Document:

Exhibit

 
 
Exhibit 10.47

KB HOME
2014 EQUITY INCENTIVE PLAN
RESTRICTED STOCK AGREEMENT
This Restricted Stock Agreement (“Agreement”) is made on [DATE] (“Award Date”) by and between KB Home, a Delaware corporation (“Company”), and [NAME] (“Holder”).  Capitalized terms used in this Agreement and not defined herein have the respective meanings given to them in the KB Home 2014 Equity Incentive Plan (“Plan”).
A G R E E M E N T
1.Award.  Subject to the terms of the Plan and this Agreement, the Company hereby awards to Holder an aggregate of [SHARES #] shares of Common Stock of the Company (the “Award”).  Except as provided in this Agreement, the shares of Common Stock subject to the Award (“Award Shares”) cannot be transferred in any manner.  A copy of the Plan is attached hereto and/or is available upon request, and is made a part hereof.
2.Lapse of Transferability Restrictions (Vesting of Award).  Subject to Section 3 below, the transferability restrictions imposed by this Agreement and the Plan on the Award Shares will lapse, and, subject to Section 7 below, the Award Shares will become freely tradable, according to the [VESTING SCHEDULE]. 
3.Forfeiture of Award Shares.  Holder will immediately forfeit all rights, title and interests in and to all Award Shares, without any consideration, that are subject to transferability restrictions under this Agreement on the date Holder experiences a Termination of Service other than a Termination of Service as a result of Holder’s death or Disability.  If Holder’s Termination of Service is due to Holder’s death or Disability, the transferability restrictions imposed by this Agreement and the Plan on the Award Shares will lapse, and, subject to Section 7 below, the Award Shares will become freely tradable on the date of such event.  “Disability” means (i) “disability” as defined in any employment agreement then in effect between Holder and the Company or applicable Affiliate or (ii) if not defined therein, or if there shall be no such agreement, “disability” as defined in the long-term disability plan then maintained by the Company or the applicable Affiliate, or (iii) if there shall be no plan, a medically determinable physical or mental impairment that can be expected to result in death or can be expected to last for a continuous period of not less than six (6) months, where such impairment causes Holder to be unable to perform in all material respects his or her duties and responsibilities to the Company or applicable Affiliate or any substantially similar duties and responsibilities.  The Company shall have the sole right to determine whether Holder’s Termination of Service constitutes a Disability.  In addition, the Committee, in its discretion, may accelerate the lapsing of the transferability restrictions under this Agreement for some or all of the Award Shares at any time, subject to the limitations on acceleration set forth in the Plan.  If and to the extent so accelerated, the transferability restrictions will lapse as of the date or upon the occurrence of the condition specified by the Committee. 
4.Delivery of Award Shares; Taxes.  Subject to the Company’s right under the Plan to record Award Shares in the Company’s books in uncertificated form, the Company will deliver to Holder (or to Holder’s estate or permitted beneficiary(ies) in the event of Holder’s death) stock certificate(s) representing those Award Shares as to which transferability restrictions have lapsed in accordance with this Agreement as soon as practicable after any such lapse, provided that Holder (or Holder’s estate or permitted beneficiary(ies)) has paid to the Company the amount of any taxes the Company is required to withhold in connection with any such lapse.  At Holder’s (or Holder’s estate’s or permitted beneficiary(ies)’) discretion, Holder (or Holder’s estate or permitted beneficiary(ies)) may direct the Company to withhold Award Shares to satisfy any tax withholding obligation that may arise upon the lapse oftransferability restrictions as provided under this Agreement.  If Holder makes an election under Section 83(b) of the Code to be taxed with respect to the Award as of the Award Date rather than as of the

date any transferability restrictions lapse or the date upon which Holder would otherwise be taxed under Section 83(a) of the Code, Holder must deliver a copy of such election to the Company promptly after filing such election with the Internal Revenue Service. 
5.Dividends.  Cash dividends or other cash distributions paid on or in respect of shares of Common Stock of the Company that are not restricted and are freely tradeable (“Unrestricted Shares”) will be equally and contemporaneously paid to Holder on or in respect of any Award Shares that are subject to transferability restrictions under this Agreement.  In addition, any stock or other non-cash distributions issued on or in respect of Unrestricted Shares will be equally and contemporaneously issued on or in respect of such Award Shares, but will be held in escrow and will be subject to the transferability restrictions and forfeiture conditions imposed under this Agreement on Award Shares.
6.Additional Terms and Adjustments.  This Award is made subject to all of the terms and conditions of the Plan, including without limitation any terms, rules, or determinations made by the Committee pursuant to its authority under the Plan and Plan provisions on adjustment of awards, non-transferability, satisfaction of tax requirements and compliance with other laws.  
7.Additional Restrictions.  The Company may impose such restrictions, conditions or limitations as it determines appropriate as to the timing and manner of any resales or other transfers of any Award Shares as to which transferability restrictions have lapsed as provided under this Agreement, including without limitation (a) restrictions under an insider trading or other Company policy, (b) restrictions designed to delay and/or coordinate the timing and manner of sales by Holder and others following a public offering of the Company’s securities, (c) stock ownership or holding requirements and (d) the required use of a specified brokerage firm for such resales or other transfers.  
8.California Law.  This Agreement will be construed, administered and enforced in accordance with the laws of the State of California.  
9.Rescission.  This Agreement and the Award will be subject to rescission by the Company if an executed original of this Agreement executed by Holder is not received by the Company within four weeks of the Award Date.
10.Compliance With Laws.  Holder acknowledges that the Plan and this Agreement are subject to compliance with all applicable laws and regulations, the rules of any Securities Exchange, and to such approvals by any listing, regulatory or governmental authority as may, in the opinion of counsel for the Company, be necessary or advisable in connection therewith.  The Award Shares shall be subject to such restrictions, and Holder shall, if requested by the Company, provide such assurances and representations to the Company as the Company may deem necessary or desirable to assure compliance with all applicable legal requirements.  
11.Entire Agreement.  This Agreement sets forth the entire agreement and understanding of the parties with respect to the subject matter of this Agreement, and supersedes all prior and contemporaneous oral and written agreements and understandings relating to such subject matter.  Holder agrees to be bound by the terms and conditions of this Agreement and of the Plan, and that in the event of any conflict between this Agreement and the terms of the Plan, the terms of the Plan shall prevail.  All designations, determinations, interpretations, and other decisions under or with respect to this Agreement or the Award will be within the sole discretion of the Committee, may be made at any time and will be final, conclusive, and binding upon all persons, including, but not limited to, the Company, any Subsidiary, Holder, any stockholder and any employee of the Company or any Affiliate. HOLDER ACKNOWLEDGES AND AGREES THAT THE COMMITTEE SHALL ADMINISTER THIS AGREEMENT AND THE AWARD, AND THAT HOLDER IS BOUND BY, AND THE AWARD IS SUBJECT TO, ANY TERMS, RULES OR DETERMINATIONS MADE BY THE COMMITTEE.
12.Non-Transferability.  The Award may not be sold, pledged, assigned or transferred in any manner other than as permitted by the Plan.

13.No Obligation.  Neither the execution and delivery of this Agreement nor the issuance of the Award shall confer upon Holder any right to be employed or engaged in any capacity by the Company or any Affiliate, or to continue in such employment or engagement, or shall interfere with or restrict in any way the rights of the Company and any Affiliate, which rights are hereby expressly reserved, to discharge Holder at any time.
14.Notice.  Any notice given hereunder to the Company will be addressed to the Company at its corporate headquarters, attention Senior Vice President, Human Resources, and any notice given hereunder to Holder will be addressed to Holder at Holder’s address as shown on the records of the Company.
15.Section 409A.  The Award is intended to be outside the scope of Section 409A of the Code, and this Agreement shall be interpreted in a manner consistent with such intent.  Notwithstanding anything to the contrary in the Plan or in this Agreement, Holder agrees that Holder (or Holder’s estate or permitted beneficiary(ies)) shall be solely responsible for the satisfaction of all taxes, interest and penalties that may be imposed on Holder or for Holder’s account in connection with this Award (including, without limitation, any taxes, interest and penalties under Section 409A), and neither the Company nor its Affiliates shall have any obligation to reimburse, indemnify or otherwise hold Holder (or Holder’s estate or permitted beneficiary(ies)) harmless from any or all of such taxes, interest or penalties.
16.Term.  Upon forfeiture of all of Holder’s rights, title, and interests in and to any and all of the Award pursuant to Section 3 above, this Agreement will terminate and be of no further force or effect. 
17.General.  If any provision of this Agreement is or becomes or is deemed to be invalid, illegal, or unenforceable in any jurisdiction or as to Holder or the Award, or would disqualify the Award under any law deemed applicable by the Committee, such provision will be construed or deemed amended to conform to the applicable laws, or if it cannot be construed or deemed amended without, in the determination of the Committee, materially altering the intent of this Agreement, such provision will be stricken as to such jurisdiction, and the remainder of this Agreement will remain in full force and effect. Headings are given to the Sections and subsections of this Agreement solely as a convenience to facilitate reference. Such headings will not be deemed in any way material or relevant to the construction or interpretation of this Agreement or any provision thereof and, in the event of any conflict, the text of this Agreement, rather than such titles or headings, will control.
IN WITNESS WHEREOF, the Company, by its duly authorized officer, and Holder have executed this Agreement as of the day and year first above written.
KB HOME
By:    Jeffrey T. Mezger 
President and Chief Executive Officer 

HOLDER:
By:___________________________
[NAME]
Date:  _________________________Exhibit
4.13

 

[ * * * ] Portions of
this agreement were omitted and a complete copy of this agreement has been provided separately to the Securities and Exchange
Commission pursuant to the company’s application requesting confidential treatment under Rule 24b-2 of the Securities Exchange
Act of 1934, as amended.

 

	 	 	 	 	 	 	 
	AWARD/CONTRACT	 1.	THIS
    CONTRACT IS A RATED ORDER UNDER DPAS (15 CFR 700)	 	 RATING	 PAGE OF PAGES
	1	         48

	2. 	CONTRACT (Proc. Inst. Ident) NO.	 3. 	EFFECTIVE DATE	 4.	REQUISITION/PURCHASE REQUEST/PROJECT NO
	HHSO100201500035C	 See
    Block 20C 	 OS164559

	5.    ISSUED BY	CODE  	ASPR–BARDA	 6.  ADMINISTERED BY (If other than Item 5)	CODE 	ASPR–BARDA01
	 	 	 	 	 	 
	ASPR–BARDA

                    200 Independence Ave., S.W.

                    Room 640–G

                    Washington DC 20201

	 	ASPR–BARDA 

    330 Independence Ave, SW, Rm G644

    Washington DC 20201	 

	 	 	 	 	 
	7.   NAME AND ADDRESS OF CONTRACTOR
    (No., Street, City, Country, State and ZIP Code)	 8.  DELIVERY	 	 
	 	      o FOB ORIGIN 	x
    OTHER (See below)
	MEDIWOUND LTD 1477616

    MEDIWOUND LTD         42 HAYARKON

    42 HAYARKON

    YAVNE 00812	 9.  DISCOUNT FOR PROMPT PAYMENT
	 	 	 
	 	10. SUBMIT INVOICES

    (4 copies unless otherwise specified)

    TO THE ADDRESS SHOWN IN	 	 ITEM
	CODE 1477616	 FACILITY
    CODE	 	 	 

	11. SHIP TO/MARK FOR 	CODE 	HHS/OS/ASPR	12. PAYMENT WILL
    BE MADE BY 	CODE 	 PSC
	HHS/OS/ASPR

    200 C St SW

    WASHINGTON DC 20201	 	 	PSC

    Program Support Center

    5600 Fishers Lane

    Room 17-21

    Rockville MD-20852	 	 
	 	 	 	 	 	 
	13.AUTHORITY
    FOR     USING OTHER THAN FULL AND OPEN COMPETITION:	 14. ACCOUNTING AND APPROPRIATION DATA
	o
    10 U.S.C. 2304 (c)
    (               ) o
    41 U.S.C. 253 (c) (               )	2015.1990002.26201

	 	 	 	 	 	 	 
	 	 	 	 	 	 
	15A.
    ITEM NO	15B.
    SUPPLIES/SERVICES	15C.

    QUANTITY	15D.
    

    UNIT	15E.
    UNIT PRICE	15F. AMOUNT
	 	

    Continued	 	 	 	 
	 	15G. TOTAL AMOUNT
    OF CONTRACT 	 	 	$40,430,469.00

16. TABLE
OF CONTENTS

	(X)	SEC.	DESCRIPTION
    	 PAGE(S)	(X)	SEC.	DESCRIPTION	 PAGE(S)
	 	PART I - THE SCHEDULE	 	PART II - CONTRACT CLAUSES
	 	A	SOLICITATION/CONTRACT
    FORM	 	 	I	CONTRACT
    CLAUSES	 
	 	B	SUPPLIES
    OR SERVICES AND PRICES/COSTS	 	 	PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
	 	C	DESCRIPTION/SPECS/WORK
    STATEMENT	 	 	J	LIST
    OF ATTACHMENTS	 
	 	D	PACKAGING
    AND MARKING	 	 	PART IV - REPRESENTATIONS AND INSTRUCTIONS
	 	E	INSPECTION
    AND ACCEPTANCE	 	 	K	REPRESENTATIONS.
    CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS	 
	 	F	DELIVERIES
    OR PERFORMANCE	 	 
	 	G	CONTRACT
    ADMINISTRATION DATA	 	 	L	INSTRS.,
    CONDS., AND NOTICES TO OFFERORS	 
	 	H	SPECIAL
    CONTRACT REQUIREMENTS	 	 	M	EVALUATION
    FACTORS FOR AWARD	 

CONTRACTING
OFFICER WILL COMPLETE ITEM 17 (SEALED-B1D OR NEGOTIATED PROCUREMENT) OR 18 (SEALED-B1D PROCUREMENT) AS APPLICABLE

	17.
    o CONTRACTOR’ S NEGOTIATED AGREEMENT (Contractor is required to sign
    this document and return ___________ copies to issuing office.) Contractor agrees to furnish and deliver all items of perform
    all the services set forth or otherwise identified above and on any continuation sheets for the consideration staled 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 specification
    as are attached or incorporated by reference herein.	16.
    þ SEALED-BIO AWARD (Contractor is not required to sign this
    document.) Your bid on Soliciation 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 bid, and (b) this award/contract. No further contractual
    document     is     necessary. (Block 18 should be     checked City when awarding a seated-bid contract.)

	 	 	 	 	 	 	 	 	 
	19A	Name And Title
    Of Signer (Type of Print)	 20A	NAME OF CONTRACTING OFFICER
	 	Sharon
    Malka

    Chief Finance Officer

    MediWound Ltd	Gal Cohen

    President & Chief Executive Officer

MediWound Ltd	 BROOKE T. BERNOLD
	19B.	NAME OF CONTRACTOR 	 	 19C. DATE SIGNED	 20B. 	UNITED STATES OF AMERICA	 	 20C. DATE SIGNED
	BY	 	 	 	 BY	 	 	 
	 	(Signature of person authorized to sign)	 	9/29/2015	 	(Signature of the Contracting Officer)	 	9/29/2015

	AUTHORIZED FOR LOCAL REPRODUCTION 

    Previous edition is NOT usable	 	STANDARD FORM 26 (Rev. 5/2011)

    Prescribed by GSA - FAR (48 CFR) 53.214(a)

 

    	 

    	 

    

 

 

PART
I – THE SCHEDULE

 

SECTION
B – SUPPLIES OR SERVICE AND PRICE / COST

 

Non-Surgical
Debridement for Definitive Care of Burn Injuries 

 

ARTICLE
B.1.   BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

 

Mediwound
Ltd. is developing NexoBrid, a unique Debridement product that enables clinicians to restore, normal skin when treating partial
thickness or full thickness burns. The product has the potential to greatly improve the patient’s quality of life while
reducing hospital stays and the need for reconstructive surgery. This product could find utility in day-to-day care, while simultaneously
improving our capability to respond to mass casualty incidents.

 

Under
the base period-of-performance, Mediwound Ltd. will further enhance their product to improve its commercial viability through
the FDA approval process and potentially complete an initial purchase, storage, and delivery of product. The contract options
may be exercised to perform follow-on studies as directed by the FDA, perform additional studies which further extend the ability
to protect children and the elderly population, and purchase additional treatment courses.

 

The Research
and Development (R&D) effort will progress in specific stages that cover the base performance segment and several options
as specified in this contract. The period of performance for the base period is 60 months.

 

ARTICLE
B.2.   BASE PERIOD

 

	CLIN	Period
    of 

    Performance	Supplies/
    Services	Total
    Est. 

    Cost	Fixed
    Fee 

    (7%)	Total
    Cost 

    Plus Fixed 

    Fee
	 	 	COST
    REIMBURSEMENT	 	 	 
	0001 

    (Base)	09/28/2015
    –
     09/27/2020	Licensure,
    approval, and clearance of product through the FDA	$22,693,160	$1,262,501	$23,955,661

    (Funded)
	 	 	FIRM
    FIXED PRICE	 	 	 
	CLIN	Period
    of 

    Performance	Supplies/
    Services	Units
    (# of 

    Product)	Unit
    Price 

    ($)	Total
    ($)
	0002 

    (Base)	09/28/2017
    – 09/27/2019*(* see advanced understanding h.)	Initial
    Purchase, storage, and delivery of product	10,588	$1,052
    

(includes 
 VMI)	$11,138,576 

(Funded)
	0002 

(Base)	09/28/2019
    –
 09/27/2020	Initial
    Purchase, storage, and delivery of product	5412	$986

 (includes 

VMI)	$5,336,232

 (Funded)
	Total CLINS 1&2	09/28/2015
    –
 09/27/2020	See
    Above Descriptions	 	 	$40,430,469

 (Funded)

 

    	2

    	 

    

 

ARTICLE
B.3.   OPTION PRICES

  

	CLIN	Period
    of 

    Performance	Supplies/
    Services	Units
    (# of 

    Product)	Unit
    Price 

    ($)	Total
    ($)
	 	 	FIRM
    FIXED PRICE	 	 	 
	0003

        

        (Option

        

        Quantity)
	60 Months	Phase IV post marketing commitments
    /Requirements (This is an option that may or may not be exercised during the base period as determined by the need and as
    established by the FDA)	N/A	N/A	$5,639,146 

(Not Funded)
	 	 	COST
    REIMBURSEMENT	 	 	 
	CLIN	Period
    of 

    Performance		Total
    Est. Cost	Fixed
    Fee 

    (7%)	Total
    Cost 

    Plus Fixed 

    Fee
	0004 A (Option Quantity)	60 Months	Pediatric Study (This is an option
    that may or may not be exercised during the base period for expansion of the label indication with guidance from the FDA)	$11,237,608	$688,011	$11,925,619

 (Not Funded)
	0004 B (Option Quantity)	60 Months	Burn Induced Compartment Syndrome
    Study(BICS) (This is an option that may or may not be exercised during the base period for expansion of the label indication
    with guidance from the FDA)	$4,185,894	$261,819	$4,447,713

 (Not Funded)
	 	 	FIRM
    FIXED PRICE	 	 	 
	CLIN	Period
    of 

    Performance	Supplies/
    Services	Units
    (# of 

    Product)	Unit
    Price 

    ($)	Total
    ($)
	0005A

        

        (Option

        

        Quantity)

        
	60 Months	US Facility validation for manufacture
    of product (in USA)	N/A	N/A	$4,819,074 

(Ceiling Not 

Funded)
	0005B

        

        (Option

        

        Quantity)

        
	12 Months	Additional Surge Capacity 1 to 23,530
    units	1 to 23,530	$986	$23,200,580 

(Ceiling Not 

Funded)
	0005B

        

        (Option

        

        Quantity)

        
	12 Months	Additional Surge Capacity 23,531 to
    47,060 units	23,531 to 

47,060	$950	$22,353,500 

(Ceiling Not 

Funded)
	Total 

CLINs  3-5	60 Months	See Above Descriptions	 	 	$72,385,632

        

        (Not

        

        Funded)

        

  

    	3

    	 

    

 

ARTICLE
B.4.    LIMITATIONS APPLICABLE TO DIRECT COSTS

 

a.    Items
Unallowable Unless Otherwise Provided

 

Notwithstanding
the clause FAR 52.216-7, Allowable Cost and Payment, incorporated in this contract, the costs of the following items or activities
shall be unallowable as direct costs unless authorized in writing in advance by the Contracting Officer:

 

	 	1.	Acquisition, by purchase or lease, of any interest
    in real property;
	 	 	 
	 	2.	Special rearrangement or alteration of facilities;
	 	 	 
	 	3.	Purchase or lease of any item of general purpose office
    furniture or office equipment regardless of dollar value. (General purpose equipment is defined as any items of personal property
    which are usable for purposes other than research, such as office equipment and furnishings, pocket calculators, etc.);
	 	 	 
	 	4.	Travel to attend general scientific meetings;
	 	 	 
	 	5.	Unapproved foreign travel
	 	 	 
	 	6.	Consultant costs, except costs incurred under firm-fixed price
    consultant agreements valued at $150,000 or less are allowable without prior authorization.
	 	 	 
	 	7.	Subcontracts; except costs incurred under firm-fixed price subcontracts
    valued at $150,000 or less are allowable without prior authorization.
	 	 	 
	 	8.	Patient care costs;
	 	 	 
	 	9.	Accountable Government property (defined as both real and personal
    property with an acquisition cost of $1,000 or more and a life expectancy of more than two years) and “sensitive items”
    (defined as items of personal property, supplies and equipment that are highly desirable and easily converted to personal
    use), regardless of acquisition value.
	 	 	 
	 	10.	Printing Costs (as defined in the Government Printing and Binding
    Regulations).
	 	 	 
	 	11.	Light Refreshment and Meal Expenditures - Requests to use contract
    funds to provide light refreshments and/or meals to either federal or nonfederal employees must be submitted to the
    Contracting Officer’s Representative (COR), with a copy to the Contracting Officer, at least six (6) weeks in advance
    of the event and are subject to “HHS Policy on Promoting Efficient Spending: Use of Appropriate Funding for Conferences
    and Meeting, Food and Promotional Items and Printing and Publications.” The request shall contain the following information:
    (a) name, date, and location of the event at which the light refreshments and/or meals will be provided; (b)
    a brief description of the purpose of the event; (c) a cost breakdown of the estimated light refreshments and/or meals
    costs; (d) the number of nonfederal and federal attendees receiving light refreshments and/or meals; and (e) if the
    event will be held at a government facility.
	 	 	 
	 	12.	Meeting room or conference space used for face to face meetings
    with USG staff in the performance of this contract. Justification for why the meeting cannot be held at a government facility
    must be provided. COA requests must be made at least (2) two weeks prior to meeting date.

 

    	4

    	 

    

 

b.
    Travel Costs

  

	 	1.	Travel incurred by the Prime Contractor in direct
    performance of this contract shall require and be consistent with advance written approval by the Contracting Officer for
    expenditures such as (transportation, lodging, subsistence, and incidental expenses).
	 	 	 
	 	2.	FAR 52.247-63 – Preference for U.S.-Flag Air Carriers is applicable.
	 	 	 
	 	3.	The Contactor shall invoice and be reimbursed for all travel costs
    in accordance with FAR 31.703 and FAR 31.205-46, Contracts with Commercial Organizations, Travel Costs.
	 	 	 
	 	4.	Requests for foreign travel must be submitted at least six weeks
    in advance and shall contain the following:
	 	 	(i)    Meeting(s) and place(s) to be visited, with costs and dates;
	 	 	(ii)   Names(s) and title(s) of Contractor personnel to travel and
    their functions in the contract project;
	 	 	(iii)  Contract purpose to be served by the travel;
	 	 	(iv)  How travel of Contractor personnel will benefit and contribute
    to accomplishing the contract project, or will otherwise justify the expenditure of AMCG contract funds;
	 	 	(v)   How such advantages justify the costs for travel and absence
    from the project of more than one person if such are suggested; and
	 	 	(vi)  What additional functions may be performed by the travelers
    to accomplish other purpose of the contract and thus further benefit the project.

 

ARTICLE
B.5.   ADVANCE UNDERSTANDINGS

 

		 	a.	Subcontracts
                                         and Consultants

 

Award
of any FFP subcontract or FFP consulting agreement in excess of $150,000 or any cost reimbursement subcontract or consulting
agreement shall not proceed without the prior written consent of the Contracting Officer via a Contracting Officer Authorization
(COA) Letter. COA letters will only be issued upon review of the supporting documentation required by FAR Clause 52.244-2, Subcontracts.
After receiving written consent of the subcontract by the contracting Officer, a copy of the signed, executed subcontract and
consulting agreement shall be provided to the Contracting Officer within ten (10) days.

 

		 	b.	Site
                                         Visits, Inspections and General Audits

 

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
allowable costs. The Contractor shall coordinate these visits and shall have the opportunity to accompany the USG on any such
visits. Under time-sensitive or critical situations, the USG reserves the right to suspend the 48 hour notice to the
Contractor. If the Government, Contractor, or other party identifies any issues during an audit, the Contractor shall capture
the issues, identify potential solutions, and provide a report to the Government for review and acceptance.

 

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

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

		·	Once
                                         corrective action is completed, the Contractor will provide a final report to the CO
                                         and COR within 10 business days.

 

    	5

    	 

    

 

c.   QA
Audits

BARDA
reserves the right to participate in QA audits. Upon completion of the QA audit the Contractor shall provide a report capturing
the findings, results, and next steps in proceeding with any potential subcontractors. If action is requested for a subcontractor,
detailed corrective and preventative plans for addressing areas of non-conformance to ICH and FDA regulations for GLP, GMP, or
GCP guidelines, as identified in the audit report, must be provided to 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. The Contractor
                                         shall complete the report within 60 days of the audit/site visit, or as negotiated with
                                         the COR in writing dependent upon the audit findings.

d.   Man-in-Plant

At
the discretion of the Government and seven (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.

e.   Confidential
Treatment of Sensitive Information

The
Contractor shall, to the extent permitted by law, guarantee strict confidentiality of the information/data that is provided 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 the information/data, 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.

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.

    	6 

    	 

    

The
Contractor may disclose information/data of a sensitive nature provided by the Government to the extent that such disclosure is:
(a) made in response to a valid order of a court of competent jurisdiction (b) otherwise required by law, (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

f.
   Emergency Use Authorization (EAU)

The
Contractor shall be responsible for generating the data to support the USG’s filing of a Pre-Emergency Use Authorization (Pre-EUA)
package for use of the product prior to FDA licensure or approval during a declared emergency, declared potential emergency, or
identification of material threat under an Emergency Use Authorization (EUA).

The
Contractor commits to supporting the potential use of the product under a pre-EUA package as submitted by BARDA or the CDC/SNS.
The Contractor shall supply BARDA or the CDC/SNS with the data needed to support such a submission, including expanded access
INDs, right to hold product, right of reference to the Contractor’s Investigational New Drug (IND), or other application that
contains the supporting data. The Contractor shall address any FDA comments on all pre-EUA packages as applicable. The Contractor
shall maintain and update, as required by the FDA, all required regulatory documentation (investigator brochure, regulatory binder,
etc.), that will be used to support use under EUA and approval/licensure.

Any
product which has not received FDA approval or licensure, but has completed submission of the Pre-EUA package and has met
the three (3) criteria listed below may be considered for procurement at the discretion of the USG. The Contractor would be required
to demonstrate the three (3) essential criteria listed below for consideration of procurement of any unapproved products by seeking
a COA. The COA shall include a product delivery schedule for consideration and the following:

		•	Substantial
                                         evidence, including a validated process, of the Contractor’s ability to manufacture a
                                         product that would be identical to the commercial scale as required for product approval
                                         or licensure. A clear understanding of the outstanding risks, if any, for approval or
                                         licensure must be demonstrated.

 

		•	Completion
                                         of pivotal clinical studies with substantial evidence of safety and efficacy for the
                                         indicated use. A list of outstanding activities and targets for completion, adverse events/safety
                                         profile which do not pose unusual risks or challenges for FDA approval or licensure shall
                                         be provided.

 

		•	Substantial
                                         evidence of product familiarity/acceptance for use in burn centers. The Contractor shall
                                         provide a list of burn centers familiar with the product, feedback received, and corrective
                                         actions required to address any concerns to ensure effective use of the product by burn
                                         care providers unfamiliar with the product. Evidence of the company’s ability to educate
                                         such providers on the use of the product (as allowed within the constraints of law) will
                                         be useful.

 

A
tentative delivery schedule of product delivery to the inventory (acceptable as in the Quality Agreement) shall be required as
part of the COA. The delivery schedule shall be updated periodically as necessary.

 

    	7 

    	 

    

 

For
information concerning EUA, please consult 

http://www.fda.gov/RegulatoryInformation/Guidances/ucm 125127 and

http://www.fda.gov/EmergencyPreparedness/Counterterrorism/MedicalCountermeasures/MCMLegalRegulatoryandPolicyFramework/ucml82568.htm

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, and agreements between BARDA and the Department of Defense and the National Institutes of Health, BARDA may share
technical deliverables and data created in the performance of this contract with colleagues within the Integrated Portfolio. This
advance understanding does not authorize BARDA to share financial information outside HHS. The Contractor is advised to review
the terms of FAR 52.227-14, Rights in Data – General, regarding the Government’s rights to deliverables submitted during performance
as well as the Government’s rights to data contained within those deliverables.

h.   Overtime
Compensation

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

i.    Option
CLINS

The
USG reserves the right to re-negotiate the option CLINS based availability of funds and feedback received from the FDA.

j.  
  Contract Number Designation

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

HHS100201500035C

h.
   Quality Agreement

The
Quality Agreement shall specify the responsibilities of both the Contractor and the USG (i.e. – CDC/SNS-Quality Control and BARDA)
for event-driven and product shipping, receiving, acceptance into the inventory and/or custody by the USG. This document shall
be drafted and signed by all parties prior to the commencement of product procurement and acceptance, transport and custody of
the product under the VMI/DMI or the CDC/SNS. The Contractor shall provide documentation and resolution for all concerns raised
by USG and commits to cooperation in execution of this agreement.

    	8 

    	 

    

SECTION
C – DESCRIPTION/SPECIFICATIONS/WORKSTATEMENT

C.1.
   STATEMENT OF WORK

 

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 dated September
28, 2015 set forth in SECTION J - List of Attachments, attached hereto and made a part of the contract.

ARTICLE
C.2.
   REPORTING REQUIREMENTS

See
Section F for specific reporting requirements.

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

ARTICLE
C.3.
   TWICE MONTHLY CONFERENCE CALLS

A
conference call between the Contracting Officer’s Representative and the Contractor’s Project Leaders/delegates and designees
shall occur twice-monthly or as directed by the Contracting Officer and Contracting Officer’s Representative. During this call
the Contractor’s Project Leaders/delegates and designees will discuss the activities since the last call, any problems that have
arisen and the activities planned until the next call takes place. The Contractor’s Project Leaders/delegates may choose to include
other key personnel on the conference call to give detailed updates on specific projects or this may be requested by the Contracting
Officer’s Representative.

ARTICLE
C.4.
   PROJECT MEETINGS

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

 

    	9 

    	 

    

  

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 date, contract number and Contractor name. The Contractor shall guarantee
that all required materials shall be delivered in immediate usable and acceptable condition.

The
US storage facility will be a subcontractor that must be acceptable to the USG and approved under a COA. Issuance of a COA shall
meet the conditions specified in the Quality Agreement between BARDA, CDC and MediWound.

 

    	10 

    	 

    

 

SECTION
E – INSPECTION AND ACCEPTANCE

ARTICLE
E.1.  INSPECTION AND ACCEPTANCE

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

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

Inspection
and acceptance will be performed at:

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 

200 C St. SW 

Washington, D.C. 20024

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

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

 

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

 

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

 

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

 

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

 

    	11 

    	 

    

SECTION
F – DELIVERIES OR PERFORMANCE

ARTICLE
F.1.   PERIOD OF PERFORMANCE

The
period of performance for this contract shall be from September 28, 2015 through September 27, 2020. The period of performance
for the base period of this contract shall be consistent with the dates set forth in SECTION B. If the Government exercises option(s),
the period of performance will be extended as described under in SECTION B of this contract.

ARTICLE
F.2.   REPORTING REQUIREMENTS

In
all cases the reports are intended to provide sufficient detail to understand the Contractor’s approach and progress to addressing
the technical requirements. The reports supplement, and do NOT replace, routine (i.e. daily) communication between the COR and
project manager and/or their designee(s) regarding project plans and progress.

A.
  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 on or before the 15th calendar day following the last day of each reporting
period and shall include the following:

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

 

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

 

Progress:

 

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

 

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

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

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

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

 

    	12 

    	 

    

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

 

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

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

 

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

B.
   Annual Progress Report

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

 

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

 

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

 

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

 

Progress:

 

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

 

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

 

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

 

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

 

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

 

    	13 

    	 

    

 

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

 

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

 

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

 

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

 

		C.	Draft Final Report and Final Report

 

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

 

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

 

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

 

Progress:

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

    	14

    	 

    

 

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

 

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

 

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

 

		E.	Other Requirements/Deliverables

 

		a.	Integrated Master Project Plan

The Contractor shall provide an Integrated Master Project Plan (including tabular and Gantt forms) to BARDA that clearly indicates
the critical path to annual deliverables and Work Breakdown Structure (WBS) elements. Attention shall be placed on providing sufficient
turnaround time for the USG (BARDA, FDA, and CDC) for review of critical documentation. The Contractor shall integrate to demonstrate
interdependencies among all CLINS. The Integrated Master Project Plan shall be incorporated into any potential contract and will
be used to monitor performance of the contract. This report shall be due within 90 days of contract award. Updates shall be due
as requested by the COR or Co- COR.

 

		i.	Critical Path Milestones

The Integrated Master Project Plan shall outline key, critical path milestones, with “Go/No Go” decision criteria (entrance
and exit criteria for each phase of the project). This report shall be due within 90 days of contract award. Updates shall be due
as requested by the COR or Co-COR.

 

		ii.	Work Breakdown Structure

The USG has provided a Contract Work Breakdown Structure (CWBS) template (See http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx)
and the Contractor shall further delineate the CWBS to Level 5 as part of their Integrated Master Project Plan. The WBS shall
be discernable and consistent. BARDA may require Contractor to furnish WBS data at the work package level or at a lower level
if there is significant complexity and risk associated with the task. This report shall be due within 90 days of contract award.
Updates shall be due as requested by the COR or Co-COR.

 

    	15

    	 

    

 

		iii.	Risk Mitigation Plan/Matrix

The Contractor shall develop and maintain a risk management plan that highlights 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 shall
reference relevant WBS/SOW elements where appropriate. The USG has provided a Risk Mitigation Matrix template (See http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx)
to be completed by any prospective Contractor. This report shall be due within 90 days of contract award. Updates shall be due
as requested by the COR or Co-COR.

 

		b.	Technology Packages

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

 

		c.	Annual/Final Invention Report

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

 

		d.	Publications

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

 

		e.	Press Releases

The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. The Contractor
shall ensure the Contracting Officer has received and approved an advanced copy of any press release not less than two (2) business
days prior to the issuance of any potential press release.

 

		g.	Incident Security Report

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

 

		h.	Security Plan

The Contractor shall submit a draft security plan within 90 days of contract award. A detailed security plan with any updates shall
be submitted for approval at least three (3) months prior to the initiation of product procurement with proper documentation. The
Contractor shall cooperate with USG representatives to develop a sustainable security plan to ensure continued security of the
premises. Security plan updates are required when an incident security report has been filed.

 

		i.	Quality Management System (QMS) Plan

The Contractor shall provide a QMS plan within 90 days of contract award with updates at least three (3) months prior to initiation
of product procurement or as directed by the COR or Co-COR. The Contractor agrees to incorporate USG feedback and address concerns
relating to QMS plans.

 

    	16

    	 

    

 

		j.	Quality Agreement Report

The Quality Agreement Report shall specify the responsibilities of both the Contractor and the USG (i.e. – CDC/SNS-Quality Control
and BARDA) for event-driven and product shipping, receiving, acceptance into the inventory and/or custody by the USG. These documents
shall be drafted and signed by all parties prior to the commencement of product procurement and acceptance, transport and custody
of the product under the VMI/DMI or the CDC/SNS. The Contractor shall provide documentation and resolution for all concerns raised
by USG and commits to cooperation in execution of this agreement. Quality Agreement Reports are due at least three (3) months prior
to initiation of product procurement or as directed by the COR or Co-COR.

 

		k.	Vendor Managed Inventory (VMI) Plan

The Contractor shall develop a plan to establish VMI in alignment with the Quality Agreement Report. Interim draft plans shall
be submitted to USG as part of the development process. Draft submission for review is due upon completion of pre-EUA package.
Final submission is required to initiate product procurement through a COA. Documents shall be updated as required by the COR or
Co-COR. Developmental updates should be reported in the monthly reports as requested by the COR or Co-COR.

 

A minimum of three (3) product deliveries from different
manufacturing lots shall be delivered and accepted by USG to the inventory (considered as substantial delivery to the inventory)
before the Contractor shall invoice for the product payment.

 

		F.	Earned Value Management System Plan

 

		a.	Earned Value Management System Plan:

 

Subject to the requirements under HHSAR Clause 352.234-3,
the Contractor shall use principles of Earned Value Management System (EVMS) in the management of this contract (include this plan
as part of the monthly, annual, and final reports). The Seven Principles are:

 

		I.	Plan all work scope for the program to completion.

 

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

 

		IV.	Use actual cost incurred and recorded in accomplishing the work performed.

 

		V.	Objectively assess accomplishments at the work performance level.

 

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

 

    	17

    	 

    

 

		VIII.	Elements of EVMS shall be applied to all CLINs as part
of the Integrated Master Project Plan, the Contractor shall submit a written summary of the management procedures that it will
establish, maintain and use to comply with EVMS requirements.

 

		b.	Performance Measurement Baseline Review (PMBR):

 

The Contractor shall submit a PMBR plan electronically
via email to the CO and COR for a PMBR to occur within 90 days of contract award. At the PMBR, the Contractor and BARDA shall
mutually agree upon the budget, schedule and technical plan baselines (Performance Measurement Baseline). These baselines shall
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.

 

		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 Contractor reporting

 

		V.	Identify risks associated with the PMB.

 

		VI.	Present any revised PMBs for approval.

 

		VII.	Present an Integrated Master Schedule: The Contractor shall deliver an initial program level Integrated Master Schedule (IMS)
that rolls up all time-phased WBS elements down to the activity level. This IMS shall include the dependencies that exist between
tasks. This IMS will be agreed to and finalized at the PMBR. DI-MGMT-81650 may be referenced as guidance in creation of the IMS
(see http://www.acq.osd.mil/pm/).

 

		VIII.	Present the Risk Management Plan.

 

		c.	Integrated Master Schedule

 

The Contractor shall submit an IMS electronically
via email as outlined in a format agreed upon by BARDA to the COR and the Contracting Officer for approval prior to the initiation
of any activities of sufficient size and cost to require EVMS. The Integrated Master Schedule shall be incorporated into the contract,
and shall be used to monitor performance of the contract. The Contractor shall include the key milestones and Go/No Go decision
gates. The Contractor shall include BARDA Portfolio Management Milestones (See the AMCG Business Toolkit for a description and
sample (http://www.phe.gov/about/amcg/contracts/Pages/toolkit.aspx) in their IMS and provide monthly updates within their
IMS. This IMS shall include the following fields at a minimum; baseline start and finish, forecast start and finish, actual start
and finish, predecessor and/or successor. The Contractor shall deliver the Integrated Master Schedule, viewed at the work package
level in MS Project file format

 

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		d.	Earned Value Contract Performance Report (EV-CPR)

 

		a.	The Offeror shall deliver an Earned Value Contract Performance
                                         Report (CPR) on a monthly basis per the instruction in DI-MGMT-81466A (see http://www.acq.osd.mil/pm/).
                                         The Contractor shall provide Format 1, Format 3, and Format 5 only. Format 1 will be
                                         reported at the Work Breakdown Structure level agreed to by BARDA and the Contractor.

 

		b.	EV Variance thresholds will be negotiated with the Contractor post-award but for planning purposes will likely be (+/-
                                                              10%). In conjunction with the CPR, the Contractor shall provide a monthly update to the IMS with up to date performance data
                                                              and shall include actual start/finish and projected start / finish dates.

 

		c.	The supplemental monthly CAP report shall contain, at the work package level, time phased budget (budgeted cost of work scheduled
(BCWS)), earned value (budgeted cost of work performed (BCWP)), and actual costs of work performed (ACWP) as captured in the Contractor’s
EVM systems.

 

		d.	The Contractor and BARDA shall participate in regular meetings to coordinate and oversee the contracting effort as requested
by the COR. Such meetings may include, but are not limited to, site visits to the Contractor’s and/or subcontractor’s
facilities, meetings with individual Contractors and other HHS officials to discuss the technical, regulatory, and ethical aspects
of the program. The Contractor shall provide data, reports, and presentations to groups of outside experts and USG personnel and
Government-contracted subject matter experts as required by the BARDA COR in order to facilitate review of contract activities.

 

		e.	The Contractor shall provide a list of individuals to serve as primary and secondary points of contact who will be available
24 hours a day, seven days a week, to be notified in case of a public health emergency.

 

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ARTICLE F.3.   DELIVERIES

 

Successful performance of the final contract shall be deemed
to occur upon performance of the work set forth in the Statement of Work dated September 28, 2015 set forth in SECTION J - List
of Attachments of this contract and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative,
of the following items in accordance with the stated delivery schedule below:

 

	Item 

No.	Description	Addresses	Deliverable Schedule
	1	Monthly Progress Report	
        CO: (1) electronic copy

         

        COR: (1) electronic copy

         
	Reports are due on or before the 15th of each month following the end of each reporting period.
	2	Annual Progress Report	
        CO: (1) electronic copy

         

        COR: (1) electronic copy

         
	Reports are due on or before the 30th calendar day following the end of each reporting period.
	3	Draft Final Progress Report	
        CO: (1) electronic copy

         

        COR: (1) electronic copy

         
	Report is due 45 Calendar days prior to the expiration date of the contract.
	4	Final Progress Report	
        CO: (1) electronic copy

         

        COR: (1) electronic copy

         
	Report is due no later than 30 calendar days after the expiration date of the contract.
	5	
        FDA/ Regulatory Agency 

        Correspondence and Meeting Summaries

         
	COR: (1) electronic copy	Reports are due within 5 business days of each meeting for Contractor’s minutes, upon receipt of minutes from FDA/ regulatory agency, and upon request from the COR or Co-COR.
	6	
        Integrated Master Project Plan

 -Critical Path Milestones 

        -Work Breakdown Structure 

        -Risk Mitigation Plan/Matrix

         
	COR: (1) electronic copy	Report is due within 90 days of contract award. Updates are due as requested by the COR or Alternate COR.
	7	Technology Packages	COR: (1) electronic copy	Upon request from the COR or Co-COR.
	8	Experimental Protocols	COR: (1) electronic copy	Upon request from the COR or Co-COR.
	9	Annual/Final Invention Report	
        CO: (1) electronic copy

         

        COR: (1) electronic copy

         
	An Annual
    Invention Report is due on or before the 30th calendar day after the completion of each reporting period. A Final
    Invention Report is due on or before the expiration date of the contract.
	10	Publications	COR: (1) electronic copy	Reports are due within 30 calendar days for manuscripts and 15 calendar days for abstracts.
	11	Press Releases	
        CO: (1) electronic copy

         

        COR: (1) electronic copy

         
	Reports/Notices are due for approval to the CO not less than two (2) business days prior to the issuance of any potential press release.
	12	Incident Security Report	
        CO: (1) electronic copy

         

        COR: (1) electronic copy

         
	Reports are due within 24 hours after occurrence of an activity or incident.
	13	Security Plan	
        CO: (1) electronic copy

         

        COR: (1) electronic copy

         
	Draft report is due within 90 days of contract award. Updates are due at least 3 months prior to product procurement or as requested by the COR or Co-COR.
	14	Quality Management System (QMS) Plan	COR: (1) electronic copy	Draft report is due within 90 days of contract award. Updates are due at least 3 months prior to product procurement or as requested by the COR or Co-COR.
	15	Quality Agreement Report	COR: (1) electronic copy	Reports are due at least 3 months prior to product procurement or as directed by the COR or Co-COR.
	16	VMI Plan	
        CO: (1) electronic copy

         

        COR: (1) electronic copy

         
	Plan is due upon completion of the Pre-EAU package.
	17	Earned Value Management Requirements	
        CO: (1) electronic copy

         

        COR: (1) electronic copy

         
	As detailed in Section F.2 Reporting Requirements, subpart -F.

  

Email Addresses: CO – matthew.rose@hhs.gov

COR – Julio.Barrera-Oro@hhs.gov

 

    	20

    	 

    

 

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

 

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

 

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

FAR 52.242-15, Stop Work Order (August 1989), Alternate
1 (April 1984)

 

    	21

    	 

    

 

 

 

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: 

 

Matthew
Rose, CO

DHHS/OS/ASPR/AMCG

200 C St.

Washington, D.C. 20024

		a.	The
                                         Contracting Officer (CO) is the only individual who can legally commit the Government
                                         to the expenditure of public funds. No person other than the CO can make any changes
                                         to the terms, conditions, general provisions, specifications or other requirements of
                                         this contract.

		b.	The
                                         Contracting Officer (CO) is the only person with authority to act as agent of the Government
                                         under this contract. Only the CO 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 reimbursement to the Contractor for any costs incurred
                                         during the performance of this contract; or (5) otherwise change any terms and conditions
                                         of this contract.

		c.	No
                                         information, other than that which may be contained in an authorized modification to
                                         this contract duly issued by the CO, shall be considered grounds for deviation from this
                                         contract.

		d.	The
Government may unilaterally change its CO designation

 

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

 

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

 

Julio
Barrera-Oro, PhD 

Contracting Officer’s Representative

Biomedical
Advanced Research and Development Authority (BARDA) 

Office of the Assistant Secretary for Preparedness and Response 

Department
of Health and Human Services 

Julio.Barrera-Oro@hhs.gov 

(202) 260-0393

 

Mailing
Address:

330
Independence Avenue, S.W. 

Room 640G

Washington,
D.C. 20201 

 

Alternate COR:

 

Narayan Iyer, PhD

Alternate
Project Officer (PO), Alternate Contracting Officer’s Representative (COR)

Biomedical
Advanced Research and Development Authority (BARDA)

Office
of the Assistant Secretary for Preparedness and Response

Department
of Health and Human Services

narayan.iyer@hhs.gov

(202)
260-0455

 

    	22 

    	 

    

  

Mailing
Address:

330
Independence Avenue, SW, RM G-640 

Washington, D.C. 20201

 

The
COR is responsible for:

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

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

		c.	Performing
                                         technical evaluation as required;

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

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

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

 

ARTICLE
G.3.     KEY PERSONNEL

 

The
key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting
any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for
example, 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. The Government may modify the contract to add or delete
key personnel at the request of the Contractor or Government.

 

The
following individuals are considered to be essential to the work being performed hereunder:

 

	Name	Title
	Gal
    Cohen	President
    and CEO
	Dr.
    Lior Rosenberg	Chief
    Medical Officer
	Dr.
    Ety Klinger	Chief
    R&D Officer
	Andrey
    Kon	Plant
    Manager
	Dr.
    Eilon Asculai	VP
    R&D
	Smadar
    Nestor	Director
    Regulatory Affairs
	Nimrod
    Leuw	Director
    of QA/QC
	Keren
    David-Zabriv	Director
    Clinical Affairs

	

 

ARTICLE
G.4.     INVOICE SUBMISSION

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

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

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

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

 

    	23 

    	 

    

 

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

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

 

ARTICLE
G.5.     INDIRECT COST RATES

		1.	The
                                         following interim provisional indirect rates will be utilized for billing purposes
                                         during the period of performance: 80%. Final rate proposals must be sent to the Contracting
                                         Officer, within 6 months of the fiscal year end. See FAR Clause 52.216-7, Allowable Cost
                                         and Payment.

		2.	The
                                         interim provisional indirect rates used in this contract have been established
                                         after approval by the AMCG/BARDA Auditor.

 

ARTICLE
G.6.      REIMBURSEMENT OF COST

 

		1)	The
Government shall reimburse the Contractor those costs determined by the Contracting Officer to be allowable (hereinafter referred
to as allowable cost) in accordance with FAR 52.216-7, Allowable Cost and Payment and FAR Subpart 31.2. 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 do not exceed on a daily basis the per diem rates set
                                         forth in the Federal Travel Regulation (FTR).

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

    	24 

    	 

    

 

 

ARTICLE
G.7.     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, interim evaluation(s)
will be prepared annually as to coincide with the Anniversary date of the contract.

 

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
may access evaluations through a secure website for review and comment at the following:

 

http://cpars.gov

 

ARTICLE
G.8.     CONTRACT COMMUNICATIONS/CORRESPONDENCE (JULY 1999)

 

The Contractor
shall identify all correspondence, reports, and other data pertinent to this contract by imprinting the contract number HHSO100201500035C
from Page 1 of the contract

 

ARTICLE
G.9.     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.

 

    	25

    	 

    

 

SECTION
H – SPECIAL CONTRACT REQUIREMENTS

 

ARTICLE
H.1.     PROTECTION OF HUMAN SUBJECTS, HHSAR 352.270-4(b) (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.2.     CLINICAL RESEARCH

 

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

 

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

 

H.2.1     Safety and Monitoring Issues

 

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

 

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

 

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

 

    	26

    	 

    

 

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

 

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

 

	 	1.	All amendments or changes to the protocol, identified
    by protocol version number, date, or both and date it is valid.
	 	2.	All changes in informed consent documents, identified by version
    number, date, or both and dates it is valid.
	 	3.	Termination or temporary suspension of patient accrual.
	 	4.	Termination or temporary suspension of the protocol.
	 	5.	Any change in IRB approval.
	 	6.	Any other problems or issues that could affect the participants
    in the studies.

  

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

 

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

 

H.2.2.     Data and Safety Monitoring Requirements

 

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

 

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

 

	 	1.	Independent Safety Monitor
    – a physician or other appropriate expert who is independent of the study and available in real time to review and recommend
    appropriate action regarding adverse events and other safety issues.
	 	2.	Independent Monitoring Committee
    (IMC) or Safety Monitoring Committee (SMC) – a small group of independent investigators and biostatisticians who review
    data from a particular study.
	 	3.	Data and Safety Monitoring Board
    – an independent committee charged with reviewing safety and trial progress and providing advice with respect to study
    continuation, modification, and termination. The Contractor may be required to use an established BARDA DSMB or to organize
    an independent DSMB. All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as
    well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials
    Policy. The Government retains the right to place a nonvoting member on the DSMB.

 

    	27

    	 

    

 

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

 

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

 

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

 

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

 

	 	1.	IRB or IEC approved clinical research protocol
    identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility,
    and exclusion criteria;
	 	2.	Documentation of IRB or IEC approval, including OHRP FWA number,
    IRB or IEC registration number, and IRB or IEC name;
	 	3.	IRB or IEC approved informed consent document, identified by version
    number, date, or both and date it is valid;
	 	4.	Plans for the management of side effects;
	 	5.	Procedures for assessing and reporting adverse events;
	 	6.	Plans for data and safety monitoring (see B above) and monitoring
    of the clinical study site, pharmacy, and laboratory;
	 	7.	Documentation that the Contractor and all study staff responsible
    for the design or conduct of the research have received Good Clinical Practice (GCP) training in the protection of human subjects.

 

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

 

Documentation
of IRB or IEC approval, including OHRP FWA number, IRB or IEC registration number, and IRB and IEC name, must be provided to the
BARA COR within 24 hours of receipt by the Contractor.

 

H.2.4.     Required Time-Sensitive Notification

 

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

 

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

 

    	28

    	 

    

 

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

 

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

 

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

 

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

 

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

 

Safety reporting for research not performed under an IND
or IDE

 

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

 

	ARTICLE H.3.	HUMAN MATERIALS

 

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

 

	ARTICLE H.4. 	CARE OF LIVE VERTEBRATE ANIMALS

 

		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.

 

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

 

	ARTICLE H.5.	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.6.	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.7.	REQUIREMENTS FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE ANIMAL SUBJECTS

 

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

 

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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.8.	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.9.	NEEDLE DISTRIBUTION

 

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

 

	ARTICLE H.10.	ACKNOWLEDGEMENT OF FEDERAL FUNDING

 

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

 

	ARTICLE H.11.	RESTRICTION ON ABORTIONS

 

The Contractor shall not use funds for any abortion.

 

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	ARTICLE H.12.	CONTINUED BAN ON FUNDING OF HUMAN EMBRYO RESEARCH

 

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

 

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

 

	ARTICLE H.13.	DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

 

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

 

	ARTICLE H.14.	OMB CLEARANCE

 

In accordance with HHSAR 352.201-70, Paperwork Reduction Act
of 1980, (44 U.S.C. section 3501) the Contractor shall not proceed with surveys or interviews until such time as Office of Management
and Budget (OMB) Clearance for conducting interviews has been obtained by the Contracting Officer’s Representative (COR) and the
Contracting Officer has issued written approval to proceed.

 

	ARTICLE H.15.	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.16.	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

 

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	ARTICLE H.17.	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.18.	RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

 

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

 

	ARTICLE H.19.	CERTIFICATION OF FILING AND PAYMENT OF TAXES

 

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

 

	ARTICLE H.20.	ELECTRONIC INFORMATION AND TECHNOLOGY ACCESSIBILITY NOTICE

 

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

 

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

 

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

 

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

 

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

 

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

 

(End of provision)

 

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	ARTICLE H. 21.	FULL EARNED VALUE MANAGEMENT SYSTEM, HHSAR 352.234-3 (October 2008) with ALTERNATE I (October 2008)

 

		a.	The Contractor shall use an Earned Value Management System (EVMS) that is compliant with the guidelines in ANSI/EIA Standard-748
(current version at the time of award) to manage this contract. If the Contractor’s current EVMS is not compliant at the time of
award, see paragraph (b) of this clause. The Contractor shall submit EVM reports in accordance with the requirements of this contract.

 

		b.	If, at the time of award, the Contractor’s EVM system is not in compliance with the EVMS guidelines in ANSI/EIA Standard-748
(current version at time of award), the Contractor shall:

 

		a.	Apply the current system to the contract; and

		b.	Take necessary and timely actions to meet the milestones in the Contractor’s EVMS plan approved by the Contracting Officer.

 

		c.	HHS will not formally validate or accept the Contractor’s EVMS with respect to this contract. The use of the Contractor’s EVMS
for this contract does not imply HHS acceptance of the Contractor’s EVMS for application to future contracts. The Contracting Officer
or designee will conduct a Compliance Review to assess the Contractor’s compliance with its approved plan. If the Contractor does
not follow the approved implementation schedule or correct all resulting system deficiencies noted during the Compliance Review
within a reasonable time, the Contracting Officer may take remedial action that may include, but is not limited to, suspension
of or reduction in progress payments, or a reduction in fee.

 

		d.	HHS will conduct a Performance Measurement Baseline Review (PMBR). If a pre-award PMBR has not been conducted, a post-award
PMBR will be conducted by HHS as early as practicable, but no later than ninety (90) days after contract award. The Contracting
Officer may also require a PMBR as part of the exercise of an option or the incorporation of a major modification.

 

		e.	The Contractor shall provide access to all pertinent records and data requested by the Contracting Officer or a duly authorized
representative as necessary to permit Government surveillance to ensure that the EVMS conforms, and continues to conform to the
requirements referenced in paragraph (a) of this clause.

 

		f.	The Contractor shall require the subcontractors specified below to comply with the requirements of the clause:

 

	ARTICLE H. 22.	CONFIDENTIALITY OF INFORMATION

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

ARTICLE
H.23.      INSTITUTIONAL RESPONSIBILITY REGARDING INVESTIGATOR CONFLICTS OF INTERESTS

 

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

idx?c=ecfr&SID=0af84ca649a74846f102aaf664da1623&rgn=div5&view=text&node=45:1.0.1.1.51&idno=
45

 

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

 

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

  

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

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

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

 

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Significant
financial interests do not include the following:

 

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

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

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

 

ARTICLE
H.24.      PUBLICATION AND PUBLICITY

 

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

 

“This
project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and
Response, Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201500035C

 

Press
Releases:

 

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

 

ARTICLE
H.25.      ACCESS TO DOCUMENTATION/DATA

 

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

 

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ARTICLE
H.26.      DISSEMINATION OF INFORMATION

 

No
information related to data obtained under this contract shall be released or publicized without the prior written consent of
the COR, whose approval shall not be unreasonably withheld, conditioned, or delayed, provided that no such consent is required
to comply with any law, rule, regulation, court ruling or similar order; for submission to any government entity’ for submission
to any securities exchange on which the Contractor’s (or its parent corporation’s) securities may be listed for trading; or to
third parties relating to securing, seeking, establishing or maintaining regulatory or other legal approvals or compliance, financing
and capital raising activities, or mergers, acquisitions, or other business transactions.

 

ARTICLE
H.27.      DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

 

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

 

ARTICLE
H.28.      IDENTIFICATION AND DISPOSITION OF DATA

 

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

 

ARTICLE
H.29.      CONFLICT OF INTEREST

 

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

 

ARTICLE
H.30.      IN-PROCESS REVIEW

 

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

 

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

 

    	38

    	 

    

 

ARTICLE
H.31.      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.32.      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 of upcoming, ongoing, or recent audits/site visits of subcontractors
                                         as part of weekly communications. The Contractor shall notify the CO and COR reasonably
                                         in advance of upcoming QA audit so that Government personnel may participate in person
                                         at BARDA’s discretion.

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

 

ARTICLE
H.33.      BARDA AUDITS

 

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

 

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

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

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

 

ARTICLE
H.34.   SECURITY REPORTING REQUIREMENT

 

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

 

    	39

    	 

    

 

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

 

    	40

    	 

    

 

 

PART
II – CONTRACT CLAUSES

 

SECTION
I - CONTRACT CLAUSES

 

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

 

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

 

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

 

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

 

	Reg	Clause	Date	Clause
    Title
	FAR	52.202-1	Nov 2013	Definitions
	FAR	52.203-3	Apr 1984	Gratuities
	FAR	52.203-5	May 2014	Covenant Against Contingent Fees
	FAR	52.203-6	Sep 2006	Restrictions on Subcontractor Sales to the Government
	FAR	52.203-7	May 2014	Anti-Kickback Procedures
	FAR	52.203-8	May 2014	Cancellation, Rescission, and Recovery of Funds for Illegal or
    Improper Activity
	FAR	52.203-10	May 2014	Price or Fee Adjustment for Illegal or Improper Activity
	FAR	52.203-12	Oct 2010	Limitation on Payments to Influence Certain Federal Transactions
	FAR	52.203-13	Apr 2010	Contractor Code of Business Ethics and Conduct
	FAR	52.203-14	Dec 2007	Display of Hotline Posters
	FAR	52.203-17	Apr 2014	Contractor Employee Whistleblower Rights and Requirement To Inform
    Employees of Whistleblower Rights
	FAR	52.204-4	May 2011	Printed or Copied Double-Sided on Postconsumer Fiber Content Paper
	FAR	52.204-7	Jul 2013	System for Award Management
	FAR	52.204-10	Jul 2013	Reporting Executive Compensation and First-Tier Subcontract Awards
	FAR	52.204-13	Jul 2013	System for Award Management Maintenance
	FAR	52.209-6	Aug 2013	Protecting the Government’s Interests When Subcontracting
    With Contractors Debarred, Suspended, or Proposed for Debarment
	FAR	52.209-10	Dec 2014	Prohibition on Contracting with Inverted Domestic Corporations
	FAR	52.210-1	Apr 2011	Market Research
	FAR	52.215-2	Oct 2010	Audit and Records – Negotiation
	FAR	52.215-8	Oct 1997	Order of Precedence - Uniform Contract Format
	FAR	52.215-10	Aug 2011	Price Reduction for Defective Cost or Pricing Data
	FAR	52.215-11	Aug 2011	Price Reduction for Defective Certified Cost or Pricing Data—Modifications.
	FAR	52.215-12	Oct 2010	Subcontractor Certified Cost or Pricing Data
	FAR	52.215-13	Oct 2010	Subcontractor Certified Cost or Pricing Data—Modifications
	FAR	52.215-15	Oct 2010	Pension Adjustments and Asset Reversions
	FAR	52.215-18	Jul 2005	Reversion or Adjustment of Plans for Postretirement Benefits (PRB)
    other than Pensions
	FAR	52.215-19	Oct 1997	Notification of Ownership Changes
	FAR	52.215-21	Oct 2010	Requirements for Certified Cost or Pricing Data and Data Other
    Than Certified Cost or Pricing Data -Modifications
	FAR	52.215-23	Oct 2009	Limitations on Pass-Through Charges
	FAR	52.216-7	Jun 2013	Allowable Cost and Payment
	FAR	52.216-8	Jun 2011	Fixed Fee
	FAR	52.219-8	Oct 2014	Utilization of Small Business Concerns
	FAR	52.219-28	July 2013	Post-Award Small Business Program Representation
	FAR	52.222-1	Feb 1997	Notice to the Government of Labor Disputes

 

    	41

    	 

    

 

	FAR	52.222-2	Jul 1990	Payment for Overtime Premiums
	FAR	52.222-3	Jun2003	Convict Labor
	FAR	52.222-21	Apr 2015	Prohibition of Segregated Facilities
	FAR	52.222-26	Apr 2015	Equal Opportunity
	FAR	52.222-35	Jul 2014	Equal Opportunity for Veterans
	FAR	52.222-36	Jul 2014	Equal Opportunity for Workers with Disabilities
	FAR	52.222-37	Jul 2014	Employment Reports on Veterans
	FAR	52.222-40	Dec 2010	Notification of Employee Rights Under the National Labor Relations
    Act
	FAR	52.222-50	Mar 2015	Combating Trafficking in Persons
	FAR	52.222-54	Aug 2013	Employment Eligibility Verification
	FAR	52.223-6	May 2001	Drug-Free Workplace
	FAR	52.223-18	Aug 2011	Encouraging Contractor Policy to Ban Text Messaging While Driving
	FAR	52.224-1	April 1984	Privacy Act Notification
	FAR	52.224-2	April 1984	Privacy Act
	FAR	52.225-13	Jun 2008	Restrictions on Certain Foreign Purchases
	FAR	52.227-1	Dec 2007	Authorization and Consent, Alternate 1 (APR 1984)
	FAR	52.227-2	Dec 2007	Notice and Assistance Regarding Patent and Copyright Infringement
	FAR	52.227-3	Apr 1984	Patent Indemnity
	FAR	52.227-11	May 2014	Patent Rights – Ownership by the Contractor
	FAR	52.227-14	May 2014	Rights in Data - General
	FAR	52.227-14	Dec 2007	Alt II
	FAR	52.228-7	Mar 1996	Insurance – Liability to Third Persons
	FAR	52.229-3	Feb 2013	Federal, State and Local Taxes
	FAR	52.230-4	May 2014	Disclosure and Consistency of Cost Accounting Practices—Foreign
    Concerns
	FAR	52.230-6	June 2010	Administration of Cost Accounting Standards
	FAR	52.232-1	Apr 1984	Payments
	FAR	52.232-2	Apr 1984	Payments under Fixed-Price Research and Development Contracts
	FAR	52.232-8	Feb 2002	Discounts for Prompt Payment
	FAR	52.232-9	Apr 1984	Limitation on Withholding of Payments
	FAR	52.232-11	Apr 1984	Extras
	FAR	52.232-17	May 2014	Interest
	FAR	52.232-20	Apr 1984	Limitation of Cost
	FAR	52.232-23	May 2014	Assignment of Claims
	FAR	52.232-25	Jul 2013	Prompt Payment
	FAR	52.232-33	Jul 2013	Payment by Electronic Funds Transfer--System for Award Management
	FAR	52.233-1	May 2014	Disputes
	FAR	52.233-3	Aug 1996	Protest After Award, Alternate I
	FAR	52.233-4	Oct 2004	Applicable Law for Breach of Contract Claim
	FAR	52.242-1	Apr 1984	Notice of Intent to Disallow Costs
	FAR	52.242-3	May 2014	Penalties for Unallowable Costs
	FAR	52.242-4	Jan 1997	Certification of Final Indirect Costs
	FAR	52.242-13	Jul 1995	Bankruptcy
	FAR	52.242-15	Aug 1989	Stop Work Order, Alternate I (Aug 1984)
	FAR	52.243-1	Aug 1987	Changes - Fixed-Price Alternate V (Apr 1984).
	FAR	52.243-2	Aug 1987	Changes—Cost-Reimbursement Alternate V (Apr 1984).
	FAR	52.243-7	Apr 1984	Notification of Changes
	FAR	52.244-2	Oct 2010	Subcontracts, Alternate 1 (Jun 2007)
	FAR	52.244-5	Dec 1996	Competition in Subcontracting
	FAR	52.244-6	Apr 2015	Subcontracts for Commercial Items
	FAR	52.245-1	Apr 2012	Government Property
	FAR	52.245-9	Apr 2012	Use and Charges
	FAR	52.246-23	Feb 1997	Limitation of Liability.
	FAR	52.246-25	Feb 1997	Limitation of Liability—Services
	FAR	52.248-1	October 2010	Value Engineering
	FAR	52.249-2	Apr 2012	Termination for the Convenience of the Government (Fixed-Price)
	FAR	52.249-6	May 2004	Termination (Cost-Reimbursement)
	FAR	52.249-8	Apr 1984	Default (Fixed-Price Supply and Service)
	FAR	52.249-9	Apr 1984	Default (Fixed-Price Research and Development)
	FAR	52.249-14	Apr 1984	Excusable Delays
	FAR	52.253-1	Jan 1991	Computer Generated Forms

 

    	42

    	 

    

 

(2)
DEPARTMENT OF HEALTH AND HUMAN SERVICES ACQUISITION REGULATION (HHSAR) (48 CFR CHAPTER 3) CLAUSES:

 

	HHSAR	352.201-70	Sept 2010	Paperwork Reduction Act
	HHSAR	352.202-1	Jan 2006	Definitions - with Alternate paragraph (h)
	HHSAR	352.203-70	Mar 2012	Anti-Lobbying
	HHSAR	352.216-70	Jan 2006	Additional Cost Principles
	HHSAR	352.222-70	Jan 2010	Contractor Cooperation in Equal Employment Opportunity Investigations
	HHSAR	352.223-70	Sept 2010	Safety and Health
	HHSAR	352.224-70	Jan 2006	Privacy Act
	HHSAR	352.227-70	Jan 2006	Publications and Publicity
	HHSAR	352.228-7	Dec 1991	Insurance - Liability to Third Persons
	HHSAR	352.231-70	Jan 2006	Salary Rate Limitation
	HHSAR	352.231-71	Jan 2001	Pricing of Adjustments
	HHSAR	352.233-71	Jan 2006	Litigation and Claims
	HHSAR	352.242-70	Jan 2006	Key Personnel
	HHSAR	352.242-73	Jan 2006	Withholding of Contract Payments
	HHSAR	352.242-74	Apr 1984	Final Decisions on Audit Findings

 

ARTICLE
I.2. ADDITIONAL CONTRACT CLAUSES

 

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.

 

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

 

1.  FAR
52.215-17, Waiver of Facilities Capital Cost of Money (October 1997). 

2.  FAR
52.227-16, Additional Data Requirements (June 1987).

 

ARTICLE
I.3. ADDITIONAL FAR CLAUSES INCLUDED IN FULL TEXT

 

352.231-70
Salary rate limitation (August 2012)

 

1.     Pursuant
to the current and applicable prior HHS appropriations acts, the Contractor shall not use contract funds to pay the direct salary
of an individual at a rate in excess of the Federal Executive Schedule Level II in effect on the date an expense is incurred.

 

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

 

    	43

    	 

    

 

Note:
The salary rate limitation does not restrict the salary that an organization may pay an individual working under an HHS contract
or order; it merely limits the portion of that salary that may be paid with Federal funds.

 

1.     The
salary rate limitation also applies to individuals under subcontracts. If this is a multiple-year contract or order, it may be
subject to unilateral modification by the Contracting Officer to ensure that an individual is not paid at a rate that exceeds
the salary rate limitation provision established in the HHS appropriations act in effect when the expense is incurred regardless
of the rate initially used to establish contract or order funding.

 

2.     See
the salaries and wages pay tables on the U.S. Office of Personnel Management Web site for Federal Executive Schedule salary levels
that apply to the current and prior periods.

 

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

 

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

 

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

 

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

 

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

 

(c)  The
total duration of this contract, including the exercise of any options under this clause, shall not exceed 8 years.

 

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

	 	 	 
	(a)	(1)	The North American Industry Classification System (NAICS) code
    for this acquisition is 541711.
	 	(2)	The small business size standard is 500 employees.
	 	(3)	The small business size standard for a concern which submits an
    offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it
    did not itself manufacture, is 500 employees.
	 	 	 
	(b)Representations.
	 	 	 
	 	(1)	The Offeror represents as part of its offer that it [X] is, [_]
    is not a small business concern.
	 	 	 
	 	(2)	[Complete only if the Offeror represented itself as a small
    business concern in paragraph (b)(1) of this provision.] The Offeror represents, for general statistical purposes, that
    it [_] is, [X] is not, a small disadvantaged business concern as defined in 13 CFR 124.1002.
	 	 	 
	 	(3)	[Complete only if the Offeror represented itself as a small
    business concern in paragraph (b)(1) of this provision.] The Offeror represents as part of its offer that it [X] is, [_]
    is not a women-owned small business concern.

 

    	44

    	 

    

 

	 	 	 
	 	(4)	Women-owned small business (WOSB) concern eligible under the WOSB
    Program. [Complete only if the Offeror represented itself as a women-owned small business concern in paragraph (b)(3) of this
    provision.] The Offeror represents as part of its offer that—
	 	 	(i)  It
        [_] is, [X] is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB
        Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and 

(ii) It
[_] is, [X] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph
(b)(4)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture.
[The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that
are participating in the joint venture: __________.] Each WOSB concern eligible under the WOSB Program participating in the joint
venture shall submit a separate signed copy of the WOSB representation.

	 	 	 
	 	(5)	Economically disadvantaged women-owned small business (EDWOSB)
    concern. [Complete only if the offeror represented itself as a women-owned small business concern eligible under the WOSB
    Program in (b)(4) of this provision.] The Offeror represents as part of its offer that—
	 	 	 
	 	 	(i)  It
    [_] is, [X] is not an EDWOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB
    Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and 

(ii) It
[_] is, [X] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph
(b)(5)(i) of this provision is accurate for each EDWOSB concern participating in the joint venture. [The Offeror shall enter the
name or names of the EDWOSB concern and other small businesses that are participating in the joint venture: __________.] Each
EDWOSB concern participating in the joint venture shall submit a separate signed copy of the EDWOSB representation.

	 	(6)	[Complete only if the Offeror represented itself as a small
    business concern in paragraph (b)(1) of this provision.] The Offeror represents as part of its offer that it [_]
    is, [X] is not a veteran-owned small business concern.
	 	 	 
	 	(7)	[Complete only if the Offeror represented itself as a veteran-owned
    small business concern in paragraph (b)(6) of this provision.] The Offeror represents as part of its offer that is [_] is,
    [_] is not a service-disabled veteran-owned small business concern.
	 	 	 
	 	(8)	[Complete only if the Offeror represented itself as a small
    business concern in paragraph (b)(1) of this provision.] The Offeror represents, as part of its offer, that –
	 	 	 
	 	 	(i) It
        [_] is, [X] is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified
        HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership
        and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with
        13 CFR part 126; and 

(ii) It
[_] is, [X] is not a HUBZone joint venture that complies with the requirements of 13 CFR part 126, and the representation in paragraph
(b)(8)(i) of this provision is accurate for each HUBZone small business concern participating in the HUBZone joint venture. [The
offeror shall enter the names of each of the HUBZone small business concerns participating in the HUBZone joint venture:__________.]
Each HUBZone small business concern participating in the HUBZone joint venture shall submit a separate signed copy of the HUBZone
representation.

 

    	45

    	 

    

 

	 	 	 
	(c) Definitions. As used in this provision—
	 	 	 
	 	“Economically disadvantaged women-owned small
    business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned
    by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the
    United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned
    small business concern eligible under the WOSB Program.
	 	“Service-disabled veteran-owned small business
    concern”—
	 	 
	 	(1)  Means
    a small business concern—
	 	 	(i)   Not
less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business,
not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and 

        (ii)  The management
and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled
veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

	 	 	 
	 	 (2) Service-disabled
    veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C.
    101(16).
	 	 	 
	 	“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 (a) of this provision.

“Veteran-owned
small business concern” means a small business concern—

	 	 	 
	 	 (1)Not
less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly
owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and 
	 	 (2)The management and daily business operations of which
are controlled by one or more veterans.
	 	 	 
	 	“Women-owned small business concern,” means
    a small business concern –
	 	 	 
	 	(1)	That
        is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent
        of the stock of which is owned by one or more women; and

	 	(2)	Whose management and daily business operations are controlled by
    one or more women.
	 	 	 
	 	“Women-owned small business (WOSB) concern eligible
    under the WOSB Program (in accordance with 13 CFR part 127),” means a small business concern that is at least 51 percent
    directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or
    more women who are citizens of the United States.
	 	 	 
	(d) Notice.
	 	 	 
	 	(1)	If this solicitation is for supplies and has been set aside, in
    whole or in part, for small business concerns, then the clause in this solicitation providing notice of the set-aside contains
    restrictions on the source of the end items to be furnished.
	 	 	 
	 	(2)	Under 15 U.S.C. 645(d), any person who misrepresents a firm’s
    status as a business concern that is small, HUBZone small, small disadvantaged, service-disabled veteran-owned small, economically
    disadvantaged women-owned small, or women-owned small eligible under the WOSB Program in order to obtain a contract to be
    awarded under the preference programs established pursuant to section 8, 9, 15, 31, and 36 of the Small Business Act or any
    other provision of Federal law that specifically references section 8(d) for a definition of program eligibility, shall –
	 	 	  (i)Be
        punished by imposition of fine, imprisonment, or both;

  (ii)Be
subject to administrative remedies, including suspension and debarment; and 

  (iii)Be
ineligible for participation in programs conducted under the authority of the Act.

 

    	46

    	 

    

 

	 	FAR
52.232-40, Providing Accelerated Payment to Small Business Subcontractors (Dec 2013)
	 	 
	(a)	Upon
receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors
under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable
contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.
	 	 
	(b)	The acceleration of payments under this clause does
    not provide any new rights under the Prompt Payment Act.
	 	 
	(c)	Include
the substance of this clause, including this paragraph (c), in all subcontracts with small business concerns, including subcontracts
with small business concerns for the acquisition of commercial items.
	 	 	 

    	47

    	 

    

 

	 	 	 
	PART III - LIST OF DOCUMENTS, EXHIBITS
    AND OTHER ATTACHMENTS
	 
	SECTION J - LIST OF ATTACHMENTS
	 	 	 
	 	The following documents are attached and incorporated
    in this contract:
	 	 	 
	 	1.	Statement of Work, dated September 29, 2015
	 	 	 
	 	2.	Invoice/Financing Instructions for Cost-Reimbursement Type Contracts
	 	 	 
	 	3.	Invoice Instructions for Fixed-Priced Type Contracts
	 	 	 
	 	4.	Sample Invoice Form
	 	 	 
	 	5.	Research Patient Care Costs
	 	 	 
	 	6.	Report of Government Owned, Contractor Held Property
	 	 	 
	 	7.	Form SF-LLL, Disclosure of Lobbying Activities
	 	 	 
	 	8.	Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01)

 

    	48

    	 

    

 

 

 

Final
Revised Proposal

Volume
II: Technical Proposal

Full
Proposal Submitted for Consideration under Solicitation 15-100-SOL-00021

Non-Surgical
Debridement for Definitive Care of Burn Injuries

This proposal is made in agreement with
all the terms and conditions of this Solicitation.

 

Advanced
Development of NexoBrid 

as
a Medical Countermeasure for Injury Associated 

with Burns

 

SOW
Portion of the Base pages 66-89

 

Submitted to: 

Biomedical Advanced Research and Development
Authority

U.S. Department of Health and Human Services

Assistant Secretary for Preparedness and
Response

Contracting Officer – Matthew Rose

ASPR-AMCG-202-205-2901

200 C St. SW

Washington, D.C. 20024

Attention: Matthew Rose, Contracting Officer

 

	
        Reference: Solicitation # 15-100-SOL-00021

         

        Prime Offeror: 

         

        MediWound Ltd.

        42 Hayarkon Street,

        Yavne, Israel 8122745

        Tel: + +972 77 9714100

        Fax: +972 77 9714111

        e-mail:

        info@mediwound.cominfo@mediwound.com

        DUNS: 5320400334

         

        September 10, 2015
	

         

         

        Business
Contact: 

         

        Gal Cohen

        President & Chief Executive Officer

         

        Technical Contact: 

        Ety Klinger, PhD

        Chief R&D Officer 

 

    	 

    	 

    

 

	Advanced Development of NexoBrid 

    as a Medical Countermeasure for Injury Associated with Burns	

 

Throughout this proposal, MediWound
refers to various trademarks, service marks and trade names that it uses in its business. The “MediWound” design logo,
“MediWound”, “NexoBrid”, “EscharEx” and other trademarks or service marks of MediWound appearing
in this proposal are the property of MediWound. MediWound has several other trademarks, service marks and pending applications
relating to its applications. Other trademarks and service marks appearing in this proposal are the property of their respective
holders.

 

TABLE OF CONTENTS

 

	1.1   Statement of Work	5
	1.   Base Period Statement of Work	5
	1.1   Program Management (WBS 1.1)	5
	1.1.1   Technical and Project Management (WBS 1.1.1)	5
	1.1.1.1.   Update Project Schedule (WBS 1.1.1.1)	5
	1.1.1.2.   Complete Project Baseline Schedule (WBS 1.1.1.2)	5
	1.1.1.3.   Complete Integrated Master Project Plan (WBS 1.1.1.3)	5
	1.1.1.4.   Base Period Management (CLIN 0001)/Report (WBS 1.1.1.4)	5
	1.1.2   Subcontractor Management (WBS 1.1.2)	6
	1.1.3   Risk management (WBS 1.1.3)	6
	1.1.4   EVMS (WBS 1.1.4)	7
	1.2   Non Clinical Toxicology (WBS 1.2)	7
	1.2.1   Safety (WBS 1.2.1)	7
	1.2.1.1   [ * * * ] (WBS 1.2.1.1)	8
	1.2.1.2   [ * * * ] (WBS 1.2.1.2)	8
	1.2.1.3   [ * * * ] (WBS 1.2.1.3)	9
	1.2.1.4   [ * * * ] (WBS 1.2.1.4)	9
	1.2.1.5   [ * * * ] (WBS 1.2.1.5)	10
	1.3   Non- Clinical Pharmacology (WBS 1.3)	10
	1.3.1   Mechanism of Action Studies (WBS 1.3.1)	10
	1.3.1.1   [ * * * ] (WBS 1.3.1.1)	11
	1.3.1.2   [ * * * ] (WBS 1.3.1.2)	11
	1.3.1.3   [ * * * ] (WBS 1.3.1.3)	12
	1.3.1.4   [ * * * ] (WBS 1.3.1.4)	12
	1.3.2   Product Characterization (WBS 1.3.2)	13
	1.3.2.6   [ * * * ] (WBS 1.3.2.1)	13
	1.3.3   Efficacy and Safety (WBS 1.3.3)	13
	1.3.3.1   [ * * * ] (WBS 1.3.3.1)	13
	1.4   Clinical (WBS 1.4)	14

 

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[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

 

    	 

    	 

    

 

	Advanced Development of NexoBrid 

    as a Medical Countermeasure for Injury Associated with Burns	

 

	1.4.1   US phase 3 study (WBS 1.4.1)	14
	1.5   Regulatory	16
	1.5.1   IND	16
	1.5.1.1   [ * * * ] (WBS 1.5.1.1)	16
	1.5.1.2   [ * * * ] (WBS 1.5.1.2)	16
	1.5.1.3   [ * * * ] (WBS 1.5.1.3)	17
	1.5.1.4   [ * * * ] (WBS 1.5.1.4)	17
	1.5.1.5   [ * * * ] (WBS 1.5.1.5)	17
	1.5.1.6   FDA Submission Request For [ * * * ] (WBS 1.5.1.6)	17
	1.5.2   BLA (WBS 1.5.2)	18
	1.5.2.1   [ * * * ] (WBS 1.5.2.1)	18
	1.5.2.2   Pre-BLA Meeting (WBS 1.5.2.2)	18
	1.5.2.3   BLA preparation and submission (WBS 1.5.2.3)	19
	1.6   Chemistry, Manufacturing and Control (CMC) (WBS 1.6)	20
	1.6.1   [ * * * ] (WBS 1.6.1)	20
	1.6.1.1   [ * * * ] (LC-MS) (WBS 1.6.1.1)	20
	1.6.1.2   [ * * * ] (WBS 1.6.1.2)	20
	1.6.1.3   [ * * * ] (WBS 1.6.1.3)	20
	1.6.2   [ * * * ] Development (WBS 1.6.2)	21
	1.6.2.1   [ * * * ] (WBS 1.6.2.1)	21
	1.6.2.2   [ * * * ] (WBS 1.6.2.2)	22
	1.6.2.3   [ * * * ] (WBS 1.6.2.3)	22
	1.6.2.4   [ * * * ] (WBS 1.6.2.4)	22
	1.6.3   Quality by Design (QbD) (WBS 1.6.3)	22
	1.6.3.1   Risk Based Design of Experiment (DOE) Plan (WBS 1.6.3.1)	22
	1.6.3.2   [ * * * ] (WBS 1.6.3.2)	23
	1.6.3.3   Statistical Analysis and Summary of the Results (WBS 1.6.3.3)	23
	1.6.4   Agriculture Raw Material Studies (WBS 1.6.4)	23
	1.6.4.1   [ * * * ] (WBS 1.6.4.1)	24
	1.6.4.2   Analytical Chemistry Testing and Statistical Analysis (WBS 1.6.4.2)	24
	1.6.5   [ * * * ] (WBS 1.6.5)	24
	1.6.5.1   [ * * * ] (WBS 1.6.5.1)	25
	1.6.5.2   [ * * * ] (WBS 1.6.5.2)	25
	1.6.5.3   File Submission, Inspection & Approving (WBS 1.6.5.3)	25

 

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[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced Development of NexoBrid 

    as a Medical Countermeasure for Injury Associated with Burns	

 

	1.6.5.4   [ * * * ] (WBS 1.6.5.4)	26
	1.6.5.5   FDA Approval of Scale-up (WBS 1.6.5.5)	26
	1.7   Procurement (WBS 1.7)	27
	1.7.1   Acquisition (WBS 1.7.1)	27
	1.7.2   Warm Base (Inventory Stockpile) (WBS 1.7.2)	27
	1.7.2.1   Setup of vendor managed inventory system (VMI) plan (WBS 1.7.2.1)	27
	1.7.2.2   Implementation of vendor managed inventory system (VMI) plan (WBS 1.7.2.2)	27
	1.7.3   Sustainment (WBS 1.7.3)	28
	1.7.4   Disposal (WBS 1.7.4)	28

 

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[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

 

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated
with Burns

	 

 

		1.1	Statement
                                         of Work

 

The Statement of Work has a separate numb
ering system from the section numbers in this document. SOW section numbers correspond to the correct WBS numbers.

 

		1.	Base
                                         Period Statement of Work

 

		1.1	Program
                                         Management (WBS 1.1)

 

Program Management encompasses contract management (e.g., contract
reporting), program management (e.g., subcontractor oversight, program progress), and risk management (e.g., EVM, risk evaluation).
Project Management milestones and activities in this section are listed below, corresponding to management in the period described.

 

		1.1.1	Technical and Project Management
                                         (WBS 1.1.1)

 

	WBS# and Title	Milestone	Deliverables
	1.1.1 Technical and Project Management	Successful completion of technical and project management activities for each option period.	Project scheduled completed and reports submitted to BARDA PO/CO after completion of each option period.

  

Objective/Description of Work: These activities encompass
all Program Management for the listed contract period.

 

		1.1.1.1.	Update Project Schedule
(WBS 1.1.1.1)

 

		1.1.1.2.	Complete Project Baseline Schedule (WBS 1.1.1.2)

 

		1.1.1.3.	Complete Integrated Master Project Plan (WBS 1.1.1.3)

 

		1.1.1.4.	Base Period Management (CLIN 0001)/Report (WBS 1.1.1.4)

 

Objective/Description of Work: An overall project schedule
in the form of a Gantt chart will be created and maintained as part of project management. This schedule will be updated and formally
completed within 90 days after the contract award.

 

Milestones:

 

Complete Project Baseline Schedule (WBS 1.1.1.2)

Complete Integrated Master Project Plan (WBS 1.1.1.3)

 

Deliverables: The project schedule will be submitted
to the BARDA PO/CO. Reports on these activities will be included as part of regular project status updates to the BARDA PO/CO as
listed below.

 

Complete Project Baseline Schedule (WBS 1.1.1.2)

 

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	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated
with Burns

	 

 

Complete Integrated Master Project Plan (WBS 1.1.1.3)

Base Period Management/ Report (WBS 1.1.1.4)

 

		1.1.2	Subcontractor Management
                                         (WBS 1.1.2)

 

	WBS# and Title	Milestone	Deliverables
	1.1.2 Subcontractor Management	Completion of subcontractor management plan	Subcontractor management plan submitted to BARDA

  

Objective/Description of Work: Company will compile all
necessary materials and finalize all aspects of the project related to preparing the Subcontractor Management Plan, including a
description of how MediWound will communicate with each subcontractor’s lead representative on a regular basis; monitor subcontractor
costs, technical performance, and conformance to schedules; and stay informed of changes and availability of the subcontractor’s
technical team personnel.

 

Milestones:

 

Completion of plan development stages as indicated above within
90 days of award.

Develop Subcontractor Management Plan (WBS 1.1.2.1)

Complete Subcontractor Plan and submit to BARDA(WBS 1.1.2.2)

Implementation of Subcontractor Management Plan (WBS 1.1.2.3)

 

Deliverables:

 

		-	Submit subcontractor management plan to BARDA within 90 days of contract award (WBS 1.1.2.2).

 

		1.1.3	Risk management (WBS 1.1.3)

 

Objective/Description of Work: MediWound will prepare
a Risk Mitigation Plan and Matrix consistent with the template provided by BARDA, and submit such documents to BARDA within 90
days of contract award. The risk mitigation plan will highlight 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 shall reference relevant
WBS/SOW elements where appropriate. MediWound will maintain and update the plan as necessary throughout the term of the contract
and provide updates as requested by the COR. A report on these activities will be included as part of regular quarterly project
status updates to the BARDA PO/CO.

 

	WBS# and Title	Milestone	Deliverables
	1.1.3 Risk Management	Completion of risk management plan	Risk management plan submitted to BARDA

  

Milestones:

 

Completion of plan development stages as indicated above.

 

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	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated
with Burns

	 

 

Develop Risk Management Plan (WBS 1.1.3.1)

Complete Risk Management Plan (WBS 1.1.3.2)

Quarterly RMP Update (WBS 1.1.3.3)

 

Deliverables:

 

		-	Complete Risk Management Plan and Submit Report to BARDA (WBS 1.1.3.2)

		-	Quarterly RMP Update Report to BARDA (WBS 1.1.3.3)

 

		1.1.4	EVMS (WBS 1.1.4)

 

	WBS# and Title	Milestone	Deliverables
	1.1.4 EVMS	Development and implementation of EVMS system.	Completion of EVMS system and regular EVMS reports to BARDA CO/PO.

  

Objective/Description of Work: MediWound will use principles
of Earned Value Management in the management of this contract and develop an EVMS plan as part of its deliverables. Documents maintained
and utilized as part of MediWound’s EVMS will include: Integrated Master Schedule, Baseline Budget, WBS Dictionary, Control
Account Work Authorization Documents, Control Account Plans, Baseline Logs and budget revision documentation, documentation required
for the Performance Measurement Baseline Review (PMBR), and Monthly Earned Value Contract Performance Report (CPR).

 

Milestones:

 

Develop EVMS Plan Within 90 days of contract award. (WBS 1.1.4.1)

Complete EVMS Plan Implementation Within 90 days of contract
award. (WBS 1.1.4.3)

 

Deliverables

 

		-	EVMS System Implementation (WBS 1.1.4.2)

		-	EVMS Monthly Report (WBS 1.1.4.4)

		-	EVMS reports will be submitted on a monthly basis to the BARDA CO/PO commencing after the first report is delivered.

 

		1.2	Non Clinical Toxicology (WBS
                                         1.2)

 

		1.2.1	Safety (WBS 1.2.1)

 

	WBS# and Title	Milestone	Deliverables
	1.2.1.1 [ * * * ]	[ * * * ]

                                                                                 
	Study report submitted to BARDA
	1.2.1.2 [ * * * ]	[
* * * ] 

                                                                                .
	Study report submitted to BARDA
	1.2.1.3 [ * * * ]	[
* * * ]
 

	Study report submitted to BARDA
	1.2.1.4 [ * * * ]	[
* * * ]
 

	Study report submitted to BARDA
	1.2.1.5 [ * * * ]	[ * * * ]

                                                                                 
	Study report submitted to BARDA

 

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[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated
with Burns

	 

 

		1.2.1.1	[ * * * ] (WBS 1.2.1.1)

 

Objective/Description
of Work: [ * * * ]

 

 

 

 

.

 

 

Milestones:

 

[ * * * ] (WBS 1.2.1.1).

 

Deliverables:

 

		-	Study protocol for BARDA review and approval.

		-	Final study report submitted to BARDA (WBS 1.2.1.1).

 

		1.2.1.2	[ * * * ] (WBS 1.2.1.2)

 

Objective/Description of Work: [ * * * ]
 

 

 

 

 

.

 

 

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[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

 

	Advanced Development of NexoBrid

as a Medical Countermeasure for Injury Associated with
Burns

	 

 

	 	 

Milestones:

 

[ * * * ] (WBS 1.2.1.2).

 

Deliverables:

 

		-	Study protocol for BARDA review/approval (WBS 1.2.1.2).

		-	Final study report submitted to BARDA (WBS 1.2.1.2).

 

		1.2.1.3	[ * * * ] (WBS 1.2.1.3).

 

Objective/Description of Work: [ * * * ]

 

 

 

 

 

 

 

 

 

 

 

Milestones:

 

[ * * * ] (WBS 1.2.1.3).

 

 

 

Deliverables:

 

		-	Study protocol for BARDA review/approval (WBS 1.2.1.3).

		-	Final study report submitted to BARDA (WBS 1.2.1.3).

 

		1.2.1.4	[ * * * ] (WBS 1.2.1.4).

 

Objective/Description of Work: [ * * * ]

 

 

 

 

 

 

 

 

 

 

	MediWound Ltd. Confidential Information	Version 3.0	Page 9 of 28

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

     

     

    

 

	Advanced Development of NexoBrid

as a Medical Countermeasure for Injury Associated with
Burns

	 

 

Milestones:

 

[ * * * ] (WBS 1.2.1.4).

 

Deliverables:

 

		-	Study protocol for BARDA review/approval (WBS 1.2.1.4).

		-	Final study report submitted to BARDA (WBS 1.2.1.4).

 

		1.2.1.5	[ * * * ] (WBS 1.2.1.5).

 

Objective/Description of Work:

 

 

 

 

 

 

 

 

 

 

Milestones:

 

[ * * * ] (WBS 1.2.1.5).

 

Deliverables:

 

		-	Study protocol for BARDA review/approval (WBS 1.2.1.5).

		-	Final study report submitted to BARDA (WBS 1.2.1.5).

 

		1.3	Non-
                                         Clinical Pharmacology (WBS 1.3)

 

		1.3.1	Mechanism
                                         of Action Studies (WBS 1.3.1)

 

	WBS# and Title	Milestone	Deliverables
	
        1.3.1.1 [ * * * ] 

         
	[ * * * ]

                                                                                
 
 
 
 
 
 

	Study reports submitted to BARDA
	1.3.1.2 [ * * * ]	[ * * * ]

..	Study report submitted to BARDA
	1.3.1.3 [ * * * ]vitro	[ * * * ]

                                                                                
 
 
 
 

	Study report submitted to BARDA
	1.3.1.4 [ * * * ]	[ * * * ]

                                                                                
 
 
 
 
 
 

	Study report submitted to BARDA

 

	MediWound Ltd. Confidential Information	Version 3.0	Page 10  of 28

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

     

     

    

 

	Advanced Development of NexoBrid

as a Medical Countermeasure for Injury Associated with
Burns

	 

 

		1.3.1.1	[ * * * ] (WBS 1.3.1.1)

 

Objective/Description of Work: [ * * * ]

 

 

 

 

 

 

.

 

 

 

Milestones:.

 

Completion of study (WBS 1.3.1.1).

 

Deliverables:

 

		-	Study protocol for BARDA review/approval (WBS 1.3.1.1).

		-	Final study report submitted to BARDA (WBS 1.3.1.1).

 

		1.3.1.2	[ * * * ]

(WBS 1.3.1.2).

 

Objective/Description of Work: [ * * * ]

 

 

 

 

 

 

 

 

	MediWound Ltd. Confidential Information	Version 3.0	Page 11  of 28

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

     

     

    

 

	Advanced Development of NexoBrid

as a Medical Countermeasure for Injury Associated with
Burns

	 

 

Milestones:.

 

Completion of study (WBS 1.3.1.2).

 

Deliverables:

 

		-	Study protocol for BARDA review/approval (WBS 1.3.1.2).

		-	Final study report submitted to BARDA (WBS 1.3.1.2).

 

		1.3.1.3	[ * * * ] (WBS 1.3.1.3)

 

Objective/Description of Work: [ * * * ]

 

 

 

 

 

 

 

 

 

 

 

Milestones:.

 

Completion of study (WBS 1.3.1.3).

 

Deliverables:

 

		-	Study protocol for BARDA review/approval (WBS 1.3.1.3).

		-	Final study report submitted to BARDA (WBS 1.3.1.3).

 

		1.3.1.4	[ * * * ] (WBS 1.3.1.4)

 

Objective/Description
of Work: [ * * * ]

 

 

 

 

 

Milestones:.

 

Completion of study (WSB 1.3.1.4).

 

Deliverables:

 

		-	Study
                                         protocol for BARDA review/approval (WBS 1.3.1.4).

 

		-	Final study report submitted to BARDA (WBS 1.3.1.4).

 

 

 

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[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

     

     

    

 

	Advanced
    Development of NexoBrid

as a Medical Countermeasure for Injury Associated with Burns	 

 

		1.3.2	Product Characterization (WBS 1.3.2)

 

	WBS# and Title	Milestone	Deliverables
	1.3.2 [ * * * ]	[ * * * ]

..	Study report submitted to BARDA

 

		1.3.2.6	[ * * * ] (WBS 1.3.2.1)

 

Objective/Description of Work: [ * * * ]

 

 

 

 

.

 

Milestones:.

 

Completion of study (WBS 1.3.2.1).

 

Deliverables:

 

		-	Study protocol for BARDA review/approval (WBS 1.3.2.1).

		-	Final study report submitted to BARDA (WBS 1.3.2.1).

 

		1.3.3	Efficacy and Safety (WBS 1.3.3)

 

		1.3.3.1	[ * * * ] (WBS 1.3.3.1)

 

	WBS# and Title	Milestone	Deliverables
	1.3.3.1 [ * * * ]	[ * * * ]

                                                                                
 
 
 

	Study report submitted to BARDA

 

Objective/Description of Work: [ * * * ]

  

 

 

 

	MediWound Ltd. Confidential Information	Version 3.0	Page 13 of 28

 

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 	 	 

     

    

 

	Advanced
    Development of NexoBrid

as a Medical Countermeasure for Injury Associated with Burns	 

 

Milestones:.

 

Completion of study (WBS 1.3.3.1).

  

Deliverables:

 

		-	Study protocol for BARDA review/approval (WBS 1.3.3.1).

		-	Final study report submitted to BARDA (WBS 1.3.3.1)

 

		1.4	Clinical
                                         (WBS 1.4)

 

		1.4.1	US
                                         phase 3 study (WBS 1.4.1)

 

	WBS# and Title	Milestone	Deliverables
	1.4.1  US phase 3 study	Completion of Phase 3 clinical trial.	Final clinical study report (CSR) accepted by BARDA.

 

Objective/Description of Work: MediWound will complete
a multicenter, multinational, randomized, controlled, assessor blinded phase 3 study in subjects with thermal burns, to evaluate
the efficacy and safety of NexoBrid compared to Gel Vehicle and compared to Standard of Care. This study is currently ongoing.

 

Study primary endpoint is to demonstrate superiority of NexoBrid
over Gel Vehicle for eschar removal as measured by incidence of complete eschar removal. The following secondary endpoints will
be evaluated in this study and compared between NexoBrid and SOC to further support the clinical benefit of NexoBrid.

 

1.     Reduction in surgical need- Demonstrate superiority
of NexoBrid over SOC in reduction of surgical need for excisional eschar removal as measured by an analysis of incidence of surgical
eschar removal (tangential/ minor/ avulsion/ Versajet and/or dermabrasion excision).

 

2.     Earlier eschar removal- Demonstrate superiority
of NexoBrid over SOC with regard to the time when complete eschar removal has been achieved. For definition of complete eschar
removal see primary endpoint.

 

3.     Blood loss related to eschar removal- Demonstrate
superiority of NexoBrid over SOC with regard to the blood loss occurred during the eschar removal procedures.

 

This clinical trial is underway, however a study protocol will
be provided to BARDA for reference. Any changes to the study protocol will be submitted to BARDA in advance for review.

 

[ * * * ]

 

 

 

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[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 	 	 

     

    

  

	Advanced
    Development of NexoBrid

as a Medical Countermeasure for Injury Associated with Burns	 

 

		•	[ * * * ]

..

 

		•	[ * * * ]

 

		•	[ * * * ]

 

175 Hospitalized adults with Deep Partial Thickness (DPT) and
Full Thickness (FT) thermal burns will be enrolled. The total duration of the study treatment and follow up period of each participating
subject is approximately 25 months. Approximately [ * * * ] sites will participate in the study from the US ([ * * * ]), Europe
([ * * * ]) and Israel and data will be monitored by local CROs from the US and Europe.

 

Milestones

 

First Patient In (WBS 1.4.1.1)

Last Patient In (WBS 1.4.1.2)

Last Patient Out (WBS 1.4.1.5)

 

Deliverables:

 

This study is currently on-going. Protocol amendments (if will
be applied) will be provided to BARDA for review and approval before submission.

  

[ * * * ] (WBS 1.4.1.3).

 

[ * * * ]

 

 

[ * * * ] (WBS 1.4.1.4).

 

[ * * * ]

 

 

 

[ * * * ] (WBS 1.4.1.6).

 

[ * * * ]

 

 

 

 

	MediWound Ltd. Confidential Information	Version 3.0	Page 15 of 28

  

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 	 	 

     

    

 

	Advanced
    Development of NexoBrid

as a Medical Countermeasure for Injury Associated with Burns	 

 

		1.5	Regulatory

 

		1.5.1	IND

 

	WBS# and Title	Milestone	Deliverables
	1.5.1  IND	Completion of all pre-BLA activities in support of NexoBrid as an MCM.	[ * * * ]

 

Objective/Description of Work: [ * * * ]

 

		1.5.1.1	[ * * * ]

(WBS 1.5.1.1)

 

Objective/Description of Work:

 

 

 

 

[ * * * ]

 

 

Milestones:

 

[ * * * ] (WBS 1.5.1.1).

 

Deliverables:

 

Final meeting minutes submitted to BARDA (WBS 1.5.1.1).

 

		1.5.1.2	[ * * * ] (WBS 1.5.1.2)

 

Objective/Description of Work:

 

[ * * * ]

 

 

 

Milestones:

 

Completion of the FDA meeting (WBS 1.5.1.2).

 

Deliverables:

 

Final official meeting minutes submitted to BARDA (WBS 1.5.1.2).

 

	MediWound Ltd.
    Confidential Information	Version 3.0	Page
    16 of 28

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 	 	 

     

    

 

   

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated with Burns 

	 

   

		1.5.1.3	[ * * * ] (WBS 1.5.1.3)

 

Objective/Description of Work:

 

[ * * * ]

 

 

 

 

  

Milestones:

 

Completion of the study protocol to FDA (WBS 1.5.1.3).

 

Deliverables:

 

Study protocol submitted to FDA for approval (WBS 1.5.1.3).

 

		1.5.1.4	[ * * * ] (WBS 1.5.1.4)

 

Objective/Description of Work:

 

[ * * * ]

 

 

 

 

 

Milestones:

 

Completion of the study protocol after FDA guidance is received
(WBS 1.5.1.4).

 

Deliverables:

 

		-	Prior to study initiation, the study protocol will be provided to BARDA for review and approval

		-	Study protocol submitted to FDA for approval (WBS 1.5.1.4).

 

		1.5.1.5	[ * * * ]

(WBS 1.5.1.5)

 

Objective/Description of Work:

 

[ * * * ]

 

 

 

 

 

Milestones:

 

[ * * * ] (WBS 1.5.1.5).

 

Deliverables:

 

[ * * * ] (WBS 1.5.1.5).

  

		1.5.1.6	FDA Submission Request For [ * * * ] (WBS 1.5.1.6)

 

	MediWound
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    17 of 28

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated with Burns 

	 

   

Objective/Description of Work:

 

In an attempt to expedite the development and review process
of NexoBrid, MediWound plans to submit a request for [ * * * ] designation. Prior to submission, the [ * * * ] application request
will be provided to BARDA for review and approval. 

 

 

 

Milestones:

 

Completion of the [ * * * ] application (WBS 1.5.1.6).

 

Deliverables:

 

[ * * * ] submitted to FDA for approval (WBS 1.5.1.6).

 

		1.5.2	BLA
                                         (WBS 1.5.2)

 

	WBS# and Title	Milestone	Deliverables
	1.5.2  BLA	Completion of all preparatory and regulatory activities for the BLA submission of NexoBrid as an MCM.	This includes all activities in support of the BLA submission.

   

Objective/Description of Work: [ * * * ]

 

 

 

 

		1.5.2.1	[ * * * ] (WBS 1.5.2.1)

 

Objective/Description of Work:

 

[ * * * ]

 

 

 

Milestones:

 

[ * * * ] (WBS 1.5.2.1).

 

Deliverables:

 

[ * * * ] (WBS 1.5.2.1).

 

		1.5.2.2	Pre-BLA Meeting (WBS 1.5.2.2)

 

Objective/Description of Work:

 

[ * * * ]

 

 

 

 

	MediWound
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[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated with Burns 

	 

 

Milestones:

 

Completion of FDA pre-BLA meeting (WBS 1.5.2.2).

 

Deliverables:

 

Final official meeting minutes submitted to BARDA (WBS 1.5.2.2).

 

		1.5.2.3	BLA preparation and submission (WBS 1.5.2.3)

 

Objective/Description of Work: [ * * * ]

 

 

 

 

 

 

 

Milestones:

 

BLA completion (WBS 1.5.2.3).

 

Deliverables:

 

[ * * * ] (WBS 1.5.2.3)

[ * * * ] (US, PIP) (WBS 1.5.2.4)

[ * * * ] (WBS 1.5.2.5)

 

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page
    19 of 28

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated with Burns 

	 

  

 

		1.6	Chemistry,
                                         Manufacturing and Control (CMC) (WBS 1.6)

 

		1.6.1	[ *
                                         * * ] (WBS 1.6.1)

 

	WBS# and Title	Milestone	Deliverables
	1.6.1  [ * * * ]	[ * * * ]

..	Reports submitted to BARDA CO/PO.

  

		1.6.1.1	[ * * * ] (LC-MS) (WBS 1.6.1.1)

 

Objective/Description of Work:

 

[ * * * ]

 

 

 

Milestones:

 

[ * * * ] (WBS 1.6.1.1).

 

Deliverables:

 

Report on method submitted to BARDA PO/CO (WBS 1.6.1.1).

 

		1.6.1.2	[ * * * ] (WBS 1.6.1.2)

 

Objective/Description of Work:

 

[ * * * ]

 

 

 

Milestones:

 

[ * * * ]

(WBS 1.6.1.2).

 

Deliverables:

 

		-	Method validation protocol submitted to BARDA for review and approval.

 

		-	Report on method submitted to BARDA PO/CO (WBS 1.6.1.2).

 

		1.6.1.3	Analytical Support and Troubleshooting (WBS 1.6.1.3)

 

MediWound will give analytical support and troubleshooting to
the production processes of NexoBrid to ensure the quality of the product.

 

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page
    20 of 28

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

 

 

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated
with Burns

	 

 

Deliverables:

 

Report on support submitted to BARDA PO/CO (WBS 1.6.1.3).

 

 

		1.6.2	[ * * * ] Development (WBS
                                         1.6.2)

 

	WBS# and Title	Milestone	Deliverables
	1.6.2.1 [ * * * ]

                                                                                 

                                                                                 
	Completion
of study to [ * * * ]

	Final development  report submitted to BARDA
	1.6.2.2 [ * * * ]

                                                                                                                                                                                   

                                                                                                                                                                                  
 

	Completion
of study to [
* * * ] 
	[ * * * ]
	1.6.2.3 MediWound will conduct [ * * * ]

                                                                                

                                                                                 

                                                                                 

                                                                                 

                                                                                 

                                                                                

	[
* * * ].
	[ * * * ]
	1.6.2.4
[ * * * ]

                                                                                                                                                                                  
 

	[ * * * ].	[ * * * ]

 

 

		1.6.2.1	NexoBrid [ * * * ] (WBS 1.6.2.1)

 

Objective/Description of Work: [ * * * ]

 

 

 

 

Milestones:

 

[ * * * ] (WBS 1.6.2.1).

 

Deliverables:

 

		-	Study protocols will be provided to BARDA for review and approval.

 

		-	Final development report submitted to BARDA (WBS 1.6.2.1).

 

 

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page
     21 of 28

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated
with Burns

	 

 

		1.6.2.2	[
* * * ] (WBS 1.6.2.2)

 

Objective/Description of Work:

 

[ * * * ]

 

 

Milestones:

 

[ * * * ] (WBS 1.6.2.2).

 

Deliverables:

 

		-	Validation protocol will be provided to BARDA for review and approval.

 

		-	Final process validation and stability reports (WBS 1.6.2.2).

 

		1.6.2.3	[ * * * ] (WBS 1.6.2.3)

 

Objective/Description of Work: [ * * * ].

 

 

 

Milestones:

 

[ * * * ] study completion (WBS 1.6.2.3).

 

Deliverables:

 

		-	[ * * * ].

 

		-	Final study report (WBS 1.6.2.3).

 

		1.6.2.4	[ * * * ] (WBS 1.6.2.4)

 

Deliverables:

 

[
* * * ] (WBS 1.6.2.4).

 

		1.6.3	Quality by Design (QbD) (WBS 1.6.3)

 

	WBS# and Title	Milestone	Deliverables
	1.6.3  Quality by Design	Completion of QbD studies defining the critical parameters and design space of the NexoBrid manufacturing process.	Reports submitted to BARDA CO/PO.

 

 

		1.6.3.1	Risk Based Design of Experiment (DOE) Plan (WBS 1.6.3.1)

 

 

	MediWound
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    22      of 28

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated
with Burns

	 

 

Objective/Description of Work: MediWound will conduct
together with [ * * * ] Ltd., or will assist other subcontractor approved by BARDA, risk based design of experiment (DOE) for creating
a design space for the NexoBrid production process. [ * * * ]

.. The objective of the QbD research is to follow the FDA initiative of the Quality by Design approach. The QbD studies will follow
the relevant ICH guidelines such as ICH Q8, ICH Q9 and Q10. QbD Studies protocol will be provided to BARDA for review and approval.

 

 

 

Milestones:

 

DOE study completion (WBS 1.6.3.1).

 

Deliverables:

 

		-	QbD Study protocol will be provided to BARDA for review and approval.

 

		-	Final study report submitted to BARDA (WBS 1.6.3.1).

 

		1.6.3.2	[ * * * ] (WBS 1.6.3.2)

 

Objective/Description of Work: [ * * * ]

 

 

 

Milestones:

 

[ * * * ] (WBS 1.6.3.2).

 

Deliverables:

 

		-	Study protocol will be provided to BARDA for review and approval.

		-	Final study report submitted to BARDA (WBS 1.6.3.2).

 

		1.6.3.3	Statistical Analysis and Summary of the Results (WBS 1.6.3.3)

 

Objective/Description of Work: [
* * * ]

 

Milestones:

 

[ * * * ] (WBS 1.6.3.3).

 

Deliverables:

 

		-	Final study report submitted to BARDA (WBS 1.6.3.3).

 

		1.6.4	Agriculture Raw Material Studies (WBS 1.6.4)

 

 

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page
    23      of 28

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced Development of NexoBrid 

    as a Medical Countermeasure for Injury Associated with Burns	

 

	WBS# and Title	Milestone	Deliverables
	1.6.4 Agriculture Raw Material Studies	[
* * * ]	Reports submitted to BARDA CO/PO.

 

 

		1.6.4.1	[ * * * ]

(WBS 1.6.4.1)

 

Objective/Description of Work: [ * * * ]

 

 

Milestones:

 

[ * * * ] (WBS 1.6.4.1).

 

Deliverables:

 

		-	Study protocols will be provided to BARDA for review and approval.

		-	Final study report submitted to BARDA (WBS 1.6.4.1).

 

		1.6.4.2	Analytical Chemistry Testing and Statistical Analysis (WBS 1.6.4.2)

 

Objective/Description of Work: [ * * * ]

..

 

Milestones:

 

Study and analysis completion (WBS 1.6.4.2).

 

Deliverables:

 

		-	Study protocols will be provided to BARDA for review and approval.

 

		-	Final study report submitted to BARDA (WBS 1.6.4.2).

 

		1.6.5	[ * * * ] (WBS 1.6.5

 

	WBS# and Title	Milestone	Deliverables
	1.6.5 [ * * * ]	[ * * * ]

 	Reports submitted to BARDA CO/PO; submissions sent to FDA for approval.

 

	MediWound Ltd. Confidential Information 	Version 3.0	 Page 24  of 28

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced Development of NexoBrid 

    as a Medical Countermeasure for Injury Associated with Burns	

 

		1.6.5.1	[ * * * ] (WBS 1.6.5.1)

 

Objective/Description of Work: [ * * * ]

 

 

 

 

Milestones:

 

Design completion (WBS 1.6.5.1).

 

Deliverables:

 

Final design submitted to BARDA (WBS 1.6.5.1).

 

		1.6.5.2	[ * * * ] (WBS 1.6.5.2)

 

		-	Objective/Description of Work: [
* * * ]

 

 

 

Milestones:

 

Validation/PQ activities completed (WBS 1.6.5.2).

 

Deliverables:

 

		-	Validation protocols will be provided to BARDA for review and approval.

		-	Report on validation activities submitted to BARDA (WBS 1.6.5.2).

 

		1.6.5.3	File Submission, Inspection & Approving (WBS 1.6.5.3)

 

		-	Objective/Description of Work: [ * * * ]

..

 

	MediWound Ltd. Confidential Information 	Version 3.0	 Page 25 of 28

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced Development of NexoBrid 

    as a Medical Countermeasure for Injury Associated with Burns	

 

 

 

 

Milestones:

 

Completion of submission preparation (WBS 1.6.5.3).

 

Deliverables:

 

[
* * * ] (WBS 1.6.5.3).

 

		1.6.5.4	[ * * * ] (WBS 1.6.5.4)

 

Objective/Description of Work: [ * * * ]

 

Milestones:

 

Completion of stability study (WBS 1.6.5.4).

 

 

 

Deliverables:

 

		-	Stability protocols for BARDA review and approval

		-	Submission of stability report to BARDA and FDA (WBS 1.6.5.4).

 

		1.6.5.5	FDA Approval of Scale-up (WBS 1.6.5.5)

 

		-	Objective/Description of Work: [ * * * ]

 

		-	. Application file will be provided to BARDA for review and approval prior to submission.

 

 

 

Milestones:

 

Completion of application for approval (WBS 1.6.5.5).

 

Deliverables:

 

Submission of application to BARDA and FDA (WBS 1.6.5.5).

 

 

	MediWound Ltd. Confidential Information 	Version 3.0	 Page 26 of 28

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced Development of NexoBrid 

    as a Medical Countermeasure for Injury Associated with Burns	

 

		1.7	Procurement
                                         (WBS 1.7)

 

		1.7.1	Acquisition
                                         (WBS 1.7.1)

 

	WBS# and Title	Milestone	Deliverables
	1.7.1 Acquisition	Acquisition of [ * * * ]of NexoBrid.	[ * * * ] of NexoBrid successfully delivered to BARDA.

 

 

		1.7.2	Warm
                                         Base (Inventory Stockpile) (WBS 1.7.2)

 

	WBS# and Title	Milestone	Deliverables
	1.7.2 Warm Base	Establishment of operational readiness to manufacture NexoBrid.	Report submitted to BARDA PO/CO.

 

 

		1.7.2.1	Setup of vendor managed inventory system (VMI) plan (WBS 1.7.2.1)

 

Objective/Description of Work: [ * * * ]

 

 

 

 

 

 

 

 

 

Milestones:

 

[ * * * ] and plan development (WBS 1.7.2.1).

 

Deliverables:

 

Submission of the VMI plan by BARDA (WBS 1.7.2.1).

 

		1.7.2.2	Implementation of vendor managed inventory system (VMI) plan (WBS 1.7.2.2)

 

Objective/Description of Work: MediWound will implement
the VMI plan with the approved vendor.

 

Milestones:

 

Implementation of VMI plan (WBS 1.7.2.2).

 

Deliverables:

 

Notification to BARDA of successful implementation (WBS 1.7.2.2).

 

 

	MediWound Ltd. Confidential Information 	Version 3.0	 Page 27 of 28

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

 

	Advanced Development of NexoBrid 

    as a Medical Countermeasure for Injury Associated with Burns	

 

		1.7.3	Sustainment (WBS 1.7.3)

 

	WBS# and Title	Milestone	Deliverables
	1.7.3 Sustainment	Replacement of expired material as necessary.	Replacement of expired material as necessary.

 

 

		1.7.4	Disposal
                                         (WBS 1.7.4)

 

	WBS# and Title	Milestone	Deliverables
	1.7.4 Disposal	Disposal of expired material as necessary.	Disposal of expired material as necessary.

 

 

	MediWound Ltd. Confidential Information 	Version 3.0	 Page 28 of 28

 

    	 

    	 

    

 

 

 

 

 

Final
Revised Proposal 

Volume
II: Technical Proposal

Full
Proposal Submitted for Consideration under Solicitation 15-100-SOL-00021

Non-Surgical
Debridement for Definitive Care of Burn Injuries

This
proposal is made in agreement with all the terms and conditions of this Solicitation.

  

Advanced
Development of NexoBrid  

as
a Medical Countermeasure for Injury Associated with Burns

 

SOW
Portion of the Options pages 89-98

 

Submitted
to: 

Biomedical
Advanced Research and Development Authority

U.S.
Department of Health and Human Services

Assistant
Secretary for Preparedness and Response

Contracting
Officer – Matthew Rose

ASPR-AMCG-202-205-2901

200
C St. SW

Washington,
D.C. 20024

Attention:
Matthew Rose, Contracting Officer

 

	Reference:
        Solicitation # 15-100-SOL-00021

         

        Prime
        Offeror: 

         

        MediWound
        Ltd. 

        42
        Hayarkon Street,

        Yavne,
        Israel 8122745

        Tel:
        + +972 77 9714100

        Fax:
        +972 77 9714111

        e-mail:
        

        info@mediwound.cominfo@mediwound.com

        DUNS:
        5320400334

         

        September
        10, 2015

         
	 

         

        Business
        Contact:

         

        

        Gal
        Cohen 

        President
        & Chief Executive Officer

         

        Technical
        Contact: 

        Ety
        Klinger, PhD

        Chief
        R&D Officer

         

         

         

    	 

    	 

    

 

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated
with Burns

	 

  

Throughout
this proposal, MediWound refers to various trademarks, service marks and trade names that it uses in its business. The “MediWound”
design logo, “MediWound”, “NexoBrid”, “EscharEx” and other trademarks or service marks of
MediWound appearing in this proposal are the property of MediWound. MediWound has several other trademarks, service marks and
pending applications relating to its applications. Other trademarks and service marks appearing in this proposal are the property
of their respective holders.

 

TABLE
OF CONTENTS

 

	1.   Option
    Period Statement of Work (CLIN 0003, 0004, 0005)	3
	1.1   Program
    Management (WBS 1.1)	3
	1.1.1   Technical
    and Project Management (WBS 1.1.1)	3
	1.1.1.5   [
    * * * ] / Report (WBS 1.1.1.5)	3
	1.1.1.6   [
    * * * ] / Report (WBS 1.1.1.6)	3
	1.1.1.7   [
* * * ]/ Report (WBS 1.1.1.7)	3
	1.1.1.8   VMI
    Implementation Option Management (CLIN 0005A)/Report (WBS 1.1.1.8)	3
	1.4   Clinical
    (WBS 1.4)	3
	1.4.2   [
    * * * ] (WBS 1.4.2)	3
	1.4.3   [
    * * * ] (WBS 1.4.3)	6
	1.5   Regulatory	8
	1.5.3   Post
    Marketing Activities (WBS 1.5.3)	8
	1.5.3.1   Marketing
    Requirement- Infrastructure/Obligation (PhV, Call Center) (WBS 1.5.3.1)	8
	1.5.3.2   Phase
    IV Post-Marketing Study (WBS 1.5.3.2)	8
	1.5.3.3   [
    * * * ] (WBS 1.5.3.3)	8
	1.6   Chemistry,
    Manufacturing and Control (CMC) (WBS 1.6)	10
	1.6.6   [
    * * * ] (WBS 1.6.6)	10
	1.6.6.1   [
    * * * ] (WBS 1.6.6.1)	10
	1.6.6.2   [
* * * ](WBS 1.6.6.2)	10
	1.6.6.3   File
    submission, Inspection & Approving (WBS 1.6.6.3)	10
	1.6.6.4   File
    submission, Inspection & Approving (WBS 1.6.6.4)	11
	1.6.6.5   File
    submission, Inspection & Approving (WBS 1.6.6.5)	11
	1.8   Surge
    Capacity (WBS 1.8)	12
	1.8.1   Acquisition
    (WBS 1.8.1)	12
	1.8.2   Warm
    Base (Inventory Stockpile) (WBS 1.8.2)	12
	1.8.3   Sustainment
    (WBS 1.8.3)	12
	1.8.4   Disposal
    (WBS 1.8.4)	12

 

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page
    2 of 12

 

[
* * * ] Portions of this agreement were omitted and a complete copy of this agreement has been provided separately to the Securities
and Exchange Commission pursuant to the company’s application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated
with Burns

	 

  

		1.	Option
                                         Period Statement of Work (CLIN 0003, 0004, 0005)

 

		1.1	Program
                                         Management (WBS 1.1)

 

Updated
SOW(s) and accompanying budgets will be provided to BARDA for each option period to define the execution of each CLIN.

 

Program
Management encompasses contract management (e.g., contract reporting), program management (e.g., subcontractor oversight, program
progress), and risk management (e.g., EVM, risk evaluation). Project Management milestones and activities in this section are
listed below, corresponding to management in the period described.

 

		1.1.1	Technical
                                         and Project Management (WBS 1.1.1)

 

	WBS#
    and Title	Milestone	Deliverables
	1.1.1
    Technical and Project Management	Successful
    completion of technical and project management activities for each option period.	Project
    scheduled completed and reports submitted to BARDA PO/CO after completion of each option period.

 

Objective/Description
of Work: These activities encompass all Program Management for the listed contract period.

 

		1.1.1.5	[
                                         * * * ] / Report (WBS 1.1.1.5)

 

		1.1.1.6	[
                                         * * * ] / Report (WBS 1.1.1.6)

 

		1.1.1.7	Post-Marketing
                                         Option Management (CLIN 0003)/ Report (WBS 1.1.1.7)

 

		1.1.1.8	VMI
                                         Implementation Option Management (CLIN 0005A)/Report (WBS 1.1.1.8)

 

Objective/Description
of Work: An overall project schedule in the form of a Gantt chart will be created and maintained as part of project management.
This schedule will be updated and formally completed within 90 days after the contract award.

 

Milestones:

 

[
* * * ] / Report (WBS 1.1.1.5)

 

Option
2 Management/ Report (WBS 1.1.1.6) 

Option
3 Management/ Report (WBS 1.1.1.7)

Option
4 Management/ Report (WBS 1.1.1.8)

 

		1.4	Clinical
                                         (WBS 1.4)

 

		1.4.2	[
                                         * * * ] (WBS 1.4.2)

 

	WBS#
    and Title	Milestone	Deliverables
	1.4.2
    [ * * * ]	Completion
    of Phase 3 clinical trial	Final
    clinical study report (CSR) accepted by BARDA.

 

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page
    3 of 12

  

[
* * * ] Portions of this agreement were omitted and a complete copy of this agreement has been provided separately to the Securities
and Exchange Commission pursuant to the company’s application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated
with Burns

	 

  

Objective/Description
of Work: [ * * * ].

 

 

[
* * * ]

 

 

 

 
  

 

  

 

 

  

 

  

Milestones:

 

First
Patient In (WBS 1.4.2.1)

Last
Patient In (WBS 1.4.2.2)

 

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page
    4 of 12

  

[
* * * ] Portions of this agreement were omitted and a complete copy of this agreement has been provided separately to the Securities
and Exchange Commission pursuant to the company’s application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated
with Burns

	 

  

Last
Patient Out (WBS 1.4.2.5)

 

Deliverables:

 

		-	Study
                                         protocol for BARDA review/approval prior to submission to FDA (WBS 1.4.2.1).

		-	Safety
                                         analysis, [ * * * ] patient (WBS 1.4.2.3)

		-	[
                                         * * * ] month follow up: Data analysis + CSR (WBS 1.4.2.4)

		-	[
                                         * * * ] month follow up: Data analysis + CSR (WBS 1.4.2.6)

 

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page
    5 of 12

  

[
* * * ] Portions of this agreement were omitted and a complete copy of this agreement has been provided separately to the Securities
and Exchange Commission pursuant to the company’s application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated
with Burns

	 

 

		1.4.3	[
                                         * * * ] (WBS 1.4.3)

 

	WBS# and Title	Milestone	Deliverables
	1.4.3
    [ * * * ]	Completion
    of Phase 3 clinical trial.	Final
    clinical study report (CSR) accepted by BARDA.

 

This
is a phase 3 study to assess NexoBrid effect on [ * * * ]. The main objective is to demonstrate the ability of NexoBrid to prevent
and resolve [ * * * ]. The study will include approximately [ * * * ] patients from US sites and will be managed locally by a
US CRO. The main endpoints will be [ * * * ].

 

 

 

[
* * * ]

 

 

 

 

Milestones:

 

Set
up (WBS 1.4.3.1) 

First
Patient In (WBS 1.4.3.2)

Last
Patient In (WBS 1.4.3.3)

Last
Patient Out (WBS 1.4.3.5)

 

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page
    6 of 12

  

[
* * * ] Portions of this agreement were omitted and a complete copy of this agreement has been provided separately to the Securities
and Exchange Commission pursuant to the company’s application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
                                         Development of NexoBrid 

as a Medical Countermeasure for Injury Associated
with Burns

	 

  

Deliverables:

 

		-	Prior
                                         to study initiation, the study protocol will be provided to BARDA for review and approval.
                                         (WBS 1.4.3.1).

		-	[
                                         * * * ] (WBS 1.4.3.4)

		-	[
                                         * * * ] (WBS 1.4.3.6)

 

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page
    7 of 12

 

[
* * * ] Portions of this agreement were omitted and a complete copy of this agreement has been provided separately to the Securities
and Exchange Commission pursuant to the company’s application requesting confidential treatment under Rule 24b-2 of the
Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
    Development of NexoBrid 

    as a Medical Countermeasure for Injury Associated with Burns	 

 

		1.5	Regulatory

 

		1.5.3	Post
                                         Marketing Activities (WBS 1.5.3)

 

	WBS# and Title	Milestone	Deliverables
	1.5.3  Post Marketing Activities	Initiation of FDA required post-marketing activities.	Successful establishment of required post-marketing activities.

 

		1.5.3.1	Marketing Requirement- Infrastructure/Obligation (PhV, Call Center) (WBS 1.5.3.1)

 

Objective/Description of Work:

 

In order to comply with regulatory requirements for NexoBrid
in the US market following approval, MediWound will establish an appropriate pharmacovigilance system, overseeing all safety aspects
of the marketed product.

 

Milestones:

 

Establishment of the pharmacovigilance system in compliance
with FDA guidance (WBS 1.5.3.1).

 

Deliverables:

 

Report on implemented pharmacovigilance system submitted to
BARDA PO/CO (WBS 1.5.3.1).

 

		1.5.3.2	Phase IV Post-Marketing Study (WBS 1.5.3.2)

 

Objective/Description of Work:

 

Following product approval, MediWound anticipates the necessity
of conducting post approval activities (as was required in Europe by the EMA) that may or may not be required during the base period
but may be required by the FDA. [ * * * ].

 

Milestones:

 

Initiation of post-approval marketing studies in compliance
with FDA guidance (WBS 1.5.3.2).

 

Deliverables:

 

Report on implemented post-approval marketing studies submitted
to BARDA PO/CO (WBS 1.5.3.2).

 

		1.5.3.3	[ * * * ] (WBS 1.5.3.3)

 

Objective/Description of Work:

 

[ * * * ]

 

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page 8 of 12

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
    Development of NexoBrid 

    as a Medical Countermeasure for Injury Associated with Burns	 

 

Milestones:

 

Initiation of post-approval marketing studies in compliance
with FDA guidance (WBS 1.5.3.3).

 

Deliverables:

 

		-	Study protocol will be provided to BARDA for review and approval.

		-	Report on implemented post-approval marketing studies submitted to BARDA PO/CO (WBS 1.5.3.3).

 

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page 9 of 12

 

    	 

    	 

    

 

	Advanced
    Development of NexoBrid 

    as a Medical Countermeasure for Injury Associated with Burns	 

 

		1.6	Chemistry,
                                         Manufacturing and Control (CMC) (WBS 1.6)

 

		1.6.6	[ * * * ]

                                         (WBS 1.6.6)

 

	WBS# and Title	Milestone	Deliverables
	1.6.6 1. [ * * * ]	[ * * * ]

..	Reports submitted to BARDA CO/PO

 

		1.6.6.1	[ * * * ] (WBS 1.6.6.1)

 

		-	Objective/Description of Work: [ * * * ]

..

  

Milestones:

 

Completion of application for approval (WBS 1.6.6.1).

 

Deliverables:

 

		-	Submission of design and technology transfer protocol and report to BARDA for review (WBS 1.6.6.1).

 

		1.6.6.2	Subcontractor Facility technical batches and validations (WBS 1.6.6.2)

 

Objective/Description of Work: [ * * * ]

..

 

Milestones:

 

Validation/PQ activities completed (WBS 1.6.6.2).

 

Deliverables:

 

Validation protocol and Report on validation activities submitted
to BARDA (WBS 1.6.6.2).

 

		1.6.6.3	File submission, Inspection & Approving (WBS 1.6.6.3)

 

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page 10 of 12

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
    Development of NexoBrid 

    as a Medical Countermeasure for Injury Associated with Burns	 

  

Objective/Description of Work: MediWound will contract
with consultants approved by BARDA, to prepare and submit a file of the [ * * * ]

..

 

Milestones:

 

Completion of submission preparation (WBS 1.6.6.3).

 

Deliverables:

 

[ * * * ] (WBS 1.6.6.3).

 

		1.6.6.4	File submission, Inspection & Approving (WBS 1.6.6.4)

 

Objective/Description of Work: MediWound will contract
with consultants approved by BARDA to [ * * * ].

 

Milestones:

 

Completion of stability study (WBS 1.6.6.4).

 

Deliverables:

 

Submission of stability protocol and report to BARDA and FDA
(WBS 1.6.6.4).

 

		1.6.6.5	File submission, Inspection & Approving (WBS 1.6.6.5)

 

Objective/Description of Work: [ * * * ]

..

 

Milestones:

 

Completion of application for approval (WBS 1.6.6.5).

 

Deliverables:

 

Submission of application to BARDA and FDA (WBS 1.6.6.5).

  

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page 11 of 12

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

	Advanced
    Development of NexoBrid 

    as a Medical Countermeasure for Injury Associated with Burns	 

 

		1.8	Surge Capacity (WBS 1.8)

 

	WBS# and Title	Milestone	Deliverables
	1.8.1 Acquisition	Acquisition of up to [ * * * ] of NexoBrid.	[ * * * ] of NexoBrid successfully delivered to BARDA.
	1.8.2 Warm Base	Establishment of operational readiness to manufacture NexoBrid.	Report submitted to BARDA PO/CO.
	1.8.3 Sustainment	Replacement of expired material as necessary.	Replacement of expired material as necessary.
	1.8.4 Disposal	Disposal of expired material as necessary.	Disposal of expired material as necessary.

 

		1.8.1	Acquisition (WBS 1.8.1)

 

	WBS# and Title	Milestone	Deliverables
	1.8.1 Acquisition	Acquisition of [ * * * ] of NexoBrid. 	[ * * * ] of NexoBrid successfully delivered to BARDA.

 

		1.8.2	Warm
                                         Base (Inventory Stockpile) (WBS 1.8.2)

 

		1.8.3	Sustainment
                                         (WBS 1.8.3)

 

		1.8.4	Disposal
                                         (WBS 1.8.4)

  

	MediWound
    Ltd. Confidential Information	Version
    3.0	Page 12 of 12

 

[ * * * ] Portions of this agreement were omitted and a complete
copy of this agreement has been provided separately to the Securities and Exchange Commission pursuant to the company’s
application requesting confidential treatment under Rule 24b-2 of the Securities Exchange Act of 1934, as amended.

    	 

    	 

    

 

 

	HHSO100201500035C	Mediwound Ltd

 

ATTACHMENT
#2

 

INVOICE/FINANCING
REQUEST INSTRUCTIONS - FOR COST-REIMBURSEMENT TYPE

CONTRACTS

 

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

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

 

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

 

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

 

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

 

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

 

Currency:
All 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).

 

     

     

    

 

	HHSO100201500035C	Mediwound Ltd

 

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

 

	(a)	Designated Billing Office
    Name and Address: Enter the designated billing office name and address, as identified in the Invoice Submission Instructions
    in Section G of the Contract Schedule.
	 	 
	(b)	Contractor’s Name, Address,
    Point of Contact, VIN, and DUNS or DUNS+4 Number: Show the Contractor’s name and address exactly as they appear
    in the contract, along with the name, title, phone number, and e-mail address of the person to notify in the event of an improper
    invoice or, in the case of payment by method other than Electronic Funds Transfer, to whom payment is to be sent. Provide
    the Contractor’s Vendor Identification Number (VIN), and Data Universal Numbering System (DUNS) number or DUNS+4. The
    DUNS number must identify the Contractor’s name and address exactly as stated on the face page of the contract. When
    an approved assignment has been made by the Contractor, or a different payee has been designated, provide the same information
    for the payee as is required for the Contractor (i.e., name, address, point of contact, VIN, and DUNS).
	 	 
	(c)	Invoice/Financing Request Number:
    Insert the appropriate serial number of the payment request.
	 	 
	(d)	Date Invoice/Financing Request Prepared:
    Insert the date the payment request is prepared.
	 	 
	(e)	Contract Number and Order Number
    (if applicable): Insert the contract number and order number (if applicable).
	 	 
	(f)	Effective Date: Insert the effective date of the contract
    or if billing under an order, the effective date of the order.
	 	 
	(g)	Total Estimated Cost of Contract/Order:
    Insert the total estimated cost of the contract, exclusive of fixed-fee. If billing under an order, insert the total estimated
    cost of the order, exclusive of fixed-fee. For incrementally funded contracts/orders, enter the amount currently obligated
    and available for payment.
	 	 
	(h)	Total Fixed-Fee: Insert the total
    fixed-fee (where applicable) or the portion of the fixed-fee applicable to a particular invoice as defined in the contract.
	 	 
	(i)	Two-Way/Three-Way Match: Identify
    whether payment is to be made using a two-way or three-way match. To determine required payment method, refer to the Invoice
    Submission Instructions in Section G of the Contract Schedule.
	 	 
	(j)	Office of Acquisitions: Insert
    the name of the Office of Acquisitions, as identified in the Invoice Submission Instructions in Section G of the Contract
    Schedule.
	 	 
	(k)	Central Point of Distribution:
    Insert the Central Point of Distribution, as identified in the Invoice Submission Instructions in Section G of the Contract
    Schedule.
	 	 
	(l)	Billing Period: Insert the beginning
    and ending dates (month, day, and year) of the period in which costs were incurred and for which reimbursement is claimed.
	 	 
	(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.

 

     

     

    

 

	HHSO100201500035C	Mediwound Ltd

 

	(n)	Amount Billed - Cumulative:
    Insert the cumulative amounts claimed by major cost element, including any adjustments and fixed-fee. If the Contract
    Schedule contains separately priced line items, identify the contract line item(s) on the payment request and include a separate
    breakdown (by major cost element) for each line item.
	 	 
	(o)	Direct Costs: Insert the major
    cost elements. For each element, consider the application of the paragraph entitled “Costs Requiring Prior Approval”
    on page 1 of these instructions.

	 	 	 
	 	(1)	Direct Labor: Include salaries
    and wages paid (or accrued) for direct performance of the contract. List individuals by name, title/position, hourly/annual
    rate, level of effort (actual hours or % of effort), breakdown by task performed by personnel, and amount claimed.
	 	 	 
	 	(2)	Fringe Benefits: List any fringe
    benefits applicable to direct labor and billed as a direct cost. Do not include in this category fringe benefits that are
    included in indirect costs.
	 	 	 
	 	(3)	Accountable Personal Property:
    Include any property having a unit acquisition cost of $5,000 or more, with a life expectancy of more than two years, and
    sensitive property regardless of cost (see the HHS Contractor’s Guide for Control of
    Government Property)(e.g. personal computers). Note this is not permitted for reimbursement without pre-authorization
    from the CO.
	 	 	 
	 	 	On a separate sheet of paper attached to the payment request,
    list each item for which reimbursement is requested. Include reference to the following (as applicable):
	 	 	 
	 	 	- Item number for the specific piece
    of equipment listed in the Property Schedule, and
	 	 	 
	 	 	- COA number, if the equipment is
    not covered by the Property Schedule.
	 	 	 
	 	 	The Contracting Officer may require the Contractor to provide
    further itemization of property having specific limitations set forth in the contract.
	 	 	 
	 	(4)	Materials and Supplies: Include
    all consumable material and supplies regardless of amount. Detailed line-item breakdown (e.g. receipts, quotes, etc.) is required.
	 	 	 
	 	(5)	Premium Pay: List remuneration
    in excess of the basic hourly rate.
	 	 	 
	 	(6)	Consultant Fee: List fees paid
    to consultants. Identify consultant by name or category as set forth in the contract or COA, as well as the effort (i.e.,
    number of hours, days, etc.) and rate billed.
	 	 	 
	 	(7)	Travel: Include domestic and
    foreign travel. Foreign travel is travel outside of Canada, the United States and its territories and possessions. However,
    for an organization located outside Canada, the United States and its territories and possessions, foreign travel means travel
    outside that country. Foreign travel must be billed separately from domestic travel.
	 	 	 
	 	(8)	Subcontract Costs: List subcontractor(s)
    by name and amount billed. Provide subcontract invoices/receipts as backup documentation. If subcontract is of the cost-reimbursement
    variety, detailed breakdown will be required. Regardless, include backup documentation (e.g. subcontractor invoices, quotes,
    etc.).

 

     

     

    

 

	HHSO100201500035C	Mediwound Ltd

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

	(p)	Cost of Money (COM): Cite the
    COM factor and base in effect during the time the cost was incurred and for which reimbursement is claimed, if
    applicable.
	 	 
	(q)	Indirect Costs: Identify the
    indirect cost base (IDC), indirect cost rate, and amount billed for each indirect cost category.
	 	 
	(r)	Fixed-Fee: Cite the formula or
    method of computation for fixed-fee, if applicable. The fixed-fee must be claimed as provided for by the
    contract.
	 	 
	(s)	Total Amounts Claimed: Insert
    the total amounts claimed for the current and cumulative periods.
	 	 
	(t)	Adjustments: Include amounts
    conceded by the Contractor, outstanding suspensions, and/or disapprovals subject to appeal.
	 	 
	(u)	Grand Totals
	 	 
	(v)	Certification of Salary Rate Limitation:
    If required by the contract (see Invoice Submission Instructions in Section G of the Contract Schedule), the Contractor
    shall include the following certification at the bottom of the payment request:
	 	 
	 	“I hereby certify that the salaries billed in this payment
    request are in compliance with the Salary Rate Limitation Provisions in Section H of the contract.”
	 	 
	**Note the Contracting Officer may require the Contractor
    to submit detailed support for costs claimed on payment requests. Every cost must be determined to be allocable, reasonable,
    and allowable per FAR Part 31.

 

     

     

    

 

	HHSO100201500035C	Mediwound Ltd

 

ATTACHMENT
#3

 

INVOICE/FINANCING
REQUEST INSTRUCTIONS FOR FIXED PRICE TYPE CONTRACTS

 

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

 

Format
Standard Form I034, Public Voucher for Purchases and Services Other Than Personal, and Standard Form I035, Public Voucher for
Purchases and Services Other than Personal--Continuation Sheet, and the payee’s letterhead or self-designed form
should be used to submit claims for reimbursement.

 

Number
of Copies: As indicated in the contract.

 

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

 

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

 

(a)
Designated Billing Office and address:

 

HHS/ASPR/BARDA

 

330
Independence Ave, Room G640 

 

Washington DC 20201 

 

ATTN: Contracting Officer

 

(b)
Invoice Number

 

(c)
Date of Invoice

 

(d)
Contract number and date

 

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

 

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

 

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

 

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

 

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

 

     

     

    

 

 

	HHSO100201500035C	Mediwound Ltd

ATTACHMENT
#4 - SAMPLE INVOICE FORM

Company
Name

	Designated
    Billing Office Name and Address:	Invoice/Finance
    Number:
	 	 
	DHHS/OS/ASPR/AMCG	Date Invoice Prepared:
	Attn:
    Contracting Officer	 
	200
    C St., S.W.	Contract No. and Title:
	 	 
	Washington,
    D.C. 20201	Effective Date &
    Period of Performance:
	 	 
	Contractor’s
    Address and Contact Information:	Total Estimated Cost
    of Order:
	 	 
	 	Office of Acquisitions:
	 	Contracting Officer (insert
    name here)
	 	Office of Acquisitions
    Management, Contracts, and
	POC:
    Name of accountant or COO or signatory authority for invoice	Grants (AMCG)
	Title:	 
	Phone:	 
	E-Mail:	Central Point of Distribution:
	 	 
	TIN:	 
	DUNS
    #:	 

	This
    invoice represents reimbursable costs for the period
    from	
	Expenditure
    Category	Amount
    Billed	 
	Current	Cumulative	Contract
    Value
	Direct
    Costs:	 	 	 
	Direct
    Labor	 	 	 
	Fringe
    Benefits               0.00%	 	 	 
	Total
    Labor Costs:	 	 	 
	 	 	 	 
	Overhead                                    0.00%	 	 	 
	 	 	 	 
	Travel	 	 	 
	Subcontracts	 	 	 
	Consultant
    Fees	 	 	 
	Materials
    and Supplies	 	 	 
	Other	 	 	 
	Total
    Direct Costs	 	 	 
	 	 	 	 
	G&A
    Rate                                    0.00%	 	 	 
	 	 	 	 
	Subtotal:	 	 	 
	 	 	 	 
	Fixed
    Fee                                       0.0	 	 	 
	 	 	 	 
	Total
    Amount Claimed	 	 	 
	 	 	 	 
	Adjustments	 	 	 
	 	 	 	 
	Grand
    Total	$	—	 	 

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

 

 

Name/signature
of signatory authority for invoicing

 

    	 

    	 

    

 

	HHSO100201500035C	Mediwound Ltd

ATTACHMENT
#5 

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)	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 patient care
                                                                                                                            costs.                                          Patient care rates or amounts shall be established by the Secretary of HHS or
                                                                                                                            his duly                                          authorized
                                                                                                                            representative.

		(c)	Prior
                                                                                                                            to submitting an invoice for 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 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.

    	 

    	 

    

 

Attachment
6

 

	REPORT
    OF GOVERNMENT OWNED, CONTRACTOR HELD PROPERTY
	CONTRACTOR:	 CONTRACT
                                         NUMBER:

                                                                                 

	ADDRESS:	REPORT
    DATE:
	ADDRESS1:	 
	ADDRESS2:	FISCAL
    YEAR:
	CITY:	 
	STATE:
	ZIP:	 	 	 
	CLASSIFICATION	BEGINNING
    OF 

    PERIOD	ADJUSTMENTS	END
    OF PERIOD
	 	#ITEMS	VALUE	GFP
    

    ADDED	CAP
    

    ADDED	DELETIONS	#ITEMS	VALUE
	LAND
    >=$25K	 	 	 	 	 	 	 
	LAND
    <$25K	 	 	 	 	 	 	 
	OTHER
    REAL >=$25K	 	 	 	 	 	 	 
	OTHER
    REAL <$25K	 	 	 	 	 	 	 
	PROPERTY
    UNDER CONST >=$25K	 	 	 	 	 	 	 
	PROPERTY
    UNDER CONST <$25K	 	 	 	 	 	 	 
	PLANT
    EQUIP >=$25K	 	 	 	 	 	 	 
	PLANT
    EQUIP <$25K	 	 	 	 	 	 	 
	SPECIAL
    TOOLING >=$25K	 	 	 	 	 	 	 
	SPECIAL
    TOOLING <$25K	 	 	 	 	 	 	 
	SPECIAL
    TEST EQUIP >=$25K	 	 	 	 	 	 	 
	SPECIAL
    TEST EQUIP <$25K	 	 	 	 	 	 	 
	AGENCY
    PECULIAR >=$25K	 	 	 	 	 	 	 
	AGENCY
    PECULIAR <$25K	 	 	 	 	 	 	 
	MATERIAL
    >=$25K (CUMULATIVE)	 	 	 	 	 	 
	PROPERTY
    UNDER MFR >=$25K	 	 	 	 	 	 	 
	PROPERTY
    UNDER MFR <$25K	 	 	 	 	 	 	 
	SIGNED
    BY:	 	 	 
	 SIGNATURE
		DATE
    SIGNED:	 

                                                                                 

                                                                                 

	 

                                                                                NAME PRINTED
	 	 

                                                                                Email

                                                                                 
	 
	 

                                                                                TITLE
	 	 

                                                                                

                                                                                TELEPHONE

                                                                                 
	 
	 	 	 	 	 	 	 	 	 	 	 	 	 	 

Report
of Government Owned, Contractor Held Property (Rev 10/2014)

 

    	 

    	 

    

	 

                           Attachment
                           7 

                           DISCLOSURE OF LOBBYING ACTIVITIES

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

(See reverse for public burden disclosure.)

	Approved
    by OMB 

    0348-0046

 

	1. Type of Federal Action:	2.
    Status of Federal Action:                 	3.
    Report Type:
	 ☐  a.
                                         contract

                b.
        grant

                c.
        cooperative agreement

                d.
        loan

                e.
        loan guarantee

                f.
        loan insurance
	        ☐ a.
                                         bid/offer/application

                       b.
        initial award

                       c.
        post-award

         
	     ☐  a.
 initial filing

                     b.
        material change

              For
        Material Change Only:

                      year
        _______ quarter __________

                      date
        of last report _____________

	4.
                                         Name and Address of Reporting Entity:

               ☐ Prime
                     ☐ Subawardee

                                           Tier
        _______, if known:

         

        

            Congressional District, if known: 4c
	5.
                                         If Reporting Entity in No. 4 is a Subawardee, Enter Name and Address of Prime:

         

         

         

         

         

         

            Congressional
        District, if known:

	6.
    Federal Department/Agency:	7.
                                         Federal Program Name/Description:

         

            CFDA
        Number, if applicable:____________

         

	8.
    Federal Action Number, if known:	9.
                                         Award Amount, if known:

            $

	10.
        a. Name and Address of Lobbying Registrant

                (if
        individual, last name, first name, Ml):

         
	b.
    Individuals Performing Services (including address if different from No. 10a) 

        (last name, first name, Ml):
	11.  Information
                                         requested through this form is authorized by title 31 U.S.C. section 1352. This disclosure
                                         of lobbying activities is a material representation of fact upon which reliance was placed
                                         by the tier above when this transaction was made or entered into. This disclosure is
                                         required pursuant to 31 U.S.C. 1352. This information will be available for public
                                         inspection. Any person who fails to file the required disclosure shall be subject to
                                         a civil penalty of not less than $10, 000 and not more than $100,000 for each such failure. 

        
	

        Signature:___________________________________________________________________

         

        Print
        Name:_________________________________________________________________

         

        Title:_______________________________________________________________________

         

        Telephone
        No.:______________________________________________ Date:____________

        

	Federal
    Use Only:	Authorized
    for Local Reproduction 

    Standard Form LLL (Rev. 7-97)

 

 

    	 

    	 

    

 

 

INSTRUCTIONS
FOR COMPLETION OF SF-LLL, DISCLOSURE OF LOBBYING ACTIVITIES

 

This
disclosure form shall be completed by the reporting entity, whether subawardee or prime Federal recipient, at the initiation
or receipt of a covered Federal action, or a material change to a previous filing, pursuant to title 31 U.S.C. section 1352.
The filing of a form is required for each payment or agreement to make payment to any lobbying entity for influencing or
attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an
employee of a Member of Congress in connection with a covered Federal action. Complete all items that apply for both the
initial filing and material change report. Refer to the implementing guidance published by the Office of Management and
Budget for additional information.

 

	 	1.	Identify the type of
    covered Federal action for which lobbying activity is and/or has been secured to influence the outcome of a covered Federal
    action.
	 	 	 
	 	2.	Identify the status of
    the covered Federal action.
	 	 	 
	 	3.	Identify the appropriate
    classification of this report. If this is a followup report caused by a material change to the information previously reported,
    enter the year and quarter in which the change occurred. Enter the date of the last previously submitted report by this reporting
    entity for this covered Federal action.
	 	 	 
	 	4.	Enter the full name,
    address, city, State and zip code of the reporting entity. Include Congressional District, if known. Check the appropriate
    classification of the reporting entity that designates if it is, or expects to be, a prime or subaward recipient. Identify
    the tier of the subawardee, e.g., the first subawardee of the prime is the 1st tier. Subawards include but are not limited
    to subcontracts, subgrants and contract awards under grants.
	 	 	 
	 	5.	If the organization filing
    the report in item 4 checks “Subawardee,” then enter the full name, address, city, State and zip code of the prime
    Federal recipient. Include Congressional District, if known.
	 	 	 
	 	6.	Enter the name of the
    Federal agency making the award or loan commitment. Include at least one organizational level below agency name, if known.
    For example, Department of Transportation, United States Coast Guard.
	 	 	 
	 	7.	Enter the Federal program
    name or description for the covered Federal action (item 1). If known, enter the full Catalog of Federal Domestic Assistance
    (CFDA) number for grants, cooperative agreements, loans, and loan commitments.
	 	 	 
	 	8.	Enter the most appropriate
    Federal identifying number available for the Federal action identified in item 1 (e.g., Request for Proposal (RFP) number;
    Invitation for Bid (IFB) number; grant announcement number; the contract, grant, or loan award number; the application/proposal
    control number assigned by the Federal agency). Include prefixes, e.g., “RFP-DE-90-001.”
	 	 	 
	 	9.	For a covered Federal
    action where there has been an award or loan commitment by the Federal agency, enter the Federal amount of the award/loan
    commitment for the prime entity identified in item 4 or 5.
	 	 	 
	 	10.	(a) 	Enter the full name,
    address, city, State and zip code of the lobbying registrant under the Lobbying Disclosure Act of 1995 engaged by the reporting
    entity identified in item 4 to influence the covered Federal action.
	 	 	 	 
	 	 	(b)	Enter the full names of the individual(s)
    performing services, and include full address if different from 10 (a). Enter Last Name, First Name, and Middle Initial (Ml).
	 	 	 	 
	 	11.	The certifying official
    shall sign and date the form, print his/her name, title, and telephone number.
	 	 	 	 

	According
    to the Paperwork Reduction Act, as amended, no persons are required to respond to a collection of information unless it displays
    a valid OMB Control Number. The valid OMB control number for this information collection is OMB No. 0348-0046. Public reporting
    burden for this collection of information is estimated to average 10 minutes per response, including time for reviewing instructions,
    searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of
    information. Send comments regarding the burden estimate or any other aspect of this collection of information, including
    suggestions for reducing this burden, to the Office of Management and Budget, Paperwork Reduction Project (0348-0046), Washington,
    DC 20503.

 

     

     

    

 

Cumulative
Inclusion Enrollment Report

 

This
report format should NOT be used for collecting data from study participants.

 

Study
Title:

 

Comments:

 

	Racial
    Categories	Ethnic
    Categories	Total
	Not
    Hispanic or Latino	Hispanic
    or Latino	Unknown/Not
    Reported Ethnicity
	Female	Male	Unknown/

    Not

    Reported	Female	Male	Unknown/

    Not

    Reported	Female	Male	Unknown/

    Not

    Reported
	American
    Indian/ Alaska Native	 	 	 	 	 	 	 	 	 	0
	Asian	 	 	 	 	 	 	 	 	 	0
	Native
    Hawaiian or Other Pacific Islander	 	 	 	 	 	 	 	 	 	0
	Black
    or African American	 	 	 	 	 	 	 	 	 	0
	White	 	 	 	 	 	 	 	 	 	0
	More
    Than One Race	 	 	 	 	 	 	 	 	 	0
	Unknown
    or Not Reported	 	 	 	 	 	 	 	 	 	0
	Total	0	0	0	0	0	0	0	0	0	0

 

	PHS
    398 / PHS 2590 (Rev. 08/12 Approved Through 8/31/2015)	 	OMB
    No. 0925-0001/0002
	 		Cumulative
    Inclusion Enrollment Report

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