Document:

EX-4.14

 Exhibit 4.14 

xxxx INDICATES CONFIDENTIAL MATERIAL OMITTED PURSUANT TO A 

REQUEST FOR CONFIDENTIAL TREATMENT AND FILED WITH THE 

SECURITIES AND EXCHANGE COMMISSION SEPARATELY WITH A REQUEST 

FOR CONFIDENTIAL TREATMENT. 
  

			
	 Release version 2.1
 December 2016

 
	  	
		  	  
 Participants Agreement

 
 Cooperative Research Centre Project

 
  

		  	 Targeting Tropomyosin as a Novel Anti-Cancer Therapy

 

		  	  
 Parties

 
 Novogen Limited

 
 University of New South Wales

 
 ICP - Firefly Pty. Limited

 

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
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 Table of Contents 
  

									
	 1.
	  	Definitions and interpretation	  	 	7	 
				
		  	1.1	  	Definitions	  	 	7	 
				
		  	1.2	  	Interpretation	  	 	10	 
				
		  	1.3	  	Priority of Agreement	  	 	11	 
			
	 2.
	  	Participant Contributions and Expectations	  	 	11	 
			
	 3.
	  	Participant Obligations	  	 	11	 
				
		  	3.1	  	General obligations	  	 	11	 
				
		  	3.2	  	Specific Obligations	  	 	12	 
				
		  	3.3	  	Work Orders	  	 	12	 
				
		  	3.4	  	Subcontract	  	 	13	 
				
		  	3.5	  	Specified Personnel	  	 	13	 
				
		  	3.6	  	Warranties	  	 	14	 
				
		  	3.7	  	Other government funding	  	 	14	 
				
		  	3.8	  	Relationship	  	 	14	 
				
		  	3.9	  	Acknowledgement of support	  	 	14	 
				
		  	3.10	  	In the event the Participant is unable to meet obligations	  	 	15	 
				
		  	3.11	  	Breach of the Participants Agreement	  	 	15	 
			
	 4.
	  	Intellectual Property Rights	  	 	15	 
				
		  	4.1	  	Intellectual Property	  	 	15	 
				
		  	4.2	  	Students engaged in the Project	  	 	16	 
				
		  	4.3	  	Moral Rights	  	 	16	 
				
		  	4.4	  	Use of Name and Trademarks	  	 	17	 
			
	 5.
	  	Participant Contributions and use of funds	  	 	17	 
				
		  	5.1	  	Project Partner Contributions	  	 	17	 
				
		  	5.2	  	Lead Participant	  	 	17	 
				
		  	5.3	  	Payments to UNSW	  	 	18	 
				
		  	5.4	  	Payments to ICP Firefly	  	 	18	 
				
		  	5.5	  	Separate Project financial accounts	  	 	19	 
				
		  	5.6	  	What CRC-P Funds can be used for	  	 	19	 
				
		  	5.7	  	What Funds cannot be used for	  	 	19	 
				
		  	5.8	  	When CRC-P Funds cannot be used	  	 	20	 
			
	 6.
	  	Repayment	  	 	20	 
				
		  	6.1	  	Misspent funds	  	 	20	 
				
		  	6.2	  	At the end of the Agreement Period	  	 	20	 
				
		  	6.3	  	Repayment Notice	  	 	20	 
				
		  	6.4	  	UNSW Reconciliation	  	 	20	 
			
	 7.
	  	GST and R&D Tax Incentive	  	 	21	 

  
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		  	7.1	  	Construction	  	21
				
		  	7.2	  	Consideration GST exclusive	  	21
				
		  	7.3	  	Payment of GST	  	21
				
		  	7.4	  	R&D Tax Incentive	  	21
			
	8.	  	Confidentiality	  	21
				
		  	8.1	  	Prohibition on disclosure	  	21
				
		  	8.2	  	Advisers and third parties	  	21
				
		  	8.3	  	Exceptions to obligations	  	22
				
		  	8.4	  	Obligation on disclosure	  	22
				
		  	8.5	  	Additional confidential information	  	22
				
		  	8.6	  	Confidential Information in Agreement Material	  	22
				
		  	8.7	  	Period of confidentiality	  	23
				
		  	8.8	  	No reduction in privacy obligations	  	23
				
		  	8.9	  	Return of information	  	23
			
	9.	  	Publication policy	  	23
			
	10.	  	Protection of personal information	  	25
				
		  	10.1	  	Definitions	  	25
				
		  	10.2	  	Application of this clause	  	25
				
		  	10.3	  	Personal Information other than Commonwealth provided Personal Information	  	25
			
	11.	  	Insurance	  	25
				
		  	11.1	  	Obligation to maintain insurance	  	25
				
		  	11.2	  	Certificates of Currency	  	26
				
		  	11.3	  	Self-Insurance or other protection	  	26
			
	12.	  	Work health and safety	  	26
			
	13.	  	Conflict of Interest	  	26
				
		  	13.1	  	Warranty	  	26
				
		  	13.2	  	Notification of a conflict of interest	  	26
			
	14.	  	Books and records	  	27
				
		  	14.1	  	Participant to keep books and records	  	27
				
		  	14.2	  	Reports	  	27
				
		  	14.3	  	Costs	  	27
			
	15.	  	Monitoring progress	  	27
			
	16.	  	Participants audit and access	  	28
			
	17.	  	Commonwealth audit and access	  	28
				
		  	17.1	  	Right to conduct audits	  	28
				
		  	17.2	  	Access by the Commonwealth	  	28
				
		  	17.3	  	Auditor-General and the Australian Information Commissioner	  	29
				
		  	17.4	  	Participants to comply with Auditor-General’s requirements	  	29
				
		  	17.5	  	No reduction in responsibility	  	29

  
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		  	17.6	  	Subcontractor requirements	  	29
				
		  	17.7	  	No restriction	  	29
				
		  	17.8	  	Costs	  	29
			
	18.	  	False or misleading information	  	30
			
	19.	  	Safe and Ethical Research	  	30
			
	20.	  	Responsible conduct of research	  	30
			
	21.	  	Survival	  	31
			
	22.	  	Changes to the Agreement	  	31
			
	23.	  	Relationship to the Funding Agreement	  	31
			
	24.	  	Agreement Period and Termination	  	32
				
		  	24.1	  	Agreement Period	  	32
				
		  	24.2	  	Change of Project Partner	  	32
				
		  	24.3	  	Withdrawal of a Project Partner from the Agreement	  	33
				
		  	24.4	  	Consequences of removal of a Project Partner	  	34
				
		  	24.5	  	Termination of this Agreement for default	  	35
				
		  	24.6	  	Termination by Notice	  	35
				
		  	24.7	  	Suspension	  	35
				
		  	24.8	  	Consequences of termination– Intellectual Property	  	35
				
		  	24.9	  	Other consequences of termination	  	35
			
	25.	  	Liability and Indemnity	  	35
				
		  	25.1	  	Indemnity	  	35
				
		  	25.2	  	Consequential loss	  	36
				
		  	25.3	  	Maximum liability	  	36
			
	26.	  	Dispute resolution	  	36
				
		  	26.1	  	No arbitration or court proceedings	  	36
				
		  	26.2	  	Notification	  	36
				
		  	26.3	  	Parties to resolve Dispute	  	36
				
		  	26.4	  	Appointment of mediator	  	36
				
		  	26.5	  	Role of mediator and obligations of parties	  	37
				
		  	26.6	  	Confidentiality	  	37
				
		  	26.7	  	Costs	  	37
				
		  	26.8	  	Termination of process	  	37
			
	27.	  	Notices and other communications	  	37
				
		  	27.1	  	Service of Notices	  	37
				
		  	27.2	  	Effective on receipt	  	37
			
	28.	  	Miscellaneous	  	38
				
		  	28.1	  	No security	  	38
				
		  	28.2	  	Nature of obligations	  	38
				
		  	28.3	  	No adverse construction	  	38

  
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		  	28.4	  	Approvals and consents	  	 	38	 
				
		  	28.5	  	Assignment and novation	  	 	38	 
				
		  	28.6	  	Costs	  	 	38	 
				
		  	28.7	  	Counterparts	  	 	38	 
				
		  	28.8	  	No merger	  	 	38	 
				
		  	28.9	  	Entire agreement	  	 	38	 
				
		  	28.10	  	Further action	  	 	38	 
				
		  	28.11	  	Severability	  	 	38	 
				
		  	28.12	  	Waiver	  	 	39	 
				
		  	28.13	  	Governing law and jurisdiction	  	 	39	 

  
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 Details 

 
  

			
	Date	  	15th     /     June     /     2017    
		  	day            month        year
		
	Parties	  	
		
	BETWEEN	  	Novogen Ltd (Lead Participant or Novogen)
		  	ABN: 37 063 259 754
		  	Suite 502, Level 5, 20 George St, Hornsby NSW 2077
		  	Email : Stephen.Palmer@novogen.com
		  	Attention : Dr Stephen Palmer
		
	AND	  	The University of New South Wales (UNSW)
		  	ABN: 57 195 873 179
		  	School of Medical Sciences, Wallace Wurth East, UNSW Australia, Kensington NSW 2052
		  	Email : p.gunning@unsw.edu.au
		  	Attention : Professor Peter Gunning
		
	AND	  	ICP - Firefly Pty. Limited (ICP Firefly)
		  	ABN: 66 071 626 358
		  	129 Queen Street, Beaconsfield NSW 2015
		  	Email : isabelle@icpfirefly.com.au
		  	Attention : Dr Isabelle Meyer-Carrive

 Background 
  

	A	The Parties have agreed to contribute to and participate in the Project. 

  

	B	Pursuant to the Funding Agreement with the Commonwealth, the CRC Project, Targeting Tropomyosin as a Novel Anti-Cancer Therapy, is funded through the Cooperative Research Centres (CRC) Programme. 

 

	C	This Agreement specifies the terms and conditions of the arrangements between the Parties and obliges them, as Participants, to make the Contributions and comply with other obligations as set out in this Agreement.

  
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	1.	Definitions and interpretation 

  

	1.1	Definitions 

 In this Agreement, except where the contrary intention is expressed, the
following definitions are used: 
  

			
	Account	  	the bank account maintained by the Lead Participant with respect to the CRC-P Funds in accordance with clause 9.4 of the Funding Agreement.
		
	Accounting Standards	  	the accounting standards maintained by the Australian Accounting Standards Board (created by section 226 of the Australian Securities and Investments Commission Act 2001 (Cth)) or other accounting standards which are
generally accepted and consistently applied in Australia.
		
	Agreement	  	this agreement between the Participants, as varied from time to time in accordance with clause 22, and including its Schedules and any attachments.
		
	Agreement Material	  	any Material created on or following the commencement of the Funding Agreement, for the purpose of, or as a result of, a Participant undertaking and performing its obligations under the Project, including any improvements to any Pre-existing Materials.
		
	Agreement Period	  	the period from the Commencement Date to the End Date
		
	Asset	  	any item of tangible property purchased, leased, created or otherwise brought into existence either wholly or in part with use of the Funds, but does not include Agreement Material.
		
	Budget	  	the budget in part 2 of Schedule 3
		
	Business Day	  	a day that is not a Saturday, Sunday, public holiday or bank holiday in the place where the act is to be performed or where a Notice is received.
		
	Commencement Date	  	5 May 2017, or the date of execution of this Agreement, whichever is the later.
		
	Commonwealth	  	the Commonwealth of Australia.
		
	Confidential Information	  	 information that is by its nature confidential and:
  

(a)    is designated by a Party as confidential; or

 
 (b)    a Party knows or ought
to know is confidential; or
  

(c)    is described in item 6 of Schedule 1,

 
 but does not include:

 
 (d)    information that is or
becomes public knowledge otherwise than by breach of this Agreement or any other confidentiality obligation.

		
	Contribution	  	the cash, personnel, facilities and services to be provided by the Participants to the CRC-P, from their own resources, for the purposes of undertaking the Project, as specified in Schedule
3.

  
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	CRC Indicia	  	the terms “CRC”, “CRC Projects”, “CRC-P”, “Cooperative Research Centre” and the CRC Programme logo and any additional items specified by the
Commonwealth from time to time.
		
	CRC Programme	  	the Cooperative Research Centres Programme.
		
	CRC Project (CRC-P)	  	the collaboration between the Participants for the purposes of undertaking the Project.
		
	CRC-P Funds	  	the Funds and any cash Contributions provided by the Participants for the purpose of the Project.
		
	End Date	  	the date on which this Agreement terminates or expires.
		
	Expected Funding	  	$1,500,000 over the course of the Agreement Period.
		
	Financial Year	  	the Australian financial year beginning 1 July and ending 30 June.
		
	Funds	  	the amounts payable by the Commonwealth to the Lead Participant under the Funding Agreement and any interest earned on those amounts.
		
	Funding Agreement	  	the funding agreement between the Commonwealth and the Lead Participant for the purposes of funding and managing the Project.
		
	Guidelines	  	the Programme Guidelines listed under item 2 of Schedule 1, and any other guidelines issued by the Commonwealth from time to time in relation to the CRC Programme and its administration.
		
	GST Law	  	A New Tax System (Goods and Services Tax) Act 1999(Cth).
		
	Intellectual Property Rights	  	 all intellectual property rights, including:
  

a)      copyright, patents, trademarks (including goodwill in those marks), designs,
trade secrets, know how, rights in circuit layouts, domain names and any right to have confidential information kept confidential;
  

b)      any application or right to apply for registration of any of the rights referred
to in paragraph (a); and
  

c)      all rights of a similar nature to any of the rights in paragraphs (a) and
(b) which may subsist in Australia or elsewhere,
  
 whether or not such rights are
registered or capable of being registered.

		
	ICP Firefly Services	  	the services as described in column 1 of Part C of Schedule 4.
		
	Law	  	any applicable statute, regulation, by-law, ordinance or subordinate legislation in force from time to time in Australia, whether made by a State, Territory, the Commonwealth, or a local
government, and includes the common law and rules of equity as applicable from time to time.
		
	Lead Participant	  	Novogen Limited ABN: 37 063 259 754.
		
	Lead Participant Services	  	the services as described in column 1 of Part A of Schedule 4.

  
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	Material	  	includes property, information, data, results, images, models, molecules, software, firmware, documented methodology or process, documentation or other material in whatever form, including any reports, specifications, business
rules or requirements, user manuals, user guides, operations manuals, training materials and instructions, and the subject matter of any category of Intellectual Property Rights.
		
	Milestone	  	a stage of completion of the Project as set out in Schedule 2.
		
	Moral Rights	  	the right of integrity of authorship (that is, not to have a work subjected to derogatory treatment), the right of attribution of authorship of a work, and the right not to have authorship of a work falsely attributed, as defined
in the Copyright Act 1968 (Cth).
		
	Notice	  	a notice, demand, consent, approval or communication issued under this Agreement.
		
	Novogen Material	  	all Agreement Material other than the Technical Assay Material.
		
	Outcomes	  	the outcomes of the Project, as set out in Schedule 2.
		
	Participant	  	a person, body or organisation that is a signatory to this Agreement.
		
	Parties	  	the parties to this Agreement.
		
	Personnel	  	 (a)    in relation to a party, any employee, officer, agent, professional
adviser or subcontractor of that party; and
  

(b)    in relation to UNSW, includes the personnel identified in paragraph (a) of this
definition and any Students

		
	Pre-existing Material	  	Material owned by a party independently of this Agreement, including any Material specified in item 3 of Schedule 1.
		
	Project	  	the project set out in Schedule 2.
		
	Project Partner	  	all Participants other than the Lead Participant.
		
	Publication	  	any form of recorded medium that makes Agreement Material public, including print, images, video or audio, and ‘Publish’ has a corresponding meaning.
		
	Quarter	  	a period of 3 months or, where the context necessitates part or multiples of that period, ending on 31 March, 30 June, 30 September or 31 December.
		
	Related Entity	  	has the meaning given to that term in the Corporations Act 2001 (Cth).
		
	R&D Tax Incentive	  	is established by Division 355 of the Income Tax Assessment Act 1997 (Cth) with functions relating to its administration included in the Industry Research and Development Act 1986 (Cth).
		
	Shortfall	  	any deficit in the total Contributions received by the Lead Participant during a Financial Year and the Contributions which should have been received by the Lead Participant during that Financial Year as specified in Schedule
3.

  
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	Specified Personnel	  	the Personnel (if any) specified in item 7 of Schedule 1.
		
	Student	  	any postgraduate or graduate student involved in the Project research.
		
	Technical Assay Material	  	 Agreement Material which is a technical assay and:
  

(a)    has been developed as part of the Project, with the purpose of testing the properties of
new chemical entities in biological systems; and
  

(b)    is not required in order for the Lead Participant to pursue Utilisation of any other
Agreement Material.

		
	Third Party Material	  	 Material owned by a third party that is:
  

(a)    included, embodied in or attached to the Agreement Material; or

 
 (b)    used in undertaking
the Project,
  
 as specified in item 4 of Schedule 1.

		
	UNSW Services	  	the services as described in column 1 of Part B of Schedule 4.
		
	UNSW Paid Amount	  	$300,000.
		
	UNSW Committed Amount	  	 (a)    if CRC-P Funds received by
UNSW during the Agreement Period meet or exceed $1,000,000, an amount which is equal to 20% of the value of the CRC-P Funds received; or
  

(b)    if CRC-P Funds received by UNSW during the
Agreement Period are less than $1,000,000, nil.

		
	Utilisation	  	technology transfer, take-up and use of research outputs by end-users. Commercial utilisation includes the manufacture, sale, hire or other
exploitation of a product or process, or the provision of a service, incorporating Agreement Material or licensing of any third party to do any of those things, or otherwise licensing or assigning the Agreement Material.
		
	WHS Laws	  	the Work Health and Safety Act 2011 (Cth), regulations made under that Act and any code of practice approved for the purpose of that Act.
		
	Work Order	  	an agreement to provide services to the CRC-P in accordance with clause 3.3.

  

	1.2	Interpretation 

 In this Agreement, except where the contrary intention is expressed:

  

	 	(a)	the singular includes the plural and vice versa, and a gender includes other genders; 

  

	 	(b)	another grammatical form of a defined word or expression has a corresponding meaning; 

  

	 	(c)	a reference to a clause, paragraph or schedule is to a clause or paragraph of, or schedule to, this Agreement; 

  
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	 	(d)	a reference to a document or instrument includes the document or instrument as novated, altered, supplemented or replaced from time to time; 

 

	 	(e)	a reference to A$, $A, dollar or $ is to Australian currency; 

  

	 	(f)	a reference to time is to Canberra, Australia time; 

  

	 	(g)	a reference to a party to a document includes the party’s executors, administrators, successors and permitted assignees and substitutes; 

 

	 	(h)	a reference to a person includes a natural person, partnership, body corporate, association, governmental or local authority or agency or other entity; 

 

	 	(i)	a reference to a statute, ordinance, code or other law includes regulations and other instruments under it and consolidations, amendments, re-enactments or replacements of any of
them; 

  

	 	(j)	the meaning of general words is not limited by specific examples introduced by including, for example or similar expressions, and the words “includes” or “including” shall be read as being followed
by “without limitation”; 

  

	 	(k)	any agreement, representation, warranty or indemnity by two or more parties (including where two or more persons are included in the same defined term) binds each of them severally and does not bind them jointly;

  

	 	(l)	any agreement, representation, warranty or indemnity in favour of two or more parties (including where two or more persons are included in the same defined term) is for the benefit of them jointly and severally;

  

	 	(m)	a rule of construction does not apply to the disadvantage of a party because the party was responsible for the preparation of this Agreement or any part of it; 

 

	 	(n)	if a day on or by which an obligation must be performed or an event must occur is not a Business Day, the obligation must be performed or the event must occur on or by the next Business Day; and 

 

	 	(o)	headings are for ease of reference only and do not affect interpretation. 

  

	1.3	Priority of Agreement 

 To the extent of any inconsistency the body of this Agreement and
the Schedules, the body of this Agreement will prevail. 
  

	2.	Participant Contributions and Expectations 

  

	 	(a)	During the Agreement Period, the Participants will make the Contributions to the CRC-P as detailed in Schedule 3. 

 

	 	(b)	During the Agreement Period, the Participants will provide the products, services and/or access for the purposes of the Project as outlined in item 4 of Schedule 2 and as well as the specific services set out in
Schedule 4. 

  

	 	(c)	UNSW will not charge any indirect on-costs to the Lead Participant for any direct or in-kind expenses related to the CRC-P or the Project. 

  

	3.	Participant Obligations 

  

	3.1	General obligations 

 Each Participant agrees that it will: 

 

	 	(a)	diligently perform its obligations as set out in this Agreement to a high professional standard; 

  
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	 	(b)	undertake the Project to achieve the Outcomes, at the times and in the manner specified in Schedule 2 of this Agreement; 

  

	 	(c)	make its Contributions to the CRC-P, through the Lead Participant, in accordance with Schedule 3 and any other requirements under this Agreement; 

 

	 	(d)	meet the due dates for the Milestones, as specified in Schedule 2; 

  

	 	(e)	undertake the Project in accordance with the Guidelines; 

  

	 	(f)	cooperate with, and provide to, the Lead Participant any information about the Contributions, any anticipated Shortfall and other activities reasonably required by the Lead Participant; 

 

	 	(g)	keep the CRC-P informed through the Lead Participant about the results of the Project and any other information relevant to the conduct of the Project in which the Participant is
involved, including through the submission of Quarterly update reports; 

  

	 	(h)	support the Lead Participant to meet its obligations to the Commonwealth under the Funding Agreement; 

  

	 	(i)	support the CRC-P in meeting its obligations in compliance with law and policy, and comply with the provisions of any relevant statutes, regulations, by-laws, and requirements of any Commonwealth, State, Territory or local authority; and 

  

	 	(j)	act reasonably and in good faith with the other Participants. 

  

	3.2	Specific Obligations 

  

	 	(a)	The Lead Participant must provide the Lead Participant Services to the CRC-P in accordance with: 

 

	 	(i)	any applicable service standards described in column 2 of Part A of Schedule 4; and 

  

	 	(ii)	all applicable Laws. 

  

	 	(b)	UNSW must provide the UNSW Services to the CRC-P in accordance with: 

  

	 	(i)	any applicable service standards described in column 2 of Part B of Schedule 4; and 

  

	 	(ii)	all applicable Laws. 

  

	 	(c)	ICP Firefly must provide the ICP Firefly Services to the CRC-P in accordance with: 

  

	 	(i)	any applicable service standards described in column 2 of Part C of Schedule 4; and 

  

	 	(ii)	all applicable Laws. 

  

	 	(d)	The Participants may vary the services specified in Schedule 4 from time to time by agreement in writing. 

  

	3.3	Work Orders 

  

	 	(a)	During the Agreement Period, the Lead Participant may submit a Work Order to a Project Partner with respect to reasonable specific services to be provided to the CRC-P in addition
to those outlined in Schedule 4. 

  
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	 	(b)	If the Lead Participant requests that a Project Partner provides a quote for services to be conducted under a Work Order prior to submitting a Work Order under clause 3.3(a), the Project Partner must, acting reasonably
and in good faith, prepare and provide an itemised quote to the Lead Participant within 10 Business Days of such request. 

  

	 	(c)	Each Work Order must be within the scope of the Project, and must comply with the Budget and Contributions relevant to the Project Partner. 

 

	 	(d)	A Project Partner will be deemed to have accepted a Work Order unless the Project Partner has given Notice to the Lead Participant within 5 Business Days of receipt of the Work Order that it cannot reasonably provide
the services described in the Work Order. 

  

	 	(e)	Each accepted Work Order will set out the full details of the services to be provided, any applicable service standards and any other relevant information and instructions. 

 

	3.4	Subcontract 

  

	 	(a)	The Project Partners must not sub-contract any of their obligations under this Agreement without the prior written permission of the Lead Participant. 

 

	 	(b)	Any sub-contracting by a Project Partner of an obligation under this Agreement: 

  

	 	(i)	must be on broadly the same terms as this Agreement; 

  

	 	(ii)	must include terms which meet the requirements of clause 13 of the Funding Agreement as if the Project Partner was the Lead Participant; and 

 

	 	(iii)	does not relieve a Project Partner of any of its liabilities or obligations under this Agreement. 

  

	 	(c)	The Project Partner is liable to the Lead Participant for the acts, defaults and omissions of the sub-contractor, or any of the
sub-contractor’s Personnel, as if they were the acts, defaults or omissions of the Project Partner. 

  

	3.5	Specified Personnel 

  

	 	(a)	Each Participant must: 

  

	 	(i)	undertake the Project or any part of the Project to which their particular expertise relates, with the active involvement of, and using the expertise of, its Specified Personnel or any persons who are appointed to
replace them in accordance with the requirements under clause 3.5(c); and 

  

	 	(ii)	ensure that each of its Specified Personnel is aware of and complies with the Participant’s obligations in undertaking the Project. 

 

	 	(b)	Where one or more of the Specified Personnel is or will become unable or unwilling to be involved in the Project, the relevant Participant must notify the Lead Participant in writing immediately of any change to the
Specified Personnel. 

  

	 	(c)	When replacing Specified Personnel, the Participants must ensure that any such replacement personnel directly involved in the Project has the time commitment, qualifications and competency to undertake the Project to
the standard required by the Agreement and have similar or better suited expertise and ability to those of the Personnel they are replacing. 

  

	 	(d)	The Commonwealth may at any time request to remove from work in respect of this Agreement any of the Specified Personnel or any of a Participant’s subcontractors or Personnel. If a request is made, the relevant
Participant must promptly arrange for the removal of such subcontractors or Personnel, and arrange for a replacement in accordance with the requirements under clause 3.5(c). 

  
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	3.6	Warranties 

 Each Participant represents and warrants that: 

 

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

  

	 	(b)	it and its subcontractors and Personnel, including its Specified Personnel, have the necessary experience, skill, knowledge, expertise and competence to undertake the Project and (where appropriate) will hold such
licences, permits or registrations as are required under any State, Territory or Commonwealth legislation to undertake the Project, and are fit and proper people. 

 

	3.7	Other government funding 

  

	 	(a)	Each Participant must provide to the Lead Participant full details of any financial assistance for activities in connection with the Project which the Participant receives from another Commonwealth, State or Territory
government source or agency after the commencement of this Agreement (Other Financial Assistance), including: 

  

	 	(i)	the amount and source of the funding; and 

  

	 	(ii)	the name of the programme under which it was provided, 

 within 10 Business Days of the
Participant receiving notice that the Other Financial Assistance has been approved. 
  

	 	(b)	The parties acknowledge that the: 

  

	 	(i)	Commonwealth may reduce, suspend or defer its payments in the event a Participant receives Other Financial Assistance, but only to the extent that this financial assistance duplicates Funds; and 

 

	 	(ii)	any reduction in Funds received will result in a corresponding reduction of funding provided under this Agreement. 

  

	3.8	Relationship 

  

	 	(a)	Each Party must not present itself, and ensure its officers, employees, agents and other Personnel do not represent themselves, as being an officer, employee, partner, agent or other Personnel of the Commonwealth or
another Participant, or as otherwise able to bind or represent the Commonwealth or another Participant. 

  

	 	(b)	This Agreement does not create a relationship of employment or agency, joint venture, partnership, or of trustee and beneficiary between the Parties. 

 

	3.9	Acknowledgement of support 

 Each Participant must, in: 

 

	 	(a)	all of its publications (including reprints and despite whether published by the Participant or other persons) that are a result of the Project; 

 

	 	(b)	any of its products, processes or inventions produced as a direct result of the Project activities; and 

  

	 	(c)	all of its promotional and advertising materials, public announcements, events and activities in relation to the Project; 

acknowledge the financial and other support received from the Commonwealth: 

 

	 	(d)	through reference to this support and the CRC Programme; 

  
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	 	(e)	in relation to clause 3.9(c), through prominent display of the CRC Indicia; and 

  

	 	(f)	by reference to any acknowledgement as otherwise specified by the Commonwealth from time to time. 

  

	3.10	In the event the Participant is unable to meet obligations 

 Each Participant must notify
the Lead Participant and all Project Partners immediately upon becoming aware of any circumstances that are likely to adversely affect the Participant’s ability to comply with the terms of this Agreement, in particular its solvency or ability
to ensure that the Project is carried out in accordance with this Agreement. This includes notification of any intent of, or changes in circumstances leading to the need for, withdrawal from the CRC-P and the
Project. The giving of Notice pursuant to this clause 3.10 will not, in any way, limit the obligations of the Participant under this Agreement or excuse the Participant in any way from the performance of those obligations. 

 

	3.11	Breach of the Participants Agreement 

 Each Participant must, within 5 Business Days of
becoming aware of any breach or suspected breach of this Agreement that would affect the Lead Participant’s ability to comply with its obligations under the Funding Agreement: 

 

	 	(a)	provide Notice to the Lead Participant and all Project Partners of that breach or suspected breach; 

  

	 	(b)	provide all information reasonably required by the Lead Participant in relation to the breach or suspected breach; 

  

	 	(c)	identify to the Lead Participant and all Project Partners the steps the Participant intends to take to address the matter; 

  

	 	(d)	keep the Lead Participant and all Project Partners informed of any action it takes to remedy the breach; and 

  

	 	(e)	provide Notice to the Lead Participant and all Project Partners once the breach is remedied, or if not remedied upon the matter being otherwise resolved. 

 

	4.	Intellectual Property Rights 

  

	4.1	Intellectual Property 

  

	 	(a)	This clause 4 does not affect the ownership of the Intellectual Property Rights in any Pre-existing Material or Third Party Material. 

 

	 	(b)	The Project Partners must obtain all necessary copyright and other Intellectual Property Rights permissions before making any Third Party Material available for the purpose of this Agreement or the Project.

  

	 	(c)	The Project Partners must specify which parts (if any) of the Intellectual Property Rights are Third Party Material and who owns the Intellectual Property Rights in that material. 

 

	 	(d)	The Intellectual Property Rights in the Agreement Material will vest in the Participants on creation as agreed in Schedule 5. 

  

	 	(e)	Each Participant will adhere to the documented arrangements and procedures for dealing with Intellectual Property Rights in Agreement Material as set out in Schedule 5. 

  
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	 	(f)	Each Participant will adhere to the documented arrangements and procedures, as set out in clause 9 to ensure that, prior to the publication or disclosure of Agreement Material (but not including reports or other such
material to be provided to the Commonwealth for the Commonwealth’s benefit), consideration is given to the potential prejudice to its subsistence or Utilisation, including the possibility that publication or disclosure might preclude the grant
of a patent or cause the loss of Intellectual Property Rights. 

  

	 	(g)	Each Participant must ensure that any Utilisation of Agreement Material in the context of this Agreement: 

  

	 	(i)	is consistent with the Milestones, the nature of the Project and the CRC Programme; and, 

  

	 	(ii)	maximises the national benefits accruing to Australia. 

  

	 	(h)	To the extent that the Commonwealth needs to use any of the Agreement Material in connection with the Funding Agreement or CRC Programme, including but not limited to: 

 

	 	(i)	the use of reports provided by the Lead Participant to the Commonwealth; or 

  

	 	(ii)	the exercise of the Commonwealth’s rights under clause 17 (Commonwealth Audit & Access); 

each Participant grants to, or must obtain for, the Commonwealth a perpetual, world-wide, royalty free,
non-exclusive licence (including the right to sublicense) to use, reproduce, adapt, modify and communicate that Material. 
  

	 	(i)	The licence granted to the Commonwealth under clause 4.1(h) does not include a right to exploit the Agreement Material for the Commonwealth’s commercial purposes. 

 

	4.2	Students engaged in the Project 

 The Participants acknowledge that UNSW has obligations
under its governing statues to ensure that Students completing a thesis are able to complete the requirements of their candidature and that this obligation extends to submitting a Student’s thesis for examination and depositing in the library a
copy of the Student’s complete thesis of work submitted for a higher degree. In accordance with this acknowledgment it is accepted that: 
  

	 	(a)	all Agreement Material created by the Student and all Intellectual Property Rights in such material (Student Material) will vest in the Participants as agreed in Schedule 5 on creation (except that the Student
owns copyright and Moral Rights in his/her thesis); 

  

	 	(b)	UNSW will procure that the Student assigns to the Participants all right, title and interest in the Student Material and agrees to do all things reasonably necessary to give effect to such ownership and assignment; and

  

	 	(c)	the Student is entitled to Publish the Student Material in accordance with clause 9 of this Agreement. 

  

	4.3	Moral Rights 

  

	 	(a)	To the extent permitted by applicable Laws and for the benefit of the Commonwealth and the Lead Participant, each Project Partner must use its best endeavours to ensure that: 

 

	 	(i)	each of the Personnel used by the Project Partner in the production or creation of the Agreement Material gives, in a form acceptable to the Lead Participant; and 

  
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	 	(ii)	any holder of Moral Rights in Third Party Material included in the Agreement Material gives, 

genuine consent in writing to the use of the Agreement Material for the Specified Acts, even if such use would otherwise be an infringement of
its or their Moral Rights and notify the Lead Participant if this consent is not obtained. 
  

	 	(b)	In this clause 4.3 Specified Acts means: 

  

	 	(i)	falsely attributing the authorship of any Agreement Material, or any content in the Agreement Material (including literary, dramatic, artistic works and cinematograph films within the meaning of the Copyright Act 1968
(Cth)); 

  

	 	(ii)	materially altering the style, format, colours, content or layout of the Agreement Material and dealing in any way with the altered Agreement Material; 

 

	 	(iii)	reproducing, communicating, adapting, publishing or exhibiting any Agreement Material; and 

  

	 	(iv)	adding any additional content or information to the Agreement Material. 

  

	4.4	Use of Name and Trademarks 

 Except as reasonably required to comply with Law, the
Funding Agreement or the rules of any financial market on which a Party or a Related Entity of a Party is listed, each Participant shall not use another Participant’s name or trademarks without the express permission of that party. 

 

	5.	Participant Contributions and use of funds 

  

	5.1	Project Partner Contributions 

  

	 	(a)	Each Project Partner shall pay its annual cash component of its Contributions into the Account within 30 days after the first day of each applicable Financial Year during the Agreement Period. 

 

	 	(b)	The Lead Participant shall send the Project Partner a tax invoice at least 14 days before the end of each Financial Year during the Agreement period, for the cash amount due at the start of the next Financial Year.
Each annual payment by the Project Partner of its cash component shall be the Contribution due plus GST, if applicable. 

  

	 	(c)	The valuation of the non-cash-in-kind Contribution of a Project Partner shall be in accordance with
the Accounting Standards and any valuation principles provided by the Commonwealth from time to time, and reported to the Lead Participant on request. 

  

	5.2	Lead Participant 

  

	 	(a)	The Lead Participant shall pay its annual cash component of its Contributions into the Account within 30 days after the Commencement Date, or within 30 days after the first day of each applicable Financial Year during
the Agreement Period (whichever is applicable). 

  

	 	(b)	The Lead Participant shall pay the CRC-P Funds out of the Account to the Project Partners in accordance with the Budget, Schedule 3 and this clause 5. 

  
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	5.3	Payments to UNSW 

  

	 	(a)	Subject to the remainder of this clause 5.3 the Lead Participant shall: 

  

	 	(i)	pay to UNSW the amount specified for Q3 in item 3 of Schedule 3 within 30 days of the Commencement Date; and 

  

	 	(ii)	make Quarterly payments of the CRC-P Funds due under item 3 of Schedule 3 to UNSW: 

  

	 	(A)	with respect to amounts from Contributions, within 30 days of the end of each Quarter during the Term; 

  

	 	(B)	with respect to amounts from the Funds, within 30 days of the receipt of the Funds from the Commonwealth. For the avoidance of doubt, the Lead Participant will not be required to pay any amount of the Funds to UNSW
unless and until such Funds have been received from the Commonwealth. 

  

	 	(b)	The Lead Participant may vary the amount specified in item 3 of Schedule 3 at any time during the Term, by giving written Notice to UNSW, provided that: 

 

	 	(i)	the Lead Participant will take into account the reasonable comments of UNSW in making any variations; and 

  

	 	(ii)	any variations must be in accordance with the Budget. 

  

	 	(c)	Any amount payable to UNSW under a Work Order will be as set out in that agreed Work Order. 

  

	 	(d)	UNSW must issue a valid tax invoice to the Lead Participant for the amount due under this clause 5.3, prior to the Lead Participant making any payment of CRC-P Funds in accordance
with this clause 5.3. 

  

	 	(e)	UNSW acknowledges and agrees that the Lead Participant is not liable for the provision of additional money to meet any expenditure in excess of the Funds or a Participant’s Contribution under the Budget, without
the written consent of the Lead Participant. 

  

	 	(f)	UNSW acknowledges and agrees that any amount specified in the Budget or due to be paid under a Work Order or this clause 5.3 will be reduced in proportion with any reduction in funding under the Funding Agreement. The
Lead Participant will seek to ensure that any such reduction will be in accordance with the aims of the Project. 

  

	5.4	Payments to ICP Firefly 

  

	 	(a)	Subject to clauses 5.4(b) and 5.4(c), and unless otherwise agreed by the Parties in writing, the Lead Participant will pay to ICP Firefly the amount as specified in each agreed Work Order as out of the CRC-P Funds as follows: 

  

	 	(i)	70% of the total cost of the Work Order within 30 days of the later of: 

  

	 	(A)	signature of the Work Order; and 

  

	 	(B)	the receipt by the Lead Participant of a validly issued tax invoice for the amount due; and 

  
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	 	(ii)	30% of the total cost of the Work Order within 30 days of the later of: 

  

	 	(A)	the receipt by the Lead Participant of a final report that meets the service standards laid out in Part C of Schedule 4; and 

  

	 	(B)	the receipt by the Lead Participant of a validly issued tax invoice for the amount due. 

  

	 	(b)	ICP Firefly acknowledges and agrees that the Lead Participant is not liable for the provision of additional money to meet any expenditure in excess of the Funds or a Participant’s Contribution under the Budget
without the written consent of the Lead Participant. 

  

	 	(c)	ICP Firefly acknowledges and agrees that: 

  

	 	(i)	any amount specified in a Work Order or due to be paid under this clause 5.4 will be reduced in proportion with any reduction in funding under the Funding Agreement; 

 

	 	(ii)	on request of the Lead Participant, ICP Firefly must immediately repay funds received under a Work Order to the extent that such funds correspond with a reduction in funding under the Funding Agreement.

 The Lead Participant will seek to ensure that any reduction of funding will be in accordance with the aims of the Project.

  

	5.5	Separate Project financial accounts 

 Each Participant must keep separate financial
accounts which must record: 
  

	 	(a)	any Contributions it makes; 

  

	 	(b)	any payments of CRC-P Funds made to it by the Lead Participant; 

  

	 	(c)	any payment made in relation to an Asset greater than $300; and 

  

	 	(d)	expenditure incurred by the Participant from CRC-P Funds in carrying out the Project. 

  

	5.6	What CRC-P Funds can be used for 

  

	 	(a)	The Participants must spend the CRC-P Funds only for the purposes of undertaking the Project. 

 

	 	(b)	The Participants must spend the CRC-P Funds only in accordance with the Budget. 

  

	 	(c)	Subject to clause 5.6(d), the Lead Participant may vary the Budget by re-allocating expenditure between heads of expenditure specified in the Budget. 

 

	 	(d)	Any variation under clause 5.6(c) which increases or decreases the amount allocated to a head of expenditure by more than 10% cannot be made without the Commonwealth’s prior written approval. 

 

	5.7	What Funds cannot be used for 

 The Participants must not spend the Funds: 

 

	 	(a)	for capital works or for the purchase or construction of facilities such as buildings or laboratories; 

  

	 	(b)	for renovation or extension of buildings and facilities unless approved by the Commonwealth in writing; 

  

	 	(c)	for any activities for which the Participants have previously been funded, or are currently being funded by the Commonwealth Government or a State or Territory government either directly or indirectly through any other
funding scheme; 

  
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	 	(d)	to reimburse a Participant for the costs associated with existing staff or other resources committed by the Participant to the Project as in-kind contributions under this
Agreement; 

  

	 	(e)	to pay a Participant for the indirect support costs of research in relation to cash-funded Project staff located in their organisation; or 

 

	 	(f)	for the indirect support costs of research conducted overseas. 

  

	5.8	When CRC-P Funds cannot be used 

  

	 	(a)	Without limiting any other right or remedy of the Lead Participant, the Lead Participant may by Notice direct a Participant not to spend CRC-P Funds if the Lead Participant
receives a notice from the Commonwealth under clause 9.3 of the Funding Agreement. 

  

	 	(b)	A Participant must not spend any CRC-P Funds after the Lead Participant issues Notice under clause 5.8(a) unless and until the Commonwealth notifies the Lead Participant otherwise
and the Lead Participant, in turn, notifies the Participant accordingly. 

  

	6.	Repayment 

  

	6.1	Misspent funds 

 The Lead Participant is entitled to recover from a Project Partner any
amount of money which has been spent by that Project Partner which: 
  

	 	(a)	in the Lead Participant’s opinion, was spent other than in accordance with this Agreement; or 

  

	 	(b)	the Commonwealth has recovered from the Lead Participant in accordance with clauses 15.3(h), 10.1 or 10.2 of the Funding Agreement. 

 

	6.2	At the end of the Agreement Period 

 After the end of this Agreement, the Lead
Participant is entitled to recover from the CRC-P Funds any funds which had been paid to a Project Partner in accordance with clause 5.2 and which have not been spent, or legally committed for expenditure by a
Project Partner in accordance with this Agreement and payable by the Participant as a current liability (written evidence of which will be required). 
  

	6.3	Repayment Notice 

  

	 	(a)	The Lead Participant may give a Project Partner a Notice requiring the Project Partner to repay to the Lead Participant (or deal with as specified by the Lead Participant) an amount which the Lead Participant is
entitled to recover under clause 6.1 and 6.2. 

  

	 	(b)	If the Lead Participant gives a Notice under clause 6.3(a), the Project Partner must repay the amount specified in the Notice in full (or deal with it as specified by the Lead Participant) within 30 days of the date of
the Notice. 

  

	6.4	UNSW Reconciliation 

  

	 	(a)	If, following the end of this Agreement for any reason other than breach of the Agreement by UNSW, UNSW has received less than the Expected Funding from the CRC-P Funds during the
Agreement Period, the Lead Participant will: 

  

	 	(i)	issue Notice to UNSW setting out the difference (if any) between the UNSW Paid Amount and the UNSW Committed Amount (Reconciliation Amount) within 30 days of the End Date; and 

  
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	 	(ii)	pay the Reconciliation Amount (if any) to UNSW within 30 days of the issue of the Notice in accordance with clause 6.4(a). 

  

	 	(b)	Any Reconciliation Amount paid by the Lead Participant to UNSW in accordance with this clause 6.4 must not be paid out of any CRC-P Funds. 

 

	7.	GST and R&D Tax Incentive 

  

	7.1	Construction 

 In this clause 7 words and expressions which are not defined in this
Agreement but which have a defined meaning in the GST Law have the same meaning as in the GST Law. 
  

	7.2	Consideration GST exclusive 

 Unless otherwise expressly stated, all prices or other sums
payable or consideration to be provided under this Agreement are exclusive of GST. 
  

	7.3	Payment of GST 

  

	 	(a)	If GST is payable by a supplier on any supply made under this Agreement, the recipient of the supply will pay to the supplier an amount equal to the GST payable on the supply, in addition to and at the same time that
the consideration for the supply is to be provided under this Agreement. 

  

	 	(b)	The Parties acknowledge that they are registered for GST and will notify the other Parties if they cease to be registered for GST. 

  

	7.4	R&D Tax Incentive 

 To assist certain Participants claim the R&D Tax Incentive,
the CRC-P must expend (or allocate) contributions from Participants on (or to) R&D activities, as defined under subdivision 355B section 355-20 of the Income Tax
Assessment Act 1997 (Cth) and maintain records of the date when such expenditure on which R&D activities occurred. 
  

	8.	Confidentiality 

  

	8.1	Prohibition on disclosure 

 Subject to clause 8.3, each Participant must not: 

 

	 	(a)	without the prior written consent of the relevant Participant, disclose that Participant’s Confidential Information to a third party or use such Confidential Information other than for the purpose of the Project;
and 

  

	 	(b)	without the prior written consent of the Commonwealth, disclose any Commonwealth Confidential Information obtained through Project-related activities to a third party or use such Confidential Information other than for
the purpose of the Project. 

  

	8.2	Advisers and third parties 

 The Participants agree that, following a request from the
Commonwealth, each Participant must provide the Lead Participant with a written undertaking from each Participant’s Personnel relating to the use and non-disclosure of the Commonwealth’s Confidential
Information in the form approved by the Commonwealth. 

  
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	8.3	Exceptions to obligations 

 The obligations on each Party under clause 8.1 will not be
taken to have been breached to the extent that Confidential Information of the other Parties or Confidential Information of the Commonwealth: 
  

	 	(a)	is disclosed by a Party to its advisers or employees solely in order to comply with obligations, or to exercise rights, under this Agreement; 

 

	 	(b)	is disclosed to a Party’s internal management personnel, solely to enable effective management or auditing of activities related to this Agreement; 

 

	 	(c)	is required by Law or rules of a financial market on which a Party or a Related Entity of a Party is listed, to be disclosed; 

  

	 	(d)	is disclosed to the Commonwealth for the purposes of the Project, the CRC Programme or as otherwise provided for under the exceptions listed in clause 20.4 of the Funding Agreement; 

 

	 	(e)	is in the public domain otherwise than due to a breach of this Agreement; and 

  

	 	(f)	is independently received from a third party who is free to disclose it. 

  

	8.4	Obligation on disclosure 

 Where a Party discloses Confidential Information of a Party or
Confidential Information of the Commonwealth to another person, pursuant to clauses 8.3(a) or (b), the disclosing party must: 
  

	 	(a)	notify the receiving person that the information is Confidential Information; 

  

	 	(b)	not provide the information unless the receiving person agrees to keep the information confidential; and 

  

	 	(c)	including, in the case of Commonwealth Confidential Information, the receiving person must give the Commonwealth a legally binding undertaking to that effect in the form approved by the Commonwealth. 

 

	8.5	Additional confidential information 

  

	 	(a)	The Parties may agree in writing during the Agreement Period that certain additional information is to constitute Confidential Information for the purposes of this Agreement. 

 

	 	(b)	Where the Parties agree in writing during the Agreement Period that certain additional information is to constitute Confidential Information for the purposes of this Agreement, this documentation is incorporated into,
and becomes Confidential Information under this Agreement, on the date by which both Parties have signed this documentation. 

  

	8.6	Confidential Information in Agreement Material 

 For the avoidance of doubt, for the
purposes of this Agreement: 
  

	 	(a)	all Agreement Material, other than Technical Assay Material, will be the “Confidential Information” of the Lead Participant; 

 

	 	(b)	all Technical Assay Material will be the “Confidential Information” of UNSW; and 

  

	 	(c)	each Party may make use of its own Confidential Information as it sees fit and without restriction under this Agreement. 

  
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	8.7	Period of confidentiality 

 The obligations under this clause 8 continue, notwithstanding
the expiry or termination of this Agreement: 
  

	 	(a)	in relation to an item of information described in item 6 of Schedule 1, for the period set out in that Schedule in respect of that item; and 

 

	 	(b)	in relation to any information which the Parties agree in writing after the date of this Agreement is to constitute Confidential Information for the purposes of this Agreement, for the period agreed by the Parties in
writing in respect of that information. If there is no agreement in writing with respect to period in which certain information is to constitute Confidential Information for the purposes of this Agreement it will be taken that that information is to
constitute Confidential Information in perpetuity until that information is made public other than through a breach of this Agreement or other confidentiality obligation. 

 

	8.8	No reduction in privacy obligations 

 The Participants agree that nothing in this
Agreement derogates from any obligation which any Party may have under the Privacy Act 1988 (Cth) as amended from time to time, in relation to the protection of ‘personal information’ as defined in that Act or information that is
protected by the Census and Statistics Act 1905 (Cth), or any other Law requiring secrecy or confidentiality in dealing with information. 
  

	8.9	Return of information 

  

	 	(a)	Subject to clause 8.9(c), the Participants agree that at the request of the Commonwealth or on the expiry or termination of the Funding Agreement, each Participant must promptly return all of the Commonwealth’s
physical and written records containing Confidential Information, and all documentation relating to that Confidential Information (including copies), to the Commonwealth in a form reasonably requested by the Commonwealth. Alternatively, the
Participants agree that if requested by the Commonwealth, each Participant must destroy such items in the manner specified by the Commonwealth and promptly certify to the Commonwealth in writing that it has done so. 

 

	 	(b)	Subject to clause 8.9(c), at the request of a Participant or on the expiry or termination of this Agreement, each other Participant must promptly return all of the requesting Participant’s Confidential Information,
and all documentation relating to that Confidential Information (including copies). 

  

	 	(c)	A Participant may retain copies of Confidential Information: 

  

	 	(i)	required to comply with Law or the rules of any financial market on which a Participant, or a Related Entity of the Participant, is listed; and/or 

 

	 	(ii)	included in any accounts, notices, agendas, submissions, memoranda, board papers and minutes for the board of the Participant. 

  

	9.	Publication policy 

  

	 	(a)	All Participants recognise and support the desire to Publish and disclose aspects of the Agreement Material that advance scientific knowledge in journals or public meeting presentations. 

  
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	 	(b)	In order for a Project Partner or its Personnel to Publish Novogen Material for any purpose other than reports to the Commonwealth under the Funding Agreement it is accepted that: 

 

	 	(i)	the applicant seeking to Publish will submit the proposed disclosure documents to the Lead Participant at least 30 days before the proposed disclosure date; 

 

	 	(ii)	the Lead Participant will complete its review of the disclosure within the 30-day review period; and 

 

	 	(iii)	if, during the review period, the Lead Participant notifies the applicant that: 

  

	 	(A)	it aims to file patent applications on any inventions disclosed in the documents or register any other intellectual property protections, then the applicant will defer disclosure for up to a total of 90 days from such
Notice being received from the Lead Participant; and 

  

	 	(B)	the Publication includes any reference to the Lead Participant’s Confidential Information, then subject to clause 9(d), the applicant party must remove such Confidential Information from the Publication prior
to Publishing the relevant work. 

  

	 	(c)	In order for a Lead Participant or ICP Firefly or its Personnel to Publish Technical Assay Material for any purpose other than reports to the Commonwealth under the Funding Agreement it is accepted that:

  

	 	(i)	the applicant seeking to Publish will submit the proposed disclosure documents to UNSW at least 30 days before the proposed disclosure date; 

 

	 	(ii)	UNSW will complete its review of the disclosure within the 30-day review period; and 

  

	 	(iii)	If, during the review period, UNSW notifies the applicant that: 

  

	 	(A)	it aims to file patent applications on any inventions disclosed in the documents or register any other intellectual property protections, then the applicant will defer disclosure for up to a total of 90 days from such
Notice being received from UNSW; and 

  

	 	(B)	the Publication includes any reference to UNSW’s Confidential Information, then subject to clause 9(d), the applicant seeking to Publish must remove such Confidential Information from the Publication prior to
Publishing the relevant work. 

  

	 	(d)	If a Student thesis includes Confidential Information, notwithstanding any other provision of this Agreement: 

  

	 	(i)	the thesis may be distributed to the candidate’s examiners, on a confidential basis; and 

  

	 	(ii)	copies of the thesis will be maintained only in the “restricted” section of the library of the educational institution of which the candidate is a student for a period of 12 months from the date of the award
of the degree. 

  

	 	(e)	Any Publication (including any Student Publication) must acknowledge the support of the Commonwealth in accordance with clause 3.9. 

  
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	10.	Protection of personal information 

  

	10.1	Definitions 

 In this clause 10 and Schedule 6: 

 

	 	(a)	the terms ‘agency’, ‘Australian Privacy Principle’ (APPs), ‘APP privacy policy’ and ‘Australian Privacy Principle Code’ (APP code) have the same meaning as they have
in section 6 of the Privacy Act 1988 (Cth) (Privacy Act) , and ‘personal information’, which also has the meaning it has in section 6 of the Privacy Act, means: 

‘information or an opinion about an identified individual, or an individual who is reasonably identifiable whether the information or
opinion is true or not and whether the information or opinion is recorded in a material form or not’. 
  

	 	(b)	‘Privacy Laws’ means all Laws relating to the privacy, confidentiality or use of any information about individuals, including the Privacy Act. 

 

	10.2	Application of this clause 

  

	 	(a)	Where the Participant deals with personal information provided by the Commonwealth for the purpose of completing the Project under this Agreement the terms of Schedule 6 will apply with respect to that personal
information. 

  

	 	(b)	Where the Participant deals with personal information provided for the purpose of completing the Project under this Agreement, other than information provided by the Commonwealth, the terms of clause 10.3 will apply
with respect to that personal information. 

  

	10.3	Personal Information other than Commonwealth provided Personal Information 

  

	 	(a)	Each Party must: 

  

	 	(i)	comply with all Privacy Laws for the collection, storage, use and disclosure of personal information as required in order for the Parties to comply with their obligations under this Agreement; 

 

	 	(ii)	not do anything with any personal information collected by it in connection with this Agreement that will cause any other Party to breach any Privacy Laws; and 

 

	 	(iii)	co-operate with each other Party to resolve any privacy complaint by any person. 

  

	 	(b)	Each Party will be responsible for determining and monitoring its own compliance with all applicable Privacy Laws. 

  

	 	(c)	Each Party will indemnify each other Party for any claims, loss or damage the indemnified party may incur as a result of the indemnifying party’s failure to comply with any obligation under this clause 10.3 or any
requirements under Privacy Laws. 

  

	11.	Insurance 

  

	11.1	Obligation to maintain insurance 

 In connection with the Project, each Participant must
have and maintain: 
  

	 	(a)	workers’ compensation insurance for an amount required by the relevant State or Territory legislation; 

  

	 	(b)	public liability insurance for an adequate amount per claim, or occurrence giving rise to a claim, in respect of activities undertaken under this Agreement (where occurrence means either a single occurrence or a series
of occurrences if these are linked or occur in connection with one another from one original cause, as the case may be); 

  
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	 	(c)	insurance over any Asset acquired pursuant to clause 14 of the Funding Agreement for its full replacement value; and 

  

	 	(d)	any other insurance required by Law or by the Commonwealth (acting reasonably). 

  

	11.2	Certificates of Currency 

 Each Participant must, within 10 Business Days of a request
from the Commonwealth or other Participants, provide a current relevant confirmation of insurance documentation from its insurers or insurance brokers certifying that it has insurance as required by clause 11.1. 

 

	11.3	Self-Insurance or other protection 

 Proof of adequate levels of self-insurance or other
protection by a Party are acceptable as an alternative to the insurances required under clause 11.1. 
  

	12.	Work health and safety 

 Each Participant must: 

 

	 	(a)	ensure the Project is undertaken in a safe manner; 

  

	 	(b)	ensure that their Personnel do not, by act or omission, place the Commonwealth in breach of its obligations under the WHS Laws; and 

  

	 	(c)	ensure that their Personnel, if using or accessing the Commonwealth’s premises or facilities, comply with all reasonable instructions, directions, policies and procedures relating to work health and safety in
operation at those premises or facilities whether specifically drawn to the attention of the Participant or which might reasonably be inferred from the circumstances. 

 

	13.	Conflict of Interest 

  

	13.1	Warranty 

 Each Participant warrants that, to the best of its knowledge after making
diligent inquiry, at the date of signing this Agreement, no conflict of interest exists or is likely to arise in the performance of its obligations under this Agreement. 

 

	13.2	Notification of a conflict of interest 

 If, during the Agreement Period, a conflict of
interest arises, or appears likely to arise, each Participant must: 
  

	 	(a)	notify the Lead Participant or the Commonwealth immediately in writing; 

  

	 	(b)	make full disclosure of all relevant information relating to the conflict; and 

  

	 	(c)	take such steps as the Commonwealth or the Lead Participant requires to resolve or otherwise deal with the conflict. 

  
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	14.	Books and records 

  

	14.1	Participant to keep books and records 

 Each Participant must: 

 

	 	(a)	keep adequate books and records, in accordance with Accounting Standards, in sufficient detail to enable: 

  

	 	(i)	all receipts and payments related to the Project to be identified and reported in accordance with this Agreement; and 

  

	 	(ii)	the amounts payable by the Commonwealth under the Funding Agreement to be determined; and 

  

	 	(b)	retain for a period of seven years after the expiry or termination of this Agreement, all books and records relating to the Project. 

 

	14.2	Reports 

 On or before the last day of each Quarter during the Agreement Period, each
Project Partner must provide to the Lead Participant, an itemised report for the previous Quarter of: 
  

	 	(a)	all money received from the Lead Participant and all expenditure associated with the Project, detailed as against each head of expenditure; 

 

	 	(b)	an overview of any Milestones and Outcomes achieved in that Quarter, and/or an evaluation of progress in achieving upcoming scheduled Milestones; 

 

	 	(c)	a list of any changes to Project Partner structure/ownership/involvement, Agreement Material, key personnel or other matters which could affect compliance with this Agreement; 

 

	 	(d)	a report in respect of that Quarter on the in-kind contributions (staff and non-staff in-kind)
contributed to the Project by the Project Partner; and 

  

	 	(e)	a declaration by the Project Partner certifying the accuracy of the particulars provided under paragraphs (a) to (d), including a statement that the CRC-P Funds have been
expended only for the Project and otherwise in accordance with this Agreement. 

  

	14.3	Costs 

 Each Participant must bear its own costs of complying with this clause 14. 

 

	15.	Monitoring progress 

  

	 	(a)	The Project Partners will provide reasonable assistance and information in relation to the Project in order for the Lead Participant to meet with the Commonwealth to discuss any issues in relation to the Project (at the
times and dates required by the Commonwealth). 

  

	 	(b)	The Project Partners must provide the Lead Participant with all reasonable assistance and information required for the Lead Participant to complete the reports required to be submitted to the Commonwealth in accordance
with the Funding Agreement. 

  

	 	(c)	If the Commonwealth conducts a review of the CRC Project in accordance with the Funding Agreement the Project Partners must provide all reasonable assistance to the Lead Participant for the Lead Participant to respond
to such review, or take any action required pursuant to such review including (where applicable): 

  

	 	(i)	undertaking any evaluation of the: 

  

	 	(A)	performance of the CRC Project; and 

  

	 	(B)	conduct of the Project; 

  
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	 	(ii)	completing surveys, questionnaires and other evaluation procedures related to the performance of the Project Partners, the CRC-P or the Programme; 

 

	 	(iii)	preparation of reports reasonably required by the Commonwealth; and 

  

	 	(iv)	responding to reasonable requests of the Commonwealth and providing information reasonably required by the Commonwealth. 

  

	16.	Participants audit and access 

  

	 	(a)	Each Project Partner must ensure that authorised representatives of the Lead Participant have full access to each of its premises used for the conduct of the Project during ordinary business hours for the purpose of
generally ensuring compliance with the requirements of the Project and this Agreement, provided that the Lead Participant provides at least 5 Business Day’s Notice. Such authorised representatives may examine and copy any books and
records maintained in relation to the performance of the Project conducted at that premises. 

  

	 	(b)	The Lead Participant will allow the authorised representatives of each Project Partner to examine any books and records maintained by the Lead Participant relation to the performance of the Project conducted at its
premises during ordinary business hours provided that the Project Partner provides at least 5 Business Day’s Notice. 

  

	17.	Commonwealth audit and access 

  

	17.1	Right to conduct audits 

 The Participants agree that the Commonwealth, or a
representative of the Commonwealth, may conduct audits relevant to the performance of a Participant’s obligations under this Agreement. Audits may be conducted of: 
  

	 	(a)	the Assets; 

  

	 	(b)	the Participant’s operational practices and procedures as they relate to this Agreement or the Funding Agreement; 

  

	 	(c)	the accuracy of the Participant’s invoices and reports; 

  

	 	(d)	the Participant’s compliance with its confidentiality and privacy obligations under this Agreement; 

  

	 	(e)	Material (including books and records) in the possession of the Participant relevant to the Project or this Agreement; and 

  

	 	(f)	any other matters determined by the Commonwealth to be relevant to the Project or this Agreement. 

  

	17.2	Access by the Commonwealth 

  

	 	(a)	The Participants agree that the Commonwealth, or a representative of the Commonwealth, may, at reasonable times and on giving reasonable Notice to the Participants: 

 

	 	(i)	access the premises of the Participants to the extent relevant to the performance of this Agreement; 

  

	 	(ii)	require the provision by the Participants or its Personnel of records and information in a data format and storage medium accessible by the Commonwealth by use of the Commonwealth’s existing computer hardware and
software; 

  
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	 	(iii)	inspect and copy documentation, books and records, however stored, in the custody or under the control of the Participants or its Personnel; and 

 

	 	(iv)	require assistance in respect of any inquiry into or concerning the Project or this Agreement. For these purposes, an inquiry includes any administrative or statutory review, audit or inquiry (whether within or external
to the Department of Industry, Innovation and Science), any request for information directed to the Commonwealth, and any inquiry conducted by Parliament or any Parliamentary committee. 

 

	 	(b)	The Participants agree that they will provide access to their computer hardware and software to the extent necessary for the Commonwealth to exercise its rights under this clause 17, and provide the Commonwealth with
any reasonable assistance requested by the Commonwealth to use that hardware and software. 

  

	17.3	Auditor-General and the Australian Information Commissioner 

 The Participants agree that
the rights of the Commonwealth under clause 17.2(a)(i) to 17.2(a)(iii) apply equally to the Auditor General or a delegate of the Auditor-General, or the Australian Information Commissioner or a delegate of the Australian Information Commissioner,
for the purpose of performing the Auditor-General’s or Australian Information Commissioner’s statutory functions or powers. 
  

	17.4	Participants to comply with Auditor-General’s requirements 

 Each Participant must
do all things necessary to comply with the Auditor-General’s or his or her delegate’s or the Australian Information Commissioner’s or his or her delegate’s requirements, notified to the Participant under clause 17.2, provided
such requirements are legally enforceable and within the power of the Auditor-General, the Australian Information Commissioner, or his or her respective delegate. 
  

	17.5	No reduction in responsibility 

 The requirement for, and participation in, audits does
not in any way reduce each Participant’s responsibility to perform their obligations in accordance with this Agreement. 
  

	17.6	Subcontractor requirements 

 Each Participant must ensure that any subcontract entered
into for the purpose of this Agreement contains an equivalent clause granting the rights specified in this clause 17. 
  

	17.7	No restriction 

 The Participants agree that nothing in this Agreement reduces, limits or
restricts in any way any function, power, right or entitlement of the Auditor-General or a delegate of the Auditor-General or the Australian Information Commissioner or a delegate of the Office of the Australian Information Commissioner. The
Participants agree that the rights of the Commonwealth under this Agreement are in addition to any other power, right or entitlement of the Auditor-General or a delegate of the Auditor-General or the Australian Information Commissioner or a delegate
of the Australian Information Commissioner. 
  

	17.8	Costs 

 Unless otherwise agreed in writing, the Participants must bear their own costs of
any reviews and/or audits by the Commonwealth. 

  
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	18.	False or misleading information 

 Each Participant: 

 

	 	(a)	acknowledges that giving false or misleading information to the Commonwealth is a serious offence under section 137.1 of the Criminal Code Act 1995 (Criminal Code); and 

 

	 	(b)	must ensure that all of its Personnel engaged in connection with this Agreement acknowledges the information contained in this clause. 

Note: Under section 137 of the Criminal Code giving false or misleading information to a Commonwealth entity is an offence, but only if the
Commonwealth entity took reasonable steps to inform the person of the offence. 
  

	19.	Safe and Ethical Research 

 When research in Australia is conducted on or involving humans or
animals, each Participant will support the CRC-P in meeting its obligations in regards to compliance with safe and ethical research by ensuring that: 

 

	 	(a)	the research complies with, and observes, all relevant ethics codes and guidelines adopted by the National Health and Medical Research Council, the Office of the Gene Technology Regulator and all other relevant
regulatory agencies operating in Australia and any place in which the research is being conducted being codes and guidelines in force from time to time during the Agreement Period, including requirements to obtain prior approval in writing
(including from any relevant ethics committee) that the research to be undertaken is so compliant; 

  

	 	(b)	one or several higher education institution(s), or Commonwealth or State research organisation(s), or medical institution(s) with a relevant ethics committee constituted in accordance with the codes and guidelines
referred to in clause 20(a) is engaged to oversee all ethical clearances which may be required under those codes and guidelines; 

  

	 	(c)	when conducting research in Australia which involves the use of ionising radiation, that persons performing procedures involving ionising radiation are appropriately trained and hold a relevant current licence from the
appropriate State authority; and 

  

	 	(d)	whenever reasonably required by the Lead Participant, a Project Partner will promptly furnish written evidence of compliance with the requirements of this clause 19. 

 

	20.	Responsible conduct of research 

  

	 	(a)	Each Participant must ensure that the research conducted by it conforms to the principles outlined in the following and successor documents: 

 

	 	(i)	the NHMRC/ARC/UA Australian Code for the Responsible Conduct of Research (2007); and 

  

	 	(ii)	if applicable, the NHMRC/ARC/AVCC National Statement on Ethical Conduct in Human Research (2007). 

  

	 	(b)	Each Participant agrees that it will: 

  

	 	(i)	promote the responsible conduct of research; 

  
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	 	(ii)	maintain high standards of responsible research; 

  

	 	(iii)	report research responsibly; 

  

	 	(iv)	respect all research participants; 

  

	 	(v)	respect animals used in research; 

  

	 	(vi)	respect the environment; and 

  

	 	(vii)	report research misconduct. 

  

	 	(c)	Each Participant must have procedures in place for dealing with instances of suspected or alleged research misconduct which are consistent with the codes and guidelines referred to in clause 20(a). 

 

	21.	Survival 

 The following clauses survive the expiry or termination of this Agreement: 

 

	 	(a)	Clause 3.1(h) (General Obligations); 

  

	 	(b)	Clause 3.4 (Subcontract) 

  

	 	(c)	Clause 3.9 (Acknowledgement of support); 

  

	 	(d)	Clause 4 (Intellectual Property Rights); 

  

	 	(e)	Clause 6 (Repayment); 

  

	 	(f)	Clause 8 (Confidentiality); 

  

	 	(g)	Clause 9 (Publication Policy); 

  

	 	(h)	Clause 10 (Protection of personal information); 

  

	 	(i)	Clause 11 (Insurance); 

  

	 	(j)	Clause 14 (Books and records) for a period of seven years from the expiry or termination of the Funding Agreement; 

  

	 	(k)	Clause 16 (Participant Audit and Access) for a period of seven years from expiry or termination of the Funding Agreement; 

  

	 	(l)	Clause 17 (Commonwealth Audit and access) for a period of seven years from the expiry or termination of the Funding Agreement, and 

  

	 	(m)	Clause 24 (Agreement Period and Termination), 

 together with any provision of this Agreement
which expressly or by implication from its nature is intended to survive the expiry or termination of this Agreement. 
  

	22.	Changes to the Agreement 

 No agreement or understanding varying this Agreement shall be legally
binding unless it is signed in writing by all Parties. 
  

	23.	Relationship to the Funding Agreement 

  

	 	(a)	Nothing in this Agreement will reduce or otherwise affect the obligations of the Lead Participant under the Funding Agreement. In the event of any inconsistency between this Agreement and the Funding Agreement, the
Funding Agreement takes precedence. 

  
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	 	(b)	Notwithstanding any other provision of this Agreement, the Parties acknowledge and agree that if any funding is reduced or suspended under the Funding Agreement, any amount payable under this Agreement will be
correspondingly reduced or suspended. 

  

	24.	Agreement Period and Termination 

  

	24.1	Agreement Period 

 This Agreement commences on the Commencement Date and will end on the
later of: 
  

	 	(a)	31st December 2020; or 

  

	 	(b)	the date on which all reporting requirements relating to the Project under the Funding Agreement have been met, 

unless otherwise terminated in accordance with this Agreement. 
  

	24.2	Change of Project Partner 

  

	 	(a)	Subject to clause 24.2(c), the Lead Participant may, acting reasonably, elect to remove from the Project a Project Partner by providing written Notice to that Project Partner, with a copy to all other Project Partners
and the Commonwealth. 

  

	 	(b)	A change of Project Partners is subject to the Lead Participant gaining the Commonwealth’s approval under clause 5.7 of the Funding Agreement. 

 

	 	(c)	The Lead Participant may remove a Project Partner from the Project with immediate effect by written Notice to the Project Partner, if: 

 

	 	(i)	the Project Partner breaches any provision of this Agreement and fails to remedy the breach within 14 days after receiving Notice requiring it to do so; 

 

	 	(ii)	the Project Partner breaches a provision of this Agreement which is not capable of remedy; 

  

	 	(iii)	the Project Partner persistently breaches a provision of this Agreement despite Notice of the breach; 

  

	 	(iv)	in the reasonable opinion of the Lead Participant, the Project Partner is not conducting the Project in a competent and diligent manner; 

 

	 	(v)	the Project Partner fails to notify the Lead Participant of a conflict of interest, or in the opinion of the Lead Participant, a conflict of interest exists which: 

 

	 	(A)	would prevent the Project Partner from performing its obligations under this Agreement; or 

  

	 	(B)	could prejudice the Utilisation of Agreement Material by the Lead Participant. 

  

	 	(vi)	the Lead Participant is unable to obtain Contributions from the Project Partner in accordance with Schedule 3, or obtain them in time to provide for the Outcomes, activities or Milestones as outlined in the Schedule 2;

  

	 	(vii)	the Project Partner rejects the Lead Participant’s reasonable request for a Work Order on 3 or more occasions; 

  
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	 	(viii)	the Project Partner does not comply with a Commonwealth direction, requiring the Project Partner to comply with any obligation owed to the Commonwealth under this Agreement; or 

 

	 	(ix)	an event specified in clause 24.2(d) occurs. 

  

	 	(d)	The Project Partner must notify the Lead Participant immediately if: 

  

	 	(i)	there is any change in the direct or indirect beneficial ownership or control of the Project Partner; 

  

	 	(i)	the Project Partner disposes of the whole or any part of its assets, operations or business other than in the ordinary course of business; 

 

	 	(ii)	the Project Partner ceases to carry on business; 

  

	 	(iii)	the Project Partner ceases to be able to pay its debts as they become due; 

  

	 	(iv)	proceedings are initiated with a view to obtaining an order for the winding up of the Project Partner, or any person convenes a meeting for the purpose of considering or passing any resolution for the winding up of the
Project Partner; 

  

	 	(v)	the Project Partner applies to come under, the Project Partner receives a notice requiring it to show cause why it should not come under, an order has been made for the purpose of placing the Project Partner under, or
the Project Partner otherwise comes under one of the forms of external administration referred to in Chapter 5 of the Corporations Act 2001 (Cth) or Chapter 11 of the Corporations (Aboriginal and Torres Strait Islander) Act 2006 (Cth)
or equivalent provisions in State or Territory legislation in relation to incorporated associations; 

  

	 	(vi)	the Project Partner being a natural person is declared bankrupt or assigns his or her estate for the benefit of creditors; 

  

	 	(vii)	where the Project Partner is a partnership, any step is taken to dissolve that partnership; or 

  

	 	(viii)	anything analogous to an event referred to in clause 24.2(d)(iv) – (vii) occurs in relation to the Project Partner. 

  

	24.3	Withdrawal of a Project Partner from the Agreement 

  

	 	(a)	A Project Partner may, acting reasonably, submit a request to withdraw from the Agreement by providing written Notice to the Lead Participant, with a copy to all other Project Partners and the Commonwealth if:

  

	 	(i)	the Lead Participant or other Project Partner is in material breach of this Agreement, and such breach has not been rectified within 30 days of Notice of the breach or the breach is incapable of remedy;

  

	 	(ii)	an event referred to in clause 24.2(d)(iii) – (viii) occurs in relation to the Project Partner; 

  

	 	(iii)	the Lead Participant: 

  

	 	(A)	ceases to carry on business; or 

  

	 	(B)	ceases to be able to pay its debts as they become due; 

  

	 	(iv)	proceedings are initiated with a view to obtaining an order for the winding up of the Lead Participant, or any person convenes a meeting for the purpose of considering or passing any resolution for the winding up of the
Lead Participant; or 

  
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	 	(v)	the Lead Participant applies to come under, or receives a notice requiring it to show cause why it should not come under, an order has been made for the purpose of placing the Lead Participant under, or the Lead
Participant otherwise comes under one of the forms of external administration referred to in Chapter 5 of the Corporations Act 2001 (Cth) or Chapter 11 of the Corporations (Aboriginal and Torres Strait Islander) Act 2006 (Cth) or equivalent
provisions in State or Territory legislation in relation to incorporated associations. 

  

	 	(b)	If a Project Partner requests withdrawal in accordance with clause 24.3(a), the Lead Participant must apply to the Commonwealth for the Project Partner to be removed in accordance with clause 5.7 the Funding Agreement.

  

	 	(c)	If the Commonwealth agrees to remove the Project Partner in accordance with clause 5.7 the Funding Agreement, the Lead Participant will give Notice to the Project Partners, and the relevant Project Partner will be
automatically removed. 

  

	24.4	Consequences of removal of a Project Partner 

  

	 	(a)	If a Project Partner is removed from the Project pursuant to clause 24.2 or 24.3, this Agreement will continue as between the Lead Participant and remaining Project Partner. 

 

	 	(b)	If a Project Partner is removed from the Project pursuant to clause 24.2 or 24.3, it: 

  

	 	(i)	is not entitled to reimbursement of any costs incurred as a result of removal; 

  

	 	(ii)	must assign its share of ownership of the Agreement Material and all Intellectual Property Rights in such material in accordance with Schedule 5 or as otherwise agreed in writing by the Participants; and

  

	 	(iii)	grants to the other Participants and Commonwealth a world-wide, irrevocable, perpetual royalty–free non-exclusive licence (including the right to sublicense) to use,
reproduce, adapt, modify and communicate any of its Pre-existing Material or Third Party Material provided for the purpose of the Project subject to any limitations provided in clause 4.1(h) and (i);

  

	 	(c)	Removal will not affect the enforceability of any rights or obligations accrued under this Agreement which survive termination. 

  

	 	(d)	From the date of removal, the Lead Participant will cease to be liable to pay or provide to the removed Project Partner any monies due under this Agreement, except to the extent those monies have been legally committed
for expenditure by the Project Partner in accordance with this Agreement and are payable by the Project Partner as a current liability (written evidence of which will be required) before the date on which the Project Partner receives Notice of the
removal. 

  

	 	(e)	From the date of removal, the removed Project Partner will cease to be liable to make any Contribution to the Project scheduled to be made after the removal date. 

 

	 	(f)	From the date of removal, the Lead Participant is entitled to recover from the removed Project Partners any CRC-P Funds provided by the Lead Participant to a Project Partner which
have not been spent, or legally committed for expenditure by the Project Partner in accordance with this Agreement and payable by the Project Partner as a current liability (written evidence of which will be required) by the date the Project Partner
receives the Notice of termination; and 

  
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	24.5	Termination of this Agreement for default 

 The Lead Participant may terminate this
Agreement with immediate effect by written Notice to the other Project Partners if any of the events detailed in clauses 24.2(c)(i) to (viii) occur. 
  

	24.6	Termination by Notice 

 The Lead Participant may terminate this Agreement with immediate
effect by written Notice where the Commonwealth terminates the Funding Agreement. 
  

	24.7	Suspension 

 If the Commonwealth suspends payment of the Funds in accordance with the
Funding Agreement, the Parties must continue to comply with the terms of this Agreement. 
  

	24.8	Consequences of termination– Intellectual Property 

 If the Lead Participant
terminates this Agreement under clause 24.5 or 24.6, all Participants must assign their share of ownership of the Agreement Material and all Intellectual Property Rights in such material in accordance with Schedule 5. 

 

	24.9	Other consequences of termination 

 If the Lead Participant terminates this Agreement
under clause 24.5 or 24.6: 
  

	 	(a)	termination will not affect the enforceability of any rights or obligations accrued under this Agreement which survive termination; 

  

	 	(b)	the Lead Participant is not obliged to pay to the Project Partners any outstanding amount of the monies due under this Agreement, except to the extent that those monies have been legally committed for expenditure by the
Project Partner in accordance with this Agreement and payable by the Project Partner as a current liability (written evidence of which will be required) by the date the Project Partner receives the Notice of termination; 

 

	 	(c)	as of the date the Project Partners receive the Notice of termination, the Participants will cease to be liable to make further Contributions to the Project; and 

 

	 	(d)	the Lead Participant is entitled to recover from Project Partners any CRC-P Funds provided by the Lead Participant to a Project Partner which have not been spent, or legally
committed for expenditure by the Project Partner in accordance with this Agreement and payable by the Project Partner as a current liability (written evidence of which will be required), by the date the Project Partner receives the Notice of
termination. 

  

	25.	Liability and Indemnity 

  

	25.1	Indemnity 

 Each Project Partner will at all times indemnify, hold harmless and defend
the Lead Participant, its officers and employees (referred to in this clause 25 as “those indemnified”) from and against any loss or liability, including: 
  

	 	(a)	loss arising from loss of, or damage to, property of the Commonwealth; 

  

	 	(b)	claims by any person in respect of personal injury or death; 

  

	 	(c)	claims by any person in respect of loss of, or damage to, any property; and 

  

	 	(d)	costs and expenses including the costs of defending or settling any claim referred to in clause 25.1(b) or clause 25.1(c), 

  
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	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 35	 

 arising out of or as a consequence of the Project Participant’s (or its Personnel’s):

  

	 	(a)	use or disposal of Assets; 

  

	 	(b)	infringement, or alleged infringement, of the Intellectual Property Rights of any person; 

  

	 	(c)	actual, likely or threatened breach of its obligations relating to Confidential Information or personal information; or 

  

	 	(d)	without limiting the preceding paragraphs, breach of this Agreement, or negligence or wrongful or unlawful act or omission. 

The Project Partner’s liability to indemnify those indemnified under clause 25 will be reduced proportionally to the extent that any
negligent act or omission of those indemnified contributed to the loss. 
  

	25.2	Consequential loss 

 The Lead Participant is not liable to any Project Partner or to any
other person for any indirect, incidental, special or consequential loss or damage, loss of profits or anticipated profits, economic loss, loss of business opportunity, loss of data or loss or damage resulting from wasted management time
irrespective of whether: 
  

	 	(a)	the loss or damage is caused by or relates to breach of contract, statute, tort (including negligence) or otherwise; or 

  

	 	(b)	the Parties or any other person previously were notified of the possibility of the loss or damage. 

  

	25.3	Maximum liability 

 The Lead Participant’s maximum liability under this Agreement
will be capped at an aggregate of XXXX. 
  

	26.	Dispute resolution 

  

	26.1	No arbitration or court proceedings 

 If a dispute arises in relation to the conduct of
this Agreement (Dispute), a Party must comply with this clause 26 before starting arbitration or court proceedings except proceedings for urgent interlocutory relief. After a Party has sought or obtained any urgent interlocutory relief, that
Party must follow this clause 26. 
  

	26.2	Notification 

 A Party claiming a Dispute has arisen must give the other Parties to the
Dispute Notice setting out details of the Dispute. 
  

	26.3	Parties to resolve Dispute 

 During the 14 days after a Notice is given under clause 26.2
(or longer period if the parties to the Dispute agree in writing), each party to the Dispute must use its reasonable efforts through a meeting of CEOs (or their nominees) to resolve the Dispute. If the parties cannot resolve the Dispute within that
period, they must refer the Dispute to a mediator if one of them requests. 
  

	26.4	Appointment of mediator 

 If the parties to the Dispute cannot agree on a mediator within
seven days after a request under clause 26.3, the chairperson of the Resolution Institute or the chairperson’s nominee will appoint a mediator. 

  
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	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 36	 

	26.5	Role of mediator and obligations of parties 

 The role of a mediator is to assist in
negotiating a resolution of the Dispute. A mediator may not make a binding decision on a party to the Dispute except if the party agrees in writing. Unless agreed by the mediator and parties, the mediation must be held within 21 days of the request
for mediation in clause 26.3. The parties must attend the mediation and act in good faith to genuinely attempt to resolve the Dispute. 
  

	26.6	Confidentiality 

 Any information or documents disclosed by a party under this clause 26:

  

	 	(a)	must be kept confidential; and 

  

	 	(b)	may only be used to attempt to resolve the Dispute. 

  

	26.7	Costs 

 Each party to a Dispute must pay its own costs of complying with this clause 26.
The parties to the Dispute must equally pay the costs of any mediator. 
  

	26.8	Termination of process 

 A Party to a Dispute may terminate any mediation process
commenced under this clause 26 by giving Notice to each other party provided it has otherwise complied with this clause 26. Clauses 26.6 and 26.7 survive termination of the mediation process. 

 

	27.	Notices and other communications 

  

	27.1	Service of Notices 

 A Notice must be: 

 

	 	(a)	in writing, in English and signed by a person duly authorised by the sender; and 

  

	 	(b)	hand delivered or sent by prepaid post or by electronic means (facsimile or email) to the Participant address for Notices specified in item 8 of Schedule 1, as varied by any Notice given by the Participant.

  

	27.2	Effective on receipt 

 A Notice given in accordance with clause 27.1 takes effect when it
is taken to be received (or at a later time specified in it), and is taken to be received: 
  

	 	(a)	if hand delivered, on delivery; 

  

	 	(b)	if sent by prepaid post, on the second Business Day after the date of posting (or on the seventh Business Day after the date of posting if posted to or from a place outside Australia); 

 

	 	(c)	if sent by facsimile, when the sender’s facsimile system generates a message confirming successful transmission of the entire Notice unless, within eight ordinary business hours after the transmission, the
recipient informs the sender that it has not received the entire Notice; or 

  

	 	(d)	if sent by email, as provided under sections 14 and 14A of the Electronic Transactions Act 1999 (Cth), 

but if the delivery, receipt or transmission is not on a Business Day or is after 5.00 pm on a Business Day, the Notice is taken to be received
at 9.00am on the next Business Day. 

  
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	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 37	 

	28.	Miscellaneous 

  

	28.1	No security 

 A Participant must not use any of the following as any form of security for
the purpose of obtaining or complying with any form of loan, credit, payment or other interest, or for the preparation of, or in the course of any litigation: 
  

	 	(a)	the CRC-P Funds; or 

  

	 	(b)	any Assets or Agreement Material. 

  

	28.2	Nature of obligations 

  

	 	(a)	Any provision in this Agreement which binds more than one person binds all each of those persons severally and does not bind them jointly. 

 

	 	(b)	Each obligation imposed on a Party by this Agreement in favour of another is a separate obligation. 

  

	28.3	No adverse construction 

 This Agreement, and any provision of this Agreement, is not to
be construed to the disadvantage of a party because that party was responsible for its preparation. 
  

	28.4	Approvals and consents 

 Except where this Agreement expressly states otherwise, a Party
may, in its discretion, give conditionally or unconditionally or withhold any approval or consent under this Agreement. 
  

	28.5	Assignment and novation 

 A Party may only assign its rights or novate its rights and
obligations under this Agreement with the prior written consent of the other party. 
  

	28.6	Costs 

 Each Party must pay its own costs of negotiating, preparing and executing this
Agreement. 
  

	28.7	Counterparts 

 This Agreement may be executed in counterparts. All executed counterparts
constitute one document. 
  

	28.8	No merger 

 The rights and obligations of the parties under this Agreement do not merge
on completion of any transaction contemplated by this Agreement. 
  

	28.9	Entire agreement 

 This Agreement constitutes the entire agreement between the Parties in
connection with its subject matter and supersedes all previous agreements or understandings between the Parties in connection with its subject matter. 
  

	28.10	Further action 

 Each Party must do, at its own expense, everything reasonably necessary
(including executing documents) to give full effect to this Agreement and any transaction contemplated by it. 
  

	28.11	Severability 

 A term or part of a term of this Agreement that is illegal or
unenforceable may be severed from this Agreement and the remaining terms or parts of the terms of this Agreement continue in force. 

  
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	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 38	 

	28.12	Waiver 

 Waiver of any provision of or right under this Agreement: 

 

	 	(a)	must be in writing signed by the Party entitled to the benefit of that provision or right; and 

  

	 	(b)	is effective only to the extent set out in any written waiver. 

 A waiver of a breach does not
operate as a waiver of any other breach. 
  

	28.13	Governing law and jurisdiction 

 This Agreement is governed by the law of the Australian
Capital Territory and each party irrevocably and unconditionally submits to the non-exclusive jurisdiction of the courts of the Australian Capital Territory. 

  
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	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 39	 

 Schedule 1 – CRC-P Details 

 
  

							
	 Item 

number
	  	Issue	  	Clause
Reference	  	 Details

	 1.
	  	Project Title	  	Background A	  	Targeting Tropomyosin as a Novel Anti-Cancer Therapy
				
	 2.
	  	Guidelines	  	1 and 3.1	  	The Cooperative Research Centres Programme Guidelines, and any related documentation developed to assist the management and administration of the CRC Programme, issued by the Commonwealth and as amended from time to time.
				
	 3.
	  	Pre-existing
Material	  	1 and 4.1	  	 Lead Participant pre-existing material

 
 All pre-existing data generated by the Lead
Participant’s sponsored research in pursuit of tropomyosin binding compounds that are relevant to the aims of the Project.
  

All other techniques, know-how, software and materials (regardless of the form or medium in which they are disclosed or
stored) that are provided by or on behalf of the Lead Participant for use in the Project.
  

Participant UNSW pre-existing material

 
 All techniques, know-how, software and materials
(regardless of the form or medium in which they are disclosed or stored) that are provided by or on behalf of UNSW for use in the Project.
  

Participant ICP Firefly pre-existing material

 
 All techniques, know-how, software and materials
(regardless of the form or medium in which they are disclosed or stored) that are provided by or on behalf of ICP Firefly for use in the Project.

				
	 4.
	  	Third Party
Material	  	1 and 4.1	  	None
				
	 5.
	  	Intellectual
 Property/Agreement
Material
	  	1 and 4.1	  	IP arrangements and Utilisation of Agreement Material are detailed in Schedule 5.
				
	 6.
	  	Confidential
Information	  	1 and 8	  	 Lead Participant’s Confidential Information
  

1.      The Participants Agreement (period of time: in
perpetuity);

  
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	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 40	 

							
		  		  		  	 2.      the Lead Participant’s
Pre-existing Material; and
  

3.      All Novogen Material and reports required to be provided to the Commonwealth
under
          the Funding Agreement.

 
 For the Novogen Material and Pre-existing
Material, the period of confidentiality persists until: (1) notified by the Lead Participant that the contents therein have sufficient intellectual property protection to ensure that disclosure could offer no detriment to commercial gain, or
(2) notified by the Lead Participant that the contents therein are no longer subject to confidentiality because of prior disclosures or discontinuance of work on the subject matter; or (3) the information is otherwise publically available
other than through breach of this Agreement or other confidentiality obligation.
  

UNSW’s Confidential Information
  

1.      UNSW’s Pre-existing Material;

 
 2.      the
Technical Assays Material; and
  
 For the Technical Assays Material and Pre-existing Material, the period of confidentiality persists until: (1) notified by UNSW that the contents therein have sufficient intellectual property protection to ensure that disclosure could offer no
detriment to commercial gain; or (2) notified by UNSW that the contents therein are no longer subject to confidentiality because of prior disclosures or discontinuance of work on the subject matter; or (3) the information is otherwise
publically available other than through breach of this Agreement or other confidentiality obligation.
  

ICP Firefly Confidential Information
  

1.      ICP Firefly’s Pre-existing
Material
  
 For Pre-existing Material, the
period of confidentiality persists until: (1) notified by ICP Firefly that the contents therein have sufficient intellectual property protection to ensure that disclosure could offer no detriment to commercial gain; or (2) notified by ICP
Firefly that the contents therein are no longer subject to confidentiality because of prior disclosures or discontinuance of work on the subject matter; or (3) the information is otherwise publically available other than through breach of this
Agreement or other confidentiality obligation.

  
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	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 41	 

							
	7.	  	Specified
Personnel	  	Clause 1.1, 3.5	  	 Novogen
  

Dr S Palmer Program Director 0.8xFTE
 Dr J Hook UNSW Research
Officer 1.0xFTE
  
 ICP Firefly

 
 Dr I Meyer-Carrive 0.1xFTE

 
 UNSW Australia

 
 Prof. P Gunning 0.1xFTE

				
	8.	  	Notice details	  	Clause 27	  	 Novogen:
  

Dr Stephen Palmer
 Program Director

Novogen Ltd
  

PO BOX 2333
 Hornsby Westfield

Hornsby NSW 1635
  

Suite 502
 20 George Street

Hornsby NSW 2077
  

Email: stephen.palmer@novogen.com
  

UNSW:
  

Professor Peter Gunning
 Head of School

School of Medical Sciences
 Wallace Wurth East

University of New South Wales
 Kensington NSW 2052

Email: p.gunning@unsw.edu.au
  

ICP Firefly:
  

Dr Isabelle Meyer-Carrive
 Managing Director/CEO

129 Queen Street
 Beaconsfield NSW 2015

Email: isabelle@icpfirefly.com.au

  
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	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 42	 

 Schedule 2 – Project Details 

 
  

	1.	Project Overview, Outcomes and impacts (clause 1 and 3.1) 

 Cancer therapies have a global market value of
$50bn/year, growing 6%/annum with constant demand for new treatments. This project aims to provide improved chemotherapy for advanced metastatic disease through an Australian innovation to selectively destroy cancer cells using anti-tropomyosin
(ATM) drugs. Prototype ATMs have demonstrated proof of concept in model systems but CRC-P investment is needed to perfect this technology and create a clinical product with high commercial value. The key
activities include protein structure research and computer-aided modelling of the target protein, manufacture and screening of compounds designed to fit and to disrupt the function of the target protein, refinement of pharmaceutic properties and
drug delivery methods, advancement to screening and testing in animal models of cancer to demonstrate evidence of efficacy and completion of all of the standard toxicology tests required for submission of an Investigational New Drug (IND)
application to the FDA. The project outcomes will be a novel anti-cancer drug with a scalable manufacturing strategy, an established delivery route, an understanding of which cancer types are most susceptible to this drug (influencing clinical
strategy) and a comprehensive portfolio of preclinical evidence supporting treatment of advanced metastatic disease. At project end, the drug will have all of the regulatory compliance data required for entry into clinical trials, with the aim of
establishing clinical efficacy within a further 3 years (end of phase II) allowing subsequent licensing deals with multinational pharmaceutical companies to advance the product through phase III and on to market approval. 

 

	2.	Project activities 

 Tropomyosin proteins are divided into a diverse array of isoforms. For reasons that are not
fully understood, but may relate to high turnover properties, cancer cells selectively develop a strong bias towards expression of the low molecular weight tropomyosin isoform Tpm3.1, on which they become dependent for survival. This provides a
selective target for a novel form of anti-cancer treatment. All tropomyosins first form dimers and then assemble on the actin core through head-to-tail interactions.
This interaction domain is a site of vulnerability that we will target by drug interference. Professor William Lehman (Boston University) is a world expert in the ultrastructure of the actin-tropomyosin polymer and will use combinations of protein
structure research (e.g. X-ray crystallography) and computer-aided molecular analysis to develop a sophisticated model of the target site. Our Novogen chemistry experts will design libraries of organic
molecules predicted to fit the target site and disrupt its normal function. These libraries will enter a screening cascade that begins with basic cell culture screens to determine the relative potential efficacy of each compound. At UNSW, high
throughput screening and high-content microscopy systems will be used to test; (1) compound potency against multiple independent adult cancer cell lines, (2) on-target impact on microfilament
depolymerisation using detection of actin filaments and computer-aided analysis, (3) potency of synergistic effects with a variety of pre-existing anti-cancer drugs to determine the potential utility of
combination therapy and the potential to overcome resistance mechanisms. Flexible investigative studies will also be conducted to determine the binding dynamics and specificity of the compounds using functional biochemistry in cell-free systems. A
selection of the top performing compounds will be submitted for in vitro predictive absorption, distribution, metabolism, excretion and toxicology (ADMET) analysis. All of these data will be collated for quantitative structure activity relationship
(QSAR) analysis for further rounds of modelling, drug design, synthesis and screening. These cycles will continue until the structure is maximally refined to meet the expectations of the target product profile. Overlapping studies will advance
selected lead candidates to preclinical formulation studies, efficacy testing in simple in vivo cancer models, drug delivery route analysis and maximum tolerated dosage analysis (at ICP Firefly). More sophisticated analyses of effects on tumour
growth and metastasis will follow, using specialised cell lines that allow whole body imaging of cancer progression and animal cancer models that are based on patient-derived explants and orthotopic tumour development. During the final stage, a lead
drug product will be selected from the top performing compounds and manufactured to GLP standards to undergo the battery of in vivo toxicity compliance testing necessary to support an IND application to the FDA. 

  
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	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 43	 

	3.	Milestones (clause 1 and 3.1) 

  

							
	 No.
	  	 Milestone
	  	 Start Date
	  	 End Date

				
	1.	  	Project Milestone Title	  	1st March 2017	  	31st August 2018
		  	Anti-tropomyosin compound libraries designed and synthesized.	  	  
		  	  
 Description
	  	  
		  	 By end date: a broad library of molecules that bind to tropomyosin 3.1 with specificity and the ability to disrupt its function in cells will
be completed. The process is cyclical—feedback from the parallel in vitro screens (Milestone 2) will improve modelling and design, allowing refinement of the activity and pharmaceutical properties.

 
 Methods: Protein structural research and computer-aided modelling (Boston University)
will dictate design of the new chemical entities (Novogen chemists), which will be manufactured by contract chemists with a strong existing Novogen relationship (GVK Hyderabad).
	  	  
				
	2.	  	Project Milestone Title	  	1st March 2017	  	28th February 2019
		  	Compound library in vitro screens completed	  	  
		  	  
 Description
	  	  
		  	 By end date: a set of lead candidate compounds (5-10) from within the chemical library generated
(Milestone 1) will have been selected, that have the most favourable (1) specificity (2) potency (3) synergy (4) pharmaceutic properties, with respect to the target product profile. This will permit advancement to the in vivo screens
(Milestone 3).
  
 Methods: High-content screens using cultured cancer cell lines (UNSW)
will be used to assess impact of drugs on actin microfilaments, cell killing potency and synergy with pre-existing anti-cancer drugs. Cell-free systems will be used to assess protein binding dynamics and
specificity (UNSW). A subset of the better-performing compounds will be screened for drug-like properties such as solubility, absorption, metabolism and cell toxicity (GVK Hyderabad).
	  	  

  
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	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 44	 

							
				
	3.	  	Project Milestone Title	  	1st March 2018	  	28th February 2019
		  	In vivo screens of lead candidates completed and single lead compound selected	  	  
		  	  
 Description
	  	  
		  	 By end date: a single lead compound from the (5-10) lead candidate molecules will have been selected
based on detailed evidence of compound efficacy in rodent models of cancer and the study of compound side-effects and pharmacokinetics in animals.
  

Methods: Mice with engrafted cancer cell lines or patient-derived tumours will be treated with lead candidates either alone or in combination with synergising
compounds identified in the in vitro screens (I C P - Firefly). Delivery routes, behaviour (pharmacokinetics) of the drugs and potential toxicities will be carefully monitored in rodents (I C P - Firefly). Some detailed analyses will investigate the
biology of compound impact using more sophisticated analytical techniques (UNSW). A variety of in vitro and vivo techniques will explore the mechanisms of action for synergism, the types of cancer that are most susceptible to the novel therapy and
the response of cell lines that are resistant to other forms of treatment, in order to develop a detailed strategy for entry into clinical trials and beyond (UNSW & Others).
	  	  
				
	4.	  	Project Milestone Title	  	1st March 2019	  	29th February 2020
		  	IND-enabling studies completed in readiness for clinical trials	  	  
		  	  
 Description
	  	  
		  	 By end date: all of the regulatory compliance studies required by the FDA for investigational new drug (IND) application will have been
completed in order to begin progression to clinical trials.
  
 Methods: The lead
compound will be manufactured to GLP standard for use in a battery of QA in vitro and in vivo tests, plus information on drug formulation, delivery route (preferably oral) and pharmacokinetic performance. Most tests performed by I C P - Firefly but
some specialist tests (e.g. cardiotoxicity and genotoxicity) performed at overseas centres.
	  	  

  
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	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 45	 

							
				
	5.	  	Project Milestone Title	  	1st March 2017	  	29th February 2020
		  	CRC-P students enrolled and CRC-P staff employed and trained	  	  
		  	  
 Description
	  	  
		  	 By end date: 1 PhD student will have been recruited, enrolled and will have completed greater than 50% of their benchwork for award of
their degree. At least 2 honours students will either have completed their degrees or will have been recruited to the program for thesis submission in late 2020. At least 2 members of staff, funded by the
CRC-P, will have been recruited to the program and trained to perform their required function within the project.
  

Methods: Search for recruitment of a competent PhD student will begin on the start date.

Supervision will be by members of the in-kind CRC-P team at UNSW and Novogen,
and internal UNSW PhD review procedures will ensure adequate progress of the student. Medical research PhDs are typically 3.5-4yrs in duration. Regardless of the PhD enrolment date, Novogen will continue to
support the PhD student beyond the life of the grant until thesis submission. Two honours students will be recruited sequentially to avoid overcommitment to teaching. The honours period of study is usually March-October of each year, which precludes
the possibility of recruitment in 2017. Ideally, the first honours student will be in 2018 and the second in 2019. Novogen will support any enrolments that overrun the life of the grant until thesis submission. At least 2 members of staff will be
recruited to the project as soon as practicable after execution of the Funding Agreement, sited primarily at UNSW and at Novogen, and will be trained by skilled members of the existing workforce to perform their required duties.
	  		  	
				
	6.	  	Completion of the Project	  		  	29th February 2020

  
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	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 46	 

	4.	Participant Expectations of the CRC-P (clause 2(b)) 

  

			
	 Item
	  	 Product / Service / Access

		
	1.	  	Draft copies of all reports prepared by the Lead Participant as part of its obligations to the Commonwealth will be circulated to all Participants for review prior to submission and final copies will be circulated after
submission.
		
	2.	  	The Lead Participant will initially organise regular individual meetings with the Participants to organise and plan Project work. At later stages of the Project, larger meetings involving all Participants may replace or add to these
meetings.
		
	3.	  	The Lead Participant will make every effort to assist the Participants in any internal or external regulatory compliance duties that arise as a consequence of the Project, including the preparation of documentation and appearance at
any meetings or hearings.
		
	4.	  	UNSW will provide reasonable building access to nominated Lead Participant staff in order for them to perform their responsibilities at UNSW.
		
	5.	  	UNSW will provide secure access to the sections of the UNSW servers storing the Agreement Material and allow the Lead Participant to make copies of the Agreement Material generated by UNSW on an ongoing basis.
		
	6.	  	UNSW will maintain conjoint appointment status for nominated Lead Participant staff in order for them to conduct Student supervision duties at UNSW.

  
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	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 47	 

 Schedule 3 – Contributions and Budget 

 
  

	1.	Participant Contributions (clause 1, 2(a) and 3.1) 

  

																					
	 Recipient/Lead Participant: Novogen Limited
	  

						
	 Contribution type
	  	2016-17	 	  	2017-18	 	  	2018-19	 	  	2019-20	 	  	Total	 
	 Cash
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	$	1,000,000	 
	 FTE
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
	 FTE value
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
	 Non-staff
in-kind
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 
	 Total value of contributions
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 
		
	 Participant:
	  	 	I C P - Firefly Pty Limited	 
						
	 Contribution type
	  	2016-17	 	  	2017-18	 	  	2018-19	 	  	2019-20	 	  	Total	 
	 Cash
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
	 FTE
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
	 FTE value
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
	 Non-staff
in-kind
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 
	 Total value of contributions
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 
		
	 Participant:
	  	 	University of New South Wales	 
						
	 Contribution type
	  	2016-17	 	  	2017-18	 	  	2018-19	 	  	2019-20	 	  	Total	 
	 Cash
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	$	300,000	 
	 FTE
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
	 FTE value
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
	 Non-staff
in-kind
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 
	 Total value of contributions
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 
	
	 TOTAL PARTICIPANT CONTRIBUTIONS
	  

						
	 Contribution type
	  	2016-17	 	  	2017-18	 	  	2018-19	 	  	2019-20	 	  	Total	 
	 Cash
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
	 FTE
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
	 FTE value
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
	 Non-staff
in-kind
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 
	 Total value of contributions
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 48	 

 Note: FTE = Full-Time Equivalent as it relates to staff in-kind
contributions. FTE Value is calculated by multiplying the FTE value by XXXX. 
  

	2.	Budget 

  

																					
	 Heads of expenditure
	  	2016-17	 	  	2017-18	 	  	2018-19	 	  	2019-20	 	  	Total	 
	 Employee
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
	 Supplier
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
	 Capital
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
	 Other
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 
	 Total expenditure
	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 	  	 	XXXXX	 
		  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 	  	  
	  
	 

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 49	 

	3.	Schedule of quarterly payments to UNSW from CRC-P account 

  

															
	 Year
	  	 Quarter
	    	Instalment
(excl. GST)	 	    	GST
component	 	    	Total
(incl. GST)	 
	 2016-17
	  	Jan-Mar (Q3)	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  	Apr-Jun (Q4)	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  		    	  
	  
	 	    	  
	  
	 	    	  
	  
	 
		  	Total for 2016-17	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  		    	  
	  
	 	    	  
	  
	 	    	  
	  
	 
					
	 2017-18
	  	Jul-Sep (Q1)	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  	Oct-Dec (Q2)	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  	Jan-Mar (Q3)	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  	Apr-Jun (Q4)	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  		    	  
	  
	 	    	  
	  
	 	    	  
	  
	 
		  	Total for 2017-18	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  		    	  
	  
	 	    	  
	  
	 	    	  
	  
	 
					
	 2018-19
	  	Jul-Sep (Q1)	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  	Oct-Dec (Q2)	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  	Jan-Mar (Q3)	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  	Apr-Jun (Q4)	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  		    	  
	  
	 	    	  
	  
	 	    	  
	  
	 
		  	Total for 2018-19	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  		    	  
	  
	 	    	  
	  
	 	    	  
	  
	 
					
	 2019-20
	  	Jul-Sep (Q1)	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  	Oct-Dec (Q2)	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  	Jan-Mar (Q3)	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  		    	  
	  
	 	    	  
	  
	 	    	  
	  
	 
		  	Total for 2019-20	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  		    	  
	  
	 	    	  
	  
	 	    	  
	  
	 
	 Total
	  	Total for all years	    	 	XXXXX	 	    	 	XXXXX	 	    	 	XXXXX	 
		  		    	  
	  
	 	    	  
	  
	 	    	  
	  
	 

 Note: These payments are intended as the regular reserve to support ongoing salary payments, student stipends, materials,
consumables and all other regular costs and are made to allow UNSW to know future income and make budget projections. Additional payments and adjustments can be made for additional items or specific
sub-projects by the development of separate Work Orders (Clause 3.3) through negotiation with the Lead Participant. 
  

	4.	Payments to I C P Firefly 

 Given the nature of the work planned by I C P Firefly, which is divided into a
series of individual sub-projects, each sub-project will be negotiated, itemized, costed and set out in individual agreements as Work Orders in accordance with clause
3.3 and clause 5.4. 

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 50	 

 Schedule 4 – Services 

 
 PART A - Lead Participant Services 

 

			
	 Service
	  	 Applicable service standard (if any)

	In-kind contributions, staff and non-staff, according to Schedule 3	  	To a quantity and quality commensurate with monetary value (Schedule 3) and reasonable expectations for fulfilment of the Project according to Budget, Milestones and other service standards (Schedule 4).
		
	Protein modelling, molecular design and design of chemical synthesis strategy	  	Acceptable for Composition of Matter patent applications
		
	Under subcontract: modelling and molecular design verification and analysis at Boston University	  	Acceptable for publication in peer reviewed journals
		
	Under subcontract: compound synthesis, initial cytotoxicity screening and shipping to other participants	  	R&D grade compounds for all in vitro and early preclinical in vivo experiments. GLP grade for all IND-enabling in vivo studies.
		
	Screening and purchase of commercial compounds and shipping to participants	  	
		
	Under subcontract: X-Ray crystallography and other molecular analyses of tropomyosin dimer N-terminus at Boston University	  	Acceptable for publication in peer reviewed journals
		
	Under subcontract: In vitro pharmaceutic property analyses to determine drug-like characteristics.	  	Where required, to a standard that is recognised by the International Conference on Harmonisation
		
	CRC-P subcontracting, alliance management, administration, accounting, reporting, project management, communications and patent applications.	  	
		
	Collaborative contribution to student and CRC-P staff supervision at UNSW and manuscript preparation for publication	  	Acceptable to UNSW internal standards, Commonwealth expectations under the Funding Agreement and scientific journal peer-review process
		
	Any other matters relating to compound design, manufacture and Utilisation or responsibilities that would reasonably be expected from the Lead Participant of the CRC-P.	  	

 PART B - UNSW Services 
  

			
	 Service
	  	 Applicable service standard (if any)

	In-kind contributions, staff and non-staff, according to Schedule 3	  	To a quantity and quality commensurate with monetary value (Schedule 3) and reasonable expectations for fulfilment of the Project according to Budget, Milestones and other service standards (Schedule 4).

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 51	 

			
	 As required by Lead Participant according to Project goals;
  

(1)    cell culture, cell biology, microscopy and in vitro compound screening using a variety of
cell lines to determine potency, structure-activity relationship data, specificity, synergy, mechanism of action, method of cell death, biomarkers and any other cell-based methods required to determine likelihood of compound utility as an
anti-cancer agent.
  

(2)    biochemistry and molecular biology experiments using a variety of existing and developed
assays to determine binding, specificity, mechanism of action, impact on actin-tropomyosin copolymer.
  

(3)    further supporting in vitro and biochemical experiments to determine proof of concept of
anti-tropomyosin technology such as analysis of tropomyosin expression and selective isoform inhibition.
	  	To a standard acceptable for journal publication, patent application, Commonwealth reporting and, when requested by the Lead Participant for the purposes of regulatory authority submissions, to a standard that is recognised by the
International Conference on Harmonisation
		
	Preparation of reports to be submitted to regulatory bodies including the Therapeutic Goods Administration and US Food and Drug Administration with respect to experiments conducted by UNSW	  	Reports must be provided if and when requested by Lead Participant, and must be to a standard that is recognised by the International Conference on Harmonisation
		
	Primary responsibility to student and CRC-P staff supervision at UNSW and collaborative contribution to manuscript preparation for publication	  	Acceptable to UNSW internal standards, Commonwealth expectations under the Funding Agreement and scientific journal peer-review process
		
	Any other services relating to in vitro analysis of the impact of the novel anti-tropomyosin compounds on biological systems or responsibilities that would reasonably be expected from UNSW according to Project goals and the
cooperative aims of the CRC-P.	  	To a standard acceptable for journal publication, patent application, Commonwealth reporting and, when requested by the Lead Participant for the purposes of regulatory authority submissions, to a standard that is recognised by the
International Conference on Harmonisation

 PART C - ICP Firefly Services 
  

			
	 Service
	  	 Applicable service standard (if any)

	In-kind contributions, staff and non-staff, according to Schedule 3	  	To a quantity and quality commensurate with monetary value (Schedule 3) and fulfilment of the Project according to Budget, Milestones and service standards (Schedule 4).

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 52	 

			
	 As required by Lead Participant according to Project goals and prepared in consultation with ICP Firefly as individual Work Orders;

 
 (1)    experiments that
determine compound efficacy against engrafted tumours in animal models of human cancer
  

(2)    experiments that determine the maximum tolerated dose, pharmacokinetics, optimal route of
delivery and formulation, absorption, metabolism and excretion of compounds and any other drug-like characteristics
  

(3)    experiments that investigate the nature of compound toxicities in animals
	  	To a standard acceptable for journal publication, patent application, Commonwealth reporting and, for the purposes of regulatory authority submissions, to a standard that is recognised by the International Conference on
Harmonisation
		
	 As required by Lead Participant according to Project goals for Investigational New Drug-enabling studies and prepared in consultation with
ICP Firefly as individual Work Orders;
 formal studies on animals, using Good Laboratory Practice grade compounds, that are required by the Therapeutic
Goods Administration and US Food and Drug Administration in order to understand the potential toxicities of candidate molecules in future clinical trials
	  	For the purposes of regulatory authority submissions, to a standard that is recognised by the International Conference on Harmonisation
		
	Preparation of reports to be submitted to regulatory bodies including the Therapeutic Goods Administration and US Food and Drug Administration with respect to experiments conducted by ICP Firefly	  	Reports must be provided if and when requested by Lead Participant, and must be to a standard that is recognised by the International Conference on Harmonisation
		
	Any other services relating to in vivo analysis of the novel anti-tropomyosin compounds or responsibilities that would reasonably be expected from ICP Firefly according to Project goals and the cooperative aims of the CRC-P.	  	To a standard acceptable for journal publication, patent application, Commonwealth reporting and, when requested by the Lead Participant for the purposes of regulatory authority submissions, to a standard that is recognised by the
International Conference on Harmonisation

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 53	 

 Schedule 5 – Intellectual Property, Agreement Material and Utilisation 

 
  

	1.	Intellectual Property Rights and Agreement Material 

  

	 	1.1.	Ownership of Novogen Material 

  

	 	(a)	Subject to the acknowledgement in clause 4.2, all Novogen Material, and all Intellectual Property Rights in such material, will vest automatically upon its creation in the Lead Participant, and each Project Partner
presently assign to the Lead Participant all Intellectual Property Rights contained in the Novogen Materials. Each Project Partner agrees to execute or procure the execution by its Personnel of any documents reasonably necessary to give effect to
this assignment, at the Lead Participant’s expense. 

  

	 	(b)	Each Project Partner must promptly disclose and communicate in writing to the Lead Participant full particulars of any Intellectual Property Rights that the Project Partner or its Personnel make, discover or conceive in
the course of the Project that is directly related to the Novogen Materials. 

  

	 	1.2.	Ownership of Technical Assay Material 

  

	 	(c)	Subject to the acknowledgement in clause 4.2, all Technical Assay Material, and all Intellectual Property Rights in such material, will vest automatically upon its creation in UNSW, and each of ICP Firefly and the Lead
Participant presently assign to UNSW all Intellectual Property Rights contained in the Technical Assay Material. Each of ICP Firefly and the Lead Participant agrees to execute or procure the execution by its Personnel of any documents reasonably
necessary to give effect to this assignment, at UNSW’s expense. 

  

	 	(d)	Each of ICP Firefly and the Lead Participant must promptly disclose and communicate in writing to UNSW full particulars of any Intellectual Property Rights that the relevant Party or its Personnel make, discover or
conceive in the course of the Project that is directly related to the Technical Assay Materials. 

  

	 	1.3.	Pre-Existing Material 

 In order to carry out
the Project and Utilise the Agreement Material, the Participants may use Intellectual Property Rights which are part of the Participant’s Pre-existing Material. Any such
Pre-existing Material remains the sole property of the relevant Participant. 
  

	 	1.4.	Licences 

  

	 	(a)	The Lead Participant grants to each Project Partner and its Personnel a non-exclusive, royalty free, licence to use the Pre-existing
Material of the Lead Participant which has been provided by or on behalf of the Lead Participant for use in the Project, and the Novogen Materials solely to the extent required to carry out the Project and perform this Agreement. 

 

	 	(b)	Each Project Partner grants to the Lead Participant a non-exclusive, perpetual, irrevocable, worldwide, royalty free licence to use (including the right to sub-licence) the
Project Partner’s Pre-existing Material which has been provided by or on behalf of that Project Partner for use in the Project, solely for the purpose of the Project and the Utilisation of the Novogen
Materials. 

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 54	 

	 	(c)	Each Project Partner grants to the other Project Partner a non-exclusive, royalty free licence to use (including the right to sub-licence)
the Project Partner’s Pre-existing Material which has been provided by or on behalf of that Project Partner for use in the Project, solely for the purpose of the Project. 

 

	 	(d)	UNSW grants: 

  

	 	(i)	to each of ICP Firefly and the Lead Participant and their Personnel a non-exclusive, royalty free, licence to use the Technical Assay Materials solely to the extent required to
carry out the Project and perform this Agreement. 

  

	 	(ii)	the licence to the Commonwealth set out in clause 4.1 of this Agreement. 

  

	 	(e)	Except for the licences described in this Schedule 5, no Participant nor any of its Personnel acquires any right or interest in any Pre-existing Material provided by or on
behalf of any other Participant. 

  

	2.	Utilisation 

  

	2.1	Utilisation 

 Subject to any licence granted to the Commonwealth or another Party under
this Agreement or the Funding Agreement: 
  

	 	(a)	The Lead Participant will be solely entitled to Utilise all Novogen Material, and all Intellectual Property Rights in such material, and resulting Intellectual Property Rights, developments, and any commercial gains
that arise from that Utilisation shall be exclusively the property of the Lead Participant. 

  

	 	(b)	UNSW will be solely entitled to Utilise the Technical Assay Material, and all Intellectual Property Rights in such material, and all resulting Intellectual Property Rights, developments, and any commercial gains that
arise from that Utilisation shall be exclusively the property of UNSW. 

  

	2.2	Cooperation 

 Each Project Partner must cooperate with the Lead Participant and promptly
do all acts and things and execute all documents which may be necessary for the purpose of vesting ownership of the legal and beneficial interest in the Agreement Material, and all Intellectual Property Rights in such material, as required under
this Agreement. 
  

	2.3	Protection Actions - Novogen Material 

  

	 	(a)	The Lead Participant will be responsible for, in the Lead Participant’s absolute discretion, procuring and maintaining any registrations, listing or other rights deemed reasonably appropriate by Lead Participant
for the protection of the Novogen Material, and all Intellectual Property Rights in such material, including: 

  

	 	(i)	filing and prosecuting any applications for registration; 

  

	 	(ii)	maintaining any registrations that issue from such applications; 

  

	 	(iii)	paying all applicable fees for such applications and registrations; 

  

	 	(iv)	abandoning any applications for registration; and 

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 55	 

	 	(v)	deciding whether to maintain any registrations that issue from such applications, 

 (each a
Protection Action). 
  

	 	(b)	Each Participant must provide all reasonable assistance necessary for the Lead Participant to undertake a Protection Action, at the Lead Participant’s expense. 

 

	 	(c)	Any costs associated with the Lead Participant undertaking any Protection Action will be borne solely by the Lead Participant. 

  

	2.4	Protection Actions - Technical Assay Material 

  

	 	(a)	UNSW will be responsible for, in UNSW’s absolute discretion, procuring and maintaining any registrations, listing or other rights deemed reasonably appropriate by UNSW for the protection of the Technical Assay
Material, and all Intellectual Property Rights in such material, including: 

  

	 	(i)	filing and prosecuting any applications for registration; 

  

	 	(ii)	maintaining any registrations that issue from such applications; 

  

	 	(iii)	paying all applicable fees for such applications and registrations; 

  

	 	(iv)	abandoning any applications for registration; and 

  

	 	(v)	deciding whether to maintain any registrations that issue from such applications, 

 (each a
UNSW Protection Action). 
  

	 	(b)	Each Participant must provide all reasonable assistance necessary for UNSW to undertake a UNSW Protection Action, at UNSW’s expense. 

 

	 	(c)	Any costs associated with UNSW undertaking any UNSW Protection Action will be borne solely by UNSW. 

  

	2.5	Infringement 

  

	 	(a)	Each Party must promptly and fully inform the other Party of: 

  

	 	(i)	any infringement or threatened infringement; 

  

	 	(ii)	any unauthorised use of or application; or 

  

	 	(iii)	any challenge or threatened challenge on the grant or validity, 

 of the Intellectual Property
Rights or title (or any aspect thereof) in the Pre-existing Material, Agreement Material, including the Technical Assay Material, or which comes to that Party’s attention (each an Infringement).

  

	 	(b)	Where a Participant reasonably suspects that an Infringement has occurred, the Participant may request any other Participant or Participants to provide information and
non-financial assistance as is reasonably necessary to assist in determining whether or not an Infringement has occurred. 

  

	 	(c)	For the avoidance of doubt, nothing in this item 2.5 will be taken as requiring a Participant to expend funds in relation to litigation or the protection of another Participant’s Intellectual Property Rights.

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 56	 

	3.	Warranty 

  

	 	(a)	Each Participant represents and warrants to the other Participants that: 

  

	 	(i)	at the date it makes Pre-existing Materials available to the Project, to its actual knowledge and belief, without the need to make additional enquiries, conduct searches or seek
legal or patent opinion, it is the owner of, or is otherwise entitled to provide, Participant’s Pre-existing Materials which it makes available for the Project; and 

 

	 	(ii)	except to the extent notified in writing to the other Participants at the time of providing the Participant’s Pre-existing Materials neither the Participant, nor its
Personnel, research fellows or students (if applicable) have entered into any agreement regarding, or have otherwise dealt with, the Participant’s Pre-existing Materials in a manner that is inconsistent
with, or restricts the exercise of the rights granted to, other Participants under this Agreement. 

  

	4.	Survival 

 This Schedule 5 survives termination or expiration of this Agreement. 

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 57	 

 Schedule 6 – Privacy Obligations with respect to information received from the Commonwealth 

 
  

	1.1	Obligations 

  

	 	(a)	Each Participant agrees in respect of the Project under this Agreement to take all necessary measures to ensure that personal information in its possession or control in connection with this Agreement is protected
against loss and unauthorised access, use, disclosure or modification. 

  

	 	(b)	Each Participant must, when requested, provide to the Commonwealth through the Lead Participant: 

  

	 	(i)	a copy of the Participant’s APP privacy policy which is compliant with APP 1; 

  

	 	(ii)	copies of the Participant’s security and data protection policies; and 

  

	 	(iii)	details of the Participant’s processes and procedures implemented to ensure compliance with the Privacy Act. 

  

	 	(c)	Each Participant agrees in respect of the Project under this Agreement: 

  

	 	(i)	to use or disclose personal information obtained, directly or indirectly, from the Commonwealth during the course of the Project under this Agreement, only for the purposes of this Agreement; 

 

	 	(ii)	not to do any act or engage in any practice that would breach an APP contained in schedule 1 of the Privacy Act, which if done or engaged in by an agency, would be a breach of that APP; 

 

	 	(iii)	to carry out and discharge the obligations contained in the APPs as if it were an agency under the Privacy Act; 

  

	 	(iv)	to notify individuals whose personal information the Participant holds, that complaints about acts or practices of the Participant may be investigated by the Privacy Commissioner who has power to award compensation
against the Participant in appropriate circumstances; 

  

	 	(v)	not to use or disclose personal information or engage in an act or practice that would breach APP 7 (direct marketing) or a registered APP Code which is applicable to the Participant, unless the use or disclosure
is necessary, directly or indirectly, to discharge an obligation of this Agreement; 

  

	 	(vi)	to follow any reasonable directions given by the Commonwealth through the Lead Participant to ensure compliance with the Privacy Act; 

 

	 	(vii)	to not transfer or transmit personal information outside of Australia except with the prior written approval of the Commonwealth, which will not be unreasonably withheld. In giving its approval the Commonwealth may
impose such conditions as it thinks fit. The Participant must comply with any term or condition imposed by the Commonwealth under this item 1.1(c)(vii); 

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 58	 

	 	(viii)	to disclose in writing to any person who asks, the content of the provisions of this Agreement (if any) that are inconsistent with an APP or a registered APP Code which is binding on a party to this Agreement;

  

	 	(ix)	to immediately notify the Commonwealth through the Lead Participant if the Participant becomes aware of a breach or possible breach of any of the obligations contained in, or referred to in, this Schedule 6,
whether by the Participant or any of its Personnel (including any complaints made about acts or practices of the Participant in connection with personal information); 

 

	 	(x)	to notify the Commonwealth through the Lead Participant of any subpoena, warrant, order, demand or request made by a foreign court or other authority for the disclosure of personal information to which the Privacy Act
applies and to not disclose such information without the prior written approval of the Commonwealth, which will not be unreasonably withheld. In giving its approval the Commonwealth may impose such conditions as it thinks fit. The Participant must
comply with any term or condition imposed by the Commonwealth under this item 1.1(c)(x); 

  

	 	(xi)	to comply with any directions, guidelines, determinations or recommendations of the Privacy Commissioner, notified to the Participant by the Commonwealth to the extent that they are not inconsistent with the
requirements of this Schedule 6; and 

  

	 	(xii)	to ensure that any Personnel of the Participant who is required to deal with personal information for the purposes of this Agreement is made aware of the obligations of the Participant as set out in this
Schedule 6. 

  

	1.2	Indemnity 

 The Project Participants agree to indemnify the Commonwealth in respect of
any loss or liability suffered or incurred by the Commonwealth which arises directly or indirectly from a breach of any of the obligations of the Agreement under this Schedule 6. 

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 59	 

 Signing page 

 
  

							
	Executed by Novogen Limited in accordance with section 127 of the Corporations Act 2001 (Cth) in the presence of	  		  		  	
				
	  
	  	f	  	  
	  	f
	Signature of director	  		  	 Signature of director/company secretary/sole director and sole company secretary

(Please delete as applicable)
	  	
				
	  
	  		  	  
	  	
	Name of director (print)	  		  	Name of director/company secretary/sole director and sole company secretary (print)	  	
				
	Signed for and on behalf of the University of New South Wales by an authorised officer in the presence of	  		  		  	
				
	  
	  	f	  	  
	  	f
	Signature of witness	  		  	Signature of officer	  	
				
	  
	  		  	  
	  	
	Name of witness (print)	  		  	Name of officer (print)	  	
				
		  		  	  
	  	
		  		  	Office held	  	

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 60	 

							
	Executed by ICP - Firefly Pty. Limited in accordance with section 127 of the Corporations Act 2001 (Cth) in the presence of	  		  		  	
				
	  
	  	f	  	  
	  	f
	Signature of director	  		  	 Signature of director/company secretary/sole director and sole company secretary

(Please delete as applicable)
	  	
				
	  
	  		  	  
	  	
	Name of director (print)	  		  	Name of director/company secretary/sole director and sole company secretary (print)	  	

  
 Confidential material
omitted and filed separately with the Commission. 

  

					
	Participants Agreement | CRC Project | Targeting Tropomyosin as a Novel Anti-Cancer Therapy	  	 	Page 61EX-10.1 2017 ATM Sales Agreement

		

			Exhibit 10.1

		

		

			 

		

		
			Aratana Therapeutics, Inc.
		

		
			﻿
		

		
			$50,000,000
		

		
			COmmon Stock
		

		
			﻿
		

		
			SALES AGREEMENT
		

		
			﻿
		

		
			December 18, 2017
		

		
			﻿
		

		
			Cowen and Company, LLC
		

		
			﻿599 Lexington Avenue
		

		
			﻿New York,  NY 10022
		

		
			﻿
		

		
			Ladies and Gentlemen:
		

		
			﻿
		

		
			Aratana Therapeutics, Inc. (the “Company”), confirms its agreement (this “Agreement”) with Cowen and Company, LLC (“Cowen”), as follows:
		

		
			1.         Issuance and Sale of Shares.  The Company agrees that, from time to time during the term of this Agreement, on the terms and subject to the conditions set forth herein, it may issue and sell through Cowen, acting as agent and/or principal, shares (the “Placement Shares”) of the Company’s common stock, par value $0.001 per share (the “Common Stock”), having an aggregate offering price of up to $50,000,000.  Notwithstanding anything to the contrary contained herein, the parties hereto agree that compliance with the limitation set forth in this Section 1 on the number of shares of Common Stock issued and sold under this Agreement shall be the sole responsibility of the Company, and Cowen shall have no obligation in connection with such compliance.  The issuance and sale of the Placement Shares through Cowen will be effected pursuant to the Registration Statement (as defined below) filed by the Company and declared effective by the Securities and Exchange Commission (the “Commission”), although nothing in this Agreement shall be construed as requiring the Company to use the Registration Statement (as defined below) to issue the Placement Shares.  
		

		
			The Company has filed, in accordance with the provisions of the Securities Act of 1933, as amended, and the rules and regulations thereunder (collectively, the “Securities Act”), with the Commission a registration statement on Form S-3 (File No. 333-219681), including a base prospectus, relating to certain securities, including the Common Stock,  to be issued from time to time by the Company, and which incorporates by reference documents that the Company has filed or will file in accordance with the provisions of the Securities Exchange Act of 1934, as amended, and the rules and regulations thereunder (collectively, the “Exchange Act”). The Company has prepared a prospectus supplement specifically relating to the Placement Shares (the “Prospectus Supplement”) to the base prospectus included as part of such registration statement.  The Company has furnished to Cowen, for use by Cowen, copies of the prospectus included as part of such registration statement, as supplemented by the Prospectus Supplement, relating to the Placement Shares.  Except where the context otherwise requires, such registration statement, as amended when it became effective, including all documents filed as part thereof or incorporated by reference therein, and including any information contained in a Prospectus (as defined below) subsequently filed with the Commission pursuant to Rule 424(b) under the Securities Act or 
		

		 

 

		deemed to be a part of such registration statement pursuant to Rule 430B or 462(b) of the Securities Act, is herein called the “Registration Statement.”  The base prospectus, including all documents incorporated therein by reference, included in the Registration Statement, as it may be supplemented by the Prospectus Supplement, in the form in which such prospectus and/or Prospectus Supplement have most recently been filed by the Company with the Commission pursuant to Rule 424(b) under the Securities Act, together with any “issuer free writing prospectus,” as defined in Rule 433 of the Securities Act regulations (“Rule 433”), relating to the Placement Shares that (i) is required to be filed with the Commission by the Company or (ii) is exempt from filing pursuant to Rule 433(d)(5)(i), in each case in the form filed or required to be filed with the Commission or, if not required to be filed, in the form retained in the Company’s records pursuant to Rule 433(g), is herein called the “Prospectus.” Any reference herein to the Registration Statement, the Prospectus or any amendment or supplement thereto shall be deemed to refer to and include the documents incorporated by reference therein, and any reference herein to the terms “amend,” “amendment” or “supplement” with respect to the Registration Statement or the Prospectus shall be deemed to refer to and include the filing after the execution hereof of any document with the Commission deemed to be incorporated by reference therein. For purposes of this Agreement, all references to the Registration Statement, the Prospectus or to any amendment or supplement thereto shall be deemed to include any copy filed with the Commission pursuant to the Electronic Data Gathering Analysis and Retrieval System (“EDGAR”).
		

		
			2.         Placements.  Each time that the Company wishes to issue and sell the Placement Shares hereunder (each, a “Placement”), it will notify Cowen by email notice (or other method mutually agreed to in writing by the parties) (a “Placement Notice”) containing the parameters in accordance with which it desires the Placement Shares to be sold, which shall at a minimum include the number of Placement Shares to be issued, the time period during which sales are requested to be made, any limitation on the number of Placement Shares that may be sold in any one Trading Day (as defined in Section 3) and any minimum price below which sales may not be made, a form of which containing such minimum sales parameters necessary is attached hereto as Schedule 1.  The Placement Notice shall originate from any of the individuals from the Company set forth on Schedule 2 (with a copy to each of the other individuals from the Company listed on such schedule), and shall be addressed to each of the individuals from Cowen set forth on Schedule 2, as such Schedule 2 may be amended from time to time. The Placement Notice shall be effective upon receipt by Cowen unless and until (i) in accordance with the notice requirements set forth in Section 4, Cowen declines to accept the terms contained therein for any reason, in its sole discretion, (ii) the entire amount of the Placement Shares have been sold, (iii) in accordance with the notice requirements set forth in Section 4, the Company suspends or terminates the Placement Notice for any reason, in its sole discretion,  (iv) the Company issues a subsequent Placement Notice with parameters superseding those on the earlier dated Placement Notice, or (v) this Agreement has been terminated under the provisions of Section 11.   The amount of any discount, commission or other compensation to be paid by the Company to Cowen in connection with the sale of the Placement Shares shall be calculated in accordance with the terms set forth in Schedule 3.  It is expressly acknowledged and agreed that neither the Company nor Cowen will have any obligation whatsoever with respect to a Placement or any Placement Shares unless and until the Company delivers a Placement Notice to Cowen and Cowen does not decline such Placement Notice pursuant to the terms set forth above, and then only upon the terms specified therein and herein.  In the event of a conflict between the terms of this Agreement and the terms of a Placement Notice, the terms of the Placement Notice will control.
		

		 

		

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			3.         Sale of Placement Shares by Cowen.  Subject to the terms and conditions herein set forth, upon the Company’s delivery of a Placement Notice, and unless the sale of the Placement Shares described therein has been declined, suspended, or otherwise terminated in accordance with the terms of this Agreement, Cowen,  for the period specified in the Placement Notice, will use its commercially reasonable efforts consistent with its normal trading and sales practices and applicable state and federal laws, rules and regulations and the rules of the Nasdaq Stock Market, Inc. (“Nasdaq”) to sell such Placement Shares up to the amount specified, and otherwise in accordance with the terms of such Placement Notice.  Cowen will provide written confirmation to the Company (including by email correspondence to each of the individuals of the Company set forth on Schedule 2, if receipt of such correspondence is actually acknowledged by any of the individuals to whom the notice is sent, other than via auto-reply) no later than the opening of the Trading Day (as defined below) immediately following the Trading Day on which it has made sales of Placement Shares hereunder setting forth the number of Placement Shares sold on such day, the volume-weighted average price of the Placement Shares sold, and the Net Proceeds (as defined below) payable to the Company.  Subject to the terms of a Placement Notice, Cowen may sell Placement Shares by any method permitted by law deemed to be an “at the market” offering as defined in Rule 415 of the Securities Act, including without limitation sales made through Nasdaq or on any other existing trading market for the Common Stock.  Notwithstanding the provisions of Section 6(ww), Cowen shall not purchase Placement Shares for its own account as principal unless expressly authorized to do so by the Company in a Placement Notice.  The Company acknowledges and agrees that (i) there can be no assurance that Cowen will be successful in selling Placement Shares, and (ii) Cowen will incur no liability or obligation to the Company or any other person or entity if it does not sell Placement Shares for any reason other than a failure by Cowen to use its commercially reasonable efforts consistent with its normal trading and sales practices to sell such Placement Shares as required under this Section 3.  For the purposes hereof, “Trading Day” means any day on which the Company’s Common Stock is purchased and sold on the principal market on which the Common Stock is listed or quoted.
		

		
			4.         Suspension of Sales.  
		

		
			(a)  The Company or Cowen may, upon notice to the other party in writing (including by email correspondence to each of the individuals of the other party set forth on Schedule 2, if receipt of such correspondence is actually acknowledged by any of the individuals to whom the notice is sent, other than via auto-reply) or by telephone (confirmed immediately by verifiable facsimile transmission or email correspondence to each of the individuals of the other party set forth on Schedule 2), suspend any sale of Placement Shares; provided, however, that such suspension shall not affect or impair either party’s obligations with respect to any Placement Shares sold hereunder prior to the receipt of such notice.  While a suspension is in effect any obligation under section 7(m), 7(n) and 7(o) with respect to the delivery of certificates, opinion, or comfort letters to Cowen, shall be waived.  Each of the parties agrees that no such notice under this Section 4 shall be effective against the other unless it is made to one of the individuals named on Schedule 2 hereto, as such schedule may be amended from time to time.
		

		
			(b)  Notwithstanding any other provision of this Agreement, during any period in which the Company is in possession of material non-public information, the Company and Cowen agree that (i) no sale of Placement Shares will take place, (ii) the Company shall not request the sale of 
		

		 

		

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		any Placement Shares, and (iii) Cowen shall not be obligated to sell or offer to sell any Placement Shares.
		

		
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			(c)  If either Cowen or the Company has reason to believe that the exemptive provisions set forth in Rule 101(c)(1) of Regulation M under the Exchange Act are not satisfied with respect to the Common Stock, it shall promptly notify the other party, and Cowen may, at its sole discretion, suspend sales of the Placement Shares under this Agreement.
		

		
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			(d)  The Registration Statement was declared effective on August 16, 2017 (the “Effective Date”).  Notwithstanding any other provision of this Agreement, during any period in which the Registration Statement is no longer effective under the Securities Act, the Company shall promptly notify Cowen, the Company shall not request the sale of any Placement Shares, and Cowen shall not be obligated to sell or offer to sell any Placement Shares.
		

		
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			5.         Settlement.
		

		
			(a)  Settlement of Placement Shares.  Unless otherwise specified in the applicable Placement Notice, settlement for sales of Placement Shares will occur on the second (2nd) Trading Day (or such earlier day as is industry practice for regular-way trading) following the date on which such sales are made (each, a “Settlement Date” and the first such settlement date, the “First Delivery Date”).  The amount of proceeds to be delivered to the Company on a Settlement Date against receipt of the Placement Shares sold (the “Net Proceeds”) will be equal to the aggregate sales price received by Cowen at which such Placement Shares were sold, after deduction for (i) Cowen’s commission, discount or other compensation for such sales payable by the Company pursuant to Section 2 hereof, (ii) any other amounts due and payable by the Company to Cowen hereunder pursuant to Section 7(g) (Expenses) hereof, and (iii) any transaction fees imposed by any governmental or self-regulatory organization in respect of such sales.   
		

		
			(b)  Delivery of Placement Shares.  On or before each Settlement Date, the Company will, or will cause its transfer agent to, electronically transfer the Placement Shares being sold by crediting Cowen’s or its designee’s account (provided Cowen shall have given the Company written notice of such designee at least one Trading Day prior to the Settlement Date) at The Depository Trust Company through its Deposit and Withdrawal at Custodian System or by such other means of delivery as may be mutually agreed upon by the parties hereto which in all cases shall be freely tradeable, transferable, registered shares in good deliverable form.  On each Settlement Date, Cowen will deliver the related Net Proceeds in same day funds to an account designated by the Company on, or prior to, the Settlement Date.  Cowen will be responsible for providing DWAC instructions or instructions for delivery by other means with regard to the transfer of Placement Shares being sold. The Company agrees that if the Company, or its transfer agent (if applicable), defaults in its obligation to deliver duly authorized Placement Shares on a Settlement Date (other than as a result of a failure by Cowen to provide instructions for delivery),  the Company agrees that in addition to and in no way limiting the rights and obligations set forth in Section 9(a) (Indemnification and Contribution) hereto, it will (i) hold Cowen harmless against any loss, claim, damage, or reasonable and documented expense (including reasonable legal fees and expenses), as incurred, arising out of or in connection with such default by the Company and (ii) pay to Cowen (without duplication) any commission, discount, or other compensation to which it would otherwise have been entitled absent such default.
		

		 

		

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			6.         Representations and Warranties of the Company.  The Company represents and warrants to, and agrees with, Cowen that as of the date of this Agreement, each Representation Date (as defined in Section 7.(m.)), each date on which a Placement Notice is given, and any date on which Placement Shares are sold hereunder: 
		

		
			(a)  The Registration Statement and any Rule 462(b) Registration Statement have been declared effective by the Commission under the Securities Act.  The Company has complied to the Commission’s satisfaction with all requests of the Commission for additional or supplemental information.  No stop order suspending the effectiveness of the Registration Statement or any Rule 462(b) Registration Statement is in effect and no proceedings for such purpose have been instituted or are pending or, to the best knowledge of the Company, contemplated or threatened by the Commission.  The Company meets the requirements for use of Form S‐3 under the Securities Act.  The sale of the Placement Shares hereunder meets the requirements or General Instruction I.B.1 of Form S-3.
		

		
			(b)  From the time of initial filing of the Registration Statement with the Commission and through the date hereof, the Company has been and is an “emerging growth company,” as defined in Section 2(a) of the Securities Act (an “Emerging Growth Company”).
		

		
			(c)  As of the determination date referenced in Rule 164(h) under the Securities Act, the Company was not, is not or will not be (as applicable) an “ineligible issuer” in connection with the offering of the Placement Shares pursuant to Rules 164, 405 and 433 under the Securities Act.  
		

		
			(d)  The Registration Statement conformed and will conform in all material respects on the Effective Date and on each Representation Date (as defined below) and each Settlement Date, and any amendment to the Registration Statement filed after the date hereof will conform in all material respects when filed, to the requirements of the Securities Act and the rules and regulations thereunder.  The Prospectus conformed and will conform, in all material respects when filed with the Commission pursuant to Rule 424(b) under the Securities Act and on each Representation Date and each Settlement Date to the requirements of the Securities Act and the rules and regulations thereunder.  The documents incorporated by reference in the Prospectus conformed, and any further documents so incorporated will conform, when filed with the Commission, in all material respects to the requirements of the Exchange Act and the rules and regulations of the Commission thereunder.
		

		
			(e)  The Registration Statement did not and will not, as of the  Effective Date or any Representation Date or Settlement Date, contain an untrue statement of a material fact or omit to state a material fact required to be stated therein or necessary to make the statements therein not misleading; provided that no representation or warranty is made as to the Agent’s Information.
		

		
			(f)  The Prospectus did not and will not, as of its date or as of any Representation Date or Settlement Date, contain an untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided that no representation or warranty is made as to the Agent’s Information.
		

		
			(g)  The documents incorporated by reference in the Prospectus did not, and any further documents filed and incorporated by reference therein will not, when they were filed or are filed 
		

		 

		

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		with the Commission contain an untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading.
		

		
			(h)  The Prospectus, together with any “issuer free writing prospectus” (as defined in Rule 433 under the Securities Act) relating to the Placement Shares (an “Issuer Free Writing Prospectus”), will not, as of each Representation Date and each Settlement Date, contain an untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading; provided that no representation or warranty is made as to the Agent’s Information.
		

		
			(i)  Each Issuer Free Writing Prospectus conformed or will conform in all material respects to the requirements of the Securities Act and the rules and regulations thereunder on the date of first use, and the Company has complied with all prospectus delivery and any filing requirements applicable to such Issuer Free Writing Prospectus pursuant to the Securities Act and rules and regulations thereunder.  The Company has not made any offer relating to the Placement Shares that would constitute an Issuer Free Writing Prospectus without the prior written consent of Cowen.  The Company has retained in accordance with the Securities Act and the rules and regulations thereunder all Issuer Free Writing Prospectuses that were not required to be filed pursuant to the Securities Act and the rules and regulations thereunder.
		

		
			(j)  The Company has been duly incorporated and is validly existing as a corporation in good standing under the laws of the State of Delaware, with power and authority (corporate and other) to own, lease and operate its properties and conduct its business as described in the Registration Statement and Prospectus and to enter into and perform its obligations under this Agreement, and has been duly qualified as a foreign corporation for the transaction of business and is in good standing under the laws of each other jurisdiction in which it owns or leases properties or conducts any business so as to require such qualification, except where the failure so to qualify or be in good standing would not, individually or in the aggregate, have a material adverse effect on the  business, prospects, management, financial position, stockholders’ equity or results of operations of the Company and its subsidiaries, considered as one entity (a “Material Adverse Effect”).
		

		
			(k)  Each of the Company’s “subsidiaries” (for purposes of this Agreement, as defined in Rule 405 under the Securities Act) has been duly incorporated or organized, as the case may be, and is validly existing as a corporation, partnership or limited liability company, as applicable, in good standing under the laws of the jurisdiction of its incorporation or organization and has the power and authority (corporate or other) to own, lease and operate its properties and to conduct its business as described in the Registration Statement and the Prospectus. Each of the Company’s subsidiaries is duly qualified as a foreign corporation, partnership or limited liability company, as applicable, to transact business and is in good standing in each jurisdiction in which such qualification is required, whether by reason of the ownership or leasing of property or the conduct of business except where the failure to be so qualified or to be in good standing would, individually or in the aggregate, have a Material Adverse Effect. All of the issued and outstanding capital stock or other equity or ownership interests of each of the Company’s subsidiaries have been duly authorized and validly issued, are fully paid and nonassessable and, except as disclosed in the Registration Statement and the Prospectus, are owned by the Company, directly or through subsidiaries, free and clear of any security interest, mortgage, pledge, lien, encumbrance or adverse 
		

		 

		

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		claim. The Company does not wholly-own or control, directly or indirectly, any corporation, association or other entity other than Vet Therapeutics, Inc. and Aratana Therapeutics NV.  
		

		
			(l)  The authorized, issued and outstanding capital stock of the Company is as set forth in the Registration Statement and Prospectus (other than for subsequent issuances, if any, pursuant to equity or employee benefit plans, which are described or referred to in the Registration Statement and the Prospectus, or upon the exercise of outstanding options or warrants, which are described or referred to in the Registration Statement and the Prospectus), and all of the issued and outstanding shares of capital stock of the Company have been duly and validly authorized and issued, are fully paid and non-assessable and conform to the descriptions thereof contained in the Prospectus; and none of the issued and outstanding shares of capital stock of the Company or any of its subsidiaries are subject to any preemptive or similar rights.
		

		
			(m)  The Placement Shares will be duly and validly authorized and, when issued and delivered by the Company pursuant to this Agreement, against payment of the consideration set forth herein in accordance with the terms of this Agreement, will be duly and validly issued and fully paid and non-assessable and will conform to the descriptions thereof contained in the Registration Statement and Prospectus; and the issuance of such Placement Shares is not subject to any preemptive or similar rights that have not been duly waived.  
		

		
			(n)  The Company has all requisite corporate power and authority to perform its obligations under this Agreement.  This Agreement has been duly and validly authorized, executed and delivered by the Company.
		

		
			(o)  The issue and sale of the Placement Shares, the execution of this Agreement by the Company and the consummation of the transactions herein contemplated will not (1) conflict with or result in a breach or violation of any of the terms or provisions of, or constitute a default under, any indenture, mortgage, deed of trust, loan agreement or other agreement or instrument to which the Company or any of its subsidiaries is a party or by which the Company or any of its subsidiaries is bound or to which any of the property or assets of the Company or any of its subsidiaries is subject, (2) result in any violation of the provisions of the certificate incorporation or by-laws or similar organizational documents of the Company or any of its subsidiaries or (3) result in any violation of any statute or any order, rule or regulation of any court or governmental agency or body having jurisdiction over the Company or any of its properties, except, in the case of clauses (1) and (3) for any such conflicts, violations, breaches or defaults that would not, individually or in the aggregate, have a Material Adverse Effect; and no consent, approval, authorization, order, registration or qualification of or with any such court or governmental agency or body is required for the issue and sale of the Placement Shares or the consummation by the Company of the transactions contemplated by this Agreement, except the registration under the Securities Act of the Placement Shares and such consents, approvals, authorizations, registrations or qualifications as may be required by FINRA or under state securities or Blue Sky laws in connection with the purchase and distribution of the Placement Shares through Cowen.
		

		
			(p)  PricewaterhouseCoopers LLP, who have certified certain financial statements of the Company and its subsidiaries, is an independent public accountant as required by the Securities Act and the rules and regulations thereunder and the Public Company Accounting Oversight Board (United States).  The financial statements, together with related schedules and notes, incorporated by reference into the Registration Statement and Prospectus comply in all material respects with 
		

		 

		

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		the requirements of the Exchange Act and present fairly in all material respects the financial position, results of operations, cash flows and changes in convertible preferred stock and stockholders’ equity (deficit) of the Company and its subsidiaries on the basis stated in the Prospectus at the respective dates or for the respective periods to which they apply; such financial statements and related schedules and notes have been prepared in accordance with generally accepted accounting principles consistently applied throughout the periods involved, except as disclosed therein; and the selected financial data and the summary financial data included in the Registration Statement and Prospectus present fairly the information shown therein and have been compiled on a basis consistent with that of the financial statements incorporated by reference into the Registration Statement. Except as included or incorporated by reference in the Registration Statement or the Prospectus, no historical or pro forma financial statements or supporting schedules are required to be included or incorporated by reference in the Registration Statement  or the Prospectus under the Exchange Act or the rules and regulations promulgated thereunder. 
		

		
			(q)  The Company maintains a system of internal accounting controls sufficient to provide reasonable assurance that (1) transactions are executed in accordance with management’s general or specific authorizations; (2) transactions are recorded as necessary to permit preparation of financial statements in conformity with generally accepted accounting principles and to maintain accountability for assets; (3) access to assets is permitted only in accordance with management’s general or specific authorization; and (4) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences.
		

		
			(r)  Except as described in the Registration Statement and the Prospectus, since the date of the latest audited financial statements incorporated by reference into the Registration Statement and Prospectus, (a) the Company has not been advised of (1) any significant deficiencies in the design or operation of internal controls that could adversely affect the ability of the Company to record, process, summarize and report financial data, or any material weaknesses in internal controls or (2) any fraud, whether or not material, that involves management or other employees who have a significant role in the internal controls of the Company, and (b) except as described in the Registration Statement and the Prospectus, since that date, there has been no change in the Company’s internal control over financial reporting that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
		

		
			(s)  The Company maintains disclosure controls and procedures (as such term is defined in Rule 13a-15 (e) of the Exchange Act) that comply with the requirements of the Exchange Act; such disclosure controls and procedures are effective.  
		

		
			(t)  Solely to the extent that the Sarbanes-Oxley Act of 2002, as amended, and the rules and regulations promulgated by the Commission and the Nasdaq Global Market thereunder (the “Sarbanes-Oxley Act”) have been applicable to the Company,  except as described in the Registration Statement and the Prospectus, there is and has been no failure on the part of the Company or any of its directors or officers to comply in all material respects with any provisions of the Sarbanes-Oxley Act.  The Company has taken all necessary actions to ensure that it is in compliance with all provisions of the Sarbanes-Oxley Act that are in effect and with which the Company is required to comply, and it is actively taking steps to ensure that it will be in compliance with other provisions of the Sarbanes-Oxley Act not currently in effect or which the Company is not required to comply with, that are reasonably expected to be applicable to the Company.
		

		 

		

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			(u)  The Company and its subsidiaries, considered as one entity, have not sustained since the date of the latest audited financial statements incorporated by reference into the Registration Statement and Prospectus any material loss or interference with its business from fire, explosion, flood or other calamity, whether or not covered by insurance, or from any labor dispute or court or governmental action, order or decree, otherwise than as set forth or contemplated in the Registration Statement and Prospectus; and, since the respective dates as of which information is given in the Registration Statement and Prospectus, (1) there has not been any change in the capital stock (other than the issuance of shares of Common Stock upon the exercise of stock options described as outstanding in, or the grant options, restricted stock or other equity-based awards under Company’s existing equity incentive plans described in, the Registration Statement and Prospectus) or long-term debt of the Company or its subsidiaries, (2) there has not been any material adverse change, or any development that would reasonably be expected to result in a prospective material adverse change, in or affecting the general affairs, business, prospects, management, financial position, stockholders’ equity or results of operations of the Company and its subsidiaries, considered as one entity, (3) there have been no transactions entered into by, and no obligations or liabilities, contingent or otherwise, incurred by the Company or any of its subsidiaries, whether or not in the ordinary course of business, which are material to the Company and its subsidiaries, considered as one entity or (4) there has been no dividend or distribution of any kind declared, paid or made by the Company or, except for dividends paid to the Company or other subsidiaries, by any of the Company’s subsidiaries, on any class of capital stock, in each case, otherwise than as set forth or contemplated in the Prospectus.
		

		
			(v)  The Company and each of its subsidiaries has good and marketable title to all real (in fee simple) and personal property owned by it, in each case free and clear of all liens, encumbrances and defects except such as are described in the Registration Statement and Prospectus or such as do not materially affect the value of such property and do not interfere with the use made and proposed to be made of such property by the Company and its subsidiaries; and any real property and buildings held under lease by the Company or any of its subsidiaries are held under valid, subsisting and enforceable leases with such exceptions as are not material and do not interfere with the use made and proposed to be made of such property and buildings by the Company or such subsidiary.
		

		
			(w)  The Company and its subsidiaries possess all permits, licenses, approvals, consents and other authorizations (collectively, “Permits”) issued by the appropriate federal, state, local or foreign regulatory agencies or bodies necessary to conduct the businesses now operated by it, except where the failure to possess such permit, license, approval, consent or authorization would not, individually or in the aggregate, reasonably be expected to have a Material Adverse Effect; the Company and its subsidiaries are in compliance with the terms and conditions of all such Permits and all of the Permits are valid and in full force and effect, except, in each case, where the failure so to comply or where the invalidity of such Permits or the failure of such Permits to be in full force and effect, individually or in the aggregate, would not have a Material Adverse Effect; and neither the Company nor any subsidiary has received any notice of proceedings relating to the revocation or material modification of any such Permits.
		

		
			(x)  Except as disclosed in the Registration Statement and Prospectus (i) to its knowledge, the Company and its subsidiaries own or possess all licenses, inventions, copyrights, know-how (including trade secrets and other unpatented and/or unpatentable proprietary or confidential 
		

		 

		

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		information, systems or procedures), trademarks, service marks and trade names, patents and patent rights and other intellectual property (collectively “Intellectual Property”)  material to the conduct of its business as described in the Registration Statement and Prospectus, (ii) to the knowledge of the Company, the conduct and the proposed conduct of the businesses of the Company and its subsidiaries, including the research, development, manufacture, sale and Company use of its products, does not and will not infringe, misappropriate, or violate any third party’s Intellectual Property, and the Company and its subsidiaries have not received since their respective dates of inception any written notice alleging the foregoing, (iii) to the knowledge of the Company, the Company and its subsidiaries are the exclusive owners of all Intellectual Property owned or purported to be owned by the Company and its subsidiaries, free and clear of all liens, encumbrances, defects, adverse claims or other restrictions, or any requirement of any past, present or future royalty payments, (iv) the Company is not aware of any infringement, misappropriation or violation by others of, or conflict by others with rights of the Company or any of its subsidiaries or with respect to, any of the Intellectual Property of the Company and its subsidiaries, and since their respective dates of inception, neither the Company nor any subsidiary has received any written notice alleging the foregoing, (v) the Company and its subsidiaries have not received any written claim asserting rights in any Intellectual Property owned by the Company and its subsidiaries that would render any such Intellectual Property invalid or inadequate to protect the interest of the Company and its subsidiaries; (vi) the Company and its subsidiaries have taken all steps reasonably necessary to secure their interest in the Intellectual Property of the Company and its subsidiaries, including obtaining all necessary assignments from its employees, consultants and contractors pursuant to a written agreement containing a present tense assignment of all Intellectual Property created by such employee, consultant or contractor, (vii) the Company and its subsidiaries have taken commercially reasonable steps to protect and maintain all Intellectual Property owned by the Company and its subsidiaries, including without limitation to preserve the confidentiality of any trade secrets, (viii) to the Company’s knowledge, all material Intellectual Property owned by or licensed to the Company and its subsidiaries is valid and enforceable and (ix) to the Company’s knowledge, neither the Company nor any subsidiary is in violation of any Company License Agreements (as defined below), other than such violations which, individually or in the aggregate, would not result in a Material Adverse Effect. The license agreements by which the Company and its subsidiaries have been licensed Intellectual Property owned by third parties (“Company License Agreements”) are valid and are in full force and effect and constitute legal, valid and binding obligations of Company and its subsidiaries, and to the Company’s knowledge, the other parties thereto.
		

		
			(y)  Other than as set forth in the Registration Statement and Prospectus, there are no legal or governmental proceedings pending to which the Company or any of its subsidiaries is a party or of which any property of the Company or any subsidiary is the subject which, if determined adversely to the Company or any such subsidiary, individually or in the aggregate, would have or may reasonably be expected to have a Material Adverse Effect, or would prevent or impair the consummation of the transactions contemplated by this Agreement, or which are required to be described in the Registration Statement or Prospectus; and, to the best of the Company’s knowledge, no such proceedings are threatened or contemplated by governmental authorities or others.
		

		
			(z)  There are no statutes, regulations, documents or contracts of a character required to be described in the Registration Statement and Prospectus (or in any document incorporated by 
		

		 

		

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		reference therein) or to be filed as an exhibit to the Registration Statement (or to any document incorporated by reference into the Registration Statement and Prospectus) which are not described or filed as required.
		

		
			(aa)  Each of the Company and its subsidiaries is insured by insurers of recognized financial responsibility against such losses and risks (including risks related to clinical trials and product liability) and in such amounts as are prudent and customary in the businesses in which it is engaged; neither the Company nor any of its subsidiaries has been refused any insurance coverage sought or applied for; and the Company has no reason to believe that it or any of its subsidiaries will not be able to renew its existing insurance coverage as and when such coverage expires or to obtain similar coverage from similar insurers as may be necessary to continue its business at a cost that would not have a Material Adverse Effect.
		

		
			(bb)  There are no relationships or related-party transactions involving the Company or any of its subsidiaries or any other person required to be described in the Prospectus which have not been described as required.
		

		
			(cc)  No material labor dispute with the employees of the Company or any of its subsidiaries exists, or, to the knowledge of the Company, is imminent.  The Company is not aware of any existing or imminent labor disturbance by the employees of any of its principal suppliers, manufacturers, customers or contractors, which, individually or in the aggregate, may reasonably be expected to result in a Material Adverse Effect.
		

		
			(dd)  Neither the Company nor any of its subsidiaries is (1) in violation of its certificate of incorporation or bylaws or similar organization documents or (2) in violation of any law, ordinance, administrative or governmental rule or regulation applicable to the Company or any of its subsidiaries, or (3) in violation of any decree of any court or governmental agency or body having jurisdiction over the Company or any of its subsidiaries, or (4) in default in the performance of any obligation, agreement or condition contained in any bond, debenture, note or any other evidence of indebtedness or in any agreement, indenture, lease or other instrument to which the Company or any of its subsidiaries is a party or by which it or any of them may be bound, or to which any of their respective properties are subject, except, in the case of clauses (2), (3) and (4), where any such violation or default, individually or in the aggregate, would not have a Material Adverse Effect.
		

		
			(ee)  The Company and its subsidiaries are not in violation of any statute or any rule, regulation, decision or order of any governmental agency or body or any court, domestic or foreign, relating to the use, production, disposal or release of hazardous or toxic substances or relating to the protection or restoration of the environment or human exposure to hazardous or toxic substances (collectively, “environmental laws”), does not own or operate any real property contaminated with any substance that is subject to any environmental laws, is not liable for any off-site disposal or contamination pursuant to any environmental laws, and is not subject to any claim relating to any environmental laws, which violation, contamination, liability or claim, individually or in the aggregate, would have a Material Adverse Effect; and the Company is not aware of any pending investigation which might reasonably be expected to lead to such a claim.
		

		
			(ff)  All United States federal income tax returns of the Company and its subsidiaries required by law to be filed have been filed and all taxes shown by such returns or otherwise 
		

		 

		

			- 11  -

		

 

		assessed, which are due and payable, have been paid, except assessments against which appeals have been or will be promptly taken and as to which adequate reserves have been provided. The Company and its subsidiaries have filed all other tax returns that are required to have been filed by it pursuant to applicable foreign, state, local or other law, except insofar as the failure to file such returns, individually or in the aggregate, would not result in a Material Adverse Effect, and has paid all taxes due pursuant to such returns or pursuant to any assessment received by the Company or any of its subsidiaries, except for cases in which the failure to pay such taxes, individually or in the aggregate, would not result in a Material Adverse Effect, or, except for such taxes, if any, as are being contested in good faith and as to which adequate reserves have been provided.  The charges, accruals and reserves on the books of the Company and its subsidiaries in respect of any income and corporation tax liability for any years not finally determined are adequate to meet any assessments or re-assessments for additional income tax for any years not finally determined.
		

		
			(gg)  Each employee benefit plan, within the meaning of Section 3(3) of the Employee Retirement Income Security Act of 1974, as amended (“ERISA”), that is maintained, administered or contributed to by the Company or its subsidiaries for employees or former employees of the Company, its subsidiaries or its affiliates has been maintained in compliance with its terms and the requirements of any applicable statutes, orders, rules and regulations, including but not limited to ERISA and the Internal Revenue Code of 1986, as amended (the “Code”), except to the extent that failure to so comply, individually or in the aggregate, would not have a Material Adverse Effect.  No prohibited transaction, within the meaning of Section 406 of ERISA or Section 4975 of the Code has occurred with respect to any such plan excluding transactions effected pursuant to a statutory or administrative exemption.
		

		
			(hh)  The statistical and market and industry-related data included in the Registration Statement and Prospectus are based on or derived from sources which the Company believes to be reliable and accurate or represent the Company’s good faith estimates that are made on the basis of data derived from such sources, and the Company has obtained the written consent to the use of such data from sources to the extent required.
		

		
			(ii)  The Company is not and, after giving effect to the offering and sale of the Placement Shares as contemplated herein and the application of the net proceeds therefrom as described in the Registration Statement and Prospectus, will not be an “investment company”, as such term is defined in the Investment Company Act of 1940, as amended (the “Investment Company Act”).  
		

		
			(jj)  There are no persons with registration rights or other similar rights to have securities registered pursuant to the Registration Statement or otherwise registered by the Company under the Securities Act, which rights have not been duly waived in writing.
		

		
			(kk)  Except as disclosed in the Registration Statement and the Prospectus, the Company has not sold, issued or distributed any shares of Common Stock during the six-month period preceding the date hereof, including any sales pursuant to Rule 144A, Regulation D or Regulation S under the Securities Act, other than shares issued pursuant to employee benefit plans, qualified stock option plans or other employee compensation plans or pursuant to outstanding options, rights or warrants.
		

		 

		

			- 12  -

		

 

		
			(ll)  The Company has not distributed and, prior to the completion of distribution of the Placement Shares, will not distribute any offering materials in connection with the offering and sale of the Placement Shares, other than the Prospectus; and neither the Company nor any of its subsidiaries has taken nor will take, directly or indirectly, any action designed to cause or result in, or which constitutes or might reasonably be expected to constitute, the stabilization or manipulation of the price of any security of the Company to facilitate the sale of the Placement Shares.  
		

		
			(mm)  Neither the Company nor any of its subsidiaries, nor, to the knowledge of the Company, after due inquiry, any director, officer or employee has in the course of its actions for, or on behalf of, the Company or any of its subsidiaries: (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official, “foreign official” as defined in the U.S. Foreign Corrupt Practices Act of 1977, as amended (collectively, the “FCPA”), from corporate funds; (iii) violated or is in violation of any provision of the FCPA, U.K. Bribery Act 2010, as amended, or any other applicable anti-bribery statute or regulation; or (iv) made any bribe, rebate, payoff, influence payment, kickback or other unlawful payment to any domestic government official, foreign official or employee; and the Company and its subsidiaries, and to the knowledge of the Company, the Company’s controlled affiliates, have conducted their respective businesses in compliance with the FCPA and U.K. Bribery Act 2010, to the extent applicable, and all other applicable anti-bribery statutes and regulations, and have instituted and maintain policies and procedures designed to ensure, and which are reasonably expected to continue to ensure, continued compliance therewith
		

		
			(nn)  The operations of the Company and its subsidiaries are and have been conducted at all times in compliance with applicable financial recordkeeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970, as amended, the money laundering statutes of all jurisdictions, the rules and regulations thereunder and any related or similar rules, regulations or guidelines, issued, administered or enforced by any governmental agency (collectively, the “Money Laundering Laws”) and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company or any of its subsidiaries with respect to the Money Laundering Laws is pending or, to the knowledge of the Company, threatened.
		

		
			(oo)  Neither the Company nor any of its subsidiaries nor, to the knowledge of the Company, any director, officer, employee or controlled affiliate of the Company or any of its subsidiaries is (i) currently the target of any sanctions administered or enforced by the Office of Foreign Assets Control of the U.S. Treasury Department, the U.S. Department of State, the United Nations Security Council, the European Union, or Her Majesty’s Treasury (collectively, “Sanctions”); or (ii) located, organized or resident in a country that is the target of Sanctions (including, without limitation, Cuba, Iran, North Korea, Sudan, and Syria); and the Company will not directly or indirectly use the proceeds of the offering, or lend, contribute or otherwise make available such proceeds to any subsidiary, joint venture partner or other person or entity, for the purpose of financing the activities of any person, or in any country or territory, that currently is the target of Sanctions or in any other manner that will result in a violation by any person (including any person participating in the transaction whether as an underwriter, advisor, investor or otherwise) of Sanctions.  The Company and its subsidiaries have not knowingly engaged in for the 
		

		 

		

			- 13  -

		

 

		past five years, are not now knowingly engaged in, and will not engage in, any dealings or transactions with any individual or entity, or in any country or territory, that at the time of the dealing or transaction is or was the subject or target of Sanctions.
		

		
			(pp)  The Common Stock is an “actively-traded security” exempted from the requirements of Rule 101 of Regulation M under the Exchange Act by subsection (c)(1) of such rule.
		

		
			(qq)  Any certificate signed by any officer of the Company delivered to Cowen or to counsel for Cowen shall be deemed a representation and warranty by the Company to Cowen as to the matters covered thereby.
		

		
			(rr)  To the Company’s knowledge, there are no affiliations or associations between any member of FINRA and any of the Company’s officers or directors, except as set forth in the Prospectus.
		

		
			(ss)  Except as described in the Registration Statement and the Prospectus, and except as would not, individually or in the aggregate, have or reasonably be expected to have a Material Adverse Effect: (i) neither the Company nor any of its subsidiaries has received any notice of adverse filing, warning letter, untitled letter or other correspondence or notice from the Center for Veterinary Medicine of the U.S. Food and Drug Administration or the Center for Veterinary Biologics of the U.S. Department of Agriculture, or any other court or arbitrator or federal, state, local or foreign governmental or regulatory authority, alleging or asserting noncompliance with the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq.) (the “FFDCA”), the Animal Drug User Fee Act (“ADUFA”) or similar law; (ii) the Company and its subsidiaries are and have been in compliance with applicable health care laws, including without limitation, the FFDCA, the ADUFA and the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), and the regulations promulgated pursuant to such laws, and comparable state laws, and all other local, state, federal, national, supranational and foreign laws, manual provisions, policies and administrative guidance relating to the regulation of the Company and its subsidiaries (collectively, “Health Care Laws”); (iii) the Company and its subsidiaries possess all licenses, certificates, approvals, clearances, authorizations, permits and supplements or amendments thereto required by any such Health Care Laws and/or to carry on its businesses as now or proposed to be conducted (“Authorizations”) and such Authorizations are valid and in full force and effect and the Company and its subsidiaries are not in violation of any term of any such Authorizations; (iv) the Company and its subsidiaries have not received notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any U.S. or non-U.S. federal, state, local or other governmental or regulatory authority, governmental or regulatory agency or body, court, arbitrator or self-regulatory organization (each, a “Governmental Authority”) or third party alleging that any product operation or activity is in violation of any Health Care Laws or Authorizations or has any knowledge that any such Governmental Authority or third party is considering any such claim, litigation, arbitration, action, suit, investigation or proceeding; (v) the Company and its subsidiaries have not received notice that any Governmental Authority has taken, is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such Governmental Authority is considering such action; (vi) the Company and its subsidiaries have filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Health Care Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct 
		

		 

		

			- 14  -

		

 

		and not misleading on the date filed (or were corrected or supplemented by a subsequent submission); and (vii) the Company and its subsidiaries have not, either voluntarily or involuntarily, initiated, conducted, or issued or caused to be initiated, conducted or issued, any recall, market withdrawal or replacement, safety alert, post-sale warning, “dear doctor” letter, or other notice or action relating to the alleged lack of safety or efficacy of any product or any alleged product defect or violation and, to the Company’s knowledge, no third party has initiated or conducted any such notice or action.
		

		
			(tt)  To the knowledge of the Company, the material research, studies and tests conducted by or on behalf of the Company and its subsidiaries have been and, if still pending, are being conducted with reasonable care and in accordance with experimental protocols, procedures and controls pursuant to all Health Care Laws and Authorizations; the descriptions of the results of such research, studies and tests contained in the Registration Statement and the Prospectus are accurate and complete in all material respects and fairly present in all material respects the data derived from such research, studies, and tests; except to the extent disclosed in the Registration Statement and the Prospectus, the Company is not aware of any research, studies or tests, the results of which the Company believes reasonably call into question in any material respect the material research, study or test results described or referred to in the Registration Statement and the Prospectus when viewed in the context in which such results are described; and except to the extent disclosed in the Registration Statement and the Prospectus,  neither the Company nor any of its subsidiaries has received any notices or correspondence from any Governmental Authority requiring the termination, suspension or material modification of any material research, study or test conducted by or on behalf of the Company or any of its subsidiaries. To the knowledge of the Company, there have been no adverse episodes or complications resulting from any material research, study or test conducted by or on behalf of the Company or any of its subsidiaries,  except to the extent disclosed in the Registration Statement and the Prospectus.
		

		
			(uu)  Except as disclosed in the Registration Statement and the Prospectus, the Company and its subsidiaries (i) do not have any material lending or other relationship with Cowen or lending affiliate of Cowen and (ii) do not intend to use any of the proceeds from the sale of the Placement Shares to repay any outstanding debt owed to any affiliate of Cowen.
		

		
			(vv)  Each financial or operational projection or other “forward-looking statement” (as defined by Section 27A of the Securities Act or Section 21E of the Exchange Act) contained in the Registration Statement or the Prospectus (i) was so included by the Company in good faith and with reasonable basis after due consideration by the Company of the underlying assumptions, estimates and other applicable facts and circumstances and (ii) is accompanied by meaningful cautionary statements identifying those factors that could cause actual results to differ materially from those in such forward-looking statement.  No such statement was made with the knowledge of an executive officer or director of the Company that is was false or misleading.
		

		
			(ww)  The Company acknowledges and agrees that Cowen has informed the Company that Cowen may, to the extent permitted under the Securities Act and the Exchange Act, purchase and sell shares of Common Stock for its own account while this Agreement is in effect, provided, that (i) no such purchase or sales shall take place while a Placement Notice is in effect (except to the extent Cowen may engage in sales of Placement Shares purchased or deemed purchased from the Company as a “riskless principal” or in a similar capacity) and (ii) the Company shall not be deemed to have authorized or consented to any such purchases or sales by Cowen.
		

		

		

		 

		

			- 15  -

		

 

		Any certificate signed by an officer of the Company and delivered to Cowen or to counsel for Cowen shall be deemed to be a representation and warranty by the Company to Cowen as to the matters set forth therein.
		

		
			The Company acknowledges that Cowen and, for purposes of the opinions to be delivered pursuant to Section 7 hereof, counsel to the Company and counsel to Cowen, will rely upon the accuracy and truthfulness of the foregoing representations and hereby consents to such reliance.
		

		
			7.         Covenants of the Company.  The Company covenants and agrees with Cowen that:
		

		
			(a)  Registration Statement Amendments.  After the date of this Agreement and during any period in which a Prospectus relating to any Placement Shares is required to be delivered by Cowen under the Securities Act (including in circumstances where such requirement may be satisfied pursuant to Rule 172 under the Securities Act), (i) the Company will notify Cowen promptly of the time when any subsequent amendment to the Registration Statement, other than documents incorporated by reference, has been filed with the Commission and/or has become effective or any subsequent supplement to the Prospectus has been filed and of any request by the Commission for any amendment or supplement to the Registration Statement or Prospectus or for additional information, (ii) the Company will prepare and file with the Commission, promptly upon Cowen’s reasonable request, any amendments or supplements to the Registration Statement or Prospectus that, in Cowen’s reasonable opinion, may be necessary or advisable in connection with the distribution of the Placement Shares by Cowen (provided, however, that the failure of Cowen to make such request shall not relieve the Company of any obligation or liability hereunder, or affect Cowen’s right to rely on the representations and warranties made by the Company in this Agreement; and provided, further, that the only remedy Cowen shall have with respect to the failure to make such filing (other than Cowen’s rights under Section 9 hereof) will be to cease making sales under this Agreement until such amendment or supplement if filed); (iii) the Company will not file any amendment or supplement to the Registration Statement or Prospectus, other than documents incorporated by reference, relating to the Placement Shares or a security convertible into the Placement Shares unless a copy thereof has been submitted to Cowen within a reasonable period of time before the filing and Cowen has not reasonably objected thereto in writing within two business days  (provided, however, that (A) the failure of Cowen to make such objection shall not relieve the Company of any obligation or liability hereunder, or affect Cowen’s right to rely on the representations and warranties made by the Company in this Agreement, (B) the Company has no obligation to provide Cowen any advance copy of such filing or to provide Cowen an opportunity to object to such filing if the filing does not name Cowen and does not relate to the transaction contemplated by this Agreement, and (C) the only remedy Cowen shall have with respect to the failure by the Company to provide Cowen with such copy or the filing of such amendment or supplement despite Cowen’s objection (other than Cowen’s right under Section 9 hereof) will be to cease making sales under this Agreement) and the Company will furnish to Cowen at the time of filing thereof a copy of any document that upon filing is deemed to be incorporated by reference into the Registration Statement or Prospectus, except for those documents available via EDGAR; (iv) the Company will cause each amendment or supplement to the Prospectus, other than documents incorporated by reference, to be filed with the Commission as required pursuant to the applicable paragraph of Rule 424(b) of the Securities Act, and (v) prior to the termination of this Agreement, the Company will notify Cowen if at any time the 
		

		 

		

			- 16  -

		

 

		Registration Statement shall no longer be effective as a result of the passage of time pursuant to Rule 415 under the Securities Act or otherwise. 
		

		
			(b)  Notice of Commission Stop Orders.  The Company will advise Cowen, promptly after it receives notice or obtains knowledge thereof, of the issuance or threatened issuance by the Commission of any stop order suspending the effectiveness of the Registration Statement, of the suspension of the qualification of the Placement Shares for offering or sale in any jurisdiction, or of the initiation or threatening of any proceeding for any such purpose; and it will promptly use its commercially reasonable efforts to prevent the issuance of any stop order or to obtain its withdrawal if such a stop order should be issued.
		

		
			(c)  Delivery of Prospectus; Subsequent Changes.  During any period in which a Prospectus relating to the Placement Shares is required to be delivered by Cowen under the Securities Act with respect to a pending sale of the Placement Shares, (including in circumstances where such requirement may be satisfied pursuant to Rule 172 under the Securities Act), the Company will use its commercially reasonable efforts to comply with all requirements imposed upon it by the Securities Act, as from time to time in force, and to file on or before their respective due dates all reports and any definitive proxy or information statements required to be filed by the Company with the Commission pursuant to Sections 13(a), 13(c), 14, 15(d) or any other provision of or under the Exchange Act.  If during such period any event occurs as a result of which the Prospectus as then amended or supplemented would include an untrue statement of a material fact or omit to state a material fact necessary to make the statements therein, in the light of the circumstances then existing, not misleading, or if during such period it is necessary to amend or supplement the Registration Statement or Prospectus to comply with the Securities Act, the Company will promptly notify Cowen to suspend the offering of Placement Shares during such period and the Company will promptly amend or supplement the Registration Statement or Prospectus (at the expense of the Company) so as to correct such statement or omission or effect such compliance;  provided,  however, that the Company may delay any such amendment or supplement if, in the reasonable judgment of the Company, it is in the best interests of the Company to do so, provided that no Placement Note is in effect during such time.
		

		
			(d)  Listing of Placement Shares.  During any period in which the Prospectus relating to the Placement Shares is required to be delivered by Cowen under the Securities Act with respect to a pending sale of the Placement Shares (including in circumstances where such requirement may be satisfied pursuant to Rule 172 under the Securities Act), the Company will use its commercially reasonable efforts to cause the Placement Shares to be listed on Nasdaq and to qualify the Placement Shares for sale under the securities laws of such jurisdictions as Cowen reasonably designates and to continue such qualifications in effect so long as required for the distribution of the Placement Shares; provided, however, that the Company shall not be required in connection therewith to qualify as a foreign corporation or dealer in securities or file a general consent to service of process in any jurisdiction.
		

		
			(e)  Delivery of Registration Statement and Prospectus.  The Company will furnish to Cowen and its counsel (at the expense of the Company) copies of the Registration Statement, the Prospectus (including all documents incorporated by reference therein) and all amendments and supplements to the Registration Statement or Prospectus that are filed with the Commission during any period in which a Prospectus relating to the Placement Shares is required to be delivered under the Securities Act (including all documents filed with the Commission during such period that are 
		

		 

		

			- 17  -

		

 

		deemed to be incorporated by reference therein), in each case as soon as reasonably practicable and in such quantities as Cowen may from time to time reasonably request and, at Cowen’s request, will also furnish copies of the Prospectus to each exchange or market on which sales of the Placement Shares may be made; provided, however, that the Company shall not be required to furnish any document (other than the Prospectus) to Cowen to the extent such document is available on EDGAR.  
		

		
			(f)  Earnings Statement.  The Company will make generally available to its security holders as soon as practicable, but in any event not later than 15 months after the end of the Company’s current fiscal quarter, an earnings statement covering a 12-month period that satisfies the provisions of Section 11(a) and Rule 158 of the Securities Act.
		

		
			(g)   Expenses. The Company, whether or not the transactions contemplated hereunder are consummated or this Agreement is terminated, in accordance with the provisions of Section 11 hereunder, will pay the following expenses incident to the performance of its obligations hereunder, including, but not limited to, expenses relating to (A) the preparation, printing and filing of the Registration Statement and each amendment and supplement thereto, of each Prospectus and of each amendment and supplement thereto, (B) the preparation, issuance and delivery of the Placement Shares, (C) the qualification of the Placement Shares under securities laws in accordance with the provisions of Section 7(d) of this Agreement, including filing fees (provided, however, that any fees or disbursements of outside counsel for Cowen in connection therewith shall be paid by Cowen except as set forth in clauses (G) and (H) below), (D) the printing and delivery to Cowen of copies of the Prospectus and any amendments or supplements thereto, and of this Agreement, (E) the fees and expenses incurred in connection with the listing or qualification of the Placement Shares for trading on Nasdaq, (F) the filing fees and expenses, if any, of the Commission, (G)  the filing fees and associated legal expenses of Cowen’s outside counsel for filings with the FINRA Corporate Financing Department, such legal expense reimbursement not to exceed $12,000 and (H) the reasonable fees and disbursements of Cowen’s outside counsel in an amount not to exceed $50,000.
		

		
			(h)  Use of Proceeds.  The Company will use the Net Proceeds as described in the Prospectus in the section entitled “Use of Proceeds.”
		

		
			(i)  Notice of Other Sales.  During the pendency of any Placement Notice given hereunder, and for 5 trading days following the termination of any Placement Notice given hereunder, the Company shall provide Cowen notice as promptly as reasonably possible before it offers to sell, contracts to sell, sells, grants any option to sell or otherwise disposes of any shares of Common Stock (other than Placement Shares offered pursuant to the provisions of this Agreement) or securities convertible into or exchangeable for Common Stock, warrants or any rights to purchase or acquire Common Stock; provided, that such notice shall not be required in connection with the (i) issuance, grant or sale of Common Stock, options to purchase shares of Common Stock or Common Stock issuable upon the exercise of options or other equity awards pursuant to any stock option, stock bonus or other stock plan or arrangement described in the Prospectus; (ii) the issuance of securities in connection with an acquisition, merger or sale or purchase of assets; (iii) the issuance or sale of Common Stock pursuant to any dividend reinvestment plan that the Company may adopt from time to time provided the implementation of such is disclosed to Cowen in advance; (iv) any shares of common stock issuable upon the exchange, conversion or redemption of securities or the exercise of warrants, options or other rights in effect or outstanding; or (v) any 
		

		 

		

			- 18  -

		

 

		shares of common stock, securities convertible into or exercisable for common stock, offered and sold in a privately negotiated transaction to vendors, customers, investors, strategic partners or potential strategic partners and otherwise conducted in a manner so as not to be integrated with the offering of common stock hereby.  Notwithstanding the foregoing provisions, nothing herein shall be construed to restrict the Company’s ability to file a registration statement under the Securities Act.
		

		
			(j)  Change of Circumstances.  The Company will, at any time during the pendency of a Placement Notice or the pendency of any sale of Placement Shares, advise Cowen promptly after it shall have received notice or obtained knowledge thereof, of any information or fact that would alter or affect in any material respect any opinion, certificate, letter or other document provided to Cowen pursuant to this Agreement.
		

		
			(k)  Due Diligence Cooperation.  The Company will cooperate with any reasonable due diligence review conducted by Cowen or its agents in connection with the transactions contemplated hereby, including, without limitation, providing information and making available documents and senior corporate officers, during regular business hours and at the Company’s principal offices, as Cowen may reasonably request.
		

		
			(l)  Required Filings Relating to Placement of Placement Shares.  The Company agrees that on such dates as the Securities Act shall require, the Company will (i) file a prospectus supplement with the Commission under the applicable paragraph of Rule 424(b) under the Securities Act (each and every filing under Rule 424(b), a “Filing Date”), which prospectus supplement will set forth, within the relevant period, the amount of Placement Shares sold through Cowen, the Net Proceeds to the Company and the compensation payable by the Company to Cowen with respect to such Placement Shares, and (ii) deliver such number of copies of each such prospectus supplement to each exchange or market on which such sales were effected as may be required by the rules or regulations of such exchange or market.
		

		
			(m)  Representation Dates; Certificate.  On or prior to the First Delivery Date and during the term of this Agreement each time the Company (i) files the Prospectus relating to the Placement Shares or amends or supplements the Registration Statement or the Prospectus relating to the Placement Shares (other than a prospectus supplement filed in accordance with Section 7(l) of this Agreement) by means of a post-effective amendment, sticker, or supplement but not by means of incorporation of document(s) by reference to the Registration Statement or the Prospectus relating to the Placement Shares; (ii) files an annual report on Form 10-K under the Exchange Act; (iii) files its quarterly reports on Form 10-Q under the Exchange Act; or (iv) files a report on Form 8-K containing amended financial information (other than an earnings release or other information “furnished” to the Commission) under the Exchange Act (each date of filing of one or more of the documents referred to in clauses (i) through (iv) shall be a “Representation Date”); the Company shall furnish Cowen (but in the case of clause (iv) above only if (1) a Placement Notice is pending, (2) Cowen reasonably determines that the information contained in such Form 8-K is material to a holder of Common Stock and (3) Cowen requests such certificate within three (3) days after the filing of such Form 8-K with the Commission) with a certificate, in the form attached hereto as Exhibit 7(m) within three (3) Trading Days of any Representation Date if requested by Cowen.  The requirement to provide a certificate under this Section 7(m) shall be waived for any Representation Date occurring at a time at which no Placement Notice is pending, which waiver shall continue until the earlier to occur of the date the Company delivers a Placement Notice 
		

		 

		

			- 19  -

		

 

		hereunder (which for such calendar quarter shall be considered a Representation Date) and the next occurring Representation Date; provided,  however, that such waiver shall not apply for any Representation Date on which the Company files its annual report on Form 10-K.  Notwithstanding the foregoing, if the Company subsequently decides to sell Placement Shares following a Representation Date when the Company relied on such waiver and did not provide Cowen with a certificate under this Section 7(m), then before the Company delivers the Placement Notice or Cowen sells any Placement Shares, the Company shall provide Cowen with a certificate, in the form attached hereto as Exhibit 7(m), dated the date of the Placement Notice.
		

		
			(n)  Legal Opinion.  On or prior to the First Delivery Date and within three (3) Trading Days of each Representation Date with respect to which the Company is obligated to deliver a certificate in the form attached hereto as Exhibit 7(m) for which no waiver is applicable, the Company shall cause (i) Latham & Watkins LLP, or other counsel satisfactory to Cowen,  to furnish to Cowen a written opinion and negative assurances statement, each in form and substance reasonably satisfactory to Cowen and its counsel, modified, as necessary, to relate to the Registration Statement and the Prospectus as then amended or supplemented and (ii) the Company’s general counsel to furnish to Cowen a written opinion in form and substance reasonably satisfactory to Cowen and its counsel, modified, as necessary, to relate to the Registration Statement and the Prospectus as then amended and supplemented;  provided,  however, that in lieu of such opinions for subsequent Representation Dates, counsel may furnish Cowen with a letter (a “Reliance Letter”) to the effect that Cowen may rely on a prior opinion delivered under this Section 7(n) to the same extent as if it were dated the date of such letter (except that statements in such prior opinion shall be deemed to relate to the Registration Statement and the Prospectus as amended or supplemented at such Representation Date).  In addition, in connection with the initial Representation Date and promptly after each Representation Date on which the Company files its Annual Report on 10-K (or, if the Company has notified Cowen that it does not then presently intend to make sales of Placement Shares under this Agreement, then the next date on which written opinions are delivered under this Agreement), the Company will furnish or cause to be furnished to Cowen and to counsel to Cowen the written opinion and letter of intellectual property counsel to the Company, dated the date of filing with the Commission of such document, in a form and substance reasonably satisfactory to Cowen and its counsel.
		

		
			(o)  Comfort Letter.  On or prior to the First Delivery Date and within three (3) Trading Days of each Representation Date with respect to which the Company is obligated to deliver a certificate in the form attached hereto as Exhibit 7(m) for which no waiver is applicable, the Company shall cause its independent accountants to furnish Cowen letters (the "Comfort Letters"), dated the date the Comfort Letter is delivered, in form and substance reasonably satisfactory to Cowen, (i) confirming that they are an independent registered public accounting firm within the meaning of the Securities Act and the PCAOB, (ii) stating, as of such date, the conclusions and findings of such firm with respect to the financial information and other matters ordinarily covered by accountants’ “comfort letters” to Cowen in connection with registered public offerings (the first such letter, the “Initial Comfort Letter”) and (iii) updating the Initial Comfort Letter with any information that would have been included in the Initial Comfort Letter had it been given on such date and modified as necessary to relate to the Registration Statement and the Prospectus, as amended and supplemented to the date of such letter.
		

		 

		

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			(p)  Market Activities.  The Company will not, directly or indirectly, (i) take any action designed to cause or result in, or that constitutes or might reasonably be expected to constitute, the stabilization or manipulation of the price of any security of the Company to facilitate the sale or resale of the Placement Shares or (ii) sell, bid for, or purchase the Common Stock to be issued and sold pursuant to this Agreement, or pay anyone any compensation for soliciting purchases of the Placement Shares other than Cowen; provided, however, that the Company may bid for and purchase shares of its common stock in accordance with Rule 10b-18 under the Exchange Act.
		

		
			(q)  Insurance.  The Company and its subsidiaries shall maintain, or cause to be maintained, insurance in such amounts and covering such risks as is reasonable and customary for the business for which it is engaged.
		

		
			(r)  Compliance with Laws.  The Company and each of its subsidiaries shall maintain, or cause to be maintained, all material environmental permits, licenses and other authorizations required by federal, state and local law in order to conduct their businesses as described in the Prospectus, and the Company and each of its subsidiaries shall conduct their businesses, or cause their businesses to be conducted, in substantial compliance with such permits, licenses and authorizations and with applicable environmental laws, except where the failure to maintain or be in compliance with such permits, licenses and authorizations could not reasonably be expected to result in a Material Adverse Change.
		

		
			(s)  Investment Company Act.  The Company will conduct its affairs in such a manner so as to reasonably ensure that neither it nor its subsidiaries will be or become, at any time prior to the termination of this Agreement, an “investment company,” as such term is defined in the Investment Company Act, assuming no change in the Commission’s current interpretation as to entities that are not considered an investment company.
		

		
			(t)  Securities Act and Exchange Act.  The Company will use its commercially reasonable efforts to comply in all material respects with all requirements imposed upon it by the Securities Act and the Exchange Act as from time to time in force, so far as necessary to permit the continuance of sales of, or dealings in, the Placement Shares as contemplated by the provisions hereof and the Prospectus.
		

		
			(u)  No Offer to Sell.  Other than a free writing prospectus (as defined in Rule 405 under the Securities Act) approved in advance by the Company and Cowen in its capacity as principal or agent hereunder, neither Cowen nor the Company (including its agents and representatives, other than Cowen in its capacity as such) will make, use, prepare, authorize, approve or refer to any written communication (as defined in Rule 405 under the Securities Act), required to be filed with the Commission, that constitutes an offer to sell or solicitation of an offer to buy Common Stock hereunder.
		

		
			(v)  Sarbanes-Oxley Act.  The Company and its subsidiaries will use their commercially reasonable efforts to comply with all effective applicable provisions of the Sarbanes-Oxley Act.
		

		
			8.         Conditions to Cowen’s Obligations. The obligations of Cowen hereunder with respect to a Placement will be subject to the continuing accuracy and completeness of the representations and warranties made by the Company herein, to the due performance by the Company of its obligations hereunder, to the completion by Cowen of a due diligence review 
		

		 

		

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		satisfactory to Cowen in its reasonable judgment, and to the continuing satisfaction (or waiver by Cowen in its sole discretion) of the following additional conditions:
		

		
			(a)  Registration Statement Effective.  The Registration Statement shall be effective and shall be available the sale of all Placement Shares contemplated to be issued by any Placement Notice.
		

		
			(b)  No Material Notices.  None of the following events shall have occurred and be continuing:  (i) receipt by the Company or any of its subsidiaries of any request for additional information from the Commission or any other federal or state governmental authority during the period of effectiveness of the Registration Statement, the response to which would require any post-effective amendments or supplements to the Registration Statement or the Prospectus; (ii) the issuance by the Commission or any other federal or state governmental authority of any stop order suspending the effectiveness of the Registration Statement or the initiation of any proceedings for that purpose; (iii) receipt by the Company of any notification with respect to the suspension of the qualification or exemption from qualification of any of the Placement Shares for sale in any jurisdiction or the initiation or threatening of any proceeding for such purpose; or (iv) the occurrence of any event that makes any material statement made in the Registration Statement or the Prospectus or any material document incorporated or deemed to be incorporated therein by reference untrue in any material respect or that requires the making of any changes in the Registration Statement, related Prospectus or such documents so that, in the case of the Registration Statement, it will not contain any materially untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein not misleading and, that in the case of the Prospectus, it will not contain any materially untrue statement of a material fact or omit to state any material fact required to be stated therein or necessary to make the statements therein, in the light of the circumstances under which they were made, not misleading. 
		

		
			(c)  No Misstatement or Material Omission.  Cowen shall not have advised the Company that the Registration Statement or Prospectus, or any amendment or supplement thereto, contains an untrue statement of fact that in Cowen’s reasonable opinion is material, or omits to state a fact that in Cowen’s opinion is material and is required to be stated therein or is necessary to make the statements therein not misleading.
		

		
			(d)  Material Changes.  Except as contemplated in the Prospectus, or disclosed in the Company’s reports filed with the Commission, there shall not have been any material adverse change, on a consolidated basis, in the authorized capital stock of the Company or any Material Adverse Change or any development that could reasonably be expected to result in a Material Adverse Change, or any downgrading in or withdrawal of the rating assigned to any of the Company’s securities (other than asset backed securities) by any rating organization or a public announcement by any rating organization that it has under surveillance or review its rating of any of the Company’s securities (other than asset backed securities), the effect of which, in the case of any such action by a rating organization described above, in the reasonable judgment of Cowen (without relieving the Company of any obligation or liability it may otherwise have), is so material as to make it impracticable or inadvisable to proceed with the offering of the Placement Shares on the terms and in the manner contemplated in the Prospectus.
		

		 

		

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			(e)  Company Counsel Legal Opinion.  Cowen shall have received the opinions of Company Counsel required to be delivered pursuant to Section 7(n) on or before the date on which such delivery of such opinion is required pursuant to Section 7(n).
		

		
			(f)  Cowen Counsel Legal Opinion.  Cowen shall have received from Covington & Burling LLP, counsel for Cowen, such opinion or opinions, on or before the date on which the delivery of the Company Counsel legal opinion is required pursuant to Section 7(n), with respect to such matters as Cowen may reasonably require, and the Company shall have furnished to such counsel such documents as they request for enabling them to pass upon such matters.
		

		
			(g)  Comfort Letter.  Cowen shall have received the Comfort Letter required to be delivered pursuant to Section 7(o) on or before the date on which such delivery of such Comfort Letter is required pursuant to Section 7(o).
		

		
			(h)  Representation Certificate.  Cowen shall have received the certificate required to be delivered pursuant to Section 7(m) on or before the date on which delivery of such certificate is required pursuant to Section 7(m).
		

		
			(i)  Secretary’s Certificate.  On or prior to the First Delivery Date, Cowen shall have received a certificate, signed on behalf of the Company by its corporate Secretary, in form and substance reasonably satisfactory to Cowen and its counsel.
		

		
			(j)  No Suspension.  Trading in the Common Stock shall not have been suspended on Nasdaq.
		

		
			(k)  Other Materials.  On each date on which the Company is required to deliver a certificate pursuant to Section 7(m), the Company shall have furnished to Cowen such appropriate further information, certificates and documents as Cowen may have reasonably requested. All such opinions, certificates, letters and other documents shall have been in compliance with the provisions hereof. The Company will furnish Cowen with such conformed copies of such opinions, certificates, letters and other documents as Cowen shall have reasonably requested.
		

		
			(l)  Securities Act Filings Made.  All filings with the Commission required by Rule 424 under the Securities Act to have been filed prior to the issuance of any Placement Notice hereunder shall have been made within the applicable time period prescribed for such filing by Rule 424.
		

		
			(m)  Approval for Listing.  The Placement Shares shall either have been (i) approved for listing on Nasdaq, subject only to notice of issuance, or (ii) the Company shall have filed an application for listing of the Placement Shares on Nasdaq at, or prior to, the issuance of any Placement Notice.
		

		
			(n)  No Termination Event.  There shall not have occurred any event that would permit Cowen to terminate this Agreement pursuant to Section 11(a).
		

		
			9.         Indemnification and Contribution.
		

		
			(a)  Company Indemnification.  The Company agrees to indemnify and hold harmless Cowen, the directors, officers, partners, employees and agents of Cowen and each person, if any, who (i) controls Cowen within the meaning of Section 15 of the Securities Act or Section 20 of the 
		

		 

		

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		Exchange Act, or (ii) is controlled by or is under common control with Cowen (a “Cowen Affiliate”) from and against any and all losses, claims, liabilities, expenses and damages (including, but not limited to, any and all reasonable investigative, legal and other expenses  incurred in connection with, and any and all amounts paid in settlement (in accordance with Section 9(c)) of, any action, suit or proceeding between any of the indemnified parties and any indemnifying parties or between any indemnified party and any third party, or otherwise, or any claim asserted), as and when incurred, to which Cowen, or any such person, may become subject under the Securities Act, the Exchange Act or other federal or state statutory law or regulation, at common law or otherwise, insofar as such losses, claims, liabilities, expenses or damages arise out of or are based, directly or indirectly, on (x) any untrue statement or alleged untrue statement of a material fact contained in the Registration Statement or the Prospectus or any amendment or supplement to the Registration Statement or the Prospectus or in any free writing prospectus or based on written information furnished by or on behalf of the Company filed in any jurisdiction in order to qualify the Common Stock under the securities laws thereof or filed with the Commission, or  (y) the omission or alleged omission to state in any such document a material fact required to be stated in it or necessary to make the statements therein in light of (other than the case of the Registration Statement) the circumstances under which they were made, not misleading; provided,  however, that this indemnity agreement shall not apply to the extent that such loss, claim, liability, expense or damage arises from the sale of the Placement Shares pursuant to this Agreement and is caused directly or indirectly by an untrue statement or omission or alleged untrue statement or omission of material fact, made in reliance upon and in conformity with the Agent’s Information.  This indemnity agreement will be in addition to any liability that the Company might otherwise have.
		

		
			(b)  Cowen Indemnification.  Cowen agrees to indemnify and hold harmless the Company and its directors and each officer of the Company that signed the Registration Statement, and each person, if any, who (i) controls the Company within the meaning of Section 15 of the Securities Act or Section 20 of the Exchange Act or (ii) is controlled by or is under common control with the Company (a “Company Affiliate”) against any and all loss, liability, claim, damage and expense described in the indemnity contained in Section 9(a), as incurred, but only with respect to untrue statements or omissions, or alleged untrue statements or omissions, made in the Registration Statement (or any amendments thereto) or the Prospectus (or any amendment or supplement thereto) in reliance upon and in conformity with the Agent’s Information.
		

		
			(c)  Procedure.  Any party that proposes to assert the right to be indemnified under this Section 9 will, promptly after receipt of notice of commencement of any action against such party in respect of which a claim is to be made against an indemnifying party or parties under this Section 9, notify each such indemnifying party of the commencement of such action, enclosing a copy of all papers served, but the omission so to notify such indemnifying party will not relieve the indemnifying party from (i) any liability that it might have to any indemnified party otherwise than under this Section 9 and (ii) any liability that it may have to any indemnified party under the foregoing provision of this Section 9 unless, and only to the extent that, such omission results in the forfeiture of substantive rights or defenses by the indemnifying party. If any such action is brought against any indemnified party and it notifies the indemnifying party of its commencement, the indemnifying party will be entitled to participate in and, to the extent that it elects by delivering written notice to the indemnified party promptly after receiving notice of the commencement of the action from the indemnified party, jointly with any other indemnifying party similarly notified, 
		

		 

		

			- 24  -

		

 

		to assume the defense of the action, with counsel reasonably satisfactory to the indemnified party, and after notice from the indemnifying party to the indemnified party of its election to assume the defense, the indemnifying party will not be liable to the indemnified party for any legal or other expenses except as provided below and except for the reasonable costs of investigation subsequently incurred by the indemnified party in connection with the defense. The indemnified party will have the right to employ its own counsel in any such action, but the fees, expenses and other charges of such counsel will be at the expense of such indemnified party unless (1) the employment of counsel by the indemnified party has been authorized in writing by the indemnifying party, (2) the indemnified party has reasonably concluded (based on advice of counsel) that there may be legal defenses available to it or other indemnified parties that are different from or in addition to those available to the indemnifying party, (3) a conflict or potential conflict exists (based on advice of counsel to the indemnified party) between the indemnified party and the indemnifying party (in which case the indemnifying party will not have the right to direct the defense of such action on behalf of the indemnified party) or (4) the indemnifying party has not in fact employed counsel to assume the defense of such action within a reasonable time after receiving notice of the commencement of the action, in each of which cases the reasonable fees, disbursements and other charges of counsel will be at the expense of the indemnifying party or parties. It is understood that the indemnifying party or parties shall not, in connection with any proceeding or related proceedings in the same jurisdiction, be liable for the reasonable fees, disbursements and other charges of more than one separate firm admitted to practice in such jurisdiction at any one time for all such indemnified party or parties. All such fees, disbursements and other charges will be reimbursed by the indemnifying party promptly as they are incurred after the indemnifying party receives a written invoice relating to fees, disbursements and other charges in reasonable detail. An indemnifying party will not, in any event, be liable for any settlement of any action or claim effected without its written consent.  No indemnifying party shall, without the prior written consent of each indemnified party, settle or compromise or consent to the entry of any judgment in any pending or threatened claim, action or proceeding relating to the matters contemplated by this Section 9 (whether or not any indemnified party is a party thereto), unless such settlement, compromise or consent includes an unconditional release of each indemnified party from all liability arising or that may arise out of such claim, action or proceeding. 
		

		
			(d)  Contribution.  In order to provide for just and equitable contribution in circumstances in which the indemnification provided for in the foregoing paragraphs of this Section 9 is applicable in accordance with its terms but for any reason is held to be unavailable from the Company or Cowen, the Company and Cowen will contribute to the total losses, claims, liabilities, expenses and damages (including any investigative, legal and other expenses reasonably incurred in connection with, and any amount paid in settlement of, any action, suit or proceeding or any claim asserted, but after deducting any contribution received by the Company from persons other than Cowen, such as persons who control the Company within the meaning of the Securities Act, officers of the Company who signed the Registration Statement and directors of the Company, who also may be liable for contribution) to which the Company and Cowen may be subject in such proportion as shall be appropriate to reflect the relative benefits received by the Company on the one hand and Cowen on the other. The relative benefits received by the Company on the one hand and Cowen on the other hand shall be deemed to be in the same proportion as the total Net Proceeds from the sale of the Placement Shares (before deducting expenses) received by the Company bear to the total compensation received by Cowen from the sale of Placement Shares on behalf of the Company.  If, but only if, the allocation provided by the foregoing sentence is not permitted by 
		

		 

		

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		applicable law, the allocation of contribution shall be made in such proportion as is appropriate to reflect not only the relative benefits referred to in the foregoing sentence but also the relative fault of the Company, on the one hand, and Cowen, on the other, with respect to the statements or omission that resulted in such loss, claim, liability, expense or damage, or action in respect thereof, as well as any other relevant equitable considerations with respect to such offering. Such relative fault shall be determined by reference to, among other things, whether the untrue or alleged untrue statement of a material fact or omission or alleged omission to state a material fact relates to information supplied by the Company or Cowen, the intent of the parties and their relative knowledge, access to information and opportunity to correct or prevent such statement or omission. The Company and Cowen agree that it would not be just and equitable if contributions pursuant to this Section 9(d) were to be determined by pro rata allocation or by any other method of allocation that does not take into account the equitable considerations referred to herein. The amount paid or payable by an indemnified party as a result of the loss, claim, liability, expense, or damage, or action in respect thereof, referred to above in this Section 9(d) shall be deemed to include, for the purpose of this Section 9(d), any legal or other expenses reasonably incurred by such indemnified party in connection with investigating or defending any such action or claim to the extent consistent with Section 9(c) hereof.  Notwithstanding the foregoing provisions of this Section 9(d),  Cowen shall not be required to contribute any amount in excess of the commissions received by it under this Agreement and no person found guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) will be entitled to contribution from any person who was not guilty of such fraudulent misrepresentation. For purposes of this Section 9(d), any person who controls a party to this Agreement within the meaning of the Securities Act, and any officers, directors, partners, employees or agents of Cowen, will have the same rights to contribution as that party, and each director of the Company and each officer of the Company who signed the Registration Statement will have the same rights to contribution as the Company, subject in each case to the provisions hereof. Any party entitled to contribution, promptly after receipt of notice of commencement of any action against such party in respect of which a claim for contribution may be made under this Section 9(d), will notify any such party or parties from whom contribution may be sought, but the omission to so notify will not relieve that party or parties from whom contribution may be sought from any other obligation it or they may have under this Section 9(d) except to the extent that the failure to so notify such other party materially prejudiced the substantive rights or defenses of the party from whom contribution is sought. Except for a settlement entered into pursuant to the last sentence of Section 9(c) hereof, no party will be liable for contribution with respect to any action or claim settled without its written consent if such consent is required pursuant to Section 9(c) hereof.
		

		
			10.        Representations and Agreements to Survive Delivery.  The indemnity and contribution agreements contained in Section 9 of this Agreement and all representations and warranties of the Company herein or in certificates delivered pursuant hereto shall survive, as of their respective dates, regardless of (i) any investigation made by or on behalf of Cowen, any controlling persons, or the Company (or any of their respective officers, directors or controlling persons), (ii) delivery and acceptance of the Placement Shares and payment therefor or (iii) any termination of this Agreement.
		

		
			11.        Termination.
		

		 

		

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			(a)  owen shall have the right by giving written notice as hereinafter specified at any time to terminate this Agreement if (i) any Material Adverse Change, or any development that could reasonably be expected to result in a Material Adverse Change has occurred that, in the reasonable judgment of Cowen, may materially impair the ability of Cowen to sell the Placement Shares hereunder, (ii) the Company shall have failed, refused or been unable to perform any agreement on its part to be performed hereunder; provided, however, in the case of any failure of the Company to deliver (or cause another person to deliver) any certification, opinion, or letter required under Sections 7(m),  7(n), or 7(o),  Cowen’s right to terminate shall not arise unless such failure to deliver (or cause to be delivered) continues for more than thirty (30) days from the date such delivery was required; or (iii) any other condition of Cowen’s obligations hereunder is not fulfilled, or (iv), any suspension or limitation of trading in the Placement Shares or in securities generally on Nasdaq shall have occurred.  Any such termination shall be without liability of any party to any other party except that the provisions of Section 7(g) (Expenses), Section 9 (Indemnification and Contribution), Section 10  (Representations and Agreements to Survive Delivery), Section 16 (Applicable Law; Consent to Jurisdiction) and Section 17 (Waiver of Jury Trial) hereof shall remain in full force and effect notwithstanding such termination. If Cowen elects to terminate this Agreement as provided in this Section 11(a),  Cowen shall provide the required notice as specified in Section 12 (Notices).
		

		
			(b)  The Company shall have the right, by giving ten (10) days notice as hereinafter specified to terminate this Agreement in its sole discretion at any time after the date of this Agreement.  Any such termination shall be without liability of any party to any other party except that the provisions of Section 7(g),  Section 9,  Section 10,  Section 16 and Section 17 hereof shall remain in full force and effect notwithstanding such termination.
		

		
			(c)  Cowen shall have the right, by giving ten (10) days notice as hereinafter specified to terminate this Agreement in its sole discretion at any time after the date of this Agreement.  Any such termination shall be without liability of any party to any other party except that the provisions of Section 7(g),  Section 9,  Section 10,  Section 16 and Section 17 hereof shall remain in full force and effect notwithstanding such termination.
		

		
			(d)  Unless earlier terminated pursuant to this Section 11, this Agreement shall automatically terminate upon the issuance and sale of all of the Placement Shares through Cowen on the terms and subject to the conditions set forth herein; provided that the provisions of Section 7(g),  Section 9,  Section 10,  Section 16 and Section 17 hereof shall remain in full force and effect notwithstanding such termination.
		

		
			(e)  This Agreement shall remain in full force and effect unless terminated pursuant to Sections 11(a),  (b),  (c), or (d) above or otherwise by mutual agreement of the parties; provided, however, that any such termination by mutual agreement shall in all cases be deemed to provide that Section 7(g),  Section 9,  Section 10,  Section 16 and Section 17 shall remain in full force and effect.
		

		
			(f)  Any termination of this Agreement shall be effective on the date specified in such notice of termination; provided, however, that such termination shall not be effective until the close of business on the date of receipt of such notice by Cowen or the Company, as the case may be. If such termination shall occur prior to the Settlement Date for any sale of Placement Shares, such Placement Shares shall settle in accordance with the provisions of this Agreement.
		

		 

		

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			12.        Notices.  All notices or other communications required or permitted to be given by any party to any other party pursuant to the terms of this Agreement shall be in writing, unless otherwise specified in this Agreement, and if sent to Cowen, shall be delivered to Cowen at Cowen and Company, LLC, 599 Lexington Avenue, New York, NY 10022, fax no. 646-562-1124, Attention:  General Counsel; or if sent to the Company, shall be delivered to Aratana Therapeutics, Inc., 11400 Tomahawk Creek Parkway, Suite 340,  Leawood, KS 66211; Attention: Steven St. Peter; (Fax: (913) 273-1594), with a copy to Latham & Watkins LLP, John Hancock Tower, 27th Floor, 200 Clarendon Street, Boston, MA 02116 (Fax:  (617) 948-6001), Attention: Peter N. Handrinos. Each party to this Agreement may change such address for notices by sending to the parties to this Agreement written notice of a new address for such purpose.  Each such notice or other communication shall be deemed given (i) when delivered personally or by verifiable facsimile transmission (with an original to follow) on or before 4:30 p.m., New York City time, on a Business Day (as defined below), or, if such day is not a Business Day on the next succeeding Business Day, (ii) on the next Business Day after timely delivery to a nationally-recognized overnight courier and (iii) on the Business Day actually received if deposited in the U.S. mail (certified or registered mail, return receipt requested, postage prepaid). For purposes of this Agreement, “Business Day” shall mean any day on which the Nasdaq and commercial banks in the City of New York are open for business.
		

		
			13.        Successors and Assigns.  This Agreement shall inure to the benefit of and be binding upon the Company and Cowen and their respective successors and the affiliates, controlling persons, officers and directors referred to in Section 9 hereof. References to any of the parties contained in this Agreement shall be deemed to include the successors and permitted assigns of such party. Nothing in this Agreement, express or implied, is intended to confer upon any party other than the parties hereto or their respective successors and permitted assigns any rights, remedies, obligations or liabilities under or by reason of this Agreement, except as expressly provided in this Agreement. Neither party may assign its rights or obligations under this Agreement without the prior written consent of the other party; provided,  however, that Cowen may assign its rights and obligations hereunder to an affiliate of Cowen without obtaining the Company’s consent.
		

		
			14.        Adjustments for Share Splits.  The parties acknowledge and agree that all share-related numbers contained in this Agreement shall be adjusted to take into account any share split, share dividend or similar event effected with respect to the Common Stock.
		

		
			15.        Entire Agreement; Amendment; Severability.  This Agreement (including all schedules and exhibits attached hereto and Placement Notices issued pursuant hereto) constitutes the entire agreement and supersedes all other prior and contemporaneous agreements and undertakings, both written and oral, among the parties hereto with regard to the subject matter hereof. Neither this Agreement nor any term hereof may be amended except pursuant to a written instrument executed by the Company and Cowen.  In the event that any one or more of the provisions contained herein, or the application thereof in any circumstance, is held invalid, illegal or unenforceable as written by a court of competent jurisdiction,  then such provision shall be given full force and effect to the fullest possible extent that it is valid, legal and enforceable, and the remainder of the terms and provisions herein shall be construed as if such invalid, illegal or unenforceable term or provision was not contained herein, but only to the extent that giving effect to such provision and the remainder of the terms and provisions hereof shall be in accordance with the intent of the parties as reflected in this Agreement.
		

		 

		

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			16.        Applicable Law; Consent to Jurisdiction. This Agreement shall be governed by, and construed in accordance with, the internal laws of the State of New York without regard to the principles of conflicts of laws. Each party hereby irrevocably submits to the non-exclusive jurisdiction of the state and federal courts sitting in the City of New York, borough of Manhattan, for the adjudication of any dispute hereunder or in connection with any transaction contemplated hereby, and hereby irrevocably waives, and agrees not to assert in any suit, action or proceeding, any claim that it is not personally subject to the jurisdiction of any such court, that such suit, action or proceeding is brought in an inconvenient forum or that the venue of such suit, action or proceeding is improper.  Each party hereby irrevocably waives personal service of process and consents to process being served in any such suit, action or proceeding by mailing a copy thereof (certified or registered mail, return receipt requested) to such party at the address in effect for notices to it under this Agreement and agrees that such service shall constitute good and sufficient service of process and notice thereof.  Nothing contained herein shall be deemed to limit in any way any right to serve process in any manner permitted by law.
		

		
			17.        Waiver of Jury Trial.  The Company and Cowen each hereby irrevocably waives any right it may have to a trial by jury in respect of any claim based upon or arising out of this Agreement or any transaction contemplated hereby.
		

		
			18.        Absence of Fiduciary Relationship.  The Company acknowledges and agrees that:
		

		
			(a)  Cowen has been retained solely to act as sales agent in connection with the sale of the Common Stock and that no fiduciary, advisory or agency relationship between the Company and Cowen has been created in respect of any of the transactions contemplated by this Agreement, irrespective of whether Cowen has advised or is advising the Company on other matters;
		

		
			(b)  the Company is capable of evaluating and understanding and understands and accepts the terms, risks and conditions of the transactions contemplated by this Agreement;
		

		
			(c)  the Company has been advised that Cowen and its affiliates are engaged in a broad range of transactions which may involve interests that differ from those of the Company and that Cowen has no obligation to disclose such interests and transactions to the Company by virtue of any fiduciary, advisory or agency relationship; and
		

		
			(d)  the Company waives, to the fullest extent permitted by law, any claims it may have against Cowen, for breach of fiduciary duty or alleged breach of fiduciary duty and agrees that Cowen shall have no liability (whether direct or indirect) to the Company in respect of such a fiduciary claim or to any person asserting a fiduciary duty claim on behalf of or in right of the Company, including stockholders, partners, employees or creditors of the Company.
		

		
			19.        Counterparts.  This Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. Delivery of an executed Agreement by one party to the other may be made by facsimile transmission.
		

		
			20.        Definitions.  
		

		

		

		 

		

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		“Agent’s Information” means, solely the following information in the Prospectus: the first and third sentences of the eighth paragraph and the tenth paragraph under the caption “Plan of Distribution” in the Prospectus.
		

		
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			- 30  -

		

 

		

			 

		

		If the foregoing correctly sets forth the understanding between the Company and Cowen, please so indicate in the space provided below for that purpose, whereupon this letter shall constitute a binding agreement between the Company and Cowen.  
		

		
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						Very truly yours,

				
	
					
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						COWEN AND COMPANY, LLC

				
	
					
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						By:  

					
					
						/s/ Rob Sine

				
	
					
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						Name:    Rob Sine

				
	
					
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						Title:  Managing Director

				
	
					
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						ACCEPTED as of the date

				
	
					
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						first-above written:

				
	
					
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						ARATANA THERAPEUTICS, INC.

				
	
					
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						By:

					
					
						/s/ Steven St. Peter

				
	
					
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						Name:  Steven St. Peter

				
	
					
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						Title:  President and Chief Executive Officer

				

		
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		SCHEDULE 1
		

		
			form of PLACEMENT NOTICE
		

		
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						From:

					
					
						[                                  ]

				
	
					
						Cc:

					
					
						[                                  ]

				
	
					
						To:

					
					
						[                                  ]

				
	
					
						Subject:

					
					
						Cowen at the Market Offering—Placement Notice

				

		
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			Gentlemen:
		

		
			Pursuant to the terms and subject to the conditions contained in the Sales Agreement between Aratana Therapeutics, Inc. (the “Company”), and Cowen and Company, LLC (“Cowen”) dated December [      ], 2017 (the “Agreement”), I hereby request on behalf of the Company that Cowen sell up to [  ] shares of the Company’s common stock, par value $0.001 per share, at a minimum market price of $_______ per share.  Sales should begin on the date of this Notice and shall continue until [DATE] [all shares are sold].
		

		
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		SCHEDULE 2
		

		
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			Aratana Therapeutics, Inc.
		

		
			Steven St. Peter
		

		
			Craig Tooman
		

		
			John Ayres
		

		
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			Cowen and Company, LLC
		

		
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			Rob Sine
		

		
			Bill Follis
		

		
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		SCHEDULE 3
		

		
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			Compensation
		

		
			Cowen shall be paid compensation equal to 3% of the gross proceeds from the sales of Common Stock pursuant to the terms of this Agreement.
		

		
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		SCHEDULE 4
		

		
			Schedule Of Subsidiaries
		

		
			1.Vet Therapeutics, Inc.
		

		
			2.Aratana Therapeutics NV
		

		
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			Exhibit 7(m) 
		

		
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			OFFICER CERTIFICATE
		

		
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			The undersigned, the duly qualified and elected _______________________, of Aratana Therapeutics, Inc. (“Company”), a Delaware corporation, does hereby certify in such capacity and on behalf of the Company, pursuant to Section 7(m) of the Sales Agreement dated December [  ], 2017 (the “Sales Agreement”) between the Company and Cowen and Company, LLC, that to the best of the knowledge of the undersigned.
		

		
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			(i)       The representations and warranties of the Company in Section 6 of the Sales Agreement (A) to the extent such representations and warranties are subject to qualifications and exceptions contained therein relating to materiality or Material Adverse Change, are true and correct on and as of the date hereof with the same force and effect as if expressly made on and as of the date hereof, except for those representations and warranties that speak solely as of a specific date and which were true and correct as of such date, and (B) to the extent such representations and warranties are not subject to any qualifications or exceptions, are true and correct in all material respects as of the date hereof as if made on and as of the date hereof with the same force and effect as if expressly made on and as of the date hereof except for those representations and warranties that speak solely as of a specific date and which were true and correct as of such date; and
		

		
			(ii)      The Company has complied with all agreements and satisfied all conditions on its part to be performed or satisfied pursuant to the Sales Agreement at or prior to the date hereof.
		

		
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						Name:

				
	
					
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						Date:

					
					
						 

					
					
						 

					
					
						 

					
					
						 

				

		
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