Document:

License Agreement between Viragen International, Inc. and Orphan Australia

 Exhibit 10.1 
 Information marked below by a [                    ] has been omitted pursuant to a request for confidential treatment filed
separately with the Commission 
 LICENSE AGREEMENT 
 This Agreement is made effective on December 22, 2006 by and between Viragen International, Inc., a company incorporated in Delaware, USA with its principal offices located at 865 SW 78th Avenue, Plantation, Florida, USA, and its Affiliates and Subsidiaries (VGN) and Orphan Australia Proprietary Limited, a
company incorporated in Victoria, Australia with its principal offices located at 48 Kangan Drive, Berwick Victoria 3806, Australia, and its Affiliates and Subsidiaries (OA); 
 WHEREAS: 
 VGN has successfully developed and registered the human prescription biologic Multiferon® (the
“Product”) in Sweden and other countries and desires to license the exclusive rights to register, market, sell and distribute the Product throughout the Territory as defined herein to OA; and, 
 OA is engaged in the business of development, sales, marketing and distribution of prescription products throughout the Territory and desires to license the Product from
VGN for the exclusive rights to market, sell and distribute the Product throughout the Territory as defined herein; now, 
 VGN and OA (hereinafter the
“Parties”) hereby agree to the terms and conditions stated herein governing this License Agreement. 
 Article 1: Definitions 
  

	 	1.1	“Affiliates and Subsidiaries” shall mean the entities owning, owned by, controlling or controlled by the respective Parties to this Agreement, and which may be
involved in the performance of this Agreement on behalf of either Party. 

  

	 	1.2	“Agreement” shall mean this agreement, including all Exhibits, and including the Safety and Technical Agreements, as amended from time to time, in accordance with
the terms herein. 

  

	 	1.3	“Amendment” shall mean a mutually agreed upon and documented change to the terms and conditions of this Agreement, including its Exhibits, executed in writing and
signed by authorized representatives of each Party to this Agreement in advance of the effective date of such change(s). 

  

	 	1.4	“Annual Product Forecast” shall mean the amount of the Products that represents OA’s best estimates of SKUs it expects to purchase from VGN during a continuous
12-month period, and as reported to VGN in advance on a calendar quarter basis as described herein. 

  

	 	1.5	“Approved Indication(s)” shall mean the precise and written descriptions for use as defined by the Registrations, the Market Authorizations and as may otherwise be
defined by the Registration Authorities in the Countries within the 

  

					
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	 	  	Territory. Approved Indication(s) shall be specified in Exhibits to this Agreement, as samples of approved Product labeling, translated into English for convenience.

  

	 	1.6	“Clinical Trial” shall mean the subjecting of humans to the Product as described by a study protocol required by Registration Authorities in the Territory.

  

	 	1.7	“CTD Dossier” shall mean the entire collection of descriptive methods of chemistry, manufacturing and controls (CMC) employed by VGN in the development,
processing, manufacture, clinical trials and testing of Product that is the subject of this Agreement. The CTD Dossier forms the basis of the Registration referred to in 1.28. 

  

	 	1.8	“Confidential Information” shall mean all information of a confidential nature relating to either Party’s business disclosed by a Party to the other
either orally, in writing or in any other tangible form, including the terms of this Agreement and all matters related to or associated with this Agreement. 

  

	 	1.9	“Country(ies)” shall mean each individual geographic region included in the Territory which has its own reimbursement authority and governing body(ies) that are
charged with reviewing and approving a Market Authorization to permit marketing of the Product within its boundaries. For the avoidance of doubt, the Countries shall mean those specified in Exhibit 2 to this Agreement, and any Amendments thereto.

  

	 	1.10	“Requested Delivery Date” shall mean a calendar date upon which OA wishes VGN to make Product available for shipment as communicated by OA under a
Purchase Order (“PO”). 

  

	 	1.11	“Effective Date” shall mean the latest date upon which this License Agreement, the Safety Agreement and the Technical Agreement was last signed by either Party to
these Agreements. 

  

	 	1.12	“Exhibit” shall mean a written and mutually agreed upon attachment to this Agreement specifying certain terms, conditions, descriptions, specifications and details
pertaining to this Agreement, and incorporated to this Agreement by reference. 

  

	 	1.13	“Expiration Date” shall mean the date which shall be specified by VGN as the last date upon which the Product shall be assured to meet the Approved Product
Specifications when stored, handled and used in accordance with its labeling, as approved in the Registrations. The Expiration Date shall be incorporated into Product labeling and packaging and shall be assigned for each Product Lot Number.

  

	 	1.14	“License Fee” shall mean the up front fee payable pursuant to Article 2 as specified in Exhibit 1 and Amendments thereto. 

  

	 	1.15	“Licensed Marks” shall mean registered and unregistered trademarks copyrights and/or designs used by VGN in relation to the Product and hereby licensed to OA
under this Agreement within the Territory attached hereto as Exhibit 3. 

  

					
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	 	1.16	“Lot Number” shall mean the unique and identifying code, comprised of alpha and/or numeric figures, assigned by Viragen to identify a distinct and separate quantity
of Product units that are manufactured under consistent and continuous processes, and as defined by Swedish Registration Authorities, the European Good Manufacturing Practices and/or the relevant regulations in the Countries in the Territory. The
Lot Number shall appear on each unit of Product, in the Product labeling and on Product packaging as approved in the Registrations. 

  

	 	1.17	“Market Authorization” shall mean the valid documented approval by the Registration Authority in each Country within the Territory permitting OA to commence
selling, marketing and distributing the Product 

  

	 	1.18	“Marketing Plan(s)” shall mean the documented list and timing of actions that OA will take in order to successfully achieve or exceed the Annual Product Forecast in
each Country, or groups of Countries, in the Territory. 

  

	 	1.19	“Milestone Payment” shall mean a payment due from OA to VGN upon achievement of a specific event as described in Exhibit 1. 

  

	 	1.20	“Parties” shall mean parties to this Agreement including VGN and OA, and their respective Affiliates, and Party shall mean the singular as appropriate.

  

	 	1.21	“Product Improvements” shall mean any modification or change to the Product, whether in physical properties or appearance, qualitative or quantitative description,
packaging or clinical indication for use, while maintaining the description “multi-subtype, human alpha interferon injection” and conforming to the Approved Product Specifications as defined in Exhibit 4 to this Agreement, as may be
amended from time to time. 

  

	 	1.22	“Product Recall” shall mean the deliberate retrieval and recovery or recall from the Territory of warehoused, distributed, marketed or sold Product due to a serious
deficiency in the quality or purity of the Product as determined by testing or inspection according to the Registration or as determined by reports of unanticipated adverse patient reactions specifically due to use of the Product.

  

	 	1.23	“Approved Product Specifications” shall mean the scientific, quantitative and qualitative descriptions of the Product, with respect to chemical, biological,
microbiological and physical properties of the Product as put forth in the Registration in the Territory, and as may be amended from time to time in accordance with the applicable regulations by the Registration Authorities, and based on Exhibit 4.

  

	 	1.24	“Product” shall mean the finished biological material, in finished packaged and labeled form and meeting the Approved Product Specifications as defined by the
Registration in the Territory, and as sold by VGN to OA, corresponding to the brand Multiferon®, multi-subtype, human interferon alpha injection. 

  

					
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	 	1.25	“PO” shall mean a legally binding Purchase Order initiated by OA and submitted to VGN in advance, specifying quantities of Product it wishes to purchase from VGN
and the Requested Delivery Date upon which OA desires VGN to make Product available for collection by OA or its carrier, according to the terms and conditions specified herein. 

  

	 	1.26	“Purchase Price” shall mean the price at which VGN agrees to sell the Product to OA, expressed in Australian Dollars (AUD), and as set forth in Exhibit 1 to
this Agreement. 

  

	 	1.27	“Registration Authority(ies)” shall mean those agencies, bodies or organizations designated by local laws and regulations in each of the Countries in the
Territory and charged with controlling the development, selling, marketing and distribution of prescription products for human use. For avoidance of doubt, all regulatory authorities shall be included in the use of this term, including authorities
governing compliance, ongoing reporting and variations or changes to the Registration. 

  

	 	1.28	“Registration(s)” shall mean the dossier(s) of scientific documentation, qualitative and quantitative data and clinical information that is required by
Registration Authorities as documented evidence of the safety and efficacy of the Product when used for its intended purpose(s). 

  

	 	1.29	“Reimbursement Authorization” shall mean the documented national approval of the application, or approval of revisions to the application, submitted by OA in each
Country in the Territory that request the setting of a reimbursement price for the Product in that Country. For avoidance of confusion this date shall be the Listing date, that is, the date from which the Product is available to patients at the
reimbursed price. 

  

	 	1.30	“Safety Agreement” shall mean the agreement between the Parties that describes in sufficient detail the obligations of VGN and OA with respect to the handling and
reporting of customer complaints, adverse events and the associated communications with Registration Authorities, attached hereto and incorporated by reference. 

  

	 	1.31	“Shipment Date” shall mean that date on which VGN transfers Products ordered by OA to the designated carrier for transport to OA. 

  

	 	1.32	“(SKUs)” shall mean the Stock Keeping Unit of measure OA intends to use to track its purchases and sales of the Product, typically the smallest quantity of Product
that OA will actually transfer to its customers in the act of making a sale. The SKU for the Product is defined in Exhibit 5. 

  

	 	1.33	“Technical Agreement” shall mean the agreement between the Parties that describes in sufficient detail the obligations of VGN and OA with respect to the
manufacturing, testing, delivery, sampling, inspection and release of the Product, attached hereto and incorporated by reference. 

  

	 	1.34	“Term” shall mean the length of time during which this Agreement shall remain in effect, and shall be not less than ten (10) years from the
Effective Date of this Agreement, or for a longer period as may be mutually agreed by the Parties and documented in the form of an Amendment to this Agreement. 

  

					
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	 	1.35	“Termination” shall mean the halting of activities in accordance with the terms of this Agreement. 

  

	 	1.36	“Territory” shall mean those specific geographical areas defined by the Country name, or as may be mutually agreed upon by the Parties, constituting the
boundaries within which the Product may be developed, sold, marketed and distributed and as further described in Exhibit 2. 

 Article 2:
License Fee and Milestone Payment 
  

	 	2.1	In consideration for VGN granting exclusive rights to the patents, trademark and know-how related to the Product to OA for the express purposes of filing applications for Market
Authorization and Reimbursement Authorization and for marketing, selling and distributing the Product in the Territory under the terms and conditions herein, OA shall pay to VGN a License Fee and Milestone Payments for the Territory in accordance
with Exhibit 1. 

 Article 3: Registration of the Product 
  

	 	3.1	The Parties will cooperate with one another on the filing for registration targeting the applicable Countries within the Territory.
[                    ] 

  

	 	3.2	VGN shall be responsible for the creation and maintenance of the Registration Dossier, including all clinical trial protocols and reports, any variations or modifications and for
maintaining its facilities, processes and documentation in compliance with the applicable regulations [                    ].

  

	 	3.3	OA will act as the local sponsor of the registration,
[                    ], and VGN will provide any and all necessary assistance in order to achieve Market Authorization throughout the
Territory at the earliest possible date. 

 Article 4: Market Analysis/Marketing Plans 
  

	 	4.1	OA has prepared a preliminary market analysis for the Territory indicating that there is sufficient economic viability to warrant the process of developing, selling, marketing and
distributing the Product. 

  

	 	4.2	OA agrees to conduct periodic market analyses in the Territory and to report the same to VGN, in a form and on a schedule mutually agreeable to the Parties, in support of the
Product throughout the Term of this Agreement, and shall conduct these market analyses no less frequently than annually following market launch. Periodic market analyses shall be used to update the Marketing Plans and the Annual Product Forecast.

  

					
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	 	4.3	After receipt of Market Authorization in a Country in the Territory and prior to receipt of Reimbursement Authorization in that Country, OA will submit to VGN for its review and
approval the Marketing Plan for the Country, or groups of Countries as the Parties may agree. Between the date of Reimbursement Authorization and actual commencing of selling the Product, the Marketing Plan may be modified or updated, as the Parties
may mutually agree. The Marketing Plan shall be in a form mutually agreeable to the Parties, but shall contain the following minimum information: 

  

	 	4.3.1	Total number of sales representatives that will sell the Product in each Country in the Territory 

  

	 	4.3.2	Planned call positioning and selling messages for the Product; 

  

	 	4.3.3	Total monthly planned physician and hospital calls; 

  

	 	4.3.4	Annual advertising and promotional plan (journal ads, professional meetings, focus groups, peer-to-peer selling, etc.); 

  

	 	4.3.5	Reporting formats for tracking sales call activity and sales results. 

  

	 	4.3.6	Plans for applying for reimbursement in each Country in the Territory. 

  

	 	4.4	VGN shall provide comments and recommendations for modifications to the Marketing Plan no later than ten (10) calendar days from the date of receipt. 

 

	 	4.5	OA shall review VGN’s comments and recommendations for changes to Marketing Plans and shall endeavor to integrate VGN’s recommendations to the extent reasonable to meet
the Annual Product Forecast. OA shall be responsible for executing the Marketing Plan. 

  

	 	4.6	VGN shall have prior approval authority for certain aspects of any Marketing Plan, which shall include; 

  

	 	4.6.1	Market Positioning 

  

	 	4.6.2	Sales claims 

  

	 	4.6.3	Use of Licensed Marks 

  

	 	4.6.4	Design of labeling and packaging (with respect to physical parameters only, to ensure appropriateness with approved manufacturing processes and compliance with the Registration).

  

	 	4.7	Following achievement of Reimbursement Authorization and market launch, OA shall report to VGN within 30 days of the end of each calendar quarter throughout the Term, excluding any
initial partial quarter, the sales results during the quarter, its adherence to the Marketing Plan, its progress in executing the Marketing Plan and any deviations from the Marketing Plan for each Country in the Territory, or groups of Countries as
mutually agreed by the Parties. 

  

					
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	 	4.8	OA will develop and execute the Marketing Plan according to reasonable efforts. The Parties recognize that the plan may change on an ongoing basis and that execution of aspects of
the Plan may not be possible due to changing market conditions, and that counter plans may be implemented instead. Such changes to the Marketing Plan may or may not allow sufficient time for the Parties to renegotiate a revised Marketing Plan. The
Parties therefore agree to regularly review the Marketing Plan. [                    ] 

  

	 	4.9	The Marketing Plan for each Country, or group of Countries, in the Territory shall be reviewed and updated at least every twelve (12) months by OA, whereby OA shall submit
updates to VGN and VGN shall have ten (10) calendar days to provide comments and recommendations for changes to OA, in accordance with Article 4.4. 

 Article 5: Registration 
  

	 	5.1	Upon completion of the Registration documentation for each Country agreed by the Parties, VGN will assist OA and use its best endeavors to ensure the timely filing for Market
Authorization in each Country in the Territory. 

  

	 	5.2	OA shall be responsible for filing the Registration with the Registration Authorities in each Country in the Territory on as timely a basis as possible. 

  

	 	5.3	OA shall be responsible for responding to any questions from the Registration Authorities including the submission of any documentation that may be required and may be provided by
VGN. VGN will provide technical support where necessary. 

  

	 	5.4	VGN shall be responsible for all costs billed by the Registration Authorities and paid by OA upon presentation of copies of original invoices redacted for other products included on
the same invoices, including post-registration variations, GMP clearance renewals, annual fees and charges, but excluding any fees associated with permitting OA to conduct its business in the Territory. All invoices will be paid by VGN within thirty
(30) calendar days of receipt by VGN. 

 Article 6: Market Authorization 
  

	 	6.1	Upon receipt of Market Authorization, OA shall notify VGN immediately in writing and provide copies of any and all documentation specifying the approval. 

 

	 	6.2	OA and VGN will cooperate with one another on the development and issuance of a joint press release to announce this important milestone to the public and respective stockholders.

  

	 	6.4	OA shall be responsible for communicating with each Country’s reimbursement agency and for filing the reimbursement application. VGN shall assist OA in the reimbursement
application process by providing all available information, including information with which it has secured Reimbursement Authorization in Sweden. Upon receipt of written confirmation of Reimbursement Authorization, OA shall provide copies of such
authorization to VGN within three (3) days of receipt. 

  

					
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	 	6.5	VGN will acknowledge receipt of notification of Reimbursement Authorization in writing. 

  

	 	6.6	OA will submit, if it has not already done so, copies of final labeling, including printed packaging and shipping materials to VGN for its final review and approval and for ordering
such materials for each Country or groups of Countries in the Territory. VGN will be responsible for ordering and stocking of all printed labeling for the Product. 

  

	 	6.7	OA will determine and communicate to VGN its desired date to officially initiate the market launch of the Product in each Country in the Territory. 

  

	 	6.8	VGN will confirm its ability to provide suitable quantities of Product prior to the intended launch date, or will work with OA to determine an alternate date that is most suitable.
VGN will take all reasonable steps within its control to ensure that it supplies Product according to OA’s desired launch date. 

 Article 7: Annual Product Forecasts 
  

	 	7.1	[                    ], OA will submit to VGN its first Annual Product
Forecast and its first PO for the Product, for the Country. As other Countries are approved for reimbursement, these will be added to the Annual Product Forecast. The Parties may agree to consolidate groups of Countries into regions for the purpose
of creating and updating the Annual Product Forecast. In the event individual Countries are added after other Countries are already approved, and provided the labeling and packaging are in a common language, the Parties may agree to limit the
requirement for submission of a Country-specific PO and instead simply add to planned POs for purchases of Product. This allowance does not apply to the Annual Product Forecast. 

  

	 	7.2	The Annual Product Forecast will represent OA’s best estimate, to its reasonable knowledge, of the quantities of Product it expects to order from VGN during the subsequent
12-month period, expressed on a calendar quarter basis, and for each Country in the Territory. This stipulation applies only to those Countries that require labeling in a different language. Where more than one Country requires the same language for
labeling and packaging materials, these Countries may be grouped together with respect to the Annual Product Forecast. 

  

	 	7.3	The Annual Product Forecast shall be expressed in SKUs, with one SKU representing the smallest quantity OA plans to sell to any third party (e.g., a carton, a case, etc.), and shall
be a non-binding forecast. 

  

	 	7.4	The Annual Product Forecast shall be in a format mutually agreeable to the Parties and shall be communicated via hard copy, via electronic mail, or via 

  

					
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	 	  	facsimile to VGN at its ViraNative, AB facility in Umeå, Sweden. VGN shall confirm receipt of the Annual Product Forecast, in writing to OA, along with any questions or
comments. 

  

	 	7.5	No later than thirty (30) calendar days prior to the end of each subsequent calendar quarter, OA will update the Annual Product Forecast and submit the update to VGN. These
quarterly updates are intended to provide OA with the opportunity to regularly communicate changes in demand for the Product and to provide VGN with as much prior notice as possible that changes in manufacturing schedules may be necessary.

  

	 	7.6	In the event OA becomes aware of significant and immediate market dynamics that cause it to believe that a change in the Annual Product Forecast should be urgently communicated to
VGN, OA may submit a non-scheduled, updated Annual Product Forecast at its own discretion and to which VGN will respond on a timely basis in the spirit of cooperation. 

  

	 	7.7	VGN will use commercially reasonable efforts to maintain sufficient manufacturing capacity to supply OA with its requirements according to the Annual Product Forecast and updates
thereto. In order to ensure OA has adequate inventory to fulfill its Annual Product Forecasts, frequent communications are desirable. 

 Article 8: Orders and Delivery of Products 
  

	 	8.1	No later than thirty (30) calendar days before the beginning of each calendar quarter, or more frequently, as agreed between the Parties, beginning on or prior to the
anticipated date of Reimbursement Authorization in a Country in the Territory and continuing throughout the Term of this Agreement, OA will submit a PO to VGN at its ViraNative AB subsidiary location in Umeå, Sweden, specifying the quantities
of Product it will require for the subsequent calendar quarter, and will specify the Requested Delivery Date(s) for quantities ordered. VGN will confirm receipt and acceptance of all POs in writing. 

  

	 	8.2	The maximum time required by VGN, from the date of receipt of a PO from OA to the date the first quantity of Product is shipped from the manufacturing facility is
[                    ]. 

  

	 	8.2.1	In the event VGN confirms receipt of a PO and fails to ship quantities
[                    ] of the dates stated in the PO (or such later date as agreed between the Parties excluding reasons of Force Majeure as
further defined in Article 22), VGN shall be assessed a late-delivery penalty. 

  

	 	8.2.2	The late-delivery penalty shall be [                    ] off the total
invoice price for every calendar day a shipment exceeds the [                    ] expectation, provided that the aggregate value of such
penalty shall not exceed the total invoice price. 

  

					
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	 	8.3	The SKU for the Product and the minimum quantities of SKUs to be provided to OA are specified in Exhibit 5 to this Agreement. Any changes to these must be agreed by both Parties and
OA agrees that its purchase quantities will comply with these minimum quantities and will construct its POs accordingly, however the Parties agree that it may be necessary for OA to purchase quantities of Product less than the minimum quantity in
the Initial Period in accordance with Article 8.11. 

  

	 	8.4	Once a PO is confirmed as received by VGN, such PO is binding and OA may not change or cancel that PO for any reason, except in the case of any material breach of this Agreement by
VGN. Such confirmation must be sent by VGN within 7 days. 

  

	 	8.5	VGN may not cancel any confirmed PO received from OA, except in the case of any material breach of this Agreement by OA. 

  

	 	8.6	The Purchase Price for the Products will be that price in effect on the date each quantity is shipped from VGN and as specified in Exhibit 1 and in Amendments thereto.

  

	 	8.7	OA, at its sole discretion, will select a carrier for temperature-controlled transport of Product to its distribution warehouse(s) from VGN’s manufacturing site in Umeå,
Sweden. Title to Product will pass to OA at the time the Product is delivered to the carrier on the Shipment Date. 

  

	 	8.7.1	VGN will package Product for shipping in appropriate insulated containers with frozen gel packs and a calibrated temperature logger to document temperature during shipment. Should
the Parties agree on a different method of packaging the Product for shipment, an Amendment will be added to the Approved Product Specifications identifying the details of such changes. 

  

	 	8.8	OA will be responsible for payment of all transport costs, including export/import fees, duties, taxes, insurance, Australian Quarantine Inspection Service permits and any other
costs necessary to transport the Product. OA shall supply the Australian Quarantine Inspection Service permits to VGN with each PO and VGN shall complete the Australian Quarantine Inspection Service permits required for shipment of Product and shall
supply such permits with the Product at the time of shipment to OA. 

  

	 	8.9	Product manufactured by VGN is temperature-sensitive and is labeled with temperature storage requirements, in accordance with Registrations. OA acknowledges this fact and will take
this into account when selecting and contracting with a carrier so that Product handled by that carrier is not adulterated via improper storage and shipping conditions with respect to temperature controls. VGN shall not be liable for any damage to
Product, concealed or otherwise, that is due to handling, storage or shipping conditions by the carrier selected by OA or by OA itself. 

  

					
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	 	8.10	VGN shall include with each shipment, and for each Product Lot Number, a certificate of analysis document specifying that the Product has been manufactured in accordance with the
relevant Registration and meets the Approved Product Specifications and as directed by the Technical Agreement between the Parties and attached hereto. 

  

	 	8.11	For the first shipment of Product to OA after the Effective Date, VGN shall supply stock with a remaining shelf-life of a minimum of
[                    ], but for subsequent shipments, VGN shall provide stock of Product with a remaining shelf-life of a minimum of
[                    ], furthermore the time period in which this
[                    ] shall apply shall be mutually agreed upon between the Parties and is defined as the ‘Initial Period’. After
the Initial Period, the Product shelf-life supplied to OA [                    ]. Failure to comply with this and resulting in OA to be left
with out-of-expiry stock will entitle OA to a credit for such stock. 

  

	 	8.12	The Pharmaceutical Benefits Branch (PBB) obligates sponsors to provide them with 6 months notification of lack of supply or cessation of supply of product that has received
Reimbursement Authorisation and that failure to do so will incur financial penalty. VGN is thus obligated to provide OA six months notice of lack of supply or cessation of supply of the Product. 

  

	 	8.13	In relation to clause 8.12, where VGN does not provide such necessary information to OA and OA incurs a penalty from the PBB, OA reserves the right to recoup the penalty fee which
it has suffered. 

  

	 	8.14	VGN shall not be obligated to accept or supply any orders for Products that are in excess of one hundred and thirty percent (130%) of the average quantities of Products ordered
during the two preceding calendar quarters. 

 Article 9: Inspection 
  

	 	9.1	OA and VGN shall each have the right to inspect the other’s facilities, including manufacturing sites, warehouses, distribution centers, laboratories and other areas that are
pertinent to the performance of this Agreement, and as specified under the Technical Agreement between the Parties. 

  

	 	9.1.1	Each Party shall provide sufficient notice of its intent to conduct facility inspections at least sixty (60) days prior to the intended inspection date.

  

	 	9.1.2	Facility inspections may be carried out only during normal operating hours and on normal operating days for each facility and in each geographic location. 

 

	 	9.1.3	The Parties agree to follow the respective standard operating procedures in effect at facilities to be inspected with respect to escorts, requests for documents and any other
aspects pertaining to facility inspections that may be in effect or revised from time to time. No photographs or films of any type shall be permitted of the respective facilities. 

  

					
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	 	9.1.4	Upon completion of any such inspection, the Parties shall meet to discuss any relevant findings from such inspections. 

  

	 	9.1.5	In the event any documented report is generated as the result of facility inspection, each Party will ensure that the other party receives a full and complete copy of such
documentation for its records and shall ensure such documentation is conspicuously marked as “Confidential”. 

  

	 	9.2	OA, at its sole discretion, may elect to inspect, or have inspected, any shipment of Product from VGN, within 30 days of receipt, to determine compliance with the Approved Product
Specifications. 

  

	 	9.3	OA shall ensure that any such inspection is in accordance with the methods and procedures of analysis that are approved in the Registration for the Territory.

  

	 	9.4	OA will notify VGN in writing of inspection results that meet Approved Product Specifications, for each Product lot number it receives, should it elect to inspect such Product.

  

	 	9.5	In the event that OA determines that any shipment of Product fails to meet the Approved Product Specifications, excluding any failure that could be assigned to the storage, handling
or delivery by the carrier, OA will immediately notify VGN in writing. VGN will cooperate with OA to confirm and determine the cause of the alleged specification failure. 

  

	 	9.6	OA agrees to provide representative samples of what it believes to be defective Product to VGN for the purposes of inspection by VGN. VGN shall ensure that any such inspection is in
accordance with the methods and procedures of analysis that are approved in the Registration for the Territory. 

  

	 	9.6.1	In the event VGN’s test results confirms the failure and VGN determines reasonably that it is responsible for the failure, then VGN will replace the shipment of Product to OA
at the earliest possible date at no additional charge to OA, including direct costs of Product, freight, duty, taxes, that OA has already paid for the initial shipment. 

  

	 	9.6.2	In the event OA determines reasonably that OA or its carrier is responsible for the failure, OA shall be responsible for any and all direct costs associated with the testing,
disposition and replacement of the subject Product and for seeking compensation from its carrier. 

  

	 	9.7	If VGN cannot confirm the alleged specification failure, or if the Parties fail to agree on the data generated by VGN, then the parties agree to have the Product inspected by a
mutually agreeable independent third party. 

  

	 	9.8	OA agrees to provide additional samples as may be necessary for the third party to conduct the necessary inspection. 

  

					
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	 	9.9	The Parties agree that the results of the independent third party, excluding the event of manifest error made and identified by the independent third party or either Party, shall be
final and binding. 

  

	 	9.10	In the event that OA is found to be in error in determining the specification failure, OA shall accept the independent third party inspection for the purposes of documenting the
inspection and releasing the subject Product for sale in the Territory. In this event, OA agrees to reimburse VGN for its costs of inspection and to pay the independent third party inspection costs. 

  

	 	9.11	In the event that VGN is found to be in error, VGN agrees to reimburse OA for its costs of inspection and to pay the independent third party inspection costs.

  

	 	9.11.1	VGN will replace the subject Product at no cost to OA, including all direct costs associated with shipment and delivery, including duties and taxes which would otherwise have been
paid by OA, provided that OA has already paid for the original shipment. The Parties will cooperate with one another on the best manner in which to pay these costs. 

  

	 	9.11.2	VGN will not accept any returns of Product for any reason. VGN agrees to reimburse OA for reasonable costs of destruction of Product which fail to meet the Approved Product
Specifications or which may be recalled due to the fault of VGN and when destroyed in a manner consistent with VGN’s prevailing procedures or as mutually agreed by the Parties, according to local law. OA will provide copies of the destruction
records, and charges, to VGN on a timely basis. Any and all other Product returns are the responsibility of OA. 

  

	 	9.11.3	VGN will use its best efforts to replace Product confirmed to fail the Approved Product Specifications at the earliest possible date to provide OA with supply.

  

	 	9.11.4	Neither VGN nor OA shall be liable to one another for any lost sales or lost sales opportunity for any reason. 

  

	 	9.12	OA undertakes not to sell any Product that is determined as being in any way defective or which fails to meet the Approved Product Specifications. 

 Article 10: Purchase Price and Payment 
  

	 	10.1	Purchase Prices for Products to be sold in the Territory are shown in Exhibit 1 to this Agreement and Amendments thereto. 

  

	 	10.2	Payment for Product ordered by OA and delivered by VGN is due in full within
[                    ] of shipment of Product from VGN’s manufacturing site. On the Shipment Date, VGN shall submit to OA with the
shipment an invoice for payment and via electronic mail or facsimile. 

  

					
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 Information marked below by a
[                    ] has been omitted pursuant to a request for confidential treatment filed separately with the Commission 
  

	 	10.3	OA shall pay the full amount, in $ AUS, on each invoice to VGN by a means mutually agreeable to the Parties (wire-transfer, company check, etc.). 

  

	 	10.4	For any invoice against which OA fails to pay the full amount within the
[                    ] period, a late-payment penalty shall be assessed beginning on day
[                    ]. The late-payment penalty shall be
[                    ] of the total invoice amount for each day beyond the
[                    ] day, provided that the aggregate value of such penalty shall not exceed the total invoice price.

 Article 11: Selling, Marketing and Distribution 
  

	 	11.1	OA agrees to use reasonable commercial efforts, customary in the trade, to market, sell and distribute the Product in order to maximize market penetration in the Territory and to
achieve or exceed the Annual Product Forecast. 

  

	 	11.2	OA shall negotiate market pricing for the Product in each Country in the Territory. 

  

	 	11.3	VGN has established a reimbursement price with the Swedish authorities and will report this information, including any rationale for the requested reimbursement price, to OA.

  

	 	11.4	OA will market, sell and distribute the Product only in the Territory specified in this Agreement. OA hereby agrees to take all necessary actions to prevent the Product purchased by
OA from being sold, marketed or distributed to any other territory. In the event OA determines by any means that the Product is or is likely to be distributed outside the Territory but from its purchased inventories, OA will immediately notify VGN
and the Parties will mutually determine the most appropriate course of action to bring such unauthorized distribution to a halt. VGN will take all necessary and possible actions to prevent the Product from being sold or offered for sale in the
Territory by any third party from outside the Territory to ensure OA its licensed exclusivity. 

  

	 	11.5	OA will sell, market and distribute the Product in complete compliance with all applicable local laws and regulations that pertain to prescription products, and will not sublicense
its rights to the Product to any third parties. OA will take all necessary actions to ensure that its selling, marketing and distribution practices are in compliance with the United States Foreign Corrupt Practices Act, or equivalent Act(s)
or regulations as may apply throughout the Territory, 

  

	 	11.6	OA shall be responsible for all advertising and promotional materials in accordance with this Agreement and prevailing regulations in each Country in the Territory.

  

	 	11.7	Product will be marketed using the Licensed Marks established by VGN. VGN shall be solely responsible for registering and maintaining its brand names, designs, trademarks and
copyrights according to local and international laws and regulations, and at its own expense. 

  

					
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 Information marked below by a
[                    ] has been omitted pursuant to a request for confidential treatment filed separately with the Commission 
  

	 	11.8	Promotional materials shall include both VGN (or ViraNative AB) and OA information, with OA information remaining dominant. Labeling and packaging 

 printing shall include any information required by local authorities under the Registration and Market Authorization. 
  

	 	11.9	VGN will provide assistance to OA on a reasonable basis for training of sales and marketing personnel with respect to Product features, benefits and attributes that are in
VGN’s possession and that are in the English language. OA will be responsible for expenses relating to travel and accommodation for its own staff to attend such training and VGN for the remaining expenses. VGN shall also make available to OA
its consultants and advisory clinicians to assist in developing the marketing and promotional materials, to the extent necessary and feasible, under VGN’s consulting agreements with such third parties. 

 Article 12: Product Improvements 
  

	 	12.1	This Agreement contemplates OA marketing the Product for
[                    ]. In the event that either or both Parties decide to develop new indications outside of
[                    ] for the Product that requires a different dosage form (defined herein as New Product) in the Territory, then the
provisions of this Article 12 shall govern the use of such New Products. 

  

	 	12.2	VGN shall have the right, at its sole discretion, to conduct research and/or development studies on the Product at its own costs and for any purpose. 

  

	 	12.3	In the event that any Product Improvement is required by Registration Authorities in order to maintain the approval status for the Product, VGN shall be responsible for development
and registration costs. The Parties agree to cooperate with one another to determine the most appropriate Registration activity and the costs of such Registration activities shall be the responsibility of VGN. 

  

	 	12.4	In the event VGN decides to develop a New Product, and does so at its own expense, then OA shall have a right of first refusal to license said improvement for the Territory under
terms and conditions to be negotiated between the Parties, as an Amendment to this Agreement 

  

	 	12.5	In the event OA decides it has no interest in the New Product itself,
[                    ]. 

  

	 	12.6	[                    ]. 

  

	 	12.7	In the event that the Parties decide to develop a New Product and OA agrees to fund the costs of development and registration, including any clinical trials required, this
improvement shall be incorporated into this Agreement via an Amendment, without any additional license fees or milestone payments being required of OA. 

  

					
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	 	12.8	In the event that VGN determines that it will be possible to use the OA-funded clinical trial data to seek Market Authorizations for a new indication outside the Territory, then the
Parties shall meet and negotiate in good faith a new agreement on the sharing of any financial benefit ultimately realized by VGN outside the Territory and pertaining specifically to the new indication. Otherwise, VGN shall not make use of any
OA-funded clinical trial data that results in a direct financial benefit to VGN. 

  

	 	12.9	In the event that OA decides to conduct clinical trials with the Product at its own expense in the Territory in any indication for the Product, OA shall communicate its plans to VGN
in advance, and permit VGN to contribute to the design of the trial, at its own expense. OA shall provide full and complete copies of any clinical trial data to VGN at no charge to VGN for the express purpose of adding the trial data to the
Registration dossier outside the Territory as evidence of additional clinical experience. 

 Article 13: Customer Complaints, Adverse Events
and Product Recalls 
  

	 	  	NOTE: For detailed requirements on Customer Complaints, Adverse Events and Product Recalls, refer to the Safety Agreement between the Parties. 

  

	 	13.1	With the exception of a Product Recall action, further defined in this Article 13, OA is solely responsible for documenting, tracking, investigating and handling all Customer
Complaints in the Territory at its own cost. 

  

	 	13.2	In the event that the Parties agree that a Product Recall is necessary, OA shall control and be responsible for all necessary local actions to affect the Product Recall. OA shall be
responsible for all local costs associated with effecting and reporting Product Recall actions, excluding situations where Article 13.4 applies. 

  

	 	13.3	VGN shall be responsible for coordination, with assistance of OA, in the investigation of the cause of the Product Recall and identifying appropriate corrective actions to permit OA
to continue selling, marketing and distributing the Product in the Territory. 

  

	 	13.4	In the event the investigation identifies that VGN is at fault for the Product Recall, VGN shall reimburse OA for all direct costs associated with the Product Recall, including cost
of goods recalled, shipping costs for returns from customers, notification costs and all other costs that are reasonable, customary and direct in nature. VGN shall not be liable to OA for lost sales or lost sales opportunity as a result of a Product
Recall. 

  

	 	13.5	In the event the investigation identifies that OA is at fault for the Product Recall, OA shall be responsible for all costs associated with the Product Recall, including the
purchase of replacement product and all customer costs associated with the Product Recall, as is customary in the trade/business in the Territory. 

  

					
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 Article 14: Public Disclosure 
  

	 	14.1	Neither Party to this Agreement shall make any disclosure to the public, to stockholders or to other parties that may be expected to be disclosed to the public without the express
written consent of the other Party. 

  

	 	14.2	Any press release naming the Parties to this Agreement, or using the Licensed Marks and disclosing any information pertaining to the Agreement itself, must be approved prior to
issuance by both Parties and in writing. 

  

	 	14.3	In the event that either Party is compelled by local laws or regulations to disclose information about this Agreement in such a manner as would be likely viewed as a public
disclosure by the other Party, the disclosing Party must immediately notify the other Party so that the non-disclosing Party may take any permissible and necessary actions to preclude the disclosure to the extent possible. 

 

	 	14.4	These restrictions on disclosure do not apply to compliance with local laws and regulations which may mandate the naming of VGN as the manufacturer of Products in order to submit
Registrations and achieve Market Authorizations or any other similar compliance matters. Both parties acknowledge that this Agreement or portion thereof may be disclosed as required by law, including but not limited to, the requirements of the
United States Securities and Exchange Commission. 

 Article 15: Term and Termination 
  

	 	15.1	This Agreement shall become effective on the Effective Date, and in the case of Amendments, on the date last signed by the Parties thereto. 

  

	 	15.2	The Term of this Agreement shall be for not less than the date falling 10 years from the Effective Date, or an extended time period as may be mutually agreed in writing by the
Parties hereto. 

  

	 	15.3	OA may terminate this Agreement upon ninety (90) days prior notice to VGN in the event that VGN becomes the subject of regulatory action from any regulatory authority that
causes an interruption in the manufacturing or supply of Products to OA in excess of ninety (90) days; 

  

	 	15.4	OA may also terminate this Agreement upon ninety (90) days prior notice to VGN in the event of any of the following conditions 

  

	 	15.4.1	In the event that VGN is found to be in breach of this Agreement and fails to cure such breach within 90 days of receipt of written notification from OA; 

 

	 	15.4.2	In the event that VGN is unable to supply Product within the time set out herein excluding reasons of Force Majeure; 

  

	 	15.4.3	In the event that VGN declares insolvency, bankruptcy or otherwise ceases its business activities; 

  

					
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 Information marked below by a
[                    ] has been omitted pursuant to a request for confidential treatment filed separately with the Commission 
  

	 	15.4.4	In the event that the documents required for Registration for the Product have not been provided by VGN to OA within
[                    ] of the Effective Date of the Agreement. 

  

	 	15.5	VGN may terminate this Agreement upon ninety (90) days prior notice to OA in the event of any of the following conditions with termination being effective only in the Country
or Countries where such condition occurs: 

  

	 	15.5.1	In the event that OA fails to file an application for Reimbursement Authorization in any Country within the Territory within
[                    ] from the date of Market Authorization in that Country, then that Country may be terminated with respect to this
Agreement; 

  

	 	15.5.2	In the event that OA is unable, for any reason (except out of stock of Product), following Reimbursement Authorization, to achieve sales in a Country in the Territory
[                    ], then that Country may be terminated with respect to this Agreement; 

  

	 	15.5.3	Pursuant to Article 4.8, in the event that OA fails to adhere to the Marketing Plan for the Product in any Country where OA does not achieve purchases of Product of
[                    ], VGN may terminate this Agreement with ninety (90) days written notice to OA, provided OA has not cured
such failure within said 90-day period. 

  

	 	15.5.4	In the event of failure by OA to comply with local laws and regulations as pertains to the selling, marketing and distribution of Products in any Country in the Territory and do not
rectify the event within 60 days of notice; 

  

	 	15.6	VGN may also terminate this Agreement upon ninety (90) days prior notice to OA in the event of any of the following conditions: 

  

	 	15.6.1	In the event that OA is found to be in breach of this Agreement and fails to cure such breach within 90 days of receipt of written notification from VGN; 

 

	 	15.6.2	In the event of the failure by OA to make payments to VGN, in accordance with this Agreement, its Exhibits and its Amendments; 

  

	 	15.6.3	In the event that OA declares insolvency, bankruptcy or otherwise ceases its business activities; 

  

	 	15.6.4	In the event that all or a portion of the business of OA, that pertains to the Product licensed from VGN, is acquired by or otherwise transferred to a third party that VGN
reasonably finds objectionable on a competitive basis. 

  

					
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	 	15.7	Effects of Termination, whether for the entire Territory defined by this Agreement, its Exhibits and its Amendments, or for an individual Country within the Territory, shall be as
agreed upon by the parties to their mutual benefit, with the exception of the rights to the Product. In the event of termination by either party and for any reason, the rights to the Product shall reside with VGN, and VGN shall be free of any
encumbrance to utilize its rights to the Product to its own benefit, in its sole discretion. 

  

	 	15.7.1	Upon termination by either party in accordance with this Agreement, the respective parties reserve all rights afforded to them under prevailing law. 

 Article 16: Representations and Warranties 
  

	 	16.1	Each Party to this Agreement hereby represents and warrants that it has the authority to enter into this Agreement and to execute its responsibilities as contemplated and
specifically stated in this Agreement and that in doing so it will not be in violation of any local laws, regulations or its own bylaws of incorporation. 

  

	 	16.2	VGN hereby represents and warrants that the Product it sells to OA shall, at the time of consignment to the carrier selected by OA meet all the applicable and Approved Product
Specifications throughout the labeled expiry date. VGN makes no representations and warranties once possession passes to OA, including fitness for use for any purpose. 

  

	 	16.3	OA hereby represents and warrants to VGN that it will ship, store, sell, market and distribute the Product in accordance with all local laws and regulations and in accordance with
the Marketing Plan(s) and will not cause any such Product to become adulterated or defective as a result of negligence on the part of OA. 

  

	 	16.4	OA hereby represents and warrants that it will market the Product in an ethical manner so as to properly position the Product among the competition in the Territory and will not
market the Product as a “loss leader” among its other products or among existing competitive products, but will actively and continuously promote the features and benefits of the Product in order to achieve or exceed the Annual Product
Forecasts. 

  

	 	16.5	The Parties make no other representations and warranties to one another under this Agreement. 

 Article 17: Indemnification 
  

	 	17.1	VGN shall hold harmless OA, its affiliates, officers, directors and its employees and shall indemnify same with respect of all claims, liabilities, costs, damages and expenses
(including reasonable attorney’s fees and expenses) arising from any act of negligence or omission of VGN in the performance of its obligations under this Agreement, including any claims in respect of personal injury or death as a result of use
of a Product that fails to meet the Approved Product Specifications as a result of negligence or willful misconduct on the part of VGN. 

  

					
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	 	17.2	OA shall hold harmless VGN, its affiliates, officers, directors and its employees and shall indemnify same with respect of all claims, liabilities, costs, damages and expenses
(including reasonable attorney’s fees and expenses) arising from any act of negligence or omission of OA in the performance of its obligations under this Agreement. 

 Article 18 Insurance 
  

	 	18.1	VGN shall effect and maintain in force a policy of insurance in the joint names of OA and VGN with a reputable product liability insurance company in the sum of US $5,000,000 for
any one claim and for each claim against any damages, liabilities, claims and costs arising from any of the causes events or circumstances referred to in Clause 17.1 and with an endorsement thereon that the insurer will not cancel the policy for any
reason whatsoever without first giving VGN not less than thirty days’ notice in writing of its intention to cancel the policy. 

 Article 19: Assignment 
  

	  	This Agreement may not be assigned by either Party to any third party without the express written consent of the other Party, except to the successors of all or a majority of the
business of OA or VGN. 

 Article 20: Confidentiality 
  

	 	20.1	The Parties hereto acknowledge that the execution of this Agreement will require the disclosure by each Party of certain Confidential Information, whether before, on or after the
Effective Date. Such Confidential Information may be in written, oral or electronic form and may or may not be conspicuously marked as “Confidential”. Therefore the Parties hereby agree, 

  

	 	20.1.1	To keep the other Party’s Confidential Information confidential at all times and to ensure that its agents, representatives, employees and sub licensees who may have access to
the Confidential Information are likewise restricted as to their disclosure of such information; 

  

	 	20.1.2	To only disclose Confidential Information to permitted sub licensees or respective responsible employees or contractors who are directly involved in the use of the Product in
accordance with this Agreement and need to know same for performance of their duties; 

  

	 	20.1.3	Ensure that Confidential Information of the other Party is protected to the same degree that it would protect its own Confidential Information. 

  

	 	20.2	In the event that a Party is required by law or government regulations to disclose Confidential Information of the other Party, it shall promptly notify the other party of the
requirement, use reasonable efforts to limit such disclosure and permit the other Party to attempt to limit the disclosure by appropriate and valid means. No such disclosure shall be made without prior notification to the other Party.

  

					
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	 	20.3	Nothing in this Agreement shall prohibit either party from complying fully with all requirements of the Securities and Exchange Commission (SEC), or equivalent international body or
agency. Wherever possible, the disclosing party shall take all precautions possible, including the redaction of Confidential Information, or portions thereof, so as to protect the interests of the other Party to the extent permitted by law.

  

	 	20.4	These provisions of confidentiality shall remain in effect from the Effective Date, throughout the Term of this Agreement for each Territory, and shall remain in effect for not less
than three (3) years following the expiration or termination of this Agreement. 

 Article 21: Patent, Trademark and Copyrights

  

	 	21.1	VGN confirms that it owns and controls the rights to the patents, trademarks and copyrights pertaining to the Product in the Territory that are the subject of this Agreement
(attached hereto as Exhibits, and as may be amended from time to time). 

  

	 	21.2	VGN has not received written notification that legal proceedings have been commenced, or are expected to be commenced, in which there may be assertions of infringement by VGN, of
the patents, trademarks or copyrights of any third party in the Territory; 

  

	 	21.3	VGN has not received notification of alleged infringement by any third party in which the validity of any of the patents, trademarks or copyrights owned by VGN in the Territory are
challenged; 

  

	 	21.4	VGN has not received notification that legal proceedings have been commenced by any third party in which the validity of any of the patents, trademarks or copyrights owned by VGN in
the Territory, are challenged; 

  

	 	21.5	VGN confirms that it has not licensed any rights to any third party for the use of patents, trademarks or copyrights pertaining specifically to the Product in the Territory that are
the subject of this Agreement, nor will it do so throughout the Term of this Agreement. 

  

	 	21.6	In the event, during the Term of this Agreement, either party becomes aware of any action by a third party alleging infringement, invalidity or inapplicability of VGN patents,
trademarks or copyrights in the Territory, the other Party shall be notified in writing. VGN shall have the right to defend its patents, trademarks and copyrights, at its own costs, and shall control such defense. 

  

	 	21.6.1	In the event that VGN elects not to defend its patents, trademarks or copyrights in any Territory, then OA shall have the right to conduct and control its own defense, as permitted
by local laws and regulations. VGN shall cooperate with such defense, but shall not be responsible for any associated expenses. 

  

	 	21.6.2	Any award granted in the defense of patents, trademarks or copyrights shall be made to the party who pays for the defense. 

  

					
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	 	21.6.3	In certain situations, the Parties may elect to jointly defend the patents, trademarks or copyrights and to share the expenses, as may be mutually agreed. In this event, any award
will be shared by the Parties, in proportion to the percentage of expenses paid, respectively. 

 Article 22: Force Majeure 

 

	  	Force Majeure means any event which arises from or is attributable to acts, events; omissions or accidents beyond the reasonable control of a Party including strikes, lock-outs or
other industrial disputes (whether involving the workforce of the Party so prevented or of any other party), acts of God, war, terrorism, riot, civil commotion, malicious damage, compliance with any law or governmental order, rule, regulation or
direction, accident, breakdown of plant or machinery, fire, flood, or storm or default of suppliers or sub-contractors liable to affect materially performance of this Agreement. 

  

	 	22.1	If either Party is prevented, hindered or delayed from or in performing any of its obligations under this Agreement (other than an obligation to pay money) by Force Majeure, then:

  

	 	22.1.1	That Party’s obligations under this Agreement shall be suspended for so long as the Force Majeure continues and to the extent that the Party is so prevented, hindered or
delayed, provided that if any event of Force Majeure continues for a period of or exceeding (6) months, the aggrieved party shall have the right to terminate this Agreement forthwith by written notice to the other party.

  

	 	22.1.2	As soon as reasonably possible and in any event within five calendar days after commencement of the Force Majeure, that Party shall notify the other Party in writing of the
occurrence of the Force Majeure, the date of commencement of the Force Majeure and the effects and likely duration of the Force Majeure on its ability to perform its obligations under this Agreement; and 

  

	 	22.1.3	As soon as reasonably possible and in any event within five calendar days of cessation of the Force Majeure, that Party shall notify the other Party in writing of the cessation of
the Force Majeure and shall resume performance of its obligations under this Agreement. 

  

	 	22.2	The Party claiming to be prevented, hindered or delayed in the performance of any of its obligations under this Agreement by reason of Force Majeure shall use reasonable endeavors
without being obliged to incur any expenditure or cost to: 

  

	 	22.2.1	Mitigate the effects of the Force Majeure upon the performance of its obligations under this Agreement; and 

  

	 	22.2.2	Bring the Force Majeure event to an end or find a solution by which the Agreement may be performed despite the continuance of the Force Majeure event. 

  

					
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 Article 23: Entire Agreement 
  

	 	23.1	Each of the Parties agrees that in entering into this Agreement it does not rely on, and has no remedy in respect of, any statement, expression of opinion, representation, warranty
or understanding (whether negligently or innocently made) of any person other than as expressly set out in this Agreement. 

  

	 	23.2	This Agreement and the Safety Agreement and the Technical Agreement, constitute the entire and only agreements and understanding of the Parties, and supersedes any previous
agreement or understanding between the Parties (and either of them), relating to the subject matter of this Agreement. 

  

	 	23.3	Nothing in this Article shall operate to limit or exclude any liability for fraud. 

 Article 24: Dispute Resolution 
  

	 	24.1	Any disputes concerning the respective Parties’ performance under this Agreement, if not specifically called out in this Agreement, shall be addressed by the Presidents of the
Parties or officer of equivalent standing. 

 Article 25: Waivers 
  

	 	25.1	A waiver of any term, provision or condition of, and any consent granted under, this Agreement will be valid only if it is in writing, signed by the Party giving the waiver or
granting the consent. Any such waiver or consent will be valid only in the particular instance and for the particular purpose for which it is given and will not constitute a waiver of any other right or remedy. 

  

	 	25.2	Any failure (in whole or in part) to exercise or delay in exercising any right, power or remedy (“Right”) available under this Agreement or in law will not constitute a
waiver of that or any other Right nor will any single or partial exercise of any Right preclude any other or further exercise of any other Right. The rights and remedies provided by this Agreement are cumulative and (unless otherwise expressly
stated in this Agreement) do not exclude any other rights or remedies available in law. 

 Article 26: Invalidity 
  

	 	26.1	If any provision of this Agreement is or becomes invalid or unenforceable, in whole or in part, in any jurisdiction, the validity and enforceability of the other provisions of this
Agreement and its validity and enforceability in any other jurisdiction shall not be affected. 

  

	 	26.2	If any provision of this Agreement is or becomes, in whole or in part, invalid or unenforceable but would be valid or enforceable if some part of that provision was deleted, that
provision shall apply with such deletions as may be necessary to make it valid. 

  

	 	26.3	The Parties agree, in the circumstances referred to in Article 26.1 and if Article 26.2 does not apply, to attempt to substitute for any invalid or unenforceable provision a valid
or enforceable provision which achieves to the greatest extent possible the same effect as would have been achieved by the invalid or unenforceable provisions. 

  

					
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 Article 27: No Partnership 
  

	  	This Agreement is not intended to and does not operate to create a partnership or joint venture between the Parties, or to authorize any Party to act as agent for the other, and
neither party shall have authority to act in the name or on behalf of or otherwise to bind the other Party in any way (including by making any representation or warranty, assuming any obligation or liability and exercising any right or power, unless
otherwise authorized herein). 

 Article 28: Notices 
  

	  	Any communication, including any notice or demand, under or in connection with this Agreement must be in writing, in English, and will be deemed to be validly served if delivered
personally or sent by fax, e-mail, by registered air mail (or as otherwise specified in this Agreement): 

  

	  	In the case of VGN, to: 

 Viragen, Inc. 
 865 SW 78th Avenue

 Suite 100 
 Plantation, FL
33324 
 (954) 233-1414 
 Marked
in each case for the attention of: Mr. Charles A. Rice 
 e-mail address: crice@viragen.com 
 In the case of OA, to: 
 Orphan Australia

 48 Kangan Drive 
 Berwick 3806

 Australia 
 Tel +61 3 9769 5744

 F +61 3 9769 5944 
 Marked in
each case for the attention of: Mr John Michailidis 
 Email address: john.michailidis@orphan.com.au 
 Article 29: Governing Law 
  

	  	This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, USA. 

  

					
		 	Orphan Australia Pty. Ltd.	  	Viragen International, Inc.
			
	      By:	 	 /s/ Alastair Young
	  	 /s/ Charles A. Rice

  

					
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		 	 Alastair Young
	  	 Charles A. Rice

		 	(Name)	  	(Name)
			
		 	 Managing Director
	  	 President & CEO

		 	(Title)	  	(Title)
			
		 	 December 22, 2006
	  	 December 21, 2006

		 	(Date)	  	(Date)

  

					
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	  	25	  	

 INDEX 
  

					
	 Article No.
	  	Page No.
	 1.
	 	Definitions	  	1
	 2.
	 	License Fee and Milestone Payment	  	5
	 3.
	 	Registration of the Product	  	5
	 4.
	 	Market Analysis/Marketing Plans	  	5
	 5.
	 	Registration	  	7
	 6.
	 	Market Authorization	  	7
	 7.
	 	Annual Product Forecasts	  	8
	 8.
	 	Orders and Delivery of Products	  	9
	 9.
	 	Inspection	  	11
	 10.
	 	Purchase Price and Payment	  	13
	 11.
	 	Selling, Marketing and Distribution	  	14
	 12.
	 	Product Improvements	  	15
	 13.
	 	Customer Complaints, Adverse Events and Product Recalls	  	16
	 14.
	 	Public Disclosure	  	17
	 15.
	 	Term and Termination	  	17
	 16.
	 	Representations and Warranties	  	19
	 17.
	 	Indemnification	  	19
	 18.
	 	Insurance	  	20
	 19.
	 	Assignment	  	20
	 20.
	 	Confidentiality	  	20
	 21.
	 	Patent, Trademark and Copyrights	  	21
	 22.
	 	Force Majeure	  	22
	 23.
	 	Entire Agreement	  	23
	 24.
	 	Dispute Resolution	  	23
	 25.
	 	Waivers	  	23
	 26.
	 	Invalidity	  	23
	 27.
	 	No Partnership	  	24
	 28.
	 	Notices	  	24
	 29.
	 	Governing Law	  	24
	 30.
	 	Exhibit 1	  	27
	 31.
	 	Exhibit 2	  	29
	 32.
	 	Exhibit 3	  	30
	 33.
	 	Exhibit 4	  	31
	 34.
	 	Exhibit 5	  	33

  

					
	 Viragen International, Inc. & Orphan Australia Pty. Ltd.
 License Agreement
	  	26	  	

 Information marked below by a
[                    ] has been omitted pursuant to a request for confidential treatment filed separately with the Commission 
 Exhibit 1 
 License and Supply
Agreement 
 Viragen and Orphan Australia 
 License Fee, Milestone Payment and Product Purchase Price 
  

	1.	In recognition of the exclusive license to the patents, trademarks, know-how and Improvements to the Product, within the Territory, Orphan Australia shall pay to Viragen within 48
hours of the last date signed below, a License Fee of [                    ]. 

  

	2.	Upon achievement of [                    ], Orphan Australia shall pay to
Viragen, within 3 calendar days of receipt of documented notification, a milestone payment of [                    ].

  

	3.	Upon the completion of [                    ], Orphan Australia shall pay
to Viragen a milestone payment equal to [                    ], or equal to
[                    ] of the
[                    ], whichever is greater. 

 NOTE: License Fee and Milestone payments shall be made via wire transfer to an account identified by Viragen in the USA. 
  

	4.	For the first [                    ] period following Reimbursement
Authorization in Australia, the purchase price for the Product shall be [                    ]. 

  

	5.	After the first [                    ] period, VGN may notify OA of an
annual price increase which shall be no greater than [                    ]. 

  

	6.	In the event that OA elects to conduct and fund clinical trials in the Territory, and in agreement with VGN, VGN shall provide the Product to be used in such trials to OA
[                    ] Clinical trials may also include “local experience trials”, whereby a leading hospital or clinician may want
to gain experience with the Product by treating one or two patients. However, this “local experience trial” should not be used extensively. 

  

	7.	In the event the Parties agree in writing to amend the definition of the Territory to add new Countries to the License Agreement, Orphan Australia shall make additional milestone
payments to Viragen upon achievement of [                    ] in each of those Countries in the amount of
[                    ]. 

  

					
	 Viragen International, Inc. & Orphan Australia Pty. Ltd.
 License Agreement
	  	27	  	

							
	Orphan Australia Pty. Ltd.	 		 	Viragen International, Inc.
				
	By:	 	 /s/ Alastair Young
	 		 	 /s/ Charles A. Rice

				
		 	 Alastair Young
	 		 	 Charles A. Rice

		 	(Name)	 		 	(Name)
				
		 	 Managing Director
	 		 	 President & CEO

		 	(Title)	 		 	(Title)
				
		 	 December 22, 2006
	 		 	 December 21, 2006

		 	(Date)	 		 	(Date)

  

					
	 Viragen International, Inc. & Orphan Australia Pty. Ltd.
 License Agreement
	  	28	  	

 Information marked below by a
[                    ] has been omitted pursuant to a request for confidential treatment filed separately with the Commission 
 Exhibit 2 
 License and Supply
Agreement 
 Viragen and Orphan Australia 
 Territory 
 The “Territory” shall be defined as Group 1 and Other Countries: 
  

	1.	Group 1 shall be comprised of Australia and New Zealand. It is understood that the decision to file applications for Market Authorization and Reimbursement in New Zealand will be
considered in light of estimated commercial returns and the changing regulatory environment between Australia and New Zealand. OA will endeavor to achieve named-patient sales in New Zealand until such a time as the Parties mutually agree on a
regulatory and commercial strategy for that Country. 

  

	2.	Other Countries may include, but may not be limited to,
[                    ]. 

  

							
	Orphan Australia Pty. Ltd.	 		 	Viragen International, Inc.
				
	By:	 	 /s/ Alastair Young
	 		 	 /s/ Charles A. Rice

				
		 	 Alastair Young
	 		 	 Charles A. Rice

		 	(Name)	 		 	(Name)
				
		 	 Managing Director
	 		 	 President & CEO

		 	(Title)	 		 	(Title)
				
		 	 December 22, 2006
	 		 	 December 21, 2006

		 	(Date)	 		 	(Date)

  

					
	 Viragen International, Inc. & Orphan Australia Pty. Ltd.
 License Agreement
	  	29	  	

 Exhibit 3 
 License and Supply Agreement 
 Viragen and Orphan Australia 
 Intellectual Property 
 The following trademark
registrations and applications and granted and pending patents are provided under the terms of this Agreement to which this Exhibit is appended. 
 Trademarks: 
  

			
	Multiferon®	 	Australia: Application No. 1143153
		 	Applied for: 26th October 2006
		
		 	New Zealand: Application No. 757849
		 	Applied for 27th October 2006

  

			
	Multiferon....The Natural Choice®	 	Applied for in Australia and New Zealand, application numbers to be advised.

 Patents and Patent Applications: 
 Methods and Uses of Antibodies in the Purification of Interferon, WO 06/000471, Filed 13th Feb 2006, Pending. Note only the future regional applications pertaining to the Territory shall be licensed under the terms of this Agreement. 
  

							
	Orphan Australia Pty. Ltd.	 		 	Viragen International, Inc.
				
	By:	 	 /s/ Alastair Young
	 		 	 /s/ Charles A. Rice

				
		 	 Alastair Young
	 		 	 Charles A. Rice

		 	(Name)	 		 	(Name)
				
		 	 Managing Director
	 		 	 President & CEO

		 	(Title)	 		 	(Title)
				
		 	 December 22, 2006
	 		 	 December 21, 2006

		 	(Date)	 		 	(Date)

  

					
	 Viragen International, Inc. & Orphan Australia Pty. Ltd.
 License Agreement
	  	30	  	

 Information marked below by a
[                    ] has been omitted pursuant to a request for confidential treatment filed separately with the Commission 
 Exhibit 4 
 License and Supply
Agreement 
 Viragen and Orphan Australia 
 Product Specification 
 Drug Product Quality Specification, SP-BN 12 
 A clear colourless solution containing no visible particles, in 1 ml type 1 glass syringes. 
 The quality specification of the drug product is provided in Table 1. 
  

			
	Table 1	 	Analytical procedures and acceptance criteria for routine control of the drug product.

  

			
	 Test and method
	  	 Acceptance criteria

	[                    ]	  	
	[                    ]	  	[                    ]
	[                    ]	  	[                    ]
		
	[                    ]	  	
	[                    ]	  	[                    ]
		
	[                    ]	  	
	[                    ]	  	[                    ]
	[                    ]	  	[                    ]
	[                    ]	  	[                    ]
		
	[                    ]	  	
	[                    ]	  	[                    ]
		
	[                    ]	  	
	[                    ]	  	[                    ]
		
	[                    ]	  	
	[                    ]	  	[                    ]
		
	[                    ]	  	
	[                    ]	  	[                    ]
		
	[                    ]	  	
	[                    ]	  	[                    ]

  

					
	 Viragen International, Inc. & Orphan Australia Pty. Ltd.
 License Agreement
	  	31	  	

 Information marked below by a
[                    ] has been omitted pursuant to a request for confidential treatment filed separately with the Commission 
  

			
	Table 1	 	Analytical procedures and acceptance criteria for routine control of the drug product.

  

			
	 Test and method
	  	 Acceptance criteria

	[                    ]	  	
	[                    ]	  	[                    ]
		
	[                    ]	  	
	[                    ]	  	[                    ]
		
	[                    ]	  	[                    ]
	[                    ]	  	[                    ]

 [                    ] 
 [                    ] 
 [                    ] 
  

							
	Orphan Australia Pty. Ltd.	 		 	Viragen International, Inc.
				
	By:	 	 /s/ Alastair Young
	 		 	 /s/ Charles A. Rice

				
		 	 Alastair Young
	 		 	 Charles A. Rice

		 	(Name)	 		 	(Name)
				
		 	 Managing Director
	 		 	 President & CEO

		 	(Title)	 		 	(Title)
				
		 	 December 22, 2006
	 		 	 December 21, 2006

		 	(Date)	 		 	(Date)

  

					
	 Viragen International, Inc. & Orphan Australia Pty. Ltd.
 License Agreement
	  	32	  	

 Exhibit 5 
 License and Supply Agreement 
 Viragen and Orphan Australia 
 Stock Keeping Units ‘SKUs’ 
 With respect to
the pre-filled syringe presentation of the Product, a Stock Keeping Unit shall equate to one tray of six (6) syringes. 
 With respect to the ampoule
presentation of the Product, a Stock Keeping Unit shall equate to one tray of five (5) ampoules. 
 The Minimum Quantity of SKUs to be provided to OA
shall be 5,000 SKUs unless otherwise provided for in this Agreement. 
  

									
	Orphan Australia Pty. Ltd.	 		 		 	Viragen International, Inc.
					
	By:	 	 /s/ Alastair Young
	 		 		 	 /s/ Charles A. Rice

					
		 	 Alastair Young
	 		 		 	 Charles A. Rice

		 	(Name)	 		 		 	(Name)
					
		 	 Managing Director
	 		 		 	 President & CEO

		 	(Title)	 		 		 	(Title)
					
		 	 December 22, 2006
	 		 		 	 December 21, 2006

		 	(Date)	 		 		 	(Date)

  

					
	 Viragen International, Inc. & Orphan Australia Pty. Ltd.
 License Agreement
	  	33Safety Agreement between Viragen International, Inc. and Orphan Australia

 Exhibit 10.2 
 Safety Agreement 
 Viragen 
 & 
 Orphan Australia 
  

					
	 1
	  	INTERPRETATION	  	2
			
	 2
	  	PURPOSE	  	6
			
	 3
	  	SCOPE	  	6
			
	 4
	  	LANGUAGE OF ALL EXCHANGE AND TERMINOLOGY	  	6
			
	 5
	  	CONTACT PERSONNEL AND METHODS FOR ADVERSE EVENT TRANSMISSION	  	6
			
	 6
	  	SAFETY DATABASE	  	7
			
	 7
	  	EXCHANGE OF ADVERSE EVENT AND ADVERSE REACTION INFORMATION	  	7
			
	 8
	  	ASSESSMENT OF ADVERSE EVENTS	  	9
			
	 9
	  	SAFETY ISSUES/SIGNALS AND REGULATORY ENQUIRIES INVOLVING SAFETY ISSUES	  	9
			
	 10
	  	REGULATORY AUTHORITY INTERACTION	  	10
			
	 11
	  	MEDICAL INFORMATION/QUESTIONS	  	11
			
	 12
	  	AMENDMENTS TO THIS SAFETY AGREEMENT	  	12
			
	 13
	  	CONFIDENTIALITY	  	12
			
	 14
	  	DURATION AND TERMINATION	  	13
			
	 15
	  	CONSEQUENCES OF TERMINATION	  	13
			
	 16
	  	RESOLVING DISPUTES	  	13
			
	 17
	  	GENERAL PROVISIONS	  	13

 SAFETY AGREEMENT 
 Date: December 22, 2006 
 PARTIES: 
 (1) Viragen International, Inc. a company incorporated in ,Delaware, USA whose registered office is at 865 SW 78th Avenue, Plantation, Florida, USA 33324 (“VGN”); and 
 (2) Orphan Australia PTY LIMITED a company incorporated in Australia whose principal place of business is at 48 Kangan Drive, Berwick, Victoria
3806 Australia (“OA”) 
 RECITALS 
 (A) VGN and OA have entered into the License Agreement (into which this Safety Agreement is hereby incorporated by reference)) and a Technical Agreement in relation to the Product for the Territory. All capitalized
terms used in this document shall have the meaning as set forth in the License Agreement as the guiding document. 
 (B) Pursuant to the
License Agreement the Parties are obligated to enter into this Agreement to provide for the Parties respective obligations in relation to medical information and pharmacovigilance services for the Product. 
 OPERATIVE PROVISIONS 
 1 INTERPRETATION 
  

	1.1	In this Agreement: 

 “Adverse Event”
means, subject to any amendment pursuant to the ICH from time to time, any untoward medical occurrence in a patient or clinical investigator subject administered the Product and which does not necessarily have a causal relationship with this
treatment for which the Product is used. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational)
product, whether or not related to the Product. A preexisting condition that worsened in severity after administration of the Product would be considered an adverse event. As for clinical studies, the definition of an Adverse Event includes any
untoward events occurring at any time after the subject’s formal entry into the study (such as signed informed consent) until the follow-up period as defined in the respective study protocol; 
 “Adverse Reaction” means a response by a patient to the Product which is noxious and unintended and which occurs at doses normally used
in man for prophylaxis, diagnosis or therapy of disease or for the restoration, correction or modification of physiological function; 
 “Awareness (Cognisant) Date” means, subject to any amendment pursuant to the ICH from time to time, the date on which that Party first becomes aware of an Adverse Event or an Adverse Reaction and in relation to a third
party 
  

					
	Viragen International, Inc and Orphan Australia	  	2/15	  	
	Safety Agreement	  		  	

 Representative of a Party such as clinical research organizations or distributors, that have contractual
and/or regulatory obligations to report Adverse Events or an Adverse Reaction to that Party the date on which such third parties first become aware of that Adverse Event or an Adverse Reaction; 
 “Calendar Day” shall mean any and each day of the calendar year. 
 “Confidential Information” means any information which is disclosed to OA by or on behalf of VGN pursuant to or in connection with this
Agreement (whether oral, written, electronic or other form, and whether or not such information is expressly stated to be confidential or marked as such) and includes the safety and pharmacovigilance information for the Product provided to VGN in
accordance with this Agreement but shall not include information provided by VGN to OA concerning the Product which VGN expressly designates in writing as being able to be provided to third parties. 
 “Data Lock Point” means, subject to any amendment pursuant to the ICH from time to time, the last date of the period for which
information is collected in relation to a Periodic Safety Update Report; 
 “ICH” means International Conference on
Harmonisation guidelines including (but not limited to) E2A, E2B, E2C, and E2D as amended and any replacement thereof from time to time; 
 “International Birth Date” means, subject to any amendment pursuant to the ICH from time to time, the date of the grant of the first Marketing Authorisation for the Product in any country worldwide; 
 “License Agreement” means the Agreement defining the exclusive licensing of rights to the Product between VGN and OA; 
 “Medical Information Enquiries” means any enquiry relating to the Product including, but not limited to, clinical and technical
information about the Product and its characteristics. It does not refer to enquiries regarding promotional activities, availability, price or distribution of the Product in the Territory. 
 “Periodic Safety Update Report” means, subject to any amendment pursuant to the ICH from time to time, a safety report generated at set
times and manner according to ICH guidelines for the purpose of demonstrating the current risk/benefit analysis of the Product according to present knowledge and produced to provide a historical perspective on the safety issues surrounding the
Product; 
 “Quarter” means each period of three months ending on 31st March, 30th June, 30th September, and 31st December in each year; 
 “Reference
Safety Information” means the recognised Adverse Reactions to the Product contained in all or any one of VGN’s Developmental Core Safety Information (DCSI) in an investigator’s brochure, VGN’s Company Core Safety Information
(CCSI) in a marketed product Company Core Data Sheet (CCDS) and either VGN’s or OA’s official local product labeling (including the local Summary of Product Characteristics (SPC)); 
  

					
	Viragen International, Inc and Orphan Australia	  	3/15	  	
	Safety Agreement	  		  	

 “Representatives” means the directors, officers, employees, agents and advisors of each
of the Parties or their respective Affiliates; 
 “Safety Issue” means any event, report, data or information which could
cause a re-evaluation of the safety of the Product including, but not limited to, Adverse Events and Adverse Reactions; 
 “Serious
Adverse Event” means, subject to any amendment pursuant to the ICH from time to time, any Adverse Event in relation to any dose of the administered Product that: 
  

	 	•	 	results in death; 

  

	 	•	 	is life threatening; 

  

	 	•	 	requires in-patient hospitalization or prolongation of existing hospitalization; 

  

	 	•	 	results in persistent or significant disability or incapacity; 

  

	 	•	 	is a congenital anomaly or birth defect; or 

  

	 	•	 	requires intervention (devices only). 

 Medical and
scientific judgment should be exercised in deciding whether expedited reporting for the Product is appropriate in other situations, such as medically important events that may not be immediately life-threatening or result in death or hospitalization
but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed above. These should also usually be considered as serious Adverse Events; 
 “Serious Adverse Reaction” means, subject to any amendment pursuant to the ICH from time to time, any Adverse Reaction in relation to any
dose of the administered Product that: 
  

	 	•	 	results in death; 

  

	 	•	 	is life threatening; 

  

	 	•	 	requires in-patient hospitalization or prolongation of existing hospitalization; 

  

	 	•	 	results in persistent or significant disability or incapacity; 

  

	 	•	 	is a congenital anomaly or birth defect; or 

  

	 	•	 	requires intervention (devices only). 

 Medical and
scientific judgment should be exercised in deciding whether expedited reporting for the Product is appropriate in other situations, such as medically important events that may not be immediately life-threatening or result in death or hospitalization
but may jeopardize the patient or may require intervention to prevent one of the other outcomes listed above. These should also usually be considered as serious Adverse Reactions; 
 “Signal” means, subject to any amendment pursuant to the ICH from time to time, an unexpected observation of an event in relation to
treatment with the Product which deviates so much from expectations that it calls for immediate and greater attention, including (but not limited to) unlabelled Adverse Reactions, increased frequency or severity of labelled Adverse Reactions and any
change in the risk/benefit/profile of the Product; 
 “Spontaneous Report” means, subject to any amendment pursuant to the
ICH from time to time, any unsolicited communication to a Party, Regulatory Authority or other person that describes an Adverse Event or an Adverse Reaction in a patient administered the Product, whether alone or together with one or more other

  

					
	Viragen International, Inc and Orphan Australia	  	4/15	  	
	Safety Agreement	  		  	

 medicinal products, and which does not derive from a study or any organized data collection scheme.
Spontaneous reports include reports from health care professionals (medically confirmed reports) and non-health care professionals or consumers (medically unconfirmed reports). All spontaneous reports received from consumers or health care
professionals are considered as suspected Adverse Reactions. Other types of report that qualify for expedited reporting include solicited reports generated by marketing programs or other methods used to encourage contact between the consumers and
either VGN or OA where the information has been obtained additionally to the main purpose of the program, and would most likely not have been the subject of voluntary reporting to a health care professional or the company. Prospective and
retrospective exposure in utero spontaneous reports are collected and followed to obtain outcome information; 
 “Unexpected Adverse
Event/Reactions” means, subject to any amendment pursuant to the ICH from time to time, an Adverse Event or an Adverse Reaction which by its nature or severity is not consistent with information in the current Reference Safety Information;

 “Valid Safety Reports” means, subject to any amendment pursuant to the ICH from time to time, the minimum information
required for expedited reporting which should at least include all of the following: 
  

	 	•	 	an identifiable patient; 

  

	 	•	 	a suspected medicinal product or therapeutic device; 

  

	 	•	 	an identifiable reporter; and 

  

	 	•	 	an Adverse Reaction or an Adverse Event; 

 “VGN’s Countries” means any country outside the Territory where VGN or its Affiliates or their representatives is the holder of the Marketing Authorisation for the Product; 
  

	1.2	In this Agreement, unless the context otherwise requires: 

  

	 	•	 	references to “persons” includes individuals, bodies corporate (wherever incorporated), unincorporated associations and partnerships; 

  

	 	•	 	reference to a “Party” is to a party to this Agreement and “Parties” is to both of them; 

  

	 	•	 	the headings are inserted for convenience only and do not affect the construction of the Agreement; 

  

	 	•	 	references to one gender include both genders; and 

  

	 	•	 	any reference to an enactment or statutory provision is a reference to it as it may have been, or may from time to time be amended, modified, consolidated or re-enacted.

  

	1.3	The Schedules comprise part of and shall be construed in accordance with the terms of this Agreement. In the event of any inconsistency between the Schedules and the terms of this
Agreement, the terms of this Agreement shall prevail. 

  

	1.4	The terms defined in clause 1.1 which are stated as being subject to amendment by any of ICH shall be deemed to be amended if and to the extent that such terms are amended or
replaced from time to time pursuant to ICH. 

  

	1.5	Terms used in this Agreement, which are not otherwise defined within the Agreement, shall have the meaning given to them in accordance with ICH Guidelines and VGN Standard Operating
Procedures (SOPs). In the event of any conflict between VGN’s SOP’s and ICH Guidelines, ICH Guidelines shall prevail. 

  

					
	Viragen International, Inc and Orphan Australia	  	5/15	  	
	Safety Agreement	  		  	

 2 PURPOSE 
  

	2.1	In consideration of the mutual obligations contained in this Agreement, the parties have agreed to provide for the procedures relating to the exchange of safety and
pharmacovigilance information for the Product between VGN and OA in order to comply with worldwide regulatory reporting requirements for the Product. 

 3 SCOPE 
  

	3.1	This Agreement covers: 

  

	 	•	 	all Spontaneous Reports of Adverse Events and Adverse Reactions in relation to the Product; 

  

	 	•	 	all Serious Adverse Reactions arising from clinical trials and post-marketing surveillance (PMS) with the Product; 

  

	 	•	 	all information required for periodic reporting in relation to the Product; and 

  

	 	•	 	all other information as required by Registration Authorities for the Product. 

 4 LANGUAGE OF ALL EXCHANGE AND TERMINOLOGY 
  

	4.1	The language of all information exchanged pursuant to this Agreement, including reports to Registration Authorities, shall (unless specifically stated otherwise) be in English, or
if any other language, accompanied by a translation into English. In the event of any conflict between the English text and the text in any other language, the English text shall prevail. 

 5 CONTACT PERSONNEL AND METHODS FOR ADVERSE EVENT TRANSMISSION 
  

	5.1	The names and details of contact personnel for VGN and OA are detailed in Schedule 2. 

  

	5.2	Any changes in names or details of any of the contact personnel for a Party in relation to the Product must be notified by that Party to the other Party in writing to the address
set out in Schedule 2 as soon as reasonably practicable after the change occurs. 

  

	5.3	Any notice given under this Agreement shall be in writing and (i) personally delivered or (ii) sent by fax or (iii) e-mail to the address of the other party as set
out in Schedule 2 (or such other address as may have been notified in writing from time to time by a party to the other party) and any such notice shall be deemed to have been served at the time of delivery (if personally delivered) or upon receipt
of confirmation of transmission by the sender’s fax machine (if sent by fax) and in the case of email upon receipt of delivery confirmation by the sender’s computer (if sent by e-mail). 

  

					
	Viragen International, Inc and Orphan Australia	  	6/15	  	
	Safety Agreement	  		  	

 6 SAFETY DATABASE 
  

	6.1	The safety information generated pursuant to this Agreement shall be added to the safety database for the Product and shall be held and maintained by VGN and shall be the central
repository for all drug safety information received worldwide for the Product. 

  

	6.2	OA acknowledges and agrees that all rights in and to the safety database shall vest in VGN. 

  

	6.3	The global safety database shall be used for all drug safety and pharmacovigilance regulatory responses and purposes for the Product. 

  

	6.4	VGN shall provide OA with such safety information contained in its safety database as reasonably requested of OA to answer any drug safety and/or pharmacovigilance related enquiries
in relation to the Product as part of its obligations under the License Agreement. 

 7 EXCHANGE OF ADVERSE EVENT AND ADVERSE REACTION
INFORMATION 
  

	7.1	All notification and response periods referred to in this Agreement will be in Calendar Days.  

  

	7.2	The relevant period for any notification or response for either Party (including their Representatives) will commence on the Awareness (Cognizance) Date. 

 

	7.3	All Adverse Events/Adverse Drug Reactions information will be exchanged, in English, in a CIOMS I format for individual case reports. OA will be responsible for initiating
CIOMS I reports for any Adverse Reaction occurring in the Territory. OA will be responsible for collecting initial information for any Adverse Event, Adverse Reaction, occurring in the Territory within the following target timeframes of the
Awareness (Cognizance) Date: 

  

	 	•	 	Death and Life-threatening reports, within 2 Calendar Days; or 

  

	 	•	 	All other reports within 4 Calendar Days. 

  

	7.4	Report should be recorded as stated by the reporter using actual, as reported, verbatim terms. 

  

	7.5	Each Party shall ensure that its facilities to receive notices for any safety issue under this Agreement are available on a 24-hour/ 7 days per week basis. 

 

	7.6	OA shall use every effort to ensure that all reports of Adverse Events and Adverse Reactions meet the minimum criteria for a Valid Safety Report. If the minimum information cannot
be obtained within the applicable timeframe specified in clauses 7.3 above, OA shall still send the report to VGN within the required period. Every effort should then be made by OA to obtain and send to VGN the missing minimum information required
for a Valid Safety Report as soon as reasonably possible. 

  

					
	Viragen International, Inc and Orphan Australia	  	7/15	  	
	Safety Agreement	  		  	

	7.7	Upon receipt of any report from OA pursuant to clause 7.3 or 7.6, VGN will notify OA of receipt of the report within two Calendar Days. 

  

	7.8	Any report is considered transmitted only after OA has received a written acknowledgement from VGN. 

  

	7.9	VGN will distribute final CIOMS I reports, in English, to the relevant person at OA (as named in Schedule 2) within 5 – 7 Calendar days of completion. 

Serious Adverse Reactions reported by VGN 
  

	7.10	VGN will report to OA the following Adverse Reactions it is aware of outside of the Territory in accordance with the following timeframes: 

  

	 	•	 	Death and life-threatening valid safety reports within 6 Calendar Days of the Awareness (Cognizance) Date. 

  

	 	•	 	All other valid safety reports involving a serious adverse event, reportable within 12 Calendar Days of the Awareness (Cognizance) Date. 

  

	 	•	 	VGN will forward a copy of all other CIOMS I reports to OA within a target of 30 Calendar Days of the Awareness (Cognizance) Date. 

 Reports received from Literature Reviews 
  

	7.11	VGN will be responsible for monitoring the worldwide scientific literature to meet global regulatory reporting requirements and for monitoring drug safety for the Product. Once an
Adverse Event or an Adverse Reaction has been identified, VGN will assess it according to seriousness and where appropriate report it to OA (providing a copy of the article) for onward reporting to the appropriate Registration Authority in the
Territory. 

  

	7.12	OA will be responsible for monitoring local scientific literature within the Territory for any reports of Adverse Events and Adverse Reactions and OA will notify VGN of any such
reports in accordance with clauses 7.3.to 7.8 (inclusive) as applicable. 

 Management of Follow up information 
 Follow up of initial reports 
  

	7.13	VGN shall be responsible for all follow-up activities for any Adverse Reactions occurring in the VGN Countries. 

  

	7.14	OA shall be responsible for all follow-up activities for any Adverse Events and Adverse Reactions occurring in the Territory. 

  

	7.15	If VGN requests any additional information in relation to a report of an Adverse Event or Adverse Reaction occurring in the Territory, OA shall be responsible for obtaining such
additional information within the timeframe referred to in clauses 7.3 to 7.8 (inclusive) as applicable. 

  

	7.16	OA shall notify VGN of any additional information it reasonably requires regarding an Adverse Reaction occurring in the VGN Countries that VGN has notified it of pursuant to this
clause 7 and VGN will use its reasonable endeavours to obtain the additional information within the applicable timeframe specified in 7.10. 

  

					
	Viragen International, Inc and Orphan Australia	  	8/15	  	
	Safety Agreement	  		  	

 8 ASSESSMENT OF ADVERSE EVENTS 
 Assessment of Listedness (Expectedness) 
  

	8.1	All Adverse Events and Adverse Reactions will be reported to VGN irrespective of any assessment regarding listedness (expectedness). 

  

	8.2	VGN shall be responsible for assessing all Adverse Events and Adverse Reactions notified to it for causality, labeling (expectedness) in accordance with the applicable nationally
approved labeling for the Product, 

  

	8.3	Based on VGN’s advice in clause 8.2, OA shall be responsible for determining if any report is required to be made to the Registration Authorities in accordance with clause 10.

 9 SAFETY ISSUES/SIGNALS AND REGULATORY ENQUIRIES INVOLVING SAFETY ISSUES 
  

	9.1	VGN will evaluate risk assessment of the Product based on reports received from any source according to their company procedures. If a significant safety signal is detected, VGN
will notify OA and coordinate an action plan to conduct an initial assessment to determine whether the signal requires further investigation. 

  

	9.2	If VGN identifies a significant safety issue as a result of its ongoing review and analysis of all information that is pertinent to the safety or benefit-risk assessment of the
product, or is aware of action which is taken by a foreign regulatory agency, including the basis for such an action VGN will inform OA promptly. OA will advise the Registration Authorities in the Territory of the above situations within 72 hours of
the Time of Awareness of OA personnel. 

  

	9.3	OA shall within 24 hours of it becoming aware notify VGN of any significant safety issues in relation to the Product. VGN and OA shall discuss in good faith how to deal with any
such significant safety issues and shall co-operate with the reasonable requests of the other party in relation to such issues. Significant safety issues relating to the Product may occur as a result of a request from a Registration Authority;
potential changes in the risk/benefit of the Product; Product quality issues that may have a clinical impact such as Product contamination or deterioration; external influences such as media or literature and ongoing safety surveillance.

  

	9.4	OA will as soon as possible inform VGN of any enquiries from any Registration Authority involving safety issues in relation to the Product in the Territory. Any response by OA to
any Registration Authority must first be approved in writing by VGN. 

  

	9.5	If OA identifies a potential safety Signal at any time, OA will promptly inform VGN and will provide such further assistance as VGN reasonably requires. 

  

	9.6	If VGN considers any changes to the labeling of the Product should be made, it will send a notice of the changes it considers appropriate in writing to OA together with supporting
documentation outlining the requirement for such change for discussion and comment by VGN. 

  

					
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	9.7	No changes to the safety labeling text for the Product in the Territory may take place without the prior written approval and involvement of VGN. 

 10 REGISTRATION AUTHORITY INTERACTION 
 Expedited Reporting
Responsibilities 
  

	10.1	Subject to clauses 7.9 to 7.11, OA will be responsible, in the Territory, for assessing the “reportability” and submitting reports of Serious Adverse Reactions for the
Product (according to current national regulations) to the relevant Registration Authorities. 

  

	10.2	OA shall provide, within a reasonable period prior to submission, VGN with a copy of all reports it intends to submit to any Registration Authority pursuant to clause 10.1. OA shall
incorporate any amendments to such reports as VGN may reasonably require. 

  

	10.3	Either Party may request an audit of the other Party on a “for cause” basis, and at least 2 weeks notice will be provided before the audit request date. An audit will not
be conducted more than twice a year unless serious compliance issues have been identified in previous audits. The audit will be for Pharmacovigilance and concentrate on adverse event collection and reporting in line with local regulations and
VGN’s/the relevant Party’s SOPs. OA is not entitled to request an audit of any entity covered under an existing and valid licensing, marketing or distribution agreement with VGN that is not a party to this Agreement, excluding
subcontractors involved in the manufacturing of the Product. 

  

	10.4	If an expedited report is submitted late by OA, OA shall promptly notify VGN of this delay, the reason for the delay and any action taken by OA to prevent a reoccurrence.

  

	10.5	VGN will be responsible for assessing ‘reportability’ and the submission of serious reports (according to current local regulations) in each country outside of the
Territory, where VGN, an affiliate or a third party is the marketing authorisation holder (MAH), regardless of whether the event originated in a VGN Country or the Territory. 

 Periodic Reporting 
  

	10.6	VGN shall prepare the Periodic Safety Update Report for the Product in the Territory, according to its internal standard operating procedures and in the format as detailed in ICH
E2C. The periodicity of the PSUR will be according to the International Birth Date (IBD) of the Product. 

  

	10.7	VGN will notify OA at least 30 days in advance of the Data Lock Point for any Periodic Safety Update Report specifying any information it requires from OA for the completion of that
Periodic Safety Update Report. OA shall provide to VGN all information requested by VGN for that Periodic Safety Update Report no later than 7 calendar days prior to the Data Lock Point. 

  

					
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	10.8	VGN will provide OA with a copy of each final Periodic Safety Update Report within 55 days of the Data Lock Point and OA shall submit each final Periodic Safety Update Report with
the Registration Authority in the Territory in accordance with regulatory timelines for submission. 

  

	10.9	Prior to regulatory submission, there should be discussion between the Parties, to promote harmonization and co-ordination if any safety signals or proposed amendments to the
Reference Safety Information are recommended. However, this must be achieved within the applicable regulatory timeframe. 

  

	10.10	Any requests for changes or amendments to the final PSUR must be made in writing to VGN by OA within 5 working days of receipt of the PSUR. 

 11 MEDICAL INFORMATION/QUESTIONS 
  

	11.1	VGN will provide appropriate information where it exists to OA to allow them to answer enquiries about the Product. Information may be in the form of Questions and Answers
documents, Standard Responses and key clinical papers. 

  

	11.2	VGN will provide to OA relevant updates of the information provided in accordance with clause 11.1 as these become available. 

  

	11.4	OA shall be responsible for ensuring that all of its activities carried out in relation to Medical Information enquiries are in compliance with all relevant laws, regulations and
guidelines in force in the Territory. 

  

	11.5	OA shall endeavour to answer all enquiries received from third parties in the Territory regarding the Product, where appropriate information has been provided by VGN in accordance
with clauses 11.1 and 11.2. The format of any responses (verbal, fax, written) shall be agreed between OA and the third party. 

  

	11.6	Where a clinical paper or other similar publication, which is covered by copyright law is provided to a third party by OA, OA shall be responsible for ensuring that copyright
legislation in force in the Territory is complied with. 

  

	11.7	OA shall address any enquiries they cannot answer to the VGN Medical Information Department as specified in Schedule 5. VGN will use its reasonable endeavours to respond to OA
within 3 business days of receipt of the enquiry, unless an alternative deadline has been agreed between OA and the VGN Medical Information Department. OA will then provide the answer directly to the original enquirer in the language(s) of the
Territory. 

  

	11.8	If a Medical Information Enquiry addressed to the VGN Medical Information Department in accordance with clause 11.7 is a request for information in connection with a report of an
Adverse Event or Adverse Reaction relating to the Product, OA shall confirm to VGN Medical Information Department that the report has been notified to VGN in accordance with clauses 7.3 and 7.6. 

  

	11.9	OA shall ensure that source documentation records are kept of all Medical Information Enquiries received from and the answers provided to third parties. 

  

					
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 12 AMENDMENTS TO THIS SAFETY AGREEMENT 
  

	12.1	If a Party becomes aware of any change of law or regulation, which affects any of the matters the subject of this Agreement, it shall notify the other Party of any such change. The
Parties shall promptly meet and discuss any such changes and negotiate in good faith any amendments to this Agreement, which either Party honestly believes are necessary or desirable as a result of such changes. 

  

	12.2	Revision of attachments (Schedules) will not require that this Safety Agreement be re-issued and signed off, but shall require the written agreement of both Parties.

  

	12.3	Changes in company personnel and methods of communication must be related to both Parties, to ensure the correct and timely flow of information. 

 13 CONFIDENTIALITY 
  

	13.1	OA agrees and undertakes that it will treat and keep confidential all Confidential Information, which it receives from VGN. 

  

	13.2	OA shall: 

  

	 	•	 	not disclose any Confidential Information to any person other than any of its directors or employees who need to know such information in order to implement the provisions of this
Agreement; 

  

	 	•	 	not use any Confidential Information other than for the purpose of complying with its obligations under or to enjoy the benefits of this Agreement; and 

  

	 	•	 	procure that any person to whom any Confidential Information is disclosed by it is aware of and complies with the restrictions contained in this clause 13. 

 

	13.3	Notwithstanding the other provisions of this clause 13, OA may disclose any Confidential Information: 

  

	 	•	 	if and to the extent required by law provided that it has provided VGN with prior written notice of such required disclosure to enable VGN to seek protection or confidential
treatment of such Confidential Information; 

  

	 	•	 	if and to the extent required by any securities exchange, regulatory or governmental body to whom that Party is subject, wherever situated; 

  

	 	•	 	if and to the extent the information is public knowledge or already known to OA at the time of disclosure or subsequently becomes public knowledge other than by breach of this
Agreement or subsequently comes lawfully into the possession of OA from a third party which is itself not subject to obligations of confidence to VGN or any of its Affiliates; and 

  

	 	•	 	if and to the extent that VGN has given its prior written consent to the disclosure. 

  

	13.4	The restrictions contained in this clause 13 shall continue to apply after termination of this Agreement without limit in time. 

  

					
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 14 DURATION AND TERMINATION 
  

	14.1	This Agreement commences on the Effective Date and shall continue in force until not less than two years after the last date of sale of the Product by OA. 

15 CONSEQUENCES OF TERMINATION 
  

	15.1	Upon the termination of this Agreement, OA shall: 

  

	 	•	 	continue to comply with its obligations under this Agreement if and to the extent it continues to have the right to sell the Product after the expiry or termination of the License
Agreement; 

  

	 	•	 	comply with its obligations in clause 7 for a period of twenty four (24) months after the date of the last sale of the Product. 

  

	15.2	Clauses 13, 15, 16 and 17, shall survive the termination of this Agreement. 

  

	15.3	The termination or expiry of this Agreement shall not release either of the parties from any liability which at the time of termination or expiry has already accrued to the other
party, nor affect in any way the survival of any other right, duty or obligation of the parties which is expressly stated elsewhere in this Agreement to survive such termination or expiry. 

 16 RESOLVING DISPUTES 
  

	16.1	If there is a disagreement between VGN and OA in the interpretation of this Agreement or any aspect of the performance by either party of its obligations under this Agreement,
representatives of the parties will resolve such dispute in accordance with the License Agreement. 

 17 GENERAL PROVISIONS 

 

	17.1	Except as expressly provided for in this Agreement, no variation to the terms of this Agreement shall be effective unless in writing and signed on behalf of each Party by a director
or other authorised person. 

  

	17.2	If any term or provision of this Agreement is held by any court or other competent authority to be void or unenforceable in whole or in part, the other provisions of this Agreement
and the remainder of the affected provision shall continue to be valid. 

  

	17.3	Failure by either Party on one or more occasions to avail itself of a right conferred by this Agreement shall not be construed as a waiver of such Party’s right to enforce such
right or any other right. 

  

	17.4	This Agreement and the Technical Agreement and the License Agreement contains the entire agreement and understanding between the Parties and supersedes all previous agreements and
understandings between the Parties with respect to the subject matter of this Agreement. Each Party acknowledges that, in entering into this Agreement, it is not relying on any representation or warranty (whether made orally or in writing) except as
expressly provided in this Agreement. 

  

					
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	17.5	Nothing in this Agreement is deemed to constitute a partnership between the Parties nor constitute any Party the agent of the other Party for any purpose. 

 

	17.6	The Parties to this Agreement do not intend that any term of this Agreement should be enforceable by any person who is not a Party to this Agreement. 

  

	17.7	The rights and remedies of each of the Parties under or pursuant to this Agreement are cumulative, may be exercised as often as such Party considers appropriate and are in addition
to its rights and remedies under general law. 

  

	17.8	Each of the Parties shall do, execute and perform and shall procure to be done, executed and performed all such further acts deeds documents and things as the other Party may
reasonably require from time to time to give full effect to the terms of this Agreement. 

  

	17.9	This Agreement may be executed in any number of counterparts and by the Parties to it on separate counterparts, each of which is an original but all of which together constitute one
and the same instrument. 

  

	17.10	As this document is incorporated by reference into the License Agreement, governing law is covered by that Agreement. 

 In Witness Whereof this Agreement has been signed by the authorised representatives of the Parties on the day and year first written above. 
  

					
	SIGNED for and on behalf of	    	)	    	
	Viragen 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

  

					
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 SCHEDULE 1: Product 
 Refer to Exhibit 4 in License Agreement 
 SCHEDULE 2: List of Contact People 
 List of Contact People – VGN Pharmacovigilance 
 Viragen 
 865 SW 78th Avenue 
 Suite 100 
 Plantation, FL 33324 
 Fax: (954) 233-1414 
  

					
	 Who to Contact
	 	 Tel No
	 	 e-mail

	Charles A. Rice	 	(954) 233-8746	 	crice@viragen.com

 List of Contact People – OA Pharmacovigilance 
 Orphan Australia Pty Ltd. 
 48 Kangan Drive Berwick, 
 Victoria, 3806 Australia 
 Fax: +61 3 9769 5944 
  

					
	 Who to Contact
	 	 Tel No
	 	 e-mail

	Tim Bownas	 	+61397092205	 	tim@orphan.com.au
	Biljana Loncar	 	+61397092222	 	biljana.loncar@orphan.com.au
	Maggie Oh	 	+61412344030	 	maggie@orphan.com.au

  

					
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