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EXCLUSIVE LICENSE AGREEMENT

License Agreement

EXCLUSIVE LICENSE AGREEMENT | Document Parties: JB CLOTHING CORP You are currently viewing:
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JB CLOTHING CORP

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Title: EXCLUSIVE LICENSE AGREEMENT
Governing Law: California     Date: 7/10/2009

EXCLUSIVE LICENSE AGREEMENT, Parties: jb clothing corp
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Exhibit 10.1

 

 

 

EXCLUSIVE LICENSE AGREEMENT

 

 

This Exclusive License Agreement and the attached Appendix A (collectively, the “Agreement”) is made and is effective this 26 th day of September 2008 (the "Effective Date") between THE REGENTS OF THE UNIVERSITY OF CALIFORNIA ("The Regents"), a California corporation having its corporate offices located at 1111 Franklin Street, Oakland, California 94607-5200, acting through The Office of Intellectual Property Administration of the University of California, Los Angeles, located at 11000 Kinross Avenue, Suite 200, Los Angeles, CA 90095-1406 and Entest BioMedical Inc. ("Licensee"), a corporation having a principal place of business at 1010 University Avenue #40 , San Diego, CA 92103.

 

RECITALS

 

 

WHEREAS, a certain invention (the "Invention"), generally characterized as “SCREENING TEST FOR GESTATIONAL DIABETES MELLITUS” (UCLA Case No. 2007-523) was made in the course of research at the University of California, Los Angeles by Brian J. Koos, and is and claimed in Regents' Patent Rights as defined below;

 

WHEREAS, Brian J. Koos is an employee of The Regents and as such is obligated to assign his/her right, title and interest in and to the Invention to The Regents;

 

WHEREAS, The Regents wishes that Regents' Patent Rights be developed and utilized to the fullest extent so that the benefits can be enjoyed by the general public.

 

WHEREAS, Licensee is a "small business concern" as defined in 15 U.S.C. §§632; and

 

The parties agree as follows:

 

1.  DEFINITIONS

 

1.1

"Regents' Patent Rights" means The Regents’ interest in any of the patent applications listed in Appendix A attached to this Agreement and assigned to The Regents (UCLA Case No. 2007-523); any continuing applications thereof including divisions; but excluding continuations-in-part except to the extent of claims entirely supported in the specification and entitled to the priority date of the parent application; any patents issuing on these applications including reissues and reexaminations; and any corresponding foreign patents or patent applications; all of which will be automatically incorporated in and added to Appendix A and made a part of this Agreement.

 

 

1.2

"Licensed Product" means any article, composition, apparatus, substance, chemical, or any other material covered by Regents' Patent Rights or whose manufacture, use or sale would, absent the license granted under this Agreement, constitute an infringement, inducement of infringement, or contributory infringement, of any claim within Regents' Patent Rights, or any service, article, composition, apparatus, chemical, substance, or any other material made, used, or sold by or utilizing or practicing a Licensed Method. This definition of Licensed Product also includes a service either used by Licensee or sublicensee or provided by Licensee or sublicensee to its customers when such service requires the use of Licensed Product or performance of Licensed Method. If the Licensed Product is a component of another product such as a kit, composition of matter or combination, such kit, composition of matter or combination is deemed to be the Licensed Product for purposes of this Agreement. Likewise, if the Licensee or sublicensees receives a Licensed Product for incorporation into another product intended for sales, transfer, lease or other disposition, then, for the purposes of this Agreement, the Licensed Product is the product intended for sale, transfer, lease, or other disposition by recipient Licensee or sublicensee.

 

 

 

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1.3

"Licensed Method" means any process, service, or method which is covered by Regents' Patent Rights or whose use or practice would, absent the license granted under this Agreement, constitute an infringement, inducement of infringement, or contributory infringement, of any claim within Regents' Patent Rights.

 

 

1.4

The "Field of Use" means all fields of use.

 

 

1.5

" Affiliate " means any corporation or other business entity in which Licensee owns or controls, directly or indirectly, at least fifty percent (50%) of the outstanding stock or other voting rights entitled to elect directors. In any country where the local law does not permit foreign equity participation of at least fifty percent (50%), then "Affiliate" means any company in which Licensee owns or controls, directly or indirectly, the maximum percentage of outstanding stock or voting rights that is permitted by local law.

 

 

1.6

“Joint Venture” means any separate entity established pursuant to an agreement between a third party and the Licensee and/or Sublicensee to constitute a vehicle for a Joint Venture, in which the separate entity manufactures, uses, purchases, Sells or acquires Licensed Products from the Licensee or Sublicensee. Each reference to Licensee herein will be meant to include its Joint Venture(s), and Licensee will be responsible for all obligations of its Joint Ventures.

 

 

1.7

"First Commercial Sale" means the first sale of any Licensed Product by Licensee or sublicensee, following approval of it's marketing by the appropriate governmental agency for the country in which the sale is to be made. When governmental approval is not required, "First Commercial Sale" means the first sale in that country.

 

 

1.8

"Final Sale" means any sale, transfer, lease, exchange or other disposition or provision of a Licensed Product and/or a Licensed Method to a Customer by a Licensee or Sublicensee. A Final Sale will be deemed to have occurred upon the earliest to occur of the following (as applicable): (a) the transfer of title to such Licensed Product and/or Licensed Method to a Customer, (b) the shipment of such Licensed Product to a Customer, (c) the provision of a Licensed Method to a Customer, (d) the provision of an invoice for such Licensed Product or Licensed Method to a Customer, or (e) payment by the Customer for Licensed Products or Licensed Methods. Exchange of Licensed Products between Licensee and sublicense(s) is not a Final Sale if the Licensed Product is intended for further sale, transfer, lease, exchange or other disposition and instead the Final Sale will be deemed to have occurred upon sale, transfer, lease, exchange or other disposition or provision of Licensed Product by recipient to the Customer. If the Licensee or sublicense transfers Licensed Product at no cost during a clinical study, clinical trial, or as a free sample in product promotion, then such sale will not be considered a Final Sale and no royalty will be owed hereunder.

 

 

 

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1.9

"Net Sales" means the total of the gross amount invoiced or otherwise charged (whether consisting of cash or any other forms of consideration) for all Final Sales, less the following deductions (to the extent included in and not already deducted from the gross amount invoiced or otherwise charged) to the extent reasonable and customary: cash, trade or quantity discounts actually granted to Customers; sales, use, tariff, import/export duties or other excise taxes imposed on particular sales, and value added taxes (“vat”) to the extent that such vat is incurred and not reimbursed, refunded, or credited under a tax authority; and allowances or credits to Customers because of rejections or returns. Income taxes are not an allowed deduction under Net Sales. If the Licensee, a sublicense, development partner or Joint Venture is a Customer, then Licensee will pay royalties on Net sales based on the total gross amount normally charged to other Customers in arms length transactions.

 

 

1.10

Sublicensee" means any party sublicensed by Licensee to make, have made, use, sell, offer for sale or import any Licensed Product or to practice any Licensed Method.

 

 

1.11

"Sublicensing Income" means income received by Licensee under or on account of sublicenses. Sublicensing Income includes income received from Sublicensees attributable to the licensed Invention in the form of license issue fees, milestone payments, and the like but specifically excludes royalties on the sale or distribution of Licensed Products or the practice of Licensed Methods. Not included in the definition of Sublicensing Income is income received by Licensee as payment or reimbursement for research costs applied to the licensed Invention and conducted by or for Licensee, including costs of materials, equipment or clinical testing.

 

 

1.12

“Customer” means any individual or entity that receives Licensed Products or Licensed Methods, provided however, that Licensee or sublicensee shall be deemed a Customer only if it receives Licensed Products or Licensed Method that are not intended for further sale, transfer, lease, exchange or other disposition.

 

 

2. GRANT

 

 

2.1

Subject to the limitations set forth in this Agreement, The Regents hereby grants to Licensee an exclusive license (the "License") under Regents' Patent Rights, in jurisdictions where Regents' Patent Rights exist, to make, have made, use, sell, offer for sale and import Licensed Products and to practice Licensed Methods in the Field of Use to the extent permitted by law. The Licensee will not make, use, sell, import, or offer for sale, Licensed Products outside the Field of Use.

 

 

2.2

The Regents expressly reserves the right to: (a) use Regents' Patent Rights and associated technology for educational and research purposes, clinical research, and research sponsored by commercial entities (b) to publicly disclose research results, and (c) allow other non-profit research institutions to use Regents' Patent Rights and associated technology for the same purposes as (a) and (b).

 

 

2.3

The Agreement will terminate immediately if Licensee files a claim including in any way the assertion that any portion of Regents’ Patent Rights is invalid or unenforceable where the filing is by the Licensee, a third party on behalf of the Licensee, or a third party at the written urging of the Licensee

 

 

 

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3. SUBLICENSES

 

 

3.1

The Regents also grants to Licensee the right to issue exclusive or nonexclusive sublicenses ("Sublicenses") to third parties to make, have made, use, sell, offer for sale or import Licensed Products and to practice Licensed Methods in any jurisdiction in which Licensee has exclusive rights under this Agreement, but Sublicenses will not include further right to sublicense on the part of the Sublicensee. Each Sublicense will be issued in writing. To the extent applicable, sublicenses must include all of the rights of and will require the performance of obligations due to The Regents (and, if applicable, the U.S. Government under 35 U.S. C. §§201-212) contained in this Agreement. Affiliates have no rights hereunder, unless, granted a Sublicense. For the purposes of this Agreement, operations of Sublicensees are deemed to be the operations of the Licensee, for which the Licensee is responsible.

 

 

3.2

Licensee must pay to The Regents Twenty-five percent (25%) of all Sublicensing Income.

 

 

3.3

On Net Sales of Licensed Products sold or disposed of by a Sublicensee, Licensee must pay to The Regents an earned royalty in accordance with Article 5 (Royalties) as if these were Licensee's Net Sales. Any royalties received by Licensee in excess of royalties due to The Regents under this Paragraph 3.3 belong to Licensee.

 

 

3.4

Licensee must provide to The Regents a copy of each Sublicense within thirty (30) days of execution, and a copy of all information submitted to Licensee by Sublicensees relevant to the computation of the payments due to The Regents under this Article 3.

 

 

3.5

If this Agreement is terminated for any reason, all outstanding Sublicenses not in default will be assigned by Licensee to The Regents, at the option of The Regents. The Sublicenses will remain in full force and effect with The Regents as the licensor or sublicensor instead of Licensee, but the duties of The Regents under the assigned Sublicenses will not be greater than the duties of The Regents under this Agreement, and the rights of The Regents under the assigned Sublicenses will not be less than the rights of The Regents under this Agreement, including all financial consideration and other rights of The Regents.

 

 

4. FEES

 

 

4.1

In partial consideration for the License, Licensee will pay to The Regents a license issue fee of Five thousand dollars ($5,000) within thirty (30) days of the Effective Date. This fee is nonrefundable and is not an advance against royalties.

 

 

4.2

Licensee must pay to The Regents a license maintenance fee of Five thousand dollars ($5,000) beginning on the one-year anniversary date of the Effective Date of this Agreement and continuing annually on each anniversary date of the Effective Date. The maintenance fee will not be due and payable on any anniversary date of the Effective Date if on that date Licensee is commercially selling a Licensed Product and paying an earned royalty to The Regents on the sales of that Licensed Product. The license maintenance fees are non-refundable and are not an advance against royalties.

 

 

 

 

 

 

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5.     ROYALTIES

 

5.1

Licensee must pay to The Regents for sales by Licensee and sublicensees an earned royalty of Six percent (6%) of Net Sales of Licensed Products or Licensed Methods.

 

 

5.2

Licensee must pay to The Regents a minimum annual royalty of Fifty thousand dollars ($50,000) for the life of Regents' Patent Rights, beginning one year after the First Commercial Sale of Licensed Product. Licensee must pay the minimum annual royalty to The Regents by February 28 of each year. The minimum annual royalty will be credited against the earned royalty due and owing for the calendar year in which the minimum payment was made.

 

 

5.3

Royalties are payable on products covered by pending patent applications and issued patents. Royalties accrue for the duration of this Agreement.

 

 

5.4

Licensee must pay royalties owed to The Regents on a quarterly basis. Licensee must pay the royalties within two (2) months of the end of the calendar quarter in which the royalties accrued.

 

 

5.5

All monies due The Regents must be paid in United States funds. When Licensed Products are sold for monies other than United States dollars, the royalties will first be determined in the currency of the country in which the Licensed Products were sold and, second, converted into equivalent United States funds. Licensee will use the exchange rate established by the Bank of America in San Francisco, California on the last day of the calendar quarter.

 

 

5.6

Any tax for the account of The Regents required to be withheld by Licensee under the laws of any foreign country must be promptly paid by Licensee for and on behalf of The Regents to the appropriate governmental authority. Licensee will use its best efforts to furnish The Regents with proof of payment of any tax. Licensee is responsible for all bank transfer charges. All payments made by Licensee in fulfillment of The Regents' tax liability in any particular country will be credited against fees or royalties due The Regents for that country.

 

 

5.7

If at any time legal restrictions prevent the acquisition or prompt remittance of United States Dollars by Licensee with respect to any country where a Licensed Product is sold, the Licensee shall pay royalties due to The Regents from Licensee’s other sources of United States Dollars.

 

 

5.8

If any patent or any claim included in Regents' Patent Rights is held invalid or unenforceable in a final decision by a court of competent jurisdiction from which no appeal has or can be taken, all obligation to pay royalties based on that patent or claim or any claim patentably indistinct from it will cease as of the date of that final decision. Licensee will not, however, be relieved from paying any royalties that accrued before that decision or that is based on another patent or claim not involved in that decision.

 

 

6. DILIGENCE

 

 

6.1

Upon the execution of this Agreement, Licensee must diligently proceed with the development, manufacture and sale ("Commercialization") of Licensed Products and must earnestly and diligently endeavor to market them within a reasonable time after execution of this Agreement and in quantities sufficient to meet the market demands for them.

 

 

 

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6.2

Licensee must endeavor to obtain all necessary governmental approvals for the Commercialization of Licensed Products.

 

 

 

6.3

The Regents has the right and option to either terminate this Agreement or reduce Licensee’s exclusive license to a nonexclusive license if Licensee fails to perform any of the terms in this Paragraph 6.3. This right, if exercised by The Regents, supersedes the rights granted in Article 2 (Grant).

 

 

 

 

6.3a

Initiate a study in humans to measure D-chiro-inositol (“DBI”) throughout pregnancy and correlate DBI levels with conventional gestational diabetes mellitus (“GDM”) assays to determine value of DBI in predicting GDM by September 1, 2010.

 

 

 

 

6.3b

Complete a study in humans to measure D-chiro-inositol (“DBI”) throughout pregnancy and correlate DBI levels with conventional gestational diabetes mellitus (“GDM”) assays to determine value of DBI in predicting GDM by September 1, 2011.

 

 

 

 

6.3c

Complete a study to measure plasma DBI levels in samples from the Hyperglycemia and Adverse Pregnancy Outcomes (HAPO) study and correlate these DBI levels to GDM incidence by June 1, 2012.

 

 

 

 

6.3d

Complete a prospective human study on DBI and its value in predicting GDM by June 1, 2013.

 

 

 

 

6.3e

Develop a urine-based test for assaying DBI by September 1, 2015.

 

 

 

 

6.3f

First Commercial Sale of a Licensed Product by September 1, 2017.

 

 

 

6.4

Licensee has the sole discretion for making all decisions as to how to commercialize any Licensed Product.

 

 

 

7. PATENT FILING, PROSECUTION AND MAINTENANCE

 

 

 

7.1

As long as Licensee is current in reimbursing patent prosecution costs, The Regents will file, prosecute and maintain the patents and applications comprising Regents' Patent Rights. These patents will be held in the name of The Regents and will be obtained with counsel of The Regents' choice. The Regents must provide Licensee with copies of each patent application, office action, response to office action, request for terminal disclaimer, and request for reissue or reexamination of any patent or patent application under Regents' Patent Rights. The Regents will consider any comments or suggestions by Licensee and will use reasonable efforts to amend patent applications to include claims reasonably requested by the License to protect the products and services contemplated under this Agreement. The Regents is entitled to take action to preserve rights and minimize costs whether or not Licensee has commented.

 

 

 

7.2

Patent Costs.

 

 

 

 

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7.2.1

Licensee will bear all costs incurred prior to this Agreement as well as during the term of this Agreement for territories elected by Licensee pursuant to Section 7.3 of this Agreement, and invoiced to The Regents in the preparation, filing, prosecution and maintenance of patent applications and patents in Regents' Patent Rights. Prosecution includes interferences, oppositions and any other inter partes matters originating in a patent office. Licensee must send payment to The Regents within thirty (30) days after Licensee's receipt of an invoice.

 

 

7.2.2

The Regents will use reasonable efforts to give Licensee estimates in advance for patent actions costing more than two thousand dollars ($2,000) in order to get input from Licensee regarding the performance of such activity and cost control. Reasonable efforts pursuant to this Paragraph 7.2.2 shall include: (A) providing to Licensee, after receipt by The Regents from The Regents’ outside counsel, copies of all estimates for fees and expenses to the extent such documents were not previously provided to Licensee by Regents’ outside counsel and (B) instructing its outside counsel to directly forward to Licensee, at the same time as its outside counsel forwards to The Regents and using the same means that The Regents’ outside counsel uses to forward to The Regents, copies of all estimates for fees and expenses. No later than (A) ten (10) weeks prior to the relevant patent action deadline (for example a patent filing bar date or an office action response deadline); or (B) within ten (10) business days of The Regents supplying the relevant cost estimate, whichever is first, Licensee will inform The Regents in writing whether or not it elects to proceed with the relevant patent action. If, based on the cost estimate, Licensee elects not to proceed with the relevant patent action such patent applications or the patents to which the office action applies, will then no longer


 
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