Document:

Exhibit 10.1

 

 

 

 

 

 

Exhibit 10.1

 

EMPLOYMENT AGREEMENT

 

 

                THIS
EMPLOYMENT AGREEMENT (this “Agreement”) is made as of and effective on the 2nd
day of October, 2012 (the “Effective Date”) by and between Southern First Bank, National Association (the
“Employer”), having its principal office at 100 Verdae Boulevard, Suite 100,
Greenville, South Carolina 29607, and Michael D. Dowling (hereinafter called
“Employee”), a resident of the state of South Carolina.  

 

                Employer
presently employs Employee as its Executive Vice President and Chief Financial
Officer.  Employer desires to provide for the continued employment of Employee
and to provide an employment arrangement which Employer has determined will
reinforce and encourage the continued dedication of Employee to Employer. 
Employee is willing to continue to serve Employer on the terms and conditions
herein provided. 

 

                In
consideration of the mutual covenants and promises herein made, and other good
and valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the parties hereto agree as follows:

 

1.     
Employment.  Employer shall continue to employ
Employee, and Employee shall continue to serve Employer, as Executive Vice
President and Chief Financial Officer and in such capacity shall perform such
duties as are consistent with that position, and as Employer from time to time
may direct.   Employee shall have such authority and responsibilities
consistent with Employee’s position as are set forth in Employer’s Bylaws or
assigned by Employer’s Board of Directors (the “Board”), Chief Executive
Officer or President from time to time.  Employee shall devote Employee’s full
business time, attention, skill and efforts to the performance of Employee’s
duties hereunder, except during periods of illness or periods of vacation and
leaves of absence consistent with Employer’s policy.  Such duties shall be
performed at Employer’s principal corporate offices or subsidiary offices as
agreed upon by Employer and Employee.  Employer reserves the right from time to
time to extend, curtail or change the title and duties of Employee.  Employee
may devote reasonable periods to service as a director or advisor to other
organizations, to charitable and community activities, and to managing
Employee’s personal investments; provided that such activities do not
materially interfere with the performance of Employee’s duties hereunder and
are not in conflict or competitive with, or adverse to, the interests of
Employer.  Unless
otherwise specified hereafter, any services performed by the Employee shall be
for the benefit of the
Employer and therefore
any payments or benefits paid to the Employee pursuant to this Agreement shall
be the sole responsibility of the
Employer; provided
however that the Employer recognizes that the Employee also currently serves as
Executive Vice
President and Chief Financial Officer of Southern
First Bancshares, Inc. (the “Company”), the bank holding company of the Employer.  Therefore, the Employer’s
obligation to make any payments owed to the Employee under this Agreement shall
be discharged to the extent compensation payments are made by the Company.

 

2.     
Term.  Unless earlier terminated as
provided in section 13 below, Employee’s employment under this Agreement shall
commence on the Effective Date and be for a term ending January 31, 2014 (the
“Term”).

 

 

 

 

 

 

 

3.     
Base Salary.  For all services rendered by
Employee under this Agreement, Employer shall pay Employee a base salary of $182,000.00
per year (the “Base Salary”).  The Base Salary shall be reviewed annually by
the Board, and may be increased beginning February 1 of each year, by the Board
or a duly appointed committee thereof, in its sole discretion.  The Base Salary
shall be paid in accordance with Employer’s standard payroll procedures, but in
any case, no less frequently than monthly.   

 

4.     
Benefits.  

 

(a)          Employee
shall be entitled, to the extent that Employee’s position, title, tenure,
salary, age, health and other qualifications make Employee eligible, to
participate in such pension, profit sharing, bonus, life insurance,
hospitalization, major medical, and other employee benefit plans or programs of
Employer currently in existence on the date hereof or later established that
generally are provided to executive employees of Employer.  Employee’s
participation in any such plan or program shall be subject to the provisions,
rules and regulations applicable thereto.  Any Company stock options or similar
awards shall be issued to Employee at an exercise price per share of not less
than the fair market value per share of the corresponding shares as of the date
of grant and the number of shares subject to such grant shall be fixed on such
date.  Any and all bonus payments made to Employee shall be paid by the earlier
of: (i) seventy (70) days after the previous year end for which the bonus was
earned by Employee and became a payable of Employer or (ii) with the first
payroll cycle following the Company’s press release announcing its previous
year’s financial performance. 

 

(b)
         At Employer’s election, Employer shall provide Employee with either an
automobile owned or leased by Employer of a make and model appropriate to
Employee’s status, or a $700 monthly automobile allowance, paid in accordance
with Employer’s standard payroll procedures, but in any case, no less
frequently than monthly.  If Employer provides Employee with an automobile
instead of a monthly automobile allowance, Employer shall reimburse Employee
for reasonable expenses associated with the automobile, including, but not
limited to, insurance, taxes, mileage, maintenance, etc., to be paid within
sixty (60) days of Employee’s written notice to Employer of such expenses.  

 

5.     
Working Facilities.  Employee shall be furnished with
an office and such other facilities and services as may be necessary or
suitable to Employee’s position and adequate for the performance of Employee’s
duties.

 

6.     
Expenses.  Employee is authorized to incur
reasonable expenses for promoting the business of Employer, including expenses
for entertainment, travel and similar items, but only to the extent that such
expenses are allowable deductions to Employer on its Federal income tax
return.  Expenses for which there is a fifty percent (50%) tax deduction
limitation for entertainment, travel and similar items shall be considered
reimbursable expenses.  Employer shall reimburse Employee for all such expenses
within sixty (60) days of Employee’s written notice to Employer of such
expenses.  Employee shall repay to Employer the amounts of any expenses claimed
which, for lack of proper documentation or otherwise, are not allowed to
Employer as deductions for Federal income tax purposes.

 

	
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7.     
Vacations.  Employee shall be entitled each
fiscal year to twenty (20) paid days off, which shall be granted on a
noncumulative basis from year-to-year, as granted by Employer to employees of
similar tenure and compensation rank, pursuant to Employer’s paid days off
policy.  Employer reserves the right to modify this and any other personnel
policy from time to time.  Any payments made by the Employer to the Employee as
compensation for paid vacation leave shall be paid in accordance with the
Employer’s standard payroll procedures.

 

8.     
Ownership of Work
Product.

 

(a)               
Employee shall
diligently disclose to Employer as soon as it is created or conceived by
Employee, and Employer shall own, all Work Product (as defined below).  To the
extent permitted by law, all Work Product shall be considered work made for
hire by Employee and owned by Employer.

 

(b)                
If any of the Work
Product may not, by operation of law, be considered work made for hire by
Employee for Employer (or if ownership of all right, title and interest of the
intellectual property rights therein shall not otherwise vest exclusively in
Employer), Employee agrees to assign, and upon creation thereof automatically
assigns, without further consideration, the ownership of all Work Product to
Employer, its successors and assigns.

 

(c)                 
Employer, its
successors and assigns, shall have the right to obtain and hold in its or their
own name copyrights, registrations, and any other protection available in the
foregoing.

 

(d)                
Employee agrees to
perform upon the reasonable request of Employer, during or after Employee’s
employment, such further acts as may be necessary or desirable to transfer,
perfect and defend Employer’s ownership of the Work Product.  When requested,
Employee will:

 

(i)                
Execute, acknowledge
and deliver any requested affidavits and documents of assignment and
conveyance;

 

(ii)              
Obtain and aid in the
enforcement of copyrights (and, if applicable, patents) with respect to the
Work Product in any countries;

 

(iii)            
Provide testimony in
connection with any proceeding affecting the right, title or interest of
Employer in any Work Product; and

 

(iv)            
Perform any other acts
deemed necessary or desirable to carry out the purposes of this Agreement.

 

(e)                 
Employer shall
reimburse all reasonable out-of-pocket expenses incurred by Employee at
Employer’s request in connection with subsection 8(d) within sixty (60) days of
Employee’s written notice to Employer of such expenses.

 

	
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(f)                 
For purposes hereof,
“Work Product” shall mean all intellectual property rights, including all Trade
Secrets (as defined below), U.S. and international copyrights, patentable
inventions, discoveries and improvements, and other intellectual property
rights, in any programming, documentation, technology or other work product
that relates to the business and interests of Employer or any Affiliates and
that Employee conceives, develops, or delivers to Employer at any time during
the Term of Employee’s employment.  “Work Product” shall also include all
intellectual property rights in any programming, documentation, technology or
other work product that is now contained in any of the products or systems
(including development and support systems) of Employer to the extent Employee
conceived, developed or delivered such Work Product to Employer prior to the
date of this Agreement while Employee was engaged as an independent contractor
or employee of Employer.  Employee hereby irrevocably relinquishes for the
benefit of Employer and its assigns any moral rights in the Work Product
recognized by applicable law.

 

9.     
Protection of Trade
Secrets and Confidential Information. 

 

(a)                 
Through exercise of
Employee’s rights and performance of Employee’s obligations under this
Agreement, Employee will be exposed to “Trade Secrets” and “Confidential
Information” (as those terms are defined below).  “Trade Secrets” shall mean
information or data of or about Employer or any Affiliates (as defined in
subsection 26(a)), including, but not limited to, technical or non-technical
data, formulas, patterns, compilations, programs, devices, methods, techniques,
drawings, processes, financial data, financial plans, product plans, or lists
of actual or potential customers, clients, distributors, or licensees, that:
(i) derive economic value, actual or potential, from not being generally known
to, and not being readily ascertainable by proper means by, other persons who
can obtain economic value from their disclosure or use; and (ii) are the
subject of efforts that are reasonable under the circumstances to maintain
their secrecy.  To the extent that the foregoing definition is inconsistent
with the definition of “trade secret” mandated under applicable law, the latter
definition shall govern for purposes of interpreting Employee’s obligations
under this Agreement.  Except as required to perform Employee’s obligations
under this Agreement, or except with Employer’s prior written permission,
Employee shall not use, redistribute, market, publish, disclose or divulge to
any other person or entity any Trade Secrets of Employer.  Employee’s
obligations under this provision shall remain in force (during and after the
Term) for so long as such information or data shall continue to constitute a
Trade Secret under applicable law.  Employee agrees to cooperate with any and
all confidentiality requirements of Employer, and Employee shall immediately
notify Employer of any unauthorized disclosure or use of any Trade Secrets of
which Employee becomes aware.

 

(b)                
Employee agrees to maintain
in strict confidence and, except as necessary to perform Employee’s duties for
Employer, not to use or disclose any Confidential Information at any time,
either during the Term of Employee’s employment or for a period of one (1) year
after Employee’s last date of employment, so long as the pertinent data or
information remains Confidential Information.  “Confidential Information” shall
mean any non-public information of a competitively sensitive or personal
nature, other than Trade Secrets, acquired by Employee during Employee’s
employment, relating to Employer or any Affiliate or Employer’s or any
Affiliate’s business, operations, customers, suppliers, products, employees,
financial affairs or industrial practices.  Notwithstanding anything herein to
the contrary, no obligation or liability shall accrue hereunder with respect to
any information that is or becomes publicly available without the fault of
Employee.

 

(c)                 
Employee will abide by
Employer’s policies and regulations, as established from time to time, for the
protection of its Confidential Information.  Employee acknowledges that all
records, files, data, documents, and the like relating to suppliers, customers,
costs, prices, systems, methods, personnel, technology and other materials
relating to Employer or its Affiliated entities shall be and remain the sole
property of Employer and/or such Affiliated entity.  Employee agrees, upon the
request of Employer, and in any event upon termination of Employee’s
employment, to turn over all copies of all media, records, documentation, etc.,
pertaining to Employer (together with a written statement certifying as to
Employee’s compliance with the foregoing).

 

	
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10.    Non-Solicitation of Customers. 
During the Employee’s employment with the Employer and for a period of one (1)
year following termination or expiration of this Agreement, Employee shall not
(except on behalf of or with the prior written consent of the Employer)
directly or indirectly solicit any individual or entity which was a customer or
client of Employer or any of its Affiliates for the purpose of providing a
service or product to such customer or client which is the same type of service
or product offered or provided by Employer or any of its Affiliates; provided,
however, that this restriction shall apply only to those customers or
clients with whom Employee had contact in connection with services or products
provided by Employer or any of its Affiliates within two (2) years prior to the
date of termination of such employment.

 

11.    Non-Solicitation of Employees. 
During the Employee’s employment with the Employer and for a period of one (1)
year following termination or expiration of this Agreement, Employee shall not,
directly or indirectly, on the Employee’s own behalf or in the service of or on
behalf of others, induce or solicit, or attempt to induce or solicit, for
employment purposes or for any type of consulting purposes any employee of or
consultant to the Employer or any of its Affiliates for the purpose of
providing services that are the same or similar to the types of services
offered or engaged in by any employee of or consultant to the Employer or any
of its Affiliates at the time of termination of Employee’s employment with
Employer.  

 

12.    Non-Competition Agreement. 
During Employee’s employment with the Employer and for a period of one (1) year
following termination or expiration of this Agreement, Employee shall not
(without the prior written consent of Employer) compete with Employer or any of
its Affiliates, directly or indirectly, engage in forming, serving as an
organizer, director, officer of, employee or agent, or consultant to, or
acquiring or maintaining more than a one percent (1%) passive investment in, a
depository financial institution or holding company thereof if such depository
institution or holding company has, or upon formation will have, one or more
offices or branches located within thirty (30) miles of any office or branch of
Employer or any of its Affiliates in existence at the time Employee’s
employment with Employer is terminated (the “Territory”).  Notwithstanding the
foregoing, Employee may serve as an officer of or consultant to a depository
institution or holding company thereof even though such institution operates
one or more offices or branches in the Territory, if Employee’s employment does
not directly involve, in whole or in part, the depository financial
institution’s or holding company’s operations in the Territory.  

 

13.    Termination and Severance
Payments.  In the event that the Employer is subject to Part 359 of the
FDIC Rules and Regulations (12 C.F.R. § 359, et seq.), any severance
payment to be paid pursuant to this section 13 will be made only as permitted
by applicable federal regulations. 

 

(a)                 
Employee’s employment
under this Agreement may be terminated prior to the end of the Term only as
follows:

 

(i)                
upon the death of
Employee;

 

(ii)              
by Employer upon the
Disability (as defined in subsection 26(d)) of Employee for a period of one
hundred and eighty (180) days;

 

(iii)            
by Employer for Cause
(as defined in subsection 26(b)) upon delivery of a Notice of Termination (as
defined in subsection 26(g)) to Employee;

 

(iv)            
by Employer without
Cause upon delivery of a Notice of Termination to Employee;

 

	
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(v)              
by Employee for Good
Reason (as defined in subsection 26(e)) upon delivery of a Notice of
Termination to the Employer within a ninety (90) day period beginning on the
thirtieth (30th) day after the occurrence of a Change in Control (as
defined in subsection 26(c)) or within a ninety (90) day period beginning on
the one (1) year anniversary of the occurrence of a Change in Control; or

 

(vi)            
by Employee upon
delivery of a Notice of Termination to Employer.

 

(b)                
If Employee’s
employment is terminated because of the Employee’s death, Employer shall pay
Employee’s estate: 

                                

(i)            any sums due Employee
as Base Salary and/or reimbursement of expenses through the end of the month
during which death occurred, paid in accordance with Employer’s standard
payroll procedures, but in any case, no less frequently than monthly; and 

 

(ii)           any bonus earned or
accrued through the date of death.  Any bonus for previous years which was not
yet paid will be paid pursuant to the terms as set forth in section 4(a).  Any
bonus that is earned in the year of death will be paid on the earlier of: (i)
seventy (70) days after the year end in which the Employee died or (ii) with
the first payroll cycle following the Company’s press release announcing its
financial performance for the year in which the Employee died.  To the extent
that the bonus is performance-based, the amount of the bonus will be calculated
by taking into account the performance of the Employer for the entire year and
prorating this through the date of Employee’s death.  

                

(c)                 
During the period of
any Disability leading up to the termination of Employee’s employment as a
result of the Disability, Employer shall:

 

(i)            continue to pay the
Employee’s full Base Salary at the rate then in effect and all perquisites and
other benefits (other than any bonus) in accordance with Employer’s standard
payroll procedures, but in any case, no less frequently than monthly, until
Employee becomes eligible for benefits under any long-term disability plan or
insurance program maintained by Employer; provided that the amount of
any such payments to Employee shall be reduced by the sum of the amounts, if
any, payable to Employee for the same period under any disability benefit or
pension plan covering the Employee; and

 

(ii)           pay Employee any
bonus earned or accrued through the date of Disability.  Any bonus for previous
years which was not yet paid will be paid pursuant to the terms as set forth in
section 4(a).  Any bonus that is earned in the year of Disability will be paid
on the earlier of: (i) seventy (70) days after the year end in which Employee
became Disabled or (ii) with the first payroll cycle following the Company’s
press release announcing its financial performance for the year in which the
Employee became Disabled.  

 

	
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(d)          If
Employee’s employment is terminated for Cause, Employee shall receive only any
sums due Employee as Base Salary and/or reimbursement of expenses through the
date of termination, paid in accordance with Employer’s standard payroll
procedures, but in any case, no less frequently than monthly. 

 

(e)          If
Employee’s employment is terminated by Employer without Cause, beginning on the
date that is six (6) months and one (1) day following the date of the
Employee’s termination, and continuing on the first day of the month for the
next eleven (11) months, the Employer shall pay to the Employee monthly
severance compensation in cash in an amount equal to one-twelfth (1/12th)
of the Employee’s Base Salary at the date of termination.  For the avoidance of
doubt, in no event will the aggregate amount of such severance compensation
exceed the Employee’s Base Salary at the date of termination.  The restrictive
covenants contained in sections 10, 11 and 12 shall not apply to Employee. 

 

(f)           If
Employee’s employment is terminated by Employee for Good Reason, in addition to
other rights and remedies available in law or equity, beginning on the date
that is six (6) months and one (1) day following the date of the Employee’s
termination, and continuing on the first day of the month for the next eleven
(11) months, the Employer shall pay Employee monthly severance compensation in
cash in an amount equal to one-twelfth (1/12th) of the Employee’s
Base Salary at the date of termination.  For the avoidance of doubt, in no event
will the aggregate amount of such severance compensation exceed the Employee’s
Base Salary at the date of termination. The restrictive covenants contained in
sections 10, 11 and 12 shall not apply to Employee.

 

 (g)         If
Employee’s employment is terminated by Employee without Good Reason, Employee
shall receive only any sums due Employee as Base Salary and/or reimbursement of
expenses through the date of termination, paid in accordance with Employer’s
standard payroll procedures, but in any case, no less frequently than monthly. 

 

(h)
         With the exceptions of the provisions of this section 13, and the
express terms of any benefit plan under which Employee is a participant, it is
agreed that, upon Employee’s Termination of Employment, Employer shall have no
obligation to Employee for, and Employee waives and relinquishes, any further
compensation or benefits (exclusive of COBRA benefits).  Unless otherwise
stated in this section 13, the effect of termination on any outstanding
incentive awards, stock options, stock appreciation rights, performance units,
or other incentives shall be governed by the terms of the applicable benefit or
incentive plan and/or the agreements governing such incentives.  Within sixty
(60) days of termination of the Employee’s employment, and as a condition to
the Employer’s obligation to pay any severance hereunder, the Employer and the
Employee shall enter into a mutually satisfactory form of release and may not
revoke such release within the revocation period stated in such release, which
shall acknowledge such remaining obligations and discharge both parties, as
well as the Employer’s officers, directors and employees with respect to their
actions for or on behalf of the Employer, from any other claims or obligations
arising out of or in connection with the Employee’s employment by the Employer,
including the circumstances of such termination.  Further provided that, if
such severance payment is made by the Employer, and if the sixty (60) day
period spans two (2) calendar years, regardless of when such release is
executed by the Employee, such severance payment must be made in the subsequent
taxable year.

 

	
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(i)            The
parties intend that the severance payments and other compensation provided for
herein are reasonable compensation for Employee’s services to Employer and
shall not constitute “excess parachute payments” within the meaning of Section
280G of the Internal Revenue Code of 1986, as amended (the “Code”), and any
regulations thereunder.  If
the Employer’s independent accountants acting as auditors for the Employer
determine that any or the aggregate value (as determined pursuant to Section
280G of the Code) of all payments, distributions, accelerations of vesting,
awards and provisions of benefits by the Employer to or for the benefit of
Employee (whether paid or payable, distributed or distributable, accelerated,
awarded or provided pursuant to the terms of this Agreement or otherwise), (a
“Payment”) would constitute an excess parachute payment and be subject to the
excise tax imposed by Section 4999 of the Code (the “Excise Tax”), such Payment
shall be reduced to the least extent necessary so that no portion of the
Payment shall be subject to the Excise Tax, but only if, by reason of such
reduction, the net after-tax benefit received by the Employee as a result of
such reduction will exceed the net after-tax benefit that would have been
received by the Employee if no such reduction were made. The Payment shall be
reduced, if applicable, by the Employer in the following order of priority: (A)
reduction of any cash severance payments otherwise payable to the Employee that
are exempt from Section 409A of the Code; (B) reduction of any other cash
payments or benefits otherwise payable to the Employee that are exempt from
Section 409A of the Code, but excluding any payments attributable to any
acceleration of vesting or payments with respect to any equity award that are
exempt from Section 409A of the Code; (C) reduction of any payments
attributable to any acceleration of vesting or payments with respect to any
equity award that are exempt from Section 409A of the Code, in each case
beginning with payments that would otherwise be made last in time; and (D)
reduction of any other payments or benefits otherwise payable to the Employee
on a pro-rata basis or such other manner that complies with Section 409A of the
Code, but excluding any payments attributable to any acceleration of vesting
and payments with respect to any equity award that are exempt from Section 409A
of the Code. If, however, such Payment is not reduced as described above, then
such Payment shall be paid in full to the Employee and the Employee shall be
responsible for payment of any Excise Taxes relating to the Payment.

 

14.    Oral Modification Not Binding. 
This Agreement supersedes all prior agreements and understandings between the
parties and may not be changed or terminated orally, and no change or attempted
waiver of the provisions hereof shall be binding unless in writing and signed
by the party against whom the same is sought to be enforced; provided, however,
that Employee’s compensation may be increased at any time by Employer without
in any way affecting any of the other terms and conditions of this Agreement,
which in all other respects shall remain in full force and effect.  

 

15.    Governing Law.  This
Agreement and all rights hereunder shall be governed by the laws of the State
of South Carolina, except to the extent governed by the laws of the United
States of America in which case federal laws shall govern.

 

16.    Remedies for Breach; Non-Waiver. 
Employee recognizes and agrees that a breach by Employee of any covenant
contained in this Agreement would cause immeasurable and irreparable harm to
Employer.  In the event of a breach or threatened breach of any covenant
contained herein, Employer shall be entitled to temporary and permanent
injunctive relief, restraining Employee from violating or threatening to
violate any covenant contained herein, as well as all costs and fees incurred
by Employer, including attorneys’ fees, as a result of Employee’s breach or
threatened breach of the covenant.  Employer and Employee agree that the relief
described herein is in addition to such other and further relief as may be
available to Employer at equity or by law.  Nothing herein shall be construed
as prohibiting Employer from pursuing any other remedies available to it for
such breach of threatened breach, including the recovery of damages from
Employee.  Failure of the Employer to enforce any of the provisions of this
Agreement or any rights with respect thereto shall in no way be considered a
waiver of such provisions or rights or in any way otherwise affect the validity
of this Agreement.

	
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17.    Consideration.  Employee
acknowledges and agrees that valid consideration has been given to Employee by
Employer in return for the promises of Employee set forth herein.

 

18.    Covenants are Independent. 
The covenants on the part of Employee contained herein shall each be construed
as agreements independent of each other and of any other provisions in this
Agreement and the unenforceability of one shall not affect the enforceability
of the remaining covenants.

 

19.    Severability and Substitution
of Valid Provisions.  To the extent that any provision or language of this
Agreement is deemed unenforceable, by virtue of the scope of the business
activity prohibited or the length of time the activity is prohibited, Employer
and Employee agree that this Agreement shall be enforced to the fullest extent
permissible under the laws and public policies of the State of South Carolina.

 

20.    Extension of Periods.  Each
of the time periods described in this Agreement shall be automatically extended
by any length of time during which Employee is in breach of the corresponding
covenant contained herein.  The provisions of this Agreement shall continue in
full force and effect throughout the duration of the extended periods.

 

21.    Reasonable Restraint.  It
is agreed by the parties that the foregoing covenants in this Agreement are
necessary for the legitimate business interests of Employer and impose a
reasonable restraint on Employee in light of the activities and business of
Employer on the date of the execution of this Agreement.

 

22.    Withholding of Taxes. 
Employer may withhold from any amounts payable to Employee under this Agreement
all federal, state, city or other taxes and withholdings as shall be required
pursuant to any applicable law, rule or regulation.

 

23.    Notices.  Any notice
required or permitted to be given under this Agreement shall be sufficient if
given in writing and either personally delivered or sent by registered or
certified mail to Employee’s residence in the case of Employee or to its
principal office in the case of Employer.

 

24.    Assignment.  The rights and
obligations of the parties to this Agreement shall inure to the benefit of and
shall be binding upon the successors and assigns of Employer.  This Agreement
shall not be terminated by any merger or consolidation whether or not the
Employer or the Company is the consolidated or surviving corporation or by
transfer of all or substantially all of the assets of the Employer or the
Company to another corporation if there is a surviving or resulting corporation
in such transfer.

 

25.    Severability. It is not the
intent of any party hereto to violate any public policy of any jurisdiction in
which this Agreement may be enforced.  If any provision of this Agreement or
the application of any provision hereof to any person or circumstances is held
invalid, unenforceable or otherwise unlawful, the remainder of this Agreement
and the application of such provision to any other person or circumstances
shall not be affected.  In addition, the applicable provision shall be reformed
to the extent (and only to the extent) necessary to make it valid, enforceable
and legal.

 

26.    Certain Definitions. 

 

	
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(a)          “Affiliate”
shall mean the Company and any business entity controlled by the Employer or
the Company, controlling or under common control with the Employer or the
Company.

                                

(b)          “Cause” shall
consist of any of: 

 

(i)            the commission by
Employee of a willful act (including, without limitation, a dishonest or
fraudulent act) or a grossly negligent act, or the willful or grossly negligent
omission to act by Employee, which is intended to cause, causes or is reasonably
likely to cause material harm to Employer or any Affiliate (including harm to
its business reputation); 

 

(ii)           the indictment of
Employee for the commission or perpetration by Employee of any felony or any
crime involving dishonesty, moral turpitude or fraud; 

 

(iii)          the material
breach by Employee of this Agreement that, if susceptible of cure, remains
uncured thirty (30) days following written notice to Employee of such breach; 

 

(iv)         the receipt of any
form of notice, written or otherwise, that any regulatory agency having
jurisdiction over Employer intends to institute any form of formal or informal
(e.g., a memorandum of understanding which relates to Employee’s
performance) regulatory action against Employee, Employer or any Affiliate (provided
that the Board determines in good faith, with Employee abstaining from
participating in the consideration of and vote on the matter, that the subject
matter of such action involves acts or omissions by or under the supervision of
Employee or that termination of Employee would materially advance Employer’s or
Affiliate’s compliance with the purpose of the action or would materially
assist Employer or Affiliate in avoiding or reducing the restrictions or
adverse effects to Employer or Affiliate related to the regulatory action); 

 

(v)          the exhibition by
Employee of a standard of behavior within the scope of Employee’s employment
that is materially disruptive to the orderly conduct of Employer’s or
Affiliate’s business operations (including, without limitation, substance abuse
or sexual misconduct) to a level which, in the Board’s good faith and
reasonable judgment, with Employee abstaining from participating in the
consideration of and vote on the matter, is materially detrimental to
Employer’s or Affiliate’s best interest, that, if susceptible of cure remains
uncured ten (10) days following written notice to Employee of such specific
inappropriate behavior; or 

 

(vi)         the failure of Employee
to devote Employee’s full business time and attention to Employee’s employment
as provided under this Agreement that, if susceptible of cure, remains uncured
thirty (30) days following written notice to Employee of such failure.

 

(c)           “Change in Control”
shall mean the occurrence during the Term of any of the following events,
unless such event is a result of a Non-Control Transaction:

 

	
  10

  

 

 

 

 

 

 

 

 (i)            the individuals who,
as of the date of this Agreement, are members of the Board of Directors of the
Company and the Employer (the “Incumbent Board”) cease for any reason to
constitute at least fifty percent (50%) of the Board of Directors of the
Company or the Employer; provided, however, that if the election,
or nomination for election by the Company’s or Employer’s shareholders, of any
new director was approved in advance by a vote of at least fifty percent (50%)
of the Incumbent Board, such new director shall, for purposes of this Agreement,
be considered as a member of the Incumbent Board; provided, further,
that no individual shall be considered a member of the Incumbent Board if such
individual initially assumed office as a result of either an actual or
threatened election contest, or other actual or threatened solicitation of
proxies or consents by or on behalf of any person other than the Board of
Directors of the Company, including by reason of any agreement intended to
avoid or settle any election contest or proxy contest;

 

(ii)           an acquisition (other
than directly from the Company or the Employer) of any voting securities of the
Company or the Employer (the “Voting Securities”) by any “Person” (as the term
“person” is used for purposes of Section 13(d) or 14(d) of the Securities Exchange
Act of 1934 (the “Exchange Act”)) immediately after which such Person has
“Beneficial Ownership” (within the meaning of Rule 13d-3 promulgated under the
Exchange Act) of twenty percent (20%) or more of the combined voting power of
the Company’s or the Employer’s then outstanding Voting Securities; provided,
however, that in determining whether a Change in Control has occurred,
Voting Securities which are acquired in a Non-Control Transaction shall not
constitute an acquisition which would cause a Change in Control;  

 

(iii)          consummation of: (a)
a merger, consolidation, or reorganization involving the Company or the
Employer; (b) a complete liquidation or dissolution of the Company or the
Employer; or (c) the sale or other disposition of all or substantially all of
the assets of the Company or the Employer to any Person (other than a transfer
to a subsidiary); or

 

(iv)         a notice of an
application is filed with the South Carolina Board of Financial Institutions,
the Office of Comptroller of the Currency (the “OCC”) or the Federal Reserve
Board or any other bank or thrift regulatory approval (or notice of no
disapproval) is granted by the Federal Reserve, South Carolina Board of
Financial Institutions, the OCC, the Federal Deposit Insurance Corporation, or any
other regulatory authority for permission to acquire control of the Company or
any of its banking subsidiaries; provided, however, that if the
application is filed in connection with a transaction which has been approved
by the Board of Directors of the Company or the Employer, then the Change in
Control shall not be deemed to occur until consummation of the transaction.

 

(d)            “Disability”
or “Disabled” shall mean as defined by Treasury Regulation       §
1.409A-3(i)(4).                        

 

(e)            “Good Reason”
shall mean the occurrence after a Change in Control of any of the events or
conditions described in subsections (i) through (vii) hereof:

 

	
  11

  

 

 

 

 

 

 

 

(i)                 
a change in the
Employee’s status, title, position or responsibilities (including reporting
responsibilities) which, in the Employee’s reasonable judgment, represents an
adverse change from Employee’s status, title, position or responsibilities as
in effect at any time within ninety (90) days preceding the date of a Change in
Control or at any time thereafter; the assignment to the Employee of any duties
or responsibilities which, in the Employee’s reasonable judgment, are
inconsistent with Employee’s status, title, position or responsibilities as in
effect at any time within ninety (90) days preceding the date of a Change in Control
or at any time thereafter; any removal of the Employee from or failure to
reappoint or reelect Employee to any of such offices or positions, except in
connection with the termination of Employee’s employment for Disability or
Cause, as a result of Employee’s death, or by the Employee other than for Good
Reason, or any other change in condition or circumstances that in the
Employee’s reasonable judgment makes it materially more difficult for the
Employee to carry out the duties and responsibilities of the Employee’s office
than existed at any time within ninety (90) days preceding the date of Change
in Control or at any time thereafter;

 

(ii)               
a reduction in
the Employee’s Base Salary or any failure to pay the Employee any compensation
or benefits to which Employee is entitled within five (5) days of the date due;

 

(iii)              
 the Employer’s
requiring the Employee to be based at any place outside a thirty (30) - mile
radius from the executive offices occupied by the Employee immediately prior to
the Change in Control, except for reasonably required travel on the Employer’s
business which is not materially greater than such travel requirements prior to
the Change in Control;

 

(iv)             
 the failure by
the Employer to (A) continue in effect (without reduction in benefit level
and/or reward opportunities) any material compensation or employee benefit plan
in which the Employee was participating at any time within ninety (90) days
preceding the date of a Change in Control or at any time thereafter, unless
such plan is replaced with a plan that provides substantially equivalent
compensation or benefits to the Employee, or (B) provide the Employee with
compensation and benefits, in the aggregate, at least equal (in terms of
benefit levels and/or reward opportunities) to those provided for under each
other employee benefit plan, program and practice in which the Employee was
participating at any time within ninety (90) days preceding the date of a
Change in Control or at any time thereafter;

 

(v)               
the insolvency
or the filing (by any party, including the Company or the Employer) of a
petition for bankruptcy of the Company or the Employer, which petition is not
dismissed within sixty (60) days;

 

(vi)             
 any material
breach by the Employer of any material provision of this Agreement; or

 

	
  12

  

 

 

 

 

 

 

(vii)            
any termination
of the Employee’s employment by the Employer purportedly (as stated in the
Notice of Termination) for Cause which does not comply with the terms of this
Agreement.

 

Any event or condition described in
clause (i) through (vii) above which occurs prior to a Change in Control but
which the Employee reasonably demonstrates (A) was at the request of a third
party, or (B) otherwise arose in connection with, or in anticipation of, a
Change in Control which actually occurs, shall constitute Good Reason for
purposes of this Agreement, notwithstanding that it occurred prior to the
Change in Control.  Employee’s right to terminate Employee’s employment for
Good Reason shall not be affected by Employee’s incapacity due to physical or
mental illness.

 

(f)           “Non-Control
Transaction” shall mean a transaction described below:

 

                (i)            the
shareholders of the Company or the Employer, immediately before such merger,
consolidation or reorganization own, directly or indirectly, immediately
following such merger, consolidation or reorganization, at least fifty percent
(50%) of the combined voting power of the outstanding voting securities of the
corporation or bank resulting from such merger, consolidation or reorganization
(the “Surviving Corporation”) in substantially the same proportion as their
ownership of the Voting Securities immediately before such merger,
consolidation or reorganization; and 

 

                (ii)           immediately
following such merger, consolidation or reorganization, the number of directors
on the board of directors of the Surviving Corporation who were members of the
Incumbent Board shall at least equal the number of directors who were
affiliated with or appointed by the other party to the merger, consolidation or
reorganization.

 

(g)          “Notice of
Termination” shall mean a written notice of termination from one party to
the other which specifies an effective date of termination, indicates the
specific termination provision in this Agreement relied upon, and, in the case
of a termination for Good Reason or for Cause, sets forth in reasonable detail
the facts and circumstances claimed to provide a basis for termination of
Employee’s employment under the provision so indicated.

 

(h)          “Terminate”, “terminated”,
“termination”, or “Termination of Employment” shall mean
separation from service as defined by Treasury Regulation § 1.409A-1(h).

 

27.   Compliance with Regulatory
Restrictions.  Notwithstanding anything to the contrary herein, and in
addition to any restrictions stated in section 13 hereof, any compensation or
other benefits paid to the Employee shall be limited to the extent required by
any federal or state regulatory agency having authority over the Company or the
Employer.  The Employee agrees that compliance by the Company or the Employer
with such regulatory restrictions, even to the extent that compensation or
other benefits paid to the Employee are limited, shall not be a breach of this
Agreement by the Company or the Employer.  

 

	
  13

  

 

 

 

 

 

 

28.  Compliance with Capital Purchase
Program Restrictions.
Notwithstanding anything to the contrary herein, any payments to the Employee
shall be limited to the extent required under the United States Treasury
Capital Purchase Program (the "CPP") and related regulations.  The
Employee agrees to such amendments, agreements, or waivers that may be required
by the United States Treasury or requested by the Employer to comply with the
terms of the CPP. 

 

29.  Compliance with the Dodd–Frank Wall
Street Reform and Consumer Protection Act.  Notwithstanding anything to the contrary herein, any
incentive payments to the Employee shall be limited to the extent required
under the Dodd–Frank Wall Street Reform and Consumer Protection Act (the
“Act”), including, but not limited to, clawbacks for such incentive payments as
required by the Act.  The Employee agrees to such amendments, agreements, or
waivers that are required by the Act or requested by the Company to comply with
the terms of the Act.  

 

30.  Compliance with Internal Revenue
Code Section 409A. 
The Employer and the Employee intend that their exercise of authority or
discretion under this Agreement shall comply with Section 409A of the Code.  If
any provision of this Agreement does not satisfy the requirements of Section
409A, such provision shall nevertheless be applied in a manner consistent with
those requirements.  In addition, each payment hereunder is intended to
constitute a separate payment from each other payment for purposes of Treasury
Regulation § 1.409A-2(b)(2).  References in this Agreement to Section 409A of
the Code include rules, regulations, and guidance of general application issued
by the Department of the Treasury under Internal Revenue Code section 409A.  

 

31.  Entire Agreement.  This Agreement supersedes any
other agreements, oral or written, between the parties with respect to the
subject matter hereof, and contains all of the agreements and understandings
between the parties with respect to the employment of Employee by Employer. 
Any waiver or modification of any term of this Agreement shall be effective only
if it is set forth in writing signed by all parties hereto.

 

32.    Counterparts.  This
Agreement may be executed in one or more counterparts, each of which shall be
deemed to be an original but all of which together will constitute one and the
same agreement.

[Signatures appear on the following page.] 

 

	
  14

  

 

 

 

 

 

 

 

                IN
WITNESS WHEREOF, the parties hereto have executed this Agreement as of the
Effective Date.

 

                                                                                                                                                                                                        EMPLOYER:

 

                                                                                                                                                                                                        SOUTHERN
FIRST BANK, 

                                                                                                        NATIONAL ASSOCIATION

 

 

 

[CORPORATE
SEAL]                                                                                                                                                                  By:/s/R. Arthur Seaver, Jr.           

                                                                                                                                                                                                        
Name: R. Arthur Seaver, Jr.

Attest:                                                                                                                                                                                           Title: Chief Executive Officer

 

 

 
/s/Julie A. Fairchild                        

Secretary

 

    

                                                                                                                                                                                                         EMPLOYEE:

 

 

 

                                                                                                                                                                                                        
/s/Michael
D. Dowling_________

                                                                                                                                                                                                         Michael
D. Dowling

 

 

 

	
  15cytori_exhibit109.htm

OMB Approval 0990-0115

 

	
NSN 7540-01-152-8069

	
26-107

	
STANDARD FORM 26 (REV. 4-85)

	
PREVIOUS EDITION UNUSABLE

	
Computer Generated

	
Prescribed by GSAFAR (48 CFR) 53.214(a)

	  	
1.THIS CONTRACT IS A RATED ORDER

	
RATING

	
PAGE        OF           PAGES

	
AWARD/CONTRACT

	
UNDER DPAS (15 CFR 350)

	
N/A

	
1

	
        55

	
2.  CONTRACT (Proc. Inst. Indent.) NO.

	
3.  EFFECTIVE DATE

	
4.  REQUISITION/PURCHASE REQUEST/PROJECT NO.

	
HHSO100201200008C

	
See Block 20C.

	
   OS99307

	
5.  ISSUED BY

	
CODE

	  	
6.  ADMINISTERED BY (If other than Item 6)

 

	
CODE

	  
	
Office of Acquisitions Management, Contracts, and Grants (AMCG)

330 Independence Ave., S.W. Room G640

Washington, D.C. 20201

	
See Block 5.

 

 

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

	
8.  DELIVERY

	
 

Cytori Therapeutics, Inc.

	
See Schedule.

	
3020 Callan Road

	
9/ DISCOUNT FOR PROMPT PAYMENT

	
San Diego, CA 92121

	
N/A.

	  	  
	
CAGE: 4AW88                      TIN: 330827593

	
10. SUBMIT INVOICES

	
ITEM

	
CODE DUNS No. 111029179

	
FACILITY CODE

	
ADDRESS SHOWN IN:

	
See Section G.

	
11.  SHIP TO/MARK FORCODE

	
  N/A

	

12.  PAYMENT WILL BE MADE BYCODE

	
  N/A

	
 

See Block 5.

	  	
   See Block 5.

	
13.  AUTHORITY FOR USING OTHER FULL AND OPEN COMPETITION:    N/A

  10 U.S.C. 2304(c)(     )                                                            41 U.S.C. 253(c)(     )

	
14.  ACCOUNTING AND APPROPRIATION DATA

Appropriation Year: 2012; Object Class: 25106; CAN# 1992002

 

	
15A. ITEM NO.

	
15B.  SUPPLIES/SERVICES

	
15C. UNIT PRICE

	
15D.  AMOUNT

	
15E.  UNIT PRICE

	
15F.  AMOUNT

	
 

See Section B.

	  	  	
 

	
 

 

	
15G.  TOTAL AMOUNT OF CONTRACT

	
$4,683,680.00

	
16.  TABLE OF CONTENTS

	

      (ü)

	

   SEC.

	

DESCRIPTION

	

PAGE(S)

	

        (ü)

	

      SEC.

	

DESCRIPTION

	
PAGE(S)

	

PART I - THE SCHEDULE

	
PART II - CONTRACT CLAUSES

	  X	

  A

	

SOLICITATION/CONTRACT FORM

	
1

	   X	

 I

	

CONTRACT CLAUSES

	
46

	  X	

  B

	

SUPPLIES OR SERVICES AND PRICE/COST

	

3

	
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACH.

	  X	

  C

	

DESCRIPTION / SPECS / WORK STATEMENT

	

9

	   X	

 J

	

LIST OF ATTACHMENTS

	
55

	  X	

  D

	

PACKAGING AND MARKING

	

10

	
PART IV - REPRESENTATIONS AND INSTRUCTIONS

	  X	

  E

	

INSPECTION AND ACCEPTANCE

	

11

	  	

 K

	

REPRESENTATIONS, CERTIFICATIONS

	
55

	  X	

  F

	

DELIVERIES OR PERFORMANCE

	

11

	  	  	

AND OTHER STATEMENTS OF OFFERORS

	  
	  X	

  G

	

CONTRACT ADMINISTRATION DATA

	

24

	  	

 L

	

INSTRS., CONDS., AND NOTICES TO OFFERORS

	  
	  X	

  H

	

SPECIAL CONTRACT REQUIREMENTS

	

29

	  	

 M

	

EVALUATION FACTORS FOR AWARD

	  
	
CONTRACTING OFFICER WILL COMPLETE ITEM 17 OR 18 AS APPLICABLE

	
17.  X CONTRACTOR’S NEGOTIATED AGREEMENT (Contractor is required to sign this document and return    2   copies to issuing office.)  Contractor agrees to furnish and deliver all items or perform all the services set forth or otherwise identified above and on any continuation sheets for the consideration stated herein.  The rights and obligations of the parties to this contract shall be subject to and governed by the following documents:  (a) this award/contract, (b) the solicitation, if any, and (c) such provisions, representations, certifications, and specifications, as are attached or incorporated by reference herein.  (Attachments are listed herein.)

	
18.  o AWARD (Contractor is not required to sign this document.)  Your offer on Solicitation Number _     _________________________________, including the additions or changes made by you which additions or changes are set forth in full above, is hereby accepted as to the items listed above and on any continuation sheets.  This award consummates the contract which consists of the following documents:  (a) the Government’s solicitation and your offer, and (b) this award/contract.  No further contractual document is necessary.

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

	
20A.  NAME OF CONTRACTING OFFICER

	
Mark Saad, Chief Financial Officer

	
       ***

	
19B.  NAME OF CONTRACTOR

	
19C.  DATE SIGNED

     9/27/12

	

20B.  UNITED STATES OF AMERICA

 

 

	
20C. DATE SIGNED

  9/27/12

	
    /s/ Mark Saad                                        

(Signature of person authorized to sign)

	  	

BY       /s/ ***                                                                           

(Signature of Contracting Officer)

	  

*** Material has been omitted pursuant to a request for confidential treatment, and the omitted contents were filed separately with the Securities and Exchange Commission.

  

  

  

HHSO100201200008C

Cytori Therapeutics, Inc.

CONTRACT TABLE OF CONTENTS

 

	
PART I – THE SCHEDULE

	
 1

	
       SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

	
 3

	
       SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

	 9
	
       SECTION D - PACKAGING, MARKING AND SHIPPING

	 10
	
       SECTION E - INSPECTION AND ACCEPTANCE

	 11
	
       SECTION F - DELIVERIES OR PERFORMANCE

	 11
	
       SECTION G - CONTRACT ADMINISTRATION DATA

	 24
	
       SECTION H - SPECIAL CONTRACT REQUIREMENTS

	 29
	
PART II – CONTRACT CLAUSES

	 46
	
       SECTION I - CONTRACT CLAUSES

	 46
	
PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

	 55
	
       SECTION J - LIST OF ATTACHMENTS

	 55
	
PART IV –REPRESENTATIONS AND CERTIFICATIONS

	 55
	
       SECTION K – REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

	 55

  

2

  

HHSO100201200008C

Cytori Therapeutics, Inc.

PART I – THE SCHEDULE

 

 

SECTION B – SUPPLIES OR SERVICES AND PRICES/COSTS

 

 

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

 

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

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

 

ARTICLE B.2. ESTIMATED COST AND FIXED FEE

 

	
a.  

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

	
b.  

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

	
c.  

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

	
d.  

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

	
e.  

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

	
f.  

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

	
CLIN

	 	
Estimated Period of Performance

	
Supplies/Services

	 	
Total Estimated Cost

	 	 	
Fixed Fee

	 	 	
Total Est.

Cost Plus

Fixed Fee

	 
	 	0001	 	
28 September 2012 through

27 September 2014

	
Studies needed to demonstrate proof-of-concept for use of the Celution System as a medical countermeasure for combined injury involving thermal burn and radiation exposure

 

Reports and Other Data Deliverables.

	 	$	***	 	 	$	***	 	 	$	4,683,680.00	 

 

*** Material has been omitted pursuant to a request for confidential treatment, and the omitted contents were filed separately with the Securities and Exchange Commission.

  

3

  

ARTICLE B. 3. OPTION PRICES

 

	
a.  

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

	
b.  

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

	
CLIN/

Option

	 	
Estimated Period of Performance

	
Supplies/Services

	 	
Total Estimated Cost

	 	 	
Fixed Fee

	 	 	
Total Estimated

Cost Plus

Fixed Fee

	 
	 	0002/1	 	
28 September 2013

through

27 September 2016

	
Research and development, regulatory, clinical, and other tasks required for completion of a Pilot Clinical Trial of the Celution System in thermal burn injury

Reports and Other Data Deliverables

	 	$	***	 	 	$	***	 	 	$	32,641,997.00	 
	 	0003/2	 	
28 September 2015

through

27 September 2017

	
Clinical, regulatory, and other tasks required for completion of a Pivotal Clinical Trial leading to FDA licensure for use of the Celution System in thermal burn injury.

Reports and Other Data Deliverables

	 	$	***	 	 	$	***	 	 	$	45,501,320.00	 
	 	0004/3	 	
28 September 2013

through

27 September 2017

	
Research and development, clinical, regulatory and other tasks required to develop and obtain FDA clearance for a *** that has ease of use and other characteristics suitable for use in thermal burn injury following a mass casualty event.

Reports and Other Data Deliverables

	 	$	***	 	 	$	***	 	 	$	23,420,322.00	 

 

  

*** Material has been omitted pursuant to a request for confidential treatment, and the omitted contents were filed separately with the Securities and Exchange Commission.

  

4

  

 

ARTICLE B. 4. PROVISIONS APPLICABLE TO DIRECT COSTS

a. Items Unallowable Unless Otherwise Provided

Notwithstanding the clauses, unless authorized in writing by the Contracting Officer, the cost of the following items or activities shall be unallowable as direct costs:

	
1)  

	
Acquisition, by purchase or lease, of any interest in real property;

	
2)  

	
Special rearrangement or alteration of facilities;

	
3)  

	
Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value;

	
4)  

	
Accountable Government Property (see the Contractor’s Guide for Control for Government Property incorporated by ARTICLE G.10. of this contract);

	
5)  

	
Travel to attend general scientific meetings;

	
6)  

	
Unapproved foreign travel – Subject to the procedure specified under subparagraph b.2 below;

	
7)  

	
Patient care costs (see Attachment 6);

	
8)  

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

	
9)  

	
Light Refreshment and Meal Expenditures - Requests to use contract funds to provide light refreshments and/or meals to either federal or nonfederal employees must be submitted to the Contracting Officer’s Representative (COR), with a copy to the Contracting Officer, at least six (6) weeks in advance of the event and are subject to “HHS Policy on Promoting Efficient Spending: Use of Appropriate Funding for Conferences and Meeting, Food and Promotional Items and Printing and Publications.” The request shall contain the following information: (a) name, date, and location of the event at which the light refreshments and/or meals will be provide; (b) a brief description of the purpose of the event; (c) a cost breakdown of the estimated light refreshments and/or meals costs; (d) the number of nonfederal and federal attendees receiving light refreshments and/or meals; and (e) if the event will be held at a government facility.

 

	
10)  

	
No overtime (premium) compensation is authorized under the subject contract. Billing of actual hours should be limited to total productive hours in a month (8 hours/day).

 

b. Travel Costs

 

	
a.  

	
Total expenditures for travel (transportation, lodging, subsistence, and incidental expenses) incurred in direct performance of this contract during the base segment or any option segment(s) shall not exceed amount negotiated in the final proposed budget without the prior written approval of the Contracting Officer.  Cost must be consistent with Federal Acquisition Regulations (FAR) 52.247-66 – Preference for U.S. Air Flag carriers.

 

	
b.  

	
Subject to the annual dollar limitation specified under B.4.b.1.a. above, the Contactor shall invoice and be reimbursed for all travel costs in accordance with FAR 31.2 – Contracts with Commercial Organizations, Subsection 31.205-46, Travel Costs.

  

5

  

ARTICLE B.5. ADVANCE UNDERSTANDINGS

	
a.  

	
Man-in-Plant

With seven (7) days advance notice to the Contractor in writing from the Contracting Officer, the Government may place a man-in-plant in the Contractor’s facility The man-in-plant shall be subject to the Contractor’s policies and procedures regarding security and facility access at all times while in the Contractor’s facility.

	
b.  

	
Subcontracts and Consultants

Prior written consent from the Contracting Officer in the form of Contracting Officer Authorization (COA) is required for any subcontract that:

· Is of the cost reimbursement type;

· Is Fixed-Price and exceeds $150,000 or 5% of the total estimated cost of the contract;

 

Contracting Officer shall request appropriate supporting documentation in order to review and determine authorization, pursuant with FAR Clause 52.244-2, Subcontracts.  After receiving written consent of the subcontract by the Contracting Officer, a copy of the signed, executed subcontract and consulting agreement shall be provided to the Contracting Officer.

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

 

	
c.  

	
Reference FAR 52.244-2 (e) Subcontracts.

 

FAR 52.244-2 (e)(1) The Contractor shall notify the Contracting Officer reasonably in advance of placing any subcontract or modification thereof for which consent is required under paragraph (d) of this clause, including the following information:

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

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

(iii). Identification of the proposed subcontractor.

(iv). The proposed subcontract price.

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

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

(vii). A negotiation memorandum reflecting-

(A). The principal elements of the subcontract price negotiations;

(B). The most significant considerations controlling establishment of initial or revised prices;

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

(D). The extent, if any, to which the Contractor did not rely on the subcontractor’s cost or pricing data in determining the price objective an in negotiating the final price;

(E). The extent to which it was recognized in the negotiation that the subcontractor’s cost or pricing data were not accurate, complete, or current; the action taken by the Contractor and the subcontractor; and  the effect of any such defective data on the total price negotiated;

(F). The reasons for any significant difference between the Contractor’s price objective and the price negotiated; and

(G). A complete explanation of the incentive fee or profit plan when incentives are used. The explanation shall identify each critical performance element, management decisions used to quantify each incentive element, reasons for the incentives, and a summary of all trade-off possibilities considered.

  

6

  

	
  

	
The Contractor shall obtain the Contracting Officer’s written consent (COA) prior to placing any consultant awards.

 

	
d.  

	
Consultants

 

Consultant fees to be paid to the following individuals: *** 

 

e.     Site Visits and Inspections

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

If BARDA, the Contractor, or other parties identifies any issues during an audit, the Contractor shall capture the issues, identify potential solutions, and provide a report to BARDA for review and acceptance.

	
·  

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

 

	
·  

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

 

	
·  

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

 

QA AUDIT:

BARDA reserves the right to participate in QA audits. Upon completion of the audit/site visit the Contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, detailed concerns for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA for review and acceptance. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.

	
·  

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

	
·  

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

 

 

*** Material has been omitted pursuant to a request for confidential treatment, and the omitted contents were filed separately with the Securities and Exchange Commission.

 

  

7

  

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

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

 

	
a.  

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

 

	
b.  

	
Fringe Benefits - Cite rate and amount

 

	
c.  

	
Overhead - Cite rate and amount

 

	
d.  

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

 

	
e.  

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

 

	
f.  

	
Consultant Fees - Identify individuals and amounts.

 

	
g.  

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

 

	
h.  

	
Equipment - Cite authorization and amount.

 

	
i.  

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

 

	
j.  

	
G&A - Cite rate and amount.

 

	
k.  

	
Total Cost

 

	
l.  

	
Fixed Fee

 

	
m.  

	
Total CPFF

 

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

g.    Confidential Treatment of Sensitive Information

 

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

 

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

 

Notwithstanding the foregoing, such information/data shall not be deemed of a sensitive nature with respect to the Contractor for purposes of this contract if such information/data:  (a) was already known to the Contractor; (b) was generally available or known, or was otherwise part of the public domain, at the time of its disclosure to the Contractor; (c) became generally available or known, or otherwise became part of the public domain, after its disclosure to, or, with respect to the information/data by, the Contractor through no fault of the Contractor; (d) was disclosed to the Contractor, other than under an obligation of confidentiality or non-use, by a third party who had no obligation to the Government that controls such information/data not to disclose such information/data to others; or (e) was independently discovered or developed by the Contractor, as evidenced by its written records, without the use of information/data belonging to the Government.

 

  

8

  

Contractor may disclose information/data of a sensitive nature provided by the Government to the extent that such disclosure is: (a) made in response to a valid order of a court of competent jurisdiction or other supra-national, federal, national, regional, state, provincial or local governmental or regulatory body of competent jurisdiction; provided, however, that the Contractor shall first have given notice to the Government and give the Government a reasonable opportunity to quash such order and to obtain a protective order requiring that the information/data of a sensitive nature that is the subject of such order be held in confidence by such court or agency or, if disclosed, be used only for the purposes for which the order was issued; and provided further that if a disclosure order is not quashed or a protective order is not obtained, the information/data disclosed in response to such court or governmental order shall be limited to that information which is legally required to be disclosed in response to such court or governmental order; (b) otherwise required by law, in the opinion of legal counsel to the Contractor as expressed in an opinion letter in form and substance reasonably satisfactory to the Government, which shall be provided to the Government at least two (2) business days prior to the Contractor’s disclosure of the information/data; or (c) made by the Contractor to the Regulatory Authorities as required in connection with any filing, application or request for Regulatory Approval; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information/data.

 

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

 

In an effort to build a robust medical countermeasure pipeline through increased collaboration, BARDA may share technical deliverables with USG entities responsible for Medical Countermeasure Development.  In accordance with recommendations from the Public Health Emergency Medical Countermeasure Enterprise Review, agreements established in the Integrated Portfolio’s Portfolio Advisory Committee (PAC) Charter, Technology Transfer Agreements (TTA) between BARDA and the Defense Threat Reduction Agency and the National Institute of Allergies and Infectious Diseases (NIAID), BARDA may share technical deliverables set forth in Article F.2 with colleagues within the Integrated Portfolio.  This advance understanding does not authorize BARDA to share financial information outside HHS.  The Contractor is advised to review the terms of FAR Clause 52.227-14 regarding the Government’s rights to deliverables submitted during performance as well as the Government’s rights to data contained within those deliverables.

 

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government as needed to perform the Statement of Work dated 28 September 2012 as set forth in SECTION J-List of Attachments, attached hereto and made a part of the contract.

 

ARTICLE C.2. REPORTING REQUIREMENTS

 

Refer to ARTICLE F.2. for specific instructions regarding Reporting Requirements.

 

ARTICLE C.3.  PROJECT MEETING CONFERENCE CALLS

	
  

	
A teleconference call between the Contracting Officer’s Technical Representative and the Contractor’s Program Manager shall occur bi-weekly (every two weeks), or at the discretion of the U.S. Government.  During this call, the Program Manager will discuss the activities during the reporting period, any problems that have arisen, and the activities planned for the ensuing reporting period.  The Contractor’s Program Manager may choose to include other key personnel on the conference call to give detailed updates on specific projects or this may be requested by the Contracting Officer’s Representative.

 

 

  

9

  

	
  

	
Contractor will be responsible for preparing an agenda for the conference call and providing to BARDA no later than 2 business days prior to the scheduled conference call.

   

ARTICLE C.4.  PROJECT MEETINGS 

 

The Contractor shall participate in Project Meetings to coordinate the performance of the contract, as requested by the Contracting Officer’s Representative.  These meetings may include face-to-face meetings with BARDA/AMCG in Washington, D.C. and at work sites of the Contractor and its subcontractors. Such meetings may include, but are not limited to, meetings of the Contractor (and subcontractors invited by the Contractor) to discuss study designs, site visits to the Contractor’s and subcontractor’s facilities, and meetings with the Contractor and HHS officials to discuss the technical, regulatory, and ethical aspects of the program. The Contractor must provide data, reports, and presentations to groups of outside experts (subject to appropriate protections for Contractor confidential or proprietary data) and USG personnel as required by the Contracting Officer’s Representative in order to facilitate review of contract activities.

 

ARTICLE C.5 SUBJECT INVENTION REPORTING REQUIREMENT

 

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

 

 

Reports and documentation submitted to the Contracting Officer shall be sent to the Contracting Officer to the address set forth in SECTION G – CONTRACT ADMINISTRATION DATA.

 

 

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

 

 

SECTION D – PACKAGING, MARKING, AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications.  At a minimum, all deliverables shall be marked with the contract number and Contractor name.  The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

Unless otherwise specified by the Contracting Officer, delivery of reports to be furnished to the Government under this contract (including invoices), shall be delivered to BARDA electronically along with a concurrent email notification to the Contracting Officer, Contract Specialist, and COR summarizing the electronic delivery.

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

  

10

  

SECTION E – INSPECTION AND ACCEPTANCE

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

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

Inspection and acceptance will be performed at:

Biomedical Advanced Research and Development Authority/Office of Acquisition Management, Contracts, and Grants (AMCG)

Office of the Assistant Secretary for Preparedness and Response

U.S. Department of Health and Human Services

330 Independence Avenue, S.W., Room G644

Washington, D.C. 20201

SECTION F – DELIVERIES OR PERFORMANCE

ARTICLE F.1.  ESTIMATED PERIOD OF PERFORMANCE

 

Under CLIN 0001, the estimated period of performance for the base performance segment of this contract shall be consistent with the dates set forth in ARTICLE B.2.  If the Government exercises its option(s) pursuant to the Option Clauses in Article G.11 and Article I.2 of the contract, the period of performance will be increased as shown in the table in Article B.3.

 

ARTICLE F.2.  DELIVERABLES

Successful performance of the final contract shall be deemed to occur upon performance of the work set forth in the Statement of Work dated 28 September 2012 set forth in SECTION J-List of Attachments of this contract and upon delivery and acceptance, as required by the Statement of Work, by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule:

 

The items specified below as described in the REPORTING REQUIREMENTS Article in SECTION C of this contract and the Statement of Work dated 23 October 2011 set forth in SECTION J-List of Attachments will be required to be delivered F.O.B. Destination as set forth in FAR 52.247-34, F.O.B. DESTINATION, (NOVEMBER 1991), and in accordance with and by the date(s) specified below and any specifications stated in SECTION D, PACKAGING, MARKING AND SHIPPING, of this contract.  All reports identified below relate solely to the development activity funded under this contract:    

  

  

11

  

                HHSO100201200008C

                Cytori Therapeutics, Inc.

	 
	
 

	 
	
 

	
CYTORI DELIVERABLES SCHEDULE

	
                         General Deliverables

	
Deliverable

	
Due Date(s)

	
BARDA Audit Reports

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

 

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

 

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

	
QA Audit

	
Notify CO and COR of upcoming, ongoing, or recent audits/site visits of subcontractors as part of weekly communications

 

Notify the COR and CO within 5 business days of report completion

	
Bi-weekly conference call agenda

	
No later than 2 business days prior to the scheduled conference call

	
Meeting/Teleconference Minutes

	
    No later than 2 business days following the meeting/teleconference

	
Data/Data Analysis

	
    Within 10 business days of request by COR or CO

	
Monthly Progress Report

	
    On the 15th calendar day following the month being reported upon

	
Annual Progress Report

	
    On or before the 15th calendar day of the month following each 12 months of the performance period

	
Draft Final Technical Report

	
    60 calendar days prior to the end of the contract and all options. BARDA shall provide comments within 30 calendar days

	
Final Technical Report

	
    On or before the end date of the contract and all options

 

  

12

  

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

	
Draft report to BARDA at least 30 business days following the end of the study

 

BARDA will provide feedback to Contractor within 15 business days of receipt

 

Final report, incorporating or addressing BARDA feedback, to BARDA within 15 business days of receipt of feedback

	
Final Invention Report

	
On or before the end date of the contract and all options

	
FDA Related Deliverables

 

	
FDA Meeting Notices

	
Notification to BARDA within 24 hours of scheduling Type A, B or C meetings OR within 24 hours of meeting occurrence for ad hoc meetings

	
FDA Meeting Minutes

	
Initial Contractor and FDA-issued draft minutes and final minutes of any meeting with the FDA within 3 business days of receipt

	
FDA Submissions

	
Draft FDA submissions to BARDA at least 15 business days prior to FDA submission.

 

BARDA will provide feedback to Contractor within 10 business days of receipt.

 

Final FDA submissions shall be submitted to BARDA concurrently or no later than 1 calendar day of it submission to CDER.

	
FDA Audits

	
Notify CO and COR within 10 business days of a scheduled FDA audit or within 24 hours of an ad hoc site visit/audit if the FDA does not provide advanced notice.

 

Contractor shall provide copies of any FDA audit report received from subcontractors that occur as a result of this contract or for this product within 3 business days of receiving correspondence from the FDA or third party.

 

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

  

13

  

	
Manufacturing Campaign Reports

	
Submit at least 15 business days prior to FDA submission.

 

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

	
Other FDA Correspondence

	
    Within 3 business days of correspondence

	
Copies of FDA Correspondence and Meeting Summaries

	
For any formal meeting with the FDA, the contractor shall forward initial draft minutes and subsequently final meeting minutes appropriately formatted within thirty (30) calendar days of the FDA meeting to the BARDA COR.

The contractor shall forward the final draft minutes of any informal meeting with the FDA to BARDA. The contractor shall forward the dates and times of any meeting with the FDA to BARDA at least 30 days prior to the meeting.

Contractor shall provide BARDA with five (5) business days in which to review and provide comments upon any document back to the contractor. 

	
Incident Report (As needed)

	
Contractor shall communicate and document all critical programmatic concerns, risks, or potential risks with BARDA.

Due within 48 hours of activity or incident or within 24 hours for a security activity or incident. Email or telephone with written follow-up to COR and CO. Additional updates due to COR and CO within 48 hours of additional developments.

 

Contractor shall submit within 5 business days a Corrective Action Plan (if deemed necessary by either party) to address any potential issues.

If corrective action is deemed necessary, Contractor must address in writing, its consideration of concerns raised by BARDA within 5 business days.

 

  

14

  

 

	
Base Period

	 	 	 	
9/28/12 to 9/27/14

	  
	
Name

	 	
WBS Number

	 	
Start Date

	
Finish/Due Date

	
Deliverable

	
Technical and Project Management

	 	 	1.1.1.4	 	
9/28/2012

	
10/22/2012

	
Updated Task/Deliverables List

	
Hiring: Base Period

	 	 	1.1.1.5	 	
10/2/2012

	
1/22/2013

	
Include in the applicable monthly report

	
Subcontractor Management

	 	 	1.1.2	 	
10/16/2012

	
1/7/2013

	
Subcontractor Management Plan

	
Risk Management

	 	 	1.1.3.3	 	
10/16/2012

	
3/11/2013

	
Risk Management Plan

	
EVMS: Implementation Plan

	 	 	1.1.4.2	 	
10/15/2012

	
3/24/2013

	
EVMS Systems Plan

	
EVMS: Implementation

	 	 	1.1.4.4	 	
3/24/2013

	
7/24/2013

	
EVMS Systems Report

	
Preclinical Studies: Multiple Final Reports

	 	 	1.3.1.3.16	 	
10/2/2012

	
5/5/2014

	
Final report submitted to and accepted by BARDA CO/COR

	
Human Preclinical Studies Report

	 	 	1.3.2.1	 	
9/28/2012

	
2/24/2014

	
Final report submitted to and accepted by BARDA CO/COR

	
Pilot Clinical Trial Clinical Protocol Draft Development Plan

	 	 	1.4.1.3	 	
9/5/2013

	
10/18/2013

	
Draft or Outline Clinical Protocol submitted to BARDA CO/COR approval

	
***

	 	 	1.5.1.2	 	
12/9/2013

	
12/9/2013

	
Meeting minutes

	
***

	 	 	1.6.1	 	
10/30/2012

	
8/19/2013

	
Final report submitted to and accepted by BARDA CO/COR

	
***

	 	 	1.6.2	 	
11/27/2012

	
8/5/2013

	
Final report submitted to and accepted by BARDA CO/COR

  

*** Material has been omitted pursuant to a request for confidential treatment, and the omitted contents were filed separately with the Securities and Exchange Commission.

 

  

15

  

 

	
Option 1: Pilot Clinical Study

	 	 	 	
9/28/2013 to 9/27/16

	  
	
Name

	 	 	 	
Start Date

	
Finish Date

	
Deliverable

	
Clinical Hiring

	 	 	1.1.1.6.1	 	
3/19/2014

	
7/8/2014

	
Include in the applicable bi-monthly report

	
Development Hiring

	 	 	1.1.1.6.2	 	
3/19/2014

	
5/20/2014

	
Include in the applicable bi-monthly report

	
*** Feasability Final Report

	 	 	1.3.1.4.1	 	
3/19/2014

	
1/21/2015

	
Final report submitted to and accepted by BARDA CO/COR

	
*** Final Report

	 	 	1.3.1.4.2	 	
3/19/2014

	
10/22/2014

	
Final report submitted to and accepted by BARDA CO/COR

	
*** Final Report

	 	 	1.3.1.4.3	 	
5/1/2014

	
7/29/2015

	
Final report submitted to and accepted by BARDA CO/COR

	
*** Final Report

	 	 	1.3.2.3.1	 	
3/19/2014

	
9/18/2014

	
Final report submitted to and accepted by BARDA CO/COR

	
*** Final Report

	 	 	1.3.2.3.2	 	
3/19/2014

	
9/8/2014

	
Final report submitted to and accepted by BARDA CO/COR

	
*** Final Report

	 	 	1.3.2.4	 	
3/19/2014

	
7/14/2014

	
Final report submitted to and accepted by BARDA CO/COR

	
*** Final Report

	 	 	1.3.2.5	 	
4/4/2014

	
11/19/2014

	
Final report submitted to and accepted by BARDA CO/COR

	
*** Final Report

	 	 	1.4.1.4	 	
3/19/2014

	
12/11/2015

	
Final report submitted to and accepted by BARDA CO/COR

	
*** Protocol Development Submission

	 	 	1.4.2.1	 	
3/23/2015

	
4/10/2015

	
Protocol submitted to and accepted by BARDA CO/COR

	
***

	 	 	1.5.1.6	 	
10/27/2014

	
10/27/2014

	
***

	
*** Report

	 	 	1.6.3.1	 	
3/9/2014

	
4/22/2014

	
Interim Report

	
*** Report

	 	 	1.6.3.2	 	
3/9/2014

	
8/5/2014

	
Interim Report

	
*** Final Report

	 	 	1.6.3.3	 	
8/6/2014

	
9/17/2014

	
Final report submitted to and accepted by BARDA CO/COR

 

 *** Material has been omitted pursuant to a request for confidential treatment, and the omitted contents were filed separately with the Securities and Exchange Commission.

 

  

16

  

 

	
Option 2: Pivotal Clinical Trial

	 	 	 	
9/28/14 to 9/27/17

	  
	
Name

	 	 	 	
Start Date

	
Finish Date

	
Deliverable

	
Clinical Hiring

	 	 	1.1.1.7	 	
6/2/2015

	
8/10/2015

	
Include in the applicable bi-monthly report

	
*** Interim Report

	 	 	1.4.2.4	 	
2/12/2016

	
2/12/2016

	
***

	
Study Complete Final Report

	 	 	1.4.2.10	 	
6/1/2017

	
6/1/2017

	
Final report submitted to and accepted by BARDA CO/COR

	
***

	 	 	1.5.3.2	 	
6/1/2017

	
6/1/2017

	
***

	
***

	 	 	1.5.3.3	 	
9/21/2017

	
9/21/2017

	
***

	 	  	  
	
Option 3: Comb. Inj. Treatment Optimization

	 	 	 	 	
9/28/13 to 9/27/17

	  
	
Name

	 	 	 	 	
Start Date

	
Finish Date

	
Deliverable

	
Clinical Hiring

	 	 	1.1.1.8	 	
6/3/2016

	
7/14/2016

	
Include in the applicable bi-monthly report

	
Research and Development Hiring

	 	 	1.1.1.9	 	
3/19/2014

	
5/27/2014

	
Include in the applicable bi-monthly report

	
***  Studies Final Report

	 	 	1.3.1.5	 	
3/19/2014

	
1/25/2017

	
Final report submitted to and accepted by BARDA CO/COR

	
*** Final Report

	 	 	1.3.2.2	 	
3/9/2014

	
8/19/2014

	
Final report submitted to and accepted by BARDA CO/COR

	
*** Final Report

	 	 	1.4.3	 	
1/13/2016

	
5/10/2017

	
Final report submitted to and accepted by BARDA CO/COR

	
***

	 	 	1.5.4	 	
4/27/2017

	
8/30/2017

	
***

	
*** Final Report

	 	 	1.6.4	 	
9/16/2015

	
5/22/2017

	
Final report submitted to and accepted by BARDA CO/COR

*** Material has been omitted pursuant to a request for confidential treatment, and the omitted contents were filed separately with the Securities and Exchange Commission.

  

  

17

  

2. Detailed Description of Select Contract Deliverables

 

Technical Reports

 

In addition to those reports required by the other terms of this contract, the Contractor shall prepare and submit the following reports in the manner stated below and in accordance with the DELIVERIES Article in SECTION F of this contract and in SECTION J-List of Attachments, attached hereto and made a part of the contract.

 A. Monthly Progress Report

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

The format should include:

A cover page that includes the contract number and title; the type of report and period that it covers; the Contractor’s name, address, telephone number, fax number, and e-mail address; and the date of submission;  The progress report shall conform to the requirements set forth in the DELIVERIES Article in SECTION F of this contract.

	
·  

	
SECTION I – EXECUTIVE SUMMARY

 

	
·  

	
SECTION II - PROGRESS

 

	
·  

	
SECTION II Part A: OVERALL PROGRESS - A description of overall progress.

 

	
·  

	
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE - A description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g., evaluating, and managing subcontractor performance, and personnel changes).

 

Estimated and Actual Expenses

This report shall also contain a narrative or table detailing whether there is a significant discrepancy (>10%) at this time between the % of work completed and the cumulative costs incurred to date. Monthly and actual expenses should be broken down to the appropriate WBS level as far as possible. This section of the report should also contain estimates for the Subcontractors’ expenses from the previous month if the Subcontractor did not submit a bill in the previous month. If the subcontractor(s) was not working or did not incur any costs in the previous month, then a statement to this effect should be included in this report for those respective subcontractors.

 

	
·  

	
SECTION II Part C: TECHNICAL PROGRESS - For each activity related to the Integrated Master Schedule, document the results of work completed and cost incurred during the period covered in relation to proposed progress, effort and budget. The report shall be in sufficient detail to explain comprehensively the results achieved. The description shall include pertinent data and/or graphs in sufficient detail to explain any significant results achieved and preliminary conclusions resulting from analysis and scientific evaluation of data accumulated to date under the contract. The report shall include a description of problems encountered and proposed corrective action; differences between planned and actual progress, why the differences have occurred and what corrective actions are planned; preliminary conclusions resulting from analysis and scientific evaluation of data accumulated to date under the project.

 

  

18

  

 

	
·  

	
SECTION II Part D: PROPOSED WORK - A summary of work proposed related to the Integrated Master Schedule for the next reporting period and preprints/reprints of papers and abstracts.

 

In accordance with FAR 52.215-2, Audit and Records-Negotiation, BARDA may request on an ad hoc basis that the Contractor provide raw data.  BARDA may request additional data at a reporting level or at lower levels, as BARDA deems necessary.

 

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

 

B. Annual Progress Report

This report shall include a summation of the results of the entire contract work for the period covered. An Annual Technical Progress Report will not be required for the period when the Final Technical Progress Report is due. Monthly Progress Reports shall not be submitted in the same month when an Annual Progress Report is due.

 

The first Annual Progress Report shall be submitted in accordance with the date set forth in ARTICLE F.2 of this contract. Each Annual Progress Report shall include:

A Cover page that includes the contract number and title; the type of report and period that it covers; the Contractor's name, address, telephone number, fax number, and email address; and the date of submission; The progress report shall conform to the requirements set forth in the DELIVERIES Article in SECTION F of this contract.

 

 

	
·  

	
SECTION I: EXECUTIVE SUMMARY - A brief overview of the work completed, and the major accomplishments achieved during the reporting period.

 

	
·  

	
SECTION II: PROGRESS

 

	
·  

	
SECTION II Part A: OVERALL PROGRESS - A description of overall progress.

 

	
·  

	
SECTION II Part B: MANAGEMENT AND ADMINISTRATIVE UPDATE - A description of all meetings, conference calls, etc. that have taken place during the reporting period. Include progress on administration and management issues (e.g. evaluating, and managing subcontractor performance; regulatory compliance audits, and personnel changes).

 

	
·  

	
SECTION II Part C: TECHNICAL PROGRESS - A detailed description of the work performed structured to follow the activities and decision gates described in the Integrated Master Schedule. The Report should include a description of any problems (technical or financial) that occurred or were identified during the reporting period, and how these problems were resolved.

 

	
·  

	
SECTION II Part D: PROPOSED WORK - A summary of work proposed for the next year period to include an updated Integrated Master Schedule.

 

	
·  

	
SECTION III Part A:  In accordance with FAR 52.215-2, Audit and Records-Negotiation, BARDA may request on an ad hoc basis that the Contractor provide raw data.  BARDA may request additional data at a reporting level or at lower levels, as BARDA deems necessary.

 

  

19

  

 

Contractor also should include the following in the Annual Progress Report:

 

	
1.  

	
Copies of manuscripts (published and unpublished), abstracts, and any protocols or methods developed specifically under the contract during the reporting period; and

 

	
2.  

	
A summary of any Subject Inventions per the requirements under FAR Clause 52.227-11.

 

 

An annual Progress Report will not be required in the same month that the Final Technical Progress Report is submitted.

 

 

C. Draft Final Technical Progress Report and Final Technical Progress Report

 

These reports are to include a summation of the work performed and results obtained for the entire contract period of performance. This report shall be in sufficient detail to describe comprehensively the results achieved. The Draft Final Report and Final Report shall be submitted in accordance with the DELIVERIES Article in SECTION F of the contract. An Annual Technical Progress Report will not be required for the period when the Final Technical Progress Report is due. The Draft Final Technical Progress Report and the Final Technical Progress Report shall be submitted in accordance with the dates set forth in ARTICLE F.2. of this contract. The report shall conform to the following format:

 

	
  

	
1.   Cover page to include the contract number, contract title, performance period covered, Contractor's name and address, telephone number, fax number, email address and submission date.

 

	
1.  

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

 

	
2.  

	
SECTION II: RESULTS - A detailed description of the work performed related to the Integrated Master Schedule, the results obtained, and the impact of the results on the scientific and/or public health community including a listing of all manuscripts (published and in preparation) and abstracts presented during the entire period of performance and a summary of all inventions.

 

Draft Technical Progress Report: The Contractor is required to submit the Draft Final Technical Progress Report to the Contracting Officer’s Representative and Contracting Officer. The Contracting Officer’s Representative and Contracting Officer will review the Draft Final Technical Progress Report and provide the Contractor with comments in accordance with the dates set forth in ARTICLE F.2. of this contract.

 

 

Final Technical Progress Report: The Contractor will deliver the final version of the Final Technical Progress Report on or before the completion date of the contract.  The final version shall include or address the Contracting Officer’s  Representative comments and Contracting Officer comments on the draft report. Final Technical Progress Report shall be submitted on or before the completion date of the contract.

 

  

20

  

 

  D.  Summary of Salient Results

 

    The Contractor shall submit, with the Final Technical Progress Report, a summary (not to exceed 200 words) of salient results achieved during the performance of the contract.

 

   E.  Other Technical Progress Reports

 

	
1.  

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

 

	
·  

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

	
·  

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

	
·  

	
Subcontractor prepared reports received by the Prime Contractor shall be submitted to the Contracting Officer’s Representative and Contracting Officer (CO) for review and comment as set forth by ARTICLE F.2. of this contract.

	
·  

	
The Government shall provide written comments to the Draft Final Report for Non-Clinical Studies and Clinical Studies in accordance with the dates set forth in ARTICLE F.2.of this contract.

	
·  

	
The comprehensive Final Report for Non-Clinical Studies and Clinical Studies will be submitted to the Contracting Officer and the Contracting Officer’s Representative as set forth by ARTICLE F.2. of this contract.. The final version shall include or address the Contracting Officer’s Representative comments and Contracting Officer comments on the draft report.

	
·  

	
See section ARTICLE F.2.  REPORTING REQUIREMENTS AND DELIVERABLES for additional clarification and deliverable requirements.

 

	
2.  

	
Audit Reports

 

	
·  

	
Within thirty (30) calendar days of a contractor-initiated audit related to conformance to FDA regulations and guidance, including adherence to GLP, GMP, GCP guidelines, the Contractor shall provide copies of the audit report.

	
·  

	
It must include a plan for addressing areas of nonconformance to FDA regulations and guidelines for GLP, GMP, or GCP guidelines as identified in the final audit report.

	
3.  

	
Other Technical Documents:

 

	
·  

	
Upon request, Contractor shall provide CO and COR with the following contract funded documents as specified below but not limited to: Process Development Reports, Assay Qualification Plan/Report, Assay Validation Plan/Report, Assay Technology Transfer Report, Batch Records, Standard Operating Procedures, Master Production Records, Certificate of Analysis, Clinical Studies Data or Reports.

	
·  

	
The CO and COR reserve the right to request within the Period of Performance a non-proprietary technical document for distribution within the USG.

 

  

21

  

 

	
·  

	
Data:  The Contractor shall provide raw data or specific analysis of data generated with contract funding at the request of the BARDA COR. See FAR 52.227-14.  Data/data analysis will be delivered to the Government pursuant to the terms set forth in ARTICLE F.2 of this contract.

 

	
·  

	
Contractor shall provide the requested document within 10 business days of CO or COR request. Contractor can request additional time on an as needed basis. If edits are recommended, the Contractor must address, in writing, concerns raised by BARDA

   F. Deliverables Arising from FDA  Correspondence

 

	
a.  

	
FDA Meetings

The Contractor shall forward the dates and times of any meeting with the FDA to BARDA and make arrangements for appropriate BARDA staff to attend the FDA meetings. BARDA staff shall include up to a maximum of four people (COR, CO and up to 2 subject matter experts).

 

	
·  

	
Contractor shall notify BARDA of upcoming FDA meeting within 24 hours of scheduling Type A, B or C meetings OR within 24 hours of meeting occurrence for ad hoc meetings.

 

	
·  

	
The Contractor shall forward initial Contractor and FDA-issued draft minutes and final minutes of any meeting with the FDA to BARDA within 3 business days of receipt. All documents shall be duly marked as either “Draft” or “Final”.

 

	
b.  

	
FDA Submissions

 

The Contractor shall provide BARDA the opportunity to review and comment upon all draft documents before submission to the FDA. Contractor shall provide BARDA with an electronic copy of the final FDA submission. All documents shall be duly marked as either “Draft” or “Final”.

 

	
·  

	
Contractor shall submit draft FDA submissions to BARDA at least 15 business days prior to FDA submission

 

	
·  

	
BARDA will provide feedback to Contractor within 10 business days of receipt

 

	
·  

	
If corrective action is recommended, the Contractor must address, in writing, its consideration of all concerns raised by BARDA

 

	
·  

	
The Contractor shall consider revising their documents to address BARDA’s concerns and/or recommendations prior to FDA submission

 

	
·  

	
Final FDA submissions shall be submitted to BARDA concurrently or no later than 1 calendar day of it submission to CDER.

 

	
c.  

	
 FDA Audits

 

In the event of an FDA inspection which occurs as a result of this contract and for the product, or for any other FDA inspection that has the reasonable potential to impact the performance of this contract, the Contractor shall provide the USG with an exact copy (non-redacted) of the FDA Form 483 and the Establishment Inspection Report (EIR). The Contractor shall provide the COR and CO with copies of the plan for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines as identified in the audit report, status updates during the plans execution and a copy of all final responses to the FDA. The Contractor shall also provide redacted copies of any FDA audits received from subcontractors that occur as a result of this contract or for this product. The Contractor shall make arrangements for BARDA representative(s) to be present during the final debrief by the regulatory inspector.

  

22

  

 

	
·  

	
Contractor shall notify CO and COR within 10 business days of a scheduled FDA audit or within 24 hours of an ad hoc site visit/audit if the FDA does not provide advanced notice.

 

	
·  

	
Contractor shall provide copies of any FDA audit report received from subcontractors that occur as a result of this contract or for this product within 3 business days of receiving correspondence from the FDA or third party.

 

	
·  

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

 

d. Manufacturing Campaign Reports

Contractor shall provide Manufacturing Campaign Reports to BARDA for review and comment prior to submission to FDA.

The COR and CO reserve the right to request within the PoP a non-proprietary Manufacturing Campaign Report for distribution within the USG.

	
·  

	
Contractor will submit Manufacturing Campaign Reports at least 15 business days prior to FDA submission.

	
·  

	
If corrective action is recommended, Contractor must address, in writing, all concerns raised by BARDA.

	
·  

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

	
·  

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

 

e. Other FDA Correspondence

The Contractor shall memorialize any correspondence between Contractor and FDA and submit to BARDA. All documents shall be duly marked as either “Draft” or “Final.”

 

	
·  

	
Contractor shall provide written summary of any FDA correspondence within 3 business days of correspondence.

 

G.   Other Reports/Deliverables

 

	
1.  

	
Meeting Minutes

 

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

 

2.   Copies of FDA Correspondence and Meeting Summaries

 

1. For any formal meeting with the FDA, the contractor shall forward initial draft minutes and subsequently final meeting minutes appropriately formatted within thirty (30) calendar days of the FDA meeting to the BARDA Contracting Officer’s Technical Representative. All documents shall be duly marked as either “Draft” or “Final”.

 

  

23

  

 

2. The contractor shall forward the final draft minutes of any informal meeting with the FDA to BARDA.

 

3. The contractor shall forward the dates and times of any meeting with the FDA to BARDA at least 30 days prior to the meeting and make arrangements for appropriate BARDA staff to attend FDA meetings. BARDA staff shall include up to a maximum of four people (COTR, CO and up to two Subject Matter Experts (SMEs)).

4. The contractor shall provide BARDA the opportunity to review and comment upon any documents to be submitted to the FDA. The contractor shall provide BARDA with five (5) business days in which to review and provide comments back to the contractor. 

 

         H.   SUBJECT INVENTION REPORTING REQUIREMENT

 

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

 

Reports and documentation submitted to the Contracting Officer shall be sent to the Contracting Officer to the address set forth in SECTION G – CONTRACT ADMINISTRATION DATA.

 

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

 

SECTION G - CONTRACT ADMINISTRATION DATA

 

ARTICLE G.1. CONTRACTING OFFICER

 

The following Contracting Officer (CO) will represent the Government for the purpose of this contract:

 

 *** Contracting Officer

DHHS/OS/ASPR/AMCG

330 Independence Avenue, S.W.

***

Washington, D.C. 20201

E-mail: ***

*** Material has been omitted pursuant to a request for confidential treatment, and the omitted contents were filed separately with the Securities and Exchange Commission.

  

24

  

 

	
1)  

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

 

	
2)  

	
The Contracting Officer is the only person with the authority to act as agent of the Government under this contract.  Only the Contracting Officer has authority to (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of  performance; (3) change the delivery schedule; (4) authorize reimburse to the Contractor of any costs incurred during the performance of this contract; (5) otherwise change any terms and conditions of this contract.

 

	
3)  

	
No information other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the US Government, other otherwise, shall be considered grounds for deviation from any stipulation of this contract.

 

	
4)  

	
The Government may unilaterally change its CO designation.

 

 

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

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

***

Contracting Officer’s Representative (COR)

Division of CBRN Countermeasures

Biomedical Advanced Research and Development Authority (BARDA)

Office of the Assistant Secretary for Preparedness and Response (ASPR)

Department of Health and Human Services (DHHS)

Mailing Address:

330 Independence Avenue, S.W.

***

Washington, D.C. 20201

Office: ***

Email: ***

The COR is responsible for:

 

	
1)  

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

 

	
2)  

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

 

	
3)  

	
Performing technical evaluation as required;

 

	
4)  

	
Performing technical inspections and acceptances required by this contract; and

 

	
5)  

	
Assisting in the resolution of technical problems encountered during performance.  The Government may unilaterally change its COR designation.

 

*** Material has been omitted pursuant to a request for confidential treatment, and the omitted contents were filed separately with the Securities and Exchange Commission.

  

25

  

ARTICLE G.3. KEY PERSONNEL

Pursuant to the Key Personnel clause incorporated in Section I of this contract, the following individuals are considered to be essential to the work being performed hereunder:

***

 

The key personnel specified in this contract are considered to be essential to work performance. At least thirty (30) business days prior to diverting any of the specified individuals to other programs or contracts, including, where practicable, an instance when an individual must be replaced as a result of leaving the employ of the Contractor, the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer.

 

ARTICLE G.4. CONTRACT FINANCIAL REPORT

 

a. Financial reports on the attached Financial Report of Individual Project/Contract (see Attachments 2 and 3) shall be submitted by the Contractor in accordance with the instructions for completing this form, which accompany the form, in an electronic copy, not later than the 30th business day after the close of the reporting period. The line entries for subdivisions of work and elements of cost (expenditure categories) which shall be reported within the total contract are discussed in paragraph e., below. Subsequent changes and/or additions in the line entries shall be made in writing.

 

b. Unless otherwise stated in that part of the instructions for completing this form, entitled "PREPARATION INSTRUCTIONS," (see Attachment 4) all columns A through J, shall be completed for each report submitted.

 

c. The first financial report shall cover the period consisting of the first full three calendar months following the date of the contract, in addition to any fractional part of the initial month. Thereafter, reports will be on a quarterly basis.

 

d. The Contracting Officer may require the Contractor to submit detailed support for costs contained in one or more interim financial reports. This clause does not supersede the record retention requirements in FAR Part 4.7.

 

e. The listing of expenditure categories to be reported is incorporated within the Attachment entitled, "Financial Report of Individual Project/Contract," located in SECTION J and made a part of this contract.

 

f. The Government may unilaterally revise the “Financial Report of Individual Project/Contract” to reflect the allotment of additional funds.

 

ARTICLE G.5. INVOICE/FINANCING REQUEST AND CONTRACT FINANCIAL REPORTING

	
1)  

	
The billing address that should be shown on the invoice is the same as defined in ARTICLE G.2. of this contract.

 

*** Material has been omitted pursuant to a request for confidential treatment, and the omitted contents were filed separately with the Securities and Exchange Commission.

  

26

  

 

	
2)  

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

 

	
3)  

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

	
4)  

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

	
5)  

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

	
6)  

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

ARTICLE G.6. REIMBURSEMENT OF COST

	
1)  

	
The Government shall reimburse the Contractor the cost determined by the Contracting Officer to be allowable (hereinafter referred to as allowable cost) in accordance with the clause entitled Allowable Cost and Payment in Section I, Contract Clauses, and FAR Subpart 31.2. Examples of allowable costs include, but are not limited to, the following:

	
a)  

	
All direct materials and supplies that are used in the performing of the work provided for under the contract, including those purchased for subcontracts and purchase orders.

	
b)  

	
All direct labor, including supervisory, that is properly chargeable directly to the contract, plus fringe benefits.

	
c)  

	
All other items of cost budgeted for and accepted in the negotiation of this basic contract or modifications thereto.

	
d)  

	
Travel costs including per diem or actual subsistence for personnel while in an actual travel status in direct performance of the work and services required under this contract subject to the following:

	
(i)  

	
Air travel shall be by the most direct route using “air coach” or “air tourist” (less than first class) unless it is clearly unreasonable or impractical (e.g., not available for reasons other than avoidable delay in making reservations, would require circuitous routing or entail additional expense offsetting the savings on fare, or would not make necessary connections).

 

	
(ii)  

	
Rail travel shall be by the most direct route, first class with lower berth or nearest equivalent.

	
(iii)  

	
Costs incurred for lodging, meals, and incidental expenses shall be considered reasonable and allowable to the extent that they do not exceed on a daily basis the per diem rates set forth in the Federal Travel Regulation (FTR).

 

  

27

  

 

	
(iv)  

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

 

ARTICLE G.7.  INDIRECT COST RATES

 

The following rates will be utilized for billing purposes during both the base and option periods:  Fringe benefits at 24%, and a general and administrative expense rate (G&A) of 50% for FY2012 and 51% for FY2013 through FY2016. The billing rates for the option period will be based on the incurred cost submission for the previous calendar year, subject to Government audit adjustments.  Final rate proposals must be sent to the Contracting Officer, within 6 months subsequent to the fiscal year end. (See also FAR Clause 52.216-7 incorporated herein)

ARTICLE G.8.  POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

1. Contractor Performance Evaluations

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, an interim evaluation shall be submitted September 27, 2013.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer whose decision will be final.

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

 

2. Electronic Access to Contractor Performance Evaluations

 

Contractors that have Internet capability may access evaluations through a secure Web site for review and comment by completing the registration form that can be obtained at the following address:

 

http://www.cpars.csd.disa.mil/cparsmain.htm

 

The registration process requires the Contractor to identify an individual that will serve as a primary contact and who will be authorized access to the evaluation for review and comment. In addition, the Contractor will be required to identify an alternate contact that will be responsible for notifying the cognizant contracting official in the event the primary contact is unavailable to process the evaluation within the required 30-day time frame.

 

ARTICLE G.9. CONTRACT COMMUNICATIONS/CORRESPONDENCE (JULY 1999)

 

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

 

  

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ARTICLE G.10. GOVERNMENT PROPERTY

 

1. In addition to the requirements of the clause, GOVERNMENT PROPERTY, incorporated in SECTION I of this contract, the Contractor shall comply with the provisions of HHS Publication, "Contractor's Guide for Control of Government Property," which is incorporated into this contract by reference. This document can be accessed at:

 

http://www.hhs.gov/hhsmanuals/ (HHS Logistics Management Manual)

 

Among other issues, this publication provides a summary of the Contractor's responsibilities regarding purchasing authorizations and inventory and reporting requirements under the contract.

 

2. Notwithstanding the provisions outlined in the HHS Publication, "Contractor's Guide for Control of Government Property," which is incorporated in this contract in paragraph 1. above, the Contractor shall use the form entitled, "Report of Government Owned, Contractor Held Property" for submitting summary reports required under this contract, as directed by the Contracting Officer or his/her designee. This form is included as an attachment in SECTION J of this contract.

 

3. Title will vest in the Government for equipment purchased as a direct cost.

 

ARTICLE G.11.  EXERCISE OF OPTIONS

 

Unless the Government exercises its option pursuant to the Option Clause set forth in Section I, Article I.2, the contract will consist only of CLIN 0001 of the Statement of Work, Deliverables and Requirements as defined in Sections C, F and J of the contract.  Pursuant to FAR Clause 52.217-9 (Option to Extend the Term of the Contract) set forth in Section I of this contract, under Article I.2, the Government may, by unilateral contract modification, require the Contractor to perform the additional CLINs listed in Section B, Article B.3., and as also defined in Sections C, F and J of this contract.  If the Government exercises an option, written notice must be given to the Contractor within 30 days after the Government has completed its analysis of the deliverables associated with the applicable GO/NO-GO Decision gates; and the Government must give the Contractor a preliminary written notice of its intent to exercise the option at least 30 days before the contract expires.  The amount of the contract may then be increased as set forth in Section B, Article B.3 provided that funds are available.

 

SECTION H - SPECIAL CONTRACT REQUIREMENTS

 

ARTICLE H.1. CLINICAL AND NON-CLINICAL TERMS OF AWARD

 

BARDA has a responsibility to obtain documentation concerning mechanisms and procedures that are in place to protect the safety of participants and animals in BARDA funded clinical trials and non-clinical studies.  Therefore, the Contractor shall develop a protocol for each clinical trial and non-clinical study funded under this contract and submit all such protocols and protocol amendments to the BARDA Contracting Officer’s Representative (COR) for evaluation and comment. Approval is required before work under a protocol may begin. BARDA COR comments will be forwarded to the Contractor within ten (10) business days. The Contractor must address, in writing, all concerns (e.g. study design, safety, regulatory, ethical, and conflict of interest) raised by the BARDA COR.

 

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

 

  

29

  

Execution of clinical and non-clinical studies requires written authorization from BARDA. The Government will provide written authorization to the Contractor upon either 1) receiving documentation in which all COR comments have been satisfactorily addressed; or 2) receiving documentation that the FDA has reviewed and commented on the protocol.

 

BARDA shall have rights to all protocols, data resulting from execution of these protocols, and final reports funded by BARDA under this contract, as set forth in PART II of this contract and defined in the FAR.  BARDA reserves the right to request that the Awardee provide any contract deliverable in a non-proprietary form to ensure BARDA has the ability to review and distribute the deliverables as BARDA deems necessary.

 

Important information regarding performing human subject research is available at http://www3.niaid.nih.gov/healthscience/clinicalstudies/.

 

Any updates to technical reports are to be addressed in the Monthly and Annual Progress Reports.  The Contractor shall advise the Contracting Officer’s Technical Representative or designee in writing and via electronic communication in a timely manner of any issues potentially affecting contract performance.

 

1. Non-Clinical Terms of Award

 

These Non-Clinical Terms of Award detail an agreement between the Biomedical Advanced Research and Development Authority (BARDA) and the Contractor; they apply to all grants and contracts that involve non-clinical research.

 

	
a.  

	
Safety and Monitoring Issues

 

	
i.  

	
PHS Policy on Humane Care and use of Laboratory Animals

Before award and then with the annual progress report, the Contractor must submit to BARDA a copy of the current Institutional Animal Care and Use Committees (IACUC) documentation of continuing review and approval and the Office of Laboratory Animal Welfare (OLAW) federal wide assurance number for the institution or site.

If other institutions are involved in the research (e.g., a multicenter trial or study), each institution’s IACUC must review and approve the protocol. They must also provide BARDA initial and annual documentation of continuing review and approval and federal wide assurance number.

The Contractor must ensure that the application, as well as all protocols, are reviewed by the performing institution’s IACUC.

To help ensure the safety of animals used in BARDA-funded studies, the Contractor must provide BARDA copies of documents related to all major changes in the status of ongoing protocols, including the following:

	
·  

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

	
·  

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

 

  

30

  

 

	
·  

	
Termination or temporary suspension of the study(ies) for regulatory issues.

	

·  

	
Termination or temporary suspension of the protocol.

	
·  

	
Any change that is made in the specific IACUC approval for the indicated study(ies).

	
·  

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

Contractor must notify BARDA of any of the above changes within five (5) working days from the time the Contractor becomes aware of such changes by email or fax, followed by a letter signed by the institutional business official, detailing notification of the change of status to the local IACUC and a copy of any responses from the IACUC.

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

 

	
ii.  

	
Non-Clinical Data and Safety Monitoring Requirements

 

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

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

BARDA will work with the Contractor on decisions regarding the type and extent of safety data accrual to be employed before the start of efficacy or safety studies.

The Contractor shall inform BARDA of any upcoming site visits and/or audits of CRP facilities funded under this effort. BARDA reserves the right to accompany the Contractor on site visits and/or audits of CRO’s as BARDA deems necessary.

 

  

31

  

	
b.  

	
BARDA Review Process before Non-Clinical study Execution Begins

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

	
·  

	
IACUC approved (signed) non-clinical research protocol identified by version number, date, or both, including details of study design, euthanasia criteria, proposed interventions, and exclusion criteria.

	
·  

	
For non-pivotal mouse studies, the Contractor will provide an annual animal care and use protocol.

	
·  

	
Documentation of IACUC approval, including OLAW federal wide number, IACUC registration number, and IACUC name.

	
·  

	
Contractor should reduce the number of animals required for a study using power of statistics.

	
·  

	
Plans for the management of side effects, rules for interventions and euthanasia criteria.

	
·  

	
Procedures for assessing and collecting safety data were appropriate.

	
·  

	
If a study is contracted through Contract Research Organizations (CROs), work orders and service agreements the Contractor shall assure an integrated safety documentation plan is in place for the study site, pharmacy service records on the dosing material to be used and excipients, and laboratory services (including histopathology).

	
·  

	
Documentation that the Contractor and all required staff responsible for the conduct of the research have received training in the protection and handling of animals, or that the CRO has the required documentation.

	
·  

	
Purchasing of animals and/or other supplies for non-clinical studies funded in part or in whole by BARDA requires written approval by the Contracting Officer in accordance with the contract. The Contractor must have the ability to return/re-sell animals, at purchase price, to distributor or a third part, in the event that the Contracting Officer Authorization is not granted.

	
·  

	
Provide justification for whether studies require good laboratory practice (GLP) conditions.

	
·  

	
Provide justification for whether studies will be classified as non-pivotal or pivotal studies.

Documentation of each of the above items shall be submitted to the BARDA for evaluation and comment in conjunction with the protocol. Execution of non-clinical studies requires written authorization from BARDA in accordance with this section of the contract.

 

  

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c.  

	
References

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

http://grants.nih.gov/grants/olaw/InvestigatorsNeed2Know.pdf

USDA Animal Welfare Act:

http://awic.nal.usda.gov/nal_display/index.php?info_center=3&tax_level=3&tax_subject=182&topic_id=1118&level3_id=6735&level4_id=0&level5_id=0&placement_default=0

2. Clinical Terms of Award

These Clinical Terms of Award detail an agreement between the Biomedical Advanced Research and Development Authority (BARDA) and the Contractor; they apply to all grants and contracts that involve clinical research.

	
i.  

	
Safety and Monitoring Issues

a. Institutional Review Board or Independent Ethics Committee Approval

Before award and then with the annual progress report, the Contractor must submit to BARDA a copy of the current IRB-or IEC-approved informed consent document, documentation of continuing review and approval and the OHRP federal wide assurance number for the institution or site.

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

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

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

	
·   

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

	
·   

	
All changes in informed consent documents, identified by version number, dates, or both and dates it is valid.

	
·    

	
Termination or temporary suspension of patient accrual.

	
·    

	
Termination or temporary suspension of the protocol.

	
·   

	
Any change in IRB approval.

	
·   

	
Any other problems or issues that could affect the participants in the studies.

 

  

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

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

b. Data and Safety Monitoring Requirements

 

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

 

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

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

	
·  

	
Independent Safety Monitor – a physician or other appropriate expert who is independent of the study and available in real time to review and recommend appropriate action regarding adverse events and other safety issues.

	
·  

	
Independent Monitoring Committee (IMC) or Safety Monitoring Committee (SMC) – a small group of independent investigators and biostatisticians who review data from a particular study.

	
·  

	
Data and Safety Monitoring Board – an independent committee charged with reviewing safety and trial progress and providing advice with respect to study continuation, modification, and termination. The Contractor may be required to use an established BARDA DSMB or to organize an independent DSMB. All phase III clinical trials must be reviewed by a DSMB; other trials may require DSMB oversight as well. Please refer to: NIAID Principles for Use of a Data and Safety Monitoring Board (DSMB) For Oversight of Clinical Trials Policy

 

  

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When a monitor or monitoring board is organized, a description of it, its charter or operating procedures (including a proposed meeting schedule and plan for review of adverse events), and roster and curriculum vitae from all members must be submitted to and approved by BARDA before enrollment starts. The Contractor will also ensure that the monitors and board members report any conflicts of interest and the Contractor will maintain a record of this. The Contractor will share conflict of interest reports with BARDA.

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

	
ii.  

	
BARDA Protocol Review Process Before Patient Enrollment Begins

 

BARDA has a responsibility to ensure that mechanisms and procedures are in place to protect the safety of participants in BARDA-supported clinical trial. Therefore, before patient accrual or participant enrollment, the Contractor must ensure the following (as applicable) are in place prior to patient accrual or enrollment at each participating institution.

· IRB- or IEC-approved clinical research protocol identified by version number, date, or both, including details of study design, proposed interventions, patient eligibility, and exclusion criteria.

· Documentation of IRB or IEC approval, including OHRP federal wide number, IRB or IEC registration number, and IRB and IEC name.

· IRB- or IEC- approved informed consent document, identified by version number, date, or both and dates it is valid.

· Plans for the management side effects.

· Procedures for assessing and reporting adverse events.

· Plans for data and safety monitoring (see B above) and monitoring of the clinical study site, pharmacy, and laboratory.

· Documentation that the Contractor and all study staff responsible for the design or conduct of the research have received training in the protection of human subjects.

Documentation to demonstrate that each of the above items are in place shall be submitted to the BARDA) for evaluation and comment in conjunction with the protocol. Execution of clinical studies requires written authorization from BARDA in accordance with this section of this contract.

 

	
iii.  

	
Investigational New drug or Investigational Device Exemption Requirements

Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed)  in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

  

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Exceptions must be granted in writing by FDA. If the proposed clinical trial will be performed under an IND or IDE, the Contractor must provide BARDA with the name and institution of the IND or IDE sponsor, the date the IND or IDE was filed with FDA, the FDA IND or IDE number, any written comments from GDA, and the written responses to those comments.

Unless FDA notifies Contractor otherwise, The Contractor must wait thirty (30) calendar days from FDA receipt of an initial IND or IDE application before initiating a clinical trial.

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

The Contractor must not use grant or contract funds during a clinical hold to fund clinical studies that are on hold. The Contractor must not enter into any new financial obligations related to clinical activities for the clinical trial on clinical hold.

	
iv.  

	
Required Time-Sensitive Notification

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

· Expedited safety report of unexpected or life-threatening experience or death – A copy of any report of unexpected or life-threatening experience or death associated with the use of an IND drug, which must be reported to FDA by telephone or fax as soon as possible but no later than seven (7) days after the IND sponsor’s receipt of the information, must be submitted to the BARDA representative or the contraction officer’s technical representative within 24 hours of FDA notification.

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

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

· Expedited safety reports – should be sent to the BARDA representative or the Contracting Officer’s Technical Representative concurrently with the report to FDA.

  

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

In case of problems or issues, the BARDA representative or the Contracting Officer’s Technical Representative will contract the Contractor within ten (10) working days by email or fax, followed within thirty (30) calendar days by an official letter to the Contractor’s Project Leader, with a copy to the institutions’ office of sponsored programs, listing issues and appropriate actions to be discussed.

· Safety reporting for research not performed under an IND or IDE.

Final decisions regarding ongoing safety reporting requirements for research not performed under an IND or IDE must be made jointly by the BARDA Project Officer or the Contracting Officer’s Technical Representative and the Contractor.

 

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

 

	
  

	
(a) The Contractor agrees that the rights and welfare of human subjects involved in research

	
  

	
under this contract shall be protected in accordance with 45 CFR Part 46 and with the Contractor's current Assurance of Compliance on file with the Office for Human Research Protections (OHRP), Department of Health and Human Services. The Contractor further agrees to provide certification at least annually that the Institutional Review Board has reviewed and approved the procedures, which involve human subjects in accordance with 45 CFR Part 46 and the Assurance of Compliance.

(b) The Contractor shall bear full responsibility for the performance of all work and services

involving the use of human subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible. The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract. The Contractor shall not deem anything in this contract to constitute the Contractor or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever, as the agent or employee of the Government. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent contractor without imputing liability on the part of the Government for the acts of the Contractor or its employees.

(c) If at any time during the performance of this contract, the Contracting Officer determines, in consultation with OHRP that the Contractor is not in compliance with any of the requirements and/or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. If the Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, after consultation with OHRP, terminate this contract in whole or in part, and the Contractor's name may be removed from the list of those contractors with approved Human Subject Assurances.

 

  

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ARTICLE H.3. HUMAN MATERIALS (ASSURANCE OF OHRP COMPLIANCE)

 

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

 

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

 

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

 

 

ARTICLE H.4. RESEARCH INVOLVING HUMAN FETAL TISSUE

 

All research involving human fetal tissue shall be conducted in accordance with the Public Health Service Act, 42 U.S.C. 289g-1 and 289g-2. Implementing regulations and guidance for conducting research on human fetal tissue may be found at 45 CFR 46, Subpart B and http://grants1.nih.gov/grants/guide/notice-files/not93-235.html and any subsequent revisions to this NIH Guide to Grants and Contracts ("Guide") Notice.

 

The Contractor shall make available, for audit by the Secretary, HHS, the physician statements and informed consents required by 42 USC 289g-1(b) and (c), or ensure HHS access to those records, if maintained by an entity other than the Contractor.

 

ARTICLE H.5. NEEDLE EXCHANGE

 

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

 

ARTICLE H.6. CARE OF LIVE VERTEBRATE ANIMALS, HHSAR 352.270-5 (October 2009)

 

(a) Before undertaking performance of any contract involving animal-related activities where the species is regulated by USDA, the Contractor shall register with the Secretary of Agriculture of the United States in accordance with 7 U.S.C. 2136 and 9 CFR sections 2.25 through 2.28. The Contractor shall furnish evidence of the registration to the Contracting Officer.

(b) The Contractor shall acquire vertebrate animals used in research from a dealer licensed by the Secretary of Agriculture under 7 U.S.C. 2133 and 9 CFR Sections 2.1-2.11, or from a source that is exempt from licensing under those sections.

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

 

  

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

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

 

ARTICLE H.7. ANIMAL WELFARE

 

All research involving live, vertebrate animals shall be conducted in accordance with the Public Health Service Policy on Humane Care and Use of Laboratory Animals. This policy may be accessed at:

 

 http://grants1.nih.gov/grants/olaw/references/phspol.htm .

 

ARTICLE H.8. PUBLICATION AND PUBLICITY

 

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

 

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

 

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

 

"This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201200008C "

 

  

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ARTICLE H.9. REVIEW OF PRESS RELEASES

 

Contractor agrees to accurately and factually represent the work conducted under the contract in all press releases.

 

Misrepresenting contract results or releasing information that is injurious to the integrity of BARDA may be construed as improper conduct. Press releases shall be considered to include the public release of information to any medium, excluding peer-reviewed scientific publications. The contractor shall ensure that the COR has received an advance copy of any press release related to the contract not less than six (6) business days prior to the issuance of the press release.

 

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

 

 

"This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201200008C"

 

ARTICLE H.10. REPORTING MATTERS INVOLVING FRAUD, WASTE AND ABUSE

 

Anyone who becomes aware of the existence or apparent existence of fraud, waste and abuse in BARDA funded programs is encouraged to report such matters to the HHS Inspector General's Office in writing or on the Inspector General's Hotline. The toll free number is 1-800-HHS-TIPS (1-800-447-8477). All telephone calls will be handled confidentially. The e-mail address is   Htips@os.dhhs.gov   and the mailing address is:

 

Office of Inspector General

Department of Health and Human Services

TIPS HOTLINE

P.O. Box 23489

Washington, D.C. 20026

ARTICLE H.11. PROHIBITION ON CONTRACTOR INVOLVEMENT WITH TERRORIST

ACTIVITIES

 

The Contractor acknowledges that U.S. Executive Orders and Laws, including but not limited to E.O. 13224 and P.L. 107-56, prohibit transactions with, and the provision of resources and support to, individuals and organizations associated with terrorism. It is the legal responsibility of the Contractor to ensure compliance with these Executive Orders and Laws. This clause must be included in all subcontracts issued under this contract.

 

ARTICLE H.12. CONFLICT OF INTEREST

 

The Contractor represents and warrants that, to the best of the Contractor's knowledge and belief, there are no relevant facts or circumstances which could give rise to an organizational conflict of interest, as defined in FAR Subpart 9.5, or that the Contractor has disclosed all such relevant information.  Prior to commencement of any work, the Contractor agrees to notify the Contracting Officer promptly that, to the best of its knowledge and belief, no actual or potential conflict of interest exists or to identify to the Contracting Officer any actual or potential conflict of interest the firm may have. In emergency situations, however, work may begin but notification shall be made within five (5) working days.  

 

  

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The Contractor agrees that if an actual or potential organizational conflict of interest is identified during performance, the Contractor shall promptly make a full disclosure in writing to the Contracting Officer. This disclosure shall include a description of actions, which the Contractor has taken or proposes to take, after consultation with the Contracting Officer, to avoid, mitigate, or neutralize the actual or potential conflict of interest. The Contractor shall continue performance until notified by the Contracting Officer of any contrary action to be taken.  Remedies include termination of this contract for convenience, in whole or in part, if the Contracting Officer deems such termination necessary to avoid an organizational conflict of interest. If the Contractor was aware of a potential organizational conflict of interest prior to award or discovered an actual or potential conflict after award and did not disclose it or misrepresented relevant information to the Contracting Officer, the Government may terminate the contract for default, debar the Contractor from Government contracting, or pursue such other remedies as may be permitted by law or this contract.

 

ARTICLE H.13. PROHIBITION ON THE USE OF APPROPRIATED FUNDS FOR LOBBYING ACTIVITIES AND HHSAR 352.203-70 ANTI-LOBBYING (Jan 2006)

The Contractor is hereby notified of the restrictions on the use of Department of Health and Human Service's funding for lobbying of Federal, State and Local legislative bodies.

Section 1352 of Title 10, United Stated Code (Public Law 101-121, effective 12/23/89), among other things, prohibits a recipient (and their subcontractors) of a Federal contract, grant, loan, or cooperative agreement from using appropriated funds (other than profits from a federal contract) to pay any person for influencing or attempting to influence an officer or employee of any agency, a Member of Congress, an officer or employee of Congress, or an employee of a Member of Congress in connection with any of the following covered Federal actions; the awarding of any Federal contract; the making of any Federal grant; the making of any Federal loan; the entering into of any cooperative agreement; or the modification of any Federal contract, grant, loan, or cooperative agreement.  For additional information of prohibitions against lobbying activities, see FAR Subpart 3.8 and FAR Clause 52.203-12.

In addition, as set forth in HHSAR 352.203-70 “Anti-Lobbying” (January 2006), the current Department of Health and Human Services Appropriations Act provides that no part of any appropriation contained in this Act shall be used, other than for normal and recognized executive-legislative relationships, for publicity or propaganda purposes, for the preparation, distribution, or use of any kit, pamphlet, booklet, publication, radio, television, or video presentation designed to support, or defeat legislation pending before the Congress, or any State or Local legislature except in presentation to the Congress, or any State or Local legislative body itself.

The current Department of Health and Human Services Appropriations Act also provides that no part of any appropriation contained in this Act shall be used to pay the salary or expenses of any contract or grant recipient, or agent acting for such recipient, related to any activity designed to influence legislation or appropriations pending before the Congress, or any State or Local legislature.

ARTICLE H.14. PRIVACY ACT APPLICABILITY

	
1)  

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

 

  

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2)  

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

	
3)  

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

ARTICLE H.15.   LABORATORY LICENSE REQUIREMENTS

The Contractor shall comply with all applicable requirements of Section 353 of the Public Health Service Act (Clinical Laboratory Improvement Act as amended). This requirement shall also be included in any subcontract for services under the contract.

ARTICLE H.16.   DISSEMINATION OF INFORMATION (May 1998)

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

ARTICLE H.17.   IDENTIFICATION AND DISPOSITION OF DATA

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

Contractor shall provide data or data analysis to Contracting Officer and Contracting Officer Representative within 20 business days of request.

ARTICLE H.18.   INFORMATION ON COMPLIANCE WITH ANIMAL CARE REQUIREMENTS

 

Registration with the U. S. Dept. of Agriculture (USDA) is required to use regulated species of animals for biomedical purposes.    USDA is responsible for the enforcement of the Animal Welfare Act (7 U.S.C. 2131 et. seq.), http://www.nal.usda.gov/awic/legislat/awa.htm.

 

The Public Health Service (PHS) Policy is administered by the Office of Laboratory Animal Welfare (OLAW) http://grants2.nih.gov/grants/olaw/olaw.htm.   An essential requirement of the PHS Policy http://grants2.nih.gov/grants/olaw/references/phspol.htm is that every institution using live vertebrate animals must obtain an approved assurance from OLAW before they can receive funding from any component of the U. S. Public Health Service.

 

The PHS Policy requires that Assured institutions base their programs of animal care and use on the Guide for the Care and Use of Laboratory Animals http://www.nap.edu/readingroom/books/labrats/ and that they comply with the regulations (9 CFR, Subchapter A) http://www.nal.usda.gov/awic/legislat/usdaleg1.htm issued by the U.S. Department of Agriculture (USDA) under the Animal Welfare Act. The Guide may differ from USDA regulations in some respects. Compliance with the USDA regulations is an absolute requirement of this Policy.

 

The Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) http://www.aaalac.org is a professional organization that inspects and evaluates programs of animal care for institutions at their request.  Those that meet the high standards are given the accredited status.  As of the 2002 revision of the PHS Policy, the only accrediting body recognized by PHS is the AAALAC.   While AAALAC Accreditation is not required to conduct biomedical research, it is highly desirable.  AAALAC uses the Guide as their primary evaluation tool.  They also use the Guide for the Care and Use of Agricultural Animals in Agricultural Research and Teaching.  It is published by the Federated of Animal Science Societies http://www.fass.org.

 

  

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ARTICLE H.19. REQUIREMENTS FOR ADEQUATE ASSURANCE OF PROTECTION OF VERTEBRATE ANIMAL SUBJECTS

The PHS Policy on Humane Care and Use of Laboratory Animals requires that applicant organizations proposing to use vertebrate animals file a written Animal Welfare Assurance with the Office for Laboratory Animal Welfare (OLAW), establishing appropriate policies and procedures to ensure the humane care and use of live vertebrate animals involved in research activities supported by the PHS. The PHS Policy stipulates that an applicant organization, whether domestic or foreign, bears responsibility for the humane care and use of animals in PHS-supported research activities. Also, the PHS policy defines “animal” as “any live, vertebrate animal used, or intended for use, in research, research training, experimentation, biological testing or for related purposes.”  This Policy implements and supplements the U.S. Government Principles for the Utilization and Care of Vertebrate Animals Used in Testing, Research, and Training, and requires that institutions use the Guide for the Care and Use of Laboratory Animals as a basis for developing and implementing an institutional animal care and use program. This Policy does not affect applicable State or local laws or regulations that impose more stringent standards for the care and use of laboratory animals. All institutions are required to comply, as applicable, with the Animal Welfare Act as amended (7 USC 2131 et. seq.) and other Federal statutes and regulations relating to animals. These documents are available from the Office of Laboratory Animal Welfare, National Institutes of Health, Bethesda, MD 20892, (301) 496-7163. See http://grants.nih.gov/grants/olaw/olaw.htm.

No PHS supported work for research involving vertebrate animals will be conducted by an organization, unless that organization is operating in accordance with an approved Animal Welfare Assurance and provides verification that the Institutional Animal Care and Use Committee (IACUC) has reviewed and approved the proposed activity in accordance with the PHS policy. Applications may be referred by the PHS back to the institution for further review in the case of apparent or potential violations of the PHS Policy. No award to an individual will be made unless that individual is affiliated with an assured organization that accepts responsibility for compliance with the PHS Policy. Foreign applicant organizations applying for PHS awards for activities involving vertebrate animals are required to comply with PHS Policy or provide evidence that acceptable standards for the humane care and use of animals will be met. Foreign applicant organizations are not required to submit IACUC approval, but should provide information that is satisfactory to the Government to provide assurances for the humane care of such animals.

ARTICLE H.20. APPROVAL OF REQUIRED ASSURANCE BY OLAW

Under governing regulations, federal funds which are administered by the Department of Health and Human Services, Office of Biomedical Advanced Research and Development Authority (BARDA) shall not be expended by the Contractor for research involving live vertebrate animals, nor shall live vertebrate animals be involved in research activities by the Contractor under this award unless a satisfactory assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 is submitted within 30 days of the date of this award and approved by the Office of Laboratory Animal Welfare (OLAW).  Each performance site (if any) must also assure compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28 with the following restriction:  Only activities which do not directly involve live vertebrate animals (i.e. are clearly severable and independent from those activities that do involve live vertebrate animals) may be conducted by the Contractor or individual performance sites pending OLAW approval of their respective assurance of compliance with 7 U.S.C. 2316 and 9 CFR Sections 2.25-2.28.  Additional information regarding OLAW may be obtained via the Internet at http://grants2.nih.gov/grants/olaw/references/phspol.htm

 

  

43

  

ARTICLE H.21. EPA ENERGY STAR REQUIREMENTS

 

In compliance with Executive Order 12845 (requiring Agencies to purchase energy efficient computer equipment) all microcomputers, including personal computers, monitors, and printers that are purchased using Government funds in performance of a contract shall be equipped with or meet the energy efficient low-power standby feature as defined by the EPA Energy Star program unless the equipment always meets EPA Energy Star efficiency levels. The microcomputer, as configured with all components, must be Energy Star compliant.

 

This low-power feature must already be activated when the computer equipment is delivered to the agency and be of equivalent functionality of similar power managed models. If the equipment will be used on a local area network, the vendor must provide equipment that is fully compatible with the network environment. In addition, the equipment will run commercial off-the-shelf software both before and after recovery from its energy conservation mode.

 

ARTICLE H.22. EXPORT CONTROL NOTIFICATION

Offerors are responsible for ensuring compliance with all export control laws and regulations that maybe applicable to the export of and foreign access to their proposed technologies.  Offerors may consult with the Department of State with any questions regarding the International Traffic in Arms Regulation (ITAR) (22 CRF Parts 120-130) and /or the Department of Commerce regarding the Export Administration Regulations (15 CRF Parts 730-774).

ARTICLE H.23. INSTITUTIONAL RESPONSIBILITY REGARDING CONFLICTING INTERESTS OF INVESTIGATORS

The Contractor shall comply with the requirements of 45 CFR Part 94, Responsible Prospective Contractors, which promotes objectivity in research by establishing standards to ensure that investigators (defined as the principal investigator and any other person who is responsible for the design, conduct, or reporting of research funded under BARDA contracts) will not be biased by any conflicting financial interest.  For the purposes of this part relating to financial interests, "Investigator" includes the Investigator's spouse and dependent children.  45 CFR Part 94 is available at the following Web site: http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr;sid=9f130b6d2d48bb73803ca91ce943be3a;rgn=div5;view=text;node=45%3A1.0.1.1.53;idno=45;cc=ecfr

 

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

 

a.   Maintain a written, enforceable policy on conflict of interest that complies with 45 CFR Part 94 and inform each

 

investigator of the policy, the investigator's reporting responsibilities, and the applicable regulations. The Contractor must take reasonable steps to ensure that investigators working as collaborators or subcontractors comply with the regulations.

 

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

 

  

44

  

c.   Require all financial disclosures to be updated during the period of the award, either on an annual basis or as new reportable Significant Financial Interests are obtained.

 

d.   Maintain records, identifiable to each award, of all financial disclosures and all actions taken by the Contractor with respect to each conflicting interest 3 years after final payment or, where applicable, for the other time periods specified in 48 CFR Part 4, subpart 4.7, Contract Records Retention.

 

e.   Establish adequate enforcement mechanisms and provide for sanctions where appropriate.

 

If a conflict of interest is identified, the Contractor shall report to the Contracting Officer the existence of the conflicting interest found. This report shall be made and the conflicting interest managed, reduced, or eliminated, at least on a temporary basis, within sixty (60) days of that identification.

 

If the failure of an investigator to comply with the conflict of interest policy has biased the design, conduct, or reporting of the BARDA-funded research, the Contractor must promptly notify the Contracting Officer of the corrective action taken or to be taken. The Contracting Officer will take appropriate action or refer the matter to the Contractor for further action which may include directions to the Contractor on how to maintain appropriate objectivity in the funded research.

 

The Contracting Officer may at any time inquire into the Contractor's procedures and actions regarding conflicts of interests in BARDA-funded research including a review of all records pertinent to compliance with 45 CFR Part 94. The Contracting Officer may require submission of the records or review them on site. On the basis of this review, the Contracting Officer may decide that a particular conflict of interest will bias the objectivity of the BARDA-funded research to such an extent that further corrective action is needed or that the Contractor has not managed, reduced, or eliminated the conflict of interest. The issuance of a Stop Work Order by the Contracting Officer may be necessary until the matter is resolved.

 

If the Contracting Officer determines that BARDA-funded clinical research, whose purpose is to evaluate the safety or effectiveness of a drug, medical device, or treatment, has been designed, conducted, or reported by an investigator with a conflict of interest that was not disclosed or managed, the Contractor must require disclosure of the conflict of interest in each public presentation of the results of the research.

 

ARTICLE H.24. QA AUDIT REPORTS

BARDA reserves the right to participate in QA audits. Upon completion of the audit/site visit the Contractor shall provide a report capturing the findings, results and next steps in proceeding with the subcontractor. If action is requested of the subcontractor, detailed concerns for addressing areas of non-conformance to FDA regulations for GLP, GMP, or GCP guidelines, as identified in the audit report, must be provided to BARDA. The Contractor shall provide responses from the subcontractors to address these concerns and plans for corrective action execution.

	
·  

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

	
·  

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

ARTICLE H.25. BARDA AUDITS

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

 

  

45

  

 

	
·  

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

	
·  

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

	
·  

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

PART II - CONTRACT CLAUSES

SECTION I - CONTRACT CLAUSES

 

ARTICLE I.1.  GENERAL CLAUSES FOR A COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT

 

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

 

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

 

	
FARCLAUSE NO.

	 	
 DATE

	
 TITLE

	 	52.202-1	 	
Jan 2012

	
Definitions (Over the Simplified Acquisition Threshold)

	 	52.203-3	 	
Apr 1984

	
Gratuities (Over the Simplified Acquisition Threshold)

	 	52.203-5	 	
Apr 1984

	
Covenant Against Contingent Fees (Over the Simplified Acquisition Threshold)

	 	52.203-6	 	
Sep 2006

	
Restrictions on Subcontractor Sales to the Government (Over the Simplified Acquisition Threshold)

	 	52.203-7	 	
Oct 2010

	
Anti-Kickback Procedures (Over the Simplified Acquisition Threshold)

	 	52.203-8	 	
Jan 1997

	
Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)

	 	52.203-10	 	
Jan 1997

	
Price or Fee Adjustment for Illegal or Improper Activity (Over the Simplified Acquisition Threshold)

	 	52.203-12	 	
Oct 2010

	
Limitation on Payments to Influence Certain Federal Transactions (Over $150,000)

	 	52.204-4	 	
May 2011

	
Printed or Copied Double-Sided on Postconsumer Fiber Content Paper(Over the Simplified Acquisition Threshold)

	 	52.204-7	 	
Feb 2012

	
Central Contractor Registration

	 	52.204-10	 	
Feb 2012

	
Reporting Executive Compensation and First-Tier Subcontract Awards ($25,000 or more)

	 	52.209-6	 	
Dec 2010

	
Protecting the Government's Interests When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment (Over $30,000)

	 	52.215-2	 	
Oct 2010

	
Audit and Records - Negotiation [Note: Applies to ALL contracts funded in whole or in part with Recovery Act funds, regardless of dollar value, AND contracts over the Simplified Acquisition Threshold funded exclusively with non-Recovery Act funds.]

	 	52.215-8	 	
Oct 1997

	
Order of Precedence - Uniform Contract Format

 

 

46

 

 

	
FAR CLAUSE NO.

	
DATE

	
TITLE

	 	52.215-10	 	
Aug 2011

	
Price Reduction for Defective Certified Cost or Pricing Data (Over $700,000)

	 	52.215-12	 	
Oct 2010

	
Subcontractor Cost or Pricing Data (Over $700,000)

	 	52.215-14	 	
Oct 2010

	
Integrity of Unit Prices (Over the Simplified Acquisition Threshold)

	 	52.215-15	 	
Oct 2010

	
Pension Adjustments and Asset Reversions (Over $700,000)

	 	52.215-18	 	
Jul 2005

	
Reversion or Adjustment of Plans for Post-Retirement Benefits (PRB) other than Pensions

	 	52.215-19	 	
Oct 1997

	
Notification of Ownership Changes

	 	52.215-21	 	
Oct 2010

	
Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing Data - Modifications

	 	52.215-22	 	
Oct 2009

	
Limitations on Pass-Through Charges – Identification of Subcontract Effort

	 	52.215-23	 	
Oct 2009

	
Limitations on Pass-Through Charges (Over the Simplified Acquisition Threshold)

	 	52.216-7	 	
Jun 2011

	
Allowable Cost and Payment

	 	52.216-8	 	
Jun 2011

	
Fixed Fee

	 	52.219-8	 	
Jan 2011

	
Utilization of Small Business Concerns (Over the Simplified Acquisition Threshold)

	 	52.219-9	 	
Jan 2011

	
Small Business Subcontracting Plan (Over $650,000, $1.5 million for Construction)

	 	52.219-16	 	
Jan 1999

	
Liquidated Damages - Subcontracting Plan (Over $650,000, $1.5 million for Construction)

	 	52.222-2	 	
Jul 1990

	
Payment for Overtime Premium (Over the Simplified Acquisition Threshold) (Note: The dollar amount in paragraph (a) of this clause is $0 unless otherwise specified in the contract.)

	 	52.222-3	 	
Jun 2003

	
Convict Labor

	 	52.222-19	 	
Mar 2012

	
Child Labor – Cooperation with Authorities and Remedies

	 	52.222-21	 	
Feb 1999

	
Prohibition of Segregated Facilities

	 	52.222-26	 	
Mar 2007

	
Equal Opportunity

	 	52.222-35	 	
Sep 2010

	
Equal Opportunity for Veterans ($100,000 or more)

	 	52.222-36	 	
Oct 2010

	
Affirmative Action for Workers with Disabilities

	 	52.222-37	 	
Sep 2010

	
Employment Reports on Veterans ($100,000 or more)

	 	52.222-40	 	
Dec 2010

	
Notification of Employee Rights Under the National Labor Relations Act (Over the Simplified Acquisition Threshold)

	 	52.222-50	 	
Feb 2009

	
Combating Trafficking in Persons

 

 

47

 

 

	
FAR CLAUSE NO.

	
DATE

	
TITLE

	 	52.222-54	 	
Jan 2009

	
Employment Eligibility Verification (Over the Simplified Acquisition Threshold)

	 	52.223-6	 	
May 2001

	
Drug-Free Workplace

	 	52.223-18	 	
Aug 2011

	
Encouraging Contractor Policies to Ban Text Messaging While Driving

	 	52.225-1	 	
Feb 2009

	
Buy American Act - Supplies

	 	52.225-13	 	
Jun 2008

	
Restrictions on Certain Foreign Purchases

	 	52.225-25	 	
Nov 2011

	
Prohibition on Contracting with Entities Engaging in Sanctioned Activities Related to Iran – Representation and Certification

	 	52.227-1	 	
Dec 2007

	
Authorization and Consent, Alternate I (Apr 1984)

	 	52.227-2	 	
Dec 2007

	
Notice and Assistance Regarding Patent and Copyright Infringement

	 	52.227-11	 	
Dec 2007

	
Patent Rights — Ownership by the Contractor (Note: In accordance with FAR 27.303(b)(2), paragraph (e) is modified to include the requirements in FAR 27.303(b)(2)(i) through (iv). The frequency of reporting in (i) is annual.

	 	52.227-14	 	
Dec 2007

	
Rights in Data — General

	 	52.227-16	 	
Jun 1987

	
Additional Data Requirements

	 	52.232-9	 	
Apr 1984

	
Limitation on Withholding of Payments

	 	52.232-17	 	
Oct 2010

	
Interest (Over the Simplified Acquisition Threshold)

	 	52.232-20	 	
Apr 1984

	
Limitation of Cost

	 	52.232-23	 	
Jan 1986

	
Assignment of Claims

	 	52.232-25	 	
Oct 2008

	
Prompt Payment, Alternate I (Feb 2002)

	 	52.232-33	 	
Oct 2003

	
Payment by Electronic Funds Transfer—Central Contractor Registration

	 	52.233-1	 	
Jul 2002

	
Disputes

	 	52.233-2	 	
Sep 2006

	
Service of Protest

	 	52.233-3	 	
Aug 1996

	
Protest After Award, Alternate I (Jun 1985)

	 	52.233-4	 	
Oct 2004

	
Applicable Law for Breach of Contract Claim

	 	52.242-1	 	
Apr 1984

	
Notice of Intent to Disallow Costs

	 	52.242-3	 	
May 2001

	
Penalties for Unallowable Costs (Over $700,000)

	 	52.242-4	 	
Jan 1997

	
Certification of Final Indirect Costs

	 	52.242-13	 	
Jul 1995

	
Bankruptcy (Over the Simplified Acquisition Threshold)

	 	52.242-15	 	
Aug 1989

	
Stop Work Order

	 	52.243-2	 	
Aug 1987

	
Changes - Cost Reimbursement, Alternate V (Apr 1984)

	 	52.244-2	 	
Oct 2010

	
Subcontracts (Over the Simplified Acquisition Threshold), Alternate I (June 2007)

	 	52.244-5	 	
Dec 1996

	
Competition in Subcontracting (Over the Simplified Acquisition Threshold)

	 	52.244-6	 	
Dec 2010

	
Subcontracts for Commercial Items

	 	52.245-1	 	
Apr 2012

	
Government Property

	 	52.245-9	 	
Apr 2012

	
Use and Charges

	 	52.246-9	 	
Apr 1984

	
Inspection of Research and Development (Short Form)

	 	52.246-23	 	
Feb 1997

	
Limitation of Liability (Over the Simplified Acquisition Threshold)

	 	52.247-34	 	
Nov 1991

	
FOB Destination

	 	52.247-63	 	
Jun 2003

	
Preference for US Flag Air Carriers

	 	52.249-6	 	
May 2004

	
Termination (Cost-Reimbursement)

	 	52.249-14	 	
Apr 1984

	
Excusable Delays

	 	52.251-1	 	
Apr 2012

	
Government Supply Sources

	 	52.253-1	 	
Jan 1991

	
Computer Generated Forms

 

  

48

  

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

 

	
HHSARCLAUSE NO.

	 	
 DATE

	
 TITLE

	 	352.201-70	 	
Jan 2006

	
Paperwork Reduction Act

	 	352.202-1	 	
Jan 2006

	
Definitions - with Alternate paragraph (h) (Jan 2006)

	 	352.203-70	 	
Mar 2012

	
Anti-Lobbying

	 	352.216-70	 	
Jan 2006

	
Additional Cost Principles

	 	352.222-70	 	
Jan 2010

	
Contractor Cooperation in Equal Employment Opportunity Investigations

	 	352.223-70	 	
Jan 2006

	
Safety and Health

	 	352.224-70	 	
Jan 2006

	
Privacy Act

	 	352.227-70	 	
Jan 2006

	
Publications and Publicity

	 	352.228-7	 	
Dec 1991

	
Insurance – Liability to Third Persons

	 	352.231-71	 	
Jan 2001

	
Pricing of Adjustments

	 	352.233-71	 	
Jan 2006

	
Litigation and Claims

	 	352.242-70	 	
Jan 2006

	
Key Personnel

	 	352.242-73	 	
Jan 2006

	
Withholding of Contract Payments

	 	352.242-74	 	
Apr 1984

	
Final Decisions on Audit Findings

	 	352.270-4	 	
Jan 2006

	
Protection of Human Subjects

	 	352.270-6	 	
Jan 2006

	
Restrictions on Use of Human Subjects

 

[End of GENERAL CLAUSES FOR A NEGOTIATED COST-REIMBURSEMENT RESEARCH AND DEVELOPMENT CONTRACT- Rev. 05/2012].

 

ARTICLE I.2. ADDITIONAL FAR CONTRACT CLAUSES INCLUDED IN FULL TEXT

 

This contract incorporates the following clauses in full text.

 

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

 

a.      FAR Clause 52.217-9, Option to Extend the Term of the Contract (Mar 2000)

 

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days after the Government has completed its analysis of the deliverables associated with the applicable GO/NO GO Decision gate; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

 

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

 

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

 

b.  FAR Clause 51.219-1 Small Business Program Representations (Apr 2012)

 

	
(a)

	
(1) The North American Industry Classification System (NAICS) code for this acquisition is 325411.

 

(2) The small business size standard is 750 employees.

 

(3) The small business size standard for a concern which submits an offer in its own name, other than on a construction or service contract, but which proposes to furnish a product which it did not itself manufacture, is 500 employees.

 

  

49

  

(b) Representations.

 

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

 

(2) [Complete only if the offeror represented itself as a small business concern in paragraph (b)(1) of this provision.] The offeror represents, for general statistical purposes, that it [_] is, [X] is not, a small disadvantaged business concern as defined in 13 CFR 124.1002.

 

(3) [Complete only if the offeror represented itself as a small business concern in paragraph (b)(1) of this provision.] The offeror represents as part of its offer that it [_] is, [X] is not a women-owned small business concern.

 

(4) Women-owned small business (WOSB) concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (b)(3) of this provision.] The offeror represents as part of its offer that—

 

(i) It [_] is, [_] is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

 

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

 

(5) Economically disadvantaged women-owned small business (EDWOSB) concern. [Complete only if the offeror represented itself as a women-owned small business concern eligible under the WOSB Program in (b)(4) of this provision.] The offeror represents as part of its offer that--

 

(i) It [_] is, [_] is not an EDWOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

 

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

 

(6) [Complete only if the offeror represented itself as a small business concern in paragraph (b)(1) of this provision.] The offeror represents as part of its offer that it [_] is, [X] is not a veteran-owned small business concern.

 

  

50

  

 

(7) [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (b)(6) of this provision.] The offeror represents as part of its offer that is [_] is, [_] is not a service-disabled veteran-owned small business concern.

 

(8) [Complete only if the offeror represented itself as a small business concern in paragraph (b)(1) of this provision.] The offeror represents, as part of its offer, that –

 

(i) It [_] is, [X] is not a HUBZone small business concern listed, on the date of this representation, on the List of Qualified HUBZone Small Business Concerns maintained by the Small Business Administration, and no material changes in ownership and control, principal office, or HUBZone employee percentage have occurred since it was certified in accordance with 13 CFR part 126; and

 

 

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

 

 

(c) Definitions. As used in this provision--

 

 

“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business concern eligible under the WOSB Program.

 

“Service-disabled veteran-owned small business concern”—

 

(1) Means a small business concern—

 

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

 

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

 

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

 

“Small business concern,” means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR Part 121 and the size standard in paragraph (a) of this provision.

 

  

51

  

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

 

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

 

(2) The management and daily business operations of which are controlled by one or more veterans.

 

“Women-owned small business concern,” means a small business concern --

 

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

 

(2) Whose management and daily business operations are controlled by one or more women.

 

 

“Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127),” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

 

 

(d) Notice.

 

(1) If this solicitation is for supplies and has been set aside, in whole or in part, for small business concerns, then the clause in this solicitation providing notice of the set-aside contains restrictions on the source of the end items to be furnished.

 

(2) Under 15 U.S.C. 645(d), any person who misrepresents a firm’s status as a business concern that is small, HUBZone small, small disadvantaged, service-disabled veteran-owned small, economically disadvantaged women-owned small, or women-owned small eligible under the WOSB Program in order to obtain a contract to be awarded under the preference programs established pursuant to section 8, 9, 15, 31, and 36 of the Small Business Act or any other provision of Federal law that specifically references section 8(d) for a definition of program eligibility, shall --

 

(i) Be punished by imposition of fine, imprisonment, or both;

 

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

 

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

 

 

(End of 52.219-1)

 

  

52

  

c.      FAR Clause 52.219-28, Post-Award Small Business Program Representation (April 2009).

 

(a) Definitions . As used in this clause--

 Long-term contract means a contract of more than five years in duration, including options. However, the term does not include contracts that exceed five years in duration because the period of performance has been extended for a cumulative period not to exceed six months under the clause at 52.217-8, Option to Extend Services, or other appropriate authority.

 Small business concern means a concern, including its affiliates, which is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR part 121 and the size standard in paragraph (c) of this clause.  Such a concern is "not dominant in its field of operation" when it does not exercise a controlling or major influence on a national basis in a kind of business activity in which a number of business concerns are primarily engaged.  In determining whether dominance exists, consideration shall be given to all appropriate factors, including volume of business, number of employees, financial resources, competitive status or position, ownership or control of materials, processes, patents, license agreements, facilities, sales territory, and nature of business activity.

(b) If the Contractor represented that it was a small business concern prior to award of this contract, the Contractor shall represent its size status according to paragraph (e) of this clause or, if applicable, paragraph (g) of this clause, upon the occurrence of any of the following:

 

(1) Within 30 days after execution of a novation agreement or within 30 days after modification of the contract to include this clause, if the novation agreement was executed prior to inclusion of this clause in the contract.

 

(2) Within 30 days after a merger or acquisition that does not require a novation or within 30 days after modification of the contract to include this clause, if the merger or acquisition occurred prior to inclusion of this clause in the contract.

 

(3) For long-term contracts--

 

(i) Within 60 to 120 days prior to the end of the fifth year of the contract; and

 

(ii) Within 60 to 120 days prior to the date specified in the contract for exercising any option thereafter.

 

(c) The Contractor shall represent its size status in accordance with the size standard in effect at the time of this representation that corresponds to the North American Industry Classification System (NAICS) code assigned to this contract. The small business size standard corresponding to this NAICS code can be found at http://www.sba.gov/contractingopportunities/officials/size/index.html .

(d) The small business size standard for a Contractor providing a product which it does not manufacture itself, for a contract other than a construction or service contract, is 500 employees.

 

  

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(e) Except as provided in paragraph (g) of this clause, the Contractor shall make the representation required by paragraph (b) of this clause by validating or updating all its representations in the Online Representations and Certifications Application and its data in the Central Contractor Registration, as necessary, to ensure that they reflect the Contractor's current status. The Contractor shall notify the contracting office in writing within the timeframes specified in paragraph (b) of this clause that the data have been validated or updated, and provide the date of the validation or update.

(f) If the Contractor represented that it was other than a small business concern prior to award of this contract, the Contractor may, but is not required to, take the actions required by paragraphs (e) or (g) of this clause.

(g) If the Contractor does not have representations and certifications in ORCA, or does not have a representation in ORCA for the NAICS code applicable to this contract, the Contractor is required to complete the following representation and submit it to the contracting office, along with the contract number and the date on which the representation was completed:

The Contractor represents that it [X] is, [ ] is not a small business concern under NAICS Code assigned to contract number.

b.           FAR 52.232-99    Providing Accelerated Payment to Small BusinessSubcontractors(DEVIATION) (AUG 2012)

This clause implements the temporary policy provided by OMB Policy Memorandum M-12-16, Providing Prompt Payment to Small Business Subcontractors, dated July 11, 2012.

(a) Upon receipt of accelerated payments from the Government, the contractor is required to make accelerated payments to small business subcontractors to the maximum extent practicable after receipt of a proper invoice and all proper documentation from the small business subcontractor.

(b) Include the substance of this clause, including this paragraph (b), in all subcontracts, with small business concerns.

(c) The acceleration of payments under this clause does not provide any new rights under the Prompt Payment Act.

 

  

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PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

 

SECTION J - LIST OF ATTACHMENTS

 

 

The following documents are attached and incorporated in this contract:

 

1. Statement of Work

 

Statement of Work, dated 28 September 2012.

 

2. Invoice/Financing Request Instructions and Contract Financial Reporting Instructions for BARDA Cost-Reimbursement Type Contracts,

 

Invoice/Financing Request Instructions and Contract Financial Reporting Instructions for BARDA Cost-Reimbursement Type Contracts, 5 pages.

 

3. Financial Report of Individual Project/Contract, 1 page

 

4. Instructions for Completing Financial Report of Individual Project/Contract, 3 pages

 

5. Inclusion Enrollment Report

 

Inclusion Enrollment Report, 5/01 (Modified OAMP: 10/01), 1 page.

 

6. Research Patient Care Costs

 

Research Patient Care Costs, 1 page.

 

7. Report of Government Owned, Contractor Held Property

 

Report of Government Owned, Contractor Held Property, 1 page. Located at: http://rcb.cancer.gov/rcb-internet/forms/Govt-Owned-Prop.pdf  (Not Attached)

 

8.  Contractor Performance Metrics Reporting

 

 

PART IV - REPRESENTATIONS AND INSTRUCTIONS

 

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

 

The following documents are incorporated by reference in this contract:

	
1)

	
Annual Representations and Certifications completed on the System for Award Management (SAM) website.

2)           Human Subjects Assurance Identification Numbers:

Cytori Therapeutics, Inc.: FWA00007108

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

***

 

*** Material has been omitted pursuant to a request for confidential treatment, and the omitted contents were filed separately with the Securities and Exchange Commission.

  

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