DEPARTMENT
OF
THE
ARMY
U.S.
ARMY
CONTRACTING
COMMAND
—
NEW
JERSEY
PICATINNY
ARSENAL,
NEW
JERSEY
07806-5000
REPLY
TO
ATTENTION
OF
21
July
2020
Army
Contracting
Command
—
New
Jersey
ACC-NJ,
Building
9
Picatinny
Arsenal,
NJ
07806
SUBJECT:
Technical
Direction
Letter
for
Medical
CRBN
Defense
Consortium
(MCDC),
Request
for
Prototype
Proposals
(RPP)
20-11,
Objective
PRE-20-11
for
"COVID-19
Pandemic
—
Large
Scale
Vaccine
Manufacturing
Demonstration"
(Pfizer,
Inc.)
REF:
Prizer
Request
for
Technical
Direction
Letter,
RPP
20-11
under
OTA
W15QKN-16-9-1002
for
Objective
PRE-20-11,
dated
20
July
2020
Advanced
Technology
International
ATTN:
(b)
(6)
,
Sr.
Contracts
Manager
315
Sigma
Drive
Summerville,
SC
29486
Dear
(b) (6)
The
Army
Contracting
Command
—
New
Jersey
(ACC-NJ),
in
supporting
the
Joint
Project
Manager
—
Medical
Countermeasure
Systems
(JPM-MCS),
issued
MCDC
RPP
20-11
on
09
June
2020.
Members
of
the
MCDC
submitted
proposals
in
accordance
with
this
RPP.
The
Government
received
and
evaluated
all
proposal(s)
submitted
and
a
Basis
of
Selection
has
been
executed,
selecting
Pfizer,
Inc.
as
the
awardee.
The
Government
requests
that
a
Firm-Fixed-Price
Project
Agreement
be
issued
to
Pfizer,
Inc.
to
award
this
proposal
under
Other
Transaction
Agreement
W15QKN-16-9-1002,
to
be
performed
in
accordance
with
the
attached
Government
Statement
of
Work
(SOW).
Based
upon
the
acceptable
update
of
Pfizer,
Inc.'s
proposal
for
"COVID-19
Pandemic
—
Large
Scale
Vaccine
Manufacturing
Demonstration"
and
1)
The
Project
Agreement
Recipient's
concurrence
with
the
requirements
included
in
the
Government
SOW;
2)
An
acceptable
milestone
schedule
that
meets
SOW
requirements,
and;
3)
The
price
proposed
that
has
been
analyzed
by
the
Government,
you
are
hereby
directed
to
issue
a
Project
Agreement
to
Pfizer,
Inc.
for
the
subject
project.
The
total
project
value
has
been
determined
fair
and
reasonable
and
Pfizer,
Inc.'s
proposal
has
been
selected
IAW
the
above
referenced
Basis
of
Selection.
The
total
approved
cost
to
the
Government
for
this
effort
is
not
to
exceed
$1,950,097,500.00.
The
break-out
of
the
costs
is
as
follows:
$1,950,000,000.00
to
perform
project
efforts
included
in
the
SOW
and
$97,500.00
for
the
Consortium
Management
Firm
(CMF)
Administrative
Cost.
The
CMF
Administrative
Cost
was
approved
as
a
"Special
Allocation"
for
Operation
Warp
Speed
(OWS)
Prototype
Projects
executed
under
the
MCDC
OTA.
The
effort
currently
has
$1,950,097,500.00
of
available
funding,
comprised
of
$1,950,000,000.00
for
the
Project
Agreement,
$67,500.00
for
the
CMF
Special
Allocation,
and
$30,000
for
other,
non
G&A,
ATI
costs,
which
will
be
incurred,
tracked,
(b)
(6)
E-mail:
Phone:
and
invoiced
in
accordance
with
Article
V
of
the
OTA.
The
COVID-19
work
shall
be
tracked
separately
using
the
funding
obligated
via
modification
P00076.
In
alignment
with
the
special
allocation
conditions,
it
is
noted
that
this
project
has
a
base
period
of
performance
,
with
a
projected
completion
date
of
.
A
customized
clause
for
the
specia
l
allocation,
will
be
incorporated
into
the
funding
modification
for
this
prototype
project.
The
prime
contractor
is
considered
a
small
business,
nontraditional
defense
contractor,
or
nonprofit
research
institution
and
determined
to
be
providing
a
significant
contribution.
The
affirmation
of
business
status
certifications
submitted
as
part
of
the
proposal
are
hereby
incorporated
into
the
agreement.
The
contractor
shall
notify
the
MCDC
CMF
of
any
deviation
from
the
final
proposed
affirmation
of
business
status
certifications
that
would
affect
the
contributions
of
the
small
business,
nontraditional
defense
contractor,
or
nonprofit
research
institution
as
proposed.
In
accordance
with
10.U.S.C.
237
lb(f),
and
upon
a
determination
that
the
prototype
project
for
this
transaction
has
been
successfully
completed,
this
competitively
awarded
prototype
OTA
may
result
in
the
award
of
a
follow-on
production
contract
or
transaction
without
the
use
of
competitive
procedures.
Points
of
Contact:
Au
eements
S
-
cialist:
(b)
(6)
(b)
(6)
Phone:
(b)
(6)
Agreements
Officer:
Regards,
(b)
(6)
(b)
(6)
Agreements
Officer
Signed
by.
(b) (6)
(b)
(6)
(b)
(6)
Attachments:
Attachment
1:
MCDC2011-003
—
Pfizer
-
7-21-2020
Attachment
2:
SOW
Appendix
1
Clause
for
MCDC
Consortium
Other
Transaction
Authority
Agreements
Statement
of
Work
For
COVI
D-19
PANDEMIC—LARGE
SCALE
VACCINE
MANUFACTURING
DEMONSTRATION
RPP
#:
20-11
Project
Identifier:
2011-003
Consortium
Member:
Member
Title
of
Proposal:
COVID-19
Pandemic--Large
Scale
Vaccine
Manufacturing
Demonstration
Requiring
Activity:
Joint
mission
between
the
Department
of
Health
and
Human
Services
and
Department
of
Defense
to
combat
COVID-19
1.0
INTRODUCTION,
SCOPE,
AND
OBJECTIVES
1.1
Introduction
This
Statement
of
Work
(the
"Statement
of
Work")
is
hereby
entered
into,
effective
as
of
July
21,
2020,
pursuant
to
that
certain
Project
Agreement
by
and
between
MCDC
and
Pfizer
dated
as
of
July
21,
2020
("this
Agreement"
or
"Project
Agreement").
An
outbreak
of
respiratory
disease
caused
by
a
novel
coronavirus
was
first
detected
in
China
in
late
2019
and
has
now
spread
worldwide,
including
the
United
States
("US").
The
virus
has
been
named
Severe
Acute
Respiratory
Disease
Coronavirus-2
("SARS-CoV-2")
and
causes
Coronavirus
Disease
2019
("COVID-19").
On
January
30,
2020,
the
International
Health
Regulations
Emergency
Committee
of
the
World
Health
Organization
("WHO"),
declared
the
outbreak
a
"Public
Health
Emergency
of
International
Concern".
On
January
31,
the
US
Department
of
Health
and
Human
Services
Secretary
("HHS"),
Alex
M.
Azar
II,
declared
a
Public
Health
Emergency
for
the
US
to
aid
the
nation's
healthcare
community
in
responding
to
COVID-
19.
On
March
11,
2020,
WHO
publicly
characterized
COVID-19
as
a
pandemic.
On
March
13,
2020
the
President
of
the
United
States
declared
the
COVID-19
outbreak
a
national
emergency.
The
Government
has
identified
COVID-19
vaccine
candidates
that
are
progressing
rapidly
through
advanced
research
and
development
activities.
Therefore,
in
response
to
a
request
by
the
Government,
Pfizer
is
proposing
to
manufacture
at-scale
and
fill-finish,
for
provision
to
the
Government,
a
state-of-the-art
candidate
vaccine,
developed
in
collaboration
with
BioNTech
and
capable
of
providing
protection
against
the
SARS-CoV-2
threat
and
related
coronaviruses,
subject
to
technical,
clinical
and
regulatory
success.
Pfizer
and
BioNTech's
program
aims
to
revolutionize
the
vaccine
field
by
providing
an
mRNA
candidate
that,
itself,
has
several
key
advantages,
including
the
efficiency
and
flexibility
of
the
platform
—
which
is
apparent
by
the
pace
of
the
vaccine
development
and
the
unprecedented
phase
1
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of,
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Firm
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Firm
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this Statement
of
Work.
US
168054648v17
A
1/2/3
trial
design
that
it
supports.
A
clear
fundamental
difference
of
this
candidate
over
more
traditional
modalities,
such
as
viral
vector
vaccines,
is
that
mRNA
is
delivered
by
protein-free
lipid
nanoparticles,
which
is
believed
to
abolish
the
risk
of
anti-vector
immunity
and
permit
boosting
to
maximize
the
level
and
duration
of
immune
responses.
The
mRNA
vaccine technology
is
also
intended
to
enable
quick
scale
up
of
production,
which
is
critical
for
bringing
a
COVID-19
vaccine
to
market
to
address
this
urgent
medical
need
while
preserving
high
quality
and
safety
standards.
The
intent
of
this
prototype
project
is
to
demonstrate
that
Pfizer
has
the
business
and
logistics
capability
to
manufacture 100M
doses
of
its
cun
-
ently
unapproved
mRNA-based
COVID-19
vaccine
for
the
Government
(b)
(4)
,
using
the
Pfizer/BioNTech
unique
mRNA
delivery
system
and
its
associated
cold
chain
requirements,
under
pandemic
conditions.
This
prototype
project
aims
to
significantly
accelerate
and
secure
US
access
to
this
promising
medical
countermeasure
based
on
domestic
manufacturing.
1.1.1
BACKGROUND
,
Pfizer
and
BioNTech
entered
into
an
agreement
for
the
co-development
and
distribution
(excluding
China)
of
a
potential
mRNA-based
coronavinis
vaccine
aimed
at
preventing
COVID-19
infection
(the
"Pfizer/BioNTech
Agreement").
Under
the
Pfizer/BioNTech
eement
•
revention
o
COVID-19
revention
o
COVID-
19
for
the
or
the
2
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Finn
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent award.
If.
however,
an
agreement
is
awarded
as
a
result
of:
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Finn
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Finn
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this
Statement
of
Work.
US
168054648v17
The
collaboration
has
rapidly
advanced
multiple
COVID-19
vaccine
candidates
into
human
clinical
testing
based
on
BioNTech's
proprietary
mRNA
vaccine
platforms,
with
the
objective
of
ensuring
rapid
worldwide
access
to
the
vaccine,
if
approved.
The
collaboration
leverages
Pfizer's
broad
expertise
in
vaccine
research
and
development,
regulatory
capabilities,
and
global
manufacturing
and
distribution
network.
The
two
companies
are
jointly
conducting
clinical
trials,
and
will
also
work
jointly
to
commercialize
the
vaccine
upon
regulatory
approval.
Pfizer
and
BioNTech
have
already
made
substantial
progress,
outside
this
Statement
of
Work
and
without
use
of
any
Government
funding,
towards
the
demonstration
of
technical
and
manufacturing
feasibility,
including
through
the
initiation
of
Phase
1/2
studies
evaluating
the
likelihood
of
safety,
tolerability
and
inununogenicity
in the
US
and
in
Germany.
The
goal
of
the
program
is
to
rapidly
develop
and
obtain
regulatory
licensure
for
a
vaccine
for
use
in
adults
>18
years
of
age,
followed
by
a
possible
pediatric
and/
or
maternal
indication
(to
protect
—4M
US
pregnant
women
at
risk
each
year).
Both
companies
aspire
to
have
an
FDA-approved
or
authorized
vaccine
ready
for
administration
in
the
US
by
October
31,
2020.
Based
on
current
information,
Pfizer
and
BioNTech
anticipate
a
2-dose
per
patient
regimen.
This
Statement
of
Work
is
designed
toward
establishing
production
capacity
and
distribution
infrastructure
sufficient
to
ensure
that
doses
of
the
vaccine
manufactured
under
this
Agreement
can
be
made
available
immediately
for
administration
in
the
US,
if
clinical
trials
are
successful
and
the
FDA
grants
an
Emergency
Use
Authorization
("EUA")
under
Section
564
of
the
Federal
Food,
Drug,
and
Cosmetic
Act
or
Biologics
License
Application
("BLA")
licensure
under
Section
351(a)
of
the
Public
Health
Service
Act
(hereafter
"FDA-approved
or
authorized").
1.1.2
ACTIVITIES
UNDERTAKEN
WITHOUT
GOVERNMENT
FUNDING
This
section
describes
activities
that
Pfizer
and
BioNTech
have
been
performing
and
will
continue
to
perfonn
without
use
of
Government
funding.
These
activities
are
described
solely
for
background
and
context
for
the
Government-funded
deliverables
itemized
in
Section
4.
A.
Regulatory
Planning
Pfizer
will
meet
the
necessary
FDA
requirements
for
conducting
ongoing
and
planned
clinical
trials,
and
with
its
collaboration
partner,
BioNTech,
will
seek
FDA
approval
or
authorization
for
the
vaccine,
assuming
the
clinical
data
supports
such
application
for
approval
or
authorization.
Given
that
these
clinical
trials
are
regulated
by
the
FDA
and
HHS,
there
is
no
need
for
separate
regulation
by
the
U.S.
Army
Medical
Research
and
Materiel
Command.
BioNTech
is
the
Investigational
New
Drug
("IND")
holder,
while
Pfizer
is
the
designated
agent
for
all
interactions
with
the
FDA
and
is
taking
the
lead
on
all
communications
with
and
submissions
to
FDA.
3
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Finn
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent award.
If.
however,
an
agreement
is
awarded
as
a
result
of:
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Finn
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Finn
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this
Statement
of
Work.
US
168054648v17
B.
Clinical
and
Regulatory
Approach
BioNTech
is
the
regulatory
sponsor
for
trials
of
the
vaccine
and
will
be
the
applicant
in
the
US
for
an
EUA
and/or
a
BLA,
and
will
ultimately
be
the
holder
of
any
such
approval
issued
in
the
US.
Pfizer
is
BioNTech's
authorized
agent
to
FDA.
As
noted
above,
Pfizer
is
the
designated
agent
for
all
interactions
with
the
FDA
and
is
taking
the
lead
on
all
communications
with
and
submissions
to
FDA.
Prior
to
commencing
clinical
development,
on
February
6,
2020,
BioNTech
obtained
feedback
from
the
Paul
Ehrlich
Institute
("PEI")
on
plans
for
rapid
vaccine
development
in
response
to
the
COVID-19
outbreak
following
a
Scientific
Advice
Meeting.
Based
on
the
PEI
feedback,
BioNTech
refined
the
clinical
program
plan
and
prepared
a
detailed
protocol
for
FIH
clinical
study
(BNT162).
Additionally,
a
meeting
was
held
by
BioNTech
on
February
24,2020
with
the
Chinese
CDC
to
discuss
a
possible
Special
Review
Procedure.
In
Germany,
BioNTech
began
a
Phase
1/2
study
(BNT162-01)
in
late
April
2020.
BNT162-01
is
a
dose-escalation
trial
investigating
the
safety
and
immunogenicity
of
COVID-19
mRNA
vaccine
candidates
in
healthy
adults.
The
primary
objective
of
the
study
is
to
describe
the
safety
and
tolerability
profiles
of
prophylactic
BNT162
vaccine
candidates
after
a
single
dose
(for
saRNA)
or
two
doses
separated
by
21
days
(uRNA
and
modRNA
candidates).
The
secondary
objective
of
the
study
is
to
describe
the
immune
response
to
the
vaccine
in
healthy
adults,
as
measured
by
a
functional
antibody
assay,
such
as
virus
neutralization.
Informed
by
BNT162-01,
the
Phase
1/2
US
study
(C4591001)
of
the
vaccine
candidates
started
in
May
2020.
Pfizer
and
BioNTech
utilized
this
approach
to
efficiently
optimize
formulation
and
dose
selection
in
the
clinic.
Study
C4591001
is
a
single,
multistage
and
multi-phase
trial
(including
the
pivotal
efficacy
portion)
designed
to
generate
the
data
needed
to
achieve
FDA
approval
or
authorization
for
use
of
one
of
the
vaccine
candidates.
This
is
a
randomized,
placebo-controlled,
observer-blind,
dose-finding
and
vaccine
candidate-selection
study
in
healthy
adults.
The
study
is
evaluating
the
safety,
tolerability,
and
immunogenicity
of
the
COVID-19
mRNA
vaccine
candidates.
The
study
consists
of
3
stages:
Stage
1:
to
identify
preferred
vaccine
candidate(s),
dose
level(s),
number
of
doses,
and
schedule
of
administration
(with
the
first
15
participants
at
each
dose
level
of
each
vaccine
candidate
comprising
a
sentinel
cohort);
Stage
2:
an
expanded-cohort
stage;
and
Stage
3:
a
final
candidate/dose
large-scale
stage.
4
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of,
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Firm
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Firm
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this Statement
of
Work.
US
168054648v17
Using
this
approach,
Pfizer
and
BioNTech
are
efficiently
working
towards
selection
of
final
candidate/dose
level.
The
study
currently
is
being
amended
to
incorporate
a
pivotal
efficacy
study
design.
Therefore,
the
study
would
be
converted
to
a
single
Phase
1/2/3
study.
The
pivotal
study
portion
(i.e.,
Phase
2b/3)
is
expected
to
enroll
up
to
—30,000
subjects
(1:1
randomized
between
vaccine
and
placebo).
Upon
gathering
adequate
safety
and
immunogenicity/efficacy
data
in
a
sufficient
number
of
subjects,
Pfizer
believes
the
vaccine
candidate
could,
with
FDA's
agreement,
be
administered
under
EUA.
As
background,
Pfizer's
and
BioNTech's
activities
to
ensure
provision
of
vaccine
on
a
timely
schedule
may
include
the
following
discrete
activities,
depending
on
emerging
data
and
regulatory
guidance.
Activity
Success
Criteria
Estimated
Timing
Candidate,
dose,
and
regimen
selection
Decision
endorsed
by
Pfizer-BioNTech
Joint
Steering
Committee
Phase
2b/3
Study
Start
Requires
FDA
(CBER)
approval
Phase
1/2/3
Demonstration
of
immunogenicity,
efficacy
(interim
analysis)
and
safety
Adequate
efficacy
and
safety
data
supports
EUA
application
(b)
(4)
(b)
(4)
EUA
Submission
to
Support
Use
in
American
Population
Acceptance
of
EUA
submission
BLA
Submission
to
Support
Use
in
American
Population
Agreement
from
FDA
(CBER)
that
proposed
licensure
package
(preclinical,
clinical,
CMC)
is
acceptable
an
d
M
EUA
Issuance
to
Support
Use
in
American
Population
EUA
issued
(b)
(4)
BLA
Approval
to
Support
Use
in
American
Population
BLA
approval
Post-Approval
Commitments
Agreed
Agreement
with
FDA
(4)
(b)
5
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of,
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Firm
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Firm
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this Statement
of
Work.
US
168054648v17
C.
Chemistry
Manufacturing
Controls
(CMC)
Pfizer
will
complete
the
necessary
CMC
and
scale-up
activities
to
demonstrate
the
ability
to
manufacture
100M
doses
I
b)
(4)
.
Pfizer
will
use
diligent
efforts
to
manufacture
and
quality
release
um!
Pfizer's
s
ualit
s
stem
100M
doses
within
the
US
in
a
non-preservative
multi-dose
vial
(
b)
(4)
Pfizer
currently
estimates
potential
production
rates
With
GMP
production
expected
to
commence
for
drug
product,
this
plan
would
allow
for
—40M
doses
to
be
supplied
under
this
Statement
of
Work
in
.
As
Pfizer
validates
the
facilities
and
makes
continuous
process
improvements,
Pfizer
currently
anticipates
such
production
rate
to
increase
starting
in
Should
clinical
data
indicate
that
a
lesser
amount
of
dosage
may
be
needed,
there
could
be
an
increase
in
the
anticipated
potential
number
of
doses
supplied
in
As
background,
to
help
ensure
delivery
of
the
doses,
Pfizer
is
undertaking
the
following
CMC
activities:
1.
Continue
with
BioNTech
to
manufacture
initial
clinical
trial
material
for
EU
and
US
Phase
1/2/3
studies,
through
mRNA
production
in
Germany
and
EU
(Puurs,
Belgium
for
fill-
finish)
and
drug
product/labelling
operations
at
EU
CMOs
and
establish
EU
based
supply
chain
for
lipid
nanoparticle
(LNP)
formulation,
fill,
finish
and
distribution
for
commercial
supply.
2.
Complete
knowledge
transfer
of
the
technology
and
manufacturing
process
from
BioNTech
and
its
CMO
i
artners
to
Pfizer
in
order
to
establish
the
s
rocess
at
Pfizer
in
the
US,
(b)
(4)
3.
Obtain
all
raw
material
supplies
for
manufacturing.
This
may
include
support
of
existing
third-party
suppliers
of
raw
materials,
qualifying
new
third-party
suppliers
and/or
in-
house
production
of
certain
raw
materials,
(b) (4)
4.
Establish
(
b)
(4)
mRNA
(drug
substance),
lipid
nanoparticle
(LNP)
formulation/fill
finish
(drug
product)
capacity
for
GMP
Covid-19
pandemic
supply
of
the
RNA-based
COVID-19
vaccine
on
US
soil.
5.
Develop
the
shipping
model
for
the
-80
°C
drug
product
in
consultation
with
CDC.
In
parallel,
Pfizer
is
prepared
to
also
evaluate
alternative
options
including:
6
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of,
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Firm
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Firm
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this Statement
of
Work.
US
168054648v17
1.
Conduct
necess
.
stabili
and
develo
•
ment
studies
to
establish
2.
Conduct
necessary
formulation
and
stability
studies
to
develop
The
CMC
program
may
include,
but
not
be
limited
to:
(a)
(b) (4)
;
(b)
drug
substance
development;
(c)
drug
product
development
(LNP
formulation,
d)
analytical
development
in
GLP
and
GMP
setting;
(e)
GLP
and
GMP
manufacturing;
and
(f)
and
shipping
of
-80
°C
frozen
product.
(b)
Drug
Substance
Development:
Pfizer
shall
scale-up
its
capabilities
for
process
optimization,
manufacture,
analysis,
release
of
GMP
materials
(mRNA)
and
securing
necessary
raw
materials
from
third
party
providers.
For
drug
substance
manufacture
Pfizer
seeks
to
build-
out
the
existina
Dunfication
suite
located
at
Pfizer's
izer
shall
supply
mcremental
resources
to
trans
er
imp
ement
new
technology
and
GMP
manufacturing
processes,
including
technical
experts,
quality
professionals,
analytical
technicians,
and
trained
operational
staff.
(c)
Drug
Product
Development
(Lipid
Nanoparticle
(LNP
Formulation,
Fill-Finish)):
Activities
Pfizer
shall
perform
may
include,
but
are
not
be
limited
to,
securing
of
necessary
lipids
for
formulation
and
manufacturing
process
development
for
BNT162;
defming
the
formulation;
and
initial
develo
ment
of
manufacturing
rocess
and
analytical
methods.
Pfizer
will
undertake
to
(d)
Analytical
Development:
Analytical
development
may
include,
but
not
be
limited
to:
methods
transfer
participation
at
receiving
site
and
in-process
testing
support;
process
verification
on
commercial
equipment;
media
fill
runs;
engineering
trials
-
re
listration
batch
manufacture
and
re•
istration
batch
stabili
ivotal
stabili
testm
(b)
(4)
7
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
pan,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of:
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Finn
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Finn
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this
Statement
of
Work.
US
168054648v17
comp
erion
Sc
es
eo
e
vaccme,
without
Government
funding:
(e)
GLP
and
GMP
Manufacturing:
Packaging
,
storage
and
distribution
of
clinical
trial
supplies
for
Phase
1/2
will
be
conducted
b
(f)
Shipping
of
-80
°C
frozen
product:
Pfizer
is
evaluatin_
extension
of
current
clinical
acka
in
confi
tion
usin
soft
boxes
and
(b)
(4)
As
background,
to
maintain
a
timely
er
is
aspiring
to
undertake
the
following
discrete
activities,
(b) (4)
1.2
Scope
The
scope
of
this
prototype
project
is
the
demonstration
by
Pfizer
of
the
supply
and
logistics
capability
to
manufacture
and
distribute
to
the
Government
of
100M
doses
of
a
novel
mRNA-
based
vaccine
that
has
received
FDA-approval
or
authorization
based
on
demonstration
of
efficacy
(hereafter
FDA-approved
or
authorized).
The
criteria
for
successful
Emergency
Use
Authorization
(EUA)
are
described
in
Emergency
Use
Authorization
of
Medical
Products
and
Related
Authorities:
Guidance
for
Industry
and
Other
Stakeholders,
January
2017;
and
Development
and
Licensure
of
Vaccine
to
Prevent
COVID-19:
Guidance
for
Industry
June
2020.
The
successful
provision
of
these
doses
shall
establish
the
effectiveness
of
a
technology
capable
of
potentially
providing
immediate
and
long-term
solutions
to
coronavirus
infections.
While
pre-clinical,
clinical,
and
chemistry/manufacturing/controls
(CMC)
activities
are
described
in
the
Background
section
of
this
Statement
of
Work,
the
Parties
acknowledge
and
agree
that
such
activities
not
related
to
the
large-scale
manufacturing
demonstration
are
out-of-scope
for
this
prototype
project
as
Pfizer
and
BioNTech
have
and
will
continue
to
fund
these
activities,
without
the
use
of
Government
funding.
8
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
pan,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent award.
If,
however,
an
agreement
is
awarded
as
a
result
of:
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Finn
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Finn
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this
Statement
of
Work.
US
168054648v17
1.3
Objective
(a)
Prototype
Project
As
set
forth
more
fully
in
Section
11.7,
the
provisions
of
this
Section
1.3
hereby
supersede
and
replace,
in
their
entirety,
the
provisions
of
Section
21.15
of
the
MCDC
Base
Agreement,
2020-532
(July
2018)
("Base
Agreement").
Consistent
with
the
Government's
objectives
under
Operation
Warp
Speed,
Pfizer
intends
to
employ
its
proprietary
manufacturing
technology
and
processes,
in
a
manner
compliant
with
applicable
laws
and
regulations,
including
21
CFR
210
and
211
and
the
Drug
Supply
Chain
Security
Act
(to
the
extent
required
for
COVID-19
medical
countermeasures,
as
defined
by
relevant
FDA
guidance),
to
manufacture
and
deliver
vaccine.
Success
of
the
prototype
project
is
defined
as
manufacture
of
100M
doses
of
Pfizer
and
BioNTech's
mRNA-based
COVID-19
vaccine
and,
upon
FDA-approval
or
authorization
as
described
above,
delivery
of
those
doses
in
accordance
with
Section
6.0.
This
effort
constitutes
a
prototype
project
because
it
will
be
used
to
evaluate
the
technical
feasibility
of
completion
of
the
prototype
project
during
the
ongoing COVID-19
pandemic
and
unprecedented
threats
to
several
components
of
the
prototype
project.
In
addition,
this
is
a
prototype
project
because
Pfizer
will
demonstrate
and
prove-out
the
at-scale,
multi-lot
proprietary
manufacturing
activities
in
order
to
assess
the
feasibility
to
support
the
necessary
quantity
of
safe
and
effective
doses
required
for
vaccination
of
the
U.S.
population
and
deliver
those
doses
within
challenging
cold
chain
requirements
in
accordance
with
Section
6.0.
Successful
completion
of
the
prototype
project
will
demonstrate
Pfizer's
capability
to
(i)
rapidly
manufacture
product,
which
can
be
further
scaled-up
to
meet
mutually
agreed
to
surge
requirements
with
limited
advance
notification
and
(ii)
distribute
large
quantities
of
the
FDA-approved
or
authorized
drug
product
in
accordance
with
Section
6.0.
For
clarity,
any
manufacturing
and
delivery
of
drug
product
in
excess
of
the
specific
quantities
set
forth
in
Section
4.0
of
this
Statement
of
Work,
shall
be
subject
to
a
separate
mutually
acceptable
production
agreement
between
Pfizer
and
the
Government.
(b)
Follow-On
Production
Contract/Options
In
accordance
with
10.U.S.C.
§
2371b(f),
and
upon
a
determination
that
the
prototype
project
is
successful,
or
at
the
accomplishment
of
particularly
favorable
or
unexpected
results
that
would
justify
transition
to
production,
the
Government
and
Pfizer
may
enter
into
a
non-competitive,
mutually-acceptable,
follow-on
production
agreement
for
additional
manufacturing
of
the
vaccine
without
the
use
of
competitive
procedures,
which
agreement
shall
reflect
an
unfunded
option
on
the
basis
set
forth
in
the
following
paragraph
(the
"Option").
Under
the
Option,
the
Government
may
request
that
Pfizer
•
roducc
and
deliver
us
to
500M
additional
doses
for
purchase
by
the
Government
for
delivery
(b)
(4)
Any
order
placed
pursuant
to
the
Option
Agreement
will
provide
for
a
9
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of,
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Firm
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Firm
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this Statement
of
Work.
US
168054648v17
b)
(4)
The
total
proposed
duration
of
this
prototype
initiative
is
with
an
expected
completion
date
minimum
of
100M
doses,
provided
that
the
aggregate
number
of
doses
ordered
under
the
Option
shall
not
exceed
500M.
Upon
any
request
pursuant
to
the
Option,
Pfizer
shall
inform
the
Government
of
appropriate
lead
times
based
on
purchase
of
raw
materials,
capacity
reservation
and
other
factors,
and
Pfizer
and
the
Government
shall
mutually
agree
on
an
appropriate
estimated
delivery
schedule.
Each
order
under
the
Option
will
be
subject
to
the
reasonably
acceptance
of
Pfizer,
it
being
understood
that
Pfizer
shall
have
no
obli
ation
to
accept
any
order
pursuant
to
the
Option
that
would
involve
(b)
(4)
As
promptly
as
practicable
following
the
effective
date
of
this
Agreement,
the
Government
and
Pfizer
will
agree
in
principle
upon
a
form
of
production
agreement
reflecting
the
Option
that
can
be
executed
as
a
binding
agreement
promptly
upon
Government
request
following
such
determination,
demonstration,
or
accomplishment.
2.0
APPLICABLE
REFERENCES
Current
Good
Manufacturing
Procedures,
21
CFR
210
and
211.
3.0
REQUIREMENTS
Pfizer
shall
conduct
manufacturing
activities
to
support
production
and
distribution
of
vaccine
doses
after
the
final
vaccine
candidate
from
its
development
program
is
selected
(currently
expected
to
occur
in
July
2020).
Subject
to
the
terms
and
conditions
of
this
Agreement,
including
without
limitation
Sections
3.1,
6.0,
11.5
and
11.6,
Pfizer
shall
use
diligent
efforts
to
manufacture,
quality
release
(using
Pfizer's
quality
system),
and
deliver
100M
doses
of
an
FDA-approved
or
authorized
vaccine
in
a
preservative-free,
multi-dose
vial
no
later
than
the
end
of
the
period
of
performance
(as
defined
in
Section
3.1).
Pfizer
anticipates
providing
the
vaccine,
subject
to
FDA
approval
or
authorization,
as
-80
°C
frozen
product
that
needs
to
be
maintained
at
or
below
that
temperature
prior
to
dosing.
The
Government
acknowledges
that
Pfizer's
responsibility
for
cold
chain
will
cease
upon
delivery
in
accordance
with
Section
6.0.
Pfizer
anticipates
providing
the
vaccine,
subject
to
FDA-approval
or
authorization,
as
a
concentrate
that
needs
to
be
diluted
at
point
of
use
prior
to
dosing.
Vaccinators
will
need
to
use
locally
sourced
0.9%
Sodium
Chloride
Injection,
USP
(Normal
Saline),
syringes
and
needles.
3.1
Period
of
Performance
(the
"period
of
performance").
If
FDA-approval
or
authorization
is
not
issued
by
October
31,2020
10
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of,
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Firm
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Firm
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this Statement
of
Work.
US
168054648v17
Pfizer
shall
provide,
(b) (4)
as
estimated
in
Section
1.1.2
above,
and
Pfizer
expects
it
will
be
unable
to
timely
complete
performance,
then
the
Parties
will
discuss
in
good
faith
a
contract
modification
to
shift
forward
the
estimated
delivery
schedule
to
reflect
the
difference
in
time
period
between
October
31,
2020
and
the
date
of
actual
regulatory
approval
or
authorization.
As
a
result
of
these
discussions,
the
Government
shall
have
the
unilateral
ability
to
extend
the
Period
of
Performance
of
this
prototype
project
in
increments
of
up
to
thirty
(30)
days
at
a
time.
In
no
event
can
this
unilateral
right
to
extend
the
period
of
performance
require
performance
(b)
(4)
or
result
in
a
requirement
for
Pfizer
to
demonstrate
the
ability
to
manufacture
more
than
100M
doses.
Notwithstanding
the
efforts
and
estimated
dates
set
forth
throughout
this
Statement
of
Work,
and
as
set
out
more
fully
in
Sections
11.5
and
11.6,
both
Parties
recognize
that
the
vaccine
is
currently
in
Phase
1/2
clinical
trials
and
that,
despite
the
diligent
efforts
of
Pfizer
and
BioNTech
in
research,
and
development
and
manufacturing,
the
prototype
project
may
not
be
successful
due
to
technical,
clinical,
regulatory
or
manufacturing
challenges
or
failures.
3.2
Management
and
Reporting
As
set
forth
more
fully
in
Section
11.7,
the
provisions
of
this
Section
3.2
hereby
supersede
and
replace,
in
their
entirety,
Section
1.05
of
the
Base
Agreement.
Pfizer
will
not
employ
any
new
or
other
Project
Management
components
and
Pfizer
shall
have
no
obligation
to
provide
any
custom
reports
to
the
Government
except
as
provided
herein.
The
Government
acknowledges
that
Pfizer
plans
to
utilize
existing
Pfizer-formatted
reports
to
provide
this
information
to
the
Government
as
described
in
the
Deliverable
table
below
at
Section
4.0.
Pfizer
shall
provide
(b)
(4)
technical
reports
providing
an
update
of
relevant
ongoing
non-
Government
funded
activities.
a
synopsis
of
the
Phase
2b/3
clinical
trial
protocol,
which
synopsis
shall
include
[Overview
of
the
Protocol,
Objectives
and
Endpoints,
Statistical
Methods,
and
Schedule
of
Activities].
Pfizer
shall
provide
copies
of
EUA
and
BLA
filings,
as
well
as
interim
and
final
data
updates
from
clinical
studies
in
a
format
determined
by
Pfizer.
Pfizer
shall
provide
weekly
prototype
production
status
reports,
including
the
number
of
batches
produced,
doses
in
the
batch,
and
release
status
of
the
fmished
doses.
In
addition
to
regular reporting
requirements,
during
the
period
of
performance,
Pfizer
shall
use
diligent
efforts
to
notify
the
Government
(b)
(4)
of
any
event,
risk,
formal
or
informal
11
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of,
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Firm
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Firm
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this Statement
of
Work.
US
168054648v17
FDA
communication,
or
other
issue
that
would
be
reasonably
expected
to
materially
change
the
anticipated
schedule
by
one
week
or
more.
Except
for
reports
expressly
contemplated
in
this
Statement
of
Work,
Pfizer
and
the
Government
agree
that
Pfizer
will
not
be
subject
to
any
reporting
requirements
contemplated
in
Section
1.05
of
the
Base
Agreement.
4.0
DELIVERABLES
As
set
forth
more
fully
in
Sections
11.5
and
11.6,
the
Government
understands
that
the
dates
set
forth
below
are
Pfizer's
best
estimate,
as
of
the
Execution
Date
of
this
Agreement,
of
its
development
and
manufacturing
timelines,
and
that
these
timeframes
are
subject
to
significant
risks
and
uncertainties.
Pfizer
will
promptly
notify
the
Government
of
any
event(s)
that
would
be
reasonably
expected
to
materially
alter
projected
Estimated
Due
Date
for
Deliverables
4.1
through
4.20.
The
Goverrunent
agrees
that
it
will
not
resell
any
of
the
deliverables
to
any
third
party.
Deliverables
Del.
#
Deliverable
Description
Estimated
Due
Date
Format
SOW
Reference
Government
Role
Data
Rights
4.1
Project
Kick-Off
materials
Telecon.
and
related
slides
--
Review
4.2
Phase
2b/3
Clinical
Trial
Synopsis
Pfizer-
deterinined
format
1
Review
4.3
Provision
of
PL
115-92
Sponsor
Authorization
Letter
--
--
Review/
Approve
4.4
Updates
on
Prototype
Production
Status
Pfizer-
determined
format
1
Review
4.5
Business
and
Technical
Report
Pfizer-
determined
format
.
Review
12
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Finn
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent award.
If,
however,
an
agreement
is
awarded
as
a
result
of:
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Finn
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Finn
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this
Statement
of
Work.
US
168054648v17
4.6
EUA
Filing
Pfizer-
determined
format
Review
b
(4)
4.7
BLA
Filing
Pfizer-
determined
format
Review
(b)
(
)
4.8
Delivery
of
100M
doses
(b) (4)
--
Receipt
4.9
Release
documentation
for
delivered
doses
b)
(A)
Pfizer-
determined
format
Review
4.10
Supply
Chain
Resiliency
Plan
or
Pfizer
Equivalent
(b)
(43
Pfizer-
determined
format
(b)
(4
Review
&
Comment
4.11
Manufacturing
Data
Requirement
or
Pfizer
Equivalent
(b)
(
0
'
Pfizer
-
determined
format
Review
&
Comment
4.12
Product
Development
Source
Material
&
Manufacturing
Reports
and
Projections
(b)
(z
Pfizer-
determined
format
Review
&
Comment
4.13
Work
Location
Report
or
Pfizer
Equivalent
Pfizer-
determined
format
Review
&
Comment
4.14
Facility
Security
Plan
or
Pfizer
Equivalent
Pfizer-
determined
format
Review
&
Comment
4.15
Confirmation
of
Registration
and
Listing
with
FDA
Review
13
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of,
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Firm
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Firm
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this Statement
of
Work.
US
168054648v17
14
uali
Mana
ement
Plan.
Pfizer
will
**
4.16
Formal
Written
Responses
from
the
FDA
Review
4.17
FDA
Inspection
and
Compliance
Notices,
Observations
and
Responses
Review
4.18
Manufacturing
Development
Plan*
I
Review
4.19
Quality
Management
Plan**
Review
4.20
Shipping
Specifications
and
Details
Review
Manufacturin
Develo
s
ment
Plan.
Pfizer
will
describe
the
manufacturing
process
for
the
vaccine
product
to
ensure
conformity
with
§501(a)(2)(B)
of
the
Food,
Drug,
and
Cosmetics
Act
(FD&C
Act,
Title
21
United
States
Code
("U.S.C."
.351
a
2
re.
ardin.
.00d
manufacturin.
iractices
"GMP"
.
This
'tan
shall
describe
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Finn
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of:
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Finn
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Finn
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this
Statement
of
Work.
US
168054648v17
Total
(Include
Payment
Type;
FFP):
I
Si
.95B
(b) (4)
The
Government
acknowledges
that,
as
set
forth
more
fully
in
Section
1.1.2,
the
above
deliverables
(other
than
the
delivery
of
doses
contemplated
by
Section
4.5)
are
being
prepared
without
the
use
of
Government
funding.
As
used
herein,
the
term
"Limited"
means
"limited
rights"
as
that
term
is
defined
in
DFARS
252.227.7013(a)(14).
5.0
MILESTONE
PAYMENT
SCHEDULE
As
set
forth
more
fully
in
Section
11.7,
the
provisions
of
this
Section
5
supersede
and
replace,
in
their
entirety,
the
provisions
of
5.04b
of
the
Base
Agreement.
As
the
clinical
trials
and
validation
of
the
product
presentation
are
ongoing,
the
estimated
timing
of
delivery
of
doses
is
subject
to
change.
Provided
the
FDA
has
granted
approval
or
authorization,
the
100M
doses
will
be
provided
by
Pfizer
to
the
Government
on
a
Firm
Fixed
Price
per
dose
basis
in
accordance
with
the
Milestone
Payment
Schedule.
Due
to
variances
in
fill/finish
yield,
Pfizer
shall
invoice
for
and
the
Government,
through
the
Consortium
Management
Firm
(CMF),
shall
pay
for
actual
quantities
delivered,
at
a
rate
of
$19.50
per
dose.
Subject
to
regulatory
and
technical
success,
Pfizer
shall
use
its
diligent
efforts
to
provide
the
Government
the
full
100M
doses
on
or
before
the
final
delivery
date.
Upon
release,
Pfizer
will
ship
the
doses
to
the
Government
as
set
forth
in
Section
6.0,
below.
Pfizer
expects
to
invoice
the
Government
(through
the
CMF)
every
month
for
released
doses
that
have
been
shipped
during
each
such
monthly
period.
The
CMF
will
pay
all
such
invoices
within
thirty
(30)
days
of
receipt
thereof.
Pfizer
shall
submit
invoices
via
email
to
MCDC-invoices@ati.org
.
(b) (4)
15
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of,
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Firm
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Firm
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this Statement
of
Work.
US
168054648v17
Except
as
contemplated
by
the
Option,
the
price
per
dose
set
forth
in
this
Statement
of
Work
is
provided
in
connection
with
Operation
Warp
Speed
and
this
specific
Statement
of
Work
only.
This
price
shall
not
serve
as
the
basis
for
pricing
under
any
separate
government
contracts
between
Pfizer
and
HES,
the
Department
of
Defense,
or
any
other
Department
or
agency
of
the
Government
by
application
of
most
favored
customer,
most
favored
nations,
or
any
other
contract
or
program-
specific
terms.
For
clarity,
the
Government
will
have
no
right
to
withhold
payment
in
respect
of
any
delivered
doses,
unless
the
FDA
has
withdrawn
approval
or
authorization
of
the
vaccine.
In
such
event,
the
Parties
will
work
in
good
faith
to
establish
an
appropriate
course
of
action
for
delivered
doses
which
have
not
et
been
administered.
B
wa
of
illustrative
ex.
'isle
onl
6.0
SHII'PING
PROVISIONS
In
coordination
with
the
Government,
Pfizer
will
conduct
a
demonstration
of
the
shipping
process
prior
to
the
first
delivery
of
doses
at
a
time
mutually
agreed
by
the
Parties.
As
set
forth
in
Section
4.0,
Pfizer
agrees
to
share
specifications
and
details
associated
with
the
shipping
process
and
containers
to
enable
the
Government
to
adequately
plan
and
prepare
for
potential
distribution
of
the
vaccine.
Pfizer
will
notify
the
Government
the
date
by
which
doses
will
become
available
for
delivery.
The
Government
will
confirm
dosage
orders
by
ship-to
location
in
advance
of
those
dates;
provided
that
each
such
ship-to
location
will
abide
by
the
specifications
provided
by
Pfizer
or
will
otherwise
be
agreed
by
Pfizer
and
the
Government.
The
number
of
ship-to
locations
and
the
manner
of
delivery
shall
be
identified
to
create
an
efficient delivery
of
the
doses,
subject
to
mutual
a
cement
of
the
arties.
The
recommended
delive
uanti
for
each
shi
o
to
location
is
16
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
pan,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of:
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Finn
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Finn
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this
Statement
of
Work.
US
168054648v17
1
1
7.0
INTELLECTUAL
PROPERTY,
DATA RIGHTS,
AND
COPYRIGHTS
As
set
forth
more
fully
in
Section
11.7,
the
provisions
of
this
Section
7.0
supersede
and
replace,
in
their
entirety,
the
provisions
of
Article
X
(Patent
Rights),
Article
XI
(Data
Rights)
of
the
Base
Agreement.
7.1
Inventions
As
between
Pfizer
and
the
Government,
Pfizer
shall
hereby
retain
all
of
its
rights,
titles
and
interests
in
and
to
any
and
all
inventions
conceived
and
reduced
to
practice
by
Pfizer
and/or
BioNTech
(i)
as
of
the
Effective
Date
of
this
Agreement,
or
(ii)
after
the
Effective
Date
of
this
Agreement,
outside
the
scope
of
this
Statement
of
Work
("Background
Inventions").
Pfizer
does
not
grant
to
the
Government
any
license
to
practice
the
Background
Inventions
under
this
Agreement.
As
between
Pfizer
and
the
Government,
all
inventions
conceived
or
first
actually
reduced
to
practice
in
the
performance
of
this
Statement
of
Work
("Subject
Inventions")
shall
be
owned
by
Pfizer.
If
invented
solely
by
Pfizer,
Pfizer
will
be
able
to
elect,
in
its
discretion,
whether
to
hold
Subject
Inventions
as
trade
secrets,
and
holding
a
Subject
Invention
as
a
trade
secret
will
not
forfeit
title
to
the
Government.
Pfizer
does
not
grant
to
the
Government
a
license
to
practice
any
Subject
Inventions
on
behalf
of
the
Government.
Notwithstanding
the
foregoing,
and
as
set
forth
more
fully
in
Section
1.1.2,
the
Government
acknowledges
that
it
is
not
funding
the
research
or
development
of
the
vaccine,
or
CMC/process
development
in
respect
thereof.
As
such,
neither
Pfizer
nor the
Government
anticipate
the
conception
or
reduction
to
practice
of
any
Subject
Inventions.
The
Government
acknowledges
that
the
Bayh-Dole
Act
does
not
apply
to
or
govern
this
Agreement.
Given
that
the
Government
will
not
fund
the
conception
or
reduction
to
practice
of
Background
Inventions
or
Subject
Inventions
hereunder,
this
Agreement
shall
neither
(i)
give
the
Government
any
rights
to
"march-in,"
as
that
term
is
defined
in
35
U.S.C.
§
203,
nor
(ii)
subject
Pfizer
to
the
manufacturing
requirements
of
35
U.S.C.
§
204.
7.2
Data
The
Government
recognizes
that
all
data
relating
to
the
vaccine
has
been
and
will
continue
to
be
generated
by
Pfizer
and
its
collaboration
partner,
BioNTech,
without
the
use
of
Government
funding.
As
between
Pfizer
and
the
Government,
Pfizer
shall
own
any
and
all
data
generated
by
Pfizer
and/or
BioNTech
(i)
as
of
the
Effective
Date
of
this
Statement
of
Work,
or
(ii)
after
the
Effective
Date
of
this
Statement
of
Work,
outside
the
scope
of
this
Statement
of
Work
("Background
Data").
As
between
Pfizer
and
the
Government,
Pfizer
also
shall
own
any
and
all
data
generated
by
Pfizer
17
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of,
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Firm
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Firm
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this Statement
of
Work.
US
168054648v17
within
the
scope
of
this
Statement
of
Work
("Subject
Data").
For
the
avoidance
of
doubt,
the
parties
do
not
anticipate
Pfizer
generating
any
Subject
Data
using
Government
funding.
Pfizer
hereby
grants
the
Government
a
non-exclusive
license
to
use
any
Background
Data
and
Subject
Data
contained
in
the
deliverables
pursuant
to
Section
4,
but
solely
to
the
extent
necessary
for
the
Government
to
perform
its
obligations
under
this
Agreement
and
arrange
administration
of
the
doses
delivered
in
accordance
with
FDA
and
other
applicable
regulations.
The
Government
will
provide
Pfizer
with
no
less
than
thirty
(30)
days'
written
notice
prior
to
releasing,
in
response
to
a
Freedom
of
Information
Act
(FOIA)
request,
any
document
submitted
by
Pfizer
to
Government.
During
this
30-day
period,
Pfizer
shall
have
the
right
to
notify
Government
which
documents,
if
any,
contain
trade
secrets
of
Pfizer,
BioNTech
or
their
respective
collaboration
partners
(or
other
information
legally
withholdable
from
release
under
FOIA).
7.3
Regulatory
Rights
Pfizer
will
seek
and
anticipates
that
it
will
achieve
FDA-approval
or
authorization
and
commercialization
of
Pfizer
and
BioNTech's
mRNA-based
Vaccine
against
SARS-CoV-2
Coronavirus
(the
"Technology").
Pfizer
and
the
Government
agree
to
the
following:
Communications.
Pfizer
will
provide
the
Government
with
all
formal
written
responses
from
the
FDA
regarding
the
Technology
(b)
(4)
Pfizer
also
shall
use
diligent
efforts
to
provide
to
the
USG
Government
any
and
all
FDA
inspection
and
compliance
notices,
observations,
and
responses
from
Pfizer
b)
(4)
The
Government
shall
limit
distribution
of
these
documents
to
HHS
and
DoD
regul
atory
personnel,
and
may
share
the
substance
of
the
documents
to
others
within
the
DoD
and
HHS
that
have
a
need
to
know.
DoD
Medical
Product
Priority.
PL
115-92
allows
the
DoD
to
request,
and
FDA
to
provide,
assistance
to
expedite
development
of
products
to
diagnose,
treat,
or
prevent
serious
or
life-
threatening
diseases
or
conditions
facing
American
military
personnel.
Pfizer
recognizes
that
only
the
DoD
can
utilize
PL
115-92.
Pfizer
shall
submit
Public
Law
115-92
Sponsor
Authorization
Letter
that
will
e
delivered
to
the
designated
OWS
POC(s)
8.0
SECURITY
/
EXPORT
CONTROL
As
set
forth
more
fully
in
Section
11.7,
the
provisions
of
this
Section
8
supersede
the
provisions
of
Article
XII
(Export
Controls).
The
following
requirements
of
Article
XVII
(Security
and
18
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of:
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Finn
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Finn
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this
Statement
of
Work.
US
168054648v17
OPSEC)
of
the
Base
Agreement
are
not
applicable
and
are
therefore
self-deleting
and
replaced
by
this
Section:
all
references
to
CUI
and
CDI,
sub-paragraphs
(1)
through
(20)
excepting
sub-
Paragraphs
(3)(e),
(4),
and
(20)(d).
The
security
classification
for
this
effort
is
Unclassified.
As
it
is
currently
not
anticipated
that
any
Controlled Unclassified
Information
("CUI")
will
be
obtained
under
this
Statement
of
Work,
other
than
Pfizer
proprietary
information,
DFARS
252.204-8012
shall
not
apply.
In
addition,
the
training
requirements
of
Article
XVII
of
the
Base
Agreement
shall
not
apply.
However,
if
CUI
is
provided,
Pfizer
will
keep
all
such
information
confidential
and
will
only
give
access
to
such
information
to
persons
with
a
legitimate
need
for
such
access.
Pfizer
agrees
to
comply
with
all
applicable
laws
regarding
commodities
and
technology
subject
to
this
Statement
of
Work.
Pfizer
will
submit
plans
and
reports
as
set
forth
in
Section
4.0
above
addressing
the
security
topics
generally
contemplated
by
Appendix
1
to
this
Statement
of
Work.
The
Government
acknowledges
that
these
plans
will
reflect
Pfizer's
established
security
procedures
in
place
with
respect
to
its
facilities
and
information
security,
which
are
at
least
as
protective
as
would
be
customary
for
a
global
company.
Pfizer
will
use
commercially
reasonable
efforts
to
implement
any
further
procedures/precautions
reasonably
requested
by
the
Government
with
respect
to
Statement
of
Work
and
Appendix
1,
at
Pfizer's
sole
discretion
and
as
long
as
such
implementation
would
not
adversely
impact
Pfizer's
ordinary
operation
of
its
facilities
and
systems
in
connection
with
its
other
business
and
products.
9.0
MISCELLANEOUS
REQUIREMENTS
(SAFETY,
ENVIRONMENTAL,
ETC.)
Intentionally
Left
Blank.
10.0
GOVERNMENT
FURNISHED
PROPERTY/MATERIAL/INFORMATION
As
set
forth
more
fully
in
Section
11.7,
the
provisions
of
this
Section
10.0
supersede
and
replace,
in
their
entirety,
the
provisions
of
Article
XIII
(Title
and
Disposition
of
Property)
of
the
Base
Agreement.
There
will
be
no
Government
furnished
equipment,
and
no
equipment
will
be
funded
by
the
Government
under
this
Statement
of
Work.
11.0
OTHER
11.1
PREP
Act.
In
accordance
with
the
Public
Readiness
and
Emergency
Preparedness
Act
("PREP
Act"),
Pub.
L.
No.
109-148,
Division
C,
Section
2,
as
amended
(codified
at
42
U.S.C.
§
247d-6d
and
42
U.S.C.
§
247d-6e),
as
well
as
the
Secretary
of
HHS's
Declaration
Under
the
Public
Readiness
and
19
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of,
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Firm
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Firm
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this Statement
of
Work.
US
168054648v17
Emergency
Preparedness
Act
for
Medical
Countermeasures
Against
COVID-19,
85
Fed.
Reg.
15198
(Mar.
17,
2020,
effective
Feb.
4,
2020),
and
amended
on
April
15,
2020,
85
Fed.
Reg.
21012,
and
on
June
8,
2020,
85
Fed.
Reg
34740
(together,
the
"Prep
Act
Declaration"):
(i)
This
Agreement
is
being
entered
into
for
purposes
of
facilitating
the
manufacture,
testing,
development,
distribution,
administration,
and
use
of
"Covered
Countermeasures"
for
responding
to
the
COVID-19
public
health
emergency,
in
accordance
with
Section
VI
of
the
PREP
Act
Declaration;
(ii)
Pfizer's
performance
of
this
Agreement
falls
within
the
scope
of
the
"Recommended
Activities"
for
responding
to
the
COVED-19
public
health
emergency
in
accordance
with
Section
B1
of
the
PREP
Act
Declaration;
and
(iii)
Pfizer
is
a
"Covered
Person"
per
Section
V
of
the
PREP
Act
Declaration.
Therefore,
in
accordance
with
Sections
IV
and
VII
of
the
PREP
Act
Declaration
as
well
as
the
PREP
Act
(42
U.S.C.
§
247d-6d),
the
Department
of
Defense
contracting
via
assisted
acquisition
on
behalf
of
the
HITS,
expressly
acknowledges
and
agrees
that
the
IIHS
Declaration
cited
above,
specifically
its
language
providing
immunity
from
suit
and
liability
is
applicable
to
this
Agreement,
as
long
as
Pfizer's
activities
fall
within
the
terms
and
conditions
of
the
PREP
Act
and
the
PREP
Act
Declaration.
The
Government
may
not
use,
or
authorize
the
use
of,
any
products
or
materials
provided
under
this
Agreement,
unless
such
use
occurs
in
the
United
States
and
is
protected
from
liability
under
a
declaration
issued
under
the
PREP
Act,
or
a
successor
COVID-19
PREP
Act
declaration
of
equal
or
greater
scope.
11.2
Terminations.
As
set
forth
more
fully
in
Section
11.7,
the
provisions
of
this
Section
11.2
hereby
supersede
and
replace,
in
their
entirety,
Sections
2.03
and
2.06
of
the
Base
Agreement:
a
(b)
(4)
20
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of:
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Finn
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Finn
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this
Statement
of
Work.
US
168054648v17
(b)
Stop-Work
Orders.
Except
as
required
by
applicable
law
or
regulation,
or
judicial
or
administrative
order,
the
Government
shall
not
have
the
authority
to
issue
a
Stop-Work
Order
to
halt
the
work
contemplated
under
this
Statement
of
Work.
(c)
Consequences
of
Termination.
In
the
event
of
termination
of
this
Agreement
pursuant
to
this
Section
11.2,
or
expiration
of
this
Agreement
at
the
end
of
the
period
of
performance
as
set
forth
in
Section
3.1,
this
Agreement
shall
forthwith
become
null
and
void
and
have
no
effect,
without
any
liability
on
the
part
of
any
Party;
provided,
however,
that
Sections
7,
11
and
12
hereof,
and
Article
VIII
(Confidential
Information)
of
the
Base
Agreement,
shall
survive
any
termination
or
expiration
of
this
Agreement;
and
provided,
further,
that
the
termination
or
expiration
of
this
Agreement
shall
not
release
any
Party
hereto
of
any
liability,
including
any
outstanding
payments
of
the
Government
for
doses
previously
delivered
hereunder,
which
at
the
time
of
termination
or
expiration
had
already
accrued
to
the
other
party
in
respect
to
any
act
or
omission
prior
thereto.
11.3
Audits.
As
set
forth
more
fully
in
Section
11.7,
the
provisions
of
this
Section
11.3
hereby
supersede
and
replace,
in
their
entirety,
the
provisions
of
Section
5.07
(Financial
Records
and
Reports)
of
the
Base
Agreement.
Pfizer's
relevant
financial
records
shall
not
be
subject
to
audit
until
the
Government
has
provided
funds
to
Pfizer.
These
records
will
be
subject
to
audit
for
a
period
not
to
exceed
three
(3)
years
after
final
payment
under
this
Agreement.
Pfizer
shall
have
the
right
to
request
use
of
a
third-party
audit
firm
to
audit
Pfizer's
books
and
records
maintained
in
connection
with
this
Agreement;
however,
in
accordance
with
10
U.S.C.
§
237
lb(c)
for
a
period
not
to
exceed
three
(3)
years
after
final
payment
under
this
Agreement,
the
Comptroller
General
shall
have
access
to
examine
the
records
of
any
party
to
the
agreement
or
any
entity
that
participates
in
the
performance
of
the
agreement.
11.4
Disputes.
As
set
forth
more
fully
in
Section
11.7,
Section
7.02
of
the
Base
Agreement
is
hereby
amended
to
add
the
following
at
the
end
of
said
section:
The
Government's
breach
of
this
Statement
of
Work
may
result
in
money
damages
and
nothing
in
the
Project
Agreement
(if
any)
or
Base
Agreement
prevents
Pfizer
from
seeking
relief
in
the
United
States
Court
of
Federal
Claims
pursuant
to
28
U.S.C.
§
1491.
11.5
Timing
Estimates.
All
timing
estimates
set
forth
in
this
Statement
of
Work
are
subject
to
change
based
on
emerging
data,
regulatory
guidance,
and
manufacturing
and
technical
developments,
among
other
risks.
21
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of,
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Firm
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Firm
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this Statement
of
Work.
US
168054648v17
provisions
so
This
Section
11.6
supersedes
the
Base
Agreement's
other
liability
e
y
to
s
e
extent
they
are
inconsistent
with
this
Statement
of
Work.
(b)
(4)
11.6
Limitation
of
Liability.
The
Government
acknowledges
and
agrees
that
Pfizer's
efforts
to
develop
and
manufacture
a
vaccine
intended
to
prevent
COVID-19
disease
caused
by
SARS-CoV-
2
are
aspirational
in
nature
and
subject
to
significant
risks
and
uncertainties.
Accordingly,
notwithstanding
anything
to
the
contrary
in
this
Statement
of
Work
or
the
Base
Agreement,
Pfizer
shall
have
no
liability
for
any
failure
to
develop,
obtain
or
maintain
U.S.
regulatory
approval
or
authorization
of
such
a
vaccine
in
accordance
with
the
estimated
schedule
described
in
this
Statement
of
Work.
Even
if
a
vaccine
is
successfully
developed
and
obtains
U.S.
regulatory
approval
or
authorization,
Pfizer
shall
have
no
liability
for
any
failure
to
deliver
doses
in
accordance
with
the
estimated
delivery
dates
set
forth
in
this
Statement
of
Work
to
the
extent
any
such
change
in
delivery
dates
is
based
on
emerging
data,
regulatory
guidance,
manufacturing
and
technical
developments,
or
other
risks
outside
Pfizer's
control;
provided,
however,
Government
retains
the
right
to
terminate
this
Agreement
or
to
issue
a
Stop-Work
Order,
as
specifically
contemplated
in
Sections
11.2(1)
and
11.2(b).
11.7
Order
of
Precedence.
Notwithstanding
the
provisions
of
Article
XXIII
(Order
of
Precedence)
of
the
Base
Agreement,
the
Parties
hereby
expressly
agree
that
to
the
extent
any
provision
of
the
Project
Agreement
(if
any)
or
this
Statement
of
Work
conflicts
with
any
provision
of
the
Base
Agreement,
the
provision
of
the
Project
Agreement
(if
any)
or
this
Statement
of
Work,
as
applicable,
shall
supersede
and
replace,
in
the
entirety,
the
conflicting
provision
of
the
Base
Agreement
and
control
the
relationship
of
the
Parties.
Without
limiting
the
generality
of
the
foregoing,
this
Section
11.7
shall
supersede
Article
XXIII
(Order
of
Precedence)
of
the
Base
Agreement
and
the
terms
of
this
Statement
of
Work
shall
constitute
"specifically
negotiated
Project
Agreement
terms"
referenced
in
the
last
sentence
thereof.
This
Statement
of
Work
hereby
supersedes,
without
limitation,
the
following
provisions
of
the
Base
Agreement:
Section
1.05
(Reporting
Requirements),
Section
2.03
(Termination
Provisions),
Section
2.06
(Stop-Work),
Section
5.07
(Financial
Records
and
Reports),
Section
8.05
(Tenn),
Article
IX
(Publications),
Article
X
(Patent
Rights),
Article
XI
(Data
Rights),
XII
(Export
Controls),
Article
XIII
(Title
and
Disposition
of
Property),
Article
XVII
(Security
and
OPSEC),
and
Sections
21.6-21.15
(Regulations)
and
the
integration
clause
above
the
signature
block
to
the
Base
Agreement.
22
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Firm
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
pan,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of:
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Finn
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Finn
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this
Statement
of
Work.
US
168054648v17
11.8
(b)
(4)
11.9
Non-Traditional
Defense
Contractor.
Pfizer
has
self-certified
that
Pfizer
meets
the
definition
of
a
"Nontraditional
Defense
Contractor"
as
defined
in
the
Base
Agreement
and
therefore
is
not
subject
to
the
cost-sharing
requirement
referenced
in
Article
VI
of
the
Base
Agreement.
11.10
Confidentiality.
As
set
forth
more
fully
in
Section
11.7,
the
provisions
of
this
Section
11.10
hereby
supersede
and
replace,
in
their
entirety,
the
provisions
of
Section
8.05
of
the
Base
Agreement.
The
obligations
of
the
Receiving
Party
under
this
Section
shall
continue
for
a
period
of
ten
(10)
years
from
the
conveyance
of
Confidential
Information.
If
Pfizer
shall
need
to
disclose
trade
secret
information
to
the
Government,
Pfizer
and
the
Government
will
first
determine
in
good
faith
whether
the
Government
desires
to
receive
any
such
trade
secret
information
and
if
the
Government
so
desires
to
receive
such
trade
secret
information,
all
such
information
shall
be
held
by
the
Government
in
confidence
in
peipetuity.
11.11
Announcements.
Neither
Pfizer
nor
the
Government
shall
make,
or
permit
any
person
to
make,
any
public
announcement
concerning
the
existence,
subject
matter
or
terms
of
this
Agreement,
the
transactions
contemplated
by
it,
or
the
relationship
between
the
Pfizer
and
the
Government
hereunder,
without
the
prior
written
consent
of
the
other,
such
consent
not
to
be
unreasonably
withheld
or
delayed,
except
as
required
by
law,
any
governmental
or
regulatory
authority
(including,
without
limitation,
any
relevant
securities
exchange),
any
court
or
other
authority
of
competent
jurisdiction.
Notwithstanding
the
foregoing,
Pfizer
and
(its
collaboration
partners)
shall
have
the
right,
but
not
the
obligation,
to prepare
and
submit
scientific
publications
and
release
information
to
the
public
about
its
Covid-19
development
program,
without
the
Government's
consent
or
involvement.
This
section
supersedes
and
replaces
Article
IX
of
the
Base
Agreement.
12.0
AGREEMENTS
OFFICER'S
REPRESENTATIVE
(AOR)
AND
ALTERNATE
AOR
CONTACT
INFORMATION
AOR
NAME:
(b)
(6)
23
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Finn
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of:
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Finn
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Finn
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this
Statement
of
Work.
US
168054648v17
MAILING
ADDRESS:
EMAIL:
PHONE:
AGENCY
NAME/DIVISION/SECTION:
BARDA/ASPR/HHS
(b) (6)
(b)
(6)
24
This
Statement
of
Work
includes
proprietary
and
confidential
commercial
data
of
Pfizer
Inc.
that
shall
not
be
disclosed
outside
the
MCDC
Management
Finn
and
the
Government
and
shall
not
be
duplicated,
used,
or
disclosed,
in
whole
or
in
part,
for
any
purpose
other
than
to
evaluate
this
Statement
of
Work
and
negotiate
any
subsequent
award.
If,
however,
an
agreement
is
awarded
as
a
result
of:
or
in
connection
with,
the
submission
of
this
data,
the
MCDC
Management
Finn
and
the
Government
shall
have
the
right
to
duplicate,
use,
or
disclose
these
data
to
the
extent
provided
in
the
resulting
agreement.
This
restriction
does
not
limit
the
MCDC
Management
Finn
and
the
Government's
right
to
use
the
information
contained
in
these
data
if
they
are
obtained
from
another
source
without
restriction.
The
data
subject
to
this
restriction
are
set
forth
on
each
page
of
this
Statement
of
Work.
US
168054648v17
Appendix
1:
Clause
for
MCDC
Consortium
Other
Transaction
Authority
Agreements
Standard
Language
OWS
for
Consortium
OTA
Required
MCDC
Base
A2reement
Modifications
The
Medical
CBRN
Consortium
(MCDC)
Base
Agreement,
Article
XVII,
SECURITY
&
OPSEC
shall
apply
to
this
Project
Agreement.
In
addition,
the
below
language
shall
replace
Paragraph
6
of
Article
XVII
of
the
MCDC
Base
Agreement.
(6)
Access
and
General
Protection/Security
Policy
and
Procedures.
This
standard
language
text
is
applicable
to
ALL
PAH
employees
working
on
critical
program
information
or
covered
defense
information
related
to
Operation
Warp
Speed
(OWS),
and
to
those
with
an
area
of
performance
within
an
Army
controlled
installation,
facility
or
area.
PAH
employees
shall
comply
with
applicable
installation,
facility
and
area
commander
installation/facility
access
and
local
security
policies
and
procedures
(provided
by
government
representative).
The
PAH
also
shall
provide
all
information
required
for
background
checks
necessary
to
access
critical
program
information
or
covered
defense
information
related
to
OWS,
and
to
meet
installation
access
requirements
to
be
accomplished
by
installation
Provost
Marshal
Office,
Director
of
Emergency
Services
or
Security
Office.
The
PAH
workforce
must
comply
with
all
personal
identity
verification
requirements
as
directed
by
DOD,
HQDA
and/or
local
policy.
In
addition
to
the
changes
otherwise
authorized
by
the
changes
clause
of
this
agreement,
should
the
Force
Protection
Condition
(FPCON)
at
any
individual
facility
or
installation
change,
the
Government
may
require
changes
in
PAH
security
matters
or
processes.
Required
SOW
Language
for
Deliverables
(in
body
of
SOW
or
Deliverables
Section)
Information
Security
Classification
guidance
for
Operation
Warp
Speed
-
The
security
level
for
this
agreement
is
UNCLASSIFIED.
"Controlled
technical
information,"
"covered
contractor
information
system,"
"covered
defense
information,"
"cyber
incident,"
"information
system,"
and
"technical
information"
are
defined
in
DFARS
Clause
252.204-7012,
Safeguarding
Covered
Defense
Information
and
Cyber
Incident
Reporting.
Personnel
Security
In
addition
to
the
industry
standards
for
employment
background
checks,
The
Contractor
must
be
willing
to
have
key
individuals,
in
exceptionally
sensitive
positions,
identified
for
additional
vetting
by
the
United
States
Government.
Supply
Chain
Resiliency
Plan
The
contractor
shall
develop
and
submit
within
30
calendar
days
after
contract
award,
a
comprehensive
Supply
Chain
Resiliency
Program
that
provides
identification
and
reporting
of
critical
components
associated
with
the
secure
supply
of
drug
substance,
drug
product,
and
work-in-process
through
to
finished
goods.
a)
A
critical
component
is
defined
as
any
material
that
is
essential
to
the
product
or
the
manufacturing
process
associated
with
that
product.
Included
in
the
definition
are
consumables
and
disposables
associated
with
manufacturing.
NOT
included
in
the
definition
are
facility
and
capital
equipment.
Consideration
of
critical
components
includes
the
evaluation
and
potential
impact
of
raw
materials,
excipients,
active
ingredients,
substances,
pieces,
parts,
software,
firmware,
labeling,
assembly,
testing,
analytical
and
environmental
componentry,
reagents,
or
utility
materials
which
are
used
in
the
manufacturing
of
a
drug,
cell
banks, seed
stocks,
devices
and
key
processing
components
and
equipment.
A
clear
example
of
a
critical
component
is
one
where
a
sole
supplier
is
utilized.
The
contractor
shall
identify
key
equipment
suppliers,
their
locations,
local
resources,
and
the
associated
control
processes
at
the
time
of
award.
This
document
shall
address
planning
and
scheduling
for
active
pharmaceutical
ingredients,
upstream,
downstream,
component
assembly,
finished
drug
product
and
delivery
events
as
necessary
for
the
delivery
of
product.
a)
Communication
for
these
requirements
shall
be
updated
as
part
of
an
annual
review,
or
as
necessary,
as
part
of
regular
contractual
communications.
b)
For
upstream
and
downstream
processing,
both
single-use
and
re-usable
in-place
processing
equipment,
and
manufacturing
disposables
also
shall
be
addressed.
For
finished
goods,
the
inspection,
labeling,
packaging,
and
associated
machinery
shall
be
addressed
taking
into
account
capacity
capabilities.
c)
The
focus
on
the
aspects
of
resiliency
shall
be
on
critical
components
and
aspects
of
complying
with
the
contractual
delivery
schedule.
Delivery
methods
shall be
addressed,
inclusive
of
items
that
are
foreign-sourced,
both
high
and
low
volume,
which
would
significantly
affect
throughput
and
adherence
to
the
contractually
agreed
deliveries.
The
contractor
shall
articulate
in
the
plan,
the
methodology
for
inventory
control,
production
planning,
scheduling
processes
and
ordering
mechanisms,
as
part
of
those
agreed
deliveries.
a)
Production
rates
and
lead
times
shall
be
understood
and
communicated
to
the
Contracting/Agreement
Officer
or
the
Contracting/Agreement
Officer's
Representative
as
necessary.
b)
Production
throughput
critical
constraints
should
be
well
understood
by
activity
and
by
design,
and
communicated
to
contractual
personnel.
As necessary,
communication
should
focus
on
identification,
exploitation,
elevation,
and
secondary
constraints
of
throughput,
as
appropriate.
Reports
for
critical
items
should
include
the
following
information:
a)
Critical
Material
b)
Vendor
c)
Supplier,
Manufacturing
/
Distribution
Location
d)
Supplier
Lead
Time
e)
Shelf
Life
f)
Transportation
/
Shipping
restrictions
The
CO
and
COR
reserve
the
right
to
request
un-redacted
copies
of
technical
documents,
during
the
period
of
performance,
for
distribution
within
the
Government.
Documents
shall
be
provided
within
ten
(10)
days
after
CO
issues
the
request.
The
Contractor
may
arrange
for
additional
time
if
deemed
necessary,
and
agreed
to
by
the
CO.
Manufacturing
Data
Requirements:
The
Contractor
shall
submit
within
30
calendar
days
after
award
detailed
data
regarding
project
materials,
sources,
and
manufacturing
sites,
including
but not
limited
to:
physical
locations
of
sources
of
raw and
processed
material
by
type
of
material;
location
and
nature
of
work
performed
at
manufacturing,
processing,
and
fill/finish
sites;
and
location
and
nature
of
non-clinical
and
clinical
studies
sites.
The
Government
may
provide
a
table
in
tabular
format
for
Contractor
to
be
used
to
submit
such
data
which
would
include
but
not
be
limited
to
the
following:
•
Storage/inventory
of
ancillary
materials
(vials,
needles,
syringes,
etc.)
•
Shipment
of
ancillary
materials
(vials,
needles,
syringes,
etc.)
•
Disposal
of
ancillary
materials
(vials,
needles,
syringes,
etc.)
•
Seed
development
or
other
starting
material
manufacturing
•
Bulk
drug
substance
and/or
adjuvant
production
•
Fill,
finish,
and
release
of
product
or
adjuvant
•
Storage/inventory
of
starting
materials,
bulk
substance,
or
filled/final
product
or
adjuvant
•
Stability
information
of
bulk
substance
and/or
finished
product
•
Shipment
of
bulk
substance
of
final
product
•
Disposal
of
bulk
substance
or
final
product
Product
Development
Source
Material
and
Manufacturing
Reports
and
Projections:
The
Contractor
shall
submit
a
detailed
spreadsheet
regarding
critical
project
materials
that
are
sourced
from
a
location
other
than
the
United
States,
sources,
and
manufacturing
sites,
including
but
not
limited
to:
physical
locations
of
sources
of
raw
and
processed
material
by
type
of
material;
location
and
nature
of
work
performed
at
manufacturing
sites;
and
location
and
nature
of
non-clinical
and
clinical
study
sites.
The
Contractor
will
provide
manufacturing
reports
and
manufacturing
dose
tracking
projections/actuals
utilizing
the
"COVID-19
Dose
Tracking
Templates",
on
any
contract/agreement
that
is
manufacturing
product
•
Contractor
will
submit
Product
Development
Source
Material
Report
o
Within
month
of
contract
award
o
Within
30
days
of
substantive
changes
are
made
to
sources
and/or
materials
o
Or
on
the
6th
month
contract
anniversary.
•
Contractor
will
update
the
Dose
Tracking
Template
weekly,
during
manufacturing
campaigns
and
COVID
response,
with
the
first
deliverable
submission
within
15
days
of
award/modification
•
The
Government
will
provide
written
comments
to
the
Product
Development
Source
Material
and
Manufacturing
Report
within
15
business
days
after
the
submission
•
If
corrective
action
is
recommended,
Contractor
must
address
all
concerns
raised
by
the
Government
in
writing
Contractor
Locations:
The
contractor
shall
submit
detailed
data
regarding
locations
where
work
will
be
performed
under
this
contract,
including
addresses,
points
of
contact,
and
work
performed
per
location,
to
include
sub-contractors.
Contractor
will
submit
Work
Locations
Report:
•
Within
5
business
days
of
contract
award
•
Within
30
business
days
after
a
substantive
location
or
capabilities
change
•
Within
2
business
days
of
a
substantive
change
if
the
work
performed
supports
medical
countermeasure
development
that
addresses
a
threat
that
has
been
declared
a
Public
Health
Emergency
by
the
HHS
Secretary
or
a
Public
Health
Emergency
of
International
Concern
(PHEIC)
by
the
WHO
Required
SOW
Language
for
Security
Section
This
project
requires
an
OPSEC
Plan
and
a
Security
Plan.
The
contractor
shall
develop
a
comprehensive
security
program
that
provides
overall
protection
of
personnel,
information,
data,
and
facilities
associated
with
fulfilling
the
Government
requirement.
This
plan
shall
establish
security
practices
and
procedures
that
demonstrate
how
the
contractor
will
meet
and
adhere
to
the
security
requirements
outlined
below
prior
to
the
commencement
of
product
manufacturing,
and
shall
be
delivered
to
the
Government
within
30
calendar
days
of
award.
The
contractor
shall
also
ensure
all
subcontractors,
consultants,
researchers,
etc.
performing
work
on
behalf
of
this
effort,
comply
with
all
Operation
Warp
Speed
and
Project
Agreement
security
requirements
and
prime
contractor
security
plans.
a)
The
Government
will
review
in
detail
and
submit
comments
within
ten
(10)
business
days
to
the
Contracting
Officer
(CO)
to
be
forwarded
to
the
Contractor.
The
Contractor
shall
review
the
Draft
Security
Plan
comments,
and,
submit
a
Final
Security
Plan
to
the
U.S.
Government
within
thirty
(10)
calendar
days
after
receipt
of
the
comments.
b)
The
Security
Plan
shall
include
a
timeline
for
compliance
of
all
the
required
security
measures
outlined
by
the
Government.
c)
Upon
completion
of
initiating
all
security
measures,
the
Contractor
shall
supply
to
the
Contracting
Officer
a
letter
certifying
compliance
to
the
elements
outlined
in
the
Final
Security
Plan.
At
a
minimum,
the
Final
Security
Plan
shall
address
the
following
items:
Security
Requirements:
1.
Facility
Security
Plan
Description:
As
part
of
the
partner
facility's
overall
security
program,
the
contractor
shall
submit
a
written
security
plan
with
their
proposal
to
the
Agreement
Officer
for
review
and
approval
by
Operation
Warp
Speed
security
subject
matter
experts.
The
performance
of
work
under
the
Project
Agreement
will
be
in
accordance
with
the
a
proved
security
plan.
The
security
'lan
will
include
the
followm
rocesses
and
procedures
at
a
minimum:
•
organization
chart
and
responsibilities
Security
Administration
•
•
•
•
•
written
security
risk
assessment
for
site
threat
levels
with
identification
matrix
(High,
Medium,
or
Low)
enhanced
security
procedures
during
elevated
threats
liaison
procedures
with
law
enforcement
annual
employee
security
education
and
training
program
•
policies
and
procedures
Personnel
Security
•
•
•
•
•
•
•
candidate
recruitment
process
background
investigations
process
employment
suitability
policy
employee
access
determination
rules
of
behavior/
conduct
termination
procedures
non-disclosure
agreements
Physical
Security
Policies
•
internal/external
access
control
and
Procedures
•
•
•
•
•
•
•
•
•
•
•
•
•
•
protective
services
identification/badging
employee
and
visitor
access
controls
parking
areas
and
access
control
perimeter
fencing/barriers
product
shipping,
receiving
and
transport
security
procedures
facility
security
lighting
restricted
areas
signage
intrusion
detection
systems
alarm
monitoring/response
closed
circuit
television
product
storage
security
other
control
measures
as
identified
Information
Security
•
•
•
•
•
identification
and
marking
of
sensitive
information
access
control
storage
of
information
document
control
procedures
retention/
destruction
re
ements
Information
•
intrusion
detection
and
prevention
systems
Technology/Cyber
Security
•
threat
identification
Policies
and
Procedures
•
•
•
•
•
•
•
•
•
employee
training
(initial
and
annual)
encryption
systems
identification
of
sensitive
information/media
password
policy
(max
days
90)
lock
screen
time
out
policy
(minimum
time
20
minutes)
removable
media
policy
laptop
policy
removal
of
IT
assets
for
domestic/foreign
travel
access
control
and
determination
•
VPN
procedures
•
WiFi
and
Bluetooth
disabled
when
not
in
use
•
system
document
control
•
system
backup
•
system
disaster
recovery
•
incident
response
•
system
audit
procedures
•
property
accountability
2.
Site
Security
Master
Plan
Description:
The
partner
facility
shall
provide
a
site
schematic
for
security
systems
which
includes:
main
access
points;
security
cameras;
electronic
access
points;
IT
Server
Room;
Product
Storage
Freezer/Room;
and
bio-
containment
laboratories.
3.
Site
Threat
/
Vulnerability
/
Risk
Assessment
Description:
The
partner
facility
shall
provide
a
written
risk
assessment
for
the
facility
addressing:
criminal
threat,
including
crime
data;
foreign/domestic
terrorist
threat;
industrial
espionage;
insider
threats;
natural
disasters;
and
potential
loss
of
critical
infrastructure (power/water/natural
gas.
etc.)
This
assessment
shall
include
recent
data
obtained
from
local
law
enforcement
agencies.
The
assessment
should
be
updated
annually.
4.
Physical
Security
Description:
Closed
Circuit
Television
(CCTV)
Monitoring
a)
Layered
(internal/external)
CCTV
coverage
with
time-lapse
video
recording
for
buildings
and
areas
where
critical
assets
are
processed
or
stored.
b)
CCTV
coverage
must
include
entry
and
exits
to
critical
facilities,
perimeters,
and
areas
within
the
facility
deemed
critical
to
the
execution
of
the
contract.
c)
Video
recordings
must
be
maintained
for
a
minimum
of
30
days.
d)
CCTV
surveillance
system
must
be
on
emergency
power
backup.
e)
CCTV
coverage
must
include
entry
and
exits
to
critical
facilities,
perimeters,
and
areas
within
the
facility
deemed
critical
to
the
execution
of
the
contract.
f)
Video
recordings
must
be
maintained
for
a
minimum
of
30
days.
g)
CCTV
surveillance
system
must
be
on
emergency
power
backup.
Facility
Lighting
a)
Lighting
must
cover
facility
perimeter,
parking
areas,
critical
infrastructure,
and
entrances
and
exits
to
buildings.
b)
Lighting
must
have
emergency
power
backup.
c)
Lighting
must
be
sufficient
for
the
effective
operation
of
the
CCTV
surveillance
system
during
hours
of
darkness.
Shipping
and
Receiving
a)
Must
have
CCTV
coverage
and
an
electronic
access
control
system.
b)
Must
have
procedures
in
place
to
control
access
and
movement
of
drivers
picking
up
or
delivering
shipments.
c)
Must
identify
drivers
picking
up
Government
products
by
government
issued
photo
identification.
Access
Control
a)
Must
have
an
electronic
intrusion
detection
system
with
centralized
monitoring.
b)
Responses
to
alarms
must
be
immediate
and
documented
in
writing.
c)
Employ
an
electronic
system
(i.e.,
card
key)
to
control
access
to
areas
where
assets
critical
to
the
contract
are
located
(facilities,
laboratories,
clean
rooms,
production
facilities,
warehouses,
server
rooms,
records
storage,
etc.).
d)
The
electronic
access
control
should
signal
an
alarm
notification
of
unauthorized
attempts
to
access
restricted
areas.
e)
Must
have
a
system
that
provides
a
historical
log
of
all
key
access
transactions
and
kept
on
record
for
a
minimum
of12
months.
f)
Must
have
procedures
in
place
to
track
issuance
of
access
cards
to
employees
and
the
ability
to
deactivate
cards
when
they
are
lost
or
an
employee
leaves
the
company.
g)
Response
to
electronic
access
control
alarms
must
be
immediate
and
documented
in
writing
and
kept
on
record
for
a
minimum
of
12
months.
h)
Should
have
written
procedures
to
prevent
employee
piggybacking
access
i)
to
critical
infrastructure
(generators,
air
handlers,
fuel
storage,
etc.)
should
be
controlled
and
limited
to
those
with
a
legitimate
need
for
access.
j)
Must
have
a
written
manual
key
accountability
and
inventory
process.
k)
Physical
access
controls
should
present
a
layered
approach
to
critical
assets
within
the
facility.
Employee/Visitor
Identification
a)
Should
issue
company
photo
identification
to
all
employees.
b)
Photo
identification
should
be
displayed
above
the
waist
anytime
the
employee
is
on
company
property.
c)
Visitors
should
be
sponsored
by
an
employee
and
must
present
government
issued
photo
identification
to
enter
the
property.
d)
Visitors
should
be
logged
in
and
out
of
the
facility
and
should
be
escorted
by
an
employee
while
on
the
premises
at
all
times.
Security
Fencing
Requirements
for
security
fencing
will
be
determined
by
the
criticality
of
the
program,
review
of
the
security
plan,
threat
assessment,
and
onsite
security
assessment.
Protective
Security
Forces
Requirements
for
security
officers
will
be
determined
by
the
criticality
of
the
program,
review
of
the
security
plan,
threat
assessment,
and
onsite
security
assessment.
Protective
Security
Forces
Operations
a)
Must
have
in-service
training
program.
b)
Must
have
Use
of
Force
Continuum.
c)
Must
have
communication
systems
available
(i.e.,
landline
on
post,
cell
phones,
handheld
radio,
and
desktop
computer).
d)
Must
have
Standing
Post
Orders.
e)
Must
wear
distinct
uniform
identifying
them
as
security
officers.
5.
Security
Operations
Description:
Information
Sharing
a)
Establish
formal
liaison
with
law
enforcement.
b)
Meet
in
person
at
a
minimum
annually.
Document
meeting
notes
and
keep
them
on
file
for
a,
minimum
of
12
months.
POC
information
for
LE
Officer
that
attended
the
meeting
must
be
documented.
c)
Implement
procedures
for
receiving
and
disseminating
threat
information.
Training
a)
Conduct
new
employee
security
awareness
training.
b)
Conduct
and
maintain
records
of
annual
security
awareness
training.
Security
Management
a)
Designate
a
knowledgeable
security
professional
to
manage
the
security
of
the
facility.
b)
Ensure
subcontractor
compliance
with
all
Government
security
requirements.
6.
Personnel
Security
Description:
Records
Checks
Verification
of
social
security
number,
date
of
birth,
citizenship,
education
credentials,
five-year
previous
employment
history,
five-year
previous
residence
history,
FDA
disbarment,
sex
offender
registry,
credit
check
based
upon
position
within
the
company;
motor
vehicle
records
check
as
appropriate;
and
local/national
criminal
history
search.
Hiring
and
Retention
Standards
a)
Detailed
policies
and
procedures
concerning
hiring
and
retention
of
employees,
employee
conduct,
and
off
boarding
procedures.
b)
Off
Boarding
procedures
should
be
accomplished
within
24
hour
of
employee
leaving
the
company.
This
includes
termination
of
all
network
access.
7.
Information
Security
Description:
Physical
Document
Control
a)
Applicable
documents
shall
be
identified
and
marked
as
procurement
sensitive,
proprietary,
or
with
appropriate
government
markings.
b)
Sensitive,
proprietary,
and
government
documents
should
be
maintained
in
a
lockable
filing
cabinet/desk
or
other
storage
device
and
not
be
left
unattended.
c)
Access
to
sensitive
information
should
be
restricted
to
those
with
a
need
to
know.
Document
Destruction
Documents
must
be
destroyed
using
approved
destruction
measures
(i.e.
shredders/approved
third
party
vendors
/
pulverizing
/
incinerating).
8.
Information
Technology
&
Cybersecurity
Description:
Identity
Management
a)
Physical
devices
and
systems
within
the
organization
are
inventoried
and
accounted
for
annually.
b)
Organizational
cybersecurity
policy
is
established
and
communicated.
c)
Asset
vulnerabilities
are
identified
and
documented.
d)
Cyber
threat
intelligence
is
received
from
information
sharing
forums
and
sources.
e)
Threats,
vulnerabilities,
likelihoods,
and
impacts
are
used
to
determine
risk.
f)
Identities
and
credentials
are
issued,
managed,
verified,
revoked,
and
audited
for
authorized
devices,
users
and
processes.
g)
Users,
devices,
and
other
assets
are
authenticated
(e.g.,
single-factor,
multifactor)
commensurate
with
the
risk
of
the
transaction
(e.g.,
individuals'
security
and
privacy
risks
and
other
organizational
risks)
Access
Control
a)
Limit
information
system
access
to
authorized
users.
b)
Identify
information
system
users,
processes
acting
on
behalf
of
users,
or
devices
and
authenticate
identities
before
allowing
access.
c)
Limit
physical
access
to
information
systems,
equipment,
and
server
rooms
with
electronic
access
controls.
d)
Limit
access
to/
verify
access
to
use
of
external
information
systems.
Training
a)
Ensure
that
personnel
are
trained
and
are
made
aware
of
the
security
risks
associated
with
their
activities
and
of
the
applicable
laws,
policies,
standards,
regulations,
or
procedures
related
to
information
technology
systems.
Audit
and
Accountability
a)
Create,
protect,
and
retain
information
system
audit
records
to
the
extent
needed
to
enable
the
monitoring,
analysis,
investigation,
and
reporting
of
unlawful,
unauthorized,
or
inappropriate
system
activity.
Records
must
be
kept
for
minimum
must
be
kept
for
12
months.
b)
Ensure
the
actions
of
individual
information
system
users
can
be
uniquely
traced
to
those
users.
c)
Update
malicious
code
mechanisms
when
new
releases
are
available.
d)
Perform
periodic
scans
of
the
information
system
and
real
time
scans
of
files
from
external
sources
as
files
are
downloaded,
opened,
or
executed.
c
olifigui
a
non
'Management
a)
Establish
and
enforce
security
configuration
settings.
b)
Implement
sub
networks
for
publically
accessible
system
components
that
are
physically
or
logically
separated
from
internal
networks.
Contingency
Planning
a)
Establish,
implement,
and
maintain
plans
for
emergency
response.
backup
operations,
and
post-disaster
recovery
for
information
systems
to
ensure
the
availability
of
critical
information
resources
at
all
times.
Incident
Response
a)
Establish
an
operational
incident
handling
capability
for
information
systems
that
includes
adequate
preparation,
detection,
analysis,
containment,
and
recovery
of
cybersecurity
incidents.
Exercise
this
capability
annually.
Media
and
Information
Protection
a)
Protect
information
system
media,
both
paper
and
digital.
b)
Limit
access
to
information
on
information
systems
media
to
authorized
users.
c)
Sanitize
and
destroy
media
no
longer
in
use.
d)
Control
the
use
of
removable
media
through
technology
or
policy.
Physical
and
Environmental
Protection
a)
Limit
access
to
information
systems,
equipment,
and
the
respective
operating
environments
to
authorized
individuals.
b)
Intrusion
detection
and
prevention
system
employed
on
IT
networks.
c)
Protect
the
physical
and
support
infrastructure
for
all
information
systems.
d)
Protect
information
systems
against
environmental
ha7ards
e)
Escort
visitors
and
monitor
visitor
activity.
Network
Protection
Employ
intrusion
prevention
and
detection
technology
with
immediate
analysis
capabilities.
9.
Transportation
Security
Description:
Adequate
security
controls
must
be
implemented
to
protect
materials
while
in
transit
from
theft.
destruction
manipulation,
or
damage.
Drivers
a)
Drivers
must
be
vetted
in
accordance
with
the
Government
Personnel
Security
Requirements.
b)
Drivers
must
be
trained
on
specific
security
and
emergency
procedures.
c)
Drivers
must
be
equipped
with
backup
communications.
d)
Driver
identity
must
be
100
percent
confirmed
before
the
pick-up
of
any
Government
product.
e)
Drivers
must
never
leave
Government
products
unattended,
and
two
drivers
may
be
required
for
longer
transport
routes
or
critical
products
during
times
of
emergency.
f)
Truck
pickup
and
deliveries
must
be
logged
and
kept
on
record
for
a
minimum
of
12
months.
Transport
Route.
a)
Transport
routes
should
be
pre-planned
and
never
deviated
from
except
when
approved
or
in
the
event
of
an
emergency.
b)
Transport
routes
should
be
continuously
evaluated
based
upon
new
threats,
significant
planned
events,
weather,
and
other
situations
that
may
delay
or
disrupt
transport.
Product
Security
a)
Government
products
must
be
secured
with
tamper
resistant
seals
during
transport,
and
the
transport
trailer
must
be
locked
and
sealed.
•
Tamper
resistant
seals
must
be
verified
as
"secure"
after
the
product
is
placed
in
the
transport
vehicle.
b)
Government
products
should
be
continually
monitored
by
GPS
technology
while
in
transport,
and
any
deviations
from
planned
routes
should
be
investigated
and
documented.
c)
Contingency
plans
should
be
in
place
to
keep
the
product
secure
during
emergencies
such
as
accidents
and
transport
vehicle
breakdowns.
10.
Security
Reporting
Requirements
Description:
The
partner
facility
shall
notify
the
Agreement
Officer
within
24
hours
of
any
activity
or
incident
that
is
in
violation
of
established
security
standards
or
indicates
the
loss
or
theft
of
government
products.
The
facts
and
circumstances
associated
with
these
incidents
will
be
documented
in
writing
for
government
review.
11.
Security
Audits
Description:
The
partner
facility
agrees
to
formal
security
audits
conducted
at
the
discretion
of
the
government.
Security
audits
may
include
both
prime
and
subcontractor.
