EX-10 9 cytx-ex1014_6.htm EX-10.14

Exhibit 10.14

OMB Appro v al 0990-0115

AWARD/CONTRACT | 1. THIS CONTRACT IS A RATED ORDER | RA TING N/A | PAGE | OF | PAGES
UNDER DPAS (15 CFR 350) |  |  | 1 | 55
2. CONTRACT (P r oc. Inst. I ndent.) NO. HHS O100201200008C | 3. E FF ECTIVE DA TE See Block 20C. | 4. REQUISITION/PURCHASE R EQUES T/PROJECT NO. OS993 07
5. ISSUED BY | CODE |  | 6. ADMINIS T ERED BY (If other th a n It e m 6) | CODE |
Office of A cquisitions Management, Contrac t s, and Grants (A MCG) 330 Independence A ve., S.W. Room G640 Washington, D.C. 20201 | See Block 5.
7. NA ME AND ADDRE SS OF CONTRACTOR (No. st r e e t, count y, state and Z IP Code) Cytori Therapeutic s, In c. | 8. DELIVERY See Schedule.
3020 Callan Road San Diego, CA 92121 | 9/ DISCOUNT FOR PROMPT P A Y M ENT N/A.
CAG E: 4 A W88 | TIN: 330827593 | 10. SUB MIT INVOICES ADDRESS SHO WN IN: | IT EM See Se cti on G.
CODE DUNS No. 111029 1 79 | FACILITY CODE
11. SHIP TO/MARK FOR | CODE | N/A | 12. PA YMENT WILL BE MADE BY | CODE | N/A
See Bl o ck 5. | See Bl o ck 5.
13. AUTHORITY FOR USING OTHER FULL AND OPEN COMPETITION: N/A ☐ 10 U.S.C. 2304(c)( ) ☐ 41 U.S.C. 253(c)( ) | 14. ACCOUNTING AND APPROPRIATION DATA Appropriation Year: 2012; Object Class: 25106; CAN# 1992002
15A. ITEM NO. | 15B. SUPPLIES/SERVICES | 15C. UNIT PRICE | 15D. AMOUNT | 15E. UNIT PRICE | 15F. AMOUNT
See Section B. |  |  |  |
| 15G. TOTAL AMOUNT OF C ONTR ACT |  | $4,683,680.00

16. TABLE OF CONTEN TS

(✓) | SEC. | DESCRIPTION | PAGE(S) | (✓) | SEC. | DESCRIPTION | PAGE(S)
PART I - THE SCHEDULE | PART II - CONTRACT CLAUSES
☒ | A | SOLICITATION/CONTRACT FORM | 1 | ☒ | I | CONTRACT CLAUSES | 46
☒ | B | SUPPLIES OR SERVICES AND PRICE/COST | 3 | PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.
☒ | C | DESCRIPTION / SPECS / WORK STATEMENT | 9 | ☒ | J | LIST OF ATTACHMENTS | 55
☒ | D | PACKAGING AND MARKING | 10 | PART IV - REPRESENTATIONS AND INSTRUCTIONS
☒ | E | INSPECTION AND ACCEPTANCE | 11 | ☐ | K | REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS | 55
☒ | F | DELIVERIES OR PERFORMANCE | 11
☒ | G | CONTRACT ADMINISTRATION DATA | 24 | ☐ | L | INSTRS., CONDS., AND NOTICES TO OFFERORS |
☒ | H | SPECIAL CONTRACT REQUIREMENTS | 29 | ☐ | M | EVALUATION FACTORS FOR AWARD |

CONTRACTING OFFICER WILL CO MPLETE ITEM 17 OR 18 AS APPLICABLE

17. ☒ CONTRACTOR’S N EGOTIATED AGRE E M ENT (C on t r a c t o r is re q u i r e d to si g n t h is do cu men t a n d re t u r n 2 c op i e s to i ss u i n g o ff i c e.) C on t ra c t o r a gr e e s to f u rn i s h a n d d e li v e r a ll i t e m s o r p e r f or m a ll t h e s e r vic e s s et f or t h o r o t he r wise i d e n tif i e d a b o ve an d o n a n y c o n ti n ua t i o n s h ee t s f o r t h e c on s i d e ra t i o n st a t e d he r e i n. T h e r i g h ts a n d ob l i ga t i on s o f t h e p ar t i e s to t h is c on t ra c t s h a ll b e s u b j e ct to a n d go v e r ne d b y t h e f o ll o w i n g d o c u m e n ts: (a) t h is a w a r d/c on t ra c t, (b) t h e s o l i cit a t i o n, if a n y, a n d (c) s u c h p r o visi o n s, re p re s en t a t i on s, c er t i fic a t i on s, a n d s pe cific a t i on s, a s a r e a tt a c h e d o r i n c o r p o ra t ed b y r e f e r e n ce h e re i n. (A tt a c h m e n ts ar e list e d h e re i n.) | 18. ☐ A W ARD (C on t ra c t o r i s n o t r eq u i r e d to s i g n t h is d o c u m e n t.) Y o u r o f f er o n S o licit a ti o n N u mb e r _ , i n c l ud i n g t h e a dd it i on s o r c h a n ge s m a d e b y y o u w h i c h a d d iti o n s o r c h a n g e s a r e s e t fo r th in f u ll a bo v e, is h e r eb y a c c e p t e d a s to t h e it e m s lis t e d a b o ve a n d o n a n y c o n ti n ua t i on s h e e ts. T h is a w a r d c on s u mm a t e s t h e c o n t r a ct w h i c h c on si s ts o f t h e f o l l o w i ng do c u m en t s: (a) t h e G o v e r n m en t’s s o licit a ti o n a n d y o u r o f f er, a n d (b) t h i s a w a r d/c on t ra c t. N o f ur t h e r c o n t ra c t ua l do c u m en t i s n e c e s s a r y.
19A. NAME AND TITLE OF SIGNER (T ype or p r i nt) Mark Saad, Chief F inanc i al Off i cer | 20A. NAME OF CONTRACTING OFFICER
19B. NAME OF CONTRACTOR | 19C. DATE SIGNED | 20B. UNITED STATES OF AMERICA BY | 20C. DATE SIGNED
(Signature of person authori zed to s i gn) | (Signature of Contract ing Off icer)
NSN 7540-01-152-8069 | 26-107 | STANDARD FORM 26 (REV. 4-85)
PREVIOUS EDITION UNUSABLE | Computer Generated | Prescribed by GSAFAR (48 CFR) 53.214(a)

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CON T R A C T T A B L E OF CON TE N T S

PART I – THE S CHE DULE | 3
SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS | 3
SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT | 9
SECTION D - PACKAGING, MARKING AND SHIPPING | 10
SECTION E - INSPECTION AND ACCEPTANCE | 11
SECTION F - DELIVERIES OR PERFORMANCE | 11
SECTION G - CONTRACT ADMINISTRATION DATA | 24
SECTION H - SPECIAL CONTRACT REQUIREMENTS | 28
PART II – CONTRACT CLAUSES | 44
SECTION I - CONTRACT CLAUSES | 44
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS | 53
SECTION J - LIST OF ATTACHMENTS | 53
PART IV –REPRESENTATIONS AND CERTIFICATIONS | 54
SECTION K – REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS | 54

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P A RT I – THE SCH E DULE

SECTION B – SUPPLIES OR SERVICES A ND PRICES/COSTS

ART ICLE B.1. BRIEF DESCRIP TION OF S U PP L I ES OR S ERVIC ES

This purpose of this contract is develop a product that will combine the wound healing properties of the Celution ® System, which has been developed by the Contractor, with a cell-friendly dressing as a medical countermeasure for use in the context of combined injury and radiation exposure, and to obtain FDA licensure of the Celution ® System with indications for use that explicitly include thermal burn.

The Research and Development (R&D) effort will progress in specific stages that cover the base performance segment and nine (9) option segments as specified in this contract. The period of performance for the base period is 24 months. Work performed during the base segment and during the option segments is considered to constitute a non-severable discrete work segment that is necessary for the R&D effort.

ART ICLE B.2. ES TIM A T ED CO ST AND FIX ED F EE

| a. | The total estimated cost of the base performance segment is $4,356,912.00. |

| b. | The total fixed fee for the base performance segment is $326,768.00. The fixed fee shall be paid subject to Allowable Cost and Payment and Fixed Fee Clauses. |

| c. | The total amount of the base performance segment, CLIN 0001, represented by the sum of the total estimated cost plus fixed fee is $4,683,680.00. |

| d. | The total amount for the base segment shall not exceed $4,683,680.00. The total amount obligated by the Government for the base segment of the contract shall not exceed $4,683,680.00 and the Government will not be responsible for any Contractor incurred costs that exceed this amount unless a modification to the contract is signed by the Contracting Officer which expressly increases this amount. |

| e. | It is estimated that the amount currently allotted will cover performance of the contract through 27 September 2014 (2 years from start date). |

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

CLIN | E s t i m a t ed P e r i o d o f P e r fo r m a n ce | S upp lies/S e r v ices | T ot al E s t i m a t ed C o st | F ixed F ee | T ot al E s t. C o st P l u s F ixed F ee
0001 | 28 September 2012 through 27 September 2014 | Studies needed to demonstrate proof-of-concept for use of the Celution S y stem as a medical counter measure for c o mbined injury involving ther mal burn and r adiation ex posure Reports and Other Data Del i verab les. | $4,356,912.00 | $326,768.00 | $4,683,680.00

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A R T I C L E B. 3. O P T I O N P RIC E S

| a. | Un l e s s t h e g o v e r n m ent e x e rc i s es i ts op t i on pu rs u a nt to the op t i on c l au s e c o nt a i ne d i n ARTICLE I.2, t he c o n t r a c t c on s i s ts o n l y of the Base W o r k s e g m ent s pe c i f i ed i n t h e S ta t e m ent of W o r k as de f i ned i n S E C T O NS C and F, f or the p r i c e s et f o r th i n A R T ICLE B.2 of the c ont r a c t. |

| b. | P u rs ua n t to F A R C l a u s e 5 2.217-9 (O p t i o n to E x t e nd th e T e r m of the Cont r a c t), t h e G o v e r n m ent m a y, b y u n i l a t e r al c o n tr a c t m od i f i c at i o n, r eq u i r e t h e C o nt r a c tor t o pe r f o r m the O p t i o n W o r k S eg m ents s pe c i f i ed i n t he S t a te m ent of W o r k as de f i ned i n SE C T I O NS C a n d F of th i s contract. If the G o v e r n m ent e x e rc i s es the/t he s e op t i on(s), w ri tten no t i c e m u s t be g i v e n to t he C ont r a c tor w i t h i n 3 0 d a y s a f ter the G o v e r n m ent has c o m p l et e d i ts an a l y s i s of t h e d e l i v e r a b l es a ss o c i at e d w i t h t he ap p li c a b l e GO/NO G O De c i s i o n g a te; and the G o v e r n m ent m u s t g i v e t h e C on t r a c tor a p r e li m i na r y w r i t t en not i c e of i ts i nte n t to e x e rcis e the op t i on at l ea s t 30 da y s be f o r e t h e c ont r a c t e x p i r e s. S pe c i f i c i n f o r m at i on r ega r d i ng t h e t i m e f r a m e f or th i s not ic e i s s et f o r th i n t h e O P T I O N CL A U S E A r t i c l e i n S E C T I O N G of th i s c ont r a c t. T he e s t i m ated c o s t of the c o n t r a c t w i l l be i n cr ea s ed as s et f o r th b e l o w: |

C L IN/ Opt i o n | E s t i m a t ed P e r i o d o f P e r fo r m a n ce | S upp lies/S e r v ices | T ot al E s t i m a t ed C o st | F ixed F ee | T ot al E s t i m a t ed C o st P l u s F ixed F ee
0002/1 | 28 September 2013 through 27 September 2016 | Research and development, regu lator y, cli n ical, and other tasks required for completion of a P il ot Cli n ical Trial of the Cel uti on S y stem in ther mal burn injury Reports and Other Data Del i verab les | $30,364,647.00 | $2,277,350.00 | $32,641,997.00
0003/2 | 28 September 2015 through 27 September 2017 | Cl ini c a l, regulator y, and other tas ks requi red for c o mpletion of a P i v otal Cl ini c al T r ial leadi ng to FDA l i censure for use of the Cel uti on S y stem in ther mal burn injur y. Reports and Other Data Del i verab les | $42,326,809.00 | $3,174,511.00 | $45,501,320.00
0004/3 | 28 September 2013 through 27 September 2017 | Research and development, c l ini c a l, regulatory and other tas ks requi r ed to de v e l op and obta in F DA clearance for a wound dress i ng that has ease of use and other character i sti cs sui tab le for use in ther mal burn injury foll owing a mass casual ty ev ent. Reports and Other Data Del i verab les | $21,786,346.00 | $1,633,976.00 | $23,420,322.00

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A R T I C L E B. 4. P R O V I S I O NS A P P L I C A B L E T O DIR E CT C O S T S

| a. | Items Unallo wable Unless Other wise P r o vided

Not w ithstanding the claus e s, unless authori zed in w r i t ing by the Contrac t ing O ff i cer, the cost of the fol l o w ing items or acti v ities shall be una ll owab le as di rect costs:

| 1) | Acquisition, by purchase or leas e, of any interest in r eal pr oper t y; |

| 2) | Special rearrangement or a lterat ion of fac ili t ies; |

| 3) | Purchase or l ease of a n y i tem of gener al purpose off i ce furniture or off i ce equ ipment regardless of dol lar value; |

| 4) | A ccountable G o vernment P roper ty (s e e the Contractor’s Guide for Control for Government P r oper ty incorporated by ARTICLE G.10. of this contract); |

| 5) | T ravel to attend general scienti f ic meetings; |

| 6) | Unapproved foreign tr a v el – S ubject to the procedure spec i f ied under subparagraph b.2 below; |

| 7) | Pat ient care costs (s ee Atta c h ment 6); |

| 8) | P r int i ng Costs (as def ined in the Government P r i nti ng and B ind ing Regul ati ons); |

| 9) | Li ght Ref reshment and Meal E xpendi tures - Requests to use c ontract funds to prov ide l ight ref res h ments and/or meals to either federal or nonfederal empl o y ees m u st be subm itted to the Contracting O ff i cer’s Representat i ve (COR), with a copy to the Contracting O ff i cer, at least s ix (6) w eeks in advan ce of the event and are sub ject to “HHS P o li cy on P romoting E ff i c ient Spend ing: Use of Appropriate Fund ing for Conferences and Meet ing, Food and P romotional Items and P r int i ng and Pub li cat i ons.” The request shall conta in the fol l owi ng infor mation: (a) name, date, and locat ion of the e v ent at w h ich the l ight ref reshments and/or meals w i ll be prov i de; (b) a br ief descr i pti on of the pu rpose of the event; (c) a c o st breakdown of the esti mated li ght ref reshments and/or meals costs; (d) the number of nonfeder al and feder al attendees rec e i vi ng l i ght ref reshments and/or meal s; and (e) if the e vent w i ll be he ld at a go vernment fac ili t y. |

| 10) | No o verti me (prem i u m) c o mpensation is authori z ed under the subject c ontract. B i l li ng of actual hours should be l i m ited to total produc t i ve hours in a month (8 hours/da y). |

| b. | T ravel Costs

| a. | Total expenditures for trav el (transpor tation, l odging, subs i stenc e, and inc i dental expenses) incurred in d i rect per for mance of this contr a ct dur i ng the base segment or any option s egment(s) shall not exceed amount negotiated in the f i nal propos ed budget without the pr ior written approv al of the Contracting O ff i cer. Cost must be cons i stent with Feder al A c qui siti on Regu lations (F AR) 52.247-66 – P r eference for U.S. A ir Flag c a rr iers. |

| b. | Subject to the annual dol lar li m itation s pec i f ied under B.4.b.1.a. abo v e, the Contactor shall i n v o i ce and be r e i mbursed for all tr a v el costs in a ccordance w ith F AR 31.2 – Contracts w ith Com mer c ial Organi zat i ons, S ubsection 31.205-46, T ravel Costs. |

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A R T I C L E B.5. A D V A N CE UND E R S T A N D IN G S

| a. | M a n-i n-P la n t |

With seven (7) da ys ad v an ce not i ce to the Contractor in w r i t ing f rom the Contrac t ing Off i cer, the G o vernment may place a man-in-plant in the Contractor’s fac i l i ty The man-in- pl ant sha ll be s ubject to the Contractor’s po li cies and p rocedures regarding secur i ty and fac ili ty access at a ll ti mes whi le in the Contractor’s faci l i t y.

| b. | Subcontracts a n d C on s u l t a nts |

Prior w ritten consent f r om the Contracting O fficer in the form of Contracting O fficer Authorization (COA) is r equired for any subc ontract tha t:

| • | Is of the cost rei mbursem ent t y pe; |

| • | Is F i xed-P r i ce and exceeds $150,000 or 5% of the total esti mated cost of the contract; |

Contracting O ff i cer shall r equest appr opr iate supporti ng documentat ion in order to rev i ew and deter m ine authori zati on, pursuant with F AR Cl ause 52.244-2, Subcontracts. A fter recei v i ng w r itten c onsent of the s ubcontract by the Contracting O ff i cer, a copy of the s igned, executed s ubcontr a ct and c onsul t ing agr eement sha ll be prov ided to the Contracting O ff i cer.

Note: Cons u lting ser vi ces a re treated as subc ontracts and s ubject to the ‘consent to subcontract’ pr o vi sions set forth in th is A r t i c le.

| c. | Re f e r e n ce F A R 52.2 4 4-2 (e) S ub c ont r a c t s. |

FAR 52.244-2 (e)(1) The Contractor sha ll not i fy the Contracti ng Off icer reasonably in advance of placing any subcontract or modi f icati on thereof for which consent is required under paragraph (d) of this clause, including the foll owing infor mation:

| (i). | A description of the supplies or services to be subcontracted. |

| (ii). | Identification of the type of subcontract to be used. |

| (iii). | Identification of the proposed subcontractor. |

| (iv). | The proposed subcontract price. |

| (v). | The subcontractor’s current, complete, and accurate cost or pricing data and Certificate of Current Cost or Pricing Data, if required by other contract provisions. |

| (vi). | The subcontractor’s Disclosure Statement or Certificate relating to Cost Accounting standards when such data are required by other provisions of this contract. |

| (vii). | A negotiation memorandum reflecting- |

(A). The princi pal elements of the subcontract price negotiati ons;

(B). The most signi f icant considerations contro lli ng establishment of initial or re vised prices;

(C). The reason cost or pr icing data were or were not required;

(D). The extent, if an y, to which the Contractor did not rely on the subcontractor’s cost or prici ng data in determ ining the price object ive an in negoti ati ng the f inal pr ice;

(E). The extent to w h ich it was recognized in the negotiation that the subcontractor’s cost or prici ng data were not accurate, complete, or current; the act ion taken by the Contractor and the subcontractor; and the effect of any such defective data on the total price negot iated;

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(F). T he r ea s ons f or a n y s i g n i f i c ant d i ff e r en c e be t ween the Cont r a c to r’s p r i c e ob j e c t i v e a nd t he p r i c e negotiated; a n d

(G). A complete exp l anat ion of the incent ive fee or prof it plan w hen incentives are used. The explanation shall identify each critical performance element, management decisi ons used to quanti fy each incent ive e lement, reasons for the incent ives, and a su m mary of all trade-off possibilities consi dered.

The Contractor sha ll obtain the Contrac t ing O ff i cer’s w r i tten c o n s ent (C O A) p ri or to placing any cons u ltant awa rds.

| d. | Consultants |

Co nsultant f ees to be paid to the f ollowing individuals:

Name | Rate Per Hour | Est. Number of Hours | Total Cost Excluding Travel Not to Exceed
Dav id Herndon M.D. | $300 | 84 | $25,200
Willi am Mc B r ide Ph.D., D.S c. | $300 | 72 | $21,600
Ma y er Tenenhaus M.D. | $300 | 84 | $25,200
Carl S chuman, M.D. | $300 | 56 | $16,800
Ken Lowe | $300 | 160 | $48,000

| e. | S i t e V i s i t s a n d I n s p e c t i on s |

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 inspec tions on an as needed basis, including colle ction of product samples and inter mediates held by the contractor, or subcontrac tor. In case of subcontractor visits and inspec tions that are independent of activities c onducted by the Contrac tor, the USG shall demonstrate cause for such visit and/or inspec tion. All costs reasonably incurred by the Contractor and s ubcont ractor for such visit and/or inspection shall be allowed costs. The Contractor shall coor d inate these visits and shall have the oppor tuni ty to ac company the USG on any such visits. Under time-sensitive or critic al situations, the USG re serves the right to suspend the 48 hour notice to the Contrac tor. The areas included under the site visit could include, but are not limited to: securit y, regulatory and quality s y s tem s, and cGMP/GLP/GCP complian ce.

If BARD A, the Contractor, or other parties ident i f ies any i ssues dur ing an aud it, the Contractor s hall capture the i ssues, identi fy potential solut i ons, and pr o v ide a report to BA RDA for rev i ew and ac ceptance.

| • | If i ssues are i dent i f ied duri ng the audit, Contractor sha ll subm it a report to BA RDA deta i li ng the f ind i ng and correcti ve ac t ion(s) with in 10 bus iness da ys of the aud it. |

| • | COR and CO w i ll rev i ew the report and pr o v ide a res ponse to the Contractor w ith 10 business da y s. |

| • | Once correcti ve action is completed, the Contractor wi ll prov i de a f i nal r eport to BA RDA. |

QA AUDIT:

BARDA reserves the right to par ticipate 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 subc ontractor. If action is requested of the s ubcontractor, detailed

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c on c e r ns f or add r e ss i ng a r eas of non-c on f o r m an c e to F DA r e g u l at i ons f or G L P, G M P, or G CP g u i d e l i ne s, as i d en t i f i ed i n t h e a ud i t r e p o r t, m u s t be p r o v i d e d to B A RDA f or r e v i e w and a cc eptan c e. T he Co n t r a c tor s ha l l p r o v i de r e s pon s es f r o m the s ub c ont r a c to r s to add r e s s the s e c on c e r ns an d p l ans f or c o rr e c t i v e a c t i on e x e c ut i on.

| • | 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.

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

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

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

| b. | Fringe Benefits - Cite rate and amount

| c. | Overhead - Cite rate and amount

| d. | Materials & Supplies - Include detailed breakdown when total amount is greater than $1,000. |

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

| f. | Consultant Fees - Identify individuals and amounts. |

| g. | Subcontracts - Attach Subcontractor invoice(s). Cite applicable COA or notification. |

| h. | Equipment - Cite authorization and amount.

| i. | Other Direct Costs - Include detailed breakdown when total amount is greater than $1,000. |

| j. | G&A - Cite rate and amount.

| k. | Total Cost

| l. | Fixed Fee

| m. | Total CPFF

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

| g. | Confidential Treatment of Sensitive Information |

The Contractor shall guarantee strict confidentiality of any information/data of a sensitive nature that is provided to the Contractor by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature.

Disclosure of information/data that is sensitive in nature, in whole or in part, by the Contractor can only be made after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer. (See also HHSAR clause 352.224-70).

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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 pu b li c d o m a i n, a f ter i ts d i sc l o s u r e t o, o r, w i t h r e s pe c t t o the i n f o r m at i on/d ata b y, t he Cont r a c tor t h r o u gh n o f au l t of the C o nt r a c to r; (d) was d i sc l o s ed t o t h e C o nt r a c to r, other than un d er an o b l i ga t i on of c on f i den t i a li t y or non-u s e, b y a t h i r d pa r t y who h ad no ob l i g a t i o n to the G o v e r n m ent t h at c ont r o l s s u c h i n f o r m at i o n/d ata not t o d i sc l o s e s u c h i n f o r m at i on/da t a to ot h e rs; or (e) was i n d e pe n den t l y d isc o v e r ed or d e v e l o ped b y t he Cont r a c to r, as e vi d en c e d b y i ts w r i tt e n r e c o r d s, w i t h o u t the u s e of i n f o r m at i on/d a t a be l on g i ng to t he G o v e r n m e nt.

Contractor m ay d i sc lose infor mation/data of a sensiti ve nature pr o v ided by the Government to the extent that such di sc losure i s: (a) made in response to a val id order of a court of competent jur i s d iction or other supra-nationa l, feder a l, nationa l, r egiona l, state, prov incial or loc al governmental or r egulatory body of c o mpetent jur i s d i ction; p r o v i d e d, h o w e v e r, that the Contractor shall f i rst ha ve g i ven not ice to the G o vernment and gi ve the Government a r easonable oppor tun i ty to quash such order and to obtain a prote ctive order requi ring that the info r mation/data of a sens i t i ve nature that is the subject of such order be he ld in c onf idence by such court or agency or, if di sc los ed, be used on ly for the purposes for whi ch the or der was i ssued; and p r o v i d e d f u r ther that if a d i sc losure order is not quashed or a protecti ve order is not obta i ned, the infor mation/data di sc los ed in response to such court or governmental or der shall be li m ited to that infor mation whi ch is legally requ i red to be d i sc l o sed in response to such c ourt or go vernmental or der; (b) otherwi se requi r ed by l a w, in the op i n ion of legal c ounsel to the Contractor as expressed in an opi n i on letter in form and s ubstance r easonably sati s factory to the G o vernment, whi ch s hall be pr o v ided to the G o vernment at least t wo (2) bus i ness da ys pr ior to the Contractor’s di sc losure of the infor mation/data; or (c) made by the Contrac tor to the Regu latory Author i t ies as requ i red in c onnec t ion wi th any f i l ing, app li cat i on or r equest for Regu latory Approval; p r o v i ded, h o we v e r, that reas onable measures shall be taken to assure conf identi al tr eatment of such infor mation/data.

| h. | S h a r i n g o f c ont r act d eli v e r a b l es w i th in U n i t ed S t a t es Go v e r n m e n t (U S G) |

In an effort to bui ld a robust medi cal counter measure pipe l ine through increased coll aborat i on, B ARDA m ay share techn i c al de l i verabl es with U SG enti t ies res pon s ible for Med i cal Counter measure Dev e l opment. In accordance w i th recom mendati ons f rom the Pub lic Hea lth E mergency Med i cal Counter measure Enterpr i se Re vi ew, a g r ee m ents e s tab l i s h e d i n t h e In t eg r a te d P o r t f o l i o’s P o r t f o li o A d v i s o r y Co m m i ttee (P A C) C ha r t e r, T e c hno l o g y T r an s f er A g r e e m ents (T T A) between B A R DA a nd t he D e f en s e T h r eat Redu c t i on A g en c y a n d t h e Nat i on a l In s t i tu t e of A l l e r g i e s and I n f e c t i ous D i s ea s es (NI A ID), BA R DA m a y s ha r e te c h n i c al d e l i v e r a b l es s et f o r th i n A r t i cl e F.2 w i th c o l l e a gues w i t h i n t he Integ r a ted P o r t f o l i o. T h i s a d v a n c e u nde rs t a nd i ng do e s not a utho r i z e B A R D A t o s ha r e f i nan c i a l i n f o r m at i on out si d e HH S. T he C o nt r a c tor i s ad v i s ed to r e v i e w t he t e r m s of F A R C l au s e 52.227-14 r e ga r d i n g the G o v e r n m ent’s r i g h ts t o d e l i v e r a b l es s ub m i tted du r i ng pe r f o r m an c e as we l l as t he G o v e r n m ent’s ri ghts to da t a c ont a i n ed w i t h i n t ho s e de l i v e r a b l e s.

SECTION C - DESCRIPTION/SPECIFIC ATIONS/WORK ST ATEMENT

ART ICLE C.1. S T A T E M E NT OF W ORK

Independent ly and not as an agent of the G o vernment, the Contractor s hall furni sh all the necessary serv i ces, qua li f i ed personne l, mater ial, equipment, and fac i l i t ies not otherwi se prov ided by the G o vernment as needed to per form the S tatement of Work dated 2 8 S e pt em b e r 2 012 as set forth in S ECTION J-Li st of Attachments, attached hereto and made a part of the c ontract.

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A R T I C L E C.2. R E P O R T ING R E Q UI R E M E N T S

Refer to ARTICLE F.2. for spec i f ic instructions regarding Repor t ing Requi rements.

ART ICLE C.3. PRO J ECT M EE TING CONF ERENCE CAL LS

A te leconference call bet w een the Contracting O ff i cer’s Techni cal Representat i ve and the Contractor’s P rogram Manager sha ll occur bi-week ly (every two w eek s), or at the di screti on of the U.S. G o vernment. Dur ing this c a l l, the P r ogram Manager wi ll d i scuss the acti v i t ies dur i ng the reporti ng per i od, any prob lems that ha ve arisen, and the ac t i v ities planned for the ensuing r eporting per i od. The Contractor’s P rogram Manager m ay c hoose to inc l ude other k ey personnel on the confe rence call to gi ve detai led updates on s pec i f ic projects or this m ay be requested by the Contr a cting O ff i cer’s Representati ve.

Contractor wi ll be responsible for pr eparing an agenda for the conference c a ll and pr o vi d i ng to B ARDA no later than 2 bus iness da ys pr ior to the s chedu l ed conference c a l l.

ART ICLE C.4. PRO J ECT M EE TINGS

The Contractor s hall par t i c ipate in P roject Meet ings to coordi nate the per for mance of the contract, as requested by the Contracting O ff i cer’s Representat i ve. These meetings m ay inc l ude face-to-face meeti ngs with B ARDA/AMCG in W a shington, D.C. and at work s ites of the Contractor and its subcontractors. Such meetings may inc lude, but are not l i m ited to, meetings of the Contractor (and subc ontractors inv ited by the Contrac tor) to d i sc u ss study des i gns, s ite v i s its to the Contractor’s and s ubcontrac tor’s fac ili t ies, and meetings with the Contractor and HHS off i c ials to di scuss the techn i cal, regu lator y, and eth i cal aspe cts of the program. The Contractor must prov i de data, r eports, and pres entat i ons to gr oups of outs ide experts (subject to appr opriate pr otections for Contrac tor conf ident i al or proprietary data) and USG pers onnel as r equired by the Contrac t i ng O ff i cer’s Representati ve in order to fac ili tate rev i ew of contract acti vi t ies.

ART ICLE C.5 SUBJ ECT INV ENTION REP ORTING RE QUIR E M ENT

All reports and documentat ion requir ed by F AR Clause 52.227-11, including, but not limited to: the invention disclosure report, the confir matory lic ense, and the G overnment support certification, shall be direc ted to the Contracting O fficer. The final invention state ment (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contr a cting O fficer on the ex piration date of the contract. See also FAR clause 52.227-11 (Patent Rights-O w nership by the Contractor).

Reports and documentati on subm itted to the Contracting O ff i cer shall be sent to the Contracting O ff i cer to the address set forth in S ECTION G – CONTRACT ADMIN I S TRA TION DA T A.

If no i n v ention is di sc losed or no ac t i v i ty has occurred on a prev i ous ly d i sc losed i n venti on dur i ng the appl i cab le r epor t ing period, a negat i ve r eport shall be subm itted to the Contracting Off i cer at the address l i sted abo ve.

SECTION D – P ACK AGING, M ARKING, A ND SHIPPING

All de liverables required under this contract shall be packaged, mar ked and s hipped in accordance with Governm ent specifications. At a mini m u m, all deliverables shall be mar ked with the c ontract number and Contractor name. The Contractor s hall guarantee that all requir ed materials s hall be delivered in im mediate us able and acceptable condition.

Unless otherwi se spec i f i ed by the Contrac t ing O ff i cer, del i very of reports to be furni shed to the G o vernment under this contract (includ ing i n v o i ces), shall be de l i ver ed to B A RDA electron i c a l ly a long with a concurrent email not i f i cation to the Contracti ng O ff i cer, Contract Special i st, and COR summari zi ng the e lectron ic de l i v er y.

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De l i v e r y of p h y s i c a l r e po r ts to b e f u r n i s h e d s h a l l be ad d r e ss ed to t he C O R, C O, a nd C S (as de f i ned i n S E C T I O N G – C O N T R A CT A DMINI S T R A T I O N D A T A).

SECTION E – INSPECTION AND A CCEPT ANCE

The Contracting O ff i cer (CO) or the duly authori zed r epresentat ive wi ll per form inspection and acceptance of mater ials and serv i ces to be prov i ded under this contract.

For the purpose of this S ECTON, the designated Contracting Off icer’s Representative (COR) is the authoriz ed representative of the Contracting Off icer. The COR will assist in resolvi ng technical issues that arise duri ng perfor mance. The COR ho w e ver is not authorized to change any contract terms or authorize any changes in the S tatement of Work or modi fy or extend the period of performance, or authorize rei mburse ment of any costs incurred duri ng perfor mance. Inspection and acceptance will be performed at:

Biomedic al Advanced Res earch and Development Authorit y/O ffice of Acquisition

Management, Contracts, and Grants (AMCG)

Off ice of the Assistant Secretary for P reparedness and Response

U.S. Department of Hea lth and Human Serv i ces

330 Independence A v enue, S.W., Room G644

Wa shington, D.C. 20201

SECTION F – DELIVERIES OR PERFORM ANCE

ART ICLE F.1. ES TIM A T ED P ERIOD OF P ERFORMANCE

Under CLIN 0001, the es t i mated per iod of per for mance for the base per for mance segment of this contract shall be cons i stent with the dates set forth in ARTICLE B.2. If the G o vernment exerc i ses its opt i on(s) pursuant to the Opti on C lauses in A rti cle G.11 and A rti cle I.2 of the contract, the per i od of per for mance w i ll be increased as sho wn in the table in A r t i c le B.3.

ART ICLE F.2. D E L I VE RABL ES

Success ful per for mance of the final contract shall be deemed to occur upon per for mance of the work set forth in the Statement of W o rk dated 2 8 S e pt e mb er 20 1 2 set forth in SECTION J-List of Attachments of this contract and upon delivery and acceptance, as r equir ed by the Statement of W o r k, by the Contracting Officer, or the duly authorized representative, of the foll o wing items in accordance with the s tated delivery schedule:

The items spec i f ied bel ow as descr ibed in the RE P ORTING RE QUIRE M ENTS A r t i c le in SECTION C of th is contract and the Statement of Work dated 23 October 2011 set forth in SECTION J-Li st of Attachments w i ll be requ i red to be del i vered F.O.B. Des t i nation as set forth in F AR 52.247-34, F.O.B. DE STINATION, (NO VE M B ER 1991), and in accordance with and by the date(s) spec i f ied be l ow and any spec i f i cat ions stated in S ECTION D, P ACK A GING, MARKING AND SHI PP ING, of this c ontract. A ll reports identi f i ed bel ow r e late solely to the dev e l opment acti v i ty funded under this contract:

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CYTORI DELIVERA BLES SCHEDULE
General Deliverables
Deliverab le | Due Date(s)
BARDA Audit Reports | If i ssues are i dent i f ied duri ng the audit, Contractor sha ll subm it a report to BA RDA deta i li ng the f ind i ng and correcti ve ac t ion(s) within 10 bus iness da ys of the audit COR and CO w i ll rev i ew the report and pr o v ide a res ponse to the Contractor with 10 business da ys Once corrective action is completed, the Contractor will provi de a f i nal report to B ARDA
QA Audit | Noti fy CO and COR of upcom ing, ongoing, or recent audits/site vi sits of subcontractors as part of week ly com muni cations Noti fy the COR and CO wi thin 5 bus iness da ys of repo rt completion
Bi-w eek ly conference c all agenda | No later than 2 bus iness da ys pr ior to the scheduled c onference call
Meet ing/Teleconference Minutes | No later than 2 bus iness da ys fo ll owi ng the meeting/te leconference
Data/Data A nal y s is | Within 10 business da ys of request by COR or CO
Monthly P rogress Report | On the 15t h ca l endar day foll owing the month being reported upon
Annual Pr ogress Report | On or before the 15t h ca lendar day of the month foll owing each 12 months of the performance period
Draft F inal Techni cal Report | 60 calendar da ys pr ior to the end of the c ontract and all opti ons. B ARDA shall pr o v ide com ments w i thin 30 c a lendar da ys
Final Technical Report | On or before the end date of the contract and all options
Draft and Final Reports for Non-Cl i n i cal Studies and Cl ini c al Studies | Draft report to B ARDA at l east 30 bus i ness da ys fol l o w ing the end of the

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| study BARDA will provide feedback to Contractor within 15 business da ys of receipt Final report, incorporat i ng or addressi ng B ARDA feedback, to BARDA with in 15 bus i ness da ys of receipt of feedback
Final In v ention Report | On or b efo re the e nd date of the c o ntract and all o pti o ns
FDA Re lated Deliverabl es
FDA Meet ing Not ices | Noti f i cat ion to BA RDA wi thin 24 hours of schedu l ing T y pe A, B or C meetings OR w i thin 24 hou rs of meeting occurrence for ad hoc meeti ngs
FDA Meet ing Minutes | Ini t i al Contractor and F DA-issued draft m inutes and f i nal m inutes of any meeting w ith the F DA with in 3 bus i ness da ys of recei pt
FDA Subm issions | Draft FDA subm i ss ions to BA RDA at least 15 bus i ness da ys pr ior to FDA subm ission. BARDA will provide feedback to Contractor within 10 business da ys of receipt. Final FDA subm issions sha ll be subm itted to B ARDA concurrently or no later than 1 ca lendar day of it subm ission to CD ER.
FDA Aud its | Noti fy CO and COR with in 10 bus iness da ys of a scheduled F DA audit or with in 24 hours of an ad hoc s ite v i s it/aud it if the F DA does not pr o v ide advanced not i ce. Contractor s hall pr o v ide c opies of any F DA aud it report recei ved f rom subcontractors that occur as a result of this contract or for this product with in 3 bus iness da ys of recei vi ng correspondence f rom the FDA or thi rd par t y.

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| Within 10 business da ys of aud it report, Contractor sha ll prov i de CO with a pl an for address i ng ar eas of nonconfor mance, if any are i dent i f ied.
Manufacturing Campaign Reports | Submit at least 15 business da ys prior to F DA submission. Final FDA subm ission sha ll be subm itted to BA RDA concurrently or no later than 1 busi ness day after subm ission to the FD A.
Other FDA Correspondence | Within 3 bus i ness da ys of correspondence
Copies of FDA Correspondence and Meet i ng Sum mar ies | For any for mal meeting wi th the FDA, the contractor shall forward ini t i al draft m inutes and subs equently f i nal meeti ng m inutes appr opr iately for matted with in thi r ty (30) calendar da ys of the FDA meeting to the BA RDA CO R. The contractor shall forward the f inal draft m inutes of any infor mal meeting with the FDA to B ARDA. The contrac tor shall forward the dates and t i mes of any meeti ng with the FDA to B ARDA at l east 30 da ys pr ior to the meeting. Contractor s hall pr o v ide B ARDA with f i ve (5) business da ys in whi ch to rev i ew and prov i de com m ents upon any document ba ck to the c ontractor.
Inc ident Report (As needed) | Contractor s hall com muni cate and document all cr i t i c al program matic concerns, r i s k s, or potent ial r i sks w i th BARD A. Due with in 48 hours of acti vi ty or incident or with in 24 hours for a secur i ty acti v i ty or incident. E mail or telephone wi th w r i tten fol l o w-up to COR and CO. A ddi t ional updates due to COR and CO w i thin 48 hours of add i t ional developments. Contractor s hall subm it w i thin 5 bus iness da ys a Cor recti ve A c t ion P lan (if deemed necessary by either par t y) to address any potenti al i ssues. If corrective ac t ion is deemed necessar y, Contractor m u st address in w riti ng, its considerat ion of concerns rai sed by B ARDA with in 5 bus iness da y s.

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Base P e riod | 9/28/12 to 9/27/14 |
Name | WBS Number | Start Date | Finish/Due Date | Deliverab le
Techni cal and P roject Management | 1.1.1.4 | 9/28/2012 | 10/22/2012 | Updated Tas k/Deli verab les Li st
Hi r i ng: Base Period | 1.1.1.5 | 10/2/2012 | 1/22/2013 | Inc lude in the appl i cab le month ly report
Subc ontractor Management | 1.1.2 | 10/16/2012 | 1/7/2013 | Subc ontractor Management Plan
Ri sk Management | 1.1.3.3 | 10/16/2012 | 3/11/2013 | Ri sk Management P l an
EVMS: Implementation Plan | 1.1.4.2 | 10/15/2012 | 3/24/2013 | EVMS S y s tems Plan
EVMS: Implementation | 1.1.4.4 | 3/24/2013 | 7/24/2013 | EVMS S y s tems Report
Preclinic al Studies: Multiple Final Reports | 1.3.1.3.16 | 10/2/2012 | 5/5/2014 | Final report subm itted to and accepted by BA RDA CO/COR
Human P rec l ini c al S tud ies Report | 1.3.2.1 | 9/28/2012 | 2/24/2014 | Final report subm itted to and accepted by BA RDA CO/COR
Pilot Clinic al T rial Clinical Protoc ol Draft Development Plan | 1.4.1.3 | 9/5/2013 | 10/18/2013 | Draft or Outl i ne C l ini c al P rotoc ol subm itted to BARDA CO/COR approval
Pilot Study Pre-IDE Meeting | 1.5.1.2 | 12/9/2013 | 12/9/2013 | Meet ing m inutes
CT-X2 P rotot y pe Porc ine Opti m i zat ion | 1.6.1 | 10/30/2012 | 8/19/2013 | Final report subm itted to and accepted by BA RDA CO/COR
CT-X2 Val i dation | 1.6.2 | 11/27/2012 | 8/5/2013 | Final report subm itted to and accepted by BA RDA CO/COR

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Option 1: Pilot Clinical Study | 9/28/2013 to 9/27/16 |
Name |  | Start Date | Finish Date | Deliverab le
Cl ini c al Hi r ing | 1.1.1.6.1 | 3/19/2014 | 7/8/2014 | Inc lude in the appl i cab le bi-monthly report
Devel opment Hi ring | 1.1.1.6.2 | 3/19/2014 | 5/20/2014 | Inc lude in the appl i cab le bi-monthly report
ADRCS and Standard of Care Feasability Final Report | 1.3.1.4.1 | 3/19/2014 | 1/21/2015 | Final report subm itted to and accepted by B ARDA CO/COR
Cell fate anal y s is F inal Report | 1.3.1.4.2 | 3/19/2014 | 10/22/2014 | Final report subm itted to and accepted by B ARDA CO/COR
Extended dur ation studies (Porcine) Final Report | 1.3.1.4.3 | 5/1/2014 | 7/29/2015 | Final report subm itted to and accepted by B ARDA CO/COR
Res idual Celase ana l y s is F inal Report | 1.3.2.3.1 | 3/19/2014 | 9/18/2014 | Final report subm itted to and accepted by B ARDA CO/COR
Skin Substitute Cell Interactions Final Report | 1.3.2.3.2 | 3/19/2014 | 9/8/2014 | Final report subm itted to and accepted by B ARDA CO/COR
Burn ADRC Character ization-Eschar Final Report | 1.3.2.4 | 3/19/2014 | 7/14/2014 | Final report subm itted to and accepted by B ARDA CO/COR
Burn ADRC Characterization-Non-Eschar Final Report | 1.3.2.5 | 4/4/2014 | 11/19/2014 | Final report subm itted to and accepted by B ARDA CO/COR
Pilot T rial Execution Final Report | 1.4.1.4 | 3/19/2014 | 12/11/2015 | Final report subm itted to and accepted by B ARDA CO/COR
Pivotal Study Proto col Development Submission | 1.4.2.1 | 3/23/2015 | 4/10/2015 | Protoc ol submitted to and a ccepted by BARDA CO/COR
IDE P i lot A pproval F i nal R eport | 1.5.1.6 | 10/27/2014 | 10/27/2014 | IDE Appr o v al
CT-X2 Har d ware Soft ware Report | 1.6.3.1 | 3/9/2014 | 4/22/2014 | Inter im Report
CT-X2 Consumable Reagent Report | 1.6.3.2 | 3/9/2014 | 8/5/2014 | Inter im Report
CT-X2 Human Use Rev i ew - F inal Report | 1.6.3.3 | 8/6/2014 | 9/17/2014 | Final report subm itted to and accepted by B ARDA CO/COR

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Option 2: Pivotal Clinical T rial | 9/28/14 to 9/27/17 |
Name |  | Start Date | Finish Date | Deliverab le
Cl ini c al Hi r ing | 1.1.1.7 | 6/2/2015 | 8/10/2015 | Inc lude in the appl i cab le bi-monthly report
Ini t iat ion of Enr o ll ment Inter im Report | 1.4.2.4 | 2/12/2016 | 2/12/2016 | First study pat i ent enrolled
Study Complete Final Repo rt | 1.4.2.10 | 6/1/2017 | 6/1/2017 | Final report subm itted to and accepted by BARDA CO/COR
PMA Submission Final Report | 1.5.3.2 | 6/1/2017 | 6/1/2017 | PMA Submitted
FDA L icensure | 1.5.3.3 | 9/21/2017 | 9/21/2017 | PMA Appr oved
Option 3: Comb. Inj. T reatment Optimization | 9/28/13 to 9/27/17 |
Name |  | Start Date | Finish Date | Deliverab le
Cl ini c al Hi r ing | 1.1.1.8 | 6/3/2016 | 7/14/2016 | Inc lude in the appl i cab le bi-monthly report
Research and Devel opment Hi ring | 1.1.1.9 | 3/19/2014 | 5/27/2014 | Inc lude in the appl i cab le bi-monthly report
Porcine Studies Final Repo rt | 1.3.1.5 | 3/19/2014 | 1/25/2017 | Final report subm itted to and accepted by BARDA CO/COR
Human Stud ies Final Repo rt | 1.3.2.2 | 3/9/2014 | 8/19/2014 | Final report subm itted to and accepted by BARDA CO/COR
510k Cli n i cal S tudy Compl etion F i nal Report | 1.4.3 | 1/13/2016 | 5/10/2017 | Final report subm itted to and accepted by BARDA CO/COR
510k Clear ance | 1.5.4 | 4/27/2017 | 8/30/2017 | 510k Clear ance by F DA
Dress ing CMC Final Report | 1.6.4 | 9/16/2015 | 5/22/2017 | Final report subm itted to and accepted by BARDA CO/COR

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2. De t a iled D es c r i pt i o n o f S e l ect C ont r a ct Deli ve r a b les

Technical Repo r ts

In addi t i on to those reports requi r ed by the other ter ms of this contract, the Contr a ctor shall prepare and subm it the foll o w i ng reports in the manner stated bel ow and in accordance with the DELI V ERIES A rti cle in SECTION F of this contract and in S ECTION J-Li st of Atta c h ments, attached hereto and made a part of the contract.

| A. | M onthly Pr og ress Rep o rt |

This report shall inc l ude a descr ipti on of the acti v ities dur ing the repor t ing period, and the acti v i t ies p lanned for the en suing r epor t ing period. The f i rst reporting period c ons i sts of the f i rst full month of per for man ce plus any f ractional part of the i n itial month. Thereafter, the reporting per i od sha ll c onsist of each cal endar month.

The for mat should inc l ude:

A cover page that includes the contract number and ti t le; the t y pe of report and pe r iod that it covers; the Contractor’s na me, address, tel ephone nu mber, fax number, and e-mail address; and the date of subm i ss ion; The progress report s hall conform to the requi rements set forth in the D ELI V ERIES A rti cle in S ECTION F of this contr a ct.

| • | SECTION I – E X E CUTIVE SUMMA RY |

| • | SECTION II - PROGRE SS |

| • | SECTION II Part A: O V E R ALL PROG R E SS - A descripti on of o ver a ll progress. |

| • | SECTION II Part B: M A N A G EMENT AND ADMINI S TRA TIVE U P D A TE - A descr iption of all meetings, conference cal l s, etc. that have taken place dur i ng the reporting per i od. Inc lude progress on adm ini stration and management i ssues (e.g., ev a l uating, and manag i ng subcontractor per for mance, and personnel c hanges). |

Estimated and Ac tual Ex penses

This report shall a l so contain a narrati ve or table detai l ing w hether there is a s igni f i cant d i screpancy (>10%) at this t i me between the % of work c o mpleted and the c u mulati ve costs incurred to date. Monthly and actual expenses should be broken do wn to the appr opr iate W BS l e v el as far as possibl e. This section of the report should a l so contain esti mates for the Subcontractors’ e xpenses f r om the pr e vi ous month if the Subcontractor did not s ubm it a bi ll in the p rev ious month. If the subcontractor(s) was not wor k ing or did not incur any costs in the pr e v ious month, then a statement to th is effect shou ld be inc l uded in th is report for those respective subcontractors.

| • | SECTION II Part C: T ECHNICAL PROG R E SS - For each acti v i ty r e lated to the Integr ated Master S chedule, document the results of work c o mpleted and cost incurred during the per i od cover ed in r e lat ion to proposed pr ogress, effort and budget. The report sha ll be in suff i c ient deta il to ex p l a in comprehens iv e ly the resul ts achi e v ed. The descr ipt i on shall inc l ude pertinent data and/or graphs in suff i c ient deta il to ex p l a in any s i gni f i cant res u lts ac h i e ved and preli m inary conc lus ions res u l t ing f r om anal y s is and sc i ent i f ic ev a l uation of data accumulated to date under the contract. The report s hall i n c lude a descr iption of pr oblems encountered and propos ed correcti ve ac t ion; di fferences bet w een pl anned and ac tual progress, why the d i fferences have occurred and what correcti ve actions are p l anned; prel i m inary conc lus i ons resul t i ng f r om ana l y s is and scient i f ic evaluation of data accumulated to date under the project. |

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| • | SE C T I O N II P a r t D: P R O P O SE D W O RK - A s u m m a r y of w o r k p r opo s ed r e l ated t o the I nteg r a ted Ma s ter S c h e du l e f or the n e x t r e p o r t i n g p e r i od a n d p r ep r i nt s/r e p r i nts of pape r s a nd ab s t r a c t s. |

In accordance w ith F AR 52.215-2, Audit and Records-Negot iat i on, BARDA m ay request on an ad hoc bas is that the Contrac tor pr o v ide raw data. B ARDA m ay request add itional data at a reporting l e v el or at l o wer lev e l s, as BA RDA deems necessar y.

A m o nthly P r o gress Re p ort will n ot be r e quired in the same m onth that the Annual Technical Pro g ress Rep o rt is sub mitted.

| B. | Annual Pr og ress Rep o rt |

This report shall inc l ude a sum mation of the results of the enti re c ontract work for the per i od c o vered. An Annual Techni cal Progress Report wi ll not be requi r ed for the per i od when the Fi nal Techni c al P rogress Report is due. Monthly Progress Reports shall not be subm itted in the same month w hen an Annual P r ogress Report is due.

The f i rst Annual Progress Report s hall be subm itted in accordance w i th the date set forth in ARTICLE F.2 of this c ont ract. Each A nnual P rogress Report s hall inc l ude:

A Co ver page that inc l udes the c ontract number and ti t le; the t y pe of report and pe r iod that it c o vers; the Contracto r's name, address, tel ephone number, fax nu mber, and email address; and the date of subm i ss ion; The progress report shall conform to the requi rements set forth in the DELIV ERI ES A r t i c le in S ECTION F of this contract.

| • | SECTION I: E X ECUTIVE SUMM A RY - A br ief overv i ew of the work c o mpleted, and the major acc o mpli shments ac h i e ved during the r eporti ng per i od. |

| • | SECTION II: PROGRESS |

| • | SECTION II Part A: O V E R ALL PROG R E SS - A descripti on of o ver a ll progress. |

| • | SECTION II Part B: M A N A G EMENT AND ADMINI S TRA TIVE U P D A TE – A descr iption of all meetings, conference cal l s, etc. that have taken place dur i ng the reporting per i od. Inc lude progress on adm ini strat i on and management i ssues (e.g. e v a luating, and managi ng subcontractor per for mance; regulatory c o mpli ance audits, and per sonnel changes). |

| • | SECTION II Part C: T ECHNICAL PROG R E SS - A detai led descr ipt ion of the work per for med structured to foll ow the activ ities and dec i s ion gates descr i bed in the Integr ated Master Schedule. The Report should inc lude a descr ipt ion of any problems (techni cal or f inanc ial) that occurred or were identi f i ed dur i ng the reporting per i od, and how these pr oblems were resolved. |

| • | SECTION II Part D: PROPOSED W ORK - A sum m a ry of work proposed for the next y ear per i od to include an updated Integrated Master S chedule. |

| • | SE C T I O N III P a r t A: I n a c c o r dan c e w i t h F A R 52.215-2, A u d i t and Re c o r d s- Nego t i a t i o n, BA R D A m a y r eque s t on an a d h oc ba s i s t hat t he C ont r a c tor p r o v i d e r aw da t a. BA R DA m a y r e q ue s t a d d i t i o nal da t a at a r e po r t i n g l e v el or at l o wer l e v e l s, as B A R D A d ee m s n e c e ss a r y. |

Contractor al so s hould include the fol l owing in the Annual P r ogress Report:

| 1. | Copies of manuscr ipts (publi shed and unpubl i shed), ab stracts, and any protocols or methods de v e loped spec i f i cally under the contract dur ing the reporting per i od; and |

| 2. | A summary of any Subject I nventions per the requirements under FAR Clau se 52.227-11. |

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A n a nnu al P r o g r ess R e p o r t will n o t b e r e qu ired in t h e sa m e m o n th t h at t h e F i n al Tec hn ical P r o g r ess Re p o r t i s s ub m i t te d.

| C. | Draft Fin al Technical P r og ress Rep o rt and Final Technical P r og r ess Repo rt |

These reports are to inc lude a sum mat ion of the work per for med and res u lts obta ined for the enti re contract period of per for mance. This report shall be in suff i c ient deta il to descr ibe comprehensi v e ly the results achieved. The Draft F inal Report and Final Report shall be s ubm itted in accordance with the DELIV ERIES A r t i c le in S ECTION F of the contract. An Annual Technical P r ogress Report w i ll not be requi r ed for the period when the Final Techni cal P r ogress Report is due. The Draft F inal Techni cal P r ogress Report and the Final Techni c al Progress Report s hall be subm itted in accordance w ith the dates set forth in ARTICLE F.2. of this contract. The report shall conform to the fol l o w i ng for mat:

| 1. | Cover page to inc lude the contract number, contr a ct title, per for mance per i od covered, Contractor's name and address, telephone nu mber, fax number, email address and s ubm i s sion date. |

| 1. | SECTION I: EXECUTIVE SUMMARY - Sum mari ze the purpose and scope of the contract effort including a s umm a ry of the m ajor acco m plish m ents r elative to the specific activities set fo rth in the Statement of W o r k. |

| 2. | SECTION II: R E SULTS - A deta i led descr iption of the work per for med related to the Integrated Master S chedu le, the results obta i ned, and the i mpact of the results on the scient i f ic and/or pub lic hea lth com muni ty including a l i sti ng of a ll manuscr ipts (publi s hed and in prepar ati on) and abstracts presented dur ing the enti re per iod of per for mance and a sum mary of a ll i n v enti ons. |

D r a f t T e c hn i c al P r o g r e s s Repo r t: The Contractor is requi red to subm it the Draft Final Techni cal P rogress Report to the Contracti ng O ff i cer’s Representat i ve and Contr a cting Off i cer. T he Cont r a cti ng Offic e r’s Rep r e sentati ve and Cont r a cting Offi c er w i ll rev iew the Draft F inal Techni cal P rogress Report and prov i de the Contractor wi th com ments in accordance with the dates set forth in ARTICLE F.2. of this contract.

F i n al T e c h n i c al P r o g r e s s R e p o r t: The Contra ctor wi ll del iv er the final v ersi on of the Final Techni cal P rogress Report on or before the completi on date of the c ontract. The f inal vers i on sha ll include or add ress the Cont r a cting Offi c er’s Repre s entati ve c omm ents and Contra cting Offi c er c o m ments on the draft report. Final Techni cal P rogress Report shall be subm itted on or before the completion date of the contract.

| D. | Summary of Salient Results |

The Contractor sha ll subm it, wi th the F i nal Techn i cal P rogress Report, a sum mary (not to exceed 200 words) of sali ent results achieved dur i ng the per for mance of the cont ract.

| E. | Other Technical Prog ress Reports |

| 1. | D r a ft R epo r t s an d F i na l R e po r ts f o r N on-C l i ni c a l S t u d i e s an d C li ni c a l S t ud i e s |

| • | The non-c l ini c al study and Cl ini c al study r eports sha ll fol l ow the for mat of Internati onal Conference on Har moni z ati on document ICH E3 “Guidel i nes on Structure and Content of Cl ini c al Study Reports” (http://www.p ha r m a c ont r a c t.c h/s uppo r t/s u_i c h_l i s te.ht m) |

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| • | D r a f t and Fi n a l R e po r ts f or Non-C l i n i c al S t u d i es a n d C l i n i c a l S t u d i es f un d ed b y th i s c ont r a c t w i l l be s u b m i tted to the Co n t r a c t i n g O ff i c e r’s Rep r e s e n ta t i v e a n d Cont r a c t i ng O ff i c er (C O) f or r e v i e w a nd c o m m ent w i t h i n the t i m e f r a m es s et f o r th b y A R T ICLE F.2.of t h i s c o n t r a c t. |

| • | Subc ontractor pr epar ed reports recei ved by the P r i me Contractor s hall be subm itted to the Contrac t i ng O ff i cer’s Representat i ve and Cont rac t ing O ff i cer (CO) for revi ew and com m ent as set forth by ARTICLE F.2. of this c ontract. |

| • | The Government shall pr o v ide w r itten com ments to the Draft F inal Report for Non-Cl i n i cal Studies and Cl ini c al Studies in accordance w i th the dates set forth in ARTICLE F.2.of this c ontr a ct. |

| • | The c o mprehensi ve Final Report for Non-C l ini c al Stud ies and Cl ini c al Studies wi ll be subm itted to the Contr a cting O ff i cer and the Contr a cting O ff i cer’s Representat i ve as set forth by ARTICLE F.2. of th is c ontract.. The f inal vers ion shall inc lude or address the Cont r a cti ng Offi c e r’s Rep res entati ve c omm ents and C ont r a cting Offi c er c o m ments on the draft report. |

| • | See sec t ion ARTICLE F.2. RE P ORTING RE QUIREM ENTS AND DELI V ERA B L ES for additi onal c lar i f i cat ion and de l i verable requi rements. |

| 2. | A ud i t R epo r t s |

| • | W ithin th i r ty (30) calendar da ys of a contractor-i n itiated aud it r e lated to confor mance to FDA regu l ations and gu idance, inc l uding adher ence to GLP, GMP, G CP gui del i nes, the Contractor s hall pr o v ide c opies of the audit report. |

| • | It must inc lude a p l an for address ing areas of nonconfor mance to FDA regulations and guidel i nes for GLP, GMP, or GCP gu i del ines as identi f i ed in the f inal aud it report. |

| 3. | O t he r T e c hn ic a l D o c u m en t s: |

| • | Upon r equest, Contractor shall pr o v ide CO and COR with the fol l owi ng contract funded documents as speci f ied be l ow but not li m ited to: P rocess De v e lopment Reports, A ss ay Q ual i f i cati on P lan/Report, A ss ay Val i dati on P l an/Report, A ss ay Technology T rans fer Report, B atch Records, Standard Operating P rocedures, Master P roduc t ion Records, Certi f i cate of A nal y s i s, C l ini cal S tud ies Data or Reports. |

| • | The CO and COR reser ve the r i ght to request with in the Per iod of Per for mance a non-pr opr ietary techn i cal document for di str ibut ion wi thin the US G. |

| • | Da t a: The Contractor sha ll prov ide r aw data or spec i f ic anal y s is of data generated w i th contract fundi ng at the r equest of the B ARDA COR. S ee F AR 52.227-14. Data/data ana l y s is w i ll be de l i ver ed to the Government purs uant to the ter ms set forth in ARTICLE F.2 of th is contract. |

| • | Contractor s hall pr o v ide the requested document with in 10 bus i ness da ys of CO or COR request. Contractor can request additi onal ti me on an as needed bas i s. If edits are recom mended, the Contractor must address, in w r iting, c oncerns rai s ed by B ARDA |

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| F. | D e l i v e r ab l e s A r i s i n g f r o m F DA C o rr e s ponden c e |

a. FDA Meetings

The Contractor sha ll for ward the dates and ti mes of any meet ing wi th the FDA to BARDA and make arrangements f or appropriate B ARDA staff to attend the FDA meeti ngs. B ARDA staff shall include up to a max i m um of four people (COR, CO and up to 2 subject matter experts).

| • | Contractor s hall noti fy BA RDA of upcom ing F DA meeting with in 24 hours of schedul ing T ype A, B or C meetings OR w i thin 24 hou rs of meeting occurrence for ad hoc meetings. |

| • | The Contractor sha ll for ward i n i t ial Contractor and F DA-i ssued draft m inutes and f inal m inutes of any meeti ng w i th the F DA to B ARDA with in 3 bus iness da ys of receipt. A ll documents shall be duly mar ked as ei ther “Draft” or “F inal”. |

b. FDA Submissions

The Contractor sha ll pr o v i de B ARDA the opportuni ty to rev i ew and com ment upon all draft documents before sub m is s ion to the FDA. Contr a ctor shall pr o v ide BARDA with an electron ic copy of the f inal FDA subm i ss ion. A ll documents sha ll be duly mar ked as either “Draft” or “F inal”.

| • | Contractor s hall subm it draft FDA s ubm i ss ions to B A RDA at l east 15 bus iness da ys pr ior to FDA subm i ss ion |

| • | BA RDA wi ll prov i de feedba ck to Contractor wi thin 10 bus iness da ys of receipt |

| • | If corrective ac t ion is recom mended, the Contractor m u st address, in w r i t i ng, its cons ider ati on of all concer ns rai sed by BA RDA |

| • | The Contractor sha ll cons i der rev i s ing the ir documents to address B ARD A’s concerns and/or recom mendations pr ior to FDA s ubm i ss ion |

| • | F inal FDA subm i ss ions sha ll be subm itted to B ARDA concurrent ly or no l ater than 1 calendar day of it s ubm i ss ion to CD ER. |

c. FDA Audits

In the e vent of an F DA ins pection w h i ch occurs as a r e sult of th is contract and for the product, or for any other FDA inspec t ion that has the reasonable potent i al to i mpact the per for mance of this contract, the Contractor sha ll provide the U SG w i th an exact copy (non-redac ted) of the FDA Form 483 and the E stab li s h ment Inspection Report (E IR). The Contractor s hall pr o v ide the COR and CO with c opies of the p lan for address i ng a reas of non-confor mance to FDA regu lat ions for GLP, GMP, or GCP gu i del ines as i dent i f ied in the aud it report, status updates dur ing the plans exec ution and a c opy of all f inal responses to the F D A. The Contractor s hall a l so pr o v i de redacted cop ies of any FDA aud its recei v ed f r om subcontractors that occur as a r e sult of th is contract or for th is product. The Contractor s hall m a ke arrangements for BA RDA r epresentati ve(s) to be present dur i ng the f inal deb r ief by the r egulatory inspe ctor.

| • | Contractor s hall noti fy CO and COR w i thin 10 bus iness da ys of a scheduled FDA audit or with in 24 hours of an ad hoc s ite v i s it/aud it if the FDA does not prov ide ad v anced noti c e. |

| • | Contractor s hall pr o v ide c opies of any F DA aud it report recei ved f rom subcontractors that occur as a result of this contract or for this product w i thin 3 bus i ness da ys of recei v ing correspondence f r om the FDA or thi rd par t y. |

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| • | W i th i n 10 bu si ne s s d a y s of au d i t r e p o r t, C o nt r a c tor s h a l l p r o v i d e CO w i th a p l an f or add r e ss i ng a r eas of n on c on f o r m an c e, i f a n y a r e i d e nt i f i e d. |

d. Manufacturing Campaign Reports

Contractor s hall pr o v ide Manufactur ing Campaign Reports to B ARDA for rev i ew and c o m ment pr ior to s ubm i ss ion to F D A.

The COR and CO reser ve the r i ght to request with in the P oP a non-proprietary Manufacturing Campaign Report for di stribut i on within the US G.

| • | Contractor wi ll subm it Manufactur ing Campaign Reports at least 15 bus iness da ys pr ior to FDA subm i ss ion. |

| • | If corrective ac t ion is recom mended, Contractor must address, in w r i t ing, all concerns rai sed by B ARD A. |

| • | Contractor s hall consider r e vi s ing r eports to address B ARD A’s concerns and/or recommendati ons prior to FDA subm i ss ion. |

| • | F inal FDA subm i ss ion sha ll be subm itted to BA RDA c oncurrently or no later than 1 business day after subm i ss ion to the F D A. |

e. Other FDA Correspondence

The Contractor sha ll m e m o r iali ze any corres pondence bet w een Contrac tor and FDA and subm it to B ARDA. A ll doc u ments shall be du ly mar ked as ei ther “Draft” or “F ina l.”

| • | Cont r a c tor s h a l l p r o v i de w r i tten s u m m a r y of a n y F D A c o rr e s pon d en c e w i t h i n 3 bu s i n e s s d a y s of c o rr e s po n den c e. |

| G. | Other Reports/Deliverables |

| 1. | Meeting Mi nutes

The Contractor shall provide an electronic copy of meeting minutes for all conference calls and face-to-face meetings including the Government and Contractor. Minutes will be submitted directly to the BARDA COR for review and official approval pursuant to the terms set forth in ARTICLE F.2 of this contract. After contract award a Kickoff meeting will be held. The contractor shall prepare and submit a report of this Kickoff meeting based on the minutes to the meeting.

| 2. | Copies of FDA Co rresp ondence and Meeting Summaries

1. For any formal meeting with the FDA, the contractor shall forward initial draft minutes and subsequently final meeting minutes appropriately formatted within thirty (30) calendar days of the FDA meeting to the BARDA Contracting Officer’s Technical R e pre s e ntati ve. All d ocum e nts shall be duly mark ed as eith er “Draft” or “Final”.

2. The contractor shall forward the final draft minutes of any in formal meeting with the FDA to BA RDA.

3. The contractor shall forward the dates and ti mes of any meeti ng with the FDA to BA RDA at l east 30 da ys prior to the meeti ng and m a ke arrangements for appropr iate BA RDA staff to attend FDA meetings. B ARDA staff s hall inc l ude up to a max i m um of four peop le (CO TR, CO and up to two Subject Matter E xperts (S M E s)).

4. The contractor sha ll pr o v ide B ARDA the opportun i ty to r e v i ew and com ment

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upon a n y do c u m ents to be s ub m i tt e d to t h e F D A. T he c ont r a c tor s h a l l p r o v i d e BA R DA w i th f iv e (5) bu s i n e s s d a y s i n w h i c h to r e v i e w a n d p r o v i de c o m m ents ba c k to the c ont r a c to r.

| H. | SUBJECT INVENTION REP ORTING RE QUIRE M ENT |

All reports and documentat ion requir ed by F AR Clause 52.227-11, including, but not limited to, the invention dis closure report, the confir m atory license, and the G overnment support cer tification, shall be direc ted to the contrac ting officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting O fficer on the expiration date of the contract. See also F AR clause 52.227-11 (Patent Rights-Ownership by the Contractor).

Reports and documentati on subm itted to the Contracting O ff i cer shall be sent to the Contracting O ff i cer to the address set forth in S ECTION G – CONTRACT ADMINIS TRA TION DA T A.

If no i n v ention is di sc losed or no ac t i v i ty has occurred on a prev i ous ly d i sc losed i n venti on dur i ng the appl i cab le r epor t ing period, a negat i ve r eport shall be subm itted to the Contracting O ff i cer at the address li s ted abo ve.

SECTION G - CONTRA CT A D MINISTR ATION D A TA

ART ICLE G.1. CONTRAC TING OFFICER

The foll o w ing Contrac t ing Off i cer (CO) w i ll r epresent the G o vernment for the purpose of th is contract:

Tho mas P. Hasti ngs-Tic kerhoff, Contracting O ff i cer

DHHS/O S/AS PR/AMCG

330 Independence A v enue, S.W. Room G640

Wa shington, D.C. 20201

E-mail: tho m a s.ha s t i n g s-t i c k e r hof f@hh s.gov

| 1) | The Contracting O ff i cer (CO) is the only ind i vi dual w ho can legally com m it the Government to the ex pend iture of pub lic funds. No person other than the Contracting O ff i cer can m a ke any changes to the ter m s, conditions, gener al pr o v i s i ons, or other stipu lat ions of th is contract. |

| 2) | The Contracting O ff i cer is the only person with the author i ty to act as agent of the Government under this contract. Only the Contrac t ing Off i cer has author i ty to (1) di rect or negoti ate any changes in the statement of wor k; (2) m odi fy or ex tend the period of per for mance; (3) change the de l i very schedul e; (4) authori ze r e i mburse to the Contractor of any costs incurred during the per for mance of this cont ract; (5) otherwi se change any ter ms and c onditi ons of this c ontract. |

| 3) | No infor mation other than that whi ch m ay be contai ned in an authori z ed modi f i cation to this contract, du ly i ssued by the Contrac t ing O ff i cer, whi ch may be recei ved f r om any person empl o yed by the US Government, other otherwi se, s hall be c ons i dered grounds for de vi ation f r om any s t ipu lat i on of this contract. |

| 4) | The Government m ay uni l aterally c hange its CO des i gnation. |

ART ICLE G.2. CONTRAC TING OFFICER'S RE P R E SENT A TIVE (COR)

The foll o w ing Contrac t ing Off i cer's Representat i ve (COR) wi ll repres ent the G o vernment for the purpose of this contract:

Nar a y an I yer, P hD

Contracting O ff i cer’s Repr e sentat i ve (COR)

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D i v i s i o n of C B RN C o un t e r m ea s u r es

Biomedic al Advanced Res earch and Development Authority (BARDA)

Off ice of the Assistant Secretary for P reparedness and Response (A SPR)

Department of Hea lth and Human Serv i ces (DHHS)

Ma i l i ng A dd r e s s:

330 Independence A v enue, S.W. Room G644

Wa shington, D.C. 20201

Off ice: 202-260-0455

Email: na r a y a n.i y e r@h h s.g ov

The COR is responsible for:

| 1) | Mon itoring the Contrac tor's techni c al progress, inc lud i ng the sur v e i l l ance and ass e s s ment of per for mance and recom mending to the Contracting O ffi cer changes in requi rements; |

| 2) | A ss i sting the Contracti ng Off i cer in interpret i ng the statement of work and any other techn i cal per for mance requi rements; |

| 3) | Per for m ing tec hni c al e v a l uati on as requi r ed; |

| 4) | Per for m ing tec hni c al inspe ctions and acceptances r equi red by th is contract; and |

| 5) | A ss i sting in the resolution of techni cal prob lems encountered during per for mance. The Government m ay un il ater a l ly change its COR des i gnat ion. |

ART ICLE G.3. K EY P ERS ONNEL

Pursuant to the Key Personnel clause incor porated in Section I of this contract, the following individuals are consider ed to be essential to the work being per for med hereunder:

NA ME | ORG ANIZ A TION | TITLE
John K. Fraser | Cytori Therapeuti cs, Inc. | Chief S cient i st
Doug las M. A rm | Cytori Therapeuti cs, Inc. | Senior VP of Operations
Kenneth K. Kleinhenz | Cytori Therapeuti cs, Inc. | VP for Regulatory and Q uality Affairs
Frank ie Yan Fung Ng | Cytori Therapeuti cs, Inc. | Project anager

The k ey personnel spec i f i ed in th is contract are cons i dered to be essent ial to work per for mance. At least thi r ty (30) business da ys prior to di verting any of the s pec i f i ed ind i v i duals to other progr ams or contracts, inc l uding, where practi cab le, an instance when an ind i v i dual must be replaced as a result of l eav i ng the e mpl oy of the Contractor, the Contrac tor shall not i fy the Contracting Off i cer and sha ll s ubm it comprehens ive justi f i cat i on for the di vers i on or rep lacement r equest (inc l udi ng pr oposed substi tutions for k ey personnel) to per m it ev a luat i on by the G o vernment of the i mpact on per for mance under this c ontract. The Contractor s hall not d i vert or otherwi se rep lace any k ey personnel wi thout the w r itten cons ent of the Contracti ng O ff i cer.

ART ICLE G.4. CONTRACT FINANCIAL R E P ORT

a. F i nancial r eports on the attached Financ ial Report of Indi v i dual P roject/Contract (see Attachments 2 and 3) s hall be subm itted by the Contr a ctor in accor dance with the instructi ons for c o mpleting th is for m, w h i ch accompany the for m, in an e lectron ic cop y, not later than the 30th business day after the c lose of the repor t ing per i od. The l ine entries for subdi vi sions of work and elements of cost (expend iture categories) which shall be repor ted with in the total contract are di scussed in paragraph e., be l o w. Subsequent c hanges and/or add itions in the li ne entr ies s hall be made in w rit ing.

b. Un less other w i se s tated in that part of the instructions for c o mpleting this for m, entitl ed "P R E PA R A TION INS TRUCTIONS," (see Attachment 4) all c o lumns A thr ough J, shall be c o mpleted for each report subm itted.

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c. T he f i rs t f i nan c i a l r e po r t s ha l l c o v er the pe ri od c o n sis t i ng of the f i rs t f u l l th r ee c a l e n dar m onths f o ll o w i n g t h e d ate o f the c ont r a c t, i n a d d i t i on t o a n y f r a c t i on a l p a r t of the i n i t i al m onth. T he r ea f te r, r epo r ts w i l l be o n a q ua r te r l y ba s i s.

d. The Contracti ng O ff i cer may requ i re the Contractor to subm it deta i led s upport for costs contained in one or more i nter im f inanc ial r eports. This c lause does not supersede the record retent ion requ i rements in F AR Part 4.7.

e. The li s t ing of expendi ture categor ies to be repor ted is incor porated with in the Attachment entitl ed, "F i nancial Report of Indi v i dual P roject/Contrac t," located in S ECTION J and made a part of this c ontract.

f. The Government may uni laterally rev i se the “F inancial Report of Indiv idual P roject/Contract” to reflect the al lotment of additional funds.

ART ICLE G.5. IN V OIC E/F I NANCING R E QUE ST AND CONTRACT FINANCIAL REP ORTING

| 1) | The bi l l ing address that should be s ho wn on the i n v o i ce is the same as def ined in ARTICLE G.2. of this c ontract. |

| 2) | The Contractor sha ll subm it an e lectron ic copy of contract monthly i n v o i ces/f inancial reports to the Contracti ng O ff i cer and Contract Special i st as def ined abo ve, in ARTICLE G of this contract. |

| 3) | Contractor i n v o i ces/f inancial reports shall conform to the for m, for mat, and content requi rements of the instruc t ions for In voi ce/F i nancing requests and Contract F inanc ial Repor t ing made a part of the contract in Section J (See al so ARTICLE B.5. and Attachment 2) . |

| 4) | Monthly in voi ces must inc l ude the cumulati ve total ex penses to date, adjusted (as app li c able) to show any amounts sus pended by the G o vernment. |

| 5) | The Contractor agrees to i mmediately noti fy the Cont racting O ff i cer in w r i t ing if there is an anti c ipated overrun (any a mount) or unexpended balance (greater than 10 per cent) of the esti mated costs for the base segment or any opt i on segment(s) (See esti mated costs under A rti cles B.2. and B.3., of the contract) and the reasons for the var i ance. A l so refer to the requi rements of the Li m itation of Cost F AR 52.232-20 c lause in the contract. |

| 6) | All i n v o i ce subm i ss ions s hall be in accordance with F AR Cl ause 52.232-25 (c) in Section I of this contract. |

ART ICLE G.6. R EIMBURSE M ENT OF CO ST

| 1) | The Government shall r e i mburse the Contractor the c o st deter m ined by the Contracting Off i cer to be a l l o w able (herei nafter refer red to as a l l owable cost) in accordance w ith the c lause entitl ed A l l o w able Cost and P a y ment in Secti on I, Contract Clauses, and F AR Subpart 31.2. E xamples of al l owable costs include, but are not li m ited to, the fol l o w ing: |

| a) | All direct materials and s upplies that are used in the per for ming of the work provided for under the c ontract, includi ng those purchas ed for subcontracts and purchase or de rs. |

| b) | A ll di rect l abor, inc l udi ng superv i sor y, that is proper ly chargeable di rec t ly to the contract, plus f r inge benef its. |

| c) | All other items of cost budgeted for and accepted in the negot iat ion of th is bas ic contract or modi f ications thereto. |

| d) | T ravel costs inc l uding per diem or actual subs i stence for personnel whi le in an actual trav el status in di rect per fo r mance of the work and ser vi ces requ i red under th is contract subject to the fol l o w ing: |

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| (i) | Ai r t r a v el s h a l l be b y t h e m o s t d i r e c t r ou t e u s i n g “a i r c oa c h” or “a i r tou r i s t” (l e s s than f i rs t c l a ss) un l e s s i t i s c l ea rl y un r e a s on a b l e or i m p r a c t i c al (e.g., not a v a il a b l e f or r ea s o n s other th a n a v o i da b l e de l a y i n m a k i ng r e s e r v a t i on s, wo u l d r e q u i r e c i rc u i t o us r ou t i ng or e nt a i l ad d i t i on a l e x p en s e o f f s ett i ng the s a v i ngs o n f a r e, or w o u l d n o t m a k e ne c e ss a r y c onne c t i on s). |

| (ii) | Rail tra vel sha ll be by the m ost direct route, f irst class with l ower berth or nearest equ ivalent. |

| (iii) | Costs incurred for lodg i ng, meals, and inc idental expenses shall be considered reasonable and allo w able to the extent that they do not exceed on a daily basis the per d iem rates set forth in the Federal Travel Regu lat ion (FTR). |

| (iv) | Travel via privately owned automobile shall be rei mbursed at not more than the current General Services Adm inistrat ion (GS A) FTR estab lished m ileage rate. |

ART ICLE G.7. INDIR ECT CO ST R A T ES

The foll o w ing rates w i ll be uti l i zed for bi l l ing purposes dur i ng both the base and opti on per i ods: Fr inge benef its at 24%, and a gener al and adm ini strati ve expense rate (G&A) of 50% for FY2012 and 51% for FY 2013 thr ough FY2016. The b i l l ing rates for the opt ion period wi ll be bas ed on the incurred cost s ubm i ss ion for the pr e v ious c a lendar yea r, subject to G o vernment audit adjustments. F inal rate pr oposals must be sent to the Contracting O ff i cer, with in 6 months subsequent to the f i scal y ear end. (S ee a l so F AR Clau se 52.216-7 incor porated herein)

ART ICLE G.8. P O ST AWARD E VAL U A TION OF C ONTR ACT OR P ERFORMANCE

1. C ont r a c to r P e r fo r m a n c e E v al u a t i on s

Inter im and f inal e v a l uations of Contractor per for mance w i ll be prepar ed on th is contract in accordance with F AR Subpart 42.15. The f inal per for mance e v a luati on wi ll be pr epared at the ti me of c o mpletion of wor k. In addi t i on to the f i nal eval uati on, an inter im eval uation shall be subm itted S eptember 27, 2013.

Inter im and f inal e v a l uations wi ll be pr o v ided to the C ontractor as soon as prac t i cable after c o mpletion of the e v a luati on. The Contractor w i ll be pe r m itted th i r ty da ys to rev i ew the document and to subm it addi t ional infor mation or a rebutting statement. If agreement cannot be reac hed between the pa rties, the matter wi ll be referred to an ind i v idual one level abo ve the Contracting O ff i cer w ho se dec i sion wi ll be f ina l.

Copies of the eval uations, Contractor res ponses, and rev i ew com ments, if an y, wi ll be retai ned as part of the contract f ile, and m ay be us ed to support future a ward dec i s ions.

2. E l ec t r on i c A c ce s s t o C o nt r ac to r P e r fo r m a n ce Ev al u a t i on s

Contractors that have Internet capab i l i ty m ay access ev a luat i ons through a secure Web s ite for revi ew and com ment by completing the r egi strat i on form that can be obtained at the foll owing address:

http://www.c p a rs.cs d.d i s a.m il/c pa r s m a i n.htm

The regi stration process requi res the Contractor to identi fy an ind i v idual that w i ll ser ve as a pr i mary contact and who wi ll be authori zed access to the e v a luati on for rev i ew and com ment. In addi t i on, the Contractor wi ll be requi r ed to i dent i fy an alternate contact that wi ll be respons i b le for noti f y ing the cogni z ant contracti ng off i c ial in the e v ent the pri mary contact is una v a il able to process the ev a l uation with in the r equ i red 30-day ti me f r a me.

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A R T I C L E G.9. C O N TR A C T C O MM UNI C A T I O N S/C O RR E SP O N D E N C E (JU L Y 1999)

The Contractor sha ll i dent i fy a ll corres pondence, r eports, and other data perti nent to th is contract by i mpr inting the contract number fr om Page 1 of the contrac t.

ART ICLE G.10. GO V ERN M E NT PRO PERTY

1. In add i t ion to the r equi r e ments of the c lause, GO VERNMENT PRO P ERT Y, incorporated in SECTION I of th is contract, the Contractor s hall comply with the prov i s i ons of HHS Pub li cat ion,

"Contractor's Guide for Control of Government Proper t y," w hich is incorporated into this contract by reference. This document can be accessed at:

http://www.hh s.g o v/hh s m a nu a l s/ (H H S L o g i s t i c s Man a ge m ent M a nu a l)

Among other issues, this publication provides a summary of the Contractor's res ponsibilities regarding purchasing autho ri zations and inventory and reporting r equirements under the c ontract.

2. Notwi thstand i ng the pr o v i s ions out li ned in the HHS Pub li cat i on, "Contractor's Gui de for Contr ol of Government P roper t y," whi ch is incorporated in this contract in par agraph 1. above, the Contractor s hall use the form entitled, "Report of Gov e rnment O wned, Contractor Held P r oper t y" for sub m itting sum mary r eports requi red under this c ontract, as di rected by the Contracti ng Off i cer or hi s/her des i gnee. This form is inc luded as an attachment in S ECTION J of this contract.

3. T itle wi ll vest in the G o v e rnment for equipment purchased as a d i rect cost.

ART ICLE G.11. E XE RCISE OF O P TIONS

Unless the G o vernment exerc i ses its opt i on pursuant to the Option C l ause set for th in Section I, A r t i c le I.2, the c ontract w i ll c ons i st only of C L IN 00 0 1 of the S tatement of W o r k, Del i verab les and Requ i rements as def ined in Sec t ions C, F and J of the c ontract. Pursuant to F A R C l a u se 52.217-9 (Opt i o n t o E x t e n d th e T e r m o f th e C ont r ac t) set for th in Sec t ion I of this contract, under A r t i cle I.2, the Government m a y, by un il ater al contract modi f i cation, requi re the Contractor to pe r form th e a dd i t i on al C L I N s lis t ed in S ec t i o n B, A r t i c l e B.3., and as al so def ined in Sections C, F and J of th is contract. If the G o vernment ex e rc i ses an option, w r itten noti ce must be g i ven to the Contractor with in 30 da ys after the G o vernment has completed its anal y s is of the de l i verables associated with the app li c able GO/NO-GO Dec i s i on gates; and the G o vernment must give the Contractor a prel i m inary w r i tten not i ce of its i ntent to exerc i se the opt ion at least 30 da ys before the contract expi res. The a mount of the contract m ay then be i n creased as set forth in Sec t ion B, A rti cle B.3 prov i ded that funds are a vai l able.

SECTION H - SPECI AL CONTR ACT REQUIREMENTS

ART ICLE H.1. CLINICAL AND NON-CLINICAL T ERMS OF A WARD

BARDA has a res ponsibility to obtain documentation concerning mechanis ms and procedures that are in place to protect the safety of pa rticipants and animals in BARDA funded clinical trials and non-clinical s tudies. Therefore, the Contractor shall develop a protocol for each clinical tr ial a nd non-clinical study funded under this contract and submit all such protocols and proto col amendments to the BARDA Contrac ting O fficer’s Representative (COR) for evaluation and com ment. Approval is required before work under a protocol m ay begin. BARDA COR com ments will be forwarded to the C ontractor within ten (10) business da y s. The Contractor must address, in w riting, all concerns (e.g. study design, safet y, regul ator y, ethical, and conflict of interest) r aised by the BARDA COR.

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

E x e c ut i on of cl i n i c a l a nd n o n-c li n i c al s t ud i es r eq u i r es w r i tten au t ho ri z a t i o n f r o m B A RD A. The Government w ill provide w ritten authorization to the Contractor upon either 1) receiving documentation in which all COR com ments have been satis factorily addressed; or 2) receiving documentation that the F DA has reviewed and com mented on the protocol.

BARDA s hall have rights to all protocols, data resulting f r om execution of these protocols, and final r eports funded by BARDA under this contract, as set forth in PART II of this contract and defined in the FAR. BARDA reserves the right to r equest that the Awardee provide any contract deliverable in a non-pr oprietary fo rm to ensure BARDA has the ability to r evi ew and distribute the deliverables as BARDA deems necessar y.

Important infor mation regardi ng per for m ing human sub ject research is a vai l able at http://www 3.n i a i d.n i h.go v/h ea l t h sc i en c e/c li n i c a l s tu d i e s/.

Any updates to technical r eports are to be addressed in the Month ly and Annual Progress Reports. The Contractor shall advise the Contracting Officer’s Technical Representat ive or designee in w riting and via electr onic com munication in a timely manner of any issues potentially affecting contract per for mance.

| 1. | Non-Clinical Terms of A ward

These Non-Cl ini cal Ter ms of Award deta il an agreement bet ween the B iomedi c al A d vanc ed Res earch and Dev e l opment Author i ty (B ARDA) and the Contractor; they app ly to a ll grants and cont racts that invol ve non-c li n i cal research.

| a. | Safety and M onitoring Issues

| i. | PHS P olicy on Hu mane Care and use of Lab o rato ry A n i mals

Before award and then with the annual progress repor t, the Contrac tor m u st submit to BARDA a copy of the current Ins titutional Animal Care and Use Com mittees (IACUC) documentation of continuing revi ew and appr oval and the O ffice of Laboratory Animal Welfare (OLA W) federal wide assurance number for the institution or site.

If other ins t itut i ons are i n vol ved in the research (e.g., a multi center trial or stud y), each insti tut ion’s IACUC must revi ew and approve the protocol. They must al so prov i de BARDA initial and annual documentation of conti nuing r e v i ew and approv al and federal wi de assurance number.

The Contractor must ensure that the appl i cation, as well as a ll protoc o l s, are rev i ewed by the per for m ing insti tution’s I ACUC.

To help ensure the safety of ani mals used in B ARDA-funded stud ies, the Contractor must prov ide B ARDA cop ies of documents related to a ll major changes in the status of ongoing protoc o l s, inc lud i ng the fol l o w ing:

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

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

| • | Termination or te m po r a r y s u s pen si on of t h e s tu d y(i e s) f or r egu l ato r y i ss ue s. |

| • | Termination or te m po r a r y s u s pen si on of t h e p r o t o c o l. |

| • | A n y c ha n ge t hat i s m ade i n the s p e c i f i c I A C U C a p p r o v al f or the i n d i c at e d s tu d y(i e s). |

| • | A n y o t her p r o b l e m s or i ss u es that c o u l d a ff e c t the sc i e nt i f i c i nt e g r i t y of the study(i e s), i.e., f r aud, m i sr ep r e s enta t i o n, m i s app r op r i at i on of f und s, et c. |

Contractor must noti fy B A RDA of any of the above changes with in f i ve (5) wor k ing da ys f r om the ti me the Contractor becomes aware of such changes by email or fax, foll o w ed by a l etter signed by the insti tutional bus i ness off i c ial, detai l ing noti f i cation of the change of status to the loc al IACUC and a c opy of any responses f rom the IACUC.

If a non-c l ini c al pr otoc ol has been r e v i ewed by an institutional b iosafety c o m m ittee (IBC) or the NIH Recombinant DNA A d v i sory Com m ittee (RAC), the Contractor must prov i de infor mation about the ini t ial and ongoi ng rev i ew and appr o v a l, if an y. See the NIH G u i del ines for Research In vol v ing Recombinant DNA Mo lecules.

| ii. | Non-Clinical Data and Safety M onito ring Requirements

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

A r i sk is m ini mal where the probabi li ty and magni tude of harm or di scomfort anti c i pated in the proposed res earch are not greater than those ordi nar i ly encounter ed in dai ly li fe or dur i ng the per for mance of routine ph y s i cal or ps y c hol ogi c al e x a m inations or tests. For e x a mple, the r i sk of dr a w ing a s mall amount of bl ood f rom a healthy s ubject for research purposes is no greater than the r i sk of doing so as part of a routine ph y s i cal exam inati on (45 C FR 46.102(i)).

BARDA will work with the Contractor on decisions rega rding the t y pe and extent of safety data accrual to be emplo y ed before the start of efficacy or safety studies.

The Contractor sha ll inform B ARDA of any upcom ing s ite vi s its and/or aud its of CRP faci li t ies funded under this effort. B ARDA reserves the right to accompany the Contrac tor on s i te vi s its and/or audi ts of CRO’s as BARDA deems necessary.

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| b. | B A R D A R e v iew Pr o ce s s b e fo r e N on-Cli n i cal s tud y E x e c ut i o n Be g i n s

BARDA is under the same polic y-driven assurances as NIH in that it has a responsibility to ensure that mechanisms and procedures are in place to protect the safety and w elfare of animals used in BARDA-funded non-clinic al trials. Therefore, before study execution, the Contractor must provide the following (as applicable) for review and com ment by BARDA:

| • | I A CUC a p p r o v ed (s i g ned) non-cl i n i c a l r e s e a rc h p r oto c ol i d e nt i f i e d b y v e rs i o n nu m be r, date, or b o th, i n cl u d i n g d e ta i l s of s tu d y de s i g n, eu t ha n a s i a cr i t e r i a, p r opo s e d i nte rv en t i o n s, a n d e xc l u si on cr i t e r i a. |

| • | F or non-p i v ot a l m ou s e s tu d i e s, t h e C o nt r a c tor w i l l p r o v i de an an n ual a n i m al c a r e and u s e p r o to c o l. |

| • | Do c u m entat i o n of I A C U C a pp r o v a l, i n c l u d i n g O L A W f ede r al w i de n u m be r, I A CUC r eg i s t r a t i o n n u m be r, and I A C UC n a m e. |

| • | Cont r a c tor s h ou l d r e d u c e t he n u m ber of an i m a l s r equ ir ed f or a s tu d y u si ng p o w er of s ta t i s t i cs. |

| • | Pl a ns f or the m anage m ent of s i de e ff e c t s, r u l es f or i nt e r v en t i ons and eut h ana si a cr i te r i a. |

| • | P r o c edu r es f or a ss e ss i ng a nd c o l l e c t i ng s a f e t y d ata we r e a p p r op ri ate.

| • | If a s tu d y i s c ont r a c t e d th r o ugh C ont r a c t Re s ea rc h Or g an i z a t i o ns (CR Os), wo r k o r de r s and s e rv i c e ag r ee m ents the Co n t r a c tor s h a l l a ss u r e a n i nt e g r at e d s a f e t y do c u m entat i o n p l an i s i n p l a c e f or t h e s tu d y s i te, p h a r m a c y s e r vi c e r e c o r ds on t he d o si ng m ate r i al to b e u s e d a nd e xc i p i e nt s, a nd l a b o r ato r y s e rv i c es (i n cl u d i ng h i s to p ath o l og y). |

| • | Do c u m entat i o n t h at t h e C o nt r a c tor a n d a l l r eq u i r ed s ta ff r e s pon s i b l e f or the c ondu c t of t h e r e s ea rc h ha v e r e c e i v ed t r a i n i n g i n t h e p r ote c t i o n a n d h an d l i ng of an i m a l s, or that the CRO has t h e r eq u i r ed do c u m en t at i o n. |

| • | P u rc ha si ng of a n i m a l s and/or other s u p p li es f or n o n-c l i n i c al s tu d i es f und e d i n pa r t or i n who l e b y BA R DA r equ i r es w r i tt e n a pp r o v a l b y t h e C o nt r a c t i ng O f f i c er i n a cc o r dan c e w i t h t he c ont r a c t. T he Cont r a c tor m u s t ha v e t h e a b i li t y to r etu r n/r e-s e l l a n i m a l s, at pu rc ha s e p r i c e, to d i s t r i bu t or or a t h i r d pa r t, i n t he e v e nt t hat t he C ont r a c t i ng O f f i c er A utho r i z at i on i s not g r ant e d. |

| • | P r o v i d e j u s t i f i c at i on f or w h e ther s tu d i es r e q u i r e g o od l a bo r ato r y p r a c t i c e

(GLP) cond itions.

| • | P r o v i d e j u s t i f i c at i on f or w h e ther s tu d i es w i l l b e c l a ss i f i e d as n o n-p i v o tal or p i v ot a l s t u d i e s. |

Documentati on of each of the abo ve items shall be s ubm itted to the BA RDA for ev a l uation and com ment in conjuncti on w ith the protocol. E xecution of non- c li n i cal studies requ i res w r i tten authori zat ion f rom BA RDA in accordance with this section of the contract.

| c. | References

Public Health Service Policy on Humane Care and Use of Laboratory Animals:

http://g r ant s.n i h.g o v/g r an ts/o l a w/I n v e s t i ga t o rs Nee d 2 Kno w.pdf

US DA Ani mal Wel fare A ct:

http://a w i c.n a l.u s d a.g o v/n a l_d i s p l a y/i nde x.ph p?i n f o_c ente r=3&t a x_l e v e l=3&ta x_s u b j e c t=1 8 2&t o p i c_i d=11 1 8&l e v e l 3_i d=6 7 3 5&l e v e l 4_i d=0&l e v e l 5_i d=0&p l a c e m ent_d e f au l t=0

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| 2. | Cli n ical T e r m s o f A w a r d

These Cli n i cal Ter ms of Award detail an agreement between the B iomedi cal A d v anced Research and Devel opment Authori ty (BARDA) and the Contractor; they apply to all grants and contracts that i n v o l ve c l ini c al research.

| i. | S a f e t y and M on i to r i n g Iss u es

a. Institutional Review Board or In dependent E th ics Committee A p p r o val

Before award and then with the annual progress repor t, the Contrac tor must submit to BARDA a copy of the current IRB-or IEC-app roved infor med consent document, documentation of continuing r eview and approval and the O HRP federal wide assurance nu mber for the ins titution or site.

If other ins t itut i ons are i n vol ved in the research (e.g., a multi center c l ini c al trial or stud y), each ins t itut ion’s IRB or I EC must rev i ew and approve the protocol. They must al so prov i de BARDA initial and annual documentation of continuing rev i ew and appr o v a l, includ ing the curr ent appr o ved infor med consent document and federal wi de number.

The Contractor must ensure that the appl i cation as w e ll as all pr otocols is rev i e w ed by their IRB or IEC.

To help ensure the safety of parti c ipants enr o l led in BARDA-funded stud ies, the Contractor must prov i de B ARDA cop ies of documents related to all major changes in the statues of ongo ing protoc o l s, inc l uding the fol l owing:

| • | A l l a m end m ents or c hang e s to the p r oto c o l, i d en t i f i ed b y p r oto c o l v e rs i o n n u m be r, date, or b o th a n d d ates i t i s v a li d. |

| • | A l l c ha n ges i n i n f o r m ed c o n s ent d o c u m ent s, i d e nt i f i e d b y v e rsi on nu m be r, date s, or bo t h a n d dates i t i s v a l i d. |

| • | Termination or te m po r a r y s u s pen si on of p a t i e nt a ccr u a l. |

| • | Termination or te m po r a r y s u s pen si on of t h e p r o t o c o l. |

| • | Any change in IRB approval. |

| • | A n y o t her p r o b l e m s or i ss u es that c o u l d a ff e c t the pa r t i c i p a nts i n t h e s tud i e s. |

The Contractor must notify BARDA through the Project Officer (PO) or Contracting Officer (CO) of any of the above changes within five (5) working days by email or fax, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IRB and a copy of any responses from the IRB or IEC.

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

b. Data and Safety Monitoring Requirements

BARDA strongly recommends independent safety monitoring for clinical trials of investigational drugs, devices, or biologics; clinical trial of licensed products; and clinical research of any type involving more than minimal risk to volunteers. Independent monitoring can take a variety of forms. Phase III

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clinical trials must be reviewed by an independent data and safety monitoring board (DSMB); other trials may require DSMB oversight as well. The Contractor shall inform BARDA of any upcoming site visits and/or audits of CRO facilities funded under this effort. BARDA reserves the right to accompany the Contractor on site visits and/or audits of CROs as BARDA deems necessary.

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

Final decisions regarding the type of monitoring to be used must be made jointly by BARDA and the Contractor before enrollment starts. Discussions with the responsible BARDA Project Officer regarding appropriate safety monitoring and approval of the final monitoring plan by BARDA must occur before patient enrollment begins and may include discussions about the appo intment of one of the fol l o w ing.

| • | I nd e p e nd e n t S a f e t y M on i t o r – a p h y s i ci an or ot h er a p p r op r i a te e x p e r t who i s i n de p en d ent of the s tu d y a n d a v a i l ab l e i n r e a l t i m e to r e vi e w and r e c o m m end app r op r i at e a c t i on r e g a r d i ng a d v e rs e e v e nts a n d other s a f e t y i ss ue s. |

| • | I nd e p e nd e n t M on i to r i n g C omm i tt ee (I M C) o r S a f e t y M on i to r i n g C omm i tt ee (S M C) – a s m a l l g r oup of i n d ep e nd e nt i n v e s t i g a to r s a n d b i o s t a t i s t i c i ans who r e v i e w data f r om a pa r t i c u l ar s tu d y. |

| • | Da t a a n d S a f e t y M on i to r i n g B o a r d – an i n d e p en d e n t c o m m i ttee c ha r ged w i t h r e v i e w i n g s a f e t y and t r i a l p r o g r e s s and p r o v i d i ng a d v i c e w i th r e s p e c t to s t u d y c on t i n uat i on, m od i f i c at i on, and t e r m i nat i o n. T he Cont r a c tor m a y b e r eq u i r ed to u s e an e s ta b li s h e d BA R DA D S M B or t o o r ga n i z e a n i nd e pe n de n t D S M B. A l l p h a s e III c l i n i c a l t r i a l s m u s t be r e v i e w e d b y a D S M B; ot h er t r i a l s m a y r e q u i r e D S MB o v e rs i g ht as we l l. |

Please refer to: NIAID Prin ciples for Use of a Data and Safety

Mon itoring B oard (DSMB) For O vers i ght of Cl i n i cal T rials Pol i cy

When a monitor or monitoring board is organi z ed, a de scr iption of it, its charter or oper ati ng proc edures (i n c luding a pr oposed meeti ng schedu le and plan for rev i ew of ad verse events), and roster and c u rr i c u l um v i tae f r om all m e mbers m u st be subm itted to and approved by B ARDA before enrol l ment starts. The Contractor wi ll a l so ensure that the monitors and board m e mbers report any conf li cts of interest and the Contractor wi ll mainta in a record of thi s. The Contractor wi ll share conf li ct of interest reports with B ARDA.

Additionall y, the Contractor must sub mit w ritten summaries of all r evi e ws conducted by the monitori ng group to the BARDA w ithin thir ty (30) da ys of revi e ws or meetings.

| ii. | BARDA Protocol Review Process Before Patient Enrollment Begins

BARDA has a res ponsibility to ensure that mechanis ms and proc edures are in place to pr otect the safety of participants in BARDA-suppor ted clinical trial. Therefore, before patient a ccrual or par ticipant enr oll ment, the Contractor must ensure the following (as applic able) are in place pr ior to patient accrual or enrollment at each par ticipating institution.

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•IR B- or I E C-a p p r o v ed c li n i c al r e s ea rc h p r oto c o l i d e nt i f i ed b y v e rs i o n nu m be r, date, or b o th, i n cl u d i n g d e ta i l s of s tu d y de s i g n, p r opo s e d i nte r v e n t i on s, p at i ent e l i g i b i li t y, and e xc l u s i o n cr i te r i a.

•Do c u m entat i o n of IRB or I E C app r o v a l, i n cl u d i ng O HR P f ede r a l w i de nu m be r, IRB or I E C r e g i s t r at i o n n u m be r, and I R B a nd I E C n a m e.

•IR B- or I E C- a pp r o v ed i n f o r m ed c on s ent do c u m ent, i d ent i f i e d b y v e rs i o n nu m be r, date, or b o th a nd dates i t i s v a l i d.

•Pl a ns f or the m anage m ent s i de e ff e c t s.

•P r o c edu r es f or a ss e ss i ng a nd r e p o r t i n g a d v e rs e e v en t s.

•Pl a ns f or data and s a f e t y m on i t o r i n g (s ee B a b o v e) an d m on i to r i n g of the c li n i c al s t ud y s i te, p h a r m a c y, a nd l a b o r ato r y.

•Do c u m entat i o n t h at t h e C o nt r a ct or a n d a l l s t u d y s ta f f r e s pon si b l e f or the de s i g n or c o n du c t of t h e r e s ea rc h h a v e r e c e i v ed t r a i n i ng i n t h e p r o t e c t i on of hu m an s ub j e c t s.

Documentati on to demonstrate that each of the above items are in p lace s hall be subm itted to the BA RDA) for evaluat ion and com m ent in conjunc t ion wi th the pr otocol. E xec uti on of c li n i cal stud ies requi res w ritten author i zation f rom BA RDA in accordance wi th this section of this contrac t.

| i i i. | I n v es t i g a t i on al New d r u g o r In v es t i g a t i on al D e v ice E xem pt i o n R e qu i r e m e nts

Cons i stent with federal r egulat i ons, c l ini c al research p rojects invol v ing the use of i n vestigat ional ther apeut i cs, vaccines, or other medi cal inter v entions (inc lud i ng li cens ed pr oducts and devices for a purpose other than that for whi ch they were li cens ed) in humans under a research protoc ol must be per for med under a Food and Dr ug Adm ini stration (FDA) investi gational new dr ug (IND) or investigat ional dev i ce exempti on (IDE).

Exceptions must be granted in w riting by FDA. If the p roposed clinical trial will be per formed under an IND or IDE, the Contrac tor must provide BARDA w ith the name and institution of the IND or IDE sponsor, the date the IND or IDE was filed with F DA, the F DA IND or IDE number, any w ritten c omments fr om GDA, and the w ritten responses to those c o m ments.

Unless F DA noti f ies Contr a ctor otherwi se, The Contr a ctor must wait thi r ty (30) calendar da ys f rom FDA receipt of an ini t i al IND or IDE appl i cat ion before initi ati ng a c li n i c al tr i a l.

The Contractor must noti fy BARDA if the FDA p laces the study on cl i n i cal ho ld and prov i de B ARDA any written com ments f r om FDA, w ritten responses to the c o m ments, and documentation in w r i t ing that the ho ld has been li fted.

The Contractor must not use grant or contract funds du r ing a c l ini c al hold to fund c li n i cal studies that are on hold. The Contractor must not enter into any new f inanc i al obl igati ons related to cl ini c al ac t i v i t ies for the c li n i cal tri al on c l ini c al hol d.

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| iv. | Re qu i r ed T i m e-S e n si t i v e N ot i f ica t i o n

Under an IND or ID E, the sponsor must prov ide F DA safety reports of ser ious adverse e vents. Under these Cl i n i cal Ter ms of A war d, the Contractor must subm it copies to the res pon s ible B ARDA repres entat ive or the Contracting Off i cer’s techni c al repres entati ve (COR) as foll o w s:

| • | E x pe d i t e d s a f e t y r e po r t of une x pe ct e d or li f e-th r ea t e n i n g e x pe ri en c e or dea t h – A c o p y of an y r e p o r t of une x pe c t e d or li f e-th r e ate n i ng e x pe r i en c e or dea t h a ss o ci ated w i t h t h e u s e of an IND d r ug, wh i c h m u s t be r epo r t e d to F DA b y t e l e ph o ne or f ax as s oon as po ss i b l e b ut n o l a t er than s e v en (7) d a y s a f ter the I N D s p o n s o r’s r e c e i pt of t h e i n f o r m at i on, m u s t be s ub m i tted to t h e B A R D A r ep r e s ent a t i v e or the c o nt r a c t i on o ff i c e r’s te c h n i c al r ep r e s ent a t i v e w i t h i n 24 h o u r s of F DA no t i f i c at i o n. |

| • | E x pe d i t e d s a f e t y r e po r ts of s e r i ous a nd u ne x pe c t ed ad v e rs e e x p e r i e n c es – A c op y of a n y r epo r t of une x pe c t e d a n d s e ri ous a d v e rs e e x pe ri en c e a ss o c i ated w i t h u s e of an I ND d r ug or a n y f i n d i n g f r om te s ts i n l abo r a to r y an i m a l s that s ug g e s ts a s i g n i f i c ant r i s k f or hu m an s ub j e c t s, wh i c h m u s t be r epo r ted i n w r i t i ng to F D A a s s oon as p o ss i b l e b u t n o l ater t h an 1 5 da y a f ter the IND s pon s o r’s r e c e i pt of the i n f o r m at i on, m u s t be s u b m i tted to t he BA R DA r e p r e s en t at i v es or the C ont r a c t i ng O ff i c e r’s T e c hn i c al Rep r e s e n ta t i v e w i th i n 2 4 h ou r s of F DA n o t i f i c at i on. |

| • | IDE r e po r ts of un a nt i c i pa te d a d v e rs e de vi c e e ff e c t – A c o p y of a n y r epo r ts of un a nt i ci pa t ed a d v e rs e d e v i c e e ff e c t s ub m i tted to F DA m u s t be s ub m i tted to t he BA R DA r e p r e s enta t i v e or the Cont r a c t i ng O ff i c e r’s T e c hn i c al R e p r e s en t at i v e w i t h i n 24 h ou r s of F DA no t i f i c at i on. |

| • | E x pe d i t e d s a f e t y r e po r ts – s hou l d be s ent t o t h e BA R DA r ep r e s ent a t i v e or the C ont r a c t i ng O ff i c e r’s T e c hn i c al R e p r e s en t at i v e c on c u rr en t l y w i t h t h e r epo r t to F D A. |

| • | O ther a d v e rs e e v ents d o c u m ented du r i n g t h e c ou rs e o f the t r i a l s ho u l d be i n c l u ded i n the a n nu a l I ND or I D E r e p o r t a n d r e p o r ted t o t h e B A R D A ann u a ll y. |

In case of prob lems or i ssues, the B ARDA repres entat i ve or the Contracting Off i cer’s Techni cal Representat i ve wi ll contract the Contractor w ithin ten (10) wor k ing da ys by email or fa x, foll o w ed with in thi r ty (30) calendar da ys by an off i c ial letter to the Contractor’s P roject Leader, w ith a copy to the insti tutions’ off i ce of sponsored progr am s, li sting i ssues and appropr iate ac t ions to be di scussed.

| • | S a f e t y r epo r t i ng f or r e s ea r c h not pe r f o r m ed under a n I ND or I D E. |

Final dec isi ons regard i ng ongo ing safety reporti ng requirements for research not perfor med under an IND or IDE must be made jointly by the B ARDA Project Off icer or the Contracting Off icer’s Technical Representative and the Contractor.

ART ICLE H.2. PRO T ECTION OF HUM AN SUBJECT S, HH SAR 352.270-4 (Jan uary 2006)

(a) The Contractor agrees that the rights and wel fare of hu man subjects i n v o lved in research under this contract sha ll be protected in accordance with 45 CFR Part 46 and with the Contractor's current Assurance of Compliance on f ile with the Off ice for Hu man Research Protect ions (OHR P), Department of Health and Human Ser vices. The Contractor further agrees to pro vide cert i f ication at l east annua l ly that the Insti tutional Revi ew B oard has revie w ed and appro ved the procedures, which i nvolve human subjects in accordance w i th 45 CFR Part 46 and the Assurance of Compli ance.

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(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 t i me during the perfor mance of this contract, the Contracti ng Off icer determ ines, in consu ltati on with OHRP that the Contractor is not in co mpliance with any of the requirements and/or standards stated in paragraphs (a) and (b) abo ve, the Contracting Off icer m ay i m mediately suspend, in who le or in part, work and further pa y ments under this contract unt il the Contractor corrects the noncompliance. The Contract ing Off icer may co m municate the notice of suspensi on by te l ephone with conf i r mation in w r iting. If the Contractor fails to complete corrective action with in the peri od of ti me desi gnated in the Contracting Off icer's written not ice of suspension, the Contracting Off icer m a y, after consultati on with OHR P, te r m inate this contract in who le or in part, and the Contr actor's name m ay be removed from the list of those contractors w i th appro ved Human Subject Assurances.

ART ICLE H.3. HUM AN MAT ERIALS (AS SURANCE OF OHRP CO M P L IANCE)

The acqui s i t i on and supply of all human spec i men mater ial (includ ing fetal mater i a l) used under this c ontract sha ll be obta ined by the Contractor in full compliance wi th applicable Federal, State and Local laws and the provisions of the Uniform Anatomical Gift Act in the United States, and no undue inducements, monetary or otherwise, will be offered to any person to influence their donation of human material.

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

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

ART ICLE H.4. R E S EARCH INV O L VING HUMAN F E T AL TIS SUE

All research involving human fetal tissue shall be c onducted in accor dance with the Public Health Service Act, 42 U.S.C. 289g-1 and 289g-2. Implementing regulations and guidance for conducting res earch on hu man fetal tissue m ay be found at 45 CFR 46, Subpart B and http://g r ant s 1.n i h.g o v/g r an t s/gu i d e/n ot i ce-f i l e s/no t 93-2 35.ht m l and a n y s u b s eq ue nt r e v i s i o ns to this NIH G uide to Gr ants and Contracts ("Guide") Notice.

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T he Cont r a c tor s h a l l m a k e a v a i l a b l e, f or a u d i t b y t h e S e cr eta r y, HH S, the p h y s i ci a n s tate m ents and i n f o r m ed c on s ents r e q u i r e d b y 4 2 U S C 28 9 g-1(b) a nd (c), or en s u r e H H S a cc e s s to tho s e r e c o r d s, i f m a i nta i n e d b y a n e nt i t y ot h er than the C o nt r a c to r.

ART ICLE H.5. N E EDLE E XCHANGE

The Contractor sha ll not use contract funds to carry out any pr ogram of di str ibuti ng ster i le need les or s yri nges for the h y poder m ic injecti on of any i l legal drug.

ART ICLE H.6. CARE OF LIVE V ERT EBR A TE ANIM A L S, HH SAR 352.270-5 (O c tober 2009)

(a) Before undertak ing performance of any contract i n v o lving an i mal-related activities where the spec ies is regulated by US D A, the Contractor sha ll register with the Secretary of Agricu lture of the Uni ted S tates in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the reg istrat ion to the Contracting Off icer.

(b) The Contractor sha ll acquire vertebrate ani mals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sect ions 2.1-2.11, or from a source that is exempt from licens ing under those sections.

(c) The Contractor agrees that the care, use and intended use of any live vertebrate ani mals in the perfor mance of this contract sha ll conform w ith the Pub lic Health Service (PHS) Poli cy on Humane Care of Use of Laboratory Ani mals (PHS Poli c y), the current A n i mal Wel fare Assurance (Assurance), the Guide for the Care and Use of Laboratory A n i mals (National Academy Press, Washington, DC) and the pert inent la ws and regu lat i ons of the Uni ted States Department of Agri culture (see 7 U.S.C. 2131 et seq. and 9 CFR Subchapter A, Parts 1-4). In case of conf lict between standards, the more stringent standard shall govern.

(d) If at any ti me during per for mance of this contract, the Contracting Off icer dete r m ines, in consultati on with the Off ice of Laboratory A n i mal Wel f are (OLA W), National Insti tutes of Health (NIH), that the Contractor is not in compliance with any of the requ irements and standards stated in paragraphs (a) through (c) above, the Contracting Off icer m ay i m mediately suspend, in whole or in part, work and further pa y ments under th is contract until the Contractor corrects the noncompli ance. Notice of the suspension m ay be communicated by telephone and conf irm ed in wri t ing. If the Contractor fails to complete corrective action with in the period of ti me designated in the Contracting Off icer's written notice of suspensi on, the Contracting Off icer m a y, in consul tation with OLA W, NIH, term inate th is contract in whole or in part, and the Contractor's name m ay be removed from the list of those contractors with appro v ed Assurances.

Note: The Contractor m ay request r egi strat i on of its fac i l i ty and a current l i sti ng of l i censed dea lers f r om the Reg ional Off i ce of the A n i mal and P lant Health Inspection Service (APHI S), US D A, for the r egion in which its research fac i l i ty is located. The locat i on of the appropr i ate AP HIS Reg ional O ff i ce, as well as infor mation c oncer n ing this program m ay be obtai ned by contacting the A n i mal Care Staff, USDA/A PHI S, 4700 Ri ver Road, R i verda le, Mar y l and 20737 (E-mail: a c e@a p h i s.u s da.g o v; W eb s i te: (http://www.a p h i s.u s d a.g o v/a n i m a l_w e l f a re).

ART ICLE H.7. ANIM AL W E L FARE

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://g r a n t s 1.n i h.g o v/g r a nt s/o l a w/r e f e r en c e s/ph s p o l.ht m .

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A R T I C L E H.8. P UB L I C A T I O N A N D P UB L ICI T Y

No infor mation r e lated to data obta ined under this contract shall be released or publ i ci zed without the pr ior w r itten con sent of B ARDA.

In addition to the requirements set forth in HHSAR Clause 352.227-70, Publications and Publicity incorporated by reference in SECTION I of this contract, Section 507 of P.L. 104-208 mandates that Contractors funded with Federal dollars, in whole or in part, acknowledge Federal funding when issuing statements, press releases, requests for proposals, bid solicitations and other documents. Contractors are required to state: (1) the percentage and dollar amounts of the total program or project costs financed with Federal money and; (2) the percentage and dollar amount of the total costs financed by nongovernmental sources.

For purposes of this contract "publication" is defined as an issue of printed material offered for distribution or any communication or oral presentation of information, including any manuscript or scientific meeting abstract. Any publication containing data generated under this contract must be submitted for BARDA review no less than thirty (30) calendar days for manuscripts and fifteen (15) calendar days for abstracts before submission for public presentation or publication.” Contract support shall be acknowledged in all such publications substantially as follows:

"This project has been funded in w hole or in part with Feder al funds f r om the Department of Health and Human Services; Office of the Assistant Secretary for Prepar edness and Response; Biomedical Ad vanced Research and Development Authorit y, under Contract No. HHSO100201200008C "

ART ICLE H.9. R E VIEW OF PRESS R E L EASES

Contractor agrees to accurately and factua l ly r epresent the work conducted under the contr a ct in a ll press rel eases.

Mi srepres enting contract r e sults or releasing infor mation that is injur i ous to the integr i ty of B ARDA may be constr ued as i mproper conduct. P ress releases s hall be cons i der ed to include the pub l ic rel ea se of infor mation to any medium, exc luding peer-rev i e w ed sc ienti f ic publ i cations. The contractor sha ll ensure that the COR has rec e i ved an advance c opy of any press rel ease r e lated to the contract not less than s ix (6) bus i ness da ys pr ior to the i ssuance of the press rel ease.

The Contractor sha ll ac knowledge the s upport of the Department of Health and Human Serv i ce, O ff i ce of the A ss i s tant Secretary for P reparedness and Response, Biomedi cal A d vanc ed Res earch and Dev e l opment Author i t y, whenever publ i ci zi ng the work under this contract in any media by inc l udi ng an ac knowl edg ment substanti a l ly as foll ows:

"This project has been funded in w hole or in part with Feder al funds f r om the Department of Health and Human Services; Office of the Assistant Secretary for Prepar edness and Response; Biomedical Ad vanced Research and Development Authorit y, under Contract No. HHSO100201200008C"

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A R T I C L E H.10. R E P O R T ING M A TT E RS IN V OL V I N G F R A U D, W A S T E A N D A BU S E

An yone w ho becomes aw a re of the exis tence or apparent existence of f raud, was te and abuse in BARDA funded programs is encouraged to r eport such matters to the HHS Inspector General's O ffice in writing or on the Inspec tor General's Hotline. The toll f ree number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls w ill be handled confidentiall y. The e-mail address is H t i p s@o s.d h h s.gov a nd t he m a il i ng add r e s s i s:

Off ice of Inspector General

Department of Hea lth and Human Serv i ces

TIPS HOTLINE P.O. Box 23489

Wa shington, D.C. 20026

ART ICLE H.11. PRO HIBITION ON CONTRACT OR IN V OL VE M ENT W I TH T ERRORIST ACT I VITIES

The Contractor ac kno w l edges that U.S. E xecut i ve Or ders and La w s, inc l uding but not li m ited to E.O. 13224 and P.L. 107-56, pr ohi b it transactions w ith, and the pr o v i s i on of resources and support to, ind i v i duals and organ i zations assoc i ated with terror i s m. It is the l egal respons i b i l i ty of the Contr a ctor to ensure compliance with these E xecut i ve Orders and La w s. This c lause must be included in a ll s ubcontracts i ssued under th is contract.

ART ICLE H.12. CONFLICT OF IN T EREST

The Contractor represents and warrants that, to the be st of the Contractor's knowledge and bel ief, there are no r e l e vant facts or c i rc u m stances which could gi ve r i se to an or gani zat i onal conf li ct of interest, as def i ned in F AR Subpart 9.5, or that the Contractor has d i sc losed a ll such rel e v ant infor mation. P r ior to com menc e ment of any wor k, the Contractor agrees to noti fy the Contrac t i ng O ff icer promptly that, to the best of its know ledge and bel ief, no actual or potential conf li ct of inter e st ex i sts or to identi fy to the Contrac t ing O ff i cer any ac tual or potential c onf li ct of interest the f i rm may ha ve. In emergency s ituations, ho w e ver, work m ay beg in but noti f i cat i on sha ll be made w i thin f ive (5) work ing da y s. The Contrac tor agrees that if an actual or potent i al or gani zat i onal conf li ct of inter e st is i dent i f ied dur i ng per for mance, the Contractor s hall promptly make a full d i sc losure in writing to the Contracti ng O ff i cer. This di sc losure s hall inc l ude a descr ipti on of actions, w h i ch the Contractor has taken or proposes to take, after consul tation with the Contrac t ing O ff i cer, to a void, m itigate, or neutrali ze the actual or potenti al conf l i ct of interest. The Contractor shall cont i nue per for mance until noti f i ed by the Contrac t ing O ff i cer of any contrary ac t ion to be taken. Remedies inc lude te r m inati on of this contract for con ven i ence, in w hole or in part, if the Contracti ng O ff i cer deems such ter m ination necessary to a void an organ i zat ional c onf l ict of interest. If the Contractor was a ware of a potent ial organi zat ional c onf li ct of i nterest pr ior to a ward or d i scover ed an actual or potential conf li ct after award and d id not di sc lose it or m i srepresented rel e v ant infor mation to the Contracti ng O ff i cer, the G o vernment m ay ter m inate the contract for default, debar the Contractor f rom Governm ent contrac t ing, or pursue s u ch other remedies as m ay be per m itted by l aw or th is contract.

ART ICLE H.13. PRO HIBITION ON THE USE OF APPRO PRI A T ED FUNDS FOR LOBBYING ACTIVITIES AND HHSAR 352.203-70 ANTI-LOBBYING (Jan 2006)

The Contractor is hereby noti f ied of the restr i c t ions on the use of Department of Heal th and Human Serv i ce's funding for lobb y ing of Feder a l, State and Loc al legi s lat i ve bodi e s.

Section 1352 of Title 10, United Stated Code (Public Law 101-121, effective 12/23/89), among other things, pr ohib its a recipient (and their sub contractors) of a Feder al c ontract, grant, loan, or c ooperative agreement f r om using appropriated funds (other than profits f r om a federal c ontract) to pay any person for influencing or attempting to influence an officer or emplo yee of any agenc y, a Member of Congress, an of ficer or emplo yee of Congress, or an emplo yee of a Member of Congress in connection with any of the foll o w ing c overed Federal

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a c t i on s; the a w a r d i n g of a n y F e d e r al c ont r a c t; t he m a k i ng of a n y F e d e r al g r ant; t h e m a k i ng of a n y F ede r al l o a n; t he e nte r i ng i nto of a n y c oo p e r at i v e ag r ee m ent; or t h e m od i f i c at i on of a n y F ede r a l c ont r a c t, g r an t, l o a n, or c o o pe r a t i v e a g r ee m ent. F or a d d i t i o n a l i n f o r m at i o n of p r oh i b i t i o ns ag a i n s t l o b b y i n g a c t i v i t i e s, s e e F A R S ub p a r t 3.8 and F A R C l au s e 5 2.203-1 2.

In addi t i on, as set forth in HHS AR 352.203-70 “Ant i-Lobb y i ng” (January 2006), the current Department of Hea lth and Human Serv i ces A ppropr iat ions A ct pr o v ides that no part of any appr opr iat ion contai ned in this A ct s hall be used, other than for nor mal and recogni zed executi ve-leg i s lat i ve r e lat i onships, for publ i c i ty or propaganda purposes, for the p reparat ion, di str i bution, or use of any k it, pamphlet, book let, publ i cati on, rad io, te l e vi sion, or video presentat i on des igned to support, or defeat legi s lat ion pendi ng before the Congr e ss, or any State or Local l egi slature e xcept in presentation to the Congress, or any State or Local leg i s lat i ve body itsel f.

The current Department of Health and Human Serv i c es Appr opr iat i ons A ct a l so prov ides that no part of any appropriat ion conta ined in th is A ct s hall be us ed to pay the salary or expenses of any c ontract or gr ant recipi ent, or agent ac t ing for such rec ipient, rel ated to any acti v i ty des i gned to inf luence leg i slati on or appr opr iat i ons pendi ng before the Congress, or any State or Local legi s lature.

ART ICLE H.14. P RIVACY ACT APP LICABILITY

| 1) | Noti f i cat ion is hereby g i ven that the Contractor and its empl o yees are subject to cr i m inal pena l t ies for v iolation of the P ri vacy A ct to the same extent as empl o y ees of the Government. The Contractor sha ll assure that each of its empl o y ees knows the prescr ibed rul es of conduct and that each is a ware that he or s he can be s ubjected to cr i m inal penal ty for v i o lati on of the A ct. A copy of 45 CFR Part 5b, P ri vacy A ct Regu l ati ons, m ay be obtained at http://www.gp o a cc e ss.go v/c f r/i nde x.ht m l |

| 2) | The P roject Off i cer is hereby des ignated as the off i c ial who is responsible for monitor ing contractor compliance wi th the P ri vacy A ct. |

| 3) | The Contractor sha ll foll ow the P ri vacy A ct guidance as contained in the P ri vacy A ct S y stem of Records number 09-25-0200. This document m ay be obtained at the fol l owing l ink: http://o m a.od.n i h.g o v/m s/p r i v a c y/p a-f il e s/0 200.htm |

ART ICLE H.15. LABO R A T ORY LICENSE R E QUIR E M E N TS

The Contractor sha ll comply with all appl i cab le r equ i r e ments of Section 353 of the Pub lic Hea lth Serv i ce A ct (Cl ini c al Laboratory Improvement A ct as a mended). This requi rement shall a l so be inc l uded in any s ubcontract for ser vi ces under the cont ract.

ART ICLE H.16. DI S S E MIN A TION OF INFORM A TION (May 1998)

No infor mation r e lated to data obta ined under this contract shall be released or publ i ci zed wi thout the pr ior w r i tten consent of the Contracting O f f i cer.

ART ICLE H.17. ID ENTIFIC A TION AND DIS P O SITION OF D A TA

The Contractor wi ll be required to prov i de certa in data generated under th is contr a ct to the Department of Hea lth and Human Serv i ces (DHHS). DHHS reserves the right to rev i ew any other data deter m ined by DHHS to ha ve been generated under this contract. The Contractor shall keep copies of all data requ i red by the Food and Drug Adm ini stration (FDA) rel e vant to this contract for the t i me spec i f ied by the FDA.

Contractor s hall pr o v ide data or data ana l y s is to Contr a cting O ff i cer and Contracti ng O ff i cer Representat i ve w ithin 20 bus iness da ys of request.

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A R T I C L E H.18. IN FO R M A T I O N O N C O M P L I A N C E W I T H A N I M A L C A R E R E Q UIR E M E N T S

Regi strat i on with the U. S. Dept. of Agr i c u lture (US D A) is requ i red to use r egu lated spec ies of ani mals for biomedi cal pur poses. U SDA is respons i b le for the enforc e ment of the A n i mal Wel fare A ct (7 U.S.C. 2131 et. seq.), ht t p://www.n a l.u s da.g o v/a w i c/l e g i sl at/a wa.h t m.

The Pub lic Heal th Serv i ce (PHS) P o li cy is adm ini ster ed by the O ff i ce of Laboratory Ani mal Wel fare (OLA W) http://g r an t s 2.n i h.g o v/g r ant s/o l a w/o l a w.ht m. A n e ss e n t i a l r e qu i r e m ent of the P HS P o li c y h t tp://g r ant s 2.n i h.g o v/g r a nt s/o l a w/r e f e r en c e s/ph s p o l.htm i s that e v e r y i n s t i t ut i on u s i ng l i v e v e r t e b r ate a n i m a l s m u s t ob t a i n an app r o v ed a ss u r an c e f r om O L A W b e f o r e th e y c a n r e c e i ve f und i ng f r o m a n y c o m pon e nt of the U. S. P u b li c H e a l t h S e r vi c e.

The PHS P o li cy requi res that A ssured ins t itut i ons base the ir programs of ani mal care and use on the G u i de for t h e C a r e a n d U s e of L abo r ato r y A n i m a l s http://www.nap.ed u/r ea d i ng r oo m/boo ks/l ab r at s/ a nd th at t he y c o m p l y w i t h t h e r e g u l a t i o ns (9 C F R, S ub c h ap t er A) h t tp://www.n a l.u s d a.g o v/a w i c/l e g i sl at/u s da l eg1.htm i ss ued b y t h e U.S. D epa r t m ent of A g r i c u l tu r e (U S D A) un de r the A n i m al W e l f a r e A c t. T he G u i de m a y d i ff er f r o m U S DA regulations in some respects. Compliance with the USDA regulations is an absol ute requ i rement of this P o li c y.

The A ssoc iation for A ssess ment and A cc red itat ion of Laboratory A n i mal Care Inte rnati onal (A A ALAC) ht t p://www.a a a l a c.o r g i s a p r o f e ss i on a l o r g an i z a t i o n t h at i n s pe c ts a nd e v a l u ates p r og r a m s of an i m al c a r e f or i n s t i tu t i ons a t t h e i r r e q ue s t. T ho s e that m eet t h e h i gh s tanda r ds a r e g i v en the a ccr ed i t ed s ta t u s. A s of the 20 0 2 r e vi si on of the P HS P o li c y, t he o n l y a ccr ed i t i ng bo d y r e c ogn i z e d b y P HS i s t h e A A A L A C. W h il e A A A L A C A ccr ed i tat i on i s n o t r eq u i r ed to c on d u c t biomedi cal research, it is highly des i rab le. A AALAC u ses the G u i de as the ir pr i mary e v a l uation tool. They al so use the G u i de for t he C a r e a nd U s e of A g r i c u l tu r a l A n i m a l s i n A g ric u l tu r a l Re s ea rc h a nd T e a c h i ng. It is publ i shed by the Feder ated of Ani mal S cience Societies http://www.f a ss.o r g.

ART ICLE H.19. RE Q UIRE M E N TS FOR AD E Q U A TE A SSURANCE OF PRO T ECTION OF VERT EBR A TE ANIM AL SUBJECTS

The PHS P o li cy on Humane Care and Use of Laboratory Ani mals requ i res that appl i cant organ i zations pr oposing to use vertebrate ani mals f i le a w r itten A n i mal Wel fare A ssurance w i th the O ff i ce for Laboratory Ani mal Wel fare (OLA W), es tabl i shing appr opr iate pol i cies and procedures to ensure the humane care and use of l i ve vertebrate an i mals invol v ed in research acti v i t ies supported by the PHS. The PHS Pol i cy s t ipu lates that an appl i cant organi zat ion, whether domestic or forei gn, bears responsibi li ty for the humane care and use of ani mals in PHS- supported research acti vi t i e s. Al so, the PHS pol i cy def ines “ani mal” as “any l i ve, vertebrate ani mal used, or intended for use, in research, res earch trai n ing, ex per i mentati on, bi o log i cal testi ng or for related purposes.” This Pol i cy i mplements and supplements the U.S. Government P r inciples for the Ut i li zation and Care of Vertebr ate A n i mals Used in Testing, Res earch, and Training, and requ i res that institut i ons use the G u ide for the Care and Use of Labo ratory A n i mals as a bas is for devel oping and i mplementing an ins t itut ional an i mal care and use p rogram. This Pol i cy does not affect appl icable State or loc al l a ws or regulations that i mpose more str ingent standards for the care and use of laboratory ani mal s. A ll institutions are r equ i red to compl y, as app li cab le, w i th the Ani mal Wel fare A ct as amended (7 USC 2131 et. seq.) and other Federal statutes and r egu lat ions r e lati ng to an i mal s. These documents are av a i lab le f rom the O ff i ce of Laboratory Ani mal Wel fare, National Institutes of Hea l th, Bethes da, MD 20892, (301) 496-7163. See htt p://g r a nt s.n i h.g o v/g r ant s/o l a w/o l a w.ht m.

No P HS s uppor ted work for research i n v o l vi ng vertebrate ani mals w i ll be conduc ted by an organ i zation, un less that organ i zation is operating in a ccordance w ith an appr o v ed A n i mal Wel fare A ssurance and pr o v ides ver i f i cation that the In st itut ional A n i mal Care and Use Com m ittee (IACUC) has r e v i e wed and appr o ved the p roposed acti vi ty in accordance w i th the PHS po li c y. App li cat i ons may be referred by the P HS back to the insti tution for further rev i ew in the case of appar ent or potential v iolations of the P HS Pol i c y. No a ward to an ind i v idual wi ll be

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m ade un l e s s t h at i n d i v i d u al i s a ff ili a t ed w i th an a ss u r ed o r g a n i z a t i o n t h at a cc epts r e s pon s i b i l i t y f or c o m p li an c e w i th the P H S P o l i c y. F o r e i gn a p p li c a nt o r ga n i z at i ons a pp l y i ng f or P HS a w a r ds f or a c t i v i t i es i n v o l v i ng v e r t e b r a t e a n i m a l s a r e r eq u i r ed to c o m p l y w i t h P HS P o li c y or p r o v i de e v i d e n c e that a cc epta b l e s t an d a r ds f or the hu m ane c a r e a nd u s e of an i m a l s w i l l be m et. F o r e i gn a p p l i c ant o r ga n i z at i ons a r e not r eq u i r ed to s ub m i t I A CUC a p p r o v a l, but s h ou l d p r o v i de i n f o r m at i on that i s s at i s f a c to r y to t he G o v e r n m ent t o p r o v i de a ss u r an c es f or the hu m ane c a r e of s u c h an i m a l s.

ART ICLE H.20. AP PRO V AL OF RE QUIR ED ASSURANCE BY O LAW

Under go verning r egu lat ion s, federal funds whi ch are adm ini stered by the Depar t ment of Health and Human Serv i ces, O ff ice of B iomedi cal A d vanc ed Research and Devel opment Authori ty (BARD A) sha ll not be expended by the Contractor for research invol v ing l i ve ver tebrate ani mal s, nor shall l i ve ver tebrate an i mals be i n vol v ed in resear ch acti v ities by the Contractor under th is a ward unless a sati s factory assurance of compliance with 7 U.S.C. 2316 and 9 C FR Sec t ions 2.25-2.28 is subm itted with in 30 da ys of the date of this award and appr o v ed by the O ff i ce of Laboratory Ani mal Wel fare (OLA W). Each per for mance s ite (if an y) must al so as sure compliance with 7 U.S.C. 2316 and 9 C FR Sec t ions 2.25-2.28 wi th the fol l owing restr i cti on: Only activ ities whi ch do not d i rectly i n v o l ve l i ve vertebr ate ani mals (i.e. are clear ly s e ver able and i ndependent f r om those acti v ities that do i n v o l ve l i ve vertebrate an i mal s) may be c onduc ted by the Contractor or ind i v idual per for mance s ites pending O L AW approval of their respec t i ve assur ance of c o mpli ance w ith 7 U.S.C. 2316 and 9 CFR Sec t ions 2.25-2.28. Add i t ional infor m ation regar d i ng OLAW may be obta ined via the Inter net at http://g r ant s 2.n i h.g o v/g r an t s/o l a w/r e f e r en c e s/ph s p o l.ht m

ART ICLE H.21. E PA ENERGY S TAR R E QUIRE M E NTS

In compliance wi th E xecut i ve Order 12845 (requi r ing Agenc ies to purchase ener gy eff i c ient c o mputer equipment) a ll m i croc o mputers, including pe rsonal computers, monitors, and pr i nters that are purc hased us ing Government funds in per for mance of a contract sha ll be equ ipped with or meet the ener gy eff i c ient l o w-po wer standby feature as def ined by the E PA Ene r gy Star program unless the equipment a l w a ys meets E PA Ene r gy Star eff i c iency l e v e l s. The m ic roc o mputer, as conf igured with all components, must be Ener gy Star compli ant.

This l o w-power feature must al ready be acti vated when the computer equ ipment is del i vered to the agency and be of equival ent functi ona li ty of s i m ilar po wer managed model s. If the equ ipment wi ll be used on a local area networ k, the v endor must prov ide equipment that is ful ly compati b le with the network envi r onm ent. In addi t ion, the equipm ent w i ll run com merc ial of f-the-shelf software both before and after recovery f rom its ener gy conser vat i on mode.

ART ICLE H.22. E XP ORT CONTROL NO TIFIC A TION

Offerors are responsi b le for ensuri ng compli ance with all export control l a ws and regu lat ions that maybe app licable to the export of and foreign access to the ir proposed technologies. Offerors may consu lt with the Department of State with any questions regarding the International Traff ic in Arms Regulation (IT AR) (22 CRF Parts 120-130) and /or the Department of Com merce regardi ng the Export Adm inistration Regu lat ions (15 CRF Parts 730-774).

ART ICLE H.23. IN S TIT U T I O NAL R E SP O N SIBILITY RE GARDING CONFLICTING INT ERES TS OF INV E S TIG A T O RS

The Contractor sha ll comply with the r equ i rements of 45 CFR Part 94, Respons i b le P rospecti ve Contractors, whi ch promotes objecti v i ty in research by establ i shing standards to ensure that i n vestigators (def i ned as the pr inc ipal i n vestigator and any other person who is r e spons i b le for the des i gn, conduct, or r eporting of research funded under BARDA c ontracts) wi ll not be b ias ed by any conf li c t ing f i nancial interest. For the pur poses of this part r e lat i ng to f i nan c ial interests, "In vestigator" inc ludes the Inves t igator's spouse and dependent chi ldr en. 45 CFR Part 94 is av a i lab le at the fol l o w ing Web s i te: h t tp://e c f r.gpoa cc e ss.go v/c g i/t/te x t/te xt-i d x?c=e c f r;s i d=9 f 130 b 6d 2d 48b b 73 8 03 c a 91 c e 9 43 b e3 a;r gn=d i v 5;v i e w=te x t;no d e=4 5%3 A 1.0.1.1.53;i d n o=4 5;cc=e c f r

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A s r eq u i r ed b y 45 C F R P a r t 94, t he Cont r a c t or s ha l l, a t a m i n i m u m:

a. Mainta in a w r itten, enfo rceable po li cy on conf li ct of interest that complies w ith 45 CFR Part 94 and inform each i n vestigator of the pol i c y, the i n ves t igator's repor t ing r e spons i b i l ities, and the app l icable regulations. The Contractor must ta ke reasonab le steps to ensure that i n vesti gato rs wor k ing as coll aborators or subcontractors comply with the regu lat ions.

b. Des ignate an off i c ial(s) to sol i c it and rev i ew f i nancial d i sc losure s tatements f r om each i n vestigator parti c ipat i ng in BA RDA-funded research. Based on establ i shed gu ide l ines cons i stent with the r egu lat ions, the de s ignated off i c ial(s) must deter m ine w hether a conf l i ct of interest ex i sts, and if so, deter m ine what a ctions should be taken to manage, r educe, or el i m inate such conf li ct. A conf li ct of interest ex i sts when the designated off i c ial(s) reasonab ly deter m ines that a Si g n i f i c a n t F i n an ci al I nte r e s t could d i rectly and signi f i c antly affect the des ign, conduct, or reporting of the B ARDA-funded res earch. The Contractor m ay requi re the manage ment of other conf li cti ng f inanc i al interes ts in additi on to those described in this paragr aph, as it deems appr opr iate. E xamples of cond itions or restr i c t ions that m ight be i mposed to manage actual or potential c onf li cts of interests are inc luded in 45 CFR Part 94, under Management of Conf li cti ng Interests.

c. Require all f inanci al d isclosures to be updated during the peri od of the a ward, either on an annual basis or as new reportable Si gni f icant Fi nancial Interests are obtained.

d. Mainta in records, i dent i f iable to each award, of all f inanc i al d i sc losures and a ll actions taken by the Contractor wi th res pect to each conf li c t ing i nterest 3 years after f inal pa y ment or, where app li cab le, for the other t i me periods spec i f ied in 48 C FR Part 4, subpart 4.7, Contract Records Retenti on.

e. E stab li sh adequate enforcement mechani s ms and prov ide for sanctions where appropriate.

If a conf li ct of interest is identi f ied, the Contractor sha ll report to the Contracti ng O ff i cer the ex i stence of the conf li c t ing interest found. This report shall be made and the conf li cti ng interest managed, reduc ed, or el i m inated, at l east on a temporary basis, with in s i x ty (60) da ys of that identi f i cation.

If the failure of an i n vestigator to comply with the c onf l ict of interest pol i cy has b i a sed the des i gn, conduct, or r epor t i ng of the B ARDA-funded research, the Contractor must promptly noti fy the Contrac t ing O ff i cer of the correcti ve action taken or to be taken. The Contracting O ff i cer wi ll take appr opr iate ac t ion or refer the matter to the Contractor for further action w h i ch m ay i n c lude di rec t ions to the Cont ractor on how to maintain appr opr iate objec t i v i ty in the funded research.

The Contracting O ff i cer m ay at any t i me inqu i re into the Contractor's procedures and actions r egar d ing conf li cts of interests in BARDA-funded research includ ing a r e v i ew of all records per t inent to compl iance with 45 CFR Part 94. The Contracti ng O ff i cer may requi re subm i ss ion of the records or rev i ew them on site. On the bas is of th is revi e w, the Contracting O ff i cer m ay de c ide that a par t i cular conf li ct of interest wi ll bias the objecti v i ty of the B ARDA-funded res earch to such an ex tent that further corrective acti on is needed or that the Contractor has not managed, reduc ed, or eli m inated the conf li ct of interest. The i ssuance of a Stop W o rk Order by the Contracting Off i cer m ay be necessary until the matter is resolv ed.

If the Contracti ng O ff i cer deter m ines that B ARDA-funded cl ini c al res earch, w hose purpose is to evaluate the safety or effectiv eness of a d rug, medi cal dev i ce, or treatment, has been des i gned, conducted, or reported by an i n vestigator w ith a conf li ct of inte rest that was not di sclosed or managed, the Contractor m u st requi re di sclosure of the conf li ct of interest in each pub lic presentat i on of the results of the research.

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A R T I C L E H.24. Q A A UDIT R E P O R T S

BARDA reserves the right to par ticipate in QA audits. Upon completion of the audit/site visit the Contractor s hall pr ovide a report capturing the findings, results and next steps in p roceeding with the subc ontractor. If action is reques ted of the subc ont ractor, detailed c oncerns for addressing areas of non-confor mance to FDA r egulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA. The Contractor shall pr o vide respon ses f r om the subcontractors to address these concerns and plans for corrective action execution.

| • | Contractor s hall noti fy CO and COR of upcom ing, ongoi ng, or rec ent audits/s ite v is its of subcontractors as part of week ly com muni cations |

| • | Contractor s hall noti fy the COR and CO w ithin 5 business da ys of report compl etion. |

ART ICLE H.25. BARDA AUDITS

Contractor s hall accom modate per i odic or ad hoc s ite v i s its by B ARD A. If B ARD A, the Contractor, or other parties ident i f ies any i ssues dur ing an aud it, the Contractor sha ll capture the i ssues, identi fy potential s o lut i ons, and prov i de a r eport to BARDA.

| • | If i ssues are i dent i f ied duri ng the audit, Contractor sha ll subm it a report to B ARDA deta i l ing the f inding and corrective action(s) w i thin 10 bus iness da ys of the audit. |

| • | COR and CO w i ll rev i ew the report and pr o v ide a res ponse to the Contractor w ith 10 bus i ness da y s. |

| • | Once corrective action is completed, the Contractor wi ll prov i de a f i nal r eport to B ARD A. |

PART II - CONTRA CT CLAUSES

SECTION I - CONTR ACT CL AUSES

ART I CLE I.1. G EN E RAL CLAUS ES F OR A C O S T-RE I M BUR SE M E NT R ES EAR CH AND DE V EL O P M E NT CO N T RACT

This c o nt ract in c o r po rat es t he f o ll owing c lau s es by r e f e r e n c e, with the same f o r ce and ef f ect as if th ey were gi v en in f ull t ext. Upon re q u es t, t he C o nt rac t i ng Off i c er will make th e ir f ull t ext availabl e. Al s o, the f ull t ext of a c lau se may be ac c es s ed e le c tr o ni cally as f o ll o w s: FAR Clau s es at: ht t p s://www.a c q u i s i t i o n.g o v/f a r/ . HH SA R C l a u se s a t: ht t p://www.h h s.go v/p o li ci e s/hh s a r/s u b pa r t352.ht m l .

a. F E D E RAL A C Q UISIT I ON R E G U L ATI ON (FAR) (48 CFR CH A PTER 1) CL AUS E S:

F AR CL A U SE N O. | D A T E | T I T LE
52.202-1 | Jan 2012 | Definitions (Over the Simplified Acquisition Threshold)
52.203-3 | Apr 1984 | Gratuities (Ov er the S i mplified Acquisition Threshold)
52.203-5 | Apr 1984 | Co v e nant Again st Co nting e nt F e es (Over the S i mpli f i ed Acquisition Thres h old)
52.203-6 | Sep 2006 | Restr i ctions on Subc ontractor Sal es to the G o vernment (Over the Simplified A cquisition Threshold)
52.203-7 | Oct 2010 | Anti-Kickback Procedures (O ver the Simplif i ed Acquisition Thr es h o ld)
52.203-8 | Jan 1997 | Can ce llati o n, R e s c i s s i o n, and Re co v e ry of Funds f or Ill e gal or Im p ro p er A c t ivity (O v er the Simpli f i ed A c qui s iti on Thr es h o ld)
52.203-10 | Jan 1997 | Pr i ce or Fee Adju s tm e nt f or Il l e gal or Im p ro p er A c tivity (Over the Simplified A cquisition Threshold)
52.203-12 | Oct 2010 | Limitation on Payments to Influen ce C ertain Federal Tran s a c ti o ns (O v er $150,000)

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F AR CL A U SE N O. | D A T E | T I T LE
5 2.2 0 4-4 | May 2011 | Pr int ed or Co p i ed D o ub le-Sid ed on P os t c o n s u m er Fib er Co nt e nt Pap er(O v er the Simpli f i ed A c qui s iti on Th r e s h o ld)
52.204-7 | Feb 2012 | Ce nt ral C o nt r a c tor R e g i s t rati on
52.204-10 | Feb 2012 | Reporting E x ecutive Compensation and Fi rst-Ti er Subcontract Awards ($25,000 or more)
52.209-6 | Dec 2010 | Pro t ec ting the G ove r n m e nt's In t e r es ts Wh en Subcontracting With Contractors D ebarred, Suspended, or Proposed f or D ebar m ent (O v er $30,000)
52.215-2 | Oct 2010 | Audit and Records - N egotiation [No t e: Applies to ALL contracts fun ded in wh o le or in p art with Reco very Act funds, regard less of dollar value, AND con tracts over the Simplified Acquisition Threshold fund ed exc lusively with n o n-R ec ove ry A ct f und s.]
52.215-8 | Oct 1997 | Order of Preceden ce - U niform Contract Format
52.215-10 | Aug 2011 | Pr i ce R e du c ti on f or De f e c tive Ce r ti f i ed Co st or P r i c ing Data (Over $700,000)
52.215-12 | Oct 2010 | Subcontrac t or Cost or P ricing Data (O ver $700,000)
52.215-14 | Oct 2010 | Int e g r ity of Unit P r i c es (Over t he Simpli f i ed A c q ui s iti on Th r e s h o ld)
52.215-15 | Oct 2010 | Pe n s i on Adju s tm e nts and A s s et Reve rs i o ns (Over $700,000)
52.215-18 | Jul 2005 | Revers i on or Adjustm ent of Plans f or P os t-Retirement Be n ef i ts (PRB) o ther than Pe n s i o ns
52.215-19 | Oct 1997 | No ti f i cat i on of Owne rs h ip Chang es
52.215-21 | Oct 2010 | Require m ents f or Certified C ost or Pr i cing Data and Data Other Than C ertif i ed C ost or Pr i cing Data - Modificati ons
52.215-22 | Oct 2009 | Limitations on Pass-Through Charges – Identification of Subcontract E f fort
52.215-23 | Oct 2009 | Limitations on Pass-Through Charges (Over the Simplified Acquisition Thres h old)
52.216-7 | Jun 2011 | Allowable C ost and Payment
52.216-8 | Jun 2011 | Fixed Fee
52.219-8 | Jan 2011 | Utilization of Small Bus iness Concerns (Over the Simplified Acquisition Thres h old)
52.219-9 | Jan 2011 | Small Busine ss Subco n t racting Plan (O ver $650,000, $1.5 milli on f or Co n s t r u c ti o n)
52.219-16 | Jan 1999 | Liquidated Damages - S ubcontracting Plan (Over $650,000, $1.5 mill i on f or Co n s t r u c ti o n)
52.222-2 | Jul 1990 | Paym e nt f or Ove r time P re mium (O v er the Simp l i f i ed Acquisition Thres h old) (Note: The dollar amount in paragraph (a) of this clause is $0 unle ss otherwi se spec i fied in the c ontrac t.)
52.222-3 | Jun 2003 | Co nvi ct Labor
52.222-19 | Mar 2012 | Child Lab or – C oo p e rati on with Auth or ities and Remedi es
52.222-21 | Feb 1999 | Pro hibiti on of S e gr e gated Fac iliti es
52.222-26 | Mar 2007 | Equal Op portunity
52.222-35 | Sep 2010 | Equal Op portunity for Veterans ($100,000 or more)
52.222-36 | Oct 2010 | Affirmative Acti on for W or k ers with Disabilities
52.222-37 | Sep 2010 | Employ ment Reports on Veterans ($100,000 or more)

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F AR CL A U SE N O. | D A T E | T I T LE
5 2.2 2 2-40 | Dec 2010 | No ti f i cat i on of Empl o y ee Rights Und er t he Nat i onal Labor R e lat i o ns A ct (O v er the Simpli f i ed A c qui s i ti on Th r e s h o ld)
52.222-50 | Feb 2009 | Co mbating Tr a ff i c king in Pe r s o ns
52.222-54 | Jan 2009 | Employ ment Eligibility Verification (Over the S i mplified Acquisition Thres h old)
52.223-6 | May 2001 | Drug-Free W orkpla ce
52.223-18 | Aug 2011 | Encouraging Contractor Policies to Ban Text Messaging While D r iving
52.225-1 | Feb 2009 | Buy Ame r i can A ct - Suppli es
52.225-13 | Jun 2008 | Restr i ctions on C ertain Foreign Purcha ses

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F AR CL A U SE N O. | D A T E | T I T LE
52.225-25 | Nov 2011 | Pro hibiti on on C o nt rac t i ng with E ntiti es E ngaging in Sanctioned Activiti es Related to I ran – R epresentation and Certif i cation
52.227-1 | Dec 2007 | Authorization and Cons ent, Alternate I (Apr 1984)
52.227-2 | Dec 2007 | No ti ce and A s s i s tan ce R e gar ding Pat e nt and Copyr ight In fr ing e m e nt
52.227-11 | Dec 2007 | Pat e nt Rights — Owne r s hip by the C o nt rac t or (No t e: In acc o r dan ce with FAR 2 7.303(b)(2), parag raph (e) is modified to include the require m ents in FAR 27.303(b)(2)(i) th ro ugh (iv). The f re q u e n cy of re p or ting in (i) is annual.
52.227-14 | Dec 2007 | Rights in Data — G eneral
52.227-16 | Jun 1987 | Additional Data Requirements
52.232-9 | Apr 1984 | Limitation on Withholding of Payments
52.232-17 | Oct 2010 | Int e r est (Over the Sim p li f i ed A c qui s iti on Thr es h o ld)
52.232-20 | Apr 1984 | Limitation of Cost
52.232-23 | Jan 1986 | Assignment of Claims
52.232-25 | Oct 2008 | Pr ompt Paym e nt, Alte r nate I (F eb 2002)
52.232-33 | Oct 2003 | Paym e nt by E l ec t ro nic Funds Tran s f er—C e nt ral Co nt rac t or R e gi s t rati on
52.233-1 | Jul 2002 | Disputes
52.233-2 | Sep 2006 | Servi ce of P ro t est
52.233-3 | Aug 1996 | Pro t est A f ter Awa r d, Al t er nate I (Jun 1985)
52.233-4 | Oct 2004 | Applicable Law f or Bre a ch of Cont ract Claim
52.242-1 | Apr 1984 | No ti ce of Int e nt to Di sal l ow C os ts
52.242-3 | May 2001 | Pe nalti es f or Unallowab le C os ts (O v er $700,00 0)
52.242-4 | Jan 1997 | Cer ti f i cati on of Final In d i r e ct Co s ts
52.242-13 | Jul 1995 | Bank r upt cy (Over the Simpli f i ed A c qui s iti on Thr es h o ld)
52.242-15 | Aug 1989 | Stop W ork O rder
52.243-2 | Aug 1987 | Chang es - C ost R e imbur se m e nt, Alte r nate V (Apr 1984)
52.244-2 | Oct 2010 | Subcontrac ts (O ver the Simplified Acquisition Th r e s h o ld), Al t er nate I (June 2007)
52.244-5 | Dec 1996 | Co mp e titi on in Sub c o ntrac ting (Over the Simpli f i ed Acquisition Thres h old)
52.244-6 | Dec 2010 | Subcontrac ts f or Co mm ercial Ite ms
52.245-1 | Apr 2012 | Gov ernment Prop erty
52.245-9 | Apr 2012 | Use and Charges
52.246-9 | Apr 1984 | In s p ec t i on of Re se a rch and D eve l o pm e nt (Short F or m)
52.246-23 | Feb 1997 | Limitation of Liability (Over the Simplified Acqu isition Th r e s h o ld)
52.247-34 | Nov 1991 | FOB Destination
52.247-63 | Jun 2003 | Pr e f er e n ce f or US Flag Air Car r i e rs
52.249-6 | May 2004 | Te r minati on (Co s t-R e i m bu rse m e nt)
52.249-14 | Apr 1984 | Excusable Delays
52.251-1 | Apr 2012 | Gov ernment Supply Sources
52.253-1 | Jan 1991 | Co mputer Ge n erat ed Fo r ms

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b. D E P AR T M E NT O F H EA L TH A ND H U M A N S E R V IC E S A C Q U I S IT I O N RE G U L A T I O N (HH SAR) (48 C F R C H A P T E R 3) C L AU S E S:

HH S A R CL A U SE N O. | D A T E | T I T LE
352.201-70 | Jan 2006 | Pap e rwo rk R e du c ti on A ct
352.202-1 | Jan 2006 | Definitions - with Alter nate parag raph (h) (Jan 2006)
352.203-70 | Mar 2012 | Anti-Lobbying
352.216-70 | Jan 2006 | Additional Cost P rinciples
352.222-70 | Jan 2010 | Co nt rac t or Co o p erat i on in E qual E mp l oym e nt Opportunity Investigations
352.223-70 | Jan 2006 | Safety and H ealth
352.224-70 | Jan 2006 | Pr ivacy A ct
352.227-70 | Jan 2006 | Publi cati o ns and Publi c i ty
352.228-7 | Dec 1991 | In s u ran ce – L iability to Thi rd P e r so ns
352.231-71 | Jan 2001 | Pr i c ing of Adju s tm e nts
352.233-71 | Jan 2006 | Litigation and Claims
352.242-70 | Jan 2006 | Key P ersonn el
352.242-73 | Jan 2006 | Withh o lding of C o nt ract Paym e nts
352.242-74 | Apr 1984 | Final Decisions on Audit Findings
352.270-4 | Jan 2006 | Pro t ec t i on of H uman S u bj ec ts
352.270-6 | Jan 2006 | Restr i ctions on Use of Human Subjects

[End of G E N ERAL CLAUSES FOR A NEGO TIATED COST-R EIMBURS E MENT RESEARCH AND DE V E L OPM ENT C ONTRACT- Rev. 05/2012].

ART ICLE I.2. ADDITIO N AL FAR CONTRACT CLAU S ES INCLUDED IN FULL T EXT

This contract incor porates the fol l o w ing clauses in full text.

FEDE R AL ACQUI SITION REGUL A TION (FAR) (48 CFR CHA P T ER 1) CL A U S E S:

a. F AR C lause 52.217-9, Opt ion to E xtend the Term of the Contract (Mar 2000)

(a) The Government m ay extend the term of this contract by w r itten noti ce to the Contractor with in 30 da ys after the Go vernment has completed its analy s is of the deliverab l es associated with the app licable GO/NO GO Decision gate; provided that the Go vernment giv es the Contractor a preli m inary w r itten notice of its intent to extend at least 30 da ys before the contract expires. The preli m inary notice does not co m m it the Go vernment to an extensi on.

(b) If the Government exercises this opt ion, the extended contract shall be considered to inc lude this option clause.

(c) The total duration of th is contract, incl uding the exercise of any opt i ons under th is clause, shall not exceed 5 y ears.

b. F AR Clause 51.219-1 S mall Bus i ness P rogram Representations (Apr 2012)

| (a) | (1) The North A merican Industry Classi f icati on S ystem (NAICS) code for th is acquisiti on is 325411. |

(2) The s mall business size standard is 750 empl o y ees.

(3) The s mall business si ze standard for a concern which subm its 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 itse lf manufacture, is 500 emplo y ees.

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(b) Rep r e s e n ta t i on s.

(1) The offeror represents as part of its offer that it [X] is, [_] is not a small business concern.

(2) [Com p l e t e o n l y i f t h e o ff e r or r ep r e s en t ed i t s e l f as a s ma l l bu s i ne s s c on c e r n i n pa r ag r a ph (b)(1) of t h i s p r o v i s i on.] The offeror represents, for general stat istical purposes, that it [_] is, [X] is not, a small d isad v antaged business concern as defined in

13 CFR 124.1002.

(3) [Com p l e t e o n l y i f t h e o ff e r or r ep r e s en t ed i t s e l f as a s ma l l bu s i ne s s c on c e r n i n pa r ag r a ph (b)(1) of t h i s p r o v i s i on.] The offeror represents as part of its offer that it [_] is, [X] is not a women-o w ned s mall bus iness concern.

(4) W o men-owned small business (WOSB) concern eligi b le under the WOSB Program. [Complete only if the offeror represented itself as a wo men-owned small busi ness concern in paragraph (b)(3) of this pro vision.] The offeror represents as part of its offer that—

(i) It [_] is, [_] is not a WOSB concern eli g ible under the WOSB Program, has provided a ll the requ ired docu ments to the WOSB Repositor y, and no change in circu mstances or adverse decisions ha ve been issued that affects its eli g ibilit y; and

(ii) It [_] is, [_] is not a jo int venture that complies with the requirements of 13 CFR part 127, and the representat i on in paragraph (b)(4)(i) of this pro vision is accurate for each WOSB concern e ligible under the WOSB Program participat ing in the joint venture. [The offeror shall enter the name or names of the WOSB concern e li g i b le under the W OSB Program and other s mall bus inesses that are participat ing in the joint venture: .] Each WOSB concern e ligi b le under the WOSB Program participating in the jo int v enture shall subm it a separate signed copy of the WOSB representation.

(5) Econom ical ly d isad v antaged women-owned small busi ness (E D WOSB) concern. [Complete only if the offeror represented itself as a wo men-owned small busi ness concern e li g i b le under the W OSB Program in (b)(4) of this provisi on.] The offeror represents as part of its offer that--

(i) It [_] is, [_] is not an E D W OSB concern eli g i b le under the WOSB Program, has provided a ll the requ ired docu ments to the WOSB Repositor y, and no change in circu mstances or adverse decisions ha ve been issued that affects its eli g ibilit y; and

(ii) It [_] is, [_] is not a jo int venture that complies with the requirements of 13 CFR part 127, and the representat i on in paragraph (b)(5)(i) of this pro vision is accurate for each E D WOSB concern part icipati ng in the joint venture. [The offeror shall enter the name or names of the E D WOSB concern and other small busi nesses that are participati ng in the joint venture: .] Each E D WOSB concern parti c i pati ng in the joint venture shall subm it a separate signed copy of the E D WOSB representat i on.

(6) [Com p l e t e o n l y i f t h e o ff e r or r ep r e s en t ed i t s e l f as a s ma l l bu s i ne s s c on c e r n i n pa r ag r a ph (b)(1) of t h i s p r o v i s i on.] The offeror represents as part of its offer that it [_] is, [X] is not a veteran-owned s mall bus iness concern.

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(7) [Co m p l ete o n l y i f the o ff e r or r ep r e s en t ed i t s e l f as a v e t e r an-o wned s m a l l b u s i n e s s c on c e r n i n pa r a g r a p h (b)(6) of th i s p r o vi si on.] T he o ff e r or r ep r e s ents as pa r t of i ts o ff er that i s [_] i s, [_] i s n ot a s e r vi c e-d i s a b l ed v ete r a n-o w ne d s m a l l bu s i n e s s c on c e r n.

(8) [Com p l e t e o n l y i f t h e o ff e r or r ep r e s en t ed i t s e l f as a s ma l l bu s i ne s s c on c e r n i n pa r ag r a ph (b)(1) of t h i s p r o v i s i on.] The offeror represents, as part of its offer, that –

(i) It [_] is, [X] is not a HU BZone small bus iness concern listed, on the date of this representati on, on the L ist of Quali f i ed HU BZone S mall Business Concerns maintained by the S mall Business Adm inistrat ion, and no material changes in o wnersh ip and control, principal off ice, or HUB Zone e mpl o yee percentage ha ve occurred since it was cert i f ied in accordance with 13 CFR part 126; and

(ii) It [_] is, [X] is not a HUBZone joint v enture that complies w i th the

requirements of 13 CFR part 126, and the representation in paragraph (b)(8)(i) of this pro vi s ion is accurate for each HU BZone small business concern partici pat ing in the HU BZone joint v enture. [T he offe r or s h a l l e nter t he n ames o f e a c h of t he HU B Z o ne s m a l l bu s i ne s s c on c e r ns pa r t i c i p at i ng i n t he HU B Z o ne j o i nt v e n tu r e: _.] Each HUB Zone small business concern part ici pating in the HUBZone joint venture shall subm it a separate signed copy of the HU BZone representati on.

(c) Def i n i t i o n s. As used in this pro vi s ion--

“Econom ical ly d isad vantaged women-o wned small business (E D WOSB) concern” means a small busi ness concern that is at least 51 percent directly and unconditi ona l ly owned b y, and the management and daily business operations of w h ich are controll ed b y, one or more women w ho are c itiz ens of the Un ited States and who are econom ical ly disad v antaged in accordance with 13 CFR part 127. It automatically quali f ies as a women-ow ned small bus i ness concern eli g i b le under the WOSB Program. “Service-disabl ed veteran-owned small busi ness concern”—

(1) Means a small business concern—

(i) Not less than 51 percent of w h ich is o w ned by one or more service- disab led veterans or, in the case of any publicly owned busi ness, not less than 51 percent of the stock of which is owned by one or more service-d isabled v eterans; and

(ii) The management and dai ly busi ness operati ons of which are controlled by one or more service-d isab l ed veterans or, in the case of a service-d isabled v eteran with permanent and se vere disabili t y, the spouse or permanent careg iver of such veteran.

(2) Service-d isabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a d isab ili ty that is ser vice-connected, as def ined in 38 U.S.C. 101(16).

“S mall business concern,” means a concern, inc lud i ng its aff iliates, that is independently o wned and operated, not dom inant in the f ield of operati on in w h ich it is bi dding on Government contracts, and qua li f i ed as a small busi ness under the criter ia in 13 CFR Part 121 and the size standard in paragraph (a) of this provisi on.

“Veteran-o w ned small business concern” means a s mall business concern—

(1) Not less than 51 percent of which is o w ned by one or more veterans (as def ined at 38 U.S.C. 101(2)) or, in the case of any publicly o w ned busi ness, not less than 51 percent of the stock of which is owned by one or more veterans; and

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(2) T he m anage m ent and d a i l y bu s i n e s s ope r a t i o ns of wh i c h a r e c ont r o l l ed b y one or m o r e v ete r an s.

“W o men-owned s mall business concern,” means a s mall bus i ness concern --

(1) That is at least 51 percent owned by one or more women; or, in the case of any pub licly owned business, at least 51 percent of the sto ck of which is owned by one or more women; and

(2) Whose management and da i ly busi ness operat i ons are contro lled by one or more women.

“W o men-owned s mall business (W O SB) concern el igible under the W O SB P r ogram (in accordance with 13 CFR part 127),” means a s mall bu s iness concern that is at l east 51 percent d i rectly and unc ondi t ionally o w ned by, and the management and da i ly bus iness operat i ons of whi ch are control led by, one or more w o men who are c i t i zens of the Uni ted States.

(d) Not i c e.

(1) If this soli c itat ion is for supp lies and has been set aside, in who le or in part, for s mall busi ness concerns, then the clause in th is soli c itat i on provi d ing not ice of the set-aside contains restricti ons on the source of the end items to be furnished.

(2) Under 15 U.S.C. 645(d), any person w ho m isrepresents a f irm’s status as a business concern that is small, HU BZone small, small disadvantaged, service-disabled veteran- o wned small, econom ically disad v antaged women-owned small, or women-o w ned s mall eligible under the WOSB Program in order to obtain a contract to be a warded under the preference programs established pursuant to secti on 8, 9, 15, 31, and 36 of the S mall Busi ness Act or a ny other provision of Federal law that speci f ical ly references section 8(d) for a def i n ition of program eligibili t y, shall --

(i) Be pun ished by i mposition of f ine, i mprisonment, or both;

(ii) Be subject to adm inistrative remedies, incl uding suspensi on and debarment; and

(iii) Be i neligible for participati on in programs conducted under the author i ty of the Act.

(End of 52.219-1)

c. FAR C lause 52.219-28, P ost-Award S mall Bus iness Program Representat ion (A pril 2009).

(a) Def i n i t i ons . As used in this cl ause--

Long-term c ontract m eans a c ont r a c t of m o r e than f i v e y e a r s i n d u r a t i on, i n c l u d i n g opt i on s. H o w e v e r, t he t e r m does n ot i n c l u de c o nt r a c ts t hat e xc e e d f i v e y e a r s i n du r at i o n be c au s e t he pe ri od of pe r fo r m an c e has b e en e x t en d ed f or a c u m u l at iv e pe r i od not to e xc eed s i x m onths un d er t h e c l au s e at 52.2 17-8, O pt i o n to E x te n d S e rv i c e s, or o t her app r o p r i a t e a u tho r i t y.

Small business concern m eans a c o n c e r n, i n cl ud i ng i t s af f ili a te s, w h i c h i s i n de pe nde n t l y o w n e d a n d o pe r a t ed, not d o m i nant i n t h e f i e l d of ope r at i o n i n w h i c h i t i s b i d d i ng o n G o v e r n m ent c ont r a c t s, and qu a li f i e d as a s m a l l b u s i ne s s under t h e cr i te r i a i n 1 3 C F R pa r t 1 2 1 a nd t he si z e s tan d a r d i n pa r a g r a p h (c) of th i s c l au s e. S u c h a c on c e r n i s "not do m i nant i n i ts f i e l d of ope r at i o n" wh e n i t d o es not e x e rc i s e a c ont r o l l i ng or m a j or i n f l u e n c e on a n at i o n al ba si s i n a k i nd of bu s i n e s s a c t i v i t y i n w h i c h a nu m ber of bu s i ne s s

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c on c e r ns a r e p r i m a r i l y e n g age d. In de t e r m i n i ng whe t her do m i nan c e e x i s t s, c on s i de r a t i o n s ha l l be g i v e n to a l l a pp r op r i ate f a c to rs, i n c l u d i ng v o l u m e o f bu s i ne ss, n u m ber of e m p l o y ee s, f i n an ci al r e s o u rc e s, c o m pet i t i v e s tatus or p o s i t i on, o w ne rs h i p or c ont r o l of m ate r i a l s, p r o c e ss e s, pa t e n t s, li c e n s e ag r ee m ent s, f a c ili t i e s, s a l es te rr i t o r y, a n d n a tu r e of bu s i n e s s a c t i v i t y.

(b) If the Contractor represented that it was a small business concern pr ior to a w ard of this contract, the Contractor shall represent its size status accordi ng to paragraph (e) of this cl ause or, if app licabl e, paragraph (g) of this cl ause, upon the occurrence of any of the foll owing:

(1) W ithin 30 da ys after execution of a no v ati on agree ment or with in 30 da ys after modi f icati on of the contract to incl ude th is clause, if the novation agreement was executed prior to inc lusi on of this clause in the contract.

(2) W ithin 30 da ys after a merger or acquisition that does not require a novation or w i thin 30 da ys after modi f ication of the contract to include th is clause, if the merger or acqu isi t ion occurred prior to inclus ion of this clause in the contract.

(3) For long-term contracts--

(i) W ithin 60 to 120 da ys prior to the end of the f i fth y ear of the contract; and

(ii) W ithin 60 to 120 da ys prior to the date speci f i ed in the contract for exercising any option thereafter.

(c) The Contractor shall represent its size status in accordance wi th the size standard in effect at the ti me of this representat ion that corresponds to the North A merican Industry Classi f ication S ystem (NAICS) code assigned to th is contract. The small business size standard correspond i ng to this NAICS code can be found at http://www.s b a.g o v/c o nt r a c t i n g op p o r tu n i t i e s/o ff i c i a l s/si z e/i n d e x.ht m l .

(d) The s mall business size standard for a Contractor providing a product w h ich it does not manufacture itse l f, for a contract other than a construction or service contract, is 500 empl o yees.

(e) Except as provided in paragraph (g) of this clause, the Contractor shall m a ke the representati on required by paragraph (b) of th is cl ause by v a lidat ing or updat i ng all its

representati ons in the Onli ne Representati ons and Cert i f icati ons A pplication and i ts data in the Central Contractor Registrat i on, as necessar y, to ensure that they ref lect the Contractor's current status. The Contractor sha ll not i fy the contract i ng off ice in writing with in the t i mefra m es speci f ied in paragraph (b) of this clause that the data ha ve been v a li dated or updated, and provide the date of the v a lidati on or update.

(f) If the Contractor represented that it was other than a small busi ness concern prior to a ward of th is contract, the Contractor m a y, but is not requ ired to, take the actions required by paragraphs (e) or (g) of this cl ause.

(g) If the Contractor does not ha ve representat ions and certi f ications in ORC A, or does not have a representation in ORCA for the N AICS code applicable to th is contract, the Contractor is requ ired to co mplete the foll owi ng representat i on and subm it it to the contracti ng off ice, along wi th the contract number and the date on which the representati on was completed:

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HHS O100201200008C

Cytori Therapeuti cs, Inc.

T h e C ont r ac to r r e p r e s e nt s th at it [X] is, [ ] is no t a s m all bu s i n e s s c on c e r n u nd er N A I CS C od e a ssi gn ed t o c ont r act numb e r.

b.F AR 52.232-99 P r o v i d ing A cceler ated P a y ment to S mall Bus i ness

Subc ontractors (DEVIATION) (AUG 2012)

This c lause i mplements the temporary po li cy pr o v ided by O MB P o li cy Memorandum M-

12-16, P r o v iding P rompt P a y ment to S mall Bus iness Subc ontractors, dated July 11,

2012.

(a) Upon recei pt of accelerated pa y ments from the Government, the contractor is required to m a ke accelerated pa y ments to small business subcontractors to the m axi m um extent practicable after recei pt of a proper inv o ice and all proper documentati on from the s mall business subcontractor.

(b) Include the substance of this clause, includ ing th is paragraph (b), in all subcontracts, with small busi ness concerns.

(c) The accelerat ion of pa y ments under this clause does not provi de any new r ights under the Prompt P a y ment Act.

PART III - LIST OF DOCUMENTS, EXHIBITS A ND OTHER A TTA CHMENTS

SECTION J - LIST OF ATT A CHMENTS

The foll o w ing documents are attached and incorporated in th is contract:

1. S tat e ment of W o rk

Statement of W o r k, dated 28 September 2012.

2. In v oice/Financing Req uest Inst r uctions and Co nt ract Financial Repo r ting

Inst r uctions for B ARDA C ost-Reimbu r sement T y pe Cont racts,

Invoi ce/F inanc i ng Request Instructions and Contract Financial Repor t i ng Instruc t i ons for

BARDA Cost-Reimbursement T ype Contracts, 5 page s.

3. Financial Repo rt of Ind ividual Pr oject/Cont r act, 1 page

4. Inst r uctions for Comp leting Financial Repo rt of I ndividual Pr oject/Cont r ac t, 3 pages

5. Inclu sion E n r ollment Repo rt

Inc lusion Enr o ll ment Report, 5/01 (Modi f i ed O AMP: 10/01), 1 page.

6. Resea rch Patient Care Costs

Research Patient Care Costs, 1 page.

7. Repo rt of Go ver nment O w ned, Cont ractor Held Pr op e r ty

Report of Government O w ned, Contractor Held P r oper t y, 1 page. Located at:

http://rc b.c a n c e r.g o v/rc b-i n t e r net/f o r m s/G o v t-O wned-P r op.pdf (N o t A t t ac h e d)

8. Cont r actor Per fo rmance Met rics Rep o r ting

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P A RT IV - RE P RE S EN T A TI O NS A N D I NSTRU C TIONS

SECTION K - REPRESENT ATIONS, CERTIFIC ATIONS AND OTHER ST ATEMENTS OF OFFERORS

The foll o w ing documents are incor porated by reference in this contract:

| 1) | Annual Representations and Certi f i cat i ons completed on the S y stem for A ward |

Management (S AM) w ebs i te.

| 2) | Human Subjects A ssurance Identi f i cat ion Number s: |

Cytori Therapeuti cs, Inc.: FW A00007108

| 3) | Ani mal Wel fare A ssurance Numbers (OLA W/PHS): |

Lovelace Res p i ratory Res earch Insti tute: A3083-01

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