LICENSE AGREEMENT BETWEEN VIRAGEN INTERNATIONAL, INC. AND ORPHAN AUSTRALIA

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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