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EXCLUSIVE LICENSE AGREEMENT

License Agreement

EXCLUSIVE LICENSE AGREEMENT | Document Parties: NEUROLOGIX INC/DE You are currently viewing:
This License Agreement involves

NEUROLOGIX INC/DE

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Title: EXCLUSIVE LICENSE AGREEMENT
Governing Law: Pennsylvania     Date: 4/9/2004
Industry: Software and Programming     Sector: Technology

EXCLUSIVE LICENSE AGREEMENT, Parties: neurologix inc/de
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EXHIBIT 10.31

 

Exclusive License Agreement

 

Between

 

Thomas Jefferson University

 

And

 

Neurologix, Inc.

 

Effective as of June 1, 2002

 

Re: DUR1-DSC06, DUR1-DSC07, DUR1-DSC08, DUR1-DSC09, DUR1-DSC010

 

In consideration of the mutual promises and covenants set forth below, the parties hereto agree as follows:

 

ARTICLE I

DEFINITIONS

 

As used in this Agreement, the following terms shall have the following meanings:

 

1.1

ACADEMIC RESEARCH PURPOSES: use of PATENT RIGHTS for academic research or other not-for-profit scholarly purposes which are undertaken at a non-profit or governmental institution that does not use the PATENT RIGHTS in the production or manufacture of products for sale or the performance of services for a fee.

 

1.2

AFFILIATE: any entity which controls, is controlled by, or is under common control with a party by ownership or control of at least fifty percent (50%) of the voting stock or other means by which control over management of an entity can be made. Unless otherwise specified, the term LICENSEE includes AFFILIATES.

 

1.3

FIELD: any and all fields of use.

 

1.4

TJU: Thomas Jefferson University, a nonprofit Pennsylvania educational corporation having offices at 1020 Locust Street, M60, Philadelphia, PA 19107.

 

1.5

LICENSED PROCESSES: the methods and processes covered by at least one VALID PATENT CLAIM under the PATENT RIGHTS, or some portion thereof.

 

1.6

LICENSED PRODUCTS: products covered by at least one VALID PATENT CLAIM under the PATENT RIGHTS, or products made or services provided in accordance with or by means of LICENSED PROCESSES.

 

1.7.1

LICENSEE: Neurologix, Inc., a corporation organized under the laws of the State of Delaware, having its principal offices at 271-32E Grand Central Parkway, Floralpark, NY 11005.


1.8

RELATED TECHNOLOGY: any invention not otherwise falling within the PATENT RIGHTS, for which a patent application has not been filed as of the date of this Agreement, that results from research conducted at TJU under the direction of Dr. Matthew During listed in Appendix A, and is based upon and builds on an invention described in an application or patent listed in Appendix A, and that is dominated (as hereafter defined) by PATENT RIGHTS of an application or patent listed in Appendix A.

 

The term DOMINATED defines a relationship between a subsequently filed patent application or patent and a previously filed patent application or patent, wherein the claim or claims of the prior patent application or patent encompass the subject matter of at least one claim in the subsequent patent application or patent such that the practice of the subsequent patent application or patent (i.e., the dominated patent) necessarily infringes one or more claims of the prior patent application or patent (i.e., the dominating patent).”

 

1.9

NET RESEARCH AND DEVELOPMENT INCOME: RESEARCH AND DEVELOPMENT INCOME less LICENSEE’s actual direct and indirect costs for research, development and/or research development services provided pursuant to contract with a third party.

 

1.10

NET SALES: the amount invoiced and received for sales, leases, or other transfers of LICENSED PRODUCTS, less:

 

 

(a)

customary trade, quantity or cash discounts and non-affiliated brokers’ or agents’ commissions 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, taxes levied on and/or other governmental charges made as to production, sale, transportation, delivery or use and paid by or on behalf of LICENSEE or sublicensees; and

 

 

(d)

reasonable charges for delivery or transportation provided by third parties, if separately stated.

 

NET SALES also includes the fair market value of any non-cash consideration received by LICENSEE or sublicensees for the sale, lease, or transfer of LICENSED PRODUCTS.

 

1.11

RESEARCH AND DEVELOPMENT INCOME: the total financial consideration received as a result of the utilization of LICENSED PRODUCTS or LICENSED PROCESSES by LICENSEE in connection with a contract with a third party for research and/or development services relating to LICENSED PRODUCTS or LICENSED PROCESSES.

 

1.12

NON-ROYALTY SUBLICENSE INCOME: the amount paid to LICENSEE by a third party (other than an AFFILIATE of LICENSEE) for the granting of a sublicense under Section 3.1 hereinafter, excluding for which royalties are paid pursuant to Section 4.2, but including, without limitation (i) license fees, (ii) milestone payments, (iii) the fair market value in cash of any non-cash consideration for such sublicense, (iv) in the event that LICENSEE receives any payment for equity in connection with such sublicense that included a premium over the fair market value of

 

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such equity, the amount of such premium, and (v) NET RESEARCH AND DEVELOPMENT INCOME.

 

SUBLICENSE INCOME shall exclude NET RESEARCH AND DEVELOPMENT INCOME.

 

1.13

PATENT RIGHTS: The patent applications and patents listed in Appendix A of this Agreement, or that are thereafter filed and claim an invention priority date based on such patents or patent applications, together with the allowed claims of all such applications, patents, and any divisions, continuations, continuations-in-part, specific claims of any continuations-in-part of such applications to the extent the specific claims are directed to subject matter described in the applications and patents listed in Appendix A in a manner sufficient to support such specific claims under 35 U.S.C., patents issuing thereon, reissues and extensions thereof, and any and all foreign patents and patent applications corresponding thereto, all to the extent owned or controlled by TJU. Upon proper exercise by LICENSEE of its rights under Sections 3.2 and 4.4 of this Agreement, a RELATED TECHNOLOGY shall thereafter be included within the PATENT RIGHTS.

 

1.14

TERRITORY: the world.

 

1.15

VALID PATENT CLAIM: a claim of an issued, unexpired patent that has not been (a) held invalid or unenforceable by a final decision of a court or governmental agency of competent jurisdiction, which decision is unappealable or was not appealed within the time allowed therefore, or (b) admitted in writing to be invalid or unenforceable by the holder(s) by reissue, disclaimer or otherwise.

 

1.16

The terms “Public Law 96-517” and “Public Law 98-620” include all amendments to those laws.

 

1.17

The terms “sold” and “sell” include, without limitation, leases and other transfers and similar transactions involving consideration.

 

ARTICLE II

REPRESENTATIONS

 

2.1

Except as otherwise disclosed in Appendix A, TJU is owner by assignment from inventors of their entire right, title and interest in and to the United States patents and patent applications as listed in Appendix A, the foreign patents and patent applications corresponding thereto, and in the inventions described and claimed therein.

 

2.2

TJU has the authority to issue licenses under the PATENT RIGHTS, to the extent owned by TJU.

 

2.3

TJU is committed to the policy that ideas or creative works produced at TJU should be used for the greatest possible public benefit, and believes that every reasonable incentive should be provided for the prompt introduction of such ideas into public use, all in a manner consistent with the public interest.

 

2.4

LICENSEE is prepared and intends to diligently develop the invention and to bring products to market which are subject to this Agreement.

 

2.5

LICENSEE is desirous of obtaining an exclusive license in the TERRITORY in order to practice the above-referenced inventions covered by the PATENT RIGHTS in the United States and in foreign countries, and to manufacture, use and sell in the commercial market the products made

 

3


in accordance therewith, and TJU is desirous of granting such a license to LICENSEE in accordance with the terms of this Agreement.

 

ARTICLE III

GRANT OF RIGHTS

 

3.1

TJU hereby grants to LICENSEE and LICENSEE accepts, subject to the terms and conditions hereof, in the TERRITORY and in the FIELD, an exclusive commercial right and license under the PATENT RIGHTS to make, have made, use, offer for sell, sell and import the LICENSED PRODUCTS, and to practice the LICENSED PROCESSES, for the life of the PATENT RIGHTS. Such license shall include the right to grant sublicenses. In the event of sublicensing, LICENSEE shall promptly provide TJU a copy of such sublicense agreement for review. In order to provide LICENSEE with commercial exclusivity for so long as the license under the PATENT RIGHTS remains exclusive, TJU agrees that it will not grant licenses under the PATENT RIGHTS to others except as required by TJU’s obligations under Section 3.3(a) or as permitted in Section 3.3(b).

 

3.2

After the execution date of this Agreement, if the Office of Technology Transfer (OTT) at TJU receives an invention disclosure which is a RELATED TECHNOLOGY, TJU shall promptly notify LICENSEE of such technology. LICENSEE shall have the option to include such RELATED TECHNOLOGY into this Agreement by including such in Appendix A and by paying an additional non-refundable annual license fee of xx thousand dollars($xx). LICENSEE shall have sixty (60) days to exercise such option upon receiving written notice from OTT at TJU, provided TJU is legally able to offer such option and license.

 

3.3

The grant and exercise of this exclusive license is subject to the following conditions:

 

 

(a)

TJU’s “Patent Policy” dated December 1, 1997, Public Law 96-517, and Public Law 98-620, and TJU’s obligations under agreements with other not-for-profit sponsors of research. Any right granted in this Agreement greater than that permitted under Public Law 96-517, or Public Law 98-620, shall be subject to modification as may be required to conform to the provisions of those statutes.

 

 

(b)

TJU reserves the right to make and use, and grant to other not-for-profit institutions non-exclusive licenses to make and use, solely for ACADEMIC RESEARCH PURPOSES the subject matter described and claimed in PATENT RIGHTS.

 

 

(c)

LICENSEE shall use diligent efforts to effect introduction of the LICENSED PRODUCTS into the commercial market as soon as practicable, consistent with sound and reasonable business practice and judgment; thereafter, until the expiration of this Agreement, LICENSEE shall endeavor to keep LICENSED PRODUCTS reasonably available to the public.

 

 

(d)

At any time after six (6) years from the effective date of this Agreement, TJU may, after providing sixty (60) days advance notice to LICENSEE with an opportunity to cure, or develop a reasonable plan that is agreeable to TJU, terminate or render this license non-exclusive if, in TJU’s reasonable judgment, the Progress Reports or other information furnished by LICENSEE do not substantially demonstrate that LICENSEE:

 

4


 

(i)

has put the licensed subject matter into commercial use in the country or countries hereby licensed, directly or through a sublicense, and is keeping the licensed subject matter reasonably available to the public; or

 

 

(ii)

is engaged in research, development, manufacturing, marketing or sublicensing activity appropriate to achieving 3.3(d)(i).

 

 

(f)

In all sublicenses granted by LICENSEE hereunder, LICENSEE shall include a requirement that the sublicensee use its commercially reasonable efforts to bring the subject matter of the sublicense into commercial use as quickly as is reasonably practical. LICENSEE shall further provide in such sublicenses that such sublicenses are subject and subordinate to the terms and conditions of this Agreement, except that : (i) the sublicensee may not grant further sublicenses; and (ii) the rate of royalty on NET SALES paid by the sublicensee to the LICENSEE need not to be limited to the rate of royalty set forth herein. Copies of all sublicense agreements shall be provided promptly to TJU.

 

 

(g)

TJU understands and acknowledges that LICENSEE will be spending considerable resources, both human and financial on the development of the LICENSED PRODUCTS in an effort to obtain the necessary approvals of LICENSED PRODUCTS in the Territory. LICENSEE further acknowledges that it is TJU’s mission to make the LICENSED PRODUCTS available to the public.

 

 

(h)

During the period of exclusivity of this license in the United States, LICENSEE shall cause any LICENSED PRODUCT produced for sale in the United States to be manufactured substantially in the United States.

 

3.4

All rights reserved to the United States Government and others under Public Law 96-517, and Public Law 98-620, shall remain and shall in no way be affected by this Agreement.

 

ARTICLE IV

ROYALTIES

 

4.1

LICENSEE shall pay to TJU a one-time non-refundable license fee in the sum of xxxx dollars ($xxx) upon execution of this Agreement.

 

4.2

LICENSEE shall pay to TJU during the term of this Agreement a royalty of x percent (x%) of NET SALES by LICENSEE and its sublicensees. In the case of sublicenses, LICENSEE shall pay to TJU a royalty of xx percent (x%) of NON-ROYALTY SUBLICENSE INCOME.

 

4.3

As consideration for the rights granted hereunder, LICENSEE shall pay to TJU during the term of this Agreement the following cash milestone payments within thirty (30) days of their occurrence (time of payment is of the essence):

 

 

(i)

xxxx dollars ($xxx) upon the filing of a New Drug Application (“NDA”) by LICENSEE;

 

 

(ii)

xxxx dollars ($xxx) upon the first approval of an NDA relating to the first LICENSED PRODUCT by the United States Food and Drug Administration (FDA);

 

5


4.4

LICENSEE shall pay TJU an additional annual license fee in the amount of xxx dollars ($xxx) for each RELATED TECHNOLOGY to be included in this Agreement.

 

4.5

Notwithstanding anything herein to the contrary, if any portion of the license pursuant to this Agreement is converted to a non-exclusive license and if other non-exclusive licenses in the same field and territory are granted, the above royalties shall, if necessary, be reduced so as not to exceed the royalty rate to be paid by any other licensees in the same field and territory during the term of the non-exclusive license.

 

4.6

On sales between LICENSEE and its AFFILIATES or sublicensees for resale, the royalty shall be paid on the NET SALES of the AFFILIATE or sublicensee.

 

4.7

No later than each anniversary of the effective date of this Agreement, LICENSEE shall pay to TJU the sum of one hundred thousand dollars ($100,000) as a non-refundable license maintenance royalty and/or advance on royalties. Such payments may only be credited against running royalties due for the calendar year in which they are paid, and Royalty Reports shall reflect such a credit. Such payments shall not be credited against milestone payments (if any) nor against royalties due for any subsequent calendar year nor for any other payments made pursuant to this license.

 

ARTICLE V

REPORTING

 

5.1

Twelve (12) months after signing this Agreement, LICENSEE shall provide to TJU a written research and development plan under which LICENSEE intends to bring the subject matter of the licenses granted hereunder into commercial use. Such plan shall include, as applicable, sublicensing plans, projections of sales and proposed marketing efforts.

 

5.2

Commencing in 2003, no later than sixty (60) days after June 30 of each calendar year, LICENSEE shall provide to TJU a detailed written annual Progress Report describing progress on research and development, regulatory approvals, manufacturing, sublicensing, research and development contracts, marketing and sales during the most recent twelve (12) month period ending June 30 and plans for the forthcoming year. If multiple technologies are covered by the license granted hereunder, the Progress Report shall provide the information set forth above for each technology. If progress differs from that anticipated in the plan required under Section 5.1, LICENSEE shall explain the reasons for the difference and propose a modified research and development plan for TJU’s review. LICENSEE shall also provide any reasonable additional data TJU requires to evaluate LICENSEE’s performance.

 

5.3

LICENSEE shall report to TJU the date of first sale of LICENSED PRODUCTS (or sales based on performance of LICENSED PROCESSES) in each country within thirty (30) days of occurrence.

 

5.4

(a) Commencin


 
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