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EXCLUSIVE LICENSE AGREEMENT

License Agreement

EXCLUSIVE LICENSE AGREEMENT 

     
 | Document Parties: NOVAVAX INC | University of Massachusetts You are currently viewing:
This License Agreement involves

NOVAVAX INC | University of Massachusetts

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Title: EXCLUSIVE LICENSE AGREEMENT
Governing Law: Massachusetts     Date: 3/16/2007
Industry: Biotechnology and Drugs    

EXCLUSIVE LICENSE AGREEMENT 

     
, Parties: novavax inc , university of massachusetts
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Exhibit 10.34

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.

EXCLUSIVE LICENSE AGREEMENT

     This Agreement, effective as of February 26, 2007 (the “Effective Date”), is between the University of Massachusetts (“University”), a public institution of higher education of the Commonwealth of Massachusetts as represented by its Worcester campus, and Novavax, Inc. (“Company”), a publicly traded corporation having a principal location at 9920 Belward Campus Drive, Rockville, MD, 20850.

R E C I T A L S

     WHEREAS, University is owner by assignment of the invention claimed in the United States Patent Applications listed on Exhibit A relating to the University’s invention disclosure number * * *; and

     WHEREAS, Company desires to obtain an exclusive license to develop and commercialize products incorporating certain Virus-Like Particles, under the rights of University in any patent rights claiming those inventions; and

     WHEREAS, University is willing to grant Company an exclusive license on the terms set forth in this Agreement;

     NOW, THEREFORE, University and Company agree as follows:

1. Definitions .

     1.1. “ Affiliate ” means any legal entity (such as a corporation, partnership, or limited liability company) that is controlled by Company. For the purposes of this definition, the term “control” means (i) beneficial ownership of at least fifty percent (50%) of the voting securities of a corporation or other business organization with voting securities or (ii) a fifty percent (50%) or greater interest in the net assets or profits of a partnership or other business organization without voting securities.

     1.2. “ Confidential Information ” means any and all information furnished by one party (the “Disclosing Party”) to the other party (the “Receiving Party”) in connection with this Agreement that is specifically designated as confidential in accordance with the terms of Article 7.

     1.3. “ Field ” means the diagnosis, prevention and/or treatment of any diseases and conditions in humans.

     1.4. “ Licensed Product ” means any product that cannot be developed, manufactured, used, or sold without infringing one or more claims under the Patent Rights.

     1.5. “ Market Approval ” means approval for the sale of Licensed Product by the United States FDA or its counterpart in other countries. In Europe, this means the approval of the European Medicines Evaluation Agency (“EMEA”).

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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.

     1.6. “ Net Sales ” means the gross amount billed or invoiced on sales of Licensed Products by Company, its Sublicensees and Affiliates, less the following: (a) customary trade, quantity, or cash discounts to non-affiliated brokers or agents to the extent actually allowed and taken; (b) amounts repaid or credited by reason of rejection or return; (c) to the extent separately stated on purchase orders, invoices, or other documents of sale, any taxes or other governmental charges levied on the production, sale, transportation, delivery, or use of a Licensed Product which is paid by or on behalf of Company, its Sublicensee or Affiliate; (d) outbound transportation costs prepaid or allowed and costs of insurance in transit; and (e) chargebacks and rebates to managed healthcare organizations or to federal, state and local governments, their agencies, or to trade customers, including without limitation, wholesalers, hospital buying groups and chain pharmacy buying groups.

     In any transfers of Licensed Products between Company and its Sublicensees or Affiliates, Net Sales are calculated based on the final sale of the Licensed Product to an independent third party. If Company, its Affiliates or Sublicensees receive non-monetary consideration for any Licensed Products, Net Sales are calculated based on the fair market value of that consideration. If Company or its Affiliates or Sublicensees use or dispose of a Licensed Product in the provision of a commercial service, the Licensed Product is sold and the Net Sales are calculated based on the sales price of the Licensed Product to an independent third party during the same Royalty Period or, in the absence of sales, on the fair market value of the Licensed Product as determined by the parties in good faith.

     1.7. “ Patent Rights ” means (i) the patent applications listed on Exhibit A and (ii) any divisional, continuation or continuation in part of those patent applications to the extent the claims are directed to subject matter specifically described therein (but excluding any continuation in part application to the extent of any claim covering an invention arising from and subject to the Sponsored Research Agreement) as well as any patents issued on these patent applications and any reissues or, reexaminations, or substitutions of such patents or patent applications, and any foreign counterparts to the foregoing patents and patent applications.

     1.8. “ Phase I Clinical Trial ” shall have the meaning ascribed by the FDA and as promulgated under 21 C.F.R. § 312.21(a).

     1.9. “ Phase II Clinical Trial ” shall have the meaning ascribed by the FDA and as promulgated under 21 C.F.R. § 312.21(b).

     1.10. “ Royalty Period ” means the partial calendar quarter commencing on the date on which the first Licensed Product is sold and every complete or partial calendar quarter thereafter during which either (a) this Agreement remains in effect or (b) Company has the right to complete and sell work-in-progress and inventory of Licensed Products pursuant to Section 8.6.

     1.11. “ Sponsored Research Agreement ” means that certain Sponsored Research Agreement entered into by and between Company and University dated as of February 26, 2007.

     1.12. “ Sublicense Income ” means payments or other value that Company receives from a Sublicensee to the extent made in consideration of the sublicense of the rights granted Company under Section 2.1., including without limitation license fees, milestone payments, and license maintenance

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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.

fees, but excluding the following payments: (a) royalties on Net Sales, (b) payments for milestone events for which a milestone is payable to University under Section 4.3, (c) payments made in consideration for the issuance of equity or debt securities of Company to the extent of fair market value, and (d) payments specifically committed to the development of Licensed Products.

     1.13. “ Sublicensee ” means any permitted sublicense of the rights granted Company under this Agreement in accordance with the terms of Section 2.2.

2. Grant of Rights .

     2.1. License Grant . Subject to the terms of this Agreement and the University’s retained rights under Section 2.3, University grants to Company an exclusive, worldwide, royalty-bearing license (with the right to sublicense through multiple tiers) under the Patent Rights to develop, make, have made, use, and sell Licensed Products in the Field.

     2.2. Sublicenses . Company may grant sublicenses of its rights under Section 2.1. with the consent of University, which consent may not be unreasonably withheld or delayed. All sublicense agreements executed by Company pursuant to this Article 2 shall expressly bind the Sublicensee to the terms of this Agreement applicable to a Sublicense. Company shall promptly furnish University with a fully executed copy of any sublicense agreement.

     2.3. Retained Rights .

     (a)  University . University retains the right to practice and use the Patent Rights for academic, non-commercial research (excluding the use with any clinical trial), teaching, and non-commercial patient care without payment of compensation to Company. University may license its retained rights under this Section to other academic or non-commercial research institutions (for use by faculty members, post-doctoral fellows, and students) solely for the purpose of practicing the rights retained under this Section and subject to terms of this Agreement, provided that University will promptly notify Company of any such license.

     (b)  Federal Government . To the extent that any invention claimed in the Patent Rights has been funded by the federal government, this Agreement and the grant of any rights in Patent Rights are subject to and governed by federal law as set forth in 35 U.S.C. §§ 201-211, and the regulations promulgated thereunder, as amended, or any successor statutes or regulations. Company acknowledges that these statutes and regulations reserve to the federal government a royalty-free, non-exclusive, non-transferable license to practice any government-funded invention claimed in the Patent Rights. If any term of this Agreement fails to conform with those laws and regulations, the relevant term is an invalid provision and shall be modified by the parties pursuant to Section 11.10.

3. Company Obligations Relating to Commercialization .

     3.1. Diligence Requirements . Company shall use or shall cause its Affiliates or Sublicensees to use diligent efforts to develop Licensed Products and to introduce Licensed Products into the commercial market. Upon receipt of Market Approval for a Licensed Product, Company and its

3 of 18


 

THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL
TREATMENT REQUEST. REDACTED ATERIAL IS MARKED WITH [* * *] AND HAS
BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

Affiliates or its Sublicensees shall make such Licensed Products reasonably available to the public. Specifically, Company shall fulfill the following obligations:

     (a) On or before execution of this Agreement, Company shall furnish University with a written research and development plan under which Company intends to develop Licensed Products (it being understood that such obligation is achieved upon the execution of the Sponsored Research Agreement).

     (b) Within sixty (60) days after the start of each calendar year, Company shall furnish University with a written report on the progress of its efforts during the prior year to develop and commercialize Licensed Products, including without limitation research and development efforts, efforts to obtain regulatory approval, marketing efforts, and sales figures. The report shall also contain a discussion of intended efforts and sales projections for the current year.

     (c) * * *.

If University determines that Company has not fulfilled its obligations under this Section 3.1, University shall furnish Company with written notice of the determination. Within ninety (90) days after receipt of the notice, Company shall either (i) cure such material breach or (ii) negotiate with University a mutually acceptable schedule of revised diligence obligations, failing which University may, immediately upon written notice to Company, terminate this Agreement or convert the exclusive license into a non-exclusive license and grant additional licenses to third parties to the Patent Rights in the Field. Any activities performed by Company’s Affiliates or Sublicensees shall be deemed activities of Company for purposes of determining Company’s compliance with the terms of this Section 3.1.

     3.2. Indemnification .

     (a)  Indemnity . Company and its Affiliates shall indemnify, defend, and hold harmless University and its trustees, officers, faculty, students, employees, and agents and their respective successors, heirs and assigns (the “Indemnitees”), against any liability, damage, loss, or expense (including reasonable attorneys fees and expenses of litigation) incurred by or imposed upon any of the Indemnitees by third parties in connection with any claims, suits, actions, demands or judgments arising out of any theory of liability (including without limitation actions in the form of tort, warranty, or strict liability and regardless of whether the action has any factual basis) to the extent caused by any product, process, or service that is made, used, or sold pursuant to any right or license granted under this Agreement. However, indemnification does not apply to any liability, damage, loss, or expense to the extent attributable to (i) the gross negligence or intentional misconduct of the Indemnitees, (ii) breach by an Indemnitee of any obligation, warranty or representation set forth in this Agreement, or (iii) the settlement of a claim, suit, action, or demand by Indemnitees without the prior written approval of Company.

     (b)  Procedures . The Indemnitees agree to provide Company with prompt written notice of any claim, suit, action, demand, or judgment for which indemnification is sought under this Agreement. Company agrees, at its own expense, to provide attorneys reasonably acceptable to University to defend against any claim. The Indemnitees shall cooperate fully with Company in the defense and will

4 of 18


 

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.

permit Company to conduct and control the defense and the disposition of the claim, suit, or action (including all decisions relative to litigation, appeal, and settlement). However, any Indemnitee may retain its own counsel, at the expense of Company, if representation of the Indemnitee by the counsel retained by Company would be inappropriate because of actual or potential differences in the interests of the Indemnitee and any other party represented by that counsel. Company agrees to keep University informed of the progress in the defense and disposition of the claim and to consult with University regarding any proposed settlement.

     (c)  Insurance . Company and its Affiliates shall maintain insurance that is reasonably adequate to fulfill any potential obligation to the Indemnitees, but not less than one million dollars ($1,000,000) for injuries to any one person arising out of a single occurrence and five million dollars ($5,000,000) for injuries to all persons arising out of a single occurrence. Company shall provide University, upon request, with written evidence of insurance. Company and its Affiliates shall continue to maintain such insurance after the expiration or termination of this Agreement during any period in which Company, its Affiliate(s) or Sublicensee(s) continues to make, use, or sell a product that was a Licensed Product under this Agreement.

     3.3. Use of University Name . In accordance with Section 7.3., Company and its Affiliates and Sublicensees may not use the name “University of Massachusetts” or any variation of that name in connection with the marketing or sale of any Licensed Products.

     3.4. Marking of Licensed Products . To the extent commercially feasible and consistent with prevailing business and legal practices, Company shall mark and shall cause its Affiliates and Sublicensees to mark all Licensed Products that are manufactured or sold under this Agreement with the number of each issued patent under the Patent Rights that applies to a Licensed Product.

     3.5. Compliance with Law . Company shall comply with, and shall ensure that its Affiliates and Sublicensees comply with, all local, state, federal, and international laws and regulations applicable to the development, manufacture, use, and sale of Licensed Products. Company expressly agrees to comply with the following:

     (a) Company, its Affiliates and Sublicensees shall obtain all necessary approvals from the United States Food & Drug Administration and any similar governmental authorities of any foreign jurisdiction in which Company, its Affiliate or Sublicensee makes, uses, or sells Licensed Products.

     (b) Company, its Affiliates and Sublicensees shall comply with all United States laws and regulations controlling the export of commodities and technical data applicable to the Licensed Products, including without limitation all Export Administration Regulations of the United States Department of Commerce. Among other things, these laws and regulations prohibit or require a license for the export of certain types of commodities and technical data to specified countries and foreign nationals. Company hereby gives written assurance that it will comply with and will cause its Affiliates and Sublicensees to comply with all United States export control laws and regulations applicable to the Licensed Products, that it bears sole responsibility for any violation of those laws and regulations by itself, or its Affiliates or Sublicensees, and that it will indemnify, defend, and hold

5 of 18


 

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.

University harmless (in accordance with Section 3.2.) for the consequences of any violation applicable to the Licensed Products.

     (c) To the extent that any invention claimed in the Patent Rights has been partially funded by the United States government, and only to the extent required by applicable laws and regulations, Company agrees that any Licensed Products used or sold in the United States will be manufactured substantially in the United States or its territories. Current law provides that if domestic manufacture is not commercially feasible under the circumstances, University may seek a waiver of this requirement from the relevant federal agency on behalf of Company.

4. Consideration for Grant of Rights .

     4.1. License Fee . In partial consideration of the rights granted Company under this Agreement, Company shall pay to University, within thirty (30) days of the Effective Date, a license fee of * * *. This license fee payment is nonrefundable and is not creditable against any other payments due to University under this Agreement.

     4.2. License Maintenance Fee . Within thirty (30) days of the beginning of each calendar year during the term of this Agreement, Company shall pay to University an annual license maintenance fee payment in the amount of * * *. These license maintenance fees are nonrefundable and are not creditable against any other payments due to University under this Agreement.

     4.3. Milestone Payments . Company shall pay University the following milestone payments for each Licensed Product (but only once with respect to each Licensed Product, irrespective of the number of indications for which such Licensed Product may be developed or approved) within thirty (30) days after the occurrence of each event by Company and its Affiliates:

 

 

 

Milestone Event

 

Milestone Payment

*      *      *

 

*      *      *

*      *      *

 

*      *      *

*      *      *

 

*      *      *

These milestone payments are nonrefundable and are not creditable against any other payments due to University under this Agreement.

     4.4. Base Royalties . In partial consideration of the rights granted Company under this Agreement, Company shall pay to University a royalty on aggregate, annual Net Sales during each calendar year of all Licensed Products, at the following rates:

     (a) * * * of the portion of annual, worldwide Net Sales of Licensed Products that is less than or equal to * * *;

     (b) * * * of the portion of annual, worldwide Net Sales of Licensed Products that is greater than * * * but less than or equal to * * *; and

6 of 18


 

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.

     (c) * * * of the portion of annual, worldwide Net Sales of Licensed Products that is greater than * * *.

     4.5. Minimum Royalty . Beginning January 1, * * *, and within thirty (30) days of each subsequent calendar year during the term of this Agreement, Company shall pay University a minimum royalty payment of * * *. Minimum royalty payments are creditable against royalties payable for Net Sales during the same calendar year. If Company fails to make any minimum royalty payment, that failure is a material breach of its obligations under this Agreement, and University may terminate this Agreement in accordance with Section 8.3.

     4.6. Royalty Term . Royalties due under Section 4.4 shall commence upon the First Commercial Sale of a Licensed Product in a particular country and will expire on a country-by-country basis upon the expiration of all issued patents or the abandonment of all pending patent applications within the Patent Rights that, absent a license, would be infringed in such country by the use or sale of the Licensed Product in such country (“Royalty Term”). As used in this Agreement, “First Commercial Sale” shall mean, with respect to any Licensed Product, the first sale or other transfer of such Licensed Product by Company, its Affiliate(s) or Sublicensee(s) to an unaffiliated customer for resale, use or consumption and not solely for evaluation or testing.

     4.7. Other Payments to University . In the event Company is legally required to make base royalty payments to University for a Licensed Product under any license agreement between the Parties other than this Agreement (whether directly or on behalf of a Sublicensee), Company may offset a total of * * * of such other base royalty against payments due to University under Sections 4.4 in the same Royalty Period under this Agreement. However, such offset may not reduce the royalty payments payable under Section 4.4 to less than * * * in the Royalty Period.

     4.8. Third-Party Royalties . In the event Company or any of its Affiliates or Sublicensees makes royalty payments to one or more third parties in connection with the manufacture, use or sale of Licensed Products, then Company may offset a total of * * * of such payments against any royalty payments that are due to University in the same Royalty Period. However, such offset may not reduce the royalty payments under Section 4.4 to less than * * * in the Royalty Period.

     4.9. Sublicense Income . Company shall pay University a total of * * * of all Sublicense Income pursuant to any sublicense agreement entered into between Company and a Sublicensee within the first twelve (12) months after the Effective Date of this Agreement, provided that the Sponsored Research Agreement is not voluntarily terminated by Company prior to the expiration thereof. If Comp


 
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