Back to top

LICENSE AGREEMENT

License Agreement

LICENSE AGREEMENT | Document Parties: Vical Incorporated You are currently viewing:
This License Agreement involves

Vical Incorporated

. RealDealDocs™ contains millions of easily searchable legal documents and clauses from top law firms. Search for free - click here.
Title: LICENSE AGREEMENT
Date: 3/3/2009
Industry: Biotechnology and Drugs     Sector: Healthcare

LICENSE AGREEMENT, Parties: vical incorporated
50 of the Top 250 law firms use our Products every day

Exhibit 10.57

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 240.24b-2.

LICENSE AGREEMENT

University of Michigan File 0867p1

This Agreement is effective as of 14 th of February, 2006 (the “Effective Date”), between Vical Incorporated (“LICENSEE”) having the address in Article 13 below, and the Regents of the University of Michigan, a constitutional corporation of the State of Michigan (“MICHIGAN”). LICENSEE and MICHIGAN agree as follows:

BACKGROUND

MICHIGAN and LICENSEE are assignees of the inventions covered by the PATENT RIGHTS (as defined below).

LICENSEE desires to obtain, and MICHIGAN desires to grant to LICENSEE, a license of the PATENT RIGHTS on the terms and conditions set forth below.

ARTICLE 1 – DEFINITIONS

1.1 “FIELD OF USE” means all fields.

1.2 “FIRST COMMERCIAL SALE” means the first sale, rental, or lease of any LICENSED PRODUCT or first commercial use of any LICENSED PROCESS by LICENSEE or a SUBLICENSEE, other than sale of a LICENSED PRODUCT or use of a LICENSED PROCESS for use in trials, such as field trials or clinical trials, being conducted to obtain FDA or other governmental approvals to market LICENSED PRODUCTS or otherwise commercially use LICENSED PROCESSES.

1.3 “LICENSED PROCESS(ES)” means any process or method that, but for access to rights to practice the PATENT RIGHTS, comprises an infringement (including contributory or inducement) of an issued, unexpired claim or a pending claim contained in the PATENT RIGHTS or uses a LICENSED PRODUCT.

1.4 “LICENSED PRODUCT(S)” means any product the manufacture, use, import, offer for sale or sale of which, but for access to rights to practice the PATENT RIGHTS, comprises an infringement (including contributory or inducement) of an issued, unexpired claim or a pending claim contained in the PATENT RIGHTS in the country in which any such product or product part is made, used, imported, offered for sale or sold.

1.5 “NET SALES” means the amount billed or invoiced, and if any amount is not billed or invoiced, the amounts received, on sales, rental or lease, however characterized, by LICENSEE and/or SUBLICENSEES of LICENSED PRODUCTS and uses of LICENSED PROCESSES, less the following deductions (so long as such deductions are not obtained in view of other consideration received by LICENSEE):

(a) trade, quantity and cash discounts actually granted to customers in such invoices for sales, rental or lease of LICENSED PRODUCTS;- or uses of LICENSED PROCESSES, including without limitation, discounts provided by means of chargebacks, rebates and administrative fees charged by customers or health care organizations determined based upon sales, but only in amounts customary in the trade;

 

1


(b) sales, tariff duties and/or use taxes separately stated in such bills or invoices with reference to particular sales and actually paid by LICENSEE or SUBLICENSEE to a governmental unit and shipping, handling and insurance charges actually paid by LICENSEE or SUBLICENSEE;

(c) actual freight expenses between LICENSEE or SUBLICENSEE and customers, to the extent such expenses are not charged to or reimbursed by customers; or

(d) rebates and amounts actually refunded or credited on returns.

Where LICENSEE receives any consideration other than cash for such transactions, fair market cash value for such consideration, to be agreed upon by the parties hereto, shall be included in NET SALES.

1.6 “PATENT RIGHTS” means MICHIGAN’S legal rights under the patent laws of the United States or relevant foreign countries for all of the following:

(a) the following United States and foreign patents and/or patent applications, and divisionals, continuations (except continuations-in-part), and foreign counterparts of the same: US. 5,910,488, “Plasmids suitable for gene therapy” and CA2164088, JP3636187 and EP0702722.

 

1.7

“ROYALTY PERIOD(S)” means the six-month periods ending on the last days of June and December each year.

1.8 “SUBLICENSEE(S)” means any person or entity sublicensed, or granted an option for a sublicense, under the PATENT RIGHTS under this Agreement.

1.9 “SUBLICENSE INCOME” means any revenue that LICENSEE receives from SUBLICENSEES or assignees in consideration for rights under the PATENT RIGHTS, including, without limitation, license issue fees, maintenance fees and milestone payments, but excluding (a) all royalties and other payments based on NET SALES, (b) all amounts paid to support research and/or development by LICENSEE, (c) all payments for equity or debt securities of LICENSEE (except that, to the extent such payments exceed the fair market value of such securities upon date of receipt, such excess shall be included in SUBLICENSE INCOME), (d) all payments tied to the provision of goods and/or services by LICENSEE, and (e) any bona fide loan except to the extent such loan is forgiven without repayment. For clarification, SUBLICENSE INCOME does not include any revenue that LICENSEE receives from SUBLICENSEES or assignees in consideration for rights to any intellectual property of LICENSEE other than the PATENT RIGHTS.

 

1.10

“TERRITORY” means worldwide.

 

2


ARTICLE 2 – GRANT OF LICENSE

2.1 MICHIGAN hereby grants to LICENSEE an exclusive license with the right to grant sublicenses (with the right to grant further sublicenses), both subject to the terms and conditions of this Agreement, in the FIELD OF USE and the TERRITORY to make, have made, import, use, market, offer for sale and sell LICENSED PRODUCTS and to practice LICENSED PROCESSES.

2.2 MICHIGAN reserves the right to practice the PATENT RIGHTS for research and/or educational purposes, and the right to grant the same limited rights to other non-profit research institutions (with no right of such non-profit research institution to grant further rights).

2.3 This Agreement shall extend until expiration of the last to expire of the licensed PATENT RIGHTS, unless sooner terminated as provided in another specific article of this Agreement.

2.4 LICENSEE agrees that LICENSED PRODUCTS used, leased or sold in the United States shall be manufactured substantially in the United States to the extent required by law.

2.5 LICENSEE acknowledges that it has been informed that the licensed PATENT RIGHTS were developed, at least in part, by employees of the Howard Hughes Medical Institute (“HHMI”) and that HHMI has a paid-up, non-exclusive, irrevocable license to use the licensed PATENT RIGHTS for HHMI’s research purposes, but with no right to assign or sublicense (the “HHMI License”). This license is explicitly made subject to the HHMI License.

2.6 To the extent that the following grant may be required by research funding agreements between MICHIGAN and the United States Government, MICHIGAN reserves the right to grant to the United States Government nonexclusive, nontransferable, irrevocable, paid-up licenses to practice or have practiced for or on behalf of the United States PATENT RIGHTS throughout the world.

ARTICLE 3 - CONSIDERATION

3.1 LICENSEE shall pay to MICHIGAN the following:

(a) A license issue fee of [***]. Such license issue fee shall be nonrefundable and is due fourteen days (14) from the complete execution of this Agreement.

(b) Running royalties according to the following schedule from the FIRST COMMERCIAL SALE until the expiration date of the last to expire of the PATENT RIGHTS or until this Agreement is terminated:

 

 

(i)

[***] of annual NET SALES up to and including [***]

 

 

(ii)

[***] of annual NET SALES over [***] and up to and including [***]

 

 

(iii)

[***] of annual NET SALES over [***]

 

 

***

Confidential Treatment Requested

 

3


If LICENSEE makes any NET SALES to any party controlled by, controlling, or under common control with LICENSEE (where “control” means the direct or indirect ownership of more than 30% of the voting stock or other ownership interests of that entity, or the power, directly or indirectly to cause the direction of the management and policies of such entity) at a price less than the price charged to-independent third parties, the running royalties payable to MICHIGAN shall be computed on the basis of the price charged to independent third parties in an arm’s length transaction.

(c) [***] of SUBLICENSE INCOME.

(d) Until the [***], an annual license maintenance fee (“Annual Fee”) of [***]. This Annual Fee is accrued on June 30 beginning [***] and is payable with the semi-annual report for the ROYALTY PERIOD in which the Annual Fee accrues.

3.2 LICENSEE shall be responsible for the payment of all taxes, duties, levies, and other charges imposed by any taxing authority with respect to the royalties payable to MICHIGAN under this agreement. Should LICENSEE be required under any law or regulation of any government entity or authority to withhold or deduct any portion of the payments on royalties due to MICHIGAN, then the sum payable to MICHIGAN shall be increased by the amount necessary to yield to MICHIGAN an amount equal to the sum it would have received had no withholdings or deductions been made. MICHIGAN shall cooperate reasonably with LICENSEE in the event LICENSEE elects to assert, at its own expense, MICHIGAN’s exemption from any such tax or deduction.

3.3 LICENSEE is not obligated to pay multiple royalties if any LICENSED PRODUCT or LICENSED PROCESS is covered by more than one claim of PATENT RIGHTS or the same LICENSED PRODUCT is covered by claims in two or more countries.

3.4 Royalty payments shall be paid to the “Regents of the University of Michigan” in United States dollars in Ann Arbor, Michigan, sent as provided in Article 13. In computing royalties, LICENSEE shall convert any revenues it receives in foreign currency into its equivalent in United States dollars at the most recent exchange rate published in the Wall Street Journal on the last business day of the ROYALTY PERIOD during which such payments are received by LICENSEE, or at such other exchange rate as the parties may agree to in writing.

3.5 Royalty payments shall be made on a semi-annual basis with submission of the reports required by Article 4. All amounts due under this Agreement shall, if overdue, be subject to a charge of interest compounded monthly until payment, at a per annum rate of five percent (5%) above the prime rate in effect at the JP Morgan Chase & Co. or its successor bank on the due date (or at the highest allowed rate if a lower rate is required by law) or $250, whichever is greater. The payment of such interest shall not foreclose MICHIGAN from exercising any other rights it may have resulting from any late payment. LICENSEE shall reimburse MICHIGAN for the costs, including reasonable attorney fees, for expenses paid in order to collect any amounts overdue more than 120 days unless there is a good faith dispute regarding whether such payment is due.

 

 

***

Confidential Treatment Requested

 

4


ARTICLE 4 - REPORTS

4.1 Until the FIRST COMMERCIAL SALE, LICENSEE shall provide to MICHIGAN a written annual report on or before July 30 of each year. The annual report shall include: reports of progress on research and development, regulatory approvals, manufacturing and sublicensing with respect to LICENSED PRODUCTS and LICENSED PROCESSES during the preceding twelve (12) months, and plans for the coming year. LICENSEE also shall report to MICHIGAN the date of FIRST COMMERCIAL SALE in each country within thirty (30) days of occurrence.

4.2 After the FIRST COMMERCIAL SALE, LICENSEE shall provide semi-annual reports to MICHIGAN. By each July 30 and January 31 (i.e., within one month after each ROYALTY PERIOD closes, including the close of the ROYALTY PERIOD immediately following any termination of this Agreement), LICENSEE shall report to MICHIGAN for that ROYALTY PERIOD:

(a) number of LICENSED PRODUCTS sold, leased or distributed by LICENSEE and each SUBLICENSEE.

(b) NET SALES, excluding the deductions provided therefor, of LICENSED PRODUCTS sold by LICENSEE and all SUBLICENSEES.

(c) accounting for all LICENSED PROCESSES used or sold by LICENSEE and all SUBLICENSEES, including NET SALES, excluding the deductions therefor.

(d) deductions applicable as provided in the definition for NET SALES above.

(e) royalties due on INCOME under Paragraph 3.1(c) above, including supporting figures.

(f) foreign currency conversion rate and calculations (if applicable) pursuant to Paragraph 3.4 and total royalties due under Paragraph 3.1(b).

(g) names and addresses of all SUBLICENSEES granted a sublicense or option therefor under the PATENT RIGHTS any time during the particular ROYALTY PERIOD.

(h) for each sublicense or amendment thereto completed in the particular ROYALTY PERIOD, the date of each agreement and amendment, the territory of the sublicense, the scope of the sublicense, and the nature, timing and amounts of all fees and royalties to be paid thereunder.

LICENSEE shall include the amount of all payments due, and the various calculations used to arrive at those amounts, including the quantity, description (nomenclature and type designation as described in Paragraph 4.3 below), country of manufacture and country of sale of LICENSED PRODUCTS and LICENSED PROCESSES. LICENSEE shall direct its authorized representative to certify that all information regarding payments due to MICHIGAN contained in reports required hereunder is correct to the best of LICENSEE’s knowledge and information and all other information contained in

 

5


reports required hereunder is correct in all material respects to the best of LICENSEE’s knowledge and information. Failure to provide reports as required under this Article 4 shall be a material breach of this Agreement.

If no payment is due, LICENSEE shall so report to MICHIGAN that no payment is due.

4.3 LICENSEE shall promptly establish and consistently employ a system of specific nomenclature and type designations for LICENSED PRODUCTS and LICENSED PROCESSES to permit identification and segregation of various types where necessary. LICENSEE shall consistently employ, and shall require SUBLICENSEES to consistently employ, the system when rendering invoices thereon and shall inform MICHIGAN, or its auditors, when requested, as to the details concerning such nomenclature system, all additions thereto and changes therein.

4.4 LICENSEE shall keep, and shall require SUBLICENSEES to keep, true and accurate records containing data reasonably required for the computation and verification of payments due under this Agreement. LICENSEE shall, and it shall require all SUBLICENSEES to: (a) open such records for inspection upon reasonable notice during business hours by either MICHIGAN auditor(s) or an independent certified accountant selected by MICHIGAN, for the purpose of verifying the amount of payments due; and (b) retain such records for six (6) years from date of origination.

The terms of this Article shall survive any termination of this Agreement. MICHIGAN is responsible for all expenses of such inspection, except that if any inspection reveals an underpayment greater than [***] of royalties due MICHIGAN, then LICENSEE shall pay all expenses of that inspection and the amount of the underpayment and interest to MICHIGAN within twenty-one (21) days of written notice thereof. LICENSEE shall also reimburse MICHIGAN for reasonable expenses required to collect the amount underpaid.

4.5 All of the payment terms in this Agreement and all information contained in reports provided hereunder may be designated confidential under the terms of the Non-Disclosure Agreement of even date herewith.

ARTICLE 5 - DILIGENCE

5.1 LICENSEE (itself or through its SUBLICENSEES) shall use commercially reasonable efforts to bring LICENSED PRODUCTS to market or one or more LICENSED PROCESSES to commercial use and to continue active, diligent marketing efforts for one or more LICENSED PRODUCTS or LICENSED PROCESSES throughout the life of this Agreement. LICENSEE (itself or through its SUBLICENSEES) has the responsibility to do all that is necessary to obtain and retain any governmental approvals to manufacture and/or sell LICENSED PRODUCTS and/or use LICENSED PROCESSES for all relevant activities of LICENSEE and SUBLICENSEES.

ARTICLE 6 - SUBLICENSING

6.1 LICENSEE shall notify MICHIGAN in writing of every sublicense agreement and each amendment thereto within thirty (30) days after their execution, and indicate the name of the

 

6


SUBLICENSEE, the territory of the sublicense, the scope of the sublicense, and the nature, timing and amounts of all fees and royalties to be paid thereunder. Upon request, LICENSEE shall provide MICHIGAN with a copy of sublicense agreements (provided that confidential information in any such sublicense agreement that is not required to be provided to MICHIGAN hereunder may be redacted).

6.2 Each sublicense granted by LICENSEE under this Agreement shall provide for its termination upon termination of this Agreement provided, however, that a sublicense granted to any SUBLICENSEE may permit such SUBLICENSEE, by written notice to MICHIGAN within sixty (60) days of the SUBLICENSEE’s receipt of written notice of such termination, to elect to continue the sublicense of rights under this Agreement granted to such SUBLICENSEE on the condition that the sublicense conforms to the requirements of Paragraph 6.3 and the SUBLICENSEE agrees in writing at the time of election to be subject to the obligations contained in this Agreement to be performed or becoming due and payable by LICENSEE from and after the time of election as if SUBLICENSEE were LICENSEE hereunder, subject to any limitations on the grant of rights (such as field limitations) to such SUBLICENSEE c


 
SITE SEARCH

AGREEMENTS / CONTRACTS

Document Title:

Entire Document: (optional)

Governing Law:(optional)


Try our advanced search >>
 

CLAUSES

Search Contract Clauses >>

Browse Contract Clause Library>>

Get Email Updates
Email:
This is only a partial view of this document. We have millions of legal documents and clauses drafted by top law firms. learn more search for free browse for free learn more