Document:

Exhibit 10.81

 

Portions of this document have
been redacted pursuant to a confidential treatment request and filed separately
with the Securities and Exchange Commission. Redacted portions have been
replaced with “*****”.

 

	
  AMENDMENT OF SOLICITATION/MODIFICATION OF
  CONTRACT

  	
  1.
  CONTRACT ID CODE

  	
  PAGE OF PAGES

  
	
  

  U

  	
  

  1

  	
  

  6

  
	
  2.
  AMENDMENT/MODIFICATION NO.

  	
  3.
  EFFECTIVE DATE

  	
  4.
  REQUISITION/PURCHASE REQ. NO.

  	
  5.
  PROJECT NO.(If applicable)

  
	
  P00003

   

  	
  25-Mar-2010

  	
  SEE SCHEDULE

  	
   

  
	
  6. ISSUED BY

  	
  CODE

  	
   HDTRA1

  	
  7.
  ADMINISTERED BY (If other than item 6)

  	
  CODE

  	
   S2401A

  
	
   

  	
   

  	
       DCMA TWIN CITIES

  	
   

  	
   

  
	
       DEFENSE THREAT REDUCTION AGENCY/BE-BC

  	
       B.H.
  WHIPPLE FEDERAL BLDG., RM 1150

  	
   

  
	
       8725 JOHN J. KINGMAN ROAD, MSC 6201

  	
       FT.
  SNELLING MN 55111

  	
   

  
	
       FORT BELVOIR VA 22060-6201

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  8. NAME AND ADDRESS OF
  CONTRACTOR (No., Street, County, State and Zip Code)

  	
   

  	
  9A. AMENDMENT OF
  SOLICITATION NO.

  
	
       AVI
  BIOPHARMA, INC.

  	
   

  	
   

  
	
       J. DAVID BOYLE II

  	
   

  	
  9B. DATED (SEE ITEM 11)

  
	
       4575 SWRESEARCH WAY STE 200

  	
   

  	
   

  
	
       CORVALLIS
  OR 97333-1299

  	
  x

  	
  10A. MOD. OF
  CONTRACT/ORDER NO.

  HDTRA1-09-C-0046

  
	
   

  	
   

  	
  10B. DATED (SEE ITEM 13)

  
	
  CODE    49WU1

  	
  FACILITY CODE

  	
  x

  	
  05-May-2009

  
	
   

  11. THIS ITEM
  ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

   

  
	
  o

  	
  The above numbered
  solicitation is amended as set forth in Item 14. The hour and date specified
  for receipt of Offer

  	
  o is extended,

  	
  o is not extended.

  
	
   

  	
   

  Offer 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 you 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)

        See Schedule

  
	
   

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

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

   

  
	
  o

  	
  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.

  
	
  o

  	
  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:

  FAR 52.243-2 Alt V.
  Changes

  
	
  o

  	
  D.  OTHER
  (Specify type of modification and authority)

   

  
	
  E.   IMPORTANT:    Contractor    o     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:      hyattc10960

  
	
  The purpose
  of this contract modification is to add tasks per SOW (Attach 1b), add funds
  in the amount of $3,970,094.20 and extend the POP on subject contract.

  
	
   

  
	
  AIC# CBM100017478

  
	
   

  
	
   

  
	
  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)

  	
  16A. NAME AND
  TITLE OF CONTRACTING OFFICER (Type or print)

  
	
  /s/
  J. David Boyle II

  Sr. VP & CFO

  	
  Terese M. Herston
  

  Contracting Officer 

  Defense Threat Reduction Agency

  
	
   

  	
  TEL:  

  	
  EMAIL:  

  
	
  15B. CONTRACTOR/OFFEROR

  	
  15C. DATE SIGNED

  	
  16B. UNITED
  STATES OF AMERICA

  	
  16C. DATE SIGNED

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  /s/ J. David
  Boyle II

  	
   

  	
   

  	
   

  	
  BY  /s/ Terese
  M. Herston

  	
   

  	
   

  
	
   

  	
  (Signature of
  person authorized to sign)

  	
   

  	
  3/24/2010

  	
   

  	
  (Signature
  of Contracting Officer)

  	
   

  	
  3/25/10

  
	
  EXCEPTION TO SF 30

  	
  30-105-04

  	
  STANDARD FORM 30
  (Rev. 10-83)

  
	
  APPROVED BY OIRM 11-84

  	
   

  	
  Prescribed by GSA

  
	
   

  	
   

  	
  FAR (48 CFR) 53.243

  
																										

 

 

HDTRA1-09-C-0046

(hyattc10960)

Page 2 of 6

 

SECTION SF 30 BLOCK 14
CONTINUATION PAGE

 

SUMMARY OF CHANGES

 

SECTION A -
SOLICITATION/CONTRACT FORM

 

The total cost of this
contract was increased by $3,970,094.20 from $4,103,402.95 to $8,073,497.15.

 

SECTION B - SUPPLIES OR
SERVICES AND PRICES

 

CLIN 0002

This CLIN has been renumbered
to CLIN 0003.

 

CLIN 0002 is added as
follows:

 

	
  ITEM NO

  	
   

  	
  SUPPLIES/SERVICES

  	
   

  	
  QUANTITY

  	
   

  	
  UNIT

  	
   

  	
  UNIT
  PRICE

  	
   

  	
  AMOUNT

  	
   

  
	
  0002

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Lot

  	
   

  	
   

  	
   

  	
  $

  	
  3,970,094.20

  	
   

  
	
   

  	
   

  	
  Non-Personal
  Services

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  CPFF

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  The contractor shall
  perform the tasks listed in the Statement of Work entitled “H1N1
  Countermeasure Development Extended Influenza Therapeutic Studies,” dated December 17,
  2009.  

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
  FOB: Destination

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  ESTIMATED
  COST

  	
   

  	
  $

  	
  3,694,954.61

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  FIXED
  FEE

  	
   

  	
  $

  	
  275,139.59

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  TOTAL
  EST COST + FEE

  	
   

  	
  $

  	
  3,970,094.20

  	
   

  
	
   

  	
   

  	
  ACRN AC

  	
   

  	
   

  	
   

  	
  $

  	
  3,970,094.20

  	
   

  
	
   

  	
   

  	
  CIN: CBM1000174780002

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

SECTION C - DESCRIPTIONS
AND SPECIFICATIONS

 

The following have been
modified:

 

252.211-9000 Description/Specifications/Work
Statement

 

The Contractor shall provide
the supplies and/or services set forth in Section B, in accordance with
the following:

 

a. Statement of Work entitled
“AVI BioPharma PMO Platform – HIN1 Countermeasure Development’, Dated 1 May 2009,
Attachment 1 to the Contract and 5 May 2009, Attachment la to the
contract.

AND:

 

2

 

HDTRA1-09-C-0046

(hyattc10960)

Page 3 of 6

 

Statement of
Work entitled “H1N1 Countermeasure Development Extended Influenza Therapeutic
Studies,” dated December 17, 2009.

 

b. Contract Data Requirements List (DD Form 1423),
Exhibit A to the Contract

 

SECTION E - INSPECTION AND ACCEPTANCE

 

The following Acceptance/Inspection Schedule
was added for CLIN 0002:

 

	
  INSPECT AT

  	
   

  	
  INSPECT BY

  	
   

  	
  ACCEPT AT

  	
   

  	
  ACCEPT BY

  	
   

  
	
  Destination

  	
   

  	
  Government

  	
   

  	
  Destination

  	
   

  	
  Government

  	
   

  

 

SECTION F - DELIVERIES OR PERFORMANCE

 

The following Delivery Schedule Item has been
deleted from CLIN 0002:

 

	
  DELIVERY DATE

  	
   

  	
  QUANTITY

  	
   

  	
  SHIP TO ADDRESS

  	
   

  	
  UIC

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  POP 05-MAY-2009 TO

  04-APR-2010

  	
   

  	
  N/A

  	
   

  	
  DEFENSE THREAT REDUCTION

  AGENCY/RD-CBM

  HEATHER MANLEY

  8725 JOHN J KINGMAN ROAD,
  MAIL

  STOP 6201,

  FORT BELVOIR VA 22060

  703-767-6281

  FOB: Destination

  	
   

  	
  HDTRA1

  

 

The following Delivery Schedule item has been
added to CLIN 0002:

 

	
  DELIVERY DATE

  	
   

  	
  QUANTITY

  	
   

  	
  SHIP TO ADDRESS

  	
   

  	
  UIC

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  POP 05-MAY-2009 TO

  30-SEP-2010

  	
   

  	
  N/A

  	
   

  	
  DEFENSE THREAT REDUCTION

  AGENCY/RD-CBM

  HEATHER MANLEY

  8725 JOHN J KINGMAN ROAD,
  MAIL

  STOP 6201,

  FORT BELVOIR VA 22060

  703-767-6281

  FOB: Destination

  	
   

  	
  HDTRA1

  

 

SECTION G - CONTRACT ADMINISTRATION DATA

 

Accounting and Appropriation

 

Summary for the Payment Office

 

As a result of this
modification, the total funded amount for this document was increased by
$3,970,094.20 from $4,103,402.95 to $8,073,497.15.

 

3

 

HDTRA1-09-C-0046

(hyattc10960)

Page 4 of 6

 

CLIN 0002:

Funding on CLIN 0002 is initiated as follows:

 

ACRN: AC

 

CIN: CBM1000174780002

 

Acctng Data: 9700400.2620
1000 B63D 255999 BD32742000 S49012 DODAAC: HD1115

 

Increase: $3,970,094.20

 

Total: $3,970,094.20

 

SECTION I - CONTRACT CLAUSES

 

The following have been modified:

 

52.244-2     SUBCONTRACTS
(JUN 2007)

 

(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.

 

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:

 

4

 

HDTRA1-09-C-0046

(hyattc10960)

Page 5 of 6

 

(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.

(iii) Identification of
the proposed subcontractor.

(iv) The proposed
subcontract price.

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

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

(vii) A negotiation
memorandum reflecting—

 

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

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

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

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

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

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

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

 

(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).

 

(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:

 

Tulane University

Burleson Research Technologies

Battelle

OSU

 

5

 

HDTRA1-09-C-0046

(hyattc10960)

Page 6 of 6

 

Helix

 

(End of clause)

 

SECTION J - LIST OF DOCUMENTS, EXHIBITS
AND OTHER ATTACHMENTS

 

The following have been modified:

LIST
OF DOCUMENTS & EXHIBITS

 

	
  ATTACHMENT

  	
   

  	
  DESCRIPTION

  
	
   

  	
   

  	
   

  
	
  1

  	
   

  	
  Statement of Work, entitled
  “AVI BioPharma PMO Platform - H1N1 Countermeasure Development”, dated 1
  May 2009, 1 Page

  
	
   

  	
   

  	
   

  
	
  la

  	
   

  	
  Statement of Work, entitled
  “AVI BioPharma PMO Platform - H1N1 Countermeasure Development”, dated 5
  May 2009, 2 Pages

  
	
   

  	
   

  	
   

  
	
  1b

  	
   

  	
  Statement
  of Work entitled “H1N1 Countermeasure Development Extended Influenza Therapeutic
  Studies,” dated December 17, 2009.

  
	
   

  	
   

  	
   

  
	
  2

  	
   

  	
  Exhibit A — CDRLs, 2
  Pages dated 30 April 2009

  

 

(End of Summary of Changes)

 

 

HDTRA1-09-C-0046/P00003

Attachment
Number 1b

 

Statement of Work

H1N1 Countermeasure Development Extended Influenza Therapeutic Studies

December 17, 2009

 

1.                                           OBJECTIVE:

 

The objective is perform a dose dependant
study against H1N1, as well perform therapeutic studies against H5N1 (Avian
Flu), Tamiflu resistant H1N1 and H3N2. The rapid response to identify a lead
RNA based therapeutic for H1N1 has been successful in both mouse and ferret
models to date. An H3N2 viral isolate was selected for mouse studies because no
mouse adapted S-OIV virus was available and the studies were designed to mimic
the emerging clinical observations as the pandemic expands. While rapid
response concerns were directed at H1N1 S-OIV initially, the threat for H5N1
has not been diminished. Further, the need for a broadly applicable flu
therapeutic is great given the emergence of multidrug resistance 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.

 

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 BioPharma’s
compounds 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 disease or
designed biological threats in the biowarfare setting.

 

3.                                           BACKGROUND:

 

The Orthomyxoviridae
are viruses with negative-sense, single stranded and segmented RNA
genomes. The influenza A are members of the orthomyxoviridae with 8 RNA
segments. The influenza virus genome is dynamic resulting in new vaccine
antigens because of shift, mutation and drift. Shift involves a reassortant
strains involving shuffling of the RNA segments between different viruses
resulting in a quantum genome change. The current S-OIV (H1N1) is a triple
reassortant virus with segments from pigs (HA, NP, NA M and NS), humans (PB1),
and birds (PB2 and PA). Mutations arise as a result of replication errors due
to a relatively low fidelity polymerase.

 

Influenza virus gains entry
to cells through the binding of a hemagglutinin (HA) molecule 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 may cross the species barrier. Swine tissues express
both forms of sialic acid enabling cells to be coinfected with avian and human
viruses. Swine adapted viruses can further combine with human and avian viruses
to produce triple reassortants such as the current SOIV (H1N1) with segments
from pigs (HA, NP, NA, M and NS), humans (PB1), and birds (PB2 and PA).

 

The current SOIV (H1N1) has
led to 684 deaths from 126,168 cases reported worldwide from April 4 to July 16,
2009. This leads to a case fatality ratio of 0.6 percent

 

1

 

HDTRA1-09-C-0046/P00003

Attachment Number 1b

 

4.                                     TASKS:

 

The following nine tasks define the
administrative, technical and operational activities to be performed.

 

4.1                               TASK 1 -
Program Management: A team of individuals at AVI
BioPharma will work together to facilitate the completion of the proposed work.

 

4.2                               TASK 10 -
Manufacture of lead compounds to support additional
ferret studies: Additional manufacturing will be required to support
the additional ferret studies.

 

4.3                               TASKS
- 11 and 12
Evaluation of lead compounds in Tamiflu resistant H1N1 S-OIV:

 

Proposed
Study Design:

1. Route of viral challenge-
intranasal

2. Route of drug delivery-
subcutaneous or intravenous

a.               Anesthesia

b.              Time of dose
with respect to viral challenge to be determined

3. Dose and design:

a.               Intended dose
escalation study with lead compound

b.              Include scramble
sequence control, saline control and Oseltamivir positive control

4. Propose repeat evaluation
study

5.
Animals: 8 groups of 6 ferrets of both genders randomized to each cohort (if
single gender only then please provide rationale)

6. Viral challenge

a.               Study 5 and 6: H1N1  (Tamiflu
resistant H1N1 strain from 2009 obtained from CDC)

7. Study design:

 

TABLE 1. Ferret Study 5 and Repeat (Study 6)

 

	
  Group

  	
   

  	
  Dose Interval

  	
   

  	
  Dose

  mg/kg

  	
   

  	
  Treatment

  Schedule

  	
   

  	
  Agent

  	
   

  	
  Animals(1)

  	
   

  
	
  1

  	
   

  	
  *****(2)

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  AVI Lead agent

  	
   

  	
  6

  	
   

  
	
  2

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  AVI Lead agent

  	
   

  	
  6

  	
   

  
	
  3

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  AVI Lead agent

  	
   

  	
  6

  	
   

  
	
  4

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  Scramble agent

  	
   

  	
  6

  	
   

  
	
  5

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  Scramble agent

  	
   

  	
  6

  	
   

  
	
  6

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  Scramble agent

  	
   

  	
  6

  	
   

  
	
  7

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  Oseltamivir

  	
   

  	
  6

  	
   

  
	
  8

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  *****

  	
   

  	
  Saline (vehicle)

  	
   

  	
  6

  	
   

  

 

(1) Availability of
females may not be feasible. If the first study is all males then repeat
studies must include females.

(2) *****

 

8.               Efficacy Endpoints

a.               A composite
endpoint: Nasal washing viral load AUC reduced by >75% at 96 hours and at
least a directionally consistent favorable effect is seen on nasal washing
inflammatory cell count AUC, fever and clinical signs.

b.              Efficacy
measures Day 0 to 7:

 

2

 

HDTRA1-09-C-0046/P00003

Attachment Number 1b

 

	
  i.

  	
   

  	
  Viral titer in nasal wash
  each day

  
	
  ii.

  	
   

  	
  Body temperature- monitored
  by telemetry

  
	
  iii.

  	
   

  	
  Weight loss- body weight
  measured daily

  
	
  iv.

  	
   

  	
  Signs of respiratory
  distress- clinical score

  
	
  v.

  	
   

  	
  Activity score

  

c.               Sacrifice 3
ferrets per group on day 3 and Day 7 to collect organs for histopathology
evaluation and viral titers in lung and spleen (save samples for sequence
determination of persistent virus, possible insight into resistance
mechanisms).

d.              Please indicate
method for determining viral titer, Q-RT-PCR or plaque assay

 

9.               Safety Endpoints

a.               No test-article-related
mortality, severe adverse events, or pulmonary findings of significant concern.

 

4.4                               TASKS
13 and 14: Evaluation of lead compounds in Emerging Avian Influenza A (H5N1)

Proposed Study Design: (Items
1-5 see above)

6.               Viral challenge Study 7 and
8: H5N1 (A/Vietnam/1203/04 obtained from CDC)

7.               Study design (see Table 1
above):

8.               Efficacy Endpoints (see
above)

9.               Safety Endpoints (see above)

 

4.5                               TASKS
15 and 16: Evaluation of lead compounds in ferret model of seasonal H3N2

Proposed Study Design: (Items
1-5 see above)

6.          Viral challenge Study 9 and
10: H3N2 (A/HongKong/68 obtained from CDC)

7.          Study design(see Table 1
above):

8.          Efficacy Endpoints (see
above)

9.          Safety Endpoints (see above)

 

4.6                               TASK 17 -
Pharmacokinetic, Pilot Toxicology and Mechanism of
Action Studies: The  rapid response provides an
agent that is active in an animal model but confidence needs to be established
for extending studies to humans. Greater flexibility is desired for the
considerations of route of administration, dose estimation and dose interval.
These parameters are determined from pharmacokinetic evaluation of the lead
therapeutic agent.

 

Initial studies to determine
the binding affinity of the lead for the target RNA will be established using a
BiaCore to measure association, dissociation and equilibrium binding constants
and establishment of an ID50 will be evaluated by in vitro translation.
Together these will facilitate the relationship between concentration and
efficacy and provide supportive information for interpretation of tissue concentrations

 

Prior to conducting
pharmacokinetic studies, an analytical method must be established. The
contractor will establish initial feasibility studies with their subcontractor
to conduct analysis of blood, tissue and urine samples. The subcontractor has developed
a 96 parallel assay technique, which is essential for rapid response evaluation
of pharmacokinetic information.

 

TASK 18 -
Rapid Response II (Additional Sequence Synthesis): An additional
rapid response exercise is planned for 2010. The exercise involves planning
monthly visits to Washington DC to meet with other groups under TMTI contracts.
The purpose of the meetings is to integrate and plan for information

 

3

 

HDTRA1-09-C-0046/P00003

Attachment Number 1b

 

transfer of sequence
information regarding infectious agents of interest to TMTI. The remaining
elements of the task are to design and synthesize oligomers for this rapid
response exercise. Time for program management under this task is included.

 

5.                                      DELIVERABLES

 

In accordance with Exhibit A.

 

4Exhibit 10.32

 

INDEPENDENT
CONTRACTOR AGREEMENT

 

INDEPENDENT
CONTRACTOR AGREEMENT dated September 9, 2009 between Hans Joerg Hunziker (“Contractor”)
whose address is Hunziker Lease and Finance, Zeughausgasse 9a, 6301, Zug,
Switzerland, and Willis Lease Finance Corporation, a Delaware corporation (“Willis
Lease”) whose address is 773 San Marin Drive, Suite 2215, Novato, CA 94998.  Contractor and Willis Lease are sometimes
referred to in this Agreement individually as a the “Party” or collectively as
the “Parties.”

 

R E C I T A L S

 

A.            Contractor has substantial experience and expertise in
the European capital markets.

 

B.            Willis Lease desires to retain the services of
Contractor, and Contractor desires to perform services for Willis Lease, on the
terms and conditions hereinafter set forth.

 

A G R E E M E N T

 

The Parties agree
as follows:

 

1.             Services.  During the
term of this Agreement, and subject to the terms and conditions hereinafter set
forth, Contractor agrees to perform services in connection with the identification
and qualification of potential investors in equity securities of Willis Lease.  Such services shall be performed from time to
time as requested by Charles F. Willis, President and Chief Executive Officer
of Willis Lease, or his designee.

 

2.             Term and Termination.

 

(a)           Term.  The term
of this Agreement shall commence September 1, 2009 and shall continue
through October 30, 2010.

 

(b)           This Agreement shall terminate at the option of the
unaffected party upon the occurrence of any of the following events:

 

(i)            The dissolution or liquidation of Willis Lease;

 

(ii)           The death or total disability of Contractor.  Total disability is any disability which
prevents Contractor from performing services hereunder for a period of twenty-one
consecutive days, or thirty nonconsecutive days;

 

1

 

(iii)          A breach by Contractor of any of Contractor’s
covenants under this Agreement which Contractor fails to cure within ten  days after written notice of such breach;

 

(iv)          The mutual written agreement of the parties to this
Agreement; or

 

(v)           Thirty days after written notice by either Party to
the other Party.

 

(c)           On termination of this Agreement for any reason
whatsoever, (i) Willis Lease shall pay to Contractor all amounts accrued
under paragraph 3 hereof up to the date of termination; (ii) Contractor
shall deliver to Willis Lease any and all completed and uncompleted tasks which
Contractor may have been performing at the time of the termination as well as
all Willis Lease data and information, in written, recorded or physical form
concerning the subject of this Agreement and entrusted to or developed by Contractor
during the term of  this Agreement; and (iii) the
terms and provisions of this Agreement shall have no further force or effect
except for Sections 6 and 9 which shall survive the termination of this
Agreement.

 

(d)           All amendments to this Agreement must be in writing
and executed by both Parties prior to the amendment taking effect.

 

3.             Compensation and Payment.

 

(a) In
consideration of the services performed by Contractor hereunder, Contractor
shall be paid fees at the rate of $200 per hour, up to a maximum of $14,000 per
month for any calendar month and not to exceed $115,000 for any 12 month period.

 

(b)     Willis Lease will reimburse Contractor for reasonable out
of pocket expenses incurred in the performance of his duties under this
Agreement.  Expenses in excess of
US$2,500 shall be pre-approved by Willis Lease.

 

(c)   Contractor shall invoice Willis Lease bi-weekly
describing, in reasonable detail, his activities in performing the services
under this Agreement.

 

4.             Relationship of the Parties.

 

(a)           Contractor
is a member of the Board of Directors of Willis Lease.  Notwithstanding that fact, the Parties intend
that the relationship between them created by this Agreement is that of principal
and independent contractor.  Neither
Contractor nor any agent, employee, or servant of Contractor shall be or shall
be

 

2

 

deemed
to be an agent, employee, or servant of Willis Lease.  The manner and means of performing services
under this Agreement shall be under the sole control of Contractor.  None of the benefits provided by Willis Lease
to its employees (including, but not limited to, compensation, insurance,
vacation pay, sick leave, profit sharing, health insurance and workers’
compensation insurance) shall be available to Contractor or any agent, employee
or servant of Contractor.  Contractor
shall be solely and entirely responsible for his acts and for the acts of his
agents, employees, servants, and subcontractors during the performance of
services under this Agreement. Contractor specifically acknowledges he is
covered under his own workers’ compensation and will not be covered under the
workers’ compensation or other insurance of Willis Lease.

 

(b)           During the term of this Agreement, including any
extensions or renewals thereof, Contractor shall perform all of the duties
required of him under the terms of this Agreement.

 

(c)           Contractor acknowledges that he does not have the
authority to bind Willis Lease to any contract, nor does Contractor have the
authority to enter into contracts on behalf of Willis Lease.  Each Party agrees not to represent in any way
the existence of (i) any authority to bind the other Party, or (ii) any
relationship between the Parties hereto other than the independent contractor
arrangement specified herein.

 

5.             Compliance with Laws and Regulations. 
In the performance of services hereunder, Contractor agrees to act in
full compliance with any and all applicable laws, rules and regulations
adopted or promulgated by any governmental agency or regulatory body, both
state and federal.  Contractor assumes
full responsibility for the payment of any and all contributions, payroll taxes
or assessments, imposed by any governmental authority with respect to
Contractor and/or any employees of Contractor engaged in the performance of
services hereunder. Contractor assumes and agrees to pay any and all gross receipts,
compensating, use, transaction, sales, or other taxes or assessments of
whatever nature or kind levied or assessed as a consequence of services
performed or compensation paid under this Agreement.

 

6.             Indemnification.  Contractor
shall indemnify, hold harmless, protect, and defend Willis Lease from and
against any and all damages, losses, liabilities, obligations, or deficiencies
resulting from, arising out of, or connected with, (i) the nonfulfillment
of any obligation on the part of Contractor to be observed or performed under
this Agreement, (ii) any and all claims made against Willis Lease by any
third Party, or third Parties, at any time after the execution and delivery of
this Agreement, arising out of, or connected with, any negligent act, or omission,
or willful misconduct of Contractor, or (iii) any demands, assessments,
judgments, costs, reasonable attorneys’ fees, or other expenses arising out of,
or connected with, any action, suit, proceeding or claim incident to any of the
foregoing.

 

3

 

7.             Arbitration.  Any and all
claims arising out of or related to the performance of services under this
Agreement, any provision or aspect of this Agreement, or any alleged breach
thereof, including any dispute as to any amount owed under this Agreement,
shall be settled by arbitration in San Francisco, California in accordance with
the rules then prevailing of the American Arbitration Association for
Commercial Disputes; provided, however, that (i) in the event
of any conflict between this and any other provision of this Agreement and such
rules, the provisions of this Agreement shall prevail, and (ii) any claim
must be presented for arbitration within six months of the date upon which the
aggrieved Party became aware of, or should have become aware of, the alleged
claim.  Failure to assert a claim within
six months shall forever bar assertion of such claim.  The results of any arbitration shall be final
and binding upon the Parties and judgment thereon may be entered in any
California or Swiss court.

 

8.    Authority.  Contractor represents and warrants that he
has the right to enter into this Agreement.

 

9.             Confidentiality.

 

(a)           Contractor acknowledges that in the course of
performance under this Agreement he will receive, may develop and have access
to the valuable, proprietary and trade secret information of Willis Lease and
that the unauthorized disclosure of Willis Lease’s proprietary and trade secret
information would irreparably damage Willis Lease.  Accordingly, Contractor agrees that all
proprietary and trade secret information received or developed by Contractor as
a consequence of this Agreement is the property of Willis Lease, shall be
maintained in confidence and will not be used, published or disclosed by
Contractor without.

 

(b)           The financial terms of this Agreement are also to be
considered Confidential Information.

 

(c)           Except in any proceeding to enforce provisions of this
Agreement, Contractor, its employees, officers, directors and agents shall not
publicize or disclose to any third party any of the terms or conditions of this
Agreement .  Notwithstanding the
foregoing, Willis Lease may describe or file this Agreement in its periodic
filings with the Securities Exchange Commission.

 

(d)           If either Party, or any one of its
employees, officers, directors or agents is served with a subpoena or other
process requiring production or disclosure of this Agreement or any of its
terms or conditions, then the person or entity receiving such a subpoena or other
process, before complying with such subpoena or other process, shall
immediately notify the other of the same and permit the other a reasonable
period of time (taking into account the terms of the subpoena or other process)
to intervene and to contest such production.

 

4

 

(e)               The obligations of confidentiality discussed in this
Agreement shall survive the termination of this Agreement.

 

10.           Conflicts of Interest.  During the
term of this Agreement, Contractor shall be under no restriction with regard to
entering into consulting arrangements with other persons or organizations,
except that Contractor shall not engage in any activities which might be in
conflict with Willis Lease’s interest, for example, working for a competitor of
Willis Lease.  Contractor agrees to
present any questions or concerns about the implementation of this provision to
Willis Lease and the parties agree to reach a mutually satisfactory resolution
of the issue.

 

11.           Miscellaneous.

 

(a)           No Waiver.  No waiver of
any breach or of any one or more of the conditions or covenants in this
Agreement by any Party hereto shall be deemed to imply or constitute a further
waiver of any other like breach, condition or covenant.

 

(b)           Entire Agreement.  This Agreement sets forth the entire agreement
and understanding between the Parties hereto as to the subject matter hereof,
and merges with and supersedes all prior discussions, agreements and
understandings of every and any nature between them with respect to such
subject matter.

 

(c)           Binding Effect. 
All terms and provisions of this Agreement shall be binding upon and
inure to the benefit of and be enforceable by the Parties hereto and their
successors and permitted assigns.

 

(d)           Assignment.  This Agreement
can neither be assigned nor can the performance of any duties be delegated by
the Contractor without the specific written authorization of Willis Lease.

 

(e)           Headings; Severability. 
The headings in the sections of this Agreement are inserted for convenience
only and shall not be considered or referred to in resolving any questions of
interpretation.  The provisions of this
Agreement are severable, and if any of or more provisions may be determined to
be judicially unenforceable, in whole or in part, the remaining provisions, and
any partially unenforceable provisions, to the extent enforceable, shall
nevertheless be binding and enforceable upon the Parties hereto.

 

(f)            Notices.  All notices,
requests, demands, and other communications hereunder shall be in writing and
shall be effective upon receipt.  All
notices shall be given or served personally or sent by facsimile or first class
mail, postage prepaid, addressed as follows:

 

5

 

	
  If to Willis Lease:

  	
   

  	
   

  
	
   

  	
   

  	
  Willis Lease Finance
  Corporation

  
	
   

  	
   

  	
  Attn: Legal Department

  
	
   

  	
   

  	
  773 San Marin Drive,
  Suite 2215

  
	
   

  	
   

  	
  Novato, CA 94998

  
	
   

  	
   

  	
  Tel.: 415-408-4700

  
	
   

  	
   

  	
  Fax: 415-408-4702

  
	
   

  	
   

  	
  Fax: 619/578-9879

  

 

	
  If to Contractor:

  	
   

  	
   

  
	
   

  	
   

  	
  Hans Joerg Hunziker

  
	
   

  	
   

  	
  Hunziker Lease and
  Finance

  
	
   

  	
   

  	
  Zeughausgasse 9a, 6301

  
	
   

  	
   

  	
  Zug, Switzerland

  
	
   

  	
   

  	
  Tel: 41 41 71044 24

  
	
   

  	
   

  	
  Fax: 41 41 71044 50

  

 

or
to such other address which the Party receiving the notice has notified the
Party giving the notice in the manner aforesaid.

 

(g)           No Trading in Willis Lease Stock 
Contractor acknowledges that he is a director of Willis Lease.  As such, his trading in Willis Lease’s stock
is subject to restriction under Willis Lease policies.

 

(j)            Governing Law. 
This Agreement shall be construed and interpreted according to the laws
of the State of California.

 

6

 

IN WITNESS
WHEREOF, the Parties hereto have executed this Agreement effective as of the
date first above written.

 

 

WILLIS
LEASE FINANCE CORPORATION

 

 

	
  By:

  	
  /s/ Thomas C. Nord

  	
   

  

 

Its:

 

 

	
  /s/ Hans Joerg Hunziker

  	
   

  
	
  By: Hans Joerg Hunziker

  	
   

  

 

7

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