LICENSE AGREEMENT

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, 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 Product that represents SOI’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 be those indications that are approved by the Swedish regulatory authorities as of the Effective Date of this Agreement, and those that may be approved through the Mutual Recognition Process in other countries within the EU, upon the initial application for approval.

1.6

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

April 16th, 2007

1

VGN & SOI

1.7

“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.

1.8

“Delivery Date” shall mean a calendar date upon which SOI wishes VGN to make shipment of Product ordered by SOI under a Purchase Order (“PO”).

1.9

“Effective Date” shall mean the latest date upon which this Agreement was last signed by either Party to the Agreement.

1.10

“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.

1.11

“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 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.

1.12

“Filled Product” shall mean the finished biological material, meeting the Product Specifications for the brand Multiferon ^® , multi-subtype, human interferon alpha injection as defined by the Registration in the Territory and filled 0.5 ml in a pre-filled syringe, 6 MIU per mL, but prior to packaging and labeling.

1.13

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

1.14

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

1.15

“Lot Number” shall mean the unique and identifying code, comprised of alpha and/or numeric figures, assigned by VGN 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.

1.16

“Market Authorization” shall mean the valid documented approval by the Registration Authority in each Country within the Territory permitting SOI to market, sell and distribute the Product.

1.17

“Activity Plan” shall mean the documented list and timing of actions that SOI will take in order to successfully achieve or exceed the Annual Product Forecast in the Territory.

1.18

“Net Sales” shall mean [ * ] .

1.19

“Parties” shall mean parties to this Agreement including VGN and SOI and Party shall mean the singular as appropriate.

1.20

“Post-Marketing Phase III Clinical Trial (hereinafter referred to as “the Clinical Trial”) shall mean a Phase III efficacy trial conducted according to a protocol as agreed upon between the Parties and the Swedish regulatory authorities in high-risk melanoma patients in the EU, and funded according to Exhibit 1.

1.21

“Product Improvements” shall mean any modification or change to the indications for use of the Product that requires new clinical trials and a new Market Authorization in the Territory,, while maintaining the description “multi-subtype, human alpha interferon injection”.

1.22

“Product Information” shall mean the Summary of Product Characteristics, patient information leaflet and product labeling.

1.23

“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.

1.24

“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 Dossier and as attached hereto as Exhibit 4, as may be amended from time to time in accordance with the applicable regulations.

1.25

“Product” shall mean the finished biological material, in finished packaged and labeled form and meeting the Product Specifications as defined by the Registration in the Territory, and as sold by VGN to SOI, corresponding to the brand Multiferon ^® , multi-subtype, human interferon alpha injection, 0.5 mL per pre-filled syringe, 6 MIU per mL.

1.26

“PO” shall mean a legally binding Purchase Order initiated by SOI and provided to VGN in advance, specifying quantities of Product it wishes to purchase from VGN and have delivered to SOI, according to the terms and conditions specified herein.

1.27

“Purchase Price(s)” shall mean the price at which VGN agrees to sell the Product to SOI , expressed in Euros (€) and as set forth in Exhibit 1 to this Agreement and its Amendments.

1.28

“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 safety, pharmacovigilance and distribution of prescription products for human use.

1.29

“Registration Dossier(s)” , in Common Technical Document (CTD) format, shall mean the dossier(s) of scientific documentation, qualitative and quantitative data, preclinical 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).

1.30

“Royalty” shall mean a calculated percentage of Net Sales to be paid by SOI to Viragen as described herein and as set forth in Exhibit 1 to this Agreement.

1.31

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

1.32

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

1.33

“(SKUs)” shall mean the Stock Keeping Unit of measure SOI intends to use to track its purchases and sales of the Product. With respect to this Agreement, one SKU shall be one printed carton holding six (6) pre-filled syringes containing 0.5 mL Multiferon ^® , 6 MIU per mL.

1.34

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

1.35

“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 Product launch date in the last-to-launch Country in the Territory or for a longer period as may be mutually agreed by the Parties and documented in the form of an Amendment to this Agreement.

1.36

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

1.37

“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 SOI for the express purposes of marketing, selling and distributing the Product in the Territory under the terms and conditions herein, SOI shall pay to VGN a License Fee in accordance with Exhibit 1.

2.2

In lieu of making any additional milestone payments to VGN, SOI hereby agrees to manage, support and fund in part the Clinical Trial, as set out in Exhibit 1, in high-risk melanoma patients according to the protocol agreed upon by the Parties and the Swedish regulatory authorities (specifically the Medicinal Products Agency (MPA). SOI shall begin patient enrollment for the Clinical Trial as soon as reasonably possible after the Effective Date of this Agreement.

2.3

SOI hereby acknowledges that VGN has made a written commitment to the MPA that the Clinical Trial will be conducted and reported in the Registration Dossier for the Product. SOI agrees to ensure that the conduct of this trial is in accordance with Good Clinical Practices, the requirements of the EMEA and the MPA and all other pertinent regulations and guidelines that apply within the EU in relation to the conduct of human clinical trials.

2.4

VGN shall part-support the Clinical Trial as stipulated in Exhibit 1.

2.5

The Clinical Trial data shall be provided to VGN in a form suitable for submission to the MPA and the EU regulatory authorities as an update to the Registration Dossier (all raw data). The Clinical Trial data shall be owned by VGN, but licensed to SOI without any further payment or monetary consideration to VGN other than that contemplated in this Agreement.

2.6

SOI hereby acknowledges that VGN has agreed to the conduct of the Clinical Trial in a formal commitment to the MPA in Sweden. This Agreement confers control of the Clinical Trial to SOI, but it is SOI’s responsibility to conduct the Clinical Trial in accordance to the relevant provisions detailed in this Agreement and specifically in this Article 2. Any material failure in the appropriate conduct of the Clinical Trial that directly causes the Clinical Trial to be inappropriate for the requirements of the regulatory authorities in the Countries within the Territory, and which material failure is the responsibility of either Party or its employees, its agents, its consultants or its contractors due to negligence or misconduct will be considered by the other Party to be a material breach of this Agreement.

3.1

VGN shall provide, to SOI at no extra cost, a complete and ready-for-submission Registration Dossier, as soon as possible following Swedish approval of the Filled Product and after completing all other preparations for MRP. All documents provided to SOI by VGN, including the Registration Dossier approved by the Swedish Authorities are accurate and correct and no document contains any untrue statement of a relevant fact.

3.2

The Parties will cooperate with one another to identify the applicable Countries within the Territory to be included in the initial registration process. The registration application shall include the Approved Indications for the Product in Sweden, as of the Effective Date, with a focus on the first-line adjuvant treatment of malignant melanoma.

3.3

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 at its own expense.

3.4

SOI shall be responsible for filing the Registration Dossier with the Registration Authorities on as timely a basis as possible following Swedish approval of the pre-filled syringe application.

3.5

VGN will be responsible for all costs and expenses in relation to the Market Authorization Application(s) for the Product filed by SOI including regulatory costs such as application fees, annual fees and catalogue fees, fees for variation applications and eventual maintenance fees. SOI is responsible for maintaining the Market Authorization(s) once obtained for the Product in any Country in the Territory in accordance with all applicable laws, rules and regulations during the Term of this Agreement. VGN will reimburse SOI for all direct out-of-pocket costs, including translations of Product Information into all applicable languages provided that such costs shall not include any overhead or general and administrative costs of SOI.

3.6

SOI shall notify VGN of any communications it receives from the Registration Authorities and VGN shall be responsible for creating responses to any questions from the Registration Authorities. SOI shall be responsible for submission of the responses, including the submission of any documentation that may be required, as provided by VGN.

3.7

Upon receipt of invoices from the Registration Authorities pertaining to the initial MRP application, all subsequent variations and updates to the Registration Dossier, SOI will provide copies of such invoices to VGN along with its own invoice for payment. VGN shall pay such invoices within thirty (30) days of receipt.

3.8

SOI shall be responsible for any named patient service related to the Product in the Territory at its own expense and in accordance with the applicable laws and regulations.

4.1

The Marketing Authorization for each Country in the Territory shall be held by [*].

4.2

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

4.3

SOI 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.

4.4

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

4.5

VGN will acknowledge receipt of notification of reimbursement authorization in writing to SOI within three (3) days of receipt.

4.6

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

4.7

VGN will confirm its ability to provide suitable quantities of Product prior to the intended launch date, or will work with SOI 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 SOI’s desired launch date.

5.1

SOI 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.

5.2

SOI 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 Activity Plan and the Annual Product Forecast.

5.3

At a frequency to be mutually agreed by the Parties, but not less than once per calendar year, including any initial partial calendar year, SOI shall submit to VGN for its review, the Activity plan(s) for the Territory.

5.4

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

5.5

SOI shall review VGN’s comments and recommendations for changes to Activity Plans and shall endeavor to integrate VGN’s recommendations to the extent reasonable to meet the Annual Product Forecast. SOI shall be responsible for executing the Activity Plan(s).

5.6

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

5.6.1

Market Positioning

5.6.2

Sales claims

5.6.3

Use of Licensed Marks

5.6.4

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

5.7

Following market launch in each Country within the Territory, SOI shall report to VGN within 30 days of the end of each calendar quarter throughout the Term, excluding any initial partial quarter, the wholesaler invoiced sales during the quarter, any and all deductions that apply, the Net Sales during the quarter, its adherence to the Activity Plan(s), its progress in effecting the Activity Plan and any deviations from the Activity Plan(s) in the Territory.

5.8

[ * ]

5.9

The Activity Plan(s) for the Territory shall be reviewed and updated at least every twelve (12) months by SOI, whereby SOI shall submit updates to VGN and VGN shall have ten (10) calendar days to provide comments and recommendations for changes to SOI, in accordance with Article 5.4 and 5.5.

6.1

As soon as possible after receipt of the reimbursement authorization for the Product in each Country, where required, or for Countries where such approval is not required, and at least sixty (60) days prior to market launch of the Product, SOI will submit to VGN its first Annual Product Forecast and its first PO for the Product, for the Country in question. As other Countries are approved for reimbursement, these will be added to the Annual Product Forecast through revisions. The Parties may agree to consolidate groups of Countries into regions for the purpose of creating and updating the Annual Product Forecast.

6.2

The Annual Product Forecast will represent SOI’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. Where more than one Country allows several languages on the labeling and packaging materials, these Countries may be grouped together with respect to the Annual Product Forecast.

6.2.1

The Parties agree to cooperate with one another in an effort to limit the number of product packaging presentations required under the MRP approval.

6.3

The Annual Product Forecast shall be expressed in SKUs, with one SKU representing one printed carton holding six (6) pre-filled syringes containing 0.5 mL of Multiferon ^® , 6 MIU per mL.

6.4

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. ViraNative shall confirm receipt of the Annual Product Forecast in writing to SOI along with any questions or comments within ten (10) calendar days of receipt.

6.5

No later than thirty (30) calendar days prior to the end of each subsequent calendar quarter, SOI will update the Annual Product Forecast and submit the update to VGN. These quarterly updates are intended to provide SOI 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.

6.6

In the event SOI 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, SOI 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.

6.7

It is understood by the Parties that the minimum sales quantities agreed as per Article 7.3, will take parallel import volumes into account and SOI will not be penalized for failing to sell the agreed volume where that part of the sales generated is parallel imported from another country.

6.8

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

7.1

No later than thirty (30) calendar days before the beginning of each calendar quarter, beginning on or prior to the anticipated date of reimbursement authorization in each Country where required, or upon Market Authorization in Countries where reimbursement authorization is not required, and continuing throughout the Term of this Agreement, SOI will submit a PO to VGN at the ViraNative AB subsidiary location in Umeå, Sweden, specifying the quantities of Product it will require for the subsequent calendar quarter, and will specify the Delivery Date(s) for quantities ordered. VGN will confirm receipt and acceptance of all POs in writing as soon as possible, but within five (5) days of receipt.

7.2

VGN will schedule its manufacturing capacity in order to meet the quantities specified in the Annual Product Forecast provided by SOI. In the event the quantities projected cannot be delivered by VGN, for any reason, VGN shall meet with SOI to discuss alternative plans for increasing manufacturing capacity so that SOI may receive the quantities of Product necessary to meet its customer demand. In general, VGN requires sixty (60) days to produce one batch of Product.

7.2.1

In the event VGN confirms receipt of a PO and fails to ship quantities within 60 days 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 21), VGN shall be assessed a late-delivery penalty.

7.2.2

The late-delivery penalty shall be one percent (1%) off the total invoice price for every calendar day a shipment exceeds the 60-day expectation, provided that the aggregate value of such penalty shall not exceed the total invoice price.

7.3

Excluding the first calendar year, or the first partial calendar year, every calendar year the Parties agree to meet and negotiate in good faith, minimum purchase quantities for the Product.

7.4

Once a PO is confirmed as received by VGN, such PO is binding and SOI may not change or cancel that PO for any reason, except in the case of any material breach of this Agreement by VGN and as stipulated in Article 8.11.5.

7.5

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

7.6

The Purchase Price for the Product 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.

7.7

SOI, 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 SOI at the time the Product is delivered to the carrier on the Shipment Date.

7.8

SOI will be responsible for payment of all transport costs, including export/import fees, duties, taxes, insurance, and any other costs necessary to transport the Product from VGN’s manufacturing site in Umeå, Sweden.

7.9

Product manufactured by VGN is temperature-sensitive and is labeled with temperature storage requirements, in accordance with the Marketing Authorization. SOI 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 SOI.

7.10

VGN shall include with each shipment, and for each Product Lot Number, a document specifying that the subject product has been manufactured and released in accordance with the relevant Marketing Authorization and meets the Product Specifications as directed by the Technical Agreement. Such document shall be in a format mutually agreed upon by the respective Parties’ quality control or quality assurance staff, and in compliance with the Marketing Authorization.

7.11

VGN shall retain samples from each Product Lot Number for its own purposes and for any stability studies that may be required by the Registration Authorities.

7.12

VGN will schedule its manufacturing capacity in order to meet the quantities specified in the Annual Product Forecast and revisions thereto. Provided VGN has a minimum of 180 days prior notice, VGN will be able to deliver those quantities forecasted to be ordered by SOI. Timely communications from SOI with respect to changes in the Annual Product Forecast will be critical to ensuring supply in the event of significant unit volume increases.

7.13

[ * ]

8.1

SOI 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