Document:

Exhibit 10.1

 

	
AWARD/CONTRACT

	
1.  this contract is a rated order

under dpas  (15 cfr 700)

		
rating  

		
page of pages

	
	1	48

	
2.  contract (Proc. Inst. Indent.) no.

HHS0100201800019C

	
3.  effective date

See Block 20C

	
4.  requisition/purchase/project no.

     OS227460

	
5.  issued by

	code	
HHS/OS/ASPR/BARDA

	
6.  administered by (If other than Item 5)                   

	code	
ASPR-BARDA01

	
 

US DEPT OF HEALTH & HUMAN SERVICES

ASST SEC OF PREPAREDNESS & RESPONSE

ACQ MANAGEMENT, CONTRACTS, & GRANTS

O’NEILL HOUSE OFFICE BUILDING

Washington  DC  20515

	
 

ASPR-BARDA

330 Independence Ave, SW, Rm G644

Washington  DC  20201

 

	
7.  name and address of contractor (No., street, county, State and ZIP Code)

 

SIGA TECHNOLOGIES, INC.  1385150

SIGA TECHNOLOGIES, INC.

31 East 62nd street

NEW YORK  NY  100658446

	
8.  delivery

	 	 
	
☐  fob origin

	
☒  other  (See below)

	 	 
	
9.  discount for prompt payment

	 
	 
	 
	 	
10.  submit invoices

(4 copies unless otherwise specified)

to the address shown in

		
item

	
code   1385150

	
facility code

	
11.  ship to/mark for                            

	
code

	HHS	
12.  payment will be made up by

	
code

	
PSC

	 	 	 	 	 
	
HHS

	 	 	
PSC

	 
	200 Independence Avenue, SW	 	 	 	 
	Washingyon DC 20201	 	 	 	 
	
13.  authority for using other than full and open competition

	
14.  accounting and appropriation data

	 
	
☐ 10 U.S.C. 2304  (c) (                   )

	
☐ 41U.S.C. 253 (c) (                      )

	
2018.199TWNP.26402

	 

	
15a.  item no

	
15b.  supplies/services

	
15c.  quantity

	
15d.  unit

	
15e.  unit price

	
15f.  amount

	 	
 

 

Continued

	 	 	 	 

	
15g.  total amount of contract

	 	
$51,641,805.00

	
16.  table of contents

	
(x)

	
sec.

	
description

	
page(s)

	
(x)

	
sec.

	
description

	
page(s)

	 	
part i – the schedule

	 	
part ii – contract clauses

	 	
a

	
solicitation/contract form

	 	
x

	
i

	
contract clauses

	
43

	
x

	
b

	
supplies or services and prices/costs

	
2

	 	
part iii – list of documents, exhibits and other attach.

	
x

	
c

	
description/specs/work statement

	
11

	
x

	
j

	
list of attachments

	
47

	
x

	
d

	
packaging and marking

	
13

	 	
part iv – representations and instructions

	
x

	
e

	
inspection and acceptance

	
14

	
x

	
k

	
representations, certifications and other statements of offerors

	
48

	
x

	
f

	
deliveries or performance

	
16

	
x

	
g

	
contract administration data

	
24

	 	
l

	
instrs., conds. and notices to offerors

	 
	
x

	
h

	
special contract requirements

	
29

	 	
m

	
evaluation factors for award

	 

	
contracting officer will complete item 17 (sealed-bid or negotiated procurement) or 18 (sealed-bid procurement) as applicable

	
17.  ☒ contractor’s negotiated agreement (Contractor is required to sign this document  and return  1  copies to issuing office.)  Contractor agrees to furnish and deliver all items or perform all the services set forth or otherwise identified above and on any continuation sheets for the consideration stated herein.  The rights and obligations of the parties to this contract shall be subject to and governed by the following documents:  (a) this award/contract, (b) the solicitation, if any, and (c) such provisions, representations, certifications, and specifications, as are attached or incorporated by reference herein.  (Attachments are listed herein.)

	
18. ☒ sealed-bid award (Contractor is not required to sign this document.) Your  bid on Solicitation Number                            18-100-SOL-00011                , including the additions or changes made by you which additions or changes are set forth in full above, is hereby accepted as to the items listed above and on any continuation sheets. This award consummates the contract which consists of the following documents:  (a) the Government's solicitation and your bid, and (b) this award/contract.  No further contractual document is necessary. (Block 18 should be checked only when awarding a sealed-bid contract.)

	
19a.  name and title of signer (Type or print.)

Phillip L. Gomez, III, CEO

	
20a.  name of contracting officer

BROOKE T. BERNOLD

	
19b.  name of contractor

 

 

by /s/ Phillip L. Gomez, III

(Signature of person authorized to sign.)

	
19c.  date signed

 

10 Sept 2018

	
20b.  united states of america

 

 

by  /s/ Brooke T. Bernold

(Signature of the Contracting Officer.)

	
20c.  date signed

 

10 Sept 2018

 

PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

	ARTICLE B.1.	
BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

This contract covers the purchase and delivery of at least one antiviral against smallpox disease as caused by the smallpox virus. SIGA will provide up to 1.7 million treatment courses of the antiviral(s) against smallpox.

Medical countermeasures (MCM) against smallpox are urgently needed should a future outbreak of this disease occur; while smallpox was declared eradicated by the WHO in 1980, advances in genetic engineering, the possibility of clandestine stocks in addition to the WHO-sanctioned smallpox repositories in the Russian Federation and in the United States make the possibility of an outbreak or an intentional release of smallpox a present threat. The 2016 Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Strategy and Implementation Plan identifies smallpox virus as a high-priority threat as determined by the Secretary of Homeland Security. Strategies to mitigate the threat of smallpox include the development and stockpiling of vaccines for the general population as well as the development of therapeutic antivirals to treat symptomatic cases of smallpox. BARDA is seeking an antiviral therapeutic(s) that can be safely and effectively used for the U.S. civilian population in individuals with symptomatic orthopoxvirus (e.g. smallpox) infections.

The United States Government (USG) desires an antiviral product which can be available both in a parenteral and nonparenteral (e.g. IV and oral dosing formulations) to be stored in the Centers for Disease Control and Prevention (CDC) Strategic National Stockpile (SNS), or stored as vendor-managed inventory (VMI), that can meet the PHEMCE product requirements for therapeutic MCMs for smallpox. This notice seeks candidate antivirals which are available both in a parenteral and nonparenteral formulation, which have efficacy data in at least two animal models accepted by the FDA for evaluation of smallpox countermeasures as a result of the Antiviral Drugs Advisory Committee meeting (Dec 14-15, 2011 – e.g. rabbitpox and monkeypox), and data demonstrating the candidate antiviral is safe and well tolerated in human subjects. Under this RFP, BARDA plans to support the procurement of smallpox antiviral(s), which will either be delivered to the SNS or maintained as VMI, using Project BioShield (PBS) funds. PBS fund will also support the necessary late-stage development to complete the regulatory pathway for approval of the product(s) being procured (if applicable) and/or efforts related to post-marketing commitments.

The contract will also support the necessary late-stage development to achieve approval of the alternative formulation of the product(s) being procured.

Under the base period-of-performance, SIGA will complete remaining development activities necessary to achieve licensure of the antiviral and manufacture and deliver antiviral product. The contract options may be exercised to perform additional studies necessary for licensure, support post-licensure commitments as required by the FDA, and procure additional antiviral regimens.

The Research and Development (R&D) effort will progress in specific stages that cover the base performance segment and options, if necessary, as specified in this contract. The period of performance for the base period is 60 months. The period of performance for the base period and all options shall not exceed 10 years.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

2

	ARTICLE B.2.	
BASE PERIOD

 

	
Base Period Cost Reimbursement CLIN

	
CLIN

	
Period of 

Performance

	
Supplies/Services

	
Estimated 

Cost

	
Fixed Fee

	
Cost + Fixed Fee 

(CPFF)

	
0001 (Base)

	
[redacted]*

	
Late stage development activities towards FDA approval for a parenteral (IV) antiviral

	
[redacted]*

	
[redacted]*

	
32,009,375

 

	
Base Period Fixed Price CLINs

	
CLIN

	
Period of

Performance

	
Supplies/Services

	
Treatment

Courses (#

of Product)

	
Unit Price

($)

	
Total ($)

	
0002 (Base)

	
[redacted]*

	
Initial purchase and delivery of a nonparenteral (oral) formulated antiviral as final drug product (FDP) to SNS.

	
35,718

	
[redacted]*

	
$11,072,580

	
0003 (Base)

	
[redacted]*

	
Initial procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS)

*course = 14 vials

	
20,000

	
[redacted]*

	
$3,200,000

	
0004 (Base)

	
[redacted]*

	
Fill/finish of final drug product (from bulk drug substance procured under CLIN0003).

	
20,000

	
[redacted]*

	
4,800,000

	
0005 (Base)

	
[redacted]*

	
Storage of final drug product in VMI for 5 years (from bulk drug substance procured under CLIN0003).

*Monthly rate/TC = [redacted]*

	
20,000

	
[redacted]*

	
[redacted]*

	
0006 (Base)

	
[redacted]*

	
Delivery of FDP to the SNS

(from bulk drug substance

 procured under CLIN0003)

	
20,000

	
[redacted]*

	
[redacted]*

 

	
ARTICLE B.3.

	
OPTION PRICES

 

	
Optional Cost Reimbursement CLINs

	
CLIN

	
Period of

Performance

	
Supplies/ Services

	
Total Est.

Cost

	
Fixed Fee

	
Total Cost Plus

Fixed Fee ($)

	
0007 (Option)

	
[redacted]*

	
Phase IV post marketing commitments (nonparenteral (oral) formulation) including [redacted]*

	
[redacted]*

	
[redacted]*

	
$40,812,609

	
0008 (Option)

	
[redacted]*

	
Phase IV post marketing commitments (parenteral (IV) formulation) including [redacted]*

	
[redacted]*

	
[redacted]*

	
$3,586,806

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

3

	
Optional Fixed Price CLINs

	
CLIN

	
Period of

Performance

	
Supplies/Services

	
Treatment

Courses (#

of Product)

	
Unit Price

($)

	
Total ($)

	
0009

(Option)

	
[redacted]*

 

	
Additional procurement of

nonparenteral (oral)

formulated antiviral as FDP and delivery to the SNS

	
363,070

	
[redacted]*

	
$112,551,700

	
0010

(Option)

	
[redacted]*

 

	
Additional procurement of

nonparenteral (oral)

formulated antiviral as FDP and delivery to the SNS

	
363,070

	
[redacted]*

	
$112,551,700

	
0011 (Option)

	
[redacted]*

	
Additional procurement of a nonparenteral (oral)

formulated antiviral as FDP and delivery to the SNS

	
363,070

	
[redacted]*

	
$112,551,700

	
0012

(Option)

	
[redacted]*

 

	
Additional procurement of

nonparenteral (oral)

formulated antiviral as FDP and delivery to the SNS

	
363,072

	
[redacted]*

	
$112,552,320

	
0013

(Option)

	
[redacted]*

 

	
Surge Capacity – Additional

procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS)

*course = 14 vials

	
64,000

	
[redacted]*

	
$10,240,000

	
0014

(Option)

	
[redacted]*

 

	
Surge Capacity – Storage of

parenteral (IV) formulated antiviral as bulk drug substance

(BDS) in VMI for 5 years (from bulk drug substance procured under CLIN0013).

*Monthly rate per TC = [redacted]*

	
64,000

	
[redacted]*

	
[redacted]*

	
0015

(Option)

	
[redacted]*

 

	
Surge Capacity –Fill/finish of

final drug product (from bulk drug substance procured under

CLIN0013)

	
64,000

	
[redacted]*

	
$15,360,000

	
0016

(Option)

	
[redacted]*

 

	
Surge Capacity – Storage of

final drug product in VMI for 5 years (from bulk drug substance procured under

CLIN0013).

*Monthly rate per TC = [redacted]*

	
64,000

	
[redacted]*

	
[redacted]*

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

4

	
0017

(Option)

	
[redacted]*

 

	
Surge Capacity – Delivery of

FDP to the SNS (from bulk drug substance procured under

CLIN0013)

*[redacted]*

	
64,000

	
[redacted]*

	
[redacted]*

	
0018

(Option)

	
[redacted]*

 

	
Surge Capacity – Additional

procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS)

*course = 14 vials

	
64,000

	
[redacted]*

	
$10,240,000

	
0019

(Option)

	
[redacted]*

 

	
Surge Capacity – Storage of

parenteral (IV) formulated antiviral as bulk drug substance

(BDS) in VMI for 5 years (from bulk drug substance procured under CLIN0018).

*Monthly rate per TC = [redacted]*

	
64,000

	
[redacted]*

	
[redacted]*

	
0020 (Option)

	
[redacted]*

 

	
Surge Capacity –Fill/finish of final drug product from bulk drug substance procured under CLIN0018).

	
64,000

	
[redacted]*

	
$15,360,000

	
0021 (Option)

	
[redacted]*

 

	
Surge Capacity – Storage of final drug product in VMI for 5 years (from bulk drug substance procured under CLIN0018).

*Monthly rate per TC: [redacted]*

	
64,000

	
[redacted]*

	
[redacted]*

	
0022

(Option)

	
[redacted]*

 

	
Surge Capacity – Delivery of

FDP to the SNS (from bulk drug substance procured under

CLIN0018).

[redacted]*

	
64,000

	
[redacted]*

	
[redacted]*

	
0023

(Option)

	
[redacted]*

 

	
Surge Capacity – Additional

procurement of parenteral (IV) formulated antiviral as bulk drug substance (BDS)

*course = 14 vials

	
64,000

	
[redacted]*

	
$10,240,000

	
0024

(Option)

	
[redacted]*

 

	
Surge Capacity – Storage of

parenteral (IV) formulated antiviral as bulk drug substance

(BDS) in VMI for 5 years (from bulk drug substance procured under CLIN0023).

*Monthly rate per TC = [redacted]*

	
64,000

	
[redacted]*

	
[redacted]*

	
0025

(Option)

	
[redacted]*

 

	
Surge Capacity –Fill/finish of

final drug product (from bulk drug substance procured under

CLIN0023).

	
64,000

	
[redacted]*

	
$15,360,000

	
0026

(Option)

	
[redacted]*

 

	
Surge Capacity – Storage of

final drug product in VMI for 5 years (from bulk drug substance procured under

CLIN0023).

*Monthly rate per TC: [redacted]*

	
64,000

	
[redacted]*

	
[redacted]*

	
0027

(Option)

	
[redacted]*

 

	
Surge Capacity – Delivery of

FDP to the SNS (from bulk drug substance procured under

CLIN0023).

*[redacted]*

	
64,000

	
[redacted]*

	
[redacted]*

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

5

	ARTICLE B.4.	
PROVISIONS TO APPLICABLE COSTS

This section prohibits or restricts the use of contract funds which includes the following items (costs unallowable unless otherwise approved by the Contracting Officer):

		a)	
Acquisition, by purchase or lease, of any interest in real property;

		b)	
Rearrangement or alteration of facilities;

		c)	
Purchase of lease of any item of general purpose office furniture or office equipment regardless of dollar value (General purpose equipment is defined as any items of personal property which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);

		d)	
Accountable Government Property (defined as both real and personal property with an acquisition cost of $1,000 or more and a life expectancy of more than two years) and “sensitive items” (defined as items of personal property, supplies and equipment that are highly desirable and easily converted to personal use), regardless of acquisition value;

		e)	
Overtime

		f)	
General scientific meetings/conferences;

		g)	
Travel costs including domestic/foreign travel;

		h)	
Costs incurred in the performance of any cost-reimbursement type subcontract (including consulting agreements);

		i)	
Costs to be paid for the performance of a fixed-price subcontract that exceeds $150,000.00;

		j)	
Patient care costs

		k)	
Refreshments and Meal Expenditures - Requests to use contract funds to provide light refreshments and/or meals to either federal or nonfederal employees must be submitted to the Contracting Officer’s Representative (COR), with a copy to the Contracting Officer, at least six (6) weeks in advance of the event and are subject to “HHS Policy on Promoting Efficient Spending: Use of Appropriate Funding for Conferences and Meeting, Food and Promotional Items and Printing and Publications.” The request shall contain the following information: (a) name, date, and location of the event at which the light refreshments and/or meals will be provided; (b) a brief description of the purpose of the event; (c) a cost breakdown of the estimated light refreshments and/or meals costs; (d) the number of nonfederal and federal attendees receiving light refreshments and/or meals; and (e) if the event will be held at a government facility;

		l)	
Promotional Items

		m)	
Printing (as defined in the Government Printing and Binding Regulations).

This article does not apply to the contract’s Fixed Price CLINs.

	ARTICLE B.5.	
ADVANCE UNDERSTANDINGS

		a.	
Subcontracts and Consultants

Award of any FFP subcontract or FFP consulting agreement in excess of $150,000 or any cost reimbursement subcontract or consulting agreement shall not proceed without the prior written consent of the Contracting Officer via a Contracting Officer Authorization (COA) Letter. COA letters will only be issued upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract and consulting agreement shall be provided to the Contracting Officer within thirty (30) calendar days of full execution. This section does not apply to the contract’s Fixed Price CLINs.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

6

		b.	
Site Visits, Inspections and General Audits

At the discretion of the USG and independent of activities conducted by the Contractor, with five (5) business days’ notice to the Contractor, the USG reserves the right to conduct site visits and inspections on an as needed basis, including collection of product samples and intermediates held by the Contractor, or subcontractor. In case of subcontractor visits and inspections that are independent of activities conducted by the Contractor, the USG shall demonstrate cause for such visit and/or inspection. All costs reasonably incurred by the Contractor and subcontractor for such visit and/or inspection shall be allowable costs. The Contractor shall coordinate these visits and shall have the opportunity to accompany the USG on any such visits. Under time-sensitive or critical situations, the USG reserves the right to suspend the five (5) business days’ notice to the Contractor.

If the Government, Contractor, or other party identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to the Government for review and acceptance.

		·	
If issues are identified during the audit, Contractor shall submit an issue report to the CO and COR within 10 business days detailing the finding and corrective action(s) of the audit.

		·	
COR and CO will review the issues report and provide a response to the Contractor within 10 business days.

		·	
Once corrective action is completed, the Contractor will provide a final report to the CO and COR within a time frame negotiated with the COR in writing after review of the issues report.

		c.	
QA Audits

BARDA reserves the right to participate in QA audits of the Contractor’s Subcontractor(s) in direct performance of this contract. BARDA reserves the right to conduct audits of the Prime Contractor’s facilities. Upon completion of the QA audit the Contractor shall provide a report capturing the findings, results, and next steps in proceeding with any potential subcontractors. If action is requested for a subcontractor, detailed corrective and preventative plans for addressing areas of non-conformance to ICH and FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to the COR for review and acceptance. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.

		·	
Contractor shall notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of bi-weekly communications.

		·	
Contractor shall notify the COR and CO within 5 business days of report completion. The Contractor shall complete the report within 60 days of the audit/site visit, or as negotiated with the COR in writing dependent upon the audit findings.

		d.	
Man-in-Plant

At the discretion of the Government and seven calendar (7) days advance notice to the Contractor in writing from the Contracting Officer, the Government may place a man-in-plant in the Contractor’s facility for the sole purpose of monitoring activities directly related to the performance of this contract during normal business hours, who shall be subject to the Contractor’s policies and procedures regarding security, facility access, and training at all times while in the Contractor’s facility. As determined by federal law, no Government representative shall publish, divulge, disclose, or make known in any manner, or to any extent not authorized by law, any information coming to him in the course of employment or official duties, while stationed in a contractor plant.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

7

		e.	
Sharing of contract deliverables within United States Government (USG)

In an effort to build a robust medical countermeasure pipeline through increased collaboration, BARDA may share technical deliverables with USG entities responsible for Medical Countermeasure Development. In accordance with recommendations from the Public Health Emergency Medical Countermeasure Enterprise Review, agreements established in the Integrated Portfolio’s Portfolio Advisory Committee (PAC) Charter, and agreements between BARDA and the Department of Defense and the National Institutes of Health, BARDA may share technical deliverables and data created in the performance of this contract with colleagues within the Integrated Portfolio. This advance understanding does not authorize BARDA to share financial information outside HHS. The Contractor is advised to review the terms of FAR 52.227-14, Rights in Data – General, regarding the Government’s rights to deliverables submitted during performance as well as the Government’s rights to data contained within those deliverables.

		f.	
Overtime Compensation

No overtime (premium) compensation is authorized under the subject contract.

		g.	
Contract Number Designation

On all correspondence submitted under this contract, the Contractor agrees to clearly identify the contract number that appears on the face page of the contract as follows:

HHSO100201800019C

		h.	
Quality Agreement

The Quality Agreement shall define, establish, and document the responsibilities of both the Contractor and the USG (i.e. – CDC/SNS-Quality Control and BARDA) for event-driven and product shipping, receiving, acceptance into the inventory and/or custody by the USG. Quality Agreement documents shall be drafted, approved, and signed by all parties prior to the commencement of product procurement, shipment, and acceptance (whether it is shipped to the CDC/SNS or maintained as VMI). The Contractor shall provide documentation and resolution for all concerns raised by USG and commits to cooperation in execution of this agreement. The parties expressly agree that the Government will not request Contractor to, nor will it distribute or relocate any Drug Product or final packaged Drug Product from the Contractor or Subcontractor's facility(ies) which has not been fully released by Contractor. A COA will be required prior to invoicing against procurement CLINs.

		i.	
CAS Compliance

Pursuant to 48 CFR 9903.202-1 and FAR Part 30, SIGA shall submit a CAS Disclosure Statement to the Contracting Officer no later than 90 days after contract award. SIGA shall submit monthly progress reports detailing their progress in becoming CAS compliant. If SIGA is unable to comply with the requirement to be CAS complaint within 90 days after award, the contract may be terminated for default.

		j.	
Risk of Loss

Subject to the provisions in FAR 52.249-8, Default (Fixed-Price Supply and Service), SIGA will retain the physical risk of loss until product is accepted at the SNS. Prior to delivery to the SNS, Contractor in its capacity as a storage provider will have physical risk of loss for such product during the period of storage.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

10

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

	ARTICLE C.1.	
STATEMENT OF OBJECTIVES

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Objectives dated [redacted]* set forth in SECTION J - List of Attachments, attached hereto and made a part of the contract.

	ARTICLE C.2.	
REPORTING REQUIREMENTS

See Section F for specific reporting requirements.

Performance of the contract will be monitored by the CO/COR on a regular basis. The Contracting Officer will be responsible for inspection and acceptance of deliverables and services. Monitoring of the contract will be based on periodic reporting by the Contractor.

All reports required herein shall be submitted in electronic format. All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post-consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

	ARTICLE C.3.	
MEETINGS/SITE VISITS

The Contractor and BARDA/AMCG shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the Contracting Officer (CO)/Contracting Officer’s Representative (COR). Such meetings may include, but are not limited to, a kickoff meeting to be held at a location determined by the COR, status update meetings and/or teleconferences, site visits to the Contractor’s and/or subcontractor’s facilities, and meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The Contractor shall provide data, reports, and presentations to groups of outside experts and USG personnel and USG-contracted subject matter experts as required by the CO/COR facilitating review of activities.

The purpose of the kickoff meeting will be to orient the Contractor to HHS/BARDA and review contract requirements. This meeting usually occurs within a month after contract award.

Bi-weekly or monthly status update meetings/teleconferences shall be scheduled and established by the between the Contracting Officer’s Representative (COR), the Contractor’s Project Leaders/delegates and Contracting Officer (CO). During this meeting the Contractor’s Project Leaders/delegates and designees will discuss the activities since the last call, any problems that have arisen and the activities planned until the next call takes place. The Contractor’s Project Leaders/delegates may choose to include other key personnel on the conference call to give detailed updates on specific projects or this may be requested by the Contracting Officer’s Representative.

The Contractor shall participate in Project Meetings to coordinate the performance of the contract, as requested by the Contracting Officer’s Representative. These meetings may include face-to-face meetings with AMCG and BARDA in Washington, D.C. and at work sites of the Contractor. Such meetings may include, but are not limited to, meetings of the Contractor to discuss study designs, site visits to the Contractor’s facilities, and meetings with the Contractor and HHS officials to discuss the technical, regulatory, and ethical aspects of the program. Subject to the data rights provisions in this contract, the Contractor will provide data, reports, and presentations to groups of outside experts and USG personnel as required by the Contracting Officer and Contracting Officer’s Representative in order to facilitate review of contract activities.

Periodic site visits shall occur on an ad hoc basis (At least twice a year).

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

11

Within thirty (30) calendar days of an FDA audit of Contractor or subcontractor facilities, the Contractor shall provide copies of the audit findings, final report, and a plan for addressing areas of nonconformance to FDA regulations and guidance for GLP, GMP or GCP guidelines as identified in the final audit report.

Other U.S. Government Audits

The USG reserves the right to conduct an audit of the Contractor with 48 hours advance notice. The USG reserves the right to accompany the Contractor on routine and for-cause site-visits/audits of subcontractor(s). At the discretion of the USG and independent of testing conducted by the Contractor, BARDA reserves the right to conduct site visits/audits and collect samples of product held by the Contractor and subcontractors.

Pre-award site visits may be made with short notice. Contractors are expected to guarantee the availability of key staff or other staff determined by the Government as essential for purposes of this site visit.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

12

SECTION D – PACKAGING, MARKING AND SHIPPING

	ARTICLE D.1.	
METHOD OF DELIVERY

Unless otherwise specified by the Contracting Officer, all deliverable items to be furnished to the Government under this contract (including invoices) shall be made by first class mail, overnight carrier, or email as described in SECTION F.3.

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the date, contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

	ARTICLE D.2.	
FOB DESTINATION DELIVERIES

The Contractor shall describe the storage conditions for each product, specifically noting the acceptable temperature range required to maintain product quality. The Contractor shall be responsible for maintaining product temperature control until the product(s) arrives at the SNS and has completed product acceptance by the USG. The Contractor shall provide the Government with an ambient exposure letter that covers the time the product(s) leaves the Contractor’s validated storage facility until arrival at DSNS. Upon Government acceptance of the product(s) to the Government, the responsibility for temperature control shall transfer to the Government as well as the responsibility for logging ambient exposure time (temperatures between 8-25°C). The Contractor will provide and place TempTale(s) on each pallet of product while the product is inside the Contractor’s validated storage facility prior to placing the product(s) onto the truck(s) of the designated carrier. The Government’s acceptance of the aforementioned responsibility applies only to temperature control and does not indicate its acceptance of the lot(s).

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

13

SECTION E – INSPECTION AND ACCEPTANCE

	ARTICLE E.1.	
INSPECTION AND ACCEPTANCE

The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided under this contract.

For the purpose of this SECTION E, the designated Contracting Officer’s Representative (COR) is the authorized representative of the Contracting Officer. The COR will assist in resolving technical issues that arise during performance. The COR however is not authorized to change any contract terms or authorize any changes in the Statement of Work or modify or extend the period of performance, or authorize reimbursement of any costs incurred during performance. The Contractor is advised to review FAR 52.243-1 Changes – Fixed Price Contracts Alternate V and FAR 52.243-2 Changes-Cost reimbursement contracts Alternative V, which is incorporated by reference into this contract in ARTICLE I.1.

Inspection and acceptance of reports will be performed at:

[redacted]*

Technical inspection and acceptance will be take place at:

[redacted]*

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duty authorized representative within 30 days of receipt.

Inspection and acceptance of batch records and analytical reports in accordance with the Quality Agreement noted in B.5.h may make physical inspection at the Contractor’s or subcontractor’s facilities unnecessary. Inspection and acceptance of other physical items will be performed at the Contractor’s or a subcontractor’s facilities as required by the Government.

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

	ARTICLE E.2.	
FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE

The contract incorporates the following clause by reference with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR 52.246-2, Inspection of Supplies – Fixed Price (August 1996)

FAR 52.246-4, Inspection of Services - Fixed Price (August 1996)

FAR 52.246-5, Inspection of Services - Cost-Reimbursement (April 1984)

FAR 52.246-8, Inspection of Research and Development – Cost-reimbursement (May 2001)

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

14

FAR 52.246-9, Inspection of Research and Development (Short Form) (April 1984)

FAR 52.246-16, Responsibility for Supplies (April 1984)

 

15

SECTION F – DELIVERIES OR PERFORMANCE

	ARTICLE F.1.	
PERIOD OF PERFORMANCE

The base period of performance of this contract shall be for sixty (60) months from the date of award. The period of performance may be extended up to an additional 5 years (10 years in total for the base plus option periods) with the exercise of option(s), structured as CLINs, as set forth in SECTION B. The period of performance for the base period of this contract shall be consistent with the dates set forth in SECTION B. If the Government exercises option(s), the period of performance will be extended as described under in SECTION B of this contract.

	ARTICLE F.2.	
DELIVERIES

Successful performance of the final contract shall be deemed to occur upon performance of the work described in SECTION C of this RFP and upon delivery and acceptance of the items described in SECTION F.3 by the Contracting Officer or their duly authorized representative.

	ARTICLE F.3.	
CONTRACT DELIVERABLES AND REPORTING REQUIREMENTS

	ARTICLE F.3.1.	
Submission of Contract Deliverables

Documents shall be delivered electronically via email to the Contracting Officer (CO) and the Contracting Officer’s Representative (COR). When electronic deliverables are not preferable by the Contracting Officer, all deliverables and reports furnished to the Government under any potential resultant contract (including invoices) shall be addressed as follows:

	 	
UPS/FedEx/Courier

	 	
USPS Mail Packages

	 	
[redacted]*

	 	
[redacted]*

	 	
UPS/FedEx/Courier

	 	
USPS Mail Packages

	 	
[redacted]*

	 	
[redacted]*

	ARTICLE F.3.2.	
REPORTING REQUIREMENTS

In all cases the reports are intended to provide sufficient detail to understand the Contractor's approach and progress to addressing the technical requirements. The reports supplement, and do NOT replace, routine (i.e. daily) communication between the COR and project manager and/or their designee(s) regarding project plans and progress. These reports shall be subject to the technical inspection and requests for clarification by the COR, and approval by the CO/COR. These reports shall be brief, factual, and prepared in accordance with the following format:

This report shall include a description of the activities during the reporting period and the activities planned for the ensuing reporting period. The first reporting period consists of the first full month of performance plus any fractional part of the initial month. Thereafter, the reporting period shall consist of each calendar month.

The Contractor shall submit a Monthly Progress Report on or before the 15th calendar day following the last day of each reporting period and shall include the following:

Title Page: The title page for this report shall include the contract number and title; the type of report and period that it covers; the Contractor's name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

16

Progress:

SECTION I - An introduction covering the purpose and scope of the contract effort.

SECTION II Part A: SUMMARY - A description or table summarizing ongoing activities.

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE – This section shall include a description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating and managing subcontractor performance and personnel changes). Please include all Quality Management System, Quality Control, and Quality Assurance Plans as part of this report or as requested by the COR.

SECTION II Part C: TECHNICAL PROGRESS – This section shall document the results of work completed and costs incurred during the period covered in relation to the proposed progress, effort, and budget. The report shall be in sufficient detail to explain comprehensively the results achieved.

SECTION II Part D: ISSUES – This section shall include a description of problems encountered and proposed corrective action; differences between planned and actual progress; why the differences have occurred and what corrective actions are planned; and if a project activity is delinquent, then what corrective action steps are planned. Revised timelines shall be provided.

SECTION II Part E: PROPOSED WORK – This section shall include a summary of work proposed as a rolling three (3) month forecast for the next reporting period, by a certain date, and by whom.

SECTION II Part F: MANUFACTURING AND SUPPLY CHAIN MANAGEMENT – This section shall include a summary of the manufacturing and supply-chain related activities. Also include in this section updates to the production plan, capacity projections, stability results, inventory and shipment/distribution information.

SECTION II Part G: CONTRACTING OFFICER APPROVALS – This section shall include a table indicating each Contracting Officer Approval (COA) request, its current status (e.g. date submitted, date approved, date returned), amount requested, and the vendor for which the COA authorizes subcontracted work to be performed.

Invoices: Summary of any invoices submitted during the reporting period.

A Monthly Progress Report will not be required in the same month Annual Progress Reports or a Final Report are due.

		A.	
Annual Progress Report

This report shall include a summation of the activities during the reporting period, and the activities planned for the ensuing reporting period. The first reporting period consists of the first full year of performance plus any fractional part of the initial year. Thereafter, the reporting period shall consist of each calendar year.

The Contractor shall submit an Annual Progress Report on or before the 30th calendar day following the last day of each reporting period and shall include the following:

Title Page: The title page for this report shall include the contract number and title; the type of report and period that it covers; the Contractor's name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

17

Progress:

SECTION I - An introduction covering the purpose and scope of the contract effort.

SECTION II Part A: SUMMARY - A description or table summarizing ongoing activities.

SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE – This section shall include a description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating and managing subcontractor performance and personnel changes). Please include all Quality Management System, Quality Control, and Quality Assurance Plans as part of this report or as requested by the COR.

SECTION II Part C: TECHNICAL PROGRESS – This section shall document the results of work completed and costs incurred during the period covered in relation to proposed progress, effort, and budget. The report shall be in sufficient detail to explain comprehensively the results achieved.

SECTION II Part D: ISSUES – This section shall include a description of problems encountered and proposed corrective action; differences between planned and actual progress; why the differences have occurred and what corrective actions are planned; and if a project activity is delinquent, then what corrective action steps are planned. Revised timelines shall be provided.

SECTION II Part E: PROPOSED WORK – This section shall include a summary of work proposed as a rolling three (3) month forecast for the next reporting period, by a certain date, and by whom.

SECTION II Part F: MANUFACTURING AND SUPPLY CHAIN MANAGEMENT – This section shall include a summary of the manufacturing and supply-chain related activities. Also include in this section updates to the production plan, capacity projections, stability results, inventory and shipment/distribution information.

SECTION II Part G: CONTRACTING OFFICER APPROVALS – This section shall include a table indicating each Contracting Officer Approval (COA) request, its current status (e.g. date submitted, date approved, date returned), amount requested, and the vendor for which the COA authorizes subcontracted work to be performed.

Invoices: Summary of any invoices submitted during the reporting period.

An Annual Progress Report will not be required for the period when the Final Technical Progress Report is due.

		B.	
Draft Final Report and Final Report

These reports are to include a summation of the work performed and results obtained for execution of various studies or technical work packages during the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Draft Final Progress Report shall be due forty-five (45) calendar days prior to the expiration date of the contract and the Final Progress Report is due no later than 30 days following the expiration date of the contract. The report shall conform to the following format:

Title Page: The title for these reports shall include the contract number and title; the type of report and period that it covers; the Contractor's name, address, telephone number, fax number, and e-mail address; and the date of submission.

Distribution List: A list of individuals receiving the Technical Progress report.

Progress:

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

18

SECTION I: EXECUTIVE SUMMARY - Summarize the purpose and scope of the contract effort including a summary of the major accomplishments relative to the specific activities set forth in the Statement of Work.

SECTION II: RESULTS - A detailed description of the work performed and the results obtained including all expenses for the entire contract period of performance.

		D.	
FDA Regulatory Agency Correspondence, Meeting Summaries, and Submissions.

		a)	
Within five business days of any formal meeting with the FDA or other regulatory agency, the Contractor shall forward the initial draft minutes to the COR. The Contractor shall forward the final minutes when available.

		b)	
Within five business days of any informal meeting with the FDA or other regulatory agency, the Contractor shall forward the initial draft minutes to the COR. The Contractor shall forward the final minutes when available and if applicable.

		c)	
The Contractor shall forward the dates and times of any meeting with the FDA and other regulatory agencies to the COR as soon as the meeting times are known and make arrangements for appropriate BARDA staff to attend the meetings.

		d)	
The Contractor shall provide the COR the opportunity to review and comment upon any documents to be submitted to the FDA or other regulatory agency. The Contractor shall provide the COR with five (5) business days in which to review and provide comments back to the Contractor prior to the Contractor’s submission to the FDA.

		e)	
The Contractor shall forward Standard Operating Procedures (SOPs) upon request from the COR.

		f)	
The Contractor shall provide raw data and/or specific analysis of data generated with USG funds upon request from the COR.

		g)	
The Contractor shall notify the Contracting Officer’s Representative and Contracting Officer within 24 hours of all FDA arrivals to conduct site visits/audits by any regulatory agency. The Contractor shall provide the USG with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR). The Contractor shall provide the Contracting Officer’s Representative and Contracting Officer copies of the plan for addressing areas of non-conformance to FDA regulations for GLP guidelines as identified in the audit report, status updates during the plans execution, and a copy of all final responses to the FDA. The Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. The redactions shall be limited to issues that are unrelated to the subcontractor’s performance on any award made under this RFP. The Contractor shall make arrangements with the COR for the appropriate BARDA representative(s) to be present during the final debrief by the regulatory inspector.

		E.	
Other Requirements/Deliverables

		a)	
Integrated Master Project Plan

[redacted]*

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

19

		1.	
Technology Packages

Technology packages developed under the contract that includes complete protocols must be submitted at the request of the Contracting Officer’s Representative. See FAR clauses 52.227-11, Patent Rights-Ownership by the Contractor, and 52.227-14, Rights in Data. This report shall be due upon request from the COR.

		2.	
Experimental Protocols

The Contractor shall submit to the COR all study/experiment/test plans, designs, and protocols prior to execution for approval or upon request by the COR when required.

		3.	
Annual/Final Invention Report

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor, including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification. An Annual Invention Report shall be due on or before the 30th calendar day after the completion of each reporting period. A Final Invention Report (see FAR 27.303 (b)(2)(ii)) shall be due on or before the expiration date of the contract. If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer.

		4.	
Publications

Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted to COR for review prior to submission. Reports shall be due within 30 calendar days for manuscripts and 15 calendar days for abstracts.

		5.	
Press Releases

The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. The Contractor shall ensure the Contracting Officer has received and approved an advanced copy of any press release not less than five (5) business days prior to the issuance of any potential press release.

		6.	
Security Report

The Contractor shall report to the government any activity; or incident that is in violation of established security standards; or indicates the loss or theft of government products. Reports shall be due within 24 hours after occurrence of an activity or incident.

		7.	
Security Plan

Please see attachments 15 and 16 for security requirements and a template for the Security Plan.

		8.	
Quality Management System Plan

The Contractor shall submit to the COR a Quality Management System Plan for approval no later than 60 days from the date of award.

		9.	
Manufacturing Plan

The Contractor shall submit to the COR a comprehensive manufacturing plan for review and approval no later than 60 days from the date of award.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

20

	
ARTICLE F.3.3.

	
DELIVERABLE SCHEDULE

 

Successful performance of the final contract shall be deemed to occur upon performance of the work set forth in the Statement of Work dated [redacted]*, set forth in SECTION J - List of Attachments of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule below:

 

	 	
Item

No.

	 	
Description

	 	
Addresses

	 	
Deliverable Schedule

	 	 	 	 	 	 	 	 
	 	
1

	 	
Bi-Weekly Meetings and Meeting Minutes

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Meeting minutes are due no later than five business days following each meeting.

	 	 	 	 	 	 	 	 
	 	
2

	 	
Monthly Progress Report

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Reports are due on or before the 15th of each month following the end of each reporting period.

	 	 	 	 	 	 	 	 
	 	
3

	 	
Annual Progress Report

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Reports are due on or before the 30th calendar day following the end of each reporting period.

	 	 	 	 	 	 	 	 
	 	
4

	 	
Draft Final Progress Report

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Report is due 45 Calendar days prior to the expiration date of the contract.

	 	 	 	 	 	 	 	 
	 	
5

	 	
Final Progress Report

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Report is due no later than 30 calendar days after the expiration date of the contract.

	 	 	 	 	 	 	 	 
	 	
6

	 	
FDA/ Regulatory Agency Correspondence and Meeting Summaries

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Reports are due within 5 business days of each meeting for Contractor’s minutes, upon receipt of minutes from FDA/ regulatory agency, and upon request from the COR.

	 	 	 	 	 	 	 	 
	 	
7

	 	
Integrated Master Project Plan -Critical Path Milestones - Work Breakdown Structure - Risk Mitigation Plan/Matrix

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Report is due within 90 days of contract award. Updates are due as requested by the COR.

	 	 	 	 	 	 	 	 
	 	
8

	 	
Technology Packages

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Upon request from the COR.

	 	 	 	 	 	 	 	 

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

21

	 	
9

	 	
Experimental Protocols

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Upon request from the COR.

	 	 	 	 	 	 	 	 
	 	
10

	 	
Annual/Final Invention Report

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
An Annual Invention Report is due on or before the 30th calendar day after the completion of each reporting period. A Final Invention Report is due on or before the expiration date of the contract.

	 	 	 	 	 	 	 	 
	 	
11

	 	
Publications

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Reports are due within 30 calendar days for manuscripts and 15 calendar days for abstracts.

	 	 	 	 	 	 	 	 
	 	
12

	 	
Press Releases

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Reports/Notices are due for approval to the CO not less than five (5) business days prior to the issuance of any potential press release.

	 	 	 	 	 	 	 	 
	 	
13

	 	
Security Report

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Reports are due within 24 hours after occurrence of an activity or incident.

	 	 	 	 	 	 	 	 
	 	
14

	 	
Security Plan

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Final plan due within 30 days of contract award.

	 	 	 	 	 	 	 	 
	 	
15

	 	
Manufacturing Plan

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Due within 60 days of contract award.

	 	 	 	 	 	 	 	 
	 	
16

	 	
Delivery Schedule

	 	
CO: (1) electronic copy

 

COR: (1) electronic copy

	 	
Due within 30 days of contract award

	 	 	 	 	 	 	 	 

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

22

	ARTICLE F.4.	
FEDERAL ACQUISITION REGULATION CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. The full text of each clause may be accessed electronically at this address: http://www.acquisition.gov/far.

FAR 52.242-15, Stop-Work Order (August 1989)

FAR 52.242-15, Stop-Work Order, Alternate 1 (April 1984)

FAR 52.246-7, Inspection of Research and Development – Fixed Price (August 1996)

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

23

SECTION G – CONTRACT ADMINISTRATION

	ARTICLE G.1.	
CONTRACTING OFFICER

The following Contracting Officer (CO) will represent the Government for the purpose of this contract:

[redacted]*

The Contracting Officer is the only individual who can legally commit and bind the Government to the expenditure of public funds. No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions or other stipulations of this contract. Any other commitment, either explicit or implied, is invalid.

The CO is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of objectives; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; (5) obligate or de-obligate funds into the contract; (6) sign written licensing agreements; or (7) otherwise change any terms and conditions of this contract.

No information, other than that which may be contained in an authorized modification to this contract duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract.

The Government may unilaterally change its CO designation.

	ARTICLE G.2	
CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

[redacted]*

The COR is responsible for:

		a.	
Monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

		b.	
Assisting the Contracting Officer in interpreting the statement of work and any other technical performance requirements;

		c.	
Performing technical evaluation as required;

		d.	
Performing technical inspections and assisting the Contracting Officer in acceptances of deliverables required by this contract;

		e.	
Assisting in the resolution of technical problems encountered during performance;

		f.	
The Government may unilaterally change its COR designation(s).

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

24

	ARTICLE G.3.	
KEY CONTRACTOR’S POINTS OF CONTACT

The Contractor shall provide primary and secondary points of contact that will be available 24 hours per day, 7 days per week, to be notified in case of a public health emergency.

	ARTICLE G.4.	
KEY PERSONNEL

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor shall notify the Contracting Officer and shall submit a justification for the diversion or replacement and a request to replace the individual. The request must identify the proposed replacement and provide an explanation of how the replacement's skills, experience, and credentials meet or exceed the requirements of the contract (including, when applicable, Human Subjects Testing requirements). If the employee of the contractor is terminated for cause or separates from the contractor voluntarily with less than thirty (30) days’ notice, the Contractor shall provide the maximum notice practicable under the circumstances. The Contractor shall not divert, replace, or announce any such change to key personnel without the written consent of the Contracting Officer. The contract will be modified to add or delete key personnel as necessary to reflect the agreement of the parties.

The following individual(s) is/are considered to be essential to the work being performed hereunder:

	
Name

	
Title

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	
[redacted]*

	ARTICLE G.5.	
INVOICE SUBMISSION

		(a)	
The Contractor shall submit an electronic copy of contract monthly invoices/financial reports to the Contracting Officer as defined above, in ARTICLE G of this contract.

		(b)	
Contractor invoices/financial reports shall conform to the form, format, and content requirements of the instructions for Invoice/Financing requests made a part of the contract at Section J, Attachments 2 & 3.

		(c)	
Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.

		(d)	
The Contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the estimated costs for the base period or any options (See estimated costs under Articles B.2 and B.3) and the reasons for the variance. Also refer to the requirements of FAR Clause 52.232-20, Limitation of Cost.

		(e)	
The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed below in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

25

		(f)	
All invoice submissions shall be in accordance with FAR Clause 52.232-25, Prompt Payment.

		(g)	
The Contractor may not invoice for any CLIN prior to delivery and acceptance of services.

		(h)	
Invoices shall submit invoices electronically to the Contracting Officer (CO), the Contracting Specialist (CS), the Contracting Officer’s Representative (COR), PSC (PSC_Invoices@psc.hhs.gov, and e-Room electronically. Unless otherwise specified by the Contracting Officer, all deliverables, invoices, and reports furnished to the Government under the resultant contract shall be addressed as follows:

	
[redacted]*

 

	
[redacted]*

 

	
[redacted]*

 

	
[redacted]*

 

	ARTICLE G.6.	
INDIRECT COST RATES

The following [redacted]* rates will be utilized for billing purposes during the period of performance:

G&A: [redacted]*%

Overhead: [redacted]*%

Fringe: [redacted]*%

[redacted]*

	ARTICLE G.7.	
PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (DECEMBER 2013)

		(a)	
Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

		(b)	
The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

		(c)	
Include the substance of this clause; include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

26

	ARTICLE G.8.	
REIMBURSEMENT OF COST

The Government shall reimburse the Contractor those costs determined by the Contracting Officer to be allowable (hereinafter referred to as allowable cost) in accordance with FAR 52.216-7, Allowable Cost and Payment and FAR Subpart 31.2.

	ARTICLE G.9.	
CONTRACT COMMUNICATIONS/CORRESPONDENCE

The Contractor shall identify all correspondence, reports, and other data pertinent to this contract by imprinting thereon the contract number HHSO100201800019C from Page 1 of the contract.

	
ARTICLE G.10.

	
POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

		(a)	
Purpose: In accordance with FAR Subpart 42.15, the Contractor’s performance will be periodically evaluated by the government in order to provide current information for current and future source selection purposes. These evaluations will therefore be marked “Source Selection Information.”

		(b)	
Performance Evaluation Period: The Contractor’s performance will be evaluated at least annually.

		(c)	
Evaluators: The performance evaluation will be completed jointly by the Contracting Officer’s Representative and the Contracting Officer.

		(d)	
Performance Evaluation Factors: The Contractor's performance will be evaluated in accordance with FAR Subpart 42.15 and Attachment #5, Contract Performance Evaluation Report. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) will be prepared Annually as to coincide with the Anniversary date of the contract.

		(e)	
Contractor Review: A copy of the evaluation will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor shall submit comments, rebutting statements, or additional information to the Contracting Officer within 30 calendar days after receipt of the evaluation.

		(f)	
Resolving Disagreements between the Government and the Contractor: Disagreements between the parties regarding the evaluation will be reviewed at a level above the Contracting Officer. The ultimate conclusion on the performance evaluation is a decision of the contracting agency.  Copies of the evaluation, Contractor's response, and review comments, if any, will be retained as part of the evaluation.

		(g)	
Release of Contractor Performance Evaluation Information: The completed evaluation will not be released to other than Government personnel and the Contractor whose performance is being evaluated. Disclosure of such information could cause harm both to the commercial interest of the Government and to the competitive position of the Contractor being evaluated, as well as impede the efficiency of Government operations.

		(h)	
Source Selection Information: Departments and agencies may share past performance information with other Government departments and agencies when requested to support future award decisions. The information may be provided through interview and/or by sending the evaluation and comment document to the requesting source selection official.

		(i)	
Retention Period: The agency will retain past performance information for a maximum period of 3 years after completion of contract performance for the purpose of providing source selection information for future contract awards.

		(j)	
Electronic Access to Contractor Performance Evaluations: Contractors may access evaluations through a secure website for review and comment at the following: http://cpars.gov

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

27

	
ARTICLE G.11.

	
GOVERNMENT PROPERTY

		(a)	
In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall comply with the provisions of HHS Publication, "Contractor's Guide for Control of Government Property," which is incorporated into this contract by reference. This document can be accessed at:

http://www.hhs.gov/hhsmanuals/  (HHS Logistics Management Manual)

Among other issues, this publication provides a summary of the Contractor's responsibilities regarding purchasing authorizations and inventory and reporting requirements under the contract.

		(b)	
Notwithstanding the provisions outlined in the HHS Publication, "Contractor's Guide for Control of Government Property," which is incorporated in this contract in paragraph 1 above, the Contractor shall use the form entitled, "Report of Government Owned, Contractor Held Property" for submitting summary reports required under this contract, as directed by the Contracting Officer or his/her designee. This form is included as an attachment in SECTION J of this contract.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

28

SECTION H – SPECIAL CONTRACT REQUIREMENTS

The Contractor is responsible for following the requirements below in conducting its own work under this Contract. The Contractor also is responsible for incorporating these provisions into any subcontract awarded, if applicable to the specific nature of the work in the subcontract. Accordingly, those provisions shall be flowed-down as applicable.

	ARTICLE H.1.	
PROTECTION OF HUMAN SUBJECTS

		(a)	
Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor's current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.

		(b)	
The Contractor shall bear full responsibility for the performance of all work and services involving the use of human subjects under this contract and shall ensure that work is conducted in accordance with the protocol(s) approved by either the IRB or IEC. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. The Contractor shall not deem anything in this contract to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.

		(c)	
Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors’ FWA via designation as agents of the institution or via individual investigator agreements (see OHRP website at: http://www.hhs.gov/ohrp/policy/guidanceonalternativetofwa.pdf).

		(d)	
If at any time during the performance of this contract, the Contracting Officer determines, in consultation with OHRP that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those Contractors with approved Human Subject Assurances.

	ARTICLE H.2.	
CLINICAL RESEARCH

These Clinical Terms apply to all grants and contracts that involve clinical research.

The Government shall have unlimited rights to all protocols, data generated from the execution of these protocols, and final reports, funded by the Government under this contract, as defined in Rights in Data Clause in FAR 52.227-14. The Government reserves the right to request that the Contractor provide any contract deliverable in a non-proprietary form, to ensure the Government has the ability to review and distribute the deliverables, as the Government deems necessary.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

29

	
ARTICLE H.2.1.

	
Safety and Monitoring Issues

Institutional Review Board (IRB) or Independent Ethics Committee (IEC) Approval

Before award and then with Annual Progress Reports, the Contractor shall submit to the Government a copy of the current IRB or IEC approved informed consent document, documentation of continuing review and approval and the Office of Human Research Protections (OHRP) FWA number for the institution or site.

If other institutions are involved in the research (e.g., a multicenter clinical trial or study), each institution's IRB or IEC must review and approve the protocol. They must also provide the Government initial and annual documentation of continuing review and approval, including the current approved informed consent document and FWA number.

The grantee institution must ensure that the applications as well as all protocols are reviewed by their IRB or IEC.

To help ensure the safety of participants enrolled in BARDA-funded studies, the Contractor must provide the Government a summary explanation and copies of documents related to all major changes in the status of ongoing protocols, including the following:

		1.	
All amendments or changes to the protocol, identified by protocol version number, date, or both and date it is valid.

		2.	
All changes in informed consent documents, identified by version number, date, or both and dates it is valid.

		3.	
Termination or temporary suspension of patient accrual.

		4.	
Termination or temporary suspension of the protocol.

		5.	
Any change in IRB approval.

		6.	
Any other problems or issues that could affect the participants in the studies.

Contractors must notify BARDA through the Contracting Officer’s Representative (COR) and Contracting Officer (CO) of any of the above changes within 24 hours by email, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IRB and a copy of any responses from the IRB or IEC.

If a clinical protocol has been reviewed by an Institutional Bio-safety Committee (IBC) or the NIH Recombinant DNA Advisory Committee (RAC), the Contractor must provide information about the initial and ongoing review and approval, if any. See the NIH Guidelines for Research Involving Recombinant DNA Molecules.

	
ARTICLE H.2.2.

	
Data and Safety Monitoring Requirements

The Contractor may be required to conduct independent safety monitoring for clinical trials of investigational drugs, devices, or biologics; clinical trials of licensed products; and clinical research of any type involving more than minimal risk to volunteers. Independent monitoring can take a variety of forms. Phase III clinical trials must have an assigned independent data and safety monitoring board (DSMB); other trials may require DSMB oversight as well. The Contractor shall inform the Government of any upcoming site visits and/or audits of Contractor facilities funded under this effort. BARDA reserves the right to accompany the Contractor on site visits and/or audits of Contractors and Subcontractors as the Government deems necessary.

The type of monitoring to be used shall be mutually agreed upon between the Contractor and the Government before enrollment starts. Discussions with the responsible COR regarding appropriate safety monitoring and approval of the final monitoring plan by BARDA must occur before patient enrollment begins and may include discussions about the appointment of one of the following:

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

30

		1.	
Independent Safety Monitor – a physician or other appropriate expert who is independent of the study and available in real time to review and recommend appropriate action regarding adverse events and other safety issues.

		2.	
Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC) – a small group of independent investigators and biostatisticians who review data from a particular study.

		3.	
Data and Safety Monitoring Board – an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination. The Contractor may be required to use an established BARDA DSMB or to organize an independent DSMB. All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) for Oversight of Clinical Trials Policy. The Government retains the right to place a nonvoting member on the DSMB.

When a monitor or monitoring board is organized, a description of it, its charter or operating procedures (including a proposed meeting schedule and plan for review of adverse events), and roster and curriculum vitae from all members must be submitted to and approved by the Government before enrollment starts.

Additionally, the Contractor must submit written summaries of all reviews conducted by the monitoring group to the Government within 30 days of reviews or meetings.

	H.2.3.	
BARDA Protocol Review Process Before Patient Enrollment Begins

BARDA has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in BARDA-supported clinical trials. Therefore, before patient accrual or participant enrollment, the Contractor must provide the following (as applicable) for review and approval by the Government:

		1.	
IRB or IEC approved clinical research protocol identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility, and exclusion criteria;

		2.	
Documentation of IRB or IEC approval, including OHRP FWA number, IRB or IEC registration number, and IRB or IEC name;

		3.	
IRB or IEC approved informed consent document, identified by version number, date, or both and date it is valid;

		4.	
Plans for the management of side effects;

		5.	
Procedures for assessing and reporting adverse events;

		6.	
Plans for data and safety monitoring (see B above) and monitoring of the clinical study site, pharmacy, and laboratory;

		7.	
Documentation that the Contractor and all study staff responsible for the design or conduct of the research have received Good Clinical Practice (GCP) training in the protection of human subjects.

BARDA comments will be forwarded to the Contractor within two weeks (10 business days) of receipt of the above information. The Contractor must address in writing all study design, safety, regulatory, ethical, and conflict of interest concerns raised by the COR to the satisfaction of the Government before patient accrual or participant enrollment can begin. After the Government receives the corrected documentation, a written Contracting Officer Authorization (COA) letter may be provided to the Contractor. This COA provides authorization to the Contractor to execute the specific clinical study funded in part or in whole by the Government.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

31

	
ARTICLE H.2.4.

	
Required Time-Sensitive Notification

Under an IND or IDE, the sponsor must provide FDA safety reports of serious adverse events. Under these Clinical Terms of Award, the Contractor must submit copies to the responsible Contracting Officer's representative (COR) as follows:

		1.	
Expedited safety report of unexpected or life-threatening experience or death – A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer's Representative within 24 hours of FDA notification.

		2.	
Expedited safety reports of serious and unexpected adverse experiences – A copy of any report of unexpected and serious adverse experience associated with use of an IND drug or any finding from tests in laboratory animals that suggests a significant risk for human subjects, which must be reported in writing to FDA as soon as possible but no later than 15 calendar days after the IND sponsor’s receipt of the information, must be submitted to the Contracting Officer’s Representative within 24 hours of FDA notification.

		3.	
IDE reports of unanticipated adverse device effect – A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to the Contracting Officer’s Representative within 24 hours of FDA notification.

		4.	
Expedited safety reports – shall be sent to the COR concurrently with the report to FDA.

		5.	
Other adverse events documented during the course of the trial shall be included in the annual IND or IDE report and reported to the COR annually.

In case of problems or issues, the COR will contact the Contractor within 10 working days by email, followed within 7 calendar days by an official letter to the Contractor. The Contractor shall forward the official letter to the principal investigator listing issues and appropriate actions to be discussed.

Safety reporting for research not performed under an IND or IDE

Ongoing safety reporting requirements for research not performed under an IND or IDE shall be mutually agreed upon by the Contracting Officer’s Representative and the Contractor.

	ARTICLE H.3.	
HUMAN MATERIALS

The acquisition and supply of all human specimen material (including fetal material) used under this contract shall be obtained by the Contractor in full compliance with applicable State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

	ARTICLE H.4.	
NEEDLE EXCHANGE

The Contractor shall not use contract funds to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

32

	ARTICLE H.5.	
ACKNOWLEDGEMENT OF FEDERAL FUNDING

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by nongovernmental sources.

	ARTICLE H.6.	
RESTRICTIONS ON ABORTIONS

The Contractor shall not use funds for any abortion.

	ARTICLE H.7.	
GUN CONTROL

The Contractor shall not use contract funds in whole or in part, to advocate or promote gun control.

	ARTICLE H.8.	
CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

The Contractor shall not use contract funds for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.204(b) and Section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)). The term "human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

Additionally, in accordance with the March 4, 1997 Presidential Memorandum entitled “Prohibition on Federal Funding for Cloning of Human Beings”, federal funds may not be used for cloning of human beings.

	ARTICLE H.9.	
DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

	ARTICLE H.10.	
CARE OF LIVE VERTEBRATE ANIMALS

(a)    Before undertaking performance of any contract involving animal-related activities where the species is regulated by the United Sates Department of Agriculture (USDA), the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

(b)    The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR 2.1 2.11, or from a source that is exempt from licensing under those sections.

(c)    The Contractor agrees that the care, use, and intended use of any live vertebrate animals in the performance of this contract shall conform with the Public Health Service (PHS) Policy on Humane Care of Use of Laboratory Animals (PHS Policy), the current Animal Welfare Assurance (Assurance), the Guide for the Care and Use of Laboratory Animals (National Academy Press, Washington, DC) and the pertinent laws and regulations of the United States Department of Agriculture (see 7 U.S.C. 2131 et seq. and 9 CFR subchapter A, Parts 1-4). In case of conflict between standards, the more stringent standard shall govern.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

33

(d)    If at any time during performance of this contract, the Contracting Officer determines, in consultation with the Office of Laboratory Animal Welfare (OLAW), National Institutes of Health (NIH), that the Contractor is not in compliance with any of the requirements and standards stated in paragraphs (a) through (c) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. Notice of the suspension may be communicated by telephone and confirmed in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with Animal Welfare Assurances.

Note: The Contractor may request registration of its facility and a current listing of licensed dealers from the Regional Office of the Animal and Plant Health Inspection Service (APHIS), USDA, for the region in which its research facility is located. The location of the appropriate APHIS Regional Office, as well as information concerning this program may be obtained by contacting the Animal Care Staff, USDA/APHIS, 4700 River Road, Riverdale, Maryland 20737 (Email: ace@aphis.usda.gov; Web site: (http://www.aphis.usda.gov/wps/portal/aphis/ourfocus/animalwelfare).

	
ARTICLE H.11.

	
ANIMAL WELFARE

All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals (PHS Policy). The PHS Policy can be accessed at: http://grants1.nih.gov/grants/olaw/references/phspol.htm.

	
ARTICLE H.12.

	
PAPERWORK REDUCTION ACT

		(a)	
This contract involves a requirement to collect or record information calling either for answers to identical questions from 10 or more persons other than Federal employees, or information from Federal employees which is outside the scope of their employment, for use by the Federal government or disclosure to third parties; therefore, the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.) shall apply to this contract. No plan, questionnaire, interview guide or other similar device for collecting information (whether repetitive or single time) may be used without the Office of Management and Budget (OMB) first providing clearance. Contractors and the Contracting Officer's Representative shall be guided by the provisions of 5 CFR part 1320, Controlling Paperwork Burdens on the Public, and seek the advice of the HHS operating division or Office of the Secretary Reports Clearance Officer to determine the procedures for acquiring OMB clearance.

		(b)	
The Contractor shall not expend any funds or begin any data collection until the Contracting Officer provides the Contractor with written notification authorizing the expenditure of funds and the collection of data. The Contractor shall allow at least 120 days for OMB clearance. The Contracting Officer will consider excessive delays caused by the Government which arise out of causes beyond the control and without the fault or negligence of the Contractor in accordance with the Excusable Delays or Default clause of this contract.

	
ARTICLE H.13.

	
RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

The Contractor shall not use contract funds to maintain or establish a computer network unless such network blocks the viewing, downloading, and exchanging of pornography.

	
ARTICLE H.14.

	
CERTIFICATION OF FILING AND PAYMENT OF TAXES

The Contractor must be in compliance with Section 518 of the Consolidated Appropriations Act of FY 2014.

	
ARTICLE H.15.

	
SUBCONTRACTING PROVISIONS

		(a)	
Small Business Subcontracting Plan

		1.	
The Small Business Subcontracting Plan, dated [redacted]* is attached hereto and made a part of this contract.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

34

		2.	
The failure of any Contractor or subcontractor to comply in good faith with FAR Clause 52.219-8, entitled "Utilization of Small Business Concerns" incorporated in this contract and the attached Subcontracting Plan, will be a material breach of such contract or subcontract and subject to the remedies reserved to the Government under FAR Clause 52.219-16 entitled, "Liquidated Damages-Subcontracting Plan."

		(b)	
Subcontracting Reports

The Contractor shall submit the following Subcontracting reports electronically via the "electronic Subcontracting Reporting System (eSRS) at http://www.esrs.gov.

		1.	
Individual Subcontract Reports (ISR)

Regardless of the effective date of this contract, the Report shall be due on the following dates for the entire life of this contract:

		·	
[redacted]*

		·	
[redacted]*

		·	
[redacted]*

	 	
2.

	
Summary Subcontract Report (SSR)

Regardless of the effective date of this contract, the Summary Subcontract Report shall be submitted annually on the following date for the entire life of this contract:

		·	
[redacted]*

For both the Individual and Summary Subcontract Reports, the Contracting Officer shall be included as a contact for notification purposes at the following e-mail address defined in SECTION F.3.

	
ARTICLE H.16.

	
ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY NOTICE

		a.	
Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998 and the Architectural and Transportation Barriers Compliance Board Electronic and Information (EIT) Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities, unless an undue burden would be imposed on the agency. Section 508 also requires that individuals with disabilities, who are members of the public seeking information or services from a Federal agency, have access to and use of information and data that is comparable to that provided to the public who are not individuals with disabilities, unless an undue burden would be imposed on the agency.

		b.	
Accordingly, any Contractor responding to this solicitation must comply with established HHS EIT accessibility standards. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of the Section 508 Final Provisions can be accessed at http://www.access-board.gov/sec508/standards.htm.

		c.	
The Section 508 accessibility standards applicable to this solicitation are stated in the clause at 352.239-74, Electronic and Information Technology Accessibility.

In order to facilitate the Government's determination whether proposed EIT supplies meet applicable Section 508 accessibility standards, Contractors must submit an HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose of the template is to assist HHS acquisition and program officials in determining whether proposed EIT supplies conform to applicable Section 508 accessibility standards. The template allows Contractors or developers to self-evaluate their supplies and document--in detail--whether they conform to a specific Section 508 accessibility standard, and any underway remediation efforts addressing conformance issues. Instructions for preparing the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://hhs.gov/web/508.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

35

In order to facilitate the Government's determination whether proposed EIT services meet applicable Section 508 accessibility standards, Contractors must provide enough information to assist the Government in determining that the EIT services conform to Section 508 accessibility standards, including any underway remediation efforts addressing conformance issues.

d. Respondents to this solicitation must identify any exception to Section 508 requirements. If a Contractor claims its supplies or services meet applicable Section 508 accessibility standards, and it is later determined by the Government, i.e., after award of a contract or order, that supplies or services delivered do not conform to the described accessibility standards, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibility of the Contractor at its expense.

(End of provision)

	
ARTICLE H.17.

	
CONFIDENTIALITY OF 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 Contracting Officer and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the Government will furnish to the Contractor or that the Contractor is expected to generate which is confidential. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential information from time to time during the performance of the contract. Failure to agree will be settled pursuant to the "Disputes" clause.

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

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

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

		f.	
Contracting Officer determinations will reflect the result of internal coordination with appropriate program and legal officials.

		g.	
The provisions of paragraph (d) of this article shall not apply to conflicting or overlapping provisions in other Federal, State or local laws.

	
ARTICLE H.18.

	
INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR CONFLICTS OF INTERESTS

The Institution (includes any Contractor, public or private, excluding a Federal agency) shall comply with the requirements of 45 CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure that Investigators (defined as the project director or principal Investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of research funded under BARDA contracts, or proposed for such funding, which may include, for example, collaborators or consultants) will not be biased by any Investigator financial conflicts of interest. 45 CFR Part 94 is available at the following Web site: http://www.ecfr.gov/cgi-in/textidx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=45

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

36

As required by 45 CFR Part 94, the Institution shall, at a minimum:

		a.	
Maintain an up-to-date, written, enforceable policy on financial conflicts of interest that complies with 45 CFR Part 94, inform each Investigator of the policy, the Investigator's reporting responsibilities regarding disclosure of significant financial interests, and the applicable regulation, and make such policy available via a publicly accessible Web site, or if none currently exist, available to any requestor within five business days of a request. A significant financial interest means a financial interest consisting of one or more of the following interests of the Investigator (and those of the Investigator's spouse and dependent children) that reasonably appears to be related to the Investigator's institutional responsibilities:

		1.	
With regard to any publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure and the value of any equity interest in the entity as of the date of disclosure, when aggregated, exceeds $5,000. Included are payments and equity interests;

		2.	
With regard to any non-publicly traded entity, a significant financial interest exists if the value of any remuneration received from the entity in the twelve months preceding the disclosure, when aggregated, exceeds $5,000, or when the Investigator (or the Investigator's spouse or dependent children) holds any equity interest; or

		3.	
Intellectual property rights and interests, upon receipt of income related to such rights and interest.

Significant financial interests do not include the following:

		4.	
Income from seminars, lectures, or teaching, and service on advisory or review panels for government agencies, Institutions of higher education, academic teaching hospitals, medical centers, or research institutes with an Institution of higher learning; and

		5.	
Income from investment vehicles, such as mutual funds and retirement accounts, as long as the Investigator does not directly control the investment decisions made in these vehicles.

		b.	
Require each Investigator to complete training regarding the Institution's financial conflicts of interest policy prior to engaging in research related to any BARDA funded contract and at least every four years. The Institution must take reasonable steps [see Part 94.4(c)] to ensure that investigators working as collaborators, consultants or subcontractors comply with the regulations.

		c.	
Designate an official(s) to solicit and review disclosures of significant financial interests from each Investigator who is planning to participate in, or is participating in, the BARDA funded research.

		d.	
Require that each Investigator who is planning to participate in the BARDA funded research disclose to the Institution's designated official(s) the Investigator's significant financial interest (and those of the Investigator's spouse and dependent children) no later than the date of submission of the Institution's proposal for BARDA funded research. Require that each Investigator who is participating in the BARDA funded research to submit an updated disclosure of significant financial interests at least annually, in accordance with the specific time period prescribed by the Institution during the period of the award as well as within thirty days of discovering or acquiring a new significant financial interest.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

37

		e.	
Provide guidelines consistent with the regulations for the designated official(s) to determine whether an Investigator's significant financial interest is related to BARDA funded research and, if so related, whether the significant financial interest is a financial conflict of interest. An Investigator's significant financial interest is related to BARDA funded research when the Institution, thorough its designated official(s), reasonably determines that the significant financial interest: Could be affected by the BARDA funded research; or is in an entity whose financial interest could be affected by the research. A financial conflict of interest exists when the Institution, through its designated official(s), reasonably determines that the significant financial interest could directly and significantly affect the design, conduct, or reporting of the BARDA funded research.

		f.	
Take such actions as necessary to manage financial conflicts of interest, including any financial conflicts of a subcontractor Investigator. Management of an identified financial conflict of interest requires development and implementation of a management plan and, if necessary, a retrospective review and mitigation report pursuant to Part 94.5(a).

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

		h.	
Maintain records relating to all Investigator disclosures of financial interests and the Institution's review of, and response to, such disclosures, and all actions under the Institution's policy or retrospective review, if applicable, for at least 3 years from the date of final payment or, where applicable, for the other time periods specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention.

		i.	
Establish adequate enforcement mechanisms and provide for employee sanctions or other administrative actions to ensure Investigator compliance as appropriate.

		j.	
Complete the certification in Section K - Representations, Certifications, and Other Statements of Contractors titled "Certification of Institutional Policy on Financial Conflicts of Interest".

If the failure of an Institution to comply with an Institution's financial conflicts of interest policy or a financial conflict of interest management plan appears to have biased the design, conduct, or reporting of the BARDA funded research, the Institution must promptly notify the Contracting Officer of the corrective action taken or to be taken. The Contracting Officer will consider the situation and, as necessary, take appropriate action or refer the matter to the Institution for further action, which may include directions to the Institution on how to maintain appropriate objectivity in the BARDA funded research project.

The Contracting Officer and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial interests, and the Institution's review of, and response to, such disclosure, regardless of whether the disclosure resulted in the Institution's determination of a financial conflict of interests. The Contracting Officer may require submission of the records or review them on site. On the basis of this review of records or other information that may be available, the Contracting Officer may decide that a particular financial conflict of interest will bias the objectivity of the BARDA funded research to such an extent that further corrective action is needed or that the Institution has not managed the financial conflict of interest in accordance with Part 94.6(b). The issuance of a Stop Work Order by the Contracting Officer may be necessary until the matter is resolved.

If the Contracting Officer determines that BARDA funded clinical research, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by an Investigator with a financial conflict of interest that was not managed or reported by the Institution, the Institution shall require the Investigator involved to disclose the financial conflict of interest in each public presentation of the results of the research and to request an addendum to previously published presentations.

	
ARTICLE H.19.

	
PUBLICATION AND PUBLICITY

The Contractor shall acknowledge the support of the Department of Health and Human Services, Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority whenever publicizing the work under this contract in any media by including an acknowledgment substantially as follows:

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

38

"This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201800019C"

Press Releases:

The Contractor shall clearly state, when issuing statements, press releases, requests for proposals, bid solicitations and other documents describing projects or programs funded in whole or in part with Federal money that: (1) the percentage of the total costs of the program or project which will be financed with Federal money; (2) the dollar amount of Federal funds for the project or program; and (3) the percentage and dollar amount of the total costs of the project or program that will be financed by non-Governmental sources.

	
ARTICLE H.20.

	
REPORTING MATTERS INVOLVING FRAUD, WASTE, AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in BARDA funded programs is encouraged to report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and the mailing address is:

Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026

	
ARTICLE H.21.

	
PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224 and Pub. L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.

	
ARTICLE H.22.

	
ACCESS TO DOCUMENTATION/DATA

The Government shall have physical and electronic access to all documentation and data generated under this contract, including: all data documenting Contractor performance, all data generated, all communications and correspondence with regulatory agencies and bodies to include all audit observations, inspection reports, milestone completion documents, and all Contractor commitments and responses. The Contractor shall provide the Government with an electronic copy of all correspondence with the FDA within 24 hours of receipt. The Government shall acquire unlimited rights to all data funded under any contract awarded in response to this RFP in accordance with FAR Subpart 27.4 and FAR Clause 52.227-14.

	
ARTICLE H.23.

	
IDENTIFICATION AND DISPOSITION OF DATA

The Contractor will be required to provide certain data generated under this contract to the Department of Health and Human Services (HHS). HHS reserves the right to review any other data determined by HHS to be relevant to this contract. The Contractor shall keep copies of all data required by the Food and Drug Administration (FDA) relevant to this contract for the time specified by the FDA.

	
ARTICLE H.24.

	
DISSEMINATION OF INFORMATION

No information related to data obtained under this contract shall be released or publicized without the prior written consent of the COR, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that no such consent is required to comply with any law, rule, regulation, court ruling or similar order; for submission to any government entity’ for submission to any securities exchange on which the Contractor’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.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

39

	
ARTICLE H.25.

	
DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to disseminate information that is deliberately false or misleading.

	
ARTICLE H.26.

	
PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING FROM ASPR FUNDED RESEARCH

All ASPR-funded investigators shall submit to the NIH National Library of Medicine's (NLM) PubMed Central (PMC) an electronic version of the author's final manuscript, upon acceptance for publication, of any peer-reviewed scientific publications resulting from research supported in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response. ASPR defines the author's final manuscript as the final version accepted for journal publication, and includes all modifications from the publishing peer review process. The PMC archive will preserve permanently these manuscripts for use by the public, health care providers, educators, scientists, and ASPR. The Policy directs electronic submissions to the NIH/NLM/PMC: http://www.pubmedcentral.nih.gov .

Additional information is available at http://www.phe.gov/Preparedness/planning/science/Pages/AccessPlan.aspx

	
ARTICLE H.27.

	
Public Health Service Act

Effective December 3, 2016, the Secretary of the Department of Health and Human Services has issued an amended declaration pursuant to section 319F-3 of the Public Health Service Act (42 U.S.C. § 247d-6d) to provide liability protection for activities related to Ebola virus disease vaccines consistent with the terms of the declaration. The rVSV-ZEBOV-GP vaccine being developed under this contract, which is also known as V920 or BPSC1001, is identified in the declaration as a covered countermeasure, and, as such, the government shall provide liability protection for activities related to V920, consistent with terms of the declaration. The Government agrees that the medical countermeasure delivered by the Contractor under this contract will not be administered for use in humans , unless the Secretary executes a Declaration under the Public Readiness and Emergency Preparedness Act (PREP Act), Section 319F-3 of the Public Health Service Act, 42 U.S.C. 247d-6d, to provide that such medical countermeasures delivered under this contract and used anywhere in the world are covered countermeasures to which section 319F-3(a) applies.

 

	
ARTICLE H.28.

	
CONFLICT OF INTEREST

The Contractor represents and warrants that, to the best of the Contractor's knowledge and belief, there are no relevant facts or circumstances which could give rise to an organizational conflict of interest, as defined in FAR 2.101 and Subpart 9.5, or that the Contractor has disclosed all such relevant information. Prior to commencement of any work, the Contractor agrees to notify the Contracting Officer promptly that, to the best of its knowledge and belief, no actual or potential conflict of interest exists or to identify to the Contracting Officer any actual or potential conflict of interest the firm may have. In emergency situations, however, work may begin but notification shall be made within five (5) working days. The Contractor agrees that if an actual or potential organizational conflict of interest is identified during performance, the Contractor shall promptly make a full disclosure in writing to the Contracting Officer. This disclosure shall include a description of actions which the Contractor has taken or proposes to take, after consultation with the Contracting Officer, to avoid, mitigate, or neutralize the actual or potential conflict of interest. The Contractor shall continue performance until notified by the Contracting Officer of any contrary action to be taken. Remedies include termination of this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid an organizational conflict of interest. If the Contractor was aware of a potential organizational conflict of interest prior to award or discovered an actual or potential conflict after award and did not disclose it or misrepresented relevant information to the Contracting Officer, the Government may terminate the contract for default, debar the Contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

40

	
ARTICLE H.29.

	
IN-PROCESS REVIEW

In Process Reviews (IPR) will be conducted at the discretion of the Government to discuss the progression of the milestones. The Government reserves the right to revise the milestones and budget pending the development of the project. Deliverables may be required when the IPRs are conducted. The Contractor’s success in completing the required tasks under each work segment must be demonstrated through the Deliverables and Milestones specified under SECTION F. Those deliverables will constitute the basis for the Government’s decision, at its sole discretion, to proceed with the work segment, or unilaterally institute changes to the work segment, or terminate the work segment.

IPRs may be scheduled at the discretion of the Government to discuss progression of the contract. The Contractor shall provide a presentation following a prescribed template which will be provided by the Government at least 30 days prior to the IPR. The Contractor shall provide a draft presentation to the Contracting Officer at least 10 days prior to the IPR.

	
ARTICLE H.30.

	
PRIVACY ACT APPLICABILITY

	1)	
Notification is hereby given that the Contractor and its employees are subject to criminal penalties for violation of the Privacy Act to the same extent as employees of the Government. The Contractor shall assure that each of its employees knows the prescribed rules of conduct and that each is aware that he or she can be subjected to criminal penalty for violation of the Act. A copy of 45 CFR Part 5b, Privacy Act Regulations, may be obtained at http://www.gpoaccess.gov/cfr/index.html

	2)	
The Project Officer/COR is hereby designated as the official who is responsible for monitoring Contractor compliance with the Privacy Act.

	3)	
The Contractor shall follow the Privacy Act guidance as contained in the Privacy Act System of Records number 09-25-0200. This document may be obtained at the following link: http://oma.od.nih.gov/ms/privacy/pa-files/0200.htm

	
ARTICLE H.31.

	
BARDA AUDITS

Contractor shall accommodate periodic or ad hoc site visits by the Government. If the Government, the Contractor, or other parties identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to the Government.

		·	
If issues are identified during the audit, Contractor shall submit a report to the CO and COR detailing the finding and corrective action(s) within 10 business days of the audit.

		·	
COR and CO will review the report and provide a response to the Contractor within 10 business days.

		·	
Once corrective action is completed, the Contractor will provide a final report to the CO and COR.

	
ARTICLE H.32.

	
SECURITY REPORTING REQUIREMENT

Violations of established security standards per the Security Plan noted in Section F.2.E.g shall be reported to the CO and COR within 24 hours upon discovery of any compromise, intrusion, loss or interference of its security processes and procedures. The Contractor shall ensure that all software components that are not required for the operation and maintenance of the database/control system has been removed and/or disabled. The Contractor shall provide to the CO and the COR information appropriate to Information and Information Technology software and service updates and/or workarounds to mitigate all vulnerabilities associated with the data and shall maintain the required level of system security.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

41

The Contractor will investigate violations to determine the cause, extent, loss or compromise of sensitive program information, and corrective actions taken to prevent future violations. The CO in coordination with BARDA will determine the severity of the violation. Any contractual actions resulting from the violation will be determined by the CO.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

42

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

ARTICLE I.1. FAR 52.252-2, CLAUSES INCORPORATED BY REFERENCE (FEBRUARY 1998)

This contract incorporates the following clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at these addresses: https://www.acquisition.gov/FAR/ . HHSAR Clauses at: http://www.hhs.gov/policies/hhsar/subpart352.html.

General Clauses for Cost-Reimbursement/Fixed Price Research and Development Contract

	
Reg

	
Clause

	
Date

	 	 	
Clause Title

	
FAR

	
52.202-1

	
Nov 2013

	 	 	
Definitions

	
FAR

	
52.203-3

	
Apr 1984

	 	 	
Gratuities

	
FAR

	
52.203-5

	
May 2014

	 	 	
Covenant Against Contingent Fees

	
FAR

	
52.203-6

	
Sep 2006

	 	 	
Restrictions on Subcontractor Sales to the Government

	
FAR

	
52.203-7

	
May 2014

	 	 	
Anti-Kickback Procedures

	
FAR

	
52.203-8

	
May 2014

	 	 	
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity

	
FAR

	
52.203-10

	
May 2014

	 	 	
Price or Fee Adjustment for Illegal or Improper Activity

	
FAR

	
52.203-12

	
Oct 2010

	 	 	
Limitation on Payments to Influence Certain Federal Transactions

	
FAR

	
52.203-13

	
Oct 2015

	 	 	
Contractor Code of Business Ethics and Conduct

	
FAR

	
52.203-14

	
Oct 2015

	 	 	
Display of Hotline Poster(s)

	
FAR

	
52.203-17

	
Apr 2014

	 	 	
Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights

	
FAR

	
52.203-18

	
Jan 2017

	 	 	
Prohibition on Contracting with Entities that Require Certain Internal Confidentiality Agreements or Statements-Representation.

	
FAR

	
52.204-4

	
May 2011

	 	 	
Printed or Copied Double-Sided on Postconsumer Fiber Content Paper

	
FAR

	
52.204-7

	
Oct 2016

	 	 	
System for Award Management

	
FAR

	
52.204-10

	
Oct 2016

	 	 	
Reporting Executive Compensation and First-Tier Subcontract Awards

	
FAR

	
52.204-13

	
Oct 2016

	 	 	
System for Award Management Maintenance

	
FAR

	
52.209-6

	
Oct 2015

	 	 	
Protecting the Government's Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment

	
FAR

	
52.209-9

	
Jul 2013

	 	 	
Updates of Publicly Available Information Regarding Responsibility Matters

	
FAR

	
52.209-10

	
Nov 2015

	 	 	
Prohibition on Contracting with Inverted Domestic Corporations

	
FAR

	
52.210-1

	
Apr 2011

	 	 	
Market Research

	
FAR

	
52.211-11

	
Sept 2000

	 	 	
Liquidated Damages—Supplies, Services, or Research and Development (Sept 2000)

	
FAR

	
52.215-2

	
Oct 2010

	 	 	
Audit and Records – Negotiation

	
FAR

	
52.215-8

	
Oct 1997

	 	 	
Order of Precedence - Uniform Contract Format

	
FAR

	
52.215-10

	
Aug 2011

	 	 	
Price Reduction for Defective Cost or Pricing Data

	
FAR

	
52.215-11

	
Aug 2011

	 	 	
Price Reduction for Defective Certified Cost or Pricing Data—Modifications.

	
FAR

	
52.215-12

	
Oct 2010

	 	 	
Subcontractor Certified Cost or Pricing Data

	
FAR

	
52.215-13

	
Oct 2010

	 	 	
Subcontractor Certified Cost or Pricing Data—Modifications

	
FAR

	
52.215-15

	
Oct 2010

	 	 	
Pension Adjustments and Asset Reversions

	
FAR

	
52.215-18

	
Jul 2005

	 	 	
Reversion or Adjustment of Plans for Postretirement Benefits (PRB) other than Pensions

	
FAR

	
52.215-19

	
Oct 1997

	 	 	
Notification of Ownership Changes

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

43

	
Reg

	
Clause

	
Date

	 	 	
Clause Title

	
FAR

	
52.215-21

	
Oct 2010

	 	 	
Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data -Modifications

	
FAR

	
52.215-23

	
Oct 2009

	 	 	
Limitations on Pass-Through Charges

	
FAR

	
52.216-7

	
Jun 2013

	 	 	
Allowable Cost and Payment

	
FAR

	
52.216-8

	
Jun 2011

	 	 	
Fixed Fee

	
FAR

	
52.219-8

	
Nov 2016

	 	 	
Utilization of Small Business Concerns

	
FAR

	
52.219-9

	
Jan 2017

	 	 	
Small Business Subcontracting Plan

	
FAR

	
52.219-16

	
Jan 1999

	 	 	
Liquidated Damages - Subcontracting Plan

	
FAR

	
52.219-28

	
July 2013

	 	 	
Post-Award Small Business Program Representation

	
FAR

	
52.222-1

	
Feb 1997

	 	 	
Notice to the Government of Labor Disputes

	
FAR

	
52.222-2

	
July 1990

	 	 	
Payment for Overtime Premiums

	
FAR

	
52.222-3

	
Jun2003

	 	 	
Convict Labor

	
FAR

	
52.222-21

	
Apr 2015

	 	 	
Prohibition of Segregated Facilities

	
FAR

	
52.222-26

	
Sept 2016

	 	 	
Equal Opportunity

	
FAR

	
52.222-29

	
Apr 2015

	 	 	
Notification of Visa Denial.

	
FAR

	
52.222-35

	
Oct 2015

	 	 	
Equal Opportunity for Veterans

	
FAR

	
52.222-36

	
Jul 2014

	 	 	
Equal Opportunity for Workers with Disabilities

	
FAR

	
52.222-37

	
Feb 2016

	 	 	
Employment Reports on Veterans

	
FAR

	
52.222-38

	
Feb 2016

	 	 	
Compliance with Veterans’ Employment Reporting Requirements

	
FAR

	
52.222-40

	
Dec 2010

	 	 	
Notification of Employee Rights Under the National Labor Relations Act

	
FAR

	
52.222-43

	
May 2014

	 	 	
Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (Multiple Year and Option Contracts)

	
FAR

	
52.222-50

	
Mar 2015

	 	 	
Combating Trafficking in Persons

	
FAR

	
52.222-54

	
Oct 2015

	 	 	
Employment Eligibility Verification

	
FAR

	
52.223-6

	
May 2001

	 	 	
Drug-Free Workplace

	
FAR

	
52.223-18

	
Aug 2011

	 	 	
Encouraging Contractor Policy to Ban Text Messaging While Driving

	
FAR

	
52.224-1

	
April 1984

	 	 	
Privacy Act Notification

	
FAR

	
52.224-2

	
April 1984

	 	 	
Privacy Act

	
FAR

	
52.225-13

	
Jun 2008

	 	 	
Restrictions on Certain Foreign Purchases

	
FAR

	
52.225-25

	
Oct 2015

	 	 	
Prohibition on Contracting with Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications

	
FAR

	
52.226-1

	
Jun 2000

	 	 	
Utilization of Indian Organizations and Indian-Owned Economic Enterprises.

	
FAR

	
52.227-1

	
Dec 2007

	 	 	
Authorization and Consent, Alternate 1 (APR 1984)

	
FAR

	
52.227-2

	
Dec 2007

	 	 	
Notice and Assistance Regarding Patent and Copyright Infringement

	
FAR

	
52.227-3

	
Apr 1984

	 	 	
Patent Indemnity

	
FAR

	
52.227-11

	
May 2014

	 	 	
Patent Rights – Ownership by the Contractor

	
FAR

	
52.227-14

	
May 2014

	 	 	
Rights in Data - General

	
FAR

	
52.227-14

	
Dec 2007

	 	 	
Rights in Data - General, Alternate 2

	
FAR

	
52.227-16

	
June 1987

	 	 	
Additional Data Requirements

	
FAR

	
52.228-7

	
Mar 1996

	 	 	
Insurance – Liability to Third Persons

	
FAR

	
52.229-3

	
Feb 2013

	 	 	
Federal, State and Local Taxes

	
FAR

	
52.230-2

	
Oct 2015

	 	 	
Cost Accounting Standards

	
FAR

	
52.230-6

	
June 2010

	 	 	
Administration of Cost Accounting Standards

	
FAR

	
52.232-1

	
Apr 1984

	 	 	
Payments

	
FAR

	
52.232-2

	
Apr 1984

	 	 	
Payments under Fixed-Price Research and Development Contracts

	
FAR

	
52.232-8

	
Feb 2002

	 	 	
Discounts for Prompt Payment

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

44

	
Reg

	
Clause

	
Date

	 	 	
Clause Title

	
FAR

	
52.232-9

	
Apr 1984

	 	 	
Limitation on Withholding of Payments

	
FAR

	
52.232-11

	
Apr 1984

	 	 	
Extras

	
FAR

	
52.232-17

	
May 2014

	 	 	
Interest

	
FAR

	
52.232-18

	
Apr 1984

	 	 	
Availability of Funds

	
FAR

	
52.232-20

	
Apr 1984

	 	 	
Limitation of Cost

	
FAR

	
52.232-22

	
Apr 1984

	 	 	
Limitation of Funds

	
FAR

	
52.232-23

	
May 2014

	 	 	
Assignment of Claims

	
FAR

	
52.232-25

	
Jan 2017

	 	 	
Prompt Payment

	
FAR

	
52.232-33

	
Jul 2013

	 	 	
Payment by Electronic Funds Transfer--System for Award Management

	
FAR

	
52.232-40

	
Dec 2013

	 	 	
Providing Accelerated Payments to Small Business Subcontractors

	
FAR

	
52.233-1

	
May 2014

	 	 	
Disputes

	
FAR

	
52.233-3

	
Aug 1996

	 	 	
Protest After Award

	
FAR

	
52.233-4

	
Oct 2004

	 	 	
Applicable Law for Breach of Contract Claim

	
FAR

	
52.242-1

	
Apr 1984

	 	 	
Notice of Intent to Disallow Costs

	
FAR

	
52.242-3

	
May 2014

	 	 	
Penalties for Unallowable Costs

	
FAR

	
52.242-4

	
Jan 1997

	 	 	
Certification of Final Indirect Costs

	
FAR

	
52.242-13

	
Jul 1995

	 	 	
Bankruptcy

	
FAR

	
52.243-1

	
Aug 1987

	 	 	
Changes - Fixed-Price Alternate V (Apr 1984).

	
FAR

	
52.243-2

	
Aug 1987

	 	 	
Changes—Cost-Reimbursement Alternate V (Apr 1984).

	
FAR

	
52.243-6

	
Apr 1984

	 	 	
Change Order Accounting.

	
FAR

	
52.243-7

	
Jan 2017

	 	 	
Notification of Changes

	
FAR

	
52.244-2

	
Oct 2010

	 	 	
Subcontracts, Alternate 1 (Jun 2007)

	
FAR

	
52.244-5

	
Dec 1996

	 	 	
Competition in Subcontracting

	
FAR

	
52.244-6

	
Nov 2017

	 	 	
Subcontracts for Commercial Items

	
FAR

	
52.245-1

	
Jan 2017

	 	 	
Government Property

	
FAR

	
52.245-9

	
Apr 2012

	 	 	
Use and Charges

	
FAR

	
52.246-23

	
Feb 1997

	 	 	
Limitation of Liability.

	
FAR

	
52.246-25

	
Feb 1997

	 	 	
Limitation of Liability—Services

	
FAR

	
52.248-1

	
Oct 2010

	 	 	
Value Engineering

	
FAR

	
52.249-2

	
Apr 2012

	 	 	
Termination for the Convenience of the Government (Fixed-Price)

	
FAR

	
52.249-6

	
May 2004

	 	 	
Termination (Cost-Reimbursement)

	
FAR

	
52.249-8

	
Apr 1984

	 	 	
Default (Fixed-Price Supply and Service)

	
FAR

	
52.249-9

	
Apr 1984

	 	 	
Default (Fixed-Price Research and Development)

	
FAR

	
52.249-14

	
Apr 1984

	 	 	
Excusable Delays

	
FAR

	
52.253-1

	
Jan 1991

	 	 	
Computer Generated Forms

 

	ARTICLE I.2.	
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR Chapter 3) CLAUSES

Full text of the HHSAR clauses can be found at https://www.hhs.gov/grants/contracts/contract-policies-regulations/hhsar/index.html

	
HHSAR

	
352.203-70

	
Dec 2015

	 	 	
Anti-Lobbying

	
HHSAR

	
352.211.2

	
Dec 2015

	 	 	
Conference Sponsorship Requests and Conference Materials Disclaimer

	
HHSAR

	
352.215-70

	
Dec 2015

	 	 	
Late Proposals and Revisions

	
HHSAR

	
352.216-70

	
Dec 2015

	 	 	
Additional Cost Principles

	
HHSAR

	
352.222-70

	
Dec 2015

	 	 	
Contractor Cooperation in Equal Employment Opportunity Investigations

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

45

	
HHSAR

	
352.223-70

	
Dec 2015

	 	 	
Safety and Health

	
HHSAR

	
352.224-70

	
Dec 2015

	 	 	
Privacy Act

	
HHSAR

	
352.224-71

	
Dec 2015

	 	 	
Confidential Information

	
HHSAR

	
352.227-70

	
Dec 2015

	 	 	
Publications and Publicity

	
HHSAR

	
352.233-71

	
Dec 2015

	 	 	
Litigation and Claims

	
HHSAR

	
352.270-5a

	
Dec 2015

	 	 	
Notice of Contractors of Requirement for Compliance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals

	
HHSAR

	
352.270-6

	
Dec 2015

	 	 	
Restriction on use of Human Subjects

	ARTICLE I.3.	
ADDITIONAL CONTRACT CLAUSES

	
ARTICLE I.3.1.

	
Additional HHS Acquisition Regulation (HHSAR) Clauses – In Full Text

352.231-70 Salary rate limitation (Dec 2015)

		(a)	
The Contractor shall not use contract funds to pay the direct salary of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date the funding was obligated

		(b)	
For purposes of the salary rate limitation, the terms “direct salary,” “salary,” and “institutional base salary” have the same meaning and are collectively referred to as “direct salary” in this clause. An individual’s direct salary is the annual compensation that the Contractor pays for an individual’s direct effort (costs) under the contract. Direct salary excludes any income that an individual may be permitted to earn outside of duties to the Contractor. Direct salary also excludes fringe benefits, overhead, and general and administrative expenses (also referred to as indirect costs or facilities and administrative costs).

The salary rate limitation does not restrict the salary that an organization may pay an individual working under a Department of Health and Human Services contract or order; it merely limits the portion of that salary that may be paid with federal funds.

		(c)	
The salary rate limitation also applies to individuals under subcontracts.

		(d)	
If this is a multiple-year contract or order, it may be subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds the salary rate limitation provision established in the HHS appropriations act used to fund this contract.

		(e)	
See the salaries and wages pay tables on the U.S. Office of Personnel Management website for federal Executive Schedule salary levels.

(End of clause)

	
ARTICLE I.3.2.

	
Additional Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clauses – In Full Text

52.217-7 Option for Increased Quantity -- Separately Priced Line Item (Mar 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

52.217-8 Option to Extend Services (Nov 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

52.217-9 Option to Extend the Term of the Contract (Mar 2000)

	(a)	
The Government may extend the term of this contract by written notice to the Contractor within 30  days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

	(b)	
If the Government exercises this option, the extended contract shall be considered to include this option clause.

	(c)	
The total duration of this contract, including the exercise of any options under this clause, shall not exceed ten years

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

46

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

The following documents are attached and incorporated in this contract:

		1.	
Statement of Objectives, dated [redacted]*, 5 pages

		2.	
Statement of Work, dated [redacted]*, 2 pages

		3.	
Invoice Instructions for Cost-Reimbursement Type Contracts

		4.	
Invoice Instructions for Fixed-Priced Type Contracts

		5.	
Sample Invoice Form

 

		6.	
Form SF-LLL, Disclosure of Lobbying Activities, 2 pages

		7.	
Protection of Human Subjects, 2 pages

 

	 	8.	
Small Business Subcontracting Plan, dated [redacted]*

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

47

PART IV – REPRESENTATIONS AND INSTRUCTIONS

SECTION K – REPRESENTATIONS AND CERTIFICATIONS

The following documents are incorporated by reference in this contract:

		1.	
The Contractor's representations and certifications, including those completed electronically via the System for Award Management (SAM), are incorporated by reference into the contract.

		2.	
Animal Welfare Assurance Numbers (Prime and Subcontractors).

		3.	
Human Subjects Assurance Identification Numbers (Prime and Subcontractors).

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

48

SECTION C – DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

	C.1.	
STATEMENT OF OBJECTIVES

[redacted]*

	C.2.	
REPORTING REQUIREMENTS

See Section F for specific reporting requirements.

Performance of the contract will be monitored by the CO/COR on a regular basis. The Contracting Officer will be responsible for inspection and acceptance of deliverables and services. Monitoring of the contract will be based on periodic reporting by the Contractor.

	C.3.	
MEETINGS/SITE VISITS

The Contractor and BARDA/AMCG shall participate in regular meetings to coordinate and oversee the contracting effort as requested by the Contracting Officer (CO)/Contracting Officer’s Representative (COR). Such meetings may include, but are not limited to, a kickoff meeting to be held at a location determined by the COR, status update meetings and/or teleconferences, site visits to the Contractor’s and/or subcontractor’s facilities, and meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The Contractor shall provide data, reports, and presentations to groups of outside experts and USG personnel and USG-contracted subject matter experts as required by the CO/COR facilitating review of activities.

The purpose of the kickoff meeting will be to orient the Contractor to HHS/BARDA and review contract requirements. This meeting usually occurs within a month after contract award. Expect Bi-weekly or monthly status update meetings/teleconferences. The schedule for these meetings will be established by the CO and COR.

Periodic site visits shall occur on an ad hoc basis (At least twice a year).

Within thirty (30) calendar days of an FDA audit of Contractor or subcontractor facilities, the Contractor shall provide copies of the audit findings, final report, and a plan for addressing areas of nonconformance to FDA regulations and guidance for GLP, GMP or GCP guidelines as identified in the final audit report.

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

7

	
Appendix D

	
Overall Page 93 of 167

Statement of Work

[redacted]*

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

ATTACHMENT #3

INVOICE/FINANCING REQUEST INSTRUCTIONS - FOR COST-REIMBURSEMENT TYPE CONTRACTS

Format: Payment requests shall be submitted on the Contractor’s self-generated form in the manner and format prescribed herein and as illustrated in the Sample Invoice/Financing Request. Standard Form 1034, Public Voucher for Purchases and Services Other Than Personal, may be used in lieu of the Contractor’s self-generated form provided it contains all of the information shown on the Sample Invoice/Financing Request. DO NOT include a cover letter with the payment request.

Number of Copies: Payment requests shall be submitted in the quantity specified in the Invoice Submission Instructions in Section G of the Contract Schedule.

Frequency: Payment requests shall not be submitted more frequently than once every two weeks in accordance with the Allowable Cost and Payment Clause incorporated into this contract. Small business concerns may submit invoices/financing requests more frequently than every two weeks when authorized by the Contracting Officer.

Cost Incurrence Period: Costs incurred must be within the contract performance period or covered by pre-contract cost provisions.

Billing of Costs Incurred: If billed costs include (1) costs of a prior billing period, but not previously billed, or (2) costs incurred during the contract period and claimed after the contract period has expired, the Contractor shall site the amount(s) and month(s) in which it incurred such costs.

Contractor’s Fiscal Year: Payment requests shall be prepared in such a manner that the Government can identify costs claimed with the Contractor’s fiscal year.

Currency: All contracts are expressed in United States dollars. When the Government pays in a currency other than United States dollars, billings shall be expressed, and payment by the Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices paid under this contract may not exceed the United States dollars authorized.

Costs Requiring Prior Approval: Costs requiring the Contracting Officer’s approval, including those set forth in an Advance Understanding in the contract, shall be identified and reference the Contracting Officer’s Authorization (COA) Number. In addition, the Contractor shall show any cost set forth in an Advance Understanding as a separate line item on the payment request.

Invoice/Financing Request Identification: Each payment request shall be identified as either:

	(a)	
Interim Invoice/Contract Financing Request: These are interim payment requests submitted during the contract performance period.

	(b)	
Completion Invoice: The completion invoice shall be submitted promptly upon completion of the work, but no later than one year from the contract completion date, or within 120 days after settlement of the final indirect cost rates covering the year in which the contract is physically complete (whichever date is later). The Contractor shall submit the completion invoice when all costs have been assigned to the contract and it completes all performance provisions.

 

1

	(c)	
Final Invoice: A final invoice may be required after the amounts owed have been settled between the Government and the Contractor (e.g., resolution of all suspensions and audit exceptions).

Preparation and Itemization of the Invoice/Financing Request: The Contractor shall furnish the information set forth in the instructions below. The instructions are keyed to the entries on the Sample Invoice/Financing Request.

	(a)	
Designated Billing Office Name and Address: Enter the designated billing office name and address, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

	(b)	
Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number: Show the Contractor’s name and address exactly as they appear in the contract, along with the name, title, phone number, and e-mail address of the person to notify in the event of an improper invoice or, in the case of payment by method other than Electronic Funds Transfer, to whom payment is to be sent. Provide the Contractor’s Vendor Identification Number (VIN), and Data Universal Numbering System (DUNS) number or DUNS+4. The DUNS number must identify the Contractor’s name and address exactly as stated on the face page of the contract. When an approved assignment has been made by the Contractor, or a different payee has been designated, provide the same information for the payee as is required for the Contractor (i.e., name, address, point of contact, VIN, and DUNS).

	(c)	
Invoice/Financing Request Number: Insert the appropriate serial number of the payment request.

	(d)	
Date Invoice/Financing Request Prepared: Insert the date the payment request is prepared.

	(e)	
Contract Number and Order Number (if applicable): Insert the contract number and order number (if applicable).

	(f)	
Effective Date: Insert the effective date of the contract or if billing under an order, the effective date of the order.

	(g)	
Total Estimated Cost of Contract/Order: Insert the total estimated cost of the contract, exclusive of fixed-fee. If billing under an order, insert the total estimated cost of the order, exclusive of fixed-fee. For incrementally funded contracts/orders, enter the amount currently obligated and available for payment.

	(h)	
Total Fixed-Fee: Insert the total fixed-fee (where applicable) or the portion of the fixed-fee applicable to a particular invoice as defined in the contract.

	(i)	
Two-Way/Three-Way Match: Identify whether payment is to be made using a two-way or three- way match. To determine required payment method, refer to the Invoice Submission Instructions in Section G of the Contract Schedule.

	(j)	
Office of Acquisitions: Insert the name of the Office of Acquisitions, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

	(k)	
Central Point of Distribution: Insert the Central Point of Distribution, as identified in the Invoice Submission Instructions in Section G of the Contract Schedule.

	(l)	
Billing Period: Insert the beginning and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.

 

2

	(m)	
Amount Billed - Current Period: Insert the amount claimed for the current billing period by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.

	(n)	
Amount Billed - Cumulative: Insert the cumulative amounts claimed by major cost element, including any adjustments and fixed-fee. If the Contract Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate breakdown (by major cost element) for each line item.

	(o)	
Direct Costs: Insert the major cost elements. For each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval” on page 1 of these instructions.

		(1)	
Direct Labor: Include salaries and wages paid (or accrued) for direct performance of the contract. List individuals by name, title/position, hourly/annual rate, level of effort (actual hours or % of effort), breakdown by task performed by personnel, and amount claimed.

		(2)	
Fringe Benefits: List any fringe benefits applicable to direct labor and billed as a direct cost.  Do not include in this category fringe benefits that are included in indirect costs.

		(3)	
Accountable Personal Property: Include any property having a unit acquisition cost of $5,000 or more, with a life expectancy of more than two years, and sensitive property regardless of cost (see the HHS Contractor’s Guide for Control of Government Property)(e.g. personal computers). Note this is not permitted for reimbursement without pre-authorization from the CO.

On a separate sheet of paper attached to the payment request, list each item for which reimbursement is requested. Include reference to the following (as applicable):

- Item number for the specific piece of equipment listed in the Property Schedule, and

- COA number, if the equipment is not covered by the Property Schedule.

The Contracting Officer may require the Contractor to provide further itemization of property having specific limitations set forth in the contract.

		(4)	
Materials and Supplies: Include all consumable material and supplies regardless of amount. Detailed line-item breakdown (e.g. receipts, quotes, etc.) is required.

		(5)	
Premium Pay: List remuneration in excess of the basic hourly rate.

		(6)	
Consultant Fee: List fees paid to consultants. Identify consultant by name or category as set forth in the contract or COA, as well as the effort (i.e., number of hours, days, etc.) and rate billed.

		(7)	
Travel: Include domestic and foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However, for an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel outside that country. Foreign travel must be billed separately from domestic travel.

		(8)	
Subcontract Costs: List subcontractor(s) by name and amount billed. Provide subcontract invoices/receipts as backup documentation. If subcontract is of the cost-reimbursement variety, detailed breakdown will be required. Regardless, include backup documentation (e.g. subcontractor invoices, quotes, etc.).

 

3

		(9)	
Other: Include all other direct costs not fitting into an aforementioned category. If over $1,000, list cost elements and dollar amounts separately. If the contract contains restrictions on any cost element, that cost element must be listed separately.

	(p)	
Cost of Money (COM): Cite the COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed, if applicable.

	(q)	
Indirect Costs: Identify the indirect cost base (IDC), indirect cost rate, and amount billed for each indirect cost category.

	(r)	
Fixed-Fee: Cite the formula or method of computation for fixed-fee, if applicable. The fixed-fee must be claimed as provided for by the contract.

	(s)	
Total Amounts Claimed: Insert the total amounts claimed for the current and cumulative periods.

	(t)	
Adjustments: Include amounts conceded by the Contractor, outstanding suspensions, and/or disapprovals subject to appeal.

	(u)	
Grand Totals

	(v)	
Certification of Salary Rate Limitation: If required by the contract (see Invoice Submission Instructions in Section G of the Contract Schedule), the Contractor shall include the following certification at the bottom of the payment request:

“I hereby certify that the salaries billed in this payment request are in compliance with the Salary Rate Limitation Provisions in Section H of the contract.”

**Note the Contracting Officer may require the Contractor to submit detailed support for costs claimed on payment requests. Every cost must be determined to be allocable, reasonable, and allowable per FAR Part 31.

 

4

ATTACHMENT #4

INVOICE/FINANCING REQUEST INSTRUCTIONS FOR FIXED PRICE TYPE CONTRACTS

General The Contractor shall submit vouchers or invoices as prescribed herein.

Format Standard Form l034, Public Voucher for Purchases and Services Other Than Personal, and Standard Form l035, Public Voucher for Purchases and Services Other than Personal--Continuation Sheet, and the payee’s letterhead or self-designed form should be used to submit claims for reimbursement.

Number of Copies: As indicated in the contract.

Frequency Invoices submitted in accordance with the Payment Clause shall be submitted monthly upon delivery of goods or services unless otherwise authorized by the Contracting Officer.

Preparation and Itemization of the Invoice The invoice shall be prepared as follows:

(a) Designated Billing Office and address:

HHS/ASPR/BARDA

200 C Street SW

Washington DC 20024

ATTN: Contracting Officer

(b) Invoice Number

(c) Date of Invoice

(d) Contract number and date

(e) Payee’s name and address. Show the Contractor’s name (as it appears in the contract), correct address, and the title and phone number of the responsible official to whom payment is to be sent. When an approved assignment has been made by the Contractor, or a different payee has been designated, then insert the name and address of the payee instead of the Contractor.

(f) Description of goods or services, quantity, unit price, (where appropriate), and total amount.

(g) Charges for freight or express shipments other than F.O.B. destination. (If shipped by freight or express and charges are more than $25, attach prepaid bill.)

(h) Equipment - If there is a contract clause authorizing the purchase of any item of equipment, the final invoice must contain a statement indicating that no item of equipment was purchased or include a completed form HHS-565, Report of Capitalized Nonexpendable Equipment.

Currency: Where payments are made in a currency other than United States dollars, billings on the contract shall be expressed, and payment by the United States Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices paid under this contract may not exceed the United States dollars authorized.

 

1

ATTACHMENT #5

SAMPLE INVOICE FORM

 

1

	 	
Company Name

	 	 
	 	
Designated Billing Office Name and Address:

	 	
Invoice/Finance Number:

	 	 	 	 
	 	
DHHS/OS/ASPR/AMCG

	 	
Date Invoice Prepared:

	 	
Attn: Contracting Officer

	 	 
	 	
200 C St., S.W.

	 	
Contract No.

	 	 	 	 
	 	
Washington, D.C. 20201

	 	
Effective Date:

	 	 	 	 
	 	
Contractor’s Address and Contact Information:

	 	
Total Estimated Cost of Order:

	 	 	 	 
	 	 	 	
Office of Acquisitions:

	 	 	 	
Contracting Officer (insert name here)

	 	 	 	
Office of Acquisitions Management, Contracts, and Grants (AMCG)

	 	 	 	 
	 	
POC: Name of accountant or COO or signatory authority for invoice

	 	 
	 	
Title:

	 	 
	 	
Phone:

	 	
Central Point of Distribution:

	 	
E-Mail:

	 	 
	 	 	 	 
	 	
TIN:

	 	 
	 	
DUNS #:

	 	 
	 	
This invoice represents reimbursable costs for the period from

	 	 

	 		
Amount Billed

	 
	
Expenditure Category

	 	
Current

	
Cumulative

	
Contract Value

	 	
Direct Costs:

	 	 	 	 	 
	 	
Direct Labor

	 	 	 	 	 
	 	
Fringe Benefits

	0.00%	 	 	 	 
	 	
Total Labor Costs:

	 	 	 	 	 
	 	 	 	 	 	 	 
	 	
Overhead          0.00%

	 	 	 	 	 
	 	 	 	 	 	 	 
	 	
Travel

	 	 	 	 	 
	 	
Subcontracts

	 	 	 	 	 
	 	
Consultant Fees

	 	 	 	 	 
	 	
Materials and Supplies

	 	 	 	 	 
	 	
Other

	 	 	 	 	 
	 	
Total Direct Costs

	 	 	 	 	 
	 	 	 	 	 	 	 
	 	
G&A Rate

	0.00%	 	 	 	 
	 	 	 	 	 	 	 
	 	
Subtotal:

	 	 	 	 	 
	 	 	 	 	 	 	 
	 	
Fixed Fee

	0.0%	 	 	 	 
	 	 	 	 	 	 	 
	 	
Total Amount Claimed

	 	 	 	 	 
	 	 	 	 	 	 	 
	 	
Adjustments

	 	 	 	 	 
	 	 	 	 	 	 	 
	 	
Grand Total

	 	 	
$          -

	 	 

	 	
I certify that all payments requested are for appropriate purposes and in accordance with the contract.

	 	 	 
	 	
Name/signature of signatory authority for invoicing

	 

 

1

	
Appendix M

	
Overall Page 550 of 551

DISCLOSURE OF LOBBYING ACTIVITIES

Approved by OMB

4040-0013

Complete this form to disclose lobbying activities pursuant to 31 U.S.C. 1352

[redacted]*

 

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission

 

	
Appendix L

	
Overall Page 547 of 551

 

ATTACHMENT #6

PROTECTION OF HUMAN SUBJECTS

[redacted]*

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.

 

	
Appendix I

	
Overall Page  432 of 551

 

ATTACHMENT #12

SMALL BUSINESS SUBCONTRACTING PLAN

OFFICE OF SMALL AND DISADVANTAGED BUSINESS UTILIZATION

SMALL BUSINESS SUBCONTRACTING PLAN

[redacted]*

* Certain material has been omitted pursuant to a request for confidential treatment. Such omitted material has been filed separately with the Securities and Exchange Commission.ADVAXIS,
INC.

FORM
OF WARRANT AGENCY AGREEMENT

 

WARRANT
AGENCY AGREEMENT (this “Warrant Agreement”) made as of September 11, 2018 (the “Issuance Date”),
between Advaxis, Inc., a Delaware corporation, with offices at 305 College Road East, Princeton, New Jersey 08540 (“Company”),
and Continental Stock Transfer and Trust Company, with offices at 17 Battery Place, 8th Floor, New York, NY 10004 (“Warrant
Agent”).

 

WHEREAS,
the Company is engaged in a public offering (the “Offering”) of Common Stock and Warrants and, in connection
therewith, has determined to issue and deliver up to 14,166,666 Warrants (the “Warrants”) to the public investors,
with each such Warrant evidencing the right of the holder thereof to purchase one share of common stock, par value $.001 per share,
of the Company’s Common Stock (the “Common Stock”) for $1.50, subject to adjustment as described herein;

 

WHEREAS,
the Company has filed with the U.S. Securities and Exchange Commission (the “Commission”) a Registration Statement,
No. 333-226988 (as the same may be amended from time to time, the “Registration Statement”) for the registration,
under the Securities Act of 1933, as amended (the “Securities Act”) of, among other securities, the Warrants and the
Common Stock issuable upon exercise of the Warrants (the “Warrant Shares”), and such Registration Statement
was declared effective on August 30, 2018;

 

WHEREAS,
the Company desires the Warrant Agent to act on behalf of the Company, and the Warrant Agent is willing to so act, in connection
with the issuance, registration, transfer, exchange and exercise of the Warrants;

 

WHEREAS,
the Company desires to provide for the form and provisions of the Warrants, the terms upon which they shall be issued and exercised,
and the respective rights, limitation of rights, and immunities of the Company, the Warrant Agent, and the holders of the Warrants
(each, a “Holder”); and

 

WHEREAS,
all acts and things have been done and performed which are necessary to make the Warrants, when executed on behalf of the Company
and countersigned by or on behalf of the Warrant Agent, as provided herein, the valid and binding obligations of the Company,
and to authorize the execution and delivery of this Warrant Agreement.

 

NOW,
THEREFORE, in consideration of the mutual agreements herein contained, the parties hereto agree as follows:

 

1.
Appointment of Warrant Agent. The Company
hereby appoints the Warrant Agent to act as agent for the Company for the Warrants, and the Warrant Agent hereby accepts such
appointment and agrees to perform the same in accordance with the terms and conditions set forth in this Warrant Agreement.

 

2.
Warrants.

 

2.1
Form of Warrant. Each Warrant shall be issued in book entry or physical certificates. Physical certificates, if any, shall
be in substantially the form of Exhibit A hereto, the provisions of which are incorporated herein, and shall be signed
by, or bear the facsimile signature of, the Chief Executive Officer, President, Chief Financial Officer or Treasurer, Secretary
or Assistant Secretary of the Company and shall bear a facsimile of the Company’s seal. In the event the person whose facsimile
signature has been placed upon any Warrant shall have ceased to serve in the capacity in which such person signed the Warrant
before such Warrant is issued, it may be issued with the same effect as if he or she had not ceased to be such at the date of
issuance. All of the Warrants shall initially be represented by one or more book-entry certificates (each a “Book-Entry
Warrant Certificate”).

 

    	 

    	 

    

 

2.2
Capitalized Terms. All capitalized terms shall have the meaning ascribed to them in the form of Warrant attached hereto
as Exhibit A, unless otherwise defined herein.

 

2.3
Effect of Countersignature. If a physical certificate is issued, unless and until countersigned by the Warrant Agent pursuant
to this Agreement, a Warrant certificate shall be invalid and of no effect and may not be exercised by the Holder thereof.

 

2.4
Registration.

 

2.4.1
Warrant Register. The Warrant Agent shall maintain books (“Warrant Register”), for the registration
of the original issuance and the registration of any transfer of the Warrants. Upon the initial issuance of the Warrants, the
Warrant Agent shall issue and register the Warrants in the names of the respective Holders in such denominations and otherwise
in accordance with instructions delivered to the Warrant Agent by the Company. To the extent the Warrants are DTC eligible as
of the Issuance Date, all of the Warrants shall be represented by one or more Book-Entry Warrant Certificates deposited with the
Depository Trust Company (the “Depository”) and registered in the name of Cede & Co., a nominee of the
Depository. Ownership of beneficial interests in the Book-Entry Warrant Certificates shall be shown on, and the transfer of such
ownership shall be effected through, records maintained (i) by the Depository or its nominee for each Book-Entry Warrant Certificate;
(ii) by institutions that have accounts with the Depository (such institution, with respect to a Warrant in its account, a “Participant”);
or (iii) directly on the book-entry records of the Warrant Agent with respect only to owners of beneficial interests that represent
such direct registration.

 

If
the Warrants are not DTC Eligible as of the Issuance Date or the Depository subsequently ceases to make its book-entry settlement
system available for the Warrants, the Company may instruct the Warrant Agent to make other arrangements for book-entry settlement
within ten (10) Business Days after the Depository ceases to make its book-entry settlement available. In the event that the Company
does not make alternative arrangements for book-entry settlement within ten (10) Business Days or the Warrants are not eligible
for, or it is no longer necessary to have the Warrants available in, book-entry form, the Warrant Agent shall provide written
instructions to the Depository to deliver to the Warrant Agent for cancellation each Book-Entry Warrant Certificate, and the Company
shall instruct the Warrant Agent to deliver to the Depository definitive warrant certificates (“Warrant Certificates”)
in physical form evidencing such Warrants. Such definitive Warrant Certificates shall be in substantially the form annexed hereto
as Exhibit A.

 

As
used herein, the term “Business Day” means any day other than Saturday, Sunday or other day on which commercial
banks in the City of New York are authorized or required by law or executive order to remain closed.

 

2.4.2
Beneficial Owner; Registered Holder. Prior to due presentment for registration of transfer of any Warrant, the Company
and the Warrant Agent may deem and treat the person in whose name such Warrant shall be registered upon the Warrant Register (“Registered
Holder”), as the absolute owner of such Warrant and of each Warrant represented thereby (notwithstanding any notation
of ownership or other writing on the Warrant Certificate made by anyone other than the Company or the Warrant Agent), for the
purpose of any exercise thereof, and for all other purposes, and neither the Company nor the Warrant Agent shall be affected by
any notice to the contrary. Any person in whose name ownership of a beneficial interest in the Warrants evidenced by a Book-Entry
Warrant Certificate is recorded in the records maintained by the Depository or its nominee shall be deemed the “beneficial
owner” thereof; provided, that all such beneficial interests shall be held through a Participant which shall be the
Registered Holder of such Warrants. As used herein, the term “Holder” refers only to a Registered Holder of the Warrants.

 

    	2

    	 

    

 

2.5
Uncertificated Warrants. Notwithstanding the foregoing and anything else herein to the contrary, the Warrants may be issued
in uncertificated form.

 

3.
Transfer and Exchange of Warrants.

 

3.1
Registration of Transfer. The Warrant Agent shall register the transfer, from time to time, of any outstanding Warrant
upon the Warrant Register, upon surrender of such Warrant for transfer, properly endorsed with signatures medallion signature
guaranteed and accompanied by appropriate instructions for transfer. Upon any such transfer, a new Warrant representing an equal
aggregate number of Warrants shall be issued and the old Warrant shall be cancelled by the Warrant Agent. The Warrants so cancelled
shall be delivered by the Warrant Agent to the Company from time to time upon request. For the avoidance of doubt, no Warrant
nor Warrant Share may be offered for sale, sold, transferred, pledged or assigned without the consent of the Company.

 

3.2
Procedure for Surrender of Warrants. Warrants may be surrendered to the Warrant Agent, together with a written request
for exchange or transfer reasonably acceptable to Warrant Agent, duly executed by the Holder thereof, or by a duly authorized
attorney, and thereupon the Warrant Agent shall issue in exchange therefor one or more new Warrants as requested by the Holder
of the Warrants so surrendered, representing an equal aggregate number of Warrants; provided, however, that except as otherwise
provided herein or in any Book-Entry Warrant Certificate, each Book-Entry Warrant Certificate may be transferred only in whole
and only to the Depository, to another nominee of the Depository, to a successor depository, or to a nominee of a successor depository;
provided further, however, that in the event that a Warrant surrendered for transfer bears a restrictive legend, the Warrant Agent
shall not cancel such Warrant and issue new Warrants in exchange therefor until the Warrant Agent has received an opinion of counsel
for the Company stating that such transfer may be made and indicating whether the new Warrants must also bear a restrictive legend.
Upon any such registration of transfer, the Company shall execute, and the Warrant Agent shall countersign and deliver, in the
name of the designated transferee a new Warrant Certificate or Warrant Certificates of any authorized denomination evidencing
in the aggregate a like number of unexercised Warrants.

 

3.3
Fractional Warrants. The Warrant Agent shall not be required to effect any registration of transfer or exchange which
will result in the issuance of a Warrant Certificate for a fraction of a Warrant.

 

3.4
Service Charges. A service charge shall be made for any exchange or registration of transfer of Warrants, as negotiated
between Company and Warrant Agent.

 

3.5
Warrant Execution and Countersignature. The Warrant Agent is hereby authorized to countersign and to deliver, in accordance
with the terms of this Warrant Agreement, the Warrants required to be issued pursuant to the provisions of this Section 5,
and the Company, whenever required by the Warrant Agent, will supply the Warrant Agent with Warrants duly executed on behalf of
the Company for such purpose.

 

    	3

    	 

    

 

4.
Other Provisions Relating to Rights of Holders
of Warrants.

 

4.1
Lost. Stolen. Mutilated, or Destroyed Warrants. If any Warrant is lost, stolen, mutilated, or destroyed, the Company will
either (i) authorize the Warrant Agent to instruct the Holder to file documents with the Warrant Agent’s insurance company
as reasonably required to obtain an open penalty bond necessary for the replacement of the Warrant Certificate or (ii) indemnify
the Warrant Agent and provide instructions to the Warrant Agent to replace such Warrant Certificate. Thereafter, the Warrant Agent
shall issue a new Warrant of like denomination, tenor, and date as the Warrant so lost, stolen, mutilated, or destroyed. Any such
new Warrant shall constitute a substitute contractual obligation of the Company, whether or not the allegedly lost, stolen, mutilated,
or destroyed Warrant shall be at any time enforceable by anyone.

 

4.2
Reservation of Common Stock. The Company shall request that the Warrant Agent at all times reserve and keep available
a number of its authorized but unissued shares of Common Stock that will be sufficient to permit the exercise in full of all outstanding
Warrants issued pursuant to this Warrant Agreement.

 

5.
Concerning the Warrant Agent and Other Matters.

 

5.1
Concerning the Warrant Agent. The Warrant Agent:

 

(a)
shall have no duties or obligations other than those set forth herein and no duties or obligations shall be inferred or implied;

 

(b)
may rely on and shall be held harmless by the Company in acting upon any certificate, statement, instrument, opinion, notice,
letter, facsimile transmission, telegram or other document, or any security delivered to it, and reasonably believed by it to
be genuine and to have been made or signed by the proper party or parties;

 

(c)
may rely on and shall be held harmless by the Company in acting upon written or oral instructions or statements from the Company
with respect to any matter relating to its acting as Warrant Agent;

 

(d)
may consult with counsel satisfactory to it (including counsel for the Company) and shall be held harmless by the Company in relying
on the advice or opinion of such counsel in respect of any action taken, suffered or omitted by it hereunder in good faith and
in accordance with such advice or opinion of such counsel;

 

(e)
solely shall make the final determination as to whether or not a Warrant received by Warrant Agent is duly, completely and correctly
executed, and Warrant Agent shall be held harmless by the Company in respect of any action taken, suffered or omitted by Warrant
Agent hereunder in good faith and in accordance with its determination;

 

(f)
shall not be obligated to take any legal or other action hereunder which might, in its judgment, subject or expose it to any expense
or liability unless it shall have been furnished with an indemnity satisfactory to it; and

 

(g)
shall not be liable or responsible for any failure of the Company to comply with any of the Company’s obligations relating
to the Registration Statement or this Warrant Agreement, including without limitation obligations under applicable regulation
or law.

 

5.2
Payment of Taxes. The Company will from time to time promptly pay all taxes and charges that may be imposed upon the Company
or the Warrant Agent in respect of the issuance or delivery of Warrant Shares upon the exercise of Warrants, but the Company shall
not be obligated to pay any transfer taxes in respect of the Warrants or such Warrant Shares. The Warrant Agent shall not register
any transfer or issue or deliver any Warrant Certificate(s) or Warrant Shares unless or until the persons requesting the registration
or issuance shall have paid to the Warrant Agent for the account of the Company the amount of such tax, if any, or shall have
established to the reasonable satisfaction of the Company that such tax, if any, has been paid.

 

    	4

    	 

    

 

5.3
Resignation. Consolidation, or Merger of Warrant Agent.

 

5.3.1
Appointment of Successor Warrant Agent. The Warrant Agent, or any successor to it hereafter appointed, may resign its duties
and be discharged from all further duties and liabilities hereunder after giving sixty (60) calendar days’ notice in writing
to the Company. If the office of the Warrant Agent becomes vacant by resignation or incapacity to act or otherwise, the Company
shall appoint in writing a successor Warrant Agent in place of the Warrant Agent. If the Company shall fail to make such appointment
within a period of thirty (30) calendar days after it has been notified in writing of such resignation or incapacity by the Warrant
Agent or by the Holder (who shall, with such notice, submit such Holder’s Warrants for inspection by the Company), then
such Holder may apply to the Supreme Court of the State of New York for the County of New York for the appointment of a successor
Warrant Agent, the expenses of which shall be paid by the Company. Any successor Warrant Agent (but not including the initial
Warrant Agent), whether appointed by the Company or by such court, shall be a corporation organized and existing under the laws
of the State of New York, in good standing, and authorized under such laws to exercise corporate trust powers and subject to supervision
or examination by federal or state authority. After appointment, any successor Warrant Agent shall be vested with all the authority,
powers, rights, immunities, duties, and obligations of its predecessor Warrant Agent with like effect as if originally named as
Warrant Agent hereunder, without any further act or deed; but if for any reason it becomes necessary or appropriate, the predecessor
Warrant Agent shall execute and deliver, at the expense of the Company, an instrument transferring to such successor Warrant Agent
all the authority, powers, and rights of such predecessor Warrant Agent hereunder; and upon request of any successor Warrant Agent
the Company shall make, execute, acknowledge, and deliver any and all instruments in writing for more fully and effectually vesting
in and confirming to such successor Warrant Agent all such authority, powers, rights, immunities, duties, and obligations.

 

5.3.2
Notice of Successor Warrant Agent. In the event a successor Warrant Agent shall be appointed, the Company shall give notice
thereof to the predecessor Warrant Agent and the transfer agent for the Common Stock not later than the effective date of any
such appointment.

 

5.3.3
Merger or Consolidation of Warrant Agent. Any corporation into which the Warrant Agent may be merged or with which it may
be consolidated or any corporation resulting from any merger or consolidation to which the Warrant Agent shall be a party shall
be the successor Warrant Agent under this Warrant Agreement without any further act.

 

5.4
Fees and Expenses of Warrant Agent.

 

5.4.1
Remuneration. The Company agrees to pay the Warrant Agent reasonable remuneration in an amount separately agreed to between
Company and Warrant Agent for its services as Warrant Agent hereunder and will reimburse the Warrant Agent upon demand for all
expenditures that the Warrant Agent may reasonably incur in the execution of its duties hereunder. One half of the total Warrant
Agent fees (not including postage) must be paid upon execution of this Warrant Agreement. The remaining half must be paid within
fifteen (15) Business Days thereafter. An invoice for any out-of-pocket and/or per item fees incurred will be rendered to and
payable by the Company within fifteen (15) Business Days of the date of said invoice. It is understood and agreed that all services
to be performed by Warrant Agent shall cease if full payment for its services has not been received in accordance with the above
schedule, and said services will not commence thereafter until all payment due has been received by Warrant Agent.

 

    	5

    	 

    

 

5.4.2
Further Assurances. The Company agrees to perform, execute, acknowledge, and deliver or cause to be performed, executed,
acknowledged, and delivered all such further and other acts, instruments, and assurances as may reasonably be required by the
Warrant Agent for the carrying out or performing of the provisions of this Warrant Agreement.

 

5.5
Liability of Warrant Agent.

 

5.5.1
Reliance on Company Statement. Whenever in the performance of its duties under this Warrant Agreement, the Warrant Agent
shall deem it necessary or desirable that any fact or matter be proved or established by the Company prior to taking or suffering
any action hereunder, such fact or matter (unless other evidence in respect thereof be herein specifically prescribed) may be
deemed to be conclusively proved and established by a statement signed by the President, Chief Executive Officer or Chief Financial
Officer of the Company and delivered to the Warrant Agent. The Warrant Agent may rely upon such statement for any action taken
or suffered in good faith by it pursuant to the provisions of this Warrant Agreement.

 

5.5.2
Indemnity. The Warrant Agent shall be liable hereunder only for its own gross negligence, willful misconduct or bad faith.
The Company agrees to indemnify the Warrant Agent and save it harmless against any and all liabilities, including judgments, claims,
losses, damages, costs and reasonable counsel fees, for anything done or omitted by the Warrant Agent in the execution of this
Warrant Agreement except as a result of the Warrant Agent’s gross negligence, willful misconduct, or bad faith.

 

5.5.3
Limitation of Liability. The Warrant Agent’s aggregate liability, if any, during the term of this Warrant Agreement
with respect to, arising from, or arising in connection with this Warrant Agreement, or from all services provided or omitted
to be provided under this Warrant Agreement, whether in contract, or in tort, or otherwise, is limited to, and shall not exceed,
the amounts paid or payable hereunder by the Company to Warrant Agent as fees and charges (not including reimbursable expenses).

 

5.5.4
Disputes. In the event any question or dispute arises with respect to the proper interpretation of this Warrant Agreement
or the Warrant Agent’s duties hereunder or the rights of the Company or of any Holder, the Warrant Agent shall not be required
to act and shall not be held liable or responsible for refusing to act until the question or dispute has been judicially settled
(and the Warrant Agent may, if it deems it advisable, but shall not be obligated to, file a suit in interpleader or for a declaratory
judgment for such purpose) by final judgment rendered by a court of competent jurisdiction, binding on all parties interested
in the matter which is no longer subject to review or appeal, or settled by a written document in form and substance satisfactory
to the Warrant Agent and executed by the Company and each other interested party. In addition, the Warrant Agent may require for
such purpose, but shall not be obligated to require, the execution of such written settlement by all of the Holders of the Warrants
and all other parties that may have an interest in the settlement.

 

5.5.5
Exclusions. The Warrant Agent shall have no responsibility with respect to the validity of this Warrant Agreement or with
respect to the validity or execution of any Warrant (except its countersignature hereof and thereof); nor shall it be responsible
for any breach by the Company of any covenant or condition contained in this Warrant Agreement or in any Warrant; nor shall it
be responsible to make any adjustments required under the provisions of Section 4 hereof or responsible for the manner,
method, or amount of any such adjustment or the ascertaining of the existence of facts that would require any such adjustment;
nor shall it by any act hereunder be deemed to make any representation or warranty as to the authorization or reservation of any
Warrant Shares to be issued pursuant to this Warrant Agreement or any Warrant or as to whether any Warrant Shares will, when issued,
be validly issued and fully paid and nonassessable.

 

    	6

    	 

    

 

5.6
Acceptance of Agency. The Warrant Agent hereby accepts the agency established by this Warrant Agreement and agrees to
perform the same upon the terms and conditions herein set forth and, among other things, shall account promptly to the Company
with respect to Warrants exercised and concurrently account for, and pay to the Company, all moneys received by the Warrant Agent
for the purchase of Warrant Shares through the exercise of Warrants.

 

6.
Miscellaneous Provisions.

 

6.1
Successors. All the covenants and provisions of this Warrant Agreement by or for the benefit of the Company or the Warrant
Agent shall bind and inure to the benefit of their respective successors and assigns.

 

6.2
Notices. Any notice, statement or demand authorized by this Warrant Agreement to be given or made by the Warrant Agent
or by a Holder to or on the Company shall be sufficiently given when so delivered if by hand or overnight delivery or if sent
by certified mail or private courier service within five (5) Business Days after deposit of such notice, postage prepaid, addressed
(until another address is filed in writing by the Company with the Warrant Agent), as follows:

 

Advaxis,
Inc.

305
College Road East

Princeton,
New Jersey 085430

Attn:
Molly Henderson, Chief Financial Officer

 

Any
notice, statement or demand authorized by this Warrant Agreement to be given or made by the a Holder or by the Company to or on
the Warrant Agent shall be sufficiently given when so delivered if by hand or overnight delivery or if sent by certified mail
or private courier service within five (5) Business Days after deposit of such notice, postage prepaid, addressed (until another
address is filed in writing by the Warrant Agent with the Company), as follows:

 

Continental
Stock Transfer and Trust Company

1
State Street, 30th Floor

New
York, NY 10004

T:
212-509-4000

 

and:

 

Cantor
Fitzgerald & Co.

499
Park Avenue

New
York, NY 10022

 

with
a copy in each case to:

 

Cooley
LLP

101
California Street, 5th Floor

San
Francisco, CA 94111

Attn:
Jonie Ing Kondracki

 

and:

 

    	7

    	 

    

 

Oppenheimer
& Co. Inc.

85
Broad Street

New
York, NY 10004

 

with
a copy in each case to:

 

Cooley
LLP

101
California Street, 5th Floor

San
Francisco, CA 94111

Attn:
Jonie Ing Kondracki

 

6.3
Applicable Law. The validity, interpretation, and performance of this Warrant Agreement and of the Warrants shall be governed
in all respects by the laws of the State of New York, without giving effect to conflicts of law principles that would result in
the application of the substantive laws of another jurisdiction. The Company hereby agrees that any action, proceeding or claim
against it arising out of or relating in any way to this Warrant Agreement shall be brought and enforced in the courts of the
State of New York or the United States District Court for the Southern District of New York, and irrevocably submits to such jurisdiction,
which jurisdiction shall be exclusive. The Company hereby waives any objection to such exclusive jurisdiction and that such courts
represent an inconvenience forum. Any such process or summons to be served upon the Company may be served by transmitting a copy
thereof by registered or certified mail, return receipt requested, postage prepaid, addressed to it at the address set forth in
Section 9.2 hereof. Such mailing shall be deemed personal service and shall be legal and binding upon the Company in any
action, proceeding or claim.

 

6.4
Persons Having Rights under this Warrant Agreement. Nothing in this Warrant Agreement expressed and nothing that may be
implied from any of the provisions hereof is intended, or shall be construed, to confer upon, or give to, any person or corporation
other than the parties hereto and the Holders of the Warrants and, for purposes of Sections 3.3, 9.3 and 9.8,
the Underwriter, any right, remedy, or claim under or by reason of this Warrant Agreement or of any covenant, condition, stipulation,
promise, or agreement hereof. The Underwriters shall be deemed to be an express third-party beneficiary of this Warrant Agreement
with respect to Sections 3.3, 9.3 and 9.8 hereof. All covenants, conditions, stipulations, promises, and
agreements contained in this Warrant Agreement shall be for the sole and exclusive benefit of the parties hereto (and the Underwriters
with respect to the Sections 3.3, 9.3 and 9.8 hereof) and their successors and assigns and of the Holders.

 

6.5
Examination of this Warrant Agreement. A copy of this Warrant Agreement shall be available at all reasonable times at the
office of the Warrant Agent in Frisco, Texas for inspection by any Holder. The Warrant Agent may require any such Holder to submit
his Warrant for inspection by it.

 

6.6
Counterparts. This Warrant Agreement may be executed in any number of original or facsimile counterparts and each of such
counterparts shall for all purposes be deemed to be an original, and all such counterparts shall together constitute but one and
the same instrument.

 

6.7
Effect of Headings. The Section headings herein are for convenience only and are not part of this Warrant Agreement and
shall not affect the interpretation thereof.

 

    	8

    	 

    

 

6.8
Amendments. This Warrant Agreement may be amended by the parties hereto without the consent of any Holder for the purpose
of curing any ambiguity, or of curing, correcting or supplementing any defective provision contained herein or adding or changing
any other provisions with respect to matters or questions arising under this Warrant Agreement as the parties may deem necessary
or desirable and that the parties deem shall not adversely affect the interest of the Holders. All other modifications or amendments,
including any amendment to increase the Exercise Price or shorten the Exercise Period, shall require the written consent of the
Underwriter and the Holders of a majority of the then outstanding Warrants.

 

6.9
Severability. This Warrant Agreement shall be deemed severable, and the invalidity or unenforceability of any term or provision
hereof shall not affect the validity or enforceability of this Warrant Agreement or of any other term or provision hereof. Furthermore,
in lieu of any such invalid or unenforceable term or provision, the parties hereto intend that there shall be added as a part
of this Warrant Agreement a provision as similar in terms to such invalid or unenforceable provision as may be possible and be
valid and enforceable.

 

6.10
Force Majeure. In the event either party is unable to perform its obligations under the terms of this Warrant Agreement
because of acts of God, strikes, failure of carrier or utilities, equipment or transmission failure or damage that is reasonably
beyond its control, or any other cause that is reasonably beyond its control, such party shall not be liable for damages to the
other for any damages resulting from such failure to perform or otherwise from such causes. Performance under this Warrant Agreement
shall resume when the affected party or parties are able to perform substantially that party’s duties.

 

6.11
Consequential Damages. Notwithstanding anything in this Warrant Agreement to the contrary, neither party to this Warrant
Agreement shall be liable to the other party for any consequential, indirect, special or incidental damages under any provision
of this Warrant Agreement or for any consequential, indirect, punitive, special or incidental damages arising out of any act or
failure to act hereunder even if that party has been advised of or has foreseen the possibility of such damages.

 

[Signature
Page Follows]

 

    	9

    	 

    

 

IN
WITNESS WHEREOF, this Warrant Agreement has been duly executed by the parties hereto as of the day and year first above written.

 

	 	ADVAXIS,
    INC.
	 	 	 
	 	By:	/s/
Molly Henderson
	 	Name:
    	Molly
    Henderson 
	 	Title:
    	Chief
    Financial Officer
	 	 	 
	 	Continental
    Stock Transfer and Trust Company
	 	 	 
	 	By:	/s/
    Stacy Aqui
	 	Name:	Stacy
Aqui
	 	Title:
    	Vice
    President

 

    	10

    	 

    

 

EXHIBIT
A

 

FORM
OF WARRANT

 

ADVAXIS,
INC.

 

Warrant
To Purchase Common Stock

 

Warrant
No.: _________

Number
of Shares of Common Stock: _____________

Date
of Issuance: September 11, 2018 (“Issuance Date”)

 

Advaxis,
Inc., a company organized under the laws of Delaware (the “Company”), hereby certifies that, for good and valuable
consideration, the receipt and sufficiency of which are hereby acknowledged, [HOLDER],
the registered holder hereof or its permitted assigns (the “Holder”), is entitled, subject to the terms set
forth below, to purchase from the Company, at the Exercise Price (as defined below) then in effect, at any time or times on or
after September 11, 2018 (the “Initial Exercisability Date”), but not after 11:59 p.m., New York time, on the
Expiration Date, (as defined below), ______________ (_____________)1 fully paid non-assessable shares of Common Stock
(as defined below), subject to adjustment as provided herein (the “Warrant Shares”). Except as otherwise defined
herein, capitalized terms in this Warrant to Purchase Common Stock (including any Warrants to Purchase Common Stock issued in
exchange, transfer or replacement hereof, this “Warrant”), shall have the meanings set forth in Section 16.
This Warrant is one of the Warrants to Purchase Common Stock (the “Warrants”) issued pursuant to (i) that certain
Underwriting Agreement, dated as of September 7, 2018 (the “Subscription Date”) by and among the Company, Cantor
Fitzgerald & Co. and Oppenheimer & Co. Inc., (ii) the Company’s Registration Statement on Form S-3 (File number
333-226988) (the “Registration Statement”) and (iii) the Company’s prospectus supplement dated as of
September 7, 2018.

 

1.
EXERCISE OF WARRANT.

 

(a)
Mechanics of Exercise. Subject to the terms and conditions hereof (including, without limitation, the limitations set forth
in Section 1(f)), this Warrant may be exercised by the Holder at any time or times on or after the Initial Exercisability Date,
in whole or in part, by delivery (whether via facsimile, electronic mail or otherwise) of a written notice, in the form attached
hereto as Exhibit A (the “Exercise Notice”), of the Holder’s election to exercise this Warrant.
Within two (2) Trading Days following the delivery of the Exercise Notice, the Holder shall make payment to the Company of an
amount equal to the Exercise Price in effect on the date of such exercise multiplied by the number of Warrant Shares as to which
this Warrant is being exercised (the “Aggregate Exercise Price”) in cash by wire transfer of immediately available
funds or, if the provisions of Section 1(d) are applicable, by notifying the Company that this Warrant is being exercised pursuant
to a Cashless Exercise (as defined in Section 1(d)). The Holder shall not be required to deliver the original Warrant in order
to effect an exercise hereunder, nor shall any ink-original signature or medallion guarantee (or other type of guarantee or notarization)
with respect to any Exercise Notice be required. Execution and delivery of the Exercise Notice with respect to less than all of
the Warrant Shares shall have the same effect as cancellation of the original Warrant and issuance of a new Warrant evidencing
the right to purchase the remaining number of Warrant Shares and the Holder shall not be required to physically surrender this
Warrant to the Company until the Holder has purchased all of the Warrant Shares available hereunder and the Warrant has been exercised
in full, in which case, the Holder shall surrender this Warrant to the Company for cancellation within three (3) Trading Days
of the date on which the final Exercise Notice is delivered to the Company. On or before the first (1st) Trading Day
following the date on which the Holder has delivered the applicable Exercise Notice, the Company shall transmit by facsimile or
electronic mail an acknowledgment of confirmation of receipt of the Exercise Notice, in the form attached to the Exercise Notice,
to the Holder and the Company’s transfer agent (the “Transfer Agent”). So long as the Holder delivers
the Aggregate Exercise Price (or notice of a Cashless Exercise) on or prior to the first (1st) Trading Day following
the date on which the Exercise Notice has been delivered to the Company, then on or prior to the earlier of (i) the second (2nd)
Trading Day and (ii) the number of Trading Days comprising the Standard Settlement Period, in each case following the date on
which the Exercise Notice has been delivered to the Company, or, if the Holder does not deliver the Aggregate Exercise Price (or
notice of a Cashless Exercise) on or prior to the first (1st) Trading Day following the date on which the Exercise
Notice has been delivered to the Company, then on or prior to the second (2nd) Trading Day following the date on which the Aggregate
Exercise Price (or notice of a Cashless Exercise) is delivered (such earlier date, the “Share Delivery Date”),
the Company shall (X) provided that the Transfer Agent is participating in The Depository Trust Company (“DTC”)
Fast Automated Securities Transfer Program, credit such aggregate number of Warrant Shares to which the Holder is entitled pursuant
to such exercise to the Holder’s or its designee’s balance account with DTC through its Deposit / Withdrawal At Custodian
system, or (Y) if the Transfer Agent is not participating in the DTC Fast Automated Securities Transfer Program, issue and dispatch
by overnight courier to the address as specified in the Exercise Notice, a certificate, registered in the name of the Holder or
its designee, for the number of Warrant Shares to which the Holder is entitled pursuant to such exercise. The Company shall be
responsible for all fees and expenses of the Transfer Agent and all fees and expenses with respect to the issuance of Warrant
Shares via DTC, if any, including without limitation for same day processing. Upon delivery of the Exercise Notice, the Holder
shall be deemed for all corporate purposes to have become the holder of record and beneficial owner of the Warrant Shares with
respect to which this Warrant has been exercised, irrespective of the date such Warrant Shares are credited to the Holder’s
DTC account or the date of delivery of the certificates evidencing such Warrant Shares, as the case may be. If this Warrant is
physically delivered to the Company in connection with any exercise pursuant to this Section 1(a) and the number of Warrant Shares
represented by this Warrant submitted for exercise is greater than the number of Warrant Shares being acquired upon an exercise,
then the Company shall as soon as practicable and in no event later than three (3) Trading Days after any exercise and at its
own expense, issue and deliver to the Holder (or its designee) a new Warrant (in accordance with Section 7(d)) representing the
right to purchase the number of Warrant Shares issuable immediately prior to such exercise under this Warrant, less the number
of Warrant Shares with respect to which this Warrant is exercised. No fractional Warrant Shares are to be issued upon the exercise
of this Warrant, but rather the number of Warrant Shares to be issued shall be rounded to the nearest whole number. The Company
shall pay any and all transfer, stamp, issuance and similar taxes, costs and expenses (including, without limitation, fees and
expenses of the Transfer Agent) which may be payable with respect to the issuance and delivery of Warrant Shares upon exercise
of this Warrant. The Company’s obligations to issue and deliver Warrant Shares in accordance with the terms and subject
to the conditions hereof are absolute and unconditional, irrespective of any action or inaction by the Holder to enforce the same,
any waiver or consent with respect to any provision hereof, the recovery of any judgment against any Person or any action to enforce
the same, or any setoff, counterclaim, recoupment, limitation or termination; provided, however, that the Company
shall not be required to deliver Warrant Shares with respect to an exercise prior to the Holder’s delivery of the Aggregate
Exercise Price (or notice of a Cashless Exercise) with respect to such exercise.

 

 

1
Insert 85% of the number of shares of Common Stock purchased pursuant to the Underwriting Agreement.

 

    	 	 	 

     

    

 

(b)
Exercise Price. For purposes of this Warrant, “Exercise Price” means $1.50 per share, subject to adjustment
as provided herein.

 

(c)
Company’s Failure to Timely Deliver Securities. If either (I) the Company shall fail for any reason or for no reason
on or prior to the applicable Share Delivery Date, (x) if the Transfer Agent is not participating in the DTC Fast Automated Securities
Transfer Program, to issue to the Holder a certificate for the number of shares of Common Stock to which the Holder is entitled
and register such Common Stock on the Company’s share register or (y) if the Transfer Agent is participating in the DTC
Fast Automated Securities Transfer Program, to credit the Holder’s balance account with DTC, for such number of shares of
Common Stock to which the Holder is entitled upon the Holder’s exercise of this Warrant or (II) a registration statement
(which may be the Registration Statement) covering the issuance or resale of the Warrant Shares that are the subject of the Exercise
Notice (the “Exercise Notice Warrant Shares”) is not available for the issuance or resale, as applicable, of
such Exercise Notice Warrant Shares and (x) the Company fails to promptly, but in no event later than two (2) Business Days after
such registration statement becomes unavailable, to so notify the Holder and (y) the Company is unable to deliver the Exercise
Notice Warrant Shares electronically without any restrictive legend by crediting such aggregate number of Exercise Notice Warrant
Shares to the Holder’s or its designee’s balance account with DTC through its Deposit / Withdrawal At Custodian system
(the event described in the immediately foregoing clause (II) is hereinafter referred to as a “Notice Failure”
and, together with the event described in clause (I) above, an “Exercise Failure”), then, in addition to all
other remedies available to the Holder, if on or prior to the applicable Share Delivery Date either (I) if the Transfer Agent
is not participating in the DTC Fast Automated Securities Transfer Program, the Company shall fail to issue and deliver a certificate
to the Holder and register such shares of Common Stock on the Company’s share register or, if the Transfer Agent is participating
in the DTC Fast Automated Securities Transfer Program, credit the Holder’s balance account with DTC for the number of shares
of Common Stock to which the Holder is entitled upon the Holder’s exercise hereunder or pursuant to the Company’s
obligation pursuant to clause (ii) below or (II) a Notice Failure occurs, and if on or after such Trading Day the Holder purchases
(in an open market transaction or otherwise) Common Stock to deliver in satisfaction of a sale by the Holder of shares of Common
Stock issuable upon such exercise that the Holder anticipated receiving from the Company (a “Buy-In”), then
the Company shall, within five (5) Trading Days after the Holder’s request and in the Holder’s discretion, either
(i) pay cash to the Holder in an amount equal to the Holder’s total purchase price (including brokerage commissions and
other out-of-pocket expenses, if any) for the shares of Common Stock so purchased (the “Buy-In Price”), at
which point the Company’s obligation to deliver such certificate (and to issue such shares of Common Stock) or credit such
Holder’s balance account with DTC for such shares of Common Stock shall terminate, or (ii) promptly honor its obligation
to deliver to the Holder a certificate or certificates representing such shares of Common Stock or credit such Holder’s
balance account with DTC, as applicable, and pay cash to the Holder in an amount equal to the excess (if any) of the Buy-In Price
over the product of (A) such number of shares of Common Stock, times (B) any trading price of the Common Stock selected by the
Holder in writing as in effect at any time during the period beginning on the applicable Exercise Date and ending on the applicable
Share Delivery Date. Nothing shall limit the Holder’s right to pursue any other remedies available to it hereunder, at law
or in equity, including, without limitation, a decree of specific performance and/or injunctive relief with respect to the Company’s
failure to timely deliver certificates representing Warrant Shares (or to electronically deliver such Warrant Shares) upon the
exercise of this Warrant as required pursuant to the terms hereof. While this Warrant is outstanding, the Company shall cause
its transfer agent to participate in the DTC Fast Automated Securities Transfer Program. In addition to the foregoing rights,
(i) if the Company fails to deliver the applicable number of Warrant Shares upon an exercise pursuant to Section 1 by the applicable
Share Delivery Date, then the Holder shall have the right to rescind such exercise in whole or in part and retain and/or have
the Company return, as the case may be, any portion of this Warrant that has not been exercised pursuant to such Exercise Notice;
provided that the rescission of an exercise shall not affect the Company’s obligation to make any payments that have accrued
prior to the date of such notice pursuant to this Section 1(c) or otherwise, and (ii) if a registration statement (which may be
the Registration Statement) covering the issuance or resale of the Warrant Shares that are subject to an Exercise Notice is not
available for the issuance or resale, as applicable, of such Exercise Notice Warrant Shares and the Holder has submitted an Exercise
Notice prior to receiving notice of the non-availability of such registration statement and the Company has not already delivered
the Warrant Shares underlying such Exercise Notice electronically without any restrictive legend by crediting such aggregate number
of Warrant Shares to which the Holder is entitled pursuant to such exercise to the Holder’s or its designee’s balance
account with DTC through its Deposit / Withdrawal At Custodian system, the Holder shall have the option, by delivery of notice
to the Company, to (x) rescind such Exercise Notice in whole or in part and retain or have returned, as the case may be, any portion
of this Warrant that has not been exercised pursuant to such Exercise Notice; provided that the rescission of an Exercise Notice
shall not affect the Company’s obligation to make any payments that have accrued prior to the date of such notice pursuant
to this Section 1(c) or otherwise, and/or (y) switch some or all of such Exercise Notice from a cash exercise to a Cashless Exercise.

 

    	 	- 2 -	 

     

    

 

(d)
Cashless Exercise. Notwithstanding anything contained herein to the contrary, if a registration statement (which may be
the Registration Statement) covering the issuance or resale of the Exercise Notice Warrant Shares is not available for the issuance
or resale, as applicable, of such Exercise Notice Warrant Shares, the Holder may, in its sole discretion, exercise this Warrant
in whole or in part and, in lieu of making the cash payment otherwise contemplated to be made to the Company upon such exercise
in payment of the Aggregate Exercise Price, elect instead to receive upon such exercise the “Net Number” of shares
of Common Stock determined according to the following formula (a “Cashless Exercise”):

 

	 	Net
    Number =	(A
    x B) - (A x C)	 
	 	 	B	 

 

For
purposes of the foregoing formula:

 

A=
the total number of shares with respect to which this Warrant is then being exercised.

 

B=
the arithmetic average of the Weighted Average Prices during the five (5) Trading Days immediately preceding the date of the applicable
Exercise Notice.

 

C=
the Exercise Price then in effect for the applicable Warrant Shares at the time of such exercise.

 

If
Warrant Shares are issued in such a cashless exercise, the Company acknowledges and agrees that in accordance with Section 3(a)(9)
of the Securities Act of 1933, as amended, the Warrant Shares shall take on the registered characteristics of the Warrants being
exercised, and the holding period of the Warrants being exercised may be tacked on to the holding period of the Warrant Shares.
The Company agrees not to take any position contrary to this Section 1(d).

 

(e)
Disputes. In the case of a dispute as to the determination of the Exercise Price or the arithmetic calculation of the Warrant
Shares, the Company shall promptly issue to the Holder the number of Warrant Shares that are not disputed and resolve such dispute
in accordance with Section 11.

 

    	 	- 3 -	 

     

    

 

(f)
Beneficial Ownership. Notwithstanding anything to the contrary contained herein, the Company shall not effect the exercise
of any portion of this Warrant, and the Holder shall not have the right to exercise any portion of this Warrant, pursuant to the
terms and conditions of this Warrant and any such exercise shall be null and void and treated as if never made, to the extent
that after giving effect to such exercise, the Holder together with the other Attribution Parties collectively would beneficially
own in excess of 4.99% (the “Maximum Percentage”) of the number of shares of Common Stock outstanding immediately
after giving effect to such exercise. For purposes of the foregoing sentence, the aggregate number of shares of Common Stock beneficially
owned by the Holder and the other Attribution Parties shall include the number of shares of Common Stock held by the Holder and
all other Attribution Parties plus the number of shares of Common Stock issuable upon exercise of this Warrant with respect to
which the determination of such sentence is being made, but shall exclude the number of shares of Common Stock which would be
issuable upon (A) exercise of the remaining, unexercised portion of this Warrant beneficially owned by the Holder or any of the
other Attribution Parties and (B) exercise or conversion of the unexercised or unconverted portion of any other securities of
the Company (including, without limitation, any convertible notes or convertible preferred stock or warrants, including the other
Warrants) beneficially owned by the Holder or any other Attribution Party subject to a limitation on conversion or exercise analogous
to the limitation contained in this Section 1(f). For purposes of this Section 1(f), beneficial ownership shall be calculated
in accordance with Section 13(d) of the Securities Exchange Act of 1934, as amended (the “1934 Act”). For purposes
of this Warrant, in determining the number of outstanding shares of Common Stock the Holder may acquire upon the exercise of this
Warrant without exceeding the Maximum Percentage, the Holder may rely on the number of outstanding shares of Common Stock as reflected
in (x) the Company’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and Current Reports on Form 8-K
or other public filing with the Securities and Exchange Commission (the “SEC”), as the case may be, (y) a more
recent public announcement by the Company or (z) any other written notice by the Company or the Transfer Agent setting forth the
number of shares of Common Stock outstanding (the “Reported Outstanding Share Number”). If the Company receives
an Exercise Notice from the Holder at a time when the actual number of outstanding shares of Common Stock is less than the Reported
Outstanding Share Number, the Company shall (i) notify the Holder in writing of the number of shares of Common Stock then outstanding
and, to the extent that such Exercise Notice would otherwise cause the Holder’s beneficial ownership, as determined pursuant
to this Section 1(f), to exceed the Maximum Percentage, the Holder must notify the Company of a reduced number of Warrant Shares
to be purchased pursuant to such Exercise Notice (the number of shares by which such purchase is reduced, the “Reduction
Shares”) and (ii) as soon as reasonably practicable, the Company shall return to the Holder any exercise price paid
by the Holder for the Reduction Shares. For any reason at any time, upon the written or oral request of the Holder, the Company
shall within two (2) Business Days confirm orally and in writing or by electronic mail to the Holder the number of shares of Common
Stock then outstanding. In any case, the number of outstanding shares of Common Stock shall be determined after giving effect
to the conversion or exercise of securities of the Company, including this Warrant, by the Holder and any other Attribution Party
since the date as of which the Reported Outstanding Share Number was reported. In the event that the issuance of Common Stock
to the Holder upon exercise of this Warrant results in the Holder and the other Attribution Parties being deemed to beneficially
own, in the aggregate, more than the Maximum Percentage of the number of outstanding shares of Common Stock (as determined under
Section 13(d) of the 1934 Act), the number of shares so issued by which the Holder’s and the other Attribution Parties’
aggregate beneficial ownership exceeds the Maximum Percentage (the “Excess Shares”) shall be deemed null and
void and shall be cancelled ab initio, and the Holder shall not have the power to vote or to transfer the Excess Shares. As soon
as reasonably practicable after the issuance of the Excess Shares has been deemed null and void, the Company shall return to the
Holder the exercise price paid by the Holder for the Excess Shares. Upon delivery of a written notice to the Company, the Holder
may from time to time increase or decrease the Maximum Percentage to any other percentage not in excess of 9.99% as specified
in such notice; provided that (i) any such increase in the Maximum Percentage will not be effective until the sixty-first (61st)
day after such notice is delivered to the Company and (ii) any such increase or decrease will apply only to the Holder and the
other Attribution Parties and not to any other holder of Warrants that is not an Attribution Party of the Holder. For purposes
of clarity, the shares of Common Stock issuable pursuant to the terms of this Warrant in excess of the Maximum Percentage shall
not be deemed to be beneficially owned by the Holder for any purpose including for purposes of Section 13(d) or Rule 16a-1(a)(1)
of the 1934 Act. No prior inability to exercise this Warrant pursuant to this paragraph shall have any effect on the applicability
of the provisions of this paragraph with respect to any subsequent determination of exercisability. The provisions of this paragraph
shall be construed and implemented in a manner otherwise than in strict conformity with the terms of this Section 1(f) to the
extent necessary to correct this paragraph or any portion of this paragraph which may be defective or inconsistent with the intended
beneficial ownership limitation contained in this Section 1(f) or to make changes or supplements necessary or desirable to properly
give effect to such limitation. The limitation contained in this paragraph may not be waived and shall apply to a successor holder
of this Warrant.

 

    	 	- 4 -	 

     

    

 

(g)
Required Reserve Amount. So long as this Warrant remains outstanding, the Company shall at all times keep reserved for
issuance under this Warrant a number of shares of Common Stock at least equal to 100% of the maximum number of shares of Common
Stock as shall be necessary to satisfy the Company’s obligation to issue shares of Common Stock under the Warrants then
outstanding (without regard to any limitations on exercise) (the “Required Reserve Amount”); provided
that at no time shall the number of shares of Common Stock reserved pursuant to this Section 1(g) be reduced other than in connection
with any exercise of Warrants or such other event covered by Section 2(c) below. The Required Reserve Amount (including, without
limitation, each increase in the number of shares so reserved) shall be allocated pro rata among the holders of the Warrants based
on the number of shares of Common Stock issuable upon exercise of Warrants held by each holder thereof on the Issuance Date (without
regard to any limitations on exercise) (the “Authorized Share Allocation”). In the event that a holder shall
sell or otherwise transfer any of such holder’s Warrants, each transferee shall be allocated a pro rata portion of such
holder’s Authorized Share Allocation. Any shares of Common Stock reserved and allocated to any Person which ceases to hold
any Warrants shall be allocated to the remaining holders of Warrants, pro rata based on the number of shares of Common Stock issuable
upon exercise of the Warrants then held by such holders thereof (without regard to any limitations on exercise).

 

(h)
Insufficient Authorized Shares. If at any time while this Warrant remains outstanding the Company does not have a sufficient
number of authorized and unreserved shares of Common Stock to satisfy its obligation to reserve for issuance the Required Reserve
Amount (an “Authorized Share Failure”), then the Company shall promptly take all action reasonably necessary
to increase the Company’s authorized shares of Common Stock to an amount sufficient to allow the Company to reserve the
Required Reserve Amount for this Warrant then outstanding. Without limiting the generality of the foregoing sentence, as soon
as practicable after the date of the occurrence of an Authorized Share Failure, but in no event later than ninety (90) days after
the occurrence of such Authorized Share Failure, the Company shall hold a meeting of its stockholders for the approval of an increase
in the number of authorized shares of Common Stock. In connection with such meeting, the Company shall provide each stockholder
with a proxy statement and shall use its reasonable best efforts to solicit its stockholders’ approval of such increase
in authorized shares of Common Stock and to cause its board of directors to recommend to the stockholders that they approve such
proposal. Notwithstanding the foregoing, if any such time of an Authorized Share Failure, the Company is able to obtain the written
consent of a majority of the shares of its issued and outstanding shares of Common Stock to approve the increase in the number
of authorized shares of Common Stock, the Company may satisfy this obligation by obtaining such consent and submitting for filing
with the SEC an Information Statement on Schedule 14C.

 

    	 	- 5 -	 

     

    

 

2.
ADJUSTMENT OF EXERCISE PRICE AND NUMBER OF WARRANT SHARES. The Exercise Price and the number of Warrant Shares shall be
adjusted from time to time as follows:

 

(a)
Adjustment Upon Issuance of Common Stock. If and whenever on or after the Subscription Date the Company issues or sells,
or in accordance with this Section 2 is deemed to have issued or sold, any shares of Common Stock (including the issuance or sale
of shares of Common Stock owned or held by or for the account of the Company, but excluding shares of Common Stock deemed to have
been issued or sold by the Company in connection with any Excluded Securities) for a consideration per share (the “New
Issuance Price”) less than a price (the “Applicable Price”) equal to the Exercise Price in effect
immediately prior to such issuance or sale or deemed issuance or sale (the foregoing a “Dilutive Issuance”),
then immediately after such Dilutive Issuance, the Exercise Price then in effect shall be reduced to an amount equal to the New
Issuance Price. For purposes of determining the adjusted Exercise Price under this Section 2(a), the following shall be applicable:

 

(i)
Issuance of Options. If the Company in any manner grants or sells any Options and the lowest price per share for which
one share of Common Stock is issuable upon the exercise of any such Options or upon conversion, exercise or exchange of any Convertible
Securities issuable upon exercise of any such Options is less than the Applicable Price, then such share of Common Stock shall
be deemed to be outstanding and to have been issued and sold by the Company at the time of the granting or sale of such Options
for such price per share. For purposes of this Section 2(a)(i), the “lowest price per share for which one share of Common
Stock is issuable upon the exercise of any such Options or upon conversion, exercise or exchange of any Convertible Securities
issuable upon exercise of any such Options” shall be equal to the sum of the lowest amounts of consideration (if any) received
or receivable by the Company with respect to any one share of Common Stock upon the granting or sale of the Options, upon exercise
of the Options and upon conversion, exercise or exchange of any Convertible Security issuable upon exercise of such Options less
any consideration paid or payable by the Company with respect to such one share of Common Stock upon the granting or sale of such
Options, upon exercise of such Options and upon conversion exercise or exchange of any Convertible Security issuable upon exercise
of such Options. No further adjustment of the Exercise Price shall be made upon the actual issuance of such shares of Common Stock
or of such Convertible Securities upon the exercise of such Options or upon the actual issuance of such shares of Common Stock
upon conversion, exercise or exchange of such Convertible Securities.

 

    	 	- 6 -	 

     

    

 

(ii)
Issuance of Convertible Securities. If the Company in any manner issues or sells any Convertible Securities and the lowest
price per share for which one share of Common Stock is issuable upon the conversion, exercise or exchange thereof is less than
the Applicable Price, then such share of Common Stock shall be deemed to be outstanding and to have been issued and sold by the
Company at the time of the issuance or sale of such Convertible Securities for such price per share. For the purposes of this
Section 2(a)(ii), the “lowest price per share for which one share of Common Stock is issuable upon the conversion, exercise
or exchange thereof” shall be equal to the sum of the lowest amounts of consideration (if any) received or receivable by
the Company with respect to any one share of Common Stock upon the issuance or sale of the Convertible Security and upon conversion,
exercise or exchange of such Convertible Security less any consideration paid or payable by the Company with respect to such one
share of Common Stock upon the issuance or sale of such Convertible Security and upon conversion, exercise or exchange of such
Convertible Security. No further adjustment of the Exercise Price shall be made upon the actual issuance of such shares of Common
Stock upon conversion, exercise or exchange of such Convertible Securities, and if any such issuance or sale of such Convertible
Securities is made upon exercise of any Options for which adjustment of the Exercise Price has been or is to be made pursuant
to other provisions of this Section 2(a), no further adjustment of the Exercise Price shall be made by reason of such issuance
or sale.

 

(iii)
Change in Option Price or Rate of Conversion. If the purchase price provided for in any Options, the additional consideration,
if any, payable upon the issue, conversion, exercise or exchange of any Convertible Securities, or the rate at which any Convertible
Securities are convertible into or exercisable or exchangeable for shares of Common Stock increases or decreases at any time,
the Exercise Price in effect at the time of such increase or decrease shall be adjusted to the Exercise Price, which would have
been in effect at such time had such Options or Convertible Securities provided for such increased or decreased purchase price,
additional consideration or increased or decreased conversion rate, as the case may be, at the time initially granted, issued
or sold. For purposes of this Section 2(a)(iii), if the terms of any Option or Convertible Security that was outstanding as of
the Subscription Date are increased or decreased in the manner described in the immediately preceding sentence, then such Option
or Convertible Security and the shares of Common Stock deemed issuable upon exercise, conversion or exchange thereof shall be
deemed to have been issued as of the date of such increase or decrease. No adjustment pursuant to this Section 2(a) shall be made
if such adjustment would result in an increase of the Exercise Price then in effect.

 

    	 	- 7 -	 

     

    

 

(iv)
Calculation of Consideration Received. If any Option and/or Convertible Security is issued in connection with the issuance
or sale or deemed issuance or sale of any other securities of the Company, which, for the avoidance of doubt, may include other
Options and/or Convertible Securities (as determined by the Holder, the “Primary Security”, and such Option and/or
Convertible Security, the “Secondary Securities” and together with the Primary Security, each a “Unit”),
together comprising one integrated transaction, the aggregate consideration per share of Common Stock with respect to such Primary
Security shall be deemed to be the lowest of (x) the purchase price of such Unit, (y) if such Primary Security is an Option and/or
Convertible Security, the lowest price per share for which one share of Common Stock is at any time issuable upon the exercise
or conversion of the Primary Security in accordance with Section 2(b)(i) or 2(b)(ii) above and (z) 90% of the arithmetic average
of the Weighted Average Prices of the Common Stock during the five (5) Trading Day period immediately following the public announcement
of such Dilutive Issuance (for the avoidance of doubt, (i) if such public announcement is released prior to the opening of the
Principal Market on a Trading Day, such Trading Day shall be the first Trading Day in such five (5) Trading Day period and (ii)
if Buyer exercises any portion of this Warrant prior to the expiration of such 5 Trading Day Period, such Warrant Shares shall
be delivered in connection with such exercise, but the Buyer shall not send any consideration in respect of such exercise until
the Exercise Price is finally determined in accordance with this Section). If any shares of Common Stock, Options or Convertible
Securities are issued or sold or deemed to have been issued or sold for cash, the consideration received therefor (for the purpose
of determining the consideration paid for such Common Stock, Option or Convertible Security) will be deemed to be the net amount
of consideration received by the Company therefor. If any shares of Common Stock, Options or Convertible Securities are issued
or sold for a consideration other than cash, the amount of such consideration received by the Company (for the purpose of determining
the consideration paid for such Common Stock, Option or Convertible Security) will be the fair value of such consideration, except
where such consideration consists of publicly traded securities, in which case the amount of consideration received by the Company
for such securities will be the arithmetic average of the Weighted Average Prices of such security for each of the five (5) Trading
Days immediately preceding the date of receipt. If any shares of Common Stock, Options or Convertible Securities are issued to
the owners of the non-surviving entity in connection with any merger in which the Company is the surviving entity, the amount
of consideration therefor (for the purpose of determining the consideration paid for such Common Stock, Option or Convertible
Security) will be deemed to be the fair value of such portion of the net assets and business of the non-surviving entity as is
attributable to such shares of Common Stock, Options or Convertible Securities (as the case may be). The fair value of any consideration
other than cash or publicly traded securities will be determined jointly by the Company and the Holder. If such parties are unable
to reach agreement within ten (10) days after the occurrence of an event requiring valuation (the “Valuation Event”),
the fair value of such consideration will be determined within five (5) Trading Days after the tenth (10th) day following such
Valuation Event by an independent, reputable appraiser jointly selected by the Company and the Holder. The determination of such
appraiser shall be final and binding upon all parties absent manifest error and the fees and expenses of such appraiser shall
be borne by the Company.

 

(v)
Record Date. If the Company takes a record of the holders of Common Stock for the purpose of entitling them (A) to receive
a dividend or other distribution payable in shares of Common Stock, Options or in Convertible Securities or (B) to subscribe for
or purchase shares of Common Stock, Options or Convertible Securities, then such record date will be deemed to be the date of
the issuance or sale of the shares of Common Stock deemed to have been issued or sold upon the declaration of such dividend or
the making of such other distribution or the date of the granting of such right of subscription or purchase, as the case may be.

 

    	 	- 8 -	 

     

    

 

(vi)
No Readjustments. For the avoidance of doubt, in the event the Exercise Price has been adjusted pursuant to this
Section 2(a) and the Dilutive Issuance that triggered such adjustment is unwound or is cancelled after the facts for any reason
whatsoever, in no event shall the Exercise Price be readjusted to the Exercise Price that would have been in effect if such Dilutive
Issuance had not occurred or been consummated.

 

(b)
Voluntary Adjustment By Company. The Company may at any time during the term of this Warrant reduce the then current Exercise
Price to any amount and for any period of time deemed appropriate by the Board of Directors of the Company.

 

(c)
Adjustment Upon Subdivision or Combination of Common Stock. If the Company at any time on or after the Subscription Date
subdivides (by any stock split, stock dividend, recapitalization or otherwise) one or more classes of its outstanding shares of
Common Stock into a greater number of shares, the Exercise Price in effect immediately prior to such subdivision will be proportionately
reduced and the number of Warrant Shares will be proportionately increased. If the Company at any time on or after the Subscription
Date combines (by combination, reverse stock split or otherwise) one or more classes of its outstanding shares of Common Stock
into a smaller number of shares, the Exercise Price in effect immediately prior to such combination will be proportionately increased
and the number of Warrant Shares will be proportionately decreased. Any adjustment under this Section 2(c) shall become effective
at the close of business on the date the subdivision or combination becomes effective.

 

(d)
Other Events. If any event occurs of the type contemplated by the provisions of this Section 2 but not expressly provided
for by such provisions (including, without limitation, the granting of stock appreciation rights, phantom stock rights or other
rights with equity features), then the Company’s Board of Directors will make an appropriate adjustment in the Exercise
Price and the number of Warrant Shares, as mutually determined by the Company’s Board of Directors and the Required Holders,
so as to protect the rights of the Holder; provided that no such adjustment pursuant to this Section 2(d) will increase
the Exercise Price or decrease the number of Warrant Shares as otherwise determined pursuant to this Section 2.

 

3.
RIGHTS UPON DISTRIBUTION OF ASSETS. In addition to any adjustments pursuant to Section 2 above, if, on or after the Subscription
Date and on or prior to the Expiration Date, the Company shall declare or make any dividend or other distribution of its assets
(or rights to acquire its assets) to holders of shares of Common Stock, by way of return of capital or otherwise (including, without
limitation, any distribution of cash, stock or other securities, property, options, evidence of indebtedness or any other assets
by way of a dividend, spin off, reclassification, corporate rearrangement, scheme of arrangement or other similar transaction)
(a “Distribution”), at any time after the issuance of this Warrant, then, in each such case, the Holder shall
be entitled to participate in such Distribution to the same extent that the Holder would have participated therein if the Holder
had held the number of shares of Common Stock acquirable upon complete exercise of this Warrant (without regard to any limitations
or restrictions on exercise of this Warrant, including without limitation, the Maximum Percentage) immediately before the date
on which a record is taken for such Distribution, or, if no such record is taken, the date as of which the record holders of shares
of Common Stock are to be determined for the participation in such Distribution (provided, however, that to the
extent that the Holder’s right to participate in any such Distribution would result in the Holder and the other Attribution
Parties exceeding the Maximum Percentage, then the Holder shall not be entitled to participate in such Distribution to such extent
(and shall not be entitled to beneficial ownership of such shares of Common Stock as a result of such Distribution (and beneficial
ownership) to such extent) and the portion of such Distribution shall be held in abeyance for the benefit of the Holder until
such time or times as its right thereto would not result in the Holder and the other Attribution Parties exceeding the Maximum
Percentage, at which time or times the Holder shall be granted such Distribution (and any Distributions declared or made on such
initial Distribution or on any subsequent Distribution held similarly in abeyance) to the same extent as if there had been no
such limitation).

 

    	 	- 9 -	 

     

    

 

4.
PURCHASE RIGHTS; FUNDAMENTAL TRANSACTIONS.

 

(a)
Purchase Rights. In addition to any adjustments pursuant to Section 2 above, if at any time on or after the Subscription
Date and on or prior to the Expiration Date the Company grants, issues or sells any Options, Convertible Securities or rights
to purchase stock, warrants, securities or other property pro rata to the record holders of any class of Common Stock (the “Purchase
Rights”), then the Holder will be entitled to acquire, upon the terms applicable to such Purchase Rights, the aggregate
Purchase Rights which the Holder could have acquired if the Holder had held the number of shares of Common Stock acquirable upon
complete exercise of this Warrant (without regard to any limitations or restrictions on exercise of this Warrant, including without
limitation, the Maximum Percentage) immediately before the date on which a record is taken for the grant, issuance or sale of
such Purchase Rights, or, if no such record is taken, the date as of which the record holders of Common Stock are to be determined
for the grant, issuance or sale of such Purchase Rights (provided, however, that to the extent that the Holder’s
right to participate in any such Purchase Right would result in the Holder and the other Attribution Parties exceeding the Maximum
Percentage, then the Holder shall not be entitled to participate in such Purchase Right to such extent (and shall not be entitled
to beneficial ownership of such Common Stock as a result of such Purchase Right (and beneficial ownership) to such extent) and
such Purchase Right to such extent shall be held in abeyance for the benefit of the Holder until such time or times as its right
thereto would not result in the Holder and the other Attribution Parties exceeding the Maximum Percentage, at which time or times
the Holder shall be granted such right (and any Purchase Right granted, issued or sold on such initial Purchase Right or on any
subsequent Purchase Right to be held similarly in abeyance) to the same extent as if there had been no such limitation).

 

(b)
Fundamental Transaction. The Company shall not enter into or be party to a Fundamental Transaction unless the Successor
Entity assumes in writing all of the obligations of the Company under this Warrant in accordance with the provisions of this Section
4(b), including agreements to deliver to the Holder in exchange for this Warrant a security of the Successor Entity evidenced
by a written instrument substantially similar in form and substance to this Warrant, including, without limitation, which is exercisable
for a corresponding number of shares of capital stock equivalent to the shares of Common Stock acquirable and receivable upon
exercise of this Warrant (without regard to any limitations on the exercise of this Warrant) prior to such Fundamental Transaction,
and with an exercise price which applies the exercise price hereunder to such shares of capital stock (but taking into account
the relative value of the shares of Common Stock pursuant to such Fundamental Transaction and the value of such shares of capital
stock, such adjustments to the number of shares of capital stock and such exercise price being for the purpose of protecting the
economic value of this Warrant immediately prior to the consummation of such Fundamental Transaction). Upon the consummation of
each Fundamental Transaction, the Successor Entity shall succeed to, and be substituted for the Company (so that from and after
the date of the applicable Fundamental Transaction, the provisions of this Warrant and the other Transaction Documents referring
to the “Company” shall refer instead to the Successor Entity), and may exercise every right and power of the Company
and shall assume all of the obligations of the Company under this Warrant with the same effect as if such Successor Entity had
been named as the Company herein. Upon consummation of each Fundamental Transaction, the Successor Entity shall deliver to the
Holder confirmation that there shall be issued upon exercise of this Warrant at any time after the consummation of the applicable
Fundamental Transaction, in lieu of the shares of Common Stock (or other securities, cash, assets or other property (except such
items still issuable under Sections 3 and 4(a) above, which shall continue to be receivable thereafter)) issuable upon the exercise
of this Warrant prior to the applicable Fundamental Transaction, such shares of common stock (or its equivalent) of the Successor
Entity (including its Parent Entity) which the Holder would have been entitled to receive upon the happening of the applicable
Fundamental Transaction had this Warrant been exercised immediately prior to the applicable Fundamental Transaction (without regard
to any limitations on the exercise of this Warrant), as adjusted in accordance with the provisions of this Warrant. Notwithstanding
the foregoing, and without limiting Section 1(f) hereof, the Holder may elect, at its sole option, by delivery of written notice
to the Company to waive this Section 4(b) to permit the Fundamental Transaction without the assumption of this Warrant. In addition
to and not in substitution for any other rights hereunder, prior to the consummation of each Fundamental Transaction pursuant
to which holders of shares of Common Stock are entitled to receive securities or other assets with respect to or in exchange for
shares of Common Stock (a “Corporate Event”), the Company shall make appropriate provision to insure that the Holder
will thereafter have the right to receive upon an exercise of this Warrant at any time after the consummation of the applicable
Fundamental Transaction but prior to the Expiration Date, in lieu of the shares of the Common Stock (or other securities, cash,
assets or other property (except such items still issuable under Sections 3 and 4(a) above, which shall continue to be receivable
thereafter)) issuable upon the exercise of the Warrant prior to such Fundamental Transaction, such shares of stock, securities,
cash, assets or any other property whatsoever (including warrants or other purchase or subscription rights) (collectively, the
“Corporate Event Consideration”) which the Holder would have been entitled to receive upon the happening of the applicable
Fundamental Transaction had this Warrant been exercised immediately prior to the applicable Fundamental Transaction (without regard
to any limitations on the exercise of this Warrant). The provision made pursuant to the preceding sentence shall be in a form
and substance reasonably satisfactory to the Holder. The provisions of this Section 4(b) shall apply similarly and equally to
successive Fundamental Transactions and Corporate Events. Notwithstanding the foregoing, in the event of a Change of Control,
at the request of the Holder delivered before the thirtieth (30th) day after such Change of Control, the Company (or
the Successor Entity) shall purchase this Warrant from the Holder by paying to the Holder, within five (5) Business Days after
such request (or, if later, on the effective date of the Change of Control), an amount equal to the Black Scholes Value of the
remaining unexercised portion of this Warrant on the effective date of such Change of Control, payable in cash; provided, however,
that, if the Change of Control is not within the Company’s control, including not approved by the Company’s Board
of Directors, Holder shall only be entitled to receive from the Company or any Successor Entity, as of the date of consummation
of such Change of Control, the same type or form of consideration (and in the same proportion), at the Black Scholes Value of
the unexercised portion of this Warrant, that is being offered and paid to the holders of Common Stock of the Company in connection
with the Change of Control, whether that consideration be in the form of cash, stock or any combination thereof, or whether the
holders of Common Stock are given the choice to receive from among alternative forms of consideration in connection with the Change
of Control.

 

    	 	- 10 -	 

     

    

 

5.
NONCIRCUMVENTION. The Company hereby covenants and agrees that the Company will not, by amendment of its Certificate of
Incorporation or Bylaws, or through any reorganization, transfer of assets, consolidation, merger, scheme of arrangement, dissolution,
issuance or sale of securities, or any other voluntary action, avoid or seek to avoid the observance or performance of any of
the terms of this Warrant, and will at all times in good faith carry out all of the provisions of this Warrant and take all action
as may be required to protect the rights of the Holder. Without limiting the generality of the foregoing, the Company (i) shall
not increase the par value of any shares of Common Stock receivable upon the exercise of this Warrant above the Exercise Price
then in effect, (ii) shall take all such actions as may be necessary or appropriate in order that the Company may validly and
legally issue fully paid and nonassessable shares of Common Stock upon the exercise of this Warrant, and (iii) shall, so long
as any of the Warrants are outstanding, take all action necessary to reserve and keep available out of its authorized and unissued
shares of Common Stock, solely for the purpose of effecting the exercise of the Warrants, the number of shares of Common Stock
as shall from time to time be necessary to effect the exercise of the Warrants then outstanding (without regard to any limitations
on exercise).

 

6.
WARRANT HOLDER NOT DEEMED A STOCKHOLDER. Except as otherwise specifically provided herein, the Holder, solely in such Person’s
capacity as a holder of this Warrant, shall not be entitled to vote or receive dividends or be deemed the holder of capital stock
of the Company for any purpose, nor shall anything contained in this Warrant be construed to confer upon the Holder, solely in
such Person’s capacity as the Holder of this Warrant, any of the rights of a stockholder of the Company or any right to
vote, give or withhold consent to any corporate action (whether any reorganization, issue of stock, reclassification of stock,
consolidation, merger, conveyance or otherwise), receive notice of meetings, receive dividends or subscription rights, or otherwise,
prior to the issuance to the Holder of the Warrant Shares which such Person is then entitled to receive upon the due exercise
of this Warrant. In addition, nothing contained in this Warrant shall be construed as imposing any liabilities on the Holder to
purchase any securities (upon exercise of this Warrant or otherwise) or as a stockholder of the Company, whether such liabilities
are asserted by the Company or by creditors of the Company. Notwithstanding this Section 6, the Company shall provide the Holder
with copies of the same notices and other information given to the stockholders of the Company generally, contemporaneously with
the giving thereof to the stockholders.

 

    	 	- 11 -	 

     

    

 

7.
REISSUANCE OF WARRANTS.

 

(a)
Transfer of Warrant. If this Warrant is to be transferred, the Holder shall surrender this Warrant to the Company, whereupon
the Company will forthwith issue and deliver upon the order of the Holder a new Warrant (in accordance with Section 7(d)), registered
as the Holder may request, representing the right to purchase the number of Warrant Shares being transferred by the Holder and,
if less than the total number of Warrant Shares then underlying this Warrant is being transferred, a new Warrant (in accordance
with Section 7(d)) to the Holder representing the right to purchase the number of Warrant Shares not being transferred.

 

(b)
Lost, Stolen or Mutilated Warrant. Upon receipt by the Company of evidence reasonably satisfactory to the Company of the
loss, theft, destruction or mutilation of this Warrant, and, in the case of loss, theft or destruction, of any indemnification
undertaking by the Holder to the Company in customary form (but without the obligation to post a bond) and, in the case of mutilation,
upon surrender and cancellation of this Warrant, the Company shall execute and deliver to the Holder a new Warrant (in accordance
with Section 7(d)) representing the right to purchase the Warrant Shares then underlying this Warrant.

 

(c)
Exchangeable for Multiple Warrants. This Warrant is exchangeable, upon the surrender hereof by the Holder at the principal
office of the Company, for a new Warrant or Warrants (in accordance with Section 7(d)) representing in the aggregate the right
to purchase the number of Warrant Shares then underlying this Warrant, and each such new Warrant will represent the right to purchase
such portion of such Warrant Shares as is designated by the Holder at the time of such surrender.

 

(d)
Issuance of New Warrants. Whenever the Company is required to issue a new Warrant pursuant to the terms of this Warrant,
such new Warrant (i) shall be of like tenor with this Warrant, (ii) shall represent, as indicated on the face of such new Warrant,
the right to purchase the Warrant Shares then underlying this Warrant (or in the case of a new Warrant being issued pursuant to
Section 7(a) or Section 7(c), the Warrant Shares designated by the Holder which, when added to the number of shares of Common
Stock underlying the other new Warrants issued in connection with such issuance, does not exceed the number of Warrant Shares
then underlying this Warrant), (iii) shall have an issuance date, as indicated on the face of such new Warrant which is the same
as the Issuance Date, and (iv) shall have the same rights and conditions as this Warrant.

 

    	 	- 12 -	 

     

    

 

8.
NOTICES. Whenever notice is required to be given under this Warrant, including, without limitation, an Exercise Notice,
unless otherwise provided herein, such notice shall be given in writing, (i) if delivered (a) from within the domestic United
States, by first-class registered or certified airmail, or nationally recognized overnight express courier, postage prepaid, electronic
mail or by facsimile or (b) from outside the United States, by International Federal Express, electronic mail or facsimile, and
(ii) will be deemed given (A) if delivered by first-class registered or certified mail domestic, three (3) Business Days after
so mailed, (B) if delivered by nationally recognized overnight carrier, one (1) Business Day after so mailed, (C) if delivered
by International Federal Express, two (2) Business Days after so mailed and (D) at the time of transmission, if delivered by electronic
mail to each of the email addresses specified in this Section 8 prior to 5:00 p.m. (New York time) on a Trading Day, (E) the next
Trading Day after the date of transmission, if delivered by electronic mail to each of the email addresses specified in this Section
8 on a day that is not a Trading Day or later than 5:00 p.m. (New York time) on any Trading Day and (F) if delivered by facsimile,
upon electronic confirmation of delivery of such facsimile, and will be delivered and addressed as follows:

 

(i)
if to the Company, to:

 

Advaxis,
Inc.

305
College Road East

Princeton,
New Jersey 08540

Attention:
Chief Financial Officer

Facsimile:
(609) 452-9818

Email:
henderson@advaxis.com

 

(ii)
if to the Holder, at such address or other contact information delivered by the Holder to Company or as is on the books and records
of the Company.

 

The
Company shall provide the Holder with prompt written notice of all actions taken pursuant to this Warrant, including in reasonable
detail a description of such action and the reason therefor. Without limiting the generality of the foregoing, the Company will
give written notice to the Holder (i) immediately upon any adjustment of the Exercise Price, setting forth in reasonable detail,
and certifying, the calculation of such adjustment and (ii) at least fifteen (15) days prior to the date on which the Company
closes its books or takes a record (A) with respect to any dividend or distribution upon the shares of Common Stock, (B) with
respect to any grants, issuances or sales of any Options, Convertible Securities or rights to purchase stock, warrants, securities
or other property to holders of shares of Common Stock or (C) for determining rights to vote with respect to any Fundamental Transaction,
dissolution or liquidation; provided in each case that such information shall be made known to the public prior to or in
conjunction with such notice being provided to the Holder. It is expressly understood and agreed that the time of exercise specified
by the Holder in each Exercise Notice shall be definitive and may not be disputed or challenged by the Company.

 

9.
AMENDMENT AND WAIVER. Except as otherwise provided herein, the provisions of this Warrant may be amended or waived and
the Company may take any action herein prohibited, or omit to perform any act herein required to be performed by it, only if the
Company has obtained the written consent of the Holder.

 

    	 	- 13 -	 

     

    

 

10.
GOVERNING LAW; JURISDICTION; JURY TRIAL. This Warrant shall be governed by and construed and enforced in accordance with,
and all questions concerning the construction, validity, interpretation and performance of this Warrant shall be governed by,
the internal laws of the State of New York, without giving effect to any choice of law or conflict of law provision or rule (whether
of the State of New York or any other jurisdictions) that would cause the application of the laws of any jurisdictions other than
the State of New York. The Company hereby irrevocably submits to the exclusive jurisdiction of the state and federal courts sitting
in The City of New York, Borough of Manhattan, for the adjudication of any dispute hereunder or in connection herewith or with
any transaction contemplated hereby or discussed herein, and hereby irrevocably waives, and agrees not to assert in any suit,
action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action
or proceeding is brought in an inconvenient forum or that the venue of such suit, action or proceeding is improper. The Company
hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding
by mailing a copy thereof to the Company at the address set forth in Section 8(i) above or such other address as the Company subsequently
delivers to the Holder and agrees that such service shall constitute good and sufficient service of process and notice thereof.
Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law. Nothing
contained herein shall be deemed or operate to preclude the Holder from bringing suit or taking other legal action against the
Company in any other jurisdiction to collect on the Company’s obligations to the Holder, to realize on any collateral or
any other security for such obligations, or to enforce a judgment or other court ruling in favor of the Holder. If either party
shall commence an action, suit or proceeding to enforce any provisions of this Warrant, the prevailing party in such action, suit
or proceeding shall be reimbursed by the other party for their reasonable attorneys’ fees and other costs and expenses incurred
with the investigation, preparation and prosecution of such action or proceeding. THE COMPANY HEREBY IRREVOCABLY WAIVES ANY
RIGHT IT MAY HAVE, AND AGREES NOT TO REQUEST, A JURY TRIAL FOR THE ADJUDICATION OF ANY DISPUTE HEREUNDER OR IN CONNECTION WITH
OR ARISING OUT OF THIS WARRANT OR ANY TRANSACTION CONTEMPLATED HEREBY.

 

11.
DISPUTE RESOLUTION. In the case of a dispute as to the determination of the Exercise Price or the arithmetic calculation
of the Warrant Shares, the Company shall submit the disputed determinations or arithmetic calculations via facsimile or electronic
mail within two (2) Business Days of receipt of the Exercise Notice or other event giving rise to such dispute, as the case may
be, to the Holder. If the Holder and the Company are unable to agree upon such determination or calculation of the Exercise Price
or the Warrant Shares within three (3) Business Days of such disputed determination or arithmetic calculation being submitted
to the Holder, then the Company shall, within two (2) Business Days submit via facsimile or electronic mail (a) the disputed determination
of the Exercise Price to an independent, reputable investment bank selected by the Company and approved by the Holder or (b) the
disputed arithmetic calculation of the Warrant Shares to the Company’s independent, outside accountant. The Company shall
cause at its expense the investment bank or the accountant, as the case may be, to perform the determinations or calculations
and notify the Company and the Holder of the results no later than ten (10) Business Days from the time it receives the disputed
determinations or calculations. Such investment bank’s or accountant’s determination or calculation, as the case may
be, shall be binding upon all parties absent demonstrable error.

 

    	 	- 14 -	 

     

    

 

12.
REMEDIES, OTHER OBLIGATIONS, BREACHES AND INJUNCTIVE RELIEF. The remedies provided in this Warrant shall be cumulative
and in addition to all other remedies available under this Warrant and any other Transaction Documents, at law or in equity (including
a decree of specific performance and/or other injunctive relief), and nothing herein shall limit the right of the Holder to pursue
actual damages for any failure by the Company to comply with the terms of this Warrant. The Company acknowledges that a breach
by it of its obligations hereunder will cause irreparable harm to the Holder and that the remedy at law for any such breach may
be inadequate. The Company therefore agrees that, in the event of any such breach or threatened breach, the holder of this Warrant
shall be entitled, in addition to all other available remedies, to an injunction restraining any breach, without the necessity
of showing economic loss and without any bond or other security being required.

 

13.
TRANSFER. This Warrant and the Warrant Shares may be offered for sale, sold, transferred, pledged or assigned without the
consent of the Company.

 

14.
SEVERABILITY; CONSTRUCTION; HEADINGS. If any provision of this Warrant is prohibited by law or otherwise determined to
be invalid or unenforceable by a court of competent jurisdiction, the provision that would otherwise be prohibited, invalid or
unenforceable shall be deemed amended to apply to the broadest extent that it would be valid and enforceable, and the invalidity
or unenforceability of such provision shall not affect the validity of the remaining provisions of this Warrant so long as this
Warrant as so modified continues to express, without material change, the original intentions of the parties as to the subject
matter hereof and the prohibited nature, invalidity or unenforceability of the provision(s) in question does not substantially
impair the respective expectations or reciprocal obligations of the parties or the practical realization of the benefits that
would otherwise be conferred upon the parties. The parties will endeavor in good faith negotiations to replace the prohibited,
invalid or unenforceable provision(s) with a valid provision(s), the effect of which comes as close as possible to that of the
prohibited, invalid or unenforceable provision(s). This Warrant shall be deemed to be jointly drafted by the Company and the Holder
and shall not be construed against any Person as the drafter hereof. The headings of this Warrant are for convenience of reference
and shall not form part of, or affect the interpretation of, this Warrant.

 

15.
DISCLOSURE. Upon receipt or delivery by the Company of any notice in accordance with the terms of this Warrant, unless
the Company has in good faith determined that the matters relating to such notice do not constitute material, nonpublic information
relating to the Company or its subsidiaries, the Company shall contemporaneously with any such receipt or delivery publicly disclose
such material, nonpublic information on a Current Report on Form 8-K or otherwise. In the event that the Company believes that
a notice contains material, nonpublic information relating to the Company or its subsidiaries, the Company so shall indicate to
such Holder contemporaneously with delivery of such notice, and in the absence of any such indication, the Holder shall be allowed
to presume that all matters relating to such notice do not constitute material, nonpublic information relating to the Company
or its subsidiaries.

 

    	 	- 15 -	 

     

    

 

16.
CERTAIN DEFINITIONS. For purposes of this Warrant, the following terms shall have the following meanings:

 

(a)
“Affiliate” means, with respect to any Person, any other Person that directly or indirectly controls, is controlled
by, or is under common control with, such Person, it being understood for purposes of this definition that “control”
of a Person means the power directly or indirectly either to vote 10% or more of the stock having ordinary voting power for the
election of directors of such Person or direct or cause the direction of the management and policies of such Person whether by
contract or otherwise.

 

(b)
“Approved Stock Plan” means any employee benefit plan which has been approved by a majority of the disinterested
members of the Board of Directors of the Company, pursuant to which the Company’s securities may be issued to any employee,
officer or director for services provided to the Company.

 

(c)
“Attribution Parties” means, collectively, the following Persons and entities: (i) any investment vehicle,
including, any funds, feeder funds or managed accounts, currently, or from time to time after the Subscription Date, directly
or indirectly managed or advised by the Holder’s investment manager or any of its Affiliates or principals, (ii) any direct
or indirect Affiliates of the Holder or any of the foregoing, (iii) any Person acting or who could be deemed to be acting as a
Group together with the Holder or any of the foregoing and (iv) any other Persons whose beneficial ownership of the Company’s
Common Stock would or could be aggregated with the Holder’s and the other Attribution Parties for purposes of Section 13(d)
of the 1934 Act. For clarity, the purpose of the foregoing is to subject collectively the Holder and all other Attribution Parties
to the Maximum Percentage.

 

(d)
“Black Scholes Value” means the value of this Warrant based on the Black-Scholes Option Pricing Model obtained
from the “OV” function on Bloomberg determined as of the day immediately following the first public announcement of
the applicable Change of Control, or, if the Change of Control is not publicly announced, the date the Change of Control is consummated,
for pricing purposes and reflecting (i) a risk-free interest rate corresponding to the U.S. Treasury rate for a period equal to
the remaining term of this Warrant as of such date of request, (ii) an expected volatility equal to 150% (iii) the underlying
price per share used in such calculation shall be the greater of (a) the highest Weighted Average Price during the five (5) Trading
Days prior to the closing of the Change of Control and (b) the sum of the price per share being offered in cash, if any, plus
the value of any non-cash consideration, if any, being offered in such Change of Control, (iv) a zero cost of borrow and (v) a
360 day annualization factor.

 

(e)
“Bloomberg” means Bloomberg Financial Markets.

 

(f)
“Business Day” means any day other than Saturday, Sunday or other day on which commercial banks in The City
of New York are authorized or required by law to remain closed.

 

    	 	- 16 -	 

     

    

 

(g)
“Change of Control” means any Fundamental Transaction other than (i) any reorganization, recapitalization or
reclassification of the Common Stock in which holders of the Company’s voting power immediately prior to such reorganization,
recapitalization or reclassification continue after such reorganization, recapitalization or reclassification to hold publicly
traded securities and, directly or indirectly, are, in all material respect, the holders of the voting power of the surviving
entity (or entities with the authority or voting power to elect the members of the board of directors (or their equivalent if
other than a corporation) of such entity or entities) after such reorganization, recapitalization or reclassification, (ii) pursuant
to a migratory merger effected solely for the purpose of changing the jurisdiction of incorporation of the Company; (iii) any
transaction undertaken solely for capital raising purposes through an offering of the Company’s equity securities in either
(y) a transaction registered under the Securities Act of 1933, as amended or (z) exempt from the registration requirements thereof
and where such transaction does not contemplate a change to the identity of a majority of the board of directors of the Company;
or (iv) a merger in connection with a bona fide acquisition by the Company of any Person in which (x) the gross consideration
paid, directly or indirectly, by the Company in such acquisition is not greater than 20% of the Company’s market capitalization
as calculated on the date of the consummation of such merger and (y) such merger does not contemplate a change to the identity
of a majority of the board of directors of the Company. Notwithstanding anything herein to the contrary, any transaction or series
of transaction that, directly or indirectly, results in the Company or the Successor Entity not having Common Stock or common
stock, as applicable, registered under the 1934 Act and listed on an Eligible Market shall be deemed a Change of Control.

 

(h)
“Closing Bid Price” and “Closing Sale Price” means, for any security as of any date, the
last closing bid price and last closing trade price, respectively, for such security on the Principal Market, as reported by Bloomberg,
or, if the Principal Market begins to operate on an extended hours basis and does not designate the closing bid price or the closing
trade price, as the case may be, then the last bid price or the last trade price, respectively, of such security prior to 4:00:00
p.m., New York time, as reported by Bloomberg, or, if the Principal Market is not the principal securities exchange or trading
market for such security, the last closing bid price or last trade price, respectively, of such security on the principal securities
exchange or trading market where such security is listed or traded as reported by Bloomberg, or if the foregoing do not apply,
the last closing bid price or last trade price, respectively, of such security in the over-the-counter market on the electronic
bulletin board for such security as reported by Bloomberg, or, if no closing bid price or last trade price, respectively, is reported
for such security by Bloomberg, the average of the bid prices, or the ask prices, respectively, of any market makers for such
security as reported in the OTC Link or “pink sheets” by OTC Markets Group Inc. (formerly Pink OTC Markets Inc.).
If the Closing Bid Price or the Closing Sale Price cannot be calculated for a security on a particular date on any of the foregoing
bases, the Closing Bid Price or the Closing Sale Price, as the case may be, of such security on such date shall be the fair market
value as mutually determined by the Company and the Holder. If the Company and the Holder are unable to agree upon the fair market
value of such security, then such dispute shall be resolved pursuant to Section 11. All such determinations to be appropriately
adjusted for any stock dividend, stock split, stock combination, reclassification or other similar transaction during the applicable
calculation period.

 

(i)
“Common Stock” means (i) the Company’s Common Stock, par value $0.001 per share, and (ii) any capital
stock into which such Common Stock shall have been changed or any capital stock resulting from a reclassification of such Common
Stock.

 

    	 	- 17 -	 

     

    

 

(j)
“Convertible Securities” means any stock or securities (other than Options) directly or indirectly convertible
into or exercisable or exchangeable for shares of Common Stock.

 

(k)
“Eligible Market” means The NASDAQ Capital Market, the NYSE American LLC, The NASDAQ Global Select Market,
The NASDAQ Global Market or The New York Stock Exchange, Inc.

 

(l)
“Excluded Securities” means any securities of the Company issued or issuable, or deemed issued or issuable
pursuant to Section 2(a): (i) in connection with any Approved Stock Plan, (ii) upon exercise of the Warrants; provided,
that the terms of such Warrants are not amended, modified or changed on or after the Subscription Date (iii) in connection with
an employment inducement grant made pursuant to Nasdaq Listing Rule 5635(c)(4); (iv)
in a Strategic Transaction; and (v) upon conversion, exercise or exchange of any Options or Convertible Securities which are outstanding
on the day immediately preceding the Subscription Date; provided, that the terms of such Options or Convertible Securities
are not amended, modified or changed on or after the Subscription Date.

 

(m)
“Expiration Date” means the date seventy two (72) months after the Initial Exercisability Date or, if such
date falls on a day other than a Business Day or on which trading does not take place on the Principal Market (a “Holiday”),
the next day that is not a Holiday.

 

    	 	- 18 -	 

     

    

 

(n)
“Fundamental Transaction” means (A) that the Company shall, directly or indirectly, including through subsidiaries,
Affiliates or otherwise, in one or more related transactions, (i) consolidate or merge with or into (whether or not the Company
is the surviving corporation) another Subject Entity, or (ii) sell, assign, transfer, convey or otherwise dispose of all or substantially
all of the properties or assets of the Company or any of its “significant subsidiaries” (as defined in Rule 1-02 of
Regulation S-X) to one or more Subject Entities, or (iii) make, or allow one or more Subject Entities to make, or allow the Company
to be subject to or have its shares of Common Stock be subject to or party to one or more Subject Entities making, a purchase,
tender or exchange offer that is accepted by the holders of at least either (x) 50% of the outstanding shares of Common Stock,
(y) 50% of the outstanding shares of Common Stock calculated as if any shares of Common Stock held by all Subject Entities making
or party to, or Affiliated with any Subject Entities making or party to, such purchase, tender or exchange offer were not outstanding;
or (z) such number of shares of Common Stock such that all Subject Entities making or party to, or Affiliated with any Subject
Entity making or party to, such purchase, tender or exchange offer, become collectively the beneficial owners (as defined in Rule
13d-3 under the 1934 Act) of at least 50% of the outstanding shares of Common Stock, or (iv) consummate a stock purchase agreement
or other business combination (including, without limitation, a reorganization, recapitalization, spin-off or scheme of arrangement)
with one or more Subject Entities whereby all such Subject Entities, individually or in the aggregate, acquire, either (x) at
least 50% of the outstanding shares of Common Stock, (y) at least 50% of the outstanding shares of Common Stock calculated as
if any shares of Common Stock held by all the Subject Entities making or party to, or Affiliated with any Subject Entity making
or party to, such stock purchase agreement or other business combination were not outstanding; or (z) such number of shares of
Common Stock such that the Subject Entities become collectively the beneficial owners (as defined in Rule 13d-3 under the 1934
Act) of at least 50% of the outstanding shares of Common Stock, or (v) reorganize, recapitalize or reclassify its shares of Common
Stock, (B) that the Company shall, directly or indirectly, including through subsidiaries, Affiliates or otherwise, in one or
more related transactions, allow any Subject Entity individually or the Subject Entities in the aggregate to be or become the
“beneficial owner” (as defined in Rule 13d-3 under the 1934 Act), directly or indirectly, whether through acquisition,
purchase, assignment, conveyance, tender, tender offer, exchange, reduction in outstanding shares of Common Stock, merger, consolidation,
business combination, reorganization, recapitalization, spin-off, scheme of arrangement, reorganization, recapitalization or reclassification
or otherwise in any manner whatsoever, of either (x) at least 50% of the aggregate ordinary voting power represented by issued
and outstanding shares of Common Stock, (y) at least 50% of the aggregate ordinary voting power represented by issued and outstanding
shares of Common Stock not held by all such Subject Entities as of the Subscription Date calculated as if any shares of Common
Stock held by all such Subject Entities were not outstanding, or (z) a percentage of the aggregate ordinary voting power represented
by issued and outstanding shares of Common Stock or other equity securities of the Company sufficient to allow such Subject Entities
to effect a statutory short form merger or other transaction requiring other stockholders of the Company to surrender their Common
Stock without approval of the stockholders of the Company or (C) directly or indirectly, including through subsidiaries, Affiliates
or otherwise, in one or more related transactions, the issuance of or the entering into any other instrument or transaction structured
in a manner to circumvent, or that circumvents, the intent of this definition in which case this definition shall be construed
and implemented in a manner otherwise than in strict conformity with the terms of this definition to the extent necessary to correct
this definition or any portion of this definition which may be defective or inconsistent with the intended treatment of such instrument
or transaction.

 

(o)
“Group” means a “group” as that term is used in Section 13(d) of the 1934 Act and as defined in
Rule 13d-5 thereunder.

 

(p)
“Options” means any rights, warrants or options to subscribe for or purchase shares of Common Stock or Convertible
Securities.

 

(q)
“Parent Entity” of a Person means an entity that, directly or indirectly, controls the applicable Person, including
such entity whose common stock or equivalent equity security is quoted or listed on an Eligible Market (or, if so elected by the
Holder, any other market, exchange or quotation system), or, if there is more than one such Person or such entity, the Person
or such entity designated by the Holder or in the absence of such designation, such Person or entity with the largest public market
capitalization as of the date of consummation of the Fundamental Transaction.

 

(r)
“Person” means an individual, a limited liability company, a partnership, a joint venture, a corporation, a
trust, an unincorporated organization, any other entity and a government or any department or agency thereof.

 

(s)
“Principal Market” means The Nasdaq Global Select Market.

 

    	 	- 19 -	 

     

    

 

(t)
“Required Holders” means the holders of the Warrants representing at least a majority of the shares of Common
Stock underlying the Warrants then outstanding.

 

(u)
“Standard Settlement Period” means the standard settlement period, expressed in a number of Trading Days, for
the Company’s primary trading market or quotation system with respect to the Common Stock that is in effect on the date
of receipt of an applicable Exercise Notice.

 

(v)
“Strategic Transaction” means a transaction or relationship in which
(1) the Company issues shares of Common Stock to a Person (or a shareholder, partner, member or other owner thereof) that the
Board of Directors of the Company determined in good faith is, itself or through its Subsidiaries, an operating company in a business
synergistic with the business of the Company and (2) the Company receives benefits in addition to the investment of funds, but
shall not include a transaction in which the Company is issuing securities primarily for the purpose of raising capital or to
a Person whose primary business is investing in securities.

 

(w)
“Subject Entity” means any Person, Persons or Group or any Affiliate or associate of any such Person, Persons
or Group.

 

(x)
“Successor Entity” means one or more Person or Persons (or, if so elected by the Holder, the Company or Parent
Entity) formed by, resulting from or surviving any Fundamental Transaction or one or more Person or Persons (or, if so elected
by the Holder, the Company or the Parent Entity) with which such Fundamental Transaction shall have been entered into.

 

(y)
“Trading Day” means any day on which the Common Stock is traded on the Principal Market, or, if the Principal
Market is not the principal trading market for the Common Stock, then on the principal securities exchange or securities market
on which the Common Stock is then traded.

 

(z)
“Transaction Documents” means any agreement entered into by and between the Company and the Holder, as applicable.

 

(aa)
“Weighted Average Price” means, for any security as of any date, the dollar volume-weighted average price for
such security on the Principal Market during the period beginning at 9:30:01 a.m., New York time (or such other time as the Principal
Market publicly announces is the official open of trading), and ending at 4:00:00 p.m., New York time (or such other time as the
Principal Market publicly announces is the official close of trading), as reported by Bloomberg through its “Volume at Price”
function or, if the foregoing does not apply, the dollar volume-weighted average price of such security in the over-the-counter
market on the electronic bulletin board for such security during the period beginning at 9:30:01 a.m., New York time (or such
other time as such market publicly announces is the official open of trading), and ending at 4:00:00 p.m., New York time (or such
other time as such market publicly announces is the official close of trading), as reported by Bloomberg, or, if no dollar volume-weighted
average price is reported for such security by Bloomberg for such hours, the average of the highest Closing Bid Price and the
lowest closing ask price of any of the market makers for such security as reported in the OTC Link or “pink sheets”
by OTC Markets Group Inc. (formerly Pink OTC Markets Inc.). If the Weighted Average Price cannot be calculated for a security
on a particular date on any of the foregoing bases, the Weighted Average Price of such security on such date shall be the fair
market value as mutually determined by the Company and the Holder. If the Company and the Holder are unable to agree upon the
fair market value of such security, then such dispute shall be resolved pursuant to Section 11 with the term “Weighted Average
Price” being substituted for the term “Exercise Price.” All such determinations shall be appropriately adjusted
for any stock dividend, stock split, stock combination, reclassification or other similar transaction during the applicable calculation
period.

 

[Signature
Page Follows]

 

    	 	- 20 -	 

     

    

 

IN
WITNESS WHEREOF, the Company has caused this Warrant to Purchase Common Stock to be duly executed as of the Issuance Date
set out above.

 

	 	ADVAXIS,
    INC.
	 	 	                
	 	By:	 
	 	Name:	 
	 	Title:	 

 

    	 	 	 

     

    

 

EXHIBIT
A

 

EXERCISE
NOTICE

 

TO
BE EXECUTED BY THE REGISTERED HOLDER TO EXERCISE THIS

WARRANT
TO PURCHASE COMMON STOCK

 

ADVAXIS,
INC.

 

The
undersigned holder hereby exercises the right to purchase _________________ shares of Common Stock (“Warrant Shares”)
of Advaxis, Inc., a company organized under the laws of Delaware (the “Company”), evidenced by the attached
Warrant to Purchase Common Stock (the “Warrant”). Capitalized terms used herein and not otherwise defined shall
have the respective meanings set forth in the Warrant.

 

1.
Form of Exercise Price. The Holder intends that payment of the Exercise Price shall be made as:

 

____________
a “Cash Exercise” with respect to _________________ Warrant Shares; and/or

 

____________
a “Cashless Exercise” with respect to _______________ Warrant Shares.

 

2.
Payment of Exercise Price. In the event that the holder has elected a Cash Exercise with respect to some or all of the Warrant
Shares to be issued pursuant hereto, the holder shall pay the Aggregate Exercise Price in the sum of $___________________ to the
Company in accordance with the terms of the Warrant.

 

3.
Delivery of Warrant Shares. The Company shall deliver to the holder __________ Warrant Shares in accordance with the terms of
the Warrant.

 

Date:
_______________ __, ______

 

	 	 
	Name
    of Registered Holder	 
	 	          	 
	By:	 	 
	Name:	 	 
	Title:	 	 

 

    	 	 	 

     

    

 

ACKNOWLEDGMENT

 

The
Company hereby acknowledges this Exercise Notice and hereby directs the Continental Stock Transfer and Trust Company to issue
the above indicated number of shares of Common Stock on or prior to the applicable Share Delivery Date.

 

	 	ADVAXIS,
    INC.
	 	 	           
	 	By:
    	 
	 	Name:	 
	 	Title:

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