Technical Agreement between Viragen International, Inc. and Orphan Australia



 Exhibit 10.3 
 Technical Agreement 
 Viragen 
 & 
 Orphan Australia 
  

					
	1	  	PURPOSE	  	2
			
	2	  	CONFIDENTIALITY	  	2
			
	3	  	MANUFACTURING AND PACKAGING	  	2
			
	4	  	REPROCESSING	  	2
			
	5	  	BATCH RELEASE DOCUMENTATION	  	2
			
	6	  	RETAINED SAMPLES AND RECORDS	  	3
			
	7	  	PRODUCT TESTING AND RELEASE	  	3
			
	8	  	RECEIPT AND DISTRIBUTION BY OA	  	3
			
	9	  	QUALITY AUDITS	  	4
			
	10	  	COMPLAINTS	  	4
			
	11	  	RECALL	  	4
			
	12	  	VALIDATION	  	4
			
	13	  	CHANGE CONTROL	  	5
			
	14	  	SUBCONTRACTING	  	5
			
	15	  	DURATION OF AGREEMENT	  	5
			
	16	  	ENTIRE AGREEMENT	  	5
			
	17	  	APPROVAL SIGNATURES	  	6

  








	1	PURPOSE 

 This Technical Agreement is between:

 Viragen International, Inc. 
 865 SW 78th Avenue, Suite 100, Plantation, Florida 33324 
 Phone: 954-233-8746 Fax: 954-233-1414 
 Hereinafter called: VGN 
 AND

 Orphan Australia 
 48 Kangan Drive Berwick VIC 3806 Australia 
 Phone: +61 3 9769 5744 Fax: +61 3 9769 5944 
 Hereinafter called: OA 
 This Agreement outlines the Quality
Assurance responsibilities of VGN and OA (together constituting the Parties) for the manufacture and distribution of the Product in Australia and is referred to in the License Agreement between the Parties. 
  

	2	CONFIDENTIALITY 

 Both Parties will treat as
confidential all data supplied by the other party in connection with the manufacture of the Products, and identified as confidential, and not themselves use (except for the purposes of manufacture stated herein), or disclose, data to a third party
except for registration purposes. 
  

	3	MANUFACTURING AND PACKAGING 

  

	3.1	VGN will be responsible for the manufacture, packaging and release for sale of the Product in accordance with the approved license application and its prevailing Standard Operating
Procedures (SOPs). 

  

	3.2	VGN will supply to OA Product meeting the Australian approved specifications. 

  

	4.	REPROCESSING 

 Viragen will not reprocess any
Product at any stage of manufacturing. 
  

	5.	BATCH RELEASE DOCUMENTATION 

 VGN agrees to provide, for each batch
of Product supplied to OA, a Certificate of Analysis certifying: 
  


					
	Viragen International, Inc and Orphan Australia	  	2/7	  	
	Technical Agreement	  		  	










	 	•	 	The batch has been manufactured and tested according to the relevant Market Authorisation and confirmed to meet all specifications 

  

	 	•	 	Released by a Qualified Person 

  

	 	•	 	The form and details of such document shall be mutually agreed by the Parties. 

  

	6.	RETAINED SAMPLES AND RECORDS 

  

	6.1	VGN agrees to ensure that reference and retained samples for each lot of Product supplied to OA are kept for a period of two years after expiry of the finished Product lot. The
amount of reference samples must be sufficient for at least two (2) analyses, excluding sterility testing. 

  

	6.2	Batch records will be retained by VGN for at least seven (7) years. 

  

	7.	PRODUCT TESTING AND RELEASE 

  

	7.1	Before shipping Products to OA, VGN will test Products according to approved testing procedures. 

  

	7.2	VGN will be responsible for testing and releasing finished Products for shipment to OA. 

  

	7.3	Release of Product for shipment to OA will include documented release and certification by a Qualified Person and said documented Release of Product is sufficient to allow OA to
commence selling the Product in the Territory. 

  

	7.4	The Qualified Person releasing the batch of Product for sale will ensure that each batch has been manufactured and checked for compliance with the requirements of the approved
Market Authorization 

  

	7.5	Any deviation from the process during manufacture must be explained and documented in the batch records and approved by VGN Quality Assurance. 

  

	7.6	VGN is responsible for investigating any test result, which fails to meet specification. Each investigation report must include corrective action, where identifiable, and be
approved by VGN Quality Assurance. In addition, see Article 9.2 through and including Article 9.12 of the License Agreement. 

  

	7.7	VGN will notify OA if any problems are discovered that may impact on batches already shipped to OA. 

  

	8.	RECEIPT AND DISTRIBUTION BY OA 

  

	8.1	OA will positively identify all batches of the Product received through a physical inspection of the external packaging (shipping cases) of the Product to confirm there is no damage
from the shipping process and the external labeling to confirm that it is current. 

  


					
	Viragen International, Inc and Orphan Australia	  	3/7	  	
	Technical Agreement	  		  	










	8.2	Any notification to the Registration Authorities with respect to post-distribution extraordinary events or significant deviations will be the responsibility of OA.


  

	9.	QUALITY AUDITS 

  

	9.1	OA reserves the right to inspect areas of VGN’s premises, or those of its contractors, connected with the manufacture and testing of the Product during normal business hours
and after giving reasonable written notice and causing minimum disruption to the operations. 

  

	9.2	VGN reserves the right to inspect areas of OA’s premises connected with the storage and distribution of Product during normal business hours and after giving reasonable written
notice and causing minimum disruption to the operations. 

  

	9.3	Refer to the License Agreement for more details on site inspections, reports and communications. 

  

	10.	COMPLAINTS 

  

	10.1	OA will have the responsibility of handling complaints with the assistance, as required, of VGN. 

  

	10.2	All Technical complaints received by OA will be forwarded for evaluation to VGN who will respond in a reasonable period, approximately ten working (10) days. All such
complaints will be entered into VGN’s complaint system. 

  

	10.3	Final disposition of complaints will be the responsibility of OA in consultation with VGN. 

  

	10.4	Refer to the License Agreement and Safety Agreement for more details on handling of Product Complaints. 

  

	11.	RECALL 

  

	11.1	OA is responsible for the recall of Product distributed in the Territory. In the event of a recall, VGN will provide support in areas of analysis and documentation review at no cost
to OA. 

  

	11.2	VGN will provide OA with such information required as the result of a regulatory agency inspection which may involve the Product, Product Recall, complaint or product investigation,
and agrees to courier said information within forty-eight (48) hours or as mutually agreed upon in writing. 

  

	11.3	Refer to the License Agreement and the Safety Agreement for details of handling Product Recall activities. 

  

	12.	VALIDATION 

  

	12.1	VGN is responsible for assuring that equipment and facilities used in the manufacture of the Product have been appropriately validated. 

  


					
	Viragen International, Inc and Orphan Australia	  	4/7	  	
	Technical Agreement	  		  	










	12.2	VGN is responsible for process validation for the manufacture of the Product. 

  

	12.3	OA is responsible for the use of appropriately validated shipping configuration(s) for the Product. 

  

	13.	CHANGE CONTROL 

  

	13.1	VGN will communicate any major or significant change affecting the quality of the Product or approved regulatory information to OA prior to implementation of the change. These
changes include production and testing sites, formulation, raw material or its source, method of manufacture, equipment, packaging, specifications of active ingredient and finished Product, analytical control methods (excluding pharmacopoeia
updates), labeling, shelf life, etc. 

  

	13.2	OA will be responsible for communicating this information to the competent authority for pre-approval before the changes are made, or in accordance with the regulations in each
Country in the Territory. 

  

	13.3	VGN will communicate all changes to the Product required by other Registration Authorities and will keep OA apprised of its plan to make such changes, including any Registration
activities that may be required. 

  

	14	SUBCONTRACTING 

  

	14.1	In the event that VGN arranges third party manufacture or packaging of the Product, VGN is responsible for ensuring that such third parties will perform all actions and provide
information such that VGN can fulfill the requirements of the Technical Agreement. 

  

	15.	DURATION OF AGREEMENT 

 This Technical Agreement
will commence from the Effective Date and will remain valid until the expiration or termination of the License Agreement between VGN and OA. This Agreement may be modified as required with the consent of both Parties. 
  

	16.	ENTIRE AGREEMENT 

 This Agreement and the Safety
Agreement and the License Agreement between the Parties contain the entire understanding of the Parties with respect to the subject matter hereof. All express or implied agreements and understandings, either oral or written, heretofore made are
expressly merged in and made a part of this Agreement. This Agreement may be amended, or any term hereof modified, only by a written instrument duly executed by both Parties hereto. In the event of conflict between this Agreement and the License
Agreement, the terms of the License Agreement shall prevail. 
  


					
	Viragen International, Inc and Orphan Australia	  	5/7	  	
	Technical Agreement	  		  	










	17.	APPROVAL SIGNATURES 

 On behalf of OA and VGN, we
agree to the conditions and respective responsibilities as set out in this document. 
  

					
	SIGNED for and on behalf of	  	)	  	
	Viragen International, Inc. by:	  	)	  	Signature
			
		  		  	Print Name Charles A. Rice
	Date: December 21, 2006	  		  	
		  		  	Title President & CEO
			
	SIGNED for and on behalf of	  	)	  	
	Orphan Australia Pty Ltd by:	  	)	  	Signature
			
		  		  	Print Name
	Date: December 22, 2006	  		  	
		  		  	Title: Scientific Affairs Manager

  


					
	Viragen International, Inc and Orphan Australia	  	6/7	  	
	Technical Agreement	  		  	









 Appendix 1: RESPONSIBILITY CHART 
 Viragen and OA 
 Schedule of Technical Responsibilities 
 OA     Approved
by:                                       
     Date: December 22, 2006 
 VGN   Approved
by:                                       
     Date: December 21, 2006 
  

					
	 	  	OA	  	VGN
	Formulation	  	 ̈	  	n
			
	Manufacturing instructions	  	 ̈	  	n
			
	Specifications for raw materials	  	 ̈	  	n
			
	raw materials supply and testing	  	 ̈	  	n
			
		  	 ̈	  	n
			
		  	 ̈	  	n
			
	In process controls	  	 ̈	  	n
			
	Specifications for bulk material	  	 ̈	  	n
			
	Bulk testing and release	  	 ̈	  	n
			
	Specifications for packaging material	  	 ̈	  	n
			
	Artwork for printed material	  	n	  	n
			
	Packaging material supply & testing	  	 ̈	  	n
			
	Retained samples raw materials	  	 ̈	  	n
			
	Retained samples bulk	  	 ̈	  	n
			
	Retained samples finished product	  	 ̈	  	n
			
	Specifications for finished product	  	 ̈	  	n
			
	Testing and release for shipment	  	 ̈	  	n
			
	Release for sale	  	 ̈	  	n
			
	Storage and shipping of finished product	  	n	  	 ̈
			
	Complaints	  	n	  	n
			
	Recall	  	n	  	n
			
	Stability testing	  	 ̈	  	n
			
	Process validation	  	 ̈	  	n
			
	Disposal of samples or rejected printed material or finished product	  	n	  	n

  


					
	Viragen International, Inc and Orphan Australia	  	7/7	  	
	Technical Agreement