Document:

First Amendment to Collaboration Agreement

 Exhibit 10.5 

 

	[***]	Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested
with respect to the omitted portions. 

 FIRST AMENDMENT 

TO 

COLLABORATION AGREEMENT 

This FIRST AMENDMENT (this “Amendment”) to the Collaboration Agreement dated as of January 28, 2011
(the “Agreement”), by and among MAP Pharmaceuticals, Inc. (“MAP”), Allergan, USA, Inc. (“Allergan USA”), Allergan Sales, LLC (“Allergan Sales”) and Allergan, Inc., (collectively
with Allergan USA and Allergan Sales, “Allergan”), is effective as of May 10, 2011 (the “Effective Date”), by and among Allergan and MAP. Capitalized terms not otherwise defined herein shall have the meanings
provided for them the Agreement. 
 RECITALS 
 WHEREAS, Allergan and MAP entered into the Agreement and now intend to modify the Agreement to (i) extend the date by which the parties shall have agreed upon and presented an initial
Commercialization Plan to the Joint Steering Committee and (ii) add a separate and independent Medical Affairs Committee with responsibility to oversee activities related to medical affairs and education. 

AGREEMENT 

NOW, THEREFORE, the parties mutually agree to amend the Agreement as follows: 

 

	1.	Section 1.95 shall be restated as follows: ““Plan” means Development Plan, Commercialization Plan, or Medical Affairs Plan, as
applicable.” 

  

	2.	Section 1.104 shall be restated as follows: ““Promotional, Sales and Marketing Expenses” and “Medical Affairs Expenses” have
the meanings as set forth in Exhibit 1.113.” 

  

	3.	In Exhibit 1.113, the definition of “Promotional, Sales, Marketing, and Medical Affairs Expenses” or “PSMM Expenses” shall be restated
as set forth below: 

 “3.1 “Promotional, Sales and Marketing Expenses” or
“PSM Expenses” means those costs which are incurred by a Party or for its account which are specifically identifiable to Commercialization, including [***], including [***] or, solely for sales representatives providing Details for
Product, [***] and [***] costs, [***], including without limitation [***], in each case consistent with the Commercialization Plan and otherwise with the terms of this Agreement. [***]. Notwithstanding anything to the contrary in the foregoing, PSM
Expenses shall always specifically exclude any [***] and the cost and expense of activities that [***]. 
 3.2
“Medical Affairs Expenses” means those costs which are incurred by a Party or for its account which are specifically identifiable to medical affairs activities, including [***].” 

  
 1 

	4.	All references in the Agreement to “PSMM Expenses” shall be restated as “PSM Expenses”. 

 

	5.	Clause (vii) of Section 3.2(b) shall be restated as follows: 

(vii) Establish, on an annual basis no later than July 1, a two (2) year forecast, containing a projection
of annual Product unit sales and associated annual PSM Expenses reflecting Commercially Reasonable Efforts of the Parties in Commercializing Product and supporting Medical Affairs Expenses reflecting Commercially Reasonable Efforts (“Annual
Forecast And Budget”), which shall be in a format determined by the JSC or mutually agreed by the Parties; 
  

	6.	Section 3.3(b), 3,3(c) and 3.3(d) shall be restated as follows: 

“3.3(b) Each Alliance Manager shall strive to create and maintain a collaborative work environment within and among
the JSC, PDC, JCC, MAC and any subcommittees. Each Alliance Manager will also: (i) attempt to resolve, in the first instance, all matters of dispute arising in the JSC, PDC, JCC, MAC or any subcommittees; (ii) coordinate the relevant
functional representatives of the Parties in developing and executing strategies and Plans for Product to Physician Targets in the Field in the Territory; (iii) provide a single point of communication for seeking consensus both internally
within the respective Parties’ organizations and between the Parties regarding key strategy and Plan issues; (iv) identify and bring disputes to the attention of the JSC in a timely manner; (v) plan and coordinate cooperative efforts
and internal and external communications; (vi) track and report progress of the Parties against all Plans and activities; and (vii) ensure that governance activities, such as the conduct of required JSC, PDC, JCC, MAC and any subcommittee
meetings, take place, including by taking meeting minutes and producing such minutes as set forth in this Agreement, and by following up on relevant action items resulting from such meetings to confirm that such activities are appropriately carried
out or otherwise managed. 
 3.3 (c) The Alliance Managers shall attend all subcommittee meetings and JSC,
PDC and JCC, MAC meetings and support the co-chairpersons of the JSC, PDC, JCC, MAC and subcommittees in the discharge of their responsibilities. Alliance Managers shall be nonvoting participants in the JSC, PDC, JCC, MAC and subcommittee meetings,
unless they are also appointed Members of the JSC, PDC, JCC, MAC or the subcommittee provided, however, that an Alliance Manager may bring any matter to the attention of the JSC or any subcommittee if such Alliance Manager reasonably believes that
such matter warrants such attention. 
 3.3 (d) The Alliance Managers shall jointly be responsible for
working with the JSC and other committee Members to prepare and circulate an agenda in advance of each meeting of the JSC, PDC, JCC, MAC and subcommittee, and to prepare and issue initial drafts of minutes of each meeting within seven
(7) Business Days thereafter. Meeting minutes will not be finalized until both Parties’ representatives on the JSC, PDC, JCC, MAC or subcommittee review and confirm the accuracy of such minutes in writing, which such representatives shall
do and approve in writing within seven (7) Business Days of receiving such minutes for review and comment.” 

  
 2 

	[***]	Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions. 

	7.	Section 3.5(b)(v) shall be restated as follows: 

 “Review and make decisions regarding post-Initial Indication Approval Development activities, taking into consideration the appropriateness of any Development activities including line extensions and
Clinical Trials for purposes of new indications in the context of the overall marketing and promotional strategy for Product;” 
  

	8.	Section 3.5(b)(xi) shall be deleted in its entirety, and the subsequent clauses of Section 3.5(b) shall be renumbered accordingly. 

 

	9.	A new Section 3.6 shall be added, which shall state as follows: 

 “3.6 Medical Affairs Committee. 
 (a)
Members; Officers. The Parties shall establish a Medical Affairs committee for Product (the “Medical Affairs Committee” or “MAC”). Each MAC member shall have suitable expertise in medical affairs and
education regarding pharmaceutical products and shall not be responsible for promotional or commercial activities. Any member of the MAC may designate a substitute with due authority and expertise conforming to that required by the immediately
preceding sentence to temporarily attend and perform the functions of that member at any meeting of the MAC. The MAC shall be chaired by a representative of ALLERGAN. The secretary of the MAC shall be the ALLERGAN Alliance Manager. 

(b) Responsibilities. The MAC shall perform the following functions: 

(i) Develop and subsequently review and make decisions relating to planned medical education and activities to support
Product such as grants and continuing medical education, publications and abstracts, field based medical affairs activities, medical information services, phase IV studies, post-marketing commitments, and other medically related professional
education expenses (the “Medical Affairs Plan”), including a budget for Medical Affairs Expenses; 
 (ii) Oversee implementation of the Medical Affairs Plan throughout the Calendar Year, including managing the budget for Medical Affairs Expenses; 

(iii) Review and make decisions regarding Phase IV Clinical Trials in the context of the overall marketing and promotional
strategy for Product; 
 (iv) Lead the review and direct Product publication strategy; and 

(v) Perform such other responsibilities that may be assigned to the MAC pursuant to this Agreement, or as may be mutually
agreed upon by the Parties from time to time. 

  
 3 

	[***]	Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions. 

 (c) Decision-Making. The MAC shall operate by unanimous consent of
its Members, with MAP’s Member Designees having, collectively, one vote and ALLERGAN’s Member Designees having, collectively, one vote in all decisions. The MAC shall use Commercially Reasonable Efforts to make timely decisions and to
resolve disputes. If the MAC is unable to resolve any dispute, controversy, or claim arising under this Agreement within a reasonable period after it first addresses such matter, then such dispute, controversy or claim shall be decided by the JSC.

 (d) MAP agrees to provide periodic updates to the MAC regarding MAP’s separate medical affairs and
education activities to the extent permitted and relevant to the Parties’ activities under this Agreement.” 
  

	10.	Section 6.2(c) shall be amended to replace “ninety (90) days following the Effective Date” with “June 1, 2011”. 

 

	11.	Except as expressly provided in this Amendment, all other terms, conditions and provisions of the Agreement shall apply and remain in full force and effect.

  
 4 

	[***]	Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions. 

 IN WITNESS WHEREOF, the parties have executed this First
Amendment to Collaboration Agreement as of the Effective Date by persons duly authorized to bind them. 
 ACKNOWLEDGED
AND AGREED: 
  

									
	ALLERGAN, INC.	 		 	MAP PHARMACEUTICALS, INC.
					
	By:	 	 /s/ Jeffrey L. Edwards
	 		 	By:	 	 /s/ Timothy S. Nelson

		 	Jeffrey L. Edwards	 		 		 	Timothy S. Nelson
		 	Executive Vice President,	 		 		 	President & CEO
		 	Finance and Business Development,	 		 		 	
		 	Chief Financial Officer	 		 		 	
				
	ALLERGAN USA, INC.	 		 		 	
					
	By:	 	 /s/ Jeffrey L. Edwards
	 		 		 	
		 	Jeffrey L. Edwards	 		 		 	
		 	Vice President and Chief Financial Officer	 		 		 	
				
	ALLERGAN SALES, LLC	 		 		 	
					
	By:	 	 /s/ Jeffrey L. Edwards
	 		 		 	
		 	Jeffrey L. Edwards	 		 		 	
		 	Vice President and Chief Financial Officer	 		 		 	

  
 5 

	[***]	Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been
requested with respect to the omitted portions.Modification to Contract

 Exhibit 10.1 

 

													
	AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT	  	1. CONTRACTOR ID CODE	  	PAGE OF PAGES
	 	  	 	  	 	  	U	  	 	  	1	  	2
	 2. AMENDMENT/MODIFICATION NO.

    P00005
	  	
3. EFFECTIVE DATE
 13-Apr-2011
	  	
4. REQUISITION/PURCHASE REQ. NO

CBM-100019095Z
	  	 5. PROJECT NO (If
applicable)

	 6.     ISSUED
BY             CODE
	  	HDTRA1	  	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)
	  	 	  	9A. AMENDMENT OF SOLICITATION NO.
	
        AVI BIOPHARMA, INC.

        J. DAVID BOYLE II

        4575 SWRESEARCH WAY STE 200

        CORVALLIS OR 97333-1299
	  		  	 	  	 
	  		  	 	  	9B. DATED (SEE ITEM 11)
	  		  	 	  	 
	  		  	X  	  	 10A. MOD OF CONTRACT/ORDER NO.

HDTRA1-10-C-0079

	  		  	X  	  	 10B. DATED (SEE ITEM 13)

04-Jun-2010

	 	  		  	 	  	 
	CODE
        49WU1	  	FACILITY CODE	  	 	  	 

																											
	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 Offer      ̈    is extended,      ̈    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)

 

	 13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.
 IT MODIFIES THE
CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

			
	 	  	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:
 52.243-2 Alt V Changes—Cost Reimbursement (Aug 1987) – Alternate V

	 	  	 D. OTHER (Specify type of modification and
authority)
  

																											
	 E.    IMPORTANT:   Contractoris
         ̈        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:    nuckolsb111278
         The
purpose of this modification is to incorporate a revised Statement of Work and adjust the contract value accordingly, from $17,741,829.40 to $13,092,616.75.
  

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 and CFO
	  	 16A.NAME AND TITLE OF CONTRACTING OFFICER (Type or Print)

         Brian D. Nuckols

TEL:703-767-3503
                        EMAIL: brian.nuckols@dtra.mil

	 15B. CONTRACTOR/OFFICER

 
 /s/ J. David Boyle
II                                

(Signature of person authorized to sign)
	  	 15.C DATE SIGNED

 
 April 13, 2011
	  	 16B. UNITED STATES OF AMERICA

 
 /s/ Brian D.
Nuckols                            
 (Signature of Contracting Officer
	  	 16C. DATE SIGNED

 
 4/14/11

  

					
	 EXCEPTION TO SF 30
 APPROVED BY OIRM 11-84
	 	30-105-04	 	 STANDARD FORM 30 (Rev. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

  

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 HDTRA1-10-C-0079 
 P00005 
 Page 2 of 2 
 SECTION SF 30 BLOCK 14 CONTINUATION PAGE 
 SUMMARY OF CHANGES 

SECTION A - SOLICITATION/CONTRACT FORM 
 The total cost of this contract was decreased by $4,649,212.65 from $17,741,829.40 to $13,092,616.75 (EST). 
 SECTION B - SUPPLIES OR SERVICES AND PRICES 
 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 17 June 2010. to The Contractor shall perform the tasks in accordance with the Statement of Work entitled “AVI BioPharma Project - H1N1 Countermeasure
Development” dated 31 March 2011. 
 The estimated/max cost has decreased by $[†] from $[†] to $[†].

 The fixed fee has decreased by $[†] from $[†] to $[†]. 

The cost constraint has changed from NTE to EST. 
 The total cost of this line item has decreased by $4,649,212.65 from $17,741,829.40 to $13,092,616.75 (EST). 
 SECTION G - CONTRACT ADMINISTRATION DATA 
 The following have been modified: 

252.232-9001 PRICES/COST 
 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. 
 (End of Summary of Changes) 

  

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 AVI BioPharma Project - H1N1 Countermeasure Development 

Original: 19 May 2010 
 Revision: 17 June 2010 
 Revision: 16 March 2011 

Revision: 18 March 2011 
 Revision: 31 March 2011 
 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 

  

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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 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 acquire 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). 

  

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 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 deaths1. 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 2010.2 

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)3. 

 

	1 	 “Influenza A (H1N1) virus resistance to oseltamivir -2008/2009 influenza season, northern hemisphere.” WHO. Web.
http://www.who.int/csr/don/2010_06_04/en/index.html. 

	2 	 “Pandemic (H1N1) 2009-update 102.” WHO. GAR, Alert and Response. Web. http://www.who.int/csr/disease/influenza/h1n1_table/en/.

	2 	 “The 2009 H1N1 Pandemic: Summary Highlights, April 2009-April 2010.” CDC. Web. http://www.cdc.gov/h1n1flu/cdcresponse.htm.

  

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 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.
(see reference in FN 3) 
  

	4.	TASKS 

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

 TASK 2. [†]: [†] 

  

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 [†]: [†] 

[†]: [†] 
 TASK 3.1 [†] 
 Task 3.1 [†] 

  

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 [†] 
 [†] 
 [†] 

Task 3.2 [†] 
 [†] 

  

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 TASK 4. [†] 

[†] 

Task 4.1 [†] 
 [†] 
 Task 4.2 & 4.3 [†] 

[†] 

  

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 [†] 
 [†] 
 [†] 

TASK 5. [†] 
 [†] 

  

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 Task 5.1 [†] [†] 

Task 5.2 [†] 
 [†] 

  

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 Task 5.3 [†]: [†] 

[†] 

[†] 

  

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 Task 5.4 [†]: [†] 

[†] 

[†] 

  

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 Task 5.5. [†]: [†] 

[†] 

[†] 

  

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 Task 5.6 [†]: [†] 

[†] 

[†] 

  

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 TASKS 6. [†] 

[†] 

Task 6.1. [†] [†] 
 Task 6.2. [†] [†] 
 Task 6.3 [†] 

[†] 

  

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 Task 6.4. [†] [†] 

TASK 7. [†] 
 [†] 
 Task 7.1 [†] [†] 

Task 7.2 [†] [†] 
 Task 7.3 [†] [†] 

  

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 Task 7.4 [†] [†] 

TASK 8. [†] 
 [†] 
 Task 8.1 [†] [†] 

  

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 Task 8.2 [†] [†] 

Task 8.3 [†] [†] 
 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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