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LICENSE AGREEMENT

License Agreement

LICENSE AGREEMENT | Document Parties: EXCHANGE COMMISSION | Novavax, Inc | Wyeth Holdings Corporation You are currently viewing:
This License Agreement involves

EXCHANGE COMMISSION | Novavax, Inc | Wyeth Holdings Corporation

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Title: LICENSE AGREEMENT
Governing Law: New York     Date: 8/9/2007
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AGREEMENT, Parties: exchange commission , novavax  inc , wyeth holdings corporation
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Exhibit 10.1
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [ * * *] AND
HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE
COMMISSION.
LICENSE AGREEMENT
by and between
WYETH HOLDINGS CORPORATION
and
NOVAVAX, INC.
dated as of
July 5, 2007

 


 
THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
LICENSE AGREEMENT
THIS AGREEMENT is made as of July 5, 2007 by and between Wyeth Holdings Corporation, having a place of business at Five Giralda Farms, Madison, New Jersey 07940 U.S.A. (“Wyeth”), and Novavax, Inc., a Delaware corporation, having its principal place of business at 9920 Belward Campus Drive, Rockville, Maryland 20850 U.S.A. (“Novavax”). Wyeth and Novavax may each be referred to herein individually as a “Party” and collectively as the “Parties”.
     Wyeth is the owner of the Licensed Patent Rights, as defined below.
     Novavax wishes to obtain a license under the Licensed Patent Rights, to practice the processes included or claimed in the Licensed Patent Rights and to make, have made, use and sell Products, as defined below.
     Wyeth is willing to grant such a license to Novavax on the terms and conditions of this Agreement.
     Wyeth and Novavax have therefore agreed as follows.
1. DEFINITIONS
     The following terms shall have the meanings indicated in this Agreement:
     1.1. “ Agreement ” means this Agreement, including all schedules hereto.
     1.2. “ Affiliate ” means as of any point in time and for so long as such relationship continues to exist with respect to any Person, any other Person controlled by, controlling, or under common control with either such Person. For this purpose, “control” means direct or indirect beneficial ownership of at least fifty percent (50%) interest in the voting stock (or the equivalent) of such Person or having the right to direct, appoint or remove a majority or more of the members of its board of directors (or their equivalent), or having the power to control the general management of such Person, by contract, law or otherwise. Notwithstanding the foregoing, the term “Affiliate” shall not include Persons in which a Party or its Affiliates owns a majority of the ordinary voting power to elect a majority of the board of directors or other governing body, but is restricted from electing such majority by contact or otherwise, until such time as such restrictions are no longer in effect.
     1.3. “ Applicable Percentage ” means [* * *].
     1.4. “Avian Influenza Strain” means strain of influenza A from a subtype of influenza virus circulating among birds (and not circulating among humans).

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
     1.5. “ Bankruptcy Event ” means, with respect to a specified Person, (i) the filing by such Person in any court or agency, pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an the appointment of a receiver or trustee of such other Party or of its assets, (ii) the filing against such Person of an involuntary petition for any bankruptcy or insolvency proceeding which petition is not dismissed within sixty (60) days after filing, (iii) the making by such Person of an assignment for the benefit of its creditors, (iv) the taking of possession of any material part of the assets of such Person by a lien holder or other encumbrancer, or (v) the levy or enforcement of any distress, execution or other process upon or against any of the material assets of such Person.
     1.6. “ Commercially Reasonable Efforts ” means those diligent efforts consistent with the exercise of prudent scientific and business judgment, as applied by a party to the development and commercialization of its own pharmaceutical products at a similar stage of development and with similar market potential, but in any event at least those efforts and resources normally used by a similarly situated company in the biotechnology/pharmaceutical industry with respect to a product owned by such company or to which such company has similar rights, which is of similar commercial potential at a similar stage in its development or product life.
     1.7. “ Covered Product ” means any unit of any Product the manufacture, sale or use of which is covered by any claim within the Licensed Patent Rights in any country where such unit of Product is manufactured, sold or used. For the avoidance of doubt, (a) if a unit of Product is manufactured in a country where at least one (1) claim of the Licensed Patent Rights covers the manufacture, sale or use of such unit of Product but such unit of Product is sold or used in another country where the manufacture, sale or use of such unit of Product is not covered by any claim of the Licensed Patent Rights, such unit of Product is a Covered Product for purposes of this Agreement, and the royalty owed on such Covered Product pursuant to Section 3.1.6 shall be due and owing on the Net Sales arising from sales of such Covered Product in the country in which sold, and (b) if a unit of Product is manufactured in a country where no claim of any Licensed Patent Right covers the manufacture, sale or use of such unit of Product but such unit of Product is sold or used in another country where at least one (1) claim of the Licensed Patent Rights covers the manufacture, sale or use of such unit of Product, such unit of Product is a Covered Product for purposes of this Agreement, and the royalty owed on such Covered Product pursuant to Section 3.1.6 shall be due and owing on the Net Sales arising from sales of such Covered Product in the country in which sold; and (c) if a unit of Product is manufactured in a country where no claim of any Licensed Patent Right covers the manufacture, sale or use of such unit of Product, and such unit of Product is sold or used in another country where the manufacture, sale or use of such unit of Product is not covered by any claim of the Licensed Patent Rights, such unit of Product is not a Covered Product for purposes of this Agreement, and no royalty would be owed on such Product.
     1.8. “ Effective Date ” means the date referenced in the opening paragraph of this Agreement.
     1.9. “ Field ” means human vaccines for the prevention and treatment of one or more Indications.

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
     1.10. [* * *].
     1.11. “ Indication ” means each of Seasonal Flu, Pandemic Flu, [* * *].
     1.12. “ Licensed Patent Rights ” means the patent applications described on Schedule 1 , all patent applications that claim priority thereto, all divisionals, continuations or continuations-in-part thereof (to the extent claiming priority to the patent applications described on Schedule 1 ), all patents that issue therefrom, and any reissue, re-examination, renewal, supplementary protection certificate or extension of any such patent, and any foreign counterparts and equivalents of any of the foregoing.
     1.13. “ Net Sales ” means the gross amount invoiced for any sale of any Product by Novavax, any Novavax Affiliate or any permitted sublicensee, as appropriate (a “Selling Person”), to a non-Affiliate in a bona fide arm’s length transaction, less the following deductions, in each case to the extent specifically related to the Product and taken by the Selling Person or otherwise paid for or accrued by the Selling Person in accordance with GAAP (“Permitted Deductions”):
     (i) trade, cash, promotional and quantity discounts and wholesaler fees;
     (ii) taxes on sales (such as excise, sales or use taxes or value added taxes) to the extent imposed upon and paid directly with respect to the sales price (and excluding national, sales or local taxes based on income);
     (iii) freight, insurance, packing costs and other transportation charges to the extent included in the invoice price to the buyer;
     (iv) amounts repaid or credits taken by reason of damaged goods, rejections, defects, expired dating, recalls, returns or because of retroactive price reductions; and
     (v) charge back payments and rebates granted to (a) managed healthcare organizations, (b) federal, state and/or provincial and/or local governments or other agencies, (c) purchasers and reimbursers, or (d) trade customers, including wholesalers and chain and pharmacy buying groups.
It is understood that accruals taken as a deduction against Net Sales will be periodically reviewed by Novavax in accordance with GAAP and if any accrual is reversed by a Selling Person a corresponding credit will be made to Net Sales in the period in which the reversal is made. Net Sales of any Product that is a Combination Product (for purposes hereof, a “Combination Product” means any product that comprises a Product and other therapeutically or diagnostically active compounds or ingredients that are not Products) shall be a fraction of such Net Sales reasonably determined as follows:

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
Except as provided below, the Net Sales amount for a sale of a Combination Product (a “Combination Sale”) shall equal the gross amount invoiced for the Combination Sale, reduced by the Permitted Deductions (the “Net Combination Sale Amount”), multiplied by the fraction A/(A+B) , where:
A is the invoice price, in the country where such Combination Sale occurs, of the Product contained in the Combination Product, if sold as a separate Product in such country by the Selling Person and B is the aggregate of the invoice price or prices, in such country, of such other products or active ingredients/components, as the case may be, included in the Combination Product if sold separately in such country by the Selling Person.
In the event that the Selling Person sells the Product included in a Combination Product as a separate Product in a country, but does not separately sell all of the other products or active ingredients/components, as the case may be, included in such Combination Product in such country, the calculation of Net Sales resulting from such Combination Sale shall be determined by multiplying the Net Combination Sale Amount by the fraction A/C where:
A is the Selling Person’s average wholesale price, in such country, of the Product contained in such Combination Product when sold as a separate Product by the Selling Person, and C is the average wholesale price, in such country, charged by the Selling Person for the entire Combination Product.
In the event that the Selling Person does not sell the Product included in a Combination Product as a separate Product in the country where such Combination Sale occurs, but does separately sell all of the other products or active ingredients/components, as the case may be, included in the Combination Product in such country, the calculation of Net Sales resulting from such Combination Sale shall be determined by multiplying the Net Combination Sale Amount by the fraction (C-D)/C , where:
C is the average wholesale price, in such country, charged by the Selling Person for the entire Combination Product, and D is the average wholesale price charged by the Selling Person for the other products or active ingredients/components, as the case may be, included in the Combination Product.
Where the calculation of Net Sales resulting from a Combination Sale in a country cannot be determined by any of the foregoing methods, the calculation of Net Sales for such Combination Sale shall be that portion of the Net Combination Sale Amount reasonably determined in good faith by the Parties as properly reflecting the value of the Product included in the Combination Product.

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
     1.14. “Non-seasonal Human Influenza Strain” means a strain of influenza A virus that has infected a human, and has not been included in the annual seasonal trivalent composition, A Non-seasonal Human Influenza Strain can be from a subtype that includes any combination of hemagglutinin and neuraminidase. As of the Effective Date, Non-seasonal Human Influenza Strains currently come from, but are not limited to, influenza A subtypes H1N1, H3N2, H5N1, H5N2, H5N3, H2N2, H7N2, H7N7, H9N1, and H9N2.
     1.15. “Non-seasonal Influenza Strain” means a Non-seasonal Human Influenza Strain, an Avian Influenza Strain, or any influenza strain that is not a Seasonal Influenza Strain.
     1.16. “ Pandemic Flu ” means influenza caused by a Non-seasonal Influenza Strain.
     1.17. “ Party ” means each party to this Agreement and their respective successors and permitted assigns.
     1.18. “ Person(s) ” means any natural person(s) or legal entity.
     1.19. “ Product ” means any product in any Field containing VLPs.
     1.20. [* * *].
     1.21. “ Royalty Payments ” is defined in Section 6.
     1.22. “ Seasonal Flu ” means influenza caused by a Seasonal Influenza Strain.
     1.23. “Seasonal Influenza Strain” means a strain of influenza virus circulating widely among humans, that is an influenza B virus or influenza A virus strain designated by World Health Organization (the “WHO”) and/or Centers for Disease Control and Prevention, the United States Department of Health and Human Services (the “CDC”) as a vaccine target for the preparation of the annual influenza vaccine trivalent composition. As of the Effective Date, current Seasonal Influenza Strains are from influenza A subtypes H1N1 and H3N2 and influenza B.
     1.24. “ Territory ” means all countries in the world.
     1.25. “Third Party” means any Person other than Wyeth, Novavax or their respective Affiliates.
     1.26. “ VLP ” means a self-assembling virus-like particle [* * *].
2. LICENSE RIGHTS; DUE DILIGENCE
     2.1. Non-Exclusive License . Subject to the terms and conditions of this Agreement, Wyeth hereby grants to Novavax a non-exclusive license, with the limited right to grant sublicenses as set forth in Section 2.2, under the Licensed Patent Rights to research, develop, make, have made, use, sell, offer for sale and import Products in the Field in the Territory.
     2.2. Sublicensing . Notwithstanding anything herein to the contrary, Novavax shall have the right to grant sublicenses only as follows:

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
     2.2.1. Sublicenses to Third Parties . Novavax shall have the right, without the consent of Wyeth, but with prompt (and in any case within ten (10) days after execution of the relevant sublicense agreement) written notice to Wyeth, to grant sublicenses under the license granted to Novavax herein to Third Parties for purposes of development and/or commercialization of Products; provided, that Novavax must obtain the prior written consent of Wyeth to sublicense the Licensed Patent Rights to any Third Party where such sublicense does not include a license to development and/or commercialization rights under other patent applications, patents or technology owned or controlled by Novavax, to such Third Party.
     2.2.2. Wyeth Retained Licensing Rights . For the avoidance of doubt, Wyeth retains the right (a) for itself and for its Affiliates, successors and assigns to research, develop, make, have made, use, sell and import Products and to otherwise make, use, sell and import Products and other products under the Licensed Patent Rights, and (b) to grant licenses and sublicenses to Third Parties to research, develop, make, have made, use, sell and import Products and other products.
     2.2.3. Sublicense Agreements; Payments; Copies of Sublicense Agreements . Novavax shall provide to Wyeth a copy of all sublicense agreements entered into under this Agreement within ten (10) days of the effective date of each sublicense agreement; provided, that Novavax may redact from such copy any information that is not reasonably necessary to establish Novavax’s compliance with the terms and conditions of this Agreement. In addition to the Royalty Payments and milestones payments described in Section 3 (which would be payable in full for Net Sales made by sublicensees and the achievement of the relevant milestone events by sublicensees), Novavax shall pay to Wyeth [* * *] of all additional amounts received by Novavax as consideration for any sublicense to the Licensed Patent Rights granted under this Agreement (i.e., such additional amounts being equal to the difference of payments received by Novavax from a sublicensee covered by this Section 2.2.3 less amounts paid to Wyeth by Novavax under Section 3.1 on Product sales or the achievement of Product milestone events, as applicable), payable within thirty (30) days after receipt of any such payment by Novavax, other than any amounts payable (i) as bona fide payments for the cost of research and development services actually performed, (ii) as equity or debt funding, or (iii) for any fair market value purchases of materials from Novavax by a Third Party sublicensee. By way of example in the context of milestone payments, if Novavax receives [* * *] from a sublicensee upon [* * *] by such sublicensee, then Novavax would be entitled to deduct the [* * *] payment due pursuant to Section 3.1.3.1 in calculating the payments due under this Section and, subject to the terms and conditions of this Agreement, the resulting payment under this Section would be [* * *]. By way of example in the context of royalty payments, if Novavax receives an [* * *] royalty from a sublicensee for Product sales, then Novavax would be entitled to deduct the [* * *] royalty due Wyeth pursuant to Section 3.1.6 in calculating the payments due under this Section and, subject to the terms and conditions of this Agreement, the resulting payment under this Section would be [* * *] of the [* * *] royalty on Product sales. Novavax shall be responsible for the payment of any royalties or other payments provided for hereunder, regardless of whether the terms of any sublicense provides for such amount to be paid by the sublicensee directly to Novavax. Novavax shall promptly provide to Wyeth any other information or documents reasonably requested by Wyeth to ascertain Novavax’s compliance with this Section 2.2. All sublicenses granted hereunder shall be consistent with and subject to the terms and conditions of this Agreement, including without limitation all payment obligations of Novavax hereunder.

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
     2.3 Restriction on other Rights . No right or license is granted to Novavax in or to any right or interest of Wyeth that is not specifically set forth in this Agreement.
     2.4 Due Diligence . Novavax shall use Commercially Reasonable Efforts to develop, manufacture and commercialize at least one Product in each Indication in the Territory. Wyeth acknowledges and agrees that, as of the Effective Date, Novavax’s development efforts will be directed primarily at the Seasonal Flu and Pandemic Flu Indications. Novavax shall provide to Wyeth on each annual anniversary of the Effective Date a written report detailing its Product research, development, manufacturing and commercialization activities. Any such reports will be held in strict confidence by Wyeth and not disclosed to any Third Party and Wyeth will use such reports only for purposes of this Agreement. Novavax shall comply with all applicable laws and regulations. Novavax shall be responsible for obtaining all regulatory approvals required for the development, manufacture and sale of Products.
3 PAYMENTS
     3.1 Payments . Novavax shall make the following payments to Wyeth as consideration for the rights granted by Wyeth hereunder:
     3.1.1 Licensing Fee . Within fifteen (15) days after the Effective Date, Novavax shall pay Wyeth a non-refundable licensing fee of [* * *].
     3.1.2 Annual License Maintenance Fee . Novavax shall pay to Wyeth an annual license maintenance fee of [* * *] for each Indication (i.e., a total of U.S. [* * *] for all [* * *] Indications) with respect to which this Agreement has not expired or been terminated, such amount payable on or before each annual anniversary of the Effective Date. Each annual license maintenance fee for a particular Indication shall be payable on each such anniversary until the First Commercial Sale of any Product for such Indication in the Territory.
     3.1.3 Milestone Payments for Products other than Pandemic Flu Products . Novavax shall pay to Wyeth the following non-refundable milestone payments within thirty (30) days after the date when each Product, other than a Product labeled solely for Pandemic Flu (i.e., if a Product is indicated solely for Pandemic Flu, the milestones in this Section 3.1.3 shall not apply, but if a Product is indicated for Pandemic Flu and one or more other Indications, both this Section 3.1.3 and Section 3.1.4 shall apply as set forth in Section 3.1.5), reaches a milestone described below with respect to each Indication (whether achieved by or on behalf of Novavax or any of its Affiliates or sublicensees):

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THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A
CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED
WITH [ * * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.
3.1.3.1 [* * *];
3.1.3.2 [* * *];
3.1.3.3 [* * *]; and
3.1.3.4 [* * *].
The total of all milestone payments that will be payable under this Section 3.1.3 for each Product is [* * *].
     3.1.4 Milestone Payments for Pandemic Flu Products

 
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