EX-10.15



 Exhibit 10.15 
  

			
	*Portions of this exhibit marked [*] are requested to be treated confidentially.	 	OMB Approval 0990-0115      

  

																																															
	 AWARD/CONTRACT
  
	 	
1.  THIS CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 350)
	 	u	 	 RATING
	 	 PAGE    OF    PAGES

	 	 	 	   N/A
	 	 1
	 	   119   
	 2. CONTRACT (Proc. Inst. Indent.) NO.
	 	 3. EFFECTIVE DATE
	 	 4. REQUISITION/PURCHASE REQUEST/PROJECT NO.

	HHSO100201300009C	 	   See Block 20C.	 	  OS111976
	   5.  ISSUED BY	 	CODE	 	 	 	 	 	 	 	 	 	 	 	 6. ADMINISTERED BY (If other than Item 6)
	 		 	CODE 	 	 	 	 
	 Office of Acquisitions Management, Contracts, and Grants
(AMCG)
 330 Independence Ave., S.W. Room G640
 Washington, D.C. 20201
  
  
	 	 	 	 	 	See Block 5.	 	 	 	 	 	 	 	 	 	 
	 7. NAME AND ADDRESS OF CONTRACTOR (No. street, county, state
and ZIP Code) 
	 	 8. DELIVERY

	  
 CEMPRA,
Inc.
 Building 4 Quadrangle
  
	 	  
   See
Schedule.

	 6340 Quadrangle Drive, Suite 100

Chapel Hill, NC 27517
  
  
	 	 9/ DISCOUNT FOR PROMPT PAYMENT
   N/A.

	CAGE:
4D2L7                                TIN: 45-4440364	 	 10. SUBMIT INVOICES

 
	 	ITEM
	CODE DUNS No. 623713034	 	FACILITY CODE	 	ADDRESS SHOWN IN:	 	See Section G.
	   11.  SHIP TO/MARK FOR	 	CODE	 	  N/A	 	 	 	12.  PAYMENT WILL BE MADE BY	 	CODE	 	N/A
	  

    See Block 5.
  
	 	 	 	  
   See Block
5.
  

	 13. AUTHORITY FOR USING OTHER FULL AND OPEN COMPETITION:    N/A
	 	 	 	 14. ACCOUNTING AND APPROPRIATION DATA

  Appropriation Year: 2013; Object Class:25106; CAN# 1992002  $17,710,427.25

	     ̈  10 U.S.C.
2304(c)(    )              
 ̈  41
 U.S.C. 253(c)(    )
  
	 	 	 
	15A. ITEM NO.	 	15B. SUPPLIES/SERVICES	 	 	 	15C. UNIT PRICE 	 	15D. AMOUNT 	 	15E. UNIT PRICE 	 	15F. AMOUNT 
	  
 See Section
B.
  
  

 
	 	 	 	 	 	 	 	 	 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	15G. TOTAL AMOUNT OF
CONTRACT            
u	 	$17,710,427.25
	16. TABLE OF CONTENTS
	(ü
) 	 	SEC. 	 	DESCRIPTION	 	PAGE(S) 	 	 	 	(ü
)	 	SEC. 	 	DESCRIPTION	 	PAGE(S)
	PART I - THE SCHEDULE	 	 	 	PART II - CONTRACT CLAUSES
	x
 	 	A	 	SOLICITATION/CONTRACT FORM	 	1	 	 	 	x
	 	I	 	CONTRACT CLAUSES	 	57
	x
 	 	B	 	SUPPLIES OR SERVICES AND PRICE/COST	 	3	 	 	 	PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
	x
 	 	C	 	DESCRIPTION / SPECS / WORK STATEMENT	 	11	 	 	 	x
	 	J	 	LIST OF ATTACHMENTS	 	63
	x
 	 	D	 	PACKAGING AND MARKING	 	13	 	 	 	PART IV - REPRESENTATIONS AND INSTRUCTIONS
	x
 	 	E	 	INSPECTION AND ACCEPTANCE	 	14	 	 	 	x
	 	K	 	REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS	 	64
	x
 	 	F	 	DELIVERIES OR PERFORMANCE	 	15	 	 	 	 	 	 
	x
 	 	G	 	CONTRACT ADMINISTRATION DATA	 	33	 	 	 	 ̈
	 	L	 	INSTRS., CONDS., AND NOTICES TO OFFERORS	 	 
	x
 	 	H	 	SPECIAL CONTRACT REQUIREMENTS	 	39	 	 	 	 ̈
	 	M	 	EVALUATION FACTORS FOR AWARD	 	 
	CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE
	 17.  x  
CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is required to sign this document and return   1    copies to issuing office.) Contractor agrees to furnish and deliver all items or perform all the services
set forth or otherwise identified above and on any continuation sheets for the consideration stated herein. The rights and obligations of the parties to this contract shall be subject to and governed by the following documents: (a) this
award/contract, (b) the solicitation, if any, and (c) such provisions, representations, certifications, and specifications, as are attached or incorporated by reference herein. (Attachments are listed herein.)

 
	 	 	 	 18.   ̈  AWARD (Contractor is not required to sign this document.) Your offer 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 listed above and on any continuation sheets. This award consummates the contract which consists of the following documents: (a) the Government’s solicitation and your offer, and (b) this award/contract. No further contractual document
is necessary.

	   19A.  NAME AND TITLE OF SIGNER  (Type or print)	 		 	20A.  NAME OF CONTRACTING OFFICER
	 	 	 	 	 	 	  

   Susan Cortes-Shrank   AMCG,  ASPR,  OS,  DHHS

 
  

	 19B.  NAME OF CONTRACTOR	 	19C.  DATE SIGNED	 		 	20B.  UNITED STATES OF AMERICA	 	 	 	20C. DATE SIGNED
		 	 	 	 	 		 		 		 		 	  
 BY
	 	  
  
	 	 	 		 	
	(Signature of person authorized to sign)	 	 	 	 	 	 	 	 	 	 	 	(Signature of Contracting Officer)	 	 	 	 	 	 


							
	 NSN 7540-01-152-8069	 	26-107	 	STANDARD FORM 26 (REV. 4-85)	 	
	 PREVIOUS EDITION UNUSABLE	 	Computer Generated	 	Prescribed by GSAFAR (48 CFR) 53.214(a)	 	








 CONTRACT TABLE OF CONTENTS 

 

					
	 PART I – THE SCHEDULE
	  	 	3	  
		
	 SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS
	  	 	3	  
		
	 SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT
	  	 	11	  
		
	 SECTION D - PACKAGING, MARKING AND SHIPPING
	  	 	13	  
		
	 SECTION E - INSPECTION AND ACCEPTANCE
	  	 	14	  
		
	 SECTION F - DELIVERIES OR PERFORMANCE
	  	 	15	  
		
	 SECTION G - CONTRACT ADMINISTRATION DATA
	  	 	32	  
		
	 SECTION H - SPECIAL CONTRACT REQUIREMENTS
	  	 	38	  
		
	 PART II – CONTRACT CLAUSES
	  	 	56	  
		
	 SECTION I - CONTRACT CLAUSES
	  	 	56	  
		
	 PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS
	  	 	62	  
		
	 SECTION J - LIST OF ATTACHMENTS
	  	 	62	  
		
	 PART IV – REPRESENTATIONS AND INSTRUCTIONS
	  	 	63	  
		
	 SECTION K – REPRESENTATIONS, CERTIFICATIONS, AND OTHER STATEMENTS OF OFFERORS
	  	 	63	  


  
 2 








 PART I – THE SCHEDULE 
 SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS 
 ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR
SERVICES 
 This contract is for the development of Solithromycin (CEM-101), a novel fluoroketolide antibiotic of the macrolide class
for the treatment of select bacterial infections. The Research and Development (R&D) effort will progress in specific stages that cover the base performance segment and four (4) option segments as specified in this contract. Work performed
during the base segment and during each option segment constitutes an independent, non-severable discrete work segment that cannot be subdivided for separate performance and is necessary to support R&D tasks related to the antibiotic. Each
non-severable, 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 will be authorized to begin. 
 The government has determined a Bona Fide
Need for each 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 must achieve a defined end-product required in each
discrete work segment, as outlined in Article F of this contract, before the Government will consider exercising any of the follow-on option segment(s). The Contractor’s success in completing the required tasks under each work segment must be
demonstrated through 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 GO/NO GO Contract Milestones and Decision
Gates will constitute the basis for the Government’s decision, at its sole discretion, to exercise any follow-on option segment(s). 

The base and option segments under Contract Line Items (CLINs) 0001 through 0005 are event driven work segments rather than time driven
CLINs. The funds for each independent, non-severable discrete work segment [requirement], regardless of duration, are separated by CLIN, and shall only be used for the scope of work covered in each discrete work segment (Attachment J). 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 extended to complete the tasks required under each work segment. It is possible
that more than one independent, non-severable discrete work segment [requirement], may be awarded at one time and that individual CLINs may overlap and/or proceed concurrently. 
 ARTICLE B.2. ESTIMATED COST AND FIXED FEE 
  

	 	a.	The total estimated cost of the base performance segment is $[*] 


	 	b.	The total fixed fee for the base performance segment is $[*]. The fixed fee shall be paid subject to Allowable Cost and Payment and Fixed Fee Clauses.



	 	c.	The total amount of the base performance segment, CLIN 0001, represented by the sum of the total estimated cost plus fixed fee is
$17,710,427.25. 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.



	 	d.	It is estimated period of performance of the base performance segment is through May 23, 2015. 


  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 3 









	 	e.	The Contractor shall maintain records of all contract costs and such records shall be subject to the Audit and Records-Negotiation and Final Decisions on Audit Findings clauses
of the General Clauses. 

  

											
	CLIN	  	Estimated
Period of
Performance  	  	Supplies/Services	 	  Total Estimated  

Cost	 	  Fixed Fee  	  	
Total Estimated

Cost Plus

Fixed Fee

	 0001
	  	24 May 2013 through 23 May 2015.	  	 Toxicology studies, PK/PD modeling, safety studies, animal model efficacy studies, select chemical
synthesis activities
  
 Reports and Other Data Deliverables.
	 	  $[*]	 	  $[*]	  	 $17,710,427.25

 
 SOW Reference
 1.2.2, 1.3.2, 1.4.1, 1.5.1, 1.5.2, 1.6.1, 1.6.2, 1.6.3, 1.6.5


 ARTICLE B. 3. OPTION PRICES 
  

	 	a.	Unless the government exercises its option pursuant to the option clause contained in ARTICLE I.2, the contract consists only of the Base Work segment specified in the Statement
of Work as defined in SECTONS C, for the price set forth in ARTICLE B.2 of the contract. 


	 	b.	Pursuant to FAR Clause 52.217-9 (Option to Extend the Term of the Contract), the Government may, by unilateral contract modification, require the Contractor to perform the Option
Work Segments specified in the Statement of Work as defined in SECTIONS C and F of this contract. If the Government exercises the/these option(s), written notice must be given to the Contractor within 30 days after the Government has completed its
analysis of the deliverables associated with the applicable GO/NO GO Decision gate; and the Government must give the Contractor a preliminary written notice of its intent to exercise the option at least 30 days before the contract expires.
Specific information regarding the time frame for this notice is set forth in the OPTION CLAUSE Article in SECTION G of this contract. The estimated cost of the contract will be increased as set forth below: 


OPTIONS 
 Option 1
(CLIN 0002) - CPFF 
 Option 2 (CLIN 0003) - CPFF 
 Option 3 (CLIN 0004) – Cost Share (Fee unallowable) 
 Option 4 (CLIN 0005) - CPFF 

 

											
	CLIN	  	Estimated
Period of
Performance  	  	Supplies/Services	 	
  Total Estimated  
 Cost
	 	  Fixed Fee  	  	
Total Estimated

Cost Plus

Fixed Fee

	 0002
	  	 24 May 2014 through 5

June 2016.
	  	 [*]
  

Reports and Other Data Deliverables.
	 	  $[*]	 	  $[*]	  	 $[*]

 
 SOW Reference
 2.4.1, 2.4.2, 2.5.2, 2.6.3, 2.6.5

	 0003
	  	14 November 2015 through 27 March 2017.	  	 [*]

Reports and Other Data Deliverables.
	 	$[*]	 	$[*]	  	 $[*]

 
 SOW Reference
 3.3.3, 3.4.1, 3.5.2, 3.6.3, 3.6.5

	 0005
	  	9 November 2017 through 23 May 2018.	  	 [*]
  

Reports and Other Data Deliverables.
	 	$[*]	 	$[*]	  	 $[*]

 
 SOW Reference
 5.5.2;



  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 4 









											
	Cost  
Share  
CLIN 
 	  	Estimated
Period of
Performance	  	Supplies/Services	 	
  Total Estimated  
 Cost of CLIN
0004
	 	
  Total Estimated  
 Cost CEMPRA
share
	  	Total Estimated
Cost 
Government
Share
	
0004  
	  	28 March 2015   through 23 May 2018.	  	 [*]
  

Reports and Other Data Deliverables.
	 	$[*]  	 	$[*]  	  	 $[*]

 
 SOW Reference

 
 4.4.2,

 


 CLIN 0004 is a cost share CLIN and is subject to FAR Clause 52.216-12 

ARTICLE B. 4. PROVISIONS APPLICABLE TO DIRECT COSTS 
  

	a.	Items Unallowable Unless Otherwise Provided 


Notwithstanding the clauses, ALLOWABLE COST AND PAYMENT and FIXED FEE, incorporated in this contract, unless authorized in writing by the
Contracting Officer, 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 Contractor’s 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 scientific instruments or equipment over $1,500 

  

	 	5)	Travel to attend general scientific meetings/conferences; 


  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 5 









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

  

	 	7)	Overtime (premium) compensation 

  

	 	8)	Entering into certain types subcontract of arrangements (See Article B.5(c) for specific obligations). Note that most consulting agreements require a Contracting Officers
Authorization (COA). 

  

	 	9)	Foreign Travel; 

  

	 	10)	Patient care costs (see Attachment 6); 

  

	b.	Travel Costs 

  

	 	1.	Total expenditures for travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract during the base segment (CLIN001) or
any option segment(s) shall not exceed $[*] without the prior written approval of the Contracting Officer. 


If, pursuant to FAR Clause 52.217-9 (Option to Extend the Term of the Contract), the Government exercises an option, travel costs
for each CLIN shall not exceed the following schedule: 
 Option 1 (CLIN 0002) -  $[*] 

Option 2 (CLIN 0003) -  $[*] 

Option 3 (CLIN 0004) -  $[*] (BARDA share which excludes Cempra’s portion of travel costs for this Cost Share CLIN) 

Option 4 (CLIN 0005) -  $[*] 
  

	 	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 COA will be required. Expenditures for foreign travel (transportation, lodging, subsistence, and 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 Contracting Officer. 

 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 breakout of 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. 

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 6 








 ARTICLE B.5. ADVANCE UNDERSTANDINGS 

 

	 	a.	FDA Guidance 

 At the time of contract award,
dated May 20, 2013, specific guidance from the FDA associated with optional CLIN 0004 ([*]) in a pediatric population is not available. The Contractor will conduct a meeting with the FDA during the base period of performance (CLIN 0001) of the
contract to determine an appropriate strategy for obtaining approval of Solithromycin (CEM-101) for the treatment of Community Acquired Bacterial Pneumonia in pediatric populations. The GO/NO GO Contract Milestone #1 under Article F of this contract
outlines the specific end products that the Contractor must meet before the Government will consider exercising the follow-on option segment [CLIN0004]. Article F of this contract describes the Go Criteria for Milestone #1 as [*].

In the event that the FDA provides guidance that extrapolation of efficacy data from adult populations is sufficient to support a label indication
for a pediatric population without performing a pediatric efficacy study, activities described in the statement of work under attachment J, item 1 may be modified. 
 The contracting officer may request a modified statement of work for CLIN 0004 to align with the FDA guidance to ensure the Contractor can obtain relevant data to support submission of a NDA for their pediatric
indication. 
 Any contract modification to the statement of work under CLIN 0004 will not impact the percentage of cost sharing under
CLIN 0004 as agreed to by the Government and the Contractor prior to contract award. The Contractor to Government cost sharing distribution of [*]%:[*]% may not be renegotiated. 

The GO/NO GO Contract Milestones and Decision Gates will constitute the basis for the Government’s decision, at its sole discretion, to
exercise CLIN 0004. 
  

	 	b.	Man-in-Plant 

 With seven (7) days
advance notice to the Contractor in writing from the Contracting Officer, the Government may place a man-in-plant in the Contractor’s facility, 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. 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. 
  

	 	c.	Security Plan 

 No Security Plan is required
at this point for this effort. It is anticipated a security waiver will be approved. In the event a security waiver cannot successfully be attained, a security plan must be delivered to the Government subsequently. 

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 7 









	 	d.	Subcontracts and Consultants 

 Prior written
consent from the Contracting Officer in the form of Contracting Officer Authorization (COA) is required for any subcontract that is a cost-reimbursement type or fixed price and exceeds $[*]. 

Contracting Officer 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 Contracting Officer, a copy of the signed, executed subcontract and consulting agreement shall be provided to the Contracting Officer. 

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

  

	 	d.	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 site visits and inspections on an as needed basis, including collection of product samples
and intermediates held by the contractor, or subcontractor. In case of subcontractor visits and inspections that are independent of activities conducted by the Contractor, the USG shall demonstrate cause for such visit and/or inspection. All costs
reasonably incurred by the Contractor and subcontractor for such visit and/or inspection shall be allowed costs. The Contractor shall coordinate these visits and shall have the opportunity to accompany the USG on any such visits. Under
time-sensitive or critical situations, the USG reserves the right to suspend the 48 hour notice to the Contractor. The areas included under the site visit could include, but are not limited to: security, regulatory and quality systems, and
cGMP/GLP/GCP compliance. 
 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 BARDA for review and acceptance. 
  

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



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



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



QA AUDIT: 
 BARDA reserves the
right to participate in QA audits. 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 BARDA for review and acceptance. The Contractor shall provide responses from the
subcontractors to address these concerns and plans for corrective action execution. 
  

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




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



 

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

 See Attachment #2 for detailed requirements for Invoicing. 

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 8 








 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), breakdown by task performed by personnel, 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 greater than $1,500. 


	 	e.	Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately domestic travel, general scientific meeting travel, and
foreign travel. 


	 	f.	Consultant Fees - Identify individuals and amounts. 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 greater than $1,500. 


	 	j.	G&A - Cite rate and amount. 


	 	k.	Total Cost 


	 	l.	Fixed Fee 


	 	m.	Total CPFF 

 Monthly invoices must include the
cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government. In order to verify allowability, further breakdown of costs may be requested at the Government’s discretion. 

See Attachment #2 for detailed requirements for Invoicing 
  

	 	f.	Confidential Treatment of Sensitive Information 

 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 Contracting Officer. 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 Contracting Officer.
(See also HHSAR clause 352.224-70). 
 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; (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. 

  
 9 








 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 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. 
  

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

 In an effort to build a robust medical countermeasure pipeline through increased collaboration, BARDA may share technical deliverables with USG entities responsible for Medical Countermeasure Development. In
accordance with recommendations from the Public Health Emergency Medical Countermeasure Enterprise Review, agreements established in the Integrated Portfolio’s Portfolio Advisory Committee (PAC) Charter, Technology Transfer Agreements (TTA)
between BARDA and the Defense Threat Reduction Agency 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
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. 
  

	 	h.	Overtime Compensation 

 No overtime (premium) compensation is
authorized under the subject contract. Billing of actual hours is limited to total productive hours in a month. 

  
 10 








 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 set forth in SECTION J-List of Attachments, attached hereto and made a part of the contract. 

ARTICLE C.2. REPORTING REQUIREMENTS 
 Refer to ARTICLE F.2. for specific instructions regarding Reporting Requirements. 
 ARTICLE C.3.
EARNED VALUE MANAGEMENT SYSTEM (EVMS) IMPLEMENTATION REQUIREMENTS 
 The Contractor and BARDA agree that the EVMS implementation
requirements that are contained in this contract are limited to the implementation requirements outlined by the 7 Principles of Earned Value Management Tier 2 System Implementation Intent Guide contained in the Attachments (Section J) of the
contract. The total amount of this contract reflects the use of the 7 Principles of EVMS Implementation. Any EVMS implementation requirements that are beyond the intent of the 7 Principles of EVMS Implementation shall not proceed until the
Contracting Officer sends a written request for a proposal to the Contractor and a bilateral modification is issued to the contract for the purposes of incorporating the additional costs for the performance of these requirements into the contract.

 Refer to ARTICLE F.2. for specifics on EVMS deliverables. 
 ARTICLE C.4. PROJECT MEETING CONFERENCE CALLS ONCE EVERY TWO WEEKS 
 A teleconference call
between the Contracting Officer’s Representative and the Contractor’s Program Manager shall occur bi-weekly (every two weeks), or at the discretion of the U.S. 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 Contracting Officer’s Representative. 
 Contractor will be responsible for
preparing an agenda for the conference call and providing to BARDA no later than 2 business days prior to the scheduled conference call. 

ARTICLE C.5. PROJECT MEETINGS
 The Contractor shall participate in Project Meetings to coordinate the performance of the contract, as requested by the Contracting Officer’s Technical Representative. These meetings may include
face-to-face meetings with BARDA/AMCG in Washington, D.C. and 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 confidential or proprietary data) and USG personnel as required by the Contracting Officer’s Technical Representative in
order to facilitate review of contract activities. 

  
 11 









	 	a.	Kickoff Meeting 

 The Contractor shall
complete a Kickoff meeting within [*] days after contract award. Contractor shall provide an itinerary/agenda no later than 5 business days before meeting. 
  

	 	b.	Quarterly and Ad-Hoc Meetings 

 At the
discretion of BARDA, the Contractor shall participate in Project Meetings to coordinate the performance of the contract, as requested by the Contracting Officer’s Representative. These meetings may include face-to-face meetings with
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 confidential or proprietary data) and USG personnel as required by the Contracting Officer’s Representative in order to facilitate review of
contract activities. 
 Contractor shall provide itinerary/agenda at least 5 business days in advance of face-to-face meeting. 

ARTICLE C.6 SUBJECT INVENTION REPORTING REQUIREMENT 
 All reports and documentation required by FAR Clause 52.227-11, including, but not limited to: the invention disclosure report, the confirmatory license, and the Government support certification, shall be
directed to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract. See also FAR clause 52.227-11 (Patent Rights-Ownership by the
Contractor). 
 Reports and documentation submitted to the Contracting Officer shall be sent to the Contracting Officer 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. 

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 12 








 SECTION D – PACKAGING, MARKING AND SHIPPING 
 All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and
Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition. 
 Report
Deliverables 
 Unless otherwise specified by the Contracting Officer, delivery of reports to be furnished to the Government under this contract
(including invoices), shall be delivered to BARDA electronically along with a concurrent email notification to the Contracting Officer, Contract Specialist, and COR summarizing the electronic delivery. 

Delivery of physical reports to be furnished shall be addressed to the COR, CO, and CS (as defined in SECTION G – CONTRACT ADMINISTRATION DATA). 

  
 13 








 SECTION E – INSPECTION AND ACCEPTANCE 

 

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


  

	 	2.	For the purpose of this SECTON, the designated Contracting Officer’s Representative (COR) is the authorized representative of the Contracting Officer. The COR will assist in
resolving technical issues that arise during performance. The COR however is not authorized to change any contract terms or authorize any changes in the Statement of Work or modify or extend the period of performance, or authorize reimbursement of
any costs incurred during performance. 

  

	 	3.	Inspection and acceptance will be performed at: 


Biomedical Advanced Research and Development Authority/Office of Acquisition 

Management, Contracts, and Grants (AMCG) 
 Office of the Assistant Secretary for Preparedness and Response 
 U.S. Department of Health and Human
Services 
 330 Independence Avenue, S.W., Room G644 
 Washington, D.C. 20201 

  
 14 








 SECTION F – DELIVERIES OR PERFORMANCE 
 ARTICLE F.1. ESTIMATED PERIOD OF PERFORMANCE 
 Under CLIN 0001, the estimated period of
performance for the base performance segment of this contract shall be consistent with the dates set forth in ARTICLE B.2. If the Government exercises its option(s) pursuant to the Option Clauses in Article G.11 and Article I.2 of the contract, the
period of performance (PoP) will 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 performance of the work set forth in the Statement of Work, dated April 17, 2013
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 Contracting Officer, or the duly authorized representative, of the following items in accordance with the
stated delivery schedule: 
 The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract and the Statement
of Work set forth in SECTION J-List of Attachments will be required to be delivered in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract. All reports
identified below relate solely to the development activity funded under this contract:
  

	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 and CO. 

							
	CDRL#	 	Deliverable	 	Deliverable Description	 	Reporting Procedures and Due
Dates
	01	 	Kickoff Meeting	 	The Contractor shall complete a Kickoff meeting after contract award	 	  
 —         
   Within [*] days 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 3 business days after the meeting.

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

 

	02	 	 Quarterly

Meetings
	 	The Contractor shall hold recurring Program Review Meetings approximately every third
month. 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 provides Quarterly Status Report five business days prior to meeting. This report is an expanded version of the Monthly Status Report.

—            Contractor shall provide itinerary, agenda and meeting slides at least 5 business days in advance of the meeting.

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

—            Contractor provides meeting minutes to COR within 3 business days after the meeting.

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

 



  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 15 









							
	CDRL#	 	Deliverable	 	Deliverable Description	 	Reporting Procedures and Due
Dates
	03	 	Project Status meeting	 	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 (with CO concurrence) and distributes agenda prior to
meeting

—            Contractor provides meeting minutes to COR within 3 business days of the meeting

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

 

	04	 	 Monthly,

Quarterly & Annual Project Status Report/Annual Meeting
	 	 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), Performance Measurement Baseline Review report (PMBR), Earned Value Management (EVM), 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.  IMS updates

 6.  Provide updated EVM CPR

 7.  Estimated and Actual Expenses.

      a. 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 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.
	 	  

—            Monthly Reports shall be submitted on the 20th calendar day of each month or the next business day, with an Annual Report submitted on the 20th 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.

 
 —            Contractor provides Annual Project Status Report deliverables 5 business days
prior to meeting. A draft report including .ppt slides should be provided 5 business days prior to the meeting. The annual report should also include information from the annual meeting due 15 business days after the meeting.

—            COR approves (with CO concurrence) and distributes agenda no later than 2 business days in advance of meeting

—            COR approves (with CO concurrence) all meeting material no later than 2 business days in advance of meeting

—            Contractor provides meeting minutes within 5 business days of meeting

—            COR reviews, comments, and approves minutes within 10 business days of receipt

—            Contractor provides FINAL annual report within 15 business days after the conclusion of the annual meeting.

—            COR reviews, comments, and approves (with CO concurrence) FINAL Annual Report

—            BARDA and Contractor shall participate in an in-process review.

 



  
 16 









							
	CDRL#	 	Deliverable	 	Deliverable Description	 	Reporting Procedures and Due
Dates
	05	 	Earned Value Management (EVM) / Contract Performance Report (CPR)	 	 Contractor will provide a monthly Contract Performance Report (CPR)
Format 1 at an agreed upon reporting level using the BARDA provided WBS and a Variance Analysis Report (Format 5).
  
 The supplemental monthly CAP report shall contain, at the work package level, time phased budget (budgeted cost of work scheduled), earned value (budgeted cost of work performed), and actual costs of work performed
as captured in Contractor’s EVM systems. The Contractor shall provide a rationale in the package of its use of % complete as EVMS methodology or identity if any other EVMS methodology is being used.
	 	 —            Contractor shall provide
EVM/CPR as part of the Monthly Progress Report on the 20th day of the month
after the end of each month
 —            Contractor shall provide top level or key changes in baseline cost as a
result of anticipated cost savings or risks
 —            BARDA may request, on a monthly or ad hoc basis that the Contractor provide
raw data at a reporting level or lower level as BARDA deems necessary.
 —            Contractor must address,
in writing, all concerns raised by BARDA.
  

	06	 	Performance Measurement Baseline Review (PMBR)	 	 PMBR Report shall address each of the items listed below and be
cross-referenced to the IMP, WBS, SOW, and Risk Management Plan.
 1. Contractor provides baseline
proposal
 2. Responsibility Assignment Matrix

3. A description of the work scope through control account Work Authorization Documents and/or WBS Dictionary
down to the control account level
 4. Template for work packages

5. IMS with the inclusion of agreed major milestones and control account plans for all control
accounts
 6. Baseline revision documentation and program log(s) risk management plan
	 	 —            Due within 90 days of
contract award

—            Contractor shall provide baseline proposal .ppt briefing 10 business days prior to meeting

—            Contractor provides agenda to COR 2 business days in advance of meeting

—            COR approves (with CO concurrence) and distributes agenda no later than 2 business days in advance of meeting

—            COR approves (with CO concurrence) all meeting material no later than 2 business days in advance of meeting

—            Contactor provides minutes within 3 business days of the meeting

—            COR reviews and approves (with CO concurrence) minutes

—            BARDA will review documentation and provide written comments and questions to Contractor

  Contractor shall address BARDA’s comments and resubmit PMBR report for BARDA approval within 10 business
days.
  

	07	 	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

—            BARDA shall provide Contractor with a written list of concerns in response plan submitted

—            Contractor must address, in writing, all concerns raised by BARDA within 20 business days of Contractor’s receipt of BARDA’s
concerns.
  

	08	 	Deviation Notification and Mitigation Strategy	 	Process for changing IMS activities associated with cost and schedule as baselined at the PMBR. Contractor shall
notify BARDA of significant changes the IMS defined as increases in cost above [*]% for Go/No Go milestones or schedule slippage of more than [*] days, which would require a PoP extension. Contractor shall provide a high level management strategy
for risk mitigation.	 	 —            Due as
needed



  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 17 









							
	CDRL#	 	Deliverable	 	Deliverable Description	 	Reporting Procedures and Due
Dates
	09	 	Go/No-Go Decision Gate Presentation	 	Contractor shall provide a presentation detailing technical progress made towards completion of Go/No-Go decision
gate milestones following a prescribed template provided by BARDA prior to the IPR	 	 —            Contractor shall provide
presentation in .ppt format 10 business days prior to the In-Process Review (IPR)
 —            Contractor shall submit
written justification of progress towards satisfying Go/No-Go criteria
 —            After reviewing, BARDA COR
and CO will provide a written response.
  

	10	 	Incident Report	 	Contractor shall communicate and document all critical programmatic concerns, risks, or potential risks with
BARDA.	 	 —            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 BARDA within 5
business days.
  

	11	 	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 PoP. 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 PoP. 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 PoP and the Final Technical Progress Report on or before the completion date of the PoP.

—            Subcontractor prepared reports received by the Prime Contractor shall be submitted to the COR and CO for review and comment no later
than 5 business days after receipt by the prime contractor
 —            COR shall provide feedback on draft report within 10 business days of
receipt, which the Contractor shall consider incorporating into the Final Report
 —            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.
  

	12	 	Draft and Final Reports for Clinical and Non-Clinical Studies	 	  

Contractor shall provide Draft and Final Clinical/Non-Clinical Study Reports to BARDA 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 Prime Contractor shall be submitted to the Contracting Officer’s Representative (COR) and Contracting Officer (CO) for review and comment no later than 5 business days after receipt by Prime
Contractor.



  
 18 









							
	CDRL#	 	Deliverable	 	Deliverable Description	 	Reporting Procedures and Due
Dates
	 	 	 	 	 	 	 —            The Government shall
provide written comments to the Draft Final Report for Clinical and Non-Clinical Studies within 10 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
BARDA.

—            Contractor shall consider revising reports to address BARDA’s recommendations prior to FDA submission.

—            Final FDA submissions shall be provided to BARDA concurrently or no later than 1 business day after submission to the FDA.

 

	13	 	Standard Operating   Procedures  	 	The Contractor shall make internal and subcontractor Standard Operating Procedures (SOPs) available for review
electronically.	 	Upon request from the Contracting Officer Representative/Contracting Officer
	14	 	Manufacturing   Campaign Reports  	 	 Contractor shall provide Manufacturing Campaign Reports to BARDA for
review and comment prior to submission to FDA.
  
 The COR and CO reserve the right to
request within the PoP a non-proprietary Manufacturing Campaign Report for distribution within the USG.
	 	 —            Contractor will 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 BARDA.
 —            Contractor shall consider
revising reports to address BARDA’s concerns and/or recommendations prior to FDA submission.
 —            Final FDA submission shall
be submitted to BARDA concurrently or no later than 1 business day after submission to the FDA.
  

	15	 	FDA Correspondence  	 	The Contractor shall memorialize any correspondence related to this contract between Contractor and FDA and submit
to BARDA. 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.
  

	16	 	FDA Meetings  	 	The Contractor shall forward the dates and times of any meeting related to this contract 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 within 5 business days of receipt. All documents shall be duly marked as either “Draft” or
“Final”.
  



  
 19 









							
	CDRL#	 	Deliverable	 	Deliverable Description	 	Reporting Procedures and Due
Dates
	17	 	FDA Submissions	 	The Contractor shall provide BARDA the opportunity to review and comment upon all draft documents before submission
to the FDA. Contractor shall provide BARDA 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 BARDA at least 15 business days prior to FDA submission
 —            BARDA 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 BARDA
 —            The Contractor shall consider revising their documents to address
BARDA’s concerns and/or recommendations prior to FDA submission
 —            Final FDA submissions
shall be submitted to BARDA concurrently or no later than 1 calendar day of it submission to CDER.
  

	18	 	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 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.
  
	 	  

—            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.
 —            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 10 business days of audit report, Contractor shall provide CO with a plan for addressing areas of nonconformance, if any are
identified.
  

	19	 	QA Audit Reports	 	BARDA reserves the right to participate in QA audits. 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 BARDA. 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 CO and COR within 5 business days of report completion.

	20	 	BARDA Audit	 	Contractor shall accommodate periodic or ad hoc site visits by BARDA. 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 BARDA.	 	 —            If issues are identified
during the audit, Contractor shall submit a report to BARDA detailing the finding and corrective action(s) within 10 business days of the audit.
 —         
   CO and COR 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.



  
 20 









							
	CDRL#	 	Deliverable	 	Deliverable Description	 	Reporting Procedures and Due
Dates
	21	 	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 PoP 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 corrective action is recommended, the Contractor must address, in writing, concerns raised by BARDA

 

	22	 	 Animal Model or Other

Technology Transfer

Package
	 	Contractor shall provide Animal Model or Other Technology Transfer Package relevant data	 	  

—            Contractor shall provide package within 10 business days of CO or COR request.

 

	23	 	 Raw Data or

Data Analysis
	 	Contractor shall provide raw data or data analysis to BARDA upon request	 	 —            Contractor shall provide
data or data analysis to CO and COR within 20 business days of request.
  

	24	 	 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 and/or option(s) POP. 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/option) POP as addendum to the Quarterly Project Status Report
  

	25	 	Publications	 	Any manuscript or scientific meeting abstract containing data generated under this contract must be submitted to
BARDA for review prior to submission	 	 —Contractor must submit all manuscript or scientific meeting abstract to CO and COR within 20
business days for manuscripts and 10 business days for abstracts
 —Contractor must address in writing all concerns raised by BARDA

—            Final submissions shall be submitted to BARDA concurrently or no later than one (1) calendar day of its submission

 

	26	 	Press Releases	 	Contractor agrees to accurately and factually represent the work conducted under this contract in all press
releases	 	 —Contractor shall ensure that the CO has received and approved an advanced copy of any press
release to this contract not less than 5 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 submissions shall be submitted to BARDA concurrently or no later than one (1) calendar day of its submission.


 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 according to FAR regulation, unless permitted to do so by law or regulation. 

  
 21 









	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 SECTION J-List of
Attachments, attached hereto and made a part of the contract. 
  

	 	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 under this article. The format should 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 e-mail address; and the date of submission; The progress report shall conform to the requirements set
forth in the DELIVERIES Article in SECTION F of this contract. 

	 	—	 	 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. 



  
 22 









	 	 
a. This report shall also contain a narrative or table detailing whether there is a significant discrepancy (>[*]%) 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 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.




	 	—	 	 SECTION III: Earned Value Management Reporting: Contractor will provide a monthly Contract Performance Report (CPR) at an agreed upon reporting level (WBS level
3) using the BARDA provided WBS and a Variance Analysis Report. EVMS shall be applied to all Cost Plus Fixed Fee CLINs as part of the Integrated Master Project Plan following the Seven Principles of Earned Value Management. In accordance with FAR
52.215-2, Audit and Records-Negotiation, BARDA may request, on a quarterly or ad hoc basis that the Contractor provide raw data. BARDA may request additional data at a reporting level or at lower levels, as BARDA deems necessary.



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

  

	 	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 under ARTICLE F.2. 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; The progress report shall conform to the requirements set forth in the DELIVERIES Article in SECTION F of this contract. 

 

	 	—	 	 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). 



  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 23 









	 	—	 	 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 report shall also contain a narrative or table detailing whether there were discrepancies between estimated and actual expenses over the past year. Actual expenses should be broken down to the appropriate
WBS level. 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. 

	 	—	 	 SECTION IV: EARNED VALUE MANAGEMENT REPORTING - Contractor will provide a quarterly Contract Performance Report (CPR) at an agreed upon (WBS level 3) reporting
level using the BARDA provided WBS and a Variance Analysis Report. EVMS shall be applied to all Cost Plus Fixed Fee CLINs as part of the Integrated Master Project Plan following the Seven Principles of Earned Value Management. In accordance with FAR
52.215-2, Audit and Records-Negotiation, BARDA may request, on a quarterly or ad hoc basis that the Contractor provide raw data. BARDA may request additional data at a reporting level or at lower levels, as BARDA deems necessary.



 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 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. 

  

	 	3.	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. 

  

	 	4.	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. 


  
 24 








 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 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 Contracting Officer’s Representative comments and Contracting Officer 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 (not to exceed 200 words) 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. 
  

	 	vi.	Other Technical Reports 

  

	 	1.	Draft Report for Clinical and Non-Clinical Studies and Final Report for Clinical and Non-Clinical Studies 


 

	 	—	 	 The non-clinical and clinical trial reports shall follow the format of International Conference on Harmonization document ICH E3 “Guidelines on Structure
and Content of Clinical Study Reports” (http://www.pharmacontract.ch/support/su_ich_liste.htm) 



	 	—	 	 Draft Final Report for Clinical and Non-Clinical Studies funded by this contract will be submitted to the Contracting Officer’s Representative and
Contracting Officer (CO) for review and comment within the time frames set forth under this section of this contract (ARTICLE F.2.). 



	 	—	 	 Subcontractor prepared reports received by the Prime Contractor shall be submitted to the Contracting Officer’s Representative and Contracting Officer (CO)
for review and comment as set forth by the table in this Article. 



	 	—	 	 The Government shall provide written comments to the Draft Final Report for Clinical and Non-Clinical Studies in accordance with the dates set forth by the table
in this Article. 



	 	—	 	 The comprehensive Final Report for Clinical and Non-Clinical Studies will be submitted to the Contracting Officer and the Contracting Officer’s
Representative set forth by the table in this Article. The final version shall include or address the Contracting Officer’s Representative comments and Contracting Officer comments on the draft report. 



  
 25 









	 	2.	Supplemental Technical Documents 

 Upon
request, Contractor shall provide CO and COR with the following contract funded documents as specified below but not limited to: Process Development Reports; Assay Qualification Plan/Report, Assay Validation Plan/Report, Assay Technology Transfer
Report, Batch Records, Contractor/Subcontractor Standard Operating Procedures (SOP’s), 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 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 BARDA 
  

	 	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 within 3 business days of
receipt. All documents shall be duly marked as either “Draft” or “Final”. 


  

	 	ii.	FDA Submissions 

 The Contractor shall
provide BARDA all documents submitted to the FDA. Contractor shall provide BARDA with an electronic copy of the final FDA submission. All documents shall be duly marked as either “Draft” or “Final”. 

 

	 	—	 	 If draft documents are submitted for BARDA review, BARDA will provide feedback to Contractor within 10 business days of receipt. 



	 	—	 	 If BARDA reviews draft documents, the Contractor shall consider revising their documents to address BARDA’s concerns and/or recommendations prior to FDA
submission. 



	 	—	 	 Final FDA submissions shall be submitted to BARDA concurrently or no later than 24 hours 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). The 

  
 26 








 
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. 
  

	 	—	 	 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. 



	 	—	 	 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 3
business days of receiving correspondence from the FDA, Subcontractor, or third party. 



	 	—	 	 Within 10 business days of audit report, Contractor shall provide CO with a plan for addressing areas of nonconformance, if any are identified.




	 	iv.	Manufacturing Campaign Reports 

 Contractor
shall provide Manufacturing Campaign Reports to BARDA for review and comment prior to submission to FDA. 
 The COR and CO reserve the
right to request within the Period of Performance (PoP) a non-proprietary Manufacturing Campaign Report for distribution within the USG. 
  

	 	—	 	 Contractor will 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 BARDA. 



	 	—	 	 Contractor shall consider revising reports to address BARDA’s concerns and/or recommendations prior to FDA submission. 



	 	—	 	 Final FDA submission shall be submitted to BARDA concurrently or no later than 1 business day after submission to the FDA. 



 

	 	v.	Other FDA Correspondence 

 The Contractor
shall memorialize any correspondence between Contractor and FDA and submit to BARDA. All documents shall be duly marked as either “Draft” or “Final.” Contractor shall provide written summary of any FDA correspondence within 3
business days of correspondence. 
  

	C.	Earned Value Management (EVM) Deliverables 

  

	 	i.	Earned Value Management (EVM) / Contract Performance Report (CPR) 

 Contractor will provide a monthly CPR at an agreed upon reporting level using WBS and Variance Analysis report formats agreed upon by BARDA. 
 The supplemental monthly Control Account Plan (CAP) report shall contain, at the work package level, time phased budget (budgeted cost of work scheduled), earned value (budgeted cost of work performed), and actual
costs of work performed as captured in Contractor’s EVM systems. The Contractor shall provide a rationale in the package of its use of % complete as EVMS methodology, or identity if any other EVMS methodology is being used. 

  
 27 









	 	—	 	 Contractor shall provide EVM/CPR as part of the Monthly Progress Report (this requirement begins only as set forth in the Contract Milestones & Related
Deliverables table, see Attachment #10) 



	 	—	 	 Contractor shall provide top level or key changes in baseline cost as a result of anticipated cost savings or risks 



	 	—	 	 BARDA may request, on a monthly or ad hoc basis that the Contractor provide raw data at a reporting level or lower level as BARDA deems necessary.




	 	—	 	 Contractor must address, in writing, all concerns raised by BARDA. 



	 	—	 	 Reporting will commence after the EVM system has been implemented but no later than 12 months after start of base period. 



 

	 	ii.	Integrated Master Plan (IMP) 

 The
Contractor shall provide an IMP including WBS, critical path milestones, and Earned Value Management Plan 
  

	 	—	 	 Contractor shall provide the draft IMP within [*] days of contract award with final due [*] months after award and updated monthly as part of the Monthly
Progress Report 



	 	—	 	 Contractor must address, in writing, all concerns raised by BARDA 



 

	 	iii.	Performance Measurement Baseline Review (PMBR) 

 PMBR Report shall address each of the items listed below and be cross-referenced to the IMP, WBS, SOW, and Risk Management Plan. 
  

	 	—	 	 Contractor provides baseline proposal 



	 	—	 	 Responsibility Assignment Matrix 



	 	—	 	 A description of the work scope through control account Work Authorization Documents and/or WBS Dictionary down to the agreed upon control account level.




	 	—	 	 Template for work packages 



	 	—	 	 Integrated Master Schedule (IMS) with the inclusion of agreed major milestones and control account plans for all control accounts 



	 	—	 	 Baseline revision documentation and program log(s) risk management plan 



	 	—	 	 PMBR is due within 90 days of contract award 



	 	—	 	 Contractor shall provide baseline proposal .ppt briefing 10 business days prior to meeting 



	 	—	 	 Contractor provides agenda to COR 2 business days in advance of meeting 



	 	—	 	 COR approves (with CO concurrence) and distributes agenda 



	 	—	 	 COR approves (with CO concurrence) all meeting material 



	 	—	 	 Contactor provides minutes with 2 business days of the meeting 



	 	—	 	 COR reviews and approves (with CO concurrence) minutes 



	 	—	 	 BARDA will review documentation and provide written comments and questions to Contractor 



	 	—	 	 Contractor shall address BARDA’s comments and resubmit PMBR report for BARDA approval within 10 business days. 



  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 28 









	 	iv.	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 



	 	¡	 	 BARDA shall provide Contractor with a written list of concerns in response plan submitted 



	 	¡	 	 Contractor must address, in writing, all concerns raised by BARDA within 20 business days of Contractor’s receipt of BARDA’s concerns.



  

	 	v.	Requirement for Notification of Deviation and Mitigation Strategy 

 Process for changing IMS activities associated with cost and schedule as baselined at the PMBR. Contractor shall notify BARDA of significant changes to the IMS defined as increases in cost above [*]% for Go/No Go
Milestones or schedule slippage of more than 30 days, which would require an extension to the period of performance. Contractor shall provide a high level management strategy for risk mitigation. Notice due within one (1) business day after
discovery. 

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 29 








 3.  Contract WBS Milestones & Related Deliverables 

 

													
	No.  	  	Milestone Definition	  	Go Criteria	  	No-Go Criteria	  	Deliverable	  	 WBS/

SOW#
	  	CLIN #
	1.	  	[*]	  	[*]	  	[*]	  	[*]	  	 1.5.1.1
  

1.5.1.2
	  	 Base

CLIN

0001

	2.	  	[*]	  	[*]	  	[*]	  	[*]	  	1.5.1.3	  	 Base
 CLIN
 0001

	3.	  	[*]	  	[*]	  	[*]	  	[*]	  	 1.3.2.3
  

1.3.2.4
	  	 Base

CLIN

0001

	4.	  	[*]	  	[*]	  	[*]	  	[*]	  	1.4.1.2	  	 Base
 CLIN
 0001

	5.	  	[*]	  	[*]	  	[*]	  	[*]	  	1.4.1.3	  	 Base

CLIN

0001

	6.	  	[*]	  	[*]	  	[*]	  	[*]	  	2.4.1.1	  	 Option 1
 CLIN

0002

	7.	  	[*]	  	[*]	  	[*]	  	[*]	  	2.5.2.2	  	 Option 1

CLIN

0002

	8.	  	[*]	  	[*]	  	[*]	  	[*]	  	 3.3.3.1

 
 3.3.3.2
	  	 Option 2
 CLIN

0003

	9.	  	[*]	  	[*]	  	[*]	  	[*]	  	3.3.3.3	  	 Option
2
 CLIN

0003




  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 30 









													
	No.  	  	Milestone Definition	  	Go Criteria	  	No-Go Criteria	  	Deliverable	  	 WBS/

SOW#
	  	CLIN #
	10.	  	[*]	  	[*]	  	[*]	  	[*]	  	3.5.2.2	  	 Option 2

CLIN

0003

	11.	  	[*]	  	[*]	  	[*]	  	[*]	  	 4.4.2.1

 
 5.5.2.1

 
 5.5.2.2
	  	 Option 3
 CLIN

0004

	12.	  	[*]	  	[*]	  	[*]	  	[*]	  	5.5.2.1	  	 Option 4

CLIN

0005

	13.	  	[*]	  	[*]	  	[*]	  	[*]	  	5.5.2.2	  	 Option 4
 CLIN

0005



 * If at any time during the contract performance period any of the above No-Go criteria are satisfied, the Government may
conduct an In-Process-Review (IPR) to evaluate whether to continue activities covered by the contract. This IPR will may occur within [*] calendar days of the No-Go criteria being satisfied. 

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 31 








 SECTION G - CONTRACT ADMINISTRATION DATA 
 ARTICLE G.1. CONTRACTING OFFICER 
 The following Contracting Officer (CO) will represent the Government for the
purpose of this contract: 
 Susan Cortés-Shrank, Contracting Officer 

DHHS/OS/ASPR/AMCG 
 330 Independence
Avenue, S.W. 
 Room G640 

Washington, D.C. 20201 
 E-mail:[*]

  

	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 COR designation. 

 The
following Contract Specialist (CS) assigned to this contract is: 
 Susan Cortés-Shrank, Contracting Officer 

DHHS/OS/ASPR/AMCG 
 330 Independence
Avenue, S.W. 
 Room G640 

Washington, D.C. 20201 
 E-mail: [*]

 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: 
 [*] 
 Contracting Officer’s Representative (COR) 
 Biomedical Advanced Research and Development Authority (BARDA) 
 Office of the Assistant Secretary for Preparedness and
Response (ASPR) 
 Department of Health and Human Services 

Mailing Address: 
 330 Independence Avenue, SW Room G640

 Washington, D.C. 20201 
 [*] (Office) 

Email: [*] 

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 32 








 Alternate COR: 

[*] 
 Branch Chief – Broad Spectrum Antimicrobials 

Division of CBRN Countermeasures 
 Biomedical Advanced
Research & Development Authority (BARDA) 
 Office of Secretary for Preparedness & Response (ASPR) 

Department of Health and Human Services 
 Mailing Address:

 330 Independence Avenue, SW Room G640 
 Washington, D.C.
20201 
 Office: [*] 
 Email: [*] 

The COR is responsible for: 

	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. 


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   	  	Prabha Fernandes, PhD	  	CEMPRA, Inc.	  	 President and CEO/

Principal Investigator

	2   	  	Gary Horwith, MD	  	CEMPRA, Inc.	  	EVP of Regulatory Affairs
	3   	  	David Oldach, MD, SVP	  	CEMPRA, Inc.	  	SVP of Clinical Research
	4   	  	David Pereira, SVP	  	CEMPRA, Inc.	  	SVP of Chemistry
	5   	  	Lily Nguyen, MBA	  	CEMPRA, Inc.	  	Director of Project Management
	6   	  	Shane Barton, CPA	  	CEMPRA, Inc.	  	Corporate Controller

 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 comprehensive justification 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. 
 ARTICLE
G.4. CONTRACT FINANCIAL REPORT 
 a. Financial reports on the attached Financial Report of Individual Project/Contract (see Attachments
2 and 3) shall be submitted by the Contractor in accordance with the instructions for completing this form, which accompany the form, in an electronic copy, not later than the 

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 33 








 
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 that part of the instructions for completing this form, entitled “PREPARATION INSTRUCTIONS,” (see Attachment 4) 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 within the Attachment entitled, “Financial Report of Individual
Project/Contract,” located in SECTION J and made a part of this contract. 
 f. The Government 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 
  

	1)	The billing address that should be shown on the invoice shall be the same as defined in ARTICLE G.2. of this contract as follows: 


DHHS/OS/ASPR/AMCG 
 Attn: Susan
Cortés-Shrank, Contracting Officer 
 330 Independence Ave., S.W. 

Room G640 
 Washington, D.C. 20201

  

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

  

	3)	Contractor invoices/financial reports shall conform to the form, format, and content requirements of the instructions for Invoice/Financing requests and Contract Financial
Reporting made a part of the contract in Section J (See also ARTICLE B.5. and Attachment 2). 

  

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


 

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

  

	6)	All invoice submissions shall be in accordance with FAR Clause 52.232-25 (c) in Section I of this contract. 


  
 34 








 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 the
clause entitled Allowable Cost and Payment in Section I, Contract Clauses, and FAR Subpart 31.7. Examples of allowable costs include, but are not limited to, the following: 


 

	 	a)	 All direct materials and supplies that are used in the performing of 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)	 Travel costs 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 comply with FAR 31.7.



  

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



 ARTICLE G.7.  INDIRECT COST RATES 
 The following rates will be utilized for billing purposes during both the base and option periods as provisional rates: 
 Fringe benefits at [*]% and an indirect rate estimated at [*]%. 
 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. 

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
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 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  
 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.csd.disa.mil/cparsmain.htm 
 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, “Contractor’s Guide for Control of Government Property,” which is incorporated into this contract by reference. This document can be accessed at: 
 http://www.hhs.gov/hhsmanuals/          (HHS
Logistics Management Manual) 
 Among other issues, this publication provides a summary of the Contractor’s responsibilities regarding purchasing
authorizations and inventory and reporting requirements under the contract. 
 2. Notwithstanding the provisions outlined in the HHS Publication,
“Contractor’s Guide for Control of Government Property,” which is incorporated in this contract in paragraph 1. above, the Contractor shall use the form entitled, “Report of Government Owned, Contractor Held Property” for
submitting summary reports required under this contract, as directed by the Contracting Officer or his/her designee. This form is included as an attachment in SECTION J of this contract. 
 3. Title will vest in the Government for equipment purchased as a direct cost. 
 ARTICLE G.11. EXERCISE OF OPTIONS

 Unless the Government exercises its option pursuant to the Option Clause set forth in Section I, Article I.2, the contract will
consist only of CLIN 0001 of the Statement of Work, Deliverables and Requirements as defined in Sections C, F and J of the contract. Pursuant 

  
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to FAR Clause 52.217-9 (Option to Extend the Term of the Contract) set forth in Section I of this contract, under Article I.2, the Government may, by unilateral contract modification,
require the Contractor to perform the additional CLINs listed in Section B, Article B.3., and as also defined in Sections C, F of this contract. If the Government exercises an option, written notice must be given to the Contractor within [*]
days after the Government has completed its analysis of the deliverables associated with the applicable GO/NO-GO Decision gates; and the Government must give the Contractor a preliminary written notice of its intent to exercise the option at
least [*] days before the contract expires. The amount of the contract may then be increased as set forth in Section B, Article B.3 provided that funds are available. 

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
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 SECTION H - SPECIAL CONTRACT REQUIREMENTS 
 If provisions set forth in this Section are not applicable to the work performed directly by the Contractor, those provisions might still apply to subcontractors performing work under this contract. It is the
Contractor’s responsibility to monitor their subcontractors to confirm that these provisions are satisfied. 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 BARDA Contracting Officer’s Representative (COR)
for evaluation and comment. Approval is required before work under a protocol may begin. BARDA 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 BARDA 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 BARDA. The Government 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. 
 BARDA shall have rights to all protocols, data resulting from execution of these protocols, and final reports funded by BARDA under this contract, as set forth in PART II of this contract and defined in the FAR.
BARDA reserves the right to request that the Awardee provide any contract deliverable in a non-proprietary form to ensure BARDA has the ability to review and distribute the deliverables as BARDA 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 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. 

  
 38 









	 	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, are 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). 



 

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



 Contractor must notify BARDA 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. 

  
 39 









	 	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.
Awardee 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. 
 A risk is minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater than those ordinarily encountered in daily life or during the performance of routine
physical or psychological examinations or tests. For example, the risk of drawing a small amount of blood from a healthy subject for research purposes is no greater than the risk of doing so as part of a routine physical examination (45 CFR
46.102(i)). 
 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 BARDA 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. 
  

	 	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 BARDA: 
  

	 	•	 	 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. 



  
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	 	•	 	 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 final protocols do not obtain approval and a 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 BARDA for evaluation and comment in conjunction with the protocol. Execution of
non-clinical studies requires written authorization from BARDA in accordance with this section of the contract. 
  

	 	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 Biomedical Advanced Research and Development Authority (BARDA) and the Contractor; they apply to all grants and contracts that involve clinical research. 

Draft protocols for each clinical study will be submitted to BARDA for evaluation and comment. BARDA comments will be addressed and/or incorporated
into the draft protocol prior to submission to the FDA for comment, if required. 
 BARDA shall have 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
in a non-proprietary form, to ensure BARDA has the ability to review and distribute the deliverables, as BARDA deems necessary. 

  
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	 	i.	Safety and Monitoring Issues 

 a.
Institutional Review Board or Independent Ethics Committee Approval 
 Before award and then with the annual progress report, the
Contractor must submit to BARDA 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 BARDA initial and annual documentation of continuing review and approval, including the current approved informed consent document and federal wide number. 

The Contractor must ensure that the application as well as all protocols are reviewed by their IRB or IEC. 

To help ensure the safety of participants enrolled in BARDA-funded studies, the Contractor must provide 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 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 or 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. 
 b. 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 

  
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(DSMB); other trials may require DSMB oversight as well. The Contractor shall inform BARDA 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 CROs as BARDA deems necessary. The Contractor shall inform BARDA 30 days in advance of a DSMB board meetings for studies funded under this effort. BARDA reserves the right to
participate in the DSMB board meetings on an impromptu basis as a non-voting member. 
 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 amount of blood form a healthy individual for research purposes is no greater than the risk of doing so as part of a routine physical examination (45 CFR 46.102I). 

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 BARDA within thirty (30) days of reviews or meetings. 

  
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	 	ii.	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: 
  

	 	—	 	 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 BARDA)
for evaluation and comment in conjunction with the protocol. Execution of clinical studies requires written authorization from BARDA in accordance with this section of this contract. 

 

	 	iii.	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
BARDA 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 BARDA if the FDA places the study on clinical hold and
provide BARDA any written comments from FDA, written responses to the comments, and documentation in writing that the hold has been lifted. 

  
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 The Contractor must not use grant or contract funds during a clinical hold to fund the 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. 
  

	 	iv.	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 BARDA representative or the Contracting Officer’s Representative
(COR) as follows: 
 • 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 BARDA representative or COR within 24 hours of FDA notification. 

• 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 day after the IND sponsor’s receipt of the information, must be submitted to the BARDA representative
or COR within 24 hours of FDA notification. 
 • IDE reports of unanticipated adverse device effect: 

A copy of any reports of unanticipated adverse device effect submitted to FDA must be submitted to BARDA representative or COR within 24 hours of
FDA notification. 
 • Expedited safety reports: 
 Sent to BARDA representative or the COR concurrently with the report to FDA. 
 • Other adverse
events documented during the course of the trial should be included in the annual IND or IDE report and reported to BARDA annually. 
 In
case of problems or issues, the BARDA representative or the Contracting Officer’s Representative will contact the Contractor within ten (10) working 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. 
  

	 	•	 	 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 BARDA Project Officer or the Contracting Officer’s Representative and
the Contractor. 

  
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 ARTICLE H.2. PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4 (January 2006) 

(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 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
Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent contractor
without imputing liability on the part of the Government for the acts of the Contractor or its employees. 
 (c) If at any time during the
performance of this contract, the Contracting Officer determines, in consultation with OHRP that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting
Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in
writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer’s written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in
whole or in part, and the Contractor’s name may be removed from the list of those contractors with approved Human Subject Assurances. 
 ARTICLE H.3. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE) 
 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). 

  
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 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. NEEDLE EXCHANGE 
 The Contractor shall not use contract funds to carry out any
program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug. 
 ARTICLE H.6. 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. 
 (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 Contracting
Officer’s written notice of suspension, the Contracting Officer may, in consultation with OLAW, NIH, terminate this contract in whole or in part, and the Contractor’s name may be removed from the list of those contractors with 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). 

  
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 ARTICLE H.7. 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.8. 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.9. PUBLICATION AND PUBLICITY 
 No information related to data obtained under this contract shall be released or publicized without the prior written consent of BARDA. 
 In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity incorporated by reference in SECTION I of this contract, 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. Contractors are required to state: (1) the percentage and
dollar amounts of the total program or project costs financed with Federal money and; (2) the percentage and dollar amount of the total costs financed by nongovernmental sources. 

For purposes of this contract “publication” is defined as an issue of printed material offered for distribution or any communication or
oral presentation of information, including any manuscript or scientific meeting abstract. Any publication containing data generated under this contract must be submitted for BARDA review no less than thirty (30) calendar days for manuscripts
and fifteen (15) calendar days for abstracts before submission for public presentation 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 Biomedical Advanced Research and Development Authority, Office
of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201300009C”. 
 ARTICLE H.10. REVIEW OF PRESS RELEASES 
 The contractor agrees to accurately and factually
represent the work conducted under the contract in all 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. The contractor shall ensure that the CO/COR has received an advance copy of any press release related to the contract not less than five
(5) working days prior to the issuance of the press release. 

  
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 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 HHSO100201300009C. 
 ARTICLE H.11. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE 
 Anyone who becomes aware of
the existence or apparent existence of fraud, waste and abuse in BARDA funded programs is encouraged to report such matters to the HHS Inspector General’s Office in writing or on the Inspector General’s Hotline. The toll free number is
1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is Htips@os.dhhs.gov and
the mailing address is: 
 Office of Inspector General 
 Department of Health and Human Services 
 TIPS HOTLINE 

P.O. Box 23489 
 Washington, D.C.
20026 
 ARTICLE H.12. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST ACTIVITIES 

The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224 and 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.13. 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 Subpart 9.5, or that the Contractor has disclosed all such relevant information. Prior to commencement of any work, the Contractor agrees to notify
the Contracting Officer promptly that, to the best of its knowledge and belief, no actual or potential conflict of interest exists or to identify to the Contracting Officer any actual or potential conflict of interest the firm may have. In emergency
situations, however, work may begin but notification shall be made within five (5) working days. The Contractor agrees that if an actual or potential organizational conflict of interest is identified during performance, the Contractor
shall promptly make a full disclosure in writing to the Contracting Officer. This disclosure shall include a description of actions, which the Contractor has taken or proposes to take, after consultation with the Contracting Officer, to avoid,
mitigate, or neutralize the actual or potential conflict of interest. The Contractor shall continue performance until notified by the Contracting Officer of any contrary action to be taken. Remedies include termination of this contract for
convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid an organizational conflict of interest. If the Contractor was aware of a potential organizational conflict of interest prior to award or
discovered an actual or potential conflict after award and did not disclose it or misrepresented relevant information to the Contracting Officer, the Government may terminate the contract for default, debar the Contractor from Government
contracting, or pursue such other remedies as may be permitted by law or this contract. 

  
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 ARTICLE H.14. PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING ACTIVITIES AND HHSAR
352.203-70 ANTI-LOBBYING (Jan 2006) 
 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 Stated
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” (January 2006), 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.15. PRIVACY ACT APPLICABILITY 
  

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


 

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


 

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

 ARTICLE H.16.    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). This requirement shall also be included in any subcontract for services under the contract. 

  
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 ARTICLE H.17.    DISSEMINATION OF INFORMATION (May 1998) 

No information related to data obtained under this contract shall be released or publicized without the prior written consent of the Contracting Officer.

 ARTICLE H.18.    IDENTIFICATION AND DISPOSITION OF DATA 
 The Contractor will be required to ensure that certain data generated under this contract is provided to the Department of Health and Human Services (DHHS). DHHS reserves the right to review any other data
determined by DHHS to have been generated under this contract. The Contractor shall ensure that copies of all data required by the Food and Drug Administration (FDA) relevant to this contract are kept for the time specified by the FDA. 

ARTICLE H.19.    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 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.20. 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 

  
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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 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 Government to provide assurances for the humane care of such animals.

 ARTICLE H.21. 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.22. REGISTRATION WITH THE SELECT AGENT PROGRAM FOR WORK INVOLVING THE POSSESSION, USE, AND/OR TRANSFER OF SELECT BIOLOGICAL AGENTS OR TOXINS 

Work involving select biological agents or toxins shall not be conducted under this contract until the Contractor and any affected subcontractor(s) are granted a
certificate of registration or are authorized to work with the applicable select agents. 
 For prime or subcontract awards to domestic institutions who
possess, use, and/or transfer Select Agents under this contract, the institution must complete registration with the Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS) or the Animal and Plant Health
Inspection Services (APHIS), U.S. Department of Agriculture (USDA), as applicable, before performing work involving Select Agents, in accordance with 42 CFR 73. No Government funds can be used for work involving Select Agents, as defined in 42 CFR
73, if the final registration certificate is denied. 

  
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 For prime or subcontract awards to foreign institutions who possess, use, and/or transfer Select Agents under this
contract, the institution must provide information satisfactory to the Government that a process equivalent to that described in 42 CFR 73
(http://www.cdc.gov/od/sap/docs/42cfr73.pdf) for U.S. institutions is in place and will be administered on behalf of all Select Agent work sponsored by these funds before using these funds for any work directly involving the Select Agents. The Contractor
must provide information addressing the following key elements appropriate for the foreign institution: safety, security, training, procedures for ensuring that only approved/appropriate individuals have access to the Select Agents, and any
applicable laws, regulations and policies equivalent to 42 CFR 73. The Government will assess the policies and procedures for
comparability to the U.S. requirements described in 42 CFR Part 73. When requested by the contracting officer, the Contractor
shall provide key information delineating any laws, regulations, policies, and procedures applicable to the foreign institution for the safe and secure possession, use, and transfer of Select Agents. This includes summaries of safety, security, and
training plans, and applicable laws, regulations, and policies. For the purpose of security risk assessments, the Contractor must provide the names of all individuals at the foreign institution who will have access to the Select Agents and
procedures for ensuring that only approved and appropriate individuals have access to Select Agents under the contract. 
 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://www.cdc.gov/od/sap/. 

ARTICLE H.23. 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 Government 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 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.24.  MANUFACTURING STANDARDS

 The Good Manufacturing Practice Regulations (GMP)(21 CFR Parts 210-211) and regulations pertaining to small molecules 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. 

  
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 ARTICLE H.25. EXPORT CONTROL NOTIFICATION 
 Offerors are responsible for ensuring compliance with all export control laws and regulations that maybe applicable to the export of and foreign access to their proposed technologies. Offerors 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.26. INSTITUTIONAL RESPONSIBILITY REGARDING CONFLICTING INTERESTS OF INVESTIGATORS 
 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 principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded under BARDA contracts) will not be biased by any conflicting financial interest. For the purposes of this part relating
to financial interests, “Investigator” includes the Investigator’s spouse and dependent children. 45 CFR Part 94 is available at the following Web site:
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=9f130b6d2d48bb73803ca91ce943be3a;rgn=div5;view=text;node=45%3A1.0.1.1.53;idno=45;cc=ecfr 
 As required by 45 CFR Part 94, the Contractor shall, at a minimum: 

a.   Maintain a written, enforceable policy on conflict of interest that complies with 45 CFR Part 94 and inform each investigator of the policy,
the investigator’s reporting responsibilities, and the applicable regulations. The Contractor must take reasonable steps to ensure that investigators working as collaborators or subcontractors comply with the regulations. 

b.   Designate an official(s) to solicit and review financial disclosure statements from each investigator participating in BARDA-funded research.
Based on established guidelines consistent with the regulations, the designated official(s) must determine whether a conflict of interest exists, and if so, determine what actions should be taken to manage, reduce, or eliminate such conflict. A
conflict of interest exists when the designated official(s) reasonably determines that a Significant Financial Interest could directly and significantly affect the design, conduct, or reporting of the BARDA-funded research. The Contractor may
require the management of other conflicting financial interests in addition to those described in this paragraph, as it deems appropriate. Examples of conditions or restrictions that might be imposed to manage actual or potential conflicts of
interests are included in 45 CFR Part 94, under Management of Conflicting Interests. 
 c.    Require all financial disclosures to be
updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained. 

d.   Maintain records, identifiable to each award, of all financial disclosures and all actions taken by the Contractor with respect to each
conflicting interest 3 years after final payment or, where applicable, for the other time periods specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention. 
 e.   Establish adequate enforcement mechanisms and provide for sanctions where appropriate. 
 If a conflict of interest is identified, the Contractor shall report to the Contracting Officer the existence of the conflicting interest found. This report shall be made and the conflicting interest managed,
reduced, or eliminated, at least on a temporary basis, within sixty (60) days of that identification. 
 If the failure of an
investigator to comply with the conflict of interest policy has biased the design, conduct, or reporting of the BARDA-funded research, the Contractor must promptly notify the Contracting Officer of the corrective action taken or to be taken. The
Contracting Officer will 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 funded research. 

  
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 The Contracting Officer may at any time inquire into the Contractor’s procedures and actions
regarding conflicts of interests in BARDA-funded research including a review of all records pertinent to compliance with 45 CFR Part 94. The Contracting Officer may require submission of the records or review them on site. On the basis of this
review, the Contracting Officer may decide that a particular 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 Contractor has not managed, reduced, or
eliminated the conflict of interest. The issuance of a Stop Work Order by the Contracting Officer may be necessary until the matter is resolved. 
 If the Contracting Officer determines that BARDA-funded clinical research, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported
by an investigator with a conflict of interest that was not disclosed or managed, the Contractor must require disclosure of the conflict of interest in each public presentation of the results of the research. 

ARTICLE H.27 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 BARDA. 

 

	 	—	 	 Within 48 hours of activity or incident or within 24 hours for a security related activity or incident, Contractor must notify BARDA.




	 	—	 	 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 BARDA within 5
business days. 

  
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 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: https://www.acquisition.gov/ 
 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	 	Jan 2012	  	Definitions
	52.203-3	 	Apr 1984	  	Gratuities
	52.203-5	 	Apr 1984	  	Covenant Against Contingent Fees
	52.203-6	 	Sep 2006	  	Restrictions on Subcontractor Sales to the Government
	52.203-7	 	Oct 2010	  	Anti-Kickback Procedures
	52.203-8	 	Jan 1997	  	Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity
	52.203-10	 	Jan 1997	  	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	 	Apr 2010	  	Contractor Code of Business Ethics and Conduct
	52.203-14	 	Dec 2007	  	Display of Hotline Poster(s)
	52.204-4	 	May 2011	  	Printed or Copied Double-Sided on Recycled Paper
	52.204-7	 	Dec 2012	  	Central Contractor Registration
	52.204-10	 	Aug 2012	  	Reporting Executive Compensation and First-Tier Subcontract Awards ($25,000 or
more)
	52.204-13	 	Dec 2012	  	Central Contractor Registration Maintenance
	52.209-6	 	Dec 2010	  	Protecting the Government’s Interests When Subcontracting With Contractors Debarred, Suspended,
or Proposed for Debarment (Over $30,000)
	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 (Over $700,000)
	52.215-12	 	 Oct 2010	  	Subcontractor Cost or Pricing Data (Over $700,000)
	52.215-14	 	Oct 2010	  	Integrity of Unit Prices
	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 2011	  	Allowable Cost and Payment




  
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	FAR
CLAUSE NO.	 	DATE	  	TITLE
	52.216-8	 	Jun 2011	  	Fixed Fee
	52.216-12	 	Apr 1984	  	Cost Sharing Contract – no fee
	52.217-9	 	Mar 2000	  	 Option to Extend the Term of the Contract

 
 (a) The Government may extend the term of this contract by written notice to the Contractor
within          [insert the period of time within which the Contracting Officer may exercise the option]; provided that the Government gives the Contractor a preliminary written notice of its intent to
extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.
  

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

 
 (c) The total duration of this contract, including the exercise of any options under this
clause, shall not exceed 5 years.

	52.219-16	 	Jan 1999	  	Liquidated Damages - Subcontracting Plan
	52.222-2	 	Jul 1990	  	Payment for Overtime Premiums
	52.222-3	 	Jun 2003	  	Convict Labor
	52.222-21	 	Feb 1999	  	Prohibition of Segregated Facilities
	52.222-26	 	Mar 2007	  	Equal Opportunity
	52.222-35	 	Sep 2010	  	Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible
Veterans (Over $100,000)
	52.222-36	 	Oct 2010	  	Affirmative Action for Workers with Disabilities
	52.222-37	 	Sep 2010	  	Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible
Veterans (Over $100,000)
	52.222-40	 	Dec 2010	  	Notification of Employee Rights Under the National Labor Relations Act
	52.222-50	 	Feb 2009	  	Combating Trafficking in Persons
	52.222-54	 	Jan 2009	  	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
	52.225-1	 	Feb 2009	  	Buy American Act - Supplies
	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	 	Dec 2007	  	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.



  
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	FAR
CLAUSE NO.	 	DATE	  	TITLE
	52.227-14	 	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.
HHSO10020XX000XXX (and subcontract         , if appropriate). 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
	52.232-9	 	Apr 1984	  	Limitation on Withholding of Payments
	52.232-17	 	Oct 2010	  	Interest
	52.232-20	 	Apr 1984	  	Limitation of Cost
	52.232-23	 	Jan 1986	  	Assignment of Claims
	52.232-25	 	Oct 2008	  	Prompt Payment, Alternate I (Feb 2002)
	52.232-33	 	Oct 2003	  	Payment by Electronic Funds Transfer--Central Contractor Registration
	52.233-1	 	Jul 2002	  	Disputes
	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 2001	  	Penalties for Unallowable Costs (Over $700,000)
	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	 	Dec 2010	  	Subcontracts for Commercial Items
	 52.245-1

Alt. II
	 	Aug 2010	  	Government Property, Alternate II (Jun 2007)
	52.245-9	 	Aug 2010	  	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
	52.253-1	 	Jan 1991	  	Computer Generated Forms



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


 

					
	HHSAR
CLAUSE NO.	 	DATE	  	TITLE
	352.202-1	 	Jan 2006	  	Definitions - with Alternate paragraph (h) (Jan 2006)
	352.203-70	 	Mar 2012	  	Anti-Lobbying
	352.216-70	 	Jan 2006	  	Additional Cost Principles
	352.222-70	 	Jan 2010	  	Contractor Cooperation in Equal Employment Opportunity Investigations
	352.223-70	 	Jan 2006	  	Safety and Health
	352.224-70	 	Jan 2006	  	Privacy Act
	352.227-70	 	Jan 2006	  	Publications and Publicity
	352.228-7	 	Dec 1991	  	Insurance - Liability to Third Persons
	352.231-70*	 	Aug 2012	  	Salary Rate Limitation
	352.231-71	 	Jan 2001	  	Pricing of adjustments
	352.233-71	 	Jan 2006	  	Litigation and Claims
	352.242-70	 	Jan 2006	  	Key Personnel
	352.242-73	 	Jan 2006	  	Withholding of Contract Payments
	352.242-74	 	Apr 1984	  	Final Decisions on Audit Findings
	352.270-4	 	Jan 2006	  	Protection of Human Subjects
	352.270-6	 	Jan 2006	  	Restriction on use of Human Subjects


 * The provisions set forth by this clause will only apply if and when any funds are obligated from HHS
funding appropriated in the 2012 government fiscal year. 
 [End of GENERAL CLAUSES FOR A NEGOTIATED COST-REIMBURSEMENT RESEARCH AND
DEVELOPMENT CONTRACT-Rev. 12/2011]. 
 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: 
 a.   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 [*] days after the Government has completed its analysis of the deliverables associated with the applicable GO/NO GO Decision
gate; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least [*] 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). FAR Clause 52.219-28, Post-Award Small Business Program Representation (April 2009).


  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
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 (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 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 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 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/contractingopportunities/officials/size/index.html. 

(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 Online Representations and Certifications Application and its data in the Central Contractor Registration, as necessary,
to ensure that they reflect the 

  
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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. 
 (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 ORCA, or does not have a representation in ORCA 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 assigned to contract number. 

[Contractor to sign and date and insert authorized signer’s name and title]. 

  
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 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 

Statement of Work, dated 22 April 2013. 
 2. Invoice/Financing Request Instructions and Contract Financial Reporting Instructions for BARDA Cost-Reimbursement Type Contracts, 
 Invoice/Financing Request Instructions and Contract Financial Reporting Instructions for BARDA Cost-Reimbursement Type Contracts, 5 pages. 

3. Financial Report of Individual Project/Contract, 1 page 
 4. Instructions for Completing Financial Report of Individual Project/Contract, 3 pages 
 5.
Inclusion Enrollment Report 
 Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01), 1 page. 

6. Research Patient Care Costs 
 Research Patient Care Costs, 1 page. 
 7. Report of Government Owned, Contractor Held Property

 Report of Government Owned, Contractor Held Property, 1 page. Located at: http://rcb.cancer.gov/rcb-internet/forms/Govt-Owned-Prop.pdf 
 8. 7 Principles of Earned Value Management Tier 2 System Implementation Guide 

  
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 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)	Representations & Certifications - Status Active on SAM.gov. 

  

	2)	Final Cost Proposal Budget received 26 March 2013. 

  

	3)	Final Technical Proposal received 22 April 2013. 

  

	4)	Human Subjects Assurance Identification Numbers: 


 i.      Duke Clinical Research Institute (DCRI): 00009025 

ii.      Celerion: FWA00003049 
  

	5)	Animal Welfare Assurance Numbers (OLAW/PHS): 


 i.      Lovelace: A3083-01 
 ii.      MPI Research: A3181-01 

  
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	3.	STATEMENT OF WORK 

  

	3.1	Preamble 

 Independently and not as an
agent 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 Broad Agency Announcement (BAA) BARDA CBRN BAA-12-100-SOL-00011. 
 The Government reserves the right to modify the milestones,
progress, schedule, budget, or product to add or delete products, process, or schedule as need may arise. Because of the nature of this (R&D) contract and 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. In any event, the Government reserves the right to change product, process, schedule, or event to add or delete part or all of these
elements as the need arises. 
  

	3.2	Overall Objectives and Scope 

 The
overall objective of this contract is to advance the development of solithromycin (SOLI) as an intravenous (IV) and orally-delivered antibiotic for use in the pediatric population for the treatment of community-acquired bacterial pneumonia (CABP)
and for protection against biothreat organisms, including Bacillus anthracis and Francisella tularensis. The scope of work is organized in 5 severable phases (Clinical Line Item Number [CLIN] 1 through 5): 

 
 



 

  
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	1.	CLIN 1 

 The Contractor will carry out the
following tasks and subtasks and in accordance with the agreed upon Integrated Master Schedule and Integrated Master Plan, which further details the conduct of the specific tasks and subtasks. 

 

	1.1	Program Management (WBS 1.1) 

 The
Contractor outsources a majority of the work to established practitioners in each discipline, with the Contractor team providing experienced program management, coordination, and oversight. All selected purchased commercial service providers for the
BARDA project have proven their ability to deliver quality work cost-effectively and on schedule. The Contractor shall provide for the following program management activities as outlined below: 

 

	 	1.1.1	The Contractor will provide 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	The Principal Investigator is responsible for overall leadership 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. 

  

	 	1.1.3	The Project Manager will oversee the monitoring and tracking day-to-day progress and timelines, coordinating communication and project activities; costs incurred; and
program management. 

  

	 	1.1.4	The Principal Investigator and the Project Manager will act as the BARDA Liaison with responsibility for effective communication with the Project Officer and
Contracting Officer. 

  

	 	1.1.5	The Contractor has adequate administrative staff and legal consultants 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	The Contractor’s Project Management Team along with support from the Finance department has responsibility for financial management and reporting on all activities
conducted by the Contractor and any subcontractors and service providers. 

  

	 	1.1.7	Contract Review Meetings 

  

	 	1.1.7.1	The Contractor’s team will participate in regular face-to-face meetings on a quarterly basis 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 Contractor 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 will participate in teleconferences every 2 weeks between the Contractor and BARDA to review technical progress. The Contractor will include
subcontractors and service providers as necessary. If additional teleconferences or face-to-face meetings are requested by BARDA, the Contractor will be available. 


 

	 	1.1.8	Integrated Master Schedule (IMS) 

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

	 	1.1.9	Integrated Master Plan (IMP) 

  

	 	1.1.9.1	 Work Breakdown Structure: The Contractor will utilize a WBS template agreed upon by BARDA for reporting on the contact. The Contractor will expand and
delineate the Contract Work 



  
 65 









	 	 
Breakdown Structure (CWBS) to a level agreed upon by BARDA as part of their Integrated Master Plan for contract reporting. The CWBS will be discernible and consistent. At BARDA’s request,
the Contractor will furnish WBS data at the work package level or at a lower level if there is significant complexity and risk associated with the task. 



 

	 	1.1.9.2	GO/ NO-GO Decision Gates/Contract Milestones: The IMP will outline 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. 


 

	 	1.1.9.3	Earned Value Management System Plan: Subject to the requirements under HHSAR Clause 352.234-4, the Contractor will use principles of Earned Value Management System
(EVMS) in the management of this contract. The Contractor will follow the Seven Principles: 

  

	 	I.	The Contractor will plan all work scope for the program to completion. 

  

	 	II.	The Contractor will break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical,
schedule, and cost objectives. 

  

	 	III.	The Contractor will integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments may be
measured. 

  

	 	IV.	The Contractor will use actual cost incurred and recorded in accomplishing the work performed. 


 

	 	V.	The Contractor will objectively assess accomplishments at the work performance level. 


 

	 	VI.	The Contractor will analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be
performed. 

  

	 	VII.	The Contractor will use earned value information in the company’s management processes. 


We understand that elements of EVMS will be applied to all applicable projects as part of the IMP. In addition, the Contractor will
submit a written summary of the management procedures that will be used to establish, maintain and comply with EVMS requirements. 
  

	 	1.1.10	Decision Gate Reporting: On completion of a stage of the product development, as defined in the agreed upon IMS and IMP, the Contractor will 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.


  

	 	1.1.11	Risk Management Plan: The Contractor will 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 will reference relevant WBS elements where appropriate. Updates to this plan will be included every 3 months (quarterly) in
the monthly Project Status Report. 

  

	 	1.1.12	Performance Measurement Baseline Review (PMBR): The Contractor will submit a plan for a PMBR to occur within [*] days of contract award. At the PMBR, the Contractor and
BARDA will mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines will be the basis for monitoring and reporting progress throughout the life of the contract. The PMBR is conducted
to achieve confidence that the baselines accurately capture the entire technical scope of work, are consistent with contract schedule requirements, are reasonably and logically planned, and have adequate resources assigned. The goals of the PMBR are
as follows: 

  

	 	I.	Jointly assess areas such as the Contractor’s planning for complete coverage of the SOW, logical scheduling of the work activities, adequate resources, and
identification of inherent risks 


  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 66 









	 	II.	Confirm the integrity of the Performance Measurement Baseline (PMB) 

  

	 	III.	Foster the use of EVM as a means of communication 

  

	 	IV.	Provide confidence in the validity of the Contractor’s reporting 

  

	 	V.	Identify risks associated with the PMB 

  

	 	VI.	Present any revised PMBs for mutual agreement 

  

	 	VII.	Present an IMS: The Contractor will deliver an initial program IMS that rolls up all time-phased WBS elements down to the activity level. This IMS will include the
dependencies that exist between tasks. This IMS will be agreed to and finalized at the PMBR. 

  

	 	VIII.	Present the Risk Management Plan 

  

	 	1.1.13	Deviation Request: During the course of contract performance, in response to a need to change IMS activities as baselined at the PMBR, the Contractor will submit a
Deviation Report. This report will be used to request a change in the agreed-upon IMS and timelines, if necessary. This report will 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. 

  

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

  

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


 

	 	II.	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; 

  

	 	III.	Updated IMS; 

  

	 	IV.	Updated EVMS; 

  

	 	V.	Updated Risk Management Plan (Every 3 months); 

  

	 	VI.	Three month rolling forecast of planned activities; 

  

	 	VII.	Progress of regulatory submissions; 

  

	 	VIII.	Estimated and actual expenses; 

  

	 	1.1.15	Data Management: The Contractor will develop and implement data management and quality control systems/procedures, including transmission, storage, confidentiality, and
retrieval of all contract data; 

  

	 	1.1.15.1	Provide for the statistical design and analysis of data resulting from the research; 


 

	 	1.1.15.2	Provide raw data or specific analyses of data generated with contract funding to the Project Officer, upon request. 


 

	1.2	[*] (WBS 1.2) 

  

	 	1.2.1	[*] (WBS 1.2.1 - reserved) 

  

	 	1.2.2	[*] (WBS 1.2.2) 

  

	 	1.2.2.1	[*] 

  

	 	1.2.2.2	[*] 

  

	1.3	[*] (WBS 1.3) 

  

	 	1.3.1	[*] (WBS 1.3.1 - reserved) 

  

	 	1.3.2	[*] (WBS 1.3.2) 


  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
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	 	1.3.2.1	[*] 

  

	 	1.3.2.2	[*] 

  

	 	1.3.2.3	[*] 

  

	 	1.3.2.4	[*] 

  

	 	1.3.2.5	[*] 

  

	 	1.3.3	[*] (WBS 1.3.3 - reserved) 

  

	1.4	[*] (WBS 1.4) 

  

	 	1.4.1	[*] (WBS 1.4.1) 

  

	 	1.4.1.1	[*] 

  

	 	1.4.1.2	[*] 

  

	 	1.4.1.3	[*] 

  

	 	1.4.1.4	[*] 

  

	 	1.4.2	[*] (WBS 1.4.2 - reserved) 

  

	1.5	[*] (WBS 1.5) 

  

	 	1.5.1	[*] (WBS 1.5.1) 

  

	 	1.5.1.1	[*] 

  

	 	1.5.1.2	[*] 

  

	 	1.5.1.3	[*] 

  

	 	1.5.1.4	[*] 

  

	 	1.5.2	[*] (WBS 1.5.2) 

  

	 	1.5.2.1	[*] 

  

	 	1.5.2.2	[*] 

  

	 	1.5.2.3	[*] 

  

	 	1.5.2.4	[*] 

  

	 	1.5.2.5	[*] 

  

	1.6	[*] (WBS 1.6) 

  

	 	1.6.1	[*] (WBS 1.6.1) 

  

	 	1.6.1.1	[*] 

  

	 	1.6.1.2	[*] 

  

	 	1.6.1.3	[*] 

  

	 	1.6.1.4	[*] 

  

	 	1.6.2	[*] (WBS 1.6.2) 

  

	 	1.6.2.1	[*] 

  

	 	1.6.3	[*] (WBS 1.6.3) 

  

	 	1.6.3.1	[*] 

  

	 	1.6.3.2	[*] 

  

	 	1.6.3.4	[*] 


  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 68 









	 	1.6.4	[*] (WBS 1.6.4 - reserved) 

  

	 	1.6.5	[*] (WBS 1.6.5). 

  

	 	    	[*] 

 1.6.5.1
 [*] 
 1.6.5.2  [*] 
  

	2.	CLIN 2 

  

	2.1	Program Management (WBS 2.1) 

  

	 	2.1.1	Program management scope is consistent with that outlined in CLIN 1. 

  

	2.2	[*] (WBS 2.2 – reserved) 

  

	2.3	[*] (WBS 2.3 – reserved) 

  

	2.4	[*] (WBS 2.4) 

  

	 	2.4.1	[*] (WBS 2.4.1) 

  

	 	2.4.1.1	[*] 

  

	 	2.4.1.2	[*] 

  

	 	2.4.2	[*] (WBS 2.4.2) 

 2.4.2.1  [*] 
  

	2.5	[*] (WBS 2.5) 

  

	 	2.5.1	[*] (WBS 2.5.1 – reserved) 

  

	 	2.5.2	[*] (WBS 2.5.2) 

  

	 	2.5.2.1	[*] 

  

	 	2.5.2.2	[*] 

  

	 	2.5.2.4	[*] 

  

	2.6	[*] (WBS 2.6) 

  

	 	2.6.1	[*] (WBS 2.6.1 - reserved) 

  

	 	2.6.2	[*] (WBS 2.6.2 - reserved) 


2.6.3 [*] (WBS 2.6.3) 
  

	 	2.6.3.1	[*] 

  

	 	2.6.3.2	[*] 

  

	 	2.6.3.3	[*] 

  

	 	2.6.3.4	[*] 

  

	 	2.6.4	[*] (WBS 2.6.4 - reserved) 

  

	 	2.6.5	[*] (WBS 2.6.5). 

  

	 	2.6.5.1	[*] (WBS 2.6.5.1) 

  

	3.	CLIN 3 

  

	3.1	Program Management (WBS 3.1) 

  

	 	3.1.1	Program management scope is consistent with that outlined in CLIN 2. 

  

	3.2	[*] (WBS 3.2 - reserved) 


  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 69 









	3.3	[*] (WBS 3.3) 

  

	 	3.3.1	[*] (WBS 3.3.1 – reserved) 

  

	 	3.3.2	[*] (WBS 3.3.2 – reserved) 

  

	 	3.3.3	[*] (WBS 3.3.3) 

  

	 	3.3.3.1	[*] 

  

	 	3.3.3.2	[*] 

  

	 	3.3.3.3	[*] 

  

	3.4	[*] (WBS 3.4) 

  

	 	3.4.1	[*] (WBS 3.4.1) 

  

	 	3.4.1.1	[*] 

  

	 	3.4.2	[*] (WBS 3.4.2 - reserved) 

  

	3.5	[*] (WBS 3.5) 

  

	 	3.5.1	[*] (WBS 3.5.1 – reserved) 

  

	 	3.5.2	[*] (WBS 3.5.2) 

  

	 	3.5.2.1	[*] 

  

	 	3.5.2.2	[*] 

  

	3.6	[*] (WBS 3.6) 

  

	 	3.6.1	[*] (WBS 3.6.1 - reserved) 

  

	 	3.6.2	[*] (WBS 3.6.2 - reserved) 

  

	 	3.6.3	[*] (WBS 3.6.3) 

  

	 	3.6.3.1	[*] 

  

	 	3.6.4	[*] (WBS 3.6.4 - reserved) 

  

	 	3.6.5	[*] (WBS 3.6.5) 

  

	 	3.6.5.1	[*] (WBS 3.6.5.1) 

  

	4.	CLIN 4 (GOVERNMENT/CONTRACTOR COST-SHARE) 

  

	4.1	Program Management (WBS 4.1) 

  

	 	4.1.1	Program management scope is consistent with that in CLIN 3. 

  

	4.2	[*] (WBS 4.2 – reserved)  

  

	4.3	[*] (WBS 4.3 - reserved) 

  

	4.4	[*] (WBS 4.4) 

  

	 	4.4.1	[*] (WBS 4.4.1 – reserved) 

  

	 	4.4.2	[*] (WBS 4.4.2) 

  

	 	4.4.2.1	[*] 

  

	4.5	[*] (WBS 4.5 - reserved) 

  

	4.6	[*] (WBS 4.6 - reserved) 

  

	5.	CLIN 5 

  

	5.1	Program Management (WBS 5.1) 


  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 70 









	 	5.1.1	Program management scope is consistent with that in CLIN 4. 

  

	5.2	[*] (WBS 5.2 - reserved) 

  

	5.3	[*] (WBS 5.3 - reserved) 

  

	5.4	[*] (WBS 5.4 - reserved) 

  

	5.5	[*] (WBS 5.5) 

  

	 	5.5.1	[*] (WBS 5.5.1 – reserved) 

  

	 	5.5.2	[*] (WBS 5.5.2) 

  

	 	5.5.2.1	[*] 

  

	 	5.5.2.2	[*] 

  

	5.6	[*] (WBS 5.6 - reserved) 

  

	6.	OTHER ITEMS 

  

	6.1	Facilities, Equipment, and Other Resources 

 The Contractor confirms the subcontractor and all purchased commercial service providers provide equipment, facilities and other resources under Federal and HHS regulations. 

  

	[*]	Confidential treatment requested; certain information omitted and filed separately with the SEC. 



  
 71 








 Attachment 2 
 INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING 
 INSTRUCTIONS
FOR BARDA COST-REIMBURSEMENT CONTRACTS 
 Format: Payment requests shall be submitted on the Contractor’s self-generated form in
the manner and format prescribed herein and as illustrated in the Sample Invoice/Financing Request. Standard Form 1034, Public Voucher for Purchases and Services Other Than Personal, may be used in lieu of the Contractor’s self-generated form
provided it contains all of the information shown on the Sample Invoice/Financing Request. DO NOT include a cover letter with the payment request. 
 Number of Copies: Payment requests shall be submitted in the quantity specified in the Invoice Submission Instructions in Section G of the Contract Schedule. 

Frequency: Payment requests shall not be submitted more frequently than once every two weeks in accordance with the Allowable Cost and Payment
Clause incorporated into this contract. Small business concerns may submit invoices/financing requests more frequently than every two weeks when authorized by the Contracting Officer. 
 Cost Incurrence Period: Costs incurred must be within the contract performance period or covered by precontract cost provisions. 
 Billing of Costs Incurred: If billed costs include (1) costs of a prior billing period, but not previously billed, or (2) costs incurred during the contract period and claimed after the
contract period has expired, the Contractor shall site the amount(s) and month(s) in which it incurred such costs. 
 Contractor’s
Fiscal Year: Payment requests shall be prepared in such a manner that the Government can identify costs claimed with the Contractor’s fiscal year. 
 Currency: All BARDA contracts are expressed in United States dollars. When the Government pays in a currency other than United States dollars, billings shall be expressed, and payment by the
Government shall be made, in that other currency at amounts coincident with actual costs incurred. Currency fluctuations may not be a basis of gain or loss to the Contractor. Notwithstanding the above, the total of all invoices paid under this
contract may not exceed the United States dollars authorized. 
 Costs Requiring Prior Approval: Costs requiring the Contracting
Officer’s approval, including those set forth in an Advance Understanding in the contract, shall be identified and reference the Contracting Officer’s Authorization (COA) Number. In addition, the Contractor shall show any cost set forth in
an Advance Understanding as a separate line item on the payment request. 
 Invoice/Financing Request Identification: Each payment
request shall be identified as either: 
  

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


 

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

  

	(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. 

  
 72 









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

  

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


  

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


 

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


 

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


 

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


 

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


 

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


  

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

  

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

  

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

  

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


  

	(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. 


  
 73 









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

  

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

  

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


 On a separate sheet of paper attached to the payment request, list each item for which reimbursement is
requested. Include reference to the following (as applicable): 
 - item number for the specific piece of equipment listed in
the Property Schedule, and 
 - COA number, if the equipment is not covered by the Property Schedule. 

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

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

  

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


 

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

  

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


 

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

  

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

  

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


  

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


 

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


  

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


  
 74 









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


 

	(u)	Grand Totals 

  

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

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

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

  
 75 








 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.

 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. 

  
 76 








 SAMPLE INVOICE/PAYMENT REQUEST AND CONTRACT FINANCIAL REPORT 

 

																	
	 (a)
	 	Designated Billing Office Name and Address:	  	(c)	 	Invoice/Financing Request No.:
	 	 	  
 DHHS/OS/ASPR/BARDA
	  	  
 (d)
	 	  

Date Invoice Prepared:

	 	 	 Attn: Contracting Officer

330 Independence Ave., S.W.
 Room G644
 Washington, D.C. 20201
	  	  
 (e)

 
 (f)

 
	 	  

Contract No. and Order No. (if applicable):             

 
 Effective Date:
  

	  
 (b)
	 	  
 Contractor’s Name, Address, Point of Contact, VIN, and DUNS or DUNS+4 Number:
	  	 (g)
  
 (h)
	 	 Total Estimated Cost of Conract/Order:

 
 Total Fixed-Fee (if applicable):

	 	 	  
 ABC CORPORATION
	  	  
 (i)
	 	  

 ̈ Two-Way Match:

	 	 	100 Main Street	  		 	 ̈ Three-Way Match
	 	 	Anywhere, USA Zip Code	  	  
 (j)
	 	  

Office of Acquisitions:

	 	 	 Name, Title, Phone Number, and E-mail Address of 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.
	  	  
 (k)
	 	  

Central Point of Distribution

	 	 	  
 VIN:
	  		 	 
	 	 	 DUNS or DUNS+4

 
	  	 	 	 
	  

(l) This invoice/financing request reimbursable costs for the period from
         to         
  

	  	  	 Cumulative Percentage

of Effort/Hrs.
	 	Amount Billed 	  	  	  	  	  	  
	
Expenditure Category*

                         
 A
	  	 Negotiated 

B 
	  	 Actual  

C  
	 	 (m) 

Current 

D 
	  	 (n) 

Cumulative 

E 
	  	 Cost at 

Completion 

F 
	  	 Contract 

Amount 

G 
	  	
Variance

H

	 (o)    Direct Costs:
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	  (1) Direct Labor
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	  (2) Fringe Benefits
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	  (3) Accountable Property
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	  (4) Materials & Supplies
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	  (5) Premium Pay
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	  (6) Consultant Fees
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	  (7) Travel
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	  (8) Subcontracts
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	  (9) Other
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	 Total Direct Costs
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	 (p)    Cost of Money
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	 (q)    Indirect Costs
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	 (r)     Fixed Fee
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	 (s)    Total Amount Claimed
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	 (t)     Adjustments
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	 (u)    Grand Totals
	  	 	  	 	 	 	  	 	  	 	  	 	  	 
	I certify that all payments are for appropriate purposes and
in accordance with the contract.
	 						 
	 	 	  
	  		  	  
	  		  		  	 
	 	 	   (Name of Official)	  	   (Title)	 		  		  	 
	 
	* Attach details as
specified in the contract


  
 77 








 Attachment 3 
  

																							
	  
 FINANCIAL REPORT OF INDIVIDUAL
 PROJECT/CONTRACT

 
 Note: Complete this Form in Accordance with Accompanying
Instructions.
  
	  	Project Task:	  	Contract No.:	  	Date of Report:	  	  

0990-0134

0990-0131

	  	
Reporting Period:
  
	  	
Contractor Name and Address:
  

	Expenditure Category*    	  	  

Percentage of

Effort/Hours
  
	  	Cumulative 
Incurred 
Cost 
at End of 
Prior Period 	  	 Incurred  
 Cost-  

-Current  
	  	 Cumulative  
 Cost to Date  

(D + E)  
	  	Estimated  
Cost to  

Complete  	  	Estimated Cost at  

Completion (F+G)  	  	Negotiated  
Contract  

Amount  	  	Variance (Over
or Under) (I-H)
	  	  

Negotiated    
	  	Actual 	  	  	  	  	  	  	  
	  

A
	  	B	  	C	  	D	  	E	  	F	  	G	  	H	  	I	  	J
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  	  


  
 78 








 Attachment 4 
 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. 


 

	(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.” 


  
 79 









	(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. 

  

	(16)	Total Costs to the Government. 


PREPARATON 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.


  
 80 








 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. 

  
 81 








 Attachment 5 
 INCLUSION ENROLLMENT REPORT 
 This report format should NOT be used
for data collection from study participants 

											
	 Study
Title:
  
	 	 	 	 	 	 	 	 	 	 
	 Total Enrollment:

 
	 	 	 	Protocol Number:
	 Contract Number:

 
	 	 	 	 	 	 	 	 	 	 
	  

PART A. TOTAL ENROLLMENT REPORT:            Number of Subjects Enrolled to Date
(Cumulative) by Ethnicity and Race
  

	Ethnic Category	 	Sex/Gender  	 		 		 	 
	 	Females  	 	Males  	 	  Unknown or Not Reported  
 	 	Total
	 Hispanic or Latino

 
	 	 	 	 	 	 	 	 	 	 
	 Not Hispanic or Latino

 
	 	 	 	 	 	 	 	 	 	 
	 Unknown (Individuals not reporting
ethnicity)
  
	 	 	 	 	 	 	 	 	 	 
	 Ethnic Category: Total of All
Subjects*
  
	 	 	 	 	 	 	 	 	 	 
	  
 Racial Categories
  
	 	 	 	 	 	 	 	 	 	 
	 American Indian/Alaska Native

 
	 	 	 	 	 	 	 	 	 	 
	 Asian

 
	 	 	 	 	 	 	 	 	 	 
	 Native Hawaiian or Other Pacific
Islander
  
	 	 	 	 	 	 	 	 	 	 
	 Black or African American

 
	 	 	 	 	 	 	 	 	 	 
	 White

 
	 	 	 	 	 	 	 	 	 	 
	 More than one race

 
	 	 	 	 	 	 	 	 	 	 
	 Unknown or not reported

 
	 	 	 	 	 	 	 	 	 	 
	 Racial Categories: Total of All
Subjects*
  
	 	 	 	 	 	 	 	 	 	 
	
 
      

	  

PART B. HISPANIC ENROLLMENT REPORT:        Number of Hispanics or Latinos Enrolled to Date
(Cumulative)
  

	  
 Racial Categories
  
	 	  

Females  
	 	  

Males  
	 	  

  Unknown or Not Reported   
	 	  
 Total

	 American Indian/Alaska Native

 
	 	 	 	 	 	 	 	 	 	 
	 Asian

 
	 	 	 	 	 	 	 	 	 	 
	 Native Hawaiian or Other Pacific
Islander
  
	 	 	 	 	 	 	 	 	 	 
	 Black or African American

 
	 	 	 	 	 	 	 	 	 	 
	 White

 
	 	 	 	 	 	 	 	 	 	 
	 More than one race

 
	 	 	 	 	 	 	 	 	 	 
	 Unknown or not reported

 
	 	 	 	 	 	 	 	 	 	 
	 Racial Categories: Total of Hispanics or
Latinos**
  
	 	 	 	 	 	 	 	 	 	 
	 *These totals must agree

** these totals must agree
	 	 	 	 	 	 	 	 	 	 


  
 82 








 Attachment 6 
 Research Patient Care Costs 
 (a)        Research
patient care costs are the costs of routine and ancillary services provided to patients participating in research programs described in this contract. 
 (b)        Research patient care costs shall be computed in a manner consistent with the principles and procedures used by the Medicare Program for determining the
part of Medicare reimbursement based on reasonable costs. The Diagnostic Related Group (DRG) prospective reimbursement method used to determine the remaining portion of Medicare reimbursement shall not be used to determine research patient care
costs. Research patient care rates or amounts shall be established by the Secretary of HHS or his/her duly authorized representative. 

(c)        Prior to submitting an invoice for research patient care costs under this contract, the contractor
must make every reasonable effort to obtain third party payment, where third party payors (including Government agencies) are authorized or are under a legal obligation to pay all or a portion of the charges incurred under this contract for research
patient care. 
 (d)        The contractor must maintain adequate procedures to identify those research
patients participating in this contract who are eligible for third party reimbursement. 

(e)        Only those charges not recoverable from third party payors or patients and which are consistent with
the terms and conditions of the contract are chargeable to this contract. 

  
 83 








 Attachment 7 

 

											
	 Contracting Site –
Contract number –
 Inventory Sheet

	  

DHHS TAG*
	  	S/N	  	TYPE	  	MAKE	  	MODEL	  	LOCATION
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  
	  	  	  	  	  	  	  	  	  	  	  


 
 *Until or unless BARDA affixes an HHS generated ID, the contractor shall track
and monitor all equipment, materials, and supplies purchased under this contract in a manner which affords a clear distinction from other contractor property. 

  
 84 











 Department of Health & Human Services 

HHS 

Office of the Assistant Secretary for Preparedness and Readiness 

ASPR 

Biomedical Advanced Research and Development Authority 
 BARDA 
 7 Principles of Earned Value 

Management 
 Tier
2 
 System Implementation 
 Intent Guide 
 21 December 2011 

 
 



 
  














 TABLE OF CONTENTS 

 
  

					
	OVERVIEW	  	 	1	  
		
	EVM IMPLEMENTATION TIERS	  	 	2	  
		
	SEVEN PRINCIPLES OF EVM	  	 	3	  
	 Principle 1: Plan all Work Scope
	  	 	3	  
		
	 Principle 2: Break Work into Finite Pieces and Define Person/Organization Responsible for Work
	  	 	3	  
		
	 Principle 3a: Integrate Scope, Schedule and Budget into a Performance Measurement Baseline
	  	 	4	  
		
	 Principle 3b: Control Changes to the Baseline
	  	 	5	  
		
	 Principle 4: Use Actual Costs Incurred and Recorded in Accomplishing the Work Performed
	  	 	5	  
		
	 Principle 5: Objectively Assess Accomplishments at the Work Performance Level
	  	 	6	  
		
	 Principle 6a: Analyze Significant Variances From the Plan
	  	 	7	  
		
	 Principle 6b: Prepare an Estimate at Completion Based on Performance to Date and Work to be Performed
	  	 	7	  
		
	 Principle 7: Use EVMS Information in the Company’s Management Processes
	  	 	7	  
		
	APPENDICES	  	 	9	  
	 APPENDIX 1: Glossary of Terms
	  	 	9	  
		
	 Appendix 2 Supplemental EVM Implementation Guideline
	  	 	15	  
		
	 Appendix 3 Sample EVM Documents
	  	 	17	  

  















 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

 OVERVIEW 
 Earned Value Management (EVM) is a program management tool, technique, and discipline that facilitates systematic planning for and monitoring of, high value, complex projects. It integrates a
project’s scope of work with the related budget and schedule to permit detailed assessment of overall performance during the life of the project. 
 Several government-wide guidance documents govern the definition and use of EVM systems. Guidelines outlining the qualities and characteristics of an EVM system are set forth in the American National
Standards Institute/Electronic Industries Alliance (ANSI/EIA) Standard-748 (most current version). More detailed and specific guidance and direction is contained in OMB Circular A-11, Preparation, Submission and Execution of the Budget,
specifically in Part 7 of that Circular A-11, Planning, Budgeting, Acquisition, and Management of Capital Assets, and its supplement, the Capital Programming Guide. Based on this collective OMB guidance, EVMS is intended to be used on those
parts of acquisitions that will involve developmental effort. This would include not only those acquisitions designated by the agency as major systems but also those acquisitions that include significant developmental, modification, or upgrade
during the operational or steady-state phase of a program. 
 The FAR rule on EVMS became effective on July 5, 2006. Its purpose is to
implement EVMS policy in accordance with OMB Circular A-11. Because the new FAR coverage applies throughout the executive branch and to agencies with disparate definitions of and processes and procedures for major systems acquisitions, the FAR
Council decided against a “one-size-fits all” approach and left several significant aspects of the detailed implementation up to the discretion of each covered agency. 
 The FAR and Health and Human Services Acquisition Regulations (HHSAR) language for EVMS will be utilized for all construction or Information Technology (IT) projects. Since most of the acquisitions at the
Biomedical Advanced Research and Development Agency (BARDA) are unique in that most acquisitions are not Information Technology projects or construction projects, BARDA is developing EVM language that incorporates the 7 Principles of Earned Value
Management. These principles allow flexibility to an EVM system structure but still meet the spirit of the ANSI/EIA Standard-748. It also incorporates discipline in implementation and operations and also provides the same reporting data outlined by
OMB. 
 The Seven Principles of Earned Value Management are as follows: 

 

	 	1.	Plan all work scope to completion 

  

	 	2.	Break down the program work scope into finite pieces that can be assigned to a responsible person or organization for control of technical, schedule and cost objectives


  

	 	3.	Integrate program work scope, schedule, and cost objectives into a performance measurement baseline plan against which accomplishments can be measured. Control changes
to the baseline. 

  

	 	4.	Use actual costs incurred and recorded in accomplishing the work performed. 


 

	 	5.	Objectively assess accomplishments at the work performance level. 

  

	 	6.	Analyze significant variances from the plan, forecast impacts, and prepare an estimate at completion based on performance to date and work to be performed.


  

	 	7.	Use earned value information in the company’s management processes. 


  
 1 

  















 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

 EVM IMPLEMENTATION TIERS 
 BARDA will be implementing a tiered approach to EVM based on the type of acquisition, size of the acquisition and the technical readiness level. There are three tiers and they are as follows: 

TIER 1 
 For all
construction contracts and IT contracts the ANSI/EIA-748 Standard for Earned Value Management Systems will apply and all relevant FAR/HHSAR clauses pertaining to EVMS will be incorporated in the contract. The National Defense Industrial Association
(NDIA) Program Management Systems Committee (PMSC) ANSI/EIA-748 Standard for Earned Value Management Systems Intent Guide should be used as guidance. 
 TIER 2 
 For countermeasure research and development contracts that have a total
acquisition costs greater than or equal to $25 million and have a Technical Readiness Level (TRL) of less than 7 will apply EVM principles for tracking cost, schedule and technical performance that comply with the 7 Principles of EVM Implementation.

 TIER 3 
 For
countermeasure research and development contracts that have total acquisition costs less than $25 million but greater than $10 million will apply EVM principles for tracking cost, schedule and technical performance that are consistent with the 7
Principles of EVM Implementation. 
 This Guide is an explanation of the intent of what is expected for a Tier 2 system implementation of the 7
Principles of EVM. 

  
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 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

 SEVEN PRINCIPLES OF EVM 
 Principle 1: Plan all Work Scope 
 In a performance measurement system implementation the
Statement of Work (SOW) should reflect all work that is to be performed. In a 7 Principles implementation a Work Breakdown Structure (WBS) shall be developed to include all elements of the SOW. The level of the WBS may not be as detailed as in a
Tier 1 implementation. It would be developed at a higher level, such as level three or four, however, the government may expand specific technical legs to lower than level four and it may retract some non-technical legs to higher than 3. It is
beneficial and required to develop a WBS dictionary that explains what work is going to be performed in each WBS in detail. This will ensure that the contractor has identified all work scope and left no major work undefined. It is recommended that
the work packages descriptions are clear and detailed so that there is an understanding of the work that is to be performed in the work packages. For the 7 Principles implementation programs it would be acceptable for the WBS Dictionary be expanded
to include information that would normally be kept on a Work Authorization Document, such as charge numbers associated with the work, period of performance, the manager who is responsible for the work, and budget associated with the WBS. The
additional “WAD info” would only be added to the lowest level (i.e. level 3 or 4) of the WBS. The roll up level WBS would only include scope. By doing this documentation is limited to one document instead of two. 

By developing a WBS and a WBS Dictionary/Work Authorization Document the work scope has been defined but the documentation is greatly reduced and the
costs associated with developing and updating the documentation is reduced. The intent of the combination document is not to reduce the level of information provided to the government but to reduce the amount of documents that need to be produced.
An example of a WBS dictionary and Work Authorization document and what is expected on the document(s) is provided. 
 Principle 2: Break
Work into Finite Pieces and Define Person/Organization Responsible for Work 
 In a 7 Principles Tier 2 implementation it is recommended
that the work be broken into finite pieces in the schedule tool. It is recommended to plan the work by the lowest level WBS. The lowest level WBS (level 3 or 4) should be the control account and the activities would act as the work packages. For
Tier 2 programs that are of larger value (greater than $25M) the expectation is that the control account will be at least at level 4 and potentially level 5. Most of the normal functions accomplished when scheduling will be required on a 7
Principles Tier 2 implementation. These normal functions include, network scheduling, horizontal and vertical traceability, forecasting schedule start and completion dates, and running critical path analysis. As part of vertical traceability it is
expected that all contract milestones will be listed on the schedule. 
 The schedule should include but is not limited to include the following
fields: 
 WBS number 
 Control Account
number 
 Work package number 
 Task
name 
 Duration 
 Baseline Start and
Finish Dates 
 Actual Start and Finish Dates 
 Forecast Start and Finish Dates 
 Predecessor/Successors 

Activity Percent Complete 
 All the work
scheduled at the lowest level WBS should be identified by a single responsible manager. This manager, known as a Control Account Manager should be identified in the schedule tool and/or in a cost tool. In a 7 Principles implementation, only
individuals at the lowest level WBS need be identified and there is no requirement for the costs to roll up by organization, although if it is not cost intensive or tool restricted then developing the OBS is recommended. In many cases, BARDA will
provide the top three levels of the WBS for the contractor to use. 

  
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 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

 Principle 3a: Integrate Scope, Schedule and Budget into a Performance Measurement Baseline

 This principle integrates the work scope, the schedule and the budget into a performance measurement baseline. Since we discussed work
scope and schedule the focus of this principle is the incorporation of the budget in a time-phased manner. The budget must be integrated with the scope of work and the schedule into a Performance Measurement Baseline (PMB). The budget is made up of
both direct and indirect dollars. An accepted way of incorporating the budget and integrating with the scope and schedule is to resource load the Microsoft Project (or other scheduling tool) schedule. This is done by loading the individual people
and their loaded rate into the tool. This budget data will be input at the work package level with a rate that includes the indirect costs. The budget will have to have the capability to be rolled up to the control account level and will need to be
reported in a way that provides the responsible manager (Control Account Manager) with information needed to manage the program. Resource loading of the schedule is not the only way to incorporate the budget. As long as the budget in the budget/EV
tool is linked to the schedule activities and it is flexible to change when schedule baseline dates change, then loading the budget in the Budget/EV tool is an acceptable way to integrate the cost and schedule baselines. The budget information will
be displayed on the time-phased Control Account Plan reports. These reports should have the flexibility to report the dollars both in total dollars, as well as, direct and indirect broken out separately. Also the report is generally required as a
deliverable on most contracts and must have the capability to include earned value or Budgeted Cost of Work Performed (BCWP) and actual costs or Actual Costs of Work Performed (ACWP). 
 Budgeting of subcontractor effort will vary depending on whether or not the subcontractor is a cost plus or fixed price subcontract. If it is cost plus then the expectation is that there will be monthly
billing of costs from the subcontractor to the prime contractor and therefore budget must be planned in accordance with the work completed and billed. If it is fixed price then the budget should be planned with work execution or milestones completed
and budget should only be planned in those months where work is expected to be completed. 
 It is recommended that management reserve and
undistributed budget be utilized in the budgeting process. Undistributed budget is budget that has not yet been distributed to a control account and it requires additional time to plan the work and distribute the budget to a control account. It is a
temporary holding account and budget should only stay in Undistributed Budget for one or two months. If the work scope is easily identified to all the control accounts then the use of Undistributed Budget may not be necessary. 

Management Reserve is budget that is set aside, normally by the Program Manager, to be used to budget future but currently unknown tasks. It is
associated with risk issues and is to be used to mitigate risk. It is not part of the Performance Measurement Baseline and it should not be used for out of scope work and to cover overruns. 

  
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 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

 Principle 3b: Control Changes to the Baseline 

A properly controlled PMB is crucial to effective program management. The timely and accurate incorporation of contractual changes ensures that the
information generated from the execution of the baseline plan provides an accurate picture of progress and facilitates correct management actions and decisions. The accurate and timely incorporation of authorized and negotiated changes into the PMB
ensures that valid performance measurement information is generated for the new scope being executed. Near term new scope effort should be planned and have budget in control accounts. Far term new scope effort that cannot be reasonably planned in
the near term can either be put in planning packages in the control account or left in Undistributed Budget if the control account has not been identified. The timely and accurate incorporation of authorized and negotiated changes into the PMB
ensures that valid performance measurement information is generated for the new scope being executed. Budget revisions are made when work is added to the contract and are traceable from authorized contract target costs to the control account budgets
or from management reserve. Management reserve may be used for future work when additional in-scope work has been identified. 
 Retroactive
changes to the baseline may mask variance trends and prevent the use of performance data to project estimates of cost and schedule at completion. Controlling retroactive adjustments, which should only be made in the current period, if possible, is
imperative because they could arbitrarily eliminate existing cost and schedule variances. 
 The use of program budget logs should be used to
track and log all budget changes. The ability to track budget values for both the internal and external changes will help in the maintenance of the performance measurement baseline from program start to completion. Contractor is expected to utilize
baseline change documentation facilitating the change. It should provide the rationale/justification, approval process, work scope additions or deletions, dollars, changes to schedules, estimate at completion, etc. It should also include contractual
change documents for external changes, such as a contract modification, letter to proceed, not to exceed letter, change order, etc., that transmit and authorize the change or addition to work, budget, and schedule. Other documents that should change
if a change of scope has been authorized is: Statement of Work, WBS (changes if applicable); WBS Dictionary (additions or deletions to scope); work authorization documents authorizing new scope, schedule and budget; schedules. 

Principle 4: Use Actual Costs Incurred and Recorded in Accomplishing the Work Performed 
 Some of the new acquisitions at BARDA will be required to be compliant with the Cost Accounting Standards. For 7 Principles implementation contractors must utilize a work order/job order/task code charge
number structure that uniquely identifies costs at the control account level. This will allow for accumulation and summarization of costs to higher levels of the work breakdown structure. Actual costs are accumulated in the formal accounting system
in a manner consistent with the way the related work is planned and budgeted. Actual costs reported in the performance reports agrees with the costs recorded in the accounting system or can be explained as timing differences. The contractor will
have to be able to incorporate and reconcile to the accounting system actual costs on their Contract Performance Reports (CPR) to the customer. 

Depending on the amount of material and subcontractors on the program, it may be necessary for reporting purposes, to include accruals, or estimated
actuals, for these costs. Since material and subcontractor invoices are not paid and recorded in the accounting system for up to several months after the work has been planned, performance data will be skewed. Accruing or estimating actual costs
based on receipt (for material) and expended hours for subcontractors will alleviate this issue. The use of accrual/estimated actuals should be reviewed on a case by case basis depending on the size of program, the amount of material or
subcontractor budget and costs. If the material and subcontract effort on the project is minimal (represents less than 5% of the project budget) then the time and effort needed to manage the accruals would outweigh the benefit of having the costs
accrued since the performance data would only be minimally affected. Although actual costs are generally reported to the USG in total dollars the system must be able to differentiate and report direct costs and indirect costs if requested.

 If the subcontractor has a fixed price contract the prime contractor, then the prime contractor must report actual costs in accordance with
the work that is accomplished. This is acheived by recording the actual costs equal to the work 

  
 5 

  















 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

 
that was performed in the EVM system and on the CPR. If the subcontractor is a cost plus contract its imperative the costs the prime reports is in accordance with the costs incurred in that
month. This is necessary to ensure that the data reported is not skewed. With this premise, fixed price subcontractors cost variances should not exist or be reported on the CPR whereas the cost reported for cost plus subcontractors should be based
on what was incurred and not what has been invoiced to date, which may be months behind. 
 Principle 5: Objectively Assess Accomplishments
at the Work Performance Level 
 In order to meet this Principle, the scheduling of the scope of work in work packages or activities need to
incorporate measurable units or milestones in order to objectively assess accomplishments or obtain what we call “earned value”. These units or milestones are given a value based on labor resources needed to accomplish the work (which
becomes the Budgeted Cost of Work Scheduled or BCWS). When they are accomplished (known as Budgeted Cost of Work Performed or BCWP) they receive the value associated with the budget which measures progress. 

Schedule status to measure progress needs to be on at least on a monthly basis although it is preferred on a bi-weekly basis. As part of the status
process progress dates, such as actual start/complete and forecast start/complete need to be updated. 
 Since Microsoft Project seems to be the
schedule tool of choice by most contractors, there are four types of earned value methodologies utilized by Microsoft Project of which two assess progress by the completion of milestones and they are the 50/50 and 0/100 methodologies. In both cases,
progress is reported for completion milestones and in the 50/50 methodology fifty percent of the value of the work package/activity is credited for starting the work. The other two earned value methodologies are assessed percent complete (also know
as Supervisor’s Estimate) and level of effort (LOE). All four methodologies are legitimate earn value measurement techniques but the assessed percent complete based or supervisor’s estimates are highly discouraged. The reason is that it is
highly subjective and is not based on any quantifiable criteria. BARDA will not accept these earned value methodologies unless approved as an exception on a case by case basis. If percent complete on work packages is used with objective measurable
activities, the contractor must show distinct relationship between the budget planned at the work package level and the value earned at the activity level. If this is done properly then the measurement will be objective and the schedule variance
will be clearly understood and easy to explain. If this is not done properly then schedule activities are not aligned with the budget in the performance measurement baseline and schedule variances will not be easy to understand. If the latter is the
case, BARDA will not accept that as an acceptable earned value methodology. 
 There are built in weaknesses with the 0/100 and 50/50
methodologies also. If the responsible manager is being asked to plan their work in monthly increments in order to utilize the 0/100 methodology then they may be asked to break the work up in pieces that don’t make logical sense or represent
the natural ending of the work. Also the 50/50 methodology, which is usually used for a two month work package, will provide skewed monthly data if the resources in the work package are not loaded equally for each month. It will give an artificial
positive or negative schedule variance the first month and vice versa the next month. 
 Additional earned value methodologies, such as the
weighted milestone methodology and percent complete with milestone gates may be utilized. The weighted milestone method allows value to be earned based on the resource value in each month, which eliminates artificial schedule variances. 

For all discrete measurable work packages or control accounts, there must be an activity in each month to measure. Gaps, in which there is nothing to
measure in a month or months is not acceptable. 
 For subcontractors that have a fixed price contract with the prime contractor, the
expectation is that there will be no cost variance. The ACWP reported on the CPR will equal the BCWP earned, regardless of the payment schedule with subcontractor. 

  
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 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

 Principle 6a: Analyze Significant Variances From the Plan 

The purpose of this principle is to ensure that the earned value data is analyzed by the contractor and reported to the customer. The 7 Principles
programs should be able to calculate the cost variance (BCWP minus Actual Cost of Work Performed (ACWP) and the schedule variance (BCWP minus BCWS) at least on a cumulative basis. It is recommended that variances be calculated on a current month
basis also. The EVM system should also provide both monthly and cumulative Cost Performance Index (BCWP divided by ACWP) and Schedule Performance Index (BCWP divided by the BCWS). This data should be provided at the control account level and at the
roll up levels and it needs to be in a format for Control Account Managers and program management to be able to utilize in managing the work. 

It is also recommended that the To-Complete Performance Index (TCPI) be included in the Control Account Manager performance report. The TCPI is a
valuable index that calculates the cost performance the control account needs to perform at in order to complete the work within the current reported EAC. When the TCPI is compared against the cumulative CPI it gives a good indication whether or not
the current EAC is reasonable. For example, if a cumulative CPI is .85 and the TCPI calculates to equal 1.15 that is the performance factor that work would need to perform at in order to meet the current EAC. If the cumulative CPI is .85 then it can
be determined that the current EAC might not be reasonable. It allows management and Project Controls the opportunity to question the Control Account Manager as to the validity of the current EAC. As a rule in thumb if the deviation between the CPI
and the TCPI is greater than .2 then the CAM should reassess the control account EAC. 
 These reports, which should be provided monthly, should
also include the current Budget at Completion (BAC) and the current Estimate at Completion (EAC). In addition, it would be a plus if the CAM could see a report with their time-phased spread of hours and dollars for their budget plan (BCWS), work
accomplished (BCWP) and actual costs (ACWP). 
 For all variances that exceed the contractual variance threshold will include a description of
what caused the variance, impact to the control account and the program, and a corrective action. 
 Principle 6b: Prepare an Estimate at
Completion Based on Performance to Date and Work to be Performed 
 Providing an updated EAC is a prime concern of the customer and the
contractor. Therefore a robust EAC process should be in place whether the program is ANSI compliant or not. 
 Based on the performance to date
the Estimates at Completion can be updated on a monthly basis by the Control Account Manager in the scheduling tool during the status process or in the cost/EVM tool at the end of the month’s process prior to submittal of the EVM report. The
EAC is an element of the performance measurement system that needs to accurately reflect the contractor’s best estimate of what it will cost to complete the project. 
 Program management should be able to validate control account manager’s EACs by looking at performance indices, such as the To-Complete Performance Index, as well as independent statistical EACs.

 Principle 7: Use EVMS Information in the Company’s Management Processes 
 One of the key areas that concerns government Program Management Offices (PMO) is the level of importance that contractor’s place on EVM as a management tool. During a site visit, such as conducting
an Integrated Baseline Review, the PMO gauges what the interest, knowledge, and most importantly, the usage of the performance measurement data in managing the program. They want to know that the managers on the program, including the program
manager, have received some earned value training. The level of involvement and use of the EVM data to manage their schedule, cost and technical issues is ascertained by questions. The PMO can also tell by how robust the EACs are and if the variance
narratives are being written with impacts to the program and corrective actions being monitored by the contractor. It is important that the contractor’s management team, including the Program Manager, utilize the data from the performance
measurement system as a management tool. They should be knowledgeable and understand the data. They should know what is causing the variances and ensure that the 

  
 7 

  















 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

 
variance narratives are written properly and answer what the issues, impacts and corrective actions are. They should be able to demonstrate that they use the information to assist them in the
management decision process. They should hold their Control Account Managers accountable to use the data and write clear proper variance analysis report (VAR). If the Control Account Manager does not write a proper VAR then Project Controls needs to
help instruct them how to do it. It is recommended that prior to the Earned Value report be sent to the government that the Program Manager has a meeting with the Control Account Managers and Project Control and review the data and ensure that the
variance analysis is complete and that the Program Manager agrees with it. This review is also used to ensure that the EACs are acceptable to the Program Manager, who is ultimately responsible for the program EAC. This is an efficient and quick way
to make any adjustments to the earned value report since all the key personnel are in one room. If the data appears to be unreliable then the PM needs to hold Project Controls accountable to ensure that they are using discipline in changing
baselines, assessing process properly, and capturing actual costs to ensure that the data that is reported is accurate. 

  
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 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

 APPENDICES 
 The following appendices provide further support in understanding the meaning and intent of properly implementing the 7 Principles of EVM. 
 Appendix 1 is a glossary of the terms used in the Intent Guide. 
 Appendix 2 is supplemental
guidance on EVM implementation. It provides some guidelines on what is expected in the implementation, required documents needed for the Performance Measurement Baseline Review, expected EVM implementation costs, EVM engines functionality needs,
explains what is expected in the monthly EVM facilitation, discusses what EVM consultants need to know, and what the expected costs of EVM to BARDA. 
 Appendix 3 are examples of some of the EVM documents that are needed in an EVM system. There are three documents and they mostly apply to Tier 2 EVM implementations. These documents are samples and are
not a reflection of the specific way the document must look. It’s included to provide contractors with an understanding of the type of information that is expected on these forms. 
 APPENDIX 1: Glossary of Terms 

			
	Actual Cost of Work Performed (ACWP)	  	The costs actually applied and recorded in accomplishing the work performed within a specified period.
		
	Actual Direct Cost	  	Those costs identified specifically with a contract, based upon the contractor’s cost identification and accumulation system as accepted by the cognizant DCAA
representatives. (See Direct Costs).
		
	Advance Agreement (AA)	  	An agreement between the contractor and the Contract Administration Office concerning the application of an approved earned value management system to contracts within the
affected facility.
		
	Authorized Work	  	That effort which has been authorized and is on contract, or that for which authorized contract costs have not been agreed to but for which written authorization has been
received.
		
	Baseline	  	(See Performance Measurement Baseline).
		
	Budget at Completion (BAC)	  	The sum of all budgets (BCWS) allocated to the contract. Synonymous with the term Performance Measurement Baseline.
		
	 Budgeted Cost for Work

Performed (BCWP)
	  	The sum of the budgets for completed Work Packages and completed portions of open Work Packages, plus the appropriate portion of the budgets for level of effort and apportioned
effort (Also see Earned Value).
		
	 Budgeted Cost for Work

Scheduled (BCWP)
	  	The sum of the budgets for completed Work Packages, planning packages, etc., scheduled to be accomplished (including in-process Work Packages), plus the amount of level of effort
and apportioned effort scheduled to be accomplished within a given time period.
		
	Change Order (CO)	  	A formal authorization by the Procuring Contracting Officer for a change of scope to an existing contract
		
	Contract Modification	  	A written and binding authorization to proceed created after change proposal negotiations.


  
 9 

  















 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 


			
	Contract Budget Base (CBB)	  	The negotiated contract cost plus the estimated cost of authorized unpriced work, where:
		
		  	(1) Negotiated Contract Cost is that cost on which contractual agreement has been reached. For an incentive contract, it is the definitized contract target cost plus/minus the
value of changes which have been priced and incorporated into the contract through contract change order or supplemental agreement. For fixed-fee contracts, it is the negotiated estimated cost. Changes to the estimated cost will consist only of the
formal contract modifications or change orders or change in the contract statement of work, not for cost growth, and
		
		  	(2) Estimated cost of authorized, unpriced work is the estimated cost (excluding fee or profit) for that work for which written authorization has been received, but for which
definitized contract prices have not been incorporated into the contract through supplemental agreement.
		
	Control Account	  	A management control point at which actual costs can be accumulated and compared to budgeted cost for work performed. A control account is a natural control point for
cost/schedule planning and control since it represents the work assigned to one responsible organizational element on one contract work breakdown structure (CWBS) element.
		
	Control Account Manager (CAM)	  	A member of a functional organization responsible for task performance detailed in a Control Account and for managing the resources authorized to accomplish the
tasks.
		
	 Control Account Plan (CAP)

Report
	  	A CAP report is a timephased report which reflects all the work and effort to be performed in a control account. The CAP report will reflect the hours and dollars by element of
cost (labor, subcontract, ODC, etc).
		
	 Contract Performance Report

(CPR)
	  	The monthly report submitted to the customer showing the current, cumulative and at completion status, the performance measurement baseline, manpower loading, and a narrative
explanation of significant program variances.
		
	Contract Target Cost	  	The dollar value (excluding fee or profit) negotiated in the original contract plus the cumulative cost (excluding fee or profit) applicable to all definitized changes to the
contract. It consists of the estimated cost negotiated for a cost plus fixed fee contract and the definitized target cost for an incentive contract. The contract target cost does not include the value of authorized/un-negotiated work, and is thus
equal to the contract budget base only when all authorized work has been negotiated/definitized.
		
	Cost Performance Index (CPI)	  	An efficiency rating reflecting a project’s budget performance - either over or under. Measured as a ratio of the budgeted value of work accomplished versus the actual costs
expended for a given project time period. The formula for CPI is BCWP/ACWP.
		
	Discrete Effort	  	Program effort that has a measurable output, product or service.
		
	Direct Costs	  	Those costs (labor, material, etc.) that can be reasonably and consistently related directly to service performed on a unit of work, and are charged directly to the contract,
without distribution to an overhead unit.
		
	Earned Value	  	See Budgeted Cost for Work Performed (BCWP)
		
	 Earned Value Management
 System
(EVMS)
	  	A project management system utilized for measuring project progress in an objective manner. Combines measurements of scope, schedule, and cost in a single integrated
system.


  
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 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 


			
	Estimate at Completion (EAC)	  	A value (expressed in dollars and/or hours) developed to represent a realistic appraisal of the final cost of tasks when accomplished. It’s the sum of direct & indirect
costs to date plus the estimate of costs for all authorized Work remaining. The EAC = ACWP + the Estimate-to-Complete.
		
	Estimate to Completion (ETC)	  	A value (expressed in dollar and/or hours) developed to represent a realistic appraisal of the cost of the work still required to be accomplished in completing a
task.
		
	Indirect Costs	  	Represents those costs, because they are incurred for common or joint objectives, are not readily subject to treatment as direct costs. (See overhead).
		
	Integrated Baseline Review (IBR)	  	 An Integrated Baseline Review (IBR) also known as Performance Measurement Baseline Review (PMBR) is a formal review led by the
Government Program Manager and Technical Support Staff. An IBR is conducted jointly with the Government and their Contractor counterparts.
  

The purpose of an IBR is to: verify the technical content of the Performance Measurement Baseline (PMB); assess the accuracy of the related resources
(budgets) and schedules; identify potential risks.

		
	Integrated Master Plan (IMP)	  	The overall program plan including the work definition, technical approach, performance criteria, and completion criteria.
		
	Integrated Master Schedule (IMS)	  	The IMS expands the IMP to the work planning level. It defines the tasks, their durations, milestones, milestone dates which relate to the IMP completion criteria, and
interdependencies required to complete the program. The IMP and IMS are used to track and execute the program.
		
	Integrated Product Team (IPT)	  	A grouping of project personnel along project objective lines rather than along organizational lines. Integrated Product Teams are work teams that represent a transition from a
functional organization structure to a multi-functional project objective arrangement.
		
	Internal Replanning	  	Replanning actions performed by the program for remaining effort within the recognized total allocated budget.
		
	Level of Effort (LOE)	  	Work that does not result in a final product, e. g., liaison, coordination, follow-up, or other support activities, and which cannot be effectively associated with a definable
end product process result. It is measured only in terms of resources actually consumed within a given time period.
		
	Management Reserve (MR)	  	An amount of the total Contract Budget Base (CBB) withheld for management control purposes rather than designated for the accomplishment of a specific task or set of tasks. It is
not a part of the Performance Measurement Baseline.
		
	Negotiated Contract Target Cost	  	The estimated cost negotiated in a Cost Plus Award Fee (CPAF), Cost Plus Fixed Fee (CPFF), Cost Plus Incentive Fee (CPIF) or Fixed Price Incentive Fee (FPIF)
contract.
		
	Original Budget	  	The budget established at, or near, the time the contract was signed, based on the negotiated contract cost.


  
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	Overhead	  	Indirect labor and material, supplies and services costs and other charges, which cannot be consistently identified with individual programs.
		
	Other Direct Costs	  	A group of accounting elements which can be isolated to specific tasks, other than labor and material. Included in ODC are such items as travel, computer time, and
services
		
	 Performance Measurement

Baseline (PMB)
	  	The time-phased budget plan against which contract performance is measured. It is formed by the budgets assigned to scheduled Control Accounts and the allocation of overhead
costs. For future effort, not planned to the Control Account level, the performance measurement baseline also includes budgets assigned to higher level WBS elements, and undistributed budgets. It equals the total assigned budget less management
reserve.
		
	Performing Organization	  	A defined unit within the program organization structure, which applies the resources to performs the authorized scope of work.
		
	Planning Package	  	A logical aggregation of far term work within a Control Account that can be identified and budgeted but not yet defined into Work Packages.
		
	Reprogramming	  	Replanning of the effort remaining in the contract, resulting in a new budget allocation which exceeds the contract budget base. The resulting baseline is called an Over Target
Baseline (OTB).
		
	Responsible Organization	  	A defined unit within program’s organization structure that is assigned responsibility for accomplishing specific tasks.
		
	Risk Register	  	Is a tool commonly used in project planning and organizational risk assessments. It is often referred to as a Risk Log. It is used for identifying, analyzing and managing
risks.
		
	 Schedule Performance Index

(SPI)
	  	An efficiency rating reflecting how quickly or slowly project work is progressing. Measured as a ratio of work accomplished versus work planned for a given period of time. The
formula for SPI is BCWP/BCWS.
		
	Significant Variances	  	Those differences between planned and actual cost and schedule performance which require further review, analysis, or action. Appropriate thresholds are established as to the
magnitude of variances which will require variance analysis.
		
	Statistical Estimate at Completion	  	Is a single point estimate that can be quickly prepared and used to test the reasonableness of the current cost estimates and budget and to indicate when a comprehensive EAC
should be prepared
		
	Time-Phased S/P/A Report	  	Provides the timphased budget, performance (earned value) and actual costs at a specific level. It may be at the reporting level, control account, and/or work package level. In
all cases the report will also provide the data at the total project level.
		
	 To-Complete Performance Index

(TCPI)
	  	An efficiency rating that provides a projection of the anticipated performance required to achieve the EAC. TCPI indicates the future required cost efficiency needed to achieve a
target EAC (Estimate At Complete). Any significant difference between TCPI and the CPI needed to meet the EAC should be accounted for by management in their forecast of the final cost.


  
 12 


  















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	Total Allocated Budget (TAB)	  	The sum of all budgets allocated to the contract. Total allocated budget consists of the performance measurement baseline and all management reserve. The total allocated budget
will reconcile directly to the Contract Budget Base (CBB). Any differences will be documented as to quantity and cause.
		
	Undistributed Budget (UB)	  	Budget applicable to contract effort which has not yet been identified to WBS elements at or below the lowest level of reporting to the Government.
		
	Variance Analysis Report (VAR)	  	The internal report completed by the Control Account Manager and submitted, through the Intermediate Manager, to the program manager for those Control Accounts which have
variances in excess of established thresholds.
		
	Variances	  	(See Significant Variances).
		
	 Work Authorization Document

(WAD)
	  	A form used to formally authorize and budget work to the Control Account Manager. This document must include, as a minimum, the Control Account number, Statement of Work,
scheduled start and finish dates, budget, and the identity of the CAM. It must be approved by Intermediate Manager, and be agreed to by the Control Account Manager.
		
	 Work Breakdown Structure

(WBS)
	  	 A product-oriented, family-tree composed of hardware, software, services, data and facilities which results from system engineering
efforts. A work breakdown structure displays and defines the product(s) to be developed and/ or produced and relates the elements of work to be accomplished to each other and to the end product.

 
 Program WBS. The work breakdown structure that covers the acquisition of a specific
defense material item and is related to contractual effort. A program work breakdown structure includes all applicable elements consisting of at least the first three levels of the work breakdown structure and extended by the program manager and /or
contractor(s). A program work breakdown structure has uniform element terminology, definition, and placement in the family tree structure.
  

Contract WBS (CWBS) The complete WBS for a contract, developed and used by a contractor within the guidelines of MIL-Handbook 881 (latest revision) or
NASA WBS Handbook (insert reference) or other customer guidelines and according to the contract work statement. It includes the approved work breakdown structure for reporting purposes and its discretionary extension to the lower levels by the
contractor, in accordance with MIL-Handbook 881 and the contract work statement. It includes all the elements for the products (hardware, software, data, or services) which are the responsibility of the contractor.

		
	Work Packages	  	 Detailed short-span jobs, or material items, identified by the contractor for accomplishing work required to complete the contract. A
Work Package has the following characteristics.
  
 It represents units of
work at levels where work is performed.
  
 It is clearly distinguishable
from all other work packages.
  
 It is assignable to a single
organizational element.
  
 It has scheduled start and finish dates and, as
applicable, interim milestones, all of which are representative of physical accomplishment.



  
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 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 


			
		  	 It has a budget or assigned value expressed in terms of dollars, man-hours or other measurable units.

 
 Its duration is limited to a relatively short span of time or it is subdivided by
discrete value milestones to facilitate the objective measurement of work performed.
  
 It is integrated with detailed engineering, manufacturing, or other schedules.

		
	Work Package Budgets	  	Resources which are formally assigned by the CAM to accomplish a Work Package, expressed in dollars and/or hours.


  
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 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

 Appendix 2 Supplemental EVM Implementation Guideline 

Implementation of a 7 Principles of EVM system should be less expensive than if there was an ANSI/EIA-748. There is no need for the system to have to go
through an EVM compliance review, plus the level of documentation should be streamlined. 
 The implementation should include: 

 

	 	—	 	 EVM Process flows that reflect how a company will build and maintain the EVM system. (EVM Procedures may also be included if the cost associated with
them is reasonable) 



	 	—	 	 EVM engine tool and a schedule tool. It is not necessary to load the schedule tool, such as Microsoft Project, with resources. This adds an extra
strep, additional costs and little to no value. It is recommended that all resource information be loaded in the EVM engine and leave the schedule tool to what it does best, measure progress through time (duration). 



	 	—	 	 The EVM Engine needs to be integrated with the company’s accounting system. 



Documentation needed for the Performance Measurement Baseline Review (PMBR) 

 

	 	—	 	 WBS Dictionary/Control Account Work Authorization Documentation 



	 	—	 	 Integrated Master Schedule 



	 	—	 	 Responsibility Assignment Matrix 



	 	—	 	 Control Account Plans 



	 	—	 	 PMB Log 



	 	—	 	 Baseline Revision Documents 



	 	—	 	 Risk Register 


 EVM
IMPLEMENTATION COSTS 
 The cost for an implementation depends on the size of the contract and the tier level of EVM. 

Tier 2 (projects greater than $25M) Implementation costs should range $75K-$150K 
 Tier 3 (projects less than $25M) 
 Implementation costs should range ($50K - $100K)

 EVM ENGINES/TOOLS 

Depending on the size of the contract would predicate the level of functionality that would be needed. For Tier 2 contracts a larger, more robust EVM
engine would be needed. For the Tier 3 small contracts MS Project or the MSP wrap-around would probably suffice although the more robust EVM engines can be used also. 
 Tier 2 
 It is recommended that one of the larger and flexible EVM engines be utilized. The
tool should have the flexibility to be able to download data from MS Project and be able to upload or input budget data to provide time-phased budget information down to the work package level. It should be able to incorporate the companies
Organization Breakdown Structure. It should be able to maintain baseline, actual costs, forecast and performance periodic data. It should be able to forecast Estimate to Complete with the ability to set up different rate tables if necessary. It
should have the capability to use all earned value methodologies. It should be able to print many types of EVM reports that can provide information to the Control Account Managers (CAM) and Program Managers (PM), as well as, the Contract Performance
Report (CPR) and the Control Account Plans (CAP) that are contract deliverables. 

  
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 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

 Tier 3 
 For Tier 3 projects, a company can certainly utilize an EVM engine as listed above or a less robust, less expensive EVM engine that provides the CPR and timephased S/P/A report. It may also use the
Microsoft Project wrap-around tools of which there are several on the market. These tools also will provide the CPR and timephased S/P/A report for contract deliverable purposes. 
 EVM FACILITATION 
 EVM facilitation pertains to the monthly process to include: 

 

	 	—	 	 Schedule Status 



	 	—	 	 Integration of accounting data into EVM engine 



	 	—	 	 Run monthly reports for Control Account Managers (Tier 2 only) 



	 	—	 	 Prepare the monthly Contract Performance Report (CPR) Formats 1 and 5 



	 	—	 	 Run the Control Account Plans for both internal and external (contract requirement) 



	 	—	 	 PMB Change Control 



Depending on the size of contract, a contractor should have an EVM/cost analyst and schedule analyst for a Tier 2 contract and one combined cost/schedule
analyst for a Tier 3 contract. The costs for a schedule analyst on a yearly basis for an employee hire should be equal to or less than $135K. For a cost analyst it should be equal to or less than $120K. If a company is bringing in a contractor to
provide staff implementation the costs should be up to $135/hr for a schedule analyst and $120/hr for an EVM/cost analyst. 
 EVM CONSULTANTS

 There may be the need to bring in consultants to help set up your EVM system and perhaps provide EVM staff augmentation to provide the
monthly facilitation. Make sure that you shop around and get several quotes. Also make sure that the consultants understand the statement of work pertaining to the BARDA EVM requirements. Most EVM consultants are used to working with companies that
have a requirement to implement an ANSI/748 compliant EVM system per the DoD requirements and it is important that they have an understanding of what is required in a 7 Principles EVM implementation so that they don’t propose much more complex
EVM system than is needed. Please be advised that the government will only accept reasonable costs associated with implementing a 7 Principles of EVM system. 
 COST OF EVM 
 BARDA is working diligently to keep the costs of EVM implementation and
facilitation at a reasonable level. Since the goal at BARDA is to provide an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies, and diagnostic tools for public health medical emergencies, it
is imperative that the funds for product development are used for that such purpose. BARDA expects the costs for implementation and monthly facilitation of EVM to range 1%-2% of development budget. This is ratified by the white paper by
Dr. Christenson titled “The Costs and Benefits of the Earned Value Management Process”. 

  
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 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

 Appendix 3 Sample EVM Documents 
 WBS 1.4.1.x Cardiac (QTc) Safety 
 Description 

Study Title: “A Phase 1 study to assess the cardiovascular safety of intravenous (IV) Panaceomycin in volunteers” (Thorough QT Study)

 We will conduct a thorough evaluation of the cardiac effect of Panaceomycin Injection via a randomized, double-blind
crossover study. A total of 100 participants (18-22 per arm) will randomize to one of five study arms to receive in a double-blind fashion a single IV infusion of either Panaceomycin Injection 10 mg/kg, Panaceomycin Injection at a
supra-therapeutic dose, ciprofloxacin (positive control), or placebo. 12-Lead digital ECGs will be collected in triplicate via Holter monitor from each participant during dosing. Seven days after dosing, participants will be re-randomized to receive
another treatment. ECGs will be collected and analyzed. A full statistical analysis and expert ECG report will be generated. Serum PK samples will also be collected at ECG collection time points and analyzed to confirm exposure. 

Targeted Outcome: No evidence of delay in cardiac repolarization induced by Panaceomycin as shown by analysis of the QT interval.


  
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 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

 Subcontractors 
  

					
	Vendor	  	
Area of Responsibility

	Phase Research	  	 ¡       
	  	Study Documentation Design and Development
	 	  	 ¡       
	  	Clinical Monitoring: Includes site initiation, interim, and close-out monitoring visits,
	 	  	 ¡       
	  	Pharmacovigilence
	 	  	 ¡       
	  	Data Management: Includes build and maintenance of electronic case report forms (eCRFs); data query generation and
resolution
	 	  	 ¡       
	  	Biostatistics
	 	  	 ¡       
	  	Medical Writing:
	 	  	 ¡       
	  	 Project Management: The Project Manager will actively facilitate Phase Research’s interaction with
the research site and provide close monitoring oversight in conjunction with the assigned CRA. Project Management will also assist in the finalization of all applicable study documents and provide coordination between study
vendors.

	 	  	 ¡       
	  	Pass-through Expenses
	 	  		  	  
 Travel
for CRA monitoring visits to clinical sites, shipping and printing costs
  

	 	  	 ¡       
  
	  	 Investigator Grants

 

	Energetics	  	
Core Cardiac Lab
  

	TBD	  	
Clinical study site(s)
  

	Pulse Tech	  	 To
provide Central Lab services
  

	Analyx	  	 To
perform PK analyses
  

	Claritron	  	 To
write the PK report
  

	Obelisk	  	 To
label and distribute study drug product
  


 Consultants 
  

			
	Joe Josephs	 	 Internal
Medical Monitor:
  
 Sponsor medical oversight

	Rolf Xerd	 	
Pharmacologist:
  
 Design and analysis consultation for PK parameters and analysis

	Julie Simms	 	 Clinical Trials
Manager
  

	Phil Thomas	 	 Medical
Writer
  

	Claire Cools	 	 SAS
Programmer
  

	Mary Doe	 	 Clinical
Contracts
  

	Jim Dodds	 	 Supply Chair
Manager
  



  
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 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

 Milestones, EV at Milestones 
 Consultants and Phase Project Management will earn value as Level of Effort activities. All other costs will earn value according to the schedule below. 

 

			
	 Signed Study Protocol

 
	  	        10% 
     
	 First participant dosed

 
	  	        20% 
     
	 40 % Enrollment

 
	  	        35% 
     
	 70% Enrollment

 
	  	        50% 
     
	 Last participant procedure (Treatment
phase)
  
	  	        60% 
     
	 Last participant follow-up

 
	  	        70% 
     
	 Database lock

 
	  	        80% 
     
	 Clinical Study Report

 
	  	        90% 
     
	 Transferred Trial Master File

 
	  	        100% 
       

 Deliverables 
  

	 	1.	Signed Study Protocol 


	 	2.	Top-line data 


	 	3.	Signed Clinical Study Report 

 External
Dependencies 
  

	 	1.	Top-line Data from an External Clinical Study Identifying Panaceomycin Maximum Tolerated Dose as a single dose in Humans. The Maximum Tolerable Dose will be defined in
a study not included in the BARDA contract. This dose will be used in selecting the Supra-therapeutic dose in this Thorough QT Study. 


	 	2.	Successful production of cGMP lot of Panaceomycin. 


	 	3.	Enrollment and retention of study participants. 

  

Sample WBS Dictionary 

  
 19 


  















 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 

  

																					
	  
 Work Authorization
  

	 	 	 Project/Contract

 
	 	BARDA	 	WBS #	 	1.1.6.2
	 	 	 WBS description

 
	 	Program Management, Meetings and Control
	 	 	 Authorization version #

 
	 	1	 	Scheduled Start	 	Oct 2010	 	Scheduled Finish	 	Sep 2012
	  
 Work Description
  

	 	 		 		 		 	  
	 		 		 		 		 		 	 
	 	 		 	staff will manage the integration and performance control of the program.
	  

For further detail, see description of scope for WBS 1.1.6.2

	 	 		 		 		 		 		 		 		 		 		 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	Budget
	 		 		 		 		 		 	
	 	 	Labor	 	$250,000	 		 		 		 		 		 	
	 	 	Subcontractors	 	$	 		 		 		 		 		 	
	 	 	Consultants	 	$	 		 		 		 		 		 	
	 	 	Material	 	$	 		 		 		 		 		 	
	 	 	Travel	 	$	 		 		 		 		 		 	
	 	 	Total  	 	$250,000	 		 		 		 		 		 	
	  
 Approvals
  

	 	 	Control Account Manager	 	Name:   Benjamin Gay	 	Signature:	 	 	 	Date:	 	 
	 	 		 	 	 		 	 	 		 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Project Manager	 	Name:   Ronald Smith	 	Signature:	 	 	 	Date:	 	 
	 	 		 	 	 		 	 	 		 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 	 	Finance	 	Name:   Denise Blessi	 	Signature:	 	 	 	Date:	 	 
	 	 		 	 	 		 		 	 	 		 	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 

  
 Sample Work Authorization
Document 

  
 20 


  















 7 Principles of EVM Tier 2 System Implementation Intent Guide 

 


																													
		  	CAP:	  	    1.1.1 Drug Production	  	Month End:       3/31/2011	  		  		  		  		  	

  

																																																							
	 Control Account

Performance
	 		 				 				 				 				 				 				 				 				 				 				 				 				 			
	 	 	 	 	Month 1	 	 	Month 2	 	 	Month 3	 	 	Month 4	 	 	Month 5	 	 	Month 6	 	 	Month 7	 	 	Month 8	 	 	Month 9	 	 	Month 10	 	 	Month 11	 	 	Month 12	 	 	Total    	 
	 BCWS
	 		 	 	200 	  	 	 	30 	  	 	 	30 	  	 	 	40 	  	 	 	60 	  	 	 	80 	  	 	 	60 	  	 	 	80 	  	 	 	15 	  	 	 	25 	  	 	 	30 	  	 	 	25 	  	 	 	675	  
	 BCWP
	 		 	 	10 	  	 	 	190 	  	 	 	60 	  	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 ACWP
	 		 	 	12 	  	 	 	190 	  	 	 	60 	  	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 SV
	 		 	 	-190 	  	 	 	160 	  	 	 	30 	  	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	 CV
	 		 	 	-2 	  	 	 	0 	  	 	 	0 	  	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 
	  
 Resource Summary
	 		 				 				 				 				 				 				 				 				 				 				 				 				 			
	 	 	 	 	Month 1	 	 	Month 2	 	 	Month 3	 	 	Month 4	 	 	Month 5	 	 	Month 6	 	 	Month 7	 	 	Month 8	 	 	Month 9	 	 	Month 10	 	 	Month 11	 	 	Month 12	 	 	Total	 
	 Labor
	 		 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	120	  
	 Sub DB
	 		 	 	 	 	 	 	20 	  	 	 	20 	  	 	 	30 	  	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	70	  
	 Sub DP
	 		 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	50 	  	 	 	70 	  	 	 	50 	  	 	 	70 	  	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	240	  
	 Sub Pack
	 		 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	5 	  	 	 	20 	  	 	 	15 	  	 	 	40	  
	 Material
	 		 	 	190 	  	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	190	  
	 ODC
	 		 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	5 	  	 	 	10 	  	 	 	 	 	 	 	 	 	 	 	15	  
	 BCWS
	 		 	 	200 	  	 	 	30 	  	 	 	30 	  	 	 	40 	  	 	 	60 	  	 	 	80 	  	 	 	60 	  	 	 	80 	  	 	 	15 	  	 	 	25 	  	 	 	30 	  	 	 	25 	  	 	 	675	  
	  

Work Package

Summary
	 		 				 				 				 				 				 				 				 				 				 				 				 				 			
	 	 	EVM    	 	Month 1	 	 	Month 2	 	 	Month 3	 	 	Month 4	 	 	Month 5	 	 	Month 6	 	 	Month 7	 	 	Month 8	 	 	Month 9	 	 	Month 10	 	 	Month 11	 	 	Month 12	 	 	Total	 
	 Sub Contract

Management
	 	  LOE    	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	10 	  	 	 	120	  
	 Purchase Materials
	 	  0/100    	 	 	190	  	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	190	  
	 Manufacture Drug

Substance
	 	  MS    	 	 	 	 	 	 	20 	  	 	 	20 	  	 	 	30 	  	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	70	  
	 Manufacture Drug

Product
	 	  MS    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	50 	  	 	 	70 	  	 	 	50 	  	 	 	70 	  	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	240	  
	 Ship
	 	  Units    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	5 	  	 	 	10 	  	 	 	 	 	 	 	 	 	 	 	15	  
	 Package & Store
	 	  Units    	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	5 	  	 	 	20 	  	 	 	15 	  	 	 	40	  
	 BCWS
	 		 	 	200 	  	 	 	30 	  	 	 	30 	  	 	 	40 	  	 	 	60 	  	 	 	80 	  	 	 	60 	  	 	 	80 	  	 	 	15 	  	 	 	25 	  	 	 	30 	  	 	 	25 	  	 	 	675	  

 Sample Control Account Plan 

  
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