SBIR Contract 75N93021C00044 Inimmune Corporat ion Phase II

Inimmune is proposin g to use an established gui nea pig model of allergic rhinitis to obtain
proof of concept of INI-2004 efficacy in a second animal species. The reasons for
consideri ng the guinea pig model instead of the dog mod el are: allergic dog availability,
time and costs.

Inimmune initially proposed to validate the use ofINI-2004 for the treatment of allergic rhinitis
in the ragweed allergic dogs Frop reitaryinfo
polony). The proposed dog studies were:
ropr
1B 1: Effi1cacy study ...._ r ______
ietaryInfo
1B.2: Window of desensitization
__,

1B.3: roprietaryinfo
INI-2004 administrations
rrop
rietaryinfo I Inimmune contacted rropr
ietaryinfo Iwhere the dog
studies were proposed , to schedule the dog studies described in this contract. Unfortunately, all
the allergic dogs from the ropr colony have not been availablef rop
ietaryinfo rietaryinfo land the
latest communications fro ':---1;==~:--------,_ _______ ___J indicated that no
allergic dogs will be availabl

r ropr
.____
ietaryInfo I .
__.has mstead ro osed that Immmun e buys rop
be sensitized over an ropr ietaryinfo
.
and use the ex ected ,'::;'r
.
netaryinfo old puppies that would
ie ensitized dogs to evaluate INI-
2004 ropr ietaryinfo The cost for buying and
sensitizing the dogs rop rietaryinfo
roprietaryInfo Thus testing roprietaryinfo
,....!::===.=-:::--:-:---:--:--:---:-:-:------:---:---.:====:::--------------.----:-:-:---t;:- ===
ropr ietaryinfo INI-2004 in allergic dogs ropr ietaryinfo would use rop rietaryinfo nds

Dog studies budgeted in the SBIR contract using the allemic dog colonv Frop rietaryinfo
I
Dog ragweedstudy # l - Efficacystudy with r ropr
ietaryinfo I
Dog ragweed study# 2 - Windowof desensitization:l''rop rietaryinfoI
Dog ragweedstudy # 3 - !Propr
ietaryInfo
~ I-2004 administrationsf roprietaryinfoI
Propr
ietar
yInfo
Current Prooosa l from
ilropr
ietary
Info
I

Propr
ietary
Info

1 1tyof t h ea IIerg1c
B ecause o f t he unava1. 1a b'l' . d ogs___
IProp
netaryinfo
~---------------~
r~r-o-prie
-tary -o~I Covid-related delays for obtaining and shipping supplies and workforce issues faced by
-·-Inf

Obtained via FOIA by WCW Project

CROs, Inimmune would like to use the established guinea pig model of allergic rhinitis/congestion
(J Appl Physiol 125: 1563-1575, 2018) to generate proof of concept in a second animal species.
Guinea pigs have been used for many years in studies of allergic airway inflammation and are
a more relevant model of human allergic rhinitis than mice. Guinea pigs can be sensitized to
ragweed, our primary allergen indication, leading to allergic symptoms similar to human
symptoms (sneezing, mucus secretion, runny nose). This model is highly relevant for our project
and would be established by Inimmune personal using the University of Montana vivarium (fee
usage) we previously used for our murine allergy studies. We have already discussed the
possibility of doing guinea pig experiment with the UM vivarium manager.
The proposed studies are :
0
Study#1: training, assay development,INI-2004 dose findin9iil,,,,ro.,.pr,,,. iet,...
_ ary
m·Ironfi
_ _.t-------,
Study#2: establish model of ragweed allergic rhinitis in GPs
Study#3: INI-2004 treatment dose-optimizationi;;;r:;;;op;;;-
rie;tary
;;;
;;;:·:T,inr;r,:
o:---L-~ _________ _J

Study#4: desensitizationwindow ,_r.op

...;
'-ri_etary
.......,.
·In
_fo
_____ ....._~
Study#5: therapeutic INJ-2004treatment ropr ietaryinfo - or repeat of study#2 or 3 if issues establishing
this animal model
Estimated timeline for completion:Fropr
ietaryinfo
. . Propr
ietary
Info
Estimated budget for these studie s:

l>ropr
ietaryInfo

Obtained via FOIA by WCW Project

 ____,~
~ ..
• • ••
' .. . . • •

ln i mmune

SBIR Ph II Development
Contract 75N93021C00044
January 20, 2022

Obtained via FOIA by WCW Project

1121 E Broadway, Suite 121, Missoula, MT
Contract Aims
_,
... ·. . .
-~n.-.-. .
ln i mmune
• Aim 1: Preclinical in vivo studieslAl: Formulation selection & optimization
(mice)1A2: Confirm 7-day effectiveness (mice)1A3: Validation in Derp lmurine
allergy model (mice)lBl: Efficacy study (dogs)lB.2: Window of desensitization
(dogs)lB.3: Repeated INl-2004 administrations (dogs)
lnimmune proposal:Do a POCstudy in the guinea pig {GP)
model of congestion instead of dog studies (availability
/delay ...)?

J Appl Physio/ 125: 1563- 1575 , 2018 . Proprietary Info

roprietary Info

roprietary Info
- - -
antibody data: lgG and lgE secondary antibodies available (also lgA if interested)Stil l digging for info rmat ion on guinea pig lgG
subtypes and if their functionalities are thought to be similar to humanVery basic flow cytomet ry (super limited guinea pig
reagents, thin k CD45, CD4, CDS)

- We are designing a GP POCstudy and budgeting itBecause the GP model uses ragweed, a relevant allergen, can we
do GP study only and not do 1A2 and 1A3 (ova model and Der p 1 murine experiments initially proposed?)

Obtained via FOIA by WCW Project 2

 •
Aim 1: Preclinical in vivo studies -~ ---:-··:· ·
~" rop-rietary
-· Ifil
-0 -----------~I nimmune

Proposalfor POCin guinea pigs

Study #1Training, assay Study #2establish model of RWP allergic Study #32004 treatment dose-finding Study #4Schedule optimization
development2004 dose rhinitis in GPs as in Litvinov et al
finding
Proprietary Info

Obtained via FOIA by WCW Project

Aim 2: Formulation and stability studies
_,
... ·. . .
-~n.-.-. .
ln i mmune
• 2A: Accelerated and long term stability roprietaryinfo n-
i.::-------,-----,---,---------------i-----_______J

going in-house work - Paid by the SBIR roprietaryinf o ment for

stabi Iit indicating assay( reqU ired fOr G~L-=-P-t 0-X----.,-w.:;;;;:
ropr;;;;;;;
ietary;;T,;7.Info
:;--------_____.__---~

roprietary Info roprietary Info

roprietary Info

roprietary Info
ouse wit anot er API
roprietary Info

Work done at uNd~ '°" _ietary

-·Info---~~ Develop and evaluate the robustness of sample
processingmethods and LC-MS/MS assay( roprietaryinfo

Proprietary Info
(for release assayof
roprietary Info
drug product for GLPtox) - :an this be charged to the SBIR?
4
Obtained via FOIA by WCW Project
 ..• •
Aim 3: Toxicologystudies -~~•
' •
.·.- .
•
•
•

ropnetary Info

• 3A: Mutagenicity Studies - Paid by lnimmune3B: Metabolism Studies

Paid by NIH3C: GLP multiple dose toxicity in rats, including pK/ADME-..........._...
a------
1---r--r---
y--r-
n------
1_m_m_u_n_e___

All contracts have been signed Analytical development starts i ~ ,___

;op-rietary
-· Inf-o __ __.I
rodent work and metabolism
I
studies start in [ roprietarylnfo

GLPmultiple dose toxicity in rats requires GLPformulated drug product - INl-2004

manufacturer """"" !scaled-upat Curia (NY);development lot -------;::::::::=========----. f~ rop-r ietary
-· Inf-o

(Paid by lnimmune) - INl-2004 formulation: kick-off meeting with Curia (Glasgow) on ~roprietarylnfo

ro.-,wo !development lot for GLPstudy ['°""""'"'" l(Paidby lnimmune)

Obtained via FOIA by WCW Project 5

 ____,~
~ ..
• • ••
' .. . . • •

ln i mmune

SBIR Ph II Development
Contract 75N93021C00044
November 24, 2021

Obtained via FOIA by WCW Project

1121 E Broadway, Suite 121, Missoula, MT
Contract Aims
_,
... ·. . .
-~n.-.-. .
ln i mmune
• Aim 1: Preclinical in vivo studieslAl: Formulation selection &
optimization (mice) - COMPLETE1A2:Confirm 7-day effectiveness
(mice)1A3: Validation in Derp lmurine allergy model (mice)lBl:
Efficacy study (dogs)lB.2: Window of desensitization (dogs)lB.3:
Repeated INl-2004 administrations (dogs)Aim 2: Formulation and
stability studies2A: Accelerated and long term stability2B: I
r~-Mo
r roprietarylnfo

lnimmune On-going; 9 month stability

Obtained via FOIA by WCW Project 2

 ..• • • .
Contract Aims ~
'
-~ .·.-. .
ln i mmune
•

• Aim 1: Preclinicalin vivo studies - DOG STUDIES

Challen es Allergic dogs have been "booked" for the past r roprietarylnfo I roprietarylnfo : zoom meeting with

ropnetary lnfo mall# of dogs may be availablerrop

riet
arylnfo 1(1 dose study) ORBuy r~prieta ogs to be sensitized r.,.... rop...,...
riet-ary.,....,.
Info-------,

for our study - expect ropnetarylnfo dogs to be successfully sensitized r roprietary lnfo INo
allergic dogs available early next
ro~:ary~!::· roprietarylnfo Received quote for sensitizing ~6 mo old puppies and testing ~rrop-riet-ary-ln fo---------~

Proprietary Info

Obtained via FOIA by WCW Project 3

Contract Aims -~ ---:-··:· · ·
• Aim 1: Preclinical in vivo studieslAl rroprietary
info
~~-------------------.1 I
nimmune
(mice)1A2: Confirm 7-day effectiveness (mice)1A3: Validation in Derp lmurine
allergy model (mice)lBl: Efficacy study (dogs)lB.2: Window of desensitization
(dogs)lB.3: Repeated INl-2004 administrations (dogs)
lnimmune proposal:Do a POCstudy in the guinea pig model
of congestion instead of dog studies (availability /delay ...)

J Appl Physio/ 125: 1563- 1575 , 2018.

roprietary
Info

roprietary
Info

- We are designing a GP POCstudy and budgeting itDoes NIH want first look at experimental design/ budget before
lnimmune start the GP studyBecause the GP model uses ragweed, a relevant allergen, can we do GP study only and
not do 1A2 and 1A3 (ova model and Der p 1 murine experiments initially proposed?)
4
Obtained via FOIA by WCW Project
 ..• • • .
Contract Aims -~ .·.-. .
~
ln i mmune
' •

• . 3: ToXicoIOgy studies3A: Mutagen iCit,_L.....;;;:- S--=-

t u=-:...d.::..:...;
i:....=
e -=-
s ----====
rop=rietary
= In=fo ===-====,---~ Ames test roprietaryInfo
• • roprietarvinfo • • L.---~ r-opne-tary.J;--:
w:--
o --------,
Mammahan cell m1cronucleustest , n Vivo m1cronucleustest
.____ M
_ e-ta_b__, olism Studies r roprietaryinfo l Paid by NIHCYP O induction and inhibition
1
- ~rop=riet
= =ary=Info=rop= rietary
=· In
=fo =====---'

Membrane drug transporters roprietaryinfo binding

4;;:;;;;
ropr;;;:;;;
ietary~ fo -
·Inro- -----i::
----:
e-a----=
ct:io
-.-
_n_____J
phenotyping roprietaryinfo mu Ip e ose oxicity in ra.__ ts-,----=- i-n-c--=1-u--,,
d-=- in__,
g
pK/ADME- Paid by lnimmune : non- pl O s u y - N/A3C2: GLP pilot study r oprietary info I
r roprietaryinfo I (method validation/sample analysis/ roprietaryinfo functlonal observation
battery)

All contracts have been signed Analytical development [~ rop-riet-ary-Info_____ ___,I

rodent work and metabolism
f
stud ie oprietaryInfo I- .

Obtained via FOIA by WCW Project 5

 Contract Aims
_,
... ·..
-~n.-.-. . •

SBIR budget:
0

r_ro-prie-tary_ im_ _________ _

ln i mmune
IProprietary Info

roprietary Info
The pre-IND
~--------------~-------------------------~
enabling tox studies will require a CRO roprietaryinfo for GLPtox studies . Could we apply some of the
unused NIH funds to pay for this cost (or other IND-enabling studies that will be done in the US?)

Obtained via FOIA by WCW Project 6

 ____,~
~ ..
• • ••
' .. . . • •

ln i mmune

SBIR Ph II Development
Contract 75N93021C00044
October 28, 2021

Obtained via FOIA by WCW Project

1121 E Broadway, Suite 121, Missoula, MT
 ..• • • .
Contract Aims ~
'•
-~ .·.-. .
ln i mmune
• Aim 1: Preclinical in vivo studieslAl: Formulation
selection & optimization (mice)1A2: Confirm 7- y
effectiveness (mice)1A3: Validation in Derp lmu ·ne,immune
allergy model (mice)lBl: Efficacy study (dogs)lB 2:
Window of desensitization (dogs)lB.3: Repeate INl-
2004 administrations (dogs)Aim 2: Formulation -[~ s, -ietary~lnfo -~

stability studies2A: Accelerated and long term

roprietaryInfo

Obtained via FOIA by WCW Project 2

 ..• • • .
Contract Aims ~
'•
-~ .·.-. .
ln i mmune
• Aim 3: Toxicology studies3A: Mutagenicity StudiesAmes
testMammalian cell micronucl s testVivo micronucleus
test3B: Metabolism StudiesCYP 50 ~dl n1etnon ~n.d
inhibitionMembrane drug tran t'~;;; rsPfasln a=prote m 0

bindingReaction phenotyping3 : Gl[roprietary

lnfo Idose toxicity
in rats, including pK/ADME3Cl: non-GLP pilot study3C2: GLP
piiot study roprietary
Info

Obtained via FOIA by WCW Project 3

Contract Aims
_,
... ·. . .
-~n.-.-. .
• Aim 3: Toxicologystudies3C:GLPMulti le dose toxicit in rats,
ln i mmune
including pK/ADM Enon-GLP and GLP studies
roprietaryinfo roprietaryinfo

budgeted at I
r oprietaryinfo

After consulting with h priej we will need to conduct the following studies for IND-enabling tox studies
roprietary Info

roprietary Info
• .,....-
c...,....
o___,,.
n..,....
t_ra_ct_ w
_ o_r -'----.--- -"dog studies} roprietaryinfo

roprietary info :Toxstudies:

Obtained via FOIA by WCW Project 4

 AWARD/CONTRACT
1. THIS
UNDER
CON T RACT
DPAS
IS A RATED
(15 C F R 700)
ORDER • IRATING
N/A
PAGE
1
OF

I
PAGES
30
2. CONTRACT (Proc. Inst. /dent.) NO. 3. EFFECTIVE DATE 14. REQUISITION/PURCHASE REQUEST/PROJECT NO.
75N93021 C00044 09/01/2021 6128197
5. ISSUED BY CODE ! 6. ADMINISTERED BY (If other than Item 5) CODE
National Inst itutes of Health
National Institutes of Allergy and Infectious Diseases
DEA, Office of Acqu is it ions AIT-RCB
5601 Fishers Lane, Room: 3D10, MSC 9821
Rockville , Maryland 20852

7. NAME AND ADDRESS OF CONTRACTOR (No., street, county , State and ZIP Code) 8. DELIVERY

• FOB ORIGIN [g] OTHER (See below):

FOB Destination
INIMMUNE CORP.
1121 E. Broadway, Suite 121
9. DISCOUNT FOR PROMPT PAYMENT
Missoula MT , 59802

N/A

10. SUBMIT INVOICES ITEM

(4 copies unless otherwise
See Article G .3
specif ied) TO THE
CODE !FACILITY CODE ADDRESS SHOWN IN
11. SHIP TO/MARK FOR CODE N/A 12. PAYMENT \1111LL
BE MADE BY CODE N/A

See Article F .2 See Article G.3

13. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION: 14. ACCOUNTING AND APPROPRIATION DATA

• 1O U.S.C. 2304(c)( )
• 41 U.S.C. 3304(a)( )
SBIR

Funding
BioD CAN

Amount
8477185

$1,836,453
;

; SOCC 25.55

15A. IT EM NO. 15B. SUPPLIES/SERV ICES 15C. QUANTITY 15D.UNIT 15E. UN IT PR ICE 15F. AMOUNT
T itle: Development of a new TLR4 agon ist for the treatment of
Allergic Rhinitis FY 2021 $1 ,836,453.00

Period: Septembe r 01 , 2021 through August 31, 2023

Contract Type: Firm-F ixed Pr ice

16. TABLE OF CONTENTS

15G. TOTAL AMOUNT OF CONTRA CT
• $1 836 ,453.00
(X) SEC. DESCRIPTION PAGE(S) (X) SEC. DESCRIPTION PAGE(S)
PART I • THE SCHEDULE PART II • CONTRACT CLAUSES
X A SOLICITATIONICONTRACT FORM 1 X I CONTRACT CLAUSES 22
X B SUPPLIES OR SERVICES AND PRICES/COSTS 4 PART Ill - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH .
X C DESCRIPTION/SPECS./WORK STATEMENT 6 X J LIST OF ATTACHMENTS 29
X D PACKAGING AND MARKING 9 PART IV - REPRESENTATIONS AND INSTRUCTIONS

X E INSPECTION AND ACCEPTANCE 10 REPRESENTATIONS, CERT IFICATIONS AND OTHER

X K
STATEMENTS OF OFFERORS
30
X F DELIVERIES OR PERFORMANCE 11
X G CONTRACT ADMINISTRATION DATA 12 L INSTRS., CONDS., AND NOTICES TO OFFERORS
X H SPECIAL CONTRACT REQUIREMENTS 16 M EVALUATION FACTORS FOR AWARD

CONTRACTING OFFICER WILL COMPLETE ITEM 17 (SEALED -BID OR NE GO TIATED PROCUREMENT) OR 18 (SEALED-BID PROCUREMENT) AS APPLI CABLE
17. [g] CONTRACTOR'S NEGOTIATED AGREEMENT (Contractor is required to 18. LJ
SEALED-BID AWARD (Contractor is not required to sign this document .)
sign this document and return _ 1_ copy to issuing office.) Contractor agrees to furnish Your bid on Solicitation Number
and deliver all items or perform all the services set forth or otheiw ise identified above including the additions or changes made by you which additions or changes are set forth in
and on any continuation sheets for the consideration stated herein. The full above, is hereby accepted as to the terms listed above and on any continuation sheets.
rights and obligations of the parties to this contract shall be subject to and governed by This award consummates the contract which consists of the following documents: (a) the
the following documents: (a) this award/contract, (b) the solicltation, if any, and (c) such Government's solicitation and your bid, and (b) this award/contract. No further contractual
provisions, representations, certifications, and specifications, as are attached or document is necessary. (Block 18 should be checked only w hen awarding a sealed-bid
incorporated by reference herein. (Attachmen ts are listed herein) contract.)
19A. NAME AND TITLE OF SIGNER (Type or Print) 20A. NAME OF CONTRACTING OFFICER

Helene Bazin-Lee rTom Bahrami

VP D iscovery Contracting Officer , OA, N IAID , NIH , DHHS
19B. NAME OF CONTRACTOR lnimmune corp 19C. DATE SIGNED 20B. UNITED STATES OF AM ERICA 20C. DATE SIGNED

BY
~ ersonalSignature
I BY Som T. Babrami -sDigitallysigne I by Som T. Bahrami
6 10:13:32 -04'00'
-5

(Signature of person authorized to sign) 08/26/2021 (Signature of Contracting Off;cefat~.

AUTHOR IZED FOR LOCAL REPRODUCTION STANDARD FORM 26 (REV. 3/2013)

Previous edition is NOT usable Obtained via FOIA by WCW Project Prescribed by GSA· FAR (48 CFR) 53.214(a)
 lnimmune Corporation: 75N93021C00044
Reference Number: SB IR PHS-2021-1 (091)

CONTRACT TABLE OF CONTENTS

PART I - THE SCHEDULE ........................................................ . ..................... 4

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES .............................. .. . ... 4
ARTICLE B.2. PRICES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
ARTICLE B.3. ADVANCE UNDERSTANDINGS ............................................ .. ......... 4
SECTION C - DESCRIPTION/SPECIFICATIONS /WORK STATEMENT . . . .. . . . . .. . . . . .. .. . .. . . . . . .. . ... . . . 6
ARTICLE C.1. STATEMENT OF WORK ...... .................. ..... .. ... .... . ...... . ..... .. .... . ... 6
ARTICLE C.2. REPORTING REQUIREMENTS . . .. . ...... . ...... . ............. . .... ........... .. ..... 6
ARTICLE C.3. INVENTION REPORTING REQUIREMENT. ......... ........ ...... ... ..... . . . ...... . ... 8
SECTION D - PACKAGING, MARKING AND SHIPPING .................. . ... ........................... 9
SECTION E - INSPECTION AND ACCEPTANCE. . .. . . . . .... . . .. . . . .. . . . . . .. . . . . .. . . ... . . . . . .. . . . . .. . . 10
SECTION F - DELIVERIES OR PERFORMANCE. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
ARTICLE F.1. PERIOD OF PERFORMANCE ... .................... .. ...................... ...... ... 11
ARTICLE F.2. DELIVERIES ....................................................................... 11
ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE , FAR 52.252-2 (FEBRUARY 1998).. . . . . .. . . 11
SECTION G - CONTRACT ADMINISTRATION DATA............................. .. .................... 12
ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR) . . .. ... . .... . . ... ... .. .......... 12
ARTICLE G.2. KEY PERSONNEL , HHSAR 352.237-75 (December 2015) .......................... . .... 12
ARTICLE G.3. INVOICE SUBMISSION . . .. . ... . .. . . . .... . ......... . . . .... . .... . . . . . .. . ... .. . . ...... 13
ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS , FAR
52.232-40 (December 2013) ....................................................................... 14
ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE ......... . . . . .. . . . . . .. 14
SECTION H - SPECIAL CONTRACT REQUIREMENTS . .. .. . . . . . . ......... . ............ ..... .... . . .... . 16
ARTICLE H.1. HUMAN SUBJECTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
ARTICLE H.2. RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC NUCLEIC ACID MOLECULES
(Including Human Gene Transfer Research ). . ...... .... . . . . ......................................... 16
ARTICLE H.3. NIH POLICY ON ENHANCING REPRODUCIB ILITY THROUGH RIGOR AND
TRANS PARENCY ............................................ . ......... . ............. .. . .... . . . . . 16
ARTICLE H.4. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RESULTING
FROM NIH-FUNDED RESEARCH ............. . ......... . ...... . ...... . ....... ... . ...... . ........ . 17
ARTICLE H.5. ACKNOWLEDGEMENT OF FEDERAL FUNDING . . .... . ...... . ... .. . .... ... . ...... . ... 17
ARTICLE H.6. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION ..... . ... . 17
ARTICLE H.7. CARE OF LIVE VERTEBRATE ANIMALS , HHSAR 352.270-5(b) (December 2015).... . ... .. 17
ARTICLE H.8. ANIMAL WELFARE . . .. . . . . .. . . .... . . . .. . . . .... . .... . . . . . .. . . . . .. . . . . .. . . . .. . . . . . .. . 18
ARTICLE H.9. INTRODUCT ION OF RODENTS AND RODENT PRODUCTS . . .... . . .... . . .... . . .... . . .. 18
ARTICLE H.10. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS ... .... . . .... . .. . .... 18
ARTICLE H.11. GUN CONTROL. .................................................................. 18
ARTICLE H.12. LIMITATIONS ON SUBCONTRACTING - SBIR .. . ... .. . . . .. . . . . . .. . ... .. . . .... . . .... . 18
ART ICLE H.13. ELECTRONIC AND INFORMA TION TECHNOLOGY ACCESSIBILI TY , HHSAR 352.239-74
(December 2015) ................................................................................. 18
ARTICLE H.14. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY NOTICE HHSAR
352 .239 -73 (December 2015) ....... . ......... . . ................................... . ............... 19
ARTICLE H.15. PUBLICATION AND PUBLICITY. ......... .... ............. ........ ...... ... ..... . .. 20

-2-

Obtained via FOIA by WCW Project

 lnimmune Corporation : 75N93021C00044
Reference Number: SBIR PHS-2021-1 (091)

ARTICLE H.16. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE . . . .... . . .. ......... 21
ARTICLE H.17. SHAR ING RESEARCH DATA. ..... . ....................... . ...... . . . ............... 21
ARTICLE H.18. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391). ..... . . . . . .... .. .. . ... 21
ARTICLE H.19. USE OF FUNDS FOR CONFERENCES , MEETINGS AND FOOD ....................... 21
PART II - CONTRACT CLAUSES . . . .. . . .... . . . .. . . . .. . . . .... . .... . . . .... . ... .. . . . . .. . . . . .. . . . . . . . . . . . .. 22
SECTION I - CONTRACT CLAUSES. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
PART Ill - LIST OF DOCUMENTS , EXHIBITS AND OTHER ATTACHMENTS ......... . ......... . .. . . .... . . .. 29
SECTION J - LIST OF ATTACHMENTS ................ . .... ... ................ . ...... . .. . ...... . ..... 29
1. Statement of Work . .. . . . . .. . . . . .. . . . . .. . . . . .. . . . . .. . . . .. . . . . . .. . ... .. . . . . . . . . . . . . . . . . .. . . . . .. . . 29
2. Invoice Instructions for NIH Fixed-Price Contracts, NIH(RC)-2 . . . . .. . . . . . . . . ... .. . . . . .. . . . . .. . . . . .. . . 29
3. Electronic Invoicing Instructions for NIH Contractors/Vendors . ...... .... . . ..... . .... ... .... ...... . . .. 29
4. Safety and Health .. . . ......... . ..... . ...... . .............. ... . . . . . . . .... . . .. . . . . .. . . . . .. . . . . ... 29
5. Disclosure of Lobbying Activities, SF-LLL. .............. . .. . ............................... . ...... 29
6. eRDS Electronic to Report Deliverable. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
7. Commitment To Protect Non-Public Information ............. . .. . . ...... .... ..... .. .... . . . . . . . . . ... 29
8. Employee Separation Checklist. . . .... . . . . ... .. . . . . ... . .. . .. .. ...... . .... . .... . . . . .. . . . . .. . . . .... 29
9. NIH Small Business Innovation Research (SBIR) Program Funding Agreement Certificat ion............. 29
10. NIH Small Business Innovation Research (SBIR) Program Life Cycle Certification . . . . .. . . . .... . . . .. . .. 29
PART IV - REPRESENTATIONS AND INSTRUCTIONS .... . . .... . . . .... ... .. . . ... .. . .... ...... . . .. . ...... 30
SECTION K - REPRESENTATIONS AND CERTIFICATIONS ... . . . .... . .. . ... . .. . . ... . . .. .. . ..... . . . .... 30
1. Annual Representations and Certifications ... . .... . . . ....... . ..... . . ...... . .... . . . .. . ... . ......... 30
2. Annual Representations and Certificat ions, FAR Clause 52.204-8 ................... .. . . . . . .. ... .. . . . 30
3. Animal Welfare Assurance Number . .... ..... .. ... .. . . . .. . ......... . ................... . . . . .... . . 30

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 In immune Corporation : 75N93021 C00044
Reference Number: SBIR PHS-2021-1 (091)

PART I - THE SCHEDULE

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The goal of this research program is to deve lop a se lf-adm inistered intranasa l TLR4 agonist to treat al lerg ic rhinitis.
Unlike ant igen-specific therapy, this allergen independent approach is expected to be broadly app licab le to a vast array
of allerge ns patients are exposed to. Such treatment would provide relief within hours of adm inistration, providing short-
term symptom contro l, and has the potentia l to deliver long-term d isease rem ission via allergen dependent T cell and B
cell memory responses. The TLR4 agonist developed by lnimmune is superior in terms of potency and stab ility to othe r
licensed TLR4 adjuvants. The first objective of this ro osal is to com lete re-clinical in vivo stud ies to select the
0 timal formulation and administration schedule roprietary lnfo

In the second objective , we will perform accelerated and long term stability stud ies of the optima l formulation and
~__ ch_a~racterization test of the nasal spray device . The third objective includes non -GLP and GLP mu ltiple dose toxicit~ roprie I
taryinfo
rroprietary
lnfolT he work proposed herein comprises the pre -cl inica l basis to advance our TLR4 agonist for the treatment of
allergic rhinitis to the pre -IND stage .

ARTICLE B.2. PRICES

a . The total fixed price of this contract is $1 ,836 ,453 .

b . Upon delivery and acceptance of the serv ices described in SECTION C of this contract and identified in the
schedu le of charges below , the Government shall pay to the Contractor the unit price(s ) set forth below:

SCHEDULE OF CHARGES FOR THE BASIC AWARD PERIOD

Progress Report Due Date Price

Quarterly Progress Report 12/ 15/2021 ~terni
zedCost
Quarterly Progress Report 03/ 15/2022
Quarterly Progress Report 06/ 15/2022
Quarterly Progress Report 09/ 15/2022
Quarterly Progress Report 12/ 15/2022
Quarterly Progress Report 03/ 15/2023
Quarterly Progress Report 06/ 15/2023
Final Report 08/31/2023
TO T AL FIRM FIXED PRICE $1 ,836 ,453

ARTICLE B.3. ADVANCE UNDERSTANDINGS

Other provisions of this contract notwithstanding , approva l of the following items within the limits set forth is he reby
granted without further author ization from the Contracting Officer.

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a. Confidential Treatment of Sensitive Information

The Contractor shall guarantee strict confident iality of the informat ion/data that it is provided by the Governmen t
during the performance of the contract. The Government has determined that the info rmation /data that the
Contractor wil l be prov ided during the performance of the contract is of a sensit ive nature .

Disclosure of the informat ion/data , in whole or in part, by the Contractor can only be made after the Contractor
receives prior written approval from the Contracting Officer . Wheneve r the Contractor is uncertain with regard
to the proper handling of information /data under the cont ract , the Contractor shal l obtain a written determina tion
from the Contracting Off icer .

b . Contract Number Designation

On a ll correspondence subm itted under this contract, the Contractor agrees to clear ly identify the two contract
numbers that appear on the face page of the contract as follows:

Contract No. 75N93021 C00044

c. SBIR Funding Agreement Certification

The SBIR Funding Agreement Cert ification form, located in SECTION J, must be comp leted at the time of award
prior to the performance of work under this contract , in accordance with the SBI R Policy Direct ive issued by SBA
(October 18, 20 12).

For additional informat ion , see NIH Policy Notice NOT-OD-13 -116, entitled , "New Program Certificatio ns
Required for SBIR and STTR Awards ," located at: http: //gran ts.n ih.gov /grants /guide /notice-files /NOT -
O D-13-116.html .

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 In immune Corporat ion : 75N9302 1C00044
Reference Number : SBIR PHS-2021-1 (091)

SECTION C - DESCRIPTION /SPECIFICATIONS /WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services ,
qualified personnel , material , equipment, and facilities , not otherwise provided by the Governme nt as needed
to perform the Description , dated 10/26/2020, set forth in SECTIO N J-List of Attachments , attached hereto and
made a part of this contract.

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electron ic format. In addition, one hardcopy of each report sha ll be
submitted to the Contracting Officer.

All electronic reports submitted sha ll be compliant w ith Section 508 of the Rehabilitation Act of 1973. Additio nal
information about test ing documents for Section 508 compliance , including guidance and spec ific checklis ts, by
application , can be found at: bll g://www.hh s.gov/web/508/index.html under "Making Files Accessible."

a. Technical Reports
In addit ion to those reports required by the other terms of this contract , the Contractor shall prepare and submit
the following reports in the manner stated below and in accordance with the DELIVERIES Article in SECT ION F
of this contract:

{Note : Beginning May 25, 2008 , the Contractor shall include, in any technical progress report submitted , the
applicable PubMed Central (PMC) or NIH Manuscript Submiss ion reference number when citing publicat ions
that arise from its NIH funded research.}

1 . Quarterly Progress Report

a. This report shall include a summation of the monthly progress reports/a description of the activities
during the report ing period and the activities planned for the ensu ing report ing period . The first reporting
period consists of the first full three months of performance including any fractional part of the initial
month. Thereafte r, the reporting period shall consist of three full calendar months.

b. A monthly report wil l not be submitted for the final month of the quarter .

c. The first report sha ll be due December 15, 202 1. Thereafter, reports shall be due on or before the 15th
Calendar day follow ing each reporting period .

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Reference Number: SBIR PHS-2021-1 (091)

Period of Performance Due Date of

Quarterly Report
09/01/2021- 11/31/2021 12/15/2021
12/01 /2021-02 /29/2022 03/15/2022
03/0l/2022 -05/31/2022 06/15/2022
06/0 l/2022-08 /31/2022 09/15/2022
09/0 l/2022-11/31/2022 12/15/2022
12/0 l /2022-02/29/2023 03/15/2023
03/0l/2023-05 /31/2023 06/15/2023
06/01 /2023-08/31/2023 08/31/2023 [see ' Final Report' section below .]

2 . Final Report

This report is to include a summat ion of the work performed and resu lts obtained for the entire
contract period of performance. This report shall be in sufficient detail to describe comprehensively
the results ach ieved. The Final Report shall be submitted in accordance with the DELIVER IES
Art icle in SECT ION F of this contract. NAn Quarterly report will not be required for the period when
the Final Report is due.

Prior the submission of a Final Report, the Contractor shall provide the Cont racting Officer with
1 copy of the draft Final Report prior to the expirat ion date of this cont ract. The Cont racting
Officer's Representative (COR) will review the draft report and provide the Contract ing Officer
with comments within 10 Calendar days after receipt. The Final Report shal l be corrected by the
Contractor , if necessary and the fina l version delivered as specified in the above paragraph.

3 . Summary of Salient Results

The Contractor shall submit, with the Final Report, a summary (not to exceed 200 words) of sa lient
resu lts achieved during the performance of the contract.

b . Other Reports/Deliverables

1. NIH Small Business Innovation Research (SBIR) Program Life Cycle Certification

In accordance with the SBIR/STTR Reauthori zation Act of 2011, the co ntractor shall comp lete and
submit the NIH Small Business Innovation Research (SBIR ) Life Cyc le Certificat ion form , located
in SECTION J , of the contract to the Contracting Officer. This cert ification is requ ired to ensure the
contractor is meeting the program 's requirements during the life cycle of the contract.

The Life Cycle Cert ification form shall be submitted as follows :

• Phase I SBIR Contractors shall submit the Cert ificat ion at the time of rece iving final payment or
disbursement.

• Phase II SB IR Contractors shal l submit the Certification prior to receiving more than 50% of the
total contract amount AND prior to final payment or disbursement.

The Contracting Officer , may , at any time after ward request further clarifications and supporting
documen tation in order to assist in the verifica tion of any information provided by the contractor .

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Reference Number : SBIR PHS-2021-1(091)

For addit ional informat ion, see NIH Policy Notice NOT-OD-13-116, entitled , "New Program
Certificat ions Required for SBIR and STTR Awards, " located at: http://grants .nih.gov/grants/guide/
notice -files/NOT-OD-13-116.html.

REPORTING REQUIREMENTS FOR USE WITH THE ELECTRONIC REPORT DELIVERABLE

SUBMISSION (eRDS) SITE
All reports required herein shall be submitted in electron ic format. All electronic contract del iverables shall be
submitted via the NIAID electronic Report Deliverable Submission (eRDS ) Site, available at the fo llow ing website:
https ://erds .niaid .nih.gov/. All electron ic reports submitted shall be comp liant with Section 508 of the Rehabilitation Act
of 1973. Additional
information about test ing documents for Section 508 compliance , including guidance and spec ific checklists, by
application , can be found at http://www.hhs .gov/web/508/index.htm l under "Making Files Accessib le."

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownersh ip by the
Contractor including, but not limited to , the invention disclosure report, the confirmatory license , and the Government
support certification , shall be directed to the Division of Extramural Inventio ns and Technology Resources
(DEITR) , OPERA , OER , NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980
(Telephone : 301-435-1986). In addition, one copy of an annua l utilizatio n report, and a copy of the final invention
statement , shall be submitted to the Contracting Officer. The fina l invent ion statement (see FAR 27.303(b)(2)(ii)) shall
be submitted to the Contracti ng Officer on the expiration date of the contract.

The annual utilization report shall be subm itted in accordance with the DELIVERIES Article in SECTION F of th is
contract. The final invention statement (see FAR 27 .303(b)(2 )(ii)) shall be submitted on the expiration date of the
contract. Al l reports shall be sent to the follow ing webs ite address: http://e_c_d
_s.niaid~

If no invention is disclosed or no activity has occurred on a previously disclosed invention duri ng the
applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed
"lnteragency Edison ," an electronic invent ion report ing system. Use of lnteragency Edison is required as it stream lines
the reporting process and greatly reduces paperwork. Access to the system is through a secure interactive Web site
to ensure that all informatio n submitted is protected . lnteragency Edison and informatio n relating to the capab ilities of
the system can be obtained from the Web ( http://www. iedison.gov), or by contact ing the Extramural Inventions and
Technology Resources Branch , OPERA, NIH.

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 In immune Corporation : 75N93021 C00044
Reference Number : SBIR PHS-2021-1 (091)

SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government
specifications. At a minimum, all de liverables shal l be marked with the contrac t numbe r and Contractor name . The
Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

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Reference Number: SBIR PHS-2021-1 (091)

SECTION E- INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly author ized representative will perform inspect ion and acceptance of mater ials
and services to be provided .

b. For the purpose of this SECTION , the CO R designated in Article G.1 . is the authorized representative of the
Contracting Officer.
c. Inspect ion and acceptance will be performed at:
National Institute of Allergy and Infectious Diseases
National Institutes of Health, DHHS
5601 Fishers Lane
Bethesda, MD 20892-9830

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

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

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

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

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Reference Number : SBIR PHS-2021-1 (091)

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The period of performance of this contract shall be from 9/01/2021 through 08/31/2023.

ARTICLE F.2. DELIVERIES

Satisfactory performance of the final contract shall be deemed to occur upon performance of the work described in the
Description Article in SECTION C of this contract and upon delivery and acceptance by the Contracting Officer , or the
duly authorized representative, of the following items in accordance with the stated del ivery schedule:

a. The items spec ified below as descr ibed in the REPORT ING REQUIREMENTS Article in SECTIO N C of this
contract will be required to be delivered F.o.b. Destination as set forth in FAR 52.247-35 , F.o.b. DESTINAT ION,
WITHI N CONS IGNEES PREMISES (APRIL 1984), and in accordance with and by the date(s) specified below :

Item Description Quantity Delivery Schedule

(1) Quarterly Progress Reports 1 electronic copy Due on or before the dates
listed in Article C.2 .
(2) Final Report and Summary 1 electronic copy Due on or before the dates
of Salient Results listed in Article C.2 .
(3) NIH Small Business 1 electronic copy Due on or before the dates
Innovation Research listed in Article C.2 .
(SBIR) Program Life Cycle
Certification
(4) Final Invention Statement 1 electronic copy Due on or before the dates
- See Article C.3. listed in Article C.2 .

b. The above items shall be addressed and delivered to :

All reports required herein shall be submitted in electronic format. All electronic contract deliverables
shall be submitted via eRDS (NIAID's electronic Report Deliverable Submission) , available at the
following website: https://erds.niaid.nih .gov.

ARTICLE F.3. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY

1998)
This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in
full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be
accessed electronically at this address: https://www .acquisition.gov/?q=browsefar.

FEDERAL ACQU ISITION REGULATION (48 CFR CHAPTER 1) CLAUSE :

52.242-15 , Stop Work Order (August 1989)

Alternate I {April 1984) is applicable to this contract.

52.242-17 , Government Delay of Work (April 1984).

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Reference Number : SBIR PHS-2021-1 (091)

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

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

Michael Minnicozzi, Ph.D.

Contracting Officer's Representative ( COR )
Division of Allergy , Immuno logy, and Transplantation
National Institute of Allergy and Infectious Diseases
560 1 Fishers Lane, Rm 6B59
Bethesda , MD 20892-9828
Phone : 240.627.3532
Email:f edacted
by agreement

The COR is responsible for: (1) monitoring the Contractor's technical progress, includ ing the surveillance and
assessment of performance and recommend ing to the Contracting Officer changes in requirements; (2) interpreting
the statement of work and any other technical performance requirements; (3) performing technica l eva luation as
required; (4) performing technical inspections and acceptances required by th is contract; and (5) assisting in the
resolution of technical problems encountered during performance .

The Contracting Officer is the only person with authority to act as agent of the Government under this contract . Only
the Contracting Officer has authority to : (1) direct or negotiate any changes in the statement of work ; (2) modify or
extend the per iod of performance ; (3) change the delivery schedule ; (4) authorize reimbursement to the Contractor
for any costs incurred during the performance of this contract ; (5) otherwise change any terms and conditions of this
contract ; or (6) sign written licensing agreements . Any signed agreement shall be incorpo rated by reference in Section
K of the contract

The Government may unilatera lly change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.237-75 (December 2015)

The key personnel spec ified in this contract are cons idered to be essential to work performance. At least 30 days prior
to the contractor voluntarily diverting any of the specified individuals to other programs or contracts the Contractor
shall notify the Contracting Officer and shal l submit a justificat ion for the diversion or replacement and a request
to replace the individual. The request must identify the proposed replacement and provide an explanat ion of how
the replacement's skills, experience, and credentia ls meet or exceed the requirements of the contrac t (including,
when app licab le, Human Subjects Testing requirements) . If the employee of the contractor is terminated for cause or
separates from the contractor volun tarily with less than thirty days notice, the Contractor shall prov ide the maximum
notice practicable under the circumstances. The Contractor shall not divert , rep lace, or announce any such change to
key personnel without the written consent of the Contracting Officer. The contract wi ll be modified to add or delete key
personnel as necessary to reflect the agreement of the parties .

(End of Clause)

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

Name Title
rersonne
l

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ARTICLE G.3. INVOICE SUBMISSION

a. Invo ice Instructions for NIH Fixed-Price Type Contracts, NIH(RC )-2, are attached and made part of this contract.
The Contractor sha ll follow the attached instr uctions and submission procedures specified below to meet the
requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. The Contracto r sha ll submit invoice to the National Institutes of Health (NIH)/Office of Financia l
Management (OFM ) via ema il at invoicing@nih .gov with a copy to the approv ing officia l, as directed
be low. The Contractor must follow step-by-step instructions as stated in the NIH/OFM Electronic
Invoicing Instruct ions for NIH ContractorsNendors, wh ich is included as an attachment in Section J of
this contract. The invoice shall be transmitted as an attachment via ema il to the address listed abov e
in one of the following formats: Word , or Adobe Portable Document Format (PDF). The Contractor
must submit on ly one invoice per emai l. Do not submit support ing documentation (e .g. , receipts ,
time sheets , vendor invoices , etc.) with your invoice unless specified elsewhere in the contract or
requested by the Contracting Officer .

The Contractor sha ll submit a copy of the e lectronic invoice to the following Approving Official
(Cont racting Officer) and Contract ing Officer's Representative:

Approving Official : Contracting Officer

Name- Maribel Miranda Email Address- ~e-

d•-ct-ed_b_
y •_
g_reem
_ en_
t ----~

Contracting Officer's Representat ive

Name - Michael Minnicozzi , PhD Email Address - r~ed

-•-ct_
ed-by_·•_gr_eem
_e
_m_______ ~
For inqu iries regarding the status of invoices , contact OFM Customer Serv ice via ema il at
ofm customer service@incontactemail.com or via phone at 301-496 -6088 . To send your inquiries
via other available communication methods refer to the OFM Custome r Service website at https ://
ofm .od .nih.gov/Pages /Customer -Serv ice .aspx .

Note : The OFM Customer Serv ice is open Eastern Standard Time Monday - Friday from 8:30 a.m. to
5:00 p .m. and is closed between 12:00 p.m. to 1 :00 p.m .

2 . In addit ion to the requirements spec ified in FAR 32.905 for a proper invoice , the Contrac tor shall
include the following informa tion on the face page of all payment requests:

a . Name of the Office of Acquisi tions . The Office of Acquisit ions for this contract is Nationa l
Institute of Allergy and Infectious Diseases .

b. Federal Taxpayer Ident ificat ion Number (TIN). If the Contractor does not have a val id TIN, it
shal l identify the Vendor Identificat ion Number (VIN) on the payme nt request. The VIN is the
number that appears after the Contractor's name on the face page of the contract. [Note : A
VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract
modified to include the VIN number.] If the Contractor has ne ither a TIN , DUNS, or VIN, contact
the Contracting Officer.

c . DUNS or DUNS+4 Number . The DUNS numbe r must ident ify the Contractor's name and
address exactly as stated in the contract and as registe red in the Central Cont ractor Registration
(CCR) database . If the Contractor does not have a valid DUNS number , it shal l identify the
Vendor Ident ification Number (VIN) on the payme nt request. The VIN is the number that
appears after the Contractor's name on the face page of the cont ract. [Note: A VIN is assigned

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to new contracts awarded on or after June 4, 2007, and any existing contract modified to include
the VIN number.} If the Contractor has neither a TIN, DUNS , or VIN, contact the Contract ing
Officer . Note: The Contractor shall not include TIN if it is a Socia l Security Number.

d. Invoice Matching Option. Th is contract requires a two-way match .

e. Unique Invoice Number . Each payment request must be identified by a unique invoice number,
which can only be used one time regard less of the number of contracts or orders held by an
organization .

f. The Contract Title is:

SB IR Topic 091 Phase II: Development of a new TLR4 agon ist for the treatment of Allergic
Rhinitis

g. Contract Line Items as follows:

Line Item# Line Item Description Period of Performance Funded Amount

1 Base Period 09/01/2021 -08/31/2023 $1,836,453

b. Inquiries regarding payment of invoices shall be directed to the des ignated bil ling office , (30 1) 496-6452.

c . The Contractor shall include the following certification on every invoice for reimbursable costs incurred with
Fiscal Year funds subject to HHSAR Clause 352 .23 1-70 , Salary Rate Limitation in SECT ION I of this contract.
For billing purposes , certified invo ices are required for the billing per iod during which the applicable Fiscal Year
funds were initially charged through the final billing period utilizing the appl icable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with HHSAR Clause
352 .231-70 , Salary Rate Limitat ion in SECTION I of the above referenced contract."

ARTICLE G.4. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS

SUBCONTRACTORS , FAR 52.232-40 (December 2013)
a. Upon receipt of accelera ted payments from the Governmen t, the Contractor shall make acce lerated payments to
its small business subcontractors under this contract , to the maximum extent pract icable and prior to when such
payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and
all other required documentation from the small business subcontractor.

b. The accelerat ion of payments under this clause does not provide any new rights under the prompt Payment Act.

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

(End of Clause)

ARTICLE G.5. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and Final evaluations of Contractor performance wil l be prepared on th is contract in accordance with
FAR Subpart 42.15. The Final performance evaluation wil l be prepared at the time of completion of work. In
addit ion to the Final evaluation , Interim evaluation(s) wi ll be prepared based on a schedule to be determined by
the Contracting Officer.

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Interim and Final evaluations w ill be prov ided to the Contractor as soon as pract icable after completion of
the evaluation. The Contractor will be perm itted thirty days to review the document and to submit additional
information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be
referred to an individual one level above the Contracting Officer , whose decision will be final.

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

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following
address :

http ://www.cpars.gQY

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Reference Number: SBIR PHS-2021-1 (091)

SECTION H - SPECIAL CONTRACT REQUIREMENTS

ARTICLE H.1. HUMAN SUBJECTS

It is hereby understood and agreed that research involving human subjects shall not be conducted under this contract,
and that no mater ial developed, modified, or delivered by or to the Government under this contract, or any subsequent
modification of such mater ial, will be used by the Contractor or made available by the Contractor for use by anyone
other than the Government, for experimenta l or therapeutic use involving humans without the prior written approval of
the Contracting Officer.

ARTICLE H.2. RESEARCH INVOLVING RECOMBINANT OR SYNTHETIC NUCLEIC ACID

MOLECULES (Including Human Gene Transfer Research)
All research projects (both NIH-funded and non-NIH-funded) involving recombinant or synthet ic nucleic acid
molecules that are conducted at or sponsored by an entity in the U.S. that receives any support for recombinant or
synthet ic nucleic acid research from NIH shall be conducted in accordance with the NIH Guidelines for Research
Involving Recombinant or Synthetic Nucleic Acid Molecules ( NIH Guidelines) available at: http://osp.od.nih .gov/office-
biotechno logy-activities/biosafety/ nih-guidelines ). All NIH-funded projects abroad that include recombinant or synthetic
nucleic acid molecules must also comply with the NIH Guidelines.

The NIH Guidelines stipulate biosafety and containment measures for recombinant or synthetic nucleic acid research ,
which is defined in the NIH Guidelines as research with (1) molecules that a) are constructed by join ing nucleic acid
molecules and b) can replicate in a living cell, i.e. recombinant nucleic acids , or (2) nucleic acid molecules that are
chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but
can base pair with naturally occurring nucleic acid molecules , i.e. synthetic nucleic acids, or (3) molec ules that result
from the replication of those described in (1) or (2). The NIH Guidelines apply to both basic and clinical research .
Specific guidance for the conduct of human gene transfer studies appears in Appendix M of the NIH Guidel ines.

Failure to comply with the NIH Guidelines may result in suspension, limitation , or termination of the contract for
any work related to recombinant or synthetic nucleic acid research or a requirement for the Contracting Officer to
approve any or all recombinant or synthet ic nucleic acid molec ule projects under this contract. This includes the
requirement for the institution to have an Institutional Biosafety Committee (IBC) registered with the NIH Office of
Science Policy that compl ies with the requirements of the NIH Guidelines. Further information about compliance w ith
the NIH Guidelines can be fo und on the NIH Office of Science Policy website availab le at: http://osp .od.nih.go.YI.

ARTICLE H.3. NIH POLICY ON ENHANCING REPRODUCIBILITY THROUGH RIGOR AND

TRANSPARENCY
Contractors shall adhere to the NIH policy of enhancing reproducibili ty through rigor and transparency by address ing
each of the four areas of the pol icy in performance of the Statement of Work and in publications, as applicable :
1) Scient ific Premise; 2) Scientific Rigor; 3) Consideration of Relevant Biological Variables , including Sex ; and 4)
Authenticat ion of Key Biologica l and/or Chemical Resources . This pol icy app lies to all NIH funded research and
deve lopment, from basic through advanced clinical studies . See NIH Guide Notice, NOT-OD- 15-103, "Enhanc ing
Reproduc ibility through Rigor and Transparency" and NOT-OD-15-102 , "Consideration of Sex as a Biological Variable
in NIH-funded Research" for more information. In addition , publications are expected to follow the guidance at http ://
www.ni h.gov/research-training/rigor-repro ducibility/princip les-guidelines-report ing-preclinical-research , whether
preclinical or otherw ise, as approp riate. More information is available at http://grants.nih.gov/reproducibi lity/index .htm,
including FAQs and a General Policy Overview.

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ARTICLE H.4. NIH POLICY ON ENHANCING PUBLIC ACCESS TO ARCHIVED

PUBLICATIONS RESULTING FROM NIH-FUNDED RESEARCH

NIH-funded investigators shall submit to the NIH Nationa l Library of Medicine's (NLM) PubMed Central (PMC) an
electronic version of the author's final manuscript, upon acceptance for publication, resulting from research supported
in who le or in part with direct costs from NIH. NIH defines the author's fina l manuscript as the final version accepted
for journal publicat ion, and includes all modificat ions from the publishing peer review process . The PMC archive will
preserve permanently these manuscripts for use by the public , health care providers , educators , scientists, and NIH.
The Policy directs electronic submissions to the NIH/ NLM/ PMC: http://www.pubmedce ntral.nih.gov.

Additional information is available at http://grants.nih.gov /g rants/guide/notice-files/NOT-OD-09-07 1.html and http://

publicaccess.nih .gov.

ARTICLE H.5. ACKNOWLEDGEMENT OF FEDERAL FUNDING

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

ARTICLE H.6. DISSEMINATION OF FALSE OR DELIBERATELY MISLEADING INFORMATION

The Contractor shall not use contract funds to dissem inate information that is del iberately false or misleading.

ARTICLE H.7. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-S(b) (December

2015)

a. Before undertak ing performance of any contract involving animal-rela ted act ivities where the species is regulated
by the United Sates Department of Agriculture (USDA) , the Contractor shall register with the Sec retary of
Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR 2.25 through 2.28. The Contractor
shall furnish evidence of the registration to the Contracting Officer .
b. The Contractor shall acquire verteb rate animals used in research from a dealer licensed by the Secretary of
Agriculture under 7 U.S.C . 2133 and 9 CFR 2.1 2.11, or from a source that is exempt from licensing under those
sections.

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

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

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

(End of clause)

ARTICLE H.8. ANIMAL WELFARE

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

In addition, the research involving live vertebrate animals shall be conducted in accordance with the description set
forth in the Vertebrate Anima l Section (VAS) of the contractor's technical proposal, as modified in the Final Proposal
Revision (FPR), dated May 19, 2021, which is incorporated by reference .

ARTICLE H.9. INTRODUCTION OF RODENTS AND RODENT PRODUCTS

No rodent or rodent product shall be delivered into the NIH, NIAID environment (NIH) directly , or through collaborative
research or holding facil ities under contract to NIAID except by permit. Direct shipments to NIH from a Division of
Veterinary Resources (DVR), Office of Research Services (ORS) approved source will be considered exempt. Non-
exempt sources must be approved by permit issued through the DVR, ORS. The permit must be obtained by the
Contractor prior to the shipment to NIH of the rodents and/or rodent products. The Contractor must be sure that this
permit exists and is current before transferring rodents or rodent products into the NIH, NIAID environment. Refusal
or negligence to do so will be considered a material breach of contract and may be treated as any other such material
breach. Applications for permits should be submitted by facsimile not less than 30 days prior (60 days in situations
where quarant ine is likely) to shipping date to : NIH Division of Veterinary Resources (DVR), Office of Research
Services (ORS), Building 14G, Service Rd. South, Room 102, BETHESDA MD 20892-5210, (301)496-2527, FAX:
(301) 402-0352.

ARTICLE H.10. RESTRICTION ON PORNOGRAPHY ON COMPUTER NETWORKS

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

ARTICLE H.11. GUN CONTROL

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

ARTICLE H.12. LIMITATIONS ON SUBCONTRACTING - SBIR

The Contractor shall perform a minimum of two-thirds of the research and/or ana lytical effort [total labor hours/total
contract costs less profit/fee] conducted under th is contract. Any deviation from th is requirement must be approved in
writing by the Contract ing Officer .

ARTICLE H.13. ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY , HHSAR

352.239-74 (December 2015)
a. Pursuant to Section 508 of the Rehabilitation Act of 1973(29 U.S.C. 794d) , as amended by the Workforce
Investment Act of 1998, all electronic and information techno logy (EIT) supplies and services developed,
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acqu ired, or mainta ined under this contract or order must comp ly with the "Architectural and Transportation
Barriers Comp liance Board Electronic and Information Tech nology (EIT) Access ibility Standards" set forth by
the Architectural and Transportation Barriers Compliance Board (also referred to as the "Access Board") in 36
CFR part 1194. Information about Section 508 is available at http://www.hhs .gov/web/508. The complete text
of Section 508 Final Provisions can be accessed at http://www .access -board.gov/guidelines-and-standards /
communicat ions-and-it/about-t he-section-508-standards.
b. The Section 508 access ibility standards applicab le to this contract or order are identified in the Statement of
Work or Specification or Performance Work Statement. The cont ractor must provide any necessary updates
to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the
simplified acquisit ion thresho ld (see FAR 2.101) when the contract or order duration is one year or less . If it
is determined by the Government that EIT supplies and services provided by the Contractor do not conform
to the described accessibil ity standards in the contract , remediation of the supp lies or services to the level of
conformance spec ified in the contract will be the respons ibility of the Contractor at its own expense .

c. The Section 508 access ibility standards applicab le to this contract are: (Contract staff must list app licable
standards)

d. In the event of a modification(s) to this contract or order.which adds new EIT supplies or services or revises the
type of, or specificat ions for, supp lies or services, the Contract ing Officer may require that the contractor subm it
a completed HHS Section 508 Product Assessment Template and any other add itional informatio n necessary
to assist the Government in determ ining that the EIT suppl ies or services conform to Section 508 accessib ility
standards. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Temp late
may be found under Section 508 policy on the HHS Web site: ( http://www .hhs.gov/web/508) . If it is determined
by the Government that EIT supplies and services provided by the Contractor do not conform to the described
accessibil ity standards in the contract, remediation of the supplies or services to the level of conformance
specified in the contract will be the respons ibility of the Contractor at its own expense.
e. If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement , the
task/delivery order requests that include EIT supplies or services wil l define the specif ications and accessib ility
standards for the order. In those cases , the Contractor may be required to provide a completed HHS
Section 508 Product Assessment Template and any other additional information necessary to assist the
Governmen t in determ ining that the EIT supplies or services conform to Section 508 accessib ility standards .
Instructions for documenting accessibility via the HHS Section 508 Product Assessment Temp late may be found
at http://www .hhs.gov/web/508. If it is determined by the Government that EIT suppl ies and services provided
by the Contractor do not conform to the descr ibed accessibi lity standards in the provided documentation ,
remediation of the suppl ies or services to the level of conformance specified in the contract will be the
responsib ility of the Contractor at its own expense .

(End of clause)

ARTICLE H.14 . ELECTRONIC AND INFORMATION TECHNOLOGY ACCESSIBILITY NOTICE

HHSAR 352.239-73 {December 2015)
a. a. Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) , as amended by the Workforce Investment Act
of 1998 and the Architectural and Transportat ion Barriers Compliance Board Electronic and Information (EIT)
Accessibility Standards (36 CFR part 1194), require that when Federal agencies develop, procure , maintain,
or use electro nic and information technology , Federal employees with disabilities have access to and use of
informat ion and data that is comparable to the access and use by Federal employees who are not individuals
with disabi lities, unless an undue burden would be imposed on the agency . Section 508 also requires that
individua ls with disabilit ies, who are members of the public seek ing information or services from a Federal
agency, have access to and use of information and data that is comparab le to that provided to the public who
are not individuals with disab ilities, unless an undue burden would be imposed on the agency .

b. b. Accordingly , any offeror responding to th is solicitation must comply with establ ished HHS EIT accessibility
standards . Information about Section 508 is available at http://www.hhs .gov/web/508 . The comp lete text of

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the Section 508 Final Provisions can be accessed at http://www .access-board.gov /guidelines -and standards /
communicat ions-and-it/about-the -section-508-standards .
c. c. The Section 508 access ibility standards applicab le to this solicitation are stated in the clause at 352.239-74,
Electronic and Information Technology Accessibi lity. In order to facil itate the Governme nt's determinat ion
whether proposed EIT supplies meet applicable Section 508 access ibility standards , offerors must submit an
HHS Section 508 Product Assessment Template, in accordance with its completion instructions. The purpose
of the temp late is to assist HHS acquisition and program officia ls in determi ning whether proposed EIT supp lies
conform to applicable Section 508 accessibi lity standards . The template allows offerors or developers to self-
evaluate their supplies and document--in detail--whether they conform to a spec ific Section 508 access ibility
standard , and any underway remediation efforts addressing conformance issues . Instructions for preparing
the HHS Section 508 Evaluation Template are available under Section 508 policy on the HHS Web site http://
www .hhs.gov/web/508 . In order to facilitate the Government's determ ination whether proposed EIT services
meet applicable Section 508 access ibility standards, offerors must provide enough information to assist the
Government in determ ining that the EIT services conform to Section 508 accessibility standards, including any
underway remed iation efforts addressing conformance issues .

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

• The "HHS Section 508 Product Assessmen t Template " is included in SECTION J - List of Attachments, of this
solicitation .

ARTICLE H.15. PUBLICATION AND PUBLICITY

In addit ion to the requirements set forth in HHSAR Clause 352.2 27-70 , Publications and Publicity incorporated by
reference in SECT ION I of th is contract, the Contractor shall acknowledge the support of the National Institutes of
Health whenever publicizi ng the work under this contract in any media by including an acknow ledgment substant ially
as follows :

"This project has been funded in whole or in part with Federal funds from the National Institute of Allergy and
Infectious Diseases , National Institutes of Health, Department of Health and Human Services, under Contract
No. 75N9302 1C00044"

a. Advanced Copies of Press Releases

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Press releases sha ll be cons idered to include the public release of information to any medium , exclud ing peer-
reviewed scie ntific publ ications. The contractor shall ensure that the Contracting Officer 's Representat ive (COR)
has received an advance copy of any press release related to this contrac t not less than four (4) work ing days
prior to the issuance of the press release.

ARTICLE H.16. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

Anyone who becomes aware of the existence or apparent existence of fraud , waste and abuse in NIH funded
programs is encouraged to report such matters to the HHS Inspector Gene ral's Office in writing or on the Inspector
General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477) . All telephone calls will be handled
confident ially. The website to file a compla int on-line is: https ://oig .hhs.gov/fraud/report -fraud/ and the mailing address
is:

US Departmen t of Health and Human Services

Office of Inspector General
ATTN: OIG HOTLINE OPERATIONS
P.O. Box 23489
Washington, D.C. 20026

ARTICLE H.17. SHARING RESEARCH DATA

The data sharing plan subm itted by the Contractor is acceptab le. The Contractor agrees to adhere to its plan and shall
request prior approval of the Contracting Officer for any changes in its plan.

The NIH endorses the sharing of final research data to serve health . This contract is expected to generate research
data that must be shared with the public and other researchers . NIH's data shar ing policy may be fou nd at the
following Web site:

NIH recognizes that data sharing may be comp licated or limited , in some cases , by institutional policies, local IRB
rules, as well as local , state and Federal laws and regulations , includ ing the Privacy Rule (see HHS-published
documentation on the Privacy Rule at http://www .hhs.gov/ocrL). The rights and privacy of peop le who part icipate in
NIH-funded research must be protected at all times ; thus , data intended for broader use should be free of identifiers
that would permit linkages to individual research participants and variables that could lead to deductive disclosure of
the identity of individual subjects .

ARTICLE H.18. HOTEL AND MOTEL FIRE SAFETY ACT OF 1990 (P.L. 101-391)
Pursuant to Public Law 101-391, no Federal funds may be used to sponsor or fund in whole or in part a meeting ,
convention , conference or train ing seminar that is conducted in, or that otherwise uses the rooms , facilities , or
serv ices of a place of public accommodation that do not meet the requirements of the fire prevent ion and control
guidelines as described in the Public Law. This restr iction appl ies to public accommodat ions both foreign and
domestic.

Public accommodations that meet the requirements can be accessed at: http ://apps .usfa.fema .gov/ hotel/ .

ARTICLE H.19. USE OF FUNDS FOR CONFERENCES, MEETINGS AND FOOD

The Contracto r shall not use contract funds (direct or indirect ) to conduct meet ings or conferences in performa nce of
this contract w ithout prior written Contract ing Officer approva l.

In addition , the use of contract funds to purchase food for mea ls, light refreshments , or beverages is express ly
prohibited .

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PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

ARTICLE 1.1. GENERAL CLAUSES FOR A FIXED -PRICE RESEARCH AND DEVELOPMENT
SBIR PHASE II CONTRACT

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

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

FAR
CLAUSE NO. DATE TITLE
52.202 - 1 Jun2020 Definitions (Over the Simplified Acquisition Threshold)
52.203-3 Apr1984 Gratuities (Over the Simplified Acquisition Threshold)
52.203-5 May 2014 Covenant Against Contingent Fees (Over the Simplified Acquisition
Threshold)
52.203 -6 Jun2020 Restrictions on Subcontractor Sales to the Government (Over the
Simplified Acquisition Threshold)
52.203-7 Jun2020 Anti-Kickback Procedures (Over the Simplified Acquisition Threshold)
52.203-8 May 2014 Cancellation, Rescission, and Recovery of Funds for Illegal or Improper
Activity (Over the Simplified Acquisition Threshold)
52.203 - 10 May 2014 Price or Fee Adjustment for Illegal or Improper Activity (Over the Simplified
Acquisition Threshold)
52.203-12 Jun2020 Limitation on Payments to Influence Certain Federal Transactions (Over
the Simplified Acquisition Threshold)
52.203-17 Jun2020 Contractor Employee Whistleblower Rights and Requirements to Inform
Employees of Whistleblower Rights (Over the Simplified Acquisition
Threshold)
52.203-19 Jan 2017 Prohibition on Requiring Certain Internal Confidentiality Agreements or
Statements
52.204-4 May 2011 Printed or Copied Double-Sided on Postconsumer Fiber Content
Paper(Over the Simplified Acquisition Threshold)
52.204-10 Jun2020 Reporting Executive Compensation and First-Tier Subcontract Awards
52.204-13 Oct 2018 System for Award Management Maintenance
52.204-25 Aug 2020 Prohibition on Contracting for Certain Telecommunications and Video
Surveillance Services or Equipment
52.209 -6 Jun2020 Protecting the Government's Interest When Subcontracting With
Contractors Debarred, Suspended, or Proposed for Debarment
52.215-2 Jun2020 Audit and Records - Negotiation
52.215-8 Oct 1997 Order of Precedence - Uniform Contract Format
52.215-10 Aug 2011 Price Reduction for Defective Certified Cost or Pricing Data (Over
$750,000)
52.215 - 12 Aug 2020 Subcontractor Certified Cost or Pricing Data
52.215-14 Jun2020 Integrity of Unit Prices (Over the Simplified Acquisition Threshold)

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FAR
CLAUSE NO. DATE TITLE
52.215-15 Oct 2010 Pension Adjustments and Asset Reversions (Over $750,000)
52.215-18 Jul2005 Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB)
other than Pensions
52.215-19 Oct 1997 Notification of Ownership Changes
52.215-21 Jun 2020 Requirements for Certified Cost or Pricing Data and Data Other Than
Certified Cost or Pricing Data - Modifications
52.219-6 Nov2020 Notice of Total Small Business Set-Aside
52.219-8 Aug 2018 Utilization of Small Business Concerns (Over the Simplified Acquisition
Threshold)
52.219-14 Mar2020 Limitations on Subcontracting
52.222-3 Jun2003 Convict Labor
52.222-21 Apr2015 Prohibition of Segregated Facilities
52.222-26 Sep 2016 Equal Opportunity
52.222-35 Jun2020 Equal Opportunity for Veterans ($150,000 or more)
52.222-36 Jun2020 Equal Opportunity for Workers with Disabilities
52.222-37 Jun 2020 Employment Reports on Veterans ($150,000 or more)
52.222-40 Dec 2010 Notification of Employee Rights Under the National Labor Relations Act
(Over the Simplified Acquisition Threshold)
52.222-50 Oct 2020 Combating Trafficking in Persons
52.222-54 Oct 2015 Employment Eligibility Verification (Over the Simplified Acquisition
Threshold)
52.223-6 May 2001 Drug-Free Workplace
52.223-18 Jun2020 Encouraging Contractor Policies to Ban Text Messaging While Driving
52.225-1 Jan 2021 Buy American - Supplies
52.225-13 Feb 2021 Restrictions on Certain Foreign Purchases
52.227-1 Dec2007 Authorization and Consent, Alternate I (Apr 1984)
52.227-2 Jun2020 Notice and Assistance Regarding Patent and Copyright Infringement
52.227-11 May 2014 Patent Rights - Ownership by the Contractor (Note: In accordance with
FAR 27.303(b)(2) , paragraph (e) is modified to include the requirements
in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is
annual.
52.227-20 May 2014 Rights in Data - SBIR Program
52.229-3 Feb 2013 Federal, State and Local Taxes (Over the Simplified Acquisition
Threshold)
52.229-4 Feb 2013 Federal, State, and Local Taxes (State and Local Adjustments) (Over the
Simplified Acquisition Threshold)
52.232-2 Apr1984 Payments under Fixed-Price Research and Development Contracts
52.232-9 Apr1984 Limitation on Withholding of Payments
52.232-17 May 2014 Interest (Over the Simplified Acquisition Threshold)
52.232-23 May 2014 Assignment of Claims
52.232-25 Jan 2017 Prompt Payment
52.232-33 Oct 2018 Payment by Electronic Funds Transfer--System tor Award Management
52.232 -39 Jun 2013 Unenforceability of Unauthorized Obligations

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FAR
CLAUSE NO. DATE TITLE
52.233-1 May 2014 Disputes
52.233-3 Aug 1996 Protest After Award
52.233-4 Oct 2004 Applicable Law for Breach of Contract Claim
52.242-13 Jul 1995 Bankruptcy (Over the Simplified Acquisition Threshold)
52.243-1 Aug 1987 Changes - Fixed Price, Alternate V (Apr 1984)
52.244-5 Dec 1996 Competition in Subcontracting (Over the Simplified Acquisition Threshold)
52.244-6 Jun 2020 Subcontracts for Commercial Items
52.246-25 Feb 1997 Limitation of Liability - Services (Over the Simplified Acquisition Threshold)
52.249-2 Apr2012 Termination for the Convenience of the Government (Fixed-Price)
52.249-9 Apr1984 Default (Fixed-Price Research and Development)(Over the Simplified
Acquisition Threshold)
52.253-1 Jan 1991 Computer Generated Forms

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

HHSAR
CLAUSE NO. DATE TITLE
352.203-70 Dec 2015 Anti-Lobbying
352.222-70 Dec 2015 Contractor Cooperation in Equal Employment Opportunity Investigations
352.227-70 Dec 2015 Publications and Publicity
352.237-75 Dec 2015 Key Personnel

{End of GENERAL CLAUSES FOR A FIXED-PRICE RESEARCH AND DEVELOPMENT SBIR PHASE If
CONTRACT- Rev. 03/2021].

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ARTICLE 1.2. AUTHORIZED SUBSTITUTION OF CLAUSES

ART ICLE 1.1. of this SECT ION is hereby modified as follows :

a. Alternate I (February 2002), of FAR Clause 52.232-25 , Prompt Payment (January 20 17)

b. FAR Clause 52.249-4, Termination for Convenience of the Government (Services ) (Short Form) (Apri l
1984), is deleted in its entirety and FAR Clause 52.249-2, Termination for Convenience of the Government
(Fixed Price) (Apr il 2012) is substituted therefor .

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ARTICLE 1.3. Additional Contract Clauses

This contract inco rporates the following clauses by reference, with the same force and effect , as if they were given in
full text. Upon request , the Contracting Officer will make their fu ll text available.

a. FEDERAL ACQU ISITION REGULAT ION (FAR) (48 CFR CHA PTER 1) CLAUSES

1. FAR Clause 52.204-14 , Service Contract Reporting Requirements (October 20 16).

2. FA R Clause 52.204-24, Representation Regarding Certain Telecommunications and

Video Surveillance Services or Equipment (Decem ber 20 19).

3. FAR Clause 52.204-25 , Prohibition on Contracting for Certain Telecommunications

(August 20 19) .

4. FAR Clause 52.204-26 Covered Telecommunications Equipment or Services-

Representation (October 2020 ).

5. FAR Clause 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations

(November 2015 ).

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

7. FAR Clause 52.219-28 , Post-Award Small Business Program Rerepresentation (Novembe r

2020).

8. FAR Clause 52.227-14, Rights in Data - General (May 20 14).

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

10. FAR Clause 52.244-5 , Competition in Subcontracting (December 1996).

b. DEPARTMENT OF HEALTH AND HU MAN SERV ICES ACQ UISITIO N REGULATION (HHSAR) (48 CHAPTER
3) CLAUSES :

1. HHSAR Clause 352 .231-70, Salary Rate Limitation (Decembe r 2015)

Note : The Salary Rate Limitation is at the Executive Level II Rate.

See the following website for Executive Schedule rates of pay: https ://www .opm.gov /policy-data -
oversig ht/pay-leave/salaries -wages / .

( For current year rates, click on Salaries and Wages/ Executive Schedule/ Rates of Pay for the
Executive Schedule . For prior year rates, click on Salaries and Wages/select Another Year at the top
of the page/ Executive Schedule/ Rates of Pay for the Executive Schedule . Rates are effective January
1 of each calendar year unless otherwise noted.)

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 In immune Corporation : 75N93021 C00044
Reference Number: SBIR PHS-2021-1(091)

ARTICLE 1.4. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

This contract incorporates the following clauses in full text.

a. FEDERAL ACQU ISITION REGULATION (FAR) (48 CFR CHAPT ER 1) CLAUSES

1. FAR Clause 52.204-21, Basic Safeguarding of Covered Contractor Information Systems (June
2016)

a. Definitions . As used in this clause--

"Covered contractor information system" means an information system that is owned or operated by a
contractor that processes, stores, or transmits Federal contract information.

"Federal contract information" means information, not intended for public release, that is provided
by or generated for the Government under a contract to develop or del iver a product or service to
the Government, but not including information provided by the Government to the public (such as on
public Web sites) or simple transactiona l information , such as necessary to process payments .

"Information" means any communication or representation of knowledge such as facts, data , or

opinions, in any medium or form , including textual, numerical , graphic, cartographic, narrat ive, or
audiov isual (Committee on Nationa l Security Systems Instruction (CNSS I) 4009).

"Information system" means a discrete set of information resources organized for the collection ,
processing , maintenance , use, sharing , dissem ination, or disposition of information (44 U.S.C. 3502) .

"Safeguarding" means measures or contro ls that are prescribed to protect information systems.

b. Safeguard ing requirements and procedures.

1. The Contractor shall apply the following basic safeguarding requirements and procedures
to protect covered contractor information systems . Requirements and procedures for basic
safeguarding of covered contractor informat ion systems shall include, at a minimum, the
followi ng security controls:

i. Limit information system access to authorized users, processes act ing on behalf
of authorized users , or dev ices (including other information systems) .

ii. Limit information system access to the types of transactions and functions that
authorized users are permitted to execute .

iii. Verify and control/limit connections to and use of external informat ion systems .

iv. Control information posted or processed on publicly accessible information

systems .

v. Identify information system users, processes acting on beha lf of users, or

dev ices.

vi. Authenticate (or verify) the identities of those users, processes , or dev ices, as a
prerequisite to allowing access to organizationa l information systems.

vii. Sanitize or destroy information system media containing Federal Contract

Information before disposa l or release for reuse.

viii. Limit phys ical access to organizationa l information systems , equ ipment, and the
respective operating environments to authorized individua ls.

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 In immune Corporation : 75N93021 C00044
Reference Number: SBIR PHS-2021-1 (091)

ix. Escort visitors and monitor visitor activity ; maintain audit logs of physical access;
and control and manage physical access dev ices.

x. Monitor, control, and protect organizational communications (i.e., informat ion

transm itted or received by organizationa l information systems) at the externa l
boundaries and key internal boundaries of the information systems .

xi. Implement subnetworks for pub licly access ible system components that are
physically or logically separated from internal networks.

xii. Identify, report, and correct information and informat ion system flaws in a timely
manner.

xiii. Provide protection from malicious code at appropr iate locations within
organizational information systems.

xiv. Update malicious code protection mechanisms when new releases are
available .

xv. Perform periodic scans of the information system and real-time scans of files
from external sources as files are downloaded, opened, or executed .

2. Other requirements . Th is clause does not relieve the Contractor of any other specific safegua rding
requirements spec ified by Federal agencies and departments relating to covered contractor
informat ion systems generally or other Federal safeguard ing requirements for controlled unclassified
informat ion (CUI) as established by Executive Order 13556.

c. Subcontracts . The Contractor shall include the substance of th is clause, including this paragraph
(c), in subcontracts under th is contract (including subcontracts for the acquisition of commercial items,
other than commerc ially available off-the-shelf items), in which the subcontractor may have Federal
contract informat ion residing in or transiting through its information system .

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 In immune Corporation : 75N93021 C00044
Reference Number: SBIR PHS-2021 -1(091)

PART Ill - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

The following documents are attached and incorporated in this contract:

1. Statement of Work
Statement of Work , dated 10/26/2020, 5 pages .

2. Invoice Instructions for NIH Fixed-Price Contracts, NIH(RC)-2

Invoice Instructions for NIH Fixed-Price Contracts , NIH(RC)-2, (3/21 ), 3 pages .

3. Electronic Invoicing Instructions for NIH Contractors/Vendors

Electronic Invoicing Instructions, 2 pages .

4. Safety and Health

Safety and Health , HHSAR Clause 352.223 -70, (12/15) , 2 pages .

5. Disclosure of Lobbying Activities , SF-LLL

Disclos ure of Lobbying Activities , SF-LLL, 2 pages .

6. eRDS Electronic to Report Deliverable

eRDS Electronic to Report Deliverable, Subm ission User Guide , 8 pages .

7. Commitment To Protect Non-Public Information

Comm itment To Protect Non-Public Information, 1 page . Located at: https://ocio.nih .gov/aboutus /public infosecurity /
acqu isitio n/ Documents /Nond isclosure .pdf

8. Employee Separation Checklist

Employee Separation Checklist , 1 page . Fillable PDF format located at: https://ocio.nih .gov/aboutus /public infosecurity /
acquisition / Documents/Emp-sep-check list.pdf

9. NIH Small Business Innovation Research (SBIR) Program Funding Agreement

Certification
NIH Smal l Business Innovat ive Research (SB IR) Program Funding Agreemen t Certification, 3 pages, located at:
https://grants .nih.g_gy/grants/funding /sbir forms/SBIR%20Funding%20Agreement%20Certi fication.pdf

10. NIH Small Business Innovation Research (SBIR) Program Life Cycle Certification
NIH Smal l Business Innovat ive Research (SB IR) Program Life Cycle Certification , 3 pages , located at: http://
grants. nih .gov/ g rants/f undi ng/sbi r forms/SB IR%20Lif e%20Cycle%20Ce rtificati on. pdf.

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 In immune Corporation : 75N93021 C00044
Reference Number: SBIR PHS-2021-1 (091)

PART IV- REPRESENTATIONS AND INSTRUCTIONS

SECTION K- REPRESENTATIONS AND CERTIFICATIONS

The following documents are incorporated by reference in this contract:

1. FAR Clause 52.204 -19 Incorporation by Reference of Representations and Certifications (December 2014 ).

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

(End of clause)

2. NIH Representat ions & Certifications

Certification for : IN IMMUNE CORP DUNS: 080350279

Certification Validity From: Mon May 10 13:46:13 EDT 2021
Certification Validity To: Tue May 10 13:46:13 EDT 2022

3. Animal Welfare Assurance Number

rrop
riet
aryInfo

END of the SCHEDULE

(CONTRACT)

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Obtained via FOIA by WCW Project

Attachment 1
Statement of Work

Obtained via FOIA by WCW Project

 INIMMUNE NIAID TOPIC 091

Appendix E

STATEMENT OF WORK

TITLE: Development of a new TLR4 agonist for the treatment of allergic rhinitis.

I. Background Information
Provide a general, brief summary of what needs the research on this contract will be addressing.
Informat ion from the Topic description may be useful to include for context.

The goal of this program is to accelerate the pre-clinical development of a single

immunomodulator, a novel TLR4 agonist, for the treatment of allergic rhinitis.
Allergic rhinitis (AR) affects over 500 million people worldwide and ca1Tiesa significant
health and economic burden. The incidence and prevalence of AR have continued to rise
rapidly in recent years and AR is estimated to affect 10 to 30% of the world population
includin g up to 40% children, who bear the greatest burden of allergic diseases. Current
therapeutic options are avoidance of allergens, symptomatic medication , and allergen specific
immunotherapy (AIT). Although symptomatic medications are effective in treating the
symptoms of AR and are generally well tolerated with few side effects, they do not alter the
underlyin g disease and do not prevent disease progression. AIT is the only treatment modality
that has been shown to alter the underlying immunologic mechanisms that cause AR and
allergic asthma, with benefits that may last for several years after treatment discontinuation.
Several drawbacks of AIT include the treatment duration , cost, potential severe side effects
and low patient adherence, thus requiring the development of alternative safe and effective
approaches for the treatment of AR. The objective of this SBIR Phase II development proposal
is to advance our TLR4 agonist for the treatment of allergic rhinitis to the pre-IND stage. The
ultimate goal of this research project is the development of anfropr ieiaryinfo!stand-alone TLR4
agonist that will provide relief against AR symptom s within hours of administration. In
addition to providing short-term symptom control , this approach also has the potential to
deliver long-term disease remission. Unlike AIT, this non allergen-specific approach 1s
expected to provide protection against a wide variety of environmental allergens.

II. Scope
Provide a one to two sentence statement of what is expected to be accomplished under the
contract.

Under this contract, we will perform extended pre-clinical IND-enabling studies including
additional rnurine efficacy studies and validate our immunomodulator in an established canine
model of AR, formulation stability studies and toxicology testing.

III . Obiectives
State the specific objectives and anticipated end results of the proposed Phase II effort

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 INIMMUNE NIAID TOPIC 091

The specifi c goal of this SBIR Phase II development proposal is to advance our lead TLR4
agonist INI-2004 toward s pre-IND by
(i) completin g in-hou se murin e preclinical efficacy studies (Task lA) and validate our
candidate in the established canine mode l of allergic rhinitis (Task 2B) to select an optima l
formulation and an administration schedule ;
(ii) perform accelerated and long term stability study of the optima l formulation (Task 2A)
and characterization test f ropr
ierary
info l(Task 2B); and
(iii) complete toxicology studie s includin g mutagenicity testing (Task 3A), metaboli sm
studie s (Task 3B), non-GLP (Task 3C.1) and a GLP multiple dose toxicity in rats (Task 3C.2)
to assess the safety of repe ated admi nistration of our TR4 agonist.

At the end of this phase II, we are anticipating obtaining the preclinical data to support the
weekl)froprietarylnfo
!admini stration of the lead formu lation ofINI-2004 fropr ietarylnfo I
rropr I
ietarylnfo and safety data in a rodent spec ie . These precli nical studie s will form the basis of our
pre-IND document.

IV. Services to be Performed .

Begin thi s section with the following langua ge: "T he contractor shall independently
perform all work and furni sh all labor , materials, supplie s, equip ment, and serv ices (excep t
as otherwi se specified in the contract ) to perform the following services:"

The contractor shall independently perform all work and furni sh all labor, materials,
supplie s, equipment , and services (except as otherwise specified in the contract) to perform
the following services.

A. Spe cific Req uirement s - List all tasks in a logical sequence, in an outline format, to
precisely describe what is expected of the contractor in perform ance of the work.
Tasks should contain enough detail to establish parameter s for the proj ect and keep
the effort focused on meeting the object ives.
Do not includ e any proprietary information.

Specifi cally, the Contractor shall :

1. Indep endently perform all work and furnish all labor , materi als, supplie s, equipm ent,
and services to complete the precli nical in vivo studies incl uding the selection of an
opt imal INI-2004 formulation and admi nistration schedule in mice using an established
OVA murine mod el and the clinically relevant Der p 1 antigen (lnimmune), and
validating this formulat ion/administration schedule in the well-estab lished canine
model of allergic rhiniti sfropr
ietary
lnfo I
a. Subact ivity: the Contra ctor will evaluate ropr
ieraryinro
formu lations of INI-200 4 and
compare them toFropr ieraryinro !formu lation m our establi shed murine OVA allergy
model (lnimmune).

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 INIMMUNE NIAID TOPIC 091

b . Subactivity: th e Contractor will co nfir m th e ~teiary effec tiveness of the optimal

formu lation of INI-2004 in our es tabli shed murin e OV A allergy m ode l
(Inimmun e).

c. Subactivity: the Contractor will valid ate the optimal formulation and ropr ietaryinfo
admin istratio n effec tive ne ss of INI-2004 in the murine Der p 1 allergy mo e
(Inim mune).

d. Subactivity: the Contractor w ill perform an efficacy stu dy in an es tabli shed m ode l
of canine allergic rhiniti s by eva lu atin g r ropr
ietaryinfo INI-200 4 in ragweed- I
sensi tized dogsfroprietaryinfo I
e. Subactivity: th e Contractor will investigate th e window of desensitization provided
by a s ingle administration of INI -2 00 4 in ragweed-sensitized do gs rropr ietaryinfo
r ropr
ietaryInfo I
f. Subactivit : the Contractor will in vest iga te the safety and efficacy o ropr
ietaryinfo
ropr
ietaryinfo of INI-2004 in ragwee d-sensitize d dogs ropr ietaryinfo
ropr
ietaryInfo

2. Ind epe nd ently perform all work and furnish all labor, materials, supplie s, equipm ent , an d
serv ices to erform the formulation and stabi lit y studi es (Inimmun e, r ropr ietaryinfo
ropr
ietaryinfo ~--------~

a. Subactivity: th e Contractor will prepare and characterize r~r-o_prie_tary

_ In_fo______ ~
ropr
ietaryinfo formulations of INI -2004 for m urine and canine studi es and perform
acce era ted and long- term stabili ty studi es on the se formulations (Inimmun e).

b. Subactivity: th e Contractor will evalu ate ropr

ietaryinfo
ropr
ietary
Info dog
'------:---:-:-------:---:---:------:-:--:---:---:--:---;:---:-------;::::=====:::;--'
ragweed studi es and in subse qu en t clinical trials (Inimmu ne ,rroprietaryinfo

3. Ind epe nd ently perform all work and furnish all labor.,..
, _m_a_t_e r~i~
al_s.,_
, _su..........
_ _.,____,___.__m~
ent , and
se rvices to perform toxicology studi es (Cova nce and ropr ietaryinfo

a. Subactivity: the Contractor will perform mutagenicity tes tin g of INI-2004

(Cova nce).

b. Subactivity: the Contractor will perform metabolism studi es of INI-2004

(Covance).

C. Subactivity: the Contractor wi ll eva luate the safety of ~rr_op-rie-tary

- In
_fo-----~
adm ini strat ions 3 doses of INI-200 4 in the lea d formulation in a pilot tox icity
study in rats roprietaryinfo

b. Subactivity: the Contractor wi ll eva luate the safety of rroprietaryinfo I

admini strat ion s (3 doses) of INI-2004 in the lead formulation in a GLP tox icity
study in rats r ropr
ietaryinfo I
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 INIMMUNE NIAID TOPIC 091

B. If the research plan includes the use of human subjects or animals, briefly describe the
parameter s of this use. Refer to Sections 4 and 8 of the Solicitation for further guidance.

The contractor 's research plan includes the use of mice and dogs to validate the
formulation and administration schedule of the TLR4 agon ist, and rats to evaluate the
safety of roprietaryinfo admini strations of the TLR4 agonist. The murine allergy
studies w1 t e pac e at t e niversity of Montana (Missoula, MT) vivarium under an
exte rnal contract agreement between Inirnmune and UM. The University of Montana
vivarium is equipped with state-of-t he art equipment including micro-isolator cages
and large holding and procedural rooms required for animal husbandry. The University
of Montana has an approved Assurance on file with the Office of Laboratory Animal
Welfare (OLA W) and AAALAC accreditation. Murine allergy studies will take place
under the University of Montana IACUC approved animal use protocol (AUP) 002-19.
Prior to any of proposed work taking place that does not fall under the experi ments
allowed by this AUP will require a new AUP to be reviewed and approved by the
University of Montana IACUC before those experimen ts take place. Plea se see the
Vertebrate Animals section of the Det ailed Approach and Methodology for further
detai ls. The dog studies will be perform ed by roprietaryinfo and the rat studies
_________
will be performed by .._roprietarylnfo _.

The contractor shall independently perform all work and furnish all labor , materials,
supplies, equipment, and services to complete animal studies in full comp liance with
the Public Hea lth Service (PHS) Policy on Humane Care and Use of Labor atory
Animals (PHS Poli cy) . The offero r (through the University of Montana) shall maintain
a written Animal Welfare Assurance (Assurance) on file with the Office of Laboratory
Animal Welfare (OLAW), National Institutes of Health (NIH) which commits the
organization to comp ly with the provi sions of the PHS Policy, the Animal Welfare Act,
the Guide for the Care and Use of Laboratory Animals (National Academy Press,
Washington, DC). Prior to starting any work involving animals, the Contractor shall
provide the Contracting Officer verification of IA CUC approval for all work performed
as part of this contract.

C. Reports & Deliverables - Describe end product s and deliverables, and describe
periodic/final report s required to monitor work progress under the contract.

The end product of this SBIR development will be the completion of the following
pre-IND-enab ling studies:

(i) selection of an optimal formulation for roprietaryinfo administration of a TLR4 agonist

to treat allergic rhiniti s

(ii) selection of an administration sched ule of the TLR4 agonist after preclinical studies
in the established canine model of allergy rhinitis

iii 1- ear stabilit stud ies of formulated INI-2004 , F,__roprietaryinfo

roprietarylnfo ___________ __.

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 INIMMUNE NIAID TOPIC 091

(iv) tox1c1ty studie s including mutagenicity and metabolism studi es and one GLP
multiple do se toxicity in rats

Deliverable s will exist in the form of 4 milestones that will be met throughout the
course of thi s SBIR:
rop
rietaryInfo
Milestone 1: Complete preclinical murine studies by
,__ __ -J

Milestone 2: Complete preclinica l canine studie s b~roprieraryinfo

~----c----....,----~~-=--=--:'..
Milestone 3: Complete formulation and stability studi es by roprieraryinfo

Milestone 4: Complete preclinical toxicology studie s byfroprieraryinfo

We will complete sem i-annual and annual technical and financial report s to monitor
work progress under this SBIR.

Page 75 of 76

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Attachment 2
Invoice Instructions

Obtained via FOIA by WCW Project

 INVOICE INSTRUCTIONS FOR NIH FIXED-PRICE CONTRACTS, NIH(RC) -2

Format : Submit payment requests on Standard Form 1034, Public Voucher for Purchases and
Services Other Than Personal, or the Contractor's self-generated form provided it contains all of
the information prescribed herein. DO NOT include a cover letter with the payment request.

Number of Copies: Submit payment requests in the quantity specified in the Invoice Submission
Instructions in Section G of the Contract Schedule.

Fre quency: Submit payment requests upon delivery and acceptance of goods or services unless
otherwise authorized by the Contracting Officer.

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

Preparat ion and Ite mization of the Pay ment Request : Prepare payment request s as follows:

Note : All information must be legible or the invoice will be considered improper and returned to
the Contractor.

(a) Designat ed Billing Offic e Na me and Addr ess: Enter the designated billing office name and
address, as identified in the Invoice Submission Instructions in Section G of the Contract
Schedule.

(b) Contractor' s Name , Addre ss, Point of Cont act, TIN , and DUNS or DUNS+4 Numb er: Show the
Contractor's name and address exactly as they appear in the contract. Any invoice identified as
improper will be sent to this address. Also include the name, title, phone number, and e-mail
address of the Point of Contact in case of questions. If the remittance name differs from the
legal business name, both names must appear on the invoice. Provide the Contractor's Federal
Taxpayer Ident ification Number (TIN) and Data Universal Numbering System (DUNS) or DUNS+4
number. The DUNS number must identify the Contractor's name and address exactly as stated
in the contract, and as registered in the System for Acquisition Management (SAM) database.

When an approved assignment of claims has been executed, the Contractor shall provide the
same information for the assignee as is required for the Contractor (i.e., name, address, point of
contact, TIN, and DUNS number), with the remittance information clearly identified as such.

(c) Invoice/Voucher Number: Identify each payment request by a unique invoice number, whic h
can only be used one time regardless of the number of contracts or orders held by an
organization. For example, if a Contractor has already submitted invoice number 05 on one of
its contracts or orders, it cannot use that same invoice number on any other contract or order.

NIH(RC)-2
Revised 3/2021
1
Obtained via FOIA by WCW Project
 Payment requests with duplicate invoice numbers will be considered improper and returned to
the Contractor.

The NIH does not prescribe a particular numbering format but suggests using a job or account
number for each contract and order followed by a sequential invoice number (example:
8675309-05). Invoice numbers are limited to 30 characters. There are no restrictions on the use
of special characters, such as colons, dashes, forward slashes, or parentheses.

If all or part of an invoice is suspended and the Contractor chooses to reclaim those costs on a
supplemental invoice, the Contractor may use the same unique invoice number followed by an
alpha character, such as "R" for revised (example: 8675309-05R).

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

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

(f) Contract Title: Insert the contract title listed on the cover page of the contract and/or Section G
of the Contract Schedule.

(g) Current Contract Period of Performance: Insert the contract start date/effective date through
the current completion date of the contract .

(h) Total Fixed-Price of Contract/Order: Insert the total fixed-price of the contract/order.

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

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

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

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

(m) Description of Supplies or Services: Provide a description ofthe supplies or services, by line item
(if applicable), quantity, unit price (where appropriate), and total amount. The item description,
unit of measure, and unit price must match those specified in the contract. For example, if the
contract specifies 1 box of hypodermic needles (100/box) with a unit price of $50.00, then the
invoice must state 1 box, hypodermic needles (100/box), $50.00, not 100 syringes at $0.50 each.
Invoices that do not match the line item pricing in the contract will be considered improper and
will be returned to the Contractor.

NIH(RC)-2
Revised 3/2021
2
Obtained via FOIA by WCW Project
(n) Amount Billed · Current Period: Insert the amount claimed for the current billing period,
including any adjustments, if applicable. If the Contract Schedule contains separately priced line
items, identify the contract line item(s) on the payment request.

(o) Amount Billed • Cumulative: Insert the cumulative amounts claimed to date, including any
adjustments as applicable. If the Contract Schedule contains separately priced line items,
identify the contract line item(s) on the payment request.

(p) Freight or Delivery Charges: Identify all charges for freight or express shipments, other than
f.o.b. destination, as a separate line item on the invoice. (If shipped by freight or express, and
charges are more than $25, attach prepaid bill.)

(q) Government Property: If the contract authorizes the purchase of any item of Government
Property (e.g., equipment), the invoice must list each item for which reimbursement is
requested. Include reference to the following (as applicable):

- item number for the specific piece of equipment listed in the Property Schedule, and
- Contracting Officer Authorization (COA) Number, if the equipment is not covered by the
Property Schedule.

NIH(RC)-2
Revised 3/2021
3
Obtained via FOIA by WCW Project
Attachment 3
Electronic Invoicing Instructions

Obtained via FOIA by WCW Project

 Instructions for Submitting Electronic Invoices via Email to the NIH Office of Financial
Management (OFM) Effective April 23, 2020
Step 1:
4 Steps to Create th e Invoice Submission Email
Send invoices to
~ the following email
VENDOR:CMO
CorpiPO:HHSN271201S99XXXP
/ HHSN302XXXXSI
INVOICE:41?':,1
...
address:
File Message Insert Options FormatText Review
invoicing@nih.gov
Calibri(Body} • 11 • A A ~ AttachFile•
B J .!::!. •- • - • +-= = Names
~Attach Item•
Step 2:
Paste
.t>.,a. ~ =~ fl~ [ll'Signature•
Subject line must
Clipboard r. BasicText r;; Include
follow this format
for the invoice you
From v are submitting
(see note below)
Send To

Cc Step 3:

Attach the invoice

Subject VENDOR:CMO
CorpjPO:HHSN271201599XXXP
/ HHSN302XXXX5jlNVOICE:412312
to the email as
either a PDFor
lnvo1Ce_Sample.pdf
115KB
V
Word document.

Step 4:
Corresponden
ce Email: XYZ@CMOCorp.com
In the body of the
email, type
"Correspondence
Email:" followed by
your email address.

Step 2 Note : The key words (Ve ndor, PO, and Invoice), Colon (:) character following the keywords and the PIPE (I)
character must be present to identify the information. The pipe ( I ) character is entered by pressing and holding the shift
key and t he backslash (\ ) key at the same time.

EXAMPLE: Vendor : name of the contractor or vendor I PO: Contract Numbe r/Release Number I lnvoice :9999999

For your reference, below is a chart list ing examples of t he correct and incorrect subject lines. Note: These are just
examples, you must enter the applicable info r mation for the invoice you are submitting.

Subject Line Correct Incorrect

Vendor : XYZ Corp I PO: Contract Number/Release Number Ilnvoice:XYASAD

XYZ Corp IPO# Contract Number\Releas e Number IInvoice # XYASAD X

XYZ Corp IPurchase Order# Contract Number\Relea se Number IInvoice# XYASAD --- x
XYZ Corp I Contra ct Number\Release Number I XYASAD X
Vendor: XYZ Corp,PO: Contract Number\Release Number,lnvoice :XYASAD X

Obtained via FOIA by WCW Project

 Instructions for Submitt ing Electronic Invoices via Email to the NIH Office of Financial
Ma nageme nt (OFM) Effective April 23, 2020

Remind e rs:

• Must submit only one invoice per email.

• Follow the system size limits that apply to the email and each invoice: individual email attachments cannot exceed
5 megabytes each; and the email plus all attachments cannot exceed a total of 30 megabytes.
• Clearly identify a valid and complete contract number on each invoice
• Clearly identify a valid and complete order number on each invoice
• Clearly identify an accurate DUNS number on each invoice
• DO NOT include confidential information such as Social Security Numbers (do not include TIN if it is a Social Security
Number)
• The invoice attached to the email must be in a PDFor Word format

The date/time that a valid invoice is submitted electronically to the email box (invoicing@nih.gov ) will be the same
date/time logged as the invoice is received by NIH.

Please do not hand- delive r invoic es to any NIH office. Pleasefollow the above electron ic submission instruc t ions until
further not ice. In addition, please note tha t your contract or order will not be modified to reflect the above changes to
the invoicing instructions. Failure to follow the above electronic submission instructions may result in invoice processing
delays.

Vendor Help
Open 8:30 am to 4:30 pm. EST Mon-Fri

.' Call: 301-496-6088

Click here to Submit Invoice for

Payment Via Email

·: Click here lo Send lr1voice Inquiries

Via Email

Click here to Chat Online

1 Click here to request a Callback

Que sti ons? Please direct inquiries regarding the status of invoices such as receipt of invoices, due date, or payment of
invoices to the OFM Commercial Accounts Branch, Customer Service Office . The OFM Customer Service contact
information and methods to contact are available at OFM website: https://ofm.od.nih.gov/Pages/Customer-Service .aspx

The Customer Service Office is open Monday - Friday from 8:30 am to 4:30 pm (Eastern Standard Time) and is closed daily
between 12:00 pm to 1:00 pm (Eastern Standard Time).

Inst ructions fo r Contr actor Court esy Copy Elect ronic Invo ice Submi ssion to th e Contr act ing Officer (CO):

The Contractor shall send the OFM-submitted invoice to the NIH Contracting Officer.

Obtained via FOIA by WCW Project

Attachment 4
Safety and Health

Obtained via FOIA by WCW Project

 Safety and Health, HHSAR 352.223-70 (DEC 2015)

a. To help ensure the protection of the life and health of all persons , and to help
prevent damage to property , the Contractor shall comply with all Federal , State ,
and local laws and regulations applicable to the work being performed under this
contract. These laws are implemented or enforced by the Environmental
Protection Agency , Occupational Safety and Health Administration (OSHA) and
other regulatory/enforcement agencies at the Federal, State, and local levels.
1. In addition , the Contractor shall comply with the following regulations
when developing and implement ing health and safety operating
procedures and practices for both personnel and facilities involving the
use or handling of hazardous materials and the conduct of research ,
development , or test projects :
I. 29 CFR 1910.1030 , Bloodborne pathogens ; 29 CFR 1910.1450,
Occupational exposure to hazardous chemicals in laboratories;
and other applicable occupational health and safety standards
issued by OSHA and included in 29 CFR part 1910. These
regulations are available at https://www.osha. gov/.
II. Nuclear Regulatory Commission Standards and Regulations,
pursuant to the Energy Reorganization Act of 1974 (42 U.S.C.
5801 et seq.). The Contractor may obtain copies from the U.S.
Nuclear Regulatory Commission , Washington , DC 20555 -0001.

2. The following Government guidelines are recommended for developing

and implementing health and safety operating procedures and practices
for both personnel and facilities :
I. Biosafety in Microbiological and Biomedical Laboratories , CDC .
This publication is available at
http://www.cdc.gov /biosafety/p ublications /index.htm.
II. Prudent Practices for Safety in Laboratories (1995), National
Research Council , National Academy Press, 500 Fifth Street NW. ,
Lockbox 285, Washington, DC 20055 (ISBN 0-309-05229-7). This
publication is available at
http ://www.nap.edu /catalog/49 11/prudent -practices -in-the -
laborato ry-handl ing-and-d isposal-of-chem icals.

b. Further, the Contractor shall take or cause to be taken additional safety measures as
the Contracting Officer , in conjunction with the Contracting Officer's Representative
or other appropriate officials, determines to be reasonably necessary. If compliance
with these additional safety measures results in an increase or decrease in the cost
or time required for performance of any part of work under this contract, the
Contracting Officer will make an equitable adjustment in accordance with the
applicable " Changes" clause set forth in this contract.

c. The Contractor shall maintain an accurate record of, and promptly report to the
Contracting Officer , all accidents or incidents resulting in the exposure of persons to

Obtained via FOIA by WCW Project

 toxic substances, hazardous materials or hazardous operations; the injury or death
of any person; or damage to property incidental to work performed under the
contract resulting from toxic or hazardous materials and resulting in any or all
violations for which the Contractor has been cited by any Federal, State or local
regulatory /enforcement agency. The report citing all accidents or incidents resulting
in the exposure of persons to toxic substances , hazardous materials or hazardous
operations ; the injury or death of any person ; or damage to property incidental to
work performed under the contract resulting from toxic or hazardous materials and
resulting in any or all violations for which the Contractor has been cited shall include
a copy of the notice of violation and the findings of any inquiry or inspection, and an
analysis addressing the impact these violations may have on the work remaining to
be performed. The report shall also state the required action(s), if any, to be taken to
correct any violation(s) noted by the Federal , State , or local regulatory/enforcement
agency and the time frame allowed by the agency to accomplish the necessary
corrective action.

d . If the Contractor fails or refuses to comply with the Federal , State or local
regulatory/enforcement agency's directive (s) regarding any violation(s) and
prescribed corrective action(s), the Contracting Officer may issue an order stopping
all or part of the work until satisfactory corrective action (as approved by the Federal,
State , or local regulatory /enforcement agencies) has been taken and documented to
the Contracting Officer. No part of the time lost due to any such stop work order shall
form the basis for a request for extension or costs or damages by the Contractor.

e. The Contractor shall insert the substance of this clause in each subcontract involving
toxic substances, hazardous materials, or hazardous operations. The Contractor is
responsible for the compliance of its subcontractors with the provisions of this
clause.

(End of clause)

Obtained via FOIA by WCW Project

Attachment 5
Disclosure of Lobbying Activities, SF-LLL

Obtained via FOIA by WCW Project

 DISCLOSURE OF LOBBYING ACTIVITIES 0MB Control Number: 4040-0013
Expiration Date: 2/28/2022
Complete this form to disclose lobbying activities pursuant to 31 U.S.C.1352

1. * Type of Federal Action: 2. * Status of Federal Action: 3. * Report Type:

!ZI a . contract D a. bid/offer/applica tion !ZI a . initia l filing
Db.grant !Z1 b. inilial award D b. material change
D c. cooperative agreemen t D c. pos t-award
D d . loan

D e . loan guarantee
D f. loan insurance

4. Name and Address of Reporting Entity:

IZ!P rime D SubAwardee
•Name
I I
• Street 1 I I Street 2 I I
'City
I I State I I Zip I
I
Cong ressiona l Disl rict, if known: I I
5. If Reporting Entity in No.4 is Subawardee, Enter Name and Address of Prime:

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

I I
I I
CFDA Number. if applicable : I I
8. Federal Action Number, if known: 9. Award Amount, if known:
$I I
I I
10. a. Name and Address of Lobbying Registrant:
Prefix I I • First Name I I Middle Name I I
• Last Name I I Suffix
I I
• Street 1 I I
Street 2
I I
• City
I I State I I Zip I I
b. Individual Performing Services (including address if different from No. 10a)

Prefix
I
1• First Name I IMiddle Name I I
I
'Last Name
I Suffix
I I
• Street 1
I I Street 2 I I
• City
I I State I I Zip
I I
11. lnfonnat ion requested through this form is authorized by tiUe 31 U.S.C. section 1352. This disclosure of lobbying activities is a material representa tion of fact upon which
reliance was placed by the tier above when the transaction was made o r entered into. Thi s disc losu re is required purs uant to 31 U.S.C. 1352. This infonnat ion will be reported to
the Congress semi-annua lly and will be available for public inspection. Any perso n who fa ils to file the required disclosure shall be subject to a civil penalty of not less than
$ 10,000 and not more than $100.000 for eac h such failure.
• Signature:
II I
•Name: Prefix
I I • First Name I I Middle Name I I
I Suffix
• Last Name
I I I
Tit le: I Telephone No.: I l oate : I I
Federal UH Only: I STANDARD FORM L LL (REV. 7/1997)
Authoozed for Loca l Reproduction

Obtained via FOIA by WCW Project

Attachment 6
eRDS

Obtained via FOIA by WCW Project

NIAID Office of Acquisitions II~ National
Institutes
ofHealth
rJTurningDiscovery
IntoHealth

Electronic Report Deliverable

Submission

User Guide for

Vendors

V2018.1.0
April 2018

Obtained viaPage
FOIA by15
1 of WCW Project
Contents
eRDS- Improving your contract delive rables submission process .......................................................................................... 3
Vendor Roles............................................................................................................................................................................. 3
Vendor Registration - How to register for an eRDS account ................................................................................................... 3
Vendor Registration - How to login if I have a registered eRDS account ................................................................................ 6
Add Vendor Submitter ................................. ........................... ................. ................................... ......................... ..................... 9
Submit New Deliverable ......................................................................................................................................................... 11
COR Inspection of Deliverable ................................................................................................................................................ 12
Re-Submission & Alternate Submissions ................................................................................................................................ 13

Obtained viaPage
FOIA by15
2 of WCW Project
eRDS - Electronic Report Deliverable Submission
Vendor Guide G 1111)
~!!=!~~:!~;ofHealtti 0

eRDS - Improving your contract deliverables submission process

The electronic Report Deliverable Submission (eRDS)application is a component of NIAID's integ rated, secure system
for the electron ic submission, capture, trac king and review of NIAID contract deliverab les. The eRDS application allows:
• Vendors to easily submit contract delivera bles.
• Procurement Technicians, Contracting Officer s Representativ e, and Contract Specialists/Officer to track and
accept contract deliverables.

Vendor Roles
eRDS has two Vendor roles:
• Vendor Ad min (VA): the 'lead' Vendor assigned to the contract by th e NIAID Contract Specialist (CS).They can
create and assign Vendor Submitters (VS) to their contracts, as well as submit deliverables themselves. The CScan
create multiple Vendor Adm ins for a contract if needed.
• Vendor Submitter (VS): created by the Vendor Admin to submit deliverables for their contracts. The VA may add
multi ple Vendor Submitters to the ir contr act as needed .

Vendor Registration - How to register for an eRDS account

How to register for an eRDS account - Applies to Vendor Admin and Vendor Submitter
Note: All Vendors (Vendor Admin/Vendor Submitter) with existing NIH EXTand eRA Commons accounts can no longer
login to electronic Report Deliverable System. All vendors must have an eRDSaccount to login.

• Follow the steps to register for an eRDSaccount:

1. Go to the eRDSRegistration https://erd s.niaid .nih.gov/
2. Click on register here

~ electronic Report Deliverable Submission Roost " .1 1.oe,n

~ N,rnor,al lnrotute-s of He-artn Homit

Welcome to NIAi D's electronic Report Deliverable Submission (eRDS)

TM •1tcttof\lc Rt port Ot. ver.b t SubmissJOnl•R.OS)is I c:ompoMnl of MAJO'sil"ltt&fMtd , steutt syam for lM eltctronic subrr!.ssion, c1pn;rt , tt1ckitl1and rt'M'Wof NIAJOR&OCOMflctdeli'ltf1blff.

To.. lrnfl"M)(tlboutthtOA, plus. visit : TM Cof'ltractr,cportlll fot MAID"1 OfflteotAcpltions.

WARNINGHOTK'£.: ThGis:sU..S.G'1111"1:'rnmffrtc:~l«~tcni.whid'sm;7f:i<:x=1.sC'd.11ndl,;:sc_,d_...,fClf•wtt....-..M~~nt:,..,wic,u'!:Jy-:.tlC1tia-dpcnO"'ll'lft.U,i~c,rc4'd~~i;or~c,l'thi1>mfnpil~~1>i..,,tT1m'llf~btt"d~r,io

tll'"' .. 1,tffl, .,_J/Dr """"'" .. .a'l,wo a:IID-

All ..,.."'..aonlh~CDIT!P,..td v,•m

Dl'I ru, bc-.. tVldlled ~. te<IIII,tCJOied,,1,- diKbcd II,, ol'ld l04IM'lbt 1led ~e luf trfhci,,I p...-;io~ ..,th.,dif,gu..,..~1.., ve.sr.,.t10 ra. Sud! a,fu,,f1Vtt011indl.OCI~IIVl'U.~p,llld 10

co,,miyl'ltiton.._,"tiaitv.-.dP'•~'fllllfCmcl'lt•.ku'-'ar1De9'th4tOll'9JlCf1'r1lCfl'll:,yilfly~wl-cthe1~0,-,,,1,1t~,cd..t0nJbli.t~wroftlltoll'lnctcrffl~.Tlwreiltt0ritf,tof.-'i11J,-y1ntt..l•r,ii-

Notice to All Current Users

BeOllnirc April 27th. all CUTent eRDS users QJI no lon ger loc:in to eRDS wit h exi ttw'tC
NIHEXTa nd eRA Common s acm unts. ADrurrent eROS auoi..m: holder s will need to a eat e a new eRDS ~m.
using One Time Pin (OTPI a uthennc~on. PleaH re~ to more deta iled instructions on the repstraoon proc.ess in FAQ's.

Want to Submit a Deliverable? Top Frequently Asked Questions

Sien in di rectly to eROS: • HowclollopntotheeRDSaepiation?

• What types of documents can I submit?

~ eRDSLog m I • I c.m't find " My Submission History-

. Where can I view m/ prewiouslysubmittEd

G) fyoudor,c,uln!1clyh1,rn•RDS•cccu l ~~!~-
@ Once you ha1,1esu cc!MSfully reg:..st.e-red, pleotie contact
IQ
your Contra ct Speciat.st to add
• Where can I lurn more about POFdocuml:m:s?'

you to tM Contract.

Obtained viaPage
FOIA by15
3 of WCW Project
3. You will be directed to One Time PIN Authentication screen. Locate' Register Here 'link and click on it .

If you are an existing user pleas e enter your registered email be low and click on ver ify emai
button

IS Enter your registered email address

II
Having trouble finding your registered email? Contact Ga
---------------------------------------

4. Complete the application and click 'Continue ' button

(3 User Registration

Email j doe@Bmal l.com

Confi rm Email jdoe@gmal l.com

First Nam• john

Middle Name

LutN ame doe

Phone phone number Is required

Company CSRANIA ID

Street Address fisherslane

Cijy city riame is required

State State nome is required

Zip 208502

Country United Statesof America

T'xb4<1" I Txb4cuj

-0•Back To Login

5. User Registration notification is displayed

Your account has been successfully created. A confirmation e-mail will be sent to the
registered e-mail address shortly.

-
Obtained viaPage
FOIA by15
4 of WCW Project
6. User email registration notification is sent that the account had been created
E.g. Email Screenshot
Thu 3/29/2018 10:13 AM

DN DO NOT REPLY<OTP@mail.nih.gov >

Account Created
To vanihext@outlook.com
New email registration is sent
to the User

NIH Logi n accou nt fo vanihext @outlook .com has been successf ully creat ed.

Fo r fur t her assistan ce o r q uest ions conta ct Adm in

7. Once you receive the email , you need to notify your Contract Specialist that you have competed the account
registrat ion for eRDSaccount with the following Information .
✓ First Name
✓ Last Name
✓ Organization
✓ Contract Number that you need access to
✓ Email used for registration of eRDSaccount
8. Once Contract Specialist adds you to the cont ract, you will receive an email notification after which you wi ll be
able to log into eRDSto accessyour Contract and submit deliverables. Refer to section "How to login if you hav e
a registered eRDS account "
Note : If you try to login to eRDS before Contract Specialist assigns you to the Contra ct you will see
the following message.
"Sorry,you are not associatedwith any contracts. Please clickhere to return to Home page."

Obtained viaPage
FOIA by15
5 of WCW Project
Vendor Registration - How to login if I have a registered eRDS account
How to login if you have a registered eRDS account - Applies to Vendor Admin and Vendor
Submitter
Note: All Vendors (Vendor Admin/Vendor Submitter) with existing NIH EXTand eRA Commons accounts can no longer
login to electronic Report Deliverable System. You must have an eRDSaccount to login .

If you have applied for an eRDSand the Contract Specialist has assigned your account to the Contract, follow the steps to
login to the eRDS application . If you have not registered for an eRDSaccount, please refer to the instructions in the "How
to register for an eRDSaccount and login" section above.
1. Go to the eRDSRegistration https://e rds.niaid.nih.gov/
2. Select 'eRDSLogin' button

ID electronic Report Deliverable Submission

National institutes of Heattn
""ci
""' .1.1.op,
Hom.

Welcome to NIAi D's electronic Report Deliverable Submission (eRDS)

Allinofma.oncnthi,atmFL"!Cf~mmaybe-l:'lt~ed ~.re;1C1,copied,.irddi~d~a:rdl0.::11,,t.'1oritei=~dlorolfici,;Jlp<.r.10~-rdvCWtgtr-'T-i;ll.~tio~Sud--rfor-n.1rion -ldl.de5~:!Yi:-d;miencryptedlo

~ W>ll'ttlll'llllr"t..,l¥ Mid p,vayN"QY,11tne1b. kt.C!1& DI' !IM'ol tt.c.DIT'ICMlc!,

.t"1ilffl'I ..,.ariv~ wlwltiir1 Mhtltiad or WYo1~>1.cd.<.01'11dlull:!1m~ u,tllinc- Wl'ffl1.llw,e: • no r""'- ()f pr,v.Ky'" tl,a. ¥!a'ftl.

Notice to All Current Users

Becinnlrc April 27th. aD awrtm •ROS UMf"I c:anno lonse, lot:In to •ROS wi th ni1firw NIHEXTand~ 'olliillne-«t to aeate • new .u>S KC:Ount.
Comimonsaca,unu. AJIcu.-...nt eROS aaoum hCMden
usinc One Time Pin (on>) authentntion . Please refer t o more deta iled instnx:tions on the repst ration proc.ess in FAQ's.

Want to Submit a Deliverable? Top Frequently Asked Questions

Signlf'I dit«:tty to eRDS:

--------
'2'.'j) I
.. eROSLogin
How do I eog.nto the eR:OS
WhM typm: of documents can I lubmrt?
applteabon?

I can't md"My SubmlUM)nHiAW- VJhtoreCMI YIIWfflVpreviouslvsu.btnlnad

~

(!) f you do not ilna u:tv hiil"Je•n itR::>S

iilCCOUnt,.repster here. Where an I learn more ~ut PDF documents?

@ One• you Nv. r.1·st•rtd , ps.u. contaet your ContrKt SQ,t,cillistto add
succHSfulJry
yoo to t N Contract.

3. Enter your eRDSregiste red ema il and click on the "Search" icon.

•J SignIn ,. New User? Register Here

If you are an existing user please enter your registered email below and click on verif y email
button

B Enter your registered email address

II
Having trouble finding your registered email? Contact E

Obtained viaPage
FOIA by15
6 of WCW Project
4. The Email with the one-time verification code is mailed to t he user email address
Thu3/29/2018 10:27AM
DN DO NOTREPLY<OTP@mail.nih.gov>
One Time VerificationCode - Transaction ID [ 114288J
lo ve1111htxtlff)ootlook.<0tn

A verification code roquo,t was made for the email account yaolht!St@ouUook
com.

Ve:rific.atlonCod~: 38048 6

Note: If you have requested mu ltiple verification codes, match the tr a nsaction ID shown be low to the one shown on the 'Code VNificat ion' screen to
conf irm that you a rc enter ing the correct code . Only the last code requested can be va lidatod~The transact ion ID for this request is 1 14288 I
for further assistance or questions contact Admin

5. Enter the verification code provided in the emai l on the 'Code Verification' screen. Ensure the transaction ID
provided in the email matches the transact ion ID provided in th e screen.
Not e: The one-time verification code sent to you is valid for the next 8 hours. If you log in within the next 8
hours, you can use the same code to login. If you try to login after 8 hours, the application will automatically
send you a new code . Alternatively, if you have issues with login using the existing code, you can click on
generate new code button at the bottom of the screen which will automatically send out a new code.
I
8 Code Verification

A one-time verification code has been sent to t he email address shown below . Wait a few minutes
as the email receipt time can vary depending on your service provider. Ensure the tran s action id in
the email notification subject matches with the screen before you enter the code

l:,!i vanihext@outlook.com

Please enter the verification code received for t ransaction idl114288 I

IQ l8048q r________
iii@+ ¢:I

Didn't receive code? Please check that there is no mistake in the registered email account.
Sometimes automated messages get categorized as spam. Check your spam folder

Generate New COde

Having trouble logging in? Contact EEi

Obtained viaPage
FOIA by15
7 of WCW Project
6. Click on 'Verify Code' button.

8 Code Verification

A one -time verification cod e has been sent to the email address shown below. Wait a few minutes
as the ema il receipt time can vary depending on your service provider. Ensure the tr ansaction id in
the email notification subject matches wit h the screen before you enter the code

l!,j vanihext@outlook
.com

Please enter the verification code received for t ransaction idl 114288 I
)a l8048q r________
1%5§1 ¢

Didn't receive code? Please check that there is no mistake in the registered email account.
Sometimes automated messages get categorized as spam. Check your spam folder

Generate New Code

Having trouble logging in? Contact tiE!!!!J

7. The notification message is displayed: "Your email address has been verified. Please select from one of the
options below' will be able to select 'Continue to Application' green button, or select 'View/Edit Profile'

0 Your email address has been verified. Please select from one of the options below

8. Select 'Contin ue to Application'.

9. User will be redirected to the 'My Contracts' page.
0
~\ ::;'..':,""'"' ., electronic Report Deliverable Submission
lilllf/ lnfectlOUSDiseases
.l Welcomll ¼lniht xt ¼I O Logout

FP.i:ilrHI My Submission Histoty FAQ How To Si.emit Aboo( Contact Us

My Cont racts VA only VA&VS

10

ContractNum~r

HHSN272200800006C Vaccine and TreatmentEvalu.ttiorlUn.ts {VTEUs): Evalumionof Comrol

Measurestor OtseasosOther Than AIDS

Not e: If you try to login to eRDSbefor e Contract Specialist assigns you to th e Contract you will see th e
following messag e.
"Sorry, you are not associated wit h any contracts. Please click here to return to Home page."

Obtained viaPage
FOIA by15
8 of WCW Project
Add Vendor Submitter
To add a Vendor Submitt er to a contract (Vendor Adm in ONLY):
Note: Vendor Adm in can add a Vendor Submitter to the Contract to submit deliverables on behalf of the Vendor. Vendor
Submitter must hav e an eRDS account before Vendor Admin can add Vendor Submitter to the Contract.

1. Select th, 1-MMbd

(Add
Submitter) button in the "Submitter Assignment" column
2. Enter First and Last Names in the "Find New Staff" fields and click Ill (Search)

Add Submitter

Contl"Mt : N01Al40074
TitS. : Sf.•u,lillyl,.)Mmln.dlr\f.c:t!Onleltlk: ... T~Gtoup
Cont,-.w:tStart Oat• · 9/29/2004 U{)():O:)A.M
Con-tt1t111\4Otte : 4/30/20 1112:00:00AM
f NIA, N!Y~F!Vt.lllOSC.0 ___n____
Vou11oltonlhl\tOl'ltl<kl V.ntlorA4m ln ~

Find New Staff:

~ N ne

3. If t he user has a registered eRDS account, it will display the result in po pup window . If the user does not have a
registered eRDSaccount, then no results will be displayed.
For example :
IAssign Submitt e r to Contra ct ,c

5 _____ B
Name Email Action

Vendorlas t, Vendorfirst vanihext@outlook.com

Vendor email
Vendor last & first name venihext@gmail. com
Submitter f

F rat t"reVIOU

4. User with Vendor Admin (VA) role can assign Submitter to Contract as a "Submitter", and click 'Close':

Submitter

Ft Provou 1 c:oi.t .. .:at

5. Once the VA assigns the New Submitter to a contract, the follow ing message is displayed . User assignedon the
contract successfully!Submitter will receive an email notificat ion after which submit t er can access t he contract and
submit deliverables .

Obtained viaPage
FOIA by15
9 of WCW Project
 Assign Submitter to Contract )(

User assigned on the contract successfully!

Name Email
,.
y Action

Vendorlast , Vendorfirst vanihext@outlook .com

C-9%:HW
6. If the submitter had already been assigned to the contract and is reassigned again, the system displays the following
message. User already assigned on this contract!

Assign Submitter to Contract )(

User already assigned on this contract!

A
Name Email y Act.ion

Vendorlast, Vendorfirst vanihext@outlook.com

M.lfiif:HW
7. The Vendor Admin (VA) can remove Vendor Staff(s) including themselves, if they haven't submitted any deliverables
yet (a zero under 'Number of Submissions by this user' column) .

8. Select the Ill (Back) button to return to 'My Contracts '

ass gne to contract

N•mo Subminiw.s
IFint Nam11, Lan Name) by this uHr Action

dot,john v1niht1xt@0utlool:.com 0
hdfohii
r°'\ NOI
Luko nln, Dmltry-OTP dmitry .lukonln@nih.go\/ 000--00-0000
\.!,.,,/ removable
doe.john Johndoe@gma ll.com SSS-555-5555 O vs
3017756039 VenOOfAdmin

- VA can removea VA of VS 1ftlleyve notye,

submitted detverables

Obtained via FOIA

Page 10 by
of WCW
15 Project
Submit New Deliverable
To Submit a New Contract Deli verabl e:

S ub rrut New Del ive ra bl e

1. Select your contract's (Submit New Deliverable) button in the "Action" column.
My Cont:rilct:s My Submission His.tory FAQ HowTo SUbmit Abou1 Conlact Us

Submit Deliverable
Co n tract : HHSN272200800006C
Tltle: vaccine and Treatment Evaluation Units (VTEUs ): Evaluation ot Control Me~es fol Diseases Other Than AIDS
Contract Start Oate: 111112007 12:00:00 AM
Contract End Date : 9/30J2017 12:00:00 AM
Vendor: Chlldren's Hospital Medical Centef
Your role on thts contract Vendor Admln

Instru ctio ns: PktaS4ill

a,mple1e !he fom, OOlow.ind upload r9'31oddoa.Jmen1s.
AJI fonn fiekb marked w1th• are requ.-ed

2. Enter the Deliverable's Name , Type, Time Frame (for recurring reports in the calendar year), and any Supplementary
Notes as needed:

Instructions: Please complete the form oeJOwano uplOaorelateOOocuments All form flekls markeo wnh • are requIreo

Deliverable Nome• : I2_0_15_ 1s_1o_ ua_rt_er_ly_P_ro_g_re_s_s_R_epo_rt__________

__ _,I <==iRequired
Deliverable Type •: Quarterly Progress Report
• <==iRequired
Time Frame: NIA • ~ determined per Deliverab le Type
supplementary Notes: I Please enter note here

Deliv erable Doc ument s •:

f o uplOadmu pie r11es
at mesamebme Select file(s) <=:i Attachments
please useIE10 0t aoove,Chromeor f1refo,<) Required
•¾IHMti -
3. Choose seiectrneis) (Select Files) to attach one or more documents. Using Internet Explorer 10 and above, Google
Chrome or Mozilla Firefox as web browsers will enable user to select multiple files at the same time . Microsoft
Office files (word, excel) and Adobe PDFare accepted.
4. Choose "Open" once User have files selected.
U Op e n
O • ia::I D..slctop • ~ I •~ 11 Sea rch De,ktop

Organize .. New folder

* N a me Siz e It em typ i!!: Datt"! mo d 1f1ed

•.
Fa vo rit es
11:lDesktop [1,;iLeadin g _SA Fe. 16,03 5 KB Adobe Ac rob a t Doc um e nt 12/10/2 0 14 3:11
'~ eRDS v2 Requ i rem f! .. 69 1 KB Mi crosoft Word Doc u ment 3/10/20 15 11 :5S
.,/1, Do w nloads
~ RQ 7236 _ 1_8_ K
_B__ M_ i_c -, o-s-oft_ W_ o_ r_d_M_ a_ c_ro
- - E-n-a b
_ l_e _d _D_o_c _u _ 7_/1_0_/20
_ 1_4_1_2 -,:U
~ Rece n t Place
~ Li b rar i es
-
File n am e: "'Leadi n g_SA Fe • • eRDS v2 Require m ents _ rev3" " RQ 7236 "' ..., IA_ I_I Fi_,_les____
~ ;:=========
~j
Open ,.,.. Cancel I

5. The attached files display next to Deliverable Documents. SelecL ififl¥@d(Submit Deliverable) to complete the
submission:

Obtained via FOIA

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 6. A delivery confirmation screen is displayed wit h a summa ry of the delivered content submitted.

Congr-atukltions. yo ur upload was successful on 6/ 1 6/ 20 1 5 10 ;27:53 AME ST. Your subm iss i on deta ds are pro v ided belo w and
can be s een under My Submiss i o n Hi s tory Reviewers hav e been notlfled and soon w m beg in r ev i ewing tfle fl i es P l eeise gtve
atleast 4 weeks for the reV1ew process to complete . Fee l free to revise yo ur s ubmi ssion and ReS u bm1t 1f neede d. If yo u don't w ish
to resubmit , yo u ma y flnd your s ubm iss ion to vtew or revi se at an y nme under My SubP1'1ss lon H ist ory.

Submissio n N :.me : 20 15 1st auarterty Prog re ss Repon

Deliverab l e Ty pe : O uane r ly Progress Report
Time Fr..1me : 1st Quarter
supp le me nt :.ry N otes :
Deliv e ra ble Do cum e nts: Lead in g _SAFe pdf
eRDS v2 Requirements_rev3 doc:x
RO 7236 d ocm

7. Upon submission oft he deliverable docume nts user can view the data on ' My Submission History' page.

CORInspection of Deliverable
COR Inspection of Deliverable (/OD) report ; My Submission History

1. Upon acceptance/re j ection of the deliverable documents , user will receive a 'Notice of Status Change' emai l with an
embedded link to eRDS. After login, user will be redirected to 'My Submission History' page.
NOTE: if deliverab les are reje cte d, a similar not ice is sent

Notice statu:;change on submitted deliverable for contract HHSN272201400005C- subjectline

<Do Nor REPLYJ Vendor
To yarbaar@yahoo.com~
cc raymond .raab@n ih.gov-- ContractSpecialist
~ •Ray,
~ l~rab~ 20151st Qu111tt=rfyProgra s Report for contr act HHSN272201400005 Cthat wa s subm itt ed on 6/ 16/ 201 5 1:S6:46PM l5 ac:ceit ed.
Plce~ c k kh!:r.E:_
to&o to t he tRDS epp lication to r evit w dt:taiits in the CORInspection of Deliver ablt Report. \

........_
linkto eRDS scenario of accepted

2. On this page, user will see contract's tit le and numbe r, submission detai ls, and document links, and the COR
Inspection of Deliverable Report PDF at the bottom of the details .

My Contr a cts My Subm1sston History FAQ How To Submit About Contact Us

My Submission History
HHSN272201400005C Subm1I New Deliverable
NI A ID C en ters of E x ce lle n ce for Influenza Research and Surveillance

•
l ; i#I
Submission Name
2016 1st Q u ~r1er1y Prog r ess
Submme<I on: 6/16120 ~ S6 46
Re p on .
C..:,
Submission

•
Documents
Lead,ng_SAFe.p df

1/
eRDS v2 Re q uirements re v 3 do c x
- Resubmitted: No DOCUmen • RQ 7238. docm -
Details - oeuverable type: 0Uarter1y Pr<><1ress Report Links
- Status: Accepted
- COR lnspecbon 01 Deliverable Report:
COR _ lnspectJon_ot_Dellverable_Report,_704_27 pdt ¢ COR Insp ection of Deliv erab le lin k

3. To review, select the CORInspection of Deliverable Report PDFto download the document through your web
browser .

Obtained via FOIA

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 NIAID

ID>
==
Offlc. of Acqullttlons
COR Inspection of Deliverable /Report
ls.sue Oat•: 6'16/2015

--
Statu s : Af)provld
........

Contract No . HHSN272201400005C
Task Order No. (H Appllc.ible) 20 15 1st Quarterly Progress Report Approved
Contractor UnYef'Sily of Rodlester
o.nvuablel Roport Typa Quarteny Progre .. Report
or Rejected
Deliverable Due Date 11I 14/20 15 12 :00:00AM indicated
Date Received 6/16/20151 :56:46 PM
Repo rtlng Peri od (H Applicable) 1st Quarter
here

TNs lette, serves as notification that your deliverab le "2015 1st Ouarterty Progress Report' has met ou- agreed upon
exped/lllonS and Is acrepted .

I
These are opl ional comments by the COR

Reviewing Officer
Cindy, Le (Coruact>'lg Officer's Repre..nto tlve)
i} If Approvedthere mayor maynot
be CORcomments

If Rejected,CORexplanationwill
be here.

Re-Submission & Alternate Submissions

Re-Submit a Deliverable

1. If user receives a 'Notice of Status Change' email notice from NIAID that the submission was not accepted (rejected),
select the embedded link in the ema il notice to go to ' My Submission History'.

Notice ,tatu, change on ,ubmITTeddeliverable for contract HHSN272201400005C- subjectline

<oo Nor REPLY> Vendor
To yarbaar@yahoo.com..,.........
cc raymond.raabCnih.gov-- ContractSpecialist
OearA.av,
Delhler?ltlle 2015 lSt Quattertv Proires s Report for contract HHSN272201400005 C thac: w;,s51.1bmm:ed o n 6/16/20 151 :56:46 PM was na: accecite d.
Please ck~ toeo to t he eRD5app lication to r eview deu,Jls 1nthe CORlnsi,ectton of ~ 11\l
erable ~oort. \

........._
linkto eRDS scenarioof Rejected

2. Under ' My Submission History' , the COR Inspection of Deliverable Report PDFwill provide an explanation for the
rejection.

Obtained via FOIA

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 NIAIO

ID>
==
Offleo of Ac qutsldo ns
COR Inspection of Deliverable /Report
tssue Date : 6116/2015
Status: RojK:ltd

Contract No. HHSN272201 400005C

Task Order No. {If App licable) 2015 1st Ouarterty Progress Repon
Contractor Urlve<sityof Rocheste r
Deliverabl e/ Report Type Quarteriy Prog ress Repon
Oellvorab la Dua Data 7115/2015 12.00 :00 AM
Date Received 6116/2015 3:34:04 PM
Reporting Period (If Applicable ) 2nd Qua rter

This letter serves as nocificallon that your deliverable'20 15 1st OuMeriy ProgressReport' has not met ouragreed
upon expectationsand is not accepteddue to the fellowingreason:

IProgress Report Is missing data on tabs OET02and OET« \

\ RejectionExplanation
ReviewingOfficer
Cindy . Le (ConlracfugOflioer"s ReP<esentalive)

3. User revises the deliverable documents and selects the 11111

(Re-Submit) button for revised deliverable
resubmission . Click OK button to get past the notification popup window .
My Contracts My Subm1ss1on Htstory FAQ How To Submit About Contact Us

My Submission History

,.•,.,
HHSN272201400005C Subm 1I New Dehve rable
NIAJD Centers or Excellence tor 1nnuenza Researcn an<J survelllance

Submission Namtt
sut>m1ss10n Documents
2015 1 st Qu.1nerly Progress Repon.
Lead ing _SAF e.pdf
- Submitted on: 6/16/2015 3 34 04 PM E S.T

Availiable after
I Resut>mmect: No
Oeuverable Type: Ouarter1y Progress Report
Status: ReJfl'!cied
eRDS v2 ReQulrements
RQ 7236 docm
_ rev3.0ocx

NIAID Accepts/ -COR lnspectN>n of Oekverabte Report:

COR _ ln specbon _ of_ Oe li verab le_Re port _ 704 _ 28 pdf
Rejects package

4. The Submit Deliverable page is the same for re-submissions, except for an additional instruction line indicating
resubmission status. After submission, user will receive the same confirmation messages and email notices

Submit Deliverable
Contract : HHSr-127220 140 0005C
Trtll! : NIAIO Centers of Excel~nce fo r lnnuenz a Research and Survei llance
Contract Start Date: 41112014 12.0 0.00 />M
Contract Eno Date: 3/3112021 12·00·00AM
Vendor: University of Roch ester
Your role on tnlS contract. Vendor Admin

Instructions: Please complete me torm bek>v.an<l upk>acJrelateo oocuments All form tiekls marl<ed witn • are requireo
TJlts tS resubmiss10nor SUbmlSSK)n
"2015 1st auartenv RrOQressRePort" <lated 6/ 1612015. 3 34.04PM

"IJ'
ResubmissionLine

5. Under ' My Submission History' , the submission details are updated w ith the revised submission . The original is also
still visible

Obtained via FOIA

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 HHSN272201400005C
NIAJDcenters or Excelaence
ror 1nnuenza
Researehand surve 11an
ce

Submission Name
SubmIssIon Documents
015 1St Quarter1y Progress Report• REVISED.
tmmed on: &'1b/20154.3 14 PM ES.T
Leading_SAFepdf
submitted: Yes
eRDSv2 Requ•ements_rev3docx
~ iginal Deli'lle1ablf!: 2015 1st auar1i:;ir1yP1ogress Report RQ7236docm
revised.......,,, - 01:lliverebe Type: Quar1erty Progress Report
Status: Submrtteed

Submission Name!
submission Documents
20151st Ou•"•~Y ProgressRepo".
Leading_SAFepdf
•
Submitted on: 6 16'20 5 3 34.U PM ES
eRDS v2 Requirements_rev3.docx
Resubmrttwd:No
RQ 7236docm
original¢ - Deliverable Type: ouanert)' Progress Report
- Status: ReJecied
COR .-ispectK>nof Oehereble Report:
COR_lnspedlon_ot_Oe iverable_Repon.]04_28pdt

Submit an Alte rnat e Deliverable

-
1
1. If user s contract requires two different types of deliverables, eRDSallows the Vendor to submit a second or
'alternate ' deliverable . On the 'My Submission History' page, there is a HIHI-NMiji (Submit New Deliverable)
button for each contract. It is available even if the last submission for a given deliverable is still under review and is
neither accepted nor rejected yet.

2. Selecting the iflfji@-§Mii

(Submit New Deliverable) button takes you to the Submit Deliverable page. After
submission, the My Submission History page is updated with the new package

HHSN272201400005C
NIAJDCenters of Excellence for Influenza Research and Surveillance
iiildi·NiMiji
Submission Nam@ Submission Documents
FIPS 199 Assessment. • FIPS 199 Assessmenlxlsx
- Subnutled on: 6116120155 08 58 PM EST
additionalor Resubmitted; No
alternate Q -Oelrverable Jype: FIPS 199 Assessmen1
- StDtus: Submi~ed

submission Name
Submission Documents
0 15 1st Quorterty Progress Report• REVISED.
Leading_SAFe pdf
bmmed on: 6/1612015 4 .1114 PM EST
submitted; Yes
eRDSv2 Requirements_rev3docx
~ riginal Dekverable: 20151st Ouarterty Progress Repon RO 7236 docm
revisedL...y' - oe11vera01e
Type:ouaMen,ProoressRepon
Status: SubmrtiBed

SubmIss1on Name
Submission Documents
2015 1st Quarter1y Progress Report.
Leading_ SAFe pdf
Submrttedoo: 6J16f.2015 3:34 04 PM E S.T
eRDSv2 Requirements_rev3docx
- Resu1>mmed: No

original Q -
Deliverable Type: Quarterly Progress Report
Status: ReJeded
RQ 7236 docm

-COR Inspection of Deiverable Report

COR_ lnspect1on_ of_Oehverable _ Report _704_ 28 pdf

Obtained via FOIA

Page 15 by
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