Exhibit 10.3


 


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


Amendment 1


 


Parnell Europe Pty Limited


 


AND


 


Eli Lilly and Company


 




    	 



    	 



    

 


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




  


This is Amendment number
1 to the agreement between Eli Lilly and Company and Parnell Europe Pty Ltd. titled Distribution and Supply Agreement and dated
February 9, 2011 (“Agreement”). By this amendment, entered into on this 2nd day of December,
2011, both parties agree as follows:


 


1.          Recitals


 


WHEREAS, Elanco and
Parnell are Parties to the Agreement in regard to the Zydax product;


 


WHEREAS, the Parties
agree to pursue revised Targeted Claims for Zydax as indicated in the revised Schedule 1, attached;


 


WHEREAS, Elanco agrees
to increase the amount of the EU Payment 1 and US Payment 1,


 


WHEREAS, Parnell agrees
to ***; and


 


NOW THEREFORE, the
Agreement is amended as follows:


 


2.          Amended
Provisions


 


a.           Schedule 1
is replaced with the revised Schedule 1 included below.


 


b.           In
section 1.0, a new definition New Trial Study is added as follows: “New Trial Study means a study with a mutually agreed
protocol that is reasonably designed to achieve and support a Zydax product in accordance with Schedule 1, as amended herein.”


 


c.           In
section 1.0, a new definition Zone is added as follows: “Zone means either the United States of America or the European
Economic Community”


 


d.           In
section 1.0, the definition of Zydax is amended to add, after the words “Schedule 4”, the phrase: “and
Schedule 1”


 


e.           In
section 2.3, the phrase “thirty (30) months” is replaced with “thirty eight (38) months.”


 


f.            In
Section 3.1(a)(i), the phrase “ and *** to be paid not later than January 10, 2012 after mutual execution of Amendment 1
to this Agreement.” is added at the end of the existing paragraph.


 


g.           In
Section 3.1(b)(i), the phrase “ and *** to be paid not later than January 10, 2012 after mutual execution of Amendment 1
to this Agreement.” is added at the end of the existing paragraph.


 


h.           A
new section is added as follows:


 




    	 



    	 



    

  


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


 


3.3           Parnell
agrees to *** in accordance with the mutually agreed protocol. ***may include ***.


 


i.            Section 13.1(a)
is replaced in its entirety as follows:


 


(a)          If registration of Zydax has not occurred in a zone by the end of the 38th month after Commencement Date,
Parnell will pay monthly damages either in US dollars or if registration has occurred in one Zone then in free goods to Elanco
beginning the first day of the first month after the 38th month post Commencement Date. Damages will be the cash amount or cash
equivalent (free goods) of $111,111.16 for the “US Delay Damages” and $55,555.50 for the “EU Delay Damages,”
respectively.


 


j.            Section 13.1(b)
is replaced in its entirety as follows:


 


(b)          Payment
of the respective US Delay Damages or EU Delay Damages will continue until Zydax is registered in the Zone that was not
registered as of the 38th month post Commencement date, or until, in each case, the EU Delay Damages are equal
to $666,666 (Six Hundred and Sixty Six Thousand and Six Hundred and Sixty Six Hundred Dollars) and the US Delay Damages are
equal to $1,333,334 (One Million Three Hundred and Thirty Three Thousand and Three Hundred and Thirty Four Hundred Dollars). For
clarity delay damages are only payable in respect of the zone in which registration of the Product has not occurred as at the end
of the 38th month post Commencement Date.


 


k.          Section 13.1(d)
is replaced in its entirety as follows:


 


(d)          In
the event that Registration for Zydax has still not been granted in either Zone, or Parnell is unable to supply the minimum supply
quantities defined in Schedule 2 by the end of the ***month after the Commencement Date either party may terminate this Agreement
by giving the other notice in writing, such termination to take effect immediately.


 


l.            Section 13.2
is replaced in Its entirety as follows:


 


13.2         In
the event that Registration for Zydax has still not been granted in any Zone by the end of ***month after the Commencement Date,
either party may terminate this Agreement by giving the other notice in writing, such termination to take effect immediately.


 


m.           Section 33.10
is replaced in its entirety as follows:


 


33.10         Clauses 13,
16, 18, 19, 22 to 30, 32 and 33 will survive the expiration or earlier termination of this Agreement.


 


3.          Amendment
Terms


 


a.           The
provisions of this Amendment, to the extent they conflict with the Agreement shall supersede such conflicting provisions


 




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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.           The
parties agree that the Agreement remains in full force and effect as amended


 


c.           The
amended provisions shall survive the termination of this amended Agreement to the extent necessary to serve the purpose intended.


 




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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


 


IN WITNESS WHEREOF,
the parties have executed this Agreement Amendment 1, effective upon the last date entered below.


 


	ELI LILLY AND COMPANY	 
	 	 	 
	By	/s/ Jeff Simmons 	 
	 	 	 
	Title	President  	 
	 	 	 
	Date	2 December 2011	 
	 	 	 
	Parnell Europe Pty Ltd	 
	 	 	 
	By	/s/ Robert Joseph	 
	 	 	 
	Title	Chief Executive Officer	 
	 	 	 
	Date	2 December 2011 	 
	 	 	 
	Attachment:  Revised Schedule 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




  


SCHEDULE 1


 


Products


 





	
        Product 
	 	Trade Name	 	Presentation	 	Active ingredient
	Zydax 100 Injection	 	Zydax	 	20mL preserved multiple dose vial	 	Glucuronoxylan Sulfate sodium ***










  


***


 


Currently the targeted
Label of Zydax will include, but not be limited to the following:


 


***


 




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