Document:

Exhibit 4.20

 

Master Services Agreement

 

	
Commencement Date

	
1 September, 2015

	 	 
	
Parties

	
IDT Australia Limited ACN 066 522 970

of 45 Wadhurst Drive, Boronia Victoria 3155

(IDT)

	 	 
	 	
Prana Biotechnology Ltd ACN 080 699 065

of Level  2, 369 Royal Parade, Parkville Victoria Australia 3052

(Prana)

 

(each a party and collectively, the parties)

 

 

Introduction

 

	A	Prana is in the business of developing drug candidates for the treatment of neurodegenerative diseases.

 

	B	IDT is in the business of formulating, developing and manufacturing API and finished dosage forms, analytical testing (including stability and microbiological testing), clinical packaging and distribution of pharmaceutical products from its facilities in Boronia, Victoria.

 

	C	Prana has sought the assistance of IDT to formulate, develop and manufacture API and finished dosage forms, analytical testing (including stability and microbiological testing), clinical packaging and distribution of clinical trial materials for Prana’s proprietary product/s such as PBT434 and PBT2 and matching placebo for clinical trials.  There may also be occasions in future where Prana may call on IDT to provide other pharmaceutical manufacturing and related services.

 

	D	This Agreement contains the terms and conditions upon which IDT will provide services to Prana.

 

Agreement

 

 

	1	Definitions and Interpretation

 

Definitions

 

		1.1	In this Agreement:

 

Agreement means this agreement including any schedule or annexure to it.

 

Agreement IP means the following:

 

		(a)	the Deliverables; and

 

		(b)	the Results,

 

and all Intellectual Property Rights throughout the world subsisting in them.

 

API means an active pharmaceutical ingredient.

 

Approved Purposes means:

 

(a)           the performance of the Services and production of the Deliverables by IDT;

 

		(b)	Prana’s input in pursuance of this Agreement to facilitate the performance of the Services by IDT; and

 

		(c)	the use of the Agreement IP by Prana for its business purposes.

 

Business Day means a day other than Saturday, Sunday or a public holiday or bank holiday in the place where an act is to be performed or a payment is to be made.

 

Cause Event means:

 

(a)           a material breach by IDT of its obligations under this Agreement or the Quality Agreement;

 

		(b)	receipt by IDT of an FDA Form 483 of the type specified in clause 4.3(b)(iii) or Warning Letter or other like document from the TGA or any other regulatory authority;

 

		(c)	any audit, inspection or product, documentation or information request by the FDA, TGA or other regulatory authority which is specific to Prana’s Products.

 

cGMP or GMP means current Good Manufacturing Practices applicable to the Products, as established and interpreted by the relevant Governmental Agencies from time to time.

 

Change Order means a change in respect of the work to be performed by IDT under a given Work Order.

 

Commencement Date means the date of this Agreement first written above.

 

Compounds means Prana’s proprietary compounds, including the compounds known as PBT2 and PBT 434 and any APIs of them.

 

Confidential Information means IDT Confidential Information or Prana Confidential Information as the context allows.

 

Corporations Law means the Corporations Act 2001 (Cth).

Deliverables means data, results, information, advice, reports, analyses, documents, materials, APIs, compounds, Investigational Medicinal Product, formulations, procedures, techniques, batch records and Product specifications, test methods and specifications and other items or things prepared, obtained, generated or derived by IDT as part of the Services, and to be delivered to Prana, all in accordance with the requirements specified in the relevant Work Order and this Agreement.

 

EMA means the European Medicines Agency, and any successor agency having substantially the same functions.

 

Existing IP of a party means the Technology owned, developed or obtained by or on behalf of that party:

 

		(a)	prior to the Commencement Date; or

 

		(b)	independent of this Agreement and without the use of the other party’s Confidential Information,

 

and includes all Intellectual Property Rights throughout the world subsisting in such Technology.

 

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FDA means the United States Food and Drug Administration, and any successor agency having substantially the same functions.

 

Force Majeure means an act of God, strike, lock-out or other labour dispute, war declared or undeclared, blockade, riot, insurrection, lightning, fire, earthquake, storm, flood, explosion, restraint of government or government agency, prohibition or any other cause whether or not of the kind listed above which is beyond the control of the party affected.

 

Governmental Agency means any court, administrative agency or commission or other governmental agency, body or instrumentality, domestic or foreign, and includes, without limitation, the FDA, EMA and TGA.

 

GST means goods and services tax under the GST Law.

 

GST Law has the same meaning as in A New Tax System (Goods and Services Tax) Act 1999 (Cth).

 

IDT Confidential Information means:

		(a)	Proposals; and

 

		(b)	all:

		(i)	Existing IP of IDT;

 

		(ii)	information concerning IDT’s affairs, assets or property or any business, property or transaction in which it may be or may have been concerned or interested;

 

		(iii)	information which, by its nature or by the circumstances of its disclosure, is or could reasonably be expected to be regarded as confidential to IDT,

 

which is or has been disclosed by IDT to Prana (whether orally, electronically or in writing) or is otherwise obtained by Prana but does not include Public Information.

 

Initial Project means the cGMP manufacture of PBT434 capsules and matching placebo capsules for a Phase 1 clinical trial to be conducted in one or more of Australia, Europe and the USA.  

 

Insolvency Event means the happening of any of the following:

 

		(a)	an application is made to a court for an order that a party be wound-up or that a provisional liquidator be appointed (unless the application is withdrawn, struck out or dismissed within 45 days of it being made);

 

		(b)	a liquidator is appointed in respect of a party;

 

		(c)	a resolution is passed or a decision taken to appoint an administrator, receiver or receiver and manager in respect of a party or there is a Controller (as defined in the Corporations Law) appointed in relation to a party or in respect of any of its assets;

 

		(d)	except to reconstruct or amalgamate while solvent on terms approved by the other party, a party enters into, or resolves to enter into, an arrangement or composition with, or assignment for the benefit of, all or any of its creditors, or it, or anyone on its behalf, proposes a reorganisation, moratorium, deed of company arrangement or other administration involving any of them or the winding up or dissolution of the party;

 

		(e)	a party is, states that it is or is presumed under any applicable law to be, insolvent; and

 

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		(f)	anything having a substantially similar effect to any of the events specified above happens under the law of any jurisdiction.

 

Intellectual Property Rights means all intellectual and industrial property rights throughout the world (whether registered or unregistered) including rights and interests (including applications for and any right to apply for registrations of such rights) in respect of or in connection with designs, discoveries, inventions (including patents), copyright (including future copyright and rights in the nature of or analogous to copyright), trade marks, database rights, confidential information, know how and trade secrets.

 

Investigational Medicinal Product or IMP means active and/or placebo capsule, produced, packaged and labelled in accordance with a Work Order.

 

Laws means the common law and any statute, regulation, order, rule, subordinate legislation, code of practice or other document enforceable under any statute, regulation, order, rule or subordinate legislation.

 

Material Form in relation to information, includes any form (whether visible or not) of storage from which the information can be reproduced, and any form in which the information is embodied or encoded and in relation to Prana’s Compounds means whatever form they are present in the possession of IDT or their Representatives.

 

Prana Confidential Information means:

		(a)	the Compounds;

 

		(b)	RFPs;

 

		(c)	Agreement IP; and

 

		(d)	all:

 

		(i)	Existing IP of Prana, including all data, results, information, analyses, papers, materials, records, notes, documents and reports concerning:

 

		(A)	the Compounds;

 

		(B)	the synthesis or commercial manufacture of the Compounds;

 

		(C)	research, tests, trials and studies planned or conducted in relation to the Compounds;

 

		(ii)	information concerning Prana’s affairs, assets or property or any business, property or transaction in which it may be or may have been concerned or interested;

 

		(iii)	information which, by its nature or by the circumstances of its disclosure, is or could reasonably be expected to be regarded as confidential to Prana,

 

which is or has been disclosed by Prana to IDT (whether orally, electronically or in writing) or is otherwise obtained by IDT but does not include Public Information

 

Premises means IDT’s facilities in Boronia, Victoria or such other facilities agreed by Prana in writing.

 

Products means IMPs (for PBT434), Compounds and such other products to be manufactured by IDT pursuant to this Agreement.

 

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Projects means:

 

(a)           the Initial Project; and

 

		(b)	any subsequent project for the delivery of agreed Services by IDT to Prana under this Agreement.

 

Proposal means a proposal for the provision of Services submitted to Prana by IDT.

 

Public Information means:

 

		(a)	information which, at the time of disclosure, was published, known publicly or otherwise in the public domain;

 

		(b)	information which, after disclosure, is published, becomes known publicly, or otherwise becomes part of the public domain through no fault of the receiving party;

 

		(c)	information which, prior to the time of disclosure, is known to the receiving party as evidenced by its written records or other tangible evidence;

 

		(d)	information which is made available to the receiving party in good faith by a third party who is under no obligation of confidence to the disclosing party;

 

		(e)	information which the receiving party is required to disclose by law, provided the receiving party has given the disclosing party prompt prior notice and assistance in any reasonable effort to obtain confidential treatment with respect to such disclosure; or

 

		(f)	information which is independently developed by or for the receiving party without use of, reliance upon, or with reference to the disclosing party’s Confidential Information.

 

Quality Agreement means the quality agreement to be entered by the parties pursuant to clause 5.7.

 

Representative in relation to a party means a director, officer, employee or contractor (approved by Prana under clause 15.4 in the case of an IDT contractor) of that party.

 

Results means:

		(a)	all results, data, information, processes, procedures, methodologies, techniques, concepts, ideas, compounds, formulations, materials, reports, analyses, documents, items or things; and

 

		(b)	all discoveries, inventions, developments, modifications, innovations, enhancements or improvements,

 

that are made, generated, brought into existence, conceived, discovered, invented, developed, created,  derived, modified, improved, enhanced, adapted or reduced to practice by either party or their Representatives (whether alone or jointly with the other party) under or in connection with or as a consequence of a Project.

 

RFP means a request submitted by Prana to IDT for a proposal for the provision of Services under this Agreement.

 

Services means for a given Project, the services to be provided by IDT under this Agreement, as agreed and specified in a Work Order for the Project.

 

Specification means a specification agreed by the parties in writing for a Deliverable which may be either:

 

		(a)	recorded in or annexed to a Work Order or incorporated therein by reference; or

 

		(b)	prepared and agreed by the parties during the course of a Project.

 

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Sub-Project in relation to a Project, means a sub-project or discrete piece of work (if any) described in the corresponding Work Order for performance by IDT, subject in each case to IDT receiving prior written approval from Prana and the parties agreeing in writing on the Specification/s for the Deliverable/s for the sub-project or discrete piece of work.

 

Technology means:

 

		(a)	proprietary compounds, samples, prototypes, formulations, ideas, knowledge, concepts, methods, techniques, processes, procedures, trade secrets, technology, discoveries, inventions, know-how, data, technical and scientific information, research and development results, development plans, test results, procedures for experiments and tests and manufacturing scale-ups, methods or schemes for synthesising chemicals and compounds, isolation and purification methods, hardware and software;

 

		(b)	patents, patentable inventions, designs, trade marks, works of copyright and rights in confidential information;

 

		(c)	all other intellectual property of any kind, whether or not protectable under patent, trade mark, copyright, design or other intellectual property laws.

 

TGA means the Australian Therapeutic Goods Administration, and any successor agency having substantially the same functions.

 

Work Order means one or more written Work Orders referencing this Agreement or otherwise attached to this Agreement and executed by both parties pertaining to the Services to be supplied by IDT under this Agreement. A template Work Order is set out in Schedule 1.

 

Interpretation

 

	 	
1.2

	
In this Agreement, unless the context requires another meaning:

 

		(a)	a reference to:

 

(i)           the singular includes the plural and vice versa;

 

		(ii)	a document (including this Agreement) is a reference to that document (including any Schedules and Annexures) as amended, consolidated, supplemented, novated or replaced;

 

		(iii)	an item, Recital, clause, Schedule or Annexure is to an item, Recital, clause, Schedule or Annexure of or to this Agreement;

 

		(iv)	a notice means a notice, approval, demand, request, nomination or other communication given by one party to another under or in connection with this Agreement;

 

		(v)	a person (including a party) includes an individual, company, other body corporate, association, partnership, firm, joint venture, trust or government agency; and

 

		(vi)	the words "including" or "includes" means "including, but not limited to", or "includes, without limitation" respectively;

 

		(b)	where a word or phrase is defined, its other grammatical forms have a corresponding meaning; and

 

		(c)	headings are for convenience only and do not affect interpretation of this Agreement.

 

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1.3          This Agreement may not be construed adversely to a party only because that party was responsible for preparing it.

 

 

	2	Term

 

2.1          This Agreement commences on the Commencement Date and continues for five (5) years or until the completion of any then current Work Order by IDT, unless terminated earlier in accordance with this Agreement. This Agreement may be extended by mutual agreement of the parties in writing.

 

 

	3	Services and Work Orders

 

		3.1	If at any time during the Term Prana wishes to engage IDT to provide Services to it, then subject to the parties entering a Work Order in respect of the Services, IDT agrees to provide the Services on the terms and conditions contained in this Agreement.

 

		3.2	Each Work Order:

 

		(a)	is incorporated herein by reference;

 

		(b)	shall be in written form similar to the sample Work Order attached to this Agreement as Annexure A;

 

		(c)	shall include a description of the specific services to be performed by IDT, the Deliverables, timelines, protocols, Specifications, fees and charges payable by Prana and such other details and terms as are agreed to by the parties; and

 

		(d)	is taken to include the Quality Agreement and all applicable Specifications.

 

		3.3	In the event of any conflict between the terms and conditions of a Work Order and a provision of this Agreement, the terms and conditions of this Agreement shall prevail unless the Work Order expressly specifies that the particular term of the Work Order takes precedence.

 

		3.4	Any change to a Work Order must be mutually agreed and documented by IDT in a written amendment to the Work Order (a “Change Order”). When a signed Change Order is received from Prana, the Change Order shall constitute an amendment to the applicable Work Order and shall be considered part of this Agreement.  No changes to a Work Order will take effect and IDT must not commence any new or changed Services unless and until it has received a signed Change Order from Prana.

 

 

	4	IDT’s Obligations and Warranties

 

		4.1	IDT will perform each Project and the associated Services at the Premises:

 

		(a)	using suitably qualified Representatives;

 

		(b)	using commercially reasonable endeavours to perform each Project and the associated Services in a timely manner in accordance with the Work Order;

 

		(c)	with due care and skill and to the best of IDT’s knowledge and expertise;

 

		(d)	in accordance with relevant local industry standards, best practice and guidelines or where none apply, relevant international industry standards, best practice and guidelines;

 

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		(e)	in accordance with cGMP, the Work Order and all Laws applicable to the operation of the Premises;

 

		(f)	in accordance with any reasonable direction given by Prana; and

 

		(g)	otherwise in accordance with the provisions of this Agreement.

 

		4.2	IDT represents and warrants that:

 

		(a)	it has the right to enter into this Agreement;

 

		(b)	it has and will maintain the requisite licences from the FDA, TGA and all other applicable governmental, municipal and public agencies, bodies and authorities for the conduct of its business at each of its premises;

 

		(c)	it has and will maintain all:

 

		(i)	rights, title, licences and interests in its Existing IP;

 

		(ii)	property, equipment and resources,

 

necessary to perform each Project and the associated Services;

 

		(d)	it and its Representatives have the necessary experience, skill, knowledge and competence to perform each Project and the associated Services.

 

		4.3	IDT will:

 

		(a)	permit all relevant inspections by the FDA, TGA or other regulatory authorities of its premises, procedures and documentation;

 

		(b)	notify Prana:

 

		(i)	within three (3) Business Days of receiving any notice of inspection from the FDA, TGA or other regulatory authority only to the extent such an inspection relates to Prana’s IMP/Compounds or may impact on IDT’s ability to supply such products;

 

		(ii)	within one (1) Business Day of receiving any request from the FDA, TGA or other regulatory authority for Prana’s IMP, Compounds, products or samples or related batch or other documentation or information;

 

		(iii)	within one (1) Business Day of receiving any FDA Form 483 or Warning Letter or other like document from the TGA or any other regulatory authority which relates to Prana’s IMP/Compounds or which may impact on IDT’s ability to supply such products (in accordance with a Work Order) or the facilities used to produce, test or package them,

 

and provide Prana with copies of all such letters, notices or documents and IDT’s response to them (in each case redacted, where appropriate, to exclude text not relevant to Prana or its IMP/Compounds).

 

		4.4	IDT must:

 

		(a)	take out and maintain during the term of this Agreement and for 12 months thereafter, appropriate public and product liability insurance policies with a reputable insurer which give coverage against all usual risks and for an amount of at least $10,000,000 per occurrence.

 

		(b)	at Prana’s request provide Prana with certificates of currency for those policies.

 

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	5	Project Obligations

 

		5.1	For each Project:

 

		(a)	IDT will designate a project leader to liaise with Prana in relation to IDT’s performance of the Services and the provision of the Deliverables (the “Project Leader”); and

 

		(b)	Prana will designate a contact who will be the point of contact for the Project Leader (the “Prana Contact”).

 

		5.2	The parties must agree in writing on the Specifications for each Deliverable and IDT must receive written authority from the Prana Contact or Prana’s Chief Operating Officer before commencing any Sub-Project.  Without such agreement and authority for a given Sub-Project, IDT must not undertake and may not charge Prana its fee for the Sub-Project or any other amount. If in relation to a given Sub-Project, Prana provides written authority to undertake the Sub-Project after the relevant commencement date specified in the Work Order, then IDT shall commence the Sub-Project as soon as is reasonably practicable thereafter.

		5.3	IDT must provide the following updates and reports to the Prana Contact for each Project:

 

		(a)	prompt email notification of any material technical or operational problems or issues encountered by IDT;

 

		(b)	fortnightly email updates (in a format acceptable to Prana) of the work undertaken and the Results obtained for the fortnight, problems encountered by IDT, the stage of each Project or Sub-Project, as applicable that IDT is up to and any other information that would be relevant to Prana in relation to the Project; and

 

		(c)	such reports specified in the applicable Work Order for the Project.

 

		5.4	IDT must create a separate project folder in the applicable department directory in its computer system:

 

		(a)	which is dedicated to Prana Projects; and

 

		(b)	accessible only by those IDT Representatives working on such projects.

 

		5.5	Copies of all letters, reports, memos, notes, documents and other written materials created or brought into existence by IDT in relation to each Project shall be saved electronically and stored by IDT in the Prana project folder.

 

		5.6	All Results arising out of the Project must be recorded in a written format.  The results captured in a written format must:

 

		(a)	be maintained and signed in accordance with IDT’s information retention policies and practices; and

 

		(b)	be made available for inspection by Prana upon request by Prana in writing.

 

		5.7	If they have not already done so, the parties agree to put a quality agreement in place for the purpose of the Services to be undertaken by IDT under this Agreement.

 

		5.8	On 14 days prior written notice, IDT must allow Prana to undertake an audit of its Premises, procedures actions and documentation in relation to Prana’s Projects, IMPs, Compounds and Agreement IP and IDT’s observance of obligations under this Agreement and the Quality Agreement. Prana audits shall be limited to one audit with a maximum of two (2) auditors for two (2) days (or otherwise as may be negotiated in advance and agreed by the parties) per calendar year except if Prana reasonably believes that a Cause Event has occurred or may occur in which case Prana may conduct an additional audit with 5 days prior written notice (or such shorter period of notice agreed by the parties in good faith having regard to the urgency of the situation).

 

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	 	5.9	If at any time during or after the termination of this Agreement, Prana requires a third party to perform any work relating to a Compound, including its manufacture, then IDT must, at the request of Prana, co-operate with Prana and the third party and provide such assistance, advice, documentation and information (including the relevant Results) as is necessary to enable the third party to perform the work requested by Prana. Prana agrees to pay all out-of-pocket expenses reasonably incurred by IDT, provided that any anticipated expenses in excess of USD$1,000 are approved by Prana in writing before they are incurred.

 

	 	5.10	If any Deliverable is not produced by IDT to Specification in accordance with this Agreement as a direct result of the negligence of, or breach of GMP or any IDT Standard Operating Procedure by, IDT or any Representative of it, then Prana may reject the Deliverable and:

 

(a)           require that IDT promptly repeat the applicable Service/s; or

 

	 	(b)	terminate the applicable Work Order in whole or in part, in which case Prana will not be liable to pay for, and IDT must immediately refund any moneys paid by Prana (if any) on account of, the Work Order or the terminated part of it, as applicable.

 

 

	6	Fees and Charges

 

		6.1	IDT shall invoice Prana in a manner consistent with the payment schedule and other terms and conditions set out in the relevant Work Order.  Payment of invoices shall be due thirty (30) days after the date of each invoice.

 

 

	7	GST

 

		7.1	Except where express provision is made to the contrary, and subject to this clause, any amount that may be payable under this Agreement is exclusive of any GST.  If GST is or becomes payable on a supply made under or in connection with this Agreement, an additional amount (Additional Amount) is payable by the party providing consideration for the supply (Recipient) equal to the amount of GST payable on that supply as calculated by the party making the supply (Supplier) in accordance with the GST Law.

 

		7.2	The Additional Amount payable under clause 7.1 must be paid at the same time and in the same manner as the consideration for the supply, subject to receipt by the Recipient of a valid tax invoice.

 

		7.3	If the rate of GST payable in respect of supplies made (or deemed to be made) in connection with this Agreement changes, the amount payable must be adjusted so that the economic benefit of this Agreement to the party receiving each payment remains the same, irrespective of the rate of GST which applies.

 

		7.4	Notwithstanding any other provision of this Agreement, if either party is required to reimburse or indemnify the other party for any cost, expense or other amount, the amount to be reimbursed or indemnified must be reduced by any part which is recoverable as an input tax credit by the party which incurred it (or representative member of that party's GST group).

 

		7.5	Terms used in this clause 7 (including "supply", "consideration", "representative member", "tax invoice" and "GST group") have the same meaning as defined in the GST Law.

 

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	8	Risk and Property

 

		8.1	Property in any Products produced by IDT pursuant to a Work Order will pass to Prana upon payment for them in full. Risk in the Products will remain with IDT while in storage at IDT’s premises but will otherwise pass to Prana on despatch from its premises to Prana or Prana’s nominee.

 

 

	9	Intellectual Property

 

		9.1	The parties acknowledge and agree that all Agreement IP will vest in and be solely owned by Prana. IDT hereby assigns all of IDT’s right, title and interest (if any) in the Agreement IP to Prana with effect from the time it is generated or comes into existence.

 

		9.2	IDT and its Representatives must give Prana all reasonable assistance and advice and execute all documents as may be required by Prana from time to time in relation to:

 

		(a)	any assignment that may be required to transfer Agreement IP to Prana;

 

		(b)	any applications by Prana for patents or other registrable Intellectual Property Rights in respect of the Agreement IP;

 

		(c)	any applications, submissions or other documents that Prana seeks to file with a regulatory authority or other government department, agency or body to obtain an approval or consent in relation to its proprietary compounds;

 

		(d)	any other purpose reasonably arising from or incidental to this Agreement.

 

		9.3	This Agreement will not affect the ownership of a party’s Existing IP which is, and will continue to be, solely owned by that party.

 

		9.4	IDT grants Prana a non-exclusive, perpetual, worldwide, royalty-free licence (with the right to grant sublicenses) to use, reproduce and adapt its Existing IP only to the extent necessary to enable Prana to use the Agreement IP for its business purposes.

 

 

	10	Confidentiality

 

		10.1	Each party:

 

		(a)	acknowledges and agrees that the Confidential Information of the other party will at all times remain the exclusive property of that other party; and

 

		(b)	undertakes to keep the Confidential Information of the other party secret and to protect and preserve the confidential nature and secrecy of that Confidential Information.

 

		10.2	Prana agrees and acknowledges in relation to IDT Confidential Information, and IDT agrees and acknowledges in relation to Prana Confidential Information, that it:

 

		(a)	may only use or reproduce the other party’s Confidential Information for the Approved Purposes;

 

		(b)	must not disclose the other party’s Confidential Information to any person except as permitted by this Agreement;

 

		(c)	must not permit unauthorised persons to have access to the other party’s Confidential Information;

 

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		(d)	must not make, or assist or permit any person (including its Representatives) to make any unauthorised use, disclosure or reproduction of the other Party’s Confidential Information;

 

		(e)	must ensure that any person who has access to the other party’s Confidential Information does not make any unauthorised use, reproduction or disclosure of that information;

 

		(f)	must enforce the confidentiality obligations imposed or required to be imposed by this Agreement, including diligently prosecuting at its cost any breach or threatened breach of those confidentiality obligations by a person to whom that party has disclosed the other Party’s Confidential Information and, where appropriate, making applications for interim or interlocutory relief; and

 

		(g)	must provide assistance reasonably requested by the other party, in relation to any proceedings the other party may take against any person for unauthorised use, copying or disclosure of the other Party’s Confidential Information.

 

		10.3	A party may disclose the other party’s Confidential Information to a Representative on a need to know basis but in each case, only to the extent necessary for the Approved Purposes, and provided the Representatives are placed under confidentiality obligations no less onerous than those set out in this Agreement.

 

		10.4	Each party must:

 

		(a)	establish and maintain effective security measures to safeguard the other party’s Confidential Information from access or use not authorised under this Agreement;

 

		(b)	keep the other party’s Confidential Information under its own control;

 

		(c)	immediately notify the other party of any suspected or actual unauthorised use, copying or disclosure of the other party’s Confidential Information;

		10.5	Either party may at any time by notice in writing to the other party request the return, deletion or destruction of all Material Forms of its Confidential Information in the possession, power or control of the other party or any of its Representatives (whether or not those Material Forms were created by the other party or its Representatives) and the other party must immediately comply with such request.  In the case of Prana Compounds to be returned by IDT, the parties acknowledge and agree that IDT may retain samples of any Compounds manufactured by it so that it may comply with its cGMP obligations.

 

		10.6	The return, deletion or destruction, as applicable, of the Material Forms of Confidential Information under clause 10.5 does not release a Party from its obligations under this clause 10.

 

		10.7	Each party acknowledges and agrees that:

 

		(a)	its breach of this Agreement would be harmful to the business interests of the other party;

		(b)	monetary damages alone would not be a sufficient remedy for a breach of this Agreement; and

		(c)	in addition to any other remedy which may be available in law or equity, a party is entitled to interim, interlocutory and permanent injunctions or any of them, to prevent breach of this Agreement and to compel specific performance of it.

 

	
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Liability

 

		11.1	Except as expressly provided to the contrary in this Agreement, all terms, conditions, warranties, guarantees, undertakings or representations of any kind made by or on behalf of a party, prescribed by statute or implied in relation to the subject matter of this Agreement are, to the fullest extent permitted by law, excluded.

 

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		11.2	Subject to clause 11.4, IDT’s liability in respect of all and any claims arising under this Agreement in relation to a Work Order, including any breach of this Agreement by IDT or any negligence of IDT or its Representatives, cannot exceed the agreed aggregate contract price for all works specified in the Work Order.

 

		11.3	Notwithstanding any other provision of this Agreement, neither party shall have any liability to the other for any consequential loss suffered or incurred by the other party, however arising.

 

		11.4	Clauses 11.2 and 11.3 shall have no application to any claim arising from a breach by either party of clause 10.

 

		11.5	Prana shall indemnify and hold harmless IDT in respect of any and all claims or demands by any third party against IDT alleging loss, damage, personal injury or death arising out of the Deliverables provided by IDT save and except for claims for loss, damage, injury or death arising directly or indirectly from any gross negligence or recklessness on the part of IDT or any intentionally harmful act or omission by IDT or any Representative of it.

 

 

	12	Termination

 

		12.1	Either party may terminate this Agreement and/or any Work Order by written notice to the other party with immediate effect from that or any later date that it may nominate if:

 

		(a)	the other party materially breaches this Agreement and fails to remedy such breach within 30 days of receipt of notice from the first party specifying the breach and requiring it to be remedied;

 

		(b)	the other party materially breaches this Agreement and the breach is incapable of remedy; or

 

		(c)	an Insolvency Event happens to the other party.

 

		12.2	Prana may terminate this Agreement and/or or any Work Order (or any part of a Work Order) by giving IDT 30 days written notice. For any incomplete Work Order, IDT must, unless otherwise directed by Prana, cease work immediately and use its commercially reasonable efforts to mitigate any reimbursable expenses or non-cancellable commitments properly incurred in accordance with this Agreement or the applicable Work Order.

 

		12.3	Upon the termination of this Agreement or any Work Order pursuant to clauses 12.1, 12.2 or 13.2, IDT may invoice Prana for Services and reimbursable expenses and non-cancellable commitments properly performed or incurred in accordance with this Agreement and the applicable Work Order through to the date of termination (Final Invoice). In the absence of any offsetting claim, Prana agrees to immediately pay all outstanding invoices and otherwise pay the Final Invoice (or so much thereof as may be due having regard to any up-front fees already paid) within 30 days of the date of the invoice. If after raising the Final Invoice, Prana’s account is in credit, then IDT shall immediately refund the credit balance.

 

		12.4	The expiry or termination of this Agreement will not affect or limit any accrued rights of the parties.

 

		12.5	Clauses 1, 4.2, 4.4, 5.9, 7, 8, 9, 10, 11, 12, 15.15 and 15.16 shall survive the termination of this Agreement.

 

13

 

	13	Force Majeure

 

		13.1	If any party to this Agreement is unable to carry out any obligation (other than to pay money), by reason of Force Majeure, then that obligation will be suspended so far as it is affected by the Force Majeure for the duration of the Force Majeure.  The party affected must promptly give written notice to the other party of the Force Majeure with full particulars thereof and so far as is known, the probable extent to which that party will be unable to perform or will be delayed in performing the obligation.

 

		13.2	If:

 

		(a)	performance of an obligation is prevented by Force Majeure; or

 

		(b)	a delay caused by Force Majeure exceeds 90 days,

 

then either party may terminate this Agreement by written notice to the other party.

 

 

	14	Notices

 

Requirements

 

		14.1	All notices must be:

 

		(a)	in legible writing and in English;

 

		(b)	addressed to the recipient at the address or facsimile number set out below or to any other address or facsimile number that a party may notify to the other:

 

	 	
to IDT:

	 
	 	 	 
	 	
Address:

	
 45 Wadhurst Drive

 Boronia Victoria 3155

	 	
 

Attention:

	
 

Managing Director

	 	
Facsimile no:

	
(03) 9801 8773

	 	 	 
	 	
to Prana:

	 
	 	 	 
	 	Address:  	Level 2, 369 Royal Parade
	 	 	Parkville Victoria 3052
	 	 	Australia
	 	 	 
	 	
Attention:

	Dianne Angus
	 	 	 
	 	
Facsimile no:          

	9348 0377

 

		(c)	signed by the party or, where the sender is a company, by an authorised representative of the sender; and

 

		(d)	sent to the recipient by hand, prepaid post or facsimile.

 

		14.2	Without limiting any other means by which a party may be able to prove that a notice has been received by the other party, a notice will be considered to have been received:

 

		(a)	if sent by hand, when left at the address of the recipient;

 

14

		(b)	if sent by prepaid post, 2 days after the date of posting; or

 

		(c)	if sent by facsimile, on receipt by the sender of an acknowledgment or transmission report generated by the sender's machine indicating that the whole facsimile was sent to the recipient's facsimile number;

 

but if a notice is served by hand, or is received by the recipient's facsimile, on a day that is not a Business Day, or after 5:00 pm (recipient's local time) on a Business Day, the notice will be considered to have been received by the recipient at 9.00 am (recipient's local time) on the next Business Day.

 

 

	15	General provisions

 

Entire agreement

 

		15.1	This Agreement and any other documents referred to in this Agreement or executed in connection with this Agreement is the entire agreement of the parties about the subject matter of this Agreement and supersedes all other representations, negotiations, arrangements, understandings or agreements and all other communications.  No party has entered into this Agreement relying on any representations made by or on behalf of the other, other than those expressly made in this Agreement.  For the avoidance of doubt, IDT’s terms and conditions for consulting/project work will have no application,

 

Further assurances

 

		15.2	Each party must, at its own expense, whenever reasonably requested by the other party, promptly do or arrange for others to do, everything reasonably necessary or desirable to give full effect to this Agreement and the transactions contemplated by this Agreement.

 

Costs

 

		15.3	Each party must pay its own costs in respect of this Agreement and the documents and transactions contemplated by this Agreement.

 

Subcontracting and Assignment

 

		15.4	IDT must not subcontract the Services or assign or otherwise transfer, create any charge, trust or other interest in, or otherwise deal in any other way with any of its rights under this Agreement without the prior written consent of Prana.  IDT shall remain responsible for any Services performed by any subcontractors to the same extent as if such Services were being performed by IDT itself.

 

Invalid or unenforceable provisions

 

		15.5	If a provision of this Agreement is invalid or unenforceable in a jurisdiction:

 

		(a)	it is to be read down or severed to the extent of the invalidity or unenforceability; and

 

		(b)	that fact does not affect the validity or enforceability of the remaining provisions.

 

Waiver and exercise of rights

 

		15.6	A waiver by a party of a provision of or of a right under this Agreement is binding on the party granting the waiver only if it is given in writing and is signed by the party or an authorised representative of the party granting the waiver.

 

		15.7	A waiver is effective only in the specific instance and for the specific purpose for which it is given.

 

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		15.8	A single or partial exercise of a right by a party does not preclude another exercise of that right or the exercise of another right.

 

		15.9	Failure by a party to exercise or delay in exercising a right does not prevent its exercise or operate as a waiver.

 

Amendment

 

		15.10	This Agreement may be amended only by a document signed by all parties.

 

Counterparts

 

		15.11	This Agreement may be signed in counterparts, both of which shall be deemed to be an original but when taken together shall constitute one and the same agreement and shall become effective when a counterpart has been signed by each of the parties hereto and delivered to the other (by facsimile, pdf or otherwise).

 

Rights cumulative

 

		15.12	The rights, remedies and powers of the parties under this Agreement are cumulative and do not exclude any other rights, remedies or powers.

 

Consents and approvals

 

		15.13	A party may give its approval or consent conditionally or unconditionally or withhold its approval or consent in its absolute discretion unless this Agreement expressly provides otherwise.

 

Successors and assigns

 

		15.14	This Agreement is binding on, and has effect for the benefit of, the parties and their respective successors and permitted assigns.

 

Governing law

 

		15.15	This Agreement is governed by the laws of Victoria.

 

		15.16	Each party irrevocably and unconditionally:

 

		(a)	submits to the non-exclusive jurisdiction of the courts of Victoria in relation to any dispute or claim arising out of or in connection with the subject matter of this agreement;

 

		(b)	waives, without limitation, any claim or objection based on absence of jurisdiction or inconvenient forum.

 

16

 

Executed as an agreement

 

	
Signed for and on behalf of

	 	 
	
IDT Australia Limited

ACN 066 522 970

	 	 
	
by its authorised  representative:

	 	 
	 	 	 
	 	 	 
	
Signature of authorised representative

	 	 
	 	 	 
	 	 	 
	
Dr Paul D R MacLeman

	 	 
	
Name (please print)

	 	 

 

Managing Director

	
Title (please print)

	 	 
	
 

Signed for and on behalf of

Prana Biotechnology Ltd

ACN 080 699 065

	 	 
	
by its authorised representative:

	 	 
	
 

 

	 	 
	
Signature of authorised representative

	 	 
	 	 	 
	 	 	 
	
Dianne Angus

	 	 
	
Name (please print)

	 	 
	
 

Chief Operating Officer

	 	 
	
Title (please print)

	 	 

 

17

 

ANNEXURE A

 

WORK ORDER NO. [#]

 

This Work Order No. [#] is issued pursuant to the Master Services Agreement dated [insert date of MSA] (the “MSA”) between Prana Biotechnology Ltd ACN 080 699 065 of Level 2, 369 Royal Parade, Parkville Victoria 3052 Australia (“Prana”) and IDT Australia Limited ACN 080 699 065 of 45 Wadhurst Drive, Boronia Victoria 3155 ("IDT").

Once executed by both parties, this Work Order will be incorporated into the MSA. Capitalized terms not defined in this Work Order shall have the meanings ascribed to them in the MSA.

[Work Orders will contain the following, as applicable:]

	1.	Background

	2.	Description of Services and Deliverables

	3.	Responsibilities

	4.	Project Timeline

	5.	Fees, Reimbursable Expenses and Payment Schedule

	6.	Any other applicable terms and conditions not covered in the MSA

	7.	Exhibits to the Work Order (e.g. specifications, Quality Agreement)

 

WORK ORDER AGREED TO AND ACCEPTED BY:

	
IDT Australia Limited

	
Prana Biotechnology Ltd

	 
	 	 	 
	 	 	 
	
By:

	
By:

	 
	 	 	 
	
Name:

	
Name:

	 
	 	 	 
	
Title:

	
Title:Exhibit 10.1

AGREEMENT TO TERMINATE MANAGEMENT SERVICES AGREEMENT

 

            THIS AGREEMENT TO TERMINATE MANAGEMENT SERVICES AGREEMENT (this “Agreement”), is made and effective as of the 30th day of September, 2016 (the “Termination Effective Date”), by and among: (i) ALGAR, INC., a Kentucky corporation (the "Manager"), (ii) SEAN GARBER, (“Garber,” collectively with the Manager, the “Manager Parties”), and (iii) INDUSTRIAL SERVICES OF AMERICA, INC., a Florida corporation (“ISA” or the "Company").  

 

RECITALS

A.      The Company and the Manager entered into a Management Services Agreement, dated December 2, 2013, but effective December 1, 2013 (the “Management Agreement”) for the Company to retain the Manager to provide certain management and advisory services to the Company.

B.      The Management Agreement provides for a final termination date of December 31, 2016.

C.      The Company has focused on working to increase efficiencies and productivity in its core business while a special committee of the Company’s Board of Directors assists the Board in evaluating strategic alternatives.  In connection with the ongoing evaluation of strategic alternatives, the Company and the Manager desire to terminate the Management Agreement as of the Termination Effective Date.

D.      Section 2(b)(iii) of the Management Agreement provides that the Manager’s Services may be terminated without Cause or by the Manager without Good Reason upon the giving of 90 days’ advance written notice.

E.      The parties desire to terminate the Management Agreement, the Term, and the Manager’s Services as of the Termination Effective Date without 90 days’ advance written notice.

F.      The parties desire to terminate the Management Agreement in accordance with the terms, conditions, provisions and limitations set forth in this Agreement.

G.      Garber as CEO and a shareholder of the Manager will receive benefits from the termination of the Management Agreement.

H.      Capitalized terms used in this Agreement have the meanings set forth for them in the Management Agreement unless expressly defined herein

 

AGREEMENT

 

In consideration of the premises, the immediate termination of the Management Agreement, the mutual covenants and conditions set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties, intending to be legally bound, agree as follows:

1.              Termination of Agreement.  The parties hereby terminate the Management Agreement, the Term, and the Manager’s Services as of the Termination Effective Date.

2.                  Compensation for Services. In full and complete satisfaction of all amounts owed to the Manager under the Management Agreement, the Company will pay the Manager: 

a.           an amount equal to $20,880.30 on the Termination Effective Date; 

b.         an aggregate amount equal to $50,000, payable in three equal monthly installments on the last day of October, November and December 2016; and 

c.       an amount equal to ten percent (10%) of the decrease in reported “Loss before income taxes” for the nine months ended September 30, 2016 as reported on the Condensed Consolidated Statements of Operations in the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2016, as filed with the U.S. Securities and Exchange Commission (the “SEC”), over the Company’s reported “Loss before income taxes” for the nine months ended September 30, 2015 as reported on the Condensed Consolidated Statements of Operations in the Company’s Quarterly Report on Form 10-Q for the period ended September 30, 2016, as filed with the SEC (the "Accrued Bonus Payment"). The Accrued Bonus Payment will be payable as follows:  subject to the availability of cash under applicable law and loan covenants, the Company shall pay the Accrued Bonus Payment to the Manager, if applicable, upon the first to occur of March 31, 2017, or the date of closing of a Change of Control Transaction (as a termination of this bonus program).  The parties acknowledge that, for purposes of the calculation of the Accrued Bonus Payment, any one-time, extraordinary or non-recurring income or expense items shall be removed from the calculation.  

3.             Nonsolicitation. Each of the Manager Parties agrees that at all times during the one-year period following the Termination Effective Date (the “Restricted Period”), the Manager Parties will not, directly or indirectly, whether for their own account or that of any other person or entity, attempt to or actually do any of the following: 

         a.      solicit, divert, or accept any portion of the business of any customer or supplier of the Company mutually designated by the Company and the Manager Parties (the “Designated Entities”) with respect to any product or service that is the same as, similar to, a substitute for, or competitive with any product or service offered by the Company;

          b.      induce any Designated Entity to cease doing business with the Company or to reduce the volume of business they do with the Company;

           c.       provide any advice to or otherwise induce a Designated Entity to cease doing business with the Company or to reduce the volume of business it does with the Company;

        d.     in any other way interfere with the Company’s business or the relationship between the Company and a Designated Entity;     

	2

         e.                 in any manner recruit, solicit, induce, entice, or persuade any employee of the Company to terminate or change the employee’s employment or other relationship with the Company or discuss the prospect of an employee of the Company leaving or changing employment with the Company; or

          f.                  hire any employee of the Company mutually designated by the Company and the Manager Parties (the “Designated Employees”). 

4.                  Equitable Remedies. Each of the Manager Parties hereby acknowledges that the restrictions contained in this Section 3, in view of the nature of the business in which the Company is engaged, are reasonable and necessary in order to protect the legitimate business interests of the Company and its affiliates. The Company and the Manager Parties acknowledge and agree that any breach or threatened breach of the provisions of this Section 3 would cause irreparable injury and that a remedy at law would be inadequate. Therefore, in the event of a breach or a threatened breach by the Manager Parties of any provision of this Section 3, the Company is entitled to an injunction or other equitable relief in any court of competent jurisdiction restraining the Manager Parties from the commission of such breach without any bond or other security being required and without the necessity of showing actual damages, and to recover its attorneys’ fees, costs and expenses related to the breach or threatened breach. Nothing contained herein should be construed as prohibiting the Company from pursuing any other remedies available to it for such breach or threatened breach, including the recovery of money damages. The covenants and disclosures in this Agreement must be construed as independent of any other provisions in this Agreement, and the existence of any claim or cause of action by the Manager Parties against the Company, whether predicated on this Agreement or otherwise does not constitute a defense to the enforcement by the Company of such covenants and agreements. 

5.                  Termination of Stock Option Agreement.  The Company and the Manager hereby terminate the Stock Option Agreement dated as of December 1, 2013 (the “Option Agreement”), between the Company and the Manager, with all exercisable stock options thereunder terminated as of the Termination Effective Date, such options having no value as the exercise price is $5.00 per share and Section 3(a)(iv) of the Option Agreement requiring that the options expire upon the expiration of the Term of the Management Agreement.  

 

6.                  Ancillary Documents.  Each of the Manager Parties hereby covenants and agrees to execute and deliver to the Company on the Termination Effective Date (i) resignations from all offices and director positions held with the Company and its subsidiaries and (ii) a Revocation of Irrevocable Proxies dated of even date herewith, for the revocation of each Irrevocable Proxy referenced in the Management Agreement.

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      7.                  Securities Law Compliance.  Each of the Manager Parties acknowledges that with respect to the fiscal year ended December 31, 2016, the Manager Party must file a Form 5 with the U.S. Securities and Exchange Commission within 45 days after the end of the fiscal year, unless the Manager Party has previously reported on Form 4 all reportable transactions that occurred during the fiscal year.  Each Manager Party hereby represents that the Manager Party has timely reported on Form 4 all transactions in the Company’s equity securities required to be filed through the Termination Effective Date.  Each Manager Party also acknowledges and agrees that (i) the Manager Party is aware that the U.S. federal securities laws prohibit trading in the securities of the Company while in possession of material, non-public information or from communicating such information to any other person under circumstances in which it is reasonably foreseeable that such person is likely to purchase or sell such securities and (ii) the Manager Party will not trade in the Company’s securities while in possession of any material, non-public information regarding the Company.

 

     8.                Transition of Manager’s Services.   Each of the Manager Parties hereby agrees to make itself reasonably available to assist the Company in the orderly transition of the Manager’s Services, including cooperation with the Company if assistance is required to locate, understand, or clarify any services performed by the Manager during the Term.

9.                    Entire Agreement.  Except as set forth herein, the Management Agreement is terminated and neither party under this Agreement will have any further obligation to the other party under the Management Agreement or the Option Agreement, other than under Sections 6, 7 and 11 of the Management Agreement, which sections will survive the Termination Effective Date.    

10.        Headings.  The headings in this Agreement are for reference only and shall not affect the interpretation of this Agreement.  

11.       Counterparts.  This Agreement may be executed in counterparts, each of which shall be deemed an original, but all of which together shall be deemed to be one and the same agreement. A signed copy of this Agreement delivered by facsimile, e-mail or other means of electronic transmission shall be deemed to have the same legal effect as delivery of an original signed copy of this Agreement.

12.          Construction.  Unless the context requires otherwise, singular nouns and pronouns used in this Agreement shall be deemed to include the plural, and pronouns of one gender shall be deemed to include the equivalent pronoun of the other gender. 

 

13.              Interpretation.  The parties to this Agreement acknowledge that each of them has participated in the negotiation of this Agreement, and no provision of this Agreement shall be construed against or interpreted to the disadvantage of any party hereto by any court or other governmental or judicial authority by reason of such party having or being deemed to have structured, dictated or drafted such provision.

	4

 

14.     Survival.  All covenants, agreements, representations and warranties made herein shall survive this Agreement and continue in full force and effect. 

 

15.        Modification.  No modification of any provision of this Agreement shall be effective unless the same is in writing and signed by all parties, and then such modification shall be effective only in the specific instance or for the purpose for which given. 

 

16.     Severability.  If any term, provision or condition, or any part thereof, of this Agreement shall for any reason be found or held to be invalid or unenforceable by any court or governmental agency of competent jurisdiction, such invalidity or unenforceability shall not affect the remainder of such term, provision or condition or any other term, provision or condition, and this Agreement shall survive and be construed as if such invalid or unenforceable term, provision or condition had not been contained therein.

 

17.   Merger and Integration.  The recitals to this Agreement are incorporated into and made a substantive part of this Agreement.  This Agreement contains the entire agreement of the parties hereto with respect to the matters covered hereby, and no other agreement, statement or promise made by any party hereto, or any employee, officer, attorney, agent or other representative of any party hereto, shall be valid or binding.

 

18.          Applicable Law.  The performance, construction and enforcement of this Agreement shall be governed by the laws of the Commonwealth of Kentucky. 

 

19.              Binding Effect.  This Agreement shall have no effect unless and until it has been executed by the parties. 

 

 

[End of Text of Agreement Only/Signature Page Follows]

	5

 

IN WITNESS WHEREOF, the parties have executed this Agreement to Terminate Management Services Agreement as of the Termination Effective Date, but actually on the date set forth below.

 

INDUSTRIAL SERVICES OF AMERICA, INC.

 

 

 

/s/ Orson Oliver                                                                       

By       Orson Oliver

Title:    Chairman and Interim Chief Executive Officer

 

Date: September 30, 2016

 

ALGAR, INC.

 

 

/s/ Sean Garber                                                                        

By       Sean Garber

Title:    Chief Executive Officer

 

Date: September 30, 2016

 

/s/ Sean Garber                                                                        

By       Sean Garber, individually

 

Date: September 30, 2016

	6

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