Document:

spro-ex101_390.htm

 

 

CONFIDENTIAL TREATMENT REQUESTED

Exhibit 10.1

 

 

 
 

	
AWARD/CONTRACT
	
1. THIS CONTRACT IS A RATED ORDER 
UNDER DPAS (15 CFR 700)
	

	
RATING
	
PAGE OF PAGES

	
1
	
2

	
2.  CONTRACT (Proc. Inst. Ident.) No.

HHS010020180015C
	
3.  EFFECTIVE DATE 

07/12/2018
	
4. REQUISITION/PURCHASE REQUEST/PROJECT NO.

OS220801

	
5. ISSUED BYCODE
	
ASPR-BARDA
	
6 ADMINISTERED BY (if other than Item 5)CODE
	
ASPR-BARDA02

	
ASPR-BARDA

200 Independence Ave., S.W.

Room 640-G

Washington DC 20201
	
US DEPT OF HEALTH & HUMAN SERVICES

ASST SEC OF PREPAREDNESS & RESPONSE

ACQ MANAGEMENT, CONTRACTS, & GRANTS

O’NEILL HOUSE OFFICE BUILDING

Washington DC 20515

	
7. NAME AND ADDRESS OF CONTRACTOR (No., Street, City, Country, State and Zip Code)

SPERO THERAPEUTICS INC 1526344

Attn:  [***]

SPERO THERAPEUTICS, INC.675 M

675 MASSACHUSETTS AVE 14TH FLR

CAMBRIDGE MA 021393309

 
	
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  152344
	
FACILITY CODE

	
11. SHIP TO/MARK FORCODE
	
HHS/OS/ASPR
	
12. PAYMENT WILL BE MADE BYCODE
	
PSC

	
HHS/OS/ASPR

200 C St SW

WASHINGTON DC 20201

 
	
PSC
	
 

	
13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION

☐ 10 U.S.C. 2304 (C) (                         )      ☐ 41 U.S.C. 253 (C) (                      )
	
14. ACCOUNTING AND APPROPRIATION DATA

2018.1992018.25106

	
15A. ITEM NO
	
15B. SUPPLIES/SERVICES
	
15C.
QUANTITY
	
15D.
UNIT
	
15E. UNIT PRICE
	
15F. AMOUNT

	
 
	
 

Continued
	
 
	
 
	
 
	
 

	
15G. TOTAL AMOUNT OF CONTRACT
	

	
$15,658,035.00

	
16.  TABLE OF CONTENTS

	
(X)
	
SEC.
	
DESCRIPTION
	
PAGES(S)
	
(X)
	
SEC.
	
DESCRIPTION
	
PAGES(S)

	
PART I – THE SCHEDULE
	
PART II – CONTRACT CLAUSES

	
 
	
A
	
SOLICITATION/CONTRACT FORM
	
 
	
 
	
I
	
CONTRACT CLAUSES
	
 

	
 
	
B
	
SUPPLIES OR SERVICES AND PRICES/COSTS
	
 
	
PART III – LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

	
 
	
C
	
DESCRIPTION/SPECS/WORK STATEMENT
	
 
	
 
	
J
	
LIST OF ATTACHMENTS
	
 

	
 
	
D
	
PACKAGING AND MARKING
	
 
	
PART IV – REPRESENTATIONS AND INSTRUCTIONS

	
 
	
E
	
INSPECTION AND ACCEPTANCE
	
 
	
 
	
K
	
REPRESENTATIONS, CERTIFICATIONS AND
	
 

	
 
	
F
	
DELIVERIES OR PERFORMANCE
	
 
	
 
	
 
	
OTHER STATEMENTS OF OFFERORS
	
 

	
 
	
G
	
CONTRACT ADMINISTRATION DATA
	
 
	
 
	
L
	
INSTRS., CONDS., AND NOTICES TO OFFERORS
	
 

	
 
	
H
	
SPECIAL CONTRACT REQUIREMENTS
	
 
	
 
	
M
	
EVALUATION FACTORS FOR AWARD
	
 

	
CONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED-BID OR NEGOTIATED PROCUREMENT) OR 18 (SEALED-BID PROCUREMENT) AS APPLICABLE

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
17. ☐ CONTRACTORS NEGOTIATED AGREEMENT (Contractor is required to sign this document and return ______ 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  ________________________________________________________, 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 ilisted 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)

Ankit Mahadevia, M.D. President & Chief Operating Officer, Spero Therapeutics, Inc.
	
20A. NAME OF CONTRACTING OFFICER

[***]

	
19B. NAME OF CONTRACTOR

	
19C. DATE SIGNED

	
20B. UNITED STATES OF AMERICA

	
20C. DATE SIGNED

 

12 July 2018

	
AUTHORIZED FOR LOCAL REPRODUCTIONSTANDARD FORM 26 (Rev. 5/2011)

Previous edition is NOT usablePrescribed by GSA-FAR (48 CFR) 53.214(a)

 

	
CONTINUATION SHEET
	
REFERENCE NO. OF DOCUMENT BEING CONTINUED

HHS0100201800015C
	
PAGE
	
Of

	
2
	
2

	
NAME OF OFFEROR OR CONTRACTOR

SPERO THERAPEUTICS INC 1526344

	
ITEM NO

(A)
	
SUPPLIES/SERVICES

(B)
	
QUANTITY

(C)
	
UNIT

(D)
	
UNIT PRICE

(E)
	
AMOUNT

(F)

	
1
	
Tax ID Number:  46-4590683

DUNS Number:  080161535

Delivery:  05/27/2018

Appr. Yr.:  2018 CAN:  1992018 Object Class:  25106

FOB:  Destination

Period of Performance:  07/12/2018 to 06/30/2021

ASPR-18-02731 -- Spero Therapeutics - Base Year funding to advance the development of SPR994 for the treatment of Drug Restraint Gram-negative Bacterial Infections

Obligated Amount:$15,658,035.00

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
	
 
	
 
	
 
	
15,658,035.00

	
AUTHORIZED FOR LOCAL REPRO
	
OPTIONAL FORM 336 (4-86)

Sponsored by GSA

FAR (48 CFR) 53.110

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

CONTRACT TABLE OF CONTENTS

PART I – THE SCHEDULE1

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS1

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT9

SECTION D – PACKAGING, MARKING, AND SHIPPING11

SECTION E – INSPECTION AND ACCEPTANCE12

SECTION F – DELIVERIES OR PERFORMANCE14

SECTION G - CONTRACT ADMINISTRATION DATA32

SECTION H - SPECIAL CONTRACT REQUIREMENTS41

PART II - CONTRACT CLAUSES64

SECTION I - CONTRACT CLAUSES64

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS72

SECTION J - LIST OF ATTACHMENTS72

PART IV - REPRESENTATIONS AND INSTRUCTIONS73

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS73

 

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

PART I – THE SCHEDULE

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

Spero Therapeutics intends to advance the development of SPR994 an extended release oral tablet formulation for use in adults to treat complicated urinary tract infections (cUTIs), including those caused by drug resistant bacteria. Key activities under this contract include further in vitro and in vivo characterization, antibiotic susceptibility test development, surveillance and PK studies, active pharmaceutical ingredient (API) and drug product (DP) registration and validation batch production as well as production of clinical trial material. To support the biodefense use of SPR994, Spero will conduct a [***] study and [***] study.

The Research and Development (R&D) effort will progress in specific phases that cover a base period of performance Contract Line Item (CLIN) 0001 followed by two option period segments (CLINs 0002 and 0003) as specified in this contract. The base period (CLIN0001) will pursue the preclinical efficacy studies and other activities required under the New Drug Application submission as well as manufacturing activities to supply the clinical program. T h e two option period segments (CLINs 0002 and 0003) will pursue the further characterization of the in vitro profile of SPR994 against target pathogens of interest and conduct clinical studies to support use of SPR994 in a pneumonic indication. Work performed during the period of performance constitutes an independent, non-severable discrete work segment that cannot be subdivided for separate performance and is necessary to support the R&D tasks related to the assay. The non-severable, discrete work segment constitutes an entire job (discrete requirement) which shall contain multiple R&D activities that when reviewed in total shall satisfy a defined end-product. The non-severable work segment will be fully funded from an appropriation source that is current at the time the work under such segment will be authorized to begin.

The Government has determined a Bona Fide Need for the non-severable discrete work segment which will conclude upon the completion of a defined task(s) that provides independent merit and value to the Government. The Contractor’s success in completing the required tasks under each work segment shall be demonstrated through the submission and approval of the Deliverables and Milestones specified under Article F of this contract. Those deliverables will support the GO/NO GO Contract Milestones and Decision Gates specified therein.

The base and option period segments are event driven work segments rather than time driven CLINs. The funds for each independent, non-severable discrete work segment (requirement), regardless of duration, shall only be used for the scope of work covered in each discrete work segment (i.e., the base period work segment and each option work segment). The periods of performance listed under each of the CLINs under Article B.2 and Article B.3 below are estimated time periods. Those individual time periods may be 

1

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

extended to complete the tasks required under each work segment. It is possible that more than one option segment (requirement), may be exercised at one time and that individual CLINs may overlap and/or proceed concurrently.

ARTICLE B.2. ESTIMATED COST

	
 
	
1.
	
CLIN 0001 (the base period segment) is a cost sharing CLIN. Money shall be provided for the total cost of performance from the Department of Health and Human Services and the Contractor.

	
 
	
2.
	
The Government shall provide money for the base period segment (CLIN 0001) in an amount not to exceed $15,658,035. The Government will not be responsible for any Contractor incurred costs that exceed this amount unless a modification to the contract is signed by the Contracting Officer which expressly increases this amount.

The contractor shall maintain records of all contract costs (including costs claimed by the Contractor as being its share) and such records shall be subject to the Audit and Records-Negotiation and Final Decisions on Audit Findings clauses of the General Clauses.

	
 
	
3.
	
Direct costs contributed by the contractor in the amount of $[***] shall not be charged to the Government under any other contract, grant, or cooperative agreement (including allocation to other grants, contracts, or cooperative agreements as part of an independent research and development program). The contractor shall report the organization’s share of the direct costs expended by category, on the Financial Report, as referenced in the CONTRACT FINANCIAL REPORT Article in SECTION G of this contract.

	
 
	
4.
	
It is estimated that the amount currently allotted will cover performance of the contract through 30 June 2021 (see chart below).

						
	
CLIN
	
Period of Performance
	
Supplies/Services
	
USG NTE Cost
	
Spero Cost Share
	
Total Cost

	
0001
	
12 July 2018 
-
30 June 2021
	
[***]
	
$15,658,035 
([***]%)
	
$[***] 
([***]%) (Indirects)
	
$[***]

 

ARTICLE B.3. OPTION PRICES

Pursuant to FAR 52.217-9, Option to Extend the Term of the Contract (Mar 2000), set forth in full in ARTICLE I.2 of this Contract, the Government may, by unilateral contract modification, require the Contractor to perform discrete portions of additional work as 

2

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

specified in the Statement of Work. If the Government decides to exercise an option(s), the Government will provide the Contractor a preliminary written notice of its intent to exercise the option at least 30 days before the contract expires.

Unless the Government exercises one or more optional CLINs, the contract consists only of the base work specified in the Statement of Work as defined in SECTIONS C and F, with estimated costs set forth in ARTICLE B.2 of the contract.

CLINs 0002 and 0003 are cost-sharing CLINs.

The Government not to exceed cost and contractor cost share specified below will be applicable in the event that the Government exercises Option 1 and/or Option 2.

							
	
CLIN
	
Opt.
	
Period of Performance
	
Supplies/Services
	
USG NTE Cost
	
Spero Cost Share
	
Total Cost

	
0002
	
1
	
15 November 2019 - 30 September 2021
	
[***]
	
$13,608,722 ([***]%)
	
$[***] 
([***]%) (Indirects)
	
$[***]

	
0003
	
2
	
15 August 2020 - 31 March 2023
	
[***]
	
$14,946,495 ([***]%)
	
$[***] 
([***]%) (Indirects)
	
$[***]

 

ARTICLE B.4. LIMITATIONS APPLICABLE TO DIRECT COSTS 

	
a.
	
Items Unallowable Unless Otherwise Provided

Notwithstanding the clauses and unless authorized in writing by the Contracting Officer (CO), the cost of the following items or activities shall be unallowable as direct costs:

	
 
	
1)
	
Acquisition, by purchase or lease, of any interest in real property;

	
 
	
2)
	
Special rearrangement or alteration of facilities;

	
 
	
3)
	
Accountable Government Property (see the HHS Contracting Guide for Control for Government Property incorporated by ARTICLE G.10. of this contract);

Note: this includes the lease or purchase of any item of general purpose office furniture or office equipment regardless of dollar value.

	
 
	
4)
	
Purchase or lease of scientific instruments or equipment over $3,500;

3

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
5)
	
Unapproved travel in excess of the dollar amounts specified under subparagraph b.1 below;

	
 
	
6)
	
Travel to attend general scientific meetings/conferences;

	
 
	
7)
	
Printing Costs (as defined in the Government Printing and Binding Regulations);

	
 
	
8)
	
Overtime (premium) compensation;

	
 
	
9)
	
Entering into certain types of subcontract of arrangements (See Article B.4(c) for specific obligations). Note that most consulting agreements require CO’s written consent;

	
 
	
10)
	
Foreign Travel (see Subparagraph b.3);

	
 
	
11)
	
Patient care costs;

	
 
	
12)
	
Light Refreshment 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 CO, 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 Meetings, 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 provide; (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.

b.Travel Costs

	
 
	
1.
	
Total expenditures for travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract during the base period (CLIN 0001) shall not exceed $[***] without the prior written approval of the CO. The contractor shall notify the CO in writing when travel expenditures have exceeded [***]% ($[***]) of the base period travel expenses. Costs must be consistent with Federal Acquisition Regulations (FAR) 52.247-63 – Preference for U.S. Air Flag carriers.

	
 
	
2.
	
Subject to the annual dollar limitation specified under B.4.b.1. above, the contactor shall invoice and be reimbursed for all travel costs in accordance with Federal Acquisition Regulation (FAR) 31.2 – Contracts with Commercial Organizations, Subsection 31.205¬46, Travel Costs.

	
 
	
3.
	
If foreign travel is necessary, a Contracting Officer Authorization (COA) will be required. Expenditures for foreign travel (transportation, lodging, subsistence, and 

4

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
		
incidental expenses) incurred in direct performance of this contract shall not exceed the amount specified in each approved COA, without the prior written approval of the CO.

Requests for foreign travel must be submitted at least four weeks in advance and shall contain the following:

	
 
	
(a)
	
meeting(s) and place(s) to be visited, with costs and dates;

	
 
	
(b)
	
name(s) and title(s) of contractor personnel to travel and their functions in the contract project;

	
 
	
(c)
	
contract purposes to be served by the travel;

	
 
	
(d)
	
how travel of contractor personnel will benefit and contribute to accomplishing the contract project, or will otherwise justify the expenditure of ASPR contract funds;

	
 
	
(e)
	
how such advantages justify the costs for travel and absence from the project of more than one person if such are suggested; and

	
 
	
(f)
	
what additional functions may be performed by the travelers to accomplish other purposes of the contract and thus further benefit the project.

ARTICLE B.5. ADVANCE UNDERSTANDINGS

a.Man-in-Plant

With seven (7) days advance notice to the contractor in writing from the CO, the Government may place a man-in-plant in the contractor’s facility, who shall be subject to the contractor’s policies and procedures regarding security and facility access at all times while in the contractor’s facility. The Government’s representative shall be provided reasonable access, during normal business hours, of the production areas being utilized in performance on the Contract. 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.

b.Security

No Security Plan is required at this point for this effort. It is anticipated that a security waiver will be approved.

c.Subcontracts

Prior written consent from the CO in the form of Contracting Officer Authorization (COA) is required for any subcontract that:

	
 
	
•
	
Is of the cost-reimbursement type; or

5

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
•
	
Is Fixed-Price and exceeds $150,000 or 5% of the total estimated cost of the Contract, whichever value is greater.

The CO shall request appropriate supporting documentation in order to review and determine authorization, pursuant with FAR Clause 52.244-2, Subcontracts. After receiving written consent of the subcontract by the CO, the contractor shall provide a copy of the signed, executed subcontract and consulting agreement to the CO.

Note: Consulting services are treated as subcontracts and subject to the ‘consent to subcontract’ provisions set forth in this Article.

d.Confidential Treatment of Sensitive Information

As a supplement to Section H.20 of the contract, the contractor shall guarantee strict confidentiality of any information/data of a sensitive nature that is provided to the contractor by the Government during the performance of the contract. The Government has determined that the information/data that the contractor will be provided during the performance of the contract is of a sensitive nature.

Disclosure of information/data that is sensitive in nature, in whole or in part, by the Contractor can only be made after the contractor receives prior written approval from the CO.

Whenever the contractor is uncertain with regard to the proper handling of information/data under the contract, the contractor shall obtain a written determination from the CO (see also HHSAR clause 352.224-71).

Notwithstanding the foregoing, such information/data shall not be deemed of a sensitive nature with respect to the contractor for purposes of this contract if such information/data: (a) was already known to the contractor at or prior to the time of its disclosure to the Contractor; (b) was generally available or known, or was otherwise part of the public domain, at the time of its disclosure to the contractor; (c) became generally available or known, or otherwise became part of the public domain, after its disclosure to, or, with respect to the information/data by, the contractor through no fault of the contractor; (d) was disclosed to the contractor, other than under an obligation of confidentiality or non-use, by a third party who had no obligation to the Government that controls such information/data not to disclose such information/data to others; or (e) was independently discovered or developed by the contractor, as evidenced by its written records, without the use of information/data belonging to the Government.

The contractor may disclose information/data of a sensitive nature provided by the Government to the extent that such disclosure is: (a) made in response to a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial or local governmental or regulatory body of 

6

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

competent jurisdiction; provided, however, that the contractor shall first have given notice to the Government and give the Government a reasonable opportunity to quash such order and to obtain a protective order requiring that the information/data of a sensitive nature that is the subject of such order be held in confidence by such court or agency or, if disclosed, be used only for the purposes for which the order was issued; and provided further that if a disclosure order is not quashed or a protective order is not obtained, the information/data disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order; (b) otherwise required by law, in the opinion of legal counsel to the Contractor as expressed in an opinion letter in form and substance reasonably satisfactory to the Government, which shall be provided to the Government at least two (2) business days prior to the contractor’s disclosure of the information/data; or (c) made by the contractor to the regulatory authorities as required in connection with any filing, application or request for regulatory approval; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information/data.

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 set forth in Article F.2 with Government 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, Technology Transfer Agreements (TTA) between BARDA and the Defense Threat Reduction Agency, Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA) and the National Institute of Allergies and Infectious Diseases (NIAID), BARDA may share technical deliverables set forth in Article F.2 with colleagues within the Integrated Portfolio. This provision applies to all deliverables and data developed during performance including deliverables and data paid for by the Contractor under the cost sharing arrangement all exercised CLINs herein. This advance understanding does not authorize BARDA to share financial information outside HHS. The Contractor is advised to review the terms of FAR Clause 52.227-14 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.Intellectual Property

7

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

BARDA agrees that all data furnished under the Contract marked with the “limited rights” legend contained in FAR 52.227-14 Alternate II shall be treated in accordance with all “limited rights” restrictions and protections described in FAR 52.227-14 Alternate II.

BARDA shall not disclose or use any data marked with the “limited rights” legend for any purpose except as specifically authorized by the “limited rights” provision in FAR 52.227-14 Alternate II, or by any express license agreement between the Government, Spero and if necessary a third party. BARDA further agrees to take all steps necessary to ensure that no other party obtains any rights in or access to Spero’s intellectual property that is marked with the “limited rights” legend.

h.Invoice Submission during end of Fiscal Year

The government will not accept invoices for processing from September 6th through October 5th because of end of year fiscal requirements. Any invoices received from September 6th through October 5th will be canceled and returned to the Contractor for resubmission beginning on October 6th.

	
 
	
i.
	
Sharing of Draft and Final Study Protocols, Top Line Data, and Final Study Reports for Studies

The Contractor shall provide the COR/CO with electronic copies of the draft and final study protocols, top line data, and final study reports for the following studies. These documents shall be delivered within 5 business days of their finalization or, if already finalized at time of contract award, within 10 business days of contract award.

	
 
	
•
	
[***]

	
 
	
•
	
[***]

8

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT 

ARTICLE C.1.  STATEMENT OF WORK

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 Work attached to this contract as Attachment 1 (SECTION J-List of Attachments).

ARTICLE C.2.  REPORTING REQUIREMENTS

Refer to ARTICLE F.2. for specific instructions regarding Reporting Requirements.

ARTICLE C.3.  PROJECT MEETING CONFERENCE CALLS

A teleconference call between the COR and the Contractor’s Program Manager shall occur bi-weekly (every two weeks), or at the discretion of the Government. During this call, the Program Manager will discuss the activities during the reporting period, any problems that have arisen, and the activities planned for the ensuing reporting period. The Contractor’s Program Manager 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 COR.

Contractor will be responsible for preparing an agenda for the conference call and providing it to the Government no later than 2 business days prior to the scheduled conference call.

ARTICLE C.4.  PROJECT MEETINGS

The Contractor shall participate in Project Meetings to coordinate the performance of the contract, as requested by the COR. These meetings may include face-to-face meetings with BARDA and AMCG in Washington, D.C. and at work sites of the contractor. Such meetings may include, but are not limited to, meetings of the contractor (and subcontractors invited by the contractor) to discuss study designs, site visits to the contractor’s and subcontractor’s facilities, and meetings with the contractor and HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The contractor must provide data, reports, and presentations to groups of outside experts (subject to appropriate protections for contractor confidential or proprietary data) and USG personnel as required by the Contracting Officer’s Technical Representative in order to facilitate review of contract activities.

a.Kickoff Meeting

The contractor shall complete a Kickoff meeting within 30 days after contract award. The contractor shall provide an itinerary/agenda no later than 5 business days before meeting.

9

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

b.Quarterly and Ad-Hoc Meetings

At the discretion of the CO/COR, the contractor shall participate in Project Meetings to coordinate the performance of the contract, as requested by the COR. These meetings may include teleconferences or face-to-face meetings with BARDA/AMCG in Washington, D.C. or at work sites of the contractor and its subcontractors. Such meetings may include, but are not limited to, meetings of the contractor (and subcontractors invited by the Contractor) to discuss study designs, site visits to the contractor’s and subcontractor’s facilities, and meetings with the contractor and HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The contractor must provide data, reports, and presentations to groups of outside experts (subject to appropriate protections for contractor’s confidential or proprietary data) and Government personnel as required by the COR, giving reasonable prior notice of such requirement to Contractor, in order to facilitate review of contract activities.

The contractor shall provide itinerary/agenda at least 5 business days in advance of face-to-face meeting.

c.Face-to-Face Project Review Meetings

The contractor shall, at a time to be determined later, present a comprehensive review of contract progress to date in a face-to-face meeting in Washington, DC. The contractor will be responsible for updating BARDA program on technical progress under the Statement of Work. Presentation must be delivered seven (7) business days prior to the scheduled meeting.

10

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

SECTION D – PACKAGING, MARKING, AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Section F. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall make reasonable efforts to ensure that all required materials shall be delivered in immediate usable and acceptable condition

Unless otherwise specified by the CO, delivery of reports to be furnished to the USG under this contract (including invoices) shall be delivered to AMCG and BARDA electronically along with a concurrent email notification to the CO, Contract Specialist, and COR (as defined in SECTION F.3. ELECTRONIC SUBMISSION) summarizing the electronic delivery.

11

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

SECTION E – INSPECTION AND ACCEPTANCE

ARTICLE E.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 CO 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.

FAR ClauseTitle and Date 

52.246-9Inspection of Research and Development (Short Form) (Apr 1984) 

ARTICLE E.2.  DESIGNATION OF GOVERNMENT PERSONNEL

For the purpose of this SECTION E, the designated COR is the authorized representative of the CO. 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.

ARTICLE E.3.  INSPECTION, ACCEPTANCE AND CONTRACT MONITORING

Inspection and acceptance of the materials services and documentation called for herein shall be accomplished by the CO or a duly authorized representative.

Inspection and acceptance will be performed at:

DHHS/OS/ASPR/AMCG

Room 11J14 – O’Neill House Office Building

Washington, DC 20515

a.Site Visits and Inspections

At the discretion of the USG and independent of activities conducted by the contractor, with 48 hours’ notice to the contractor, the USG reserves the right to conduct reasonable site visits of facilities utilized by contractor in performance under the contract and inspections on an as needed basis, including collection of product samples and intermediates held at the location of the contractor, or subcontractor, provided any site visit or inspection shall not cause disruption to ongoing manufacturing and/or business operations of the contractor.  All product samples and intermediates collected by the Government shall subsequently be destroyed or returned to Contractor at the Contractor’s discretion.  All costs reasonably incurred by the Contractor and subcontractor for such visit and/or 

12

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

inspection shall be allowable costs subject to the Allowable cost requirements in FAR Subpart 31.2.  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 48 hour notice to the Contractor.  The areas included under the site visit: security, regulatory and quality systems, manufacturing processes and cGMP/GLP/GCP compliance as related to activities funded under this contract.

If the USG, 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 USG for review and acceptance:

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

	
 
	
•
	
COR and CO will review the report and provide a response to the Contractor within ten (10) business days.

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

13

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

SECTION F – DELIVERIES OR PERFORMANCE

ARTICLE F.1.  ESTIMATED PERIOD OF PERFORMANCE

The estimated period of performance for this contract shall be consistent with the dates set forth in the base period CLIN 0001 and set forth in ARTICLE B.2.  If the Government exercises its Option(s) pursuant to the Option Clause in ARTICLE I.3 of the contract, the period of performance shall be increased as shown in the table in Article B.3.

ARTICLE F.2.  DELIVERABLES

Successful performance of the final contract shall be deemed to occur upon completion of performance of the work set forth in the Statement of Work dated 28 March 2018, set forth in SECTION J - List of Attachments of this contract and upon delivery and acceptance, as required by the Statement of Work, by the CO, of each of the deliverables described in SECTION C, SECTION F, and SECTION J.

All deliverables and reporting documents listed within this section shall be delivered electronically (as defined in SECTION F.3.  ELECTRONIC SUBMISSION) to the CO, CS, and the COR unless otherwise specified by the CO.

a.Summary of Contract Deliverables

Unless otherwise specified by the CO, the deliverables identified in this SECTION F shall also be delivered electronically to the designated eRoom along with a concurrent email notification sent to the CO, CS, COR, and Alternate COR stating delivery has been made.

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).  Hard copies of deliverables and reports furnished to the USG under the resultant Contract (including invoices) shall be addressed as follows:

HHS/ASPR/AMCG:

ATTN: [***] (Contracting Officer)

HHS/OS/ASPR/AMCG

O’Neill House Office Building

200 C St SW

Washington, DC 20515

Email: [***]

HHS/ASPR/BARDA:

ATTN: [***] (Contracting Officer Representative)

14

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

HHS/OS/ASPR/BARDA

O’Neill House Office Building

200 C St SW

Washington, DC 20515

Email: [***] 

	
 
	
1.
	
Summary of Contract Deliverables-Unless otherwise stated, each deliverable in the table below shall be provided as one (1) electronic copy to the COR, CS, and CO as set forth in SECTION D.

				
	
CDRL#
	
Deliverable
	
Deliverable Description
	
Reporting Procedures and Due Dates

	
01
	
Kickoff Meeting
	
The Contractor shall complete a Kickoff meeting after contract award
	
•Within a month of contract award.

•Contractor shall provide itinerary and agenda at least 5 business days in advance of site visit.

•COR approves and distributes itinerary and agenda within 3 business days.

•Contractor provides meeting minutes to COR within 5 business days after the meeting.

•COR reviews, comments, and approves minutes within 10 business days.

	
02
	
Quarterly Meetings
	
The Contractor shall hold recurring teleconference or face- to-face Program Review Meetings approximately every third month either in Washington D.C. or at work sites of the Contractor or subcontractors.  The meetings will be used to discuss contract progress in relation to the Program Management deliverables described below as well as study designs, technical, regulatory, and ethical aspects of the program.
	
•Contractor shall provide itinerary and agenda at least 5 business days in advance of site visit

•COR approves and distributes itinerary and agenda within 3 business days.

•Contractor provides meeting minutes to COR within 5 business days after the meeting.

•COR reviews, comments, and approves minutes within 10 business days.

15

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

				
	
CDRL#
	
Deliverable
	
Deliverable Description
	
Reporting Procedures and Due Dates

	
03
	
Biweekly Teleconference Meetings
	
The Contractor shall participate in teleconferences every two weeks with BARDA to discuss the performance of the contract.
	
•Contractor provides agenda to COR no later than 2 business days in advance of meeting.

•COR approves and distributes agenda prior to meeting.

•Contractor provides meeting minutes to COR within 5 business days following the meeting.

•COR reviews, comments, and approves minutes within 10 business days following the meeting.

16

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

				
	
CDRL#
	
Deliverable
	
Deliverable Description
	
Reporting Procedures and Due Dates

	
04 (Monthly)

05 (Annual)
	
Monthly & Annual Technical Progress Reports
	
The Monthly and Annual Technical Progress report shall address each of the below items and be cross-referenced to the Work Breakdown Structure (WBS), Statement of Work (SOW), Integrated Master Schedule (IMS) and Contract Performance Report (CPR).

1.An Executive Summary highlighting the progress, issues and relevant manufacturing, non-clinical, clinical and regulatory activities.  The Executive Summary should highlight only critical issues for that reporting period and resolution approach; limited to 2-3 pages.

2.Progress in meeting contract milestones – broken out by subtasks within each milestone, overall project assessment, problems encountered and recommended solutions.  The reports shall detail the planned and actual progress during the period covered, explaining occurrences of any differences between the two and the corrective steps.

3.The reports shall also include a three-month rolling forecast of the key 

planned activities, referencing the WBS/IMS.

4.A tracking log of progress on regulatory submissions with the FDA number, description of submission, date of submission, status of submission and next steps.

5.Estimated and Actual Expenses.

6.This report shall also contain a narrative or table detailing whether there is a significant discrepancy (>10%) at this time between the % of work completed and the cumulative costs incurred to date.  Monthly and actual expenses should be broken down to the appropriate WBS level.  This section of the report should also contain estimates for the Subcontractors’ expenses from the previous month if the Subcontractor did not submit a bill in the previous costs in the previous month, then a statement to this effect should be included in this report for those respective subcontractors.
	
•Monthly Reports shall be submitted on the 20th day of the month after the end of each month with an Annual Report submitted on the 30th calendar day of the final month of each contract year for the previous twelve calendar months.  Monthly progress reports are not required for the periods when the Annual Report(s) and Final Report are due.  The COR and CO will review the monthly reports with the Contractor and provide feedback.

17

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

				
	
CDRL#
	
Deliverable
	
Deliverable Description
	
Reporting Procedures and Due Dates

	
06
	
Risk Management Plan
	
The Contractor shall provide a Risk Management Plan that outlines the impacts of each risk in relation to the cost, schedule, and performance objectives.  The plan shall include risk mitigation 

strategies.  Each risk mitigation strategy will capture how the corrective action will reduce impacts on cost, schedule, and performance.
	
•Due within 90 days of contract award.

•Contractor provides updated Risk Management Plan in Monthly Progress Report.

•The COR shall provide the contractor with a written list of concerns in response plan submitted.

•Contractor must address in writing, all concerns raised by the COR within 20 business days of contractor’s receipt of the COR’s concerns.

	
07
	
Incident Report
	
Contractor shall communicate and document all critical programmatic concerns, risks, or potential risks with the COR or CO.
	
•Due within 48 hours of activity or incident or within 24 hours for a security activity or incident.

•Email or telephone with written follow-up to COR and CO.

•Additional updates due to COR and CO within 48 hours of additional developments.

•Contractor shall submit within 5 business days a Corrective Action Plan (if deemed necessary by either party) to address any potential issues.

•If corrective action is deemed necessary, Contractor must address in writing, its consideration of concerns raised by CO/COR within 5 business days of receiving such concerns in writing

18

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

				
	
CDRL#
	
Deliverable
	
Deliverable Description
	
Reporting Procedures and Due Dates

	
08
	
Draft and Final Reports for Clinical and Non-Clinical Studies
	
Contractor shall provide Draft and Final Clinical/Non-Clinical Study Reports to the COR and CO for review and comment.
	
•Draft report due within 45 calendar days after completion of analysis and at least 15 business days prior to submission to FDA.

•Subcontractor prepared reports received by the Contractor shall be submitted to the COR comment no later than 5 business days after receipt by Contractor.

•The Government will provide written comments to the Draft Final Report for Clinical and Non-Clinical Studies within 15 business days after the submission.

•Final report due 30 calendar days after receiving comments on the Draft Final Report for Clinical and Non-Clinical Studies.  If corrective action is recommended, Contractor must address, in writing, all concerns raised by the CO and COR in writing.

•Contractor shall consider revising reports to address CO/COR’s recommendations prior to FDA submission.

•Final FDA submissions shall be provided to CO/COR concurrently or no later than 1 business day after submission to the FDA.

	
09
	
Standard Operating Procedures
	
The Contractor shall make internal and, to the extent possible, subcontractor Standard Operating Procedures (SOPs) specific to SPR 994 (oral carbapenem) available for review electronically.
	
Upon request from the COR/CO.

	
10
	
Manufacturing Campaign Reports
	
Contractor shall provide

Manufacturing Campaign Reports specific to SPR 994 (oral carbapenem) to the COR and CO for review and comment prior to submission to FDA.

 

The COR and CO reserve the right to request within the period of performance a non-proprietary Manufacturing Campaign Report specific SPR 994 (oral carbapenem) for distribution within the USG.
	
•Contractor shall submit Manufacturing Campaign Reports at least 15 business days prior to FDA submission.

•If corrective action is recommended, Contractor must address, in writing, all concerns raised by CO/COR in writing.

•Contractor shall consider revising reports to address CO/COR’s concerns and/or recommendations prior to FDA submission.

•Final FDA submission shall be submitted to CO/COR’s concurrently or no later than 1 business day after submission to the FDA.

	
11
	
FDA Correspondence
	
The Contractor shall memorialize any correspondence between Contractor and FDA specific to SPR 994 (oral carbapenem) and submit to the CO and COR.  All documents shall be duly marked as either “Draft” or “Final”.
	
•Contractor shall provide written summary of any FDA correspondence within 5 business days of correspondence.

19

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

				
	
CDRL#
	
Deliverable
	
Deliverable Description
	
Reporting Procedures and Due Dates

	
12
	
FDA Meetings
	
The Contractor shall forward the SPR 994 (oral carbapenem) dates and times of any meeting with the FDA to the CO and COR and 

make arrangements for appropriate BARDA staff to attend the FDA meetings.  BARDA staff shall include up to a maximum of four people (COR, CO and up to 2 subject matter experts).
	
•Contractor shall notify CO/COR of upcoming FDA meeting within 24 hours of scheduling Type A, B or C meetings OR within 24 hours of meeting occurrence for ad hoc meetings.

•The Contractor shall forward initial Contractor and FDA-issued draft minutes and final minutes of any meeting with the FDA to BARDA within 5 business days of receipt.  All documents shall be duly marked as either “Draft” or “Final”.

	
13
	
FDA Submissions
	
The Contractor shall provide the COR the opportunity to review and comment upon all draft submissions specific to the SPR 994 (oral carbapenem) before submission to the FDA.  Contractor shall provide the COR with an electronic copy of the final FDA submission.  All documents shall be duly marked as either “Draft” or “Final”.
	
•Contractor shall submit draft FDA submissions to the COR and CO at least 15 business days prior to FDA submission.

•CO/COR will provide feedback to Contractor within 10 business days of receipt.

•If corrective action is recommended, the Contractor must address, in writing, its consideration of all concerns raised by the CO/COR.

•The Contractor shall consider revising their documents to address CO/COR’s concerns and/or recommendations prior to FDA submission.

•Final FDA submissions shall be submitted to CO/COR concurrently or no later than 1 calendar day of its submission to CDER.

20

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

				
	
CDRL#
	
Deliverable
	
Deliverable Description
	
Reporting Procedures and Due Dates

	
14
	
FDA Audits
	
In the event of an FDA inspection which occurs as a result of this contract and for the product, or for any other FDA inspection that has the reasonable potential to impact the performance of this contract, 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 COR and CO with copies of the plan for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP 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 audit reports received from subcontractors that occur as a result of this contract or for this product.  The Contractor shall provide the opportunity for COR/CO representative(s) to be present during the final debrief by the regulatory inspector of Contractor facilities.
	
•Contractor shall notify CO and COR within 10 business days of a scheduled FDA audit or within 48 hours of an ad hoc site visit/audit if the FDA does not provide advanced notice.

•Contractor shall provide copies of any FDA audit report received from subcontractors that occur as a result of this contract or for this product within 5 business days of receiving correspondence from the FDA or third party.

•Within 15 business days of audit report of Contractor facilities, Contractor shall provide CO and COR with a plan for addressing areas of nonconformance, if any are identified.

	
15
	
QA Audit Reports
	
The Government reserves the right to participate in QA audits subject to reasonable advance notice provided to the Contractor.  Upon completion of the audit/site visit the Contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor.  If action is requested of the subcontractor, detailed concerns for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to the CO and COR.  The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.
	
•Contractor shall notify CO and COR 10 days in advance of upcoming, ongoing, or recent audits/site visits of subcontractors as part of weekly communications.

•Contractor shall notify the COR and CO within 5 business days of report completion.

21

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

				
	
CDRL#
	
Deliverable
	
Deliverable Description
	
Reporting Procedures and Due Dates

	
16
	
BARDA Audit
	
Contractor shall accommodate periodic or ad hoc site visits by BARDA subject to reasonable advance notice provided to the Contractor.  If BARDA, 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 CO and COR.
	
•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 with 10 business days.

•Once corrective action is completed, the Contractor will provide a final report to BARDA.

	
17
	
Technical Documents
	
Upon request, Contractor shall provide CO and COR with deliverables from the following contract funded activities: Process Development Reports, Assay Qualification Plan/Report, Assay Validation Plan/Report, Assay Technology Transfer Report, Batch Records, SOPs, Master Production Records, Certificate of Analysis, Clinical Studies Data or Reports.  The CO and COR reserve the right to request within the period of performance a non-proprietary technical document for distribution within the Government.
	
•Contractor shall provide technical document within 10 business days of CO or COR request.  Contractor can request additional time on an as needed basis.

•If corrective action is recommended, the Contractor must address, in writing, concerns raised by the CO and COR in writing.

	
18
	
Animal Model or Other Technology Transfer Package
	
Contractor shall provide Animal Model or Other Technology Transfer Package relevant data.
	
•Contractor shall provide data within 10 business days of COR or CO request.

22

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

				
	
CDRL#
	
Deliverable
	
Deliverable Description
	
Reporting Procedures and Due Dates

	
19
	
Raw Data or Data Analysis
	
Contractor shall provide raw data or data analysis to the CO and COR upon request.
	
•Contractor shall provide data or data analysis to CO and COR within 20 business days of request.

	
20
	
Product Transition Strategy
	
Contractor shall provide a 2-4 page summary document containing a Product Transition Strategy to support transition of the product(s) prior to end of the base period of performance.  The Product Transition Strategy should provide a strategic plan for further development and/or stockpiling of the product.  The transition strategy shall provide options and/or a specific approach for the transition of MCM product for further development, procurement, approval and/or stockpile.
	
•Contractor shall provide a Product Transition Strategy to support transition of the product(s) 90 days prior to the end of the base period of performance as addendum to the Final Technical Progress Report.

	
21
	
Publications
	
Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted to the CO and COR for review prior to submission.
	
•Contractor must submit all manuscript or scientific meeting abstract to PO and CO within 30 business days for manuscripts and 15 business days for abstracts.

•Contractor must address in writing all concerns raised by the CO/COR in writing.

•Final submissions shall be submitted to the CO/COR concurrently or no later than one (1) calendar day of its submission.

23

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

				
	
CDRL#
	
Deliverable
	
Deliverable Description
	
Reporting Procedures and Due Dates

	
22
	
Press Releases
	
Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases.
	
•With the exception of ad-hoc press releases required by applicable law or regulations, Contractor shall ensure that the CO has received and approved an advanced copy of any press release to this contract not less than 2 business days prior to the issuance of the press release.

•If corrective action is required, the Contractor agrees to accurately and factually represent 

the work conducted under this contract in all press releases.

•Any final press releases shall be submitted to the CO/COR no later than 1 (one) calendar day prior to its release.

	
23
	
Draft and Final Technical Progress Report
	
A Draft Final Technical Progress Report containing a summation of the work performed and the results obtained for the entire contract period of performance.  The draft report shall be duly marked as ‘Draft’.

The Final Technical Progress Report incorporating feedback received from BARDA and containing a summation of the work performed and the results obtained for the entire contract period of performance.  The final report shall document the results of the entire contract.  This report shall be in sufficient detail to fully describe the progress achieved under all milestones.  The final report shall be duly marked as ‘Final’.
	
•Contractor shall provide a draft Technical Progress Report 75 calendar days before the end of the period of performance and the Final Technical Progress Report on or before the completion date of the period of performance.

•Subcontractor prepared reports received by the contractor shall be submitted to the COR and CO for review and comment no later than 5 business days after receipt by the contractor.

•The COR will provide feedback on draft report within 15 calendar days of receipt, which the Contractor shall consider incorporating into the Final Report.

•The contractor shall submit, with the Final Technical Progress Report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

	
24
	
Draft and Final Study Protocols
	
Contractor shall provide all Draft and Final Study Protocols to COR for evaluation.
	
•The Contractor will submit all proposed protocols to the CO and COR at least 10 business days prior to study start.

24

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

				
	
CDRL#
	
Deliverable
	
Deliverable Description
	
Reporting Procedures and Due Dates

	
25
	
Clinical Study Status Update
	
Contractor shall provide PO with a status update of clinical studies that are actively enrolling patients to include by study site: 

cumulative enrollment; new enrollments; screen failures; patients dropped from study; AE and SAEs; activation or inactivation of study sites; investigator appointments or changes; and status of IRB/IEC review/approval/renewal.  Contractor will provide proposed format for BARDA PO review and approval.
	
•Update will be submitted by e-mail or other electronic format to be provided by CO and CO by the end of the 20th business day of each new month.

•Updates, to the extent they are available, will be presented during biweekly teleconferences.

•If no changes have occurred since the prior update only a simple statement that there is no new data required.

 

NOTE: Pursuant to federal law, no Government personnel shall publish, divulge, disclose, or otherwise make known to any non-government entity any Contractor data marked with the limited rights proprietary legend specified under FAR 52.227-14 Alt II (g)(3) , unless permitted to do so by law or regulation.

2.Detailed Description of Select Contract Deliverables 

A.Monthly and Annual Progress Reports

In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with this Article F of this contract, and in the Statement of Work, attached to this contract (see SECTION J-List of Attachments).

i.Monthly Progress Report

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 according to the dates set forth in the summary table (“Summary of Contract Deliverables”) under this article.  The progress report shall conform to the requirements set forth in the DELIVERIES Article in SECTION F of this contract.  

The format should include:

25

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
•
	
A cover page that includes 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;

	
 
	
•
	
SECTION I – EXECUTIVE SUMMARY 

	
 
	
• 
	
SECTION II - PROGRESS

	
 
	
•
	
SECTION II Part A: OVERALL PROGRESS - A description of overall progress.

	
 
	
•
	
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE - 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).

	
 
	
•
	
SECTION II Part C: TECHNICAL PROGRESS - For each activity related to Gantt chart, document the results of work completed and cost 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.  The description shall include pertinent data and/or graphs in sufficient detail to explain any significant results achieved and preliminary conclusions resulting from analysis and scientific evaluation of data accumulated to date under the contract.  The report 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; preliminary conclusions resulting from analysis and scientific evaluation of data accumulated to date under the project.

	
 
	
•
	
SECTION II Part D: PROPOSED WORK - A summary of work proposed related to Gantt chart for the next reporting period and preprints/reprints of papers and abstracts.

	
 
	
•
	
SECTION III: Estimated and Actual Expenses.

	
 
	

	
a. This section of the report shall contain a narrative or table detailing whether there is a significant discrepancy (>10%) at this time between the % of work completed and the cumulative costs incurred to date.  Monthly and actual expenses should be broken down to the appropriate WBS level.

	
 
	

	
b. This section of the report should also contain estimates for the Subcontractors’ expenses from the previous month if the Subcontractor did not submit a bill in the previous month.  If the subcontractor(s) was not working or did not incur any costs in the previous month, then a statement to this effect should be included in this report for those respective subcontractors.

A Monthly Progress Report will not be required in the same month that the Annual Progress Report is submitted.

26

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

ii.Annual Progress Report

This report shall include a summation of the results of the entire contract work for the period covered.  Monthly Progress Reports shall not be submitted in the same month when an Annual Progress Report is due.  Furthermore, an Annual Progress Report will not be required for the period when the Final Report is due.  The first Annual Progress Report shall be submitted in accordance with the date set forth in the table (“Summary of Contract Deliverables”) under ARTICLE F.2. of this contract.  The progress report shall conform to the requirements set forth in the DELIVERIES Article in SECTION F of this contract.

Each Annual Progress Report shall include:

	
 
	
•
	
A Cover page that includes the contract number and title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and email address; and the date of submission;

	
 
	
•
	
SECTION I: EXECUTIVE SUMMARY - A brief overview of the work completed, and the major accomplishments achieved during the reporting period.

	
 
	
•
	
SECTION II: PROGRESS

	
 
	
•
	
SECTION II Part A: OVERALL PROGRESS - A description of overall progress.

	
 
	
•
	
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE - A high level summary of critical meetings, etc. that have taken place during the reporting period.  Include progress on administration and management to critical factors of the project (e.g. regulatory compliance audits and key personnel changes).

	
 
	
•
	
SECTION II Part C: TECHNICAL PROGRESS - A detailed description of the work performed structured to follow the activities and decision gates outlined at the Integrated Baseline Review and as described in the Integrated Master Plan.  The Report should include a description of any problems (technical or financial) that occurred or were identified during the reporting period, and how these problems were resolved.

	
 
	
•
	
SECTION II Part D: PROPOSED WORK - A summary of work proposed for the next year period to include an updated Gantt Chart.

	
 
	
•
	
SECTION III: Estimated and Actual Expenses.

	
 
	

	
a. This section of the report shall contain a narrative or table detailing whether there were discrepancies between estimated and actual contract-funded expenses over the past year.  Actual expenses should be broken down to the appropriate WBS level.  

27

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
		
This section of the report should also contain estimates for outstanding costs for the previous year which may have been incurred, but not yet billed.

Contractor also should include the following in the Annual Progress Report:

	
 
	
1.
	
Copies of manuscripts (published and unpublished), abstracts, and any protocols or methods developed specifically under the contract during the reporting period; and

	
 
	
2.
	
A summary of any Subject Inventions per the requirements under FAR Clause 52.227-11.

iii. Draft Final Report and Final Report

These reports are to include a summation of the work performed and results obtained for the entire contract period of performance.  This report shall be in sufficient detail to describe comprehensively the results achieved.  The Draft Final Report and Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of the contract.  An Annual Progress Report will not be required for the period when the Final Report is due.  The Draft Final Report and the Final Report shall be submitted in accordance with the dates set forth in the table (“Summary of Contract Deliverables”) under ARTICLE F.2. of this contract.  The report shall conform to the following format:

	
 
	
1.
	
Cover page to include the contract number, contract title, performance period covered, Contractor’s name and address, telephone number, fax number, email address and submission date.

	
 
	
2.
	
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.

	
 
	
3.
	
SECTION II: RESULTS - A detailed description of the work performed related to WBS and Gantt chart, the results obtained, and the impact of the results on the scientific and/or public health community including a listing of all manuscripts (published and in preparation) and abstracts presented during the entire period of performance and a summary of all inventions.

Draft Final Report: The Contractor is required to submit the Draft Final Report to the Contracting Officer’s Representative and Contracting Officer.  The Contracting Officer’s Representative and Contracting Officer will review the Draft Final Report and provide the Contractor with 

28

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

comments in accordance with the dates set forth in ARTICLE F.2. of this contract.

Final Report: The Contractor will deliver the final version of the Final Report on or before the completion date of the contract.  The final version shall include or address the COR’s and CO’s written comments on the draft report.  Final Report shall be submitted on or before the completion date of the contract.

iv.Summary of Salient Results

The Contractor shall submit, with the Final Report, a summary of salient results achieved during the performance of the contract.

v.Audit Reports

Within thirty (30) calendar days of an audit related to conformance to FDA regulations and guidance, including adherence to GLP, GMP, GCP guidelines, the Contractor shall provide copies of the audit report (so long as received from the FDA) and a plan for addressing areas of nonconformance to FDA regulations and guidelines for GLP, GMP, or GCP guidelines as identified in the final audit report and as related to activities funded under this contract.

vi.Supplemental Technical Reports

The Government reserves the right to request within the Period of Performance a non-proprietary technical document for distribution within the USG. Contractor shall provide technical document within 10 business days of CO or COR request.  Contractor can request additional time on an as needed basis.  If edits are recommended, the Contractor must address, in writing, concerns raised by the CO/COR in writing.

B.Deliverables Arising from FDA Correspondence

i.FDA Meetings

The Contractor shall forward the dates and times of any meeting with the FDA to BARDA and make arrangements for appropriate BARDA staff to attend the FDA meetings.  BARDA staff shall include up to a maximum of four people (COR, CO and up to 2 subject matter experts).

	
 
	
•
	
Contractor shall notify BARDA of upcoming FDA meeting within 24 hours of scheduling Type A, B or C meetings OR within 24 hours of meeting occurrence for ad hoc meetings.

	
 
	
•
	
The Contractor shall forward initial Contractor and FDA-issued draft minutes and final minutes of any meeting with the FDA to BARDA 

29

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
		
within 5 business days of receipt.  All documents shall be duly marked as either “Draft” or “Final.”

ii.FDA Submissions

The Contractor shall provide the COR the opportunity to review and comment upon all draft submissions before submission to the FDA.  Contractor shall provide COR with an electronic copy of the final FDA submission.  All documents shall be duly marked as either “Draft” or “Final.”

	
 
	
•
	
The COR will provide feedback to Contractor within 10 business days of receipt.

	
 
	
•
	
If corrective action is recommended, the Contractor must take into consideration concerns raised by COR/CO.  The COR/CO may request a response in writing for a specific concern prior to FDA submission.

	
 
	
•
	
Final FDA submissions shall be submitted to the COR concurrently or no later than 1 calendar day of their submission to FDA.

iii.FDA Audits

In the event of an FDA inspection which occurs as a result of this contract and for the product, or for any other FDA inspection that has the reasonable potential to impact the performance of this contract, the Contractor shall provide the USG with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR) within five (5) business days after the Contractors receipt of those documents.  The Contractor shall provide the COR and CO with copies of the plan for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP 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 Contractor shall make arrangements for BARDA representative(s) to be present during the final debrief by the regulatory inspector.

	
 
	
•
	
The Contractor shall notify CO and COR within 10 business days of a scheduled FDA audit or within 24 hours of an ad hoc site visit/audit if the FDA does not provide advanced notice.

	
 
	
•
	
The Contractor shall provide copies of any FDA audit report received from subcontractors that occur as a result of this contract or for this product within 5 business days of receiving correspondence from the FDA, Subcontractor, or third party.

30

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
•
	
Within 15 business days of audit report, the Contractor shall provide the CO with a plan for addressing areas of nonconformance, if any are identified.

iv.Other FDA Correspondence

The Contractor shall submit any formal correspondence between Contractor and FDA to COR and CO.  All documents shall be duly marked as either “Draft” or “Final.” Contractor shall provide copies of any formal FDA correspondence within 5 business days of correspondence.

ARTICLE F.3.  ELECTRONIC SUBMISSION

For electronic delivery, the Contractor shall upload documents to the appropriate folder on https://eroom.bardatools.hhs.gov/eRoom (“eRoom”) which is the designated USG file sharing system.  The USG shall provide two contractor representatives authorized log in access to the file share program.  Each representative must complete a mandatory training provided by the USG prior to gaining user access.  A notification email should be sent to the CO and COR upon electronic delivery of any documents.

ARTICLE F.4.  SUBJECT INVENTION REPORTING REQUIREMENT

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, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer.  A final invention statement (see FAR 27.303 (b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

Reports and documentation submitted to the Contracting Officer shall be sent to the address set forth in SECTION G – CONTRACT ADMINISTRATION DATA.

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 at the address listed above.

31

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1.  CONTRACTING OFFICER

The following Contracting Officers (CO) will represent the USG for the purpose of this contract:

[***]

HHS/OS/ASPR/AMCG

O’Neill House Office Building

200 C St SW

Washington, DC 20515

Email: [***]

	
 
	
1)
	
The Contracting Officer is the only individual who can legally commit 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.

	
 
	
2)
	
The Contracting Officer is the only person with the 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 work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimburse to the Contractor of any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract.

	
 
	
3)
	
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 US Government, other otherwise, shall be considered grounds for deviation from any stipulation of this contract.

	
 
	
4)
	
The Government may unilaterally change its CO designation, after which it will notify the Contractor in writing of such change.

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:

[***]

HHS/OS/ASPR/BARDA

O’Neill House Office Building

200 C St SW

Washington, DC 20515

Email: [***]

The COR is responsible for:

32

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
1)
	
Monitoring the Contractor’s technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements;

	
 
	
2)
	
Assisting the Contracting Officer in interpreting the statement of work and any other technical performance requirements;

	
 
	
3)
	
Performing technical evaluation as required;

	
 
	
4)
	
Performing technical inspections and acceptances required by this contract; and

	
 
	
5)
	
Assisting in the resolution of technical problems encountered during performance.  The Government may unilaterally change its COR designation, after which it will notify Contractor in writing of such change.

ARTICLE G.3.  KEY PERSONNEL

Pursuant to the Key Personnel clause incorporated in Section I of this contract, the following individuals are considered to be essential to the work being performed hereunder:

				
	
 
	
NAME
	
ORGANIZATION
	
TITLE

	
1
	
[***]
	
Spero
	
[***]

	
2
	
[***]
	
Spero
	
[***]

	
3
	
[***]
	
Spero
	
[***]

	
4
	
[***]
	
Spero
	
[***]

	
5
	
[***]
	
Spero
	
[***]

 

The key personnel specified in this contract are considered to be essential to work performance.  At least thirty (30) business days prior to diverting any of the specified individuals to other programs or contracts, including, where practicable, an instance when an individual must be replaced as a result of leaving the employ of the Contractor, the Contractor shall notify the Contracting Officer and shall submit a comprehensive justification (including a Curriculum Vitae for the recommendation replacement) for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract.  The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer.

33

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

ARTICLE G.4.  CONTRACT FINANCIAL REPORT

	
 
	
a.
	
Financial reports on the attached Financial Report of Individual Project/Contract shall be submitted by the Contractor to the CO with a copy to the COR in accordance with the instructions for completing this form, which accompany the form, in an original and one electronic copy, not later than the 30th business day after the close of the reporting period.  The line entries for subdivisions of work and elements of cost (expenditure categories), which shall be reported within the total contract, are discussed in paragraph e., below.  Subsequent changes and/or additions in the line entries shall be made in writing.

	
 
	
b.
	
Unless otherwise stated in the instructions for completing this form, all columns A through J, shall be completed for each report submitted.

	
 
	
c.
	
The first financial report shall cover the period consisting of the first full three calendar months following the date of the contract, in addition to any fractional part of the initial month.  Thereafter, reports will be on a quarterly basis.

	
 
	
d.
	
The Contracting Officer may require the Contractor to submit detailed support for costs contained in one or more interim financial reports.  This clause does not supersede the record retention requirements in FAR Part 4.7.

	
 
	
e.
	
The listing of expenditure categories to be reported is incorporated as a part of this contract and can be found under SECTION J Attachment 3 entitled, “Financial Report of Individual Project/Contract”.

	
 
	
f.
	
The USG may unilaterally revise the “Financial Report of Individual Project/Contract” to reflect the allotment of additional funds.

ARTICLE G.5.  INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING

Documents shall be delivered electronically to the Contracting Officer (CO), the Contracting Specialist (CS), the Contracting Officer’s Representative (COR) and PSC.  Unless otherwise specified by the Contracting Officer all deliverables and reports furnished to the Government under the resultant contract (including invoices) shall be addressed as follows:

			
	
[***]

HHS/OS/ASPR/AMCG

O’Neill House Office Building 200 C St SW

Washington, DC 20515 

Email: [***] 
	
[***]

HHS/OS/ASPR/BARDA O’Neill House Office Building 200 C St SW

Washington, DC 20515 

Email: [***]
	
psc_invoices@psc.hhs.gov

 

And

 

Designated e-room.

 

 

34

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
a.
	
Contractor invoices/financial reports shall conform to the form, format, and content requirements of the instructions for Invoice/Financing requests and Contract Financial Reporting.

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

	
 
	
c.
	
The Contractor agrees to immediately notify the CO 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.  (See estimated costs under Articles B.2) and the reasons for the variance.  These requirements are in addition to the specified requirements of FAR Clause 52.232-20, Limitation of Cost that is incorporated by reference under Article I.1 which states;

	
 
	
d.
	
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 above 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.

	
 
	
e.
	
An electronic copy of the payment request shall be uploaded into the designated eRoom (as defined in SECTION F.3 ELECTRONIC SUBMISSION) and an e-mail notification of the upload will be provided to the CO and COR.

	
 
	
f.
	
All invoice submissions shall be in accordance with FAR Clause 52.232-25, Prompt Payment (Oct 2008).

	
 
	
g.
	
Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget.

Limitation of Cost (Apr 1984)

	
 
	
(a)
	
The parties estimate that performance of this contract, exclusive of any fee, will not cost the Government more than (1) the estimated cost specified in the Schedule or, (2) if this is a cost-sharing contract, the Government’s share of the estimated cost specified in the Schedule.  The Contractor agrees to use its best efforts to perform the work specified in the Schedule and all obligations under this contract within the estimated cost, which, if this is a cost-sharing contract, includes both the Government’s and the Contractor’s share of the cost.

	
 
	
(b)
	
The Contractor shall notify the Contracting Officer in writing whenever it has reason to believe that—

	
 
	
(1)
	
The costs the Contractor expects to incur under this contract in the next 60 days, when added to all costs previously incurred, will exceed 75 percent of the estimated cost specified in the Schedule; or

35

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
(2)
	
The total cost for the performance of this contract, exclusive of any fee, will be either greater or substantially less than had been previously estimated.

	
 
	
(c)
	
As part of the notification, the Contractor shall provide the Contracting Officer a revised estimate of the total cost of performing this contract.

	
 
	
(d)
	
Except as required by other provisions of this contract, specifically citing and stated to be an exception to this clause—

	
 
	
(1)
	
The Government is not obligated to reimburse the Contractor for costs incurred in excess of (i) the estimated cost specified in the Schedule or, (ii) if this is a cost-sharing contract, the estimated cost to the Government specified in the Schedule; and

	
 
	
(2)
	
The Contractor is not obligated to continue performance under this contract (including actions under the Termination clause of this contract) or otherwise incur costs in excess of the estimated cost specified in the Schedule, until the Contracting Officer (i) notifies the Contractor in writing that the estimated cost has been increased and (ii) provides a revised estimated total cost of performing this contract.  If this is a cost-sharing contract, the increase shall be allocated in accordance with the formula specified in the Schedule.

	
 
	
(e)
	
No notice, communication, or representation in any form other than that specified in paragraph (d)(2) of this clause, or from any person other than the Contracting Officer, shall affect this contract’s estimated cost to the Government.  In the absence of the specified notice, the Government is not obligated to reimburse the Contractor for any costs in excess of the estimated cost or, if this is a cost-sharing contract, for any costs in excess of the estimated cost to the Government specified in the Schedule, whether those excess costs were incurred during the course of the contract or as a result of termination.

	
 
	
(f)
	
If the estimated cost specified in the Schedule is increased, any costs the Contractor incurs before the increase that are in excess of the previously estimated cost shall be allowable to the same extent as if incurred afterward, unless the Contracting Officer issues a termination or other notice directing that the increase is solely to cover termination or other specified expenses.

	
 
	
(g)
	
Change orders shall not be considered an authorization to exceed the estimated cost to the Government specified in the Schedule, unless they contain a statement increasing the estimated cost.

	
 
	
(h)
	
If this contract is terminated or the estimated cost is not increased, the Government and the Contractor shall negotiate an equitable distribution of all property produced or purchased under the contract, based upon the share of costs incurred by each.

36

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

The Contractor agrees to provide a detailed breakdown on invoices of the following cost categories:

	
 
	
a.
	
Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort (actual hours or % of effort), and amount claimed.

	
 
	
b.
	
Fringe Benefits - Cite rate and amount

	
 
	
c.
	
Overhead - Cite rate and amount

	
 
	
d.
	
Materials & Supplies - Include detailed breakdown when total amount is over $3,500.

	
 
	
e.
	
Travel - Identify travelers, dates, destination, purpose of trip, and total breaking out amounts for transportation (plane, car etc), lodging, M&IE. Cite COA, if appropriate.  List separately, domestic travel, general scientific meeting travel, and foreign travel.

	
 
	
f.
	
Consultant Fees - Identify individuals, amounts and activities.  Cite appropriate COA

	
 
	
g.
	
Subcontracts - Attach subcontractor invoice(s).  Cite appropriate COA

	
 
	
h.
	
Equipment - Cite authorization and amount.  Cite appropriate COA

	
 
	
i.
	
Other Direct Costs - Include detailed breakdown when total amount is over $3,500.

	
 
	
j.
	
G&A - Cite rate and amount.

	
 
	
k.
	
Total Cost (and applicable cost-shared ratio)

	
 
	
l.
	
Fee (if applicable)

	
 
	
m.
	
Total Cost Plus Fixed Fee

Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the USG.  Nothing in this section discharges the Contractor’s responsibility to comply with any applicable FAR Parts 30 or 31 clauses’ relating to cost reimbursement subcontracts.  In order to verify allowability, further breakdown of costs may be requested at the USG’s discretion.  The Contractor shall subcontract with Firm Fixed Price Contracts to the maximum extent practicable.

Additional instructions and an invoice template are provided in Attachment 2, Invoice/Financing Request Instructions and Contract Financial Reporting Instructions for Cost-Reimbursement Type Contracts.  All invoices must be signed by a representative of the Contractor authorized to certify listed charges are accurate and comply with government regulations.  Invoices should be 

37

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

submitted electronically (in accordance with ARTICLE F.3., (ELECTRONIC SUBMISSION) Only with signature.

If applicable, the Contractor shall convert any foreign currency amount(s) in the monthly invoice to U.S. dollars each month, on the 1st of the month, using the foreign exchange rate index published on www.federalreserve.gov.  Payment of invoices is subject to the U.S. dollar limits within the Total Estimated Cost of each active CLIN(s) in Section B under the contract.

ARTICLE G.6.  REIMBURSEMENT OF COST

	
 
	
1)
	
The Government shall reimburse the Contractor the cost determined by the Contracting Officer to be allowable (hereinafter referred to as allowable cost) in accordance with FAR Clause 52.216-7, Allowable Cost and Payment incorporated by reference in Section I, Contract Clauses, of this contract, and FAR Subpart 31.2. Examples of allowable costs include, but are not limited to, the following:

	
 
	
a)
	
All direct materials and supplies that are used in performing the work provided for under the contract, including those purchased for subcontracts and purchase orders.

	
 
	
b)
	
All direct labor, including supervisory, that is properly chargeable directly to the contract, plus fringe benefits.

	
 
	
c)
	
All other items of cost budgeted for and accepted in the negotiation of this basic contract or modifications thereto.

	
 
	
d)
	
Approved Travel costs (See Article B.4.b. above) including per diem or actual subsistence for personnel while in an actual travel status in direct performance of the work and services required under this contract subject to the following:

	
 
	
(i)
	
Air travel shall be by the most direct route using “air coach” or “air tourist” (less than first class) unless it is clearly unreasonable or impractical (e.g., not available for reasons other than avoidable delay in making reservations, would require circuitous routing or entail additional expense offsetting the savings on fare, or would not make necessary connections).

	
 
	
(ii)
	
Rail travel shall be by the most direct route, first class with lower berth or nearest equivalent.

	
 
	
(iii)
	
Costs incurred for lodging, meals, and incidental expenses shall be considered reasonable and allowable to the extent that they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulation (FTR).

	
 
	
(iv)
	
Travel via privately owned automobile shall be reimbursed at not more than the current General Services Administration (GSA) FTR established mileage rate.

38

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

ARTICLE G.7.  INDIRECT COST RATE

The following contractor established provisional billing rates are incorporated into the contract, and will be utilized for billing purposes during the base period pending the establishment of final indirect cost rates for each fiscal year or until revised by the Contracting Officer in accordance with the provisions of FAR 42.705-1. FAR clause 52.216-7 will be utilized for billing purposes during the base period as a provisional indirect rate:

			
	
Spero Therapeutics
	
 
	
 

	
Rate Type
	
Rate
	
Allocation Base

	
Fringe Benefits
	
[***]%
	
Direct Labor Costs

	
Overhead
	
[***]%
	
Direct Labor & Fringe Costs

	
G&A
	
[***]%
	
Direct Labor, Fringe, Overhead, and Other Direct Costs

 

Use of the above provisional rates does not change any cost ceilings, contract obligations, or specific allowance or disallowance provided for in the contract.

Final rate proposals must be sent to the Contracting Officer, within 6 months subsequent to the fiscal year end.  (See also FAR Clause 52.216-7 incorporated herein).  Employees of any affiliate organization subsidiary of the Contractor shall be charged as per the labor rate schedule specified in Contractor’s business proposal.

ARTICLE G.8.  POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

1.Contractor Performance Evaluations

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15.  The final performance evaluation will be prepared at the time of completion of work.  In addition to the final evaluation, an interim evaluation shall be submitted annually.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation.  The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement.  If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

2.Electronic Access to Contractor Performance Evaluations

39

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

Contractors that have Internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address:

http://www.cpars.gov

The registration process requires the Contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment.  In addition, the Contractor will be required to identify an alternate contact that will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

ARTICLE G.9.  CONTRACT COMMUNICATIONS/CORRESPONDENCE (JULY 1999)

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

ARTICLE G.10.  GOVERNMENT PROPERTY

	
 
	
1.
	
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, “HHS Contracting 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.

	
 
	
2.
	
Notwithstanding the provisions outlined in the HHS Publication, “HHS Contracting 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 attached to this contract (see SECTION J- List of Attachments).

	
 
	
3.
	
Title will vest in the Government for equipment purchased as a direct cost.

40

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

SECTION H - SPECIAL CONTRACT REQUIREMENTS

The Contractor, depending upon the nature of the work, is responsible for following the provisions 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  CLINICAL AND NON-CLINICAL TERMS OF AWARD

BARDA has a responsibility to obtain documentation concerning mechanisms and procedures that are in place to protect the safety of participants and animals in BARDA funded clinical trials and non-clinical studies.  Therefore, the Contractor shall develop a protocol for each clinical trial and non-clinical study funded under this contract and submit all such protocols and protocol amendments to the COR evaluation and comment.  Approval by the COR is required before work under a protocol may begin.  The COR comments will be forwarded to the Contractor within ten (10) business days.  The Contractor must address, in writing, all concerns (e.g. study design, safety, regulatory, ethical, and conflict of interest) noted by the COR.

If the draft protocols are to be submitted to the FDA, BARDA review shall occur before submission, pursuant to the terms set forth by ARTICLE F.2 of this contract.  The Contractor shall consider revising their protocols to address BARDA’s concerns and recommendations prior to FDA submission.  The Contractor must provide BARDA with a copy of FDA submissions, within the time frame set forth by ARTICLE F.2 of this contract.

Execution of clinical and non-clinical studies requires written authorization from the Government.  The USG will provide written authorization to the Contractor upon either 1) receiving documentation in which all COR comments have been satisfactorily addressed; or 2) receiving documentation that the FDA has reviewed and commented on the protocol.

The Government shall have unlimited rights to all protocols, data resulting from execution of these protocols, and final reports funded by BARDA under this contract, as set forth in the FAR clauses referenced in PART II of this contract.  The Government reserves the right to request that the Contractor provide any contract deliverable in a non-proprietary form (e.g. redacted and /or abridged as necessary as reasonably determined by the Contractor) to ensure the Government has the ability to review and distribute the deliverables as the Government deems necessary.

Important information regarding performing human subject research is available at http://www3.niaid.nih.gov/healthscience/clinicalstudies/.

Any updates to technical reports are to be addressed in the Monthly and Annual Progress Reports.  The Contractor shall advise the Contracting Officer’s Representative or 

41

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

designee in writing and via electronic communication in a timely manner of any issues potentially affecting contract performance.

1.Non-Clinical Terms of Award

These Non-Clinical Terms of Award detail an agreement between the Biomedical Advanced Research and Development Authority (BARDA) and the Contractor; they apply to all grants and contracts that involve non-clinical research.

a.Safety and Monitoring Issues

	
 
	
i.
	
PHS Policy on Humane Care and use of Laboratory Animals

Before award and then with the annual progress report, the Contractor must submit to BARDA a copy of the current Institutional Animal Care and Use Committees (IACUC) documentation of continuing review and approval and the Office of Laboratory Animal Welfare (OLAW) federal wide assurance number for the institution or site.

If other institutions are involved in the research (e.g., a multicenter trial or study), each institution’s IACUC must review and approve the protocol.  They must also provide BARDA initial and annual documentation of continuing review and approval and federal wide assurance number.

The Contractor must ensure that the application, as well as all protocols, is reviewed by the performing institution’s IACUC.

To help ensure the safety of animals used in BARDA-funded studies, the Contractor must provide BARDA copies of documents related to all major changes in the status of ongoing protocols, including the following:

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

	
 
	
•
	
All material changes in IACUC policies and procedures, identified by version number, date, and all required signatories (if applicable).

	
 
	
•
	
Termination or temporary suspension of the study(ies) for regulatory issues.

	
 
	
•
	
Termination or temporary suspension of the protocol.

	
 
	
•
	
Any change that is made in the specific IACUC approval for the indicated study(ies).

42

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
•
	
Any other problems or issues that could affect the scientific integrity of the study(ies), i.e., fraud, misrepresentation, misappropriation of funds, etc.

The Contractor must notify the CO and COR of any of the above changes within five (5) working days from the time the Contractor becomes aware of such changes by email or fax, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IACUC and a copy of any responses from the IACUC.

If a non-clinical protocol has been reviewed by an institutional biosafety 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.

	
 
	
ii.
	
Non-Clinical Data and Safety Monitoring Requirements

BARDA strongly recommends continued safety monitoring for all non-clinical studies of investigational drugs, devices, or biologics.  FDA expects non-clinical studies to include safety in addition to efficacy.  The Contractor should consider evaluation of clinical relevant safety markers in the pivotal and non-pivotal, non-clinical studies.  In preparation for clinical trials of licensed or not yet licensed products, it is imperative that BARDA- sponsored studies of any type measure the risk and safety parameters that are elicited and provide a safety profile from the studies for future human risk assessment.

BARDA will work with the Contractor on decisions regarding the type and extent of safety data accrual to be employed before the start of efficacy or safety studies.

The Contractor shall inform CO and COR of any upcoming site visits and/or audits of CRO facilities funded under this effort.  BARDA reserves the right to accompany the Contractor on site visits and/or audits of CRO’s as BARDA deems necessary, provided reasonable prior notice is given to the Contractor.

b.BARDA Review Process before Non-Clinical study Execution Begins

BARDA is under the same policy-driven assurances as NIH in that it has a responsibility to ensure that mechanisms and procedures are in place to protect the safety and welfare of animals used in BARDA-funded non-clinical trials.  Therefore, before study execution, the Contractor must provide the following (as applicable) for review and comment by Government:

43

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
•
	
IACUC approved (signed) non-clinical research protocol identified by version number, date, or both, including details of study design, euthanasia criteria, proposed interventions, and exclusion criteria.

	
 
	
•
	
For non-pivotal mouse studies, the Contractor will provide an annual animal care and use protocol.

	
 
	
•
	
Documentation of IACUC approval, including OLAW federal wide number, IACUC registration number, and IACUC name.

	
 
	
•
	
Contractor should reduce the number of animals required for a study using power of statistics.

	
 
	
•
	
Plans for the management of side effects, rules for interventions and euthanasia criteria.

	
 
	
•
	
Procedures for assessing and collecting safety data were appropriate.

	
 
	
•
	
If a study is contracted through Contract Research Organizations (CROs), work orders and service agreements the Contractor shall assure an integrated safety documentation plan is in place for the study site, pharmacy service records on the dosing material to be used and excipients, and laboratory services (including histopathology).

	
 
	
•
	
Documentation that the Contractor and all required staff responsible for the conduct of the research have received training in the protection and handling of animals, or that the CRO has the required documentation.

	
 
	
•
	
Purchasing of animals and/or other supplies for non-clinical studies funded in part or in whole by BARDA requires written approval by the Contracting Officer in accordance with the contract.  The Contractor must have the ability to return/re-sell animals, at purchase price, to distributor or a third part, in the event that the Contracting Officer Authorization is not granted.

	
 
	
•
	
Provide justification for whether studies require good laboratory practice (GLP) conditions.

	
 
	
•
	
Provide justification for whether studies will be classified as non-pivotal or pivotal studies.

Documentation of each of the above items shall be submitted to the CO and COR for evaluation and comment in conjunction with the protocol.  Execution of non-clinical studies requires written authorization from the Contracting Officer in accordance with this section of the contract.

44

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

c.References

Public Health Service Policy on Humane Care and Use of Laboratory Animals: http://grants.nih.gov/grants/olaw/InvestigatorsNeed2Know.pdf

USDA Animal Welfare Act:

http://awic.nal.usda.gov/nal_display/index.php?info_center=3&tax_level=3&tax_subject=182&topic_id=1118&level3_id=6735&level4_id=0&level5_id=0&placement_default=0

	
2.
	
Clinical Terms of Award

These Clinical Terms of Award detail an agreement between the Government and the Contractor; they apply to all grants and contracts that involve clinical research.

Draft protocols for each clinical study will be submitted to the CO and the COR for evaluation and comment.  CO/COR comments will be addressed and/or incorporated into the draft protocol prior to submission to the FDA for comment, if required.

BARDA shall have unlimited rights to all protocols, data generated from the execution of these protocols, and final reports, funded by BARDA under this contract, as defined in Rights in Data Clause in FAR 52.227-14.  BARDA reserves the right to request that the Contractor provide any contract deliverable funded under this contract without any restrictive legends to ensure BARDA has the ability to review and distribute the deliverables, as BARDA deems necessary.

a.Safety and Monitoring Issues

	
 
	
i.
	
Institutional Review Board or Independent Ethics Committee Approval

Before initiating enrollment of subjects then with the annual progress report, the Contractor must submit to the CO and COR a copy of the current IRB-or IEC-approved informed consent document, documentation of continuing review and approval and the OHRP federal wide assurance 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 CO and the COR initial and annual documentation of continuing review and approval, including the current approved informed consent document and federal wide assurance number.

The Contractor must ensure that the application as well as all protocols are reviewed by their IRB or IEC or that of the CRO to which the contractor assigns the responsibility.

45

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

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

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

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

	
 
	
•
	
Termination or temporary suspension of patient accrual.

	
 
	
•
	
Termination or temporary suspension of the protocol.

	
 
	
•
	
Any change in IRB approval.

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

The Contractor must notify BARDA through the COR and CO of any of the above changes within five (5) working days by email or fax, 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 biosafety 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.

	
 
	
ii.
	
Data and Safety Monitoring Requirements

BARDA strongly recommends independent safety monitoring for clinical trials of investigational drugs, devices, or biologics; clinical trial 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 be reviewed by an independent data and safety monitoring board (DSMB); other trials may require DSMB oversight as well.  The Contractor shall inform the CO and COR of any upcoming site visits and/or audits of CRO facilities funded under this effort.  The CO and COR reserves the right to accompany the Contractor on site visits and/or audits of CROs as the Government deems necessary.

A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research and not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.  For examples, the risk of drawing a small 

46

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of a routine physical examination (45 CFR 46.1021).

Final decisions regarding the type of monitoring to be used must be made jointly by BARDA and the Contractor before enrollment starts.  Discussions with the responsible BARDA Project Officer 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:

	
 
	
▪
	
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.

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

	
 
	
▪
	
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

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 BARDA before enrollment starts.  The Contractor will also ensure that the monitors and board members report any conflicts of interest and the Contractor will maintain a record of this.  The Contractor will share conflict of interest reports with BARDA.

Additionally, the Contractor must submit written summaries of all reviews conducted by the monitoring group to the CO and COR within thirty (30) days of reviews or meetings.

	
 
	
iii.
	
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 ensure the following (as applicable) are in place at each participating institution, prior to patient accrual or enrollment:

47

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
•
	
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.

	
 
	
•
	
Documentation of IRB or IEC approval, including OHRP federal wide number, IRB or IEC registration number, and IRB and IEC name.

	
 
	
•
	
IRB- or IEC- approved informed consent document, identified by version number, date, or both and dates it is valid.

	
 
	
•
	
Plans for the management of side effects.

	
 
	
•
	
Procedures for assessing and reporting adverse events.

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

	
 
	
•
	
Documentation that the Contractor and all study staff responsible for the design or conduct of the research have received training in the protection of human subjects.

Documentation to demonstrate that each of the above items are in place shall be submitted to the CO and COR for evaluation and comment in conjunction with the protocol.  Execution of clinical studies requires written authorization from the CO and COR in accordance with this section of this contract.

	
 
	
iv.
	
Investigational New drug or Investigational Device Exemption Requirements  Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

Exceptions must be granted in writing by FDA.  If the proposed clinical trial will be performed under an IND or IDE, the Contractor must provide the CO and COR with the name and institution of the IND or IDE sponsor, the date the IND or IDE was filed with FDA, the FDA IND or IDE number, any written comments from FDA, and the written responses to those comments.

Unless FDA notifies Contractor otherwise, The Contractor must wait thirty (30) calendar days from FDA receipt of an initial IND or IDE application before initiating a clinical trial.

The Contractor must notify the CO and COR if the FDA places the study on clinical hold and provide the CO and COR any written comments from FDA, written responses to the comments, and documentation in writing that the hold has been lifted.  The Contractor must not use grant or contract funds during a clinical hold to fund clinical studies that are on hold.  The Contractor must not enter into any new financial obligations related to clinical activities for the clinical trial on clinical hold.

48

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
v.
	
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 COR as follows:

	
 
	
i.
	
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 (7) days after the IND sponsor’s receipt of the information, must be submitted to the COR within 24 hours of FDA notification.

	
 
	
ii.
	
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 days after the IND sponsor’s receipt of the information, must be submitted to the COR within 24 hours of FDA notification.  For medical devices, adverse events should be reported under the MedWatch (MDR) program with reporting timelines of 5 days for serious adverse events or 30 days for reportable events.

	
 
	
iii.
	
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 COR within 24 hours of FDA notification.

	
 
	
iv.
	
Expedited safety reports:

Sent to the COR concurrently with the report to FDA.

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

In case of problems or issues, the COR will contact the Contractor within ten (10) business days by email or fax, followed within thirty (30) calendar days by an official letter to the Contractor’s Project Manager, with a copy to the institutions’ office of sponsored programs, listing issues and appropriate actions to be discussed.

49

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
vi.
	
Safety reporting for research not performed under an IND or IDE.

Final decisions regarding ongoing safety reporting requirements for research not performed under an IND or IDE must be made jointly by the COR and the Contractor.

ARTICLE H.2.  PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (December 2015)

	
 
	
a.
	
The 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 federal wide 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 a proper manner and as safely as is feasible.  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 USG.  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.
	
If at any time during the performance of this contract, the CO 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 CO may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance.  The CO 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 CO’s written notice of suspension, the CO 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.3.  HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

50

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

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 Federal, 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.

The Contractor shall provide written documentation that all human materials obtained as a result of research involving human subjects conducted under this contract, by collaborating sites, or by subcontractors identified under this contract, were obtained with prior approval by the Office for Human Research Protections (OHRP) of an Assurance to comply with the requirements of 45 CFR 46 to protect human research subjects.  This restriction applies to all collaborating sites without OHRP- approved Assurances, whether domestic or foreign, and compliance must be ensured by the Contractor.

Provision by the Contractor to the Contracting Officer of a properly completed “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263(formerly Optional Form 310), certifying IRB review and approval of the protocol from which the human materials were obtained constitutes the written documentation required.  The human subject certification can be met by submission of a self-designated form provided that it contains the information required by the “Protection of Human Subjects Assurance Identification/IRB Certification/Declaration of Exemption”, Form OMB No. 0990-0263 (formerly Optional Form 310).

ARTICLE H.4.  RESEARCH INVOLVING HUMAN FETAL TISSUE

All research involving human fetal tissue shall be conducted in accordance with the Public Health Service Act, 42 U.S.C. 289g-1 and 289g-2.  Implementing regulations and guidance for conducting research on human fetal tissue may be found at 45 CFR 46, Subpart B and http://grants1.nih.gov/grants/guide/notice-files/not93-235.html and any subsequent revisions to this NIH Guide to Grants and Contracts (“Guide”) Notice.

The Contractor shall make available, for audit by the Secretary, HHS, the physician statements and informed consents required by 42 USC 289g-1(b) and (c), or ensure HHS access to those records, if maintained by an entity other than the Contractor.

ARTICLE H.5.  CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5 (October 2009)

	
 
	
a.
	
Before undertaking performance of any contract involving animal-related activities where the species is regulated by 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 sections 2.25 through 2.28.  The Contractor shall furnish evidence of the registration to the Contracting Officer.

51

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
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 Sections 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.

	
 
	
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 CO’s written notice of suspension, the CO 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 approved 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 (E-mail: ace@aphis.usda.gov; Web site: (http://www.aphis.usda.gov/animal_welfare). 

ARTICLE H.6.  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.  This policy may be accessed at: http://grants1.nih.gov/grants/olaw/references/phspol.htm 

ARTICLE H.7.  INFORMATION ON COMPLIANCE WITH ANIMAL CARE REQUIREMENTS

Registration with the U.S. Dept. of Agriculture (USDA) is required to use regulated species of animals for biomedical purposes.  USDA is responsible for the enforcement of 

52

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

the Animal Welfare Act (7 U.S.C. 2131 et. seq.), http://www.nal.usda.gov/awic/legislat/awa.htm 

The Public Health Service (PHS) Policy is administered by the Office of Laboratory Animal Welfare (OLAW) http://grants2.nih.gov/grants/olaw/olaw.htm.  An essential requirement of the PHS Policy http://grants2.nih.gov/grants/olaw/references/phspol.htm is that every institution using live vertebrate animals must obtain an approved assurance from OLAW before they can receive funding from any component of the U.S. Public Health Service.

The PHS Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals http://www.nap.edu/readingroom/books/labrats/ and that they comply with the regulations (9 CFR, Subchapter A)http://www.nal.usda.gov/awic/legislat/usdaleg1.htm issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act. The Guide may differ from USDA regulations in some respects.  Compliance with the USDA regulations is an absolute requirement of this Policy.

The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) http://www.aaalac.org is a professional organization that inspects and evaluates programs of animal care for institutions at their request.  Those that meet the high standards are given the accredited status.  As of the 2002 revision of the PHS Policy, the only accrediting body recognized by PHS is the AAALAC.  While AAALAC Accreditation is not required to conduct biomedical research, it is highly desirable.  AAALAC uses the Guide as their primary evaluation tool.  They also use the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching.  It is published by the Federated of Animal Science Societies http://www.fass.org.

ARTICLE H.8.  REQUIREMENTS FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE ANIMAL SUBJECTS

The PHS Policy on Humane Care and Use of Laboratory Animals requires that applicant organizations proposing to use vertebrate animals file a written Animal Welfare Assurance with the Office for Laboratory Animal Welfare (OLAW), establishing appropriate policies and procedures to ensure the humane care and use of live vertebrate animals involved in research activities supported by the PHS.  The PHS Policy stipulates that an applicant organization, whether domestic or foreign, bears responsibility for the humane care and use of animals in PHS-supported research activities.  Also, the PHS policy defines “animal” as “any live, vertebrate animal used, or intended for use, in research, research training, experimentation, biological testing or for related purposes.” This Policy implements and supplements the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, and requires that institutions use the Guide for the Care and Use of Laboratory Animals as a basis for developing and implementing an institutional animal care and use program.  This Policy does not affect applicable State or local laws or regulations that impose more 

53

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

stringent standards for the care and use of laboratory animals.  All institutions are required to comply, as applicable, with the Animal Welfare Act as amended (7 USC 2131 et. seq.) and other Federal statutes and regulations relating to animals.  These documents are available from the Office of Laboratory Animal Welfare, National Institutes of Health, Bethesda, MD 20892, (301) 496-7163. See http://grants.nih.gov/grants/OLAW/olaw.htm 

No PHS supported work for research involving vertebrate animals will be conducted by an organization, unless that organization is operating in accordance with an approved Animal Welfare Assurance and provides verification that the Institutional Animal Care and Use Committee (IACUC) has reviewed and approved the proposed activity in accordance with the PHS policy.  Applications may be referred by the PHS back to the institution for further review in the case of apparent or potential violations of the PHS Policy.  No award to an individual will be made unless that individual is affiliated with an assured organization that accepts responsibility for compliance with the PHS Policy.  Foreign applicant organizations applying for PHS awards for activities involving vertebrate animals are required to comply with PHS Policy or provide evidence that acceptable standards for the humane care and use of animals will be met.  Foreign applicant organizations are not required to submit IACUC approval, but should provide information that is satisfactory to the USG to provide assurances for the humane care of such animals.

ARTICLE H.9.  APPROVAL OF REQUIRED ASSURANCE BY OLAW

Under governing regulations, federal funds which are administered by the Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority (BARDA) shall not be expended by the Contractor for research involving live vertebrate animals, nor shall live vertebrate animals be involved in research activities by the Contractor under this award unless a satisfactory assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 is submitted within 30 days of the date of this award and approved by the Office of Laboratory Animal Welfare (OLAW).  Each performance site (if any) must also assure compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 with the following restriction: Only activities which do not directly involve live vertebrate animals (i.e. are clearly severable and independent from those activities that do involve live vertebrate animals) may be conducted by the Contractor or individual performance sites pending OLAW approval of their respective assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28.  Additional information regarding OLAW may be obtained via the Internet at http://grants2.nih.gov/grants/olaw/references/phspol.htm

ARTICLE H.10.  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 should report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline.  The toll free number is 

54

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

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.11.  PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES

The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to EO13224 and P.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.12.  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 (DHHS).  DHHS reserves the right to review any other data determined by DHHS 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.13.  EXPORT CONTROL NOTIFICATION

Contractors are responsible for ensuring compliance with all export control laws and regulations that may be applicable to the export of and foreign access to their proposed technologies.  Contractors may consult with the Department of State with any questions regarding the International Traffic in Arms Regulation (ITAR) (22 CRF Parts 120-130) and /or the Department of Commerce regarding the Export Administration Regulations (15 CRF Parts 730-774).

ARTICLE H.14.  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, and that the Contractor has disclosed all such relevant information.  Prior to commencement of any work, the Contractor agrees to notify the CO 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) 

55

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

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 CO.  This disclosure shall include a description of actions which the Contractor has taken or proposes to take, after consultation with the CO, to avoid, mitigate, or neutralize the actual or potential conflict of interest.  The Contractor shall continue performance until notified by the CO of any contrary action to be taken.  Remedies include termination of this contract for convenience, in whole or in part, if the CO 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 CO, the USG may terminate the contract for default, debar the Contractor from USG contracting, or pursue such other remedies as may be permitted by law or this contract.

ARTICLE H.15.  INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR FINANCIAL CONFLICTS OF INTEREST

The Contractor 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.

If the failure of an Investigator 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 Contractor must promptly notify the CO of the corrective action taken or to be taken.  The CO will consider the situation and, as necessary, take appropriate action or refer the matter to the Contractor for further action, which may include directions to the Contractor on how to maintain appropriate objectivity in the BARDA-funded research project.

The CO and/or HHS may inquire at any time before, during, or after award into any Investigator disclosure of financial interests, and the Contractor’s review of, and response to, such disclosure, regardless of whether the disclosure resulted in the Contractor’s determination of a financial conflict of interests.  The CO 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 CO 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 45 CFR Part 94.  The issuance of a Stop Work Order by the CO may be necessary until the matter is resolved.

If the CO 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, 

56

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

conducted, or reported by an Investigator with a financial conflict of interest that was not disclosed managed or reported the Contractor 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.16.  NEEDLE DISTRIBUTION

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.

ARTICLE H.17.  RESTRICTION ON ABORTIONS

The Contractor shall not use contract funds for any abortion.

ARTICLE H.18.  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 a March 4, 1997 Presidential Memorandum, Federal funds may not be used for cloning of human beings.

ARTICLE H.19.  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.20.  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 CO and the Contractor may, by mutual consent, identify elsewhere in this contract specific information and/or categories of information which the USG will furnish to the Contractor or that the Contractor is expected to generate which is confidential and providing further that the Government is not entitled to unlimited rights to that information pursuant to FAR 52.227-14. Similarly, the Contracting Officer and the Contractor may, by mutual consent, identify such confidential 

57

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
		
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 should obtain a written determination from the Contracting Officer prior to any release, disclosure, dissemination, or publication.

	
 
	
f.
	
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.21.  ACCESS TO DOCUMENTATION/DATA

The USG 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 Offeror commitments and responses. Contractor shall provide the USG with an electronic copy of all correspondence and submissions to the FDA within 5 business days of receipt. The USG shall acquire unlimited rights to all data funded or furnished under this contract in accordance with FAR Subpart 27.4 and FAR Clause 52.227-14.

ARTICLE H.22.  EPA ENERGY STAR REQUIREMENTS

In compliance with Executive Order 12845 (requiring Agencies to purchase energy efficient computer equipment), all microcomputers, including personal computers, monitors, and printers that are purchased using USG funds in performance of a contract shall be equipped with or meet the energy efficient low-power standby feature as defined by the EPA Energy Star program unless the equipment always meets EPA Energy Star efficiency levels. The microcomputer, as configured with all components, must be Energy Star compliant.

This low-power feature must already be activated when the computer equipment is delivered to the agency and be of equivalent functionality of similar power managed 

58

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

models. If the equipment will be used on a local area network, the vendor must provide equipment that is fully compatible with the network environment. In addition, the equipment will run commercial off-the-shelf software both before and after recovery from its energy conservation mode.

ARTICLE H.23.  ACKNOWLEDGMENT OF FEDERAL FUNDING

Section 507 of P.L. 104-208 mandates that Contractors funded with Federal dollars, in whole or in part, acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid solicitations and other documents. This requirement is in addition to the continuing requirement to provide an acknowledgment of support and disclaimer on any publication reporting the results of a contract funded activity.

Publication and Publicity

No information related to data obtained under this contract shall be released or publicized without providing the CO and COR with at least thirty (30) days advanced notice and an opportunity to review the proposed release or publication.

Contract support shall be acknowledged in all such publications substantially as follows:

“This project has been funded 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; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201800015C.”

	
 
	
A.
	
Press Releases

Misrepresenting contract results or releasing information that is injurious to the integrity of BARDA may be construed as improper conduct. Press releases shall be considered to include the public release of information to any medium, excluding peer-reviewed scientific publications. With the exception of ad-hoc press releases required by applicable law or regulations, the Contractor shall ensure that the COR has received an advance copy of any press release related to the contract not less than two (2) business days prior to the issuance of the press release.

The Contractor shall acknowledge the support of the Department of Health and Human Service, 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:

“This project has been funded 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; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201800015C.”

59

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

ARTICLE H.24.  PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING ACTIVITIES AND HHSAR 352.203-70 ANTI-LOBBYING (December 2015)

The Contractor is hereby notified of the restrictions on the use of Department of Health and Human Service’s funding for lobbying of Federal, State and Local legislative bodies.

Section 1352 of Title 10, United States Code (Public Law 101-121, effective 12/23/89), among other things, prohibits a recipient (and their subcontractors) of a Federal contract, grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions; the awarding of any Federal contract; the making of any Federal grant; the making of any Federal loan; the entering into of any cooperative agreement; or the modification of any Federal contract, grant, loan, or cooperative agreement. For additional information of prohibitions against lobbying activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.

In addition, as set forth in HHSAR 352.203-70 “Anti-Lobbying”, the current Department of Health and Human Services Appropriations Act provides that no part of any appropriation contained in this Act shall be used, other than for normal and recognized executive- legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support, or defeat legislation pending before the Congress, or any State or Local legislature except in presentation to the Congress, or any State or Local legislative body itself.

The current Department of Health and Human Services Appropriations Act also provides that no part of any appropriation contained in this Act shall be used to pay the salary or expenses of any contract or grant recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress, or any State or Local legislature.

ARTICLE H.25.  PRIVACY ACT APPLICABILITY

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 USG.  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

The Project Officer is hereby designated as the official who is responsible for monitoring contractor compliance with the Privacy Act.

60

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

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.26.  LABORATORY LICENSE REQUIREMENTS

The Contractor shall comply with all applicable requirements of Section 353 of the Public Health Service Act (Clinical Laboratory Improvement Act as amended) (42 U.S.C. 263a and 42 CFR Part 493). This requirement shall also be included in any subcontract for services under the contract.

ARTICLE H.27.  QUALITY ASSURANCE (QA) AUDIT REPORTS

BARDA reserves the right to participate in QA audits as related to activities funded under this contract. Upon completion of the audit/site visit the Contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, detailed concerns for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to the CO and COR. 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 weekly communications.

	
 
	
•
	
Contractor shall notify the COR and CO within five (5) business days of report completion.

ARTICLE H.28.  BARDA AUDITS

Contractor shall accommodate periodic or reasonable ad hoc site visits during normal business hours by the USG with forty-eight (48) hours advance notice. If the USG, 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 USG.

	
 
	
•
	
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 with ten (10) business days.

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

ARTICLE H.29.  RESTRICTION ON EMPLOYMENT OF UNAUTHORIZED ALIEN WORKERS

61

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

The Contractor shall not use contract funds to employ workers described in section 274A (h)(3) of the Immigration and National Act, which reads as follows:

“(3) Definition of unauthorized alien – As used in this section, the term ‘unauthorized alien’ with respect to the employment of an alien at a particular time, that the alien is not at that time either an alien lawfully admitted for permanent residence, or (B) authorized to be so employed by this Act or by the Attorney General.”

ARTICLE H.30.  NOTIFICATION OF CRITICAL PROGRAMMATIC CONCERNS, RISKS, OR POTENTIAL RISKS

If any action occurs that creates a cause for critical programmatic concern, risk, or potential risk to BARDA or the Contractor an Incident Report shall be delivered to the CO and COR.

	
 
	
•
	
Within 48 hours of activity or incident or within 24 hours for a security related activity or incident, Contractor must notify the CO and COR.

	
 
	
•
	
Additional updates due to the COR and CO within 48 hours of additional developments.

	
 
	
•
	
Contractor shall submit within 5 business days a Corrective Action Plan (if deemed necessary by either party) to address any potential issues.

If corrective action is deemed necessary, Contractor must address in writing, its consideration of concerns raised by the CO and COR within 5 business days.

ARTICLE H.31. PROTECTION OF PERSONNEL WHO WORK WITH NONHUMAN PRIMATES

All Contractor personnel who work with nonhuman primates or enter rooms or areas containing nonhuman primates shall comply with the procedures set forth in NIH Policy Manual 3044-2, entitled, “Protection of NIH Personnel Who Work with Nonhuman Primates,” located at the following URL: http://www1.od.nih.gov/oma/manualchapters/intramural/3044-2/

ARTICLE H.32.  DISSEMINATION OF INFORMATION (May 2004)

Other than scientific and technical articles for which the contractor can assert a copyright under FAR Clause 52.227-14 (c) no information related to data obtained under this contract shall be released or publicized without the prior written consent of the CO.  In the event that the contractor seeks to publicize data through a scientific or technical article, the contractor shall provide the CO and COR with a minimum of thirty (30) business days to review the article prior to publication.

Listings of HHS select agents and toxins, biologic agents and toxins, and overlap agents or toxins as well as information about the registration process, can be obtained on the Select Agent Program Web site at http://selectagents.gov

62

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

ARTICLE H.33.  MANUFACTURING STANDARDS

The Good Manufacturing Practice Regulations (GMP)(21 CFR Parts 820) will be the standard to be applied for manufacturing, processing, packaging, storage and delivery of this product.

If at any time during the life of the contract, the Contractor fails to comply with GMP in the manufacturing, processing, packaging, storage, stability and other testing of the manufactured drug substance or product and delivery of this product and such failure results in a material adverse effect on the safety, purity or potency of the product (a material failure) as identified by the FDA, the Contractor shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure.  If, within the thirty (30) calendar day period, the Contractor fails to take such an action to the satisfaction of the USG Project Officer, or fails to provide a remediation plan that is acceptable to the COR, then the contract may be terminated.

ARTICLE H.34  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.35.  IN-PROCESS REVIEW

In Process Reviews (IPR) will be conducted at the discretion of the USG to discuss the progression of the milestones. The USG reserves the right to revise the milestones and budget pending the development of the project. Deliverables such as an overall project summary report and/or slides will 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 USG’s decision, at its sole discretion, to proceed with the work segment, or institute changes to the work segment, or terminate the work segment.

63

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

IPRs may be scheduled at the discretion of the USG to discuss progression of the contract. The Contractor shall provide a presentation following a prescribed template which will be provided by the USG at least 30 business days prior to the IPR. Subsequently, the contractor will be requested to provide a revised/final presentation to the Contracting Officer at least 10 business days prior to the IPR.

64

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

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: http://www.acquisition.gov/far. HHSAR clauses at http://www.hhs.gov/policies/hhsar/subpart352.html

General Clauses for Cost-Reimbursement Research and Development Contract

	
 
	
a.
	
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

			
	
FAR CLAUSE NO.
	
DATE
	
TITLE

	
52.202-1
	
Nov 2013
	
Definitions

	
52.203-3
	
Apr 1984
	
Gratuities

	
52.203-5
	
May 2014
	
Covenant Against Contingent Fees

	
52.203-6
	
Sep 2006
	
Restrictions on Subcontractor Sales to the Government

	
52.203-7
	
May 2014
	
Anti-Kickback Procedures

	
52.203-8
	
May 2014
	
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity

	
52.203-10
	
May 2014
	
Price or Fee Adjustment for Illegal or Improper Activity

	
52.203-12
	
Oct 2010
	
Limitation on Payments to Influence Certain Federal Transactions (Over $150,000)

	
52.203-13
	
Oct 2015
	
Contractor Code of Business Ethics and Conduct

	
52.203-14
	
Oct 2015
	
Display of Hotline Poster(s)

	
52.203-17
	
Apr 2014
	
Contractor Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower Rights

	
52.204-4
	
May 2011
	
Printed or Copied Double-Sided on Recycled Paper

	
52.204-7
	
Oct 2016
	
System for Award Management

	
52.204-10
	
Oct 2016
	
Reporting Executive Compensation and First-Tier Subcontract Awards

	
52.204-13
	
Oct 2016
	
System for Award Management Maintenance

65

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

			
	
FAR CLAUSE NO.
	
DATE
	
TITLE

	
52.209-6
	
Oct 2015
	
Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment

	
52.209-9
	
Jul 2013
	
Updates of Publicly Available Information Regarding Responsibility Matters

	
52.209-10
	
Nov 2015
	
Prohibition on Contracting With Inverted Domestic Corporations

	
52.210-1
	
Apr 2011
	
Market Research

	
52.215-2
	
Oct 2010
	
Audit and Records – Negotiation

	
52.215-8
	
Oct 1997
	
Order of Precedence - Uniform Contract Format

	
52.215-10
	
Aug 2011
	
Price Reduction for Defective Cost or Pricing Data

	
52.215-12
	
Oct 2010
	
Subcontractor Cost or Pricing Data

	
52.215-14
	
Oct 2010
	
Integrity of Unit Prices (Over the Simplified Acquisition Threshold)

	
52.215-15
	
Oct 2010
	
Pension Adjustments and Asset Reversions

	
52.215-17
	
Oct 1997
	
Waiver of Facilities Capital Cost of Money

	
52.215-18
	
Jul 2005
	
Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions

	
52.215-19
	
Oct 1997
	
Notification of Ownership Changes

	
52.215-21
	
Oct 2010
	
Requirements for Cost or Pricing Data or Information Other Than Cost or Pricing Data - Modifications

	
52.215-23
	
Oct 2009
	
Limitations on Pass-Through Charges (Over the Simplified Acquisition threshold)

	
52.216-7
	
Jun 2013
	
Allowable Cost and Payment

	
52.216-12
	
Apr 1984
	
Cost Sharing Contract – No Fee

	
52.219-8
	
Nov 2016
	
Utilization of Small Business Concerns

	
52.222-2
	
Jul 1990
	
Payment for Overtime Premiums

	
52.222-3
	
Jun 2003
	
Convict Labor

	
52.222-21
	
Apr 2015
	
Prohibition of Segregated Facilities

	
52.222-26
	
Sept 2016
	
Equal Opportunity

	
52.222-35
	
Oct 2015
	
Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans

66

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

			
	
FAR CLAUSE NO.
	
DATE
	
TITLE

	
52.222-36
	
Jul 2014
	
Affirmative Action for Workers with Disabilities

	
52.222-37
	
Feb 2016
	
Employment Reports on Veterans

	
52.222-40
	
Dec 2010
	
Notification of Employee Rights Under the National Labor Relations Act

	
52.222-50
	
Mar 2015
	
Combating Trafficking in Persons Alternate I

	
52.222-54
	
Oct 2015
	
Employment Eligibility Verification

	
52.223-6
	
May 2001
	
Drug-Free Workplace

	
52.223-18
	
Aug 2011
	
Encouraging Contractor Policy to Ban Text Messaging While Driving

	
52.224-1
	
April 1984
	
Privacy Act Notification

	
52.224-2
	
April 1984
	
Privacy Act

	
52.225-13
	
Jun 2008
	
Restrictions on Certain Foreign Purchases

	
52.227-1
	
Dec 2007
	
Authorization and Consent, Alternate I (Apr 1984)

	
52.227-2
	
Dec 2007
	
Notice and Assistance Regarding Patent and Copyright Infringement

	
52.227-3
	
Apr 1984
	
Patent Indemnity

	
52.227-11
	
May 2014
	
Patent Rights - Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph (e) is modified to include the requirements in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual.

	
52.227-14
	
May 2014
	
Rights in Data-General

67

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

			
	
FAR CLAUSE NO.
	
DATE
	
TITLE

	
52.227-14-
Alternate II
	
Dec 2007
	
Rights in Data – General, Alternate II.

 

Completed portion as follows: 

Limited Rights Notice (Dec 2007)

 

(a)These data are submitted with limited rights under Government Contract No HHSO100201800015C. These data may be reproduced and used by the Government with the express limitation that they will not, without written permission of the Contractor, be used for purposes of manufacture nor disclosed outside the Government; except that the Government may disclose these data outside the Government for the following purposes, provided that the Government 

makes such disclosure subject to prohibition against further use and disclosure:

 

(i)Use (except for manufacture) by support service contractors.

(ii)Evaluation by nongovernment evaluators.

(b)This Notice shall be marked on any reproduction of these data, in whole or in part.

	
52.227-16
	
Jun 1987
	
Additional Data Requirements

	
52.230-2
	
Oct 2015
	
Cost Accounting Standards

	
52.230-6
	
June 2010
	
Administration of Cost Accounting Standards

	
52.232-9
	
Apr 1984
	
Limitation on Withholding of Payments

	
52.232-17
	
May 2014
	
Interest

	
52.232-20
	
Apr 1984
	
Limitation of Cost

	
52.232-23
	
May 2014
	
Assignment of Claims

	
52.232-25
	
Jan 2017
	
Prompt Payment, Alternate I (Feb 2002)

	
52.232-33
	
July 2013
	
Payment by Electronic Funds Transfer—System for Award Management

	
52.232-39
	
Jun 2013
	
Unenforceability of Unauthorized Obligations

	
52.232-40
	
Dec 2013
	
Providing Accelerated Payments to Small Business

	
52.233-1
	
May 2014
	
Disputes

	
52.233-2
	
Sept 2006
	
Service of Protest

	
52.233-3
	
Aug 1996
	
Protest After Award, Alternate I (Jun 1985)

	
52.233-4
	
Oct 2004
	
Applicable Law for Breach of Contract Claim

	
52.242-1
	
Apr 1984
	
Notice of Intent to Disallow Costs

	
52.242-3
	
May 2014
	
Penalties for Unallowable Costs

	
52.242-4
	
Jan 1997
	
Certification of Final Indirect Costs

	
52.242-13
	
Jul 1995
	
Bankruptcy

	
52.242-15
	
Aug 1989
	
Stop Work Order. Alt I (Aug 1984)

	
52.243-2
	
Aug 1987
	
Changes - Cost Reimbursement, Alternate V (Apr 1984)

	
52.244-2
	
Oct 2010
	
Subcontracts, Alternate I (June 2007)

	
52.244-5
	
Dec 1996
	
Competition in Subcontracting

	
52.244-6
	
Jan 2017
	
Subcontracts for Commercial Items

68

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

			
	
FAR CLAUSE NO.
	
DATE
	
TITLE

	
52.245-1
	
Jan 2017
	
Government Property

	
52.245-9
	
Apr 2012
	
Use and Charges

	
52.246-9
	
Apr 1984
	
Inspection of Research and Development (Short Form)

	
52.246-23
	
Feb 1997
	
Limitation of Liability

	
52.247-63
	
Jun 2003
	
Preference for U.S.-Flag Air Carriers

	
52.249-6
	
May 2004
	
Termination (Cost-Reimbursement)

	
52.249-14
	
Apr 1984
	
Excusable Delays

	
52.251-1
	
Apr 2012
	
Government Supply Sources

	
52.253-1
	
Jan 1991
	
Computer Generated Forms

 

	
 
	
b.
	
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:

			
	
HHSAR

CLAUSE NO.
	
DATE
	
TITLE 

	
352.211-3
	
Dec 2015
	
Paperwork Reduction Act

	
352.203-70
	
Dec 2015
	
Anti-Lobbying

	
352.222-70
	
Dec 2015
	
Contractor Cooperation in Equal Employment Opportunity Investigations

	
352.223-70
	
Dec 2015
	
Safety and Health

	
352.224-70
	
Dec 2015
	
Privacy Act

	
352.227-70
	
Dec 2015
	
Publications and Publicity

	
352.231-70
	
Dec 2015
	
Salary Rate Limitation

	
352.233-71
	
Dec 2015
	
Litigation and Claims

	
352.237-75
	
Dec 2015
	
Key Personnel

	
352.270-4a
	
Dec 2015
	
Protection of Human Subjects

	
352.270-6
	
Dec 2015
	
Restriction on use of Human Subjects

 

ARTICLE I.2. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

This contract incorporates the following clauses in full text.  
FEDERAL ACQUISITION REGULATION (FAR) (48 CFR CHAPTER 1) CLAUSES:

FAR Clause 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 

69

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

written notice to the Contractor within 30 days of the end of the current performance period.

FAR Clause 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 after the Government has completed its analysis of the deliverables associated with the applicable milestone. The Government will provide 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 5 years.

FAR 52.219-1 Small Business Program Representations (Oct 2014)

	
 
	
(1)
	
The North American Industry Classification System (NAICS) code for this acquisition is 541711.

	
 
	
(2)
	
The small business size standard is 500 employees.

	
 
	
(3)
	
The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

FAR Clause 52.219-28, Post-Award Small Business Program Representation (July 2013)

	
 
	
a.
	
Definitions.  As used in this clause-- 

Long-term contract means a contract of more than five years in duration, including options. However, the term does not include contracts that exceed five years in duration because the period of performance has been extended for a cumulative period not to exceed six months under the clause at 52.217-8, Option to Extend services, or other appropriate authority.

Small business concern means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR part 121 and the size standard in paragraph (c) of this clause. Such a concern is “not dominant in its field of operation” when it does not exercise a controlling or major influence on a national basis in a kind of business activity in which a number of business concerns are primarily engaged. In determining whether dominance exists, consideration shall be 

70

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

given to all appropriate factors, including volume of business, number of employees, financial resources, competitive status or position, ownership or control of materials, processes, patents, license agreements, facilities, sales territory, and nature of business activity.

	
 
	
b.
	
If the Contractor represented that it was a small business concern prior to award of this contract, the Contractor shall re-represent its size status according to paragraph (e) of this clause or, if applicable, paragraph (g) of this clause, upon the occurrence of any of the following:

(1)Within 30 days after execution of a novation agreement or within 30 days after modification of the contract to include this clause, if the novation agreement was executed prior to inclusion of this clause in the contract.

(2)Within 30 days after a merger or acquisition that does not require a novation or within 30 days after modification of the contract to include this clause, if the merger or acquisition occurred prior to inclusion of this clause in the contract.

(3)For long-term contracts-- 

(i)Within 60 to 120 days prior to the end of the fifth year of the contract; and

(ii)Within 60 to 120 days prior to the date specified in the contract for exercising any option thereafter.

	
 
	
c.
	
The Contractor shall represent its size status in accordance with the size standard in effect at the time of this re-representation that corresponds to the North American Industry Classification System (NAICS) code assigned to this contract. The small business size standard corresponding to this NAICS code can be found at http://www.sba.gov/content/table-small-business-size-standards. 

	
 
	
d.
	
The small business size standard for a Contractor providing a product which it does not manufacture itself, for a contract other than a construction or service contract, is 500 employees.

	
 
	
e.
	
Except as provided in paragraph (g) of this clause, the Contractor shall make the representation required by paragraph (b) of this clause by validating or updating all its representations in the Representations and Certifications section of the System for Award Management (SAM) and its other data in SAM, as necessary, to ensure that they reflect the Contractor’s current status. The Contractor shall notify the contracting office in writing within the timeframes specified in paragraph (b) of this clause that the data have been validated or updated, and provide the date of the validation or update.

71

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
f.
	
If the Contractor represented that it was other than a small business concern prior to award of this contract, the Contractor may, but is not required to, take the actions required by paragraphs (e) or (g) of this clause.

	
 
	
g.
	
If the Contractor does not have representations and certifications in SAM, or does not have a representation in SAM for the NAICS code applicable to this contract, the Contractor is required to complete the following representation and submit it to the contracting office, along with the contract number and the date on which the representation was completed:

The Contractor represents that it [ X] is, [ ] is not a small business concern under NAICS Code 334516 assigned to contract number HHSO100201800015C.

72

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

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 Work, dated 22 March 2018 ( 6 pages)

	
 
	
2.
	
Milestones/Deliverables Chart, dated 22 March 2018 (2 pages)

	
 
	
3.
	
Gantt Chart, dated 22 March 2018 (1 page)

	
 
	
4.
	
Invoice/Financial Request Instructions and Contract Financial Reporting Instructions for BARDA Cost-Reimbursement Type Contracts (5 pages)

	
 
	
5.
	
Report of Government Owned, Contractor Held Property (1 page)

Located at: https://oamp.od.nih.gov/sites/default/files/DGS/contracting-forms/Govt-Owned-Prop.pdf

	
 
	
6.
	
Disclosure of Lobbying Activities (2 pages)

	
 
	
7.
	
Financial Report of Individual Project/Contract (1 Page)

	
 
	
8.
	
Instructions For Completing “Financial Report of Individual Project Contract” (3 pages)

73

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

The following documents are incorporated by reference in this contract:

	
 
	
1)
	
Animal Research Assurance Identification Numbers: To be provided prior to study execution.

	
 
	
2)
	
Human Subjects Assurance Identification Numbers: To be provided prior to study execution.

End of Contract No: HHSO100201800015

74

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

 

Attachment 1

Statement of Work

BARDA Broad Agency Announcement (BAA)

(Solicitation # BAA-16-100-SOL-00001)

Advanced Research and Development of Chemical, Biological, Radiological, and Nuclear

Medical Countermeasures

(SPR994)

Topic Area of Interest No. (#3),

Contractual Statement of Work 

PREAMBLE

Independently and not as an agency of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work submitted in response to the BARDA Broad Agency Announcement (BAA) BARDA CBRN BAA-16-100-SOL-00001.

The Government reserves the right to modify the milestones, progress, schedule, budget, or deliverables to add or delete deliverables, process, or schedules if the need arises. Because of the nature of this research and development (R&D) contract and the complexities inherent in this and prior programs, at designated milestones the Government will evaluate whether work should be redirected, removed, or whether schedule or budget adjustments should be made. The Government reserves the right to change the product, process, schedule, or events to add or delete part or all of these elements as the need arises.

Overall Objectives and Scope

The overall objective of this contract is to advance the development of SPR994 as an oral therapy for use in adults to treat complicated urinary tract infections (cUTIs), including those caused by drug resistant bacteria. The scope of work for this contract includes administrative, biological, pre-clinical, clinical, and manufacturing development activities. The SPR994 Research and Development (R&D) effort will progress in specific stages that cover the base performance segment and two option segments that are broken down as discrete work segments as follows:

	
 
	
•
	
CLIN 1 (Base Period)

	
 
	
•
	
CLIN 2 (Option 1)

	
 
	
•
	
CLIN 3 (Option 2)

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

Outside the scope of the BARDA contract, Spero will collaborate with DTRA and BARDA to conduct [***].

1.0CLIN1 (Base period)

[***]

	
1.1
	
PROGRAM MANAGEMENT (WBS 1.1)

The Contractor shall provide for the following as outlined below and in the contract deliverables list:

	
1.1.1
	
The overall management, integration and coordination of all contract activities, including a technical and administrative infrastructure to ensure the efficient planning, initiation, implementation, and direction of all contract activities;

	
1.1.2
	
A Principal Investigator (PI) responsible for project management, communication, tracking, monitoring and reporting on status and progress, and modification to the project requirements and timelines, including projects undertaken by subcontractors; The contract deliverables list (reference), identifies all contract deliverables and reporting requirements for this contract.

	
1.1.3
	
Project Manager(s) with responsibility for monitoring and tracking day-to-day progress and timelines, coordinating communication and project activities; costs incurred; and program management.

	
1.1.4
	
A BARDA Liaison with responsibility for effective communication with the Project Officer and Contracting Officer.  May be the PI or Project Manager.

	
1.1.5
	
Administrative and legal staff to provide development of compliant subcontracts, consulting, and other legal agreements, and ensure timely acquisition of all proprietary rights, including IP rights, and reporting all inventions made in the performance of the project.

	
1.1.6
	
Administrative staff with responsibility for financial management and reporting on all activities conducted by the Contractor and any subcontractors.

	
1.1.7
	
Contract Review Meetings.

	
 
	
1.1.7.1
	
The Contractor shall participate in regular meetings to coordinate and oversee the contract effort as directed by the Contracting and Project Officers.  Such meetings may include, but are not limited to, meeting of the Contractors and subcontractors to discuss clinical manufacturing progress, product development, product assay development, scale up manufacturing development, clinical sample assays development, preclinical/clinical study designs and regulatory issues; meetings with individual contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects of the program; and meeting with technical consultants to discuss technical data provided by the Contractor.

	
 
	
1.1.7.2
	
The Contractor shall participate in teleconferences every two weeks between the Contractor and subcontractors and BARDA to review technical progress.  Teleconferences or additional face-to-face meetings shall be more frequent at the request of BARDA.

	
1.1.8
	
Integrated Master Schedule

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
1.1.8.1
	
Within 30 calendar days of the effective date of the contract, the Contractor shall submit a first draft of an updated Integrated Master Schedule in a format agreed upon by BARDA to the Project Officer and the Contracting Officer for review and comment.  The Integrated Master Schedule shall be incorporated into the contract, and will be used to monitor performance of the contract.  Contractor shall include the key milestones and Go/No Go decision gates.  The IMS for the period of performance will be accepted by BARDA at the PMBR

	
1.1.9
	
Integrated Master Plan

	
1.1.10
	
Work Breakdown Structure:  The Contractor shall utilize a WBS template agreed upon by BARDA for reporting on the contact.  The Contractor shall expand and delineate the Contract Work Breakdown Structure (CWBS) to a level agreed upon by BARDA as part of their Integrated Master Plan for contract reporting.  The CWBS shall be discernable and consistent.  BARDA may require Contractor to furnish WBS data at the work package level or at a lower level if there is significant complexity and risk associated with the task.

	
1.1.11
	
GO/ NO-GO Decision Gates:  The Integrated Master Plan outlines key milestones with “Go/No Go” decision criteria (entrance and exit criteria for each phase of the project).  The project plan should include, but not be limited to, milestones in manufacturing, non-clinical and clinical studies, and regulatory submissions.

	
1.1.12
	
Earned Value Management System Plan:  N/A.  The Government has waived the requirement for an EVM plan on this contract.

	
1.1.13
	
Decision Gate Reporting:  On completion of a stage of the product development, as defined in the agreed upon Integrated Master Schedule and Integrated Master Plan, the Contractor shall prepare and submit to the Project Officer and the Contracting Officer a Decision Gate Report that contains (i) sufficient detail, documentation and analysis to support successful completion of the stage according to the predetermined qualitative and quantitative criteria that were established for Go/No Go decision making; and (ii) a description of the next stage of product development to be initiated and a request for approval to proceed to the next stage of product development.

	
1.1.14
	
Risk Management Plan:  The Contractor shall develop a risk management plan within 90 days of contract award highlighting potential problems and/or issues that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate remediation plans.  This plan should reference relevant WBS elements where appropriate.  Updates to this plan shall be included every three months (quarterly) in the monthly Project Status Report.

	
1.1.15
	
Performance Measurement Baseline Review (PMBR):  N/A.  The Government has waived the requirement for an EVM monitoring on this contract.

	
1.1.16
	
Deviation Request:  During the course of contract performance, in response to a need to change IMS activities as baselined at the PMBR, the Contractor shall submit a Deviation Report.  This report shall request a change in the agreed-upon IMS and timelines.  This report shall include:  (i) discussion of the justification/rationale for the proposed change; (ii) options for addressing the needed changes from the agreed upon timelines, including a cost-benefit analysis of each option; and (iii) recommendations for the preferred option that includes a full analysis and discussion of the effect of the change on the entire product development program, timelines, and budget.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
1.1.17
	
Monthly and Annual Reports:  The Contractor shall deliver Project Status Reports on a monthly basis.  The reports shall address the items below cross referenced to the WBS, SOW, IMS, and EVM:

	
 
	
•
	
Executive summary highlighting the progress, issues, and relevant activities in manufacturing, non-clinical, clinical, and regulatory;

	
 
	
•
	
Progress in meeting contract milestones, detailing the planned progress and actual progress during the reporting period, explaining any differences between the two and corrective steps;

	
 
	
•
	
Updated IMS;

	
 
	
•
	
Updated Risk Management Plan (Every 3 months);

	
 
	
•
	
Three month rolling forecast of planned activities;

	
 
	
•
	
Progress of regulatory submissions;

	
 
	
•
	
Estimated and actual expenses;

	
1.1.18
	
Data Management:  The Contractor shall develop and implement data management and quality control systems/procedures, including transmission, storage, confidentiality, and retrieval of all contract data; Provide for the statistical design and analysis of data resulting from the research; Provide raw data or specific analyses of data generated with contract funding to the Project Officer, upon request.

	
1.2
	
NON-CLINICAL DEVELOPMENT (WBS 1.2)

N/A

	
1.3
	
NON-CLINICAL EFFICACY (WBS 1.3)

 

[***]

 

	
1.4
	
CLINICAL STUDIES (WBS 1.4)

 

[***]

 

	
1.5
	
REGULATORY (WBS 1.5)

N/A

	
1.6
	
CMC (WBS 1.6)

 

[***]

 

2.0CLIN 2 (OPTION 1)

 

[***]

 

2.1PROGRAM MANAGEMENT (WBS 1.1)

Program management scope in CLIN 1 is consistent with the program management scope in each option year.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

2.2NON-CLINICAL DEVELOPMENT (WBS 1.2) 

N/A

2.3NON-CLINICAL EFFICACY (WBS 1.3)

 

[***]

 

2.4CLINICAL STUDIES (WBS 1.4)

 

[***]

 

2.5REGULATORY (WBS 1.5) 

N/A

2.6CMC (WBS 1.6)

 

[***]

 

3.0CLIN 3 (OPTION 2)

 

[***]

 

3.1PROGRAM MANAGEMENT (WBS 1.1)

Program management scope in CLIN 1 is consistent with the program management scope in each option year.

3.2NON-CLINICAL DEVELOPMENT (WBS 1.2) 

N/A

3.3NON-CLINICAL EFFICACY (WBS 1.3) 

N/A

3.4CLINICAL STUDIES (WBS 1.4)

 

[***]

 

3.5REGULATORY (WBS 1.5) 

N/A

3.6CMC (WBS 1.6) 

N/A

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

Attachment 2

 

							
	
Milestone Number
	
GO/NO GO Project 
Milestone
	
Go Criteria
	
No-Go Criteria
	
Deliverable
	
SOW #
	
CLIN

	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]
	
[***]

 

[***]

 

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

Attachment 4 - Invoice Reporting

INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING

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 B of the Contract.

Frequency:  Payment requests should not be submitted more frequently than once every two weeks in accordance with the Allowable Cost and Payment Clause incorporated into this contract unless otherwise instructed by the Contract Officer.  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 previously established 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 cite 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, which are not 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:

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
(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.

	
(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 B and F 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.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
(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.

	
(h)
	
Total Fixed-Fee:  Insert the total fixed-fee (where applicable).

	
(i)
	
Two-Way/Three-Way Match:  Identify payment to be made using a three-way match.

	
(j)
	
Office of Acquisitions:  Insert the name of the Office of Acquisitions, as identified 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.

	
(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)

	
 
	
(2)
	
Direct Labor:  Include salaries and wages paid (or accrued) for direct performance of the contract.

For Level of Effort contracts only, the Contractor shall provide the following information on a separate sheet of paper attached to the payment request:

- hours or percentage of effort and cost by labor category (as specified in the Level of Effort Article in Section F of the contract) for the current billing period, and

- hours or percentage of effort and cost by labor category from contract inception through the current billing period.  (NOTE:  The Contracting Officer may require the Contractor to provide additional breakdown for direct labor, such as position title, employee name, and salary or hourly rate.)

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
	
(3)
	
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.

	
 
	
(4)
	
Accountable Personal Property:  Include permanent research equipment and general purpose equipment having a unit acquisition cost of $1,000 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).  Show permanent research equipment separate from general purpose equipment.

On a separate sheet of paper attached to the payment request, list each item for which reimbursement is requested.  An asterisk (*) shall precede the item if the equipment is below the $1,000 approval level.  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.

	
 
	
(5)
	
Materials and Supplies:  Include equipment with unit costs of less than $1,000 or an expected service life of two years or less, and consumable material and supplies regardless of amount.

	
 
	
(6)
	
Premium Pay:  List remuneration in excess of the basic hourly rate.

	
 
	
(7)
	
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.

	
 
	
(8)
	
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.

	
 
	
(9)
	
Subcontract Costs:  List subcontractor(s) by name and amount billed.  Cite applicable COA or notification.

	
 
	
(10)
	
Other:  List all other direct costs in total unless exceeding $1,000 in amount.  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.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
(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.

	
(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.”

	
(w)
	
Signature

The Contracting Officer may require the Contractor to submit detailed support for costs claimed on one or more interim payment requests.

Financial Reporting Instructions:

These instructions are keyed to the Columns on the sample invoice/financing request.

Column A - Expenditure Category:  Enter the expenditure categories required by the contract.

Column B - Cumulative Percentage of Effort/Hrs. - Negotiated:  Enter the percentage of effort or number of hours agreed to for each employee or labor category listed in Column A.

Column C - Cumulative Percentage of Effort/Hrs. - Actual:  Enter the percentage of effort or number of hours worked by each employee or labor category listed in Column A.

Column D - Amount Billed - Current:  Enter amounts billed during the current period. 

Column E - Amount Billed - Cumulative:  Enter the cumulative amounts to date.

Column F - Cost at Completion:  Enter data only when the Contractor estimates that a particular expenditure category will vary from the amount negotiated.  Realistic estimates are essential.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

Column G - Contract Amount:  Enter the costs agreed to for all expenditure categories listed in Column A.

Column H - Variance (Over or Under):  Show the difference between the estimated costs at completion (Column F) and negotiated costs (Column G) when entries have been made in Column F.  This column need not be filled in when Column F is blank.  When a line item varies by plus or minus 10 percent, i.e., the percentage arrived at by dividing Column F by Column G, an explanation of the variance should be submitted.  In the case of an overrun (net negative variance), this submission shall not be deemed as notice under the Limitation of Cost (Funds) Clause of the contract.

Modifications:  Any modification in the amount negotiated for an item since the preceding report should be listed in the appropriate cost category.

Expenditures Not Negotiated:  An expenditure for an item for which no amount was negotiated (e.g., at the discretion of the Contractor in performance of its contract) should be listed in the appropriate cost category and all columns filled in, except for G.  Column H will of course show a 100 percent variance and will be explained along with those identified under H above.

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

INSTRUCTIONS FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES

This disclosure form shall be completed by the reporting entity, whether subawardee or prime Federal recipient, at the initiation or receipt of a covered Federal action, or a material change to a previous filing, pursuant to title 31 U.S.C. section 1352.  The filing of a form is required for each payment or agreement to make payment to any lobbying entity for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with a covered Federal action.  Complete all items that apply for both the initial filing and material change report.  Refer to the implementing guidance published by the Office of Management and Budget for additional information.

	
 
	
1.
	
Identify the type of covered Federal action for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal action.

	
 
	
2.
	
Identify the status of the covered Federal action.

	
 
	
3.
	
Identify the appropriate classification of this report.  If this is a followup report caused by a material change to the information previously reported, enter the year and quarter in which the change occurred.  Enter the date of the last previously submitted report by this reporting entity for this covered Federal action.

	
 
	
4.
	
Enter the full name, address, city, State and zip code of the reporting entity.  Include Congressional District, if known.  Check the appropriate classification of the reporting entity that designates if it is, or expects to be, a prime or sub award recipient.  Identify the tier of the sub awardee, e.g., the first sub awardee of the prime is the 1st tier.  Sub awards include but are not limited to subcontracts, sub grants and contract awards under grants.

	
 
	
5.
	
If the organization filing the report in item 4 checks “Sub-awardee,” then enter the full name, address, city, State and zip code of the prime Federal recipient.  Include Congressional District, if known.

	
 
	
6.
	
Enter the name of the Federal agency making the award or loan commitment.  Include at least one organizational level below agency name, if known.  For example, Department of Transportation, United States Coast Guard.

	
 
	
7.
	
Enter the Federal program name or description for the covered Federal action (item 1).  If known, enter the full Catalog of Federal Domestic Assistance (CFDA) number for grants, cooperative agreements, loans, and loan commitments.

	
 
	
8.
	
Enter the most appropriate Federal identifying number available for the Federal action identified in item 1 (e.g., Request for Proposal (RFP) number; Invitation for Bid (IFB) number; grant announcement number; the contract, grant, or loan award 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

CONFIDENTIAL TREATMENT REQUESTED

	
 
		
number; the application/proposal control number assigned by the Federal agency).  Include prefixes, e.g., “RFP-DE-90-001.”

	
 
	
9.
	
For a covered Federal action where there has been an award or loan commitment by the Federal agency, enter the Federal amount of the award/loan commitment for the prime entity identified in item 4 or 5.

	
 
	
10.
	
(a) Enter the full name, address, city, State and zip code of the lobbying registrant under the Lobbying Disclosure Act of 1995 engaged by the reporting entity identified in item 4 to influence the covered Federal action.

(b) Enter the full names of the individual(s) performing services, and include full address if different from 10 (a). Enter Last Name, First Name, and Middle Initial (MI).

	
 
	
11.
	
The certifying official shall sign and date the form, print his/her name, title, and telephone number.

According to the Paperwork Reduction Act, as amended, no persons are required to respond to a collection of information unless it displays a valid OMB Control Number.  The valid OMB control number for this information collection is OMB No. 0348-0046.  Public reporting burden for this collection of information is estimated to average 10 minutes per response, including time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.  Send comments regarding the burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to the Office of Management and Budget, Paperwork Reduction Project (0348-0046), Washington, DC 20503.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

 

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

Attachment 8

INSTRUCTIONS FOR COMPLETING

“FINANCIAL REPORT OF INDIVIDUAL PROJECT/CONTRACT”

GENERAL INFORMATION

Purpose.  This Quarterly Financial Report is designed to: (1) provide a management tool for use by be BARDA in monitoring the application of financial and personnel resources to the BARDA contracts; (2) provide contractors with financial and personnel management data which is usable in their management processes; (3) promptly indicate potential areas of contract underruns or overruns by making possible comparisons of actual performance and projections with prior estimates on individual elements of cost and personnel; and (4) obtain contractor’s analyses of cause and effect of significant variations between actual and prior estimates of financial and personnel performance.

REPORTING REQUIREMENTS

Scope.  The specific cost and personnel elements to be reported shall be established by mutual agreement prior to award.  The Government may require the contractor to provide detailed documentation to support any element(s) on one or more financial reports.

Number of Copies and Mailing Address.  An original and two (2) copies of the report(s) shall be sent to the contracting officer at the address shown on the face page of the contract, no later than 30 working days after the end of the period reported.  However, the contract may provide for one of the copies to be sent directly to the Contracting Officer’s Technical Representative.

REPORTING STATISTICS

A modification which extends the period of performance of an existing contract will not require reporting on a separate quarterly report, except where it is determined by the contracting officer that separate reporting is necessary.  Furthermore, when incrementally funded contracts are involved, each separate allotment is not considered a separate contract entity (only a funding action).  Therefore, the statistics under incrementally funded contracts should be reported cumulatively from the inception of the contract through completion.

Definitions and Instructions for Completing the Quarterly Report.  For the purpose of establishing expenditure categories in Column A, the following definitions and instructions will be utilized.  Each contract will specify the categories to be reported.

	
(1)
	
Key Personnel.  Include key personnel regardless of annual salary rates.  All such individuals should be listed by names and job titles on a separate line including those whose salary is not directly charged to the contract but whose effort is directly associated with the contract.  The listing must be kept up to date.

	
(2)
	
Personnel--Other.  List as one amount unless otherwise required by the contract.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

	
(3)
	
Fringe Benefits.  Include allowances and services provided by the contractor to employees as compensation in addition to regular salaries and wages.  If a fringe benefit rate(s) has been established, identify the base, rate, and amount billed for each category.  If a rate has not been established, the various fringe benefit costs may be required to be shown separately.  Fringe benefits which are included in the indirect cost rate should not be shown here.

	
(4)
	
Accountable Personal Property.  Include nonexpendable personal property with an acquisition cost of $1,000 or more and with an expected useful life of two or more years, and sensitive items regardless of cost.  Form HHS 565, “Report of Accountable Property,” must accompany the contractor’s public voucher (SF 1034/SF 1035) or this report if not previously submitted.  See “Contractor’s Guide for Control of Government Property.”

	
(5)
	
Supplies.  Include the cost of supplies and material and equipment charged directly to the contract, but excludes the cost of nonexpendable equipment as defined in (4) above.

	
(6)
	
Inpatient Care.  Include costs associated with a subject while occupying a bed in a patient care setting.  It normally includes both routine and ancillary costs.

	
(7)
	
Outpatient Care.  Include costs associated with a subject while not occupying a bed.  It normally includes ancillary costs only.

	
(8)
	
Travel.  Include all direct costs of travel, including transportation, subsistence and miscellaneous expenses.  Travel for staff and consultants shall be shown separately.  Identify foreign and domestic travel separately.  If required by the contract, the following information shall be submitted: (i) Name of traveler and purpose of trip; (ii) Place of departure, destination and return, including time and dates; and (iii) Total cost of trip.

	
(9)
	
Consultant Fee.  Include fees paid to consultant(s).  Identify each consultant with effort expended, billing rate, and amount billed.

	
(10)
	
Premium Pay.  Include the amount of salaries and wages over and above the basic rate of pay.

	
(11)
	
Subcontracts.  List each subcontract by name and amount billed.

	
(12)
	
Other Costs.  Include any expenditure categories for which the Government does not require individual line item reporting.  It may include some of the above categories.

	
(13)
	
Overhead/Indirect Costs.  Identify the cost base, indirect cost rate, and amount billed for each indirect cost category.

	
(14)
	
General and Administrative Expense.  Cite the rate and the base.  In the case of nonprofit organizations, this item will usually be included in the indirect cost.

	
(15)
	
Fee.  Cite the fee earned, if any.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

	
(16)
	
Total Costs to the Government. 

PREPARATION INSTRUCTIONS

These instructions are keyed to the Columns on the Quarterly Report.

Column A--Expenditure Category.  Enter the expenditure categories required by the contract.

Column B--Percentage of Effort/Hours Negotiated.  Enter the percentage of effort or number of hours agreed to during contract negotiations for each labor category listed in Column A.

Column C--Percentage of Effort/Hours-Actual.  Enter the cumulative percentage of effort or number of hours worked by each employee or group of employees listed in Column A.

Column D--Cumulative Incurred Cost at End of Prior Period.  Enter the cumulative incurred costs up to the end of the prior reporting period.  This column will be blank at the time of the submission of the initial report.

Column E--Incurred Cost-Current Period.  Enter the costs which were incurred during the current period.

Column F--Cumulative Incurred Cost to Date.  Enter the combined total of Columns D and E.

Column G--Estimated Cost to Complete.  Make entries only when the contractor estimates that a particular expenditure category will vary from the amount negotiated.  Realistic estimates are essential.

Column H--Estimated Costs at Completion.  Complete only if an entry is made in Column G.

Column I--Negotiated Contract Amount.  Enter in this column the costs agreed to during contract negotiations for all expenditure categories listed in Column A.

Column J--Variance (Over or Under).  Complete only if an entry is made in Column H.  When entries have been made in Column H, this column should show the difference between the estimated costs at completion (Column H) and negotiated costs (Column I).  When a line item varies by plus or minus 10 percent, i.e., the percentage arrived at by dividing Column J by Column I, an explanation of the variance should be submitted.  In the case of an overrun (net negative variance), this submission shall not be deemed as notice under the Limitation of Cost (Funds) Clause of the contract.

Modifications.  List any modification in the amount negotiated for an item since the preceding report in the appropriate cost category.

Expenditures Not Negotiated.  List any expenditure for an item for which no amount was negotiated (e.g., at the discretion of the contractor in performance of its contract) in the appropriate cost category and complete all columns except for I.  Column J will of course show a 100 percent variance and will be explained along with those identified under J above.

 

Portions of this Exhibit, indicated by the mark “[***],” were omitted and have been filed separately with the

Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment

pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.Document

Exhibit 10.1

SANDRIDGE ENERGY, INC.
_________________________________

2016 OMNIBUS INCENTIVE PLAN
(Amended and Restated as of August 8, 2018)
_________________________________

ARTICLE I 
PURPOSE
The purpose of this SandRidge Energy, Inc. 2016 Omnibus Incentive Plan is to enhance the profitability and value of the Company for the benefit of its stockholders by enabling the Company to offer Eligible Individuals cash and stock-based incentives in order to attract, retain and reward such individuals and strengthen the mutuality of interests between such individuals and the Company’s stockholders. The Plan is effective as of the date set forth in Article XIV.
ARTICLE II  
DEFINITIONS
For purposes of the Plan, the following terms shall have the following meanings:
2.1 “Affiliate” means each of the following: (a) any Subsidiary; (b) any Parent; (c) any corporation, trade or business (including, without limitation, a partnership or limited liability company) that is directly or indirectly controlled 50% or more (whether by ownership of stock, assets or an equivalent ownership interest or voting interest) by the Company or one of its Affiliates; (d) any trade or business (including, without limitation, a partnership or limited liability company) that directly or indirectly controls 50% or more (whether by ownership of stock, assets or an equivalent ownership interest or voting interest) of the Company; (e) any other entity in which the Company or any of its Affiliates has a material equity interest and which is designated as an “Affiliate” by resolution of the Committee; and (f) any Person (as defined below) that a Person either directly or indirectly through one or more intermediaries is in common control with, is controlled by or controls, each within the meaning of the Securities Act (as defined below); provided that, unless otherwise determined by the Committee, the Common Stock subject to any Option constitutes “service recipient stock” for purposes of Section 409A of the Code or otherwise does not subject the Option to Section 409A of the Code.
2.2 “Award” means any award under the Plan of any Stock Option, Restricted Stock Award, Performance Award, Other Stock-Based Award or Other Cash-Based Award. All Awards shall be granted by, confirmed by, and subject to the terms of, an Award Agreement issued by the Company.

1

2.3 “Award Agreement” means the written or electronic agreement setting forth the terms and conditions applicable to an Award.
2.4 “Board” means the Board of Directors of the Company.
2.5 “Cause” means, unless otherwise determined by the Committee in the applicable Award Agreement, with respect to a Participant’s Termination of Employment or Termination of Consultancy, the following: (a) in the case where there is no employment agreement, consulting agreement, change in control agreement or similar agreement in effect between the Company or an Affiliate and the Participant at the time of the grant of the Award (or where there is such an agreement but it does not define “cause” (or words of like import)), termination due to a Participant’s: (i) refusal or neglect to perform Participant’s duties with the Company; (ii) breach of a written policy of the Company as in effect from time to time; (iii) commission of an act of fraud or dishonesty resulting in economic or financial injury to the Company; (iv) engagement in illegal conduct or gross misconduct; (v) breach of any agreement with the Company or an Affiliate; (vi) indictment for, conviction of, or a plea of guilty or nolo contendere to any felony or other crime involving moral turpitude; or (vii) failure to reasonably cooperate, following a request to do so by the Company, in any internal or governmental investigation of the Company or any of its Affiliates; or (b) in the case where there is an employment agreement, consulting agreement, change in control agreement or similar agreement in effect between the Company or an Affiliate and the Participant at the time of the grant of the Award that defines “cause” (or words of like import), “cause” as defined under such agreement; provided, however, that with regard to any agreement under which the definition of “cause” only applies on occurrence of a change in control, such definition of “cause” shall not apply until a change in control actually takes place and then only with regard to a termination thereafter. With respect to a Participant’s Termination of Directorship, “cause” means an act or failure to act that constitutes cause for removal of a director under applicable Delaware law. 
2.6 “Change in Control” has the meaning set forth in Section 10.2.
2.7 “Change in Control Price” has the meaning set forth in Section 10.1.
2.8 “Code” means the Internal Revenue Code of 1986, as amended. Any reference to any section of the Code shall also be a reference to any successor provision and any Treasury Regulation and other official guidance and regulations promulgated thereunder.
2.9 “Commission” means the United States Securities and Exchange Commission.
2.10 “Committee” means any committee of the Board duly authorized by the Board to administer the Plan. If no committee is duly authorized by the Board to administer the Plan, the term “Committee” shall be deemed to refer to the Board for all purposes under the Plan.
2.11 “Common Stock” means the common stock, $0.001 par value per share, of the Company.

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2.12 “Company” means SandRidge Energy, Inc., a Delaware corporation, and its successors by operation of law.
2.13 “Consultant” means any natural person who is an advisor or consultant to the Company or its Affiliates.
2.14 “Control” means the possession, directly or indirectly, of the power to direct or cause the direction of management and policies of a Person, whether through the ownership of stock, by agreement or otherwise and “Controlled” has a corresponding meaning.
2.15 “Disability” means, unless otherwise determined by the Committee in the applicable Award Agreement, with respect to a Participant’s Termination, a permanent and total disability as defined in Section 22(e)(3) of the Code. The Committee shall determine when a Disability has occurred. Notwithstanding the foregoing, for Awards that are subject to Section 409A of the Code, Disability shall mean that a Participant is disabled under Section 409A(a)(2)(C)(i) or (ii) of the Code.
2.16 “Effective Date” means the effective date of the Plan as defined in Article XIV.
2.17 “Eligible Employees” means each employee of the Company or an Affiliate.
2.18 “Eligible Individual” means an Eligible Employee, Non-Employee Director or Consultant who is designated by the Committee in its discretion as eligible to receive Awards subject to the conditions set forth herein.
2.19 “Exchange Act” means the Securities Exchange Act of 1934, as amended. Reference to a specific section of the Exchange Act or regulation thereunder shall include such section or regulation, any valid regulation or interpretation promulgated under such section, and any comparable provision of any future legislation or regulation amending, supplementing or superseding such section or regulation.
2.20 “Fair Market Value” means, for purposes of the Plan, unless otherwise provided in an Award Agreement or as required by any applicable provision of the Code or any regulations issued thereunder, as of any date and except as provided below: (a) if the Common Stock is traded, listed or otherwise reported or quoted on a national securities exchange, the last sales price reported for the Common Stock on the applicable date on the principal national securities exchange in the United States on which it is then traded, listed or otherwise reported or quoted; or (b) if the Common Stock is not traded, listed or otherwise reported or quoted on a national securities exchange, the Committee shall determine in good faith the Fair Market Value in whatever manner it considers appropriate, taking into account the requirements of Section 409A of the Code and any other applicable laws, rules or regulations. For purposes of the grant of any Award, the applicable date shall be the trading day immediately prior to the date on which the Award is granted. For purposes of the exercise of any Award, the applicable date shall be the date a notice of exercise is received by the Committee or, if not a day on which the applicable market is open, the next day that it is open.

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2.21 “Family Member” means “family member” as defined in Section A.1.(a)(5) of the general instructions of Form S-8 of the Commission.
2.22 “Good Reason” means, unless otherwise determined by the Committee in the applicable Award Agreement, the following: (a) in the case where there is no employment agreement, consulting agreement, change in control agreement or similar agreement in effect between the Company or an Affiliate and the Participant at the time of the grant of the Award (or where there is such an agreement but it does not define “good reason” (or words of like import)), the occurrence, without the Participant’s consent, of either of the following events: (i) any material diminution of the Participant’s title, duties, responsibilities or authorities; or (ii) any breach by the Company or the employing Affiliate, as applicable, of any of its material obligations to the Participant. Prior to resigning for Good Reason, the Participant shall give written notice to the Company or the employing Affiliate, as applicable, of the facts and circumstances claimed to provide a basis for such resignation not more than sixty (60) days following the Participant’s knowledge of such facts and circumstances, and the Company or the employing Affiliate, as applicable, shall have ten (10) business days after receipt of such notice to cure (and if so cured, the Participant shall not be permitted to resign for Good Reason in respect thereof) and the Participant shall resign within ten (10) business days following the Company’s or the employing Affiliate’s, as applicable, failure to cure; or (b) in the case where there is an employment agreement, consulting agreement, change in control agreement or similar agreement in effect between the Company or an Affiliate and the Participant at the time of the grant of the Award that defines “good reason” (or words of like import), “good reason” as defined under such agreement; provided, however, that with regard to any agreement under which the definition of “good reason” only applies on occurrence of a change in control, such definition of “good reason” shall not apply until a change in control actually takes place and then only with regard to a termination thereafter.
2.23 “Incentive Stock Option” means any Stock Option awarded to an Eligible Employee of the Company, its Subsidiaries and its Parents (if any) under the Plan intended to be and designated as an “Incentive Stock Option” within the meaning of Section 422 of the Code.
2.24 “Lead Underwriter” has the meaning set forth in Section 13.19.
2.25 “Lock-Up Period” has the meaning set forth in Section 13.19.
2.26 “Non-Employee Director” means a director or a member of the Board of the Company or any Affiliate who is not a then current employee of the Company or any Affiliate.
2.27 “Non-Qualified Stock Option” means any Stock Option awarded under the Plan that is not an Incentive Stock Option.
2.28 “Other Cash-Based Award” means an Award granted pursuant to Section 9.3 of the Plan and payable in cash at such time or times and subject to such terms and conditions as determined by the Committee in its sole discretion.

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2.29 “Other Stock-Based Award” means an Award under Article IX of the Plan that is valued in whole or in part by reference to, or is payable in or otherwise based on, Common Stock, including, without limitation, an Award valued by reference to an Affiliate.
2.30 “Parent” means any parent corporation of the Company within the meaning of Section 424(e) of the Code.
2.31 “Participant” means an Eligible Individual to whom an Award has been granted pursuant to the Plan.
2.32 “Performance Award” means an Award granted to a Participant pursuant to Article VIII hereof contingent upon achieving certain Performance Goals.
2.33 “Performance Goals” means goals established by the Committee as contingencies for Awards to vest and/or become exercisable or distributable based on one or more of the performance goals set forth in Exhibit A hereto.
2.34 “Performance Period” means the designated period during which the Performance Goals must be satisfied with respect to the Award to which the Performance Goals relate.
2.35 “Plan” means this SandRidge Energy, Inc. 2016 Omnibus Incentive Plan, as amended from time to time.
2.36 “Principal” means Carl C. Icahn.
2.37 “Principal Stockholder” means any of Icahn Partners LP, any Affiliate of Icahn Partners LP, the Principal and any Related Party. 
2.38 “Proceeding” has the meaning set forth in Section 13.8.
2.39 “Related Party” means (1) the Principal and his siblings, his and their respective spouses and descendants (including stepchildren and adopted children) and the spouses of such descendants (including stepchildren and adopted children) (collectively, the “Family Group”); (2) any trust, estate, partnership, corporation, company, limited liability company or unincorporated association or organization (each, an “Entity” and collectively “Entities”) Controlled by one or more members of the Family Group; (3) any Entity over which one or more members of the Family Group, directly or indirectly, have rights that, either legally or in practical effect, enable them to make or veto significant management decisions with respect to such Entity, whether pursuant to the constituent documents of such Entity, by contract, through representation on a board of directors or other governing body of such Entity, through a management position with such Entity or in any other manner (such rights, hereinafter referred to as “Veto Power”); (4) the estate of any member of the Family Group; (5) any trust created (in whole or in part) by any one or more members of the Family Group; (6) any individual or Entity who receives an interest in any estate or trust listed in clauses (4) or (5), to the extent of such interest; (7) any trust or estate, substantially all the beneficiaries of which (other than charitable organizations or foundations)
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 consist of one or more members of the Family Group; (8) any organization described in Section 501(c) of the Code, over which any one or more members of the Family Group and the trusts and estates listed in clauses (4), (5) and (7) have direct or indirect Veto Power, or to which they are substantial contributors (as such term is defined in Section 507 of the Code); (9) any organization described in Section 501(c) of the Code of which a member of the Family Group is an officer, director or trustee; or (10) any Entity, directly or indirectly (a) owned or Controlled by or (b) a majority of the economic interests in which are owned by, or are for or accrue to the benefit of, in either case, any Person or Persons identified in clauses (1) through (9) above. For the purposes of this definition, and for the avoidance of doubt, in addition to any Person or Persons that may be considered to possess Control, (x) a partnership shall be considered Controlled by a general partner or managing general partner thereof, (y) a limited liability company shall be considered Controlled by a managing member of such limited liability company and (z) a trust or estate shall be considered Controlled by any trustee, executor, personal representative, administrator or any other Person or Persons having authority over the control, management or disposition of the income and assets therefrom.
2.40 “Reorganization” has the meaning set forth in Section 4.2(b)(ii).
2.41 “Restricted Stock” means an Award of shares of Common Stock under the Plan that is subject to restrictions under Article VII.
2.42 “Restriction Period” has the meaning set forth in Section 7.3(a) with respect to Restricted Stock.
2.43 “Rule 16b-3” means Rule 16b-3 under Section 16(b) of the Exchange Act as then in effect or any successor provision.
2.44 “Section 162(m) of the Code” means the exception for performance-based compensation under Section 162(m) of the Code and any applicable Treasury Regulations thereunder.
2.45 “Section 409A of the Code” means the nonqualified deferred compensation rules under Section 409A of the Code and any applicable Treasury Regulations and other official guidance thereunder.
2.46 “Securities Act” means the Securities Act of 1933, as amended and all rules and regulations promulgated thereunder. Reference to a specific section of the Securities Act or regulation thereunder shall include such section or regulation, any valid regulation or interpretation promulgated under such section, and any comparable provision of any future legislation or regulation amending, supplementing or superseding such section or regulation.
2.47 “Stock Option” or “Option” means any option to purchase shares of Common Stock granted to Eligible Individuals granted pursuant to Article VI.
2.48 “Subsidiary” means any subsidiary corporation of the Company within the meaning of Section 424(f) of the Code.

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2.49 “Ten Percent Stockholder” means a person owning stock possessing more than ten percent (10%) of the total combined voting power of all classes of stock of the Company, its Subsidiaries or its Parent.
2.50 “Termination” means a Termination of Consultancy, Termination of Directorship or Termination of Employment, as applicable.
2.51 “Termination of Consultancy” means: (a) that the Consultant is no longer acting as a consultant to the Company or any of its Affiliates; or (b) when an entity (other than the Company) that is retaining a Participant as a Consultant ceases to be an Affiliate, unless the Participant otherwise is, or thereupon becomes, a Consultant to the Company or another Affiliate at the time the entity ceases to be an Affiliate. In the event that a Consultant becomes an Eligible Employee or a Non‐Employee Director upon the termination of such Consultant’s consultancy, unless otherwise determined by the Committee, in its sole discretion, no Termination of Consultancy shall be deemed to occur until such time as such Consultant is no longer a Consultant, an Eligible Employee or a Non-Employee Director. Notwithstanding the foregoing, the Committee may otherwise define Termination of Consultancy in the Award Agreement or, if no rights of a Participant are reduced, may otherwise define Termination of Consultancy thereafter, provided that any such change to the definition of the term “Termination of Consultancy” does not subject the applicable Award to Section 409A of the Code.
2.52 “Termination of Directorship” means: (a) that the Non-Employee Director has ceased to be a director of the Company or any of its Affiliates; or (b) when an entity (other than the Company) for which the Participant is serving as a Non-Employee Director ceases to be an Affiliate, unless the Participant otherwise is, or thereupon becomes, a Non-Employee Director of the Company or another Affiliate at the time the entity ceases to be an Affiliate. In the event that a Non-Employee Director becomes an Eligible Employee or a Consultant upon the termination of such Non-Employee Director’s directorship, unless otherwise determined by the Committee, in its sole discretion, such Non-Employee Director’s ceasing to be a director of the Company or an Affiliate shall not be treated as a Termination of Directorship, unless and until the Participant has a Termination of Employment or Termination of Consultancy, as the case may be.
2.53 “Termination of Employment” means: (a) a termination of employment (for reasons other than a military or personal leave of absence granted by the Company) of a Participant from the Company and all of its Affiliates; or (b) when an entity (other than the Company) which is employing a Participant ceases to be an Affiliate, unless the Participant otherwise is, or thereupon becomes, employed by the Company or another Affiliate at the time the entity ceases to be an Affiliate. In the event that an Eligible Employee becomes a Consultant or a Non‐Employee Director upon the termination of such Eligible Employee’s employment, unless otherwise determined by the Committee, in its sole discretion, no Termination of Employment shall be deemed to occur until such time as such Eligible Employee is no longer an Eligible Employee, a Consultant or a Non‐Employee Director. Notwithstanding the foregoing, the Committee may otherwise define Termination of Employment in the Award Agreement or, if no rights of a Participant are reduced, may otherwise define Termination of Employment
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 thereafter, provided that any such change to the definition of the term “Termination of Employment” does not subject the applicable Award to Section 409A of the Code.
2.54 “Transfer” means: (a) when used as a noun, any direct or indirect transfer, sale, assignment, pledge, hypothecation, encumbrance or other disposition (including the issuance of equity in any entity), whether for value or no value and whether voluntary or involuntary (including by operation of law), and (b) when used as a verb, to directly or indirectly transfer, sell, assign, pledge, encumber, charge, hypothecate or otherwise dispose of (including the issuance of equity in any entity) whether for value or for no value and whether voluntarily or involuntarily (including by operation of law). “Transferred” and “Transferable” shall have a correlative meaning.
ARTICLE III  
ADMINISTRATION
3.1 The Committee. The Plan shall be administered and interpreted by the Committee. Each member of the Committee shall qualify as (a) a “non-employee director” under Rule 16b-3, (b) an “outside director” under Section 162(m) of the Code and (c) an “independent director” under the rules of any national securities exchange or national securities association, as applicable. If it is later determined that one or more members of the Committee do not so qualify, actions taken by the Committee prior to such determination shall be valid despite such failure to qualify.
3.2 Grants of Awards. The Committee shall have full authority to grant, pursuant to the terms of the Plan, to Eligible Individuals: (i) Stock Options, (ii) Restricted Stock, (iii) Performance Awards; (iv) Other Stock-Based Awards; and (v) Other Cash-Based Awards. In particular, the Committee shall have the authority:
(a) to select the Eligible Individuals to whom Awards may from time to time be granted hereunder;
(b) to determine whether and to what extent Awards, or any combination thereof, are to be granted hereunder to one or more Eligible Individuals;
(c) to determine the number of shares of Common Stock to be covered by each Award granted hereunder;
(d) to determine the terms and conditions, not inconsistent with the terms of the Plan, of any Award granted hereunder (including, but not limited to, the exercise or purchase price (if any), any restriction or limitation, any vesting schedule or acceleration thereof, or any forfeiture restrictions or waiver thereof, regarding any Award and the shares of Common Stock relating thereto, based on such factors, if any, as the Committee shall determine, in its sole discretion);
(e) to determine the amount of cash to be covered by each Award granted hereunder;

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(f) to determine whether, to what extent and under what circumstances grants of Options and other Awards under the Plan are to operate on a tandem basis and/or in conjunction with or apart from other awards made by the Company outside of the Plan;
(g) to determine whether and under what circumstances a Stock Option may be settled in cash, Common Stock and/or Restricted Stock under Section 6.4(d); 
(h) to determine whether a Stock Option is an Incentive Stock Option or Non‐Qualified Stock Option;
(i) to impose a “blackout” period during which Options may not be exercised; 
(j) to determine whether to require a Participant, as a condition of the granting of any Award, to not sell or otherwise dispose of shares of Common Stock acquired pursuant to the exercise of an Award for a period of time as determined by the Committee, in its sole discretion, following the date of the acquisition of such Award;
(k) to modify, extend or renew an Award, subject to Article XI and Section 6.4(l), provided, however, that such action does not subject the Award to Section 409A of the Code without the consent of the Participant; and
(l) solely to the extent permitted by applicable law, to determine whether, to what extent and under what circumstances to provide loans (which may be on a recourse basis and shall bear interest at the rate the Committee shall provide) to Participants in order to exercise Options under the Plan.
For the sake of clarity and to the extent permitted by applicable law, the Board or the Committee may delegate to an officer of the Company the authority to make Awards hereunder.

3.3 Guidelines. Subject to Article XI hereof, the Committee shall have the authority to adopt, alter and repeal such administrative rules, guidelines and practices governing the Plan and perform all acts, including the delegation of its responsibilities (to the extent permitted by applicable law and applicable stock exchange rules), as it shall, from time to time, deem advisable; to construe and interpret the terms and provisions of the Plan and any Award issued under the Plan (and any Award Agreements relating thereto); and to otherwise supervise the administration of the Plan. The Committee may correct any defect, supply any omission or reconcile any inconsistency in the Plan or in any agreement relating thereto in the manner and to the extent it shall deem necessary to effectuate the purpose and intent of the Plan. The Committee may adopt special guidelines and provisions for persons who are residing in or employed in, or subject to, the taxes of, any domestic or foreign jurisdictions to comply with applicable tax and securities laws of such domestic or foreign jurisdictions. Notwithstanding the foregoing, no action of the Committee under this Section 3.3 shall impair the rights of any Participant without the Participant’s consent. To the extent applicable, the Plan is intended to comply with the applicable requirements of Rule 16b-3, and with respect to Awards intended to be “performance-based,” the applicable provisions of Section 162(m) of the Code, and the Plan shall be limited, construed and interpreted in a manner so as to comply therewith.

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3.4 Decisions Final. Any decision, interpretation or other action made or taken in good faith by or at the direction of the Company, the Board or the Committee (or any of its members) arising out of or in connection with the Plan shall be within the absolute discretion of all and each of them, as the case may be, and shall be final, binding and conclusive on the Company and all employees and Participants and their respective heirs, executors, administrators, successors and assigns.
3.5 Delegations and Designations/Liability.
(a) The Committee may designate employees of the Company and professional advisors to assist the Committee in the administration of the Plan and (to the extent permitted by applicable law and applicable exchange rules) may grant authority to officers to grant Awards and/or execute agreements or other documents on behalf of the Committee.
(b) The Committee may employ such legal counsel, consultants and agents as it may deem desirable for the administration of the Plan and may rely upon any opinion received from any such counsel or consultant and any computation received from any such consultant or agent. Expenses incurred by the Committee or the Board in the engagement of any such counsel, consultant or agent shall be paid by the Company. The Committee, its members and any person designated or granted authority pursuant to sub-section (a) above shall not be liable for any action or determination made in good faith with respect to the Plan. To the maximum extent permitted by applicable law, no officer or employee of the Company or its Affiliates or member or former member of the Committee or of the Board shall be liable for any action or determination made in good faith with respect to the Plan or any Award granted under it.
ARTICLE IV  
SHARE LIMITATION
4.1 Shares. • The aggregate number of shares of Common Stock that may be issued or used for reference purposes or with respect to which Awards may be granted under the Plan shall not exceed 4,597,163 shares (subject to any increase or decrease pursuant to Section 4.2) (the “Share Reserve”), which may be either authorized and unissued Common Stock or Common Stock held in or acquired for the treasury of the Company or both. The maximum number of shares of Common Stock with respect to which Incentive Stock Options may be granted under the Plan shall be equal to the Share Reserve. If any Option or Other Stock-Based Award granted under the Plan expires, terminates or is canceled for any reason without having been exercised in full, the number of shares of Common Stock underlying any unexercised Award shall again be available for the purpose of Awards under the Plan. If any shares of Restricted Stock, Performance Awards or Other Stock-Based Awards denominated in shares of Common Stock awarded under the Plan to a Participant are forfeited for any reason, including in connection with the satisfaction of minimum withholding tax obligations as described in Section 13.4 below, the number of forfeited shares of Restricted Stock, Performance Awards or Other Stock-Based Awards denominated in shares of Common Stock shall again be available for purposes of Awards under the Plan. Any Award under the Plan settled in cash shall not be counted against the foregoing maximum share limitation. The maximum grant date fair value of all Awards granted to any director during any calendar year shall not exceed $750,000.

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(a) Individual Participant Limitations. To the extent required by Section 162(m) of the Code for Awards under the Plan to qualify as “performance-based compensation,” the following individual Participant limitations shall apply:
(i) The maximum number of shares of Common Stock subject to any Award of Stock Options, or shares of Restricted Stock, or Other Stock-Based Awards for which the grant of such Award or the lapse of the relevant Restriction Period is subject to the attainment of Performance Goals in accordance with Section 7.3(a)(ii) which may be granted under the Plan during any fiscal year of the Company to any Participant shall be 500,000 shares per type of Award (which shall be subject to increase or decrease pursuant to Section 4.2), provided that the maximum number of shares of Common Stock for all such types of Awards to any Participant does not exceed 500,000 shares (which shall be subject to increase or decrease pursuant to Section 4.2) during any fiscal year of the Company.  
(ii) There are no annual individual share limitations applicable to Participants on Restricted Stock or Other Stock-Based Awards for which the grant, vesting or payment (as applicable) of any such Award is not subject to the attainment of Performance Goals.
(iii) The maximum number of shares of Common Stock subject to any Performance Award that may be granted under the Plan during any fiscal year of the Company to any Participant shall be 500,000 shares (which shall be subject to any further increase or decrease pursuant to Section 4.2) with respect to any fiscal year of the Company.
(iv) The maximum value of a cash payment made under a Performance Award which may be granted under the Plan with respect to any fiscal year of the Company to any Participant shall be $2,000,000, if the Performance Period is limited to a single fiscal year, and $6,000,000, if the Performance Period spans multiple fiscal years.
(v) The individual Participant limitations set forth in this Section 4.1(b) (other than Section 4.1(b)(iii)) shall be cumulative; that is, to the extent that shares of Common Stock for which Awards are permitted to be granted to a Participant during a fiscal year are not covered by an Award to such Participant in a fiscal year, the number of shares of Common Stock available for Awards to such Participant shall automatically increase in the subsequent fiscal years during the term of the Plan until used.
4.2 Changes.
(a) The existence of the Plan and the Awards granted hereunder shall not affect in any way the right or power of the Board or the stockholders of the Company to make or authorize (i) any adjustment, recapitalization, reorganization or other change in the Company’s capital structure or its business, (ii) any merger or consolidation of the Company or any Affiliate, (iii) any issuance of bonds, debentures, preferred or prior preference stock ahead of or affecting the Common Stock, (iv) the dissolution or liquidation of the Company or any Affiliate, (v) any sale or transfer of all or part of the assets or business of the Company or any Affiliate or (vi) any other corporate act or proceeding.

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(b) Subject to the provisions of Section 10.1:
(i) If the Company at any time subdivides (by any split, recapitalization or otherwise) the outstanding Common Stock into a greater number of shares of Common Stock, or combines (by reverse split, combination or otherwise) its outstanding Common Stock into a lesser number of shares of Common Stock, then the respective exercise prices for outstanding Awards that provide for a Participant elected exercise and the number of shares of Common Stock covered by outstanding Awards shall be appropriately adjusted by the Committee to prevent dilution or enlargement of the rights granted to, or available for, Participants under the Plan.
(ii) Excepting transactions covered by Section 4.2(b)(i), if the Company effects any merger, consolidation, statutory exchange, spin-off, reorganization, sale or transfer of all or substantially all the Company’s assets or business, or other corporate transaction or event in such a manner that the Company’s outstanding shares of Common Stock are converted into the right to receive (or the holders of Common Stock are entitled to receive in exchange therefor), either immediately or upon liquidation of the Company, securities or other property of the Company or other entity (each, a “Reorganization”), then, subject to the provisions of Section 10.1, (A) the aggregate number or kind of securities that thereafter may be issued under the Plan, (B) the number or kind of securities or other property (including cash) to be issued pursuant to Awards granted under the Plan (including as a result of the assumption of the Plan and the obligations hereunder by a successor entity, as applicable), or (C) the purchase price thereof, shall be appropriately adjusted by the Committee to prevent dilution or enlargement of the rights granted to, or available for, Participants under the Plan.
(iii) If there shall occur any change in the capital structure of the Company other than those covered by Section 4.2(b)(i) or 4.2(b)(ii), including by reason of any extraordinary dividend (whether cash or equity), any conversion, any adjustment, any issuance of any class of securities convertible or exercisable into, or exercisable for, any class of equity securities of the Company, then the Committee shall adjust any Award and make such other adjustments to the Plan to prevent dilution or enlargement of the rights granted to, or available for, Participants under the Plan.
(iv) Any such adjustment determined by the Committee pursuant to this Section 4.2(b) shall be final, binding and conclusive on the Company and all Participants and their respective heirs, executors, administrators, successors and permitted assigns. Any adjustment to, or assumption or substitution of, an Award under this Section 4.2(b) shall be intended to comply with the requirements of Section 409A of the Code and Treasury Regulation §1.424-1 (and any amendments thereto), to the extent applicable. Except as expressly provided in this Section 4.2 or in the applicable Award Agreement, a Participant shall have no additional rights under the Plan by reason of any transaction or event described in this Section 4.2.
(v) Fractional shares of Common Stock resulting from any adjustment in Awards pursuant to Section 4.2(a) or this Section 4.2(b) shall be aggregated until, and eliminated at, the time of exercise or payment by rounding-down for fractions less than one-half and rounding-up for fractions equal to or greater than one-half. No cash settlements shall be
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 required with respect to fractional shares eliminated by rounding. Notice of any adjustment shall be given by the Committee to each Participant whose Award has been adjusted and such adjustment (whether or not such notice is given) shall be effective and binding for all purposes of the Plan.
4.3 Minimum Purchase Price. Notwithstanding any provision of the Plan to the contrary, if authorized but previously unissued shares of Common Stock are issued under the Plan, such shares shall not be issued for a consideration that is less than as permitted under applicable law.
ARTICLE V
ELIGIBILITY
5.1 General Eligibility. All current and prospective Eligible Individuals are eligible to be granted Awards. Eligibility for the grant of Awards and actual participation in the Plan shall be determined by the Committee in its sole discretion.
5.2 Incentive Stock Options. Notwithstanding the foregoing, only Eligible Employees of the Company, its Subsidiaries and its Parent (if any) are eligible to be granted Incentive Stock Options under the Plan. Eligibility for the grant of an Incentive Stock Option and actual participation in the Plan shall be determined by the Committee in its sole discretion.
5.3 General Requirement. The vesting and exercise of Awards granted to a prospective Eligible Individual are conditioned upon such individual actually becoming an Eligible Employee, Consultant or Non-Employee Director, respectively.
ARTICLE VI  
STOCK OPTIONS
6.1 Options. Stock Options may be granted alone or in addition to other Awards granted under the Plan. Each Stock Option granted under the Plan shall be of one of two types: (a) an Incentive Stock Option or (b) a Non-Qualified Stock Option.
6.2 Grants. The Committee shall have the authority to grant to any Eligible Employee one or more Incentive Stock Options, Non-Qualified Stock Options, or both types of Stock Options, in each case, pursuant to an Award Agreement. The Committee shall have the authority to grant any Consultant or Non-Employee Director one or more Non-Qualified Stock Options. To the extent that any Stock Option does not qualify as an Incentive Stock Option (whether because of its provisions or the time or manner of its exercise or otherwise), such Stock Option or the portion thereof which does not so qualify shall constitute a separate Non-Qualified Stock Option.
6.3 Incentive Stock Options. Notwithstanding anything in the Plan to the contrary, no term of the Plan relating to Incentive Stock Options shall be interpreted, amended or altered, nor shall any discretion or authority granted under the Plan be so exercised, so as to disqualify
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 the Plan under Section 422 of the Code, or, without the consent of the Participants affected, to disqualify any Incentive Stock Option under such Section 422.
6.4 Terms of Options. Options granted under the Plan shall be subject to the following terms and conditions and shall be in such form and contain such additional terms and conditions, not inconsistent with the terms of the Plan, as the Committee shall deem desirable, including those set forth in an Award Agreement:
(a) Exercise Price. The exercise price per share of Common Stock subject to a Stock Option shall be determined by the Committee at the time of grant, provided that the per share exercise price of a Stock Option shall not be less than 100% (or, in the case of an Incentive Stock Option granted to a Ten Percent Stockholder, 110%) of the Fair Market Value of the Common Stock at the time of grant.
(b) Stock Option Term. The term of each Stock Option shall be fixed by the Committee, provided that no Stock Option shall be exercisable more than ten (10) years after the date the Option is granted; and provided, further, that the term of an Incentive Stock Option granted to a Ten Percent Stockholder shall not exceed five (5) years.
(c) Exercisability. Unless otherwise provided by the Committee in accordance with the provisions of this Section 6.4, Stock Options granted under the Plan shall be exercisable at such time or times and subject to such terms and conditions as shall be determined by the Committee at the time of grant. If the Committee provides, in its discretion, that any Stock Option is exercisable subject to certain limitations (including, without limitation, that such Stock Option is exercisable only in installments or within certain time periods), the Committee may waive such limitations on the exercisability at any time at or after the time of grant in whole or in part (including, without limitation, waiver of the installment exercise provisions or acceleration of the time at which such Stock Option may be exercised), based on such factors, if any, as the Committee shall determine, in its sole discretion.
(d) Method of Exercise. Subject to whatever installment exercise and waiting period provisions apply under Section 6.4(c), to the extent vested, Stock Options may be exercised in whole or in part at any time during the Option term, by giving written notice of exercise to the Company (or to its agent specifically designated for such purpose) specifying the number of shares of Common Stock to be purchased (which notice may be provided in an electronic form to the extent acceptable to the Committee and the Company). Such notice shall be accompanied by payment in full of the purchase price as follows: (i) in cash or by check, bank draft or money order payable to the order of the Company; (ii) solely to the extent permitted by applicable law, if the Common Stock is traded on a national securities exchange, and the Committee authorizes, through a procedure whereby the Participant delivers irrevocable instructions to a broker reasonably acceptable to the Committee to deliver promptly to the Company shares of Common Stock with an aggregate value equal to the purchase price; (iii) by having the Company withhold shares of Common Stock issuable upon exercise of the Stock Option; or (iv) on such other terms and conditions as may be acceptable to the Committee (including, without limitation, with the consent of the Committee, by payment in full or in part in the form of Common Stock owned by the Participant, based on the Fair Market Value of the
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 Common Stock on the payment date as determined by the Committee). No shares of Common Stock shall be issued until payment therefor, as provided herein, has been made or provided for.
(e) Non-Transferability of Options. No Stock Option shall be Transferable by the Participant other than by will or by the laws of descent and distribution, and all Stock Options shall be exercisable, during the Participant’s lifetime, only by the Participant. Notwithstanding the foregoing, the Committee may determine, in its sole discretion, at the time of grant or thereafter that a Non-Qualified Stock Option that is otherwise not Transferable pursuant to this Section is Transferable to a Family Member in whole or in part and in such circumstances, and under such conditions, as specified by the Committee. A Non-Qualified Stock Option that is Transferred to a Family Member pursuant to the preceding sentence (i) may not be subsequently Transferred other than by will or by the laws of descent and distribution; (ii) remains subject to the terms of the Plan and the applicable Award Agreement; and (iii) may be exercised by such Family Member. Any shares of Common Stock acquired upon the exercise of a Non-Qualified Stock Option by a permissible transferee of a Non-Qualified Stock Option or a permissible transferee pursuant to a Transfer after the exercise of the Non-Qualified Stock Option shall be subject to the terms of the Plan and the applicable Award Agreement.
(f) Termination by Death or Disability. Unless otherwise determined by the Committee at the time of grant, or if no rights of the Participant are reduced, thereafter, if a Participant’s Termination is by reason of death or Disability, all Stock Options that are held by such Participant that are vested and exercisable at the time of the Participant’s Termination may be exercised by the Participant (or in the case of the Participant’s death, by the legal representative of the Participant’s estate) at any time within a period of one (1) year from the date of such Termination, but in no event beyond the expiration of the stated term of such Stock Options; provided, however, that, in the event of a Participant’s Termination by reason of Disability, if the Participant dies within such exercise period, all unexercised Stock Options held by such Participant shall thereafter be exercisable, to the extent to which they were exercisable at the time of death, for a period of one (1) year from the date of such death, but in no event beyond the expiration of the stated term of such Stock Options.
(g) Involuntary Termination Without Cause. Unless otherwise determined by the Committee at the time of grant, or if no rights of the Participant are reduced, thereafter, if a Participant’s Termination is by involuntary termination by the Company without Cause, all Stock Options that are held by such Participant that are vested and exercisable at the time of the Participant’s Termination may be exercised by the Participant at any time within a period of ninety (90) days from the date of such Termination, but in no event beyond the expiration of the stated term of such Stock Options.
(h) Voluntary Resignation. Unless otherwise determined by the Committee at the time of grant, or if no rights of the Participant are reduced, thereafter, if a Participant’s Termination is voluntary (other than a voluntary termination described in Section 6.4(i)(y) hereof), all Stock Options that are held by such Participant that are vested and exercisable at the time of the Participant’s Termination may be exercised by the Participant at any time within a
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 period of thirty (30) days from the date of such Termination, but in no event beyond the expiration of the stated term of such Stock Options.
(i) Termination for Cause. Unless otherwise determined by the Committee at the time of grant, or if no rights of the Participant are reduced, thereafter, if a Participant’s Termination (x) is for Cause or (y) is a voluntary Termination (as provided in Section 6.4(h)) after the occurrence of an event that would be grounds for a Termination for Cause, all Stock Options, whether vested or not vested, that are held by such Participant shall thereupon terminate and expire as of the date of such Termination.
(j) Unvested Stock Options. Unless otherwise determined by the Committee at the time of grant, or if no rights of the Participant are reduced, thereafter, Stock Options that are not vested as of the date of a Participant’s Termination for any reason shall terminate and expire as of the date of such Termination.
(k) Incentive Stock Option Limitations. To the extent that the aggregate Fair Market Value (determined as of the time of grant) of the Common Stock with respect to which Incentive Stock Options are exercisable for the first time by an Eligible Employee during any calendar year under the Plan and/or any other stock option plan of the Company, any Subsidiary or any Parent exceeds $100,000, such Options shall be treated as Non-Qualified Stock Options. In addition, if an Eligible Employee does not remain employed by the Company, any Subsidiary or any Parent at all times from the time an Incentive Stock Option is granted until three (3) months prior to the date of exercise thereof (or such other period as required by applicable law), such Stock Option shall be treated as a Non-Qualified Stock Option. Should any provision of the Plan not be necessary in order for the Stock Options to qualify as Incentive Stock Options, or should any additional provisions be required, the Committee may amend the Plan accordingly, without the necessity of obtaining the approval of the stockholders of the Company.
(l) Form, Modification, Extension and Renewal of Stock Options. Subject to the terms and conditions and within the limitations of the Plan, including those set forth in the following sentence, Stock Options shall be evidenced by such form of agreement or grant as is approved by the Committee, and the Committee may (i) modify, extend or renew outstanding Stock Options granted under the Plan (provided that the rights of a Participant are not reduced without such Participant’s consent and provided, further, that such action does not subject the Stock Options to Section 409A of the Code without the consent of the Participant), and (ii) accept the surrender of outstanding Stock Options (to the extent not theretofore exercised) and authorize the granting of new Stock Options or other Awards in substitution therefor (to the extent not theretofore exercised). Notwithstanding the foregoing, except in connection with a corporate transaction involving the Company in accordance with Section 4.2 (including, without limitation, any stock dividend, stock split, extraordinary cash dividend, recapitalization, reorganization, merger, consolidation, split-up, spin-off, combination, or exchange of shares), an outstanding Stock Option may not be modified to reduce the exercise price thereof nor may a new Stock Option at a lower price be substituted for a surrendered Stock Option, unless such action is approved by the stockholders of the Company.

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(m) Early Exercise. The Committee may provide that a Stock Option include a provision whereby the Participant may elect at any time before the Participant’s Termination to exercise the Stock Option as to any part or all of the shares of Common Stock subject to the Stock Option prior to the full vesting of the Stock Option, and such shares shall be subject to the provisions of Article VII and be treated as Restricted Stock, which will remain subject to the original vesting schedule applicable to the predecessor Stock Option. Unvested shares of Common Stock so purchased may be subject to a repurchase option in favor of the Company or to any other restriction the Committee determines to be appropriate.
(n) Other Terms and Conditions. The Committee may include a provision in an Award Agreement providing for the automatic exercise of a Non-Qualified Stock Option on a cashless basis on the last day of the term of such Option if the Participant has failed to exercise the Non-Qualified Stock Option as of such date, with respect to which the Fair Market Value of the shares of Common Stock underlying the Non-Qualified Stock Option exceeds the exercise price of such Non-Qualified Stock Option on the date of expiration of such Option, subject to Section 13.4. Stock Options may contain such other provisions, which shall not be inconsistent with any of the terms of the Plan, as the Committee shall deem appropriate. The recipient of a Stock Option under this Article VI shall not be entitled to receive, currently or on a deferred basis, dividends or dividend equivalents in respect of the number of shares of Common Stock covered by the Stock Option. The Company will evidence each Participant’s ownership of Common Stock issued upon exercise of a Stock Option pursuant to a designated system, such as book entries by the transfer agent; if a stock certificate for such shares of Common Stock is issued, it will be substantially in the form set forth in Section 7.2(c).
ARTICLE VII 
RESTRICTED STOCK

7.1 Awards of Restricted Stock. Shares of Restricted Stock may be issued either alone or in addition to other Awards granted under the Plan. The Committee shall determine the Eligible Individuals, to whom, and the time or times at which, grants of Restricted Stock shall be made, the number of shares to be awarded, the price (if any) to be paid by the Participant (subject to Section 7.2), the time or times within which such Awards may be subject to forfeiture, the vesting schedule and rights to acceleration thereof, and all other terms and conditions of the Awards.
The Committee may condition the grant or vesting of Restricted Stock upon the attainment of specified performance targets (including, the Performance Goals) or such other factor as the Committee may determine in its sole discretion, including to comply with the requirements of Section 162(m) of the Code.
7.2 Awards and Certificates. If required by the Award Agreement, Eligible Individuals selected to receive Restricted Stock shall not have any right with respect to such Award, unless and until such Participant has complied with all of the applicable terms and conditions of such Award. Further, such Award shall be subject to the following conditions:

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(a) Purchase Price. The purchase price of Restricted Stock shall be fixed by the Committee. Subject to Section 4.3, the purchase price for shares of Restricted Stock may be zero to the extent permitted by applicable law, and, to the extent not so permitted, such purchase price may not be less than par value.
(b) Acceptance. Awards of Restricted Stock must be accepted within a period of sixty (60) days (or such shorter period as the Committee may specify at grant) after the grant date, by the Participant executing the Restricted Stock Award Agreement (if required by the Committee) and paying whatever price (if any) the Committee has designated thereunder.
(c) Legend. The Company will evidence each Participant’s ownership of Restricted Stock pursuant to a designated system, such as book entries by the transfer agent. If a stock certificate for such shares of Restricted Stock is issued, such certificate shall be registered in the name of such Participant, and shall, in addition to such legends required by applicable securities laws, bear an appropriate legend referring to the terms, conditions, and restrictions applicable to such Award, substantially in the following form:
“The anticipation, alienation, attachment, sale, transfer, assignment, pledge, encumbrance or charge of the shares of stock represented hereby are subject to the terms and conditions (including forfeiture) of the SandRidge Energy, Inc. (the “Company”) 2016 Omnibus Incentive Plan (the “Plan”) and an Agreement entered into between the registered owner and the Company, dated __________. Copies of such Plan and Agreement are on file at the principal office of the Company.”
(d) Custody. If stock certificates are issued in respect of shares of Restricted Stock, the Committee may require that any stock certificates evidencing such shares be held in custody by the Company until the restrictions thereon shall have lapsed, and that, as a condition of any grant of Restricted Stock, the Participant shall have delivered a duly signed stock power or other instruments of assignment (including a power of attorney), each endorsed in blank with a guarantee of signature if deemed necessary or appropriate by the Company, which would permit transfer to the Company of all or a portion of the shares subject to the Restricted Stock Award in the event that such Award is forfeited in whole or part or otherwise transferred to the Company.
7.3 Restrictions and Conditions. The shares of Restricted Stock awarded pursuant to the Plan shall be subject to the following restrictions and conditions:
(a) Restriction Period. • The Participant shall not be permitted to Transfer shares of Restricted Stock awarded under the Plan during the period or periods set by the Committee (the “Restriction Period”) commencing on the date of such Award, as set forth in the Restricted Stock Award Agreement and such agreement shall set forth a vesting schedule and any event that would accelerate vesting of the shares of Restricted Stock. Within these limits, based on service, attainment of Performance Goals pursuant to Section 7.3(a)(ii) and/or such other factors or criteria as the Committee may determine in its sole discretion, the Committee may
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 condition the grant or provide for the lapse of such restrictions in installments in whole or in part, or may accelerate the vesting of all or any part of any Restricted Stock Award and/or waive the deferral limitations for all or any part of any Restricted Stock Award.
(i) If the grant of shares of Restricted Stock or the lapse of restrictions is based on the attainment of Performance Goals, the Committee shall establish the objective Performance Goals and the applicable vesting percentage of the Restricted Stock applicable to each Participant or class of Participants in writing prior to the beginning of the applicable fiscal year or at such later date as otherwise determined by the Committee and while the outcome of the Performance Goals are substantially uncertain. Such Performance Goals may incorporate provisions for disregarding (or adjusting for) changes in accounting methods, corporate transactions (including, without limitation, dispositions and acquisitions) and other similar type events or circumstances. With regard to a Restricted Stock Award that is intended to comply with Section 162(m) of the Code, to the extent that any such provision would create impermissible discretion under Section 162(m) of the Code or otherwise violate Section 162(m) of the Code, such provision shall be of no force or effect.
(b) Rights as a Stockholder. Except as provided in Section 7.3(a) and this Section 7.3(b) or as otherwise determined by the Committee in an Award Agreement, the Participant shall have, with respect to the shares of Restricted Stock, all of the rights of a holder of shares of Common Stock of the Company, including, without limitation, the right to receive dividends (the payment of which may be deferred until, and conditioned upon, the expiration of the applicable Restriction Period, as determined in the Committee’s sole discretion), the right to vote such shares and, subject to and conditioned upon the full vesting of shares of Restricted Stock, the right to tender such shares. 
(c) Termination. Unless otherwise determined by the Committee at grant or, if no rights of the Participant are reduced, thereafter, subject to the applicable provisions of the Award Agreement and the Plan, upon a Participant’s Termination for any reason during the relevant Restriction Period, all Restricted Stock still subject to restriction will be forfeited in accordance with the terms and conditions established by the Committee at grant or thereafter.
(d) Lapse of Restrictions. If and when the Restriction Period expires without a prior forfeiture of the shares of Restricted Stock, such earned shares (and to the extent ownership of such shares is evidenced by stock certificates, the stock certificates for such shares) shall be delivered to the Participant. All legends shall be removed from said certificates at the time of delivery to the Participant, except as otherwise required by applicable law or other limitations imposed by the Committee.
ARTICLE VIII  
PERFORMANCE AWARDS
8.1 Performance Awards. The Committee may grant a Performance Award to a Participant payable upon the attainment of specific Performance Goals. The Committee may grant Performance Awards that are intended to qualify as “performance-based compensation” under Section 162(m) of the Code, as well as Performance Awards that are not intended to
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 qualify as “performance-based compensation” under Section 162(m) of the Code. If the Performance Award is payable in shares of Restricted Stock, such shares shall be transferable to the Participant only upon attainment of the relevant Performance Goal in accordance with Article VII. If the Performance Award is payable in cash, it may be paid upon the attainment of the relevant Performance Goals either in cash or in shares of Restricted Stock (based on the then current Fair Market Value of such shares), as determined by the Committee, in its sole and absolute discretion. Each Performance Award shall be evidenced by an Award Agreement in such form that is not inconsistent with the Plan and that the Committee may from time to time approve. With respect to Performance Awards that are intended to qualify as “performance-based compensation” under Section 162(m) of the Code, the Committee shall condition the right to payment of any Performance Award upon the attainment of objective Performance Goals established pursuant to Section 8.2(c).
8.2 Terms and Conditions. Performance Awards awarded pursuant to this Article VIII shall be subject to the following terms and conditions:
(a) Earning of Performance Award. At the expiration of the applicable Performance Period, the Committee shall determine the extent to which the Performance Goals established pursuant to Section 8.2(c) are achieved and the percentage of each Performance Award that has been earned.
(b) Non-Transferability. Subject to the applicable provisions of the Award Agreement and the Plan, Performance Awards may not be Transferred during the Performance Period.
(c) Objective Performance Goals, Formulae or Standards. With respect to Performance Awards that are intended to qualify as “performance-based compensation” under Section 162(m) of the Code, the Committee shall establish the objective Performance Goals for the earning of Performance Awards based on a Performance Period applicable to each Participant or class of Participants in writing prior to the beginning of the applicable Performance Period or at such later date as permitted under Section 162(m) of the Code and while the outcome of the Performance Goals are substantially uncertain. Such Performance Goals may incorporate, if and only to the extent permitted under Section 162(m) of the Code, provisions for disregarding (or adjusting for) changes in accounting methods, corporate transactions (including, without limitation, dispositions and acquisitions) and other similar type events or circumstances. To the extent that any such provision would create impermissible discretion under Section 162(m) of the Code or otherwise violate Section 162(m) of the Code, such provision shall be of no force or effect, with respect to Performance Awards that are intended to qualify as “performance-based compensation” under Section 162(m) of the Code.
(d) Dividends. To the extent determined by the Committee, Participants shall be entitled to receive an amount equal to the dividends paid on the number of shares of Common Stock covered by the Performance Award; provided that the Committee may, in its sole discretion, provide for either of the following at the time of grant: (i) dividends or dividend equivalents will be paid as accrued but will be subject to the same vesting terms and conditions
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 as the underlying Performance Award; or (ii) payment of dividends or dividend equivalents shall be deferred until, and conditioned upon, settlement of the underlying Performance Award.
(e) Payment. Following the Committee’s determination in accordance with Section 8.2(a), the Company shall settle Performance Awards, in such form (including, without limitation, in shares of Common Stock or in cash) as determined by the Committee, in an amount equal to such Participant’s earned Performance Awards. Notwithstanding the foregoing, the Committee may, in its sole discretion, award an amount less than the earned Performance Awards and/or subject the payment of all or part of any Performance Award to additional vesting, forfeiture and deferral conditions as it deems appropriate.
(f) Termination. Subject to the applicable provisions of the Award Agreement and the Plan, upon a Participant’s Termination for any reason during the Performance Period for a given Performance Award, the Performance Award in question will vest or be forfeited in accordance with the terms and conditions established by the Committee at grant.
(g) Accelerated Vesting. Based on service, performance and/or such other factors or criteria, if any, as the Committee may determine, the Committee may, at or after grant, accelerate the vesting of all or any part of any Performance Award.
ARTICLE IX  
OTHER STOCK-BASED AND CASH-BASED AWARDS

9.1 Other Stock-Based Awards. The Committee is authorized to grant to Eligible Individuals Other Stock-Based Awards that are payable in, valued in whole or in part by reference to, or otherwise based on or related to shares of Common Stock, including but not limited to, shares of Common Stock awarded purely as a bonus and not subject to restrictions or conditions, shares of Common Stock in payment of the amounts due under an incentive or performance plan sponsored or maintained by the Company or an Affiliate, stock equivalent units, restricted stock units, and Awards valued by reference to book value of shares of Common Stock. Other Stock-Based Awards may be granted either alone or in addition to or in tandem with other Awards granted under the Plan.
Subject to the provisions of the Plan, the Committee shall have authority to determine the Eligible Individuals, to whom, and the time or times at which, such Awards shall be made, the number of shares of Common Stock to be awarded pursuant to such Awards, and all other conditions of the Awards. The Committee may also provide for the grant of Common Stock under such Awards upon the completion of a specified Performance Period.
The Committee may condition the grant or vesting of Other Stock-Based Awards upon the attainment of specified Performance Goals as the Committee may determine, in its sole discretion; provided that to the extent that such Other Stock-Based Awards are intended to comply with Section 162(m) of the Code, the Committee shall establish the objective Performance Goals for the grant or vesting of such Other Stock-Based Awards based on a Performance Period applicable to each Participant or class of Participants in writing prior to the beginning of the applicable Performance Period or at such later date as permitted under Section
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 162(m) of the Code and while the outcome of the Performance Goals are substantially uncertain. Such Performance Goals may incorporate, if and only to the extent permitted under Section 162(m) of the Code, provisions for disregarding (or adjusting for) changes in accounting methods, corporate transactions (including, without limitation, dispositions and acquisitions) and other similar type events or circumstances. To the extent that any such provision would create impermissible discretion under Section 162(m) of the Code or otherwise violate Section 162(m) of the Code, such provision shall be of no force or effect, with respect to Performance Awards that are intended to qualify as “performance-based compensation” under Section 162(m) of the Code.
9.2 Terms and Conditions. Other Stock-Based Awards made pursuant to this Article IX shall be subject to the following terms and conditions:
(a) Non-Transferability. Subject to the applicable provisions of the Award Agreement and the Plan, shares of Common Stock subject to Awards made under this Article IX may not be Transferred prior to the date on which the shares are issued, or, if later, the date on which any applicable restriction, performance or deferral period lapses.
(b) Dividends. To the extent determined by the Committee, Participants shall be entitled to receive an amount equal to the dividends paid on the number of shares of Common Stock covered by Awards made under this Article IX; provided that the Committee may, in its sole discretion, provide for either of the following at the time of grant: (i) dividends or dividend equivalents will be paid as accrued but will be subject to the same vesting terms and conditions as the underlying Award; or (ii) payment of dividends or dividend equivalents shall be deferred until, and conditioned upon, settlement of the underlying Award.
(c) Vesting. Any Award under this Article IX and any Common Stock covered by any such Award shall vest or be forfeited to the extent so provided in the Award Agreement, as determined by the Committee, in its sole discretion.
(d) Price. Common Stock issued on a bonus basis under this Article IX may be issued for no cash consideration. Common Stock purchased pursuant to a purchase right awarded under this Article IX shall be priced, as determined by the Committee in its sole discretion.
9.3 Other Cash-Based Awards. The Committee may from time to time grant Other Cash-Based Awards to Eligible Individuals in such amounts, on such terms and conditions, and for such consideration, including no consideration or such minimum consideration as may be required by applicable law, as it shall determine in its sole discretion. Other Cash-Based Awards may be granted subject to the satisfaction of vesting conditions or may be awarded purely as a bonus and not subject to restrictions or conditions, and if subject to vesting conditions, the Committee may accelerate the vesting of such Awards at any time in its sole discretion. The grant of an Other Cash-Based Award shall not require a segregation of any of the Company’s assets for satisfaction of the Company’s payment obligation thereunder.

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ARTICLE X  
CHANGE IN CONTROL PROVISIONS
10.1 Benefits. In the event of a Change in Control of the Company (as defined below), and except as otherwise provided by the Committee in an Award Agreement, a Participant’s unvested Awards shall not vest automatically and a Participant’s Awards shall be treated in accordance with one or more of the following methods as determined by the Committee in its sole discretion (with such determination having final and binding effect on all parties), and which determination need not treat all Awards (or portions thereof) in an identical manner:
(a) Awards, whether or not then vested, shall be continued, assumed, or have new rights substituted therefor, as determined by the Committee in a manner consistent with the requirements of Section 409A of the Code, and restrictions to which shares of Restricted Stock or any other Award granted prior to the Change in Control are subject shall not lapse upon a Change in Control and the Restricted Stock or other Award shall, where appropriate in the sole discretion of the Committee, receive the same distribution as other Common Stock on such terms as determined by the Committee; provided that the Committee may decide to award additional Restricted Stock or other Awards in lieu of any cash distribution. Notwithstanding anything to the contrary herein, for purposes of Incentive Stock Options, any assumed or substituted Stock Option shall comply with the requirements of Treasury Regulation Section 1.424-1 (and any amendment thereto).
(b) The Committee, in its sole discretion, may provide for the purchase of any Awards by the Company or an Affiliate for an amount of cash or other property (including shares of the resulting entity in connection with a Change in Control) equal to the excess (if any) of the Change in Control Price (as defined below) of the shares of Common Stock covered by such Awards, over the aggregate exercise price of such Awards (such excess, if any, the “Spread”). If the Spread applicable to an Award is zero or a negative number, then the Award may be cancelled without making a payment to the Participant. For purposes hereof, “Change in Control Price” shall mean the highest price per share of Common Stock paid in any transaction related to a Change in Control of the Company.
(c) The Committee may, in its sole discretion, terminate all outstanding and unexercised Stock Options or any Other Stock-Based Award that provides for a Participant elected exercise, effective as of the date of the Change in Control, by delivering notice of termination to each Participant at least twenty (20) days prior to the date of consummation of the Change in Control, in which case during the period from the date on which such notice of termination is delivered to the consummation of the Change in Control, each such Participant shall have the right to exercise in full all of such Participant’s Awards that are then outstanding (without regard to any limitations on exercisability otherwise contained in the Award Agreements), but any such exercise shall be contingent on the occurrence of the Change in Control, and, provided that, if the Change in Control does not take place within a specified period after giving such notice for any reason whatsoever, the notice and exercise pursuant thereto shall be null and void.

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(d) The Committee may, in its sole discretion, make any other determination as to the treatment of Awards in connection with such Change in Control as the Committee may determine. Any escrow, holdback, earnout or similar provisions in the definitive agreement(s) relating to such transaction may apply to any payment to the holders of Awards to the same extent and in the same manner as such provisions apply to the holders of shares of Common Stock. 
Notwithstanding any other provision herein to the contrary, the Committee may, in its sole discretion, provide for accelerated vesting or lapse of restrictions, of an Award at any time.
10.2 Change in Control. Unless otherwise determined by the Committee in the applicable Award Agreement or other written agreement with a Participant approved by the Committee, a “Change in Control” shall be deemed to occur if:
(a) any “person,” as such term is used in Sections 13(d) and 14(d) of the Exchange Act (“Person”) becoming the beneficial owner (as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of voting securities of the Company (the “Voting Securities”) representing 50% or more of the combined voting power of the Company’s then outstanding securities; provided, however, that in determining whether a Change in Control has occurred pursuant to this paragraph (a), the acquisition of securities of the Company in a Non-Control Acquisition (as hereinafter defined) shall not constitute a Change in Control. A “Non-Control Acquisition” shall mean an acquisition by (i) an employee benefit plan (or a trust forming a part thereof) maintained by (A) the Company or (B) any corporation or other Person the majority of the voting power, voting equity securities or equity interest of which is owned, directly or indirectly, by the Company (for purposes of this definition, a “Majority-Owned Entity”), (ii) the Company, any Principal Stockholder or any Majority-Owned Entity, or (iii) any Person in connection with a Non-Control Transaction (as hereinafter defined);
(b) consummation of a reorganization, merger, consolidation or other business combination (any of the foregoing, a “Business Combination”) of the Company or any direct or indirect subsidiary of the Company with any Person unless such Business Combination is a Non-Control Transaction (as hereinafter defined). A “Non-Control Transaction” shall mean a Business Combination in which: 
(i) the shareholders of the Company immediately before such Business Combination, or one or more Principal Stockholders, own directly or indirectly immediately following such Business Combination at least a majority of the combined voting power of the outstanding voting securities of (A) the corporation resulting from such Business Combination (the “Surviving Corporation”), if fifty percent (50%) or more of the combined voting power of the then outstanding voting securities by the Surviving Corporation is not Beneficially Owned (within the meaning of Rule 13d-3 promulgated under the Exchange Act), directly or indirectly, by another Person (a “Parent Corporation”) or (B) if there is one or more than one Parent Corporation, the ultimate Parent Corporation; and
(iii) no Person other than (A) the Company or another corporation that is a party to the agreement of Business Combination, (B) any Majority-Owned Entity, (C) any
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 employee benefit plan (or any trust forming a part thereof) that, immediately prior to the Business Combination, was maintained by the Company or any Majority-Owned Entity, (D) any Person who, immediately prior to the Business Combination, had Beneficial Ownership of 50% or more of the then outstanding Shares or Voting Securities, or (E) any Principal Stockholder, has Beneficial Ownership, directly or indirectly, of 50% or more of the combined voting power of the outstanding voting securities or common stock of (x) the Surviving Corporation, if there is no Parent Corporation, or (y) if there is one or more than one Parent Corporation, the ultimate Parent Corporation.; or 
(c) a complete liquidation or dissolution of the Company; or 
(d) the consummation of a sale or other disposition by the Company of all or substantially all of the assets of the Company and its Subsidiaries taken as a whole to any Person other than (i) a sale or transfer to a Majority-Owned Entity or a Principal Stockholder (or one or more Principal Stockholders acting together) or (ii) the distribution to the Company’s shareholders of the stock of a Majority-Owned Entity or any other assets. 
Notwithstanding the foregoing, a Change in Control shall not be deemed to occur solely because any Person (the “Subject Person”) acquired Beneficial Ownership of more than the permitted amount of the then outstanding Shares or Voting Securities as a result of the acquisition of Shares or Voting Securities by the Company which, by reducing the number of Shares or Voting Securities then outstanding, increases the proportional number of shares Beneficially Owned by the Subject Persons; provided that if a Change in Control would occur (but for the operation of this sentence) as a result of the acquisition of Shares or Voting Securities by the Company and, after such share acquisition by the Company, the Subject Person becomes the Beneficial Owner of any additional Shares or Voting Securities and such Beneficial Ownership increases the percentage of the then outstanding Shares or Voting Securities Beneficially Owned by the Subject Person, then a Change in Control shall occur. With respect to any Award that is characterized as “nonqualified deferred compensation” within the meaning of Section 409A of the Code, an event shall not be considered to be a Change in Control under the Plan for purposes of payment of such Award unless such event is also a “change in ownership,” a “change in effective control” or a “change in the ownership of a substantial portion of the assets” of the Company within the meaning of Section 409A of the Code.
ARTICLE XI  
TERMINATION OR AMENDMENT OF PLAN
Notwithstanding any other provision of the Plan, the Board may at any time, and from time to time, amend, in whole or in part, any or all of the provisions of the Plan (including any amendment deemed necessary to ensure that the Company may comply with any regulatory requirement referred to in Article XIII or Section 409A of the Code), or suspend or terminate it entirely, retroactively or otherwise; provided, however, that, unless otherwise required by law or specifically provided herein, the rights of a Participant with respect to Awards granted prior to such amendment, suspension or termination, may not be impaired without the consent of such Participant, including as set forth in Section 6.3. Notwithstanding anything herein to the contrary, the Board may amend the Plan or any Award Agreement at any time without a Participant’s
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 consent to comply with applicable law, including Section 409A of the Code. The Committee may amend the terms of any Award theretofore granted, prospectively or retroactively, but, subject to Article IV or as otherwise specifically provided herein, no such amendment or other action by the Committee shall impair the rights of any holder without the holder’s consent.
ARTICLE XII
UNFUNDED STATUS OF PLAN
The Plan is intended to constitute an “unfunded” plan for incentive and deferred compensation. With respect to any payment as to which a Participant has a fixed and vested interest but which are not yet made to a Participant by the Company, nothing contained herein shall give any such Participant any right that is greater than those of a general unsecured creditor of the Company.
ARTICLE XIII
GENERAL PROVISIONS
13.1 Legend. The Committee may require each person receiving shares of Common Stock pursuant to a Stock Option or other Award under the Plan to represent to and agree with the Company in writing that the Participant is acquiring the shares without a view to distribution thereof. In addition to any legend required by the Plan, the certificates for such shares (if any) may include any legend that the Committee deems appropriate to reflect any restrictions on Transfer. All certificates for shares of Common Stock (to the extent such shares are certificated) delivered under the Plan shall be subject to such stop transfer orders and other restrictions as the Committee may deem advisable under the rules, regulations and other requirements of the Commission, any stock exchange upon which the Common Stock is then listed or any national securities exchange system or over-the-counter market upon whose system the Common Stock is then quoted, any applicable federal or state securities law, and any applicable corporate law, and the Committee may cause a legend or legends to be put on any such certificates to make appropriate reference to such restrictions.
13.2 Other Plans. Nothing contained in the Plan shall prevent the Board from adopting other or additional compensation arrangements, subject to stockholder approval if such approval is required, and such arrangements may be either generally applicable or applicable only in specific cases.
13.3 No Right to Employment/Directorship/Consultancy. Neither the Plan nor the grant of any Option or other Award hereunder shall give any Participant or other employee, Consultant or Non-Employee Director any right with respect to continuance of employment, consultancy or directorship by the Company or any Affiliate, nor shall the Plan nor the grant of any Option or other Award hereunder limit in any way the right of the Company or any Affiliate by which an employee is employed or a Consultant or Non-Employee Director is retained to terminate such employment, consultancy or directorship at any time.
13.4 Withholding of Taxes. The Company shall have the right to deduct from any payment to be made pursuant to the Plan, or to otherwise require, prior to the issuance or
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 delivery of shares of Common Stock or the payment of any cash hereunder, payment by the Participant of, any federal, state or local taxes required by law to be withheld. Upon the vesting of Restricted Stock (or other Award that is taxable upon vesting), or upon making an election under Section 83(b) of the Code, a Participant shall pay all required withholding to the Company. Any minimum statutorily required withholding obligation with regard to any Participant may be satisfied, subject to the consent of the Committee, by reducing the number of shares of Common Stock otherwise deliverable or by delivering shares of Common Stock already owned. Any fraction of a share of Common Stock required to satisfy such tax obligations shall be disregarded and the amount due in respect of such fraction of a share shall be paid instead in cash by the Participant.
13.5 No Assignment of Benefits. No Award or other benefit payable under the Plan shall, except as otherwise specifically provided by law or permitted by the Committee, be Transferable in any manner, and any attempt to Transfer any such benefit shall be void, and any such benefit shall not in any manner be liable for or subject to the debts, contracts, liabilities, engagements or torts of any person who shall be entitled to such benefit, nor shall it be subject to attachment or legal process for or against such person.
13.6 Listing and Other Conditions.
(a) Unless otherwise determined by the Committee, as long as the Common Stock is listed on a national securities exchange, system sponsored by a national securities association or recognized over-the-counter market, the issuance of shares of Common Stock pursuant to an Award shall be conditioned upon such shares being listed on such exchange, system or market. The Company shall have no obligation to issue such shares unless and until such shares are so listed, and the right to exercise any Option or other Award with respect to such shares shall be suspended until such listing has been effected.
(b) If at any time counsel to the Company shall be of the opinion that any sale or delivery of shares of Common Stock pursuant to an Option or other Award is or may in the circumstances be unlawful or result in the imposition of excise taxes on the Company under the statutes, rules or regulations of any applicable jurisdiction, the Company shall have no obligation to make such sale or delivery, or to make any application or to effect or to maintain any qualification or registration under the Securities Act or otherwise, with respect to shares of Common Stock or Awards, and the right to exercise any Option or other Award shall be suspended until, in the opinion of said counsel, such sale or delivery shall be lawful or will not result in the imposition of excise taxes on the Company.
(c) Upon termination of any period of suspension under this Section 13.6, any Award affected by such suspension which shall not then have expired or terminated shall be reinstated as to all shares available before such suspension and as to shares which would otherwise have become available during the period of such suspension, but no such suspension shall extend the term of any Award.
(d) A Participant shall be required to supply the Company with certificates, representations and information that the Company requests and otherwise cooperate with the
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 Company in obtaining any listing, registration, qualification, exemption, consent or approval the Company deems necessary or appropriate.
13.7 Governing Law. The Plan and actions taken in connection herewith shall be governed and construed in accordance with the laws of the State of Delaware (regardless of the law that might otherwise govern under applicable Delaware principles of conflict of laws).
13.8 Jurisdiction; Waiver of Jury Trial. Any suit, action or proceeding with respect to the Plan or any Award Agreement, or any judgment entered by any court of competent jurisdiction in respect of any thereof, shall be resolved only in the courts of the State of Delaware or the United States District Court for the District of Delaware and the appellate courts having jurisdiction of appeals in such courts. In that context, and without limiting the generality of the foregoing, the Company and each Participant shall irrevocably and unconditionally (a) submit in any proceeding relating to the Plan or any Award Agreement, or for the recognition and enforcement of any judgment in respect thereof (a “Proceeding”), to the exclusive jurisdiction of the courts of the State of Delaware, the court of the United States of America for the District of Delaware, and appellate courts having jurisdiction of appeals from any of the foregoing, and agree that all claims in respect of any such Proceeding shall be heard and determined in such Delaware State court or, to the extent permitted by law, in such federal court, (b) consent that any such Proceeding may and shall be brought in such courts and waives any objection that the Company and each Participant may now or thereafter have to the venue or jurisdiction of any such Proceeding in any such court or that such Proceeding was brought in an inconvenient court and agree not to plead or claim the same, (c) waive all right to trial by jury in any Proceeding (whether based on contract, tort or otherwise) arising out of or relating to the Plan or any Award Agreement, (d) agree that service of process in any such Proceeding may be effected by mailing a copy of such process by registered or certified mail (or any substantially similar form of mail), postage prepaid, to such party, in the case of a Participant, at the Participant’s address shown in the books and records of the Company or, in the case of the Company, at the Company’s principal offices, attention General Counsel, and (e) agree that nothing in the Plan shall affect the right to effect service of process in any other manner permitted by the laws of the State of Delaware.
13.9 Construction. Wherever any words are used in the Plan or an Award Agreement in the masculine gender they shall be construed as though they were also used in the feminine gender in all cases where they would so apply, and wherever words are used herein in the singular form they shall be construed as though they were also used in the plural form in all cases where they would so apply.
13.10 Other Benefits. No Award granted or paid out under the Plan shall be deemed compensation for purposes of computing benefits under any retirement plan of the Company or its Affiliates nor affect any benefit under any other benefit plan now or subsequently in effect under which the availability or amount of benefits is related to the level of compensation.
13.11 Costs. The Company shall bear all expenses associated with administering the Plan, including expenses of issuing Common Stock pursuant to Awards hereunder.

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13.12 No Right to Same Benefits. The provisions of Awards need not be the same with respect to each Participant, and such Awards to individual Participants need not be the same in subsequent years.
13.13 Death/Disability. The Committee may in its discretion require the transferee of a Participant to supply it with written notice of the Participant’s death or Disability and to supply it with a copy of the will (in the case of the Participant’s death) or such other evidence as the Committee deems necessary to establish the validity of the transfer of an Award. The Committee may also require that the agreement of the transferee to be bound by all of the terms and conditions of the Plan and the applicable Award Agreement.
13.14 Section 16(b) of the Exchange Act. All elections and transactions under the Plan by persons subject to Section 16 of the Exchange Act involving shares of Common Stock are intended to comply with any applicable exemptive condition under Rule 16b-3. The Committee may establish and adopt written administrative guidelines, designed to facilitate compliance with Section 16(b) of the Exchange Act, as it may deem necessary or proper for the administration and operation of the Plan and the transaction of business thereunder.
13.15 Section 409A of the Code. The Plan is intended to comply with the applicable requirements of Section 409A of the Code and shall be limited, construed and interpreted in accordance with such intent. To the extent that any Award is subject to Section 409A of the Code, it shall be paid in a manner that will comply with Section 409A of the Code, including proposed, temporary or final regulations or any other guidance issued by the Secretary of the Treasury and the Internal Revenue Service with respect thereto. Notwithstanding anything herein to the contrary, any provision in the Plan that is inconsistent with Section 409A of the Code shall be deemed to be amended to comply with Section 409A of the Code and to the extent such provision cannot be amended to comply therewith, such provision shall be null and void. The Company shall have no liability to a Participant, or any other party, if an Award that is intended to be exempt from, or compliant with, Section 409A of the Code is not so exempt or compliant or for any action taken by the Committee or the Company and, in the event that any amount or benefit under the Plan becomes subject to penalties under Section 409A of the Code, responsibility for payment of such penalties shall rest solely with the affected Participants and not with the Company. Notwithstanding any contrary provision in the Plan or Award Agreement, any payment(s) of “nonqualified deferred compensation” (within the meaning of Section 409A of the Code) that are otherwise required to be made under the Plan to a “specified employee” (as defined under Section 409A of the Code) as a result of such employee’s separation from service (other than a payment that is not subject to Section 409A of the Code) shall be delayed for the first six (6) months following such separation from service (or, if earlier, the date of death of the specified employee) and shall instead be paid (in a manner set forth in the Award Agreement) upon expiration of such delay period.
13.16 Successors and Assigns. The Plan and any applicable Award Agreement(s) shall be binding on all successors and permitted assigns of a Participant, including, without limitation, the estate of such Participant and the executor, administrator or trustee of such estate.

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13.17 Severability of Provisions. If any provision of the Plan or any Award Agreement shall be held invalid or unenforceable, such invalidity or unenforceability shall not affect any other provisions hereof, and the Plan and/or Award Agreement shall be construed and enforced as if such provisions had not been included.
13.18 Payments to Minors, Etc. Any benefit payable to or for the benefit of a minor, an incompetent person or other person incapable of receipt thereof shall be deemed paid when paid to such person’s guardian or to the party providing or reasonably appearing to provide for the care of such person, and such payment shall fully discharge the Committee, the Board, the Company, its Affiliates and their officers, directors/managers, employees, agents and representatives with respect thereto.
13.19 Lock-Up Agreement. As a condition to the grant of an Award, if requested by the Company and the lead underwriter of any public offering of Common Stock (the “Lead Underwriter”), a Participant shall irrevocably agree not to sell, contract to sell, grant any option to purchase, transfer the economic risk of ownership in, make any short sale of, pledge or otherwise transfer or dispose of, any interest in any Common Stock or any securities convertible into, derivative of, or exchangeable or exercisable for, or any other rights to purchase or acquire Common Stock (except Common Stock included in such public offering or acquired on the public market after such offering) during such period of time following the effective date of a registration statement of the Company filed under the Securities Act that the Lead Underwriter shall specify (the “Lock-Up Period”). The Participant shall further agree to sign such documents as may be requested by the Lead Underwriter to effect the foregoing and agree that the Company may impose stop-transfer instructions with respect to Common Stock acquired pursuant to an Award until the end of such Lock‐Up Period.
13.20 Headings and Captions. The headings and captions herein are provided for reference and convenience only, shall not be considered part of the Plan, and shall not be employed in the construction of the Plan.
13.21 Section 162(m) of the Code. Notwithstanding any other provision of the Plan to the contrary, the provisions of the Plan requiring compliance with Section 162(m) of the Code shall not apply to Awards granted under the Plan that are not intended to qualify as “performance-based compensation” under Section 162(m) of the Code.
13.22 Company Recoupment of Awards. A Participant’s rights with respect to any Award hereunder shall in all events be subject to (i) any right that the Company may have under any Company recoupment policy or other agreement or arrangement with a Participant, or (ii) any right or obligation that the Company may have regarding the clawback of “incentive-based compensation” under Section 10D of the Exchange Act and any applicable rules and regulations promulgated thereunder from time to time by the Commission.
ARTICLE XIV
EFFECTIVE DATE OF PLAN

The Plan shall become effective upon its adoption by the Board.

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ARTICLE XV
TERM OF PLAN

No Award shall be granted pursuant to the Plan on or after the tenth anniversary of the earlier of the date that the Plan is adopted or the date of stockholder approval, but Awards granted prior to such tenth anniversary may extend beyond that date; provided that no Award (other than a Stock Option) that is intended to be “performance-based compensation” under Section 162(m) of the Code shall be granted on or after the fifth anniversary of the stockholder approval of the Plan unless the Performance Goals are re-approved (or other designated Performance Goals are approved) by the stockholders no later than the first stockholder meeting that occurs in the fifth year following the year in which stockholders approve the Performance Goals. For purposes of the Plan, approval by the bankruptcy court shall serve as stockholder approval, unless otherwise prohibited by law.
ARTICLE XVI
NAME OF PLAN

The Plan shall be known as the “SandRidge Energy, Inc. 2016 Omnibus Incentive Plan.”

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EXHIBIT A
 
PERFORMANCE GOALS

To the extent permitted under Section 162(m) of the Code, performance goals established for purposes of Awards intended to be “performance-based compensation” under Section 162(m) of the Code, shall be based on the attainment of certain target levels of, or a specified increase or decrease (as applicable) in one or more of the following:

•    Production growth; 
•    Reserve growth; 
•    Reserve replacement; 
•    Lease operating expense; 
•    Revenue growth; 
•    Finding/development costs; 
•    Net sales; 
•    Operating income; 
•    Pre- or after-tax income; 
•    Operating profit minus capital charges; 
•    Cash flow, including operating cash flow, free cash flow, cash flow return on equity and cash flow return on investment; 
•    Net income; 
•    Earnings per share; 
•    Earnings before interest and taxes; 
•    Earnings before interest, taxes, depreciation and/or amortization; 
•    Return on equity; 
•    Return on invested capital; 
•    Return on assets; 
•    Economic value added (or an equivalent measure); 
•    Share price performance; 
•    Total stockholder return;
•    Improvement in or achievement of expense levels; 
•    Improvement in or achievement of working capital levels; 
•    Innovation as measured by a percentage of sales of new products; 
•    Market share; 
•    Productivity ratios; 
•    Completion and/or integration of acquisitions of businesses or companies; 
•    Completion of divestitures and asset sales; and 
•    Any combination of any of the foregoing business criteria.
With respect to Awards that are intended to qualify as “performance-based compensation” under Section 162(m) of the Code, to the extent permitted under Section 162(m) of the Code, the Committee may, in its sole discretion, also exclude, or adjust to reflect, the impact of an event or occurrence that the Committee determines should be appropriately excluded or adjusted, including:

A-1

(a) restructurings, discontinued operations, extraordinary items or events, and other unusual or non-recurring charges as described in Accounting Standards Codification 225-20, “Extraordinary and Unusual Items,” and/or management’s discussion and analysis of financial condition and results of operations appearing or incorporated by reference in the Company’s Form 10-K for the applicable year;
(b) an event either not directly related to the operations of the Company or not within the reasonable control of the Company’s management; 
(c) a change in tax law or accounting standards required by generally accepted accounting principles; or 
(d) a decision to accelerate or defer capital expenditures or expenses contrary to the timing reflected in the Company’s annual financial plan.
Performance goals may also be based upon individual participant performance goals, as determined by the Committee, in its sole discretion. In addition, Awards that are not intended to qualify as “performance-based compensation” under Section 162(m) of the Code may be based on the performance goals set forth herein or on such other performance goals as determined by the Committee in its sole discretion or without regard to any performance goals.
In addition, such performance goals may be based upon the attainment of specified levels of Company (or subsidiary, division, other operational unit, administrative department or product category of the Company) performance under one or more of the measures described above relative to the performance of one or more other companies or one or more groups of companies (e.g. an index). With respect to Awards that are intended to qualify as “performance-based compensation” under Section 162(m) of the Code, to the extent permitted under Section 162(m) of the Code, but only to the extent permitted under Section 162(m) of the Code (including, without limitation, compliance with any requirements for stockholder approval), the Committee may also:
(a) designate additional business criteria on which the performance goals may be based; or
(b) adjust, modify or amend the aforementioned business criteria.

A-2

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