Document:

Stand Alone Stock Option Grant

 EXHIBIT 10.2 
 AVI BIOPHARMA, INC. 
 STAND ALONE STOCK OPTION GRANT 

NOTICE OF GRANT OF STOCK OPTION 
 This grant (the “Option”) shall be governed by this Notice of Grant of Stock Option (the “Notice of Grant”) and the Terms and Conditions of Stock Option Grant (the “Terms and
Conditions”), attached hereto as Exhibit A (together, the “Agreement”). Terms not otherwise defined in the Notice of Grant shall be defined in the Terms and Conditions of Stock Option Grant. 

 

			
	 Participant:
	  	 Effie Toshav

		
	 Address:
	  	  

		
		  	 Seattle, Washington

Participant has been granted an Option to purchase Common Stock of the Company, subject to the terms and conditions of
this Agreement, as follows: 
  

			
	 Date of Grant
	  	 January 10, 2011

		
	 Vesting Commencement Date
	  	 January 10, 2011

		
	 Number of Shares Granted
	  	 650,000

		
	 Exercise Price per Share
	  	 $2.58

		
	 Total Exercise Price
	  	 $1,677,000.00

		
	 Type of Option
	  	 Nonstatutory Stock Option

		
	 Term/Expiration Date
	  	 10 years/January 10, 2021

Vesting Schedule: 
 Subject to accelerated vesting as set forth below or in the Agreement, this Option will be exercisable, in whole or in part, in accordance with the following schedule: 

Twenty-five percent (25%) of the Shares subject to the Option will vest on the one (1) year
anniversary of the Vesting Commencement Date, and one forty-eighth (1/48th) of the Shares subject to the Option will vest each month thereafter on the same day of the month as the Vesting Commencement Date (and if there is no corresponding day, on the last day of the
month), subject to Participant continuing to be a Service Provider through each such date. 

  
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 Accelerated Vesting and Extended Post-Termination Exercise Period:

 Termination for other than Cause, Death or Disability Apart from a Change of Control. If prior to
a Change of Control or after twelve (12) months following a Change of Control, the Company (or any parent or subsidiary or successor of the Company) terminates Participant’s employment with the Company other than for Cause, death or
disability after providing at least thirty (30) days advance notice to Participant, or Participant resigns from such employment for Good Reason as a result of clause (iv) of such term, then, subject to Section 9 of the Employment
Agreement, Participant will be entitled to accelerated vesting as to 50% of any unvested Shares subject to the Option and an extension of the post-termination exercise period applicable to the Option to one hundred and eighty (180) days
following the date of Participant’s termination of employment (but in no event beyond the Term/Expiration Date). 
 Termination for other than Cause, Death or Disability or Resignation by Participant for Good Reason upon or within Twelve Months Following a Change of Control. If upon a Change of Control or within
the Change of Control Period, the Company (or any parent or subsidiary or successor of the Company) terminates Participant’s employment with the Company other than for Cause, death or disability after providing at least thirty (30) days
advance notice to Participant, or Participant resigns from such employment for Good Reason, then, subject to Section 9 of the Employment Agreement, Participant will be entitled to accelerated vesting as to 100% of any unvested Shares subject to
the Option and an extension of the post-termination exercise period applicable to the Option to one hundred and eighty (180) days following the date of Participant’s termination of employment (but in no event beyond the Term/Expiration
Date). 
 Termination for Cause, Death or Disability; Resignation without Good Reason. If
Participant’s employment with the Company (or any parent or subsidiary or successor of the Company) terminates voluntarily by Participant (except upon resignation for Good Reason during the Change of Control Period), for Cause by the Company or
due to Participant’s death or disability, then all vesting will terminate immediately with respect to the Option. 
 Termination Period: 
 This Option will be exercisable for
three (3) months after Participant ceases to be a Service Provider, unless (i) such termination is due to Participant’s death or Disability, in which case this Option will be exercisable for twelve (12) months after Participant
ceases to be a Service Provider, or (ii) such termination is by the Company for Cause, in which case this Option will be exercisable for twenty-four (24) hours after Participant ceases to be a Service Provider. Notwithstanding the
foregoing sentence, in no event may this Option be exercised after the Term/Expiration Date as provided above and may be subject to earlier termination as provided in Section 14(c) of the Terms and Conditions. 

[signature page to follow] 

  
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 By Participant’s signature and the signature of the Company’s
representative below, Participant and the Company agree that this Option is granted under and governed by the terms and conditions of this Agreement. Participant has reviewed this Agreement in their entirety, has had an opportunity to obtain the
advice of counsel prior to executing this Agreement and fully understands all provisions of the Agreement. Participant hereby agrees to accept as binding, conclusive and final all decisions or interpretations of the Administrator upon any questions
relating to the Agreement. Participant further agrees to notify the Company upon any change in the residence address indicated below. 
  

			
	 PARTICIPANT
	  	 AVI BIOPHARMA, INC.

		
	 /s/ Effie Toshav
	  	 /s/ Christopher Garabedian

		
	 Signature
	  	 By

		
	 Effie Toshav
	  	 Chief Executive Officer

		
	 Print Name
	  	 Title

		
	 Address:
	  	
		
	  
	  	
		
	  
	  	

 [signature page of the E. Toshav notice of stock option grant]

  
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 EXHIBIT A 

TERMS AND CONDITIONS OF STOCK OPTION GRANT 

1. Definitions. As used herein, the following definitions shall apply: 

(a) “Administrator” means the Committee as will have administrative authority under this Agreement, in
accordance with Section 4 of the Terms and Conditions. 
 (b) “Affiliate” means any
corporation or any other entity (including, but not limited to, partnerships and joint ventures) controlling, controlled by, or under common control with the Company. 

(c) “Applicable Laws” means the requirements relating to the administration of equity-based awards under
U.S. state corporate laws, U.S. federal and state securities laws, the Code, any stock exchange or quotation system on which the Common Stock is listed or quoted and the applicable laws of any foreign country or jurisdiction that may apply to this
Option. 
 (d) “Award Transfer Program” means any program instituted by the Administrator that
would permit Participants the opportunity to transfer for value the Option to a financial institution or other person or entity approved by the Administrator. 
 (e) “Board” means the Board of Directors of the Company. 
 (f) “Cause” is defined as (i) an act of dishonesty made by Participant in connection with Participant’s responsibilities as an employee, (ii) Participant’s conviction
of, or plea of nolo contendere to, a felony or any crime involving fraud, embezzlement or any other act of moral turpitude; (iii) Participant’s gross misconduct; (iv) Participant’s unauthorized use or disclosure of any
proprietary information or trade secrets of the Company or any other party to whom Participant owes an obligation of nondisclosure as a result of Participant’s relationship with the Company; (v) Participant’s willful breach of any
obligations under any written agreement or covenant with the Company; or (vi) Participant’s continued failure to perform her employment duties after Participant has received a written demand of performance from the Company which
specifically sets forth the factual basis for the Company’s belief that Participant has not substantially performed her duties and has failed to cure such non-performance to the Company’s satisfaction within ten (10) business days
after receiving such notice. 
 (g) “Change of Control” means the occurrence of any of the
following events: 
 (i) any “person” (as such term is used in Sections 12(d) and 13(d) of the
Exchange Act) is or becomes the “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act), directly or indirectly, of securities of the Company representing more than 50% of the total voting power represented by the
Company’s then outstanding voting securities; or 
 (ii) the date of the consummation of a merger or
consolidation of the Company with any other corporation that has been approved by the shareholders of the Company, other than a merger or consolidation which would result in the voting securities of the

  
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Company outstanding immediately prior thereto continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or its parent) at least
fifty percent (50%) of the total voting power represented by the voting securities of the Company or such surviving entity or its parent outstanding immediately after such merger or consolidation; or 

(iii) the date of the consummation of the sale or disposition by the Company of all or substantially all the
Company’s assets. 
 For purposes of this definition, persons will be considered to be acting as a group if
they are owners of a corporation that enters into a merger, consolidation, purchase or acquisition of stock, or similar business transaction with the Company. 
 Notwithstanding the foregoing, a transaction shall not be deemed a Change of Control unless the transaction qualifies as a “change in control event” within the meaning of Section 409A of
the Code, as it has been and may be amended from time to time, and any proposed or final Treasury Regulations and Internal Revenue Service guidance that has been promulgated or may be promulgated thereunder from time to time. 

Further and for the avoidance of doubt, a transaction shall not constitute a Change of Control if: (i) its sole
purpose is to change the state of the Company’s incorporation, or (ii) its sole purpose is to create a holding company that shall be owned in substantially the same proportions by the persons who held the Company’s securities
immediately before such transaction. 
 (h) “Change of Control Period” means the period of time
within twelve (12) months following a Change of Control. 
 (i) “Code” means the Internal
Revenue Code of 1986, as amended. Reference to a specific section of the Code or Treasury Regulation thereunder will include such section or regulation, any valid regulation or other official applicable guidance promulgated under such section, and
any comparable provision of any future legislation or regulation amending, supplementing or superseding such section or regulation. 
 (j) “Committee” means the Compensation Committee of the Board. 
 (k) “Common Stock” means the common stock of the Company. 
 (l) “Company” means AVI BioPharma, Inc., an Oregon corporation, or any successor thereto. 
 (m) “Consultant” means any person, including an advisor, engaged by the Company or a Parent or a Subsidiary to render services to such entity other than as an Employee. 

(n) “Director” means a member of the Board. 

(o) “Disability” means total and permanent disability as defined in Section 22(e)(3) of the Code,
provided that the Administrator in its discretion may determine 

  
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whether a permanent and total disability exists in accordance with uniform and non-discriminatory standards adopted by the Administrator from time to time. 

(p) “Employee” means any person, including Officers and Directors, employed by the Company or any Parent
or Subsidiary of the Company. Neither service as a Director nor payment of a director’s fee by the Company will be sufficient to constitute “employment” by the Company. 

(q) “Employment Agreement” means the Executive Employment Agreement by and between the Company and
Participant, effective January 10, 2011. 
 (r) “Exchange Act” means the Securities
Exchange Act of 1934, as amended. 
 (s) “Exchange Program” means a program under which
(i) the Option is surrendered or cancelled in exchange another stock option (which may have higher or lower exercise prices and different terms), equity awards of a different type, and/or cash, (ii) Participant would have the opportunity
to transfer for value the Option to a financial institution or other person or entity selected by the Administrator, and/or (iii) the exercise price of the Option is reduced or increased. The Administrator will determine the terms and
conditions of any Exchange Program in its sole discretion. 
 (t) “Fair Market Value” means, as
of any date, the value of Common Stock determined as follows: 
 (i) If the Common Stock is listed on any
established stock exchange or a national market system, including without limitation the Nasdaq Global Market, the Nasdaq Global Select Market or the Nasdaq Capital Market, its Fair Market Value shall be the closing sales price for such stock (or,
if no closing sales price was reported on that date, as applicable, on the last trading date such closing sales price is reported) as quoted on such exchange or system on the day of determination, as reported in The Wall Street Journal or
such other source as the Administrator deems reliable; 
 (ii) If the Common Stock is regularly quoted by a
recognized securities dealer but selling prices are not reported, its Fair Market Value shall be the mean between the high bid and low asked prices for the Common Stock on the day of determination (or, if no bids and asks were reported on that date,
as applicable, on the last trading date such bids and asks are reported); or 
 (iii) In the absence of an
established market for the Common Stock, the Fair Market Value will be determined in good faith by the Administrator. 
 (u) “Good Reason” means the termination by Participant upon the occurrence of any of the below described events. Participant must provide notice to the Company of the existence of such
event within ninety (90) days of the first occurrence of such event, and the Company will have thirty (30) days to remedy the condition, in which case no Good Reason shall exist. If the Company fails to remedy the condition within such
thirty (30) day period, Participant must terminate employment within two (2) years of the first occurrence of such event. The events which constitute a Good Reason termination are: (i) the assignment of a different title or change
that results in a 

  
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material reduction in Participant’s duties or responsibilities; (ii) a material reduction by the Company in Participant’s base compensation, other than a reduction in her base
salary that is part of a general salary reduction affecting employees generally and provided the reduction is not greater, percentage-wise, than the reduction affecting other employees generally or failure to provide an annual increase in base
compensation commensurate with other executives; provided, however, in determining whether to provide an annual increase in base compensation commensurate with an annual increase provided to other executives, the Company may take into account
factors such as market levels of compensation, Participant’s overall performance, and other factors reasonably considered by the Company’s compensation committee and/or Board, so long as such determination is not made in bad faith with the
intent to discriminate against Participant; (iii) relocation of Participant’s principal place of business of greater than seventy-five (75) miles from its then location; or (iv) Participant is required to report to any person
other than the Chief Executive Officer of the Company or Board. 
 (v) “Incentive Stock Option”
means an Option that by its terms qualifies and is otherwise intended to qualify as an incentive stock option within the meaning of Section 422 of the Code and the regulations promulgated thereunder. 

(w) “Nonstatutory Stock Option” means an Option that by its terms does not qualify or is not intended to
qualify as an Incentive Stock Option. 
 (x) “Officer” means a person who is an officer of the
Company within the meaning of Section 16 of the Exchange Act and the rules and regulations promulgated thereunder. 
 (y) “Option” means the stock option set forth in the Notice of Grant. 
 (z) “Outside Director” means a Director who is not an Employee. 
 (aa) “Parent” means a “parent corporation,” whether now or hereafter existing, as defined in Section 424(e) of the Code. 

(bb) “Participant” means the holder of the Option. 

(cc) “Service Provider” means an Employee, Director or Consultant. 

(dd) “Share” means a share of the Common Stock, as adjusted in accordance with Section 14(a) of the
Terms and Conditions. 
 (ee) “Subsidiary” means a “subsidiary corporation”, whether
now or hereafter existing, as defined in Section 424(f) of the Code. 
 2. Grant of Option. The
Company hereby grants to the Participant named in the Notice of Grant the Option to purchase the number of Shares, as set forth in the Notice of Grant, at the exercise price per Share set forth in the Notice of Grant (the “Exercise
Price”), subject to all of the terms and conditions in this Agreement. 

  
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 3. Vesting Schedule. The Option awarded by this Agreement will vest
in accordance with the vesting provisions set forth in the Notice of Grant. Shares scheduled to vest on a certain date or upon the occurrence of a certain condition will not vest in Participant in accordance with any of the provisions of this
Agreement, unless Participant will have been continuously a Service Provider from the Date of Grant until the date such vesting occurs. 
 4. Authority of the Administrator. 
 (a) Powers of the
Administrator. Subject to the provisions of this Agreement, the Administrator will have the authority, in its discretion: 
 (i) to determine the terms and conditions of any, and to institute any Exchange Program; 
 (ii) to construe and interpret the terms of the Agreement and the Option; 
 (iii) to prescribe, amend and rescind rules and regulations relating to the Agreement, including rules and regulations relating to sub-plans established for the purpose of satisfying applicable foreign
laws or for qualifying for favorable tax treatment under applicable foreign laws; 
 (iv) to modify or amend
the Option (subject to Section(s) 4(d)(i) and 21 of the Terms and Conditions), including but not limited to the discretionary authority to extend the post-termination exercisability period of the Option and to extend the maximum term of the Option;

 (v) to allow Participant to satisfy withholding tax obligations in such manner as prescribed in
Section 7 of the Terms and Conditions; 
 (vi) to allow a Participant to defer the receipt of the payment
of cash or the delivery of Shares that would otherwise be due to such Participant under the Option pursuant to such procedures as the Administrator may determine; and 

(vii) to make all other determinations deemed necessary or advisable for administering the Agreement. 

(b) Effect of Administrator’s Decision. The Administrator’s decisions, determinations and
interpretations will be final and binding on the Participant and any other holders of Shares subject to the Option. 
 (c) No Liability. Under no circumstances shall the Company, its Affiliates, the Administrator, or the Board incur liability for any indirect, incidental, consequential or special damages (including
lost profits) of any form incurred by any person, whether or not foreseeable and regardless of the form of the act in which such a claim may be brought, with respect to the Agreement or the Company’s, its Affiliates’, the
Administrator’s or the Board’s roles in connection with the Agreement. 
 (d) Limitations.

  
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 (i) Prohibition Against Repricing. Notwithstanding
Section 4(a)(iv), the Administrator may not modify or amend the Option to reduce the exercise price of the after it has been granted (except for adjustments made pursuant to Section 14), and neither may the Administrator cancel the
outstanding Option and immediately replace it with any other award with a lower exercise price, unless such action is approved by shareholders prior to such action being taken. 

(ii) Buyout Provisions. The Administrator may at any time offer to buy out for a payment in cash an Option
previously granted based on such terms and conditions as the Administrator will establish and communicate to the Participant at the time that such offer is made. Notwithstanding anything contained in this Section 4(d)(ii) to the contrary,
the Administrator shall not be allowed to authorize the buyout of an underwater Option without the prior consent of the Company’s shareholders. 
 5. Exercise of Option. 
 (a) Right to Exercise. This
Option may be exercised only within the term set out in the Notice of Grant, and may be exercised during such term only in accordance with the terms of this Agreement. 

(b) Method of Exercise. This Option is exercisable by delivery of an exercise notice, in the form attached as
Exhibit B (the “Exercise Notice”) or in a manner and pursuant to such procedures as the Administrator may determine, which will state the election to exercise the Option, the number of Shares in respect of which the Option is being
exercised (the “Exercised Shares”), and such other representations and agreements as may be required by the Company pursuant to the provisions of the Agreement. The Exercise Notice will be completed by Participant and delivered to the
Company. The Exercise Notice will be accompanied by payment of the aggregate Exercise Price as to all Exercised Shares together with any applicable tax withholding. This Option will be deemed to be exercised upon receipt by the Company of such fully
executed Exercise Notice accompanied by the aggregate Exercise Price. 
 (c) Termination of Relationship as a
Service Provider. If a Participant ceases to be a Service Provider, the Participant may exercise her Option within such period of time as is specified in the Notice of Grant to the extent that the Option is vested on the date of termination (but
in no event later than the expiration of the term of such Option as set forth in the Notice of Grant). Unless otherwise provided by the Administrator, if on the date of termination the Participant is not vested as to her entire Option, the Shares
covered by the unvested portion of the Option will forfeit. If after termination the Participant does not exercise her Option within the time specified by the Administrator, the Option will terminate, and the Shares covered by such Option will
forfeit. 
 6. Method of Payment. Payment of the aggregate Exercise Price will be by any of the
following, or a combination thereof, at the election of Participant: 
 (a) cash; 

(b) check; 

  
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 (c) consideration received by the Company under a formal cashless exercise
program adopted by the Company in connection with the Agreement; or 
 (d) surrender of other Shares which have
a Fair Market Value on the date of surrender equal to the aggregate Exercise Price of the Exercised Shares, provided that accepting such Shares, in the sole discretion of the Administrator, will not result in any adverse accounting consequences to
the Company. 
 7. Tax Obligations. 

(a) Withholding of Taxes. Notwithstanding any contrary provision of this Agreement, no certificate representing
the Shares will be issued to Participant, unless and until satisfactory arrangements (as determined by the Administrator) will have been made by Participant with respect to the payment of income, employment and other taxes which the Company
determines must be withheld with respect to such Shares. To the extent determined appropriate by the Company in its discretion, it will have the right (but not the obligation) to satisfy any tax withholding obligations by reducing the number of
Shares otherwise deliverable to Participant. If Participant fails to make satisfactory arrangements for the payment of any required tax withholding obligations hereunder at the time of the Option exercise, Participant acknowledges and agrees that
the Company may refuse to honor the exercise and refuse to deliver the Shares if such withholding amounts are not delivered at the time of exercise. 
 (b) Code Section 409A. Under Code Section 409A, an option that vests after December 31, 2004 (or that vested on or prior to such date but which was materially modified after
October 3, 2004) that was granted with a per Share exercise price that is determined by the Internal Revenue Service (the “IRS”) to be less than the Fair Market Value of a Share on the date of grant (a “Discount Option”) may
be considered “deferred compensation.” A Discount Option may result in (i) income recognition by Participant prior to the exercise of the option, (ii) an additional twenty percent (20%) federal income tax, and
(iii) potential penalty and interest charges. The Discount Option may also result in additional state income, penalty and interest charges to the Participant. Participant acknowledges that the Company cannot and has not guaranteed that the IRS
will agree that the per Share exercise price of this Option equals or exceeds the Fair Market Value of a Share on the Date of Grant in a later examination. Participant agrees that if the IRS determines that the Option was granted with a per Share
exercise price that was less than the Fair Market Value of a Share on the date of grant, Participant will be solely responsible for Participant’s costs related to such a determination. 

8. Rights as Shareholder. Neither Participant nor any person claiming under or through Participant will have any
of the rights or privileges of a shareholder of the Company in respect of any Shares deliverable hereunder unless and until certificates representing such Shares will have been issued, recorded on the records of the Company or its transfer agents or
registrars, and delivered to Participant. After such issuance, recordation and delivery, Participant will have all the rights of a shareholder of the Company with respect to voting such Shares and receipt of dividends and distributions on such
Shares. 

  
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 9. Compliance With Code Section 409A. The Option will be
designed and operated in such a manner that it is either exempt from the application of, or comply with, the requirements of Code Section 409A such that the grant, payment, settlement or deferral will not be subject to the additional tax or
interest applicable under Code Section 409A, except as otherwise determined in the sole discretion of the Administrator. The Agreement is intended to meet the requirements of Code Section 409A and will be construed and interpreted in
accordance with such intent, except as otherwise determined in the sole discretion of the Administrator. To the extent that the Option or payment, or the settlement or deferral thereof, is subject to Code Section 409A the Option will be
granted, paid, settled or deferred in a manner that will meet the requirements of Code Section 409A, such that the grant, payment, settlement or deferral will not be subject to the additional tax or interest applicable under Code
Section 409A. 
 10. Leaves of Absence/Transfer Between Locations. Unless the Administrator provides
otherwise and except as required by Applicable Laws, vesting of the Option granted hereunder will be suspended during any unpaid leave of absence. A Participant will not cease to be an Employee in the case of (i) any leave of absence approved
by the Company or (ii) transfers between locations of the Company or between the Company, its Parent, or any Subsidiary. 
 11. No Guarantee of Continued Service. PARTICIPANT ACKNOWLEDGES AND AGREES THAT THE VESTING OF SHARES PURSUANT TO THE VESTING SCHEDULE HEREOF IS EARNED ONLY BY CONTINUING AS A SERVICE PROVIDER AT
THE WILL OF THE COMPANY (OR THE PARENT OR SUBSIDIARY EMPLOYING OR RETAINING PARTICIPANT) AND NOT THROUGH THE ACT OF BEING HIRED, BEING GRANTED THIS OPTION OR ACQUIRING SHARES HEREUNDER. PARTICIPANT FURTHER ACKNOWLEDGES AND AGREES THAT THIS
AGREEMENT, THE TRANSACTIONS CONTEMPLATED HEREUNDER AND THE VESTING SCHEDULE SET FORTH HEREIN DO NOT CONSTITUTE AN EXPRESS OR IMPLIED PROMISE OF CONTINUED ENGAGEMENT AS A SERVICE PROVIDER FOR THE VESTING PERIOD, FOR ANY PERIOD, OR AT ALL, AND WILL
NOT INTERFERE IN ANY WAY WITH PARTICIPANT’S RIGHT OR THE RIGHT OF THE COMPANY (OR THE PARENT OR SUBSIDIARY EMPLOYING OR RETAINING PARTICIPANT) TO TERMINATE PARTICIPANT’S RELATIONSHIP AS A SERVICE PROVIDER AT ANY TIME, WITH OR WITHOUT
CAUSE. 
 12. Address for Notices. Any notice to be given to the Company under the terms of this
Agreement will be addressed to the Company at AVI BioPharma, Inc., 3450 Monte Villa Parkway, Bothell, WA 98021, or at such other address as the Company may hereafter designate in writing. 

13. Non-Transferability of Option. 

(a) This Option may not be transferred in any manner otherwise than by will or by the laws of descent or distribution and
may be exercised during the lifetime of Participant only by Participant. 
 (b) Notwithstanding anything to the
contrary in the Agreement, in no event will the Administrator have the right to determine and implement the terms and conditions of any Award Transfer Program without shareholder approval. 

  
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 14. Adjustments; Dissolution or Liquidation; Merger or Change of
Control. 
 (a) Adjustments. In the event that any dividend or other distribution (whether in the
form of cash, Shares, other securities, or other property), recapitalization, stock split, reverse stock split, reorganization, merger, consolidation, split-up, spin-off, combination, repurchase, or exchange of Shares or other securities of the
Company, or other change in the corporate structure of the Company affecting the Shares occurs, the Administrator, in order to prevent diminution or enlargement of the benefits or potential benefits intended to be made available under the Agreement,
will adjust the number, class, and price of Shares covered by the Option. 
 (b) Dissolution or
Liquidation. In the event of the proposed dissolution or liquidation of the Company, the Administrator will notify each Participant as soon as practicable prior to the effective date of such proposed transaction. To the extent it has not been
previously exercised, the Option will terminate immediately prior to the consummation of such proposed action. 

(c) Change of Control. Subject to the terms of the Employment Agreement, in the event of a merger or Change of
Control, the Option will be treated as the Administrator determines without a Participant’s consent, including, without limitation, that (i) the Option will be assumed, or substantially equivalent awards will be substituted, by the
acquiring or succeeding corporation (or an affiliate thereof) with appropriate adjustments as to the number and kind of shares and prices; (ii) upon written notice to a Participant, that the Participant’s Option will terminate upon or
immediately prior to the consummation of such merger or Change of Control; (iii) the Option will vest and become exercisable, realizable, or payable, in whole or in part prior to or upon consummation of such merger or Change of Control, and, to
the extent the Administrator determines, terminate upon or immediately prior to the effectiveness of such merger of Change of Control; (iv) (A) the termination of the Option in exchange for an amount of cash and/or property, if any, equal
to the amount that would have been attained upon the exercise of the Option or realization of the Participant’s rights as of the date of the occurrence of the transaction (and, for the avoidance of doubt, if as of the date of the occurrence of
the transaction the Administrator determines in good faith that no amount would have been attained upon the exercise of the Option or realization of the Participant’s rights, then the Option may be terminated by the Company without payment), or
(B) the replacement of the Option with other rights or property selected by the Administrator in its sole discretion; or (v) any combination of the foregoing. 

In the event that the successor corporation does not assume or substitute for the Option (or portion thereof), the
Participant will fully vest in and have the right to exercise all of her outstanding Options that are not assumed or substituted for, including Shares as to which the Option would not otherwise be vested or exercisable. In addition, if the Option is
not assumed or substituted for in the event of a Change of Control, the Administrator will notify the Participant in writing or electronically that the Option will be fully vested and exercisable for a period of time determined by the Administrator
in its sole discretion, and the Option will terminate upon the expiration of such period. 
 For the purposes of
this subsection 14(c), the Option will be considered assumed if, following the merger or Change of Control, the Option confers the right to purchase or receive, for each Share subject to the Option immediately prior to the merger or Change of
Control, the 

  
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consideration (whether stock, cash, or other securities or property) received in the merger or Change of Control by holders of Common Stock for each Share held on the effective date of the
transaction (and if holders were offered a choice of consideration, the type of consideration chosen by the holders of a majority of the outstanding Shares); provided, however, that if such consideration received in the merger or Change of Control
is not solely common stock of the successor corporation or its Parent, the Board may, with the consent of the successor corporation, provide for the consideration to be received upon the exercise of the Option, for each Share subject to the Option,
to be solely common stock of the successor corporation or its Parent equal in fair market value to the per share consideration received by holders of Common Stock in the merger or Change of Control. 

Notwithstanding anything in this subsection (c) to the contrary, if a payment under the Agreement is subject to
Section 409A of the Code and if the change of control definition contained in the Agreement does not comply with the definition of “change in control” for purposes of a distribution under Section 409A of the Code, then any
payment of an amount that is otherwise accelerated under this Section will be delayed until the earliest time that such payment would be permissible under Section 409A of the Code without triggering any penalties applicable under
Section 409A of the Code. 
 15. Date of Grant. The date of grant of the Option will be, for all
purposes, the date on which the Administrator makes the determination granting the Option, or such other later date as is determined by the Administrator. Notice of the determination will be provided to each Participant within a reasonable time
after the date of such grant. 
 16. Binding Agreement. Subject to the limitation on the transferability
of this grant contained herein, this Agreement will be binding upon and inure to the benefit of the heirs, legatees, legal representatives, successors and assigns of the parties hereto. 

17. Additional Conditions to Issuance of Stock. If at any time the Company will determine, in its discretion, that
the listing, registration or qualification of the Shares upon any securities exchange or under any state or federal law, or the consent or approval of any governmental regulatory authority is necessary or desirable as a condition to the issuance of
Shares to Participant (or her estate), such issuance will not occur unless and until such listing, registration, qualification, consent or approval will have been effected or obtained free of any conditions not acceptable to the Company. The Company
will make all reasonable efforts to meet the requirements of any such state or federal law or securities exchange and to obtain any such consent or approval of any such governmental authority. Assuming such compliance, for income tax purposes the
Exercised Shares will be considered transferred to Participant on the date the Option is exercised with respect to such Exercised Shares. 
 18. Electronic Delivery. The Company may, in its sole discretion, decide to deliver any documents related to Options awarded under the Agreement or future options that may be awarded under the
Agreement by electronic means or request Participant’s consent to participate by electronic means. Participant hereby consents to receive such documents by electronic delivery and agrees to participate through any on-line or electronic system
established and maintained by the Company or another third party designated by the Company. 

  
 -13-

 19. Captions. Captions provided herein are for convenience only and
are not to serve as a basis for interpretation or construction of this Agreement. 
 20. Agreement
Severable. In the event that any provision in this Agreement will be held invalid or unenforceable, such provision will be severable from, and such invalidity or unenforceability will not be construed to have any effect on, the remaining
provisions of this Agreement. 
 21. Entire Agreement. This Agreement constitutes the entire agreement of
the parties with respect to the subject matter hereof and supersedes in their entirety all prior undertakings and agreements of the Company and Participant with respect to the subject matter hereof, and may not be modified adversely to
Participant’s interest except by means of a writing signed by the Company and Participant. Notwithstanding anything to the contrary in this Agreement, the Company reserves the right to revise this Agreement as it deems necessary or advisable,
in its sole discretion and without the consent of Participant, to comply with Code Section 409A or to otherwise avoid imposition of any additional tax or income recognition under Section 409A of the Code in connection to this Option.

 22. Acknowledgment. By accepting this Option, Participant expressly warrants that he or she has
received an Option pursuant to this Agreement, and has received, read and understood a description of the Agreement. 
 23. Governing Law. This Agreement will be governed by the laws of the State of Oregon, without giving effect to the conflict of law principles thereof. For purposes of litigating any dispute that
arises under this Option or this Agreement, the parties hereby submit to and consent to the jurisdiction of the State of Oregon, and agree that such litigation will be conducted in the state courts of Oregon, or the federal courts for the United
States for the District of Oregon, and no other courts, where this Option is made and/or to be performed. 

  
 -14-

 EXHIBIT B 

AVI BIOPHARMA, INC. 
 STAND-ALONE STOCK OPTION GRANT 
 EXERCISE NOTICE 

AVI BioPharma, Inc. 
 3450 Monte Villa Parkway 
 Bothell, WA 98021 

Attention:
                             

Exercise of Option. Effective as of today,
                            ,
            , the undersigned (“Purchaser”) hereby elects to purchase
                             shares (the “Shares”) of the Common Stock of AVI BioPharma,
Inc. (the “Company”) under and pursuant to the Stand Alone Stock Option Agreement dated                      (the
“Agreement”). The purchase price for the Shares will be $            , as required by the Agreement. 

Delivery of Payment. Purchaser herewith delivers to the Company the full purchase price of the Shares and any
required tax withholding to be paid in connection with the exercise of the Option. 
 Representations of
Purchaser. Purchaser acknowledges that Purchaser has received, read and understood the Agreement and agrees to abide by and be bound by their terms and conditions. 

Rights as Shareholder. Until the issuance (as evidenced by the appropriate entry on the books of the Company or of
a duly authorized transfer agent of the Company) of the Shares, no right to vote or receive dividends or any other rights as a shareholder will exist with respect to the Shares subject to the Option, notwithstanding the exercise of the Option. The
Shares so acquired will be issued to Purchaser as soon as practicable after exercise of the Option. No adjustment will be made for a dividend or other right for which the record date is prior to the date of issuance, except as provided in
Section 14 of the Agreement. 
 Tax Consultation. Purchaser understands that Purchaser may suffer
adverse tax consequences as a result of Purchaser’s purchase or disposition of the Shares. Purchaser represents that Purchaser has consulted with any tax consultants Purchaser deems advisable in connection with the purchase or disposition of
the Shares and that Purchaser is not relying on the Company for any tax advice. 
 Entire Agreement;
Governing Law. The Agreement are incorporated herein by reference. This Exercise Notice and the Agreement constitute the entire agreement of the parties with respect to the subject matter hereof and supersede in their entirety all prior
undertakings and agreements of the 

  
 -1-

 
Company and Purchaser with respect to the subject matter hereof, and may not be modified adversely to the Purchaser’s interest except by means of a writing signed by the Company and
Purchaser. This Agreement is governed by the internal substantive laws, but not the choice of law rules, of Oregon. 
  

					
	 Submitted by:
	 		  	 Accepted by:

			
	 PURCHASER
	 		  	 AVI BIOPHARMA, INC.

			
	 	 		  	 
	 Signature
	 		  	 By

			
	 	 		  	 
	 Print Name
	 		  	 Its

			
	 Address:
	 		  	
			
	 	 		  	
			
	 	 		  	
			
		 		  	 
		 		  	 Date Received

  
 -2-Modification No. PZ0001 to Contract Number HDTRA1-10-C-0079

 Exhibit 10.3 

 

							
	AMENDMENT OF
SOLICITATION/MODIFICATION OF CONTRACT	  	1. CONTRACT ID CODE    	  	PAGE OF PAGES
	  	S	  	1  	  	35

											
	 2. AMENDMENT/MODIFICATION NO.

PZ0001
	  	
3. EFFECTIVE DATE       
 03-Mar-2011
	  	 4. REQUISITION/PURCHASE REQ. NO.    

CBM 100019095Z
	  	5. PROJECT NO. (if applicable)  
	6. ISSUED BY	  	CODE    	  	HDTRA 1                
  	  	7. ADMINISTERED BY (If other than Item 6)	  	CODE      	  	S4801A             
	 	
	 DEFENSE THREAT REDUCTION
AGENCY/BE-BC
 8725 JOHN J. KINGMAN ROAD, MSC 6201
 FORT BELVOIR VA 22060-6201
  
  
	  	 DCMA SEATTLE
 CORPORATE CAMPUS EAST III, 3009 112TH AVE
 BELLVUE WA 98004-8019

 
  

							
	8. NAME AND ADDRESS OF CONTRACTOR (No. street, county, State and ZIP Code)	 	(X)	  	 9A. AMENDMENT OF SOLICITATION
 NO.

		 	
	 AVI BIOPHARMA, INC.

J. DAVID BOYLE II
 4574 SW RESEARCH WAY STE
200
 CORVALLIS OR 97333-1299
	 	 ̈	  	 
	 	  	 9B. DATED (SEE ITEM 11)
  

 

	 	x	  	
10A. MODIFICATION OF CONTRACT/ORDER NO.
 HDTRA1-10-C-0079

	 	  	 10B. DATED (SEE ITEM 13)

 

	 	  	
	CODE 49WU1	 	FACILITY CODE	 	 	  	04-Jun-2010

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS 

 
  ̈ The above numbered
solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers    ̈ is
extended,   ̈ is not extended. 
 Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods: 

(a) By completing items 8 and 15, and returning
                             copies of the amendment; (b) By acknowledging receipt of this amendment
on each copy of the offer submitted; or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO
THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment your desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to
the solicitation and this amendment, and is received prior to the opening hour and date specified. 
  

 
 12. ACCOUNTING AND APPROPRIATION DATA (If
required) 
  
  

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. 

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14. 

 

			
	CHECK ONE  	 	 A.   THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify
authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO.                      IN ITEM 10A.

	 ̈	 
	 ̈	 	 B.   THE
ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43. 103(b).

 

	x	 	 C.   THIS SUPPLEMENTAL AGREEMENT IS
ENTERED INTO PURSUANT TO AUTHORITY OF:
 DFARS 252.217-7027, Contract Definitization (10USC2304(c)(2))

 

	 ̈	 	 D.   OTHER (Specify type of modification and
authority)

	  
 E.
IMPORTANT: Contractor   ̈ is
not,  x is required to sign this document and return         1         copies to the issuing office.

 

 14. DESCRIPTION OF AMENDMENT/MODIFICATION
(Organized by UCF section headings, including solicitation/contract subject matter where feasible.) 
 Modification Control
Number:    nuckolsb11171 
 The purpose of this modification is to definitize Letter Contract HDTRA1-10-C-0079, dated June 4,
2010 and change costs to reflect those agreed upon. 
 Except as provided herein, all terms and conditions of the document referenced in Item 9A
or 10A, as heretofore changed, remains unchanged and in full force and effect. 
  

							
	 15A.
NAME AND TITLE OF SIGNER (Type or
print)                                        

  
 J. David Boyle II — SVP & CFO

 
	  	 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type
or print)
  
 VICTOR E. CRAMER - Contracting Officer

 

							
	15B. CONTRACTOR/OFFEROR	  	15C. DATE SIGNED    	  	16B. UNITED STATES OF AMERICA	  	16C. DATE SIGNED
	 	 	 	
	/s/ J. David Boyle II	  	 	  	/s/ Victor E. Cramer	  	
	(Signature of person authorized to
sign)	  	03/03/2011	  	(Signature of Contracting Officer)	  	03-Mar-2011

			
	NSN 7540-01-152-8070	  	                             
   STANDARD FORM 30 (REV. 10-83)
	Previous edition unusable	  	                             
             Prescribed by GSA FAR (48 CFR) 53.243

  

 

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HDTRA1-10-C-0079 

PZ0001 
 Page 2 of 35

  

 SECTION SF 30 BLOCK 14 CONTINUATION PAGE 
 SUMMARY OF CHANGES 
 SECTION A - SOLICITATION/CONTRACT FORM 

The total cost of this contract was decreased by $258,170.60 from $18,000,000.00 to $17,741,829.40. 

The vendor signature required has changed from not required to required. 

The number of award copies required 1 has been added. 
 SECTION B - SUPPLIES OR SERVICES AND PRICES 
 Global Changes 

CLIN 0001 – CLIN 0002 
 The contract type has changed from COST to CPFF. 
 CLIN 0001 

The CLIN extended description has changed from The Contractor shall perform the tasks in accordance with the Statement of Work entitled
“AVI BioPharma Project - H1N1 Countermeasure Development” dated 19 May 2010 to The Contractor shall perform the tasks in accordance with the Statement of Work entitled “AVI BioPharma Project - H1N1 Countermeasure
Development” dated 17 June 2010. 
 The estimated/max cost has decreased by $[†] from $18,000,000.00 to
$[†]. 
 The fixed fee $[†] has been added. 
 The total cost of this line item has decreased by $258,170.60 from $18,000,000.00 to $17,741,829.40. 
  

																			
	ITEM NO	  	SUPPLIES/SERVICES	  	QUANTITY	 	  	UNIT	 	  	UNIT PRICE	 	  	AMOUNT	 
	 0001
	  		  				  	 	Lot	  	  				  	$	17,741,829.40	  
		  	Non-personal services	  	  			
		  	CPFF	  	  			
		  	The Contractor shall perform the tasks in accordance with the Statement of Work entitled “AVI BioPharma Project - H1N1 Countermeasure Development” dated 17
June 2010.	   	  			
		  	FOB: Destination	  	  			
		  	PURCHASE REQUEST NUMBER: CBM100019095Z	  	  			
			
		  	ESTIMATED COST	  	  	$	[†]	  
		  	FIXED FEE	  	  	$	[†]	  
		  		  				  				  				  	 	 	 
		  	TOTAL EST COST + FEE	  	  	$	17,741,829.40	  

 SUBCLIN 000101 

 
  

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HDTRA1-10-C-0079 

PZ0001 
 Page 3 of 35

  

																			
	ITEM NO	  	SUPPLIES/SERVICES	  	QUANTITY	 	  	UNIT	 	  	UNIT PRICE	 	  	AMOUNT	 
	 000101
	  		  				  				  				  	$	[†	] 
		  	 Funding
	  				  				  				  			
		  	 CPFF
	  				  				  				  			
		  	 FOB: Destination
	  				  				  				  			
				
		  	 ESTIMATED COST
	   
	  				  	$	[†	] 
		  	 FIXED FEE
	   
	  				  	$	[†	] 
		  		  				  				  				  	 	 	 
		  	 TOTAL EST COST + FEE
	   
	  				  	$	[†	] 
		  	 ACRN AA
	  				  				  				  	$	[†	] 
		  	 CIN: 000000000000000000000000000000
	  				  				  				  			
						
		  	 CLIN 0002
	  				  				  				  			

  

																			
	ITEM NO	  	SUPPLIES/SERVICES	  	QUANTITY	 	  	UNIT	 	  	UNIT PRICE	 	  	AMOUNT	 
	 0002
	  		  				  				  				  	 	NSP	  
		  	CDRLs	  				  				  				  			
		  	CPFF	  				  				  				  			
		  	The contractor shall deliver the data in accordance with the CDRLs in Exhibit A.	  	  			
		  	This Clin applies to Clins 0001.	  	  			
		  	FOB: Destination	  				  				  				  			
				
		  	ESTIMATED COST	  	  				  	$	[†	] 
		  	FIXED FEE	  	  				  	$	[†	] 
		  		  				  				  				  	 	 	 
		  	TOTAL EST COST + FEE	  	  				  	$	[†	] 

 SECTION D - PACKAGING AND MARKING

 The following have been added by full text: 
 252.247-9001 PACKAGING AND MARKING 
 (a) All data contained in Exhibit A, Contract Data
Requirements List (CDRL), DD Form 1423 delivered under this contract shall be delivered using best commercial practices to meet the packaging requirements of the carrier and to insure delivery, to the addressees specified on the Data Item Cover
Sheet, at destination and in accordance with applicable security requirements. 
 (b) All data and correspondence submitted to the Contracting
Officer shall reference the Contract Number, the CDRL number, and the date submitted. A copy of all correspondence sent to the Contracting Officer’s Representative (COR) or Project Manager shall be simultaneously provided to the Contracting
Officer. 
 SECTION E - INSPECTION AND ACCEPTANCE 
 The following have been modified: 
 252.246-9000 INSPECTION AND ACCEPTANCE (JUL 2007) 

 
  

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HDTRA1-10-C-0079 

PZ0001 
 Page 4 of 35

  

 Government inspection and acceptance of data is specified on the Contract Data Requirements List, DD
Form 1423. In accordance with FAR 52.246-8, inspection and acceptance for all work performed at any and all times under this contract shall be the responsibility of the: 
     X     Contracting Officer’s Representative (COR) or Project Manager (PM). The Wide Area Work Flow (WAWF) Acceptor DoDDAC is located in
DTRA 252.201-9000 Project Manager or DTRA 252.201-9002 Contracting Officer’s Representative. 

             Administrative Contracting Officer (ACO). The WAWF Acceptor DoDAAC can be
found in the “Administered By” block on page 1 of the contract. 
 (End of Clause) 

SECTION F - DELIVERIES OR PERFORMANCE 
 The
following have been added by reference: 
  

							
	52.242-15 Alt I	  	Stop-Work Order (Aug 1989) - Alternate I	  	APR 1984	  	
	52.247-34	  	F.O.B. Destination	  	NOV 1991	  	

 The following have been added by full text: 

DEFINITIZATION/FINAL DELIVERY 
 This Supplemental Agreement is issued to definitize and supersede Letter Contract HDTRA1-10-C-0079, and constitutes full settlement of all claims and adjustments arising under the Letter Contract, except
that any costs incurred thereunder shall be considered to have been made under this definitive modification. The referenced Letter Contract obligated $[†] to this contract. Modification P00002 obligated an additional $[†] to this contract.
This Supplemental Agreement PZ0001 obligates $[†] for a total amount obligated on this contract of $[†]. The period of performance of this contract is from June 4, 2010 to June 3, 2011. 

SECTION G - CONTRACT ADMINISTRATION DATA 
 The
following have been added by full text: 
 252.216-9005 PROFIT OR FEE ON TRAVEL COSTS (JUL 2008) 

Travel shall not be a profit or fee bearing cost element. 
 (End of clause) 
 252.232-9000    CONTRACT FUNDING PROFILE (OCT 1998)

 Subject to FAR Clause 52.232-22, Limitation of Funds, the amount of $[†] is obligated for work to be performed during the period
beginning with contract award and continuing through fund expenditure. Additional incremental funding planned, but not obligated, is: 
 FY11
    $[†] 
 (End of clause) 
 252.232-9001 PRICES/COST 
  

 

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HDTRA1-10-C-0079 

PZ0001 
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 a. Subject to the provisions of the Clauses of this Contract entitled LIMITATION OF FUNDS, ALLOWABLE COST
AND PAYMENT, and FIXED FEE, the total allowable cost under this Contract shall not exceed $[†], which is the total estimated cost of the Contractor’s performance hereunder, exclusive of fixed fee. In addition, the Government shall pay the
Contractor a fixed fee of $[†] for the performance of this Contract. It is understood and agreed that the Government’s obligation is limited to INCREMENTAL FUNDING in the amount of $[†]. Within this amount ($[†]), the fixed fee
shall bear the same relationship to the total fixed fee, as the costs incurred bear to the total estimated cost. 
 b. Interim payment vouchers
may be submitted for provisional payment pursuant to the Clauses of this Contract entitled ALLOWABLE COST AND PAYMENT and FIXED FEE. 

252.232-9007    PAYMENT INFORMATION IN CENTRAL CONTRACTOR REGISTRATION (CCR) DATABASE 

This contract contains FAR clause 52.204-7, Central Contractor Registration. All contractors must be registered in the CCR database prior to award, during
performance, and through final payment of any contract, except for awards to foreign vendors for work to be performed outside the United States. 
 The Contractor is responsible for the accuracy and completeness of the data within the CCR, and for any liability resulting from the Government’s reliance on inaccurate or incomplete data. In
addition to the contractor’s requirement to confirm on an annual basis that its information in the CCR database is accurate and complete, the contractor’s information in the CCR database must be updated whenever changes occur to the
contractor’s remit-to data (e.g., account number, vendor name and address, etc.) and the paying office notified of any changes. The contractor’s failure to maintain accurate information in the CCR database could result in payment delays
for which the Government shall not be liable. 
 252.242-9003    ASSIGNMENT OF CONTRACT ADMINISTRATION SERVICES (CAS)
FUNCTIONS (AUG 2009) 
 a. The contract administration functions stated in FAR 42.302(a) are assigned to: See Page 1, Section A, Block 6 of
this contract. 
 b. Notwithstanding that assignment, in accordance with FAR 42.202(b)(2), the following functions are determined to be best
performed by the PCO and are retained by the DTRA Contracting Office: 
 (1) FAR 42.302(a)(3) Conduct Postaward orientation conferences.

 (2) FAR 42.302(a)(20) Perform Postaward Security Administration. 
 (3) FAR 42.302(a)(40) Perform engineering surveillance to assess compliance with contractual terms for schedule, cost, and technical performance in the areas of design, development, and production.

 (4) FAR 42.302(a)(51) In accordance with FAR 52.244-2, consent to the placement of subcontracts which have experimental, developmental, or
research work as one of its purposes. 
 (5) Approval or disapproval of the data items listed on Exhibit A, DD Form 1423, Contract Data
Requirements List. 
 (END OF CLAUSE) 
  

 

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 SECTION H - SPECIAL CONTRACT REQUIREMENTS 
 The following have been added by full text: 
 252.223-9002    PROTECTION OF
HUMAN SUBJECTS (AUG 2010) 
 All research under this contract involving human subjects must be conducted in accordance with 32 CFR 219, 10 USC
980, and DoDD 3216.02, as well as other applicable federal and state regulations. Contractors must be cognizant of and abide by the additional restrictions and limitations imposed on the DoD regarding research involving human subjects, specifically
as regards vulnerable populations (32 CFR 219 modifications to subparts B¬D of 45 CFR 46), recruitment of military research subjects (32 CFR 219), and surrogate consent (10 USC 980). Defense Threat Reduction Agency (DTRA) Directive 3216.01
establishes the DTRA Human Subjects Protection Program, sets forth the policies, defines the applicable terms, and delineates the procedures necessary to ensure DTRA compliance with federal and DoD regulations and legislation governing human subject
research. The regulations mandate that all DoD activities, components, and agencies protect the rights and welfare of human subjects of study in DoD-supported research, development, test and evaluation, and related activities hereafter referred to
as “research”. The requirement to comply with the regulations applies to new starts and to continuing research. 
 The DTRA directive
requires that research using human subjects may not begin or continue until the Defense Threat Reduction Agency’s Research Oversight Board (ROB) has reviewed and approved the proposed protocol. Contractors and subcontractors are required to
submit a valid federal assurance for their organization (institution, laboratory, facility) that has been issued by either DoD or the Department of Health and Human Services, and documentation of review of proposed protocols by the local
Institutional Review Board (IRB) to include consent forms for any planned research using human subjects to the DTRA ROB for its review through the contracting officer’s representative (if assigned) or the contracting officer. The ROB review is
separate from, and in addition to, local IRB review. 
 Written approval to begin research or subcontract for the use of human subjects under
the proposed protocol will be provided in writing from the DTRA ROB, through the contracting officer. A copy of this approval shall be maintained by both the contractor and the government. Any proposed modifications or amendments to the approved
protocol or consent forms must be submitted to the local IRB and the DTRA ROB for review and approval. Examples of modifications/amendments to the protocol include but are not limited to: 
 1) a change of the Principal Investigator 
 2) changes in duration or intensity of exposure to some
stimulus or agent 
 3) changes in the information requested of volunteers, or changes to the use of specimens or data collected 

4) changes in perceived or measured risks or benefits to volunteers that require changes to the study 

Research pursuant to such modifications or amendments shall not be initiated without IRB and ROB approval except when necessary to eliminate apparent and
immediate hazards to the subject(s). 
 Research projects lasting more than one year require IRB review at least annually, or more frequently as
required by the responsible IRB. ROB review and approval is required annually. The contractor or subcontractor must provide documentation of continued IRB review of protocols for ROB review and approval in accordance with the Contract Data
Requirements List. Research must not continue without renewed ROB approval unless necessary to eliminate apparent and immediate hazards to the subject(s). 
 Non-compliance with any provision of this clause may result in withholding of payments under the contract pursuant to the contract’s payments clause(s) and/or contract termination pursuant to the
contract’s 
  

 

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HDTRA1-10-C-0079 

PZ0001 
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termination clause(s). The government shall not be responsible for any costs incurred for research involving human subjects prior to protocol approval by the ROB. 

252.235-9001    PROHIBITION OF USE OF LABORATORY ANIMALS (JULY 2010) (DTRA) 

The contractor shall obtain approval from the US Army Medical Research and Material Command (MRMC), Animal Care and Use Review Office (ACURO) prior to
conducting research on live nonhuman vertebrates. Studies involving non-human primates, dogs, cats, or marine mammals will require a site visit by an ACURO laboratory animal veterinarian as a condition of approval. DoD may also conduct site visits
involving research on other animals when deemed appropriate. The animal research facility is responsible for notifying the DoD sponsor if Association for the Assessment and Accreditation of Laboratory Animal Care accreditation is lost or the
facility is under USDA inspection. DoD also has the right to a site inspection under these circumstances. 
 The contractor (including
subcontractors) is expressly forbidden to use laboratory animals in any manner whatsoever without the express written approval of MRMC ACURO. 

The contractor shall complete the ACURO Animal Use Appendix for Research Involving Animals found at the following web site:
https://mrmc-www.army.mil/index.cfm?pageid=Research_Protections.acuro_AnimalAppendix. Submit the completed ACURO appendix, contact information, the DTRA contract number and a copy of the contract for processing to the email address listed at the
ACURO website. Once ACURO approves the effort, the contractor will receive written approval to begin animal use from the US Army MRMC ACURO by separate email. The contractor shall promptly provide a copy of the approval to the contracting officer
and contracting officer representative. After approval, changes or protocol amendments must be submitted to and approved by ACURO before implementation. 
 The contractor, or subcontractors as appropriate, shall submit the most recent U.S. Department of Agriculture Animal Care Inspection Report annually in accordance with the CDRL. 

Non-compliance with any provision of this clause may result in the termination of the contract. 

(End of Clause) 
 The following
have been modified: 
 252.201-9002    CONTRACTING OFFICER’S REPRESENTATIVE (MAY 2007) 

 

					
	a.	  	The Contracting Officer’s Representative (COR) for this contract is:
	    X    	  	See Separate Letter	  	
		  	Transformational Medical Technologies (TMT)	  	
		  	Defense Threat Reduction Agency	  	
		  	8725 John J. Kingman Rd, MS 6201	  	
		  	Fort Belvoir VA 22060-6201	  	
		  	WAWF Acceptor DoDAAC: HDTRA1	  	
		  		  	
	  
	  	  
	  	
		  	Defense Threat Reduction Agency/	  	
		  	1680 Texas St SE	  	
		  	Kirtland AFB NM 87117-5669	  	

  
  

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HDTRA1-10-C-0079 

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		  	Telephone number (505)         -        	  	
		  	e-mail address @abq.dtra.mil.	  	
		  	WAWF Acceptor DoDAAC: HDTRA2	  	

 b. The COR will act as the Contracting Officer’s Representative for technical matters providing technical
direction and discussion as necessary with respect to the specification/statement of work and monitoring the progress and quality of the Contractor’s performance. The COR is NOT an Administrative Contracting Officer (ACO) and does not have the
authority to take any action, either directly or indirectly that would change the pricing, quality, quantity, place of performance, delivery schedule, or any other terms and conditions of the contract, or to direct the accomplishment of effort,
which goes beyond the scope of the specifications/statement of work in the contract. 
 c. When, in the opinion of the contractor, the COR
requests effort outside the existing scope of the contract, the contractor shall promptly notify the Contracting Officer in writing. No action shall be taken by the contractor under such direction until the Contracting Officer has issued a
modification to the contract or has otherwise resolved the issue. 
 The following have been deleted: 

 

							
	252.201-9001	  	Contracting Office Point of Contact (POC)	    	AUG 2001	  	
	252.204-9000	  	DTRA - Mailing Addresses/ Instructions	    	NOV 2004	  	

 SECTION I - CONTRACT CLAUSES 
 The following have been added by reference: 
  

							
	52.202-1	  	Definitions	    	JUL 2004	  	
	52.203-3	  	Gratuities	    	APR 1984	  	
	52.203-5	  	Covenant Against Contingent Fees	    	APR 1984	  	
	52.203-6	  	Restrictions On Subcontractor Sales To The Government	    	SEP 2006	  	
	52.203-7	  	Anti-Kickback Procedures	    	OCT 2010	  	
	52.203-8	  	Cancellation, Rescission, and Recovery of Funds for Illegal or Improper Activity	    	JAN 1997	  	
	52.203-10	  	Price Or Fee Adjustment For Illegal Or Improper Activity	    	JAN 1997	  	
	52.203-12	  	Limitation On Payments To Influence Certain Federal Transactions	    	OCT 2010	  	
	52.203-13	  	Contractor Code of Business Ethics and Conduct	    	APR 2010	  	
	52.203-14	  	Display of Hotline Poster(s)	    	DEC 2007	  	
	52.204-4	  	Printed or Copied Double-Sided on Recycled Paper	    	AUG 2000	  	
	52.204-7	  	Central Contractor Registration	    	APR 2008	  	
	52.204-10	  	Reporting Executive Compensation and First-Tier Subcontract Awards	    	JUL 2010	  	
	52.209-6	  	Protecting the Government’s Interest When Subcontracting With Contractors Debarred, Suspended, or Proposed for Debarment	    	SEP 2006	  	
	52.209-9	  	Updates of Publicly Available Information Regarding Responsibility Matters	    	JAN 2011	  	
	52.215-2	  	Audit and Records—Negotiation	    	OCT 2010	  	
	52.215-8	  	Order of Precedence—Uniform Contract Format	    	OCT 1997	  	

  

 

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	52.215-10	  	Price Reduction for Defective Certified Cost or Pricing Data	    	OCT 2010	  	
	52.215-12	  	Subcontractor Certified Cost or Pricing Data	    	OCT 2010	  	
	52.215-15	  	Pension Adjustments and Asset Reversions	    	OCT 2010	  	
	52.215-17	  	Waiver of Facilities Capital Cost of Money	    	OCT 1997	  	
	52.215-18	  	Reversion or Adjustment of Plans for Postretirement Benefits(PRB) Other than Pensions	    	JUL 2005	  	
	52.215-19	  	Notification of Ownership Changes	    	OCT 1997	  	
	52.215-21	  	Requirements for Certified Cost or Pricing Data or Information Other Than Certified Cost or Pricing Data—Modifications	    	OCT 2010	  	
	52.215-23	  	Limitations on Pass-Through Charges	    	OCT 2009	  	
	52.216-8	  	Fixed Fee	    	MAR 1997	  	
	52.219-8	  	Utilization of Small Business Concerns	    	MAY 2004	  	
	52.219-28	  	Post-Award Small Business Program Rerepresentation	    	APR 2009	  	
	52.222-3	  	Convict Labor	    	JUN 2003	  	
	52.222-21	  	Prohibition Of Segregated Facilities	    	FEB 1999	  	
	52.222-26	  	Equal Opportunity	    	MAR 2007	  	
	52.222-35	  	Equal Opportunity For Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans	    	SEP 2010	  	
	52.222-36	  	Affirmative Action For Workers With Disabilities	    	OCT 2010	  	
	52.222-37	  	Employment Reports on Veterans	    	SEP 2010	  	
	52.222-40	  	Notification of Employee Rights Under the National Labor Relations Act	    	DEC 2010	  	
	52.222-50	  	Combating Trafficking in Persons	    	FEB 2009	  	
	52.222-54	  	Employment Eligibility Verification	    	JAN 2009	  	
	52.223-6	  	Drug-Free Workplace	    	MAY 2001	  	
	52.223-14	  	Toxic Chemical Release Reporting	    	AUG 2003	  	
	52.223-18	  	Contractor Policy to Ban Text Messaging While Driving	    	SEP 2010	  	
	52.225-13	  	Restrictions on Certain Foreign Purchases	    	JUN 2008	  	
	52.227-1 Alt I	  	Authorization And Consent (Dec 2007) - Alternate I	    	APR 1984	  	
	52.227-2	  	Notice And Assistance Regarding Patent And Copyright Infringement	    	DEC 2007	  	
	52.227-11 Alt II	  	Patent Rights—Ownership by the Contractor (Dec 2007) - Alternate II	    	DEC 2007	  	
	52.228-7	  	Insurance—Liability To Third Persons	    	MAR 1996	  	
	52.232-9	  	Limitation On Withholding Of Payments	    	APR 1984	  	
	52.232-17	  	Interest	    	OCT 2010	  	
	52.232-20	  	Limitation Of Cost	    	APR 1984	  	
	52.232-23 Alt I	  	Assignment of Claims (Jan 1986) - Alternate I	    	APR 1984	  	
	52.232-25 Alt I	  	Prompt Payment (Oct 2008) Alternate I	    	FEB 2002	  	
	52.232-33	  	Payment by Electronic Funds Transfer—Central Contractor Registration	    	OCT 2003	  	
	52.233-1 Alt I	  	Disputes (Jul 2002) - Alternate I	    	DEC 1991	  	
	52.233-3 Alt I	  	Protest After Award (Aug 1996) - Alternate I	    	JUN 1985	  	
	52.233-4	  	Applicable Law for Breach of Contract Claim	    	OCT 2004	  	
	52.242-1	  	Notice of Intent to Disallow Costs	    	APR 1984	  	
	52.242-3	  	Penalties for Unallowable Costs	    	MAY 2001	  	
	52.242-4	  	Certification of Final Indirect Costs	    	JAN 1997	  	
	52.242-13	  	Bankruptcy	    	JUL 1995	  	

  

 

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	52.243-2 Alt V	  	Changes—Cost-Reimbursement (Aug 1987) - Alternate V	    	APR 1984	  	
	52.244-5	  	Competition In Subcontracting	    	DEC 1996	  	
	52.244-6	  	Subcontracts for Commercial Items	    	OCT 2010	  	
	52.245-1	  	Government Property	    	AUG 2010	  	
	52.245-9	  	Use And Charges	    	AUG 2010	  	
	52.246-8	  	Inspection Of Research And Development Cost Reimbursement	    	MAY 2001	  	
	52.246-25	  	Limitation Of Liability—Services	    	FEB 1997	  	
	52.249-6	  	Termination (Cost Reimbursement)	    	MAY 2004	  	
	52.251-1	  	Government Supply Sources	    	AUG 2010	  	
	52.253-1	  	Computer Generated Forms	    	JAN 1991	  	
	252.203-7000	  	Requirements Relating to Compensation of Former DoD Officials	    	JAN 2009	  	
	252.203-7001	  	Prohibition On Persons Convicted of Fraud or Other Defense-Contract-Related Felonies	    	DEC 2008	  	
	252.203-7002	  	Requirement to Inform Employees of Whistleblower Rights	    	JAN 2009	  	
	252.203-7003	  	Agency Office of the Inspector General	    	SEP 2010	  	
	252.204-7000	  	Disclosure Of Information	    	DEC 1991	  	
	252.204-7003	  	Control Of Government Personnel Work Product	    	APR 1992	  	
	252.204-7004 Alt A	  	Central Contractor Registration (52.204-7) Alternate A	    	SEP 2007	  	
	252.204-7008	  	Export-Controlled Items	    	APR 2010	  	
	252.205-7000	  	Provision Of Information To Cooperative Agreement Holders	    	DEC 1991	  	
	252.209-7004	  	Subcontracting With Firms That Are Owned or Controlled By The Government of a Terrorist Country	    	DEC 2006	  	
	252.211-7003	  	Item Identification and Valuation	    	SEP 2010	  	
	252.211-7007	  	Reporting of Government-Furnished Equipment in the DoD Item Unique Identification (IUID) Registry	    	NOV 2008	  	
	252.215-7000	  	Pricing Adjustments	    	DEC 1991	  	
	252.215-7002	  	Cost Estimating System Requirements	    	DEC 2006	  	
	252.222-7006	  	Restrictions on the Use of Mandatory Arbitration Agreements	    	DEC 2010	  	
	252.225-7004	  	Report of Intended Performance Outside the United States and Canada—Submission after Award	    	OCT 2010	  	
	252.225-7004	  	Report of Intended Performance Outside the United States and Canada—Submission after Award	    	OCT 2010	  	
	252.225-7006	  	Quarterly Reporting of Actual Contract Performance Outside the United States	    	OCT 2010	  	
	252.225-7012	  	Preference For Certain Domestic Commodities	    	JUN 2010	  	
	252.226-7001	  	Utilization of Indian Organizations and Indian-Owned Economic Enterprises, and Native Hawaiian Small Business Concerns	    	SEP 2004	  	
	252.227-7014	  	Rights in Noncommercial Computer Software and Noncommercial Computer Software Documentation	    	JUN 1995	  	
	252.227-7016	  	Rights in Bid or Proposal Information	    	JUN 1995	  	
	252.227-7019	  	Validation of Asserted Restrictions—Computer Software	    	JUN 1995	  	
	252.227-7027	  	Deferred Ordering Of Technical Data Or Computer Software	    	APR 1988	  	
	252.227-7030	  	Technical Data—Withholding Of Payment	    	MAR 2000	  	

  

 

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	252.227-7037	  	Validation of Restrictive Markings on Technical Data	    	SEP 1999	  	
	252.227-7039	  	Patents—Reporting Of Subject Inventions	    	APR 1990	  	
	252.231-7000	  	Supplemental Cost Principles	    	DEC 1991	  	
	252.232-7003	  	Electronic Submission of Payment Requests and Receiving Reports	    	MAR 2008	  	
	252.232-7010	  	Levies on Contract Payments	    	DEC 2006	  	
	252.235-7002	  	Animal Welfare	    	DEC 1991	  	
	252.235-7010	  	Acknowledgment of Support and Disclaimer	    	MAY 1995	  	
	252.235-7011	  	Final Scientific or Technical Report	    	NOV 2004	  	
	252.243-7002	  	Requests for Equitable Adjustment	    	MAR 1998	  	
	252.244-7000	  	Subcontracts for Commercial Items and Commercial Components (DoD Contracts)	    	AUG 2009	  	
	252.245-7002	  	Reporting Loss of Government Property	    	FEB 2011	  	
	252.247-7023	  	Transportation of Supplies by Sea	    	MAY 2002	  	
	252.247-7024	  	Notification Of Transportation Of Supplies By Sea	    	MAR 2000	  	
	252.251-7000	  	Ordering From Government Supply Sources	    	NOV 2004	  	

 The following have been added by full text: 
 52.216-7    ALLOWABLE COST AND PAYMENT (DEC 2002) 
 (a) Invoicing. 

(1) The Government will make payments to the Contractor when requested as work progresses, but (except for small business concerns) not more often than
once every 2 weeks, in amounts determined to be allowable by the Contracting Officer in accordance with Federal Acquisition Regulation (FAR) subpart 31.2 in effect on the date of this contract and the terms of this contract. The Contractor may
submit to an authorized representative of the Contracting Officer, in such form and reasonable detail as the representative may require, an invoice or voucher supported by a statement of the claimed allowable cost for performing this contract.

 (2) Contract financing payments are not subject to the interest penalty provisions of the Prompt Payment Act. Interim payments made prior to
the final payment under the contract are contract financing payments, except interim payments if this contract contains Alternate I to the clause at 52.232-25. 
 (3) The designated payment office will make interim payments for contract financing on the 30th day after the designated billing office receives a proper payment request. 

In the event that the Government requires an audit or other review of a specific payment request to ensure compliance with the terms and conditions of
the contract, the designated payment office is not compelled to make payment by the specified due date. 
 (b) Reimbursing costs. (1) For
the purpose of reimbursing allowable costs (except as provided in subparagraph (b)(2) of the clause, with respect to pension, deferred profit sharing, and employee stock ownership plan contributions), the term “costs” includes only—

 (i) Those recorded costs that, at the time of the request for reimbursement, the Contractor has paid by cash, check, or other form of actual
payment for items or services purchased directly for the contract; 
  

 

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 (ii) When the Contractor is not delinquent in paying costs of contract performance in the ordinary course of
business, costs incurred, but not necessarily paid, for— 
 (A) Supplies and services purchased directly for the contract and associated
financing payments to subcontractors, provided payments determined due will be made— 
 (1) In accordance with the terms and conditions of
a subcontract or invoice; and 
 (2) Ordinarily within 30 days of the submission of the Contractor’s payment request to the Government;

 (B) Materials issued from the Contractor’s inventory and placed in the production process for use on the contract; 

(C) Direct labor; 
 (D) Direct travel;

 (E) Other direct in-house costs; and 
 (F) Properly allocable and allowable indirect costs, as shown in the records maintained by the Contractor for purposes of obtaining reimbursement under Government contracts; and 

(iii) The amount of financing payments that have been paid by cash, check, or other forms of payment to subcontractors. 

(2) Accrued costs of Contractor contributions under employee pension plans shall be excluded until actually paid unless— 

(i) The Contractor’s practice is to make contributions to the retirement fund quarterly or more frequently; and 

(ii) The contribution does not remain unpaid 30 days after the end of the applicable quarter or shorter payment period (any contribution remaining unpaid
shall be excluded from the Contractor’s indirect costs for payment purposes). 
 (3) Notwithstanding the audit and adjustment of invoices
or vouchers under paragraph (g) of this clause, allowable indirect costs under this contract shall be obtained by applying indirect cost rates established in accordance with paragraph (d) of this clause. 

(4) Any statements in specifications or other documents incorporated in this contract by reference designating performance of services or furnishing of
materials at the Contractor’s expense or at no cost to the Government shall be disregarded for purposes of cost-reimbursement under this clause. 
 (c) Small business concerns. A small business concern may receive more frequent payments than every 2 weeks. 
 (d) Final indirect cost rates. (1) Final annual indirect cost rates and the appropriate bases shall be established in accordance with Subpart 42.7 of the Federal Acquisition Regulation (FAR) in
effect for the period covered by the indirect cost rate proposal. 
  

 

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 (2)(i) The Contractor shall submit an adequate final indirect cost rate proposal to the Contracting Officer
(or cognizant Federal agency official) and auditor within the 6-month period following the expiration of each of its fiscal years. Reasonable extensions, for exceptional circumstances only, may be requested in writing by the Contractor and granted
in writing by the Contracting Officer. The Contractor shall support its proposal with adequate supporting data. 
 (ii) The proposed rates shall
be based on the Contractor’s actual cost experience for that period. The appropriate Government representative and the Contractor shall establish the final indirect cost rates as promptly as practical after receipt of the Contractor’s
proposal. 
 (3) The Contractor and the appropriate Government representative shall execute a written understanding setting forth the final
indirect cost rates. The understanding shall specify (i) the agreed-upon final annual indirect cost rates, (ii) the bases to which the rates apply, (iii) the periods for which the rates apply, (iv) any specific indirect cost
items treated as direct costs in the settlement, and (v) the affected contract and/or subcontract, identifying any with advance agreements or special terms and the applicable rates. The understanding shall not change any monetary ceiling,
contract obligation, or specific cost allowance or disallowance provided for in this contract. The understanding is incorporated into this contract upon execution. 
 (4) Failure by the parties to agree on a final annual indirect cost rate shall be a dispute within the meaning of the Disputes clause. 
 (5) Within 120 days (or longer period if approved in writing by the Contracting Officer) after settlement of the final annual indirect cost rates for all years of a physically complete contract, the
Contractor shall submit a completion invoice or voucher to reflect the settled amounts and rates. 
 (6)(i) If the Contractor fails to submit a
completion invoice or voucher within the time specified in paragraph (d)(5) of this clause, the Contracting Officer may— 
 (A) Determine
the amounts due to the Contractor under the contract; and 
 (B) Record this determination in a unilateral modification to the contract.

 (ii) This determination constitutes the final decision of the Contracting Officer in accordance with the Disputes clause. 

(e) Billing rates. Until final annual indirect cost rates are established for any period, the Government shall reimburse the Contractor at billing rates
established by the Contracting Officer or by an authorized representative (the cognizant auditor), subject to adjustment when the final rates are established. These billing rates— 
 (1) Shall be the anticipated final rates; and 
 (2) May be prospectively or retroactively
revised by mutual agreement, at either party’s request, to prevent substantial overpayment or underpayment. 
 (f) Quick-closeout
procedures. Quick-closeout procedures are applicable when the conditions in FAR 42.708(a) are satisfied. 
  

 

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 (g) Audit. At any time or times before final payment, the Contracting Officer may have the Contractor’s
invoices or vouchers and statements of cost audited. Any payment may be (1) Reduced by amounts found by the Contracting Officer not to constitute allowable costs or (2) Adjusted for prior overpayments or underpayments. 

(h) Final payment. (1) Upon approval of a completion invoice or voucher submitted by the Contractor in accordance with paragraph (d)(4) of this
clause, and upon the Contractor’s compliance with all terms of this contract, the Government shall promptly pay any balance of allowable costs and that part of the fee (if any) not previously paid. 

(2) The Contractor shall pay to the Government any refunds, rebates, credits, or other amounts (including interest, if any) accruing to or received by
the Contractor or any assignee under this contract, to the extent that those amounts are properly allocable to costs for which the Contractor has been reimbursed by the Government. Reasonable expenses incurred by the Contractor for securing refunds,
rebates, credits, or other amounts shall be allowable costs if approved by the Contracting Officer. Before final payment under this contract, the Contractor and each assignee whose assignment is in effect at the time of final payment shall execute
and deliver— 
 (i) An assignment to the Government, in form and substance satisfactory to the Contracting Officer, of refunds, rebates,
credits, or other amounts (including interest, if any) properly allocable to costs for which the Contractor has been reimbursed by the Government under this contract; and 
 (ii) A release discharging the Government, its officers, agents, and employees from all liabilities, obligations, and claims arising out of or under this contract, except— 

(A) Specified claims stated in exact amounts, or in estimated amounts when the exact amounts are not known; 

(B) Claims (including reasonable incidental expenses) based upon liabilities of the Contractor to third parties arising out of the performance of this
contract; provided, that the claims are not known to the Contractor on the date of the execution of the release, and that the Contractor gives notice of the claims in writing to the Contracting Officer within 6 years following the release date or
notice of final payment date, whichever is earlier; and 
 (C) Claims for reimbursement of costs, including reasonable incidental expenses,
incurred by the Contractor under the patent clauses of this contract, excluding, however, any expenses arising from the Contractor’s indemnification of the Government against patent liability. 

(End of clause) 

52.222-2    PAYMENT FOR OVERTIME PREMIUMS (JUL 1990) 
 (a) The use of overtime is authorized under this contract if the overtime premium cost does not exceed $[†] or the overtime premium is paid for work — 

(1) Necessary to cope with emergencies such as those resulting from accidents, natural disasters, breakdowns of production equipment, or occasional
production bottlenecks of a sporadic nature; 
 (2) By indirect-labor employees such as those performing duties in connection with
administration, protection, transportation, maintenance, standby plant protection, operation of utilities, or accounting; 
  

 

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 (3) To perform tests, industrial processes, laboratory procedures, loading or unloading of transportation
conveyances, and operations in flight or afloat that are continuous in nature and cannot reasonably be interrupted or completed otherwise; or 

(4) That will result in lower overall costs to the Government. 
 (b) Any request for estimated overtime premiums that exceeds the amount specified above shall include all estimated overtime for contract completion and shall— 

(1) Identify the work unit; e.g., department or section in which the requested overtime will be used, together with present workload, staffing, and other
data of the affected unit sufficient to permit the Contracting Officer to evaluate the necessity for the overtime; 
 (2) Demonstrate the effect
that denial of the request will have on the contract delivery or performance schedule; 
 (3) Identify the extent to which approval of overtime
would affect the performance or payments in connection with other Government contracts, together with identification of each affected contract; and 
 (4) Provide reasons why the required work cannot be performed by using multishift operations or by employing additional personnel. 
 * Insert either “zero” or the dollar amount agreed to during negotiations. The inserted figure does not apply to the exceptions in paragraph (a)(1) through (a)(4) of the clause. 

(End of clause) 

52.232-22    LIMITATION OF FUNDS (APR 1984) 
 (a) The parties estimate that performance of this contract will not cost the Government more than (1) the estimated cost specified in the Schedule or, (2) if this is a cost-sharing
contract, the Government’s share of the estimated cost specified in the Schedule. The Contractor agrees to use its best efforts to perform the work specified in the Schedule and all obligations under this contract within the estimated
cost, which, if this is a cost-sharing contract, includes both the Government’s and the Contractor’s share of the cost. 
 (b) The
Schedule specifies the amount presently available for payment by the Government and allotted to this contract, the items covered, the Government’s share of the cost if this is a cost-sharing contract, and the period of performance it is
estimated the allotted amount will cover. The parties contemplate that the Government will allot additional funds incrementally to the contract up to the full estimated cost to the Government specified in the Schedule, exclusive of any fee. The
Contractor agrees to perform, or have performed, work on the contract up to the point at which the total amount paid and payable by the Government under the contract approximates but does not exceed the total amount actually allotted by the
Government to the contract. 
 (c) The Contractor shall notify the Contracting Officer in writing whenever it has reason to believe that the
costs it expects to incur under this contract in the next 60 days, when added to all costs previously incurred, will exceed 75 percent of (1) the total amount so far allotted to the contract by the Government or, (2) if this is a
cost-sharing contract, the amount then allotted to the contract by the Government plus the Contractor’s corresponding share. The notice shall state the estimated amount of additional funds required to continue performance for the period
specified in the Schedule. 
  
  

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 (d) Sixty days before the end of the period specified in the Schedule, the Contractor shall notify the
Contracting Officer in writing of the estimated amount of additional funds, if any, required to continue timely performance under the contract or for any further period specified in the Schedule or otherwise agreed upon, and when the funds will
be required. 
 (e) If, after notification, additional funds are not allotted by the end of the period specified in the Schedule or another
agreed-upon date, upon the Contractor’s written request the Contracting Officer will terminate this contract on that date in accordance with the provisions of the Termination clause of this contract. If the Contractor estimates that the funds
available will allow it to continue to discharge its obligations beyond that date, it may specify a later date in its request, and the Contracting Officer may terminate this contract on that later date. 

(f) Except as required by other provisions of this contract, specifically citing and stated to be an exception to this clause— 

(1) The Government is not obligated to reimburse the Contractor for costs incurred in excess of the total amount allotted by the Government to this
contract; and 
 (2) The Contractor is not obligated to continue performance under this contract (including actions under the Termination clause
of this contract) or otherwise incur costs in excess of (i) the amount then allotted to the contract by the Government or, (ii) if this is a cost-sharing contract, the amount then allotted by the Government to the contract plus the
Contractor’s corresponding share, until the Contracting Officer notifies the Contractor in writing that the amount allotted by the Government has been increased and specifies an increased amount, which shall then constitute the total amount
allotted by the Government to this contract. 
 (g) The estimated cost shall be increased to the extent that (1) the amount allotted by the
Government or, (2) if this is a cost-sharing contract, the amount then allotted by the Government to the contract plus the Contractor’s corresponding share, exceeds the estimated cost specified in the Schedule. If this is a cost-sharing
contract, the increase shall be allocated in accordance with the formula specified in the Schedule. 
 (h) No notice, communication, or
representation in any form other than that specified in subparagraph (f)(2) above, or from any person other than the Contracting Officer, shall affect the amount allotted by the Government to this contract. In the absence of the specified notice,
the Government is not obligated to reimburse the Contractor for any costs in excess of the total amount allotted by the Government to this contract, whether incurred during the course of the contract or as a result of termination. 

(i) When and to the extent that the amount allotted by the Government to the contract is increased, any costs the Contractor incurs before the increase
that are in excess of (1) the amount previously allotted by the Government or, (2) if this is a cost-sharing contract, the amount previously allotted by the Government to the contract plus the Contractor’s corresponding share, shall
be allowable to the same extent as if incurred afterward, unless the Contracting Officer issues a termination or other notice and directs that the increase is solely to cover termination or other specified expenses. 

(j) Change orders shall not be considered an authorization to exceed the amount allotted by the Government specified in the Schedule, unless they contain
a statement increasing the amount allotted. 
 (k) Nothing in this clause shall affect the right of the Government to terminate this contract.
If this contract is terminated, the Government and the Contractor shall negotiate an equitable distribution of all property produced or purchased under the contract, based upon the share of costs incurred by each. 

 
  

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 (l) If the Government does not allot sufficient funds to allow completion of the work, the Contractor is
entitled to a percentage of the fee specified in the Schedule equalling the percentage of completion of the work contemplated by this contract. 

(End of clause) 

52.244-2    SUBCONTRACTS (OCT 2010) 
 (a) Definitions. As used in this clause— 
 Approved purchasing system means a
Contractor’s purchasing system that has been reviewed and approved in accordance with Part 44 of the Federal Acquisition Regulation (FAR). 
 Consent to subcontract means the Contracting Officer’s written consent for the Contractor to enter into a particular subcontract. 
 Subcontract means any contract, as defined in FAR Subpart 2.1, entered into by a subcontractor to furnish supplies or services for performance of the prime contract or a subcontract. It includes, but is
not limited to, purchase orders, and changes and modifications to purchase orders. 
 (b) When this clause is included in a fixed-price type
contract, consent to subcontract is required only on unpriced contract actions (including unpriced modifications or unpriced delivery orders), and only if required in accordance with paragraph (c) or (d) of this clause. 

(c) If the Contractor does not have an approved purchasing system, consent to subcontract is required for any subcontract that— 

(1) Is of the cost-reimbursement, time-and-materials, or labor-hour type; or 
 (2) Is fixed-price and exceeds— 
 (i) For a contract awarded by the Department of Defense,
the Coast Guard, or the National Aeronautics and Space Administration, the greater of the simplified acquisition threshold or 5 percent of the total estimated cost of the contract; or 
 (ii) For a contract awarded by a civilian agency other than the Coast Guard and the National Aeronautics and Space Administration, either the simplified acquisition threshold or 5 percent of the total
estimated cost of the contract. 
 (d) If the Contractor has an approved purchasing system, the Contractor nevertheless shall obtain the
Contracting Officer’s written consent before placing the following subcontracts: 
 (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 (b), (c), or (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. 
  

 

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 (iii) Identification of the proposed subcontractor. 

(iv) The proposed subcontract price. 
 (v) The
subcontractor’s current, complete, and accurate certified 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 certified 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 certified cost or pricing data in determining the price objective and in negotiating the final price; 

(E) The extent to which it was recognized in the negotiation that the subcontractor’s certified 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. 
 (2) The Contractor is not required to notify the Contracting Officer in advance of entering into any subcontract for which consent is not required under paragraph (c), (d), or (e) of this clause.

 (f) Unless the consent or approval specifically provides otherwise, neither consent by the Contracting Officer to any subcontract nor
approval of the Contractor’s purchasing system shall constitute a determination— 
 (1) Of the acceptability of any subcontract terms
or conditions; 
 (2) Of the allowability of any cost under this contract; or 
 (3) To relieve the Contractor of any responsibility for performing this contract. 
 (g) No
subcontract or modification thereof placed under this contract shall provide for payment on a cost-plus-a-percentage-of-cost basis, and any fee payable under cost-reimbursement type subcontracts shall not exceed the fee limitations in FAR
15.404-4(c)(4)(i). 
  
  

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 (h) The Contractor shall give the Contracting Officer immediate written notice of any action or suit filed
and prompt notice of any claim made against the Contractor by any subcontractor or vendor that, in the opinion of the Contractor, may result in litigation related in any way to this contract, with respect to which the Contractor may be entitled to
reimbursement from the Government. 
  

	(i)	The Government reserves the right to review the Contractor’s purchasing system as set forth in FAR Subpart 44.3. 

(j) Paragraphs (c) and (e) of this clause do not apply to the following subcontracts, which were evaluated during negotiations: 

[†] 
 [†] 

[†] 
 [†] 

[†] 
 [†] 

[†] 
 [†] 

[†] 
 (End of clause) 

52.249-14    EXCUSABLE DELAYS (APR 1984) 
 (a) Except for defaults of subcontractors at any tier, the Contractor shall not be in default because of any failure to perform this contract under its terms if the failure arises from causes beyond the
control and without the fault or negligence of the Contractor. Examples of these causes are (1) acts of God or of the public enemy, (2) acts of the Government in either its sovereign or contractual capacity, (3) fires,
(4) floods, (5) epidemics, (6) quarantine restrictions, (7) strikes, (8) freight embargoes, and (9) unusually severe weather. In each instance, the failure to perform must be beyond the control and without the fault or
negligence of the Contractor. “Default” includes failure to make progress in the work so as to endanger performance. 
 (b) If the
failure to perform is caused by the failure of a subcontractor at any tier to perform or make progress, and if the cause of the failure was beyond the control of both the Contractor and subcontractor, and without the fault or negligence of either,
the Contractor shall not be deemed to be in default, unless— 
 (1) The subcontracted supplies or services were obtainable from other
sources; 
 (2) The Contracting Officer ordered the Contractor in writing to purchase these supplies or services from the other source; and

 (3) The Contractor failed to comply reasonably with this order. 
 (c) Upon request of the Contractor, the Contracting Officer shall ascertain the facts and extent of the failure. If the Contracting Officer determines that any failure to perform results from one or more
of the causes above, the delivery schedule shall be revised, subject to the rights of the Government under the termination clause of this contract. 
 (End of clause) 
  

 

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 52.252-2    CLAUSES INCORPORATED BY REFERENCE (FEB 1998) 

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the
Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): 
 http://farsite.hill.af.mil/ 
 (End of clause) 

252.201-9003    LIMITATION OF AUTHORITY (JUN 2009) 
 No person in the Government, other than a Contracting Officer, has the authority to provide direction to the Contractor, which alters the Contractor’s obligations or changes this contract in any way.
If any person representing the Government, other than a Contracting Officer, attempts to alter contract obligations, change the contract specifications/statement of work or tells the contractor to perform some effort which the Contractor believes to
be outside the scope of this contract, the Contractor shall immediately notify the Procuring Contracting Officer (PCO). Contractor personnel shall not comply with any order or direction which they believe to be outside the scope of this contract
unless the order or direction is issued by a Contracting Officer. 
 252.203-9000    Use of Senior Mentors (JUNE 2010)

 (a) The use of senior mentors by the Defense Threat Reduction Agency (DTRA) enhances the readiness of the Agency across a wide range of
strategic, operational, joint, functional, technical, management and development mission areas. The relevant prior service, joint force experience, and unique expertise of these senior consultants provide senior leadership with valuable insights and
contribute to the continuous improvement of the Agencies’ operations. 
 (b) For the purposes of this clause, Senior Mentor is defined as a
retired flag, general or other military officers (O-6) or retired senior civilian official (Senior Executive Service (SES), Senior Level (SL), Scientific and Professional (ST)) who provides expert experience-based mentoring, teaching, training,
advice, and recommendations to senior military officers, staffs and students as they participate in war games, warfighting courses, operational planning, operational exercises, and decision-making exercises. 

(c) In accordance with Secretary of Defense Memorandum entitled “Policy on Senior Mentors” dated April 1, 2010, DTRA will hire all senior
mentors as highly qualified experts (HQE) under 5 U.S.C. 9903. This policy balances the need for DTRA to secure the specialized knowledge required for these operational exercises with the need to hire such experts in a manner that promotes public
trust and confidence. 
 (d) The Contractor shall not include the use of senior mentors in bids or proposals for services/supplies offered to
DTRA. 
 (e) The Contractor shall include the substance of this clause in all subcontracts. 

(End of Clause) 

252.203-9004    ETIOLOGIC AGENTS—BIOLOGICAL DEFENSE RESEARCH PROGRAM (FEB 2008) 

 
  

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 5) For purpose of this contract etiologic agent—biological defense program is defined as: any viable
microorganism, or its toxin which causes or may cause human disease, including those agents listed in 42 CFR 73, 9 CFR 121, and 7 CFR 331, of the Department of Health and Human Services and Department of Agriculture regulations, respectively, and
any agent of biological origin that poses a degree of hazard to those agents and is further identified by the US Army. The contractor shall comply with the following when working with etiologic agents: 

1. 29 Code of Federal Regulations 1910, Occupational Health and Safety; 
 2. US Department of Health and Human Services (DHHS) and US Department of Agriculture, Select Agent Program(s), 42 CFR 73, 9 CFR 121, and 7 CFR 331; and 

3. DHHS Publication No. 93-8395, Biosafety in Microbiological and Biomedical Laboratories, latest edition. 

6) Etiologic agents shall be packaged, labeled, shipped, and transported in accordance with applicable Federal, State, and local laws and regulations, to
include: 
 1. 42 CFR 72 (Interstate Shipment of Etiologic Agents); 
 2. 49 CFR 172 and 173 (Department of Transportation); 
 3. 9 CFR 122 (USDA Restricted Animal
Pathogens); 
 4. International Air Transport Association Dangerous Goods Regulations; 
 5. The United States Postal Service shall not be used for transportation of BDRP related etiologic agents; and 
 6. If performance is outside of the United States, any additional procedures required by the nation where the work is to be performed. 
 252.203-9005, Implementation of Contractor Code of Business Ethics and Conduct (Dec 2008) 

In accordance with FAR clause 52.203-13, Contractor Code of Business Ethics and Conduct, the designated “agency Office of the Inspector General”
is the DoD OIG at the following address: 
 Office of the Inspector General 
 United States Department of Defense 
 Investigative Policy and Oversight 

Contractor Disclosure Program 
 400 Army Navy
Drive, Suite 1037 
 Arlington, VA 22202-4704 
 Toll Free Telephone: 866-429-8011 
 252.204-9004    IMPLEMENTATION OF
DISCLOSURE OF INFORMATION (JUN 2007) 
 In accordance with DFARS 252.204-7000 Disclosure of Information, any information to be released shall be
submitted at least 45 days before the proposed release date, for security and policy review. Submit one copy to each below: 
  

 

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 (a) Office of Public Affairs, DTRA/DIR/COS/PA, 8725 John J. Kingman Dr, MS 6201, Ft Belvoir VA 22060-6201.

 (b) Contracting Officer 
 (c)
Program Manager 
 (d) Task Order Manager 
 (End of Clause) 
 252.209-9002    NON-GOVERNMENT SUPPORT PERSONNEL (JAN
2008) 
 The following companies may have access to contractor information, technical data or computer software that may be marked as
proprietary or otherwise marked with restrictive legends: Suntiva LLC (contract specialist support); Systems Research and Analysis (SRA, managing JPRAS); ITT Corporation (DTRIAC Technical Engineering Services); Booz Allen Hamilton (Administrative
Support) and The Tauri Group (Advisory and Assistance Services). Each contract contains organizational conflict of interest provisions and/or includes contractual requirements for non-disclosure of proprietary contractor information or data/software
marked with restrictive legends. The contractor, by submitting a proposal or entering into this contract, is deemed to have consented to the disclosure of its information to Suntiva LLC, SRA, ITT Corporation, Booz Allen Hamilton and The Tauri Group
under conditions and limitations described herein. 
 252.215-9004    KEY PERSONNEL (FEB 2000) 

The personnel listed below are considered essential to the work being performed hereunder. Prior to removing, replacing, or diverting any of the specified
individuals, the Contractor shall notify the Contracting Officer reasonably in advance and shall submit justification (including proposed substitutions) in sufficient detail to permit evaluation of the impact on this Contract. No deviation shall be
made by the Contractor without the prior written consent of the Contracting Officer; provided, that the Contracting Officer may ratify in writing the change, such ratification shall constitute the consent of the Contracting Officer required by this
paragraph. The personnel listed below may, with the consent of the contracting parties, be amended from time to time during the course of the Contract to either add or delete personnel as appropriate. 

Principal Investigator 

252.216-9003    CONSULTANTS (OCT 1998) 
 Services of consultants shall be at rates and for periods approved in advance by the Contracting Officer. Requests for approval shall be submitted to the Contracting Officer sufficiently in advance
of the need to use a consultant under this Contract. The request shall include (a) a copy of the proposed consultant agreement, (b) a brief biography of the consultant, and (c) an indication of the area(s) in which consultant’s
expertise will be utilized and why it is essential for contract performance. In addition, significant deviations from the dollar amount approved for consultant services, or changes in the consultants to be utilized, must likewise be approved in
advance upon submission of adequate justification. 
 252.227-7013    RIGHTS IN TECHNICAL DATA—NONCOMMERCIAL ITEMS.
(NOV 1995) 
 (a) Definitions. As used in this clause: 
  

 

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 (1) Computer data base means a collection of data recorded in a form capable of being processed by a
computer. The term does not include computer software. 
 (2) Computer program means a set of instructions, rules, or routines recorded in a
form that is capable of causing a computer to perform a specific operation or series of operations. 
 (3) Computer software means computer
programs, source code, source code listings, object code listings, design details, algorithms, processes, flow charts, formulae and related material that would enable the software to be reproduced, recreated, or recompiled. Computer software does
not include computer data bases or computer software documentation. 
 (4) Computer software documentation means owner’s manuals,
user’s manuals, installation instructions, operating instructions, and other similar items, regardless of storage medium, that explain the capabilities of the computer software or provide instructions for using the software. 

(5) Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or
assembly used by the manufacturer to produce an item or component or to perform a process. 
 (6) Developed means that an item, component, or
process exists and is workable. Thus, the item or component must have been constructed or the process practiced. Workability is generally established when the item, component, or process has been analyzed or tested sufficiently to demonstrate to
reasonable people skilled in the applicable art that there is a high probability that it will operate as intended. Whether, how much, and what type of analysis or testing is required to establish workability depends on the nature of the item,
component, or process, and the state of the art. To be considered “developed,” the item, component, or process need not be at the stage where it could be offered for sale or sold on the commercial market, nor must the item, component, or
process be actually reduced to practice within the meaning of Title 35 of the United States Code. 
 (7) Developed exclusively at private
expense means development was accomplished entirely with costs charged to indirect cost pools, costs not allocated to a government contract, or any combination thereof. 
 (i) Private expense determinations should be made at the lowest practicable level. 
 (ii) Under
fixed-price contracts, when total costs are greater than the firm-fixed-price or ceiling price of the contract, the additional development costs necessary to complete development shall not be considered when determining whether development was at
government, private, or mixed expense. 
 (8) Developed exclusively with government funds means development was not accomplished exclusively or
partially at private expense. 
 (9) Developed with mixed funding means development was accomplished partially with costs charged to indirect
cost pools and/or costs not allocated to a government contract, and partially with costs charged directly to a government contract. 
 (10)
Form, fit, and function data means technical data that describes the required overall physical, functional, and performance characteristics (along with the qualification requirements, if applicable) of an item, component, or process to the extent
necessary to permit identification of physically and functionally interchangeable items. 
  

 

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 (11) Government purpose means any activity in which the United States Government is a party, including
cooperative agreements with international or multi-national defense organizations, or sales or transfers by the United States Government to foreign governments or international organizations. Government purposes include competitive procurement, but
do not include the rights to use, modify, reproduce, release, perform, display, or disclose technical data for commercial purposes or authorize others to do so. 
 (12) Government purpose rights means the rights to— 
 (i) Use, modify, reproduce, release,
perform, display, or disclose technical data within the Government without restriction; and 
 (ii) Release or disclose technical data outside
the Government and authorize persons to whom release or disclosure has been made to use, modify, reproduce, release, perform, display, or disclose that data for United States government purposes. 

(13) Limited rights means the rights to use, modify, reproduce, release, perform, display, or disclose technical data, in whole or in part, within the
Government. The Government may not, without the written permission of the party asserting limited rights, release or disclose the technical data outside the Government, use the technical data for manufacture, or authorize the technical data to be
used by another party, except that the Government may reproduce, release or disclose such data or authorize the use or reproduction of the data by persons outside the Government if reproduction, release, disclosure, or use is— 

(i) Necessary for emergency repair and overhaul; or 
 (ii) A release or disclosure of technical data (other than detailed manufacturing or process data) to, or use of such data by, a foreign government that is in the interest of the Government and is
required for evaluational or informational purposes; 
 (iii) Subject to a prohibition on the further reproduction, release, disclosure, or use
of the technical data; and 
 (iv) The contractor or subcontractor asserting the restriction is notified of such reproduction, release,
disclosure, or use. 
 (14) Technical data means recorded information, regardless of the form or method of the recording, of a scientific or
technical nature (including computer software documentation). The term does not include computer software or data incidental to contract administration, such as financial and/or management information. 

(15) Unlimited rights means rights to use, modify, reproduce, perform, display, release, or disclose technical data in whole or in part, in any manner,
and for any purpose whatsoever, and to have or authorize others to do so. 
 (b) Rights in technical data. The Contractor grants or shall obtain
for the Government the following royalty free, world-wide, nonexclusive, irrevocable license rights in technical data other than computer software documentation (see the Rights in Noncommercial Computer Software and Noncommercial Computer Software
Documentation clause of this contract for rights in computer software documentation): 
 (1) Unlimited rights. 

 
  

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 The Government shall have unlimited rights in technical data that are— 

(i) Data pertaining to an item, component, or process which has been or will be developed exclusively with Government funds; 

(ii) Studies, analyses, test data, or similar data produced for this contract, when the study, analysis, test, or similar work was specified as an
element of performance; 
 (iii) Created exclusively with Government funds in the performance of a contract that does not require the
development, manufacture, construction, or production of items, components, or processes; 
 (iv) Form, fit, and function data; 

(v) Necessary for installation, operation, maintenance, or training purposes (other than detailed manufacturing or process data); 

(vi) Corrections or changes to technical data furnished to the Contractor by the Government; 
 (vii) Otherwise publicly available or have been released or disclosed by the Contractor or subcontractor without restrictions on further use, release or disclosure, other than a release or disclosure
resulting from the sale, transfer, or other assignment of interest in the technical data to another party or the sale or transfer of some or all of a business entity or its assets to another party; 

(viii) Data in which the Government has obtained unlimited rights under another Government contract or as a result of negotiations; or 

(ix) Data furnished to the Government, under this or any other Government contract or subcontract thereunder, with- 

(A) Government purpose license rights or limited rights and the restrictive condition(s) has/have expired; or 

(B) Government purpose rights and the Contractor’s exclusive right to use such data for commercial purposes has expired. 

(2) Government purpose rights. 
 (i) The
Government shall have government purpose rights for a five-year period, or such other period as may be negotiated, in technical data— 

(A) That pertain to items, components, or processes developed with mixed funding except when the Government is entitled to unlimited rights in such data
as provided in paragraphs (b)(ii) and (b)(iv) through (b)(ix) of this clause; or 
 (B) Created with mixed funding in the performance of a
contract that does not require the development, manufacture, construction, or production of items, components, or processes. 
 (ii) The
five-year period, or such other period as may have been negotiated, shall commence upon execution of the contract, subcontract, letter contract (or similar contractual instrument), contract modification, or option exercise that required development
of the items, components, or processes or creation of the data described in 
  

 

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paragraph (b)(2)(i)(B) of this clause. Upon expiration of the five-year or other negotiated period, the Government shall have unlimited rights in the technical data. 

(iii) The Government shall not release or disclose technical data in which it has government purpose rights unless- 

(A) Prior to release or disclosure, the intended recipient is subject to the non-disclosure agreement at 227.7103-7 of the Defense Federal Acquisition
Regulation Supplement (DFARS); or 
 (B) The recipient is a Government contractor receiving access to the data for performance of a
Government contract that contains the clause at DFARS 252.227-7025, Limitations on the Use or Disclosure of Government-Furnished Information Marked with Restrictive Legends. 
 (iv) The Contractor has the exclusive right, including the right to license others, to use technical data in which the Government has obtained government purpose rights under this contract for any
commercial purpose during the time period specified in the government purpose rights legend prescribed in paragraph (f)(2) of this clause. 

(3) Limited rights. 
 (i) Except as provided in
paragraphs (b)(1)(ii) and (b)(1)(iv) through (b)(1)(ix) of this clause, the Government shall have limited rights in technical data— 
 (A)
Pertaining to items, components, or processes developed exclusively at private expense and marked with the limited rights legend prescribed in paragraph (f) of this clause; or 
 (B) Created exclusively at private expense in the performance of a contract that does not require the development, manufacture, construction, or production of items, components, or processes. 

(ii) The Government shall require a recipient of limited rights data for emergency repair or overhaul to destroy the data and all copies in its
possession promptly following completion of the emergency repair/overhaul and to notify the Contractor that the data have been destroyed. 

(iii) The Contractor, its subcontractors, and suppliers are not required to provide the Government additional rights to use, modify, reproduce, release,
perform, display, or disclose technical data furnished to the Government with limited rights. However, if the Government desires to obtain additional rights in technical data in which it has limited rights, the Contractor agrees to promptly enter
into negotiations with the Contracting Officer to determine whether there are acceptable terms for transferring such rights. All technical data in which the Contractor has granted the Government additional rights shall be listed or described in a
license agreement made part of the contract. The license shall enumerate the additional rights granted the Government in such data. 
 (4)
Specifically negotiated license rights. 
 The standard license rights granted to the Government under paragraphs (b)(1) through (b)(3) of this
clause, including the period during which the Government shall have government purpose rights in technical data, may be modified by mutual agreement to provide such rights as the parties consider appropriate but shall not provide the Government
lesser rights than are enumerated in paragraph (a)(13) of this clause. Any rights so negotiated shall be identified in a license agreement made part of this contract. 

 
  

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 (5) Prior government rights. 
 Technical data that will be delivered, furnished, or otherwise provided to the Government under this contract, in which the Government has previously obtained rights shall be delivered, furnished, or
provided with the pre-existing rights, unless— 
 (i) The parties have agreed otherwise; or 

(ii) Any restrictions on the Government’s rights to use, modify, reproduce, release, perform, display, or disclose the data have expired or no
longer apply. 
 (6) Release from liability. 
 The Contractor agrees to release the Government from liability for any release or disclosure of technical data made in accordance with paragraph (a)(13) or (b)(2)(iii) of this clause, in accordance with
the terms of a license negotiated under paragraph (b)(4) of this clause, or by others to whom the recipient has released or disclosed the data and to seek relief solely from the party who has improperly used, modified, reproduced, released,
performed, displayed, or disclosed Contractor data marked with restrictive legends. 
 (c) Contractor rights in technical data. All rights not
granted to the Government are retained by the Contractor. 
 (d) Third party copyrighted data The Contractor shall not, without the written
approval of the Contracting Officer, incorporate any copyrighted data in the technical data to be delivered under this contract unless the Contractor is the copyright owner or has obtained for the Government the license rights necessary to perfect a
license or licenses in the deliverable data of the appropriate scope set forth in paragraph (b) of this clause, and has affixed a statement of the license or licenses obtained on behalf of the Government and other persons to the data
transmittal document. 
 (e) Identification and delivery of data to be furnished with restrictions on use, release, or disclosure. (1) This
paragraph does not apply to restrictions based solely on copyright. 
 (2) Except as provided in paragraph (e)(3) of this clause, technical data
that the Contractor asserts should be furnished to the Government with restrictions on use, release, or disclosure are identified in an attachment to this contract (the Attachment). The Contractor shall not deliver any data with restrictive markings
unless the data are listed on the Attachment. 
 (3) In addition to the assertions made in the Attachment, other assertions may be identified
after award when based on new information or inadvertent omissions unless the inadvertent omissions would have materially affected the source selection decision. Such identification and assertion shall be submitted to the Contracting Officer as soon
as practicable prior to the scheduled date for delivery of the data, in the following format, and signed by an official authorized to contractually obligate the Contractor: Identification and Assertion of Restrictions on the Government’s Use,
Release, or Disclosure of Technical Data. 
 The Contractor asserts for itself, or the persons identified below, that the Government’s
rights to use, release, or disclose the following technical data should be restricted— 
  

							
	 Technical data

to be Furnished
 With Restrictions \1/
	  	Basis for
Assertion \2/	  	Asserted
Rights
Category \3/	  	Name of Person
Asserting
Restrictions \4/

  

 

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	 (LIST)
	  	(LIST)	 	(LIST)	 	(LIST)

 \1/ If the assertion is applicable to items,
components or processes developed at private expense, identify both the data and each such items, component, or process. 
 \2/ Generally, the
development of an item, component, or process at private expense, either exclusively or partially, is the only basis for asserting restrictions on the Government’s rights to use, release, or disclose technical data pertaining to such items,
components, or processes. Indicate whether development was exclusively or partially at private expense. If development was not at private expense, enter the specific reason for asserting that the Government’s rights should be restricted.

 \3/ Enter asserted rights category (e.g., government purpose license rights from a prior contract, rights in SBIR data generated under
another contract, limited or government purpose rights under this or a prior contract, or specifically negotiated licenses). 
 \4/ Corporation,
individual, or other person, as appropriate. 
  

			
	Date	 	  

	
	  

	Printed Name and Title
	
	  

	Signature
	
	(End of identification and assertion)

 (4) When
requested by the Contracting Officer, the Contractor shall provide sufficient information to enable the Contracting Officer to evaluate the Contractor’s assertions. The Contracting Officer reserves the right to add the Contractor’s
assertions to the Attachment and validate any listed assertion, at a later date, in accordance with the procedures of the Validation of Restrictive Markings on Technical Data clause of this contract. 

(f) Marking requirements. The Contractor, and its subcontractors or suppliers, may only assert restrictions on the Government’s rights to use,
modify, reproduce, release, perform, display, or disclose technical data to be delivered under this contract by marking the deliverable data subject to restriction. Except as provided in paragraph (f)(5) of this clause, only the following legends
are authorized under this contract: the government purpose rights legend at paragraph (f)(2) of this clause; the limited rights legend at paragraph (f)(3) of this clause; or the special license rights legend at paragraph (f)(4) of this clause;
and/or a notice of copyright as prescribed under 17 U.S.C. 401 or 402. 
 (1) General marking instructions. The Contractor, or its
subcontractors or suppliers, shall conspicuously and legibly mark the appropriate legend on all technical data that qualify for such markings. The authorized legends shall be placed on the transmittal document or storage container and, for printed
material, each page of the printed material containing technical data for which restrictions are asserted. When only portions of a page of printed material are subject to the asserted restrictions, such portions shall be identified by circling,
underscoring, with a note, or other appropriate identifier. Technical data transmitted directly from one computer or computer terminal to another shall contain a notice of asserted restrictions. Reproductions of

  
  

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technical data or any portions thereof subject to asserted restrictions shall also reproduce the asserted restrictions. 
 (2) Government purpose rights markings. Data delivered or otherwise furnished to the Government purpose rights shall be marked as follows: 

 

			
	Government Purpose Rights
		
	Contract No.	 	  

			
		
	Contractor Name	 	  

			
		
	Contractor Address	 	  

			
	
	  

			
		
	Expiration Date	 	  

 The Government’s rights to use, modify, reproduce, release, perform, display, or disclose these technical data are restricted by paragraph (b)(2) of the Rights in Technical Data—Noncommercial
Items clause contained in the above identified contract. No restrictions apply after the expiration date shown above. Any reproduction of technical data or portions thereof marked with this legend must also reproduce the markings. 

(End of legend) 
 (3) Limited rights markings.
Data delivered or otherwise furnished to the Government with limited rights shall be marked with the following legend: 
 Limited Rights

  

			
	Contract No.	 	  

			
		
	Contractor Name	 	  

			
		
	Contractor Address	 	  

	
	  

 The Government’s rights to use, modify, reproduce, release, perform, display, or disclose these technical data are restricted by paragraph (b)(3) of the Rights in Technical Data—Noncommercial
Items clause contained in the above identified contract. Any reproduction of technical data or portions thereof marked with this legend must also reproduce the markings. Any person, other than the Government, who has been provided access to such
data must promptly notify the above named Contractor. 
 (End of legend) 
 (4) Special license rights markings. (i) Data in which the Government’s rights stem from a specifically negotiated license shall be marked with the following legend: 

Special License Rights 
  

 

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 The Government’s rights to use, modify, reproduce, release, perform, display, or disclose these data
are restricted by Contract No.              (Insert contract number)             , License
No.              (Insert license identifier)             . Any reproduction of technical data or portions
thereof marked with this legend must also reproduce the markings. 
 (End of legend) 
 (ii) For purposes of this clause, special licenses do not include government purpose license rights acquired under a prior contract (see paragraph (b)(5) of this clause). 

(5) Pre-existing data markings. If the terms of a prior contract or license permitted the Contractor to restrict the Government’s rights to use,
modify, reproduce, release, perform, display, or disclose technical data deliverable under this contract, and those restrictions are still applicable, the Contractor may mark such data with the appropriate restrictive legend for which the data
qualified under the prior contract or license. The marking procedures in paragraph (f)(1) of this clause shall be followed. 
 (g) Contractor
procedures and records. Throughout performance of this contract, the Contractor and its subcontractors or suppliers that will deliver technical data with other than unlimited rights, shall— 

(l) Have, maintain, and follow written procedures sufficient to assure that restrictive markings are used only when authorized by the terms of this
clause; and 
 (2) Maintain records sufficient to justify the validity of any restrictive markings on technical data delivered under this
contract. 
 (h) Removal of unjustified and nonconforming markings. (1) Unjustified technical data markings. The rights and obligations of
the parties regarding the validation of restrictive markings on technical data furnished or to be furnished under this contract are contained in the Validation of Restrictive Markings on Technical Data clause of this contract. Notwithstanding any
provision of this contract concerning inspection and acceptance, the Government may ignore or, at the Contractor’s expense, correct or strike a marking if, in accordance with the procedures in the Validation of Restrictive Markings on Technical
Data clause of this contract, a restrictive marking is determined to be unjustified. 
 (2) Nonconforming technical data markings. A
nonconforming marking is a marking placed on technical data delivered or otherwise furnished to the Government under this contract that is not in the format authorized by this contract. Correction of nonconforming markings is not subject to the
validation of Restrictive Markings on Technical Data clause of this contract. If the Contracting Officer notifies the Contractor of a nonconforming marking and the Contractor fails to remove or correct such marking within sixty (60) days, the
Government may ignore or, at the Contractor’s expense, remove or correct any nonconforming marking. 
 (i) Relation to patents. Nothing
contained in this clause shall imply a license to the Government under any patent or be construed as affecting the scope of any license or other right otherwise granted to the Government under any patent. 

(j) Limitation on charges for rights in technical data. (1) The Contractor shall not charge to this contract any cost, including, but not limited
to, license fees, royalties, or similar charges, for rights in technical data to be delivered under this contract when— 
 (i) The
Government has acquired, by any means, the same or greater rights in the data; or 
 (ii) The data are available to the public without
restrictions. 
 (2) The limitation in paragraph (j)(1) of this clause— 
  
  

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 (i) Includes costs charged by a subcontractor or supplier, at any tier, or costs incurred by the Contractor
to acquire rights in subcontractor or supplier technical data, if the subcontractor or supplier has been paid for such rights under any other Government contract or under a license conveying the rights to the Government; and 

(ii) Does not include the reasonable costs of reproducing, handling, or mailing the documents or other media in which the technical data will be
delivered. 
 (k) Applicability to subcontractors or suppliers. (1) The Contractor shall ensure that the rights afforded its subcontractors
and suppliers under 10 U.S.C. 2320, 10 U.S.C. 2321, and the identification, assertion, and delivery processes of paragraph (e) of this clause are recognized and protected. 
 (2) Whenever any technical data for noncommercial items is to be obtained from a subcontractor or supplier for delivery to the Government under this contract, the Contractor shall use this same clause in
the subcontract or other contractual instrument, and require its subcontractors or suppliers to do so, without alteration, except to identify the parties. No other clause shall be used to enlarge or diminish the Government’s, the
Contractor’s, or a higher-tier subcontractor’s or supplier’s rights in a subcontractor’s or supplier’s technical data. 

(3) Technical data required to be delivered by a subcontractor or supplier shall normally be delivered to the next higher-tier contractor, subcontractor,
or supplier. However, when there is a requirement in the prime contract for data which may be submitted with other than unlimited rights by a subcontractor or supplier, then said subcontractor or supplier may fulfill its requirement by submitting
such data directly to the Government, rather than through a higher-tier contractor, subcontractor, or supplier. 
 (4) The Contractor and
higher-tier subcontractors or suppliers shall not use their power to award contracts as economic leverage to obtain rights in technical data from their subcontractors or suppliers. (5) In no event shall the Contractor use its obligation to
recognize and protect subcontractor or supplier rights in technical data as an excuse for failing to satisfy its contractual obligations to the Government. 
 (End of clause) 
 252.235-7004    PROTECTION OF HUMAN SUBJECTS (JUL 2009)
(a) Definitions. As used in this clause— 
 (1) Assurance of compliance means a written assurance that an institution will comply with
requirements of 32 CFR Part 219, as well as the terms of the assurance, which the Human Research Protection Official determines to be appropriate for the research supported by the Department of Defense (DoD) component (32 CFR 219.103).

 (2) Human Research Protection Official (HRPO) means the individual designated by the head of the applicable DoD component and identified in
the component’s Human Research Protection Management Plan as the official who is responsible for the oversight and execution of the requirements of this clause, although some DoD components may use a different title for this position.

 (3) Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains data
through intervention or interaction with the individual, or identifiable private information (32 CFR 219.102(f)). For example, this could include the use of human organs, tissue, and body fluids from individually identifiable living human subjects
as well as graphic, written, or recorded information derived from individually identifiable living human subjects. 
 (4) Institution means any
public or private entity or agency (32 CFR 219.102(b)). 
  

 

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 (5) Institutional Review Board (IRB) means a board established for the purposes expressed in 32 CFR
Part 219 (32 CFR 219.102(g)). 
 (6) IRB approval means the determination of the IRB that the research has been reviewed and may be
conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements (32 CFR 219.102(h)). 
 (7) Research means a systematic investigation, including research, development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition
constitute research for purposes of 32 CFR Part 219, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research
activities (32 CFR 219.102(d)). 
 (b) The Contractor shall oversee the execution of the research to ensure compliance with this clause. The
Contractor shall comply fully with 32 CFR Part 219 and DoD Directive 3216.02, applicable DoD component policies, 10 U.S.C. 980, and, when applicable, Food and Drug Administration policies and regulations. 

(c) The Contractor shall not commence performance of research involving human subjects that is covered under 32 CFR Part 219 or that meets exemption
criteria under 32 CFR 219.101(b), or expend funding on such effort, until and unless the conditions of either the following paragraph (c)(1) or (c)(2) have been met: 
 (1) The Contractor furnishes to the HRPO, with a copy to the Contracting Officer, an assurance of compliance and IRB approval and receives notification from the Contracting Officer that the HRPO has
approved the assurance as appropriate for the research under the Statement of Work and also that the HRPO has reviewed the protocol and accepted the IRB approval for compliance with the DoD component policies. The Contractor may furnish evidence of
an existing assurance of compliance for acceptance by the HRPO, if an appropriate assurance has been approved in connection with previous research. The Contractor shall notify the Contracting Officer immediately of any suspensions or terminations of
the assurance. 
 (2) The Contractor furnishes to the HRPO, with a copy to the Contracting Officer, a determination that the human research
proposed meets exemption criteria in 32 CFR 219.101(b) and receives written notification from the Contracting Officer that the exemption is determined acceptable. The determination shall include citation of the exemption category under 32 CFR
219.101(b) and a rationale statement. In the event of a disagreement regarding the Contractor’s furnished exemption determination, the HRPO retains final judgment on what research activities or classes of research are covered or are exempt
under the contract. 
 (d) DoD staff, consultants, and advisory groups may independently review and inspect the Contractor’s research and
research procedures involving human subjects and, based on such findings, DoD may prohibit research that presents unacceptable hazards or otherwise fails to comply with DoD procedures. 
 (e) Failure of the Contractor to comply with the requirements of this clause will result in the issuance of a stop-work order under Federal Acquisition Regulation clause 52.242-15 to immediately
suspend, in whole or in part, work and further payment under this contract, or will result in other issuance of suspension of work and further payment for as long as determined necessary at the discretion of the Contracting Officer. 

(f) The Contractor shall include the substance of this clause, including this paragraph (f), in all subcontracts that may include research involving
human subjects in accordance with 32 CFR Part 219, DoD Directive 3216.02, and 10 U.S.C. 980, including research that meets exemption criteria under 32 CFR 219.101(b). This clause does not apply to subcontracts that involve only the use of
cadaver materials. 
 (End of clause) 

252.235-9000    SOURCES OF INFORMATION (JULY 2000) 

 
  

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 a. The results of the research to be delivered to the Government under this Contract shall embody the most
recent reliable information in the field which is available to the Contractor from private and governmental sources, and the Contractor agrees to utilize all sources of such information available to it. In this connection, information in this field
which is in the control of DTRA shall, with the consent of the Contracting Officer’s Representative (COR) and under such safeguards and procedures as he/she may prescribe, be made available to the Contractor on request. Additionally, the
Contractor is encouraged to make use of the resources available through the Defense Threat Reduction Information Analysis Center (DTRIAC), 1680 Texas Street, Southeast, Kirtland AFB, New Mexico 87117. 

b. Reasonable assistance in obtaining access to information, or in obtaining permission to use Government or private facilities, will be given to the
Contractor by DTRA. Specifically, the Contractor must register with the Defense Technical Information Center, ATTN: DTIC, 8725 John J. Kingman Road, Suite 0944, Fort Belvoir, VA 22060-6218, in accordance with Defense Logistics Agency (DLA)
Regulation 4185.10, Certification and Registration for Access to DoD Defense Technical Information. DD Form 1540, the registration form, shall be forwarded to the DTRA Contracting Officer for approval (DFARS 35.010(b)). 

(End of clause) 

252.242-9000    CONTRACTOR PERFORMANCE ASSESSMENT REPORTING SYSTEM (CPARS) 
 1. As required by FAR Part 42.1503, and DTRA policy for the Contractor Performance Assessment Reporting System (CPARS) and Past Performance Automated Information System (PPAIS) effective July, 2001,
the Government shall complete a CPAR each year of the period of performance of this contract. The contractor will have an opportunity to provide their comments in each CPAR before it is finalized. In accordance with DTRA CPARS policy the completed
CPARs will be entered into the Department of Defense Past Performance Automated Information System (PPAIS), a retrieval system for source selection teams to access the CPARs of contractors’ performance. The DTRA CPARS and PPAIS policy includes
an explanation of the process and procedures that will be utilized under this contract. A copy is available for contractor reference via the DTRAlink (www.dtra.mil) by accessing Acquisition, How We Do Business. 

2. The CPARs shall occur annually in accordance with the schedule established below: 
 (i) Initial CPAR: 12 months after contract start date (date performance begins) 

TBD (by PCO) 
 (ii) Interim
CPAR(s) will be performed annually on the anniversary of the contract start date according to the following schedule: 
 TBD (by
PCO) 
 (iii) A Final CPAR will be completed upon contract termination, transfer of program management/contract management responsibility
outside of DTRA, the delivery of the final end item on contract and/or the completion of the performance period. 
 (iv) An Out-of-Cycle CPAR
may be required when there is a significant change in performance that alters the assessment in one or more evaluation area(s). An Out-of-Cycle CPAR is optional and shall be processed in accordance with
Attachment              
 3. Each CPAR shall only cover the period
elapsing from the last annual CPAR. The final CPAR shall not be used to summarize or “roll-up” the contractor’s performance under the entire contract. Each annual CPAR and the final CPAR together will comprise a total picture of
contractor performance. 
  
  

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 4. At the request of the Government, a verbal, informal review of the Contractor’s performance may be
held 3-6 months before the completion of the Interim or Final Evaluation periods. This review entails discussing any problems or areas of concern regarding the Contractor’s performance to date. No written evaluation form or other formal
documentation is required for this evaluation. It may be conducted with the Contractor by telephone, teleconference or face-to-face. This is designed to offer the Contractor an opportunity to correct known deficiencies or weaknesses prior to the
formal written evaluation. 
 5. As set forth in DTRA CPARS policy, any disagreements between the Contractor and the Program Manager regarding
the CPAR(s) that cannot be resolved shall be reviewed by the designated Reviewing Official prior to finalization of the CPAR. 
 6. Special
Requirements for Indefinite Delivery Contracts (IDIQ and Requirements type), CPARs shall be processed (select one) 

             for all existing orders (combined) at the time the CPAR is processed

              on an order-by-order basis 

             on a grouped order basis 

7. The policy and procedures set forth in this clause and DTRA CPARS policy are not subject to “Disputes” as described in FAR Part 33.

 252.245-9000    Government Property (AUG 2009) 
 (a) In accordance with FAR 52.245-1(b), Property Management, and FAR 52.245-1(f), Contractor Plans and Systems, the Contractor shall have a system to manage (control, use, preserve, protect, repair and
maintain) Government property in its possession. 
 (b) The Contract Data Requirements Lists (CDRLs) associated with the Property for this
Contract are contained in Exhibit “A” and included in Section J of this contract. The spreadsheet required by the CDRL entitled “Master Government Property List (MGPL) will be incorporated in Section J of this contract.

 (c) The Contractor shall provide to the Government an updated MGPL according to the CDRL. 

(d) The Government Site Visits/Physical Inventory – The DTRA will annually verify the Property in the Possession of the Contractor. The
Contactor’s Point of Contact shall coordinate with the Program Manager/Contracting Officer Representative or DTRA Accountable Property Officer (APO) on prearranged site visits upon request. 

(e) The Contractor shall annually conduct and provide to the DTRA a physical inventory report of ALL Government Property in its possession according to
the Master Government Property List (Physical Inventory) CDRL. 
 (f) The physical inventory report shall be validated/confirmed via signature
by both the Contractor’s Property Administrator and the DTRA’s Government Representative (i.e. COR, APO, etc.). Inventory discrepancies must be reported immediately to the Contracting Officer, COR/Program Manager and resolved by the DTRA
APO. 
 (g) The Contractor shall provide all CDRL reports to the Government electronically in a spreadsheet using Microsoft Office Excel. Unless
otherwise specified, the contractor shall submit all data through the IUID Registry. 
  

 

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 (End of Clause) 
 252.247-9000    GOVERNMENT CONTRACTOR TRAVEL (JUL 2007) 
 The Joint Travel
Regulation (JTR), Appendix E, Part I.A.1.b., states invitational travel applies to individuals acting in a capacity that is related directly to, or in connection with, official DOD activities; however, this does not include a
contractor’s employee traveling in the performance of the contract. Appendix E, Part I.B.4. RESTRICTIONS, further states invitational travel must not be authorized for contractors. Appendix E, Part III states neither the JFTR nor the
JTR may be used as official contractor travel regulations as they apply to uniformed personnel and Defense Department civilian employees and contain provisions, the use of which is illegal by contractors. The JTR can be viewed at
https://secureapp2.hqda.pentagon.mil/perdiem 
 Discounts may be obtained for some travel related services (identified below); however,
commercial vendors are under no obligation to extend Government rates for the Government’s travel and transportation programs to contractors working on behalf of the Federal Government. Contractors must contact their Contracting Officer
Representative (COR) to obtain a Government Contractor Official Travel Letter of Identification, signed by the authorizing Contracting Officer. 

Contract City-Pair Air Passenger Transportation Program and Other Government Fares. Use of GSA contract city-pair air passenger fares is governed
by GSA’s contracts with the airlines and by the Defense Transportation Regulation (DOD 4500.9-R), Part I, Chapter 103. Use of other airfares reserved for Government employees on official business is governed by the airline fare
structure and rules. Government contractors are not eligible to participate in the GSA city-pairs program for air passenger transportation services as of October 1, 1998. 
 Rail Service. Commercial passenger rail vendors may voluntarily offer discount rates to contractors traveling who are on official Government business at the vendor’s discretion. 

Lodging Programs. GSA and Services’ lodging programs may voluntarily offer discount rates to contractors who are on official Government
business at the vendor’s discretion. 
 Car Rental Program. Military Surface Deployment and Distribution Command (SDDC) negotiates
special rate agreements with car rental companies available to all Government employees and uniformed personnel while traveling on official Government business. Some commercial car rental companies may voluntarily offer similar discount rates to
Government contractors at the vendor’s discretion. 
 The following have been deleted: 

 

							
	 52.216-23
	  	Execution And Commencement Of Work	  	APR 1984	  	
	 52.216-24
	  	Limitation Of Government Liability	  	APR 1984	  	
	 52.216-26
	  	Payments Of Allowable Costs Before Definitization	  	DEC 2002	  	
	 252.217-7027
	  	Contract Definitization	  	OCT 1998	  	

 (End of Summary of Changes) 

 
  

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 AVI BioPharma Project - H1N1 Countermeasure Development 

Original: 19 May 2010 
 Revision: 17 June 2010 
 Statement of Work 

 

	1.	OBJECTIVE 

 Completion of the tasks
described in this Statement of Work (SOW) will enable human clinical evaluation of the safety of AVI BioPharma’s lead compound as a therapeutic against influenza, initially against H1N1 and potentially against H5N1 and H3N2 strains if the
animal efficacy data are promising. The need for a broadly applicable influenza therapeutic is great given the emergence of multidrug resistant influenza strains. The urgency for such a therapeutic is linked to the capacity for influenza
reassortants to acquire viral segments that will confer drug resistance. A resurgence of the 2009 pandemic causative H1N1 strain in a multidrug resistance form would leave many patients without adequate treatment. 

 

	2.	SCOPE 

 This proposal builds on AVI
BioPharma’s novel RNA-based therapeutic platform in two critical areas. First the work builds on the experience with H1N1 influenza in the evaluation of AVI-7100 (previously designated as AVI-7367) for the purpose of inhibiting multiple
serotypes of influenza viral growth and pathogenesis. Second the work expands the depth of understanding in the potential for relatively rapid response to emerging infectious diseases or to designed biological threats in the biological warfare
setting. During the period of this proposal, AVI BioPharma will progress AVI-7100 from the remaining research phase activities, through IND-enabling preclinical studies, transfer manufacturing from the development to cGMP manufacturing facilities,
and complete two Phase I human clinical safety trials in normal healthy volunteers. 
  

	3.	BACKGROUND 

 The Orthomyxoviridae
comprised of Influenza A, B and C are enveloped viruses with negative-sense, single stranded and segmented RNA genomes. Among this family the Influenza A viruses, containing 8 RNA segments, are capable of undergoing rapid and extensive
“shifts” in antigenic composition through RNA segment reassortment between different strains resulting in a quantum genome change. Minor antigenic changes or “drift” also occur due to an accumulation of mutations in the coding
regions of the different segments due to relatively low fidelity polymerase Influenza virus gains entry to cells through the binding of a hemagglutinin (HA) molecule 

 
  

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to sialic acid residues on host cells. Humans express sialic acids on the cell surface linked as a 2,6 N-glycans while birds express the sialic acid
linked through a 2,3 N-glycans. An avian virus that acquires the ability to bind a 2, 6-linked sialic acids by mutation or reassortment acquires the potential
capability to infect human cells. Swine tissues express both forms of sialic acid enabling porcine cells to be co-infected with avian and human viruses. Swine adapted viruses can further recombine with human and avian viruses to produce triple
reassortants such as the current swine-origin influenza A (H1N1) virus (S-OIV) with segments from pigs (HA, NP, NA, M and NS), human (PB1), and bird. (PB2 and PA) 
 The S-OIV pandemic emerged in 2009 resulting from the spread of a new strain of H1N1. As of 25th of April, worldwide more than 214 countries and overseas territories or communities have reported
laboratory confirmed cases of pandemic influenza H1N1 2009, including over 17,919 deaths. Evidence of resistance to common treatments (oseltamivir) is emerging. The cumulative total for reports of antiviral resistant isolates of pandemic (H1N1) 2009
virus is 285. There have been no new cases reported since the situation update on 7 May 2010. 
 In the US the CDC developed a method to
provide an estimated range of the total number of 2009 H1N1 cases, hospitalizations and deaths in the United States, as well as a breakdown of these estimates by age groups. This method uses data on influenza-associated hospitalizations collected
through CDC’s Emerging Infections Program, which conducts surveillance for laboratory-confirmed influenza-related hospitalizations in children and adults. Currently an estimated 60 million people were infected with H1N1 (range of 43
to 88 million cases) between April 2009 and March 13, 2010. The number of people hospitalized due to H1N1 during this period is estimated at 270,000 cases (range of 192, 000 to 398,000 cases). During this period an estimated 12,270
deaths were related to H1N1 (range of 8,720 to 18,050 cases). 
 The data by age provided in the updated estimates continues to confirm that
people younger than 65 years of age are more severely affected by this disease relative to people 65 and older compared with seasonal flu. With seasonal influenza, about 60 percent of seasonal flu-related hospitalizations and 90 percent of
flu-related deaths occur in people 65 years and older. With 2009 H1N1, approximately 90% of estimated hospitalizations and 87 percent of estimated deaths from April through March 13, 2009 occurred in people younger than 65 years
old, based on this method. 
  
  

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	4.	TASKS 

 The following eight tasks define
the administrative, technical and operational activities to be performed. 
 TASK 1 – [†]:[†] 

TASK 2 – [†]:[†] 

[†]:[†] 

[†]:[†] 
  

 

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 TASK 3. [†] 
 Task 3.1. [†]. 
 [†] 
 [†] 
 [†] 
 Task 3.2 [†]. 
 [†] 
 TASK 4: [†]. 
 [†] 
 Task 4.1 [†]. 
 [†] 
  
  

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 [†] 
 Task 4.2 & 4.3 [†]. 
 [†] 

[†] 
 [†] 

TASK 5. [†]. 
 [†] 

 
  

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 Task 5.1 [†]. 
 [†] 
 Task 5.2 [†]. 
 [†] 
 Task 5.3. [†]. 
 [†] 
 [†] 

 
  

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 [†] 
 Task 5.4 [†]:[†] 
 [†] 

[†] 
  

 

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 Task 5.5. [†]:[†] 
 [†] 
 [†] 
 Task 5.6 [†]:[†] 
 [†] 

 
  

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 [†] 
 TASKS 6. [†]. 
 [†] 
 Task 6.1. [†]: 
 [†] 
  
  

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 [†] 
 Task 6.2. [†]. 
 [†] 
 Task 6.3. [†] 
 [†] 
 Task 6.4. [†] 
 [†] 
  
  

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 TASK 7. [†]. 
 [†] 
 Task 7.1. [†]. 
 [†] 
 Task 7.2. [†]. 
 [†] 
  

 

	†	DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

  

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 TASK 8. [†]. 
 [†] 
 Task 8.1. [†]. [†] 

Task 8.2 [†]. [†] 
 Task 9.
[†]. 
 [†] 
  

 

	†	DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

  

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 Task 9.1. [†]. 
 [†] 
 Task 9.3. [†]. [†] 

Task 9.4. [†]. [†] 
  

 

	†	DESIGNATES PORTIONS OF THIS DOCUMENT THAT HAVE BEEN OMITTED PURSUANT TO A REQUEST FOR CONFIDENTIAL TREATMENT FILED SEPARATELY WITH THE COMMISSION

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