AMENDMENT to the Clinical Trial Agreement between Prana Biotechnology Limited and The University of Rochester

Exhibit 4.39

AMENDMENT

to the Clinical Trial Agreement between
Prana Biotechnology Limited

and
The University of Rochester

WHEREAS, The University of Rochester (“Institution”) and Prana Biotechnology Limited (“Sponsor”) have entered into a Clinical Trial Agreement dated October 7, 2011 relating to clinical trial services with regard to the product PBT2 (“Agreement”), and

WHEREAS, the Protocol for the Study has been amended February 3, 2012 and thus changes are needed to the Budget, and the Institution and Sponsor have agreed upon a revised Budget,

NOW, THEREFORE, the parties hereby agree to amend the Agreement effective February 17, 2012, by replacing Attachment A to the Agreement with the amended Protocol attached hereto as Attachment Al, and also by replacing Attachment B to the Agreement with the revised Budget attached hereto as Attachment B1.

Except as provided herein, all terms and conditions of the Agreement remain unchanged and in full force.

PRANA BIOTECHNOLOGY LIMITED			UNIVERSITY OF ROCHESTER
BY:			BY:
Name:	XXXXXX XXXXX			Xxxxxx X. Xxxxxxxx
Title:	CHIEF OPERATING OFFICER			Assistant Director
				Office of Research & Project Administration
DATE:	February 20, 2012		DATE:

ATTACHMENT A1

AMENDED PROTOCOL

ATTACHMENT B1

REVISED BUDGET

AMENDMENT 2

to the Clinical Trial Agreement between

Prana Biotechnology Limited

and

The University of Rochester

WHEREAS, The University of Rochester (“Institution”) and Prana Biotechnology Limited (“Sponsor”) have entered into a Clinical Trial Agreement dated October 7, 2011, as amended February 17, 2012, relating to clinical trial services with regard to the product PBT2 (“Agreement”), and

WHEREAS, Institution and Sponsor have agreed upon a revised Budget,

NOW, THEREFORE, the parties hereby agree to amend the Agreement effective May, 2012, by replacing Attachment B1 to the Agreement with the revised Budget attached hereto as Attachment B2.

Except as provided herein, all terms and conditions of the Agreement remain unchanged and in full force.

PRANA BIOTECHNOLOGY LIMITED			UNIVERSITY OF ROCHESTER
BY:			BY:
Name:	XXXXXX XXXXX			Xxxxxx X. Xxxxxxxx
Title:	CHIEF OPERATING OFFICER.			Assistant Director
				Office of Research & Project Administration
DATE:	28th September 2012.		DATE:	10/3/2012

Amendment 2 to MSA

- Budget V26, 1150112.

University of Rochester

Encompassing the Huntington Study Group

Clinical Trials Coordination Center (CTCC)

Biostatistics Department

000 Xxxxxxxxxx Xxxx.

Xxxxxxxxx, XX 00000

000-000-0000

Prana

Project Name Reach2HD

Confidential

Please note: This budget proposal is based on the Scope of Work and Protocol (version #2, February 3, 2012) agreed on February 3, 2012. Should the Protocol or SOW change, the HSG & CTCC will require a revised budget, adjusted SOW, protocol and Agreement with the potential for additional funding to complete the outlined tasks. This budget proposal is valid to June 30, 2012.

	PROJECT TITLE:		Reach2HD
	Protocol Title:		PBT2-203 Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-Center, Phase lia Study of two doses of PBT2.
	Principal Investigator:		Kayson, UR Prime Institution: UR Subcontract to JHU, Xxxxxx Subcontracts to 20 Sites
	Timeline:	Planning: Enrollment: Implementation: Close Out:	6 Months 9 Months 6 Months 4 Months	01 October 2011 to 31 March 2012 31 March 2012 to 31 December 2012 01 January 2013 to 30 June 2013 01 July 2013 to 31 October 2013
	# of Sites		20	Approx 15 USA; Approx 5 Aust
	# of Subjects		100 Randomized

Planning Phase

 01 October 2011 to

 31 March 2012

Enrollment Phase

 31 March 2012 to

 31 December 2012

LPI Phase

 01 January 2013 to

 30 June 2013

Close Out Phase

 01 July 2013 to 31

 October 2013

Top Level Summary		Planning	Enrollment	Implementation	Close Out Phase		Total
							-
							-
	CTCC Budget	221,587	580,374	347,240	219,478		1,368,679
	Other Budget	20,000	40,000	70,000	30,000		160,000
	Total UR Direct Costs	241,587	620,374	417,240	249,478		1,528,679
	Contract/Consortium (Sites, JHU)	89,637	1,222,081	971,351	283,646	#	2,566,715
	Total Direct Costs	331,224	1,842,456	1,383,590	533,123	#	4,095,393
	Facilities and Administrative Costs	93,305	392,131	146,034	87,317	#	718,787
	Total Costs	424,530	2,234,587	1,534,624	620,440	#	4,814,181

Pass Thru Costs Invoiced Directly to Sponsor outside of the payment schedule for Trial:

Source Document Worksheets printing and distribution -- to be a pass thru cost

Operations Manual Printing and Distribution -- to be a pass thru cost

Drug Instruction Card printing and distribution -- to be a pass thru cost

Travel and Conference costs -- to be a pass thru cost (include Orientation Meeting)

IRB fees -- to be a pass thru cost

Site Audit Fees (applicable for a ‘not for cause’ audit) -- to be a pass thru cost

Site Pharmacy Start up fees as needed ($1,000 to $2,500 based upon actual needs at enrolling sites) -- to be a pass thru cost

Screen Failures to be paid based upon assessments completed per subject, to be paid at the end of enrollment -- as a pass thru cost

Subject Travel to attend study visits (above stipend for instances of hardship and pre-approved by sponsor) -- as a pass thru cost

Unscheduled Visits for enrolled subjects to be invoiced to Sponsor as incurred

Subcontracts to MGH (Xxxxxx and Xxxxx) and Melborne, Australia (Xxxxx) to be held by Sponsor

Steering Committee and Safety Monitoring Committee Fees to be paid directly to committee members by Sponsor

Monitoring visits to Australian sites to be the direct responsibility of Sponsor

Central Laboratory analysis activities -- paid directly by Sponsor

Central ECG analysis activities -- paid directly by Sponsor

Copyright Fees -- paid directly by Sponsor

Any material changes to the SOW will necessitate a modification to the budget and a contract amendment.

Example of SOW changes include, but not limited to: Protocol Amendments, Adding Sites, Interim Analyses, Ancillary Studies.

JHU Subcontact		Planning		Enrollment		LPI		Close Out
Employement Costs		66,398		107,894		70,341		61,008
Consultant POs		-		-		-		-
Computing Costs		-		-		-		-
Equipment Purchases		-		-		-		-
Travel Costs		-		-		-		-
Operating Costs (T, P/C, P, O)		-		-		-		-
Other Costs
Facilities and Administrative Costs
Total Direct Costs		66,398		107,894		70,341		61,008

	Planning Phase   01 October 2011 to 31 March 2012	Enrollment Phase   31 March 2012 to 31 December 2012	LPI Phase   01 January 2013 to 30 June 2013	Close Out Phase   01 July 2013 to 31 October 2013
	6 months	9 months	6 months	4 months

EMPLOYMENT COSTS
% of Effort Data		Planning		Enrollment		LPI		Close Out
		% Effort	Person Months	% Effort	Person Months	% Effort	Person Months	% Effort	Person Months
Xxxxxx, Xxx	Co Investigator	30%	3.60	30%	3.60	30%	3.60	30%	3.60
TBD	Research Asst	10%	1.20	10%	1.20	10%	1.20	30%	3.60
TBD	Asst Professor	15%	1.80	15%	1.80	15%	1.80	15%	1.80
Total Employment Costs		66,398		107,894		70,341		61,008
Facilities and Administrative Costs to JHU		23,239		37,763		24,620		21,353
JHU Total Cost		89,637		145,656		94,961		82,361

BIOSTATS				Planning			Enrollment			LPI			Close Out
Employment Costs					-			-			-			-
Consultant POs					-			-			-			-
Computing Costs					-			-			-			-
Equipment Purchases					-			-			-			-
Travel Costs					-			-			-			-
Operating Costs (T, P/C, P, O)					-			-			-			-
Other Costs					20,000			40,000			70,000			30,000
Other Costs
Other Costs
Total Direct Costs					20,000			40,000			70,000			30,000

One Time Start up Fee			$	3,500
Ophthalmologic Visit Costs:	Exam		$	460					$	180		$	180
	Color Vision		$	186					$	186		$	186
	OCT		$	364					$	364		$	354
	Confrontation VF		$	140								$	140
	Ophthalmoscopy		$	70					$	70		$	70
	Fundus Photos		$	165								$	165
			$	1,385		$	-		$	800		$	1,105
Visually Evoked Response****	The VER will occur for approximately 50% of the subjects enrolled; will be paid for as occurring at $425 per VER includes the assessment and reading											$	425
	Total Per Subject Fee for Subjects not receiving the Visual Evoked Response Assessment Per Subject Fee composed of Screening Visit thru Week 28 follow Up Visit											$	20,129
	Total Per Subject Fee for Subjects receiving the Visual Evoked Response Assessment											$	21,404

SNAP Assessment Cost to be determined

		Budget Details:			Planning Xxxxx			Xxxxxxxxxx Xxxxx			XXX Xxxxx
			000		00 October 2011 to 31 March 2012			31 March 2012 to 31			01 January 2013 to 30 June 2013
		$	20,129			6 months			9 months			6 months
		$	2,012,850
			0	%		0
			50	%				$	1,006,425
			40	%							$	805,140
			10	%											201285

	PROJECT TITLE:		Reach2HD
	Protocol Title:		PBT2-203 Randomized, Double Blind, Placebo Controlled, Parallel Group, Multi-Center, Phase lia Study of two doses of PBT2.
	Principal Investigator:		Kayson, UR
			Prime Institution: UR
			Subcontract to JHU, Xxxxxx
			Subcontracts to 20 Sites
	Timeline:	Planning:	6 Months	01 October 2011 to 31 March 2012
		Enrollment:	9 Months	31 March 2012 to 31 December 2012
		Implementations:	6 Months	01 January 2013 to 30 June 2013
		Close Out:	4 Months	01 July 2013 to 31 October 2013
	# of Sites		20	Approx 15 USA; Approx 5 Aust
	# of Subjects		100 Randomized
		Total Budget				4,814,181
		Less: Budget associated with Site Subcontract Payments				(2,154,100)
		and associated indirect costs				(175,000)
		Budget Subject to Milestone Payment Scheme				2,485,081
		Payment Scheme:
								Billed and Rec’d
		The amount due to the University of Roachester will be invoiced according to the following Milestone driven scheme:
			Completion of Fully Executed Contract		10%	248,508		390,445
			IND for Protocol opened		10%	248,508		390,445
			Receipt of initial IRB approval of protocol		5%	124,254		-
			Initial Enrollment		10%	248,508		90,913
				Subtotal of cashflow through initial enrollment		869,778		871,803
			Quarterly Payment During Enrollment and Implementation Phases
				Month 3 of Enrollment	9%	223,657		221,633
				Month 6 of Enrollment	9%	223,657
				Month 9 of Enrollment	9%	223,657
				Month 3 of Implementation	9%	223,657
				Month 6 of Implementation	9%	223,657
				Subtotal of cashflow thru Implementation		1,118,286
			Payment upon completion of Subject Enrollment
				Database Lock	10%	248,508
				Top Line Results	5%	124,254
				CSR	5%	124,254
				Subtotal of final payments		497,016
			Total of all payments not subject to subcontract			2,485,081
	Site Payment Scheme: Invoices will be forwarded to sponsor on a calendar quarter for basis for costs incurred in paying sites for completed visits. Not more than $2,329,100 will be invoiced to sponsor, invoices will only include the costs of fully completed and documented visits. The following is an estimate of the invoice amounts:

	Quarter ended June 30, 2012		$	116,455
	Quarter Ended September 30, 2012		$	582,275
	Quarter Ended December 31, 2012		$	465,820
	Quarter Ended January 31, 2013		$	465,820
	Quarter Ended March 31, 2013		$	349,365
	Quarter Ended June 30, 2013		$	349,365
	Total		$	2,329,100

NOTE: If the FDA delays the implementation of the study according to the agreed timeline, the parties have the right to re-negotiate the milestones according to a agreed, revised timeline.

(a) Should the above timeline for planning, Enrollment Implementation and/or Close out exceed the budgeted period for reasons outside the control of the Clinical Trials Coordination Center (CTCC), the CTCC will request that the Scope of Work be revisited and the budget be revised (if necessary) to allow for an expanded Planning, Enrollment, Implementation and/or Close out timeframe and associated additional costs. In good faith, Prana will decide if  the proposed budget or timeframe changes can be accommodated by Prana. In any event, the CTCC will not be under an obligation to continue the study without the required additional funds to cover an extended budget period and Prana will not obliged to continue the Study outside the budgeted period.

(b) If the above timeline for Planning, Enrolment, Implementation and Close out exceed the budgeted period for reasons within the control of the Clinical Trials Coordination Center (CTCC), Prana may withhold payments and/or require the CTCC to undertake activities to restore as far as possible the Study to the Initial Timeline at CTCC’s cost. If a delay in recruitment timeline is for reason of particular obligations on patients as prescribed by the Protocol, and the impact of those Protocol obligations cannot otherwise be resolved by the parties Project Team, the delay will not be deemed an event within the control of the CTCC.

(c) If the above timeline for Planning, Enrollment, Implementation and Close Out is less than the budgeted period, the Scope of Work will be revisited by the parties and the budget be revised (if necessary) to adjust for the reduced timeframe and additional costs. For each month of reduced timeline of the Study, Prana will pay a pro-rata amount of the above Quarterly Payments to the CTCC as a bonus for earlier Study completion.

	Analysis of monitoring Activities
	Budget Components					Planning						Enrollment						Implementation LP1 Duration			Close out				Total
	Effort			Site Monitor Employee			0	%		-			80	%					80%			0		%
	Fees			Independent Monitor/Contractor Fees								$	43,200					$	21,600						$	64,800
	Travel			Site Monitor Travel Costs								$	100,800					$	36,000		$	7,200			$	144,000
	TOTAL											$	144,000					$	57,600		$	7,200			$	208,800
				Based upon the budgeted effort, independent contractor costs and the associated travel costs, a total of 120 to 123 site monitor visits are budgeted. The details of these visits is set out below. Approximately 120 visits will provide 8 visits per site over the enrollment and LPI phase.

							Planning phase 6 months			Xxxxxxxxxx Xxxxx 0 xxxxxx			XXX Xxxxx 0 months			Close Out Phase 4 months
Effort Analysis		Monitor Effort----------->						0	%		80	%		80	%		0	%
		Independent Contractor Hourly Fees ---->					$	-		$	43,200		$	21,600		$	-
		Effort
		80% of one FTE indicates 32 hours per work week for a total of 2080 hours over the 15 month implementation period.
		2080 total available hours divided by 24 hours per monitor trip yields 87 site visits.
		Therefore, in the 15 months there are enough hours budgeted for approximately 87 visits to sites.
		Independent Contractor
		A total of 9 visits to four sites are budgeted to be handled by up to three independent contractors. In aggregate, 36 visits are budgeted with each visit planned to be 24 hours at a rate of $75 per hour.   The computation is 36 visits multiplied by 24 hours per visit multiplied by $75 per hour.
		36 visits x 24 hours per visit x $75 per hour results in $64,800.
		In total approximately 123 site monitor visits are budgeted over the 15 month enrollment and LPI phase. This represents between approximately 8 visits per site. 120 Visits divided by 15 sites equals 8.0 visits per site. Over the fifteen month period, sites will be visited more then once every two months.
											A total of $144,000 is budgeted for travel to sites for monitoring visits.
Travel Analysis		Budgeted Dollars For Travel									A total of 8 visits for each of the 15 US based sites is budgeted = 120 total site visits.
											A total of $1,200 is budgeted for each trip:
		$	100,800		paid during enrollment						Trip Costs are calculated as follows: $650 for airfare, $300 for two nights lodging,
		$	36,000		paid during LPI duration						$150 for meals and $100 for all other out of pocket costs.
		$	7,200		paid during close out						$1,200 x 120 visits = $144,000
		$	144,000		Total Site Monitor Travel Budget