This Other Transaction Authority for Prototype Agreement is entered into between the United States ofAmerica, hereinafter called the “Government”, pursuant to and under U.S. Federal law, and AstraZeneca alarge business, non-traditional defense contractor, hereinafter called the “Awardee”. The United States ofAmerica and Awardee are sometimes referred to herein individually as a “Party” and collectively as the“Parties.”
WHEREAS, the Awardee is eligible for an Other Transaction Authority for Prototype Agreement inaccordance with 10 USC § 2371b(d)(1)(A) as amended by the National Defense Authorization Act for
Fiscal Year 2018 as they are non-traditional defense contractor;
WHEREAS, in accordance with 10 U.S.C. 2371b, The Department of Defense currently has authority toaward “other transactions” (OTs) in certain circumstances for prototype projects that are directly relevant
to enhancing the mission effectiveness of military personnel and the supporting platforms, systems,
components, or materials proposed to be acquired or developed by the Department of Defense, or to
improvement of platforms, systems, components, or materials in use by the Armed Forces. To the maximum
extent practicable, competitive procedures shall be used when entering into agreements to carry out projects
under subsection (a);WHEREAS, a prototype can generally be described as a physical or virtual model used to evaluate thetechnical or manufacturing feasibility or military utility of a particular technology or process, concept, end
item, or system;
WHEREAS, this Agreement meets the criteria for a prototype project;
NOW THEREFORE, the Parties have agreed as follows:
ARTICLE 1. SCOPE
A.
This Other Transaction Authority for Prototype 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. § 2371b and is not a procurement contract
governed by the Federal Acquisition Regulation (FAR), a grant, or a cooperative 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 be construed as, forming, by implication orotherwise, a partnership, a corporation, or other business organization. This Agreement is not subject to the
Bayh-Dole Act, 35 U.S.C. §§ 200-212.
B.
The Parties agree that the sole purpose of this Agreement is to conduct a Phase 3 prophylaxis trialof a monoclonal antibody drug product (AZD7442) against the SARS-CoV-2 virus, technology transfer ofmanufacturing capabilities in preparation to scale the manufacturing process, rapid scale up of large-scale
manufacturing, and delivery of 100,000 doses by (b) (4), to include stockpiling anddevelopment of a distribution process capable of delivering AZD 7442 to point of care facilities,(hereinafter referred to as the “Prototype Project” or “Technology”). Consistent with the Government’s
objectives under Operation Warp Speed (“OWS”), AstraZeneca will exercise commercially reasonable
efforts to employ its proprietary manufacturing technology and processes, in a manner compliant withapplicable laws and regulations, including 21 CFR 210 and 211 and the Drug Supply Chain Security Act(“DSCSA”) (to the extent required for COVID-19 medical countermeasures, as defined by relevant U.S.
Food and Drug Administration (“FDA”) guidance), to manufacture and deliver the AZD7442 drug product.
The Awardee shall develop the Prototype Project as described in the Awardee’s Statement of Work (SOW),
which is incorporated herein and attached hereto as Appendix A.

C.
This effort constitutes a prototype project because the project will be used to evaluate the technicalfeasibility during the ongoing COVID-19 pandemic and unprecedented threats to several components of
the Prototype Project. In addition, this is a prototype project because AstraZeneca will demonstrate andprove-out the at-scale, multi-lot proprietary manufacturing activities in order to assess the feasibility tosupport the necessary quantity of safe and effective regimens required for treatment of the U.S. population.
D.
The Prototype Project will be deemed successful where the Awardee’s efforts meet the key
technical requirements and are sufficient to meet an FDA Emergency Use Authorization (EUA) or licensure
and/or has demonstrated capability to rapidly manufacture and deliver (b) (4)of AZD7442
product. Follow on production pursuant to 10 U.S.C. § 2371b is anticipated to be 1 million doses, which
the Parties agree to negotiate such terms in good faith pursuant to a separate agreement.
ARTICLE 2. Term and Termination.
A.
Term: The Term of this Agreement commences upon the Effective Date and extends through final
payment. This Agreement is anticipated to end on the later of (i) nineteen (19) months after the Effective
Date and (ii) issuance of the final clinical study report for the Phase 3 prophylaxis trial of AZD7442. A
transaction for a prototype project is complete upon the written determination of the appropriate official forthe matter in question that efforts conducted under a Prototype OT: (1) met the key technical goals of a
project, or (2) accomplished a particularly favorable or unexpected result that justifies the completion of
the prototype.
B.
Termination for Convenience, Safety or Product Failure: The Government may terminate thisAgreement for any or no reason by providing at least ninety (90) calendar days’ prior written notice to theAwardee. The Government and Awardee will negotiate in good faith a reasonable and timely adjustmentof all outstanding issues between the Parties as a result of termination for convenience, consistent with theterms of this Agreement.
In addition, in the event that AstraZeneca notifies the Government of a Product Failure, then either Party
may notify the other Party of its intent to terminate this Agreement, which termination shall be effective
thirty (30) days after the date of such notice. As used herein, “Product Failure” means: (a) the Productpresents a risk of death, a life-threatening condition or a serious safety or health concern to patients; (b) the
Product fails to achieve the end points in its pivotal clinical trials for the treatment of SARS-CoV-2 infection
in patients such that AstraZeneca’s receipt of Regulatory Approval for the Product for such indication in
the United States is not reasonably likely based upon such clinical trial results; or (iii) AstraZeneca receives
a final unconditional non-approval letter from the FDA with respect to the Product that has rendered
AstraZeneca’s receipt of Regulatory Approval for the Product in such country not reasonably likely.
AstraZeneca shall have no liability to repay the Government for milestone payments made prior to thenotification of termination. With respect to milestones which have not been completed, AstraZeneca shallbe entitled to payment based on a percentage of the work performed toward said milestones, plus reasonablecharges that AstraZeneca can demonstrate to the satisfaction of the Government using its standard record
keeping system, have resulted from the termination. By way of example, these costs may include, but are
not necessarily limited to, costs associated with non-cancellable agreements with vendors to obtain
manufacturing capacity or supplies in the performance of this prototype project agreement. AstraZeneca
shall not be required to comply with the cost accounting standards or contract cost principles for thispurpose. This paragraph does not give the Government any right to audit AstraZeneca’s records (but, forclarity, does not limit any other rights of the Government to audit AstraZeneca’s records). AstraZeneca
shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

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 shallbe incorporated through Appendix D.
H.
Disputes: For any disagreement, claim, or dispute arising under this Agreement, the parties shallcommunicate with one another in good faith and in a timely and cooperative manner. Whenever disputes,
disagreements, or misunderstandings arise, the parties shall attempt to resolve the issue by discussion andmutual agreement as soon as practicable. Failing resolution by mutual agreement, the aggrieved party shallrequest a resolution in writing from the AO. The AO will review the matter and render a decision in writing
within sixty (60) calendar days. Thereafter, 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 by
mutual consent to explore and establish and Alternate Disputes Resolution procedure to resolve this dispute.
The Awardee shall proceed diligently with performance under this agreement pending resolution of the
dispute.
Either Party may recover interest on any amounts submitted for payment and denied during the disputes
process. Interest on an amount found due on a disagreement, claim or dispute shall accrue from the date
the payment was due until such time as the claim is paid and, in the event such interest is payable by theGovernment, shall be payable and paid to the Awardee in accordance with the Prompt Payment Act. Simple
interest shall accrue and be paid at the same rate as that which the Secretary of the Treasury shall specify
as applicable for each successive 6-month period under the Prompt Payment Act.
ARTICLE 6. Inspection/AcceptanceA.
Inspection: The Government has the right to inspect and test all work called for by this Agreement,
to the extent practicable at all places and times, including the period of performance, and in any event before
acceptance. The Government may also inspect the premises of the Awardee or any subawardee engaged
after the Effective Date, with seven (7) days advance notice to the Awardee, or fourteen (14) days advancenotice to any such subawardee. The scope and duration of any such Government inspection will be mutuallyagreed between the Parties in writing in advance, such agreement not to be unreasonably withheld. The
Government shall perform inspections and tests in a manner that will not unduly delay the work and will
be subject to the Awardee’s or subawardee’s, as applicable, policies and procedures regarding security andfacility access at all times while on the premises. If the Government performs any inspection or test on thepremises 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 and convenient
performance of these duties. Except as otherwise provided in the Agreement, the Government shall bear
the expense of Government inspections or tests made at other than the Awardee’s or subawardee’s premises.
B.
Acceptance: The Government shall inspect/accept or reject the work as promptly as practicable
after completion/delivery, unless otherwise specified in the Agreement. Government failure to inspect andaccept or reject the work shall not relieve the Awardee from responsibility, nor impose liability on the
Government, for nonconforming work. Work is nonconforming when it is defective in material orworkmanship or is otherwise not in conformity with Agreement requirements. The Government has theright to reject nonconforming work. Inspection/Acceptance of the supply deliverables should not exceed
90 days after completion.

ARTICLE 7. Financial MattersA.
Generally. This Agreement is a Milestone payment type Other Transaction Authority agreement,
unless otherwise denoted. The payments provided under this Agreement are intended to compensate theAwardee for performance under this Agreement. The Awardee shall use its best efforts to complete thePrototype Project based on the estimated cost.
B.

Milestones. Delineated in Appendix B of this agreement.

Recipient will provide AOR and AO notification of milestone success and any documentation that supports
successful completion of the milestone. Within ten (10) business days of receipt, the AOR will either, 1)
confirm milestone completion and authorize the Recipient to invoice against the completed milestone or,2) notify the Recipient of any deficiencies, additional documentation or clarifications reasonably needed by
the Government to complete its review of the milestone. The Parties agree that payments will be madeupon the AOR’s acceptance of completed milestones. These payments reflect value received by theGovernment toward the accomplishment of the Prototype Project goals.
C.
Obligation. Under no circumstances shall the Government's financial obligation exceed the amountobligated in this Agreement or by amendment to the Agreement. The amount of Government funds
obligated and available for payment under this Agreement and subsequent modifications shall be set forthin the Government’s electronic system (PD2). A PD2 version of the Agreement will be issued for reportingand payment purposes. The Government may incrementally fund this agreement. The Government is not
obligated to provide payment to the Awardee for amounts in excess of the amount of obligated funds
allotted by the Government.
D.
Invoicing and Payment. After accomplishment of each milestone, the Awardee will submit thecorresponding invoice through a Government provided invoicing and payment system, as detailed in
Section 7.E. In addition, the Awardee will provide notification to the AOR that a payment has been
submitted. Payments will be made by the cognizant Defense Finance and Accounting Services office, as
indicated below, in accordance with the Prompt Payment Act. Payments shall be made in the amounts set
forth in the milestone table in Section 7.B, provided the AOR has verified the completion of the applicablemilestones. The Government will pay AstraZeneca in US dollars.
The amounts stated as payable by the Government to the Awardee pursuant to this Agreement are statedexclusive of any Taxes that may be chargeable in respect of that payment and shall not be reduced on
account of any Taxes unless required by applicable law. The Awardee alone shall be responsible for paying
any and all Taxes (other than withholding Taxes required to be paid by the Government under applicablelaw) levied on account of, or measured in whole or in part by reference to, any payments it receives. If theAwardee is entitled under any applicable Tax treaty to a reduction of rate of, or the elimination of, or
recovery of, applicable withholding Tax, it shall deliver to the Government or the appropriate governmental
authority (with the assistance of the Government to the extent that this is reasonably required and isexpressly requested in writing) the prescribed forms necessary to reduce the applicable rate of withholding
or to relieve the Government of its obligation to withhold Tax, and the Government shall apply the reduced
rate of withholding, or dispense with the withholding, as the case may be, to the extent it complies with theapplicable Tax treaty. If, in accordance with the foregoing, the Government withholds any amount, it shallmake timely payment to the proper Taxing Authority of the withheld amount, and send to the Awardee
proof of such payment within 90 days following that payment.
As used herein: Taxes means all taxes of any kind, and all charges, fees, customs, levies, duties, imposts,
required deposits or other assessments, including all federal, state, local or foreign net income, capital gains,gross income, gross receipt, property, franchise, sales, use, excise, withholding, payroll, employment, social

security, worker’s compensation, unemployment, occupation, capital stock, transfer, gains, windfall profits,
net worth, asset, transaction and other taxes, and any interest, penalties or additions to tax with respect
thereto, imposed upon any person by any Taxing Authority or other governmental authority underapplicable law, whether disputed or not, and including any obligation to indemnify or otherwise assume or
succeed to the Tax liability of any other person by law, by contract or otherwise. Taxing Authority means
any governmental authority or any subdivision, agency, commission or authority thereof or any quasigovernmental body exercising tax regulatory authority.
The Awardee shall maintain adequate records to account for all funding under this Agreement. Neither the
Cost Accounting Standards nor any other aspect of the Federal Acquisition Regulation or its supplements
apply to AstraZeneca’s accounting of costs under this Agreement. Cost shall be accounted for inaccordance with AstraZeneca’s commercial accounting practices. AstraZeneca has an established andagrees to maintain an established accounting system which complies with International Financial ReportingStandards and the requirements of this Agreement, and shall ensure that appropriate arrangements havebeen made for receiving, distributing and accounting for Federal funds. An acceptable accounting system
is one in which all costs, cash receipts and disbursements for which AstraZeneca is entitled toreimbursement under Article 6 are controlled and documented properly.
E. WIDE AREA WORKFLOW PAYMENT INSTRUCTIONS (MAY 2013)
a. Definitions. As used in this clause—i. Department of Defense Activity Address Code (DoDAAC) is a six position code thatuniquely identifies a unit, activity, or organization.
ii. Document type means the type of payment request or receiving report available forcreation in Wide Area WorkFlow (WAWF).
iii. 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 252.232- 7003, Electronic
Submission of Payment Requests and Receiving Reports.
c. WAWF access. To access WAWF, the Awardee shall (i) have a designated electronic businesspoint 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 WebBased 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 whensubmitting payment requests and receiving reports in WAWF for this Agreement:
i. Document type. The Awardee shall use the following document type: Voucher
ii. Inspection/acceptance location. The Awardee shall select the following
inspection/acceptance location(s) in WAWF, as specified by the contracting officer.

iii. 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 andreceiving 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

W911QY
W911QYW56XNH

g. Payment request and supporting documentation. The Awardee shall ensure a payment
request includes appropriate contract line item and subline item descriptions of the work
performed or supplies delivered, costs, fee (if applicable), and all relevant back-up
documentation in support of each payment request.
h. 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)i.

WAWF point of contact.
i. The Awardee may obtain clarification regarding invoicing in WAWF from thefollowing contracting activity's WAWF point of contact.
ii. 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 theright to examine records of any Party to the Agreement 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 tothis Agreement or any entity that participates in the performance of the Agreement, or any subordinate
element of such Party or entity, that has not entered into any other agreement (contract, grant, cooperative
agreement, or “other transaction”) that provides for audit access by a government entity in the year prior to
the date of this Agreement. 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 paragraph shall be included
in all sub-agreements to the Agreement other than sub-agreements with a component of the U.S.
Government. The Comptroller General may not examine records pursuant to a clause included in anagreement more than three years after the final payment is made by the United States under the agreement.

B. Detailed Description of Select Contract Deliverables
1.
Supremacy Clause: In the event of any conflict or inconsistency between the narrative descriptions
provided in this Section and the Table above, the Table shall govern.
2.

Draft Report for Clinical and Non-Clinical Studies and Final Report for Clinical and Non-ClinicalStudies
I.
II.

III.

IV.
V.

3.

The clinical trial reports shall follow the format of International Conference on
Harmonization document ICH E3 “Guideline for Industry on Structure andContent of Clinical Study Reports”
Draft Final Report for Clinical and Non-Clinical Studies funded by this Agreement
will be submitted to the Agreements Officer’s Representative (AOR) andAgreements Officer (AO) for review and comment within the time frames set forthin the table (“Summary of Agreement Deliverables”) under ARTICLE F.2.
Subawardee prepared reports received by the Awardee shall be submitted to theAgreements Officer’s Representative (AOR) and Agreements Officer (AO) for
review and comment as set forth by the table in this Article. Awardee shall consider
revising reports to address BARDA’s recommendations prior to FDA submission.
The Government shall provide written comments to the Draft Final Report for
Clinical and Non-Clinical Studies in accordance with the dates set forth by thetable in this Article.
The comprehensive Final Report for Clinical and Non-Clinical Studies will be
submitted to the Agreements Officer and the Agreements Officer’s Representative
set forth by the table in this Article.

Ad Hoc Meetings

In addition to the bi-weekly meetings and monthly program updates, additional ad hoc meetings to address
specific issues or to convey time-sensitive updates or scientific data related to the program will be held.
4.

Regulatory Documentation and Technical Data Packages

As indicated in Article 13, the Awardee shall work in consultation with the Government Regulatory andQuality Affairs staff for the development of all regulatory submission packages to the FDA and include
Government Regulatory and Quality Affairs staff in all formal discussions with the FDA. The Awardee
shall provide the Government copies of all technical data generated by the Awardee prior to and duringperformance of the project, necessary to pursue FDA approval and notify the Government of FDA decisions
as these take place.
If applicable, the Awardee shall prepare an IND/BLA in the Electronic Common Technical Document(eCTD) format for submission to the FDA and the Government. The awardee shall submit all pre-IND,
IND, pre-EUA, and/or BLA report submissions to the AOR for review.
All documentation submitted to the Government must have quality oversight from an appropriate,
independent Quality group not reporting to the executing management group (for example; clinical trials
group, data management group, etc.).

5.

Miscellaneous Data Submissions

If applicable, the Awardee must submit to the Government all Point Papers, Briefings, Technical
Performance Plans (TPP), Program Development Plans (PDP), Regulatory Strategy, Technology Transfer
Report and Gap Analysis, Formulation Development, Feasibility and Optimization Reports, United States
Army Medical Research and Material Command Animal Care and Use Review Office (USAMRDCACURO) Approvals, Human Resources Operations Branch (HROB) Approvals, Technical Presentations
and Publications, and any formal technical reports that have been prepared for eventual submission to FDA
or other regulatory agencies. Examples include the following reports related to: pharmaceuticaldevelopment, manufacturing development, manufacturing validation, completed batch records, certificatesof analysis, analytical development and validation, drug substance and product stability, nonclinical testing,and clinical testing. Examples include clinical performance and clinical quality documentation.
6.

Work Breakdown Structure

Three-level WBS with costs and schedule (top level is program, level two (2) is phase, level three (3) aremajor tasks). For WBS level two (2), show breakdown for labor, material, and other indirect costs.
WBS shall be updated annually or thirty (30) calendar days after a Statement of Work modification.
Government review/approval is fifteen (15) calendar days after receipt of first submittal. Provide changes
to draft within ten (10) calendar days of such request. Provide final document within ten (10) calendar days
after approval of changes is received.
7.

Quality Agreement

The Awardee shall submit a quality agreement within (b) (4)of award for Government review.
Upon acceptance the agreement is to be executed by both parties. The Awardee will ensure appropriatequality agreements are in place with applicable subawardees to enable the Awardee to comply with its
quality obligations to the Government , in accordance with FDA guidance and regulations, including but
not limited to the November 2016 Guidance for Industry, "Contract Manufacturing Arrangements for
Drugs: Quality Agreements.
8.

Supply Chain Resiliency Plan

The Awardee shall develop and submit within (b) (4)of Agreement award, a comprehensive
Supply Chain Resiliency Program that provides identification and reporting of critical components
associated with the secure supply of drug substance, drug product, and work-in-process through to finishedgoods.
A critical component is defined as any material that is essential to the product or the manufacturing process
associated with that product. Included in the definition are consumables and disposables associated with
manufacturing. NOT included in the definition are facility and capital equipment.
Consideration of critical components includes the evaluation and potential impact of raw materials,
excipients, active ingredients, substances, pieces, parts, software, firmware, labeling, assembly, testing,analytical and environmental componentry, reagents, or utility materials which are used in the
manufacturing of a drug, cell banks, seed stocks, devices and key processing components and equipment.
A clear example of a critical component is one where a sole supplier is utilized.
The Awardee shall identify key equipment suppliers, their locations, local resources, and the associatedcontrol processes at the time of award. This document shall address planning and scheduling for active

pharmaceutical ingredients, upstream, downstream, component assembly, finished drug product anddelivery events as necessary for the delivery of product.
a) Communication for these requirements shall be updated as part of an annual review, or asnecessary, as part of regular contractual communications.
b) For upstream and downstream processing, both single-use and re-usable in-place
processing equipment, and manufacturing disposables also shall be addressed. For finished goods,
the inspection, labeling, packaging, and associated machinery shall be addressed taking into accountcapacity capabilities.
c) The focus on the aspects of resiliency shall be on critical components and aspects ofcomplying with the Agreement delivery schedule. Delivery methods shall be addressed, inclusive of
items that are foreign-sourced, both high and low volume, which would significantly affectthroughput and adherence to the contractually agreed deliveries.
The Awardee shall articulate in the plan, the methodology for inventory control, production
planning, scheduling processes and ordering mechanisms, as part of those agreed deliveries.
a) Production rates and lead times shall be understood and communicated to the Agreements
Officer or the Agreements Officer's Representative as necessary.
b) Production throughput critical constraints should be well understood by activity and by
design, and communicated to contractual personnel. As necessary, communication should focus on
identification, exploitation, elevation, and secondary constraints of throughput, as appropriate.
Reports for critical items should include the following information:
I.
II.
III.
IV.
V.
VI.

Critical Material
Vendor
Supplier, Manufacturing / Distribution Location
Supplier Lead Time
Shelf Life
Transportation / Shipping restrictions

The AO and AOR reserve the right to request un-redacted copies of technical documents provided in
response to this subsection, during the period of performance, for distribution within the Government.
Documents shall be provided within ten (10) days after AO issues the request. The Awardee may arrange
for additional time if deemed necessary, and agreed to by the AO. The Government will have Limited
Rights in any documents provided under this subsection.
9.

Manufacturing Data Requirements

The Awardee shall submit within (b) (4)of execution of this OTA detailed data regarding
project materials, sources, and manufacturing sites, including but not limited to: physical locations ofsources of raw and processed material by type of material; location and nature of work performed at
manufacturing, processing, and fill/finish sites; and location and nature of non-clinical and clinical studies
sites. The Government may provide a table in tabular format for Awardee to be used to submit such data,intended to ensure material development, which would include but not be limited to the following:a. Storage/inventory of ancillary materials (vials, needles, syringes, etc.)

b.
c.
d.
e.
f.
g.
h.
i.
j.
10.

Shipment of ancillary materials (vials, needles, syringes, etc.)
Disposal of ancillary materials (vials, needles, syringes, etc.)
Seed development or other starting material manufacturing
Bulk drug substance and/or adjuvant production
Fill, finish, and release of product or adjuvant
Storage/inventory of starting materials, bulk substance, or filled/final product or adjuvant
Stability information of bulk substance and/or finished material
Shipment of bulk substance of final material
Disposal of bulk substance or final material

Operational Security (OPSEC) Plan

The Awardee shall develop an OPSEC Standard Operating Procedure (SOP)/Plan within ninety (90)calendar-days of Agreement award to be reviewed and approved by the responsible Government OPSEC
officer. This plan will be submitted to the AOR for coordination of approvals. This SOP/Plan will include
identifying the critical information related to this Agreement, why it needs to be protected, where it islocated, who is responsible for it, and how to protect it.
11.

Security Plan

The Awardee shall develop a comprehensive security program that provides overall protection of personnel,
information, data, and facilities associated with fulfilling the Government requirement. This plan shallestablish security practices and procedures that demonstrate how the Awardee will meet and adhere to thesecurity requirements outlined below prior to the commencement of product manufacturing, and shall bedelivered to the Government within (b) (4)of award. The Awardee shall also use
commercially reasonable efforts to ensure all subawardees, consultants, researchers, etc. performing work
on behalf of this effort, comply with all Government security requirements and Awardee security plans.
However, the Government acknowledges that, in order to combat the global pandemic and launch
AZD7442 as quickly as possible, the Awardee has entered into a number of contracts prior to the Execution
Date. The Awardee will flow-down the provisions of the Security Plan to (i) all sub-agreements/contracts
executed after the Execution Date, and (ii) all sub-agreements/contracts executed prior to the Execution
Date which cover manufacturing/fill/finish/storage activities under this Agreement; provided that in no
event will the Awardee be required to flow-down any provisions to any sub-awardee which has a preexisting direct relationship with the Government. The Awardee will have a period of (b) (4)toamend any existing agreements to reflect these flow-down requirements or, in the alternative, todemonstrate the sub-awardee’s material compliance with any such flow-down requirements.
The Government will review in detail and submit comments within (b) (4)to theAgreements Officer (AO) to be forwarded to the Awardee. The Awardee shall review the Draft Security
Plan comments, and, submit a Final Security Plan to the U.S. Government within (b) (4)after receipt of the comments.
The Security Plan shall include a timeline for compliance of all the required security measures outlined by
the Government.
Upon completion of initiating all security measures, the Awardee shall supply to the Agreements Officer aletter certifying compliance to the elements outlined in the Final Security Plan.
At a minimum, the Final Security Plan shall address the following items:
Government Security Requirements:Access Control

Training

Audit and Accountability

Configuration
Management

Contingency Planning

Incident Response

Media and Information
Protectionf) Identities and credentials are issued, managed, verified, revoked,
and audited for authorized devices, users and processes.
g) Users, devices, and other assets are authenticated (e.g., singlefactor, multifactor) commensurate with the risk of the transaction(e.g., individuals’ security and privacy risks and otherorganizational risks)a) Limit information system access to authorized users.
b) Identify information system users, processes acting on behalf ofusers, or devices and authenticate identities before allowing
access.
c) Limit physical access to information systems, equipment, andserver rooms with electronic access controls.
d) Limit access to/ verify access to use of external information
systems.
a) Ensure that personnel are trained and are made aware of the
security risks associated with their activities and of the applicablelaws, policies, standards, regulations, or procedures related to
information technology systems.
a) Create, protect, and retain information system audit records to theextent needed to enable the monitoring, analysis, investigation,and reporting of unlawful, unauthorized, or inappropriate system
activity. Records must be kept for minimum must be kept for 12months.
b) Ensure the actions of individual information system users can be
uniquely traced to those users.
c) Update malicious code mechanisms when new releases areavailable.
d) Perform periodic scans of the information system and real timescans of files from external sources as files are downloaded,
opened, or executed.
a) Establish and enforce security configuration settings.
b) Implement sub networks for publically accessible systemcomponents that are physically or logically separated from internal
networks.
a) Establish, implement, and maintain plans for emergency response,
backup operations, and post-disaster recovery for information
systems to ensure the availability of critical information resources
at all times.
a) Establish an operational incident handling capability for
information systems that includes adequate preparation, detection,
analysis, containment, and recovery of cybersecurity incidents.
Exercise this capability annually.
a) Protect information system media, both paper and digital.
b) Limit access to information on information systems media toauthorized users.
c) Sanitize and destroy media no longer in use.
d) Control the use of removable media through technology or policy.

ARTICLE 9. Most Favored CustomerA.

In the event that the Parties agree to a follow-on production pursuant to 10 U.S.C. § 2371b,
Awardee agrees that it shall sell to the U.S. Government the first million doses of AZD7442 at a
price of (b) (4) . Any additional doses will be sold to the U.S. Government at a price to benegotiated and agreed by the Parties.

B.

If Awardee develops a like product (commercialized version or derivative of the production modelof the Prototype) with similar capability and intended application, but at a lower unit price (“Like
Product”) regardless of quantity, Awardee shall make the U.S. Government aware of that similar
product and the technical and price differences between that product and the Prototype. Such
notification shall be made to the OTAO in writing, of which email is an acceptable form, within(b) (4)of such offering.

ARTICLE 10. Confidential Information
A.

“Confidential information”, as used in this article, means information or data of a personal nature
about an individual, or proprietary information or data submitted by or pertaining to an institution
or organization.

B.

The Agreements Officer and the Awardee may, by mutual consent, identify elsewhere in thisAgreement specific information and/or categories of information which the Government will
furnish to the Awardee or that the Awardee is expected to generate which is confidential. Similarly,
the Agreements Officer and the Awardee may, by mutual consent, identify such confidential
information from time to time during the performance of the contract. Failure to agree will besettled pursuant to the "Disputes" clause.

C.

If it is established elsewhere in this Agreement that information to be utilized under this Agreement,
or a portion thereof, is subject to the Privacy Act, the Awardee will follow the rules and proceduresof disclosure set forth in the Privacy Act of 1974, 5 U.S.C. 552a, and implementing regulations andpolicies, with respect to systems of records determined to be subject to the Privacy Act.

D.

Confidential information, as defined in paragraph (a) of this article, shall not be disclosed without
the prior written consent of the individual, institution, or organization.

E.

Whenever the Awardee is uncertain with regard to the proper handling of material under the
Agreement, or if the material in question is subject to the Privacy Act or is confidential information
subject to the provisions of this article, the Awardee shall obtain a written determination from theAgreements Officer prior to any release, disclosure, dissemination, or publication.

F.

Agreements Officer Determinations will reflect the result of internal coordination with appropriate
program and legal officials.

G.

The provisions of this Article shall not apply to conflicting or overlapping provisions in other
Federal, State or local laws.

H.

Awardee shall include the requirements set forth in this Article in all Sub-awards entered into after
the date of effectiveness of this Agreement. Awardee acknowledges that confidential information
will not be provided to sub-agreement holders unless or until Article 10 flows down to the relevant
sub-agreement, and such entity agrees to be in substantial compliance with this Article 10.

ARTICLE 11. Intellectual Property Rights
A.
Limited Representation. AstraZeneca represents that, to its knowledge, the intellectual property
license(s) and other rights held by or granted to AstraZeneca, including but not limited to those under the
Vanderbilt University License Agreement with respect to AZD7442 (AZD1061 + AZD8895) and the
University of Texas System license (on behalf of University of Texas Southwestern Medical Center) withrespect to AZD7442 (AZD1061 + AZD8895), are sufficient to enable Astra Zeneca to perform its
obligations under this Agreement.
B.
Background IP and Materials. The Awardee and the Government each retain any intellectual
property (IP) rights to their own materials, technical data (as defined in 22 C.F.R. § 120.10), technology,
information, documents, or know-how—or potential rights, such as issued patents, patent applications,invention disclosures, copyrighted works, or other written documentation—that exist prior to execution ofthis Agreement or are developed outside the scope of this Agreement (“Background IP”).
C.
Awardee’s Background IP. Awardee warrants that it (or its upstream licensor) has filed patentapplication(s) or is the assignee of issued patent(s) identified and listed in Appendix E which contain claims
that are related to research contemplated under this Agreement. The Background IP identified and listed inAppendix E is specifically excluded from the definitions of “Agreement Invention” contained in thisAgreement. The Government acknowledges that the Awardee will continue to perform research anddevelopment efforts in respect of AZD7422, including formulation and delivery work, and improvements to
the TM mutation, which work is outside the scope and funding terms of this Agreement and, as a result, any
intellectual property generated by the Awardee in the performance of such work constitutes Background IP.
Awardee acknowledges that the Government has funded a subset Awardee’s Background IP under the
Vanderbilt University License Agreement with respect to AZD7442 (AZD1061+AZD8895) (the“Vanderbilt Agreement”). Furthermore, on November 21, 2017, Agreement HR0011-18-3-001 entitled,“Technology Investment Agreement between MedImmune, LLC and The Defense Advanced Research
Projects Agency,” was executed with the overall goal of developing an end to end process to identify anovel monoclonal antibody and deliver this antibody using in vivo expression technologies (the “DARPA
Agreement”). On December 19, 2017, a Cooperative Agreement, HR0011-18-2-001, was executed
between Defense Advanced Research Projects Agency (“DARPA”) and Vanderbilt University Medical
Center to fund research related to “RRADD: Rational and Rapid Ab Design and Delivery” (together with
the Vanderbilt Agreement and the DARPA Agreement, the “Pre-Existing Agreements”) DARPA andBARDA established an MOU to cooperative fund an effort to complete R&D, preclinical, and early clinicaldevelopment of monoclonal antibodies targeting SARS-CoV-2.
D.
Government’s Background IP. The Government is not providing any Background IP under thisAgreement and therefore lists “None” in Appendix E.
E.
Agreement Inventions. In the unlikely event that an invention is conceived or first actually reduced
to practice in the performance of this Agreement (“Agreement Invention”), ownership of any Agreement
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 will follow inventorship in accordance with U.S. patentlaw. Neither the Government nor Awardee anticipate the conception or reduction to practice of any
Agreement Invention. The Government acknowledges that in the absence of any Agreement Invention, theBayh-Dole Act, (35 U.S.C. §§ 200-212) does not apply, nor govern, this Agreement. Since, in the absenceof any Agreement Invention, the Bayh-Dole Act, does not apply to this Agreement, as such, title toAgreement Inventions will accrue to the inventor or inventor-organization. In the absence of any Agreement
Invention, the Government shall not have any rights to “march-in,” as that term is defined in 35 U.S.C. §203, and Awardee is not subject to the manufacturing requirements of 35 U.S.C. § 204.
In the event an Agreement Invention exists, 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 an Agreement Invention ismade either by an Awardee employee (“Sole Awardee Agreement Invention”) or made by a Government
employee (“Sole Government Agreement Invention”) the entire rights to that sole Awardee Agreement
Invention or Sole Government Agreement Invention will be respectively assigned to the Awardee or theGovernment. If an Awardee employee and a Government employee jointly make an Agreement Invention(“Joint Agreement Invention”), it will be owned jointly by the Awardee and the Government. Ownershipof inventions made in whole or in part with Sub-awardee or collaborator employees, including employeesof other components of the Government, will be determined solely pursuant to an agreement between theAwardee and the applicable Sub-awardee or collaborator. Notwithstanding the foregoing, neither theGovernment nor Awardee anticipate the Government making a Sole Government Agreement Invention,
nor the Parties jointly making a Joint Agreement Invention, as Awardee employees are solely responsible,
as between the Parties, for performing the Prototype Project under this Agreement.
F.
Patent Applications. Each Party shall disclose any Agreement Inventions for which the Party plans
to file a patent application within (b) (4)of the time it was conceived or first reduced to practiceunder this Agreement. The Parties will respectively have the option, in their discretion, to file a patentapplication claiming any Agreement Invention made solely by their respective employees (but, for clarity,
are not obligated to file a patent application claiming any Agreement Invention, and will not forfeit title byelecting to hold an Agreement Invention as a trade secret). The Parties will consult with each other regarding
the options for filing a patent application claiming a Joint Agreement Invention. Within one (1) year of
being notified of the discovery of an Agreement Invention for which a patent application is planned, eachParty will provide notice of any filing of a patent application to the other Party. The Parties will reasonably
cooperate with each other in the preparation, filing, and prosecution of any patent application claiming a
Joint Agreement Invention. Any Party filing a patent application will bear expenses associated with filingand prosecuting the application, as well as maintaining any patents that issue from the application, unlessotherwise agreed by the Parties. Executive Order No. 9424 of 18 February 1944 requires all executive
Departments and agencies of the Government to forward through appropriate channels to the Commissioner
of Patents and Trademarks, for recording, all Government interests in patents or applications for patents.
G.
Patent Prosecution. Awardee agrees to take responsibility for the preparation, filing, prosecution,and maintenance of any and all patents and patent applications listed as Awardee Background IP that are
relevant to the 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. With respect to any Sole Awardee Agreement Invention or a Joint Agreement Invention,prior to acting on a decision by Awardee to abandon or not file in any country a patent or patent application
covering an Sole Awardee Agreement Invention or a Joint Agreement Invention, Awardee shall so informthe Government in a timely manner to allow Awardee to thoughtfully consider the Government's comments
regarding such a proposed decision. Nothing in this ARTICLE shall restrict the Government in its
preparation, filing, prosecution and maintenance of a patent or patent application covering an Agreement
Invention.
H.

Licenses.

i.
Background IP. The Awardee acknowledges the Government’s pre-existing rights in
Background IP generated in the performance of the Pre-Existing Agreements, and nothing in thisAgreement is intended to alter any rights the Government may have in Background IP generated inperformance thereof. For clarity, the Awardee does not grant to the Government any license or right to use
any of the Background IP identified in Appendix E which was not generated in the performance of a

Government funding agreement.
ii.
Agreement Inventions. Any Sole Awardee Agreement Invention is subject to anonexclusive, nontransferable, irrevocable, paid-up license for the Government, to practice and havepracticed the Agreement Invention on behalf of the Government. For any Sole Government Agreement
Invention, upon the Recipient's request, the Government agrees to enter into good faith negotiations with
the Recipient regarding the Recipient's receipt of a nonexclusive commercialization license covering theGovernment’s interest in any Sole Government Agreement Invention.
ARTICLE 12. Data Rights
A.
Background Data. “Background Data” shall mean all technical data, as the term is defined in
DFARS 252.227-7013 (a) (15), that exists prior to execution of this Agreement, or are developed outside
the scope of this Agreement. Awardee warrants that it has identified and listed Background Data inAppendix F. The Parties acknowledge and agree that: (i) the Government has been granted rights to certain
technical data that are independent of this Agreement, and may be disclosed in Awardee’s Background
Data listed in Appendix F; and (ii) the Government’s rights in said technical data are not superseded orotherwise reduced by this Agreement.
All Background Data shall be owned by the Awardee. AstraZeneca grants the Government a non-exclusive
license to use any Background Data solely to the extent necessary for the Government to perform its
obligations under this Agreement and arrange administration of treatment courses delivered in accordancewith FDA and other applicable regulations.
As used herein, “Limited Rights” means, in respect of any technical data, the rights to use, modify,
reproduce, perform, display, or disclose data, in whole or in part, within the Government solely for research
purposes in respect of the prophylaxis and treatment of COVID-19. The Government will ensure that
disclosed information is safeguarded in accordance with the restrictions of this Agreement. The
Government may not, without the prior written permission of the Awardee, release or disclose the data
outside the Government, use the data for competitive procurement or manufacture, release or disclose thedata for commercial purposes, or authorize the data to be used by another party. The Parties shall maintainthe confidentiality of all data subject to or designated as falling within Limited Rights.
As used herein, “Government Purpose Rights” means the rights to (i) use, modify, reproduce, release,perform, display, or disclose data solely within the Government, (ii) release or disclose data outside theGovernment, and (iii) authorize persons to whom release or disclosure has been made to use, modify,
reproduce, release, perform, display, or disclose that data; in each case (i)-(iii) solely as required for
Government purposes. Government purposes do not include the rights to use, modify, reproduce, release,perform, display, or disclose data for commercial or competitive purposes or to authorize others to do so.
Even where disclosure is made for Government purposes, such disclosure will be governed by a contractual
terminology or a non-disclosure agreement restricting further dissemination of the information andotherwise ensuring compliance with the government's rights and obligations in the disclosed data.
B.
Subject Data. All data generated in connection with the performance of this Agreement, or thatarises out of the use of any materials or enabling technology provided or used by the Awardee in theperformance of this Agreement, other Awardee materials or Awardee confidential information, whether
conducted by the Government or the Awardee (collectively, the “Subject Data”), shall be owned by theAwardee.
Subject Data in any document that would disclose an Agreement Invention will be subject to Limited Rights
until publication of patent application in accordance with Article 11 of this Agreement.

The Awardee agrees to retain and maintain all Subject Data (i) in a clear and readable manner, such that
the Government reasonably could use such Subject Data in connection with its rights under Article 18 and(ii) in accordance with the Awardee’s established record retention practices. In the event of exercise of theGovernment's rights as potentially granted under Article 2, paragraph C, the Awardee agrees to deliver at
no additional cost to the Government, all Subject Data, in Awardee's possession and developed under thisAgreement, necessary for the Government to exercise its rights under Article 18within sixty (60) calendar
days from the date of the written request. The Government shall retain Limited Rights, as defined in Article
I above, to this delivered Subject Data.
C.
Marking of Data. Pursuant to paragraph A above, the Awardee will use reasonable efforts to markany Data delivered to the Government under this Agreement with Limited Rights with the following legend:“LIMITED RIGHTS” The Government’s right to use, modify, reproduce, perform, display, or disclose thisData is restricted by Agreement W911QY-21-9-0001 between the Government and the Awardee(disclosure is limited within the Government). Any reproduction of this Data or portions thereof marked
with this legend must also reproduce the markings.”
Notwithstanding the foregoing, in the event the Government receives Background Data or Subject Datadelivered under this Agreement that is not marked with the foregoing legend the Government shall treatsuch information as if it were marked with the foregoing legend.
D.
All Technical Data and Software (each term as defined under DFARS 252.227-7013) which shallbe delivered under this Agreement with less than unlimited rights shall be identified in reasonablespecificity and particular rights granted (Government Purpose (as defined in this Agreement), Limited (asdefined in this Agreement), or Restricted (as defined in DFARS 252.227-7013)) prior to entering into theAgreement. All other Technical Data and Software developed under funding of this agreement shall bedelivered with Limited Rights as provided for within this Article.
ARTICLE 13. Regulatory Rights
A. This Agreement involves research with an investigational drug, biologic or medical device that isregulated by the FDA and requires FDA pre-market approval or licensure before commercial authorization.
It is expected that this contract will result in the FDA authorization, licensure, and commercialization of
the “Technology. The Awardee is the Sponsor of the Regulatory Application (an investigational new drug
application (IND), investigational device exemption (IDE), emergency use authorization (EUA), 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 researchunder this contract. As 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),
the Awardee has certain standing before the FDA that entitles it to exclusive communications related to theRegulatory Application.
B. The Parties agree that Awardee has invested significant time and resources in its platform and IP and is
the best company situated to manage production of the Technology. At the same time, the Parties
acknowledge that the Government has made significant investments in the prototype. Accordingly, theAwardee and the Government agree to the following:i.

The Awardee will provide to the Government all data including top-line summaries andkey conclusions from all studies supporting the regulatory filing and commercial approvalto the extent that such data, summaries, and conclusions are funded by this Agreement. In

addition, the Awardee will offer the Government the opportunity to review and provide
comments on a final draft of regulatory submissions which include data funded by thisAgreement. The Government will review any such submissions promptly upon receipt. The
Awardee will reasonably consider any comments provided by the Government, and prior
to submission will provide notification to the Government of any additional edits orrevisions. The Awardee will keep the Government apprised of planned FDA meetings andpost-meeting outcomes relating to activities funded by this Agreement.
ii.

Communications. The Awardee shall provide the Government with all formal and informal
communications and summaries thereof to or from FDA, regarding the Technology within(b) (4) , and use best efforts to ensure that the Government representatives are invited toparticipate in any formal or informal Sponsor meetings with FDA. Awardee shall (1)ensure that the Government representatives are consulted and are invited to participate inany formal or informal Sponsor meetings with FDA related to the Technology; and (2)notify the FDA that the Government has the right to discuss with FDA any development
efforts regarding the Technology.

iii.

Public Law 115-92 Sponsor Authorization Letter. Public Law 115-92 allows the DoD torequest, and FDA to provide, assistance to expedite development of products to diagnose,
treat, or prevent serious or life-threatening diseases or conditions facing American military
personnel. The Awardee recognizes that only the DoD can utilize PL 115-92. As such, theAwardee will work proactively with the Government to leverage this law to its maximum
potential under this Agreement. The Awardee shall submit Public Law 115-92 Sponsor
Authorization Letter that will be delivered to the designated OWS POC(s) within (b (b)) (4)of award. For clarity, any information delivered to the Government pursuant to the Sponsor
Authorization Letter shall be subject to the Data Rights in Article 8.

iv.

Rights of Reference. Awardee hereby grants to the Government and its permitted
sublicensees the right to request from Recipient, which request shall not be unreasonably
declined or delayed, a limited “right of reference or use” (as that term is defined in 21
C.F.R. § 314.3(b), as amended from time to time) strictly for COVID-19 or other Material
Threat (as defined at Section 319 of the Public Health Service Act) Purposes to Awardee’s
filings to the FDA in connection with the Regulatory Application, and Awardee shallprovide appropriate notification of the Government’s access and reference rights to theapplicable regulatory authorities requested by the Government for the limited purposes
described above. Awardee agrees to provide a letter of cross-reference to the Government
and file such letter with the appropriate FDA office. The USG will agree to any reasonable
request for information connected to its reliance on the right of reference provided under
this Section. This provision is in addition to any rights in technical data described earlier
in this document.

ARTICLE 14. Regulatory Compliance.
A.
The manufacturing described in the Statement of Work will comply with Current Good
Manufacturing Practices (cGMP) regulations at 21 CFR 210 and 211. Production shall occur using cGMP
validated manufacturing process, fully compliant with 21 CFR 210 and 211, for bulk drug substance andfill and finished drug product, with a ramp-up capacity that provides doses sufficient for the government totreat the US population.
B.
Production and distribution shall comply with applicable provisions of the Drug Supply Chain
Security Act (DSCSA), Sections 581-585 of PL 113-54 (Nov 27, 2013), taking into account FDA’s regularguidance for the COVID-19 public health response.
C.
The clinical trial described in the Statement of Work will comply with ICH Good Clinical Practices(GCP) regulations at 21 CFR Part 11.
D.
All clinical sites and IRBs utilized in the clinical trial described in the Statement of Work arerequired to register with the Office for Human Research Protections (OHRP) and receive Federal Wide
Assurance (FWA) numbers in accordance with human subject protections regulations 45 C.F.R 46.103.
ARTICLE 15. Foreign Access to Data.
A.
Export Compliance. The Parties will comply with any applicable U.S. export control statutes orregulations in performing this Agreement.
ARTICLE 16. Scientific Publications and Press Releases.
A.
The Awardee shall not release any reports, manuscripts, press releases, or abstracts about the work
being performed under this Agreement without written notice in advance to the Government.
B.
Unless otherwise specified in this Agreement, the Awardee may publish the results of its work
under this Agreement. The Awardee shall promptly send a copy of each submission to the AOR for security
review prior to submission, and the Government’s consent shall not be unreasonably withheld or delayed(and in no event by more than(b) (4)). The Awardee shall also inform the AOR when the abstract
article or other publication is published, and furnish a copy of it as finally published.
C.
Unless authorized in writing by the AO, the Awardee shall not display Government logos including
Operating Division or Staff Division logos on any publications.
D.
The Awardee shall not reference the products(s) or services(s) awarded under this contract incommercial advertising, as defined in FAR 31.205-1, in any manner which states or implies Government
approval or endorsement of the product(s) or service(s) provided.
E.
The Awardee shall include this clause, including this section (d) in all subawards where thesubawardee may propose publishing the results of its work under the subaward. The Awardee shallacknowledge the support of the Government whenever publicizing the work under this Agreement in any
media by including an acknowledgement substantially as follows:“This project has been funded in whole or in part by the U.S. Government under Agreement No. W911QY21-9-0001. The US Government is authorized to reproduce and distribute reprints for Governmental
purposes notwithstanding any copyright notation thereon.”
ARTICLE 17. Immunity from Liability.
In accordance with the Public Readiness and Emergency Preparedness Act (“PREP Act”), Pub. L. No. 109148, Division C, Section 2, as amended (codified at 42 U.S.C. § 247d-6d and 42 U.S.C. § 247d-6e), as wellas the Secretary of HHS’s Declaration Under the Public Readiness and Emergency Preparedness Act for
Medical Countermeasures Against COVID-19, 85 Fed. Reg. 15198 (Mar. 17, 2020, effective Feb. 4, 2020),
and amended on April 15, 2020, 85 Fed. Reg. 21012 (together, the “Prep Act Declaration”):

business days, of any filing that anticipates Federal bankruptcy protection; orv. The Government terminates this agreement for cause in accordance with Article 2(C).
B.
If one or more of the conditions listed in section (A) occur, AstraZeneca, upon the request of theGovernment, shall provide the following items necessary for the Government to pursue FDA
licensure/authorization and manufacturing of the Technology with a third party for exclusive sale to the
U.S. Government:
i. a writing evidencing a non-exclusive, nontransferable, irrevocable (except for cause), royaltyfree paid-up license to practice or have practiced for or on behalf of the U.S. Government any
AstraZeneca Background IP and Background Data, as those terms are defined in Articles 11 and
12 of this Agreement, necessary to manufacture or have manufactured the Technology;
ii.necessary FDA regulatory filings or authorizations owned or controlled by AstraZeneca related
to the Technology and any confirmatory instrument pertaining thereto; andiii. any outstanding Deliverables contemplated or materials purchased under this Agreement.
C.
The Government acknowledges that, under the Awardee’s pre-existing agreement with its
upstream licensor, Vanderbilt University, if (i) the Awardee fails to use commercially reasonable efforts
to bring AZD7442 to market, or (ii) fails to file for approval of a BLA or an EUA by (b) (4)the upstream licensor has the right to obtain licenses and technology transfer from the Awardee such thatthe upstream licensor is able to commercialize AZD7442 in the United States.
Awardee shall notify the Government within 30 days if Awardee becomes aware that the upstream
licensor intends or has threatened to exercise its rights to obtain licenses and technology transfer fromAwardee. If the upstream licensor exercises this right, Awardee shall so notify the Government within 30
days, and the Government agrees that it will not exercise its rights in the foregoing Section 18.B without
prior consent from Vanderbilt. If the upstream licensor notifies the Awardee that it declines tocommercialize AZD7442 in the United States, the Awardee will notify the Government within thirty (30)days after receipt of such notice, in which case the Government may elect to exercise its rights under theforegoing Section 18.B. If the Government, or any third party designated by the Government, obtains any
such license or sublicense from the Awardee, the Government, or any such designated third party, shall besolely liable for all royalties, costs and other expenses incurred by the Awardee and payable to a third
party in consideration for such license or sublicense (including, but not limited to, payment obligations
the Awardee has to its upstream licensor for AZD7442).
D.
The Awardee acknowledges that a scenario may arise in which the Awardee terminates productdevelopment efforts and gives notice to the Government as provided in Section 18.A(i), but that suchtermination does not constitute a violation of the Awardee’s “commercially reasonable efforts” obligation
to Vanderbilt, and therefore does not trigger Vanderbilt’s rights to exercise step-in rights as described in
Section 18.C. The Awardee acknowledges that, in such a scenario, the Government may continue toexercise its rights as set forth in Section 18.B.
E.
This Article will survive the acquisition or merger of the Awardee by or with a third party. This
Article will survive the expiration of this agreement.

ARTICLE 19. Miscellaneous Clauses.
A.
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. Whenrequested by either Party, all evidence and information in possession of the Party pertaining to such claim
or lawsuit will be provided to the other at no cost to the requesting Party.
B.
Limitation of Liability. Except for claims of non-payment of amounts due under Article 7, any
claims for damages of any nature whatsoever pursued under this Agreement shall be limited to direct
damages only up to the aggregate amount of Government funding disbursed as of the time the dispute arises.
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 beenadvised of the possibility of such damages.
C.
Disclosure of Information. Performance under this Agreement may require the Awardee to accessnon-public data and information proprietary to a Government agency, another Government contractor, orof such nature that its dissemination or use other than as specified in the work statement would be adverseto the interests of the Government or others. Neither the Awardee, nor Awardee personnel, shall divulge
nor release data nor information developed or obtained from or on behalf of the Government underperformance of this Agreement which information specifically relates to AZD7442 (i.e., would not apply
more broadly to AstraZeneca’s other antibody programs, such as its manufacturing platform), except asauthorized by Government personnel or upon written approval of the AO in accordance with OWS or other
Government policies and/or guidance. The Awardee shall not use, disclose, or reproduce proprietary datathat bears a restrictive legend, other than as specified in this Agreement, or any information at all regarding
this agency.
The Awardee shall comply with all Government requirements for protection of non-public information.
Unauthorized disclosure of nonpublic information is prohibited by the Government’s rules. Unauthorized
disclosure may result in termination of the Agreement, replacement of an Awardee employee, or otherappropriate redress. Neither the Awardee nor the Awardee’s employees shall disclose or cause to bedisseminated, any information concerning the operations of the activity, which could result in, or increase
the likelihood of, the possibility of a breach of the activity’s security or interrupt the continuity of its
operations.
No information related to data obtained under this Agreement shall be released or publicized without theprior written consent of the AOR, whose approval shall not be unreasonably withheld, conditioned, ordelayed, provided that no such consent is required to comply with any law, rule, regulation, court ruling or
similar order; for submission to any Government entity for submission to any securities exchange on which
the Awardee’s (or its parent corporation’s) securities may be listed for trading; or to third parties relating
to securing, seeking, establishing or maintaining regulatory or other legal approvals or compliance,
financing and capital raising activities, or mergers, acquisitions, or other business transactions.
D.
Force Majeure. Neither Party will be liable to the other Party for failure or delay in performing its
obligations hereunder if such failure or delay arises from circumstances beyond the control and without thefault or negligence of the Party (a Force Majeure event). Examples of such circumstances are: authorizedacts 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.
E.

Severability. If any provision of this Agreement, or the application of any such provision to anyperson or set of circumstances, is determined to be invalid, unlawful, void or unenforceable to any extent,
the remainder of this Agreement, and the application of such provision to persons or circumstances otherthan those as to which it is determined to be invalid, unlawful, void or unenforceable, will not be impaired
or otherwise affected and will continue to be valid and enforceable to the fullest extent permitted by law.
F.
Choice of Law. This Agreement and the resolution of disputes hereunder will be governed,
construed, and interpreted by the statutes, regulations, and/or legal precedent applicable to the Governmentof the United States of America. Unless explicitly stated, the Parties do not intend that this Agreement be
subject to the Federal Acquisition Regulation either directly or indirectly or by operation of law. When aspecific FAR requirement is incorporated by reference in this Agreement, the text of the clause alone will
apply without application or incorporation of other provisions of these regulations.
G.
Order of Precedence. In the event of a conflict between the terms of this Agreement and theattachments incorporated herein, the conflict shall be resolved by giving precedence in descending order asfollows: (i) the Articles of this Agreement, and the Appendices to the Agreement.
H.
Access and General Protection/Security Policy and Procedures. This standard language text is
applicable to ALL employees working on critical information related to OWS with an area of performancewithin a Government controlled installation, facility or area. Employees shall comply with applicableinstallation, facility and area commander installation/facility access and local security policies andprocedures (provided by government representative). The performer also shall provide all information
required for background checks necessary to access critical information related to OWS, and to meet
Government installation access requirements to be accomplished by installation Director of Emergency
Services or Security Office. The workforce must comply with all personnel identity verification
requirements as directed by the Government and/or local policy. In addition to the changes otherwise
authorized by the changes clause of this agreement, should the security status of OWS change theGovernment may require changes in performer security matters or processes. In addition to the industry
standards for employment background checks, The Contractor must be willing to have key individuals, in
exceptionally sensitive positions, identified for additional vetting by the United States Government.
I.
Financial Disclosure by Clinical Investigators. The Awardee does and shall comply with therequirements of 21 CFR Part 54, Financial Disclosure by Clinical Investigators.
J.
Performance by Affiliates. The Government acknowledges and agrees that the Awardee may
perform its obligations under this Agreement through one or more of its affiliates, provided that theAwardee will be responsible for the full and timely performance as and when due under, and observanceof, all the covenants, terms, conditions and agreements set forth in this Agreement by its affiliates.
K.

Subcontracts.
1. The Government acknowledges that, in order to combat the global pandemic and launch (b) (4)as quickly as possible, Recipient has entered into a number of contracts prior to the Execution Date, and
the Government agrees that it will not require these contracts to be renegotiated. Therefore, except asotherwise expressly set forth in this Article 19.K, any provision requiring Recipient to flow-down an
obligation to its sub-agreement holders will apply only to sub-agreements executed by Recipient
following the Execution Date of this Agreement.
2. For clarity, as detailed within the Articles themselves, the following Articles require flow-down
to subagreements/contracts executed after the Execution Date:(i)

Article 10: Confidential Information.

(ii)Article 8.B.11: Security Plan.

(iii)
Article 14.d: Requirement to register with the OHRP and receive FWA.
3. Section 19.L will be flowed-down to all subagreements/contracts as set forth in FAR 52.204-25,
whether executed before or after the Execution Date.
L.
Use of Covered Telecommunications. FAR 52.204-25 Prohibition on Contracting for Certain
Telecommunications and Video Surveillance Services or Equipment is hereby incorporated by reference.

(b) (6)Appendix D
Government Property
Government Property: “Government Property” means any property (i) furnished by the Government andfacilitating performance of this Agreement, (ii) acquired by the Awardee under cost reimbursement terms ofthis Agreement, or (iii) acquired by the Awardee under fixed price terms of this Agreement (FP-GP) if
specifically identified in this Government Property Appendix. Except for commercial off the shelf softwareand licenses thereto, Government Property does not include intellectual property and software. The
Government owns and holds title to all Government Property.
The Government shall deliver to the Awardee any Government Property required to be furnished as
described in this Agreement together with related data and information needed for its intended use. The
delivery and/or performance dates specified in this Agreement are based upon the expectation that theGovernment-furnished property will be suitable for performance and will be delivered to the Awardee by
the dates stated in the Agreement. If not so suitable, the Awardee shall give timely written request to the AO
who will advise the Awardee on a course of action to remedy the problem.
FPGP includes: [Mark N/A if none]:N/A

The Awardee shall have, initiate and maintain a system of internal controls to manage, control, use, preserve,
protect, repair, account for and maintain Government Property in its possession and shall initiate andmaintain the processes, systems, procedures, records required control and maintain accountability ofGovernment Property. The Awardee shall include this clause in all subcontracts under which Government
Property comes into the possession of any subawardee. Unless otherwise provided for in this Agreement orapproved by the AO, the Awardee shall not: (i) use Government Property for any purpose other than to fulfill
the requirements of this Agreement, or (ii) alter the Government Property.
The Awardee shall establish and implement property management plans, systems, and procedures regarding
its acquisition of Government Property, its receipt of Government Property, in addition to, the status, dates
furnished or acquired, identification, quantity, cost, marking, date placed in service, location, inventory anddisposition of Government Property, to include a reporting process for all discrepancies, loss of Government
Property, physical 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 to exceed 120 days pending
receipt of such instructions. Storage shall be at no additional cost to the Government unless otherwise notedin 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 ordestruction 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, reasonable wear and tear or manufacturing defects. THE AWARDEE SHALL BE LIABLE
FOR LOSS OF GOVERNMENT PROPERTY IN AWARDEE’S POSSESSION, EXCEPT WHEN ANYONE OF THE FOLLOWING APPLIES:(I) AO GRANTS RELIEF OF RESPONSIBILITY AND LIABILITY FOR LOSS OF THE PARTICULARGOVERNMENT PROPERTY; (II) GOVERNMENT PROPERTY IS DELIVERED OR SHIPPED UNDER
THE GOVERNMENT’S INSTRUCTIONS; OR (III) GOVERNMENT PROPERTY IS DISPOSED OF IN
ACCORDANCE WITH THE GOVERNMENT’S DIRECTIONS.

W911QY2190001
Page 2 of 33
Section B - Supplies or Services and Prices

ITEM NO
0001

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 1 Security and Supply Planning
FFP
Security Plan, Supply Chain Resilieny Plan, Manufacturing Data Requirements,
Product Material Source Report and Quality Agreement in accordance with theterms of the agreement.
FOB: Destination
PSC CD: AN14

NET AMTITEM NO
000101

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600001(b) (4)(b) (4)

W911QY2190001
Page 3 of 33
ITEM NO
0002

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS2 Operational Security Standard OP
FFP
MS 2 Operational Security SOP in accordance with the terms of the agrement.
FOB: Destination
PSC CD: AN14

NET AMTITEM NO
000201

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600002

ITEM NO
0003

SUPPLIES/SERVICESQUANTITY
1(b) (4)(b) (4)UNIT
Each

UNIT PRICE(b) (4)AMOUNT(b) (4)

MS 3 Contract Closeout
FFP
MS 3 Contract Summary Report in accordance with the terms of the agreement.
FOB: Destination
PSC CD: AN14

NET AMT(b) (4)

W911QY2190001
Page 4 of 33

ITEM NO
000301

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600003

ITEM NO0004(b) (4)(b) (4)

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 4 Provent-Enabling Activities
FFP
MS 4 Clinical Study Protocol & IB in accordance with the terms of the agreement.
FOB: Destination
PSC CD: AN14

NET AMTAMOUNT(b) (4)(b) (4)

W911QY2190001
Page 5 of 33
ITEM NO
000401

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600004

ITEM NO
0005

SUPPLIES/SERVICESQUANTITY
1(b) (4)(b) (4)UNIT
Each

UNIT PRICE(b) (4)AMOUNT(b) (4)

MS 5 Provent-Dosing
FFP
MS 5 Provent Dosing in accordance with the terms of the agreement.
FOB: Destination
PSC CD: AN14

NET AMTITEM NO
000501

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICE(b) (4)AMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600005(b) (4)(b) (4)

W911QY2190001
Page 6 of 33

ITEM NO
0006

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 6 Provent-Efficacy Results
FFP
MS 6 Provent-Efficacy Results in accordance with the terms of the agreement.
FOB: Destination
PSC CD: AN14

NET AMTITEM NO
000601

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600006(b) (4)(b) (4)

W911QY2190001
Page 7 of 33
ITEM NO
0007

SUPPLIES/SERVICESQUANTITY
1

UNIT
Each

UNIT PRICE(b) (4)AMOUNT(b) (4)

MS 7 Provent-Completion
FFP
MS 7 Provent-Completion in accordance with the terms of the agreement.
FOB: Destination
PSC CD: AN14

NET AMTITEM NO
000701

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICE(b) (4)AMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600007(b) (4)(b) (4)

W911QY2190001
Page 8 of 33
ITEM NO
0008

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 8 StormChaser-Enabling Activities
FFP
MS 8 StormChaser-Enabling Activities in accordance with the terms of theagreement.
FOB: Destination
PSC CD: AN14

NET AMTITEM NO
000801

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600008

ITEM NO
0009

SUPPLIES/SERVICESQUANTITY
1(b) (4)(b) (4)UNIT
Each

UNIT PRICE(b) (4)AMOUNT(b) (4)

MS 9 StormChaser-Dosing
FFP
MS 9 StormChaser-Dosing in accordance with the terms of the agreement.
FOB: Destination
PSC CD: AN14

NET AMT(b) (4)

W911QY2190001
Page 9 of 33

ITEM NO
000901

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600009

ITEM NO0010(b) (4)(b) (4)

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 10 StormChaser-Efficacy Results
FFP
MS 10 StormChaser-Efficacy Results in accordance with the terms of theagrement.
FOB: Destination
PSC CD: AN14

NET AMTAMOUNT(b) (4)(b) (4)

W911QY2190001
Page 10 of 33
ITEM NO
001001

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600010

ITEM NO0011(b) (4)

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 11 StormChaser-Completion
FFP
MS 11 StormChaser-Completion in accordance with the terms of the agreement.
FOB: Destination
PSC CD: AN14

NET AMTITEM NO
001101

SUPPLIES/SERVICESQUANTITY(b) (4)UNIT

UNIT PRICEAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600011(b) (4)(b) (4)

W911QY2190001
Page 11 of 33

ITEM NO
0012

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICEJob(b) (4)(b
MS 12 StormChaser-Mobile Units
COST
MS 12 StormChaser-Mobile Units in accordance with the terms of the agreement.
FOB: Destination
PSC CD: AN14
ESTIMATED COST

ITEM NO
001201

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)

Funding
COST
PURCHASE REQUEST NUMBER: 0011560606
ESTIMATED COST
ACRN AA
CIN: GFEBS001156060600012

ITEM NO0013(b) (4)(b) (4)

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 13 Mfg. Capability-Batch 1 Mfg
FFP
MS 13 Mfg. Capability-Batch 1 Mfg in accordance with the terms of theagreement.
FOB: Destination
PSC CD: AN14

NET AMTAMOUNT(b) (4)(b) (4)

W911QY2190001
Page 12 of 33
ITEM NO
001301

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600013

ITEM NO0014(b) (4)(b) (4)

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 14 Mfg. Capability-Batch 2 Mfg
FFP
MS 14 Mfg. Capability-Batch 2 Mfg in accordance with the terms of theagreement.
FOB: Destination
PSC CD: AN14

NET AMTAMOUNT(b) (4)(b) (4)

W911QY2190001
Page 13 of 33
ITEM NO
001401

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600014

ITEM NO0015(b) (4)(b) (4)

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 15 Mfg. Capability-Batch 3 Mfg
FFP
MS 15 Mfg. Capability-Batch 3 Mfg in accordance with the terms of theagreement.
FOB: Destination
PSC CD: AN14

NET AMTAMOUNT(b) (4)(b) (4)

W911QY2190001
Page 14 of 33
ITEM NO
001501

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600015

ITEM NO0016(b) (4)

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 16 Mfg. Capability-Batch 4 Mfg
FFP
MS 16 Mfg. Capability-Batch 4 Mfg in accordance with the terms of theagreement.
FOB: Destination
PSC CD: AN14

NET AMTITEM NO
001601

SUPPLIES/SERVICESQUANTITY(b) (4)UNIT

UNIT PRICEAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600016(b) (4)(b) (4)

W911QY2190001
Page 15 of 33

ITEM NO
0017

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 17 Mfg. Capability-Batch 5 Mfg.
FFP
MS 17 Mfg. Capability-Batch 5 Mfg in accordance with the terms of theagreement.
FOB: Destination
PSC CD: AN14

NET AMTITEM NO
001701

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600017(b) (4)(b) (4)

W911QY2190001
Page 16 of 33
ITEM NO
0018

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 18 Mfg. Capability-Batch 6 Mfg.
FFP
MS 18 Mfg. Capability-Batch 6 Mfg in accordance with the terms of theagreement.
FOB: Destination
PSC CD: AN14

NET AMTITEM NO
001801

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600018(b) (4)(b) (4)

W911QY2190001
Page 17 of 33
ITEM NO
0019

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 19 Mfg. Capability-Batch 7 Mfg
FFP
MS 19 Mfg. Capability-Batch 7 Mfg in accordance with the terms of theagreement.
FOB: Destination
PSC CD: AN14

NET AMTITEM NO
001901

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600019(b) (4)(b) (4)

W911QY2190001
Page 18 of 33
ITEM NO0020

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 20 Tech Transfer-(b) (4)FFP
MS 20 Tech Transfer - (b) (4)in accordance with the terms of theagreement.
FOB: Destination
PSC CD: AN14

NET AMTITEM NO002001

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)(b) (4)AMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600020

ITEM NO0021(b) (4)(b) (4)

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 21 Tech Transfer-(b) (4)FFP
MS 21 Tech Transfer - (b) (4)in accordance with the terms of theagreement.
FOB: Destination
PSC CD: AN14

NET AMTAMOUNT(b) (4)(b) (4)

W911QY2190001
Page 19 of 33

ITEM NO002101

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600021

ITEM NO0022(b) (4)(b) (4)

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 22 Tech Transfer-(b) (4)FFP
MS 22 Tech Transfer - (b) (4)in accordance with the terms of theagreement.
FOB: Destination
PSC CD: AN14

NET AMTAMOUNT(b) (4)(b) (4)

W911QY2190001
Page 20 of 33
ITEM NO002201

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600022

ITEM NO0023(b) (4)(b) (4)

SUPPLIES/SERVICESQUANTITY
UNIT
UNIT PRICE1
Each(b) (4)
MS 23 Tech Transfer-(b) (4)FFP
MS 23 Tech Transfer - (b) (4)in accordance with the terms of theagreement.
FOB: Destination
PSC CD: AN14

NET AMTAMOUNT(b) (4)(b) (4)

W911QY2190001
Page 21 of 33
ITEM NO002301

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600023

ITEM NO
0024

SUPPLIES/SERVICESQUANTITY
1(b) (4)(b) (4)UNIT
Each

UNIT PRICE(b) (4)AMOUNT(b) (4)

MS 24 Distribution Setup
FFP
MS 24 Distribution Ordering System Setup and Establishment in accordance withthe terms of the agreement.
FOB: Destination
PSC CD: AN14

NET AMT(b) (4)

W911QY2190001
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ITEM NO002401

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICEAMOUNT(b) (4)

Funding
FFP
PURCHASE REQUEST NUMBER: 0011560606

NET AMT
ACRN AA
CIN: GFEBS001156060600024

ITEM NO
0025

SUPPLIES/SERVICESQUANTITY(b) (4)(b) (4)

UNIT
Job

UNIT PRICEAMOUNT(b) (4)

MS 25 Distribution AZD 7422
COST
MS 25 Distribution AZD 7422 in accordance with the terms of the agreement.
FOB: Destination
PSC CD: AN14
ESTIMATED COST

ITEM NO002501

SUPPLIES/SERVICESQUANTITY

UNIT

UNIT PRICE(b) (4)AMOUNT(b) (4)

Funding
COST
PURCHASE REQUEST NUMBER: 0011560606
ESTIMATED COST
ACRN AA
CIN: GFEBS001156060600025(b) (4)(b) (4)

W911QY2190001
Page 23 of 33
Section E - Inspection and Acceptance

INSPECTION AND ACCEPTANCE TERMS
Supplies/services will be inspected/accepted at:
CLIN
0001
000101
0002
000201
0003
000301
0004
000401
0005
000501
0006
000601
0007
0007010008
000801
0009
0009010010
0010010011
0011010012
0012010013
0013010014
0014010015
0015010016
0016010017
0017010018
0018010019
0019010020
0020010021
0021010022
002201INSPECT AT
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A

INSPECT BY
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A

ACCEPT AT
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A
Destination
N/A

ACCEPT BY
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A
Government
N/A

W911QY2190001
Page 24 of 33
0023
0023010024
0024010025
002501

Destination
N/A
Destination
N/A
Destination
N/A

Government
N/A
Government
N/A
Government
N/A

Destination
N/A
Destination
N/A
Destination
N/A

Government
N/A
Government
N/A
Government
N/A

W911QY2190001
Page 25 of 33
Section F - Deliveries or Performance

DELIVERY INFORMATION
CLIN

DELIVERY DATE(b) (4)QUANTITYSHIP TO ADDRESS

0001

1

N/A
FOB: Destination

000101

N/A

N/A

0002

1

N/A
FOB: Destination

000201

N/A

N/A

0003

1

N/A
FOB: Destination

000301

N/A

N/A

0004

1

N/A
FOB: Destination

000401

N/A

N/A

0005

1

N/A
FOB: Destination

000501

N/A

N/A

0006

1

N/A
FOB: Destination

000601

N/A

N/A

0007

1

N/A
FOB: Destination

000701

N/A

N/A

0008

1

N/A
FOB: Destination

000801

N/A

N/A

0009

1

N/A
FOB: Destination

000901

N/A

N/A

DODAAC /
CAGE

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

N/A

W911QY2190001
Page 27 of 330021(b) (4)

1

N/A
FOB: Destination

002101

N/A

N/A

0022

1

N/A
FOB: Destination

002201

N/A

N/A

0023

1

N/A
FOB: Destination

002301

N/A

N/A

0024

1

N/A
FOB: Destination

002401

N/A

N/A

0025

002501

N/A

N/A

N/A

N/A

N/A
FOB: Destination
N/A

N/A

N/A

W911QY2190001
Page 28 of 33
Section G - Contract Administration Data

ACCOUNTING AND APPROPRIATION DATA
AA: 0212020202120400000664643255
COST CODE: A5XAHAMOUNT: (b) (4)S.0074658.5.23

6100.9000021001

ACRN

CLIN/SLINCINAMOUNTAA

000101000201000301000401000501000601000701000801000901001001001101001201001301001401001501001601001701001801001901002001002101002201002301002401002501

GFEBS001156060600001
GFEBS001156060600002
GFEBS001156060600003
GFEBS001156060600004
GFEBS001156060600005
GFEBS001156060600006
GFEBS001156060600007
GFEBS001156060600008
GFEBS001156060600009
GFEBS001156060600010
GFEBS001156060600011
GFEBS001156060600012
GFEBS001156060600013
GFEBS001156060600014
GFEBS001156060600015
GFEBS001156060600016
GFEBS001156060600017
GFEBS001156060600018
GFEBS001156060600019
GFEBS001156060600020
GFEBS001156060600021
GFEBS001156060600022
GFEBS001156060600023
GFEBS001156060600024
GFEBS001156060600025(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)

AGREEMENT ADMINISTRATION
A. In no event shall any understanding of agreement, modification, change order, or other matter in deviation fromthe terms and conditions of this agreement between the contractor and a person other than the Agreement Officer be
effective or binding upon the Government. All such actions must be formalized by a proper agreement document
executed by the Agreement Officer.
B. The telephone number and e-mail addresss of the Agreement Officer and Agreement Specialist are:Agreements Officer:(b) (6)

Telephone: (b) (6)E-mail: (b) (6)Agreement Specialist:(b) (6)

Telephone: (b) (6)E-mail: (b) (6)C. The telephone number and e-mail address of the Government Program Manager is:
Government Program Manager:(b) (6)

Telephone: (b) (6)W911QY2190001
Page 29 of 33
E-mail: (b) (6), (b) (4)ACCOUNTING AND APPROPRIATION DATA
AA: 0212020202120400000664643255
COST CODE: A5XAHAMOUNT: (b) (4)S.0074658.5.23

6100.9000021001

ACRN

CLIN/SLINCINAMOUNTAA

000101000201000301000401000501000601000701000801000901001001001101001201001301001401001501001601001701001801001901002001002101002201002301002401002501

GFEBS001156060600001
GFEBS001156060600002
GFEBS001156060600003
GFEBS001156060600004
GFEBS001156060600005
GFEBS001156060600006
GFEBS001156060600007
GFEBS001156060600008
GFEBS001156060600009
GFEBS001156060600010
GFEBS001156060600011
GFEBS001156060600012
GFEBS001156060600013
GFEBS001156060600014
GFEBS001156060600015
GFEBS001156060600016
GFEBS001156060600017
GFEBS001156060600018
GFEBS001156060600019
GFEBS001156060600020
GFEBS001156060600021
GFEBS001156060600022
GFEBS001156060600023
GFEBS001156060600024
GFEBS001156060600025(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)

CLAUSES INCORPORATED BY FULL TEXT

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.

W911QY2190001
Page 30 of 33“Payment request” and “receiving report” are defined in the clause at 252.232-7003, Electronic Submission ofPayment Requests and Receiving Reports.
(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.
____________________________________________________________(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.

W911QY2190001
Page 31 of 33(2) Fast Pay requests are only permitted when Federal Acquisition Regulation (FAR) 52.213-1 is included in thecontract.
[Note: The Contractor may use a WAWF “combo” document type to create some combinations of invoice andreceiving report in one step.](3) Document routing. The Contractor 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

W911QY

Admin DoDAAC**

W911QY

Inspect By DoDAAC

W56XNH

Ship To CodeW56XNH(*Contracting Officer: Insert applicable DoDAAC information. If multiple ship to/acceptance locations apply, insert“See Schedule” or “Not applicable.”)(**Contracting Officer: If the contract provides for progress payments or performance-based payments, insert the
DoDAAC for the contract administration office assigned the functions under FAR 42.302(a)(13).)(4) Payment request. The Contractor shall ensure a payment request includes documentation appropriate to the typeof payment request in accordance with the payment clause, contract financing clause, or Federal Acquisition
Regulation 52.216-7, Allowable Cost and Payment, as applicable.
(5) Receiving report. The Contractor shall ensure a receiving report meets the requirements of DFARS Appendix F.
(g) WAWF point of contact.
(1) The Contractor may obtain clarification regarding invoicing in WAWF from the following contracting activity’s
WAWF point of contact.
_________________________________________________________________(b) (6)(b) (6)

W911QY2190001
Page 32 of 33(b) (6)(2) Contact the WAWF helpdesk at 866-618-5988, if assistance is needed.
(End of clause)W911QY2190001
Page 33 of 33
Section I - Contract Clauses
CLAUSES INCORPORATED BY REFERENCE

52.232-22

Limitation Of Funds

APR 1984

W911QY2190001(rtotten21443)
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:
P00001" The purpose of this modification is to designate this agreement as an Health ResouSces Priority
Allocation (HRPAS) rated order (45 CFR 101) as approved by the Secretary of Health and Human
Services on 10 November 2020
# Block 1 of the agreement SF 26 is hereby revised to incorporate a DPAS rating of (b) (4) .
$ The Awardee is hereby authorized to effect this rating on all vendors necessary to support the
prototype development. Companies are required by law to accept rated orders and to provide
preferential scheduling even over previously accepted orders if necessary to meet requireddelivery date(s)% Article 19, paragraph M is hereby incorporated to add the following:B “This is a rated order certified for national defense, emergency preparedness, andenergy program use, and the Awardee shall follow all the requirements of the Defense
Priorities and Allocations System regulation (15 CFR 700).”& All other terms and conditions remain the same and in full force and effect.

SECTION A - SOLICITATION/CONTRACT FORM
The DPAS code (b)(4) 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

P00002

4. REQUISITION/PURCHASE REQ. NO.
0011560606

03-Dec-2020

6. ISSUED BY

CODE

3

5. P ROJECT NO.(If applicable)

W911QY

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 SOLICIT AT ION NO.

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)ASTRAZENECA PHARMACEUTICALS LP
1800 CONCORD PIKEWILMINGTON DE 19803-2902

9B. DATED (SEE IT EM 11)
MOD. OF CONTRACT/ORDER NO.
X 10A.
W911QY2190001

CODE

10B. DAT ED (SEE ITEM 13)
X 09-Oct-2020
FACILIT Y CODE
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICIT AT IONS

36WK2The 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 modification is to increase the value and funding of CL N 0004 by (b) (4), and decrease the value and fundingof CL N 0008 by (b) (4).

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
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
03-Dec-2020(Signature of Contracting Officer)
30-105-04

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

W911QY2190001
P00002
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:
P00002
A. The purpose of this modification is as follows:

1. CLIN 0004 is hereby increased by (b) (4)from (b) (4)to (b) (4)2. CLIN 00401, ACRN AA, is hereby increased by(b) (4)from (b) (4).
(b) (4)
3. CLIN 0008 is hereby decreased by (b) (4)from (b) (4)to (b) (4)4. CLIN 000801 is hereby decreased by (b) (4)from (b) (4)to.
(b) (4).
to.

B. As a result of the the changes indicated in paragraph A, the total value of this agreement remains unchanged.

C. The parties hereby agree that changes effected by this modification constitute both theconsideration and the equitable adjustment due under any clause of this agreement resulting
from the incorporation of the changes identified in paragraph A.
D. All other terms and conditions remain the same and in full force and effect.

SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0004
The unit price amount has increased by (b) (4)The total cost of this line item has increased by (b) (4)from (b) (4)from (b) (4)to (b) (4).
to (b) (4).

CLIN 0008
The unit price amount has decreased by (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)from (b) (4)to (b) (4).
to (b) (4).

SECTION F - DELIVERIES OR PERFORMANCE
The following Delivery Schedule item for CLIN 0001 has been changed from:
DELIVERY DATEQUANTITYSHIP TO ADDRESS

30-OCT-2020

1

N/A
FOB: Destination

DODAAC /CAGE

W911QY2190001
P00002
Page 3 of 3To:
DELIVERY DATE

30-OCT-2020

QUANTITYSHIP TO ADDRESS

N/A
FOB: Destination

SECTION G - CONTRACT ADMINISTRATION DATA
Accounting and Appropriation
Summary for the Payment Office
SUBCLIN 000401:
AA: 0212020202120400000664643255
S.0074658.5.23
6100.9000021001 A5XAH (CIN
GFEBS001156060600004) was increased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 000801:
AA: 0212020202120400000664643255
S.0074658.5.23
6100.9000021001 A5XAH (CIN
GFEBS001156060600008) was decreased by (b) (4)from (b) (4)to (b) (4)(End of Summary of Changes)

DODAAC /CAGE

1. CONTRACT ID CODEAMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

PAGE OF P AGES

1
2. AMENDMENT/MODIFICATION NO.

3. EFFECTIVE DATE

P00003

4. REQUISITION/PURCHASE REQ. NO.
0011560606

15-Jan-2021

6. ISSUED BY

CODE

6

5. P ROJECT NO.(If applicable)

W911QY

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 SOLICIT AT ION NO.

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)ASTRAZENECA PHARMACEUTICALS LP
1800 CONCORD PIKEWILMINGTON DE 19803-2902

9B. DATED (SEE IT EM 11)
MOD. OF CONTRACT/ORDER NO.
X 10A.
W911QY2190001

CODE

10B. DAT ED (SEE ITEM 13)
X 09-Oct-2020
FACILIT Y CODE
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICIT AT IONS

36WK2The 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 modification is to definitize costs by revising CL N and funding values, and incorporate Government Furnished Equipment
under Appendix D of the Agreement. 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
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
15-Jan-2021(Signature of Contracting Officer)
30-105-04

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

W911QY2190001
P00003
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:
P00003
A. The purpose of this modification is as follows.
1. Costs are hereby definitized based on the Governments cost share submitted under
spreadsheet “Cost_Proposal_Spreadsheet_AZD7422_response 07Dec20 v2” dated 4
December 2020.
2.

As a result, the total cost of this agreement is hereby reduced by (b) (4), to (b) (4).

, from(b) (4)

3.

The following CLINS are hereby revised to account for the change:
CLIN
0004
0005
0006
0008
0009
0010
0011
0012
0020
0021
0022
0023

4.

BY

FROM

TO

(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)

As a result of this modification, the total funded amount for this document was decreased byfrom (b) (4)to (b) (4).
Funding under the following CLINS is hereby revised to account for the definitization:(b) (4)

5.

CLIN
0004
0005
0006
0008
0009
0010
0011
0012
0020
0021
0022
0023

BY

FROM
(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)(b) (4)TO

W911QY2190001
P00003
Page 3 of 6

6.

Government Furnished Equipment is hereby added to Appendix D of the agreement, under
Attachment 1 to this modification.

7.

The terms of the cost share for StormChaser costs are hereby revised to (b) (4)with no changes to the Awardee’s contribution. (b) (4)B. The parties hereby agree that changes effected by this modification constitute both the consideration and theequitable adjustment due under any clause of this agreement resulting from the incorporation of the changes
identified in paragraph A.

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 decreased by (b) (4)from (b) (4)to (b) (4)CLIN 0004
The unit price amount has decreased by (b) (4)from (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4).
to (b) (4).

SECTION B - SUPPLIES OR SERVICES AND PRICES.

CLIN 0005
The unit price amount has increased by (b) (4)The total cost of this line item has increased by (b) (4)from (b) (4)from (b) (4)to (b) (4).
to (b) (4).

CLIN 0006
The unit price amount has increased by (b) (4)The total cost of this line item has increased by (b) (4)from (b) (4)from (b) (4)to (b) (4).
to (b) (4).

CLIN 0008
The unit price amount has decreased by (b) (4)from (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4).
to (b) (4)CLIN 0009
The unit price amount has decreased by (b) (4)The total cost of this line item has decreased by (b) (4)to (b) (4).
to (b) (4)from (b) (4)from (b) (4).

.

W911QY2190001
P00003
Page 4 of 6

CLIN 0010
The unit price amount has decreased by (b) (4)from (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4).
to (b) (4).

CLIN 0011
The unit price amount has decreased by (b) (4)from (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4).
to (b) (4).

CLIN 0012
The estimated/max cost has increased by (b) (4)The total cost of this line item has increased by (b) (4)from (b) (4)from (b) (4)to (b) (4)to (b) (4)CLIN 0020
The unit price amount has decreased by (b) (4)from (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4).
to (b) (4)CLIN 0021
The unit price amount has decreased by (b) (4)from (b) (4)to (b) (4).
The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4)CLIN 0022
The unit price amount has decreased by (b) (4)from (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)

.
.

.

.

to (b) (4).
to (b) (4)CLIN 0023
The unit price amount has decreased by (b) (4)from (b) (4)to (b) (4).
The total cost of this line item has decreased by (b) (4)from (b) (4)to (b) (4).

.

SECTION F - DELIVERIES OR PERFORMANCE
The following Delivery Schedule item for CLIN 0005 has been changed from:
DELIVERY DATEQUANTITYSHIP TO ADDRESS

30-NOV-2020

1

N/A
FOB: Destination

DODAAC /CAGE

W911QY2190001
P00003
Page 6 of 6
GFEBS001156060600008) was decreased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 000901:
AA: 0212020202120400000664643255
S.0074658.5.23
6100.9000021001 A5XAH (CIN
GFEBS001156060600009) was decreased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 001001:
AA: 0212020202120400000664643255
S.0074658.5.23
6100.9000021001 A5XAH (CIN
GFEBS001156060600010) was decreased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 001101:
AA: 0212020202120400000664643255
S.0074658.5.23
6100.9000021001 A5XAH (CIN
GFEBS001156060600011) was decreased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 001201:
AA: 0212020202120400000664643255
S.0074658.5.23
6100.9000021001 A5XAH (CIN
GFEBS001156060600012) was increased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 002001:
AA: 0212020202120400000664643255
S.0074658.5.23
GFEBS001156060600020) was decreased by (b) (4)from (b) (4)6100.9000021001 A5XAH (CIN
to (b) (4)SUBCLIN 002101:
AA: 0212020202120400000664643255
S.0074658.5.23
6100.9000021001 A5XAH (CIN
GFEBS001156060600021) was decreased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 002201:
AA: 0212020202120400000664643255
S.0074658.5.23
6100.9000021001 A5XAH (CIN
GFEBS001156060600022) was decreased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 002301:
AA: 0212020202120400000664643255
S.0074658.5.23
6100.9000021001 A5XAH (CIN
GFEBS001156060600023) was decreased by (b) (4)from (b) (4)to (b) (4)(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

P00005

4. REQUISITION/PURCHASE REQ. NO.
0011560606

15-Mar-2021

6. ISSUED BY

CODE

4

5. P ROJECT NO.(If applicable)

W911QY

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 SOLICIT AT ION NO.

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code)ASTRAZENECA PHARMACEUTICALS LP
1800 CONCORD PIKEWILMINGTON DE 19803-2902

9B. DATED (SEE IT EM 11)
MOD. OF CONTRACT/ORDER NO.
X 10A.
W911QY2190001

CODE

10B. DAT ED (SEE ITEM 13)
X 09-Oct-2020
FACILIT Y CODE
11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICIT AT IONS

36WK2The 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 Artricle 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 modification is to revise costs and funding under CL Ns 0009 - 0011, and revise Article 4 and 6 of the Agreement. Alllother 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)/ CONTRACT SPECIALIST(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
15-Mar-2021(Signature of Contracting Officer)
30-105-04

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

W911QY2190001
P00005
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:
P00004

A. The purpose of this modification is as follows.
1. In accordance with Appendix B of the Agreement, the costs for CLINs 0009 –0011 are hereby reduced to incorporate a (b) (4)to the Stormchaser
Trial based on the Government’s cost share identified in modification P00003
as follows:
Stormchaser
CLIN
BY
0009 (b) (4)0010 (b) (4)0011 (b) (4)
Total

FROM

TO

(b) (4)

2. As a result, the total cost of this agreement is hereby reduced by, from (b) (4), to (b) (4).
(b) (4)
3. Funding under the following CLINS is hereby reduced based on paragraph
A.1 as follows:
Stormchaser
CLIN
BY
000901 (b) (4)001001 (b) (4)001101 (b) (4)
Total

FROM

TO

(b) (4)

4. As a result, the total funding of this agreement is hereby reduced by, from (b) (4), to (b) (4).
(b) (4)
5. Article 4 of the agreement is hereby revised to replace the Agreements Officer
and Agreements Specialist with the following:W911QY2190001
P00005
Page 3 of 4
Government Representatives:
Agreements Officer (AO)(b) (6), (b) (4)ACC-APG-Fort Detrick
110 Thomas Johnson Dr.
Frederick, MD 21702(b) (6), (b) (4)Other Transaction Agreement Specialist (OTAS)(b) (6), (b) (4)ACC-APG-Fort Detrick
110 Thomas Johnson Dr.
Frederick, MD 21702(b) (6), (b) (4)6. Article 6, paragraph B, is hereby revised to add the following:“Title and Physical Risk of Loss. Title to the product will transfer to theGovernment when the product leaves the Awardee’s facility for shipment to
the distributor(s). Risk of Loss will be retained by the Awardee until the
product is delivered to the administering hospitals and other designatedhealthcare providers (“Providers”) by Distributor, at which time title and riskof loss and damages then passes from Government and Awardee respectively,
immediately to the Provider.”B. The parties hereby agree that changes effected by this modification constitute both theconsideration and the equitable adjustment due under any clause of this agreement
resulting from the incorporation of the changes identified in paragraph A.
C. 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 decreased by (b) (4).

from (b) (4)to

SECTION B - SUPPLIES OR SERVICES AND PRICES

CLIN 0009
The unit price amount has decreased by (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)from (b) (4)to (b) (4).
to (b) (4).

W911QY2190001
P00005
Page 4 of 4

CLIN 0010
The unit price amount has decreased by (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)from (b) (4)to (b) (4).
to (b) (4).

CLIN 0011
The unit price amount has decreased by (b) (4)The total cost of this line item has decreased by (b) (4)from (b) (4)from (b) (4)to (b) (4).
to (b) (4).

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 decreased by (b) (4)from (b) (4)to (b) (4).
SUBCLIN 000901:
AA: 0212020202120400000664643255
S.0074658.5.23
6100.9000021001 A5XAH (CIN
GFEBS001156060600009) was decreased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 001001:
AA: 0212020202120400000664643255
S.0074658.5.23
6100.9000021001 A5XAH (CIN
GFEBS001156060600010) was decreased by (b) (4)from (b) (4)to (b) (4)SUBCLIN 001101:
AA: 0212020202120400000664643255
S.0074658.5.23
6100.9000021001 A5XAH (CIN
GFEBS001156060600011) was decreased by (b) (4)from (b) (4)to (b) (4)(End of Summary of Changes)