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LICENSE AGREEMENT

License Agreement

LICENSE AGREEMENT | Document Parties: NEOPROBE CORP | THE REGENTS OF THE UNIVERSITY OF CALIFORNIA You are currently viewing:
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NEOPROBE CORP | THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

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Title: LICENSE AGREEMENT
Governing Law: California     Date: 3/31/2006
Industry: Biotechnology and Drugs    

LICENSE AGREEMENT, Parties: neoprobe corp , the regents of the university of california
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EXHIBIT 10.11

 

 

 

LICENSE AGREEMENT

 

BETWEEN

 

NEOPROBE CORPORATION

 

AND

 

THE REGENTS OF THE UNIVERSITY OF CALIFORNIA

 

FOR

 

CASE NO. SD1998-088

 

 

TABLE OF CONTENTS

 

 

 

Definitions

2

 

 

 

Grant

4

 

 

 

Considerations

5

 

 

 

Reports, Records and Payments

9

 

 

 

Patent Matters

11

 

 

 

Governmental Matters

13

 

 

 

Termination of Agreement

13

 

 

 

Limited Warranty and Indemnification

15

 

 

 

Use of Names and Trademarks

16

 

 

 

Miscellaneous Provisions

17

 


 

 

LICENSE AGREEMENT

 

This agreement ("Agreement") is made by and between Neoprobe Corporation a Delaware corporation having an address at 425 Metro North Place North, Suite 300, Dublin, Ohio 43017-1367 ("LICENSEE") and The Regents Of The University Of California, a California corporation having its statewide administrative offices at 1111 Franklin Street, Oakland, California 94607-5200 ("UNIVERSITY"), represented by its San Diego campus having an address at University of California, San Diego, Technology Transfer & Intellectual Property Services, Mail-code 0910, 9500 Gilman Drive, La Jolla, California 92093-0910 ("UCSD").

 

This Agreement is effective on the date of the last signature (“Effective Date”).

 

RECITALS

 

WHEREAS, the inventions disclosed in UCSD Case Docket No. SD1998-0088 and titled “MACROMOLECULAR CARRIER FOR DRUG AND DIAGNOSTIC AGENT DELIVERY“ ("Invention"), were made in the course of research at UCSD by Dr. Dave Vera (hereinafter and collectively, the "Inventor ") and are covered by Patent Rights as defined below;

 

WHEREAS, the research was sponsored in part by the Government of the United States of America and as a consequence this license is subject to overriding obligations to the Federal Government under 35 U.S.C. §§ 200-212 and applicable regulations;

 

WHEREAS, the Inventor is an employee of UCSD, and is obligated to assign all of his right, title and interest in the Invention to UNIVERSITY;

 

WHEREAS, LICENSEE entered into a secrecy agreement (UC Control No 1999-20-0208) with UNIVERSITY, effective July 17, 1998 ("Secrecy Agreement"), for the purpose of evaluating the Invention;

 

WHEREAS, UNIVERSITY is desirous that the Invention be developed and utilized to the fullest possible extent so that its benefits can be enjoyed by the general public;

 

WHEREAS, LICENSEE is desirous of obtaining certain rights from UNIVERSITY for commercial development, use, and sale of the Invention, and use of the Invention in Combination Products in the field of Scintigraphy and intraoperative use in Scintillation Counting and the UNIVERSITY is willing to grant such rights; and

 

WHEREAS, LICENSEE understands that UNIVERSITY may publish or otherwise disseminate information concerning the Invention at any time and that LICENSEE is paying consideration thereunder for its early access to the Invention, not continued secrecy therein.

 

 

NOW, THEREFORE, the parties agree:

 

ARTICLE 1. DEFINITIONS

 

The terms, as defined herein, shall have the same meanings in both their singular and plural forms.

 

1.1

"Affiliate" means any corporation or other business entity in which LICENSEE owns or controls, directly or indirectly, at least twenty percent (20%) of the outstanding stock or other voting rights entitled to elect directors, or in which LICENSEE is owned or controlled directly or indirectly by at least twenty percent (20%) of the outstanding stock or other voting rights entitled to elect directors; but in any country where the local law does not permit foreign equity participation of at least twenty percent (20%), then an "Affiliate" includes any company in which LICENSEE owns or controls or is owned or controlled by, directly or indirectly, the maximum percentage of outstanding stock or voting rights permitted by local law.

 

1.2

"Sublicensee" means a third party to whom LICENSEE grants a sublicense of   certain rights granted to LICENSEE under this Agreement.

 

1.3

“EPO Member States” means Austria, Belgium, Switzerland, Cyprus, Germany, Denmark, Spain, Finland, France, Turkey, Greece, Ireland, Italy, Liechtenstein, Luxembourg, Monaco, Netherlands, Portugal, Sweden, and the United Kingdom.

 

1.4

“Scintigraphy” means an external imaging examination of the patient following the injection of a radioactive substance using a device to image gamma radiation, such as a gamma camera.

 

1.5

“Scintillation Counting” means an external or internal scan examination of a patient, or tissue of organ of such patient following the injection of a radioactive substance using a hand-held gamma radiation detection probe.

 

1.6

"Field" means diagnostic use in Scintigraphy and Scintillation Counting which is   a radio-labeled-carbohydrate-conjugated macromolecule that directs radioactivity   to lymphoid tissue.

 

1.7

"Territory" means the United State, EPO Member States, and Japan.

 

1.8

"Term" means the period of time beginning on the Effective Date and ending on the later of (i) the expiration date of the longest-lived Patent Rights; or (ii) the twenty-first (21st) anniversary of Effective Date.

 


 

 

1.9

"Patent Rights" means any of the following: the US patent application (serial number 09/569,466, titled "MACROMOLECULAR CARRIER FOR DRUG AND DIAGNOSTIC AGENT DELIVERY") disclosing and claiming the Invention, filed by Inventor and assigned to UNIVERSITY; and continuing applications thereof including divisions, substitutions, and continuations-in-part (but only to extent the claims thereof are enabled by disclosure of the parent application); any patents issuing on said applications including reissues, reexaminations and extensions; and any corresponding foreign applications or patents.

 

1.10

"Sponsor Rights" means all the applicable provisions of any license to the United States Government executed by UNIVERSITY and the overriding obligations to the Federal Government under 35 U.S.C. §§ 200-212 and applicable governmental implementing regulations and the overriding obligations to NIH   under the sponsorship agreement with the same.

 

1.11

"Licensed Method" means any method that is covered by Patent Rights the use of which would constitute, but for the license granted to LICENSEE under this Agreement, an infringement of any pending or issued and unexpired claim within Patent Rights.

 

1.12

"Licensed Product" means any composition or product that is covered by the claims of Patent Rights, or that is produced by the Licensed Method, or the manufacture, use, sale, offer for sale, or importation of which would constitute, but for the license granted to LICENSEE by UNIVERSITY herein, an infringement of any pending or issued and unexpired claim within the Patent Rights.

 

1.13

"Net Sales" means the total of the gross invoice prices of Licensed Products sold by LICENSEE, its Sublicensee, an Affiliate, or any combination thereof, less the sum of the following actual and customary deductions where applicable and separately listed: cash, trade, or quantity discounts; sales, use, tariff, import/export duties or other excise taxes imposed on particular sales (except for value-added and income taxes imposed on the sales of Product in foreign countries); transportation charges; or credits to customers because of rejections or returns. For purposes of calculating Net Sales, transfers to a Sublicensee or an Affiliate of Licensed Product under this Agreement for (i) end use (but not resale) by the Sublicensee or Affiliate shall be treated as sales by LICENSEE at list price of LICENSEE, or (ii) resale by a Sublicensee or an Affiliate shall be treated as sales at the list price of the Sublicensee or Affiliate.

 

1.14

“Patent Costs” means all out-of-pocket expenses for the preparation, filing, prosecution, and maintenance of all United States and foreign patents included in Patent Rights. Patent Costs shall also include reasonable out-of-pocket expenses for patentability opinions, inventorship determination, preparation and prosecution of patent application, re-examination, re-issue, interference, and opposition activities related to patents or applications in Patent Rights.

 

 


 

1.15

"Combination Product" means any product which is a Licensed Product and contains other product(s) or product component(s) that (i) does not use Invention or Patent Rights; (ii) the sale, use or import by itself does not contribute to the infringement of Patent Rights; (iii) can be sold separately by LICENSEE, its Sublicensee or an Affiliate; and (iv) enhances the market price of the final product(s) sold, used or imported by LICENSEE, its Sublicensee, or an Affiliate.

 

1.16

"Technology" means the written technical information relating to the Invention which the Inventors provide to LICENSEE prior to the Effective Date.

 

1.17

“Third Party” means any individual or entity other than LICENSEE or   UNIVERSITY or an Affiliate of LICENSEE or UNIVERSITY.

 

ARTICLE 2. GRANTS

 

2.1   License. Subject to the limitations set forth in this Agreement and Sponsor's Rights, UNIVERSITY hereby grants to LICENSEE and Affiliates, and LICENSEE hereby accepts, a license under Patent Rights to make, use, sell, offer for sale, and import Licensed Products and to practice Licensed Methods and to use the Technology in the Field within the Territory and during the Term.

 

The license granted herein is exclusive for Patent Rights and UNIVERSITY shall not grant to third parties a further license under Patent Rights in the Field, within the Territory and during the Term.

 

2.2 Sublicense.  

 

(a)   The license granted in Paragraph 2.1 includes the right of LICENSEE to grant sublicense to third parties during the Term but only for as long the license is exclusive.

 

(b)   With respect to sublicense granted pursuant to Paragraph 2.2(a), LICENSEE shall:

 

(1) not receive, or agree to receive, anything of value in lieu of cash as considerations from a third party under a sublicense granted pursuant to Paragraph 2.2(a) without the express written consent of UNIVERSITY;

 

(2) to the extent applicable, include all of the rights of and obligations due to UNIVERSITY (and, if applicable, the Sponsor's Rights) and contained in this Agreement;

 

(3) promptly provide UNIVERSITY with a copy of each sublicense issued; and

 

 

(4) collect and guarantee payment of all payments due, directly or indirectly, to UNIVERSITY from Sublicensees and summarize and deliver all reports due, directly or indirectly, to UNIVERSITY from Sublicensees.

 

(c) Upon termination of this Agreement for any reason, UNIVERSITY, at its sole discretion, shall determine whether LICENSEE shall cancel or assign to UNIVERSITY any and all sublicenses.

 

2.3   Reservation of Rights. UNIVERSITY reserves the right to:

 

(a)   use the Invention, Technology and Patent Rights for educational and research purposes;

 

(b)   publish or otherwise disseminate any information about the Invention and Technology at any time; and

 

(c)   allow, in compliance with University policy, other nonprofit institutions to use Invention, Technology and Patent Rights for educational and research purposes in their facilities.

 

ARTICLE 3. CONSIDERATIONS

 

3.1   Fees and Royalties. The parties hereto understand that the fees and royalties payable by LICENSEE to UNIVERSITY under this Agreement are partial considerations for the license granted herein to LICENSEE under Patent Rights. Subject to the provisions of this Agreement   LICENSEE shall pay UNIVERSITY:

 

(a)   a license issue fee of Twenty-Five Thousand Dollars ($25,000) within thirty (30) days of the Effective Date this Agreement;

 

(b)   license maintenance fees of Twenty-Five Thousand Dollars ($25,000) per year. The first license maintenance fee shall be due no later than August 8, 2003 and shall include an additional two thousand Dollars ($2,000) as interest, and shall be non-transferable and survive termination. The second license maintenance fee shall be due on the second anniversary of the effective date of the license. Subsequent license maintenance fees shall be payable on the third anniversary of the Effective Date and annually thereafter on each anniversary; provided however, that LICENSEE's obligation to pay this fee shall end on the date when LICENSEE is commercially selling a Licensed Product;

 


*

Portions have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment.

 

(c)   milestone payments in the amounts payable according to the following schedule or events:

 

 

Amount

 

Date or Event

 

 

 

 

(1)

$[*]

 

The first successful regulatory clearance, to be substituted for the appropriate milestone payment listed below in (14)-(25).

(2)

$[*]

 

The earlier of year-end 2002 or commencement of phase 2 trial for melanoma

(3)

$[*]

 

The earlier of year-end 2002 or commencement of phase 2 trial for breast cancer

(4)

$[*]

 

The earlier of year-end 2003 or commencement of phase 2 trial for colo-rectal cancer

(5)

$[*]

 

commencement of phase 2 trial for stomach cancer

(6)

$[*]

 

commencement of phase 2 trial for cervical cancer

(7)

$[*]

 

commencement of phase 2 trial for any cancer that is not melanoma, breast, colo-rectal, stomach, or cervical

(8)

$[*]

 

The earlier of year-end 2004 or completion of phase 3 trial for melanoma

(9)

$[*]

 

The earlier of year-end 2004 or completion of phase 3 trial for breast cancer

(10)

$[*]

 

The earlier of year-end 2005 or completion of phase 3 trial for colo-rectal cancer

(11)

$[*]

 

completion of phase 3 trial for stomach cancer

(12)

$[*]

 

completion of phase 3 trial for cervical cancer

(13)

$[*]

 

completion of phase 3 trial for any cancer that is not melanoma, breast, colo-rectal, stomach, or cervical

 

 

 

 

 

(14)

$[*]

 

The earlier of year-end 2004 or US regulatory clearance granted for melanoma

(15)

$[*]

 

The earlier of year-end 2004 or US regulatory clearance granted for breast cancer

(16)

$[*]

 

The earlier of year-end 2005 or US regulatory clearance granted for colo-rectal cancer

(17)

$[*]

 

US regulatory clearance granted for stomach cancer

(18)

$[*]

 

US regulatory clearance granted for cervical cancer

(19)

$[*]

 

US regulatory clearance granted for any cancer that is not melanoma, breast, colo-rectal, stomach, or cervical

(20)

$[*]

 

Regulatory clearance granted in any EPO Member States or Japan for melanoma

(21)

$[*]

 

Regulatory clearance granted in any EPO Member States or Japan for breast cancer

(22)

$[*]

 

Regulatory clearance granted in any EPO Member States or Japan for colo-rectal cancer

(23)

$[*]

 

Regulatory clearance granted in any EPO Member States or Japan for stomach cancer

(24)

$[*]

 

Regulatory clearance granted in any EPO Member States or Japan for cervical cancer

(25)

$[*]

 

Regulatory clearance granted in any EPO Member States or Japan for any cancer that is not melanoma, breast, colo-rectal, stomach, or cervical

 

 

(d)

an earned royalty of [*]% on Net Sales of Licensed Products by LICENSEE and/or its Affiliate(s) provided however that;

 

 


*

Portions have been omitted and filed separately with the Securities and Exchange Commission pursuant to a request for confidential treatment.

 

(i) if LICENSEE is required to license the intellectual property of a Third Party to make, have made, use, sell, offer to sell or import Licensed Products, the earned royalty due hereunder shall be reduced in the proportion of one half percent (0.5%) for every one percent (1.0%) of royalty due to such Third Party.

 

(ii) the earned royalty due on Net Sales of Combination Product by LICENSEE and/or its Affiliate(s) shall be calculated as below:

 

Earned Royalties due UNIVERSITY = A/(A+B+C . . .) x Royalty Rate on Net Sales of the Licensed Products applicable in (i) or (ii) x Net Sales of Combination Product, where:

 

A is the separately listed sale price of the Licensed Product or Licensed Product components; and

 

B and C . . . are the separately listed sale prices of the individual products or product components, respectively, that satisfied the requirements outlined in Paragraph 1.13. If LICENSEE does not separately sell any of the B, C . . . products or product components used in Combination Product, the purchase price paid by LICENSEE in the procurement of said products or product components shall be used.

 

(iii) under no circumstances shall the royalty due to University be less than sixty percent (60%) of the amount due without the deductions allowable under 3.1(c)(i) or (ii), therefore the royalties due to University shall never be less than three percent (3%) on Net Sales of Licensed Products by Licensee or its Affiliates."

 

(e)   [*]% of all sublicense fees received by LICENSEE from its Sublicensees that are not earned royalties, excluding research support, received by LICENSEE, provided however that such research support shall not include executive and clerical salaries, legal expenses, or other costs not directly related to research;

 

(f)   on each and every sublicense royalty payment received by LICENSEE from its Sublicensees on sales of Licensed Product by Sublicensee, fifty percent (50%) of the royalties received by LICENSEE;

 

 

(g)   beginning the calendar year of commercial sales of the first License Product by LICENSEE, its Sublicensee, or an Affiliate and if the total earned royalties paid by LICENSEE under Paragraphs 3.1(d) and (f) to UNIVERSITY in any such year cumulatively amounts to less than Twenty-Five Thousand Dollars ($25,000) (“ minimum annual royalty ”), LICENSEE shall pay to UNIVERSITY a minimum annual royalty on or before February 28 following the last quarter of such year the difference between amount noted above and the total earned royalty paid by LICENSEE for such year under Paragraphs 3.1(d) and (f); provided, however, that for the year of commercial sales of the first Licensed Product, the amount of minimum annual royalty payable shall be pro-rated for the number of months remaining in that calendar year.

 

 

All fees and royalty payments specified in Paragraphs 3.1(a) through 3.1(g) above shall be paid by LICENSEE pursuant to Paragraph 4.3 and shall be delivered by LICENSEE to UNIVERSITY as noted in Paragraph 10.1.

 

3.2 Patent Costs. LICENSEE shall reimburse UNIVERSITY all past (prior to the Effective Date) and future (on or after the Effective Date) Patent Costs plus a fifteen percent (15%) patent service fee within thirty (30) days following receipt by LICENSEE of an itemized invoice from UNIVERSITY.

 

3.3 Due Diligence.

 

(a) LICENSEE shall:

 

(1)   diligently proceed with the development, manufacture and sale of Licensed Products;

 

(2)   market Licensed Products in the United States within six (6) months of receiving regulatory approval to market such Licensed Product's;

 

(3)   reasonably fill the market demand for Licensed Products following commencement of marketing at any time during the term of this Agreement; and

 

(4)   obtain all necessary governmental approvals for the manufacture, use and sale of Licensed Products.

 

(b)   If LICENSEE fails to perform any of its obligations specified in Paragraphs 3.1(c) and 3.3(a)(1)-(4), then UNIVERSITY shall have the right and option to either terminate this Agreement as outlined in Paragraph 7.1 or change LICENSEE's exclusive license to a nonexclusive license provided that LICENSEE has not cured such failure to perform within ninety (90) days written notice from UNIVERSITY of said failure. This right, if exercised by UNIVERSITY, supersedes the rights granted in Article 2.

 

 

ARTICLE 4. REPORTS, RECORDS AND PAYMENTS

 

4.1   Reports.  

 

(a)   Progress Reports .

 

(1)   Beginning January 1, 2002 and ending on the date of first commercial sale of a Licensed Product in the United States, LICENSEE shall submit to UNIVERSITY semi-annual progress reports covering LICENSEE's (and Affiliate's and Sublicensee's) activities to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same. Such reports shall include a summary of work completed; summary of work in progress; current schedule of anticipated events or milestones; market plans for introduction of Licensed Products; and summary of resources (dollar value) spent in the reporting period.

 

(2)   LICENSEE shall also report to UNIVERSITY, in its immediately subsequent progress report, the date of first commercial sale of a Licensed Product in each country.

 

(b)   Royalty Reports. After the first commercial sale of a Licensed Product anywhere in the world, LICENSEE shall submit to UNIVERSITY quarterly royalty reports on or before each February 28, May 31, August 31 and November 30 of each year. Each royalty report shall cover LICENSEE's (and each Affiliate's and Sublicensee's) most recently completed calendar quarter and shall show:

 

(1)   the gross sales, deductions as provided in Paragraph 1.11, and Net Sales during the most recently completed calendar quarter and the royalties, in US dollars, payable with respect thereto;

 

(2)   the number of each type of Licensed Product sold;

 

(3)   sublicense fees and royalties received during the most recently completed calendar quarter in US dollars, payable with respect thereto;

 

(4)   the method used to calculate the royalties; and

 

(5)   the exchange rates used.

 

If no sales of Licensed Products has been made and no sublicense revenues has been received by LICENSEE during any reporting period, LICENSEE shall so report.

 

 

4.2   Records & Audits.  

 

(a)   LICENSEE shall keep, and shall require its Affiliates and Sublicensees to keep, accurate and correct records of all Licensed


 
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