
FREDERICK MD 21702
FOB: Destination

W56XNHSECTION G - CONTRACT ADMINISTRATION DATA
Accounting and Appropriation
Summary for the Payment Office
As a result of this modification, the total funded amount for this document was increased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 001001:
Funding on SUBCLIN 001001 is initiated as follows:
ACRN: AP
CIN: GFEBS001158860100010
Acctng Data: 09720202021013000018170552520252
Increase: (b) (4)Total: (b) (4)Cost Code: AHPDD(End of Summary of Changes)

S.0074658.1.1.17

6100.9000021001

W911QY‐20‐9‐0003, Project 20-05

2.1.2.2.4

Appendix A‐2 Rev 4

The Awardee shall perform, record and report physical inventory resultsof all Contractor Acquired Property in the contractor's possession, if theAwardee purchases material or equipment using USG funds, as approved by the
AOR during performance of the project.

2.1.2.2.5

2.1.2.2.6

2.1.2.2.7

Incident Reporting
2.1.2.2.5.1
The Awardee shall report any incident to the USG that
could result in more than a one-month delay in schedulefrom the most recent IMS critical path delivered to the
USG in an incident report. In addition, the Awardee shallprovide advanced notice of critical path schedulechanges resulting in more than a 15-day calendar shiftthat are not handled as Incident Reports. The Ology Bio
PM will provide written notification (via email) to theAOR.
2.1.2.2.5.2
The Awardee shall telephonically contact the program
manager for the USG no later than 24 hours after theincident is identified.
2.1.2.2.5.3
The Awardee shall submit a written summary report
within three business days of an incident, to include what
happened, the impact, the availability of any available
corrective actions, and a timeline for any corrective
actions to be in place. If additional time is required for the
Root Cause Analysis, the Ology Bio PM will work with
the AOR to agree on timing of the written summary report.
The Awardee shall provide the draft Quality Agreement within ten
calendar days of project award. The draft Quality Agreement will be
submitted via e-mail to the USG technical representatives. The USG shall
respond with comments or acceptance ten calendar days following
receipt of the draft Quality Agreement. The final agreement withincorporated changes shall be submitted five calendar days after receipt
of USG comments. The USG will provide written acceptance.
The Awardee shall support USG quality audits of the Awardee’s systems
and procedures as outlined in the Quality Agreement, insofar as they
relate to the service and control of the USG’s product. These audits may
be performed at times mutually agreed upon by the Awardee and the
USG. The Awardee shall provide the USG with monthly follow-ups on
the status of audit observation commitments found in the USG annual
audit or regulatory inspection, as they apply to the USG’s product.

1 CONTRACT ID CODEAMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT
2 AMENDMENT/MODIFICATION NO

3 EFFECTIVE DATE

P00025CODE

1

55 PROJECT NO (If applicable)

4 REQUISITION/PURCHASE REQ NO
SEE SCHEDULE

02-Mar-2021

6 ISSUED BY

PAGE OF PAGESW911QY

7 ADMINISTERED BY (If other than item 6)

W911QYCODE

W6QK ACC-APG NATICK DIVISION
110 THOMAS JOHNSON DR SUITE #240
FREDERICK MD 21702

W6QK ACC-APG NATICK DIVISIONBLDG 1 GENERAL GREENE AVENUE
NATICK MA 01760-5011

9A. AMENDMENT OF SOLICITATION NO.

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)OLOGY BIOSERVICES, INC
NANOTHERAPEUTICS
13200 NW NANO COURT
ALACHUA FL 32615-8726

9B. DATED (SEE ITEM 11)
MOD. OF CONTRACT/ORDER NO.
X 10A.
W911QY2090003

CODE

10B. DATED (SEE ITEM 13)
X 22-Feb-2020
FACILITY CODE
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

3GQS9The above numbered solicitation is amended as set forth in Item 14 The hour and date specified for receipt of Offer

is extended,

is not extended

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:
copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;(a) By completing Items 8 and 15, and returningor (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers FAILURE OF YOUR ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN
REJECTION OF YOUR OFFER If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter,
provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified

12. ACCOUNTING AND APPROPRIATION DATA (If required)
See Schedule
13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.
IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.
A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE
CONTRACT ORDER NO. IN ITEM 10A.
B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying
office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:
X D. OTHER (Specify type of modification and authority)
In accordance w ith Article 5 of the Agreement.
E. IMPORTANT: Contractor

is not,X

is required to sign this document and return1

copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter
where feasible.)
Modification Control Number: (b) (6)The purpose of this Amendment is to incorporate Appendix A-2 Rev 4, decrease the value of Project 20-05 under CLIN 0002 accordingly,
incorporate incremental funding for CLIN 0005, and update the AOR appointments for Projects 20-04 and 20-09. All other terms andconditions remain the same and in full force and effect.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)(b) (6)TEL

15B. CONTRACTOR/OFFEROR(Signature of person authorized to sign)
EXCEPTION TO SF 30
APPROVED BY OIRM 11-84

15C. DATE SIGNED/ CONTRACT NG OFFICER(b) (6)

EMA L:(b) (6)

16B UNITED STATES OF AMERICA

16C. DATE SIGNED

BY

01-Mar-2021(b) (6)(Signature of Contracting Officer)
30-105-04

STANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243

W911QY2090003
P00025
Page 2 of 5
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00025

A. The purpose of this Amendment is as follows:a. Appendix A‐2 Rev 4 is hereby incorporated into this Agreement. This revision
incorporates a number of programmatic changes including reduction in thesubcontracted manufacturing effort (b) (4)and changes to the fill finish effort.
This revision supesedes the previously incorporated Appendix A‐2 Rev 3 in full.
fromi. The value of CLIN 0002 is hereby reduced by (b) (4)(b) (4)to (b) (4)ii. Funding on SLIN 000203, ACRN AL is hereby reduced by (b) (4)from(b) (4)to (b) (4)b. (b) (4)c. The AOR for Project 20‐04, CLIN 0004 is hereby changed from Nicole Dorsey to Shannon
Brooks and the CLIN description is updated accordingly.
d. (b) (4)B. The total value of this agreement is decreased by (b) (4)from (b) (4)tofrom (b) (4)to(b) (4)

C. Total funding for this agreement is decreased by (b) (4)(b) (4)

D. The parties hereby agree that changes affected by this Amendment constitute both theconsideration and equitable adjustment due under any Article in this Agreement resulting fromincorporation of Appendix A‐2 Rev 4.
E. All other terms remain the same an in full force and effect.

SECTION A - SOLICITATION/CONTRACT FORM

to (b) (4)The total cost of this contract was decreased by (b) (4)SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0002

from (b) (4)W911QY2090003
P00025
Page 5 of 5(End of Summary of Changes)

W911QY2190002(b) (6))
Page 2 of 2
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGES(End of Summary of Changes)

W911QY2190002((b) (6))
Page 2 of 2
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
AMENDMENT P00002

The purpose of this Amendment is to designate this Agreement as a Defense Priority and
Allocation System (DPAS) rated order (15 CFR 700) as approved by the Department of Healthand Human Services (HHS) Industrial Policy group. The changes are as follows:a. Block 1 or the Agreement SF26 is hereby revised to incorporate a DPAS rating of DOH5.
b. Article 14, Paragraph N is hereby incorporated into the Agreement to add the following:“This Agreement has been granted approval for a DO-H5 DPAS rating for national
defense, emergency preparedness, and energy program use. The Awardee shallfollow all requirements of the DPAS Regulation, 15 CFR 700. This rating can only
be used on contracts and orders to support the expansion of production capacity.”
The Awardee is hereby authorized to effect this rating on all vendors necessary to support
the expansion of production capacity only at the DoD Advanced Development
Manufacturing facility.
Additionally, the Government has added the AOR acronym to the Primary Program
Manager listing in the Government Program Managers table listed in Article 3, Paragraph B.
All other Terms and Conditions remain in full force and effect.

SECTION A - SOLICITATION/CONTRACT FORM
The DPAS code DO-H5 has been added.
(End of Summary of Changes)

1. CONTRACT ID CODEAMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

PAGE OF P AGES

1
2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

P00004

4. REQUISITION/PURCHASE REQ. NO.
0011559735

15-Mar-2021

6. ISSUED BY

CODE

2

5. P ROJECT NO.(If applicable)

7. ADMINISTERED BY (If other than item 6)

W911QY

W911QYCODE

W6QK ACC-APG NATICK DIVISION
110 THOMAS JOHNSON DR SUITE #240
FREDERICK MD 21702

W6QK ACC-APG NATICK DIVISIONBLDG 1 GENERAL GREENE AVENUE
NATICK MA 01760-5011

9A. AMENDMENT OF SOLICIT AT ION NO.

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)OLOGY BIOSERVICES, INC
NANOTHERAPEUTICS
13200 NW NANO COURT
ALACHUA FL 32615-8726

9B. DATED (SEE IT EM 11)
MOD. OF CONTRACT/ORDER NO.
X 10A.
W911QY2190002

CODE

10B. DAT ED (SEE ITEM 13)
X 20-Oct-2020
FACILIT Y CODE
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICIT AT IONS

3GQS9The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer

is extended,

is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:(a) By completing Items 8 and 15, and returning
copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE
RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN
REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter,
provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNT ING AND APPROPRIATION DATA (If required)
13. T HIS IT EM APPLIES ONLY TO MODIFICATIONS OF CONT RACT S/ORDERS.
IT MODIFIES T HE CONT RACT /ORDER NO. AS DESCRIBED IN ITEM 14.
A. THIS CHANGE ORDER IS ISSUED PURSUANT T O: (Specify authority) THE CHANGES SET FORT H IN ITEM 14 ARE MADE IN T HE
CONT RACT ORDER NO. IN ITEM 10A.
B. THE ABOVE NUMBERED CONT RACT /ORDER IS MODIFIED TO REFLECT T HE ADMINISTRAT IVE CHANGES (such as changes in paying
office, appropriation date, etc.) SET FORT H IN IT EM 14, PURSUANT T O T HE AUT HORIT Y OF FAR 43.103(B).
C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUT HORIT Y OF:
X D. OT HER (Specify type of modification and authority)
The terms and Conditions of This Agreement, Article 5, Section D.
E. IMPORT ANT: ContractorX

is not,is required to sign this document and returncopies to the issuing office.

14. DESCRIPT ION OF AMENDMENT /MODIFICAT ION (Organized by UCF section headings, including solicitation/contract subject matter
where feasible.)
Modification Control Number: (b) (6)See Continuation Page.
All other Terms and conditions remain in full force and effect.

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

16A. NAME AND T ITLE OF CONTRACTING OFFICER (Type or print)/ CONTRACTING OFFICER(b) (6)TEL:(b) (6)

15B. CONT RACT OR/OFFEROR(Signature of person authorized to sign)
EXCEPTION T O SF 30
APPROVED BY OIRM 11-84

15C. DATE SIGNEDEMAIL:(b) (6)

16B UNIT ED ST AT ES OF AMERICA

16C. DAT E SIGNED

B

15-Mar-2021(b) (6)(Signature of Contracting Officer)
30-105-04

ST ANDARD FORM 30 (Rev. 10-83)
Prescribed by GSA
FAR (48 CFR) 53.243

W911QY2190002
P00004
Page 2 of 2
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
AMENDMENT P00004
The purpose of this Change Order is to incorporate the following:
A. Changes to the work performed under Project 21-01
1) Awardee proposed changes to the designs of project 21-01 are accepted in so far as they remain in scopeof the original project to expand the manufacturing facility at the ADM.
2) Awardee proposed changes to the project schedule are accepted in so far as it represents an expedited
path to completion.
B. The Awardee is hereby authorized to proceed with the redesign efforts at the expedited schedule project
timeline at no increase in cost to the Agreement value. These efforts shall be performed in accordance with Article
1 Section E of the Agreement in terms of expending Government funds in advance of the completion of the realestate transaction.
C. The Awardee is hereby authorized to expend no more than (b) (4)of Government funds in advance ofcompletion of the Real Estate Transaction for the purpose of making the deposit against the required fill/finish
system. This shall not increase the total cost of project 21-01 and the Government shall have the ability to redirect the delivery location of the instrument should this Agreement terminate prior to the system’s delivery andinstallation.
D. Definitization of the final redesign, project timeline, cost for the fill/finish system deposit, Agreement Terms andtotal value to the Agreement shall occur within 10 days of this Amendment.
E. All other terms and conditions remain unchanged.

(End of Summary of Changes)

W911QY2190002(b) (6))
Page 2 of 4
SECTION SF 30 BLOCK 14 CONTINUATION PAGE
SUMMARY OF CHANGESSECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:
P00005This Amendment makes the following changes:

1) Incorporates revised terms and conditions into the Agreement in the following:a. Article 1, Section E: Language to allow the Awardee to expend Government funds forthe deposit of the fill/finish system in advance of the completion of the real estatetransaction is hereby added.
b. Article 7, Section E: The cost sharing and total project values are changed based on thenegotiated total changes to the cost of project 21Ͳ01 and changes in the cost sharing
arrangement.
c. Article 7, Section H: SubͲParagraphs 2) and 3) are hereby added into the Agreement:
2) For all proposed projects, the Government and Awardee shall establish a budget
based on current approved or submitted indirect rate calculations reviewed by the
Defense Contract Audit Agency (DCAA) for such elements as fringe benefits, Overhead(OH), and General and Administrative (G&A) costs unless otherwise negotiated in thesubͲsections below:
a. The Government and Awardee agree to establish a (b) (4) on General and
Administrative costs on subcontractor efforts performed under project 21Ͳ01.
Should the results of a DCAA audit indicate that the rate(s) utilized in Agreement varies
from the rate determined appropriate by the Government, the Agreement amount shallbe adjusted downward or upward depending on final audit and review by DCAA.
3) For all projects that include the acquisition of real property (buildings and immovable
Government Property) for which the Government has agreed to fund as a direct cost associatedwith one or more projects issued under this Agreement, the Awardee agrees to remove these costs
from future depreciation calculations and G&A valuations. The Awardee may include the costsof maintenance, upkeep and indirect costs to ensure the continued use of the property in thecalculations of G&A, Fringe and Overhead in so far as they do not duplicate costs associated withother pools or direct cost elements.

d. Article 14, Section O is hereby incorporated into the Agreement in its entirety:
O. Project Timelines and Delivery Schedule of OTA Project 20Ͳ01, ADM Expansion
Project.
1) Awardee acknowledges that timely completion of the ADM Expansion Project isessential to meet the Government's stated objectives under this Agreement.
Accordingly, Awardee represents that it will use its best efforts to adhere to theproject timelines and delivery schedules incorporated into Appendix B.
2) Awardee shall promptly notify the Government if, at any time during performanceof the Agreement, it has a reasonable belief that any task listed within Appendix B
will be completed seven (7) or more days after the date indicated in Appendix B("Schedule Slip"). If Awardee identifies a Schedule Slip, it shall arrange a meetingW911QY2190002(b) (6)
Page 4 of 4
AA: 09720202021013000018170552520252
GFEBS001155973500001) was decreased by (b) (4)(End of Summary of Changes)

S.0074658.1.1.4
from (b) (4)6100.9000021001 AHPDD (CIN
to (b) (4)