Exhibit 10.1


 


CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS
OF THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY
WITH THE SECURITIES AND EXCHANGE COMMISSION 


 


DISTRIBUTION AND SUPPLY AGREEMENT


 


PARNELL NORTH AMERICA PTY LTD


ABN 36
138 251 537 


 


and


 


VÉTOQUINOL CANADA INC 


 



    	 



    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


Table
of Contents


 


	 	 	Page
	 	 	 
	1.	Interpretation	1
	 	 	 
	2.	Scope	6
	 	 	 
	3.	Establishment Fee	7
	 	 	 
	4.	Minimum Safes Quantities	7
	 	 	 
	5.	Appointment	8
	 	 	 
	6.	Restrictions	9
	 	 	 
	7.	Term	9
	 	 	 
	8.	Registrations of Products	9
	 	 	 
	9.	Marketing of Products	10
	 	 	 
	10.	Marketing Plans and Reports	11
	 	 	 
	11.	Pricing	12
	 	 	 
	12.	Purchase Orders	12
	 	 	 
	13.	Delivery	14
	 	 	 
	14.	Late Delivery or Failure to Deliver	14
	 	 	 
	15.	Invoices and Payment	15
	 	 	 
	16.	Adverse Experience Reporting	16
	 	 	 
	17.	Product Recall	16
	 	 	 
	18.	Packaging and Markings	17
	 	 	 
	19.	Trade Mark	19
	 	 	 
	20.	Product Warranties	19
	 	 	 
	21.	General Warranties	19
	 	 	 
	22.	Contract Management	20
	 	 	 
	23.	Records and Audits	21
	 	 	 
	24.	Confidentiality	22
	 	 	 
	25.	Dispute Resolution	23
	 	 	 
	26.	Force Majeure	24
	 	 	 
	27.	IPR Infringement Indemnity	25
	 	 	 
	28.	Indemnities	26
	 	 	 
	29.	Limitation of Liability	26
	 	 	 
	30.	Insurances	26
	 	 	 
	31.	Notices	27


 




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Table
of Contents


(continued)


 


	 	 	Page
	 	 	 
	32.	Termination	28
	 	 	 
	33.	After Termination	29
	 	 	 
	34.	Miscellaneous	29


 


	 	SCHEDULE 1	 
	 	 	 
	 	SCHEDULE 2	 
	 	 	 
	 	SCHEDULE 3	 
	 	 	 
	 	SCHEDULE 4	 
	 	 	 
	 	SCHEDULE 5	 


 


 




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Date: 29.09.2009


 


Parties


 


PARNELL NORTH AMERICA PTY LTD

ABN 36 138 251 537

Unit 4, 476 Gardeners Road, Alexandria, New South Wales, Australia

(Parnell)


 


And


 


VÉTOQUINOL CANADA INC.

2000 chemln Georges, Lavaltrie, Quebec J5T 3S5

(Vétoquinol)


 


Background


 


A.           Parnell
is engaged in the research, development, manufacture and sale of animal health products.


 


B.           Vétoquinol
carries on business in Canada of marketing, selling and distributing animal health products.


 


C.          
[Vétoquinol has represented to Parnell that] Vétoquinol has the technical skills, facilities and other resources
to enable it to effectively distribute animal health products in Canada.


 


D.           Parnell
has offered to appoint Vétoquinol as its exclusive distributor of the Products in Canada and Vétoquinol has accepted
such appointment, on the terms and conditions set out in this Agreement.


 


Operative Provisions


 


		1	Interpretation



 


1.1          In
this Agreement, unless the context otherwise requires:


 


Vétoquinol
Contract Manager means the person appointed by Vétoquinol in that role in accordance with Clause 22.2.


 


Agreement means
the following (each as amended from time to time in accordance with this Agreement) in order of priority:


 


(a)          the
Clauses of this document;


 


(b)          its
Schedules; and


 


any other documents generated in
accordance with this document and/or incorporated by reference.


 




    	 



    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


Approved Sub-Distributors
has the meaning given to it in Clause 5.3(a).


 


Business Day
means any day a bank is open for business in Sydney, Australia and Montreal Canada, excluding weekends and bank and public holidays.


 


Claim means
a claim, demand or proceedings.


 


Commencement Date
means the date of this Agreement.


 


Confidential Information
means in relation to a Party (Disclosing Party) information that:


 


(a)          is
by its nature confidential;


 


(b)          is
designated by that Party as confidential; or


 


(c)          the
other Party (Recipient) knows, or ought to know, is confidential and includes:


 


(i)          information
comprised in or relating to any Intellectual Property Rights of the Disclosing Party;


 


(ii)         information
relating to the financial position of the Disclosing Party and in particular includes information relating to the assets or liabilities
of the Disclosing Party and any other matter that does or may affect the financial position or reputation of the Disclosing Party;


 


(iii)        information
relating to the internal management and structure of the Disclosing Party, or the personnel, policies and strategies of the Disclosing
Party;


 


(iv)        information
of the Disclosing Party to which the Recipient has access that has any actual or potential commercial value to the Disclosing Party
or to the person or corporation which supplied the information;


 


(v)         information
in the Recipient’s possession relating to the Disclosing Party’s clients or suppliers, and like information;


 


but
excludes information which:


 


(vi)        the
Recipient creates (whether alone or jointly with any person) independently of the Disclosing Party’s Confidential Information
(if the Recipient has evidence in writing that the information falls within this exception); or


 


(vii)       that
is public knowledge (and has become so otherwise than as a result of a breach of confidentiality by a Recipient or any person to
whom the Recipient has disclosed the information).


 


CPI means the
quarterly Consumer Price Index as published by the Australian Bureau of Statistics.


 




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Contract Manager
means the Vétoquinol Contract Manager and the Parnell Contract Manager.


 


Cost of Goods
means the Price paid for the Products by Vétoquinol Ex-Works (Inco Terms 2000) Parnell


 


Damages means
liabilities, losses, damages, costs and expenses arising in contract, tort or statute, including reasonable legal fees and disbursements
and costs of investigation, litigation, settlement, judgment, interest and penalties.


 


Establishment Fee
means the payment specified in Clause 3.1.


 


Estroplan means
Parnell’s hormone injection product containing cloprostenol. VDD means the Veterinary Drugs Directorate of Canada.


 


Force Majeure Event
means any one or more of the following events:


 


(a)          fire,
flood, earthquake, elements of nature or act of God;


 


(b)          riot,
civil disorder, rebellion or revolution;


 


(c)          strike,
lockout, other industrial disturbance or labour difficulty,


 


(d)          war,
act of public enemy, blockade


 


(e)          unavailability
of any essential equipment or materials;


 


(f)          unavoidable
accident; or


 


(g)          lack
of transportation.


 


Government Agency
means any government or any governmental, semi-governmental, administrative, fiscal or judicial body, department, commission, authority,
tribunal, agency or entity responsible for granting Registration in the Territory.


 


GMP means Good
Manufacturing Practice as required by the VDD or any other regulatory authority


 


Gross Margin
means ***.


 


GST Act means
the A New Tax System (Goods and Services Tax) Act 1999 (Cth).


 


Insolvency Event
means any of the following events occurring to a Party:


 


(a)          that
Party disposes of the whole of its assets, operations or business other than in the normal course of business;


 


(b)          an
arrangement is entered into between that Party and its creditors other than for the purposes of reconstruction under Part 5.1
or 5.3A of the Corporations Act;


 




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(c)          that
Party ceases pursuant to section  495E of the Corporations Act to be able to pay its debts as they become due;


 


(d)          a
mortgagee enters into possession or disposes of the whole or any part of that Party’s assets or business;


 


(e)          a
receiver, a receiver and manager, a trustee in bankruptcy, a liquidator, a provisional liquidator, an administrator or other like
person is appointed over the whole or any part of that Party’s assets or business; or


 


(f)          a
voluntary administrator is appointed in relation to it.


 


Intellectual Property
Rights or IPR means all intellectual property rights at any time protected by statute or common law, including:


 


(a)          patents,
copyright and any registered intellectual property rights (including rights in circuit layouts under the Circuit Layouts Act and
similar rights in other countries in circuit layouts), registered designs, trade marks, 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).


 


Law means any
applicable statute, regulation, by-law, ordinance or subordinate legislation in force from time to time in Australia or in the
Territory, and includes the common law as applicable from time to time.


 


Marketing Plan
means the plan described in Clause 10.1.


 


Minimum Sales Quantity
means the minimum quantity of each of the Products which Vétoquinol must purchase from Parnell during each Year, as specified
in Schedule 2.


 


Net Effective Selling
Price means the net revenue divided by the total units sold of each of the Products


 


Parnell Contract
Manager means the person appointed by Parnell in that role in accordance with Clause 22.1.


 


Person means
any individual, corporation, partnership, limited liability company, entity or any combination.


 


Personnel (of a
Party) means the officers, employees, contractors (including Approved Sub Contractors and their employees) and agents of that
Party and its Related Corporations (but in the case of Vétoquinol, excluding Parnell’s Personnel).


 


Product Unit
means a unit of a Product in the standard sized vials used by Parnell to distribute the Products.


 




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Price means
the price payable by Vétoquinol ***determined by Parnell for the Products as set out in Schedule 1 from time to time
during the Term and ***.


 


Products means:


 


(a)          at
the date of this Agreement - the products identified in Schedule 1 as being the subject of a Registration; and


 


(b)          after
the date of this Agreement - those products identified in Schedule 1 which become the subject of a Registration in the Territory


 


Purchase Order
means a purchase order for Products submitted to Parnell by Vétoquinol that conforms with both Clause 12.2 and Clause 12.5.


 


Records has
the meaning given to it in Clause 22.


 


Registration
means any consent, registration, filing, agreement, certificate, license, approval, permit, authority or exemption granted by or
from Government Agency necessary for the importation and/or the sale of the Products in the Territory.


 


Related Corporation
means a related body corporate within the meaning given to that term in Section 9 of the Corporations Act.


 


Specifications means
the specifications of the Products as set out in Schedule 4 which is pursuant to the requirements of the registration of the Products.


 


Term means the
term of this Agreement as specified in Clause 7.


 


Territory means
Canada.


 


Trade Mark means
any one or more of the Product or Company trade marks specified in Schedule 3.


 


Vétoquinol
Contract Manager means the person appointed by Vétoquinol in that role in accordance with Clause 22.2.


 


Year means each
twelve month period from January to December each calendar year during the currency of the Agreement with the first year starting
at the Commencement Date and finishing December 31, 2009.


 


1.2          In
this Agreement, unless the context otherwise requires:


 


(a)          headings
are for convenience only and do not affect the interpretation of this Agreement;


 


(b)          words
importing the singular include the plural and vice versa;


 


(c)          words
importing a gender include any gender;


 




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(d)         other
parts of speech and grammatical forms of a word or phrase defined in this Agreement have a corresponding meaning;


 


(e)         an
expression importing a natural person includes any company, partnership, joint venture, association, corporation or other body
corporate and any Governmental Agency;


 


(f)          a
reference to any thing (including, but not limited to, any right) includes a part of that thing;


 


(g)         a
reference to a part, clause, Party, annexure, exhibit or schedule is a reference to a part and clause of, and a Party, annexure
exhibit and schedule to, this Agreement and a reference to this Agreement includes any annexure, exhibit and schedule;


 


(h)         a
reference to a statute, regulation, proclamation, ordinance or by-law includes all statutes, regulations, proclamations, ordinances
or by-laws amending, consolidating or replacing it, and a reference to a statute includes all regulations, proclamations, ordinances
and by-laws issued under that statute;


 


(i)          a
reference to a document includes all amendments or supplements to, or replacements or novations of, that document;


 


(j)          a
reference to a Party to a document includes that Party’s successors and permitted assigns;


 


(k)         where
the day on or by which any thing is to be done is not a Business Day, that thing must be done on or by the preceding Business Day;


 


(l)          a
reference to an agreement other than this Agreement includes an undertaking, agreement or legally enforceable arrangement or understanding
whether or not in writing;


 


(m)        a
reference to an asset includes all property of any nature, including, but not limited to, a business, and all rights, revenues
and benefits; and


 


(n)         a
reference to a document includes any agreement in writing, or any certificate, notice, instrument or other document of any kind.


 


1.3          In
this Agreement a reference to $ or dollars is a reference to the lawful currency of Canada.


 


		2	Scope



 


2.1          Parnell
has offered to appoint Vétoquinol as the exclusive distributor of the Products in the Territory as a result of Vétoquinol’s
representation to Parnell that Vétoquinol has the capability to:


 


(a)         effectively
distribute, market and sell the Products in the Territory; and


 




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(b)          to
develop and grow that market for the products which Parnell has available for sale in the Territory.


 


2.2          Parnell
represents the Products possess unique offerings in established markets in the Territory which:


 


(a)          will
enable Vétoquinol to immediately commence exclusively distributing marketing and selling Estroplan 20mL in the Territory.


 


		3	Establishment Fee



 


3.1          In
consideration of:


 


(a)          Vétoquinol’s
appointment as the exclusive distributor of the Products in the Territory;


 


(b)          the
work carried out by Parnell to gain registration of Products in the Territory;


 


(c)          the
potential market value which Vétoquinol will be able to derive from Parnell’s Registrations for the Products in the
Territory,


 


and in recognition of Parnell’s
agreement to the terms and conditions set out in this Agreement, Vétoquinol agrees to pay to Parnell an amount of $200,000
(Establishment Fee).


 


3.2          Vétoquinol
must pay to Parnell the Establishment Fee according to the following payment schedule:


 


(a)          $200,000
payable within *** of the date on the ***of the ***.


 


3.3          If
Parnell does not receive payment of the Establishment Fee from Vétoquinol within the time specified for payment in Clause 3.2
then this Agreement will, by virtue of this fact alone, cease to have any further force or effect whatsoever and the provisions
of Clause 33 (with any necessary changes being made) will apply.


 


		4	Minimum Sales Quantities



 


4.1          The
continued operation of this Agreement is conditional on Vétoquinol purchasing from Parnell the Minimum Sales Quantity of
Product, as specified in Schedule 2. Vétoquinol’s obligation to purchase the Minimum Sales Quantity for Estroplan
100mL only commences after *** for Estroplan 100mL and the 100mL ***.


 


4.2          If
Vétoquinol fails to purchase from Parnell the Minimum Sales Quantity in accordance with Clause 4.1 for two consecutive
years and Parnell ***, Parnell can terminate the Agreement by providing written notice of termination as set forth in Clause 32.


 




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		5	Appointment



 


5.1          Parnell,
by this Agreement, appoints Vétoquinol as its exclusive distributor of the Products in the Territory.


 


5.2          During
the Term:


 


(a)          Parnell
will not supply any Products containing Cloprostenol or Dinaprost to any third Party in the Territory;


 


(b)          Parnell
will not appoint any other Person to distribute the Products in the Territory.


 


(c)          Parnell
will inform in writing its distributors in the USA of the appointment of Vétoquinol as exclusive distributor of the Products
in the Territory and shall ensure that the exclusivity granted by it to Vétoquinol is effective.


 


5.3          Vétoquinol
is entitled to appoint sub-distributors of the Products and to authorize such sub-distributors to market, distribute and sell the
Products in the Territory provided that:


 


(a)          Vétoquinol
obtains Parnell’s prior written approval to the appointment of the sub-distributor (Approved Sub-Distributor);


 


(b)          the
Approved Sub-Distributor itself does not have the right to appoint any further sub-distributors;


 


(c)          the
Approved Sub-Distributor is to have no contractual relationship with Parnell and Vétoquinol will ensure that all of the
Approved Sub-Distributor’s communications regarding the Products are dealt with by Vétoquinol;


 


(d)          Vétoquinol
will require, by contractual obligation, that the Approved Sub- Distributor complies with the provisions of this Agreement as though
the Approved Sub-Distributor were a Party to this Agreement; and


 


(e)          where
an Approved Sub-Distributor is required by contractual obligation to do, or not to do, something, Vétoquinol must enforce
those contractual obligations where the Approved Sub-Distributor defaults.


 


(f)          For
the purposes of this Clause 5.3 the term Approved Sub-Distributors does not extend to wholesalers who distribute the
Products to veterinary clinics or farmers under a prescription from a licensed veterinarian in their normal course of business.


 


5.4          At
all times, Vétoquinol must distribute, market and sell the Products in the Territory in accordance with the statutory requirements
and industry standards applicable in the Territory.


 




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5.5          Vétoquinol
must not do any act, matter or thing, or omit to do any act, matter or thing which would jeopardize the goodwill of Parnell or
the reputation of the Products in the Territory.


 


5.6          Vétoquinol
must not directly or indirectly:


 


(a)          export
the Products from the Territory;


 


(b)          distribute
the Products to any person outside the Territory; or


 


(c)          distribute
the Products to any persons in the Territory whom Vétoquinol knows they will distribute the Products outside the Territory
or export the Products from the Territory.


 


5.7          Parnell
must not directly or indirectly:


 


(a)          distribute
the Products to any person whom Parnell knows, intends to distribute the Products in the Territory or export the Products to the
Territory.


 


5.8          Vétoquinol
must refer to Parnell any enquiries or orders received by Vétoquinol for the supply of the Products outside the Territory.


 


		6	Restrictions



 


6.1          During
the Term, Vétoquinol must not promote, market, sell or distribute to any third Party in the Territory any products containing
Cloprostenol or Dinaprost other than those described in Schedule 1.


 


6.2          If
during the Term Parnell can not supply Products that are the subject of a Purchase Order for a period of more than 120 days after
the Delivery Date, Vétoquinol may provide written notice of intention to sell an alternative product containing Cloprostenol.
The alternative product sold by Vétoquinol must not use the Estroplan brand name or trade dress and must be a product that
is registered in the Territory.


 


		7	Term



 


7.1          The
term of Vétoquinol’s appointment as exclusive distributor under this Agreement commences on the Commencement Date
and continues for seven (7) years from the Commencement Date. This Agreement will be extended for a subsequent terms of three (3)
years except if terminated by either Party with a *** written notice or until the appointment is terminated early in accordance
with Clause 3.3, Clause 4.2 or in accordance with Clause 32.1.


 


		8	Registrations of Products



 


8.1          Parnell
will use all reasonable commercial endeavours to obtain and maintain (where it is required to do so by virtue of the nature of
the Products) the Registration of Products identified in Schedule 1 so as to enable Vétoquinol to market, sell and
distribute the Products in the Territory.


 




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8.2          Subject
to Clause 8.3, if the Registration of a Product is terminated (and Registration of the Product is required) and Vétoquinol
is thus unable to market, sell and distribute the product in the Territory then:


 


(a)          Parnell
is entitled to remove the Product from Schedule 1; and


 


(b)          Vétoquinol
will cease to be entitled to market, sell and distribute that Product in the Territory.


 


Parnell will not be
required to repay the Establishment Fee (as defined in Clause 3) to Vétoquinol if the Registration of a Product is
terminated and the Product is removed from Schedule 1, however, Vétoquinol will be entitled to terminate this Agreement
and shall be able to claim damages as prescribed in Clause 33.


 


8.3          At
the Commencement Date, Estroplan 100mL vial is not yet approved. Parnell will use all reasonable commercial efforts to secure approval
for this variant of the Product in the Territory


 


		9	Marketing of Products



 


9.1          Vétoquinol
must use all reasonable commercial endeavors to:


 


(a)          promote
the Products in the Territory; and


 


(b)          maximize
the sales of the Products in the Territory.


 


9.2          Vétoquinol
has complete responsibility for the sale of the Products to prospective customers in the Territory and must undertake these activities
at its expense.


 


9.3          Parnell
licenses Vétoquinol to use the marketing materials which are developed by Parnell and supplied by it to Vétoquinol.


 


9.4          Vétoquinol
must develop, at its own expense, marketing materials to promote the Products in the Territory. Parnell will assist Vétoquinol
in the developing of marketing materials.


 


9.5          Vétoquinol
must not use marketing materials developed by it unless those marketing materials have been provided to Parnell for review. Such
marketing materials will be deemed to have been reviewed by Parnell where they are submitted to Parnell by Vétoquinol and
Parnell does not notify Vétoquinol in writing of any objection to those marketing materials within 10 Business Days.


 


9.6          Vétoquinol
is responsible for the accuracy and completeness of the marketing materials created by it except for the factual information provided
by Parnell and used by Vétoquinol without modification in the context used by Parnell.


 


9.7          Vétoquinol
must not make any representation or warranty about the Products other than those contained in the information or marketing materials
provided by Parnell or prepared by Vétoquinol and approved by Parnell in accordance with Clause 9.5.


 




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9.8          Vétoquinol
must not misuse the Estroplan brand or do any act or omission that may otherwise damage the Estroplan brand. If Parnell believes
that Vétoquinol has or is intending to do an act or omission that does or may cause damage to the Estroplan brand both parties
must meet in good faith to discuss the offending act or omission and agree a suitable remedy. If agreement can not be reached,
Parnell is entitled to terminate the contract, however, Vétoquinol shall immediately be able to claim the damages prescribed
in Clause 33.4


 


		10	Marketing Plans and Reports



 


10.1        No
later than the first day of each Year, other than the first year, Parnell and Vétoquinol must have agreed, in accordance
with Clause 10.2, a written plan (to be prepared by Vétoquinol) in a form to be agreed between the Parties relating
to the marketing, sale and distribution of the Products in the Territory by Vétoquinol for the Year to which it relates
(Marketing Plan).


 


10.2        The
process for the approval of the Marketing Plan is as follows:


 


(a)          In
the first year Vétoquinol must prepare and submit to Parnell an Marketing Plan no later than 30 days after the Commencement
Date. Parnell must notify Vétoquinol of its comments no later than 15 days thereafter.


 


(b)          No
later than 60 days before the start of each subsequent Year, Vétoquinol must prepare and submit to Parnell a draft Marketing
Plan for that Year


 


(c)          No
later than 30 days after receipt by Parnell of the draft Marketing Plan, Parnell must notify Vétoquinol of its comments
to the draft Marketing Plan


 


(d)          Representatives
of Parnell and Vétoquinol may also meet to discuss (or discuss by telephone) any matters concerning the Marketing Plan.


 


(e)          Parnell
and Vétoquinol must negotiate in good faith to reach agreement on the Marketing Plan that maximizes sales of the Products
and maximizes profits for both Parties no later than 10 Business Days prior to the commencement of the Year to which the draft
Marketing Plan relates.


 


10.3        Vétoquinol
must report in writing to Parnell against the Marketing Plan at quarterly intervals during the Term, such report to be in the form
agreed between the Parties and received by Parnell within 15 Business Days of the end of each quarter Year.


 


10.4        Vétoquinol
must provide any other information reasonably requested by Parnell in relation to Vétoquinol’s marketing activities
under this Agreement when requested to do so by Parnell.


 


10.5        If
at any time an event occurs which has, or is likely to have, a material impact on the annual sales forecast being a change greater
than 10% of the agreed annual sales forecast in the Marketing Plan then, Vétoquinol must immediately give Parnell written
notice detailing:


 


(a)          when
the event occurred;


 




    	11



    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


(b)          describing
the nature of the event;


 


(c)          Vétoquinol’s
view of the impact the event will have; and


 


(d)          in
the event of a decrease in the annual sales forecast Vétoquinol’s plan of action that it will take to minimize the
impact of the event (Mitigation Plan).


 


10.6        Vétoquinol
must then take action at the time and in the manner contemplated by that Mitigation Plan.


 


10.7        Vétoquinol
must keep Parnell informed in a timely manner of any general market, economic and regulatory developments that Vétoquinol,
acting reasonably, considers may adversely or beneficially effect the sales of the Products by it in the Territory.


 


		11	Pricing



 


11.1        The
price payable by Vétoquinol to Parnell for the supply of the Products will be calculated by reference to the ***.


 


11.2        Parnell
must notify Vétoquinol of any price changes for any Product ***.


 


11.3        In
the event that ***must *** with respect to ***. In the event that ***for the ***


 


11.4        Upon
the new price taking effect under this Clause, Schedule 1 will be deemed to have been amended by the deletion of the old Price
and the insertion of the new Price.


 


11.5        For
the purpose of all calculations and determinations made under this Agreement, the Price is the ***.


 


11.6        If,
at any time during the Term, ***in the Territory results in Vétoquinol having to sell a Product in the Territory *** (Relevant
Event) then, *** (RE Notice), *** must meet to *** as to the *** in order to *** to a ***. If the ***days of a RE Notice
being given (and the RE Notice *** then subject to preservation of *** in Clause 33.4., *** after notice of termination is
given


 


		12	Purchase Orders



 


12.1        Vétoquinol
is entitled at any time during the Term of the Agreement to request the supply of Estroplan 20 from Parnell, subject to Clauses 12.3 and 12.4.
Vétoquinol will make these requests by submitting a Purchase Order to Parnell.


 


12.2        Vétoquinol
is entitled to submit a Purchase Order to Parnell for the supply of Estroplan 100mL on and from the earlier of:


 


(a)          the
date on which Parnell notifies Vétoquinol in writing that Estroplan 100mL is approved; or


 


(b)          ***;


 




    	12



    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


12.3        A
Purchase Order submitted by Vétoquinol, under this Agreement, must:


 


(a)          be
for a minimum quantity of


 


(i)          ***of
Product AND/OR


 


(ii)         ***of
Product


 


Except for
the first Purchase Order, which must be for *** of Product


 


(b)          be
in writing;


 


(c)          be
dated;


 


(d)          not
be inconsistent with the terms of this Agreement; and


 


(e)          be
signed by Vétoquinol.


 


12.4        A
Purchase Order submitted by Vétoquinol, under this Agreement, must also specify the following:


 


(a)          subject
to the Minimum Sales Quantities, the quantity of the Products required;


 


(b)          the
date by which Vétoquinol requires delivery of the Products which will not be less than ***, unless otherwise agreed in writing
by both Parties;


 


(c)          the
reference number of the Purchase Order; and


 


(d)          any
other special instructions Vétoquinol requires Parnell to observe in relation to the Products, the subject matter of the
Purchase Order (including any special delivery instructions).


 


12.5        A
Purchase Order will not be binding on Parnell unless it is signed by Vétoquinol.


 


12.6        Each
Purchase Order will be accepted by Parnell within five (5) days , such acceptance not to be unreasonably withheld and will constitute
a separate binding contract between Parnell and Vétoquinol for the delivery by Parnell, and the purchase by Vétoquinol,
of the Products specified in the Purchase Order on the terms and conditions set out in this Agreement. 


 


12.7        Vétoquinol
is not entitled to vary the requested delivery date or quantity of the Products specified in any Purchase Order given by it under
this Agreement, except if agreed by Parnell.


 


12.8        Notwithstanding
anything to the contrary in this Agreement, in the first Purchase Order placed on Parnell for Estroplan, Vétoquinol will
purchase a minimum quantity of *** of Estroplan from Parnell in ***.


 




    	13



    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


		13	Delivery



 


13.1        Subject
to Vétoquinol ordering the minimum order quantity specified in Clause 12.3, Parnell will only deliver product that
has a ***.


 


13.2        The
Products sold by Parnell to Vétoquinol pursuant to an accepted Purchase Order will be sold *** (as defined in Incoterms).


 


13.3        Parnell
will deliver Products, the subject of an accepted Purchase Order, with accompanying documentation including certificate of analysis
and commercial invoice by making the Products available *** as is notified from time to time by Parnell to Vétoquinol).


 


13.4        Notwithstanding
Clause 13.3, the first Purchase Order submitted by Vétoquinol for Estroplan will be available *** instead of the address
specified in Clause 13.3.


 


13.5        Parnell
has no obligation to arrange loading of, carriage of or insurance for those Products sold by Parnell to Vétoquinol pursuant
to an accepted Purchase Order. At the request of Vétoquinol, Parnell may assist in making arrangements at Vétoquinol
expense for the loading of and carriage of those Products.


 


13.6        Parnell
will give written notice as to the date on which Products, the subject of an accepted Purchase Order, will be available for collection
by Vétoquinol (Delivery Notice).


 


13.7        Vétoquinol
is deemed to take delivery of the Products on the date on which a Delivery Notice is given to Vétoquinol.


 


13.8        Parnell
bears all risk of loss or damage to Products until the Delivery Notice relating to those Products is given to Vétoquinol
on and from which date Vétoquinol bears all risk of loss or damage to the Products.


 


13.9        Parnell
will make all reasonable commercial efforts to make the Products, the subject of an accepted Purchase Order, available for collection
by or on behalf of Vétoquinol promptly after notice of Parnell’s acceptance is given in respect of the Purchase Order.


 


13.10      In
the event that Parnell makes arrangements on behalf of Vétoquinol for the carriage of goods all undertakings will be made
with best endeavours but no liability is assumed by Parnell. Any invoices payable for delivery of goods will be payable by Vétoquinol
for which Parnell will provide a relevant invoice.


 


		14	Late Delivery or Failure to Deliver



 


14.1        Subject
to Clause 14.2, ***not be ***which are the ***provided that:


 


(a)          Vétoquinol
may by written notice to Parnell (Delivery Reject Notice) reject delivery of those Products where delivery takes place ***
nominated in the relevant Purchase Order (Sunset Delivery Date); and


 




    	14



    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


(b)          to
the extent that Parnell is not ***, the ***will be *** in which the *** occurs.


 


14.2        Despite
any other provisions contained in this agreement, the amount to be payable by Parnell shall not exceed $200,000 in any such
case.


 


14.3        If:


 


(a)          Vétoquinol
places a Purchase Order for a quantity of Estroplan within the *** of this Agreement; and


 


(b)          Parnell
is unable to deliver *** Product/Estroplan specified in that Purchase Order (Affected Estroplan Quantity) by the *** because
it is *** for whatever reason, except in case of Force Majeure as defined in Clause 26 herein , or because the
*** has not been ***, or because the *** has been *** then, even if the Agreement is terminated by Vétoquinol or Parnell
for just cause *** to *** as agreed damages ***that (i) elapses after the *** up to the month which is ***and (ii) in which the
Affected Estroplan Quantity is not delivered or if the *** occurs more than ***then ***that (i) elapses after the *** up to the
month which is ***and (ii) in which the Affected Estroplan Quantity is not delivered.


 


		15	Invoices and Payment



 


15.1        Any
invoice submitted by Parnell to Vétoquinol under this Agreement must be in writing, be dated, relate to the Products and
must include (as the case may require):


 


(a)          the
reference number of the Purchase Order;


 


(b)          confirmation
of the quantity of the Products delivered;


 


(c)          the
address to which the Products was delivered;


 


(d)          the
Actual Delivery Date;


 


(e)          the
total amount of the invoice; and


 


(f)          the
reference number of the invoice.


 


15.2        The
price payable by Vétoquinol for Products, which are the subject of a Purchase Order accepted in writing by Parnell, will
be invoiced by Parnell on the date on which it gives written notice of its acceptance of the Purchase Order to Vétoquinol
(Invoice Date).


 


15.3        Subject
to Clause (a), invoices issued by Parnell are payable by Vétoquinol as follows:


 


(a)          Vétoquinol
must pay Parnell’s invoice *** of the date of the Delivery Notice (in accordance with Clause 13.6)


 




    	15



    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


15.4        Vétoquinol
must pay the amount which has become due and payable under any invoice, issued by Parnell, by wire transfer to the bank account
nominated by Parnell to Vétoquinol for this purpose.


 


15.5        Subject
to Clause 15.6, if Vétoquinol fails to pay an invoice by the due date, interest will accrue on the unpaid amount until
it is paid at the rate of ten percent (10%) per annum. Interest is payable on demand and in addition to the amount on which interest
is charged.


 


15.6        If
Vétoquinol disputes the amount claimed to be due to Parnell under any invoice issued by Parnell, Vétoquinol must
pay the amount which is not in dispute and notify Parnell in writing about the amount in dispute and the grounds for the dispute.
Such a dispute is to be resolved in accordance with the procedure set out in Clause 25. If as a result of the dispute resolution
process, an amount is found to have been properly invoiced by Parnell and payable by Vétoquinol then, interest will be payable
on the unpaid amount from the due date to the date of payment in accordance with Clause 15.5.


 


		16	Adverse Experience Reporting



 


16.1        Parnell
as the owner of the Registration is responsible for meeting Adverse Experience Reporting obligations as required by the VDD and
any other regulatory agency. In order for Parnell to meet those obligations, Vétoquinol must:


 


(a)          immediately
provide a written report to Parnell setting out any information received by Vétoquinol, or of which it becomes aware, concerning
any side effect, toxicity, lack of efficacy or any other adverse reaction associated with the use of the Products, whether or not
considered to be attributable to use or administration of the Products.


 


(b)          If
Vétoquinol is required to report any information concerning any side effect, toxicity, lack of efficacy or any other adverse
reaction associated with the administration or use of the Products to a Government Agency, provide a copy of that report to Parnell
together with copies of all correspondence between Vétoquinol and the Government Agency.


 


16.2        Parnell
must immediately provide Vétoquinol with written notice of any information concerning any side effect, toxicity, lack of
efficacy or other adverse reaction associated with administration or use of the Products, whether or not considered to be attributable
to the Products, of which it is notified or becomes aware.


 


		17	Product Recall



 


17.1        If
either Party (acting reasonably) determines that any quantity of the Products supplied by it needs to be recalled, it must immediately
give written notice to the other Party (Recall Determination Notice).


 


17.2        Upon
a Recall Determination Notice being given, representatives of each Party must meet (either in person or by teleconference) to determine
whether a Product recall should be implemented and, if so, by which Party the Product recall should be implemented.


 




    	16



    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


17.3        In
the absence of agreement between the Parties concerning the implementation of the Product recall, Parnell will be responsible for
determining the Product recall strategy and Vétoquinol will be responsible for implementing the Product recall in the Territory
and Parnell will be responsible for any necessary negotiations and communications with the VDD or any regulatory authorities.


 


17.4        Each
Party will cooperate with the other (and any wholesalers of Vétoquinol and/or Approved Sub-Distributors) in relation to
the Product recall.


 


17.5        Subject
to Clause 17.6, all direct costs incurred by Vétoquinol in implementing the Product recall in the Territory are to
be borne by Parnell. In addition, Parnell must pay to Vétoquinol subject to the limitation in Clause 29.2 an account
of profit for lost sales attributed to the act or omission of Parnell or its personnel which caused the Product recall by it giving
Vétoquinol a credit for that amount in relation to future supplies of the Products made by Parnell to Vétoquinol.


 


17.6        If
a Product recall is caused by any voluntary act or omission of Vétoquinol or its personnel, Vétoquinol must:


 


(a)          pay
all costs associated with the implementation of the Product recall;


 


(b)          must
reimburse Parnell for all reasonable direct costs incurred by it in managing such Product recall (and implementing it if Vétoquinol
refuses or neglects to do so); and


 


(c)          pay
to Parnell an account of profit for lost sales attributed to the act or omission of Vétoquinol or its personnel which caused
the Product recall subject to the limitation in Clause 29.2.


 


		18	Packaging and Markings



 


18.1        In
this Clause reference to packaging includes the livery or trade dress of the primary and secondary packaging together with
the labeling on the primary and secondary packaging.


 


18.2        Parnell
acknowledges that Vétoquinol trade dress includes:


 


(a)          materials
in which Vétoquinol owns copyright; and


 


(b)          trade
marks owned by Vétoquinol (Vétoquinol Content).


 


Vétoquinol
grants a license to Parnell to reproduce the Vétoquinol Content for the purpose of enabling Parnell to comply with its obligations
under this Clause.


 


18.3        Parnell
will supply the Products:


 


(a)          in
packaging with:


 




    	17



    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


(i)          Vétoquinol’s
trade dress as agreed in writing from time to time between the Parties such agreement not to be unreasonably withheld or delayed;
and


 


(ii)         Parnell’s
trade mark and/or logo as agreed in writing from time to time between the Parties such agreement not to be unreasonably withheld
or delayed; and


 


(b)          with
labeling (on primary and secondary packaging) in accordance with the legislative requirements of the Territory as specified by
Vétoquinol.


 


18.4        Vétoquinol
may request a modification to the packaging of the Products not more than once in each Year.


 


18.5        If
Vétoquinol wishes to request changes to the packaging of the Products in accordance with Clause 18.4, it must give
notice to Parnell in writing and submit details of the proposed modification for Parnell’s approval. Subject to Clause 18.9,
Parnell reserves the right not to implement requested changes to the packaging in the interest of consistent branding for the Products
in other countries.


 


18.6        Once
a modification to the packaging has been approved by Parnell in writing, the modification will be implemented once all existing
packaging materials developed for use in the Territory have been used up.


 


18.7        Vétoquinol
must not alter, obscure, remove, conceal or otherwise interfere with any markings or indications of the source or origin of the
Products placed by Parnell on the original packaging and external makeup of the Products except as may be required by a Government
Agency and with Parnell’s written approval.


 


18.8        Parnell
is responsible for ensuring that the specifications for packaging, labeling and package inserts comply with the requirements of
the Laws of the Territory and the requirements of any Government Agency in the Territory.


 


18.9        Where
packaging has to be modified to meet the requirements of a change in Law in the Territory or a change in the requirements of a
Government Agency in the Territory and Vétoquinol becomes aware of this requirement Vétoquinol must immediately notify
Parnell of the change in requirements in writing.


 


18.10      Parnell
has no obligation to incorporate such modifications until all existing packaging has been utilized unless there is a requirement
by the VDD that the modification to the packaging must be implemented sooner.


 


18.11      In
the case where the changes are only required by Vétoquinol, Parnell will modify the packaging at Vétoquinol’s
cost.


 




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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


		19	Trade Mark



 


19.1        For
the purpose of enabling Vétoquinol to exercise its rights under this Agreement, Parnell grants an exclusive license to Vétoquinol
to use the Trade Mark in the Territory in conjunction with the marketing, distribution and sale of the Products but only in the
manner directed in writing by Parnell.


 


19.2        Without
limiting the generality of Clause 19.1, Vétoquinol must submit marketing materials, on which a Trade Mark appears,
for Parnell’s prior written approval.


 


19.3        A
Trade Mark may only be used in the manner approved.


 


19.4        Vétoquinol
must only use a Trade Mark in accordance with the written instructions given to it by Parnell.


 


19.5        Vétoquinol
must use, in its distribution and sale of the Products, the Trade Mark which relates to the Product.


 


		20	Product Warranties



 


20.1        Parnell
warrants to Vétoquinol that each batch of Products will:


 


(a)          be
free from defects at the time of delivery;


 


(b)         conform
to the Specification for the Products;


 


(c)          be
manufactured in accordance with GMP and all Laws and Registrations; and


 


(d)          not
infringe any Intellectual Property Rights or other rights of any third Party.


 


		21	General Warranties



 


21.1        Parnell
warrants to Vétoquinol that:


 


(a)          Parnell
and each of its Approved Sub-Contractors has, or will have at the relevant time, the resources, capacity, expertise and ability
to supply the Products;


 


(b)          Parnell
has the requisite power and authority to enter into this Agreement to carry out the obligations imposed on it by this Agreement;


 


(c)          the
execution and delivery of this Agreement has been properly authorized;


 


(d)          this
Agreement constitutes a legal, valid and binding obligation on its part;


 


(e)          this
Agreement does not conflict with any provision of its constitution or other constituent document or any Law; and


 




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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


(f)          Parnell
has all licenses, registrations, consents, approvals and permits relevant to the obligations imposed on it by this Agreement;


 


(g)          it
owns, or has the right to use and will at all times own or have the right to use, ail Intellectual Property Rights in the Products;
and


 


(h)          (where
it is not the owner of such Intellectual Property Rights) it has, and will at all relevant times have, full authority to grant
all of the licenses granted by it under this Agreement.


 


(i)           it
shall sell the Products to Vétoquinol free and clear of any liens, claims or encumbrances


 


(j)           Parnell
will comply with the terms of the Manufacturing Quality Agreement specified in Schedule 5 and shall cause its third
Party manufacturer, if any, to comply with the MQA to assure that the Product meets specifications as approved by the VDD or other
regulatory agencies


 


(k)          the
formulation and use of the Product and the processes and methods used to create the Product do not and will not infringe any valid
Canadian patent or any other patent.


 


21.2         Vétoquinol
warrants to Parnell that:


 


(a)          Vétoquinol
has the requisite power and authority to enter into this Agreement to carry out the obligations imposed on it by this Agreement;


 


(b)          the
execution and delivery of this Agreement has been properly authorized;


 


(c)          this
Agreement constitutes a legal, valid and binding obligation on its part;


 


(d)          this
Agreement does not conflict with any provision of its constitution or other constituent document or any Law; and


 


(e)          Vétoquinol
has all licenses, Registrations, consents, approvals and permits relevant to the obligations imposed on it by this Agreement.


 


(f)          Vétoquinol
will comply with the terms of the Manufacturing Quality Agreement specified in Schedule 5


 


		22	Contract Management



 


22.1        Parnell
will nominate a person to act as its contract manager to manage the operation of this Agreement for Parnell and to represent Parnell
(either in person or through his or her delegate) in all day to day dealings with Vétoquinol (Parnell Contract Manager).


 




    	20



    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


22.2        Vétoquinol
will nominate a person to act as its contract manager to manage the operation of this Agreement for Vétoquinol and to represent
Vétoquinol in all day to day dealings with Parnell (Vétoquinol Contract Manager).


 


22.3        The
Vétoquinol Contract Manager will:


 


(a)          be
the single point of contact for Parnell for the purposes of this Agreement;


 


(b)          have
the authority and be given the responsibility to perform for Vétoquinol each of the tasks referred to in this Clause 22;


 


(c)          be
a full time employee of Vétoquinol; and


 


(d)          have
a strong working knowledge of Vétoquinol’s business operations and the Products.


 


22.4        The
Contract Managers will (unless otherwise agreed):


 


(a)          meet
by teleconference at the times agreed by the Parties, but at least every three months during the currency of this Agreement or
on two Business Days notice at the request of either Party if an issue arises in relation to this Agreement;


 


(b)          review
and discuss (at a minimum):


 


(i)          Reports
submitted by Vétoquinol;


 


(ii)         performance
of Vétoquinol as measured against the Marketing Plan; or


 


(c)          at
any time raise any issues of concern or interest relating to this Agreement; and


 


(d)          work
in good faith to resolve any issues of concern, and if they are unable to resolve them refer the matter for resolution in accordance
with Clause 25.


 


		23	Records and Audits



 


23.1        Vétoquinol
agrees to establish and maintain line systems recording transactions and matters relating to:


 


(a)          the
supply of the Products;


 


(b)          its
performance; and


 


(c)          customer
feedback on the Products


 


(Records).


 




    	21



    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


23.2        By
written request of Parnell, which may be done, on 10 Business Days notice, an independent auditor which is accepted by Vétoquinol
as being independent, acceptance not to be unreasonably withheld, may inspect the Records at a mutually agreed time.


 


23.3        Parnell
will use reasonable commercial endeavors to minimize the impact of any such inspection on Vétoquinol’s business. Vétoquinol
will not unreasonably withhold its agreement to the time for an audit.


 


23.4        Parnell
will retain all Records for completed transactions:


 


(a)          for
a period of seven years after the completion of the transactions to which the Records relate unless otherwise agreed between the
Parties; or


 


(b)          until
the termination of this Agreement, whichever is the sooner.


 


23.5        Parnell
must comply with all statutory obligations imposed upon it or Vétoquinol in relation to the retention of the Records and,
to the extent that those obligations are inconsistent with the provisions of this Agreement, it will comply with the statutory
obligations.


 


		24	Confidentiality



 


24.1        Each
Party (Recipient) must keep confidential the other Party’s (Disclosing Party’s) Confidential Information.


 


24.2        A
Recipient may only disclose the Disclosing Party’s Confidential Information, for the purpose of performing its obligations
under this Agreement, to:


 


(a)          officers,
employees, accountants, auditors, legal advisers and other professional advisers (approved by the Disclosing Party to receive Confidential
Information) of the Recipient, or officers and employees any person with whom the Recipient has a confidentiality agreement that
imposes on that person confidentiality obligations no less stringent than those imposed on Recipients under this Agreement, who:


 


(i)          have
a need to know (and only to the extent that each has a need to know); and


 


(ii)         have
been directed and have agreed to keep confidential the Confidential Information on terms consistent with this Agreement; or


 


(b)          the
extent, and to the persons, required by Law or an applicable regulatory body.


 


24.3        A
Recipient must, at its own expense:


 


(a)          ensure,
at all times, that each officer, employee and subcontractor to whom the Disclosing Party’s Confidential Information has been
disclosed under this Clause 24 keeps that information confidential;


 




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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


(b)          establish
and maintain effective security measures to safeguard the Disclosing Party’s Confidential Information from unauthorized access
or use;


 


(c)          keep
the Disclosing Party’s Confidential Information under its control (whether it has physical possession of the Confidential
Information or not);


 


(d)          immediately
take all steps to prevent or stop, and comply with any direction issued by the Disclosing Party from time to time regarding, a
suspected or actual breach; and


 


(e)          immediately
notify the Disclosing Party of any suspected or actual unauthorized use, copying or disclosure of the Disclosing Party’s
Confidential Information.


 


24.4        Parnell
will provide assistance reasonably requested by Vétoquinol in relation to any proceedings that Vétoquinol may take
against any person (other than Parnell) for unauthorized use, copying or disclosure of Vétoquinol’s Confidential Information.


 


24.5        Vétoquinol
will provide assistance reasonably requested by Parnell in relation to any proceedings that Parnell may take against any person
(other than Vétoquinol) for unauthorized use, copying or disclosure of Parnell’s Confidential Information.


 


24.6        Each
Party acknowledges that it is aware that any breach of this Clause 24 may result in damage to the other Party and that each
Party is entitled to enforce its rights by specific performance or injunction proceedings as monetary damages may not be sufficient
relief.


 


24.7        On
termination of this Agreement, each Recipient agrees that:


 


(a)          it
must continue to keep confidential in accordance with this Clause 24 the Disclosing Party’s Confidential
Information; and


 


(b)          its
rights to use and disclose the Disclosing Party’s Confidential Information cease other than in relation to information which
the Recipient is required to disclose in order to comply with any reporting obligations to relevant regulatory bodies.


 


24.8        Neither
Party will make any public statements about the Agreement, the Products or its relationship with the other Party without the other
Party’s prior written approval.


 


24.9        All
references in this Clause to the “Disclosing Party” or the “Disclosing Party’s Confidential Information”
apply to a third Party whose Confidential Information is used in the performance of, or is necessary to the supply of the Products
as if the third Party was a Party to this Agreement.


 


		25	Dispute Resolution



 


25.1        If
a Party considers that a dispute has arisen, it may issue a notice to the other Party, setting out reasonable particulars of the
matter in dispute (a Dispute Notice).


 




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25.2        The
Parties must promptly hold good faith discussions to attempt to resolve the dispute and must (subject to privilege) furnish to
the other Party all information with respect to the dispute which is appropriate in connection with its resolution.


 


25.3        If
the dispute has not been resolved within 15 Business Days, or such longer period as the Parties may agree, this dispute resolution
procedure will be taken to be exhausted by the Parties and either Party may commence court proceedings in relation to a Dispute.


 


25.4        Except
where the dispute renders it impossible to do so, the Parties will continue performing their respective obligations under this
Agreement while a dispute is being resolved, unless and until such obligations are terminated or expire in accordance with this
Agreement.


 


25.5        Each
Party must use its best endeavors to ensure that where a dispute is reasonably foreseeable, it is dealt with at a sufficiently
early stage to ensure that there is a minimum effect on the ability of either Party to perform its obligations under this Agreement.


 


25.6        Despite
anything in this Clause 25, a Party may at any time commence court proceedings in relation to any dispute or claim arising
under or in connection with this Agreement where that Party seeks urgent or interlocutory relief.


 


25.7        Product
Quality Complaints


 


(a)          Any
complaint by Vétoquinol on defects of the Products delivered by Parnell shall be notified in writing by Vétoquinol
to Parnell within twenty (20) days business days from the date of the delivery of the Products in Vétoquinol’s facility
and Vétoquinol shall simultaneously send samples of such defective products to Parnell. In the case Vétoquinol becomes
aware of any defect in the Products which may not have been obvious at the delivery by visual inspection of such products, Vétoquinol
shall notify such defect to Parnell without any delay.


 


(b)          Upon
representative samples of the Defective Product Quantity being delivered to Parnell it will undertake a comprehensive investigation
of the cause of the product quality defect. In the event the defect is due solely to a fault by Parnell, Parnell shall replace
the Defective Product Quantity as soon as practicable and free of charge. Subject to the provisions of this Clause 24, in
the event that Parnell does not find a fault that is due solely to Parnell the product will be deemed to have been delivered and
payable.


 


		26	Force Majeure



 


26.1        If
either Party is prevented from, or impeded in, performing any of its obligations under this Agreement due to a Force Majeure Event,
it must promptly give notice to the other Party specifying:


 


(a)          the
circumstances constituting the Force Majeure Event; and


 


(b)          the
extent and likely duration of those circumstances.


 




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    	CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF THIS DOCUMENT.  EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED WITH AN ASTERISK ***, HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.



    

 


26.2        If
either Party gives a notice under Clause 26.1 that Party’s obligations under this Agreement, will be suspended for as
long as the Force Majeure Event may continue to prevent it from, or impede it in, performing any of its obligations under this
Agreement.


 


26.3        If
there Is a Force Majeure Event, the notifying Party must:


 


(a)          make
every reasonable effort to minimize the effects of the Force Majeure Event;


 


(b)          use
its best efforts to overcome the Force Majeure Event; and


 


(c)          promptly
resume performance of its obligations under this Agreement as soon as reasonably possible after cessation of the Force Majeure
Event.


 


		27	IPR Infringement Indemnity



 


27.1        Parnell
indemnifies Vétoquinol and its respective Personnel (those indemnified) against all Damages that any of those indemnified
may suffer or incur in connection with any Claim that the marketing, sale and distribution of the Products infringes the Intellectual
Property Rights or moral rights of any person (IPR Infringement Claim), and must satisfy any settlement of or judgment given
in any IPR Infringement Claim.


 


27.2        If
a third Party makes an IPR Infringement Claim against Vétoquinol:


 


(a)          Vétoquinol
must promptly notify Parnell; and


 


(b)          Parnell
must ensure that the IPR Infringement Claim is promptly and appropriately defended.


 


27.3        Parnell
will have sole control and conduct of IPR Infringement Claims and any resulting settlement negotiations, unless Vétoquinol
requests, by giving notice to Parnell to defend or settle itself any IPR Infringement Claim, which (in Vétoquinol’s
reasonable opinion) is not being conducted in accordance with Clause  27.2.


 


27.4        On
receiving a request from Vétoquinol under Clause 27.3, Parnell must accept Vétoquinol’s request and provide
all assistance reasonably required by Vétoquinol to defend or settle that IPR Infringement Claim, in which case Vétoquinol
will consult with Parnell during the proceedings and before settling the IPR Infringement Claim.


 


27.5        If
Parnell is defending the IPR Infringement Claim in accordance with Clause  27.2(b):


 


(a)          Vétoquinol
will provide, Parnell promptly with all reasonable assistance Parnell requires in relation to, and in its defense of, the IPR Infringement
Claim; and


 


(b)          Parnell
must not unnecessarily or unreasonably take, or fail to take, any action if to do so would damage the name and reputation of Vétoquinol.


 




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27.6        If
a Product becomes, or in Parnell’s reasonable opinion is likely to become, the subject of an IPR infringement Claim Parnell
is entitled to cease to offer that Product for sale in the Territory and, by notice in writing to Vétoquinol, terminate
Vétoquinol’s right to distribute that Product whereupon that Product will cease to be included in Schedule 1.
Parnell is entitled to exercise its rights under this Clause subject to the damages prescribed in Clause 33.4 payable to Vétoquinol.


 


		28	Indemnities



 


28.1        Each
Party (Indemnifier) indemnifies the other Party, its Personnel, their successors and assigns (Indemnified) but against
any and all Damages that the Indemnified may sustain or incur in connection with any claim made or asserted against them in respect
of the personal injury or death or tangible property damage arising out of or in connection with the use of or administration of
the Products.


 


28.2        The
amounts referred to in Clause 28.1 are not payable to the extent they are due to the negligence, breach of contract, fraud
or willful misconduct of the Indemnified.


 


		29	Limitation of Liability



 


29.1        Other
than as specified in this Agreement and to the fullest extent permitted by law all implied conditions and warranties are, by the
operation of this Clause, excluded.


 


29.2        The
liability of either Party for breach of this Agreement or in tort, or for any other common law or statutory cause of action arising
out of the operation of this Agreement (including an indemnity), will be limited (subject to Clauses 29.3 and 29.4,
in aggregate, to $200,000.


 


29.3        For
the avoidance of doubt, but subject to Clause 29.1, the limitations and exclusions in Clause 29.2 do not apply to loss
incurred by either Party in respect of:


 


(a)          breach
of confidence;


 


(b)          liability
for personal injury or property damage;


 


(c)          liability
under the IP indemnity;


 


(d)          fraud
by either Party Parnell or either Party’s Personnel; or


 


(e)          unlawful
or willful acts and omissions.


 


29.4        Without
limiting any of their respective obligations under this Agreement each Party must mitigate losses suffered under this Agreement.


 


		30	Insurances



 


30.1        Each
Party (an Insuring Party) must take out and maintain during the currency of the Agreement a comprehensive product liability
insurance policy to cover all sums which may become legally liable to pay consequent upon:


 




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(a)          the
death of or bodily injury (including disease or illness) to any natural person or animal; and


 


(b)          loss
of, or damage to, real or personal property (including the loss of use thereof), in connection with supply of the Products.


 


30.2        Each
Insuring Party must ensure that:


 


(a)          the
insurance policy taken out in accordance with Clause 30.1 will be effected with a reputable insurance company;


 


(b)          the
products liability cover referred to in Clause 30.1 is for a minimum cover of $ 10 million for each claim and in the aggregate;


 


(c)          the
insurance policy taken out in accordance with Clause 30.1 cannot be amended or cancelled without written notice being given
to the other Party;


 


(d)          the
insurance policy taken out in accordance with Clause 30.1 will comply with the laws of all the jurisdictions in which
Parnell will be performing its obligations under this Agreement;


 


30.3        Each
Insuring Party must comply with all of the terms and conditions of any insurance policy taken out under this Clause.


 


30.4        Each
Insuring Party must, within 20 business days of the Commencement Date and on request being made by the other Party, promptly provide
to the other Party copies of certificates or other evidence of currency for insurance policies effected in accordance with this
Clause 30.


 


		31	Notices



 


31.1        A
Party giving notice or notifying under this Agreement must do so in writing:


 


(a)          directed
to the recipient’s address specified in this Clause, as varied by any notice; and


 


(b)          hand
delivered or sent by prepaid post or sent by facsimile or sent by email to that address.


 


31.2        The
Parties’ addresses, facsimile numbers and email addresses are:


 


Parnell: 


 


North America (Aust) Pty Ltd


 


Vétoquinol: 


 


Vétoquinol SA 


 






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31.3        A
notice given in accordance with Clause 31.1 is taken to be received: 


 


(a)          if
hand delivered, on delivery;


 


(b)          if
sent by prepaid post, five Business Days after the date of posting; or


 


(c)          if
sent by facsimile, when the sender’s facsimile system generates a message confirming successful transmission of the total
number of pages of the notice unless, within one Business Day after that transmission, the recipient informs the sender that it
has not received the entire notice; or


 


(d)          if
sent by email, one Business Day after the time of dispatch if receipt is confirmed by the recipient within one Business Day after
the time of dispatch.


 


31.4        Where
a Party’s postal address, email address or facsimile number changes from that noted above, that Party will provide a written
notice to the other Party notifying it of such change.


 


		32	Termination



 


32.1        In
addition to any other entitlement it has to terminate this Agreement in accordance with its terms, Parnell may, by written notice
to Vétoquinol, terminate this Agreement if:


 


(a)          Vétoquinol
materially breaches this Agreement and the breach cannot be, or is not, rectified within ***after a notice from Parnell specifying
the breach;


 


(b)          an
Insolvency Event occurs in relation to Vétoquinol; or


 


(c)          any
other event specified in this Agreement as giving rise to a right for Parnell to terminate occurs,


 


which notice will take
effect on the day on which it is given.


 


32.2        In
addition to any other entitlement it has to terminate this Agreement in accordance with its terms, Vétoquinol may, by notice
to Parnell, terminate this Agreement:


 


(a)          if
Parnell materially breaches this Agreement and the breach cannot be, or is not, rectified within ***after a notice from Vétoquinol
specifying the breach subject to the damages prescribed in 33.4 payable to Vétoquinol.; or


 


(b)          if
an Insolvency Event occurs in relation to Parnell, or


 


(c)          any
other event specified in this Agreement as giving rise to a right for Vétoquinol to terminate occurs, which in certain cases
is also subject to the damages prescribed in 14.3 and 33.4 payable to Vétoquinol.


 


(d)          in
the case Parnell cannot supply Product on conditions given in Clause 6.2 and except if due to Force Majeure, Vétoquinol
shall be entitled to terminate this Agreement and shall be able to claim damages as prescribed in Article 33.4.


 




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which notice will take
effect on the day on which it is given.


 


32.3        If
as a result of any merger or acquisition or business reconstruction undertaken by Parnell (whether as a buyer or a seller) Parnell
(or its successor or assign) determines that it wishes to have the right to market, sell and distribute the Products in the Territory
then upon written notice of agreement by Vétoquinol, Parnell (or its successor or assign) may terminate this Agreement by
giving 12 months notice in writing to Vétoquinol which notice may be given at any time after the Commencement Date.


 


		33	After Termination



 


33.1        After
notice of termination is given:


 


(a)          ***
any ***and ***for the ***; and


 


(b)          ***to
***of the Products which it ***provided that ***of the Products ***. If *** this ***then the ***for the ***will be the ***that
***any *** for ***. In the event of ***that are *** not *** in the ***.


 


(c)          Any
sums owing from Parnell to Vétoquinol shall be paid


 


33.2        After
notice of termination is given, ***whether or not *** of Products which are the *** to the ***. *** will ***of its *** of the ***.
If *** that it will *** then *** and ***in respect ***will be ***.


 


33.3        Termination
of this Agreement in its entirety (or as it relates to the Products) will not affect any accrued rights of either Party.


 


33.4        If
the Agreement *** of its *** or if the *** with *** and in particular *** of the *** as described in *** to ***as agreed


 


(a)          ***(i)
up to the month which is *** and (ii) ***up to the month which is ***.


 


		34	Miscellaneous



 


34.1        This
Agreement (including its Schedules):


 


(a)          constitutes
the entire agreement between the Parties as to its subject matter; and


 


(b)          in
relation to that subject matter, supersedes any prior understanding or agreement between the Parties and any prior condition, warranty,
indemnity or representation imposed, given or made by a Party.


 


34.2        Each
Party must use reasonable efforts to do all things necessary or desirable to give full effect to this Agreement.


 




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34.3        The
failure of a Party at any time to require performance of any obligation under this Agreement is not a waiver of and is without
prejudice to that Party’s right:


 


(a)          to
exercise any right that Party may have under this Agreement or otherwise in relation to the other Party’s acts or omissions;


 


(b)          to
claim Damages for breach of that obligation; and


 


(c)          at
any other time to require performance of that or any other obligation under this Agreement,


 


unless written notice
to that effect is given in accordance with Clause 31.


 


34.4        Waiver
of any provision of or right under this Agreement:


 


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


 


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


 


34.5        Except
as expressly provided otherwise in this Agreement, a right, power, remedy, entitlement or privilege given or granted to a Party
under this Agreement is cumulative with, without prejudice to and not exclusive of any other right, power, remedy, entitlement
or privilege granted or given under this Agreement or by Law.


 


34.6        A
Party will not be liable to the other Party for any damages to the extent that the breach giving rise to the damages was caused
by the other Party’s failure to perform its obligations under this Agreement, including a failure resulting from the other
Party’s negligence or breach of this Agreement.


 


34.7        Nothing
in this Agreement, or any circumstances associated with it or its performance, give rise to any relationship of partnership or
employer and employee, joint venture or fiduciary duty between Vétoquinol and Parnell.


 


34.8        Part
or all of any provision of this Agreement that is illegal or unenforceable may be severed from this Agreement and the remaining
provisions of this Agreement continue in force.


 


34.9        Clauses 15, 24, 25, 26, 27, 28, 29, 31, 33 and 34
will survive the expiration or earlier termination of this Agreement.


 


34.10      This
Agreement is governed by the law applicable in New South Wales. Each Party irrevocably and unconditionally submits to the jurisdiction
of the courts exercising jurisdiction in that State.


 


34.11      The
Parties agree that good faith and fair dealing shall be applied throughout this agreement


 


[Schedules commence next page]


 




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SCHEDULE 1

[Products and Price]


 


	Product	***	***
	
        Estroplan 

        20ml vial
	***	***
	
        Estroplan 

        100mL Glass vial
	***	***



 



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SCHEDULE 2


 


***


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


 


***


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


 


***




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SCHEDULE 3



[Product Trade Marks]


 





	Product	 	Trademark
	 	 	 
	Estroplan 20mL	 	Estroplan
	 	 	 
	Estroplan 100mL	 	Estroplan







 




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SCHEDULE 4



[Product Specifications]


 


	Product Name:	ESTROPLAN INJECTION
	 	 
	TEST	LIMIT/SPECIFICATION
	***	***
	***	***
	***	***
	***	***
	***	***
	***	***
	***	***
	***	***
	***	***




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DISTRIBUTION AND SUPPLY AGREEMENT 


   


SCHEDULE 5



[Manufacturing Quality Agreement (“MQA”)]


 


		1.	Purpose



 


This agreement outlines
operational responsibilities of Vétoquinol, Parnell, and Hospira, with respect to product(s) listed in Annex 3 that
are supplied to Vétoquinol by Parnell, but are manufactured by Hospira. Vétoquinol acts as the importer and the
distributer of the products in Canada since the products are owned by Parnell. Hospira will be responsible for the manufacturing,
packaging, and labeling of the products listed in Schedule 1, in accordance with Parnell’s specifications and in compliance
with current Good Manufacturing Practices. If there is any inconsistency between the terms and conditions of this MQA and the
Quality Assurance Agreement dated 27 June 2009 between Parnell and Hospira, the terms of the Quality Assurance Agreement
between Parnell and Hospira will prevail to the extent of such inconsistency.


 


A matrix of responsibilities
included at the end of this document identifies the parties primarily responsibilities for the various aspects of this MQA.


 


		2.	MQA Specific Information



 


This MQA commences
with the effective date of signature and will be valid for a period of five (5) years from that date. The agreement may be reviewed
and modified as needed with the consent of both parties.


 


It is the responsibility
of all parties to maintain this document in a current state and to ensure that required approvals have been given. Any request
for modification to this document must be made in writing to the other parties stating the reason for the modification. All parties,
prior to implementation of modifications, must agree to all modifications to this document.


 


Modifications to this
MQA must be presented as a revision to the original MQA and reviewed and approved by all parties.


 


Annex 1 is a
detailed listing of all activities covered by this MQA, conducted or to be conducted by Vétoquinol, Parnell, and Hospira.


 


Modification of Annex 1
or Annex 2 can be made and approved separately, but in all cases, new approval will be automatically linked to the current
approved MQA.


 


		3.	Communication



 


Parnell, Hospira and
Vétoquinol have identified key contact personnel and designates for critical quality processes to ensure that responsible
individuals are contacted for issue resolution. Annex 2 is a listing of all key contact titles and designates for each party.
Changes to key personnel or their designates must be confirmed in writing and Annex 2 revised as necessary.


 




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Vétoquinol
may, upon notice to Parnell, designate an employee of any of its affiliates to act as a contact person with regard to the responsibilities
and obligations of Vétoquinol hereunder or to fulfill the duties or exercise the rights of Vétoquinol set out herein.


 


		4.	Abbreviations and Definitions of Terms






		4.1.	Abbreviations



 


		4.1.1.	Annual Product Review: APR



		4.1.2.	Certificate of Analysis: CoA



		4.1.3.	Batch Certificate: BC



		4.1.4.	Current Good Manufacturing Practices: cGMP’s



		4.1.5.	Current Good Laboratory Practices: cGLP’s



 


		4.2.	Definitions of Terms



 


		4.2.1.	Master formula



 


A document
or set of documents specifying the raw materials with their quantities and the packaging materials, together with a detailed description
of the procedures and precautions required to produce a specified quantity of a finished product as well as the processing instructions,
including the in-process controls.


 


		4.2.2.	Batch Record



 


Batch record
consists of a manufacturing document, packaging document, labeling document, and exception documentation, such as non-conformance
material report (“Deviation”), certificate of analysis, and additional documentation, which may have been processed
as part of the production/packaging record of the batch.


 


		4.2.3.	cGMP or current Good Manufacturing Practices



 


Shall mean
good manufacturing practice requirements under applicable laws, guidelines, policies, codes, requirements and standards from time
to time promulgated by relevant regulatory authority.


 


		4.2.4.	Contractor



 


Any Contractor,
packager, or other Product support services who performs processing, packaging, and/or testing of a Product or any intermediate
step of manufacture, or other Product support service, is a contractor.


 


		4.2.5.	Deviation report



 


Report used
to obtain approvals to temporarily modify or to document excursions from operating, manufacturing, packaging, testing instructions,
test results, or procedures. The Deviation does not permanently change existing instructions/SOP or procedures; it is intended
to be a specific/one time or period of time use document.


 




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		4.2.6.	Lot Number



 


Lot number
is used to identify a specific lot or batch of manufactured or packaged material. Each manufacturing and packaging run conducted
for a Product by Hospira will have its own specific lot number issued by Hospira.


 


		4.2.7.	Material



 


All drug
substances, excipients, printed or unprinted components, which are used during the manufacturing or packaging process for a Product.


 


		4.2.8.	Reinspection



 


Visual or
mechanical evaluation performed to remove/correct defective units and for which the process is not expected to have an adverse
effect on Product quality. Reinspection should involve the use of a Deviation, except where standard procedure allows for such
routine activity in the course of normal processing.


 


		4.2.9.	Reprocessing



 


Subjecting
all or part of a lot of a Bulk Product, Semi-Finished Product or Product to a previous step in the validated manufacturing process
due to failure to meet predetermined specifications.


 


		4.2.10.	Rework



 


Subjecting
Bulk Product, Semi-Finished Product or Product of a single lot to an alternate manufacturing process due to the failure to meet
predetermined specifications.


 


		4.2.11.	Non-Conformance



 


Status of
a Drug product, Excipient, Semi-finished or Finished product, Printed or Non-printed material that is found not meeting its pre-established
specifications following physical examination or review of analytical results, therefore impacting on the identity, strength,
quality and purity of the Drug product, Excipient, Semi-finished or Finished product, Printed or Non-printed material.


 


		4.2.12.	Bulk Product



 


Any product
listed in Schedule 1 hereto, which has completed all manufacturing stages up to, but not including, packaging in a primary container.


 


		4.2.13.	Semi-Finished Product



 


Any product
listed in Schedule 1 hereto, which has completed all processing stages up to, but not including, final packaging.


 



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		4.2.14.	Product



  


Any product
listed in Schedule 1 hereto, which has completed all processing stages up to final packaging.


 


		5.	Supplier and Manufacturer Facilities






		5.1.	Parnell facility is currently located at:



 


Parnell North America Pty. Ltd.


Unit 4


Century Estate


476 Gardeners Road


Alexandria NSW 2015, Australia


  


		5.2.	Hospira facility is currently located at:



 


Hospira Australia PTY Ltd


1 Lexia Place,


Mulgrave, VIC 3170, Australia


 


Hospira will hold
a current license to manufacture. Hospira agrees to maintain their license to manufacture throughout the term of this MQA, as
per the local laws and regulations. Also, Vétoquinol is notified in writing of any sub-contractor involved in the manufacturing
of the products manufactured for Parnell since these must also appear on Vétoquinol’s Canadian Establishment Licence.


 


		6.	Change Control



 


Hospira shall maintain
a documented system of procedures for controlling changes, which may affect the Products, including, but not limited to, changes
to Materials, Bulk Product, Semi-finish Product, Product, and Manufacturing / Packaging / Labeling operations. When Vétoquinol
initiates a request for change on any applicable specifications, the appropriate Parnell department shall be provided with the
proposed specifications and appropriate documentation, which summarizes and justifies each change.


 


		7.	Master Processing Documentation



 


Master processing
document includes specifications for raw material, packaging material and master formula for packaged dosage form.


 


Changes to these documents
are subject to the change control policy described in section 6. After any change, a copy of the revised document will be placed
in the master documentation.


 


		7.1.	Master Manufacturing Document



 


The Master
Manufacturing Document specifies the manufacturing process and Materials used to manufacture a specific Bulk Product. Parnell,
with the assistance of Hospira, has the responsibility to assure that those documents are consistent with the Product Marketing
Authorization. The Master Manufacturing Document will be developed by Hospira. Original Master Manufacturing Documents will be
maintained on-site by Hospira. Hospira shall provide copies of initial and all revised Master Manufacturing Documents to Parnell
and Vétoquinol on a timely basis. Vétoquinol will retain a copy of the Original Master Manufacturing Document in
its file.


 




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		7.2.	Master Packaging Document (including labeling)



 


The Master
Packaging Document specifies the packaging process and packaging materials used to package Product. Parnell, with the assistance
of Hospira, has the responsibility to assure that those documents are consistent with the Product Marketing Authorization. The
Master Packaging Document will be developed by Hospira. Regarding the Master Labeling Document, they will be developed by Hospira,
but must be revised/approved by Parnell and Vétoquinol prior to its use. Original Master Packaging Documents will be maintained
on-site by Hospira. Hospira shall provide copies of original and all revised master packaging documents to Parnell and Vétoquinol
on a timely basis. Vétoquinol will retain a copy of the Original Master Packaging Document in its file.


 


		8.	Material Sourcing



 


All Materials used
to manufacture and/or package a Product should be sourced as per this agreement unless otherwise specified in writing and with
the agreement of Parnell, Hospira and Vétoquinol (if needed).


 


		8.1.	Drug Substance



 


Hospira
will utilize only drug substances meeting specifications described on the Master Manufacturing document and sourced from approved
suppliers.


 


		8.2.	Excipients



 


Hospira
will utilize only excipients as defined in the Master Manufacturing Document. Excipients will either comply with the most recent
Pharmacopoeia monograph or Parnell specifications when such an excipients is not included in a Pharmacopoeia monograph. Hospira
will source excipients from approved supplier.


 


		8.3.	Packaging Material (Unprinted)



 


Hospira
will utilize only unprinted packaging material in direct contact with the product as defined in the Master Packaging Document.
Packaging material will be ordered from supplier previously approved by Hospira. Any proposed change in the sourcing of the packaging
material in direct contact with product will be discussed with and approved by Parnell and Vétoquinol prior to its
implementation.


 


		8.4.	Packaging Material (Printed)



 


Hospira
will utilize only printed packaging material meeting Parnell and Vétoquinol specifications and sourced from Hospira approved
suppliers. Hospira will supply Parnell and Vétoquinol with a controlled copy of their specifications for review and approval.
Parnell and Vétoquinol will be responsible for approvals of any new printed material including any modifications (new version)
and reprint.


 




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		9.	Testing



 


Analytical specifications
used for Drug Substances and Products are developed and maintained by Parnell and Hospira. Hospira will ensure that products will
be sampled and tested according to approved testing procedures.


 


Hospira will be responsible
for the analysis of raw materials, packaging articles, and finished products.


 


		10.	Printed Packaging Material Control



 


Hospira shall maintain
a formal system for Printed Packaging Material control which shall ensure that only those labels, graphics, printed matter and
other packaging Materials which have been approved and/or provided by Parnell and Vétoquinol shall be used. Hospira’s
Printed Packaging Material control system shall include, but shall not be limited to: (i) secure storage of all packaging Materials;
(ii) accountability records; and (iii) packaging line clearance of labeling. Hospira shall ensure that a sample of all printed
packaging material used in respect of a Product shall be included in the batch/packaging record for the Product.


 


Hospira shall sample,
examine and approve all Printed Packaging Materials prior to use. Parnell and Vétoquinol shall provide, in writing, approved
proof copy for all Printed Packaging Materials used by Hospira. Any proposed change to the Printed Packaging Material specification
will be communicated to Parnell and Vétoquinol for approval prior to its implementation.


 


		11.	Bulk Product Packaging



 


The packaging of Bulk
Product(s) will be done at the Hospira facility according to the specific procedures and instructions described in the Master
Packaging Document.


 


The packaging of Bulk
Product(s) by Hospira must be in accordance to Hospira specifications and in compliance with all cGMP’s and any other applicable
regulatory requirements and applicable laws and regulations. Hospira will prepare complete and detailed documentation, for each
lot. This complete documentation must be readily accessible for review and inspection by Parnell, Vétoquinol and/or regulatory
authorities if requested.


 


		12.	Inspection of the Product(s)



 


The inspection of
the Product(s) carried out by Hospira is appropriately documented in detail.


 


Vétoquinol
reserves the right to inspect and/or test all batches of the subject Product(s) produced by Hospira, prior to release and distribution
by Parnell.


 




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		13.	Initial Product release and Shipment



 


Approval of the initial
release, which is defined as the release by Parnell to Vétoquinol, is under the responsibility of Parnell. In that regard,
Parnell shall ensure that shipped products comply with the Master Manufacturing and/or Packaging Document and are produced in
compliance with applicable cGMP’s prior to initial release.


 


Parnell will proceed
with the initial Product release to Vétoquinol upon satisfactory review and approval by Parnell QA unit of the following:


 


a)           A
CoA for the relevant lot of product will be sent by Parnell immediately after it is available, to Vétoquinol.


 


b)          Exception
documentation, such as, but not limited to, non-conformance material report, Deviation, certificate of analysis, and additional
documentation, which may have been processed as part of the Production/packaging record of the batch.


 


c)           For
each lot manufactured, Parnell will provide in writing to Vétoquinol a Batch Certificate (BC) confirming the initial release
of the Product along with copies of documents stated in articles 14 b) if exist.


 


The BC must
include the following:


 


Be printed
on a letterhead of the exporter.


 


Name
of the product.


 


Importing
country.


 


Marketing
authorization number for the product in Canada. This is the DIN number of the product. This information will be supplied by
Vétoquinol.


 


Product
Strength/Potency: Identity (name) and amount per unit dose are required for all active ingredients.


 


Dosage
form: pharmaceutical form.


 


Package
size: (contents of containers) and type (e.g., vials, bottles, blisters)


 


Lot
number.


 


Date
of fabrication/manufacture.


 


Expiry
date.


 


Name
and address of fabricator(s)/manufacturer(s) - manufacturing recognized building(s): All recognized buildings involved in
the manufacture of the batch including packaging and quality control of the batch, should be listed. The name(s) and address(es)
given must correspond to the information provided on the manufacturing authorization/establishment license.


 




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Number(s)
of manufacturing authorization(s)/license(s) or certificate(s) of GMP compliance held by fabricator(s)/manufacturer(s): A
number should be given for each recognized building listed in the previous item.


 


Result
of analysis: Should include the approved specifications, describe all results obtained, and refer to the analytical methods
used (May refer to a separate certificate of analysis, which must be dated, signed, and attached).


 


Comments/remarks:
Any additional information that might be of value to the importer and/or inspector who must verify the compliance of the batch
certificate (e.g., specific storage or transportation conditions).


 


Certification
statement: Should cover the fabrication/manufacturing, including packaging and quality control. The following text should
be used: “I hereby certify that the above information is authentic and accurate. This batch of product has been manufactured
using Master Manufacturing Document number XX version YY, has been packaged using Master Packaging Document number XX version
YY and quality controlled, at the above- mentioned recognized building(s) in full compliance with the GMP requirements of the
local regulatory authority and with the specifications in the marketing authorization of the importing country. The batch processing,
packaging, and analysis records were reviewed and found to be in compliance with GMP”.


 


Name
and position/title of person approving the batch release: Must include the person’s company/recognized building name
and address, if more than one company is mentioned under Item 10.


 


Signature
of person approving the batch release.


 


Date
of signature.


 


		14.	Final Product Release



 


Approval of the final
release and shipment of Product, which is defined as the release to the marketplace, is under the responsibility of Vétoquinol.


 


Vétoquinol
will analyze and/or positively identify all batches of product supplied by Parnell through a physical inspection of the product
and the labeling. The labeling will be checked to see if it is current, and products will also be inspected for defects or damage.


 


Based on the analysis
and/or the positive identification, inspection and verification of the documentation package provided by Parnell, Vétoquinol
will undertake release of the product to the market.


 




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		15.	Notification and Approval of Deviations and Non-Conformances






		15.1.	Deviations



 


Hospira
shall have a written procedure in place for performing a systematic investigation for causes in the event that (i) any Product
or process fails to meet Specifications or (ii) any process Deviation occurs in respect of any Product.


 


Hospira
shall not void an Out of Specification (OOS) results by retesting unless the investigation determines that laboratory error caused
the OOS results. All OOS data and investigation results, whether or not the OOS results are voided by Hospira, shall be retained
by Hospira. Summaries of OOS investigation report will be sent to Vétoquinol as part of the BC. All deviations will be
fully investigated and fully documented by Hospira.


 


		15.2.	Non-Conformance



 


Material
or Products not meeting established specifications are to be handled as non-conformances and documented as such, based on Hospira
standard operating procedures. Actions taken to investigate the non-conformance and to justify the release of the lot of material
must be fully documented.


 


Parnell,
Hospira and Vétoquinol will approve the non-conformance document as stated below prior to initial release. Any resulting
corrective actions shall be followed through timely closure. Approval by the appropriate quality assurance functions are solicited
and obtained via facsimile copy or by any appropriate electronic means (ex: PDF format).


 


	Non-conformance	 	Approval Requirements
	Drug substance	 	Parnell and Hospira
	Excipient	 	Hospira
	Bulk Product, Semi-Finished 

    Product, Finished Product	 	Parnell and Hospira
	Unprinted Packaging Materials 

    sourced by Hospira	 	Hospira
	Printed Packaging Materials	 	Parnell, Vétoquinol, and Hospira


 


		16.	Retained Samples






		16.1.	Retained Samples of Materials



 


Hospira
shall retain samples from each incoming lot of Material (excepting unprinted and printed packaging materials) in an amount sufficient
to comply with any specific regulatory requirements applicable to each Product and, in any case, sufficient to permit the performance
of at least two (2) full rounds of release testing, not including microbiological testing. Hospira shall hold and retain such
samples for a minimum of one (1) year following the expiration of the last lot of finished Product containing said Material. At
the request of Vétoquinol, acting reasonably, Hospira shall provide such samples to Vétoquinol. Hospira agrees to
store the retained samples under appropriate Product label storage conditions and in a secure area for a period of time as defined
in this MQA.


 




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		16.2.	Retained Samples of Products



 


Hospira
and Vétoquinol shall both sample each lot of Product to comply with any specific regulatory requirements and in an amount
sufficient to permit the performance of at least two (2) full rounds of release testing, not including microbiological testing.


 


		17.	Storage and transportation of Products / Environmental
Monitoring



 


Hospira agrees to
store the Bulk Product, Semi-Finished Product, and/or Finished Product(s) under appropriate Product label storage conditions and
in a secure area, to ensure they comply with all the quality specifications and attributes and all applicable laws and regulations.
If special storage conditions are known to be necessary by one party, they will be noted and supplied in writing to the other
party. Parnell agrees to ship the Finished Products to Vétoquinol in the appropriate Product label storage conditions (controlled
conditions). Either Vétoquinol will send Parnell data loggers prior to the shipment or Parnell will provide to Vétoquinol
proof of the respect of the Product label storage conditions during the shipping process.


 


		18.	Stability Activities



 


The responsibility
for ongoing stability testing (according to ICH) lies with and data interpretation lies with Parnell. Since the stability testing
is done on an ongoing basis by Parnell, Vétoquinol may periodically ask for stability data from Parnell.


 


		19.	Annual Product Review (APR)



 


The Annual Product
Review (APR) will be prepared and reviewed by Vétoquinol according to Vétoquinol policies and procedures. Parnell
shall fully cooperate with Vétoquinol in the preparation of APR for each Product. Parnell must forward a copy of the information
requested by Vétoquinol for APR purposes to Vétoquinol in a timely manner.


 


		20.	Product Complaints



 


Parnell and Vétoquinol
are responsible for investigating any adverse event or Product- related complaint as reported following use on the Canadian market
and for determining if, when and to what extent such adverse event or Product-related complaint shall be reported to a governmental
or regulatory authority. Hospira will assist in investigating Product-related complaints and/or adverse event at the request of
Parnell and Vétoquinol and provide a written report on the results of the investigation to Parnell in a timely manner agreed
to by the parties, depending on the urgency of the situation. Hospira shall assist Parnell and Vétoquinol including, but
not limited to, reviewing and testing as necessary product samples (including as necessary retention and complaint samples) and
reviewing Product batch manufacturing and analytical records. Vétoquinol will communicate with the customers and/or regulatory
authorities the results of the complaint investigation, if necessary.


  




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		21.	Returned Goods



  


The specific handling
of returned Product after distribution to the Canadian market will be under the responsibility of Vétoquinol, unless a
product recall was initiated at the request of or in conjunction with Parnell.


 


		22.	Recall of the Marketed Products



 


Parnell and Vétoquinol
shall be responsible for determining whether and when to recall any Product lot and for all matters relating to the implementation
of the recall. At the request of Parnell and Vétoquinol, Hospira shall provide reasonable assistance and co-operation with
any recall decisions.


 


In the event of recall
or withdrawal of finished product or raw materials - if such product or raw material violates applicable laws, regulations, agreed
upon specifications, or are deemed unacceptable for some other reason, whether or not such action is requested by any governmental
agency - Hospira shall immediately notify Parnell and Vétoquinol in writing. During a Product recall, or withdrawal Hospira
shall fully cooperate with Parnell and Vétoquinol in conducting the necessary investigational activities.


 


In the event of a
recall, Vétoquinol shall provide copies of all communications to Health Canada to Hospira.


 


		23.	Audits and Inspections of Facilities and Products



 


Vétoquinol
reserves the right to audit Hospira’s facilities and systems, as they relate to the packaging and control of Product(s),
with the exception of information and operations which constitute Hospira’s trade secrets.


 


For such permitted
audits (unrelated to product quality and safety problems as provided in paragraph below), Vétoquinol shall provide a minimum
of sixty (60) calendar days notification, with actual audit dates subject to mutual agreement with Parnell and Hospira based on
the availability of Parnell and Hospira Quality personnel and prior audit commitments. During any such audit, Vétoquinol
may inspect any of the documents that Hospira is obliged to maintain under this Agreement. Such audits will be restricted to no
more than 2 auditors over two (2) business days in any twelve (12) month period.


 


Product Quality or
Safety Audits: In the event of significant product quality or safety problems associated with product manufacture, Parnell will
arrange with Hospira to allow Vétoquinol to conduct audits to address such product quality or safety problems. Such audits
shall be scheduled promptly after notice to Parnell from Vétoquinol following a quality or safety occurrence, but in any
event not longer that the audit period required for regulatory compliance.


 


Prior approval by
Hospira and confidentiality agreements are required to be established with any third party conducting audits of Hospira facilities
and systems, on behalf of Vétoquinol or Parnell.


 




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In association with
Parnell, Vétoquinol reserves the right to be on-site at Hospira during the manufacturing and/or packaging of Product(s),
and/or during the inspection of Bulk Product, Semi-Finished Product, and/or Product(s) by any regulatory agencies. Hospira shall
respond to, and forward all responses to observations, generated during an inspection, within thirty (30) days from their issuance.


 


		24.	Reprocessing and Rework



 


Reprocessing and rework
should always be considered a significant deviation. Those activities can only be performed per agreement between both Hospira
and Parnell. Reprocessing and/or rework of Material or Bulk Product, Semi-Finished Product, or Finished Products must be documented
to state reason and justification for reprocessing and/or rework. This documentation will be retained as part of the batch documentation
for the lot affected. Parnell will inform Vétoquinol of any rework and/or reprocessing activities on the lots supplied.


 


		25.	Validation



 


Hospira will be responsible
for validation activities, which include cleaning, equipment, facility, processes and analytical methods, in accordance with cGMP
and in compliance with applicable regulations. All Parties shall cooperate to transfer validated methods to Vétoquinol,
if needed or requested by Parnell and Vétoquinol. All validation shall be properly documented. Vétoquinol or Parnell
may review executed validation documents when auditing Hospira site of manufacture. Parnell and Hospira shall inform Vétoquinol
when an analytical method is significantly modified.


 


		26.	Training



 


Hospira shall ensure
that its staff, employees and other personnel (i) are familiar with applicable cGMP and (ii) receive initial and ongoing cGMP
and other training relevant and specific to their job responsibilities.


 


Qualified personnel
in accordance with a written program shall conduct all training. Hospira shall retain all training records and shall periodically
assess the effectiveness of its ongoing training program.


 


		27.	Documents retention



 


Hospira shall retain
all documents, records and reports associated with the Manufacturing of any and all Product lots, including any and all investigation
reports related thereto, for at least one (1) year following the Expiration Date for each such finished Product lots, or as mutually
agree with Parnell and Vétoquinol. All such documents, records and reports shall be stored and maintained by Hospira in
such a manner that they are (i) readily retrievable and (ii) protected from damage or loss. Hospira shall notify Vétoquinol
or Parnell prior to the destruction of all such documents, records and reports relating to Product.


 




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Annex 1: Distribution of Responsibility
Matrix


 


Manufacturing Quality Agreement 


 


	Section Name	 	Responsible Parties
	 	 	Vétoquinol	 	Parnell	 	Hospira
	MQA Specific Information	 	X	 	X	 	 
	Communication	 	X	 	X	 	X
	Supplier facilities (section 6)	 	 	 	 	 	 
	■    Bulk Products, Semi-Finished
    Product, and Product – Sub-contractor selection	 	 	 	 	 	X
	Change Control (7)	 	 	 	 	 	X
	Master Manufacturing Document (8.1)	 	 	 	 	 	 
	■    Regulatory compliance	 	 	 	X	 	X
	■    Development	 	 	 	 	 	X
	■    Review & Approval	 	 	 	 	 	X
	Master Packaging Document (including labeling) (8.2)	 	 	 	 	 	 
	■    Regulatory compliance	 	 	 	X	 	X
	■    Development	 	 	 	 	 	X
	■    Review & Approval	 	X	 	X	 	X
	Material sourcing (9)	 	 	 	 	 	 
	■    Drug substance	 	 	 	 	 	X
	■    Excipients	 	 	 	 	 	X
	■    Packaging material (unprinted)	 	 	 	X	 	X
	■    Packaging material (printed)	 	 	 	X	 	X
	Testing (10)	 	 	 	 	 	 
	■    Analytical specification development
    & approval (CoA)	 	 	 	 	 	X
	■    Product sampling for testing	 	 	 	 	 	X
	■    Analysis of Raw Materials	 	 	 	 	 	X
	■    Analysis of Packaging articles	 	 	 	 	 	X
	■    Analysis if Finished Products	 	 	 	 	 	X
	Printed Packaging Material Control (11)	 	 	 	 	 	 
	■    Label control system	 	 	 	 	 	X
	■    Specifications	 	X	 	X	 	X
	Bulk Product Packaging (12)	 	 	 	 	 	 
	■    Executed packaging document
    preparation	 	 	 	 	 	X
	■    Packaging operation	 	 	 	 	 	X
	Inspection of the Product(s) (13)	 	 	 	 	 	X
	Initial Product Release (14)	 	 	 	 	 	 
	■    Initial release (for shipment)
    and supply of release documents	 	 	 	X	 	X
	Final release to market (15)	 	X	 	 	 	 
	Notification and Approval of Deviations and Non-Conformances (16)	 	 	 	 	 	 
	■    Deviations notification/investigation
    (including OOS results)	 	 	 	 	 	X
	■    Deviations approval (including
    OOS results)	 	 	 	 	 	X
	■    Non-conformances approval -
    Drug substance	 	 	 	X	 	X
	■    Non-conformance approval - Excipient	 	 	 	 	 	X


 




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	Section Name	 	Responsible Parties
	 	 	Vétoquinol	 	Parnell	 	Hospira
	■    Non-conformance approval - Bulk
    Product, semi-Finished Product, Finished Product	 	 	 	X	 	X
	■    Non-conformance approval - Unprinted
    Packaging material	 	 	 	 	 	X
	■    Non-conformance approval - Printed
    Packaging material	 	X	 	X	 	X
	Retained Samples (17)	 	 	 	 	 	 
	■    Retained Samples of Materials	 	 	 	 	 	X
	■    Retained Samples of Products	 	X	 	 	 	X
	Storage and transportation of Product(s)/
    Environmental Monitoring (18)	 	 	 	X	 	X
	Stability activities (19)	 	 	 	X	 	 
	Annual Product Review (APR) (20)	 	X	 	X	 	X
	Product complaints - Product (21)	 	 	 	 	 	 
	■    Receipt/reply	 	X	 	 	 	 
	■    Investigation	 	X	 	X	 	X
	■    Regulatory follow-up	 	X	 	 	 	 
	Returned Goods (22)	 	X	 	 	 	 
	Recall of marketed Product(s) (23)	 	X	 	X	 	 
	Audits and Inspections of facilities and Product(s) (24)	 	 	 	 	 	 
	■    Audit	 	X	 	 	 	 
	Reprocessing and Rework (25)	 	 	 	X	 	X
	Validation (26)	 	 	 	 	 	 
	■    Cleaning	 	 	 	 	 	X
	Equipment	 	 	 	 	 	X
	■    Facility	 	 	 	 	 	X
	■    Process	 	 	 	 	 	X
	■    Analytical Method	 	 	 	 	 	X
	Training (27)	 	 	 	 	 	X
	Documentation retention (28)	 	X	 	 	 	X


  




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Annex 2: Key Contact Personnel


 


Manufacturing Quality Agreement


 


	Vétoquinol

        Coordinator, Quality Control

         

        Line Perreault

         

        Director, Quality Assurance

        Richard Poudrier

        


        Director, Scientific Affairs

        Pierre Gadbois d.m.v.
	 	Parnell

        Director, Regulatory and Clinical Science

         

        Fenella Cochrane

         

        Director, Quality

        Brett Lieurance

         

	 	 	 
	Hospira

        Site Quality Manager

         

        Brian Laskowski

         

        Contract Manufacturing Manager

        Brian Martin
	 	 


 




    	S-5-15



    	 



    
 


DISTRIBUTION AND SUPPLY AGREEMENT
Executed as an agreement:


 

	EXECUTED for an on behalf of	)	 
	Parnell North America	)	 
	Pty Limited by a director	)	 
	in the presence of:	 	 
	 	 	 
	/s/ Erika Kristy Vikor	 	/s/ Robert Joseph
	Signature of witness	 	Signature of director
	 	 	 
	Erika Kristy Vikor	 	Robert Joseph
	Name	 	Name
	 	 	 
	 	 	 
	EXECUTED for an on behalf of	)	 
	Vétoquinol by a director	)	 
	in the presence of:	)	 
	 	 	 
	/s/ Christelle Georges	 	/s/ Etienne Frechin
	Signature of witness	 	Signature of Chairman and Managing Director
	 	 	 
	 	 	 
	Name: Christelle GEORGES	 	Name: Etienne FRECHIN