Document:

exhibit_4-41.htm

Exhibit 4.41

 

 

Master Laboratory Services Agreement

 

This Master Laboratory Services Agreement (the “Agreement,”) dated as of 26 August, 2013 is by and between Prana Biotechnology Ltd ACN 080 699 065, an Australian limited liability company whose address is Level 2, 369 Royal Parade, Parkville Victoria 3052 (“Sponsor”) and WIL Research Laboratories, LLC (together with its subsidiaries), a Delaware limited liability company, whose address is 1407 George Road, Ashland, Ohio 44805 (hereinafter collectively referred to as “WIL”).

 

WITNESSETH

 

WHEREAS, Sponsor has now, and from time to time in the future may have, the desire to engage WIL to perform research and/or laboratory services; and

 

WHEREAS, WIL desires to provide such services on the terms and conditions set forth herein.

 

NOW THEREFORE, in consideration of the premises and of the mutual promises and covenants contained herein, the adequacy of which is hereby acknowledged by each of the parties, the parties hereto agree as follows:

 

	
1.

	

Services and Work Order

 

WIL shall use its commercially reasonable efforts to provide all services (“Services”) for each study (each a “Study”) as set forth in a Work Order (as defined below). Services provided by WIL shall be subject to the terms and conditions of this Agreement. All such Services shall be the subject of a Work Order substantially in the form of Exhibit A (each a “Work Order”). Each Work Order shall include, without limitation, the following with respect to the applicable Study: (i) the Study protocol (“Protocol”) and deliverables; and (ii) a fee and payment schedule for the Services. After a Work Order is agreed upon and executed by the parties hereto, such Work Order shall then be a part of this Agreement. There will be no limit to the number of Work Orders that may be added to this Agreement. WIL shall have no obligation to reserve Study space at its facilities; to receive animal models; to purchase Study supplies; nor shall WIL have any obligation to commence Services with respect to a particular Study until the relevant Work Order is executed by both parties hereto; provided, that WIL may reserve Study space at its facilities and/or purchase non-anirnal Study supplies for a Study before a Work Order is executed upon the Sponsor executing a Study outline, which Study outline shall be substantially in the form attached hereto as Exhibit B (each a “Study Outline”). Notwithstanding the foregoing, in no event shall WIL be obliged to receive animal models until a Work Order is executed for the relevant Study.

	
P: 419-289-8700

Email: info@wilresearch.com

1407 George Road, Ashland, OH 44805

	
www.wilresearch.com

 

 

  

  

  

	
2.

	
Change Orders

 

In the event that Sponsor would like WIL to alter the Services to be provided under a given Work Order, the parties hereto shall agree upon a written change order substantially in the form of Exhibit C (each a “Change Order”) prior to the provision of said changed Services. The Change Order shall constitute an amendment to the applicable Work Order and shall be considered part of this Agreement.

 

	
3.

	
Study Director

 

WIL shall appoint a study director to be responsible for each Study (the “Study Director”). The Study Director will coordinate performance of the Study with the Sponsor’s designated representative, which representative shall have responsibility over all matters related to performance of the Study on behalf of Sponsor. WIL will not change the Study Director without the prior approval of Sponsor, which approval shall not be unreasonably delayed, conditioned, or withheld.

 

	
4.

	
Payment for Services

 

Sponsor shall pay WIL for Services provided in connection with a Study in accordance with the terms of the applicable Work Order (subject to, where applicable, the delivery of the relevant deliverables referable to the payment). WIL shall electronically submit invoices to the Sponsor on each date a payment is due in accordance with the applicable Work Order. Invoices will be submitted to the following email address sforan@pranabio.com with a copy to krowe@pranabio.com. Sponsor shall remit payment through ACH or wire transfer to the bank account provided below and payment is due within 30 days of receipt of the electronically submitted invoice. In the event Sponsor fails to pay an invoice within 30 days of the due date, WIL, upon written notice to Sponsor, may in its sole discretion, charge the Sponsor a late fee equal to 1.5% per month on the unpaid balance of such invoice until such invoice is paid in full (including any assessed late fees).

 

The Sponsor shall remit all payments directly to WIL Research Laboratories, LLC at the following bank account:

 

For Direct Deposits/Wire Transfers:

 

	
Bank Name:

	
Citibank N.A.

	 	 
	
Bank Address:

	
Totowa, NJ 07512

	 	 
	
Bank Routing #:

	
021272655

	 	 
	
Bank Account #:

	
759455772

	 	 
	
Swift Account #:

	
CITIUS33

	 	 
	
Account Name:

	
WIL Research Laboratories, LLC

 

  

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5.

	
Term and Termination

 

a)           The term of this Agreement shall be five (5) years from the date hereof, unless earlier terminated as permitted herein. The term of this Agreement shall automatically extend for successive one year periods, unless either party gives the other party written notice that it will not extend this Agreement at least sixty (60) days prior to the end of the then current term.

 

b)           Either party may terminate this Agreement upon ninety (90) days’ prior written notice to the other party. In the event at the time of any such termination there are uncompleted Studies, then subject to paragraph (c) below, this Agreement shall remain in full force and effect with respect to and for the duration of such uncompleted Studies.

 

c)           Sponsor may at any time terminate a Study upon written notice to WIL. Immediately upon receipt of such notice, WIL shall use its commercially reasonable efforts to minimize the cost to Sponsor resulting from such termination. In the event of such termination, Sponsor shall pay to WIL: (a) all amounts due and owing under the applicable Work Order through the date of termination, whether invoiced or not; (b) all charges for the work performed and expenses (including uncancellable or unreimbursed expenses) incurred by WIL prior to termination, and (c) any and all expenses which may reasonably be incurred, by WIL in connection with terminating the Study.

 

d)           In circumstances where WIL is unable to mitigate all or part of the costs and expenses (collectively, “Costs”) incurred by it as a result of a delay or termination (caused by Sponsor) prior to the commencement of a Study, then in full satisfaction of such Costs, Sponsor may be required to pay a fee (or an equitable proportion thereof having regard to amounts recovered through mitigation or otherwise from Sponsor under paragraph (c)). Any such fee due to WIL in respect of a delay to the agreed commencement date of the Study (caused by Sponsor) or termination for convenience by Sponsor, will be mutually agreed upon by both parties and set forth in the applicable Work Order.

 

e)           In addition to any provisions which, by their nature, are intended to survive the termination or expiration of this Agreement, the following provisions shall survive the termination or expiration of this Agreement: 5(c) and (d), 6, 7, 8, 12 and 17.

 

	
6.

	
Confidential Information

 

Each party hereto hereby agrees to continue to abide by the terms of the Confidentiality Agreement by and between Sponsor and WIL dated 17th July 2013 (the “Confidentiality Agreement”). For purposes of this Agreement, the term “Confidential Information” shall have the meaning ascribed in the Confidentiality Agreement. Any violation of the terms of the Confidentiality Agreement shall be deemed to be a violation of the terms of this Agreement. All Work Product (as defined below) and the compound(s) and information submitted by Sponsor for the purpose of a Study shall constitute Confidential Information of Sponsor.

 

  

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7.

	
Work Product; Delivery and Archiving

 

a)           Assuming the payment by Sponsor of all amounts invoiced hereunder, all tissues, tissue blocks, specimens, slides and data prepared or generated by WIL in the course of performing Services for Sponsor hereunder (“Work Product”) shall be owned by Sponsor and shall be delivered to Sponsor upon its request. Any Work Product shipped by WIL to Sponsor or any third party will be appropriately packaged and labeled as defined by WIL’s standard operating procedures and delivered to a common carrier for shipment. Sponsor shall hold WIL harmless from and against all loss or damage or claims of loss or damage to any Work Product during shipment by a common carrier. Sponsor shall be responsible for the insurance premium and for notifying WIL, in writing, of its desire to insure shipments at a rate that exceeds the common carrier’s standard liability limit. In the event that a claim results, Sponsor shall be responsible for substantiating (if required by the insurer) the value of the Work Product and seeking reimbursement of any loss.

 

b)           Subject to receipt of a delivery request from Sponsor in accordance with Section 7(a), WIL will archive the Work Product of each Study for a period of 1 year, or as otherwise set forth in the relevant Work Order or Protocol, from the date WIL issues the final report (“FR Date”) under the Study. Upon expiration of such period, Sponsor shall provide written notification to WIL to either (i) request the transfer of such Study’s Work Product to Sponsor or a third party (such transfer to be made in accordance with Section 7(a) above) or (ii) provide notification of its intention to continue to archive the Study’s Work Product at WIL. If Sponsor fails to so notify WIL, subject to Section 7(c) below, WIL will archive such Work Product until Sponsor provides further written instructions. With respect to the archiving of such Work Product, unless otherwise set forth in the relevant Work Order, WIL may commence charging Sponsor at a mutually agreed rate not exceeding WIL’s then standard current rates for the provision of such archiving services from and after the expiration of the period of year from the FR Date, WIL will invoice Sponsor on an annual basis for such archiving services and the payment provisions of Section 4 shall apply thereto.

 

c)           Notwithstanding the foregoing, upon completion of a Study or at any time after the period of 3 years from the FR Date, WIL may make a written request to Sponsor for permission to dispose of the Work Product or any of Sponsor’s other property. Failure by Sponsor to respond to such request within 120 days of receipt shall be considered as tacit approval by Sponsor for disposal of the Work Product or Sponsor’s other property in the manner described in WIL’s written request.

 

d)           If Sponsor fails to pay any invoice for archiving services within 30 days of the due date, WIL may, in its sole discretion, upon 30 days written notice to Sponsor, destroy the archived Work Product.

 

e)           Upon completion of a Study, all compounds and/or other substances that are furnished to WIL by Sponsor and which have not been consumed during the Study, or which are not required to be stored as samples for purposes of validating the Study, shall be returned to Sponsor or at Sponsor’s direction, destroyed.

 

 

-4-

 

 

 

	
8.

	
Intellectual Property (IP) Ownership

 

a)           WIL agrees that all (i) information, data and reports collected, generated or prepared during a Study; all discoveries, inventions or improvements, whether patentable or not, other than WIL IP (as defined below) arising out of a Study and relating to the articles or substances studied or the use thereof; and (iii) all intellectual and industrial property rights throughout the world subsisting in or relating to the foregoing shall be the property of the Sponsor (“Sponsor IP”). WIL hereby assigns any and all of WIL’s right, title and interest in such Sponsor IP to Sponsor with effect as and from the time it is generated or comes into existence. At the request and sole and reasonable expense of Sponsor, WIL agrees to execute all relevant documents required by Sponsor to confirm such assignment to Sponsor of any and all of WIL’s right, title and interest in Sponsor IP.

 

b)           Sponsor shall have no property rights in WIL’s testing methods, practices, procedures, tests, test apparatus, equipment or information related to the conduct of WIL’s business, or any inventions, improvements or developments related thereto (“WIL IP”). Such WIL IP shall be the sole and exclusive property of WIL and WIL warrants that its use of WIL IP will not infringe the intellectual property rights of any third party.

 

	
9.

	
Independent Contractors

 

WIL and Sponsor agree that WIL is an independent contractor and that no provision in this Agreement shall be construed to make WIL an employee, agent or representative of Sponsor, or shall be deemed to create a partnership or joint venture between the parties. Neither party shall hold itself out to third persons as purporting to act on behalf of, or serving as the agent of, the other party.

 

	
10.

	
Subcontract

 

WIL shall not subcontract any Services to be provided hereunder, without obtaining Sponsor’s prior consent, which shall not be unreasonably delayed, withheld or conditioned.

 

11.   Compliance with Law

 

In the performance of this Agreement, WIL shall comply fully with all applicable laws, rules, and regulations, including those of the United States Department of Agriculture, the Association for Assessment and Accreditation of Laboratory Animal Care International, Good Laboratory Practices as promulgated by the Food and Drug Administration, the Environmental Protection Agency and all other regulatory agencies having jurisdiction over a Study. In the event any such government regulatory requirements shall change during the course of a Study, and such new requirements necessitate a change in a Work Order (including a change to a Protocol), WIL will submit to Sponsor a revised technical and compensation proposal for Sponsor’s review and acceptance prior to making any changes to such Study; provided, that WIL shall not under any circumstances be required to continue a Study if such continuance would be in violation of a law, rule or regulation. In the event of a conflict between government regulations, Sponsor and WIL shall mutually agree in writing as to the applicable regulations to be followed by WIL in its performance of the Study. In fulfilling all its obligations hereunder, Sponsor agrees to comply fully with all applicable laws, rules and regulations.

 

  

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12.

	
Indemnification and Limitations

 

a)           WIL shall indemnify, defend and hold harmless Sponsor, its directors, officers, owners and employees from and against all third party loss or damage (including reasonable attorney fees and expenses) arising from (i) WIL’s material breach of this Agreement or (ii) the gross negligence or willful misconduct of WIL, except to the extent such loss or damage relates to the gross negligence or willful misconduct of Sponsor or a Sponsor indemnitee or the material breach of this Agreement by Sponsor.

 

b)           Sponsor shall indemnify, defend and hold harmless WIL, its directors, officers, owners and employees from and against all third party loss or damage (including reasonable attorney fees and expenses) arising from (i) Sponsor’s material breach of this Agreement, (ii) the gross negligence or willful misconduct of Sponsor or (iii) Sponsor’s use or exploitation of any Sponsor IP, Work Product or Sponsor Confidential Information, except to the extent such loss or damage relates to the gross negligence or willful misconduct of WIL or a WIL indemnitee or the material breach of this Agreement by WIL.

 

c)           Other than as specifically set forth herein, WIL makes no representations or warranties concerning the services. Except in relation to claims arising out of a breach by either party of their obligations of confidentiality, under no circumstances shall either party be liable to the other for any indirect, consequential, punitive, exemplary or special damages, including lost profits or cost of replacement materials. Subject to any limitations on remedies set forth herein, in no event shall WIL be liable to Sponsor under a Work Order for any amounts in excess of the of the greater of (i) with respect to any claim arising under such Work Order, the value of insurance proceeds actually recovered by WIL on account of such claim for damages incurred by Sponsor; or (ii) the total contract price specified in the Work Order,. This limitation shall not apply in relation to any breach by WIL of its confidentiality obligations.

 

	
13.

	
Material Errors

 

In the event WIL commits a material error in the performance of Services for a Study, which material error causes the results of such Study to be unusable for Sponsor’s stated purposes set forth in the relevant Protocol, at Sponsor’s election, WIL will at Sponsor’s election either (i) rerun that part of the Study (or, if necessary, the whole Study) as soon as possible at WIL’s cost or (ii) refund to Sponsor the sums paid to WIL as of that date on account of the Study.  The foregoing shall be the Sponsor’s sole remedy with respect to errors of WIL in the conduct of a Study.

 

	
14.

	
Force Majeure

 

Provided a party has, to the extent that it is reasonably capable of doing so, implemented reasonable precautions to avoid or minimize the impact of any of the following circumstances, a party shall not be liable in any delay in performing its obligations (other than payment obligations) under this Agreement if its performance is delayed or prevented by acts of God, fire, terrorist acts, explosion, war, riots, strikes, law or any other cause (except financial) beyond such party’s control, but only to the extent of and during the reasonable continuance of such disability. A time for performance required by the Agreement which falls due during or subsequent to the occurrence of any of the causes referred to in this paragraph shall be deferred for a period of time equal to the period of disability resulting from such cause.

 

  

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15.

	
Insurance

 

WIL shall secure and maintain in full force and effect at all times during the term of this Agreement, a policy or policies of insurance which shall be commensurate with industry standards for services substantially similar to the Services.

 

	
16.

	
Quality Assurance and Study Monitoring

 

Upon not less than five (5) days’ prior written notice, Sponsor shall have the right to (i) inspect WIL’s premises at reasonable times and with reasonable frequency, during the course of WlL’s performance of Services hereunder and (ii) review procedures then being used by WIL in its performance of Services for Sponsor, as well as all experimental data generated from said Services, including, but not limited to all written reports, notes, schedules, or similar Work Product which may document work done and results achieved.

 

	
17.

	
Miscellaneous

 

a)           This Agreement shall be interpreted in accordance with the laws of the State of Ohio without regard for its conflicts of laws principles. Actions brought under this Agreement shall be brought in any court of competent jurisdiction in the State of Ohio. Should any Ohio court find any provision to be invalid or contrary to public policy, the provisions not so found shall remain in effect and binding upon the parties. Sponsor and WIL agree to attempt in good faith to replace any invalid or unenforceable provision of this Agreement with a provision which is valid and enforceable and which expresses as closely as possible the intention of the original provision.

 

b)           This is a personal services contract and may not be assigned by either party without the express written consent of the other, which consent shall not be unreasonably withheld, provided, however, that either party is free to assign this Agreement without consent in connection with a transaction resulting in a change of control, merger, consolidation, acquisition of all or substantially all of its assets, or other similar transaction.

 

c)            The word “Agreement” as used herein means and includes this instrument, all Work Orders, Protocols and Study Outlines and any amendments, supplements, additions, schedules, exhibits or appendices to any of the foregoing which are mutually executed by WIL and Sponsor.

 

d)           This Agreement (including the Work Orders, Study Outlines and/or Protocols issued hereunder) and the Confidentiality Agreement represent the entire contract between Sponsor and WIL. There are no oral or written promises, terms, conditions, or obligations other than those contained in this Agreement (including the Work Orders, Study Outlines and/or Protocols issued hereunder) and the Confidentiality Agreement. This Agreement (including the Work Orders, Study Outlines and/or Protocols issued hereunder) and the Confidentiality Agreement supersede all prior negotiations, representations or agreements, either written or oral, between the parties on the subject. No waiver of any term, provision or condition of this Agreement (including the Work Orders, Study Outlines and/or Protocols issued hereunder) or the Confidentiality Agreement whether by conduct or otherwise in any one or more instances shall be deemed to be or construed as a further or continuing waiver of any such term, provision or condition of any other term, provision or condition of this Agreement (including the Work Orders, Study Outlines and/or Protocols issued hereunder) or the Confidentiality Agreement. In the event the terms of a Work Order, Study Outline, Protocol or any other agreement between the parties hereto contradict any provision of this Agreement, this Agreement shall control.

 

  

-7-

  

 

e)           Each individual signing this Agreement certifies that he or she is authorized to sign this Agreement on behalf of the party which he or she represents, and to bind that party to the terms and conditions herein stated.

 

f)           Any notices given hereunder shall be sent by fax or email, with a confirmation copy sent via overnight courier to the following addresses (or such other address as a party may designate as a notice address in a written notice to the other party) and shall be deemed delivered when received (or if received on a weekend or holiday, on the next business day thereafter) as follows:

 

If to Sponsor:

 

Dianne Angus

Chief Operating Officer

Prana Biotechnology Ltd

Level 2, 369 Royal Parade, Parkville Victoria 3052 Australia

Phone: +61 3 9349 4906

Fax:     +61 3 9348 0377

Email: dangus@pranabio.com

 

If to WIL:

 

David R. Baumgartner, CPA

Vice President

WIL Research Laboratories, LLC

1407 George Road

Ashland, OH 44805

Phone: (419) 289-8700

Email: dbaumgartner@wilresearch.com

 

g)           Sponsor shall not use WIL’s name or the names of WIL’s employees in any advertising or sales promotional material or in any publication without prior written permission of WIL. WIL shall not use Sponsor’s name or the names of Sponsor’s employees in any advertising or sales promotional material or in any publication without prior written permission of Sponsor.

 

h)           In the event of a dispute relating to this Agreement, the parties shall attempt to resolve the dispute prior to taking any action. Should the dispute not be resolved within thirty (30) days, each party shall be free to seek any remedy legally available to it in accordance with this Agreement before a court of competent jurisdiction in the State of Ohio. Notwithstanding the foregoing, either party shall be free to seek interim legal relief in a court of competent jurisdiction in the State of Ohio in the event that the other party’s breach of this Agreement would reasonably be expected to cause such party irreparable harm.

 

  

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i)           Unless otherwise agreed to in writing, neither party shall solicit for hire any employee of the other during the term of this Agreement and for twelve (12) months thereafter, provided, that this provision shall not prevent either party from utilizing general solicitations for hiring purposes, and hiring persons who respond to such general solicitations.

 

j)           This Agreement, and any Work Order, Change Order, or Outline executed hereunder, may be executed in one or more counterparts, each of which will be deemed an original, and all of which together will be deemed to be one and the same instrument. Signatures to this Agreement and any Work Order, Change Order, or Outline transmitted by facsimile transmission, by electronic mail in “portable document format” (“.pdf”)  form, or by any other electronic means intended to preserve the originals graphic and pictorial appearance of a document, will have the same effect as physical delivery of the paper document bearing the original signatures, and shall be deemed original signatures by both parties.

 

[Signature Page Follows]

 

  

-9-

  

 

IN WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by the respective authorized representatives.

	  	  	  	  	  	  	  	  	  
	
PRANA BIOTECHNOLOGY LTD

	  	  	
WIL RESEARCH LABORATORIES, LLC

	  	  	  	  	  
	
By:

		  	
By:

	
	  	
Name: Dianne Angus

	  	  	
Name: David R. Baumgartner, CPA

	  	
Title: Chief Operating Officer

	  	  	
Title: Vice President

	  	  	  	  	  	  	  	  
	  	
Date:

	
29 August 2013

	  	
Date:

	
29 August 2013

	  

 

 

  

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EXHIBIT A

 

SAMPLE WORK ORDER

 

	
WIL Project Number:    WIL-______________________

	
Date: ______________

 

Pursuant to the Master Laboratory Services Agreement dated ____________, 2013, by and between Sponsor and WIL Research Laboratories, LLC (the “Master Services Agreement”) and in consideration of the mutual promises contained therein and for other good and valuable consideration the receipt and adequacy of which each of the parties does hereby acknowledge, the parties hereby agree to amend the Master Services Agreement by adding the attached Work Order entitled ____________________________________, which is designated Work Order WIL- ________________ (“Work Order”). This Work Order is effective as of ______________, 200___. Any capitalized terms used herein and not defined shall have the meanings ascribed to them in the Master Services Agreement.

	
1.

	

PROTOCOL

 

WIL shall conduct the studies described in and required by the Protocol (as identified below). Except as otherwise provided by this Work Order or the Master Services Agreement, WIL shall follow the procedures and methodology, and shall observe and comply with the schedules, specified in the Protocol. Incorporated herein as a part of this Work Order is the study protocol (the “Protocol”) identified as follows: “__________________________________”. Should the Protocol be amended, supplemented or revised in any fashion after the date hereof, WIL will have the right to adjust the Protocol (including fees and payment schedule) to reflect required changes. Any such amendment, supplement or revision shall only be effective if signed by both parties hereto.

 

	
2.

	

FEE AND PAYMENT SCHEDULE

 

Total contract price of __________________________________ ($____________) which the Sponsor shall pay upon receipt of proper invoices in the following installments:

 

	 	(a)	<Insert>percent or $____________upon authorization and/or execution of this Work Order;

	 	(b)	<Insert>percent or $____________ upon commencement of Study;

	 	(c) 	<Insert>percent or $____________ upon completion of the in-life phase;

	 	

(d)

	<Insert>percent or $____________ upon issuance of audited draft report for Study; and

	 	

(e) 

	<Insert>percent or $____________ upon issuance of final report or 45 days after the audited draft report has been issued.

 

	
P: 419-289-8700

Email: info@wilresearch.com

1407 George Road, Ashland, OH 44805

	
www.wilresearch.com

 

 

  

  

  

 

The contract price set forth in this Section 2 does not include the archiving of Work Product beyond what is contemplated in the Master Services Agreement.

 

In the event that additional costs are incurred beyond the amount specified in this Work Order as a result of the need for additional Services or a change (having been agreed to by the Sponsor and WIL in writing) in the scope and/or schedule of the work to be performed, the Sponsor agrees to pay such reasonable additional costs upon receipt of a proper invoice.

 

IN WITNESS WHEREOF, the parties here have caused this Work Order to be executed by their respective authorized representatives.

	  	  	  	  	  	  	  
	
[NAME OF SPONSOR]

	  	
WIL RESEARCH LABORATORIES, LLC

	  	  	  	  	  
	
By:  

	
SAMPLE – NOT FOR SIGNATURE

	  	
By:  

	

SAMPLE – NOT FOR SIGNATURE

	  	
Name:

	  	  	
Name:

	  	
Title:

	  	  	
Title:

	  	
Date:

	  	  	  	
Date:

	  

 

  

  

  

 

Standard Payment Milestones

 

	

  Length of Study  

	

  Authorization  

	

  Commencement  

	

Equal

  Quarterly  

Payments

	

End of In-

Life (or

  Completion)  

	

  AD/UD  

  Report

	

  Final Report or  

45 days after

AD/UD

	  	  	  	  	  	  	  
	

  Studies < 1 mos.

	

50%

	  	  	

40%

	  	

10%

	  	  	  	  	  	  	  
	

  Studies < 6 mos.

	

20%

	

30%

	  	

40%

	

5%

	

5%

	  	  	  	  	  	  	  
	

  Studies > 6 mos.

	

20%

	

25%

	

45%

	  	

5%

	

5%

	  	  	  	  	  	  	  
	

  1 Yr. Studies

	

20%

	

20%

	

50%

	  	

5%

	

5%

	  	  	  	  	  	  	  
	

  2 Yr. Studies

	

15%

	

15%

	

60%

	  	

5%

	

5%

	  	  	  	  	  	  	  
	

  NOTE:  Inhalation Studies, NHP Studies may require higher authorization percentages

	  	  

 

  

  

  

 

 

EXHIBIT B

 

 

«Date»

Proposal: «Proposal_Number»

 

 

Proposal for

«Client»

	  	  
	  	
Proposal provided by:

	  	
X

	  	
X

	  	
X

	  	
X

	  	
X

	 	 
	  	
Contact information:

	  	
X

	  	
X

	  	
X

	  	
X

	  	
X

	 	 
	  	
X  

	 	X
	 	X
	 	X
	 	X

 

 

  

  

  

 

 

	«Proposal_Number»	Page: 15 of 16

 

Proposal Summary

	
  Study  

	
  Base Study  

Fee

	
Optional

	
  Total Study  

Fee

	  
	  	  	  	  	  	  	
Authorized

	  	  	  	  	  	
$

	o
	  	  	  	  	  	
$

	o
	  	  	  	  	  	
$

	o

 

Authorization Statement

 

«Client» (“Sponsor”) hereby awards the above described proposal to WIL Research Laboratories, LLC (“WIL”) and requests WIL to proceed with the necessary activities to initiate these studies, including but not limited to, protocol development, contract finalization, study room reservation and definitive scheduling of study-related activities.

 

Sponsor understands that by executing this document it acknowledges financial responsibility for all costs and expenses incurred by WIL in preparation of the Study, and if the Study is cancelled by Sponsor, Sponsor hereby agrees to reimburse WIL for all such costs and expenses.

	  	  	  	  	  	  	  
	  	  	  	  	  	  	  
	
Signature of Authorized Sponsor Representative

	  	
Date

	  	  	  	  	  
	
Name:

	  	  	  
	  	  	  	  	  	  
	
Title:

	  	  	  
	  	  	  	  
	
Company:

	  	  	  

 

	
  CONFIDENTIAL  

	  

 

  

  

  

 

EXHIBIT C

 

WIL Research Laboratories, LLC

Change Order

 

	  	  
	
WIL Study #: WIL-______________

	
Change Order #: ______

	
Sponsor Name: ______________________________

	
Date Issued: _______________

	
Sponsor Study #: ______________

	  
	
PO # ____________

	  
	  	  

 

	
A.

	

The indicated Work Order is amended as follows:

 

	
   

	

i.

	
Protocol

 

	
   

	

 

	

The project description is identified as:

[Enter study title as defined in original Work Order]

 

	
   

	

ii.

	

Compensation

 

	
   

	

 

	

An [increase] [or] [decrease] of US$________.00 is agreed to by the Sponsor and WIL.

The reason for this change is described in item B below.

 

	
   

	

 

	

The total price is increased from _________ ($_________.00) to___________($________). The $__________.00 fee represents additional costs incurred for modifications to the project as requested by the Sponsor. One Hundred percent of the additional charge ($__________) will be due upon execution of this Change Order.

 

	
B. 

	

Reason for change:

 

	
 

	
[____________________________]

 

	

C.

	
Except as expressly amended hereby, the Work Order shall continue to be and remain in full force and effect in accordance with its terms.

 

AGREED TO, ACKNOWLEDGED, AND ACCEPTED BY:

 

The parties have caused this Change Order to be executed by their duly authorized representatives, and entered into as of the date of the last party below to execute.

	  	  	  	  	  	  	  	  	  
	
[Sponsor Name]

	  	
WIL Research Laboratories, LLC

	  	  	  	  	  	  	  	  	  
	
By:

	
SAMPLE – NOT FOR SIGNATURE

	  	
By: 

	
SAMPLE – NOT FOR SIGNATURE

	
Print Name:

	  	  	
Print Name:

	  
	
Title:

	  	  	
Title:

	  
	
Date: 

	  	  	
Date: 

	  

 

  

  

  

 

AMENDMENT #1

TO

MASTER LABORATORY SERVICES AGREEMENT

 

THIS AMENDMENT (“Amendment”) is made as of 19th day of November, 2013 (the “Effective Date”) by and between Prana Biotechnology, Ltd., ACN 080 699 065, an Australian limited liability company whose address is Level 2, 369 Royal Parade, Parkville Victoria 3052 (“Sponsor”) and WIL Research Laboratories LLC (together with its subsidiaries), a Delaware limited liability company, with a principal place of business at 1407 George Road, Ashland, OH 44805 (hereinafter collectively referred to as “WIL”).

 

Sponsor entered into a Master Laboratory Services Agreement with WIL, dated as of 26 August 2013 as amended (the “Agreement”). The parties hereby agree to amend the Agreement as follows:

 

	

1.  

	

Section 4. Payments for Services - In line 5, replace the text “following email address sforan@pranabio.com” with “email address of the Sponsor’s designated representative”.

 

	

2.  

	

Section 5. Term and Termination shall have section 5.c) and 5.d) replaced in its entirety and a new section 5.e) shall be added.

 

	
 

	

c)            Sponsor may at any time terminate a Study upon written notice to WIL. Immediately upon receipt of such notice, WIL shall use its commercially reasonable efforts to minimize the cost to Sponsor resulting from such termination (Mitigation). In the event of such termination, where WIL is not in material breach of this Agreement or the applicable Work Order or Protocol, Sponsor shall pay to WIL (unless otherwise minimized or avoided through Mitigation): (a) all amounts due and owing under the applicable Work Order up to the date of termination, whether invoiced or not; (b) all charges for the work performed and expenses (including uncancellable or non-reimbursable expenses) reasonably incurred by WIL prior to or in connection with termination to the extent that they relate to then current and immediately following milestone payment of the Study (as described in the Fee and Payment Schedule in the Work Order) and have not otherwise been satisfied under sub-paragraph (a) herein.

 

	
 

	

d)             If the commencement of a Study is delayed and this is solely caused by Sponsor, then provided WIL (i) is not in material breach of this Agreement or the applicable Work Order or Protocol and; (ii) has used its commercially reasonable efforts to minimize the costs resulting from the delay, Sponsor may be required to pay a weekly fee as mutually agreed between the parties and set the forth in the Work Order (or an equitable proportion thereof having regard to the results of WIL’s mitigation efforts). If the Sponsor subsequently terminates the Work Order, then the weekly payments shall cease and the termination provisions of Section 5.c) shall apply.

 

	
 

	

e)            For the purpose of paragraphs (c) and (d), WIL will provide Prana with all relevant documentation evidencing or supporting the amounts, charges and expenses which it seeks to recover from Sponsor on the termination or delay of a Study.

 

  

  

  

 

	
3.

	

Section 12. Indemnification and Limitations section 12.c) shall be replaced in its entirety.

 

	
 

	

c)            Other than as specifically set forth herein, WIL makes no representations or warranties concerning the services. Except in relation to claims arising out of a breach by either party of their obligations of confidentiality or claims made by Sponsor against WIL under Section 13 as a consequence of Major Errors made by WIL for Studies of duration greater than 12 months, under no circumstances shall either party be liable to the other for any indirect, consequential, punitive, exemplary or special damages, including lost profits or cost of replacement materials. Subject to any limitations on remedies set forth herein and with the exception of claims arising out of Major Errors which occur in Studies of duration greater than 12 months (“Major Event Claims”) or claims in respect of any breach by WIL of its confidentiality obligations, in no event shall WIL be liable to Sponsor with respect to any claims arising under or in connection with a Work Order (whether for breach of the Work Order or otherwise) for any amounts in excess of the greater of (i), the value of insurance proceeds actually recovered by WIL on account of such claims for damages incurred by Sponsor; or (ii) the total contract price specified in the Work Order, For a Major Event Claim under a Work Order for a Study of duration greater than 12 months, WIL will not be liable to Sponsor for any amounts in excess of the greater of (i), one and one-half times the total contract price specified in the Work Order where the Major Event occurs within 9 – 18 months after the commencement of the Study; or (ii) two times the total contract price specified in the Work Order where the Major Event occurs later than 18 months after the commencement of the Study.

 

	
4. 

	
Section 13. Material Errors shall be replaced in its entirety.

 

If WIL commits a material error in the performance of Services as described in the relevant Protocol for a Study (“Error”) then it must immediately notify Sponsor in writing and provide full details of the Error. Where the Error (whether notified by WIL or otherwise ascertained by Sponsor) has or will, as mutually agreed between Sponsor and WIL, caused the results of such Study to be unusable for Sponsor’s stated objectives set forth in the relevant Protocol (“Major Error”), WIL will at Sponsor’s direction in writing either: (i) rerun that part of the Study (or, if necessary, the whole Study) as soon as possible at WIL’s cost or (ii) refund to Sponsor the sums paid to WIL as of that date on account of the Study. Sponsor may also terminate the Work Order by written notice to Sponsor and/or claim from WIL in pursuance of its rights at law, whether in contract, tort (including negligence) or otherwise, any additional losses, costs, expenses, damages suffered or incurred by Sponsor as a result of the Major Error and the consequent delay in completion of the Study.

 

In all other respects, the terms of the Agreement shall remain unmodified and in full force and effect.

 

The parties have indicated their acceptance of the terms of this Amendment by the signatures set forth below. Each individual signing on behalf of a corporate entity hereby personally represents and warrants his or her legal authority to legally bind that entity.

	  	  	  	  	  	  	  	  	  	  
	
PRANA BIOTECHNOLOGY LTD.

	  	
WIL RESEARCH LABORATORIES LLC

	  
	  	  	  	  	  	  	  	  	  	  
	
By: 

		  	
by: 

		  
	  	  	  	  	  	  	  	  	  	  
	
Print Name: 

	
GEOFFREY REMPLER

	  	
Print Name: 

	
John Maxwell

	  
	  	  	  	  	  	  	  	  	  	
	
Title:

	
CEO

	  	
Title:

	
Vice President

	  	  	  	  	  	  	  	  	  
	
Date:

	
18 December 2013

	  	
Date:

	
12-16-13

	 	 	 	 	 

 

  

  

  

 

WORK ORDER

	  	  
	
WIL Project Number: WIL-41505

	
Date: 19 December 2013

	
PO Number:

	  

 

          Pursuant to the Master Laboratory Services Agreement dated 26 August 2013, and as amended on 19 November 2013 by and between PRANA BIOTECHNOLOGY LIMITED (Sponsor) and WIL RESEARCH LABORATORIES, LLC (the “Master Services Agreement”) and in consideration of the mutual promises contained therein and for other good and valuable consideration the receipt and adequacy of which each of the parties does hereby acknowledge, the parties hereby agree to amend the Master Services Agreement by adding the attached Work Order entitled “A 2-year Oral Gavage Carcinogenicity Study in Sprague Dawley Rats,” which is designated Work Order WIL-41505 (“Work Order”). This Work Order is effective as of 19 December 2013. Any capitalized terms used herein and not defined shall have the meanings ascribed to them in the Master Services Agreement.

	  	  
	1.        PROTOCOL

 

          WIL shall conduct the studies described in and required by the Protocol (as identified below). Except as otherwise provided by this Work Order or the Master Services Agreement, WIL shall follow the procedures and methodology, and shall observe and comply with the schedules, specified in the Protocol. Incorporated herein as a part of this Work Order is the study protocol (the “Protocol”) identified as follows: “A 2-year Oral Gavage Carcinogenicity Study in Sprague Dawley Rats.” Should the Protocol be amended, supplemented or revised in any fashion after the date hereof, WIL will have the right to adjust the Protocol (including fees and payment schedule) to reflect required changes. Any such amendment, supplement or revision shall only be effective if signed by both parties hereto.

	  	  
	2.        FEE AND PAYMENT SCHEDULE

 

          Total contract price of One Million Three Hundred Fifty One Thousand Six Hundred Dollars ($1,351,600.00), which the Sponsor shall pay upon receipt of proper invoices in the following installments:

 

	  	
 (a) Fifteen percent or $202,740.00 upon authorization and/or execution of this Work Order;

	  	
 (b) Fifteen Five percent or $202,740.00 upon commencement of Study;

	  	
 (c) Sixty percent or $810,960.00 in 8 quarterly payments of $101,370.00, to begin three months after commencement of study;

	  	
 (d) Five percent or $67,580.00 upon issuance of audited draft report for Study; and

	  	
 (e) Five percent or $67,580.00 upon issuance of final report or 45 days after the audited draft report has been issued.

 

P: 419-289-8700

Email: info@wilresearch.com

1407 George Road, Ashland, OH 44805

www.wilresearch.com

	  
	
We have listening down to a science. 

	  

  

  

  

 

          The contract price set forth in this Section 2 includes the archiving of Work Product for a period of five (5) years from the date WIL issues the final report (“FR. Date”) under this Study.

 

          In the event the study is delayed and such delay is caused solely by Sponsor. Sponsor will be required to pay W1L a weekly fee of $8,000.00 throughout the period of the delay. If Sponsor subsequently terminates this Work Order. then the weekly payments will cease and the termination provisions of Section 5.c) of the Master Laboratory Service Agreement shall apply.

 

          In the event that additional costs are incurred beyond the amount specified in this Work Order as a result of the need for additional Services or a change (having been agreed to by the Sponsor and WIL in writing) in the scope and/or schedule of the work to be performed, the Sponsor agrees to pay such reasonable additional costs upon receipt of a proper invoice.

 

          IN WITNESS WHEREOF, the parties here have caused this Work Order to be executed by their respective authorized representatives.

 

	  	  	
 Prana Biotechnology Limited

	  	  	
WIL Research Laboratories, LLC

	  
	  	 	  	  	 	  
	
By: 

	  	  	
By: 

	  	  
	  	
Name: Geoffrey Kempler

	  	  	
Name: John Maxwell

	  
	  	
Title: Chief Executive Officer

	  	  	
Title: Vice President

	  	
Date: 22 December 2013

	  	  	
Date: December 19,2013exhibit_4-42.htm

Exhibit 4.42

 

Quotient Clinical Limited Master Services Agreement

 

This Agreement is made on 10th December, 2013

 

Between

	  	  
	
(1)

	
Quotient Clinical Limited a company registered in England and Wales under number 02393366 whose registered office is at Mere Way, Ruddington Business Park, Nottingham, NG11 6JS United Kingdom (“Quotient Clinical”); and

	  	  
	
(2)

	
Prana Biotechnology Ltd a company registered in Australia under number ACN 080 699 065 whose registered office is at Level 2, 369 Royal Parade, Parkville 3052, Victoria, Australia (“Customer”);

 

Recitals

	  	  
	
(A)

	
Quotient Clinical is engaged in the development of formulations and conduct of clinical research in relation to pharmaceutical products.

	  	  
	
(B)

	
Customer is engaged in the development of pharmaceutical products.

	  	  
	
(C)

	
Quotient Clinical and Customer wish to establish an ongoing relationship under which, from time to time, Customer may request that Quotient Clinical performs research and other services in relation to the Customer’s pharmaceutical products.  They have agreed to enter into this Agreement to set out the terms of such relationship.

 

It is agreed

	  	  
	
1

	
Definitions

	  	  
	  	
ABPI means the Association of British Pharmaceutical Industry in the United Kingdom.

	  	  
	  	
Affiliates means any parent or subsidiary companies of a party

	  	  
	  	
Agreement means this Master Services Agreement

	  	  
	  	
Background Material means any and all data, materials, pharmaceutical products, formulation methods, software, know-how, inventions and/or discoveries of a party which is/are in existence at the date of this Agreement or which is/are developed or arise(s) independently of any Research

	  	  
	  	
Background Intellectual Property means any Intellectual Property in and to any Background Material

	  	  
	  	
Clinical Protocol means a protocol for the conduct of Research agreed in writing between the parties

	  	  
	  	
Commencement Date means the date of this Agreement set out above

	  	  
	  	
Confidential Information means all information disclosed by one party to the other whether in oral or written form in relation to Quotient Clinical performing the Research with Customer’s Materials and includes without limitation in respect of Confidential Information of the Customer: Research Output, Customer’s Materials, Customer Data, any information contained in Background Material provided by Customer, a Clinical Protocol (except to the extent that the same contains or constitutes any Background Material of Quotient Clinical) which shall all be deemed to be the Confidential Information of the Customer.

 

	
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Customer Data means documents, data and information relating to any Materials and/or Research

	  	  
	  	
Force Majeure means any circumstance beyond the reasonable control of the party affected by it and includes for each party, acts of god, industrial disputes, telecommunications failure, power supply failure, computer breakdown, failure of suppliers to meet delivery requirements and absence of key personnel for an extended period due to illness or injury

	  	  
	  	
Good Clinical Practice (GCP) means good clinical practice as set out in the ICH guidance on Good Clinical Practice as defined in ICH topic E6 and laid down in directive 2005/28/EC

	  	  
	  	
Good Manufacturing Practice (GMP) means good manufacturing practice as laid down in directive 2003/94/EC and the requirements defined in: The Rules Governing Medicinal Products in the European Community Volume 4, including the Investigational Medicinal Products Annex 13, and as applied to APIs for Use in Clinical Trials, as covered within the EU Guidance to Good Manufacturing Practice Part II, Section 19 and ICH Q7 Section 19

	  	  
	  	
Intellectual Property means all patents, trade marks or trading names (whether or not registered), rights in know-how, design rights (whether or not registered), copyright, database rights, rights in inventions and know-how, all applications for the same and all rights having equivalent or similar effect, in each case subsisting at any time, anywhere in the world

	  	  
	  	
Materials means any materials and/or substances or pharmaceutical products which are the subject of Research

	  	  
	  	
Payment Schedule means the document set out at appendix 2 of a Work Order 

	 	 
	 	Proposal means the proposal and costing document set out at appendix 1 of a Work Order
	  	  
	  	
QC Non-Cancellable Costs means such of the non-cancellable costs specified in the Work Order which Quotient Clinical has not been able to avoid or mitigate pursuant to clauses 7.2 or 8.8, as applicable.

	  	  
	  	
Regulations means the Medicines for Human Use (Clinical Trials) Regulations 2004 and as amended in 2006 and any subsequent amendments made to those regulations

	  	  
	  	
Research means any trial, study and/or services to be carried out by Quotient Clinical which are set out in the relevant Proposal

	  	  
	  	
Research Output means any data, results and/or materials produced by Quotient Clinical, in the course of and relating to Research (whether individually, collectively or jointly with the Customer and on whatever media), which it is required to deliver to the Customer pursuant to the relevant Proposal, including, without limitation, any and all reports and case report forms, but excluding any Background Materials.

	  	  
	  	
Service Providers means subcontractors (of whatever level) and agents of Quotient Clinical and their employees

 

	
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Sponsor has the meaning given to it in the Regulations

	  	  	  
	  	
Term means the period of five (5) years from the Commencement Date

	  	  	  
	  	
Trial Subject means a person who is administered and/or who consumes any Materials in connection with Research

	  	  	  
	  	
Work Order means a document (in substantially the same form as that set out in schedule 1) which has been issued by Quotient Clinical and agreed by both parties as envisaged under clause 2.1.

	  	  	  
	
2

	
The Research

	  	  	  
	
2.1

	
In consideration of the first Work Order the parties agree that if, at any time during the Term, it is agreed that Quotient Clinical will perform any particular trial, study and/or services for the Customer, a document in substantially the form set out in schedule 1 will be completed and issued by Quotient Clinical in relation to such trial, study and/or services, and will be signed by both parties. Each such Work Order will constitute a separate contract between the parties for the performance by Quotient Clinical of the relevant Research, and the payment by the Customer of the amounts set out in the relevant Proposal (and the performance by the Customer of its other obligations), in accordance with the terms of this Agreement and the relevant Work Order (to the exclusion of any other terms and/or conditions which the Customer may attempt or purport to impose).

	  	  	  
	
2.2

	
Quotient Clinical shall carry out all Research in accordance with the relevant Clinical Protocol and with due skill and care in accordance with industry best practice and  strictly in accordance with the Proposal, the Regulations and all other applicable laws, Good Clinical Practice and Good Manufacturing Practice. Quotient Clinical must inform Customer within 24 hours of any serious adverse events and significant deviations from, or breaches of the standards applied to the Services, to enable Customer to meet its requirements for reporting such events to the applicable Regulatory Authority.

	  	  	  
	
2.3

	
All services to be provided by Quotient Clinical under this Agreement and any Work Order will be deemed to be provided at the Customer’s request and the Customer accepts that it is responsible for verifying that those services are suitable for its own needs.

	  	  	  
	
2.4

	
The Customer  may  during  this Agreement  inspect  and/or audit Quotient  Clinical’s performance of any Research on giving Quotient Clinical at least 48 hours  written notice. The Customer shall use its reasonable endeavours not to cause any disruption to Quotient Clinical’s business in carrying out such inspection or audit.

	  	  	  
	
2.5

	
The Customer shall ensure that its employees co-operate fully with Quotient Clinical and any Service Providers in relation to the provision of any Research (including without limitation complying with Quotient Clinical’s normal and reasonable codes of staff and security practice). The Customer shall comply with its obligations as set out in any Proposal in a timely manner.

	  	  	  
	
2.6

	
The Customer shall provide to Quotient Clinical:

	  	  	  
	  	
(a)

	
all information and support necessary to enable Quotient Clinical to fulfil all of its obligations under the Regulations in relation to any Research including for the avoidance of doubt completing any necessary applications or notifications to the licensing authority under the Regulations, any ethics committee, any other investigator, any medical practitioner and/or any person subject to or connected with the relevant clinical trial; and

 

	
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(b)

	
a copy of the Investigator’s Brochure and where available, the Investigational Medicinal Product Dossier for the relevant pharmaceutical product and at all times during any Research and during the preparation of any report relating to the same, also promptly provide Quotient Clinical with written notifications containing details of any applicable and relevant new information and data (as it emerges) relating to the safety and safe usage of the relevant Materials including any new and relevant preclinical and clinical pharmacovigilence information and data.

	  	  	  
	  	
The Customer warrants and undertakes to Quotient Clinical that all such  information is and will at all times be to the best of its knowledge accurate, complete and not false or misleading.

	  	  	  
	
2.7

	
Subject to this clause 2.7, where it states in a Work Order that Quotient Clinical will act as the Legal Representative of the Customer for the purposes of the relevant Research and to facilitate the parties’ compliance with the Regulations, the provisions of schedule 2 shall apply to that Work Order. For the avoidance of doubt, Quotient Clinical shall be responsible for ensuring that Regulatory authorisations (clinical trial approval and ethics committee Approval) are in place on behalf of Customer. The Customer acknowledges and agrees that it shall be the Sponsor in relation to all Research and that Quotient Clinical is not taking on any Sponsor obligations pursuant to this Agreement or any Work Order. The Customer shall ensure that it complies with its obligations under the Regulations and with all other applicable laws and regulations. In particular, the Customer acknowledges that it shall be solely responsible for ensuring that it has all necessary intellectual property rights, licences and permissions in relation to its pharmaceutical products to allow Quotient Clinical to carry out all Research. Quotient Clinical shall otherwise ensure that at all times any Clinical Protocol reflects all the requirements of the Regulations. Subject to Quotient Clinical’s compliance with this clause 2.7, the Customer shall indemnify and keep indemnified Quotient Clinical against all losses, claims, costs, expenses, damages and liabilities arising out of a breach by the Customer of any laws or regulations in relation to any Research and/or the relevant Materials including its obligations as Sponsor of any Research pursuant to the Regulations.

	  	  	  
	
2.8

	
Should Quotient Clinical become aware of any mistake or error or failure by it (or its Service Provider) to comply in any way with this Agreement (collectively called “Quality Breaches”) Quotient Clinical must immediately notify Customer in writing. If in the reasonable opinion of Customer, a Quality Breach (whether notified by Quotient Clinical or otherwise ascertained by Customer) has or will render (on its own or together with any other Quality Breach) any Research Data or work performed by Quotient Clinical inaccurate, unusable or requiring repetition (“Major Quality Breach”), then Quotient Clinical will at the Customer’s election either (i) repeat the relevant part or parts of a Work Order (or the whole Work Order, if the nature or scale of the Quality Breaches in the reasonable opinion of Customer necessitate this)   as soon as possible at Quotient Clinical’s cost in accordance with the agreed specification or Protocol (as applicable); or (ii)   refund to Customer the sums paid to Quotient Clinical on account of the the relevant part or parts of the Work Order or the whole Work Order, as applicable. The foregoing shall not be Customer’s sole remedy in the event of such failure by Quotient and Customer shall retain its right to seek all other remedies available under law or equity.

 

	
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3

	
Payment

	  	  	  
	
3.1

	
Unless otherwise stated in this Agreement, the Customer shall pay all Quotient Clinical’s invoices within 30 days on presentation of such invoice.

	  	  	  
	
3.2

	
Quotient Clinical shall present all invoices to the Customer for Research in accordance with the relevant Payment Schedule. All charges set out in this Agreement and/or any Work Order are exclusive of Value Added Tax or any similar taxes, levies or duties, for which the Customer will be additionally liable.

	  	  	  
	
3.3

	
If any payment that is due to be made under this Agreement and/or a Work Order by the Customer to Quotient Clinical is not paid within the period of 30 days after presentation of the relevant invoice:

	  	  	  	  
	  	  	
(a)

	
Quotient Clinical reserves the right to charge interest thereon, on a day to day basis after the 30 day payment period has elapsed at an annual rate of 4% above the National Westminster Bank plc’s base rate from time to time applicable until the sum is paid; and

	  	  	  	  
	  	  	
(b)

	
Quotient Clinical may suspend all work under this Agreement and any Work Order until payment has been made in accordance with clause 3.1 or arrangements as to payment or credit have been established which are satisfactory to Quotient Clinical.

	  	  	  
	
4

	
Supply of Materials and Customer Data

	  	  	  
	
4.1

	
The Customer shall promptly supply to Quotient Clinical, free of charge, the Customer Materials and Customer Data reasonably required by Quotient Clinical to enable it to perform any Research in accordance with a Proposal and hereby authorises Quotient Clinical and its Service Providers to use, modify and copy the same to the extent necessary to enable Quotient Clinical to carry out such Research. Any Customer Materials and Customer Data provided by the Customer shall remain the property of the Customer at all times and Quotient Clinical shall ensure that it uses such Materials and Customer Data solely for the purpose of carrying out the relevant Research and keeps them secure and in confidence.

	  	  	  
	
4.2

	
Quotient Clinical shall maintain accurate records of its use, storage, handling and administration of Materials in accordance with best industry practice and in accordance with GCP and GMP requirements (as applicable) and otherwise in such format as the Customer shall require and shall supply the Customer with copies thereof upon the Customer’s written request.

	  	  	  
	
4.3

	
As soon as practicable following completion of Research or upon termination of a Work Order, Quotient Clinical shall, if so requested in writing by the Customer, return to the Customer any Materials which remain unused, any copies of Customer Data provided to it by the Customer pursuant to this Agreement, all Confidential information and Background Material of the Customer previously disclosed to Quotient Clinical, all Research Output and the Work Order which are in Quotient Clinician’s power, possession or control.

	  	  	  
	
4.4

	
The Customer warrants and undertakes that it has the right to give to Quotient Clinical all Materials and Customer Data which it provides to Quotient Clinical and that the use by Quotient Clinical and its Service Providers of such Materials and/or Customer Data will not infringe the Intellectual Property or other rights of any person.

 

	
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4.5

	
The Customer shall indemnify and keep indemnified Quotient Clinical in respect of any losses, costs, damages, claims and/or expenses incurred by Quotient Clinical and/or any Service Provider due to any third party allegation or claim that any such use referred to at clause 4.4 infringes the lntellectual Property of any third party.

	  	  	  	  
	
5

	
Confidentiality

	  	  	  	  
	
5.1

	
Subject to clauses 5.2, 5.3, 6.5 and 6.6, each party agrees to keep confidential and not to disclose any and all Confidential Information of the other party, except to its Affiliates and to those of its employees (and in the case of Quotient Clinical any Service Providers) who are required to have access to such confidential information for the purpose of performing the obligations under this Agreement and/or any Work Order and who are legally obligated to maintain confidentiality on terms no less restrictive than provided for in this Agreement and have been informed of the confidential nature of such information.

	  	  	  	  
	
5.2

	
The obligations set out in clause 5.1 shall not apply to any Confidential Information which:

	  	  	  	  
	  	  	
(a)

	
at the date of its disclosure is in the public domain or which subsequently enters the public domain through no act or omission on the part of the receiving party:

	  	  	  	  
	  	  	
(b)

	
at the date of its disclosure is already known to the receiving party as evidenced by written records:

	  	  	  	  
	  	  	
(c)

	
is independently developed by the receiving party or is lawfully disclosed to the receiving party by a third party as evidenced by written records; or

	  	  	  	  
	  	  	
(d)

	
is required to be disclosed by the receiving party in order to comply with a legal obligation.

	  	  	  	  
	  	
In relation to any information which is created by (rather than disclosed to) one party but which is, pursuant to this Agreement and/or any Work Order, deemed to be the Confidential Information of the other party on creation, any reference in clauses 5.2 (a) to (b) above to “disclosure” shall mean “creation” and to “receiving party” shall mean “creating party”.

	  	  	  	  
	
5.3

	
All confidential information containing personal data shall be handled in accordance with applicable law, including but not limited to the UK Data Protection Act 1998

	  	  	  	  
	
5.4

	
Subject to prior written approval of the Customer, Quotient Clinical may refer to the Customer as its client on its website and in marketing materials and proposals.

	  	  	  	  
	
6

	
Intellectual Property

	  	  	  	  
	
6.1

	
Subject to clauses 6.3 and 6.5, the Research Output and all lntellectual Property subsisting in it shall be solely owned by Customer and Quotient Clinical hereby assigns to the Customer all its right, title and interest in and to any Research Output and the lntellectual Property rights therein.

	  	  	  	  
	
6.2

	
At the request and reasonable expense of the Customer, Quotient Clinical shall do all such things and sign all documents or instruments reasonably necessary to vest in the Customer the rights in Research Output and confirm the assignment pursuant to clause 6.1.

 

	
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6.3

	
Save as set out in clause 6.4, nothing in this Agreement and/or any Work Order shall transfer or grant any right, title or interest to any Background Material and/or Background Intellectual Property of either party to the other party.

	  	  	  	  
	
6.4

	
The Customer hereby grants to Quotient Clinical a royalty-free, non-exclusive licence to use the Customer’s Background Intellectual Property solely to the extent necessary for Quotient Clinical to perform its obligations set out in this Agreement and/or any Work Order.

	  	  	  	  
	
6.5

	
Quotient Clinical shall own any improvements to its Background Intellectual Property arising and/or developed by it in the performance of this Agreement and/or any Work Order and shall be fully entitled to use and exploit in any way it deems fit any skills, techniques, concepts or know-how acquired, developed or used in the course of performing any Research.

	  	  	  	  
	
6.6

	
Quotient Clinical may submit a copy of any proposed publication to the Customer who shall have 30 days in which to determine (a) if the timing is appropriate for any such publication, (b) amendments are required to enable Customer to approve the publication or (c) being mindful that the results are the Confidential Information of the Customer - if the nature or content of the publication is appropriate for publication. Customer’s determination on publication approval is final.

	  	  	  	  
	
6.7

	
The Customer undertakes that, prior to pubiication of any information, article, paper, report or other material containing Research Results (other than company announcements and regulatory submissions), it wiil submit a copy of such publication to Quotient Clinical who shall have 30 days in which to request amendments thereto which, to the extent that such proposed amendment are reasonable and pertain to a correction of an error, the Customer shall be obliged to incorporate prior to such publication.

	  	  	  	  
	
7

	
Delays

	  	  	  	  
	
7.1

	
If any part of any Research is delayed soley due to a new request of the Customer not contemplated in the applicable Work Order or due to the wilful act or omission of the Customer and this occurs:

	  	  	  	  
	  	  	
(a)

	
greater than 90 days prior to dosing, then no part of the QC Non-Cancellable Costs will be payable by the Customer;

	  	  	  	  
	  	  	
(b)

	
between 90 and 61 days prior to dosing, then 50% of the QC Non-Cancellable Costs will be payable by the Customer:

	  	  	  	  
	  	  	
(c)

	
between 60 and 31 days prior to dosing, then 75% of the QC Non-Cancellable Costs will be payable by the Customer;

	  	  	  	  
	  	  	
(d)

	
30 days or less prior to dosing, then all of the QC Non-Cancellable Costs will be payable by the Customer.

	  	  	  	  
	  	  	
The Customer will also be liable to pay Quotient Clinical:

	  	  	  	  
	  	  	
(e)

	
such tangible costs and expenses (excluding fixed operating costs) which:

	  	  	  	  
	  	  	  	
(A)

	
Quotient Clinical cannot avoid or mitigate pursuant to clause 7.2;

	  	  	  	  	  
	  	  	  	
(B)

	
do not constitute QC Non-Cancellable Costs; and

 

	
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(C)

	
have been directly incurred by Quotient Clinical in relation to the Work Order as a consequence of the delay and constitute non- cancellable sums which it is liable to pay third party subcontractors or service providers.

	  	  	  	  	  
	
7.2

	
Quotient Clinical shall use its reasonable endeavours to mitigate the costs and expenses referred to in clause 7.1. In its subcontractor/service provider contracts, Quotient Clinical must also use its best endeavours to negotiate the Inclusion of a requirement that these suppliers use their reasonable endeavours to mitigate any non-cancellable or non-refundable costs payable by Quotient Clinical.

	  	  	  	  	  
	
7.3

	
The Customer shall make the payment set out in clause 7.1 within 30 days of invoice on presentation of Quotient Clinical’s invoice for the same. Quotient Clinical’s invoice must be accompanied by copies of relevant documentation supporting the invoiced sums.

	 	 
	
8

	
Duration and Termination

	  	  	  	  	  
	
8.1

	
This Agreement shall come into force on the Commencement Date and shall, unless terminated earlier pursuant to any of the provisions of this clause 8 (and subject to clause 8.11) below, remain in force until the Customer has received the final Research Output to be delivered by Quotient Clinical, and Quotient Clinical has received ail sums payable to it, under this Agreement and all Work Orders. For the avoidance of doubt, each Work Order shall come into force on the date that it has been signed by both parties and shall (subject to earlier termination in accordance with this clause 8 and to the provisions of clause 8.11) remain in force until the Customer has received the Research Output to be delivered by Quotient Clinical, and Quotient Clinical has received all sums payable to it, pursuant to that Work Order.

	  	  	  	  	  
	
8.2

	
Either party may terminate this Agreement, and/or any Work Order (and the relevant Research), forthwith by giving notice in writing to the other party if the other party, (being a company) enters into liquidation or a provisional liquidator is appointed in respect of it, shall pass a resolution or suffer an order of a court to be made for its winding up, or if a receiver, administrator, administrative receiver or manager or similar officer is appointed in respect of the whole or any part of its assets, or if a notice of intention to appoint an administrator or an application for the appointment of an administrator shall be presented or filed in respect of it, or (being an individual or partnership) the other shall suspend payment or propose to enter into any composition with creditors or become unable to pay its debts (or have no reasonable prospect of doing so) or suffer a bankruptcy order or if anything analogous or similar to the above occurs to the other in any jurisdiction;

	  	  	  	  	  
	
8.3

	
The Customer may terminate this Agreement and/or a specific Work Order (and the relevant Research), forthwith by giving notice in writing to Quotient Clinical, if Quotient Clinical is in material breach of any of its obligations under or in connection with this Agreement and/or a Work Order and (where the breach is capable of remedy) fails to remedy the same within 30 days of a request specifying the breach and requiring it to be remedied.

	  	  	  	  	  
	
8.4

	
Quotient Clinical may terminate this Agreement and/or any Work Order (and the relevant Research), forthwith by giving notice in writing to the Customer, if the Customer is in material breach of any of its obligations under or in connection with this Agreement and/or a Work Order and (where the breach is capable of remedy) fails to remedy the same within 30 days of a request specifying the breach and requiring it to be remedied.

 

	
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8.5

	
Subject to clause 8.6, the Customer may terminate this Agreement or any Work Order (and the relevant Research) on giving Quotient Clinical not less than 14 days notice in writing.

	  	  	  	  	  
	
8.6

	
On termination of any Work Order (whether by termination of the Agreement or by termination of that Work Order) by the Customer pursuant to clause 8.5, then the Customer shall;

	  	  	  	  	  
	  	  	
(i)

	
pay to Quotient Clinical:

	  	  	  	  
	  	  	  	
(A)

	
50% of the QC Non-Cancellable Costs, if the Work Order is terminated between 90 and 61 days prior to the agreed date for dosing;

	  	  	  	  	  
	  	  	  	
(B)

	
75% of the QC Non-Cancellable Costs, if the Work Order is terminated between 60 and 31 days prior to the agreed date for dosing;

	  	  	  	  	  
	  	  	  	
(C)

	
100% of the QC Non-Cancellable Costs, if the Work Order is terminated less than 30 days prior to the agreed date for dosing;

	  	  	  	  	  
	  	  	
(ii)

	
pay to Quotient Clinical (in full without set off or deduction of any kind) any amounts (for work done) which Quotient Clinical has already invoiced to the Customer but which remain unpaid at the date of termination and/or which Quotient Clinical is entitled to invoice in accordance with the relevant Payment Schedule; and

	  	  	  	  
	  	  	
(iii)

	
pay to Quotient Clinical such tangible costs and expenses (excluding fixed operating costs) which :

	  	  	  	  
	  	  	  	
(A)

	
Quotient Clinical cannot avoid or mitigate pursuant to clause 8.8;

	  	  	  	  	  
	  	  	  	
(B)

	
do not constitute QC Non-Cancellable Costs; and

	  	  	  	  	  
	  	  	  	
(C)

	
have or will be directly incurred by Quotient Clinical in relation to the then current stage of the Work Order as a consequence of the termination and constitute non-cancellable sums which it is liable to pay third party subcontractors or service providers;

	  	  	  	  	  
	  	  	  	
provided that any payments made in accordance with this clause 8.6 are contemplated in the Work Order and do not in aggregate exceed the aggregate of the amounts set out in the relevant Payment Schedule up to completion of the Work Order (less what has already been paid by Customer pursuant to the Payment Schedule).

	  	  	  	  
	
8.7

	
On termination of any Work Order (whether by termination of the Agreement or by termination of that Work Order) by Quotient Clinical pursuant to clauses 8.2 or 8.4, then the Customer shall:

	  	  
	  	  	
(i)

	
pay to Quotient Clinical:

	  	  	  	  	  
	  	  	  	
(A)

	
50% of the QC Non-Cancellable Costs, if the Work Order is terminated between 90 and 61 days prior to the agreed date for dosing;

	
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(B)

	
75% of the QC Non-Cancellable Costs, if the Work Order is terminated between 60 and 31 days prior to the agreed date for dosing;

	  	  	  	  	  
	  	  	  	
(C)

	
100% of the QC Non-Cancellable Costs, if the Agreement is terminated less than 30 days prior to the agreed date for dosing;

	  	  	  	  	  
	  	  	
(ii)

	
pay to Quotient Clinical (in full without set off or deduction of any kind) any amounts (for work done) which Quotient Clinical has already invoiced to the Customer but which remain unpaid at the date of termination and/or which Quotient Clinical is entitled to invoice in accordance with the relevant Payment Schedule; and

	  	  	  	  
	  	  	
(iii)

	
pay to Quotient Clinical such tangible costs and expenses (excluding fixed operating costs) which :

	  	  	  	  
	  	  	  	
(A)

	
Quotient Clinical cannot avoid or mitigate pursuant to clause 8.8;

	  	  	  	  	  
	  	  	  	
(B)

	
do not constitute QC Non-Cancellable Costs; and

	  	  	  	  	  
	  	  	  	
(C)

	
have or will be directly incurred by Quotient Clinical in relation to the the then current stage of the Work Order as a consequence of the termination and constitute non-cancellable sums which it is liable to pay third party subcontractors or service providers,

	  	  	  	  	  
	  	
provided that any payments made in accordance with this clause 8.7 are contemplated in the Work Order and do not in aggregate exceed the aggregate of the amounts set out in the relevant Payment Schedule up to completion of the Work Order (less what has already been paid by Customer pursuant to the Payment Schedule).

	  	  
	
8.8

	
Quotient Clinical shall use its reasonable endeavours to mitigate the costs and expenses referred to in clauses 8.6 and 8.7. In its subcontractor/service provider, Quotient Clinical must also use its best endeavours to negotiate the inclusion of a requirement that these suppliers use their reasonable endeavours to mitigate any non-cancellable or non-refundable costs payable by Quotient Clinical.

	  	  
	
8.9

	
The Customer shall make the payments and reimbursements set out in clauses 8.6 and 8.7 within 30 days of presentation of Quotient Clinical’s invoice for the same. Quotient Clinical’s invoice must be accompanied by copies of relevant documentation supporting the invoiced sums.

	  	  
	
8.10

	
On termination of any incomplete Work Order (whether by termination of this Agreement or by termination of that Work Order) by the Customer pursuant to clauses 8.2 or 8.3, Quotient Clinical shall immediately refund all payments made by Customer in respect of the Work Order. The foregoing shall not be Customer’s sole remedy in the event of such failure by Quotient and Customer shall retain its right to seek all other remedies available under law or equity.

	  	  
	
8.11

	
Termination of this Agreement and/or any Work Order shall be without prejudice to all rights and remedies which have accrued thereunder prior to such termination. Any provision of this Agreement and/or any Work Order which expressly or by implication is intended to survive (including, without limitation, the provisions of clauses 1, 2.3, 2.6, 2.7, 2.8, 3.1, 3.3, 4.4, 4.5, 5, 6, 7, 8.6, 8.7, 8.8, 8.9, 8.10, 9, 10.2, 11, 12 and 13) shall survive the expiry or sooner termination of this Agreement or that Work Order (as applicable). For the avoidance of doubt, if this Agreement terminates, each Work Order shall terminate, but termination or expiry of one Work Order shall not of itself affect the continuation of another Work Order or (subject to clause 8.1 above) this Agreement.

	
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9

	
Indemnity

	  	  
	
9.1

	
Customer confirms it accepts its obligations to provide compensation for Subjects in line with the ABPI Guidelines on Medical Experiments in non-patient Human Volunteers published in 1998 and ABPI Guidelines for Phase 1 Clinical Trials published in 2012 and any relevant guidelines referenced therein, including but not limited to the Guidance for Insurance and Compensation in the event of injury in Phase I clinical trials, and any further amendments to these Guidelines as appropriate.

	  	  
	
9.2

	
The Customer shall indemnify and keep indemnified Quotient Clinical and shall pay such sums to Quotient Clinical as would keep Quotient Clinical’s employees and Service Providers indemnified, from and against any and all losses, costs, expenses (including legal expenses), claims, damages and liabilities arising out of or in connection with any claim made by a third party which arises out of the performance of the Research and/or administration to, and/or consumption by, any Trial Subject of any Materials during the course of any Research PROVIDED:

	  	  
	  	  	
(a)

	
that the Customer shall not be liable pursuant to this clause 9.2 for any losses, costs, claims, expenses, damages or other liability to the extent that these are directly caused by:

	  	  	  	 	  
	  	  	  	
(i)

	the failure of Quotient Clinical or of any Service Provider to comply with this Agreement, the relevant Work Order, the relevant Clinical Protocol for the Research or to observe Good Clinical Practice or Good Manufacturing Practice, the Regulations or any other applicable laws;
	  	  	  	 	  	 	  
	  	  	  	
(ii)

	any negligent act or omission or any breach of any law by Quotient Clinical or any Service Provider; and
	  	  	  	 	  	 	  
	  	  	
(b)

	
that as soon as reasonably practical following receipt by Quotient Clinical of a notice of any kind whatsoever of any claim or lawsuit which would fall under this clause 9.2, Quotient Clinical notifies the Customer in writing thereof and, subject to the Customer giving to Quotient Clinical such security as to costs and damages as Quotient Clinical may reasonably require, the Customer, and/or its insurers, shall take over and conduct the settlement and/or defence of such claim or lawsuit.

	  	  	  	 	  
	
9.3

	
Subject to clause 11, Quotient Clinical shall indemnify and keep indemnified the Customer against all losses, costs, expenses (including legal expenses), claims, damages and liabilities arising out of any claim made by a third party which arises out of the administration to a Trial Subject of any relevant Materials during the course of Research to the extent that this is directly due to Quotient Clinical’s failure to comply with the Clinical Protocol for the relevant Research or to observe Good Clinical Practice in administering the relevant Materials as part of that Research PROVIDED that as soon as reasonably practical following receipt by Customer of a notice of any kind whatsoever of any claim or lawsuit which would fall under this section 9.3 the Customer notifies Quotient Clinical in writing thereof, the Customer makes no admission or statement prejudicial to the claim in question and, subject to Quotient Clinical giving to the Customer such security as to costs and damages as the Customer may reasonably require, Quotient Clinical, and/or its insurers, shall take over and conduct the settlement and/or defence of such claim or lawsuit.

	
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10

	
Insurance

	  	  
	
10.1

	
Quotient Clinical shall secure and maintain in full force and effect throughout the term of this Agreement appropriate insurance coverage for its responsibilities in connection with this Agreement.

	  	  
	
10.2

	
The Customer shall maintain in force a no fault clinical trials insurance coverage policy with a reputable insurer to provide coverage to Trial Subjects sustaining bodily injury as a result of use of the Materials. Such cover shall provide for a minimum cover of AUD10 Million. Customer is willing to provide indemnity to Quotient Clinical in this regard as detailed in Clause 9, Indemnity and upon Quotient Clinical’s request, Customer shall make available for Quotient Clinical’s and/or Ethics Committee review, policy documents, certificates and any other relevant documents, as required, evidencing such insurance.

	  	  
	
11

	
Limitation of Liability

	  	  
	
11.1

	
Nothing in this Agreement or any Work Order shall exclude or restrict either party’s liability for death or personal injury caused by that party’s negligence, for fraudulent misrepresentation, for breach of any provision in clause 5 or 6 or to the extent that any restriction or exclusion of liability is prohibited bylaw.

	  	  
	
11.2

	
Subject to clause 11.1, in no event shall a party be liable in contract (including under any indemnity), tort (including negligence), breach of statutory duty or otherwise howsoever to the other party for:

	  	  
	  	  	
(a)

	
any loss of profit, loss of business, loss of goodwill, loss of contracts, loss of revenues or loss of anticipated savings; or

	  	  	  	  
	  	  	
(b)

	
any increased costs or expenses; or

	  	  	  	  
	  	  	
(c)

	
any special, indirect, or consequential loss or damage of any nature whatsoever, whatever the cause thereof, 

	  	  	  	  
	 	(collectively, “Consequential Losses”) in each case arising out of or in connection with this Agreement or any Work Order provided that in the case of a claim by Customer under a Work Order in relation to a Major Quality Breach, Quotient will be liable for Consequential Losses but only to the extent of an amount not exceeding the Work Order contract price net of any refunds due to Customer by Quotient under clause 2.8 of this Agreement.
	 	 
	
11.3

	
Subject to clause 11.1, the entire liability of Quotient Clinical to the Customer arising out of or in connection with a Work Order, whether arising from contract (including under any indemnity), tort (including negligence), or otherwise, shall not exceed three times the amount which is stipulated in the Proposal for that Work Order as to be paid by the Customer to Quotient Clinical.

	  	  
	
11.4

	
Subject to clause 11.1 (and subject to and by virtue of clause 11.3) the total aggregate liability of Quotient Clinical to the Customer arising out of or in connection with this Agreement and/or any Work Orders, whether arising from contract (including under any indemnity), tort (including negligence), or otherwise, shall not, in any event, exceed three times the total of the amounts which are stipulated in the Proposals for ah Work Orders under this Agreement as to be paid by the Customer to Quotient Clinical.

 

	
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11.5

	
For the avoidance of doubt, if Quotient Clinical becomes liable to the Customer as a result of an act or omission in the course of or in relation to a particular Work Order including, without limitation any act or omission which constitutes a breach of a term of this Agreement) the Customer shall subject to clauses 11.1 and 11.2 only be entitled to make a claim against Quotient Clinical under the relevant Work Order referred to above and the limit at clause 11.3 will apply.

	  	  
	
11.6

	
The Customer accepts that Quotient Clinical cannot act other than in accordance with the terms of any authorisation issued by the licensing authority for any Research and in accordance with the Regulations and all other relevant legal duties and obligations. Accordingly Quotient Clinical is not responsible for, and shall have no liability to the Customer for (provided that it or any Service Provider of it has not contributed in any way to Customer suffering), any delay, damage, liability or loss of or to the Customer (whether arising in contract, tort (including negligence) or otherwise) arising from the actions or failure to act of any licensing authority or ethics committee or as a result of Quotient Clinical complying with Its obligations under the Regulations or other legal duty or obligation including any obligation to provide notice or information to others regarding any Research and/or any obligation to safeguard the health and safety of any of its employees, the subject of any clinical trial or any other person who may be affected by any such trial,

	  	  	  	  	  
	
12

	
Interpretation

	 	 
	
12.1

	
Any references in this Agreement to clauses or schedules are to clauses of, or schedules to, this Agreement, and references in a schedule or part of a schedule to a paragraph are to paragraphs of that schedule or part of that schedule. The schedules shall have effect as part of this Agreement.

	  	  
	
12.2

	
Headings shall be ignored in construing this Agreement and/or any Work Order.

	  	  
	
12.3

	
References to a statute or statutory provision includes that provision as from time to time modified or re-enacted or consolidated whether before or after the date of this Agreement and any statutory instrument, order, by-law or other provision that may have been or may be made under it from time to time.

	  	  
	
12.4

	
Unless the context otherwise requires, words imparting the singular shall include the plural and vice versa and reference to any masculine, feminine or neuter gender shall include the other genders.

	  	  
	
12.5

	
A reference to a “person” or “persons” shall include companies, corporations, firms, unincorporated bodies of persons, local or other statutory authority and partnerships wherever and howsoever incorporated. The words “include”, “including”, or “includes” are to be construed as if they were immediately followed by the words “without limitation”.

	  	  
	
12.6

	
In the case of conflict or ambiguity, the order of precedence for this Agreement and the documents attached to or referred to in this Agreement shall be as follows:

	  	  
	  	  	
(a)

	
The Clinical Protocol

	  	  	  	  
	  	  	
(b)

	
the clauses of these terms and conditions;

	
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(c)

	
the schedules to this Agreement

	  	  	  
	  	
provided that, in the event of any conflict or inconsistency between a term of this Agreement and a term of a Work Order, the term of the Work Order shall (for the purposes of interpreting that Work Order) prevail.

	  	  	  
	
12.7

	
All references to time in this Agreement and/or any Work Order are to UK time. A reference to “Business Days” are to any day other than a Saturday, Sunday or public holiday in England.

	  	  	  
	
12.8

	
Unless the context otherwise requires, any reference in this Agreement or a Work Order to a “party” shall be to one of the parties thereto (and reference to “parties” shall be construed accordingly).

	  	  	  
	
13

	
General

	  	  	  
	
13.1

	
Quotient Clinical may upon written agreement from the Customer be entitled to sub-contract all or any of its obligations under this Agreement and/or any Work Order, at any time, to any person.

	  	  	  
	
13.2

	
Neither party shall, without the prior written agreement of the other party assign, novate, transfer sub-contract or otherwise dispose of any of the Customer’s rights or obligations arising under this Agreement and/or any Work Order.

	  	  	  
	
13.3

	
Provided each party has, where reasonably practicable, put appropriate precautions in place enabling it to avoid the effect of a Force Majeure, neither party shall be liable for any failure to perform, or delay in performing, any of its obligations (other than payment obligations) if and to the extent that the failure or delay is caused by Force Majeure and the time for performance of the obligation, the performance of which is affected by Force Majeure, shall be extended accordingly.

	  	  	  
	
13.4

	
This Agreement (together with all other documents to be entered into pursuant to it) sets out the entire agreement and understanding between the parties in connection with the subject matter thereof, and supersedes all proposals and Prior agreements, arrangements and understandings between the parties.

	  	  	  
	
13.5

	
Each party acknowledges that in entering into this Agreement and/or any Work Order (and any other document to be entered into pursuant to it) it does not rely on any representation, warranty, collateral contract or other assurance of any person (whether party to this Agreement or otherwise) that is not set out in this Agreement or that Work Order (as applicable) or any document referred to in it. Each party waives all rights and remedies which, but for this clause, might otherwise be available to it in respect of any such representation, warranty, collateral contract or other assurance. The only remedy available to any party in respect of any representation, warranty, collateral contract or other assurance that is set out in this Agreement or a Work Order (or any document referred to in it) is for breach of contract under the terms of this Agreement or that Work Order (or the relevant document) as applicable.

	  	  	  
	
13.6

	
Except as expressly stated in this Agreement (or a Work Order, in which case such exception will only apply for the purposes of that Work Order) all conditions, warranties, stipulations and other statements whatsoever (except as to title to goods) that would otherwise be implied or imposed by statute, at common law, by a course of dealing or otherwise howsoever are excluded to the fullest extent permitted by law.

 

	
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13.7

	
The parties shall do any other acts and execute any other documents that are necessary in order to give full effect to the terms of this Agreement and/or any Work Order.

	  	  	  
	
13.8

	
No variation of this Agreement or any Work Order shall be effective unless it is in writing and is signed by or on behalf of each of the parties.

	  	  	  
	
13.9

	
The rights and remedies of the parties in connection with this Agreement and any Work Order are cumulative and, except as expressly stated in this Agreement or that Work Order as applicable, are without prejudice to and are not exclusive of any other rights or remedies provided by law or equity or otherwise. Except as expressly stated in this Agreement or any Work Order any right or remedy may be exercised (wholly or partially) from time to time.

	  	  	  
	
13.10

	
Unless expressly stated elsewhere in this Agreement (or a Work Order), all notices to be given to a party under this Agreement (or that Work Order, as applicable) shall be in writing in English and shall be marked for the attention of the person, and delivered by hand or sent by first class prepaid post to the address detailed at the first page of this Agreement. A notice shall be treated as having been received:

	  	  	  
	  	
(a)

	
if delivered by hand between 9.00 am and 5.00 pm on a Business Day (which time period is referred to in this clause 13 as “Business Hours”), when so delivered; and if delivered by hand outside Business Hours, at the next start of Business Hours;

	  	  	  
	  	
(b)

	
if sent by first class post, at 9.00 am on the fifth Business Day after posting if posted on a Business Day and at 9.00 am on the seventh Business Day after posting in any other case; and

	 	 
	  	
in proving that a notice has been given it shall be sufficient to prove that delivery was made, or that the envelope containing the notice was properly addressed and posted.

	  	  	  
	  	
E-mailed notices are not valid for the purposes of this Agreement and/or any Work Order but this does not invalidate any other lawful mode of service.

	  	  	  
	
13.1 1

	
The parties intend each provision of this Agreement and each Work Order to be severable and distinct from the others. If a provision of this Agreement or a Work Order is held to be illegal, invalid or unenforceable, in whole or in part, the parties intend that the legality, validity and enforceability of the remainder of this Agreement or Work Order (as relevant) shall not be affected.

	  	  	  
	
13.12

	
Any person who is not a party to this Agreement (or a Work Order) cannot enforce any term of this Agreement (or that Work Order, as applicable) under the Contracts (Rights of Third Parties) Act 1999, but this does not affect any right or remedy of a third party which exists or is available apart from that Act.

	  	  	  
	
13.13

	
This Agreement may be entered into in any number of counterparts and by the parties on separate counterparts, all of which taken together shall constitute one and the same instrument. However, this Agreement shall not come into force until each of the Customer and Quotient Clinical have signed at least one counterpart.

	  	  	  
	
13.14

	
The validity, construction and performance of this Agreement and any Work Order shall be governed by and construed in accordance with the law of England and Wales. Each party irrevocably agrees to submit to the non-exclusive jurisdiction of the courts of England and Wales over any claim, dispute or matter arising under or in connection with this Agreement or a Work Order.

 

	
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13.15

	
In relation to all matters arising out of or in connection with this Agreement or a Work Order, each of the parties hereby:

	  	  
	  	  	
(a)

	
waives any objections on the grounds of venue or forum non conveniens or any similar ground; and

	  	  	  	  
	  	  	
(b)

	
consents to service of process by mail or in any other manner permitted by the relevant law.

 

Signed by the parties or their duly authorised representatives on the date of this Agreement

 

	
Signed by

	)	
	
  duly authorised for and on behalf of

	)	 
	
Quotient Clinical Limited

	)	     SIMON A. LEE, CCO
	 	  	  
	
Signed by

	)	
	
  duly authorised for and on behalf of

	)	 
	
Prana Biotechnology Ltd

	)	     DIANNE ANGUS, COO

	
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Schedule 1

 

TEMPLATE WORK ORDER

(NUMBER [♦])

 

This Work Order is entered into by and between Prana Biotechnology Limited (“Customer”) and Quotient Clinical Limited, a company registered in England and Wales under number 02393366 whose registered office is at Newmarket Road, Fordham, Cambridgeshire, CB7 5WW (“Quotient Clinical”) and is supplemental, and entered pursuant, to the Master Services Agreement dated [♦] between the Customer and Quotient Clinical (“Agreement”).

 

The parties hereby agree as follows;

	
1

	
Work Order

	  	  	  
	  	
This document and its appendices constitute a “Work Order” under the Agreement. The terms and conditions set out in the Agreement (including, without limitation, the provisions of clause 11 of the Agreement) shall apply to this Work Order.

	  	  	  
	
2

	
Services and Payment of Fees and Expenses

	  	  	  
	  	
2.1

	
The specific services to be provided by Quotient Clinical, and the amount(s) to be paid by the Customer to Quotient Clinical in return, pursuant to this Work Order (together with the related timescales, invoicing dates, and invoicing and payment details) are set forth in the following appendices which shall for all purposes form part of this Work Order:

	  	  	  
	  	  	
     Appendix 1

	
Proposal

	  	  	
     Appendix 2

	
Payment Schedule

	  	  	  
	  	
2.2

	
[Quotient Clinical will act as the Legal Representative of the Customer for the purposes of the trial, study, and/or other services described in appendix 1 to this Work Order]*

	  	  	  
	
3

	
Term

	  	  	  
	  	
This Work Order shall come into force on the date that it has been signed by or on behalf of both parties and shall remain in force in accordance with clause 8 of the Agreement.

 

* To be deleted by Quotient Clinical as appropriate

 

	
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	4	Amendments

 

	  	
No modification, amendment, or waiver of this Work Order shall be effective unless in writing and duly executed and delivered by each party to the other.

	  	  
	
5

	
Signatures

	  	  
	  	
Signed by the parties or their duly authorised representatives on the dates set out below

 

	
Signed by

	
)

	  
	
  duly authorised for and on behalf of

	
)

	  
	
Quotient Clinical Limited

	
)

	  
	
Date

	  	  
	 	 	 
	
Signed by

	
)

	  
	
  duly authorised for and on behalf of

	
)

	  
	
Prana Biotechnology Ltd

	
)

	  
	
Date

	  	  

	
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Appendix 1 (Work Order Number [s])

 

Proposal

 

[w][Insert agreed proposal, deliverables, timeline and costing document]

 

Amount to be paid by the Customer: [w]

	
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Appendix 2 (Work Order Number [s])

 

Payment Schedule

	  	
Payment Milestone – Invoicing Dates

	
Amount

	
1

	
Signature of Work Order

	
30%

	
2

	
First dosing day

	
20%

	
3

	
Last subject, last visit

	
30%

	
4

	
Database lock

	
10%

	
5

	
Dispatch of draft CSR

	
5%

	
6

	
Dispatch of final CSR

	
5%

 

The non-cancellable recruitment and screening, clinic and manufacturing labour costs for the Research are:

	
Study Period

	
Dates

	
Amount

	
1

	
[w]

	
£[w]

	
2

	
[w]

	
£[w]

 

Invoices will be addressed to:

	  	
Name [w]

	  	
Address [w]

	  	
Phone [w]

	  	
Fax [w]

	  	
Email [w]

 

Payments will be made by wire transfer to:

 

Payments will be made by wire transfer to:

	
Account

	
Quotient Clinical Ltd

	
Bank Name

	
Ulster Bank

	
Address

	
Belfast City Office 1

	  	
BT1 5UB

	  	  
	
Account No.

	
10669356

	
Sort Code

	
98-00-60

	
Swift Code

	
ULSBGB2B

	
IBAN No.

	
GB41ULSB98006010669356

 

Or such other account and/or payment method as Quotient Clinical may notify to the Customer for that purpose from time to time.

	
SDS002 T2 V4

	
Quotient Clinical/ Prana Confidential

	
Page 20 of 21

 

  

  

  

 

Schedule 2

 

The Medicines for Human use (Clinical Trials) Regulations 2004

 

	
1

	
For the purposes of the Regulations, Quotient Clinical agrees that it shall act as Legal Representative for the relevant Research throughout the duration of the Research in addition to the other services described in this Agreement and/or the Work Order provided that the Customer fulfils and continues to fulfil all its obligations to Quotient Clinical under this Agreement and the Work Order, including for the avoidance of doubt the obligation to pay all monies due to Quotient Clinical in accordance with the provisions of this Agreement and the Work Order.

	  	  
	
2

	
For the purposes of this schedule 2 any word or phrase with a defined meaning in the Regulations shall be construed in this schedule in accordance with the meanings ascribed in the Regulations.

	  	  
	
3

	
Quotient Clinical shall provide the Customer with a copy of all correspondence from the licensing authority relating to the relevant Research upon request from the Customer and will in any event provide a copy of any authorisation and any notice received from the licensing authority related to the Research within 2 Business Days of its receipt by Quotient Clinical.

	
SDS002 T2 V4

	
Quotient Clinical/ Prana Confidential

	
Page 21 of 21

 

  

  

  

 

Work Order Number  1

 

This Work Order is entered into by and between Prana Biotechnology Limited, in Australia under number ACN 080 699 065 whose registered office is at Level 2, 369 Royal Parade, Parkville 3052, Victoria, Australia (“Customer”) and Quotient Clinical Limited, a company registered in England and Wales under number 05221615 whose registered office is at Trent House, Mere Way, Ruddington Business Park, Nottingham NG11 6JS (“Quotient Clinical”) and is supplemental, and entered pursuant, to the Master Services Agreement dated 12th December 2013 between the Customer and Quotient Clinical (“Agreement”).

 

The parties hereby agree as follows;

	  	  	  
	
1

	
Work Order

	  	  	  
	  	
This document and its appendices constitute a “Work Order” under the Agreement. The terms and conditions set out in the Agreement shall apply to this Work Order.

	  	  	  
	
2

	
Services and Payment of Fees and Expenses

	  	  	  
	  	
2.1

	
The specific services to be provided by Quotient Clinical, and the amount(s) to be paid by the Customer to Quotient Clinical in return, pursuant to this Work Order (together with the related timescales, invoicing milestones, and invoicing and payment details) are set forth in the following appendices which shall for all purposes form part of this Work Order:

	
Appendix 1

	
Proposal

	
Appendix 2

	
Payment Schedule

	
Appendix 3

	
Legal Representative

	
3

	
Term

	  	  
	  	
This Work Order shall come into force on the date that it has been signed by or on behalf of both parties and shall remain in force in accordance with clause 8 of the Agreement.

	  	  
	
4

	
Amendments

	  	  
	  	
No modification, amendment, or waiver of this Work Order shall be effective unless in writing and duly executed and delivered by each party to the other.

	
SDS002 T2 V4

	
Quotient Clinical/ Prana Confidential

	
Page 1 of 5

  

  

  

	  	  
	
5

	
Signatures

	  	  
	  	
Signed by the parties or their duly authorised representatives on the dates set out below

	
Signed by

	  	
)

	  
	
duly authorised for and on behalf of

	  	
)

	  
	
Quotient Clinical Limited

	  	
)

	  
	
Date

	  	  	  
	  	  	  	  
	
Signed by

	  	
)

	
	
duly authorised for and on behalf of

	  	
)

	  
	
Prana Biotechnology Limited

	  	
)

	
Geoffrey Kempler, CEO

	 
	
Date

	  	  	12 December, 2013

	
SDS002 T2 V4

	
Quotient Clinical/ Prana Confidential

	
Page 2 of 5

 

  

  

  

Appendix 1 Work Order Number 1

	  	  	  
	  	
“A Phase 1, Open-Label Study of the Absorption, Metabolism, Excretion and the Absolute Bioavailability of PBT2 in Healthy Male Subjects.”

	  	  	  
	  	
Customer Reference no.:

	
TBC

	  	
QUOTIENT Reference no.:

	
QBR116882

 

Proposal

 

Quotient’s formal proposal reference “QBR116682 Prana Biotechnology Proposal ivMT_ADME version 3” dated 9th December 2013 is attached here:

 

 

The services to be provided by Quotient are detailed in sections 3, 6, 8, 9, 10, 11, 12 and 13 of the Proposal.

 

The division of responsibilities to be applied during provision of the services is detailed in section 7 of the Proposal.

 

The approximate timeline for study delivery is detailed in section 4 of the Proposal. A detailed Gantt chart will be provided at the point of signature. Once agreed, the Gantt chart will be incorporated into this Work Order

	
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Page 3 of 5

 

  

  

  

 

Appendix 2 Work Order Number 1

 

In consideration of the services to be provided, a fee of £498,903.00 (Four hundred and ninety eight thousand, nine hundred and three pounds) shall become payable by the Customer. Such fee to be paid in accordance with the following payment schedule:

 

Payment Schedule

 

	  	
Payment Milestone – Invoicing Dates

	
Amount

	
Value

	
1

	
Signature of Work Order

	
30%

	
£149,670.90

	
2

	
First dosing day

	
20%

	
£99,780.60

	
3

	
Last subject, last visit

	
30%

	
£149,670.90

	
4

	
Database lock

	
10%

	
£49,890.30

	
5

	
Dispatch of draft CSR

	
5%

	
£24,945.15

	
6

	
Dispatch of final CSR

	
5%

	
£24,945.15

	
Total  

	
100%

	
£498,903.00

 

Pursuant to clauses 7.1, 8.6 and 8.7, the QC Non-Cancellable costs associated with recruitment, screening, manufacture and clinical conduct are:

 

	
Study Period

	
Dates

	
Amount

	
1

	
First Subject First Dose Period 1

	
£22,984

	
2

	
First Subject First Dose Period 2

	
£22,984

 

Invoices will be addressed to:

	  	  	  
	  	
Name

	
Dr. Caroline Herd

	  	
Address

	
Prana Biotechnology Ltd,

	  	  	
Level 2 369 Royal Parade,

	  	  	
Parkvile, VIC 3052, Australia

	  	
Phone

	
+61 (0)3 9349 4906

	  	
Fax

	
+61 (0)3 9348 0377

	  	
Email

	
cherd@pranabio.com

 

Payments will be made by wire transfer to:

	  	  
	
Account

	
Quotient Clinical Ltd

	
Bank Name

	
HSBC Bank PLC

	
Address

	
22 Central Avenue

	  	
West Bridgford

	  	
Nottinghamshire

	  	
NG2 5GR

	
Account No.

	
81727109

	
Sort Code

	
40-35-19

	
Swift Code

	
MIDLGB22

	
IBAN No.

	
GB69MIDL40351981727109

 

Or such other account and/or payment method as Quotient Clinical may notify to the Customer for that purpose from time to time.

	
SDS002 T2 V4

	
Quotient Clinical/ Prana Confidential

	
Page 4 of 5

 

  

  

  

 

Appendix 3

 

The Medicines for Human use (Clinical Trials) Regulations 2004

	  	  
	
1

	
For the purposes of the Regulations, Quotient Clinical agrees that it shall act as Legal Representative for the relevant Research throughout the duration of the Research in addition to the other services described in this Agreement and/or the Work Order provided that the Customer fulfils and continues to fulfil all its obligations to Quotient Clinical under this Agreement and the Work Order, including for the avoidance of doubt the obligation to pay all monies due to Quotient Clinical in accordance with the provisions of this Agreement and the Work Order.

	  	  
	
2

	
For the purposes of this schedule 2 any word or phrase with a defined meaning in the Regulations shall be construed in this schedule in accordance with the meanings ascribed in the Regulations.

	  	  
	
3

	
Quotient Clinical shall provide the Customer with a copy of all correspondence from the licensing authority relating to the relevant Research upon request from the Customer and will in any event provide a copy of any authorisation and any notice received from the licensing authority related to the Research within 2 Business Days of its receipt by Quotient Clinical.

	
SDS002 T2 V4

	
Quotient Clinical/ Prana Confidential

	
Page 5 of 5

 

  

  

  

 

	  	  	  	 
	
 

Change Order Form

 

	 
	
CHANGE ORDER NUMBER: 1

	
SPONSOR: Prana Biotechnology Limited

	 
	
DRUG NAME: PBT2

	
SPONSOR REFERENCE #: PBT2-102

	 
	
STUDY #: QBR116682

	 
	
PROJECT MANAGER: Itesh Govan/Sue Sweet

	 
	
DATE OF REQUEST: 19 Mar 2014

	
PREPARED BY: Itesh Govan

	 
	
BRIEFLY DESCRIBE ORIGINAL ASSUMPTION AND NEW REQUEST BELOW:

	 
	  	  	 
	
1.

	
Prana has confirmed that they would like Quotient to sub-contract the monitoring of the study and have agreed to use Jane Muir of Wirral Clinical Consultancy Limited.

	 
	  	  	 
	
2.

	
Prana has confirmed that they would like Quotient to perform the QP importation and QP release of capsules (manufactured in Canada and labelled in Australia).

	 
	  	  	 
	
3.

	
Prana has confirmed that they would like to have the IV plasma samples from Part 1 of the study tested for total radioactivity by AMS at Vitalea.

	 
	  	  	 
	
IMPACT:

	 
	 	 
	
1.

	
Setting up a sub-contract agreement with Jane Muir.

	 
	  	  	 
	
2.

	
An additional 10 hours of QP resource on the assumption that all supporting documentation requested by Quotient is supplied by Prana.

	 
	  	  	 
	
3.

	
Inclusion of these additional samples in the Work Order with Vitalea (samples were already being taken for other testing and costs have been received from Vitalea).

	 
	  	  	 
	
TIMING: Effective immediately upon signature

	 
	
COST OF CONTRACT AMENDMENT:

	 
	  	  	 
	
1.

	
£8,250 for sub-contact with Jane Muir. This cost does not include travel expenses and any agreed additional activities (see attached proposal from Jane Muir), which will be handled as pass through costs.

	 
	 	 	 
	
2.

	
£1,375 for 10 hours QP resource.

	 
	 	 	 
	
3.

	
£20,585 for additional AMS testing at Vitalea.

	 
	 	 	 
	
4.

	  	 
	  	  	 
	
TOTAL = £30,210

	 
	 	 
	
PAYMENT TERMS:

	 
	 	 
	
100% on signature

	 
	  	  	 

	
SDS002 F3 V3

	
Quotient Clinical/Client Confidential

	
Page 1 of 2

 

  

  

  

 

	  	  	  	  	  	  	  	  	  	  
	
AMENDMENT:

	
This Change Order Form shall constitute a Contract Amendment to the Work Order Number 1 between Prana and Quotient Clinical Ltd effected on 12 Dec 2013 and shall apply only to the scope of services and revised payment schedule listed herein or attached hereto. In all other respects the terms and conditions of the Agreement shall remain in full force and effect and shall be applied to this Contract Amendment.

	  	  	  	  	  	  	  	  	  	  
	
SPONSOR APPROVAL:

	
QUOTIENT CLINICAL APPROVAL:

	  	  	  	  	  	  	  	  		  
	
Signature

	  	  	
Signature

	  
	
Name

	 	  	
Name

	SIMON A. LEE	  
	
Title

	 	  	
Title

	CCO	  
	
Date

	 	  	
Date

	20 March 2014	  
	  	  	  	  	  	  	  	  	  	  

	
SDS002 F3 V3

	
Quotient Clinical /Client Confidential

	
Page 2 of 2

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