Document:

EX-10.11

 Exhibit 10.11 
  

			
	CONFIDENTIAL	 	

 GS KO LICENCE ROW 

LICENSE AGREEMENT 
 between 

LONZA SALES AG 
 and 

NEXVET BIOPHARMA PTY LTD 

  
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	CONFIDENTIAL	 	

  

 INDEX 
  

							
	 ARTICLE
	  	 TITLE
	  	 PAGE
	 
			
	  1.	  	DEFINITIONS	  	 	3	  
			
	  2.	  	SUPPLY OF THE SYSTEM, CDACF VERSION 8 SYSTEM AND SYSTEM KNOW-HOW	  	 	7	  
			
	  3.	  	OWNERSHIP OF PROPERTY AND INTELLECTUAL PROPERTY	  	 	8	  
			
	  4.	  	LICENSES	  	 	8	  
			
	  5.	  	PAYMENTS	  	 	9	  
			
	  6.	  	ROYALTY PROCEDURES	  	 	12	  
			
	  7.	  	LIABILITY AND WARRANTIES	  	 	13	  
			
	  8.	  	CONFIDENTIALITY	  	 	15	  
			
	  9.	  	INTELLECTUAL PROPERTY ENFORCEMENT	  	 	16	  
			
	10.	  	TERM AND TERMINATION	  	 	17	  
			
	11.	  	ASSIGNMENT	  	 	18	  
			
	12.	  	GOVERNING LAW AND JURISDICTION	  	 	18	  
			
	13.	  	FORCE MAJEURE	  	 	19	  
			
	14.	  	ILLEGALITY	  	 	19	  
			
	15.	  	MISCELLANEOUS	  	 	20	  
			
	16.	  	NOTICE	  	 	20	  
			
	17.	  	INTERPRETATION	  	 	21	  
			
	APPENDIX	  		  			
			
	1	  	Patent Rights	  			
			
	2	  	CDACF Version 8 Base Powders	  			
			
	3	  	CDACF Version 8 Supplements, Media and Feeds	  			
			
	4	  	CDACF Version 8 Know-How	  			

  
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	CONFIDENTIAL	 	

  

 THIS AGREEMENT is made the 16th day of December 2013 

BETWEEN 
 LONZA SALES AG incorporated and registered in
Switzerland whose registered office is at Muenchensteinerstrasse 38, CH-4002, Basel, Switzerland (hereinafter referred to as “Lonza”), and 

NEXVET BIOPHARMA PTY LTD of Level 39, 385 Bourke Street, Melbourne 3000, Victoria, Australia, (hereinafter referred to as “Licensee”) 

WHEREAS 
  

	A.	Lonza is the proprietor of the System and the CDACF Version 8 System and has the right to grant rights to certain Intellectual Property Rights in relation thereto (all as hereinafter defined), and 

 

	B.	The Licensee wishes to take a licence under such Intellectual Property Rights of which Lonza is the proprietor to commercially exploit the Product (as hereinafter defined) in the form hereunder. 

NOW THEREFORE the parties hereby agree as follows: 
  

	1.	Definitions 

 In this Agreement the following words and phrases shall have the following
meanings: 
  

	 	1.1	“Affiliate” means any company, corporation, limited liability company, partnership or other entity which directly or indirectly controls, is controlled by or is under common control, directly or
indirectly, with the relevant party to this Agreement. “Control” means the ownership of more than fifty percent (50%) of the issued share capital of the party in question or the legal power to direct or cause the direction of the
general management and policies of the party in question. 

  

	 	1.2	“CDACF Version 8 Base Powders” means the powders set out in Appendix 2. 

  

	 	1.3	“CDACF Version 8 Feeds” means the concentrated nutrient solutions used in order to maintain the growth and productivity of mammalian cells, as more fully set out in Appendix 3. 

 

	 	1.4	“CDACF Version 8 Media” means the solutions of nutrients used in mammalian cell culture, as more fully set out in Appendix 3. 

 

	 	1.5	“CDACF Version 8 Know-How” means any Know-How specifically relating to the CDACF Version 8 Base Powders, CDACF Version 8 Feeds, CDACF Version 8 Media or the CDACF Version 8 Supplements used either in
combination or individually, as set out in Appendix 4. 

  
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	CONFIDENTIAL	 	

  

	 	1.6	“CDACF Version 8 System” means the CDACF Version 8 Base Powders, CDACF Version 8 Feeds, CDACF Version 8 Media, CDACF Version 8 Know-How and the CDACF Version 8 Supplements used either in combination or
individually. 

  

	 	1.7	“CDACF Version 8 Supplements” means the supplement solutions, as more fully set out in Appendix 3. 

  

	 	1.8	“Cell Lines” means those cell lines referred to in Clause 2.1.1. 

  

	 	1.9	“Combination Product” means any diagnostic or therapeutic product comprising Product and one or more other pharmaceutically active ingredient(s). 

 

	 	1.10	“Competing Contract Manufacturer” shall mean any third party who, together with its affiliates, undertakes or performs more than fifty percent (50%) of their business as a third party manufacturer
of monoclonal antibodies and/or therapeutic proteins or any product of a similar nature to which this Agreement relates. 

  

	 	1.10	“Confidential Information” means any Know-How and confidential information disclosed by one party to the other in connection with this Agreement including for the avoidance of doubt the terms of this
Agreement itself. In the case of Lonza, Confidential Information shall mean System Know-How, CDACF Version 8 System Know-How and all information relating to the System and/or CDACF Version 8 System and any other materials, specifications or
information which is provided and/or disclosed by Lonza, its Affiliates and their respective officers, employees, agents and advisors to the Licensee and its officers, employees, agents and advisors, whether directly or indirectly, including,
without limitation, all agreements, research databases, trade secrets, Intellectual Property Rights, business and/ or commercial and/ or financial data (including data pertaining to Lonza’s suppliers, agents, distributors and customers),
specifications, technical designs, documents and drawings which are related to the System, the CDACF Version 8 System and/or Lonza’s business. 

  

	 	1.11	“Effective Date” means the date first above written. 

  

	 	1.12	“First Commercial Sale” means the date of the first sale or other disposal of Product for consideration by the Licensee or its Sublicensee. 

 

	 	1.13	“Intellectual Property Rights” means all rights, title and interests, vested and/or arising out of any industrial or intellectual property, whether protected at common law or under statute, which
includes (without limitation) any rights and interests in copyrights, designs, trademarks, servicemarks, trade-names, technology, business names, logos, commercial symbols, processes, developments, licenses, trade secrets, goodwill, drawings,
computer software, formulae, technical information, research data, procedures, designs, Confidential Information and any other knowledge of any nature whatsoever throughout the world whether in existence today or which will come into existence in
the future, and including all applications for patents, copyrights, trademarks, trade names, rights to apply and any amendments/modifications or renewals thereto; and all other intellectual property rights. 

  
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	CONFIDENTIAL	 	

  

	 	1.14	“Know-How” means any technical and other information, whether patented or unpatented, including, but without prejudice to the generality of the foregoing, ideas, concepts, trade secrets, know-how,
inventions, discoveries, data, formulae, specifications, processes, procedures for experiments and tests and other protocols, results of experimentation and testing, fermentation and purification techniques and assay protocols. 

 

	 	1.15	“Losses” means losses, damages, costs and expenses. 

  

	 	1.16	“Net Selling Price” means *** 

 *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  
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 *** 
  

	 	1.17	“Patent Rights (Lonza)” means the patents and applications, short particulars of which are set out in Appendix 1A hereto, and all patents and applications thereof of any kind throughout the world
whether national or regional including but without prejudice to the generality of the foregoing, author certificates, inventor certificates, improvement patents, utility certificates and models and certificates of addition, and including any
divisions, renewals, continuations, continuations in part, reissues, patent disclosures, improvements and extensions of reissue thereof. 

  

	 	1.18	“Patent Rights (Third Party)” means the patents and applications, short particulars of which are set out in Appendix 1B hereto, and to the extent granted to Lonza by the owners of the Patent Rights
(Third Party), all patents and applications thereof of any kind throughout the world whether national or regional including but without prejudice to the generality of the foregoing, author certificates, inventor certificates, improvement patents,
utility certificates and models and certificates of addition, and including any divisions, renewals, continuations, continuations in part, reissues, patent disclosures, improvements and extensions of reissue thereof. 

 

	 	1.19	“Product” means the felinised IgG kappa antibody produced by the Cell Line known as NV-02 that binds to NGF and of which Licensee is the proprietor and which is obtained by the expression of any one
gene or of any combination of genes by use of the System, or any formulation containing the same. 

  

	 	1.20	“Strategic Partner” means a party with whom Licensee has entered into a contractual relationship, to identify a therapeutic target, collaborate in the performance of research and development and/or
commercialization of a Product or a product of which the Strategic Partner is the proprietor. In no event may any entity that is primarily a Competing Contract Manufacturer be deemed a Strategic Partner for the purposes of this Agreement.

  

	 	1.21	“Sublicensee” means a party with whom Licensee has entered into a contractual relationship, under which such party has been granted the right to make or manufacture the Product and to whom Licensee has
sub-licensed its rights under this Agreement pursuant to clause 4.3, provided always that the obligations in Clause 4.3 have been satisfied. 

  

	 	1.22	“System” means Lonza’s glutamine synthetase gene expression system known as GS XceedTM consisting of the Cell Lines and the Vectors, and the System Know-How, whether used individually or in
combination with each other. For the avoidance of doubt, any gene proprietary to Licensee inserted into the System for the purposes of producing Product does not form part of the System. 

 

	 	1.23	“System Know-How” means Know-How relating directly or indirectly to the System known to Lonza from time to time, of which Lonza is the proprietor. 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed
separately with the Commission. 

  
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	 	1.24	“Target Animal Efficacy Study” means the first animal treated in a pivotal efficacy study performed under GCPv with Centre for Veterinary Medicine (CVM) protocol concurrence. 

 

	 	1.25	“Territory” means world-wide. 

  

	 	1.26	“Valid Claim” means a claim within the Patent Rights (Lonza) or the Patent Rights (Third Party) (including any re-issued and unexpired patents) which, but for the licence and other rights granted
pursuant to Clauses 4.1 and 4.3 hereof, would be infringed by the manufacture, use, sale, offer for sale, exportation or importation of Product by Licensee or its Sublicensees and which also (a) has not been cancelled, withdrawn, abandoned or
rejected by any administrative agency or other body of competent jurisdiction, and (b) has not been revoked, held invalid or declared unpatentable or unenforceable in a decision of a court or other governmental agency of competent jurisdiction
that is unappealable or unappealed within the time allowed for appeal, and (c) which has not been admitted to be invalid or unenforceable through re-issue or disclaimer or otherwise. 

 

	 	1.27	“Vectors” means those vectors referred to in Clause 2.1.1. 

  

	2.	Supply of the System, CDACF Version 8 System and System Know-How 

  

	2.1	Unless previously supplied by Lonza under a separate agreement, Lonza shall, if requested by Licensee in writing, arrange for the supply ex-works Lonza’s premises, Slough, Berkshire (Incoterms 2010) to Licensee of
the following: 

  

	 	2.1.1	Vectors *** 

  

	 	2.1.2	Cell Lines *** 

  

	 	2.1.3	System Know-How 

 System Know-How contained as at the date hereinabove in (a) manuals of
operating procedures for the System, (b) regulatory information in pdf format, and (c) Vector nucleotide sequences. 
  

	2.2	In the event that Licensee requires any additional quantities of the materials referred to in Clauses 2.1.1 and 2.1.2, and if Lonza at its sole discretion is willing to supply such additional materials, such supply
shall be subject to the payment of an additional fee by Licensee to Lonza in accordance with Lonza’s prices at the time. 

  

	2.3	In relation to the CDACF Version 8 System, Lonza shall following signature of this Agreement (a) provide Licensee with details of how to purchase the CDACF Version 8 Base Powders and CDACF Version 8 Supplements to
enable Licensee (and only Licensee) to make CDACF Version 8 Feeds and CDACF Version 8 Media and (b) supply Licensee with the CDACF Version 8 Know-How. 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed
separately with the Commission. 

  
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	2.4	Licensee shall use the System only in the expression of Product by insertion of gene(s) coding for Product(s) into the System, and shall not use, cause the use of or permit to be used the System for any purpose not
directly authorised by this Agreement. 

  

	2.5	The CDACF Version 8 System may only be used in conjunction with the System and may not be used in conjunction with any other gene expression system or for any other purpose whatsoever. 

 

	2.6	Lonza shall make available to Licensee, subject to Licensee paying any charge Lonza may (acting reasonably) make available to Licensee updates to the CDACF Version 8 Know-How and/or the System Know-How from time to
time. 

  

	3.	Ownership of Property and Intellectual Property 

  

	3.1	It is hereby acknowledged and agreed that as between the parties any and all property and Intellectual Property Rights in the System and System Know-How is vested in Lonza. Similarly it is hereby acknowledged that as
between the parties any and all Intellectual Property Rights in the Product and any gene proprietary to Licensee, or any of its licensors or sublicensees, inserted into the System for the purpose of producing Product, is vested in Licensee, or its
applicable licensors and sublicensees. 

  

	3.2	The provisions of this Clause 3 shall survive termination of this Agreement. 

  

	4.	Licenses 

  

	4.1	Lonza hereby grants to Licensee: 

  

	 	(a)	a world-wide non-exclusive licence under the System Know-How, CDACF Version 8 Know-How, and the Patent Rights (Lonza) (with the right to sublicense, subject to Clause 4.3 below); 

 

	 	(b)	a world-wide non-exclusive sublicence under the Patent Rights (Third Party) (with the right to sublicense, subject to Clause 4.3 below); 

in each case (a) and (b) to use, develop, manufacture, market, sell, offer for sale, distribute, import and export Product in the
Territory (“Commercial Activities”). 
  

	4.2	Save as expressly provided by Clause 2.4 above, the Licensee hereby undertakes not to make any modifications or adaptations to the System and the CDACF Version 8 System during the subsistence of this Agreement.

  

	4.3	Subject to the provisions of this Clause 4.3, Licensee shall be entitled to grant a sublicence to the rights granted by Clause 4.1 to any one or more third parties for the purposes of any such third party producing
Product for Licensee provided always: 

  

	 	4.3.1	Licensee shall ensure such Sublicensee’s use of the System, the CDACF Version 8 System, Lonza’s Intellectual Property Rights and the Product is undertaken solely for undertaking Commercial Activities, for or
on behalf of Licensee; and 

  
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	 	4.3.2	The Sublicensee shall not, by virtue of this Agreement, be granted any right or licence, either express or implied, under any patent or proprietary right vested in Lonza or otherwise, to use the System, the CDACF
Version 8 System, Lonza’s Intellectual Property Rights or the Product other than for undertaking Commercial Activities for or on behalf of Licensee and Licensee agrees to ensure that such Sublicensee shall not assign, transfer, further
sublicense or otherwise make over the benefit or the burden of the rights granted to it pursuant to this Agreement; and 

  

	 	4.3.3	Any sublicence granted shall be expressly subject and subordinate to the terms of this Agreement, and it shall be Licensee’s responsibility to ensure the strict adherence by any Sublicensee hereunder to the terms
and conditions of this Agreement; and 

  

	 	4.3.4	Prior to the grant of any sublicence pursuant to this Clause 4 Licensee shall obtain the written consent of Lonza (such consent not to be unreasonably withheld, conditioned or delayed), to the grant of such sublicence.

  

	 	4.3.5	Licensee shall not sublicense the rights sublicensed to it under the *** patents listed in Appendix 1B to *** or any of its affiliates or its or their successors with affiliate meaning for the purposes of this Clause
4.3.5 any entity controlling, controlled by, or under common control with *** . 

  

	4.4	If, on a country-by-country basis, any granted patents that form part of the Patent Rights (Lonza) or Patent Rights (Third Party) (including any re-issued patents and unexpired patents), subsequently expire or no longer
contain a Valid Claim such Patent Rights shall automatically fall outside the scope of this Agreement and the provisions of Clauses 4.1 to 4.3 shall only apply, with respect to granted patents, to those granted patents which contain a Valid Claim
and form part of the Patents Rights (Lonza) or Patent Rights (Third Party) for as long as those granted patents remain in force. 

  

	4.5	Notwithstanding clause 4.4, on a country-by-country basis, where no Valid Claim remains in force, the provisions of Clauses 4.1 to 4.3 shall only apply for as long as the System Know-How and CDACF Version 8 Know-How (as
appropriate) remain secret and substantial. 

  

	4.6	No licence is granted save as expressly provided herein and no licence in addition thereto shall be deemed to have arisen or be implied by way of estoppel or otherwise. 

 

	5.	Payments 

  

	5.1	In consideration of the licence granted to Licensee pursuant to Clause 4.1 above, and in consideration for the right to sublicense the rights granted by Clause 4.1 pursuant to Clause 4.3, Licensee shall pay Lonza as
follows, subject to the adjustment as set forth in Clause 5.2: 

 *** Portions of this
page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  
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	 	5.1.1	in respect of Product manufactured by Lonza, a royalty of *** percent (***%) of the-Net Selling-Price; 

  

	 	5.1.2	where Licensee or Licensee’s Strategic Partner manufactures Product: 

  

	 	5.1.2.1	a payment of pounds sterling *** (£***) due annually during the course of this Agreement, and being first payable upon commencement of Target Animal Efficacy Study for registration in US or EU (or equivalent
study) and thereafter on each anniversary of such date; and 

  

	 	5.1.2.2	a royalty of *** percent (***%) of the Net Selling Price of such Product manufactured. 

  

	 	5.1.3	where any party other than Lonza, Licensee or Licensee’s Strategic Partner manufactures Product: 

  

	 	5.1.3.1	a payment of pounds sterling *** (£***) per sublicence due annually during the course of such sublicence (irrespective as to the years of manufacture), and being first payable on the commencement date of the
relevant sublicence; and 

  

	 	5.1.3.2	a royalty of *** percent (***%) of the-Net Selling Price of such-Product-manufactured. 

  

	5.2	The Licensee’s obligation to pay royalties for Product according to 5.1.1, 5.1.2.2 and 5.1.3.2 shall apply on a country-by-country basis until the later of (i) expiry of the last Valid Claim or (ii) the
date being ten (10) years from the date of the First Commerical Sale of Product following marketing authorisation of the Product. If, on a country-by-country basis, the manufacture and/or sale of the Product are not protected by a Valid Claim
(either because no patent or application was ever filed for such territory or the patent or application is no longer of effect) then in respect of sales in such countries: 

 

	 	(a)	the royalties referred to in 5.1.1, 5.1.2.2 and 5.1.3.2 shall be due only in respect of the System Know-How; 

  

	 	(b)	the royalties referred to in 5.1.1 and 5.1.2.2 shall be at the rate of *** per cent (***%) and *** per cent (***%) respectively of the Net Selling Price; 

 

	 	(c)	the royalties referred to in 5.1.3.2 shall be at the rate of *** per cent (***%) of the Net Selling Price. 

  

	5.3	For the avoidance of doubt the licence to use the CDACF Version 8 System is given in consideration of the obligations incumbent upon the Licensee under the terms of this Agreement but is otherwise royalty-free.

  

	5.4	Subject always to Clause 5.5, if, during the term of this Agreement, Licensee is required to take a bona fide royalty-bearing licence under intellectual property rights owned by *** and which are required in order to
operate the GS System or the CDACF Version 8 System in order to use, develop, manufacture, market, sell, offer for sale, distribute, import and export Product in the Territory (the “*** Licence”): 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed
separately with the Commission. 

  
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	 	(a)	Licensee may deduct from royalties due under this Agreement on such Product *** percent (***%) of the royalties actually paid by Licensee to *** , but in no event will the royalties paid to Lonza under this Agreement be
less than *** percent (***%) of the amount due pursuant to Clauses 5.1.1, 5.1.2.2 and 5.1.3.2 hereof. This provision will apply only to prospective running royalties payable to *** on the same basis as required by Clause 5 hereof; 

 

	 	(b)	with regard to lump-sum license fees, milestone payments and minimum annual royalties in excess of accrued royalties, Licensee may, once the Product is commercialised and offered for sale for use in patients after
having been appropriately licensed and approved for such use, deduct from royalties due under this Agreement on such Product *** percent (***%) of such lump-sum license fees, milestone payments and minimum annual royalties in excess of accrued
royalties actually paid by Licensee to ***, but in no event will the royalties paid to Lonza under this Agreement be less than *** percent (***%) of the amount due pursuant to Clauses 5.1.1, 5.1.2.2 and 5.1.3.2 hereof. 

 

	 	(c)	no credit will be allowed for any amount paid for rights not required to permit Licensee to use, develop, manufacture, market, sell, offer for sale, distribute, import and export Product in the Territory, as provided in
this Agreement. 

 For the avoidance of doubt, Licensee shall not be entitled to recover for the same loss or damage under this
Clause and under Clause 7.2A. 
  

	5.5	Licensee shall not agree any arrangement with *** under which any fees or royalties under any *** Licence are lowered or made more favourable to Licensee as a consequence of any arrangements made with regard to any
damages or settlement which Licensee pays to *** and for which Licensee would seek indemnification from Lonza pursuant to Clause 7.2A. If there is any dispute as to whether Licensee has structured any arrangements it has entered into with *** so as
to maximise the sums for which Lonza is required to indemnify them under Clause 7.2A and/or reduce the licence fees or other payments which Licensee is required to pay to *** , the matter shall be referred to an independent third party
(“Expert”) who shall assess the terms of any settlement and licence arrangement with *** and determine how much of any such settlement and licence arrangement attributable as damages for historic infringement (and therefore the subject of
the indemnity from Lonza under Clause 7.2A) and how much is attributable to any new licence arrangements between Licensee and *** , to which the provisions of Clause 5.4(a) and (b) shall apply. The Expert must be a person with an appropriate
level of expertise in licensing and / or valuation to be able to determine the dispute, and must be agreed to by the parties, or if not agreed within a reasonable time of the dispute arising, must be appointed by the then President of the Licensing
Executives Society of Britain & Ireland. The costs of the Expert shall be shared equally between the parties and the parties agree to be bound by the determination of the Expert save in the event of manifest error. 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed
separately with the Commission. 

  
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	6.	Royalty Procedures 

  

	6.1	Licensee shall, and shall ensure that its Sublicensees shall, keep true and accurate records and books of account containing all data necessary for the calculation of royalties payable to Lonza. Such records and books
of account shall, upon reasonable notice having been given by Lonza (which in no event shall be less than thirty (30) days prior notice), be open at all reasonable times during regular business hours for inspection by independent auditors
selected by Lonza and reasonably acceptable to Licensee. Such independent auditors shall agree to maintain the confidentiality of the information and materials disclosed during the audit. Any such audit shall be conducted in a manner that does not
interfere unreasonably with the operations of Licensee’s business. Lonza may perform an audit once each calendar year. Each audit shall begin upon the date specified by Lonza and shall be completed as soon as reasonably practicable. Lonza shall
pay the costs of the independent auditors conducting such audit, unless the results of the audit reveal an underpayment of 5% or more by Licensee, in which case, Licensee shall pay the reasonable costs of the independent auditors. If an audit
concludes that an overpayment or underpayment has occurred during the audited period, such payment shall be remitted by the party responsible for such payment to the other party within thirty (30) days after the date such auditor’s written
report identifying the overpayment or underpayment is delivered to the party responsible for such payment. 

  

	6.2	Licensee shall prepare a statement in respect of each calendar quarter which shall show for the immediately preceding quarter details of the sales of Product on a country by country basis and the royalty due and payable
to Lonza thereon. 

 Such statement shall be submitted to Lonza within thirty (30) days after the end of the calendar
quarter to which it relates, together with a remittance for the royalties due to Lonza. 
  

	6.3	All sums due under this Agreement: 

  

	 	6.3.1	shall be made in pounds sterling to Lonza. Payments due to Lonza in currencies other than pounds sterling shall first be calculated in the relevant local currency before being calculated at the rate of exchange in
effect at the close of business on the day payment is due or made, whichever is earlier, provided always that where payment is made after the date provided therefor herein conversion shall be at the rate in effect at the date of payment if this is
more favourable to Lonza. The rate of exchange shall be the mean value of the Pound Spot Rate in London first published in the Financial Times on the day following the day for determining such rates. 

 

	 	6.3.2	are exclusive of any Value Added Tax or of any other applicable taxes, levies, imposts, duties and fees of whatever nature imposed by or under the authority of any government or public authority, and shall be paid by
Licensee (other than taxes on Lonza’s income). The parties agree to co-operate in all respects reasonably necessary to take advantage of such double taxation treaties as may be available. 

 

	6.4	Where Lonza does not receive payment of any sum by the due date, interest shall accrue thereafter on the sum due and owing to Lonza at the rate of two percent (2%) per annum over the base rate from time to time of
National Westminster Bank plc, interest to accrue on a day-to-day basis without prejudice to Lonza’s right to receive payment on the due date. 

  
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	7.	Liability and Warranties 

  

	7.1	Lonza gives no representation or warranty that the Patent Rights (Lonza) or Patent Rights (Third Party) which are patent applications will be granted or if granted will be valid nor that the exercise of the rights
granted to Licensee hereunder will not infringe other patent rights or intellectual property rights vested in Lonza or any third party. 

  

	7.2	Lonza warrants that: 

  

	 	(a)	the patents included in the Patent Rights (Lonza) are the only patents that must be licensed from Lonza and/or its Affiliates in order to operate the System; 

 

	 	(b)	it is entitled to grant the rights and licences contained herein in accordance with the terms and conditions of this Agreement; 

  

	 	(c)	as at the date of this Agreement, to the best of Lonza’s knowledge and belief, the GS System and the CDACF Version 8 System do not infringe the intellectual property rights of any third party, including any *** patents not listed in Appendix 1B ; 

  

	 	(d)	as at the date of this Agreement, to the best of Lonza’s knowledge and belief, Lonza is not in breach of any licence with any third party, including, in particular, the licence with *** , pursuant to which Lonza is
licensed any of the Patent Rights (Third Party); 

  

	 	(e)	as at the date of this Agreement, to the best of Lonza’s knowledge and belief, Lonza is not aware of any facts, matters or circumstances under which Lonza’s rights to the Patent Rights (Third Party) (including
the rights to sublicense those rights to the Licensee) will be terminated or withdrawn. 

  

	7.2A	Lonza shall (subject always to Clauses 5.5, 7.6 and 7.8) indemnify and hold harmless each of Licensee and its Affiliates, and their respective officers, employees and agents at all times in respect of any and all:

  

	 	(i)	legal fees which Licensee properly incurs; and 

  

	 	(ii)	any damages or other amounts (including legal costs incurred by ***) which Licensee is ordered to pay to *** by a court of competent jurisdiction, or which Licensee properly agrees to pay in settlement with ***
(provided that such settlements shall not include any element of lost profits, lost revenue or indirect or consequential losses); 

in each case ((i) and (ii)) which arise (and to the extent that they arise) directly from any claim (actual or threatened) by *** against
Licensee in relation to US patent number 8377674 that the use in accordance with the terms of this Agreement of the GS System and the CDACF Version 8 System infringes any intellectual property rights of *** . For the avoidance of doubt, Licensee
shall not be entitled to recover for the same loss or damage under this Clause and under Clause 5.4. 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed
separately with the Commission. 

  
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	CONFIDENTIAL	 	

  

	7.3	Subject to Clause 5.4, the Licensee hereby acknowledges that in order to exploit the rights granted herein the Licensee may require licences under Lonza patent rights (other than those herein licensed) or under third
party patent rights (including those vested in Affiliates of Lonza) that may be infringed by the use by the Licensee of the rights licensed herein and it is hereby agreed that it shall be the Licensee’s responsibility to satisfy itself as to
the need for such licences and if necessary to obtain such licences. 

  

	7.4	Each party (“Indemnifying Party”) shall indemnify and hold harmless the other party and its Affiliates, and their respective officers, employees and agents (each an “Indemnified Party”)
at all times in respect of any and all Losses suffered or incurred as a result of any contractual, tortious or other claims or proceedings by third parties (collectively “Third Party Claims”) against Indemnified Party arising out of
the Indemnifying Party’s breach of this Agreement, including breach of representations and warranties, violation of applicable law, negligence or wilful misconduct. 

 

	7.5	With respect to product liability claims or proceedings, the following shall apply: (a) except to the extent provided in (b) below, Licensee shall indemnify and hold harmless Lonza, its Affiliates and their
respective officers, employees and agents at all times in respect of any and all losses, damages, costs and expenses suffered or incurred as a result of any tortious claims or proceedings of death or bodily injury (in each case to humans) relating
to the Product, and (b) Lonza shall indemnify and hold harmless Licensee, its Affiliates and their respective officers, employees and agents at all times in respect of any and all losses, damages, costs and expenses suffered or incurred as a
result of any tortious claims or proceedings of death or bodily injury (in each case to humans) relating to the Product to the extent such claims or proceedings result from defects in the Cell Lines and Vectors, or from Lonza’s breach of this
Agreement. 

  

	7.6	Notice. If a party receives notice of any claim for an indemnity under Clauses 7.4 or 7.5 (an “Indemnifying Claim”), the Indemnified Party shall, as promptly as is reasonably possible, give the
Indemnifying Party notice thereof; provided, however, that failure to give such notice promptly shall only relieve the Indemnifying Party of any indemnification obligation hereunder to the extent such failure diminishes the ability of the
Indemnifying Party to respond to or to defend the Indemnified Party against such Indemnifying Claim of the Indemnifying Party. The parties shall consult and cooperate with each other regarding the response to and the defence of any such indemnifying
claim and the Indemnifying Party shall assume the defence or represent the interests of the Indemnified Party in respect of such indemnifying claim of the Indemnifying Party, that shall include the right to select and direct legal counsel and other
consultants to appear in proceedings on behalf of the Indemnified Party and to propose, accept or reject offers of settlement, all at its sole cost; provided, however, that no such settlement shall be made without the written consent of the
Indemnified Party, such consent not to be unreasonably withheld. The Indemnified Party shall not agree any settlement of any such claim without the prior written consent of the Indemnifying Party. Nothing herein shall prevent the Indemnified Party
from retaining its own counsel and participating in its own defence at its own cost and expense. 

  

	7.7	Any condition or warranty other than those relating to title which might otherwise be implied or incorporated within this Agreement by reason of statute or common law or otherwise is hereby expressly excluded.

  

	7.8	 EXCEPT FOR EITHER PARTY’S BREACH OF CLAUSE 8 HEREOF IN NO EVENT SHALL EITHER PARTY AND/OR THEIR RESPECTIVE AFFILIATES BE LIABLE TO THE OTHER
PARTY, THEIR AFFILIATES AND/OR THEIR RESPECTIVE OFFICER’S, EMPLOYEES AND AGENTS WITH RESPECT TO ANY SUBJECT 

  
 14 

			
	CONFIDENTIAL	 	

  

	 	
MATTER OF THIS AGREEMENT WHETHER IN CONTRACT IN TORT IN NEGLIGENCE OR FOR BREACH OF STATUTORY DUTY OR OTHERWISE FOR LOSS OF PROFITS, SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, EXEMPLARY OR
CONSEQUENTIAL DAMAGES. Nothing in this Agreement shall limit or exclude the liability of either party for its fraud, or for death or personal injury (in each case to humans) arising from its negligence or for any other liability that cannot be
limited or excluded as a matter of law. 

  

	7.9	The terms of this Clause 7 shall survive expiration or termination of this Agreement for whatever reason. 

  

	8.	Confidentiality 

  

	8.1	Licensee expressly acknowledges that Confidential Information disclosed by Lonza pursuant to this Agreement is supplied in circumstances imparting an obligation of confidence and Licensee agrees to keep such
Confidential Information secure, secret and confidential and undertakes to respect Lonza’s proprietary rights therein and to use the same for the sole purpose of this Agreement and not during the period of this Agreement or at any time for any
reason whatsoever to disclose, cause or permit to be disclosed such Confidential Information to any third party other than its Sublicensee hereunder for use in accordance with the terms of this Agreement. Licensee shall procure that only its
employees and employees of its Sublicensee hereunder shall have access to Confidential Information and then only on a need to know basis and that all such employees shall be informed of their secret and confidential nature and shall be subject to
the obligations of confidentiality and non-use no less stringent than those set out herein. 

  

	8.2	Licensee hereby undertakes and agrees to keep the System and the CDACF Version 8 System secure and safe from loss, damage, theft, misuse and unauthorised access and shall procure that the System and the CDACF Version 8
System shall be made available only to employees of Licensee and employees of its Sublicensee hereunder on a need to know basis and subject to the same obligations of confidence as provided in Clause 8.1 hereof, and to use the same for the sole
purpose of this Agreement. 

  

	8.3	Both parties undertake and agree not to at any time for any reason whatsoever disclose or permit to be disclosed to any third party or otherwise make use of or permit to be made use of any trade secrets or confidential
information or materials relating to the business affairs or finances of the other or of any suppliers, agents, distributors, licensees or other customers of the other which comes into their possession pursuant to this Agreement. 

 

	8.4	The obligations of confidence referred to in this Clause 8 shall not extend to any information which the receiving party demonstrates: 

 

	 	8.4.1	is or shall become generally available to the public otherwise than by reason of a breach by the recipient party of such information of the provisions of this Clause 8; 

 

	 	8.4.2	is known to the recipient party of such information and is at its free disposal prior to its receipt from the other; 

  
 15 

			
	CONFIDENTIAL	 	

  

	 	8.4.3	is subsequently disclosed to the recipient party without obligations of confidence by a third party owing no such obligation of confidentiality to the disclosing party; or 

 

	 	8.4.4	can be demonstrated by competent written evidence as having been independently developed by the recipient of the information in question without access to or use or knowledge of the information of the disclosing party.

  

	8.5	Notwithstanding the foregoing it is acknowledged between the parties that Lonza or Licensee may be required to disclose Confidential Information to a government agency for the purpose of any statutory, regulatory or
similar legislative requirement applicable to the production of Product, or to a court of law or to meet the requirements of any Stock Exchange to which the parties may be subject. In such circumstances the disclosing party will inform the other
party prior to disclosure being made as to the nature of the required disclosure, shall only make the disclosure to the extent legally required and shall seek to impose obligations of secrecy wherever possible. Notwithstanding such disclosure such
Confidential Information shall otherwise remain subject to this Clause 8. 

  

	8.6	Each party hereto expressly agrees that any breach or threatened breach of the undertakings of confidentiality provided hereunder by a party may cause irreparable harm to the other party (“Non-Breaching
Party”) and that money damages may not provide a sufficient remedy to the Non-Breaching Party for any breach or threatened breach. In the event of any breach and/or threatened breach, then in addition to all other remedies available at law
or in equity, the Non-Breaching Party shall be entitled to seek injunctive relief and any other relief deemed appropriate by the Non-Breaching Party. 

  

	8.7	The obligations of both parties under this Clause 8 shall survive the expiration or termination of this Agreement for whatever reason. 

 

	9.	Intellectual Property Enforcement 

  

	9.1	Lonza hereby undertakes and agrees that at its own cost and expense it will: 

  

	 	9.1.1	prosecute or procure prosecution of such of the Patent Rights (Lonza) which are patent applications diligently so as to secure the best commercial advantage obtainable, as determined by Lonza in its commercially
reasonable discretion, and will pursue, as determined by Lonza in its commercially reasonable discretion, all necessary actions against any third party that Lonza reasonably believes is infringing, misappropriating or violating any Lonza
Intellectual Property Rights; and 

  

	 	9.1.2	pay or procure payment of all renewal fees in respect of the Patent Rights (Lonza) to ensure they are valid and subsisting for the full term thereof and in particular will procure such renewal of the registrations
thereof as may be necessary from time to time so far as it is reasonable to do so with particular reference to commercial considerations. 

  

	9.2	 Licensee shall promptly notify Lonza in writing of any infringement or improper or unlawful use of or of any challenge to the validity of the Patent
Rights (Lonza) and/or Know-How. Lonza undertakes and agrees to take all such steps and proceedings and to do all other acts and things as may in Lonza’s sole discretion be necessary to

  
 16 

			
	CONFIDENTIAL	 	

  

	 	
restrain any such infringement or improper or unlawful use or to defend such challenge to validity and Licensee shall permit Lonza to have the sole conduct of any such steps and proceedings
including the right to settle them whether or not Licensee is a party to them. Licensee shall have the right at its own cost and for its own benefit to initiate, prosecute and control the enforcement of the Patent Rights (Lonza) against infringement
by a Third Party in the Territory if all of the following conditions are fulfilled (a) the product manufactured through the infringing activity is a competing product to the Product, (b) Lonza has not granted rights to third parties which
prevent Lonza from granting such a right to enforce to Licensee, and (c) Lonza does not initiate proceedings within sixty (60) days of being requested to do so by Licensee. 

 

	9.3	As soon as practicable after Lonza becomes aware, Lonza shall promptly notify Licensee of any allegation that any of the Patent Rights (Third Party) infringe any rights of any third party or of any challenge to the
validity of any of the Patent Rights (Third Party). Lonza shall keep Licensee reasonably informed of the outcome of any such allegations and / or challenges, including the extent to which any such allegations or challenges may impact on the ability
for the Licensee to continue to be a sublicensee of such rights. 

  

	10.	Term and Termination 

  

	10.1	Unless terminated earlier in accordance with the provisions of this Clause 10 or Clause 14, this Agreement shall continue in force in each country of the world, until expiry of the last Valid Claim, or for so long as
the System Know-How and/or CDACF Version 8 Know-How is identified and remains secret and substantial, whichever is later. 

  

	10.2	Licensee may terminate this Agreement by giving sixty (60) days’ notice in writing to Lonza. 

  

	10.3	Either Lonza or Licensee may terminate this Agreement forthwith by notice in writing to the other upon the occurrence of any of the following events: 

 

	 	10.3.1	if the other commits a breach of this Agreement which in the case of a breach capable of remedy shall not have been remedied within thirty (30) days of the receipt by the other of a notice identifying the breach
and requiring its remedy. 

  

	 	10.3.2	if the other is unable to pay its debts or enters into compulsory or voluntary liquidation (other than for the purpose of effecting a reconstruction or amalgamation in such manner that the company resulting from such
reconstruction or amalgamation if a different legal entity shall agree to be bound by and assume the obligations of the relevant party under this Agreement) or compounds with or convenes a meeting of its creditors or has a receiver or administrator
appointed over all or any part of its assets or takes or suffers any similar action in consequence of a debt, or ceases for any reason to carry on business. 

  

	10.4	 If at any time during this Agreement Licensee knowingly, directly or indirectly, opposes or assists any third party to oppose the grant of letters
patent or any patent application within any of the Patent Rights (Lonza)=or disputes or knowingly, directly or indirectly, assists any third party to dispute the validity of any patent within any of

  
 17 

			
	CONFIDENTIAL	 	

  

	 	
the Patent Rights (Lonza) or any of the claims thereof Lonza shall be entitled at any time thereafter to terminate all or any of the licences granted hereunder forthwith by notice to Licensee.

  

	10.5	If this Agreement expires or is terminated for any reason any and all licences granted hereunder shall terminate with effect from the date of termination and Licensee shall destroy all Vectors, Cell Lines forthwith and
shall certify such destruction immediately thereafter in writing to Lonza provided that Licensee shall be entitled to sell any Product in its sole discretion remaining in its possession or control at the time that termination becomes effective,
provided that such sales shall be completed within six (6) months of the date of expiry or termination of this Agreement and any stocks of Product still remaining shall be destroyed (with an appropriate written certificate of such destruction
being immediately sent to Lonza). Licensee shall pay Lonza the royalties in respect of such sales in accordance with Clause 6. 

  

	10.6	Termination for whatever reason or expiration of this Agreement shall not affect the accrued rights of the parties arising in any way out of this Agreement as at the date of termination. The right to recover damages
against the other and all provisions which are expressed to survive this Agreement shall remain in full force and effect. 

  

	11.	Assignment 

  

	11.1	Save as expressly provided by Clause 4, neither party shall be entitled to assign, transfer, charge or in any way make over the benefit and/or the burden of this Agreement without the prior written consent of the other
which consent shall not be unreasonably withheld or delayed, save that either party shall be entitled without the prior written consent of the other party to assign, transfer, charge, sub-contract, deal with or in any other manner make over the
benefit and/or burden of this Agreement (i) to an Affiliate or (ii) to any joint venture company of which Lonza or Licensee, as the case may be, is the beneficial owner of at least fifty percent (50%) of the issued share capital
thereof or (iii) to any company with which that party may merge or (iv) to any company to which that party may transfer its assets and undertaking. 

  

	11.2	This Agreement shall be binding upon the successors and assigns of the parties and the name of a party appearing herein shall be deemed to include the names of its successors and assigns provided always that nothing
herein shall permit any assignment by either party except as expressly provided herein. 

  

	12.	Governing Law and Jurisdiction 

  

	12.1	The validity, construction and performance of this Agreement shall be governed by English law and the parties submit to the non-exclusive jurisdiction of the courts of England and Wales. 

 

	12.2	Either party shall have the right to take proceedings in any other jurisdiction for the purposes of enforcing a judgement or order obtained from any court of competent jurisdiction. Subject to the remainder of this
clause 12, the parties shall have the right to proceed to a suitable jurisdiction for the purpose of enforcing a judgment, award, or order (including without limitation seeking specific performance) and injunctive reliefs. 

  
 18 

			
	CONFIDENTIAL	 	

  

	12.3	Except for any disputes requiring a Party to seek urgent interlocutory or injunctive relief, any disputes relating to issues arising from this Agreement shall, in the absence of resolution within thirty (30) days of the
dispute arising, be referred to senior executives of the Licensee and Lonza, who shall discuss the matter and attempt to resolve it by mutual consent. If the senior executives of the Licensee and Lonza cannot resolve the dispute within thirty (30)
days of the matter being referred to them, either party may, by written notice to the other party, invoke the mediation procedure set out in clause 12.4 below. 

 

	12.4	If a dispute arises between the parties that the parties cannot resolve pursuant to clause 12.3 above, the parties agree to attempt in good faith to resolve such dispute by mediation administered by the CEDR
(Centre for Effective Dispute Resolution) in London. The parties agree that they shall share equally the cost of any mediation fees, and the cost of the mediator. Each party must bear its owns attorneys’ fees and associated costs and expenses.
The place of any mediation shall be London, England. If efforts at mediation are unsuccessful within sixty (60) days of either party referring the dispute to mediation either party may pursue its rights in a court of law. 

 

	13.	Force Majeure 

 Neither party shall be in breach of this Agreement if there is any total
or partial failure of performance by it of its duties and obligations under this Agreement occasioned by any act of God (including without limitation, fire), act of government or state, war, civil commotion, insurrection, embargo, epidemic,
terrorism or earthquake, prevention from or hindrance in obtaining any raw materials, energy or other supplies, labour disputes of whatever nature and any other reason beyond the control of either party. If either party is unable to perform its
duties and obligations under this Agreement as a direct result of the effect of one of the reasons set out in this Clause 13 such party shall give written notice to the other of such inability stating the reason in question. The operation of
this Agreement shall be suspended during the period (and only during the period) in which the reason continues. Forthwith upon the reason ceasing to exist the party relying upon it shall give written notice to the other of this fact. If the reason
continues for a period of more than ninety (90) days and substantially affects the commercial basis of this Agreement the party not claiming under this Clause 13 shall have the right to terminate this Agreement by giving written notice of such
termination to the other party. 
  

	14.	Illegality 

  

	14.1	If any provision or term of this Agreement or any part thereof shall become or be declared illegal, invalid or unenforceable for any reason whatsoever including but without limitation by reason of the provisions of any
legislation or other provisions having the force of law or by reason of any decision of any Court or other body or authority having jurisdiction over the parties hereto or this Agreement including the EC Commission or the European Court of
Justice: 

  

	 	(i)	such provision shall, so far as it is illegal, invalid or unenforceable, be given no effect by the parties and shall be deemed not to be included in this Agreement; 

  
 19 

			
	CONFIDENTIAL	 	

  

	 	(ii)	the other provisions of this Agreement shall be binding on the parties as if such provision was not included therein; and 

  

	 	(iii)	the parties agree to negotiate in good faith to amend such provision to the extent possible for incorporation herein in such reasonable manner as most closely achieves the intention of the parties without rendering such
provision invalid or unenforceable. 

  

	15.	Miscellaneous 

  

	15.1	This Agreement embodies and sets forth the entire agreement and understanding of the parties and supersedes all prior oral and written agreements, understandings or arrangements relating to the subject matter of this
Agreement. Neither party shall be entitled to rely on any agreement, understanding or arrangement which is not expressly set forth in this Agreement. 

  

	15.2	This Agreement shall not be amended, modified, varied or supplemented except in writing signed by duly authorised representatives of the parties. 

 

	15.3	No failure or delay on the part of either party hereto to exercise any right or remedy under this Agreement shall be construed or operated as a waiver thereof nor shall any single or partial exercise of any right or
remedy under this Agreement preclude the exercise of any other right or remedy or preclude the further exercise of such right or remedy as the case may be. The rights and remedies provided in this Agreement are cumulative and are not exclusive of
any rights or remedies provided by law. 

  

	15.4	Except as required by law, the text of any press release or other communication to be published by or in the media whether of a scientific nature or otherwise and concerning this Agreement shall require the prior
written approval of Lonza and Licensee. 

  

	15.5	Each of the parties shall be responsible for its respective legal and other costs incurred in relation to the preparation of this Agreement. 

 

	15.6	The parties do not intend that any term hereof should be enforceable by virtue of the Contracts (Rights of Third Parties) Act 1999, or by any other statute or common-law principle, by any person who is not a party to
this Agreement. 

  

	16.	Notice 

  

	16.1	Any notice or other document to be given under this Agreement shall be in writing and shall be deemed to have been duly given if sent by e-mail (to the e-mail address set out below) and receipt of such notice is
expressly confirmed by the other party or is-left at or sent by registered post or by a reputable overnight courier to a party or delivered in person to a party at the address set out below for such party or such other address as the party may from
time to time designate by written notice to the other(s): 

  

	 	Address	of Lonza 

	 	Lonza	Sales AG, Muenchensteinerstrasse 38 CH-4402, Basel, Switzerland 

  
 20 

			
	CONFIDENTIAL	 	

  

			
	With a copy to:	  	 Lonza Biologics Plc
 228 Bath Road,
Slough, Berkshire SL1 4DX
 Facsimile: 01753 777001

 Address of Licensee  

Nexvet Biopharma Pty Ltd of Level 39, 385 Bourke Street, Melbourne 3006, Victoria, Australia 

E-mail: mark.heffernan@nexvet.com 

For the attention of: Mark Heffernan, PhD, CEO 
  

	16.2	All such notices and documents shall be in the English language. Any such notice or other document shall be deemed to have been received by the addressee seven (7) working days following the date of dispatch of the
notice or other document by post or, where the notice or other document is sent by hand, at the time of such delivery. To prove the giving of a notice or other document it shall be sufficient to show that it was dispatched. 

 

	17.	Interpretation 

  

	17.1	The headings in this Agreement are inserted only for convenience and shall not affect the construction hereof. 

  

	17.2	Where appropriate words denoting a singular number only shall include the plural and vice versa. 

  

	17.3	Reference to any statute or statutory provision includes a reference to the statute or statutory provision as from time to time amended, extended or re-enacted. 

 

	17.4	References to the recitals, clauses and appendix shall be deemed to be a reference to the recitals, clauses and appendix to this Agreement and shall form an integral part of this Agreement. 

 

	17.5	Reference in this Agreement to either Lonza or Licensee (as the case may be) shall, unless repugnant to the subject or context thereof, include their respective Affiliates, successors and assigns, save that the
obligation to indemnify pursuant to clauses 7.4 shall only be obligations on Lonza and Licensee respectively, and the obligation to indemnify in clause 7.5 shall only be on Licensee. No Affiliates shall be obligated to provide any
indemnification. 

  
 21 

			
	CONFIDENTIAL	 	

  

 AS WITNESS the hands of the duly authorized representatives of the parties hereto 

 

									
	 Signed for and on behalf of
 LONZA SALES
AG
	 		 	By:	 	/s/ Sven Frie	 	
		 		 		 	  

		 		 	Name:	 	Sven Frie	 	
		 		 		 	  

		 		 	Title:	 	Director Sales and Business Dev	 	TITLE
		 		 		 	  
	 	
					
	 Signed for and on behalf of
 LONZA SALES
AG
	 		 	By:	 	/s/ Cordula Altekruger	 	
		 		 		 	  

		 		 	Name:	 	Cordula Altekruger	 	
		 		 		 	  

		 		 	Title:	 	Legal Counsel	 	TITLE
		 		 		 	  
	 	
					
	 Signed for and on behalf of
 NEXVET BIOPHARMA
PTY LTD
	 		 	By:	 	/s/ illegible	 	
		 		 		 	  

		 		 	Name:	 		 	
		 		 		 	  

		 		 	Title:	 	CEO	 	TITLE
		 		 		 	  
	 	

  
 22 

			
	 CONFIDENTIAL
 GS KO LICENCE
ROW
	 	

  

 APPENDIX 1A 

PATENT RIGHTS (LONZA) 
  

			
	 Lonza Ref. No.
	  	***
		
	 Subject Matter:
	  	***
		
	 Title:
	  	***
		
	 Origin:
	  	***
		
	 Registered Owner:
	  	***
		
	 Inventors:
	  	***
		
	 Priority Application Dates:
	  	***
	 Earliest Publication Date/No.:
	  	***

  

							
	 Territory
	 	 Appl. Date
	 	 Patent No.
	 	 Expiry Date

	 ***
	 		 		 	

 *** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission. 

  
 23 

			
		 	

  

			
	 Lonza Ref. No.
	  	***
		
	 Subject Matter:
	  	***
		
	 Title:
	  	***
		
	 Origin:
	  	***
	 Registered Owner:
	  	***
		
	 Priority Application Date:
	  	***
	 Earliest Publication Date/No.:
	  	***

  

									
	 Territory
	 	 Appl. Date
	 	 Patent No.
	 	 Application No.
	 	 Expiry Date

	 ***
	 		 		 		 	

 *** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission. 
  

  

			
		 	

  

			
	 Lonza Ref. No.
	  	***
		
	 Subject Matter:
	  	***
		
	 Title:
	  	***
		
	 Origin:
	  	***
	 Registered Owner:
	  	***
		
	 Priority Application Date:
	  	***
	 Earliest Publication Date/No.:
	  	***

  

									
	 Territory
	 	 Appl. Date
	 	 Patent No.
	 	 Application No.
	 	 Expiry Date

	 ***
	 		 		 		 	

 *** Portions of this page have been omitted pursuant to a request for
Confidential Treatment and filed separately with the Commission. 

  

			
	Lonza Ref:	  	***
		
	Subject Matter:	  	***
		
	Title:	  	***
		
	Priority Date:	  	***
		
	Earliest Publication Date:	  	***

  

							
	 Territory
	 	 Appl. Date
	 	 Patent Application

or* Patent Number
	 	 Patent Expiry Date

				
	 ***
	 		 		 	

  
  

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed
separately with the Commission. 

 APPENDIX 1B 

PATENT RIGHTS (THIRD PARTY) 
  

			
		
	Subject Matter:	  	***
		
	Title:	  	***
		
	Origin:	  	***
		
	Registered Owner:	  	***

  

									
	 Territory
	 	 Appl. Date
	 	 Patent No.
	 	 Filing No.
	 	 Expiry Date

					
	 ***
	 		 		 		 	

  
  

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed
separately with the Commission. 

 *** PATENT PORTFOLIO 

*** 
  

 
  
 *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

 *** PATENT PORTFOLIO CONTINUED 

 

					
	 Title
	  	 Application Number
	  	 Date of Filing

			
	 ***
	  	***	  	***
			
	 ***
	  	***	  	***
			
	 ***
	  	***	  	***

  
  
  

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed
separately with the Commission. 

 *** 
  

			
		
	Subject Matter:	  	***
		
	Title:	  	***
		
	Origin:	  	***
		
	Registered Owner:	  	***
		
	European Patent No.	  	***
		
	Expiry date:	  	***

  
  
  

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed
separately with the Commission. 

 APPENDIX 2 

CDACF VERSION 8 BASE POWDERS 
 ***

  
  
  

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed
separately with the Commission. 

 APPENDIX 3 

CDACF VERSION 8 SUPPLEMENTS, MEDIA AND FEEDS 

*** 
  
  

 
 *** Portions of this page have
been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

 APPENDIX 4 

CDACF VERSION 8 KNOW-HOW 
 *** 

 
  
 *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.EX-10.12

 Exhibit 10.12 

MASTER COLLABORATION, SUPPLY AND DISTRIBUTION AGREEMENT 

BETWEEN 
 VIRBAC, a company organized under the
law of FRANCE, with registered office at 1ère avenue 2065 M – L.I.D., 06516, Carros, France - registered under number 417 350 311 RCS at Grasse, France, acting for itself and its Affiliates, herein duly represented by Christian Karst,
Member of the Executive Board, 
 Hereinafter referred to as “VIRBAC”; 

AND 
 NEXVET IRELAND LIMITED, a company organised
under the laws of Ireland, with registered office at 88 Harcourt Street, Dublin 2 Ireland, with registered number 550752, represented by Dr Mark Heffernan, Chief Executive Officer and Director, Hereinafter referred to as “NEXVET”

 NEXVET and VIRBAC are hereafter referred individually as the “Party” and collectively as the “Parties”. 

RECITALS 
 Whereas VIRBAC is a global
pharmaceutical company exclusively dedicated to animal health. VIRBAC is engaged in the research, development, manufacture and distribution of veterinary products. 

Whereas NEXVET develops and commercialises biological veterinary products. 

Whereas VIRBAC has offered to advise NEXVET in the development of Products in the Territory. 

Whereas NEXVET has offered to appoint VIRBAC as its exclusive distributor of the Products in the Territory and VIRBAC has accepted such appointment, on
the terms and conditions set out in the present agreement. 
 THEREFORE IT HAS BEEN FURTHER AGREED AS FOLLOWS: 

 

	1.	DEFINITIONS 

  

	1.1.	For the purposes of the present agreement, the following words shall have the following respective meanings: 

Agreement means this master collaboration, supply and distribution agreement for Products and all the annexes attached hereto, including
the Specific Distribution Agreements entered from time to time pursuant to this master collaboration, supply and distribution agreement for Products. 

  
 1/62 

 
  

 Affiliates means with respect to either Party any other company directly or indirectly
controlling, controlled by or under control with such Party. For the purposes of this definition “control” means owning or controlling, in the aggregate, forty nine percent (49%) or greater of the voting rights. 

Asian Territory means Japan, South Korea, Taiwan, the Philippines, Malaysia, Singapore, the Peoples’ Republic of China, Indonesia,
Thailand, India, Vietnam and Myanmar. 
 Commercial Margin means the Net Sales less the Total Cost of Goods less the Cost of Selling.

 Competing Products means canine, feline or equine monoclonal antibody targeting the same molecular target (for example, for NV-01:
canine monoclonal antibodies targeting NGF). 
 Cost of Goods means the costs incurred by or on behalf of NEXVET in the production of
the Products, including materials, labour and industrial overheads together with all ancillary expenses arising from such production such as duties, custom fees, freight and insurance. 

Cost of Selling means the total direct and variable cost of storage, delivery, selling, advertising and promotion of the Product(s) by
or on behalf of VIRBAC. These costs include direct and variable distribution, sales and marketing staff expenses (salaries and commissions), internal or external warehousing fees, sales meeting, sales and marketing staff travelling expenses, fees
and all other direct and variable operating costs related to distribution, sales and marketing. Notwithstanding the foregoing, for each Product the Cost of Selling in: 
  

	 	•	 	Year 1, Year 2 and Year 3 shall be [***] of VIRBAC’s Net Sales of the applicable Product; 

  

	 	•	 	Year 4 and Year 5 shall be [***] of VIRBAC’s Net Sales of the applicable Product; and 

  

	 	•	 	Year 6 and thereafter shall be [***] of VIRBAC’s Net Sales of the applicable Product. 

 For
each Product “Year 1” shall be a twelve (12) month period starting on the date of the First Commercialization of the Product and subsequent “Years” shall be calculated accordingly. 

Confidential Information means information not generally known to the public which gives a Party or a third party some competitive or
business advantage or the opportunity of obtaining such an advantage. The Confidential Information may pertain to, among other things: financial, economic, scientific and technical information such as formula, designs, methods, systems, procedures,
devices, know-how, computer hardware, computer software, costs, sales as well as facts with respect to the identities, personnel, projects, needs and policies of a Party 

Development Plans means the document as defined in Article 10 “Development Plans” agreed between the Parties and included in
each Specific Distribution Agreement. A Development Plan template is included in Annex 3. 
 Excluded Licensed Molecules means
those molecules which, as at the date of this Agreement, are the subject of a third party agreement, being: 
  

	 	(a)	a canine anti-TNF-a canine p80TNFR-Fc covered and / or claimed in patent number PCT/GB2013/050433 filed on 22 February 2013 and entitled “Tumour necrosis factor
receptor fusion proteins and methods of using the same”, including the molecule with the internal research code of NV-08; and 

  

	 	(b)	any new canine anti-TNF-a monoclonal antibody derived from the research activities on NEXVET’s canine anti-TNF-a monoclonal
antibody with an internal research code of NV-06. 

  
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

 Excluded Territory means: 

 

	 	(a)	in relation to the Excluded Licensed Molecules, the Asian Territory; or 

  

	 	(b)	a country within the Territory in which NEXVET may license a Pre-Development Candidate to a third party. 

Field means veterinary field. 

First Commercialization means the first commercial arm’s length bona fide sale of a Product by or on behalf of VIRBAC in a Major
Country, excluding the sale or provision of any Products by way of samples or for the purpose of clinical trials. 
 Force Majeure
means any event outside the reasonable control of either party affecting its ability to perform any of its obligations under this Agreement including act of God, fire, flood, lightning, war, revolution, act of terrorism, riot or civil commotion but
excluding strikes of the affected party’s own employees. 
 Freedom To Operate Analysis or FTO Analysis means an analysis
obtained from a patent attorney opining on the ability for a Product to be exploited (including manufactured, marketed, distributed and sold) in the Territory without a claim that such exploitation infringes a third party’s patent rights. 

GMP means current good manufacturing practices according to rules governing medicinal products in the European Union Volume IV
“Good manufacturing practices for medicinal products”(http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol4_en.htm) and other applicable laws, regulations and practices of a similar nature in other jurisdictions within the
Territory. 
 Important Country means [***]. 

Intellectual Property Rights means all intellectual property rights subsisting anywhere in the world, including: 

 

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

  

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

whether or not such rights are registered or capable of being registered. 

Joint Steering Committee (or JSC) means the joint steering committee as defined in Article 11 “Joint Steering Committee”. 

Major Countries means [***]. 

Manufacturer means such third party manufacturer(s) of the Products. For each Product, the Manufacturer(s) shall be defined in its
Specific Distribution Agreement. 
 Manufacturing Margin means NEXVET’s [***] margin on the Cost of Goods being the difference
between the Purchase Price and the Cost of Goods. However, the Manufacturing Margin shall not exceed NEXVET’s share of the Commercial Margin. 

For the sake of clarity and by way of a worked example: if the Purchase Price from NEXVET is [***] and the Cost of Goods is [***], the
Manufacturing Margin will be [***]. 
 Manufacturing Site(s) means the site(s) where the Products are manufactured. For each Product
the Manufacturing Site(s) shall be defined in its Specific Distribution Agreement. 

  
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

 Marketing Authorization means the sale or /and the import authorisation, marketing
authorisation, other governmental licenses, approvals, permits and other authorisations required and which are granted by the authorities to enable the Parties to import, market and sell the Products in the Territory. 

Marketing Authorization Holder, MAH or MH means the holder of the Marketing Authorization for a Product, which shall be NEXVET unless
agreed otherwise pursuant to the Specific Distribution Agreement. 
 Net Sales means the invoiced price of Products sold by VIRBAC to
third parties less, to the extent identified on the invoice, any costs of packing, insurance, transport, delivery, VAT and any other government taxes, duties or levies, and normal rebates, free goods, trade discounts and other allowances granted and
any reimbursements of Products already sold but returned by customers. 
 New Product means a product that is solely developed and/or
owned by NEXVET, or to which NEXVET has exclusive rights, which is (i) a canine, feline or equine monoclonal antibody which has been derived from the PETization technology or (ii) a canine, feline or equine receptor fusion protein, and for
either of which a Specific Distribution Agreement has not been entered into by the Parties. 
 New Product Notice has the meaning
given in Article 6.1. 
 NEXVET Fees means the sums due to NEXVET under this Agreement as described in Article 19.2 (Financial Terms)
being NEXVET’s share of the Commercial Margin, which includes the Manufacturing Margin. 
 NEXVET Know-how means any technical
and other information relating to the Products, the New Products or PETization, whether patented or unpatented, including, but without prejudice to the generality of the foregoing, ideas, concepts, trade secrets, know-how, inventions, discoveries,
data, formulae, specifications, processes, procedures for experiments and tests and other protocols, results of experimentation and testing, lab and commercial scale fermentation and purification techniques for biologics, assay protocols. It also
includes marketing data and knowledge to build and gather a Registration Dossier. 
 NEXVET Technology means the Patent together with
the NEXVET Know-how and all data and any manufacturing process related to the Products owned or controlled by NEXVET.

NV-01 means pharmaceutical canine monoclonal antibody product under its finished form targeting nerve growth factor (NGF)
covered by the Patent. 
 Patent means the patent(s) which are set out in Annex 1 and associated patent applications,
including, without limitation, any patents issuing on any such patent applications, as well as any divisionals, continuations, continuations-in-part, substitutions, re-examinations, reissues, renewals, extensions, supplementary protection
certificates and the like, and any foreign counterparts of any of the foregoing, all as updated from time to time by NEXVET. 

Pharmacovigilance Data Exchange Agreement means the agreement for the exchange of data relating to pharmacovigilance for each Product to
be entered into between the Parties which shall be in the form of the template agreement set out in Annex 8 and which shall be annexed to the Specific Distribution Agreement of each Product. 

Pre-Development Candidate means a product for which no New Product Notice has been issued by NEXVET. 

Products means a product for which the Parties have entered a Specific Distribution Agreement. A list of current Products is set
out in Annex 2. This list may be updated from 

  
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time to time as new Specific Distribution Agreements are entered into by the Parties in relation to New Products. For clarification, Products are products that are solely owned by NEXVET and any
products that are in-licensed by NEXVET from third parties or are developed in conjunction with third parties may not be Products due to contractual obligations owed by NEXVET to such third parties. 

Purchase Price means the Ex-Works price paid by VIRBAC to NEXVET for the Products which is equal to the Cost of Goods plus the
Manufacturing Margin. 
 Quality Agreement means the agreement for the quality of each Product to be entered into between the Parties
which shall be in the form of the template agreement set out in Annex 4 and which shall be annexed to the Specific Distribution Agreement of each Product. 

Quarter means one of the four quarters that make up the financial year, i.e. January, February and March; April, May and June; July,
August and September; and October, November and December. 
 Registration Dossier means any and all information, processes,
techniques and data necessary to be submitted or filed with a regulatory authority to obtain Marketing Authorization relating to the Products, including all administrative, technical, scientific, or other data and information (including raw data) as
well as Product samples if and to the extent required to be filed or submitted to a regulatory authority within the Territory to obtain a Marketing Authorization. 

Specifications means the specifications for each Product as detailed in its Specific Distribution Agreement. 

Specific Distribution Agreement means the agreement for the distribution of each Product to be entered into between the Parties which
shall be in the form of the template agreement set out in Annex 5. 
 Target Product Profile means the target product profile
of each Product as discussed from time to time through the JSC, agreed between the Parties and referenced in each Specific Distribution Agreement. 

Territory means (i) for all Products other than the Excluded Licensed Molecules, worldwide except the USA and Canada; (ii) for
any Products that are the Excluded Licensed Molecules, worldwide except the USA, Canada and the Asian Territory. 
 Total Cost of
Goods means the Cost of Goods paid by VIRBAC to NEXVET for the Products plus all ancillary expenses paid by VIRBAC arising from such purchase such as duties, custom fees, freight and insurance. 

Trademark means all the trademarks, trademark rights, service trademarks, trade usage, logotypes, domain names, whether registered or
not which are owned or licensed by NEXVET and which are used with the Products and which are set out in the applicable Specific Distribution Agreement. 

Trade Dress means VIRBAC’s presentation and labelling as the distinctive configuration, colour, format, designs, trademarks and
logos incorporated into the packaging and label presentation of any Products, but excludes the Trademarks. 
 VIRBAC Trademarks means
any trademarks, trademark rights, service trademarks, trade usage, logotypes, domain names, whether registered or not, which are owned or licensed by VIRBAC, excluding the Trademarks. 

 

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

 

	 	(i)	first Articles 1 to 40 of this Agreement; 

  
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	 	(ii)	then second the Annexes to this Agreement; and 

  

	 	(iii)	then third the Specific Distribution Agreements entered pursuant to this Agreement. 

  

	1.3.	The headings in this Agreement are inserted for convenience only and shall not affect the interpretation or construction of this Agreement. 

 

	1.4.	Words expressed in the singular shall include the plural and vice versa. Words referring to a particular gender include every gender. References to a person include an individual, company, body corporate, corporation,
unincorporated association, firm, partnership or other legal entity. 

  

	1.5.	The words “other”, “including” and “in particular” shall not limit the generality of any preceding words or be construed as being limited to the same class as any preceding words where a
wider construction is possible. 

  

	1.6.	References to any statute or statutory provision shall include (i) any subordinate legislation made under it, (ii) any provision which it has modified or re-enacted (whether with or without modification), and
(iii) any provision which subsequently supersedes it or re-enacts it (whether with or without modification) whether made before or after the date of this Agreement. 

 

	2.	PURPOSE 

  

	2.1.	VIRBAC shall advise NEXVET in the development of the Products and the New Products in the Territory and in the Field. 

  

	2.2.	Subject to the terms and conditions of this Agreement, NEXVET hereby appoints VIRBAC as its sole and exclusive distributor of the Products in the Field in the Territory for the term of the Agreement and VIRBAC hereby
accepts that appointment subject to the terms of this Agreement. 

  

	2.3.	In the Territory, NEXVET shall exclusively supply to VIRBAC and VIRBAC shall purchase exclusively from NEXVET the Products for distribution and sale during the term of this Agreement. 

 

	2.4.	All quantities of Products shall be supplied by NEXVET to VIRBAC in accordance with the terms and conditions of this Agreement, the Specific Distribution Agreement, the Target Product Profile, the Specifications, the
Marketing Authorizations and all applicable laws. 

  

	2.5.	NEXVET grants to VIRBAC the right to sell and distribute the Products under NEXVET’s Trademarks in the Territory in the Field, subject to and in accordance with the terms and conditions of this Agreement, the
Specifications, the Marketing Authorizations and all applicable laws. 

  

	2.6.	The Parties agree to enter into a Quality Agreement and a Pharmacovigilance Agreement for each Product which shall be in the form of the template Quality Agreement set out in Annex 4 and the template
Pharmacovigilance Data Exchange Agreement set out in Annex 8 modified as applicable to reflect the requirements of the relevant Product and attached to each Specific Distribution Agreement. 

 

	2.7.	In accordance with the terms of Article 6 “First option to New Product”, NEXVET grants to VIRBAC a right of first negotiation to enter into a Specific Distribution Agreement to distribute New Products.

  
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	3.	EXCLUSIVITY  

  

	3.1.	Subject to Article 3.2, during the term of the applicable Specific Distribution Agreement and subject to the other terms of this Agreement, NEXVET is not allowed to distribute the Products by itself or its Affiliates or
through any third party in any country within the Territory. 

  

	3.2.	NEXVET is allowed to distribute and sell a Product in the Territory itself only as of the first full calendar year following the [***] anniversary of the First Commercialization of this Product. In this case
VIRBAC’s right to exclusively distribute the applicable Product is revoked and it shall become NEXVET’s sole but not exclusive distributor for the applicable Product in the Field and in the Territory. 

For the sake of clarity and by way of a worked example: If a Product’s First Commercialization in on [***] then NEXVET shall be allowed to
distribute and sell that Product itself as from [***] and VIRBAC shall continue to have a right to distribute the applicable Product from this date in accordance with the terms of this Agreement. 

Where NEXVET exercises its rights in accordance with this Article 3.2 to distribute and sell a Product in the Territory itself only, NEXVET
shall compensate VIRBAC by paying to VIRBAC for each Product a sum equal to [***] of VIRBAC’s Net Sales for the Product in the Territory for the previous 12 (twelve months). This compensatory payment is in consideration for the losses
potentially suffered by VIRBAC and it is VIRBAC’s sole and exclusive remedy for NEXVET exercising its rights under this Article 3.2. This compensatory payment shall be paid within [***] date of invoice. 

 

	3.3.	If NEXVET decides to distribute a Product in the Territory itself only in accordance with Article 3.2 above, NEXVET shall notify VIRBAC at least [***] before distributing this Product and the Parties’ obligations
to communicate, under the framework of the JSC, the clinical, regulatory, marketing and sales input for this Product shall immediately cease to apply. 

  

	3.4.	During the term of the applicable Specific Distribution Agreement, if NEXVET distributes a Product in the Territory itself in accordance with Article 3.2 above, NEXVET must only distribute that Product (i) under a
different trade dress to the Trade Dress that is used for the Product by VIRBAC, and (ii) under trademarks that shall not be identical with or similar to the Trademarks licensed to VIRBAC by NEXVET and used by VIRBAC in accordance with the
applicable Specific Distribution Agreement. For the avoidance of doubt, once a Specific Distribution Agreement expires or is terminated, VIRBAC’s licence to use the Trademarks in relation to that Product also terminates, and NEXVET shall be
free to distribute the Product using the Trademarks but with a different trade dress from VIRBAC’s Trade Dress. VIRBAC will remain the owner of the Trade Dress. 

 

	4.	NON COMPETITION  

 For each Product, VIRBAC is not allowed in the Territory to
distribute itself or through a third party a Competing Product in a country where a Marketing Authorization has been obtained for a period of [***] from the First Commercialization of such Product. 

For each Product, and for so long as a Specific Distribution Agreement for that Product is in place, NEXVET is not allowed in the Territory to
distribute itself or through a third party a Competing Product under a trademark that is identical with or similar to the Trademarks that are licensed to VIRBAC for such Product. 

  
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	5.	LINK BETWEEN THE AGREEMENT AND SUBSEQUENT SPECIFIC DISTRIBUTION AGREEMENT 

  

	5.1.	Each Specific Distribution Agreement subsequently signed between the Parties in application of the Agreement, shall be an integral part of the Agreement and be governed by the Agreement. 

 

	5.2.	The Parties shall use the Specific Distribution Agreement template as attached in Annex 5. 

  

	5.3.	Each Specific Distribution Agreement must be signed by the legal representative of each Party. 

  

	6.	FIRST OPTION TO NEW PRODUCT 

  

	6.1.	The Parties acknowledge and agree that NEXVET has the right to manage its owns business and as such it is free to manage and exploit any Pre-Development Candidates as NEXVET, in its absolute discretion, deems
appropriate. For a period of [***] from the date of execution of this Agreement, NEXVET will notify VIRBAC via the JSC if a development candidate should be nominated as a New Product in the Territory (taking into account any Excluded Territory, if
applicable, with respect to the development candidate), on the basis that NEXVET (i) has developed a reasonable overview of the proposed target product profile of such development candidate, (ii) has obtained minimum safety and efficacy
information from proof of concept studies, (iii) has a realistic estimation of cost of goods of such development candidate and (iv) solely owns or has the exclusive rights to the development candidate. 

This [***] period shall automatically expire unless otherwise agreed in writing by the Parties before the expiry date. 

 

	6.2.	VIRBAC has the first option right to negotiate a Specific Distribution Agreement with NEXVET in the Territory for a New Product. VIRBAC has [***] days from the receipt of a New Product Notice to inform NEXVET in writing
of its interest in negotiating the distribution of the New Product (a “VIRBAC Notice”). 

  

	6.3.	The Parties have [***] months from the date of the VIRBAC Notice to negotiate a term sheet and [***] using all reasonable endeavours to negotiate and execute the terms and conditions for the Specific Distribution
Agreement of the New Product. The timescales set out in this Article 6.3 may be extended by mutual agreement of the Parties in writing. 

  

	6.4.	If the Parties fail to agree the terms and conditions for the Specific Distribution Agreement of a New Product in the agreed timeframes set out in Article 6.3 then VIRBAC shall have no rights in relation to such New
Product. 

  

	7.	TERM 

  

	7.1.	The Agreement is deemed to come into force on November 24th, 2014 and shall remain in force for 10 (ten) years from the date of First Commercialization of the first Product (“Initial Term”).

  

	7.2.	The duration of each Specific Distribution Agreement for each Product shall be set forth in the Specific Distribution Agreement itself. If the term of a Specific Distribution Agreement exceeds the term of this Agreement
then the following articles of this Agreement shall survive solely of the purpose of applying to the applicable Specific Distribution Agreement until the expiration or termination of such Specific Distribution Agreement: 

Article 1 (Definitions); 
 Article
2 (Purpose) 

  
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 Article 3 (Exclusivity) 

Article 8 (Responsibilities) 

Article 9 (Minimum Annual Net Sales Obligations) 

Article 10 (Development Plans) 

Article 11 (Joint Steering Committee) 

Article 12 (Marketing Authorization) 

Article 13 (Manufacturing and Batch Release) 

Article 14 (Supply and Delivery) 

Article 15 (Defects) 
 Article 16
(Recall of the Product) 
 Article 17 (Rolling Forecast and Orders) 

Article 18 (Pharmacovigilance) 

Article 19 (Financial Terms) 

Article 20 (Right of first refusal for Registration Dossier) 

Article 21 (Intellectual Property Rights) 

Article 21A (Infringement of Nexvet Technology or Trademarks by a third party) 

Article 22 (Trademarks and Packaging) 

Article 23 (Audits) 
 Article 24
(Liability - Insurance) 
 Article 25 (Confidentiality) 

Article 26 (Termination and Consequences of Termination) 

Article 27 (Remaining Stock) 

Article 28 (Notice) 
 Article 29
(Material Safety data Sheet) 
 Article 30 (Notification to Anti-Poison Center) 

Article 31 (Information) 
 Article
32 (Force Majeure) 
 Article 38 (Applicable Law and Jurisdiction) 
  

	7.3.	Unless agreed otherwise in writing by the Parties in advance of the ninth anniversary of the First Commercialization of the First Product, this Agreement shall automatically extend by a period of two (2) years on the
expiry of the Initial Term and shall continue to automatically extend on the expiry of each such two (2) year extension periods by additional two (2) year extension periods unless agreed otherwise by the Parties in writing. 

 

	8.	RESPONSIBILITIES 

  

	8.1.	VIRBAC Responsibilities 

 VIRBAC shall: 

 

	 	(a)	provide clinical, regulatory, marketing and sales input via a Joint Steering Committee (JSC). This shall include the provision of annual budgets (i.e. expenses forecasted), marketing strategy, pricing, forecast,
demand/orders post-launch and any subsequent country launch plans for the Important Countries. 

  

	 	(b)	advise NEXVET in the drafting of regulatory submissions in the countries within the Territory. This advice shall include reviewing and commenting on draft regulatory submissions prepared by NEXVET. 

 

	 	(c)	sell the Products according to the terms of the Agreement. 

  

	 	(d)	subject to Article 9 “Minimum Annual Net Sales Obligations”, meet or exceed Minimum Annual Obligations for each Product. 

  

	 	(e)	Subject to Article 18 “Pharmacovigilance”, VIRBAC shall be responsible for the local management of complaints and shall transfer any data in the timelines defined in Article 18 and the Pharmacovigilance Data
Exchange Agreement entered into by the Parties in each Specific Distribution Agreement. 

  

	 	(f)	Not itself apply for, or cause or allow any Affiliate or any third party to apply for, or become involved with any application by any other person for the registration of any trademark that is the same as any of the
Trademarks, or that is similar to or capable of being confused with any of the Trademarks, 

  
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 VIRBAC shall use commercially reasonable endeavours to launch the Products within [***] after the
issuance of the Marketing Authorization and it shall launch the Products no later than [***] after the issuance of the Marketing Authorization by each national authority. 

VIRBAC warrants that VIRBAC’s employees, any VIRBAC Affiliates, and any VIRBAC agents and/or any third party distributors engaged by
VIRBAC, shall comply with any applicable laws and regulations in the Territory in relation to such acts, and shall otherwise comply with VIRBAC’s obligations under this Agreement. 

 

	8.2.	NEXVET Responsibilities 

 NEXVET shall: 

 

	 	(a)	file, prosecute and maintain the Patents at its own costs. 

  

	 	(b)	conduct and provide to the JSC a Freedom To Operate analysis for the Products in the Territory. This analysis should be performed and updated regularly at the request of the JSC by professional patent attorneys.

  

	 	(c)	execute all pre-clinical and clinical development activities at its owns costs in accordance with Development Plan as agreed between the Parties. 

 

	 	(d)	share all development information via the JSC including pre-clinical, clinical development and more generally all information related to the development of the Products worldwide. 

 

	 	(e)	register the Registration Dossier at its own costs. NEXVET will be the owner of the Registration Dossier and the holder of the Marketing Authorization. 

 

	 	(f)	register, maintain and prosecute at its owns costs the Trademarks, 

  

	 	(g)	during the term of any Specific Distribution Agreement, NEXVET shall, notably, refrain from registering, from using itself, or from licensing to other partners, any trademarks that are identical with or similar to any
Trademarks which have been licensed to VIRBAC in the Territory under a Specific Distribution Agreement (unless and until that Specific Distribution Agreement expires or is terminated and VIRBAC’s licence to use such Trademarks ceases),

  

	 	(h)	use commercially reasonable endeavours to obtain the Marketing Authorizations for the Products at its own costs in accordance with the Target Product Profile agreed between the Parties. 

 

	 	(i)	use commercially reasonable endeavours to maintain the Marketing Authorizations within the Territory and NEXVET shall bear all the costs related to such maintenance (including but not limited to the ongoing stability
studies). 

  

	 	(j)	supply the Products to VIRBAC in accordance with the terms of this Agreement and the applicable Specific Distribution Agreement. 

  

	 	(k)	fund any development candidates which may become New Products. 

  

	9.	MINIMUM ANNUAL NET SALES OBLIGATIONS 

  

	9.1.	The minimum annual net sales obligations for each Product in the entire Territory shall be defined in the relevant Specific Distribution Agreement (“Minimum Annual Net Sales Obligations”).

  
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	9.2.	If VIRBAC fails to meet the Minimum Annual Net Sales Obligations for a Product during [***], VIRBAC shall have the right, as its exclusive remedy, to pay to NEXVET an amount equal to the difference between the
applicable NEXVET Fees which relate to the Minimum Annual Net Sales Obligations of such Product which VIRBAC has failed to achieve and the actual NEXVET Fees paid by VIRBAC for such Product during the [***] in which VIRBAC failed to meet the Minimum
Annual Net Sales Obligations (hereinafter the “Amount”). 

 For the sake of clarity and as example: 

For a Product, if Minimum Annual Obligations are not achieved for [***] where: 

 

	 	•	 	Minimum NEXVET Fees is [***] for the [***]; and 

  

	 	•	 	Actual NEXVET Fees paid by VIRBAC for the [***] is [***]; 

 VIRBAC shall have the right to pay
to NEXVET [***]. 
  

	9.3.	If VIRBAC has not made the payment referred to in Article 9.2 above to NEXVET within [***] of the issuance of the invoice corresponding to the Amount then NEXVET may terminate the applicable Specific Distribution
Agreement on notice to VIRBAC without any obligation to pay compensation of any kind. In such case, NEXVET shall issue a credit note corresponding to the Amount or cancel the applicable invoice. Upon such termination, VIRBAC’s rights to
distribute the Product or use any of the Trademarks shall terminate, and NEXVET shall then have the right to distribute the relevant Product in the Territory itself or through a third party, and shall have the right to use the Trademarks in relation
to the relevant Product. If VIRBAC does make the payment referred to in Article 9.2 then the applicable Specific Distribution Agreement shall continue subject to its terms and, for the avoidance of doubt, VIRBAC’s obligation to achieve the
Minimum Annual Net Sales Obligations shall continue. 

  

	9.4.	VIRBAC shall be relieved of its obligation to achieve the Minimum Annual Net Sales Obligations in the full applicable calendar year and the following years in case of: 

 

	 	(a)	Co-distribution of the Product in the Territory in accordance with NEXVET’s right in Article 3 (Exclusivity). 

  

	9.5.	Subject to Article 9.6 below: 

  

	 	(1)	VIRBAC shall be relieved of its obligation to achieve the Minimum Annual Net Sales Obligations in the full applicable calendar year to the extent that its failure to achieve the applicable Minimum Annual Net Sales
Obligations is caused by one or more of the causes described below: 

  

	 	(a)	NEXVET’s material breach of this Agreement or of the applicable Specific Distribution Agreement, where such material breach directly and materially affects VIRBAC’s ability to achieve the applicable Minimum
Annual Net Sales Obligations and where such material breach is not remedied by NEXVET within [***] of receipt of a notification from VIRBAC requiring the remedy of such material breach; or 

 

	 	(b)	no delivery of the Products by NEXVET for more than [***] (“No Delivery Period”); or 

  

	 	(c)	material modification of the Marketing Authorization for quality, safety or pharmacovigilance issues where such modification is not able to be rectified and such modification negatively impacts the Target Product
Profile in an Important Country and in a way that materially limits VIRBAC’s ability to achieve the Minimum Annual Net Sales Obligations. 

For the purposes of Article 9.5(1)(b), where the No Delivery Period is spread across [***] then VIRBAC shall have the right to elect which
calendar year’s Minimum 

  
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Annual Net Sales Obligation it shall be relieved of. VIRBAC shall only be able to elect to obtain relief for [***] Minimum Annual Net Sales Obligations and it shall be required to achieve the
Minimum Annual Net Sales in [***]. For the sake of clarity and by way of a worked example: 
 [***] 

 

	 	(2)	VIRBAC shall be relieved of its obligation to achieve the Minimum Annual Net Sales Obligations in the applicable [***], on a pro-rata basis, to the extent that its failure to achieve the applicable Minimum Annual Net
Sales Obligations is caused by one or more of the causes described below: 

  

	 	(a)	an event of Force Majeure which materially limits its ability to achieve the Minimum Annual Net Sales Obligations; or 

  

	 	(b)	no delivery of the Products for [***] or less or late delivery of the Products by NEXVET by at least [***] on [***] consecutive orders, with such late deliveries materially limiting VIRBAC’s ability to achieve the
Minimum Annual Net Sales Obligations; or 

  

	 	(c)	material modification of the Marketing Authorization for quality, safety or pharmacovigilance issues where such modification negatively impacts the Target Product Profile in an Important Country and in a way that
materially limits VIRBAC’s ability to achieve the Minimum Annual Net Sales Obligations (provided that such modification is rectified within a period of [***] of the modification); 

PROVIDED THAT for Articles 9.5 (2)(a), (2)(b) and 2(c) only, once the issue which has led to VIRBAC obtaining relief from its obligation
to achieve the Minimum Annual Net Sales Obligations has been resolved VIRBAC shall again be obligated to achieve the Minimum Annual Net Sales Obligations. In such a case the Minimum Annual Net Sales Obligations will be recalculated by NEXVET and
agreed by the JSC on a pro-rata basis to take into account the period during which VIRBAC was relieved of its obligation to achieve the Minimum Annual Net Sales Obligations. This recalculation may take in account [***] Minimum Annual Net Sales
Obligations if the events referred to in Articles 9.5 (2)(a), (2)(b) and 2(c) continue across [***]. 
  

	9.6.	VIRBAC shall only be able to avail of the relief set out in Article 9.5 if it is in full compliance with its corresponding obligations directly linked to the Minimum Annual Net Sales Obligations in this Agreement.

  

	9.7.	The Parties shall discuss the reassessment of the Minimum Annual Net Sales Obligations in case of: 

  

	 	(a)	the arrival of a Competing Product and/or any new breakthrough product with a different technology for the same indication, or 

  

	 	(b)	VIRBAC being prohibited from selling a Product in any Important Country due to: 

  

	 	(i)	an inability to obtain, or a loss of, a Marketing Authorization in any Important Country, notwithstanding reasonable efforts by NEXVET to obtain or maintain such Marketing Authorization and through no fault of either
Party; or 

  

	 	(ii)	a third party having intellectual property rights that would be infringed by the exploitation of the Product in the Important Country (as determined through the conduct of a FTO Analysis) and where NEXVET has not been
able to either obtain a licence to such third party rights or to manufacture, package or prepare to sell the Product in a way that does not infringe such third party rights, notwithstanding reasonable efforts to do so; or 

 

	 	(c)	a material improvement in the applicable Target Product Profile. If the Target Product Profile is so improved the Parties shall discuss increasing the applicable Minimum Annual Net Sales Obligations. 

  
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	10.	DEVELOPMENT PLANS 

  

	10.1.	Each Specific Distribution Agreement shall include a Development Plan. Each Development Plan shall include separate components describing NEXVET’s proposed development and regulatory activities with the goal of
obtaining Marketing Authorizations according to the Target Product Profile agreed between the Parties, in the Territory. The Development Plan shall be in the form of the Development Plan template set out in Annex 3. 

 

	10.2.	Each component of a Development Plan shall also include the proposed timeline for the activities described thereunder. 

  

	10.3.	The Development Plan shall become effective once approved by the JSC and material changes may only be amended thereafter by the JSC. 

 

	11.	JOINT STEERING COMMITTEE 

  

	11.1.	Establishment 

 Promptly after the signature of the Agreement, VIRBAC and NEXVET shall
establish a joint steering committee (the “JSC”) to oversee the development, registration, manufacture, technical support, marketing and sales of the Products in the Field. 

 

	11.2.	Responsibilities 

 The JSC shall be responsible for: 

 

	 	(i)	establishing (either by itself or through project teams), reviewing, sharing all Development Plans for the Territory and approving all Development Plans for the Territory, 

 

	 	(ii)	reviewing and monitoring activities under the Development Plans and the progress thereof in the Territory, 

  

	 	(iii)	managing the integration and coordination of the development and the manufacturing of the Products in the Territory, 

  

	 	(iv)	the choice of the Trademarks, 

  

	 	(v)	facilitating access to and ensuring the exchange of information between the Parties related to the Products in the Field in the Territory, 

 

	 	(vi)	ensuring that the development of the Products in the Field for the Territory proceed in a coordinated and expeditious manner, 

  

	 	(vii)	sharing and reviewing marketing and sales plans for the Territory, 

  

	 	(viii)	discussing and agreeing on the technical support and any additional studies (for instance clinical studies) related to such technical support. It is agreed between the Parties that NEXVET shall not unreasonably withhold
its agreement to conduct these post-approval studies if such studies are necessary to market and support the Products in the Territory. The Parties shall discuss the sharing of the costs of any such studies, 

 

	 	(ix)	discussing and agreeing on the publication plans in relation to any Products and the participation to conferences and conventions for the Territory, 

  
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	 	(x)	discussing and agreeing on the life cycle development of the Products (for example new indications, new formulations), 

  

	 	(xi)	seeking to resolving disputes between the Parties in accordance with the dispute resolution procedure set in Article 39 “Dispute Resolution Procedure”; and 

 

	 	(xii)	defining and agreeing the scope and object of the Freedom to Operate Analysis for each Product and ongoing review of the same. 

  

	11.3.	Membership 

 The JSC shall be comprised of an equal number of representatives from each
of NEXVET and VIRBAC. The exact number of such representatives shall be 3 (three) for each of VIRBAC and NEXVET, or such other number as the Parties may agree. The JSC shall allow attendance of ad hoc members from both parties according to the
topics to be addressed during the meetings. 
  

	11.4.	Decision Making 

 The decisions of the JSC shall be made by unanimous decision of the
representatives (for sake of clarity ad hoc members do not participate to the vote). If the JSC fails to reach unanimous consent on a particular matter within [***] after the JSC meeting, either Party may refer such matter to the Chief Executive
Officers of each of the Parties for resolution. 
 Where agreement is not reached, VIRBAC’s Board will have the final say on
(i) marketing (excluding decisions related to the Trademarks for which final say shall rest with NEXVET’s CEO), (ii) decisions as to whether or not to launch the Product(s) in a particular country within the Territory where VIRBAC
reasonably determines, taking into account the FTO Analysis, that there is a reasonable risk that such launch will infringe a third party’s Intellectual Property Rights (“Third Party Rights Risk”), and (iii) pricing
decisions in the Territory. NEXVET CEO will have the final say on Product development, registration and manufacturing decisions. 
 To the
extent that VIRBAC decides not to launch a Product(s) in a particular country within the Territory within [***] after the issuance of the Marketing Authorization by the applicable national authority due to a Third Party Rights Risk VIRBAC shall
inform NEXVET of such in writing, the Parties shall meet within [***] of the date of such notice to determine whether the launch is to be delayed for a reasonable period of time (and if so the length of that delay) or shall not take place at all. If
VIRBAC decides not to launch the Product(s) at all due to the Third Party Rights Risk or still will not launch the Product(s) after the agreed delay period due to the Third Party Rights Risk, either Party shall have the right to partially terminate
the applicable Specific Distribution Agreement on [***] notice in relation to the applicable country and upon such partial termination all of VIRBAC’s rights in respect of the applicable Product in the applicable country shall cease and NEXVET
shall be free to market and distribute the Product(s) in that country either itself or through a third party as it determines in its absolute discretion. In such case, NEXVET shall market and distribute the Product in the applicable country under a
different trade dress to the Trade Dress that is used for the Product by VIRBAC. NEXVET will however be free to use the Trademarks in relation to the Product in the applicable country. In addition, the Minimum Annual Net Sales Obligations will be
recalculated by the Parties and agreed by the JSC to take into account the loss of the applicable country. 
 Each Party will bear its own
costs in relation to the JSC. The JSC should meet four times a year with at least two meetings face-to-face per annum. 
  

	11.5.	NEXVET information sharing through the JSC 

 Through the JSC, NEXVET shall keep VIRBAC
informed of the following: 
  

	 	(i)	Development Plans and their progress outside the Territory, 

  
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	 	(ii)	The process of the integration and coordination of the development and the manufacturing of Products outside the Territory, 

  

	 	(iii)	Information relating to the same or similar Products outside the Territory, 

  

	 	(iv)	The progress of marketing and sales plans for the Products outside the Territory, 

  

	 	(v)	Information on publication plans, conferences and conventions outside the Territory in relation to the Products. 

  

	 	(vi)	The progress made in connection with Trademark protection in the Territory and the risks encountered which can prevent the use of the Trademarks in the Territory by VIRBAC. 

Unless indicated otherwise by NEXVET, all such information shall be Confidential Information of NEXVET and Article 25 shall apply to such
information. 
  

	11.6.	Through the JSC, VIRBAC shall keep NEXVET informed of the following: 

  

	 	(i)	Marketing, launch and annual budget plans for the Product in the Territory, 

  

	 	(ii)	Market information on similar technology and/or products to any Products in the Territory in so far as VIRBAC is aware of such, 

  

	 	(iii)	Information on inventory holdings by VIRBAC and its distributors for the Product to the extent this information is available, 

  

	 	(iv)	Pharmacovigilance issues for the Product(s); 

  

	 	(v)	Potential new products and target product profiles that would enhance the collaboration between the Parties. 

  

	12.	MARKETING AUTHORIZATION 

  

	12.1.	NEXVET shall be responsible, at its own expenses, for obtaining and maintaining in its own name the Marketing Authorization and any other governmental or certifying body permits, authorizations and certifications
necessary. NEXVET shall be the holder of the Marketing Authorization in the Territory unless agreed otherwise pursuant to each Specific Distribution Agreement. 

  

	12.2.	VIRBAC shall provide reasonable cooperation with NEXVET in obtaining and maintaining the Marketing Authorization in the Territory. All these documents shall be provided in English language. VIRBAC will not invoice
NEXVET for any internal costs for this cooperation. 

  

	12.3.	Where additional studies are required for the purpose of obtaining the Marketing Authorization, the cost of said additional studies shall be borne by NEXVET. 

 

	13.	MANUFACTURING AND BATCH RELEASE  

  

	13.1.	Manufacturing 

 NEXVET shall procure that the Products are manufactured by the Product
Manufacturer. Nevertheless, the Products shall be manufactured under NEXVET’s responsibility and liability even when the Manufacturer is not NEXVET. NEXVET shall remain responsible to VIRBAC for the acts of the Manufacturer even though the
Manufacturer is a third party. 

  
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 NEXVET warrants to VIRBAC that: 

 

	 	(1)	the Manufacturing Site shall comply with the Product Authorization, GMP or equivalent manufacturing standards and with all applicable laws and, in particular, the Manufacturer shall avoid any contamination with other
products and/or active ingredients manufactured by the Manufacturer; and. 

  

	 	(2)	the Manufacturer has and shall have full capacity and authority to fulfil the obligations established under the Agreement and, shall have all necessary licenses, permits and consents to manufacture the Product for sale
of the Products in any country of the Territory. 

 NEXVET shall inform the JSC if it proposes to change the Product
Manufacturing Site and/or the Product Manufacturer. NEXVET shall provide the JSC with at least [***] written notice of any such changes. 
  

	13.2.	Batch release 

 NEXVET acts as the manufacturer and the batch releaser of the Products.
Quality control proceedings shall be performed in compliance with the Marketing Authorization and all applicable laws. 
 NEXVET shall send
to VIRBAC the following documents with every batch of Product: certificate of analysis and the batch release documentation, at the following address: 

VIRBAC 
 [***] 

Both Parties shall ensure or procure that when they are in possession of a batch of Products that such Products are stored in compliance with
relevant government requirements and that they shall at all times handle the Products in compliance with the Marketing Authorization. 

NEXVET shall ensure that it will keep all the batch documentation of the Products after date of delivery of the Products to VIRBAC in
accordance with any applicable regulatory requirements and/or applicable laws. 
  

	14.	SUPPLY AND DELIVERY  

  

	14.1.	NEXVET warrants that the Products shall meet the applicable Product Specification as set in the Specific Distribution Agreement. 

  

	14.2.	All Products shall be delivered subject to and in accordance with the terms of this Agreement and the applicable Specific Distribution Agreement to the exclusion of any other terms either Party may seek to impose on or
around the time of delivery. The Specific Distribution Agreements will include delivery details which apply to the applicable Products (such as timeline, minimum order quantity, consequences of late delivery etc.), PROVIDED THAT NEXVET shall set the
minimum order quantities for each Product(s). 

  

	14.3.	The Products shall be delivered to VIRBAC with at least [***] of their approved shelf live remaining and in any event with at the minimum [***] of their approved shelf live remaining unless otherwise agreed by the
Parties in each Specific Distribution Agreement. 

  

	14.4.	NEXVET shall promptly inform VIRBAC in the event NEXVET cannot, for whatsoever reason, deliver the Product within the agreed delivery date. Time of delivery shall not be of the essence. 

 

	14.5.	VIRBAC storage of the Products: VIRBAC must store the Products in a proper manner in conditions which adequately protect and preserve the Products without any charge to NEXVET and not tamper with any identification upon
the Products or their packaging. In particular, VIRBAC shall ensure that it stores and maintains the Products in accordance with the applicable specifications and the Marketing Authorization. 

  
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	14.6.	The penalty in case of late delivery of the Product shall be defined in each Specific Distribution Agreement. 

  

	14.7.	Retention of Title: 

  

	 	(a)	Risk in respect of the Products supplied to VIRBAC shall pass to VIRBAC on delivery. 

  

	 	(b)	Title to and property in the Products supplied under a Specific Distribution Agreement shall remain vested in NEXVET (even though they have been delivered and risk has passed to VIRBAC) until: the price of the Products
has been paid, discharged or satisfied in full whether or not due for payment. 

  

	 	(c)	VIRBAC acknowledges that it is in possession of the Products solely as bailee for NEXVET until such time as title in the Products passes to VIRBAC. 

 

	 	(d)	Until title to and property in the Products pass to VIRBAC, NEXVET may at any time without prior notice to VIRBAC require VIRBAC to deliver the Products up to NEXVET and NEXVET may repossess and resell the Products if
any of the events specified in Article 26.5 as giving rise to a right for NEXVET to terminate this Agreement occurs, or if any sum due to VIRBAC from NEXVET under this Agreement or on any other account or under any other contract is not paid when
due; 

  

	 	(e)	NEXVET’s rights and remedies set out in this Article 14.7 represent the sole and exclusive remedy of NEXVET and the entire liability and obligation of VIRBAC with respect to this article. 

 

	15.	DEFECTS  

  

	15.1.	Provided the Products present a visible defect, VIRBAC shall inform NEXVET and NEXVET shall, without prejudice of any other indemnities set out in the Agreement, at its own expenses and immediately, take back the
defective Products and refund VIRBAC the amounts already paid or to replace the defective Products with other Products immediately. 

  

	15.2.	In the event that Products contain a latent defect, VIRBAC shall notify the existence of such latent defect within [***] of said discovery. If NEXVET disagrees or disputes the written notification from VIRBAC, the
Parties shall submit samples of the rejected Products to a mutually acceptable independent laboratory for analysis, whose analysis results on the matter shall be final and binding. The Party found to be in error shall bear the cost of such analysis.

  

	15.3.	In the event such laboratory shows that the relevant batch does not meet the agreed quality, VIRBAC may reject such batch which NEXVET shall replace with Products to be delivered free of charge and as soon as reasonably
applicable or if the Products are already on the market, NEXVET shall replace the Products free of charge, without prejudice of any other indemnities set out in the Agreement. 

 

	15.4.	NEXVET shall not be liable for Products’ failure to comply with the applicable specification in any of the following events: 

  

	 	(a)	the defect has arisen because VIRBAC has failed to comply with Article 14.5, or more generally has failed to follow NEXVET’s instructions as to the storage, commissioning, installation, use and maintenance of the
Products or (if there are none) good trade practice regarding the same; 

  

	 	(b)	VIRBAC alters such Products without the written consent of NEXVET; 

  
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	 	(c)	the defect arises as a result of fair wear and tear, wilful damage, negligence, or abnormal storage or working conditions; or 

  

	 	(d)	the Products differ from the applicable specification as a result of changes made to ensure they comply with applicable statutory or regulatory requirements. 

 

	16.	RECALL OF THE PRODUCT 

  

	16.1.	VIRBAC shall maintain an efficient distribution system within the Territory and shall establish and maintain a batch tracing and recall system which will enable it to identify, with minimum delay, customers within the
Territory who will have been supplied with any particular batch of the Products and to recall such Products. VIRBAC shall provide all reasonable assistance requested by NEXVET in relation to a recall of the Products or a field alert.

  

	16.2.	In the event that the Authorities require a recall of the Product or if NEXVET believes that a recall of the Products may be necessary or appropriate, NEXVET shall immediately notify VIRBAC. In the latter case (if
NEXVET believes a recall is necessary), the two parties shall discuss whether a recall is necessary but NEXVET, as the MAH, with exception of local regulatory requirements, is responsible for the final decision of any recalls or field alert
activities and for corresponding communication with health authorities. 

  

	16.3.	VIRBAC shall use its reasonable endeavours to perform and coordinate recalls or field alert activities as required by NEXVET according to Article 16.2 from time to time. 

 

	16.4.	NEXVET shall provide any information reasonably required by VIRBAC relating to recall or field alert activities within [***] of the request, if such information is readily available at NEXVET. 

 

	17.	ROLLING FORECAST AND ORDERS  

  

	17.1	Rolling forecast 

 VIRBAC will at least [***] before the end of December of each calendar
year notify NEXVET in writing of the estimated rolling forecast for the Products for the following calendar year. Such forecasts are non-binding and will be updated as necessary on a Quarterly basis. 

VIRBAC shall use its reasonable endeavours to hold stock(s) of the Products sufficient to meet the total demand of the market in the Territory.

  

	17.2	Orders 

 VIRBAC will place firm purchase orders for the Products by email or fax giving
not less than [***] notice prior to the required date of delivery to enable NEXVET to arrange its schedule for production. 
 In the event
that VIRBAC places orders for quantities in excess of its estimated requirements and/or for delivery within a shorter period than [***], NEXVET will use its reasonable endeavours to comply with such request. 

All orders will be deemed accepted and binding [***] from receipt of the orders by NEXVET. If orders are not accepted, NEXVET shall indicate in
writing the reasons of refusal and, if applicable, the date of the possible delivery of the Products. 

  
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	18.	PHARMACOVIGILANCE  

  

	18.1	Subject to the provisions of Article 8: 

  

	 	(a)	The Parties shall be responsible for the compliance with the pharmacovigilance obligations as defined under local rules in the Territory, and shall comply with a Pharmacovigilance Data Exchange Agreement to be entered
into between the Parties in each Specific Distribution Agreement, in a form substantially the same as set out in Annex 8 of this Agreement. By way of assisting and advising NEXVET on the distribution of the Product in the Territory, VIRBAC
shall take all reasonable steps to inform NEXVET of any local rules within the Territory that may be applicable with respect to the Product and with which NEXVET may have to comply. 

 

	 	(b)	VIRBAC shall be responsible for the local management of complaints and shall transfer any data within [***] of receipt of the first information to NEXVET for serious cases. For the other non-serious cases, VIRBAC shall
transfer any data within [***] of receipt of the first information to NEXVET. 

  

	 	    	NEXVET as the Marketing Authorization Holder shall be responsible for preparing and submitting the reports (expedited and periodic) to the concerned agencies. 

 

	 	(c)	Each Party shall provide, within a reasonable deadline or the legal deadline, any information requested by the other Party in order to comply with the local pharmacovigilance obligations in the Territory.

  

	 	(d)	All relevant information relating to pharmacovigilance must be shared between NEXVET and VIRBAC in order to allow the parties to assume their obligations and responsibilities. 

 

	 	(e)	NEXVET being the MAH will be responsible for the communication on pharmacovigilance with the authorities. 

  

	19.	FINANCIAL TERMS  

  

	19.1	Milestone payment 

 In recognition and consideration of the research and development work
conducted by NEXVET, VIRBAC shall pay to NEXVET a milestone payment or payments for each Product (“Milestone Payment”). 

The trigger event(s) and the amount of the Milestone Payment shall be defined in each Specific Distribution Agreement for each Product and
shall be paid by VIRBAC to NEXVET within [***] of the date of the trigger event(s). For the sake of clarity, a Milestone Payment is paid only once for each trigger event for that Product, unless specified otherwise. 

If a Specific Distribution Agreement is terminated before a trigger event(s) occurs then no Milestone Payment will be due for the applicable
Product. 
  

	19.2	NEXVET Fees 

  

	19.2.1	The NEXVET Fees will be defined in each Specific Distribution Agreement for each Product. 

 The
NEXVET Fees shall be determined based on the share of the Commercial Margin between NEXVET and VIRBAC. 

  
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 The Parties acknowledge and agree that: 

 

	 	(i)	the payment of the NEXVET Fees shall incorporate the deferred payment of the Manufacturing Margin for the Product; and 

  

	 	(ii)	the Manufacturing Margin shall not exceed NEXVET’s share of the Commercial Margin. 

  

	19.2.2	NEXVET shall invoice the Products at the Purchase Price as follows: 

  

	 	•	 	an invoice for the Manufacturing Margin whereby the payment of the invoice shall be deferred and included in the Quarterly NEXVET Fee calculation; 

 

	 	•	 	an invoice for the Cost of Goods that shall be raised on delivery of the Products. 

  

	19.2.3	The NEXVET Fees shall be invoiced on a Quarterly basis as follows: 

  

	 	(i)	the Manufacturing Margin; and 

  

	 	(ii)	the remaining balance of NEXVET’s share of the Commercial Margin. 

 The NEXVET Fees shall
be estimated on a Quarterly basis by VIRBAC based on VIRBAC’s sales, and such estimation shall be provided to NEXVET within [***] from the end of the Quarter. NEXVET shall issue an invoice based on this estimation to VIRBAC. 

 

	19.2.3	At the end of each calendar year, and in any event by the end of January each year, VIRBAC shall calculate and communicate to NEXVET the exact NEXVET Fees to be paid to NEXVET for the preceding year less amounts already
paid by VIRBAC for the 3 (three) first Quarters of the relevant year. NEXVET shall issue the corresponding invoice on receipt of the required information from VIRBAC. 

 

	19.2.4	For sake of clarity, a financial example is set out in Annex 9. 

  

	19.3	Purchase Price of the Products 

 The Purchase Price of the Products shall be Ex-Works
Product Manufacturer (Incoterms 2010), unless otherwise mentioned in the Specific Distribution Agreement. 
 The Purchase Price of each
Product shall be disclosed and agreed between the Parties through the JSC and shall be stated in each Specific Distribution Agreement. 

During the term of the Agreement, NEXVET shall use its reasonable endeavours to reduce its costs in line with any specified requirements in the
Specific Distribution Agreement. 
  

	19.4	Cost of Selling 

 VIRBAC shall use the Cost of Selling as defined in Section 1
«Definitions » of the Agreement for the calculation of the Commercial Margin. 
  

	19.5	Payments 

 Unless otherwise agreed in this Agreement, all the invoices shall be paid by
VIRBAC to NEXVET within [***] from the date of the invoice. 
 The invoices and payment shall be made to NEXVET in Euros by wire transfer to
the bank account specified in any invoice. 
 The functional currency in the VIRBAC’s group’s foreign subsidiaries is the current
local currency. The financial income statements of foreign companies for which the functional currency is not the Euro are converted using the published Banque de France foreign exchange reference monthly average rate. Payments to Nexvet will be
calculated on this basis. For the purpose of calculations, the Net Sales will be converted from Euro to USD using the Banque de France’s published foreign exchange reference monthly average rate for the period and compared to the USD Minimum
Annual Net Sales Obligations amounts disclosed in the Specific Distribution Agreement. 

  
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	20.	RIGHT OF FIRST REFUSAL FOR REGISTRATION DOSSIER 

  

	20.1.	If NEXVET receives a bona fide proposal from a third party for the assignment of the Registration Dossier for any of the Products, NEXVET shall notify VIRBAC of the receipt of a third party proposal for the assignment
of the Registration Dossier, but not the details. 

  

	20.2.	VIRBAC will have a [***] period from the receipt of the notification from NEXVET to make an offer to purchase the Registration Dossier. At the end of that period, NEXVET shall consider all offers and be free to
assign the Registration Dossier to whichever entity (being the third party or VIRBAC) to whom NEXVET, in its sole discretion, determines. 

  

	21.	THIRD PARTY INTELLECTUAL PROPERTY RIGHTS INDEMNITY  

  

	21.1	NEXVET shall hold harmless and fully indemnify VIRBAC, and shall compensate and reimburse VIRBAC, against any damages, expenses and costs awards suffered and/or incurred by VIRBAC in connection with any third
party’s claim that its Intellectual Property Rights have been infringed arising out of VIRBAC’s use of the Trademarks in accordance with this Agreement and resulting from the making, offering, putting on the market, marketing, importing,
stocking, manufacturing, the distribution of the Products in the Territory in accordance with this Agreement. 

  

	21.2	VIRBAC shall hold harmless and fully indemnify NEXVET, and shall compensate and reimburse NEXVET, against any damages and costs awards suffered and/or incurred by NEXVET in connection with any third party claim of
infringement of that third party’s Intellectual Property Rights arising out of the use of the VIRBAC Trademarks, the Trade Dress and any marketing material used by or on behalf of VIRBAC in relation to the sale, marketing or distribution of the
Products, PROVIDED THAT the indemnity shall apply only to such damages and costs arising from any such infringement which relates to the VIRBAC Trademarks, the Trade Dress or VIRBAC’s marketing material. 

 

	21.3	The party that is seeking to be indemnified under either Article 21.1 or Article 21.2 (each an “Indemnified Party”) agrees to promptly notify the other party (the “Indemnifying Party”)
in writing of any claim or allegation by a third party, and to: 

  

	 	21.2.1	make no admission without the Indemnifying Party’s prior written consent (such consent not to be unreasonably withheld); 

  

	 	21.1.2	allow the Indemnifying Party to have sole conduct and control of the defence of any such claim or any related settlement negotiations; and 

 

	 	21.2.3	give the Indemnifying Party all reasonable assistance (at the Indemnifying Party’s cost) with such defence or any related settlement negotiations. 

 

	21.4	If any claim is made pursuant to Article 21.1 above, or if, in the reasonable opinion of NEXVET, such as claim is likely to be made, NEXVET shall promptly and at its own expense either: 

 

	 	21.4.1	procure such rights as are necessary to enable VIRBAC to continue distributing the Products. In such case, these expenses (such as royalties) should not be taken out of the Commercial Margin that will be shared between
VIRBAC and NEXVET and should be borne exclusively by NEXVET; or 

  

	 	21.4.2	modify or replace the infringing part of the Products (without curtailing in any material aspect the Products) so as to avoid the infringement or alleged infringement. 

  
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	21.5	The foregoing indemnity in Article 21.1 will not apply to any claim that is based upon or arising from (i) any misuse of the Products by VIRBAC without the consent of NEXVET, (ii) any alternation of the
Products by VIRBAC, or (iii) VIRBAC’s continued use of the Products subsequent to receipt of notice of any claimed infringement. 

  

	21.6	Subject to the additional remedy available to VIRBAC under Article 22.1(d) below, this Article 21 represents the sole and exclusive remedy of either Party (as applicable) and the entire liability and obligation of the
other Party (as applicable) with respect to infringement or claims of infringement or misappropriation of any third party’s Intellectual Property Rights. 

  

	21A.	INFRINGEMENT OF NEXVET TECHNOLOGY OR TRADEMARKS BY A THIRD PARTY 

  

	21A.1	Each Party shall promptly give notice in writing to the other if it becomes aware of any infringement or suspected infringement of the Trademarks, the NEXVET Technology or any other Intellectual Property Rights relating
to the Products within the Territory. 

  

	21A.2	NEXVET has the first right, but not the obligation, at NEXVET’s cost and in its sole discretion, to take action in relation to any unauthorised use of any of the NEXVET Technology or the Trademarks. NEXVET will
have absolute control over any litigation involving or affecting the NEXVET Technology or the Trademarks. VIRBAC acknowledges and agrees that NEXVET will retain any and all damages or awards arising from any proceedings undertaken pursuant to this
Article 21A.2. VIRBAC must provide NEXVET with all reasonable assistance in connection with any action taken by NEXVET under this Article 21A.2 and NEXVET must indemnify VIRBAC from and against all expenses, losses, damaged and costs
whatsoever arising directly or indirectly as a result of any action taken under this Article 21A.2. 

  

	21A.3	If NEXVET does not take action under Article 21A.2 within [***] of being notified of a claim in accordance with Article 21A.1, VIRBAC may, with the prior written consent of NEXVET, take action at VIRBAC’s
cost, provided that: 

  

	 	(a)	VIRBAC must consult with, and have due regard to the interests of NEXVET; 

  

	 	(b)	NEXVET will have the option at any time to direct VIRBAC in relation to the action or to assume control of the action from VIRBAC; and 

 

	 	(c)	VIRBAC must not settle or compromise any action without the prior written consent of NEXVET. 

VIRBAC will retain any and all damages or awards arising from any proceedings taken under this Article 21A.3. NEXVET will provide VIRBAC with
all reasonable assistance in connection with any action taken by VIRBAC under this Article (including being joined to proceedings or allowing proceedings to be instituted in NEXVET’s name if required). VIRBAC must indemnify NEXVET from and
against all expenses, losses, damaged and costs whatsoever arising directly or indirectly as a result of any action taken under this Article 21A.3. 
  

	22.	TRADEMARKS AND PACKAGING 

  

	22.1.	Trademark licence 

  

	 	(a)	The Products shall be distributed by VIRBAC in the Territory under the Trademarks in accordance with and subject to this Agreement. 

  

	 	(b)	 NEXVET grants to VIRBAC an exclusive, revocable, non-transferable licence in the Territory, to use the applicable Trademarks in the promotion,
advertisement and sale of the Products only, subject to, and for the duration of, the applicable Specific 

  
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Distribution Agreement. VIRBAC acknowledges and agrees that all rights in the Trademarks shall remain in NEXVET, and that VIRBAC has and will acquire no right in them by virtue of the discharge
of its obligations under this Agreement or the applicable Specific Distribution Agreement, except for the right to use the Trademarks as expressly provided in the Specific Distribution Agreement. Any goodwill in any of the Trademarks that is
generated by or on behalf of VIRBAC during the term of this Agreement or any Specific Distribution Agreement enures for the benefit of NEXVET. 

  

	 	(c)	NEXVET is responsible, at its own costs, in the Territory, to obtain the registration of the Trademarks, to maintain and to police the registered Trademarks. The cost of the Trademark licence is included in the global
amount paid by VIRBAC within the framework of this Agreement and VIRBAC shall not pay additional fees for the licence granted by NEXVET to sell the Products under its Trademarks. 

 

	 	(d)	NEXVET agrees to reimburse VIRBAC for any direct costs incurred by VIRBAC for the destruction of packaging and re-working of artwork in the event of a final and binding decision that any of the Trademarks infringe the
rights of a third party in the Territory. 

  

	 	(e)	To the extent that any Trademark is no longer able to be used by VIRBAC due to a final and binding decision that the Trademark infringes the rights of a third party in the Territory, NEXVET will use its reasonable
endeavours to provide a replacement Trademark for the Products, in which case all the provisions of this Agreement with respect to the Trademarks will be applied to this new Trademark. 

 

	22.2.	All representations of the Trademarks that VIRBAC intends to use shall be submitted to NEXVET for written approval before use and shall not be used unless such approval is provided by NEXVET in writing within [***]
which approval shall not be unreasonably withheld. 

  

	22.3.	VIRBAC shall comply with all rules for the use of the Trademarks issued by NEXVET (including those set out in any branding manual issued by NEXVET) and shall not, without the prior written consent of NEXVET, alter or
make any addition to the labelling or packaging of the Products displaying the Trademarks. VIRBAC shall not alter, deface or remove any reference to the Trademarks, any reference to NEXVET or any other name displayed on the Products or their
packaging or labelling. 

  

	22.4.	VIRBAC shall not do, or omit to do, anything in its use of the Trademarks that could adversely affect their validity or reputation. 

  

	22.5.	VIRBAC shall immediately on request enter into any further agreements with NEXVET, in a form satisfactory to NEXVET, necessary for the recording, registration or safeguarding of NEXVET’s Trademark rights for the
marketing of the Products under the Trademarks. 

  

	22.6.	VIRBAC shall not use the Trademarks as part of the name under which VIRBAC conducts its business, or any connected business, or under which it sells or services any products (except the Products), or in any other way,
except as expressly permitted hereunder. 

  

	22.7.	VIRBAC shall not sub-license, assign, transfer, charge, or otherwise encumber the right to use, reference, or designate the Trademarks to any other party, except as otherwise expressly permitted under this Agreement or
a Specific Distribution Agreement. 

  

	22.8.	Upon termination of this Agreement or the applicable Specific Distribution Agreement for any reason, VIRBAC will immediately stop using all or any part of the Trademarks, except where permitted to sell remaining stock
pursuant to Article 27. 

  

	22.9.	 Trade Dress: NEXVET shall deliver the Products with their primary and secondary packaging in compliance with the Marketing Authorization and in
accordance with 

  
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VIRBAC’s graphic arts and packaging Trade Dress directions; provided that graphic arts and packaging Trade Dress meet NEXVET ́s instructions over the format, blisters, sizes. In no
event shall NEXVET be authorized to make any changes in VIRBAC’s graphic arts and packaging Trade Dress. 

  

	22.10	NEXVET alone is responsible for the registration, maintenance and protection of any of the Trademarks, marks or designs that relate to the Products, except for any of the VIRBAC Trademarks or the Trade Dress, in which
case, VIRBAC is responsible for the registration, maintenance and protection of any Intellectual Property Rights in the VIRBAC Trademarks or the Trade Dress. 

  

	22.11	Ownership of Trademarks and VIRBAC Trademarks and Trade Dress 

  

	 	(a)	NEXVET hereby acknowledges VIRBAC’s ownership of the VIRBAC Trademarks and Trade Dress, whether or not registered, and shall not acquire any rights in respect thereof. NEXVET shall not register or file in its own
name or in the name of any other person or company any signs such as trademarks, company names or domain names, consisting of or containing the VIRBAC Trademarks or the name VIRBAC. NEXVET shall not register, use or file any signs being confusingly
similar to or containing the VIRBAC Trademarks or the name VIRBAC. 

  

	 	(b)	NEXVET undertakes not to infringe, directly or indirectly, or help the infringement of any of the VIRBAC Trademarks and/or Trade Dress. This obligation shall apply within and outside the Territory and shall survive the
expiration or termination of this Agreement for any reason whatsoever. 

  

	 	(c)	VIRBAC hereby acknowledges NEXVET’s ownership of the Trademarks, whether or not registered, and shall not acquire any rights in respect thereof except for the licensed rights under any Specific Distribution
Agreement. VIRBAC shall not register or file in its own name or in the name of any other person or company any signs such as trademarks, company names or domain names, consisting of or containing the Trademarks or the name NEXVET. VIRBAC shall not
register, use or file any signs being confusingly similar to or containing the Trademarks or the name NEXVET. 

  

	 	(d)	VIRBAC undertakes not to infringe, directly or indirectly, or help the infringement of any Trademarks. This obligation shall apply within and outside the Territory and shall survive the expiration or termination of this
Agreement for any reason whatsoever. 

  

	23.	AUDITS 

  

	23.1.	Subject to Article 25, each Party or, at Parties election, its professional advisers or auditors has the right to audit the other Party at its own expenses in order to verify the compliance with the terms of the
Agreement including any financial aspects (such as Cost of Goods). In addition and subject to obtaining the consent of the Manufacturer, VIRBAC has the right to inspect the Manufacturer Site(s). 

 

	23.2.	Each Party shall provide at least [***] notice prior to the audit. 

  

	23.3.	During an audit, each Party undertakes to cooperate closely and particularly to provide the other Party or its nominated auditors with all requested elements linked with the audit scope. 

 

	23.4.	In case of assignment of the Agreement to a competitor of VIRBAC, such assignee will not be authorized to audit VIRBAC directly. In such case, the assignee and VIRBAC shall appoint an independent audit firm and such
audit firm will be bound by an agreement for the conduct of the audit with VIRBAC and the assignee 

  
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	24.	LIABILITY – INSURANCE 

  

	24.1	Each Party will maintain insurance coverage in accordance with the present article at all times commencing on the coming into force of this Agreement and continuing during the term of the Agreement. Each Party shall
take out all insurance policies with a reputable insurance company, registered in a country member of the European Union, in accordance with their contractual obligations allowing each Party to fully defend their rights. Each of the general
liability insurance and the Products liability insurance coverage obtained by each of the Parties shall be not less than [***] per event or series of connected events and per year and either Party shall produce a brokers letter as evidence of its
compliance with this obligation on the request of the other Party from time to time. 

  

	24.2	Limitation of Liability 

  

	 	(i)	Subject to Articles 24.2 (ii) and (iii), the total aggregate liability of each Party in respect of any loss or damage (material and/or immaterial) suffered by the other Party and arising out of or in connection
with this Agreement, regardless of the form of action whether in contract, tort (including negligence or breach of statutory duty), indemnity, misrepresentation or otherwise in connection with this Agreement shall not exceed: 

 

	 	(a)	[***] for Specific Distribution Agreement for NV-01; 

  

	 	(b)	[***] per Specific Distribution Agreement for the other Products; 

 and in any event, 

 

	 	(c)	[***] in aggregate for this Agreement and all Specific Distribution Agreements. 

  

	 	(ii)	Subject to Article 24.2(iii), neither Party shall be liable to the other Party, in contract, tort (including negligence) or for breach of statutory duty or in any other way for: (a) any loss of goodwill or
reputation; or (b) any special or indirect or consequential losses; in any case, whether or not such losses were within the contemplation of any Party at the date of this Agreement, or were suffered or incurred by any party arising out of or in
connection with this Agreement. 

  

	 	(iii)	Nothing in this Agreement excludes or limits: 

  

	 	(a)	either Party’s liability for fraud or fraudulent misrepresentation; or 

  

	 	(b)	either Party’s liability for any liability which cannot legally be excluded or limited; or 

  

	 	(c)	either Party’s liability arising under Article 21 (Third Party Intellectual Property Indemnity). 

  

	25.	CONFIDENTIALITY 

  

	25.1.	The Parties undertake that they will not, at any time whether during or following the term of this Agreement, divulge, disclose or communicate Confidential Information in any manner to any person or entity other than in
compliance with this Article 25. 

  

	25.2.	The Parties shall only disclose Confidential Information to employees, agents, authorised representatives and advisors on a need to know basis and shall in any event remain liable for their employees, agents, authorised
representatives and advisors who receive the Confidential Information as well as any other person involved in the execution of the relevant project. Employees shall be bound to respect the same confidentiality duties. 

  
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	25.3.	The restrictions on the use or disclosure of Confidential Information set out in this Article 25 shall not apply: 

  

	 	(i)	to any information which a Party can demonstrate by documentation as independently developed by a Party or lawfully received free of restriction from another source having the right to furnish such information.

  

	 	(ii)	after the information has become generally known or available to the public without breach of this Agreement by a Party or its Affiliates 

 

	 	(iii)	to any information which at the time of disclosure to a Party was known to such Party or its Affiliates free of restriction and evidenced by documentation in such Party’ s possession 

 

	 	(iv)	to the extent that the other Party agrees in writing that the information is free of such restrictions. 

  

	25.4.	Provided that one of the Parties is required to produce the information pursuant to an order issued by a court or regulatory body, this Party shall, prior to such production, immediately notify the other Party of the
order to the extent legally permitted. 

  

	25.5.	Nevertheless, if the regulatory body insists for the production of the information, the Parties shall give the information and shall use their reasonable endeavours to obtain protective orders preventing the further
disclosure of the information beyond that mandated by the relevant court or regulatory body. 

  

	25.6.	The obligations set out in this Article 25 shall survive the termination or expiry of this Agreement. 

  

	26.	TERMINATION AND CONSEQUENCES OF TERMINATION  

  

	26.1	Should the Commercial Margin of any Product fail to exceed [***] of Net Sales on a consistent basis for [***] or the Parties agree that the Commercial Margin is likely to fall below [***] of Net Sales on a
consistent basis for [***], the Parties agree to meet via the JSC to discuss the issue in order to try and find a way to ensure the Commercial Margin exceeds [***] of Net Sales. 

If a solution cannot be agreed by the Parties within [***] of the first meeting of the JSC on the issue then either Party shall have the
right to terminate the applicable SDA on [***] written notice period without any obligation to pay any compensation of any kind. If either Party does so terminate the Parties will work together to ensure an orderly termination
and to seek to minimise the disruption on the other Party. 
  

	26.2	Each Party shall have the right to immediately terminate the Agreement in the event that the other Party is in material breach of the Agreement and fails to remedy the material breach within [***] after having received
registered letter from the other Party. Termination under this clause is without prejudice to any other remedy to which it may be entitled at law, in equity, or otherwise under this Agreement. 

In addition, in case of termination of the Agreement for material breach of NEXVET during the first year following the payment of the last
milestone, NEXVET shall fully reimburse to VIRBAC the total amount of the milestone as defined in article “Milestones Payments” of the Agreement and in each Specific Distribution Agreement. 

  
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	26.3	VIRBAC, without any charge, shall be entitled to terminate the Agreement forthwith at any time during the term of the Agreement, with [***] prior written notice in case of: 

 

	 	(i)	NEXVET not obtaining the Marketing Authorization for NV-01 in Europe within [***] of the date of the Specific Distribution Agreement for NV-01; or 

 

	 	(ii)	studies performed by or on behalf of NEXVET according to the Development Plan resulting in a material failure to comply at minimum with the Target Product Profile for NV-01; or 

 

	 	(iii)	Material deviation from a Development Plan for NV-01 where the agreement of the JSC has not been obtained in advance; or 

  

	 	(iv)	If, in the reasonable opinion of VIRBAC after review of the FTO Analysis, the distribution of all Products using NEXVET Technology in the Important Countries is prevented as a result of a potential infringement of a
third party’s Intellectual Property Rights and NEXVET is not able to either obtain promptly a licence from the third party, without any cost to VIRBAC, or change the applicable Product so that it does not infringe that third party’s
Intellectual Property Rights; 

  

	26.4	VIRBAC, without any charge, shall be entitled to terminate a Specific Distribution Agreement forthwith at any time during the term of the applicable Specific Distribution Agreement, with [***] prior written notice in
case of: 

  

	 	(i)	If, in the reasonable opinion of VIRBAC after review of the FTO Analysis, the distribution of the applicable Product in the Important Countries is prevented as a result of a potential infringement of a third
party’s Intellectual Property Rights and NEXVET is not able to either obtain promptly a licence from the third party, without any cost to VIRBAC, or change the applicable Product so that it does not infringe that third party’s Intellectual
Property Rights; or 

  

	 	(ii)	Material deviation from a Development Plan where the agreement of the JSC has not been obtained in advance. 

  

	26.5	In the following events, VIRBAC and NEXVET shall each have the right to terminate this Agreement by providing a [***] period of notice: 

 

	 	(i)	the other Party is unable to pay its debts within the meaning of section 214 of the Companies Act 1963 or is otherwise insolvent; 

  

	 	(ii)	the other Party proposes to make or makes any compromise, composition, arrangement or scheme of arrangement with or for the benefit of any of its creditors; 

 

	 	(iii)	the other Party passes a resolution that the Party be wound up (except for the purpose of bona-fide solvent reconstruction or amalgamation); 

 

	 	(iv)	a receiver, examiner or manager is appointed to, or any distress, execution or other process is levied or enforced or served out upon or against, the other Party or any part of the other Party’s assets, undertaking
or revenues; or 

  

	 	(v)	a petition is made or proceedings are commenced in relation to any of the events described in above in this Article 26.5 or similar or analogous events or proceedings occur or are taken under the law of any other
jurisdiction. 

  

	26.6.	Termination of this Agreement (in whole or in part) shall not affect any rights, remedies, obligations or liabilities of the Parties that have accrued up to the date of termination, including the right to claim damages
in respect of any breach of the Agreement which existed at or before the date of termination. 

  

	26.7.	Termination or expiry of this Agreement (in whole or in part) shall not affect any rights, remedies, obligations or liabilities of the parties that have accrued up to the date of termination or expiry, including the
right to claim damages in respect of any breach of the Agreement which existed at or before the date of termination or expiry. 

  
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	26.8.	Subject to Article 27 (Remaining Stock), if this Agreement terminates (for any reason) or expires then all rights and licences granted in this Agreement shall automatically terminate, unless otherwise agreed in writing
in advance by the Parties. 

  

	26.9.	On termination or expiry of this Agreement each of the Parties shall immediately return to the other party (or, if the other party so requests by notice in writing, destroy) all of the other party’s property in its
possession at the date of termination, including all of its Confidential Information, together with all copies of such Confidential Information and shall certify that it has done so, and shall make no further use of such Confidential Information.

  

	27.	REMAINING STOCK 

 Upon termination for whatsoever reason or expiration of the
Agreement, all existing orders shall be honoured and, subject to the terms of Article 19 “Financial Terms” and any financial terms in any Specific Distribution Agreement continuing to apply, VIRBAC shall have the right to sell any
remaining inventory of the Product for a limited term agreed between the Parties which shall in any event be at least [***]. 
  

	28.	NOTICE 

 All written notice permitted or required by the provisions of this
Agreement (unless otherwise provided) shall be deemed so delivered when actually delivered by hand, Return Receipt Requested, registered post or fax. 

All notices shall be addressed as follows: 

To NEXVET: 
 Company
Secretary 
 Nexvet Ireland Limited 

[***] 
 To VIRBAC: 

[***] 
  

	29.	MATERIAL SAFETY DATA SHEET 

 NEXVET shall complete a Material Safety Data Sheet
(MSDS) regarding the Products. In this regard, NEXVET commits to complete the document attached in Annex 6 of this Agreement for each Product. 
  

	30.	NOTIFICATION TO “ANTI-POISON CENTER” 

 To be in compliance with
regulations in France regarding Products sold to companies located in France such as VIRBAC, NEXVET commits: 
  

	 	•	 	Either to describe the formula of any Product in the MSDS, 

  

	 	•	 	or, to send a document to VIRBAC confirming that NEXVET has sent directly the description of the formula of any Product to the following Anti-Poison Center: 

[***] 

  
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	31.	INFORMATION 

 NEXVET shall, at least [***] prior to the first supply of any
Products, send to VIRBAC the information required in the form attached in Annex 7 in order for VIRBAC to be able to reference any new Product. 
  

	32.	FORCE MAJEURE 

  

	32.1.	Neither Party to this Agreement shall be liable for failure or delay in the performance of its obligations where such failure or delay is due to an event of Force Majeure. 

 

	32.2.	It is agreed that such Party shall not be held responsible for any default or loss of trade or profit consequent upon such cause provided that the Party so affected shall give prompt written notice to the other Party
and shall be excused of performance hereunder to an extent and for the duration of such prevention, restriction or interference. 

  

	32.3.	The Party so affected shall promptly notify the other Party when the cause or causes preventing, restricting or interfering with its performance hereunder have been removed. If a Force Majeure subsists for more than 90
(ninety) successive days, either Party may terminate this Agreement immediately by registered letter to the other Party without creating any liability for damages. 

 

	32.4.	Nevertheless, neither Party shall be relieved of an obligation to make a due to an event of Force Majeure. 

  

	33.	NO RIGHT TO SET-OFF 

 A Party’s obligation to make any required payments
under the Agreement shall not be subject to any right of offset, set-off, deduction or counterclaim. 
  

	34.	INDEPENDENT CONTRACTOR 

 Each Party declares and acknowledges to be an independent
contractor. Nothing herein contained in the Agreement shall be construed so as to create a partnership or joint venture; and neither Party hereto shall be liable for the debts or obligations of the other. 

 

	35.	ASSIGNMENT – SUB-LICENSE 

 The Agreement will be binding on the successors of
either Party. 
 Both Parties shall have the right to assign this Agreement or any of the Specified Distribution Agreement to any of their
Affiliates without prior agreement of the other Party. 
  

	36.	ENTIRE AGREEMENT 

 The Agreement contains all of the terms and conditions mutually
agreed by the Parties hereto with reference to the subject matter hereof. 
 Any alteration or amendments to the Agreement must be mutually
agreed upon and shall only be effective if presented in writing and signed by the authorised representatives of both Parties. 

  
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 This Agreement constitutes the entire Agreement about the Products in the Territory between the
Parties and supersedes any and all prior agreement either written or oral. 
 Part or all of any provision of this Agreement that is illegal
or unenforceable may be severed from this Agreement but the remaining provisions of this Agreement continue in force. 
  

	37.	PRESS RELEASE 

 The wording of any press release shall be agreed between the
Parties prior any communication or publication. 
  

	38.	APPLICABLE LAW AND JURISDICTION 

  

	38.1.	The Agreement and any dispute or non-contractual obligation arising out of, or in connection with, it shall be governed by, and construed in accordance with the laws of Ireland. 

 

	38.2.	Subject to compliance with Article 39, each Party hereby submits to the exclusive jurisdiction of the courts of Ireland over any dispute or non-contractual obligation arising out of or in connection with the Agreement.

  

	39.	DISPUTE RESOLUTION PROCEDURE 

  

	39.1.	If a dispute arises out of or in connection with this Agreement or any Specific Distribution Agreement or the performance, validity or enforceability of either, then: 

 

	 	(i)	either Party may call a meeting of the JSC by giving not less than [***] written notice to the other, and each Party shall procure that an authorised representative attends all such meetings; 

 

	 	(ii)	those attending the relevant JSC meeting shall use all reasonable endeavours to resolve the dispute. If the meeting fails to resolve the dispute within [***] of its being referred to it, either Party may refer the
dispute to the Member of the Executive Board and/or the Chief Executive Officers of the Parties by notice in writing, who shall co-operate to resolve the dispute as amicably as possible within [***] of the dispute being referred to them;

  

	 	(iii)	if the Member of the Executive Board and/or the Chief Executive Officers fail to resolve the dispute in the allotted time, the Parties may within that period agree in writing to enter into an alternative dispute
resolution procedure with the assistance of a mediator agreed by the Parties. Any reference to mediation shall be made in accordance with the procedures of the Centre for Effective Dispute Resolution (“CEDR”). The mediation shall be
conducted by a single mediator appointed by the Parties or, if the Parties are unable to agree on the identity of the mediator within [***] after the date of the request that the dispute be resolved by mediation, or if the person appointed is unable
or unwilling to act, the mediator shall be appointed by CEDR on the application of either Party. The mediation shall be conducted in English at a venue to be agreed between the parties. Mediation is without prejudice to the rights of the parties in
any future proceedings; and 

  

	 	(iv)	if the Parties reach a settlement, such settlement shall be reduced to writing and, once signed by a duly authorised representative of each of the Parties, shall be and remain binding on the Parties. 

 

	39.2.	The procedure in this Article 39 shall be binding on the Parties with regard to participation in the mediation but not as to its outcome. All negotiations connected with the dispute shall be conducted in strict
confidence and without prejudice to the rights of the parties in any future legal proceedings. 

  
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	39.3.	Except for any party’s right to seek interim or interlocutory relief in the courts pursuant to Article 39.5, no party may commence other legal proceedings under the jurisdiction of the courts or any other form of
arbitration until [***] after the appointment of a mediator. 

  

	39.4.	The parties shall bear their own legal costs of complying with Articles 39.1(i) 39.1(iv), but the costs and expenses of mediation shall be borne by the parties equally. 

 

	39.5.	Notwithstanding the provisions of this Article 39, either Party may take proceedings or seek remedies before the courts or any competent authority of any country for interim or interlocutory remedies in relation to any
breach of this Agreement or infringement by the other Party of that Party’s intellectual property rights. 

  

	40.	COUNTERPART SIGNATURES 

 This Agreement may be executed in any number of
counterparts, each of which when executed and delivered shall constitute an original of this Agreement but all the counterparts shall together constitute the same agreement. 

No counterpart shall be effective until each party has executed at least one counterpart. 

Annex 1 – Patents 
 Annex 2
– Products (Target Product Profile and then summary of product characteristic) 
 Annex 3 – Template for Development Plan 

Annex 4 – Template for Quality Agreement 

Annex 5 – Template for Specific Distribution Agreement 

Annex 6 – Material Safety Data Sheet 

Annex 7 – Information 
 Annex
8 – Pharmacoviligance Data Exchange Agreement (PDEA) 
 Annex 9 – Financial Example 

IN WITNESS OF THE ABOVE the Parties have signed this Agreement on the date written at the head of this Agreement. 

 

									
	VIRBAC	 		 	NEXVET
			
	/s/ Christian Karst	 		 	/s/ Mark Heffernan
					
	NAME:	 	CHRISTIAN KARST	 		 	NAME:	 	DR MARK HEFFERNAN
	TITLE:	 	MEMBER OF THE EXECUTIVE BOARD	 		 	TITLE:	 	CHIEF EXECUTIVE OFFICER AND DIRECTOR
			
	DATE: 28 November 2014	 		 	DATE: 26 November 2014

  
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 ANNEX 1 – PATENTS 

PCT/GB2012/051002 - Family 1 
 “Anti-nerve growth factor
antibodies and methods of preparing and using the same” – Priority Date: 06 May 2011 
  

							
	 Country
	  	 Application No.

(Patent No.)
	  	 Filing Date
	  	 Renewal (R)

Expiry Date (E)

	 Australia
	  	2012252151	  	8/5/2012	  	 •     R: 8/5/2016

•     E: 8/5/2032

				
	 Brazil
	  	BR11203028654.7	  	“	  	 •     R: 8/5/2015

•     E: 8/5/2032

				
	 China
	  	201280033616.8	  	“	  	 •     E: 8/5/2032

				
	 Europe
	  	12723730.3	  	“	  	 •     R: 8/6/2015

•     E: 8/5/2032

				
	 Hong Kong
	  	TBA	  	“	  	 •     E: 8/5/2032

				
	 India
	  	9470/DELNP/2013	  	“	  	 •     E: 8/5/2032

				
	 Japan
	  	2014-509817	  	“	  	 •     E: 8/5/2032

				
	 Korea
	  	10-2013-7032543	  	“	  	 •     E: 8/5/2032

				
	 Malaysia
	  	PI2013702079	  	“	  	 •     E: 8/5/2032

				
	 New Zealand
	  	617446	  	“	  	 •     E: 8/5/2032

				
	 Russia
	  	2013154304	  	“	  	 •     E: 8/5/2032

				
	 Singapore
	  	201308192.2	  	8/5/2012	  	 •     E: 8/5/2032

				
	 United Kingdom        
	  	1320045.6	  	“	  	 •     E: 8/5/2032

 PCT/GB2012/051008 - Family 4 

“Therapeutic canine immunoglobulins and methods of using the same” – Priority Date: 06 May 2011 

 

							
	 Country
	  	 Application No.

(Patent No.)
	  	 Filing Date
	  	 Renewal (R)

Expiry Date (E)

	 Australia
	  	2012252156	  	8/5/2012	  	 •     R: 8/5/2016

•     E: 8/5/2032

				
	 Brazil
	  	BR1120130285230	  	“	  	 •     R: 8/5/2015

•     E: 8/5/2032

				
	 China
	  	201280033531.X	  	“	  	 •     E: 8/5/2032

				
	 Europe
	  	12723733.7	  	“	  	 •     R: 8/6/2015

•     E: 8/5/2032

				
	 Hong Kong
	  	14109146.8	  	“	  	 •     E: 8/5/2032

				
	 India
	  	9473/DELNP/2013	  	“	  	 •     E: 8/5/2032

				
	 Japan
	  	2014-509820	  	“	  	 •     E: 8/5/2032

				
	 Korea
	  	10-2013-7032546	  	“	  	 •     E: 8/5/2032

				
	 Malaysia
	  	PI2013702082	  	“	  	 •     E: 8/5/2032

				
	 New Zealand
	  	617450	  	“	  	 •     E: 8/5/2032

  
 32/62 

 
  

							
	 Country
	  	 Application No.

(Patent No.)
	  	 Filing Date
	  	 Renewal (R)

Expiry Date (E)

	Russia	  	2013154302	  	“	  	 •     E: 8/5/2032

				
	 Singapore
	  	201308190.6	  	8/5/2012	  	 •     E: 8/5/2032

				
	 United Kingdom
	  	1320053.0	  	“	  	 •     E: 8/5/2032

  
 33/62 

 
  

 ANNEX 2 - PRODUCTS 

2.1 List of Products 
 1/ Product included in
the Agreement: 
 NV-01 
 2/ New Products: 

In accordance with Article 6 of the Agreement. Right of first negotiation to New Products, owned by NEXVET in the Field and in the Territory. 

2.2 Target Product Profile: 
 2.2.1 Target
Product Profile of NV-01: 
 [***] 
 UNIT DOSING TABLE 

[***] 
 2.2.2 Target Product Profile of the new Products:

 To be added in each Specific Distribution Agreement 

2.3 Summary of product characteristics of the Products 

To be added in each Specific Distribution Agreement 

  
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

 ANNEX 3 – Template for Development Plans 

  
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	Nexvet Biopharma Pty Ltd	 	Product Development Plan

  

 
  

 Contents [right click on TOC to update headings and page numbers] 

 

											
	1	  	Executive Summary	  	 	5	  
	2	  	Commercial	  	 	6	  
		  	2.1	  	Summary	  	 	6	  
		  		  	2.1.1	  	Accessible Population	  	 	6	  
		  		  	2.1.2	  	Market Size	  	 	6	  
		  		  	2.1.3	  	Customer Needs	  	 	6	  
		  		  	2.1.4	  	Future Trends	  	 	6	  
		  	2.2	  	NV-01 Target Product Profile	  	 	6	  
		  		  	2.2.1	  	Product Definition	  	 	6	  
		  		  	2.2.2	  	Indications	  	 	6	  
		  		  	2.2.3	  	Label Highlights	  	 	6	  
		  	2.3	  	Competitor Landscape	  	 	6	  
		  		  	2.3.1	  	Current Competition	  	 	6	  
		  		  	2.3.2	  	Potential Future Competitors	  	 	6	  
		  	2.4	  	Competitive Positioning	  	 	6	  
		  		  	2.4.1	  	NV-01 SWOT Analysis	  	 	6	  
		  		  	2.4.2	  	Differentiation	  	 	6	  
		  		  	2.4.3	  	Marketing Strategy	  	 	6	  
		  	2.5	  	COGs and Pricing	  	 	6	  
		  		  	2.5.1	  	Pricing	  	 	6	  
		  		  	2.5.2	  	Cost of Goods	  	 	6	  
	3	  	Intellectual Property	  	 	7	  
		  	3.1	  	Summary of IP Status	  	 	7	  
		  	3.2	  	Current Patents	  	 	7	  
	4	  	Draft Package Insert	  	 	8	  
		  	4.1	  	Draft US Package Insert	  	 	8	  
	5	  	Regulatory Strategy	  	 	9	  
		  	5.1	  	Summary	  	 	9	  
		  	5.2	  	North America	  	 	9	  
		  		  	5.2.1	  	United States	  	 	9	  
		  		  	5.2.2	  	Canada	  	 	9	  
		  	5.3	  	Europe	  		  	 	9	  
		  	5.4	  	Japan	  		  	 	9	  
		  	5.5	  	Australia and New Zealand	  	 	9	  
		  	5.6	  	Other Markets	  	 	9	  
	6	  	Biopharmaceutical Product Development and Manufacturing	  	 	10	  
		  	6.1	  	Summary	  	 	10	  
		  	6.2	  	Cell Bank	  	 	10	  
		  	6.3	  	Drug Substance (DS)	  	 	10	  
		  		  	6.3.1	  	Description	  	 	10	  
		  		  	6.3.2	  	Characterization of DS	  	 	10	  
		  		  	6.3.3	  	Manufacture of Bulk DS	  	 	10	  
		  		  	6.3.4	  	Proposed Impurities Analysis	  	 	10	  
		  		  	6.3.5	  	Reference Standards	  	 	10	  
		  		  	6.3.6	  	Analytical Methods and Acceptance Criteria	  	 	10	  
		  		  	6.3.7	  	Risk of canine infectious disease transmission from NV-01 derived from Lonza CHO cells	  	 	10	  

  
  

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		  		  	6.3.8	  	DS Stability	  	 	10	  
		  		  	6.3.9	  	Manufacturing Facility	  	 	10	  
		  	6.4	  	Drug Product (DP)	  	 	10	  
		  		  	6.4.1	  	Description of Drug Product	  	 	10	  
		  		  	6.4.2	  	Method of Manufacture	  	 	10	  
		  		  	6.4.3	  	Analytical Methods and Acceptance Criteria	  	 	10	  
		  		  	6.4.4	  	Stability Testing Program	  	 	10	  
	7	  	Clinical Development	  	 	11	  
		  	7.1	  	Summary	  	 	11	  
		  	7.2	  	Target Label Claim	  	 	11	  
		  	7.3	  	Completed and Ongoing Studies	  	 	11	  
		  	7.4	  	Mechanism of Action	  	 	11	  
		  	7.5	  	Dosage Characterization	  	 	11	  
		  		  	7.5.1	  	Dose Justification	  	 	11	  
		  		  	7.5.2	  	Dose Selection Study (Contingency)	  	 	11	  
		  	7.6	  	Dosing Interval Selection	  	 	11	  
		  		  	7.6.1	  	Background	  	 	11	  
		  		  	7.6.2	  	Objective	  	 	11	  
		  		  	7.6.3	  	Ongoing Study	  	 	11	  
		  		  	7.6.4	  	Timing	  	 	11	  
		  	7.7	  	Immunogenicity Assay Development and Assessment	  	 	11	  
		  	7.8	  	Route of Administration	  	 	11	  
		  		  	7.8.1	  	Background	  	 	11	  
		  		  	7.8.2	  	Objective	  	 	11	  
		  		  	7.8.3	  	Proposed Study	  	 	11	  
		  		  	7.8.4	  	Timing	  	 	11	  
		  	7.9	  	Pivotal Pharmacokinetics	  	 	12	  
		  		  	7.9.1	  	Background	  	 	12	  
		  		  	7.9.2	  	Objective	  	 	12	  
		  		  	7.9.3	  	Proposed Study	  	 	12	  
		  		  	7.9.4	  	Timing	  	 	12	  
		  	7.10	  	Pivotal Clinical Study in Veterinary Patients	  	 	12	  
		  		  	7.10.1	  	Background	  	 	12	  
		  		  	7.10.2	  	Objective	  	 	12	  
		  		  	7.10.3	  	Proposed Study	  	 	12	  
		  		  	7.10.4	  	Timing	  	 	12	  
		  	7.11	  	Efficacy Protocol Outlines	  	 	12	  
	8	  	Target Animal Safety	  	 	13	  
		  	8.1	  	Summary	  	 	13	  
		  	8.2	  	Margin of Safety Study	  	 	13	  
		  		  	8.2.1	  	Background	  	 	13	  
		  		  	8.2.2	  	Objective	  	 	13	  
		  		  	8.2.3	  	Proposed Study	  	 	13	  
		  		  	8.2.4	  	Timing	  	 	13	  
		  	8.3	  	Immunogenicity Study	  	 	13	  
		  		  	8.3.1	  	Background	  	 	13	  
		  		  	8.3.2	  	Objective	  	 	13	  
		  		  	8.3.3	  	Proposed Study	  	 	13	  

  
  

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		  				  	8.3.4	  	Timing	  	 	13	  
		  	 	8.4	  	  	 Safety Observations in Veterinary Patient Study
	  	 	13	  
		  	 	8.5	  	  	 Definition of Safe Interval before NSAID Administration
	  	 	13	  
		  				  	8.5.1	  	 Background
	  	 	13	  
		  				  	8.5.2	  	 Strategy
	  	 	13	  
		  	 	8.6	  	  	 Safety Protocol Outlines
	  	 	13	  
	 9
	  	  
	 Toxicology, User and Environmental Safety
	  	 	14	  
		  	 	9.1	  	  	 Summary
	  	 	14	  
		  	 	9.2	  	  	 Toxicology
	  	 	14	  
		  	 	9.3	  	  	 User Safety
	  	 	14	  
		  	 	9.4	  	  	 Environmental Safety
	  	 	14	  
	 10
	  	  
	 Scientific Disclosure and Publications
	  	 	15	  
		  	 	10.1	  	  	 Primary Disclosure
	  	 	15	  
		  	 	10.2	  	  	 Publications
	  	 	15	  
		  	 	10.3	  	  	 Conferences
	  	 	15	  
	 11
	  	  
	 Project Plan and Costs
	  	 	16	  
		  	 	11.1	  	  	 Estimated Filing and Approval Dates
	  	 	16	  
		  	 	11.2	  	  	 Key Milestones and Timelines
	  	 	16	  
		  	 	11.3	  	  	 Budget and Cost Estimates
	  	 	16	  
		  	 	11.4	  	  	 Gantt Chart
	  	 	16	  

  
  

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	1	Executive Summary 

  
  

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	2	Commercial 

  

	2.1	Summary 

  

	2.1.1	Accessible Population 

  

	2.1.2	Market Size 

  

	2.1.3	Customer Needs 

  

	2.1.4	Future Trends 

  

	2.2	NV-01 Target Product Profile 

  

	2.2.1	Product Definition 

  

	2.2.2	Indications 

  

	2.2.3	Label Highlights 

  

	2.3	Competitor Landscape 

  

	2.3.1	Current Competition 

  

	2.3.2	Potential Future Competitors 

  

	2.4	Competitive Positioning 

  

	2.4.1	NV-01 SWOT Analysis 

  

	2.4.2	Differentiation 

  

	2.4.3	Marketing Strategy 

  

	2.5	COGs and Pricing 

  

	2.5.1	Pricing 

  

	2.5.2	Cost of Goods 

  
  

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	3	Intellectual Property 

  

	3.1	Summary of IP Status 

  

	3.2	Current Patents 

  
  

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	4	Draft Package Insert 

  

	4.1	Draft US Package Insert 

  
  

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	5	Regulatory Strategy 

  

	5.1	Summary 

  

	5.2	North America 

  

	5.2.1	United States 

  

	5.2.2	Canada 

  

	5.3	Europe 

  

	5.4	Japan 

  

	5.5	Australia and New Zealand 

  

	5.6	Other Markets 

  
  

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	6	Biopharmaceutical Product Development and Manufacturing 

  

	6.1	Summary 

  

	6.2	Cell Bank 

  

	6.3	Drug Substance (DS) 

  

	6.3.1	Description 

  

	6.3.2	Characterization of DS 

  

	6.3.3	Manufacture of Bulk DS 

  

	6.3.4	Proposed Impurities Analysis 

  

	6.3.5	Reference Standards 

  

	6.3.6	Analytical Methods and Acceptance Criteria 

  

	6.3.7	Risk of canine infectious disease transmission from NV-01 derived from Lonza CHO cells. 

  

	6.3.7.1	Background 

  

	6.3.7.2	Canine adventitious agent mitigation for NV-01 

  

	6.3.8	DS Stability 

  

	6.3.9	Manufacturing Facility 

  

	6.4	Drug Product (DP) 

  

	6.4.1	Description of Drug Product 

  

	6.4.2	Method of Manufacture 

  

	6.4.3	Analytical Methods and Acceptance Criteria 

  

	6.4.4	Stability Testing Program 

  
  

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	7	Clinical Development 

  

	7.1	Summary 

  

	7.2	Target Label Claim 

  

	7.3	Completed and Ongoing Studies 

  

	7.4	Mechanism of Action 

  

	7.5	Dosage Characterization 

  

	7.5.1	Dose Justification 

  

	7.5.2	Dose Selection Study (Contingency) 

  

	7.5.2.1	Background 

  

	7.5.2.2	Objective (Contingency) 

  

	7.5.2.3	Proposed Study (Contingency) 

  

	7.5.2.4	Timing 

  

	7.6	Dosing Interval Selection 

  

	7.6.1	Background 

  

	7.6.2	Objective 

  

	7.6.3	Ongoing Study 

  

	7.6.4	Timing 

  

	7.7	Immunogenicity Assay Development and Assessment 

  

	7.8	Route of Administration 

  

	7.8.1	Background 

  

	7.8.2	Objective 

  

	7.8.3	Proposed Study 

  

	7.8.4	Timing 

  
  

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	7.9	Pivotal Pharmacokinetics 

  

	7.9.1	Background 

  

	7.9.2	Objective 

  

	7.9.3	Proposed Study 

  

	7.9.4	Timing 

  

	7.10	Pivotal Clinical Study in Veterinary Patients 

  

	7.10.1	Background 

  

	7.10.2	Objective 

  

	7.10.3	Proposed Study 

  

	7.10.4	Timing 

  

	7.11	Efficacy Protocol Outlines 

  
  

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	8	Target Animal Safety 

  

	8.1	Summary 

  

	8.2	Margin of Safety Study 

  

	8.2.1	Background 

  

	8.2.2	Objective 

  

	8.2.3	Proposed Study 

  

	8.2.4	Timing 

  

	8.3	Immunogenicity Study 

  

	8.3.1	Background 

  

	8.3.2	Objective 

  

	8.3.3	Proposed Study 

  

	8.3.4	Timing 

  

	8.4	Safety Observations in Veterinary Patient Study 

  

	8.5	Definition of Safe Interval before NSAID Administration 

  

	8.5.1	Background 

  

	8.5.2	Strategy 

  

	8.6	Safety Protocol Outlines 

  
  

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	9	Toxicology, User and Environmental Safety 

  

	9.1	Summary 

  

	9.2	Toxicology 

  

	9.3	User Safety 

  

	9.4	Environmental Safety 

  
  

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	10	Scientific Disclosure and Publications 

  

	10.1	Primary Disclosure 

  

	10.2	Publications 

  

	10.3	Conferences 

  
  

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	11	Project Plan and Costs 

  

	11.1	Estimated Filing and Approval Dates 

  

	11.2	Key Milestones and Timelines 

  

	11.3	Budget and Cost Estimates 

  

	11.4	Gantt Chart 

  
  

16 of 16 

 ANNEX 4 – Template for Quality Agreement 

BACKGROUND 
 The purpose of the quality agreement
(hereinafter referred to as the “Quality Agreement”) is to define the terms and conditions to the quality tasks to assure the manufacture and supply of safe Product(s), suitable for pharmaceutical use in order to complete the Supply
Agreement. 
 NOW, THEREFORE in consideration of the mutual agreements hereinafter set forth, the Parties intending to be legally bound hereby agree as
follows: 

  
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 CONTENT: 

1. SCOPE AND PURPOSE OF THE AGREEMENT 
 NEXVET
undertakes to carry out the manufacture, packaging, control, release and supply to VIRBAC of the product(s) listed in exhibit 1, hereafter referred to PRODUCTS(s). 

VIRBAC undertakes to market, sell and distribute the PRODUCT(s). 

NEXVET is the holder of Marketing authorisations of the PRODUCT(s), hereafter referred to as MAH. 

NEXVET has adequate premises, equipment, knowledge, experience, competent personnel and manufacturing authorisation to undertake satisfactorily the work
ordered by VIRBAC. 
 This Quality Agreement is set to define responsibilities relative to quality tasks to assure the manufacture and supply of safe
PRODUCT(s), suitable for pharmaceutical use. 
 This Quality Agreement also includes commitments between VIRBAC and NEXVET regarding the provision of
information, documents, or samples, and communication and notification rules, related to quality. 
 Contact persons for good execution of this Quality
Agreement are listed in exhibit 3. 
 2. APPLICABLE GMP STANDARD 

NEXVET shall manufacture the PRODUCT(s) in compliance with cGMP. 

“Current Good Manufacturing Practices” (cGMP) means all applicable standards relating to the manufacture of the PRODUCT(s) listed in exhibit 1. For
the purposes of this agreement, cGMP shall mean the principles defined in the EU Guideline Eudralex Volume 4: Good Manufacturing Practise, Medicinal Products for Human and Veterinary Use promulgated by any European Governmental Authority having
jurisdiction over the manufacture of the PRODUCT(s), in the form of laws or guidance documents. 
 3. RESPONSIBILITIES 

Details on division of responsibilities between NEXVET and VIRBAC are presented in exhibit 2. 

4. CERTIFICATE OF ANALYSIS / RELEASE 
 The
following documentation is required for batches of PRODUCT shipped to VIRBAC: 
  

	 ̈	Certificates of Analysis and Release  

 The Certificates of Analysis and Release shall be dated and
signed by a qualified person of NEXVET’s Quality Unit, or it may be produced by a computer system which provides a degree of control equivalent to that given by a signature. 

The Certificate of Analysis must include – as a minimum – 
  

	 ̈	Manufacturer’s name and address, incl. telephone number (original manufacturing site), 

  

	 ̈	PRODUCT name, pharmaceutical form and SUBSTANCE(s) dosage, 

  

	 ̈	Manufacturer’s batch number, 

  

	 ̈	Reference to the agreed specification, 

  

	 ̈	Test parameters and corresponding specification requirements, 

  

	 ̈	Test results (numerical, where applicable) for each chemical, physical or microbiological test performed, 

  

	 ̈	Manufacturing date, date of release and expiration of the PRODUCT. 

  
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 The Certificate of Release states that the subject batch was produced in accordance to the applicable Marketing
Authorisation, to the approved manufacturing process, and in compliance with all applicable cGMP requirements as well as this Quality Agreement. The Certificate of release also makes reference to deviations that occurred relating to production or
control and to their closure. It also states on batch suitability for shipment to the market. 
 Certificate of Analysis and Certificate of Release may be
issued as separate documents or combined to a single document, as appropriate. 
  

	 ̈	Product Samples 

 NEXVET should provide VIRBAC two samples of finished product of each packaging batch
for handling of complaints. 
 5. CHANGE CONTROL 

NEXVET shall have a documented and effective change control system in place. 

NEXVET is required to provide advanced notification to VIRBAC of any significant changes to the process, specifications, control, storage, labelling and
packaging, equipment, facilities (including introduction of new critical product) and utilities which may have an impact on the quality of the PRODUCT, and/or on regulatory obligations of VIRBAC, and/or on its use by VIRBAC. 

Principles: 
  

	 ̈	Notification of changes is required for information of VIRBAC. 

  

	 ̈	Where the change requires regulatory notification or approval, NEXVET is responsible for the submission of all necessary change notifications to all competent authorities in full compliance with the applicable
regulations. NEXVET will inform VIRBAC of the receipt of the necessary acknowledgement of the validity of the notification and, depending on the type of change, the acceptance or approval of the change by the competent authorities.

 6. RIGHT TO AUDIT 
 NEXVET shall
allow –upon signature of appropriate confidentiality agreement– VIRBAC or its representatives to carry out on-site audits by appointment. NEXVET shall permit -or obtain allowance from manufacturing sub-contractor where applicable- all
reasonable access to the manufacturing, packaging, warehousing and laboratory areas related to the manufacture of the PRODUCT(s), including pertinent documentation. Any such audit shall take place during normal business hours and must not interfere
with NEXVET’s manufacturing operations. With exception of critical quality issue, NEXVET and VIRBAC should agree on an audit date within [***] from first request. 

The results of the audit and the observation(s) shall be sent to NEXVET by means of a written report within 4 weeks. NEXVET must ensure a satisfactory follow
up to the observations made during the audit performed by VIRBAC, and take corrective actions mutually agreed upon by the parties. Answer from NEXVET audit report should be supplied to VIRBAC within 4 weeks. 

The audit frequency shall depend upon the results of the previous audit(s) and the quality performance of NEXVET. In the absence of critical quality incidents
the frequency shall be not more than once every 3 years. If quality issues arise VIRBAC shall have the right to audit more frequently. 
 7. AUTHORITY
INSPECTIONS 
 NEXVET is responsible for maintaining valid manufacturing authorisation or licence including the manufacture of the PRODUCT(s). Any
change in manufacturing authorisation that impacts the manufacture or supply of PRODUCT(s) should be notified by NEXVET to VIRBAC without delay. 

  
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*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

 8. SUB-CONTRACTING 

NEXVET is fully responsible for the quality of the materials or services provided by sub-contractors and for all commitments as agreed upon with this Quality
Agreement. This must be assured through quality agreements with the respective sub-contractors and technical delivery specifications. 
 A list of current
sub-contractors related to the manufacture of the PRODUCT(s) is provided in Appendix 4. 
 Where NEXVET would like to use a new sub-contractor, this list
needs to be updated and is subject of the established change control procedure (see section 5). 
 9. RETENTION OF SAMPLES 

NEXVET will store sufficient retention samples of PRODUCT(s) in commercial packaging and of all starting materials suitably packaged, to perform at least two
(2) full specification analyses. Samples are to be retained for at least one (1) year after the expiry date of the batch. 
 NEXVET will make
PRODUCT(s) retention samples available to VIRBAC promptly upon VIRBAC’s justified request. 
 NEXVET shall keep available any retention samples
relevant to assessing the quality of the PRODUCT(s) in the event of complaints and/or recall procedures. This requirement shall continue even in case of termination of the supply of PRODUCT(s). 

10. RETENTION OF RECORDS / DOCUMENTATION 
 NEXVET
will store the original master batch records, the executed batch records, and all other original documentation that is related to the manufacture of the PRODUCT and that is required to be maintained under cGMPs, protected from destruction and
unauthorised access, for at least one (1) year after the expiry date of the batch assigned by NEXVET or for five (5) years after certification of the batch, which ever is the longer. 

NEXVET will retain the original manufacturing records for validation batches for the entire term of the marketing authorisation validity. 

NEXVET shall keep available any records relevant to assessing the quality of the PRODUCT(s) in the event of complaints and/or recall procedures. This
requirement shall continue even in case of termination of the supply of PRODUCT(s). 
 11. STABILITY 

NEXVET will perform on-going stability studies for the PRODUCT(s). 

NEXVET is responsible for assigning shelf life to the PRODUCT(s) and for determining suitable storage and shipping conditions, based upon stability studies
and marketing authorisation. 
 12. COMPLAINTS 

All complaints related to the PRODUCT(s) reported, regardless of source (e.g., customers, veterinaries, pharmacists, sales representatives, VIRBAC or
affiliates) will be handled by VIRBAC and communicated to NEXVET. 
 VIRBAC will make relevant information and samples of the affected PRODUCT(s) available
to assist in the investigation of NEXVET. 
 NEXVET is responsible for recording and investigating all quality-related complaints on the PRODUCT(s) and will
maintain the complete complaint database and complaint files. 
 NEXVET will complete their investigation and respond to VIRBAC in writing to all complaints
within [***] of receipt with formal written report on the complaint detailing identifiable root causes and corrective and preventive actions where applicable. 

  
 39/62 

 
  

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

 13. RECALL 

VIRBAC shall maintain an efficient distribution system within the Territory and shall establish and maintain a batch tracing and recall system which will
enable it to identify, with minimum delay, customers within the Territory who will have been supplied with any particular batch of the Products and to recall such Products. 

In the event that NEXVET believes that a recall of the PRODUCT(s) may be necessary or appropriate, NEXVET shall immediately notify VIRBAC. The two parties
will take joint decisions on the disposition of PRODUCT(s). 
 NEXVET, as MAH, with exception of local regulatory requirements*, is responsible for the
final decision of any recalls or field alert activities and for corresponding communication with health authorities. 
 VIRBAC is responsible for the
performance and the coordination of any recalls or field alert activities. 
 NEXVET shall provide any information required by VIRBAC relating to recall or
field alert activities within [***] of the request, if such information is readily available at NEXVET. 
  

	*	In France, Belgium and Switzerland as applicable, the distributor of the PRODUCT will be responsible for the final decision, communications with authorities and the coordination of any recalls or field alert
activities. 

 14. PRODUCT QUALITY REVIEW 

NEXVET shall conduct an annual Product Quality Review (PQR) for the PRODUCT(s), according to the requirements of cGMP. 

NEXVET will provide VIRBAC with copies of the relevant information of its PQR of the previous annual period, upon request, within [***]. 

15. STORAGE AND DISTRIBUTION 
 NEXVET shall make
commercially reasonable efforts to exclude, during packaging, storage, and shipping of the PRODUCT(s), the possibility of deterioration, contamination, or mix-ups with any other material. 

NEXVET and VIRBAC shall comply with the following requirements in relation to shipment and distribution of the PRODUCT(s). 

 

	 ̈	Compliance with storage conditions stated on the labels 

  

	 ̈	Ability to recall PRODUCT from distribution network 

  

	 ̈	Quarantine PRODUCT with questionable quality 

  

	 ̈	Qualification of hauliers and shipping agents used to transport the PRODUCT(s). 

 16. STARTING MATERIALS

 NEXVET is responsible for GMP certification of Active Pharmaceutical Ingredient suppliers. 

17. DEVIATIONS / OOS 
 NEXVET will notify VIRBAC
promptly in the event of any critical deviation(s) that can potentially affect the quality of the PRODUCT(s). 
 For all confirmed OOS stability test
results that indicate that the PRODUCT(s) has (have) failed to remain within specifications, NEXVET will notify VIRBAC promptly. 

  
 40/62 

 
  

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

 18. REGULATORY DOCUMENTS 

NEXVET shall be responsible for preparation of registration documents related to PRODUCT(s) and submission of such registration documents to any regulatory
authority, including maintaining such submissions. 
 19. PRODUCT RELEASE 

NEXVET has the responsibility to perform the release of the PRODUCT(s) prior to shipment. 

NEXVET will not ship any PRODUCT(s) to any destination, as identified by the VIRBAC, until the PRODUCT(s) is (are) released for shipment, unless prior written
approval has been received from the VIRBAC to perform such a shipment under quarantine. 
 20. SPECIFICATIONS 

Specifications for manufacturing and testing of the PRODUCT(s), intermediates, starting materials and packaging components, as applicable, are detailed in
relevant sections of marketing authorisation and/or in supply agreement. 
 21. RELATED AGREEMENTS 

This Quality Agreement supersedes any prior Quality Agreement under the scope of this agreement. 

Where any inconsistencies should arise between the supply agreement and this Quality Agreement, the supply agreement will take precedence over the Quality
Agreement in all non-quality related matters unless otherwise stated in the supply agreement. The Quality Agreement will take precedence in all quality related matters. 

 

			
	VIRBAC
		
		 	Quality Assurance Director
		
	Date	 	  

		
	Signature	 	  

  

			
	NEXVET
		
		 	Quality Management Division
		
	Date	 	  

		
	Signature	 	  

  
 41/62 

 
  

 EXHIBIT 1 

List of Products 
  

			
	 Pharmaceutical and dosage form
	  	 Country

	[To be completed.]	  	

  
 42 

 EXHIBIT 2 

Division of Responsibilities 
  

							
	 A Regulatory Compliance
	 	 VIRBAC
	 	 NEXVET

	1.	 	Marketing authorisation holder	 	[***]	 	[***]
	2.	 	Supply of marketing authorisation and all necessary documentation for manufacture, control and/or release	 	[***]	 	[***]
	3.	 	Adhere to approved registration documentation incl. all described manufacturing and packaging processes and specifications, materials and PRODUCT(s) control testing and specifications (Marketing Authorisation, NDA, as
applicable)	 	[***]	 	[***]
	4.	 	Maintaining valid manufacturing license(s), as applicable	 	[***]	 	[***]
	5.	 	Maintaining site master file, as applicable	 	[***]	 	[***]
	6.	 	Approving significant changes	 	[***]	 	[***]
	7.	 	Submitting change notifications/applications to authorities	 	[***]	 	[***]
			
	 B Purchasing and control of materials
	 	 VIRBAC
	 	 NEXVET

	8.	 	Setting specification for ACTIVE SUBSTANCE	 	[***]	 	[***]
	9.	 	Purchasing ACTIVE SUBSTANCE	 	[***]	 	[***]
	10.	 	Qualifying and monitoring ACTIVE SUBSTANCE suppliers	 	[***]	 	[***]
	11.	 	Purchasing materials according to specifications	 	[***]	 	[***]
	12.	 	Qualifying and monitoring material suppliers	 	[***]	 	[***]
	13.	 	Performing an identity check on all incoming materials	 	[***]	 	[***]
	14.	 	Testing of incoming materials (incl. ACTIVE SUBSTANCE), as appropriate	 	[***]	 	[***]
	15.	 	Taking retention samples of materials (incl. ACTIVE SUBSTANCE)	 	[***]	 	[***]
	16.	 	Release of materials (incl. ACTIVE SUBSTANCE) for involvement in production of PRODUCT(s)	 	[***]	 	[***]
			
	 C Manufacturing and Testing of bulk PRODUCT(s)
	 	 VIRBAC
	 	 NEXVET

	17.	 	Setting manufacturing process and specifications for manufacture of bulk PRODUCT(s), incl. IPCs – in accordance with marketing authorisation	 	[***]	 	[***]
	18.	 	Generating Master Batch Record (bulk PRODUCT(s))	 	[***]	 	[***]
	19.	 	Approving Master Batch Record (bulk PRODUCT(s))	 	[***]	 	[***]
	20.	 	Manufacturing bulk PRODUCT(s) according to Master Batch Procedure	 	[***]	 	[***]
	21.	 	Generating Batch Production Record (bulk PRODUCT(s))	 	[***]	 	[***]
	22.	 	Approving Batch Production Record (bulk PRODUCT(s))	 	[***]	 	[***]
	23.	 	Assigning batch numbers	 	[***]	 	[***]
	24.	 	Sampling during production of bulk PRODUCT(s)	 	[***]	 	[***]

  
 43 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

							
	 C Manufacturing and Testing of bulk PRODUCT(s)
	 	 VIRBAC
	 	 NEXVET

	25.	 	Performing IPCs	 	[***]	 	[***]
	26.	 	Investigating OOS results and critical deviations relating to bulk production	 	[***]	 	[***]
			
	 D Purchasing and Testing of Primary Packaging Material
	 	 VIRBAC
	 	 NEXVET

	27.	 	Specifying primary packaging material for PRODUCT	 	[***]	 	[***]
	28.	 	Artworks approval for printed components	 	[***]	 	[***]
	29.	 	Developing test methods for primary packaging material, if needed	 	[***]	 	[***]
	30.	 	Purchasing primary packaging material including labelling	 	[***]	 	[***]
	31.	 	Testing and releasing primary packaging material	 	[***]	 	[***]
	32.	 	Taking retention samples of primary packaging material	 	[***]	 	[***]
			
	 E Primary Packaging of PRODUCT(s) (semi-finished PRODUCT)
	 	 VIRBAC
	 	 NEXVET

	33.	 	Setting manufacturing process and specifications for primary packaging of PRODUCT(s), incl. IPCs and incl. labelling if applicable – in accordance with marketing authorisation and artworks	 	[***]	 	[***]
	34.	 	Generating Master Batch Record (primary packaging of PRODUCT(s))	 	[***]	 	[***]
	35.	 	Approving Master Batch Record (primary packaging of PRODUCT(s))	 	[***]	 	[***]
	36.	 	Primary packaging of PRODUCT(s) according to Master Batch Procedure	 	[***]	 	[***]
	37.	 	Generating Batch Production Record (primary packaging of PRODUCT(s))	 	[***]	 	[***]
	38.	 	Approving Batch Production Record (primary packaging of PRODUCT(s))	 	[***]	 	[***]
	39.	 	Assigning packaging batch numbers, if applicable	 	[***]	 	[***]
	40.	 	Sampling during primary packaging of PRODUCT(s)	 	[***]	 	[***]
	41.	 	Performing IPCs	 	[***]	 	[***]
	42.	 	Investigating OOS results and critical deviations relating to primary packaging	 	[***]	 	[***]
			
	 D Purchasing and Testing of Secondary Packaging Material
	 	 VIRBAC
	 	 NEXVET

	43.	 	Specifying packaging (II) material for PRODUCT – in accordance with marketing authorisation	 	[***]	 	[***]
	44.	 	Artworks approval for printed components	 	[***]	 	[***]
	45.	 	Developing test methods for packaging (II) material, if needed	 	[***]	 	[***]
	46.	 	Purchasing packaging (II) material including labelling	 	[***]	 	[***]
	47.	 	Testing and releasing packaging (II) material	 	[***]	 	[***]
	48.	 	Taking retention samples of packaging (II) material	 	[***]	 	[***]

  
 44 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

							
	 F Secondary Packaging and Labelling of PRODUCT(s)
	 	 VIRBAC
	 	 NEXVET

	49.	 	Setting manufacturing process and specifications for secondary packaging and labelling of PRODUCT(s), incl. IPCs and labelling – in accordance with marketing authorisation and artworks	 	[***]	 	[***]
	50.	 	Generating Master Batch Record (Secondary packaging of PRODUCT(s))	 	[***]	 	[***]
	51.	 	Approving Master Batch Record (Secondary packaging of PRODUCT(s))	 	[***]	 	[***]
	52.	 	Secondary Packaging and Labelling of PRODUCT(s) according to Master Batch Procedure	 	[***]	 	[***]
	53.	 	Generating Batch Production Record (Secondary packaging of PRODUCT(s))	 	[***]	 	[***]
	54.	 	Approving Batch Production Record (Secondary packaging of PRODUCT(s))	 	[***]	 	[***]
	55.	 	Assigning packaging batch numbers, if applicable	 	[***]	 	[***]
	56.	 	Sampling during secondary packaging of PRODUCT(s)	 	[***]	 	[***]
	57.	 	Performing IPCs	 	[***]	 	[***]
	58.	 	Investigating OOS results and critical deviations relating to packaging operations	 	[***]	 	[***]
			
	 G Quality Control and release of PRODUCT(s)
	 	 VIRBAC
	 	 NEXVET

	59.	 	Setting testing procedures and specifications for PRODUCT(s) – in accordance with marketing authorisation	 	[***]	 	[***]
	60.	 	Generating Control Records	 	[***]	 	[***]
	61.	 	Approving Control Records	 	[***]	 	[***]
	62.	 	QC sampling of PRODUCT(s)	 	[***]	 	[***]
	63.	 	Performing quality control on PRODUCT(s)	 	[***]	 	[***]
	64.	 	Investigating OOS results and critical deviations	 	[***]	 	[***]
	65.	 	Defining amount for retention samples	 	[***]	 	[***]
	66.	 	Sampling and storing retention samples, until shipment to CG (if requested)	 	[***]	 	[***]
	67.	 	Approving analytical records for the PRODUCT	 	[***]	 	[***]
	68.	 	Purchasing / providing of (certified) reference standards	 	[***]	 	[***]
	69.	 	Review of production and control records, incl. OOS and deviation reports	 	[***]	 	[***]
	70.	 	Release of batch	 	[***]	 	[***]
			
	 H Storage and Shipment
	 	 VIRBAC
	 	 NEXVET

	71.	 	Storing PRODUCT under labelled conditions	 	[***]	 	[***]
	72.	 	Qualifying of carrier	 	[***]	 	[***]
	73.	 	Preparing PRODUCT for dispatch and loading of vehicles	 	[***]	 	[***]
	74.	 	Maintaining storage conditions during transportation	 	[***]	 	[***]

  
 45 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

							
	 I Documents (Generation and Approval)
	 	 VIRBAC
	 	 NEXVET

	75.	 	Supply of marketing authorisation and all necessary documentation for manufacture	 	[***]	 	[***]
	76.	 	Generating Master Batch Procedures/Records	 	(ref. to previous tables)
	77.	 	Approving Master Batch Procedures/Records	 	(ref. to previous tables)
	78.	 	Generating Batch Production and Control Records	 	(ref. to previous tables)
	79.	 	Approving Batch Production and Control Records	 	(ref. to previous tables)
	80.	 	Archiving the original documents and providing copies, if requested	 	[***]	 	[***]
	81.	 	Providing Certificates of Analysis of materials, if requested	 	[***]	 	[***]
	82.	 	Issuing Certificate of Analysis for PRODUCT	 	[***]	 	[***]
	83.	 	Issuing reports on full-scale OOS investigations and critical deviations	 	[***]	 	[***]
	84.	 	Providing development reports, test procedures, validation documents, etc and other source documents requested by CG	 	[***]	 	[***]
			
	 J Qualification / Validation
	 	 VIRBAC
	 	 NEXVET

	85.	 	Qualifying of equipment, utilities and facilities	 	[***]	 	[***]
	86.	 	Preparing and approving equipment and facility qualification protocols and reports used for the PRODUCT(s)	 	[***]	 	[***]
	87.	 	Validating the manufacturing process	 	[***]	 	[***]
	88.	 	Preparing and approving process validation protocols and reports for the PRODUCT(s)	 	[***]	 	[***]
	89.	 	Validating cleaning procedures	 	[***]	 	[***]
	90.	 	Preparing and approving cleaning validation approach applicable to the PRODUCT(s)	 	[***]	 	[***]
	91.	 	Validating / transferring analytical methods	 	[***]	 	[***]
	92.	 	Preparing and approving analytical validation / transferring approach applicable to the PRODUCT(s)	 	[***]	 	[***]
	93.	 	Retaining qualification and validation documentation	 	[***]	 	[***]
	94.	 	Validating computerised systems	 	[***]	 	[***]
	95.	 	Preparing and approving validation protocols and reports for computer validation	 	[***]	 	[***]
			
	 K Stability Program
	 	 VIRBAC
	 	 NEXVET

	96.	 	Preparing and approving protocol for on going stabilities	 	[***]	 	[***]
	97.	 	Performing stability on going stabilities	 	[***]	 	[***]
	98.	 	Approving stability reports on on-going stabilities	 	[***]	 	[***]
	99.	 	Determining shelf life	 	[***]	 	[***]

  
 46 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

							
	 L Product Quality Review
	 	 VIRBAC
	 	 NEXVET

	 100.
	 	Preparing annual PQR report	 	[***]	 	[***]
	 101.
	 	Reviewing PQR reports	 	[***]	 	[***]
			
	 M Complaints and Recall
	 	 VIRBAC
	 	 NEXVET

	 102.
	 	Receiving complaints from external customers	 	[***]	 	[***]
	 103.
	 	Forwarding complaints related to PRODUCT to CA	 	[***]	 	[***]
	 104.
	 	Investigating complaints related to PRODUCT	 	[***]	 	[***]
	 105.
	 	Implementing corrective actions, if necessary	 	[***]	 	[***]
	 106.
	 	Responding to external customers	 	[***]	 	[***]
	 107.
	 	Deciding to initiate recall	 	[***]	 	[***]
	 108.
	 	Notifying authorities, external customers, or consumers	 	[***]	 	[***]
	 109.
	 	Clarifying root cause	 	[***]	 	[***]
	 110.
	 	Storing or disposing returned product	 	[***]	 	[***]

 [***] 

 

							
	 N Sub-Contracting
	 	 VIRBAC
	 	 NEXVET

	 111.
	 	Approving sub-contracting operations	 	[***]	 	[***]
	 112.
	 	Qualifying sub-contractor	 	[***]	 	[***]
	 113.
	 	Procuring of sub-contracted products or services	 	[***]	 	[***]
	 114.
	 	Quality monitoring sub-contracted operation	 	[***]	 	[***]

  
 47 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

 Exhibit 3 

Persons to whom communication should be addressed 
  

					
	 	  	 VIRBAC
	  	 NEXVET

			
	Quality Assurance	  	[To be completed.]	  	
			
	 Release of the finished products/

Qualified Person
	  		  	
			
	Regulatory Department	  		  	

  
 48 

 Exhibit 4 

List of agreed third party subcontractors 
  

					
	 Name
	  	 Address
	  	 Approved activity

	 [To be completed.]
	  		  	

  
 49 

 Document Change History Record 

 

			
	 VERSION NUMBER/

ISSUE DATE
	  	 Reason for Change

		
	Version 01 / 24 November 2014	  	Creation

  
 50 

 Annex 5 – Template for Specific Distribution Agreements 

SPECIFIC DISTRIBUTION AGREEMENT 
 THIS
SPECIFIC AGREEMENT is made between: 
 VIRBAC, a company organized under the law of FRANCE, with registered office at 1ère avenue 2065 M
– L.I.D., 06516, Carros, France - registered under number 417 350 311 RCS at Grasse, France, acting for itself and its Affiliates, herein duly represented by Christian Karst, Member of the Executive Board, 

Hereinafter referred to as “VIRBAC”; 
 AND

 NEXVET IRELAND LIMITED, a company organised under the laws of Ireland, with registered office at 88 Harcourt Street, Dublin 2 Ireland, with
registered number 550752, represented by Dr Mark Heffernan, Chief Executive Officer & Director, 
 Hereinafter referred to as
“NEXVET”  
 WHEREAS: 
 A
Master Collaboration, Supply and Distribution Agreement of Product has been entered into between VIRBAC and NEXVET on the November 24th, 2014 (the “Agreement”) whereby NEXVET and
VIRBAC have agreed the general terms upon which NEXVET shall provide the Product to VIRBAC and/or its Affiliates. 
 VIRBAC is willing to purchase
                     Product from NEXVET, distribute
                     Product and NEXVET is willing to provide such
                     Product to VIRBAC, subject to the terms and conditions of the Agreement and this Specific Distribution Agreement. 

Article 1. Definitions 

                     Product means 

 

	Article 2.	Purpose of this Specific Agreement 

 2.1 The purpose of this Specific Distribution Agreement is to
specify the conditions under which VIRBAC will place orders to NEXVET for the provision of                      Product in accordance with the Target
Product Profile defined in Exhibit 1, the Marketing Authorization and the Specification defined in Exhibit 3 and to distribute
                     Products in the Territory. 
 2.2
The provisions of the Agreement not otherwise modified in the Specific Distribution Agreement apply to the Specific Distribution Agreement. To the extent that there is any inconsistency between this Specific Distribution Agreement and the Agreement,
the terms of the Agreement shall prevail, unless expressly stated otherwise in this Specific Distribution Agreement. 
 2.3 Capitalized terms that are not
otherwise defined in this Specific Distribution Agreement have the meanings specified in the Agreement. 

  
 51 

	Article 3.	Development plans 

 The Development Plan for
                     Product shall describe all the proposed development and regulatory activities of NEXVET, including the proposed timelines for
such activities, to obtain the Marketing Authorizations in the Territory and according to the Target Product Profile defined in Exhibit 1. 
 Such
Development Plan shall be approved by the JSC and included in Exhibit 2 within [***] of execution of this Specific Distribution Agreement. 
  

	Article 4.	Marketing Authorization 

 If the Marketing Authorization for
                     Product in Europe is not obtained within
                     from the date of execution of the Agreement, then VIRBAC has the right to terminate this Specific Distribution Agreement. 

 

	Article 5.	Minimum Annual Net Sales Obligations 

  

	Article 6.	Manufacturing 

 The Manufacturer(s) and the Manufacturing Site(s) for
                     Product shall be defined by NEXVET and included by amendment to this Specific Distribution Agreement no later than [***] prior
to the first filing of the Registration Dossier before the Authority in the Territory. 
  

	Article 7.	Supply and Delivery 

 NEXVET warrants that
                     Product shall meet the applicable Specification as set in Exhibit 3. Such Specification shall be included in Exhibit
3 Agreement no later than [***] prior the first filing of the Registration Dossier before the Authority in the Territory. 
 The
                     Product shall be delivered within a maximum of [***] from the date of receipt of VIRBAC’s orders, and, unless agreed
otherwise in writing, shall be delivered Ex-Works Incoterms 2010 at the Manufacturing Site. 
 The minimum order quantity will be set regularly by NEXVET
and advised to VIRBAC in writing. The minimum order quantity will initially be set no later than [***] prior to the first filing of the Registration Dossier before the Authority in the Territory. 

 

	Article 8.	Pharmacovigilance 

 A pharmacovigilance data exchange agreement shall be agreed by the Parties and
included in Exhibit 4 no later than [***] prior to the first filing of the Registration Dossier before the Authority in the Territory. 
  

	Article 9.	Financial terms 

 9.1 Milestone Payment 

9.2 NEXVET Fees 
 9.3 Purchase Price of
                     Product 

  
 52 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

	Article 10.	Term 

 The Specific Distribution Agreement is deemed to come into force on
                     and shall remain in force for 10 (ten) years from the date of First Commercialization of
                     Product (“Initial Term”). 

The Specific Distribution Agreement shall thereafter automatically be renewed by periods of 2 (two) years, unless a written notice of termination is sent, by
registered letter and confirmed by email, by one of the Parties, no later than 6 (six) months prior to the expiration of the Initial Term or any 2 (two) year extension thereof. 

 

	Article 11.	Trademarks 

 The Trademark(s) for
                     Product shall be agreed by the JSC and included by amendment to this Specific Distribution Agreement no later than [***] prior
to the first filing of the Registration Dossier before the Authority of                      Product within the Territory. 

 

	Article 12.	Quality Agreement 

 A Quality Agreement shall be negotiated and agreed between the Parties and included
in Exhibit 4 no later than [***] prior to the first filing of the Registration Dossier before the Authority of                     
Product in the Territory. 
  

	Article 13.	Material Safety Data Sheet 

 NEXVET shall complete a Material Safety Data Sheet (MSDS) regarding NV-01
Product. This MSDS shall be included in Exhibit no later than [***] prior to the first filing of the Registration Dossier before the Authority
                     Product in the Territory. 
  

	Article 14.	Counterpart Signatures 

 This Specific Distribution Agreement may be executed in any number of
counterparts, each of which when executed shall constitute an original of this Specific Distribution Agreement, but all the counterparts together constitute the same Specific Distribution Agreement. No counterpart shall be effective until each party
has executed at least one counterpart. 
 IN WITNESS OF THE ABOVE the Parties have signed this Specific Distribution Agreement on the date written at the
head of this Specific Distribution Agreement. 
  

									
	VIRBAC	 		 	NEXVET
					
	By:	 	  
	 		 	By:	 	  

					
	Name:	 	  
	 		 	Name:	 	  

					
	Title:	 	  
	 		 	Title:	 	  

			
	Date and place	 		 	Date and place

  
 53 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

 Annex 6– Material Safety Data Sheet 

  
 54 

  

			
	SAFETY DATA SHEET (REGULATION (EC) No 1907/2006 – REACH)	  	Date: 08/11/2013 Page 1/6
	Version: N°2 (18/06/2013)	  	Revision: N°1 (18/06/2013
	à renseigner / to complete	  	
	matrice – matrice

  

 

 

 
 SAFETY DATA SHEET 

(REACH regulation (EC) n°1907/2006 – n°453/2010) 
  

 
 SECTION 1: IDENTIFICATION
OF THE SUBSTANCE/MIXTURE AND OF THE COMPANY/UNDERTAKING 
 1.1 Product identifier 

Product name: matrice 
 Product
code: matrice. 
 1.2 Relevant identified uses of the substance or mixture and uses advised against 

 

			
	Species cibles	  	N/A
		
	Galenic aspect	  	N/A
		
	Class	  	N/A
		
	Medicine	  	veterinary

 1.3 Details of the supplier of the safety data sheet 

Registered company name: à renseigner / to complete. 

Address: à renseigner / to complete. à renseigner / to complete. à renseigner / to complete. 

Telephone: à renseigner / to comple. Fax: à renseigner / to complete. 

à renseigner / to complete 

1.4 Emergency telephone number: +33 (0)1 45 42 59 59. 

Association/Organisation: INRS / ORFILA http://www.centres-antipoison.net. 

 
  

SECTION 2: HAZARDS IDENTIFICATION 

2.1 Classification of the substance or mixture 

In compliance with EC regulation No. 1272/2008 and its amendments. 

This mixture does not present a physical hazard. Refer to the recommendations regarding the other products present on the site. 

This mixture does not present a health hazard with the exception of possible occupational exposure thresholds (see paragraphs 3 and 8). 

This mixture does not present an environmental hazard. No known or foreseeable environmental damage under standard conditions of use. 

In compliance with directives 67/548/EEC, 1999/45/EC and their amendments. 

This mixture does not present a physical hazard. Refer to the recommendations regarding the other products present on the site. 

This mixture does not present a health hazard with the exception of possible occupational exposure thresholds (see paragraphs 3 and 8). 

This mixture does not present an environmental hazard. No known or foreseeable environmental damage under standard conditions of use. 

2.2 Label elements 
 In
compliance with EC regulation No. 1272/2008 and its amendments. 
 No labelling requirements for this mixture. 

In compliance with directives 67/548/EEC, 1999/45/EC and their amendments. 

No labelling requirements for this mixture. 

  
 – Made under license
of European Label System® MSDS software from InfoDyne – http://www.infodyne.fr – 

  

			
	SAFETY DATA SHEET (REGULATION (EC) No 1907/2006 – REACH)	  	Date: 08/11/2013 Page 2/6
	Version: N°2 (18/06/2013)	  	Revision: N°1 (18/06/2013
	à renseigner / to complete	  	
	matrice – matrice

  

 

 2.3 Other hazards 

No data available. 
  

 
 SECTION 3:
COMPOSITION/INFORMATION ON INGREDIENTS 
 3.1 Substances 

No substances fulfil the criteria set forth in annexe II section A of the REACH regulation (EC) n° 190 7/2006. 

3.2 Mixtures 
 No
substances fulfil the criteria set forth in annexe II section A of the REACH regulation (EC) n° 190 7/2006. 
  

 
 SECTION 4: FIRST AID
MEASURES 
 As a general rule, in case of doubt or if symptoms persist, always call a doctor. 

NEVER induce swallowing by an unconscious person. 

4.1 Description of first aid measures 

In the event of exposure by inhalation: 

Transport outdoors, keep the patient warm and in the rest, if the breath is irregular or stopped, to practise the artificial breath. Make
nothing absorb by the mouth. If the person is unconscious, to place in position of recovery and call on to a doctor. 
 In the event of
splashes or contact with eyes: 
 Wash thoroughly with soft, clean water for 15 minutes holding the eyelids open. 

If there is any redness, pain or visual impairment, consult an ophthalmologist. 

In the event of splashes or contact with skin: 

Watch out for any remaining product between skin and clothing, watches, shoes, etc. 

In the event of swallowing: 

Seek medical attention, showing the label. 

Give nothing by the mouth – If the person is unconscious Place her on the highly-rated and call a doctor. 

4.2 Most important symptoms and effects, both acute and delayed 

No data available. 
 4.3
Indication of any immediate medical attention and special treatment needed 
 No data available. 

 
  

SECTION 5: FIREFIGHTING MEASURES 

Non-flammable. 
 5.1
Extinguishing media 
 Suitable methods of extinction 

In the event of a fire, use: 

– sprayed water or water mist 

– foam 
 –
multipurpose ABC powder 
 – carbon dioxide (CO2) 

Unsuitable methods of extinction 

In the event of a fire, do not use: 

– water jet 
 5.2 Special
hazards arising from the substance or mixture 
 A fire will often produce a thick black smoke. Exposure to decomposition products may
be hazardous to health. 
 Do not breathe in smoke. 

  
 – Made under license
of European Label System® MSDS software from InfoDyne – http://www.infodyne.fr – 

  

			
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 In the event of a fire, the following may be formed: 

– carbon monoxide (CO) 

– carbon dioxide (CO2) 

5.3 Advice for firefighters 

No data available. 
  

 
 SECTION 6: ACCIDENTAL
RELEASE MEASURES 
 6.1 Personal precautions, protective equipment and emergency procedures 

Consult the safety measures listed under headings 7 and 8. 

For fire-fighters 

Fire-fighters will be equipped with suitable personal protective equipment (See section 8). 

6.2 Environmental precautions 

Prevent any material from entering drains or waterways. 

6.3 Methods and material for containment and cleaning up 

Retrieve the product by mechanical means (sweeping/vacuuming). 

6.4 Reference to other sections 

No data available. 
  

 
 SECTION 7: HANDLING AND
STORAGE 
 Requirements relating to storage premises apply to all facilities where the mixture is handled. 

7.1 Precautions for safe handling 

Always wash hands after handling. 

Fire prevention: 
 Prevent
access by unauthorised personnel. 
 Recommended equipment and procedures: 

For personal protection, see section 8. 

Observe precautions stated on label and also industrial safety regulations. 

Prohibited equipment and procedures: 

No smoking, eating or drinking in areas where the mixture is used. 

7.2 Conditions for safe storage, including any incompatibilities 

No data available. 
 Storage

  

			
	Temperature	  	N/A
		
	Keep away	  	N/A

 Packaging 

Always keep in packaging made of an identical material to the original. 

7.3 Specific end use(s) 

No data available. 
  

 
 SECTION 8: EXPOSURE
CONTROLS/PERSONAL PROTECTION 
 8.1 Control parameters 

No data available. 

  
 – Made under license
of European Label System® MSDS software from InfoDyne – http://www.infodyne.fr – 

  

			
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 8.2 Exposure controls 

Personal protection measures, such as personal protective equipment 

Pictogram(s) indicating the obligation of wearing personal protective equipment (PPE): 

 
 

 
 Use personal protective equipment that is clean and has been properly maintained. 

Store personal protective equipment in a clean place, away from the work area. 

Never eat, drink or smoke during use. Remove and wash contaminated clothing before re-using. Ensure that there is adequate ventilation,
especially in confined areas. 
 – Eye / face protection 

Avoid contact with eyes. 

Before handling powders or dust emission, wear mask goggles in accordance with standard EN166. 

– Hand protection 

Wear suitable protective gloves in the event of prolonged or repeated skin contact. 

Type of gloves recommended: 

– Natural latex 
 –
Nitrile rubber (butadiene-acrylonitrile copolymer rubber (NBR)) 
 – PVC (polyvinyl chloride) 

– Butyl Rubber (Isobutylene-isoprene copolymer) 

– Body protection 

Work clothing worn by personnel shall be laundered regularly. 

After contact with the product, all parts of the body that have been soiled must be washed. 

– Respiratory protection 

Avoid breathing dust. 
 Type of
FFP mask: 
 Wear a disposable half-mask dust filter in accordance with standard EN149. 

 
  

SECTION 9: SECTION 9: PHYSICAL AND CHEMICAL PROPERTIES 

9.1 Information on basic physical and chemical properties 

General information: 
  

			
	Physical state:	  	Solid.
		
	Color:	  	N/A

 Important health, safety and environmental information 

 

			
	pH:	  	Not relevant.
		
	Boiling point/boiling range:	  	Not relevant.
		
	Flash point interval:	  	Not relevant.
		
	Vapour pressure (50°C):	  	Not relevant.
		
	Density:	  	Not stated.
		
	Water solubility:	  	Soluble.
		
	Melting point/melting range:	  	Not relevant.
		
	Self-ignition temperature:	  	Not relevant.
		
	Decomposition point/decomposition range:	  	Not relevant.

 9.2 Other information 

No data available. 

  
 – Made under license
of European Label System® MSDS software from InfoDyne – http://www.infodyne.fr – 

  

			
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SECTION 10: STABILITY AND REACTIVITY 

10.1 Reactivity 
 No data
available. 
 10.2 Chemical stability 

This mixture is stable under the recommended handling and storage conditions in section 7. 

10.3 Possibility of hazardous reactions 

No data available. 
 10.4
Conditions to avoid 
 Avoid: 

– formation of dusts 

– frost 
 Dusts can form an
explosive mixture with air. 
 10.5 Incompatible materials 

10.6 Hazardous decomposition products 

The thermal decomposition may release/form: 

– carbon monoxide (CO) 

– carbon dioxide (CO2) 
  

 
 SECTION 11: TOXICOLOGICAL
INFORMATION 
 11.1 Information on toxicological effects 

No data available. 
 11.1.1
Substances 
 No toxicological data available for the substances. 

11.1.2 Mixture 
 No
toxicological data available for the mixture. 
  
  

SECTION 12: ECOLOGICAL INFORMATION 

12.1 Toxicity 
 12.1.1
Substances 
 No aquatic toxicity data available for the substances. 

12.1.2 Mixtures 
 No
aquatic toxicity data available for the mixture. 
 12.2 Persistence and degradability 

No data available. 
 12.3
Bioaccumulative potential 
 No data available. 

12.4 Mobility in soil 
 No
data available. 
 12.5 Results of PBT and vPvB assessment 

No data available. 
 12.6
Other adverse effects 
 No data available. 

  
 – Made under license
of European Label System® MSDS software from InfoDyne – http://www.infodyne.fr – 

  

			
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SECTION 13: DISPOSAL CONSIDERATIONS 

Proper waste management of the mixture and/or its container must be determined in accordance with Directive 2008/98/EC. 

13.1 Waste treatment methods 

Do not pour into drains or waterways. 

Waste: 
 Waste management
is carried out without endangering human health, without harming the environment and, in particular without risk to water, air, soil, plants or animals. 

Recycle or dispose of waste in compliance with current legislation, preferably via a certified collector or company. 

Do not contaminate the ground or water with waste, do not dispose of waste into the environment. 

Soiled packaging: 
 Empty
container completely. Keep label(s) on container. 
 Give to a certified disposal contractor. 

 
  

SECTION 14: TRANSPORT INFORMATION 

Exempt from transport classification and labelling. 

Transport product in compliance with provisions of the ADR for road, RID for rail, IMDG for sea and ICAO/IATA for air transport (ADR 2011
– IMDG 2010 – ICAO/IATA 2012). 
  
  

SECTION 15: REGULATORY INFORMATION 

15.1 Safety, health and environmental regulations/legislation specific for the substance or mixture 

– Particular provisions: 

No data available. 
 15.2
Chemical safety assessment 
 No data available. 
  

 
 SECTION 16: OTHER
INFORMATION 
 Since the user’s working conditions are not known by us, the information supplied on this safety data sheet is based
on our current level of knowledge and on national and community regulations. 
 The mixture must not be used for other uses than those
specified in section 1 without having first obtained written handling instructions. It is at all times the responsibility of the user to take all necessary measures to comply with legal requirements and local regulations. 

The information in this safety data sheet must be regarded as a description of the safety requirements relating to the mixture and not as a
guarantee of the properties thereof. 
 Abbreviations: 

ADR: European agreement concerning the international carriage of dangerous goods by Road. 

IMDG: International Maritime Dangerous Goods. 

IATA: International Air Transport Association. 

ICAO: International Civil Aviation Organisation 

RID: Regulations concerning the International carriage of Dangerous goods by rail. 

WGK: Wassergefahrdungsklasse (Water Hazard Class). 

  
 – Made under license
of European Label System® MSDS software from InfoDyne – http://www.infodyne.fr – 

 Annex 7 - Information 

 
 

 

  
 55 

 ANNEX 8: Pharmacovigilance Data Exchange Agreement (PDEA) 

1. SCOPE 
 This document describes the actions,
time frames and assigned responsibilities which the Parties will adopt to ensure compliance to regulatory obligations for Pharmacovigilance. 
 This
agreement shall become effective on the date signed by both parties and will supersede all previous pharmacovigilance arrangements as applicable. 
 The
communication language of the data exchange will be English. 
 2. DEFINITIONS 

2.1 Veterinary medicinal product (VMP) 
 Any active
substance (AI) or combination of AI which may be administered to animals with a view to treating or preventing disease in animals, making a medical diagnosis or to restoring, correcting or modifying physiological functions in animals. 

2.2 Adverse Event (AE) 
 An adverse event is any
observation in animals, whether or not considered to be product-related, that is unfavourable and unintended and that occurs after use of a veterinary medicinal product (VMP), regardless of whether the product was used as recommended on the Summary
of Product Characteristics (SPC) (i.e. on label use or off-label use). 
 Possible adverse events include: 

Ø Adverse Reaction (AR): An adverse reaction (AR) is a reaction to a VMP which is harmful and unintended and
occurs at doses normally used in animals for the prophylaxis, diagnosis or treatment of disease or to restore, correct or modify a physiological function. 

Ø Serious Adverse Reaction (SAR): An adverse reaction which results in death, is life-threatening, results in
significant disability or incapacity, is a congenital anomaly/birth defect, or which results in permanent or prolonged signs in the animals treated. 
 Ø Human Adverse Reaction: A reaction which is noxious and unintended and occurs in a human being following exposure to a VMP. 

Ø A Suspected Lack of Expected Efficacy (SLEE): The apparent inability of an authorised VMP to have the
expected efficacy in an animal according to the claims of the SPC and following use of the product in accordance with the SPC. 
 Ø Investigation of the validity of the withdrawal period: Where levels of VMP residues in tissues or food products of treated food producing animals are above the established maximum residue levels while the
recommended withdrawal period of the given VMP has been respected. 
 Ø Potential environmental problems: A
situation where animals of non-target species, other animals, human beings or plants are suspected to be adversely affected through exposure to a VMP present in the environment. 

Ø Transmission of an infectious agent via a VMP. 

2.3 Date of first receipt (DFR) 
 Calendar date
when the first personnel of VIRBAC is notified of the mentioned adverse events. 
 To be notified in this context means VIRBAC becoming aware of a suspicion
of adverse event by any means: written or oral report from a sales representative, phone call or e-mail or paper mail received from a veterinarian, the animal owner or any other health care professional or product vendor, including question or
information received on a website or a facebook page managed directly by VIRBAC suggesting that an adverse event occurred in animal or human being. 

  
 56 

 2.4 Periodic Safety Update Report (PSUR) 

A periodical scientific report on AE that have been reported to the MAH during a specific period. 

3. PRODUCTS AND TERRITORY 
 The obligations
described in this PDEA apply to the Product(s) and Territory listed in each Specific Distribution Agreement. 
 4. RESPONSIBILITIES 

All relevant information should be shared between VIRBAC and NEXVET in order to allow the two parties to assume their obligations and responsibilities with
regard to safety issues of the Product(s). 
 4.1 Responsibilities of the SUPPLIER (MAH) 

NEXVET must ensure that an appropriate system of pharmacovigilance is in place in order to assure responsibility for the products on the market and to ensure
that appropriate regulatory action can be taken, when necessary. 
 As the Marketing Authorisation Holder (MAH) in the EU/EEA area, NEXVET shall be
responsible for the following activities: 
 Ø Reporting to the concerned National Competent authorities
(preparation and submission of PSURs according to the agreed calendar, electronic submission of adverse events) and responses to their requests for information. 

Ø Signal detection and continuous monitoring of the Product’s safety profile. 

Ø Maintaining the safety related regulatory documentation (SPC) for the Product(s). 

Ø Evaluation and communication of changes to the benefit-risk balance of Product(s). 

Ø Interaction between safety issues and Product(s) defects. 

Ø Identification of AE from the published peer reviewed scientific literature. 

4.2 Responsibilities of VIRBAC (DISTRIBUTOR) 
 As
the distributor in the Territory, VIRBAC shall be in charge of the following operations: 
 Ø Maintenance of
a local system of pharmacovigilance, i.e. comprising the necessary resources for the collection and transmission of AE to the SUPPLIER. 
 Ø Transmission to NEXVET of any request regarding pharmacovigilance issues from the national competent authority. VIRBAC shall provide reasonable assistance to NEXVET to answer questions from the competent
authority. 
 Ø Upon NEXVET’s demand received within a sufficient delay, transmission to NEXVET of
sales data to enable the preparation of PSURs 
 Ø Writing job description detailing their missions for all
personnel who may receive or process AE data, including sales representatives and telephone operator. Writing internal business rules or procedures detailing AE management and transmission to NEXVET. Staff receive appropriate training. 

Ø Appointment of a Contact Person (CP) in charge of processing and transmission of safety reports. A Deputy of
the CP is named in order to maintain the continuity of pharmacovigilance operations in case of the CP’s absence. 

Ø Back up procedure in case of absence of the CP described in internal business rule or procedure in order to
ensure the continuity of the pharmacovigilance operations. 
 Ø Identification of AE related to the
Product(s) from the nationally-published peer reviewed scientific literature and transmission to NEXVET. 

  
 57 

 5. DATA EXCHANGE OF INDIVIDUAL REPORTS 

VIRBAC shall be responsible for collecting all AE either received directly from the national competent authority or veterinarians or other health care
professionals or any other user of the Product(s), including AE occurring during clinical trials conducted by VIRBAC. Reports will be written in english. 

The individual AE reports need to fulfil the four (4) minimum criteria to the reportable: 

Ø an identifiable source (e.g. veterinarian, pharmacist, animal owner): name and complete address of the
reporter, 
 Ø animal/human details: breed, age, sex, 

Ø suspect product(s): Brand name and authorisation number, 

Ø reaction details. 

Once at least the four minimal aforementioned information needed to consider a case as reportable are available to VIRBAC, the calculation of the delay to
report the case to NEXVET starts. 
 VIRBAC shall forward to NEXVET reports of serious and human adverse reaction within [***] of DFR to enable their
electronic submission by the SUPPLIER to the european database Eudravigilance Veterinary within the legal delay (15 calendar days). 
 All other adverse
event reports shall be forwarded to NEXVET [***] of DFR. 
 VIRBAC shall ensure active follow-up as necessary about all AE and forward any follow-up
information to the SUPPLIER within the same delay, i.e. [***] after reception respectively. 
 The reporting form given in Appendix 1 of this PDEA shall be
completed and transmitted to NEXVET. 
 6. AUDIT 

The Parties agree on the principle that audits might be conducted upon need. 

Made in                      in two copies, on
                     
  

					
	FOR NEXVET	 		 	FOR VIRBAC
			
	  
	 		 	  

  
 58 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

 APPENDIX 1 of the PDEA 

CONTACT DETAILS AND PHARMACOVIGILANCE REPORT FORM 

For the SUPPLIER: 
  

			
	Name:	 	
	Job Title:	 	Contact person
	Tel.	 	
	E-mail:	 	
		
	Name:	 	
	Job Title:	 	Deputy of the contact person
	Tel.	 	
	E-mail:	 	

 For VIRBAC: 
  

			
	Name:	 	[***]
	Job Title:	 	[***]
	Tel.	 	[***]
	E-mail:	 	[***]
	Address:	 	[***]
		
	Name:	 	[***]
	Job Title:	 	[***]
	Tel.	 	[***]
	E-mail:	 	[***]
	Address:	 	[***]

  
 59 

*** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

									
	 VETERINARY
PHARMACOVIGILANCE
 Form for reporting suspected adverse events

	 	 
	1 - SUBSIDIARY OR COMPANY	 	2 - ORIGINAL REPORTER
	 	 	 
	 Name of sender:

 
 Address:
	 	Name:	 	 
	 	  
 Address:
	 	 
	Case reference:	 		 		 	 	 
	Type of
report:  ¡  Initial    ¡  Follow-up	 		 	Telephone / Fax /Email:	 	 
	Date of First info Receipt (DFR):	 		 	 ¡  Veterinarian    ¡  Physician    ¡ 
 Pharmacist

¡  
Owner    ¡  Other:

	 	 
	3 - VETERINARIAN / PHARMACIST / PHYSICIAN	 	4 - ANIMAL OWNER / HUMAN PATIENT
	 			 	 
	Name:	 		 		 	Name:	 	 
	 			 	 
	Address:	 		 		 	Address:	 	 
	 ¡  Identical to original reporter
  
	 		 	 
	 	 
	5 - ANIMAL DATA	 	 
	 			 
	N° of animals
treated:	 	N° of animals affected:	 	N° of animals died:	 	 
	 			 
	Animal characteristics (animals affected):	 	Species:	 		 	 
	 				 
	Breed/production type:	 		 	        Weight:	 	Age:	 	 
	Sex/physiological
status:  ¡  Female    ¡  Male    ¡  Pregnant    ¡ 
 Neutered    ¡  Lactating    ¡  Other:	 	 
	State of health at time of treatment:     ¡  Good    ¡  Fair    ¡  
Poor    ¡  Critical    ¡  Unknown	 	 
	 	 
	 Reason(s) for treatment [prevention against what disease and
diagnosis]:
  
	 	 
	 
	6 - PRODUCTS DATA AND TREATMENT DETAILS
	 
	
List of all medications used concurrently and during the previous week:
  

	 Product(s) trade name (incl. dosage and strength)

Company name
	 	 	 	 	 	 	 	 
	 Active substance(s)

Pharmaceutical form
	 	 	 	 	 	 	 	 
	 Batch Number

Expiry date
	 	 	 	 	 	 	 	 
	 Dose

Frequency of treatment
	 	 	 	 	 	 	 	 
	 Route

Site of administration
	 	 	 	 	 	 	 	 
	Who administered the product(s)?	 	 	 	 	 	 	 	 
	Use according label	 	 	 	 	 	 	 	 
	Start date of treatment	 	 	 	 	 	 	 	 
	Stop date or duration	 	 	 	 	 	 	 	 
	Action after reaction (drug withdrawn, dose reduced)?	 	 	 	 	 	 	 	 
	Did reaction abate after stopping drug treatment?	 	 	 	 	 	 	 	 
	Did reaction reappear after reintroduction?	 	 	 	 	 	 	 	 
	Storage details	 	 	 	 	 	 	 	 

  

			
	GEDOQ FOR00352 version 05	  	DOC APPLICABLE

 Confidential – For discussion purpose only 

 

													
	  

7 - EVENT DATA (safety issue in animals/lack of expected efficacy/withdrawal period issue/ environmental problem/transmission of infectious
agents)

	 
	Date or time to onset of
signs:                                        
            Duration of reaction:
	 
	Describe the sequence of events incl. administration of product(s), all clinical signs, site of reaction,
severity, laboratory tests, necropsy results, possible contributing factors (if necessary use extra sheet):
	 
	Treatment given to address this adverse reaction:    ¡ Yes             ¡ No            Details:
	 
	Outcome of reaction to date:
	 	  	Euthanised	 	    Died    	 	
Under  

treatment  
	  	With sequelae  	 	    Recovered    	  	  Unknown  
	N° of
 animals:	  	 	 	 	 	 	  	 	 	 	  	 
	Date when:	  	 	 	 	 	 	  	 	 	 	  	 
	 
	8 - PREVIOUS EXPOSURE AND EVENT(S) TO PRODUCT(S)
	 		 
	 Previous exposure to product(s)?

Previous reaction to product(s)?
	 	
¡
Yes            ¡
No        Which one(s):                        Date:

¡
Yes            ¡
No        Which one(s):                        Date:
	  	 
	
Description of reaction, treatment given and outcome:
  

	 
	9 - DETAILS OF SUSPECTED ADVERSE EVENT(S) IN HUMANS
	 
	
Sex:                    Age/date of
birth:                     Occupation (with relevance to exposure):
  

Date of
exposure:                                        
                    Date of reaction:

	 
	
Nature and duration of exposure, reaction details (including symptoms and treatment of the reaction) and outcome:

 
 Identification of the physician or poison center or pharmacovigilance center if
consulted:
  

	 
	10 - FOR SUBSIDIARY OR COMPANY USE / CAUSALITY ASSESSMENT
	 
	¡
 A (probable)        ¡ B
(possible)        ¡ O
(unclassified)        ¡ O1
(inconclusive)        ¡ N (unlikely)
	 
	
Reasons for assessment and comments:
  

 

 Date: 
 Name of the
original reporter (see section 2 of the document) or the person responsible for completing this form: 
 Signature (if reporting form printed):

  

			
	¡ Attachments included	  	¡ Reports to follow

  
 61 

 Confidential – For discussion purpose only 

ANNEX 9 - FINANCIAL EXAMPLE 

  
 62 

 Annex 9 – Financial Example 
  

 
 Nexvet recovers Manufacturing
Margin from Commercial Margin 
 [***] 
 *** Portions of
this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

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