LICENSE AGREEMENT BETWEEN NEOPROBE CORPORATION AND THE REGENTS OF THE UNIVERSITY OF CALIFORNIA FOR CASE NO. SD1998-088
EXHIBIT
10.11
BETWEEN
NEOPROBE
CORPORATION
AND
THE
REGENTS OF THE UNIVERSITY OF CALIFORNIA
FOR
CASE
NO.
SD1998-088
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Definitions
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2
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Grant
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4
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Considerations
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5
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Reports,
Records and Payments
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9
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Patent
Matters
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11
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Governmental
Matters
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13
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Termination
of Agreement
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13
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Limited
Warranty and Indemnification
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15
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Use
of Names and Trademarks
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16
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Miscellaneous
Provisions
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17
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This
agreement ("Agreement") is made by and
between Neoprobe Corporation a Delaware corporation
having an address at ▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇, ▇▇▇▇▇ ▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇
▇▇▇▇▇-▇▇▇▇ ("LICENSEE") and The Regents Of The University Of California, a
California corporation having its statewide administrative offices at ▇▇▇▇
▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇ ("UNIVERSITY"), represented
by
its San Diego campus having an address at University of California, San Diego,
Technology Transfer & Intellectual Property Services, Mail-code 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 ▇▇. ▇▇▇▇ ▇▇▇▇ (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:
The
terms, as defined herein, shall have the same meanings in both their singular
and plural forms.
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1.1
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"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.
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| 1.2 |
"Sublicensee"
means a third party to whom LICENSEE grants a sublicense of certain
rights granted to LICENSEE under this
Agreement.
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1.3
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“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.
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1.4
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“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.
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1.5
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“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.
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| 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.
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1.7
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"Territory"
means the United State, EPO Member States, and
Japan.
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1.8
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"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.
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1.9
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"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.
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1.10
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"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.
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1.11
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"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.
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1.12
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"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.
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1.13
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"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.
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1.14
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“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.
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1.15
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"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.
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1.16
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"Technology"
means the written technical information relating to the Invention
which
the Inventors provide to LICENSEE prior to the Effective
Date.
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| 1.17 |
“Third
Party” means any individual or entity other than LICENSEE or UNIVERSITY
or an Affiliate of LICENSEE or
UNIVERSITY.
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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.
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 ($2,000) as interest, and shall be non-transferable and
survive termination. The second license maintenance fee shall be due on the
second anniversary of the effective date of the license. Subsequent license
maintenance fees shall be payable on the third anniversary of the Effective
Date
and annually thereafter on each anniversary; provided however, that LICENSEE's
obligation to pay this fee shall end on the date when LICENSEE is commercially
selling a Licensed Product;
| * |
Portions
have been omitted and filed separately with the Securities and
Exchange
Commission pursuant to a request for confidential
treatment.
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(c) milestone
payments
in the
amounts payable according to the following schedule or events:
| Amount |
Date
or Event
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(1)
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$[*]
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The
first successful regulatory clearance, to be substituted for the
appropriate milestone payment listed below in
(14)-(25).
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(2)
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$[*]
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The
earlier of year-end 2002 or commencement of phase 2 trial for
melanoma
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(3)
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$[*]
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The
earlier of year-end 2002 or commencement of phase 2 trial for breast
cancer
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(4)
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$[*]
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The
earlier of year-end 2003 or commencement of phase 2 trial for colo-rectal
cancer
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(5)
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$[*]
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commencement
of phase 2 trial for stomach cancer
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(6)
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$[*]
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commencement
of phase 2 trial for cervical cancer
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(7)
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$[*]
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commencement
of phase 2 trial for any cancer that is not melanoma, breast, colo-rectal,
stomach, or cervical
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(8)
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$[*]
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The
earlier of year-end 2004 or completion of phase 3 trial for
melanoma
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(9)
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$[*]
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The
earlier of year-end 2004 or completion of phase 3 trial for breast
cancer
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(10)
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$[*]
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The
earlier of year-end 2005 or completion of phase 3 trial for colo-rectal
cancer
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(11)
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$[*]
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completion
of phase 3 trial for stomach cancer
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(12)
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$[*]
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completion
of phase 3 trial for cervical cancer
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(13)
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$[*]
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completion
of phase 3 trial for any cancer that is not melanoma, breast, colo-rectal,
stomach, or cervical
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(14)
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$[*]
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The
earlier of year-end 2004 or US regulatory clearance granted for
melanoma
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(15)
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$[*]
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The
earlier of year-end 2004 or US regulatory clearance granted for
breast
cancer
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(16)
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$[*]
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The
earlier of year-end 2005 or US regulatory clearance granted for
colo-rectal cancer
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(17)
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$[*]
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US
regulatory clearance granted for stomach cancer
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(18)
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$[*]
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US
regulatory clearance granted for cervical cancer
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(19)
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$[*]
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US
regulatory clearance granted for any cancer that is not melanoma,
breast,
colo-rectal, stomach, or cervical
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(20)
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$[*]
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Regulatory
clearance granted in any EPO Member States or Japan for
melanoma
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(21)
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$[*]
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Regulatory
clearance granted in any EPO Member States or Japan for breast
cancer
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(22)
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$[*]
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Regulatory
clearance granted in any EPO Member States or Japan for colo-rectal
cancer
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(23)
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$[*]
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Regulatory
clearance granted in any EPO Member States or Japan for stomach
cancer
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(24)
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$[*]
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Regulatory
clearance granted in any EPO Member States or Japan for cervical
cancer
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(25)
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$[*]
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Regulatory
clearance granted in any EPO Member States or Japan for any cancer
that is
not melanoma, breast, colo-rectal, stomach, or
cervical
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(d)
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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.
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(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.
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 Products manufactured, used, and sold,
and
sublicense fees received under this Agreement. Such records shall be retained
by
LICENSEE for at least three (3) years following a given reporting period.
(b) Upon
five
(5) business days prior notice to LICENSEE all records shall be available during
normal business hours for inspection at the expense of UNIVERSITY by
UNIVERSITY’s Internal Audit Department or by a Certified Public Accountant
selected by UNIVERSITY and in compliance with the other terms of this Agreement
for the sole purpose of verifying reports and payments. Such inspector shall
not
disclose to UNIVERSITY any information other than information relating to the
accuracy of reports and payments made under this Agreement or other compliance
issues. In the event that any such inspection shows an under reporting and
underpayment in excess of five percent (5%) for any twelve (12) month period,
then LICENSEE shall pay the cost of the audit as well as any additional sum
that
would have been payable to UNIVERSITY had the LICENSEE reported correctly,
plus
an interest charge at a rate of ten percent (10%) per year. Such interest shall
be calculated from the date the correct payment was due to UNIVERSITY up to
the
date when such payment is actually made by LICENSEE. For underpayment not in
excess of five percent (5%) for any twelve (12) month period, LICENSEE shall
pay
the difference within thirty (30) days without interest charge or inspection
cost.
4.3 Payments.
(a) All
fees
and royalties due UNIVERSITY shall be paid in United States dollars and all
checks shall be made payable to "The Regents of the University of California",
referencing UNIVERSITY' taxpayer identification number, ▇▇-▇▇▇▇▇▇▇. When
Licensed Products are sold in currencies other than United States dollars,
LICENSEE shall first determine the earned royalty in the currency of the country
in which Licensed Products were sold and then convert the amount into equivalent
United States funds, using the exchange rate quoted in the Wall Street Journal
on the last business day of the applicable reporting period.
(b) Royalty
Payments.
(1) Royalties
shall accrue when Licensed Products are invoiced, or if not invoiced, when
delivered to a third party or Affiliate.
(2) LICENSEE
shall pay earned royalties quarterly on or before February 28, May 31, August
31
and November 30 of each calendar year. Each such payment shall be for earned
royalties accrued within LICENSEE's most recently completed calendar
quarter.
(3) Royalties
earned on sales occurring or under sublicense granted pursuant to this Agreement
in any country outside the United States shall not be reduced by LICENSEE for
any taxes, fees, or other charges imposed by the government of such country
on
the payment of royalty income, except that all payments made by LICENSEE in
fulfillment of UNIVERSITY' tax liability in any particular country may be
credited against earned royalties or fees due UNIVERSITY for that country.
LICENSEE shall pay all bank charges resulting from the transfer of such royalty
payments.
(4) If
at any
time legal restrictions prevent the prompt remittance of part or all royalties
by LICENSEE with respect to any country where a Licensed Product is sold or
a
sublicense is granted pursuant to this Agreement, LICENSEE shall convert the
amount owed to UNIVERSITY into US currency and shall pay UNIVERSITY directly
from its US sources of fund for as long as the legal restrictions
apply.
(5) LICENSEE
shall not collect royalties from, or cause to be paid on Licensed Products
sold
to the account of the US Government or any agency thereof as provided for in
the
license to the US Government.
(6) In
the
event that any patent or patent claim within Patent Rights is held invalid
in a
final decision by a patent office from which no appeal or additional patent
prosecution has been or can be taken, or by a court of competent jurisdiction
and last resort and from which no appeal has or can be taken, all obligation
to
pay royalties based solely on that patent or claim or any claim patentably
indistinct therefrom shall cease as of the date of such final decision. LICENSEE
shall not, however, be relieved from paying any royalties that accrued
before
the date of such final decision, that are based on another patent or claim
not
involved in such final decision.
(c)
Late
Payments. In the event royalty, reimbursement and/or fee payments are not
received by UNIVERSITY when due, LICENSEE shall pay
to
UNIVERSITY interest charges at a rate of ten percent (10%) per year. Such
interest shall be calculated from the date payment was due until actually
received by UNIVERSITY.
5.1
Patent
Prosecution and Maintenance.
(a) Provided
that LICENSEE has reimbursed UNIVERSITY for Patent Costs
pursuant to Paragraph 3.2, UNIVERSITY shall diligently prosecute and maintain
the United States and, if available, foreign patents, and applications in Patent
Rights using counsel of its choice. UNIVERSITY shall provide LICENSEE with
copies of all relevant documentation relating to such prosecution and LICENSEE
shall keep this documentation confidential. The counsel shall take instructions
only from UNIVERSITY, and all patents and patent applications in Patent Rights
shall be assigned solely to UNIVERSITY.
(b) UNIVERSITY
shall consider amending any patent application in Patent Rights to include
claims reasonably requested by LICENSEE to protect the products contemplated
to
be sold by LICENSEE under this Agreement.
(c) LICENSEE
shall apply for an extension of the term of any patent in Patent Rights if
appropriate under the Drug Price Competition and Patent Term Restoration Act
of
1984 and/or European, Japanese and other foreign counterparts of this law.
LICENSEE shall prepare all documents for such application, and UNIVERSITY shall
execute such documents and to take any other additional action as LICENSEE
reasonably requests in connection therewith.
(d) LICENSEE
may elect to terminate its reimbursement obligations with respect to any patent
application or patent in Patent Rights upon three (3) months' written notice
to
UNIVERSITY. UNIVERSITY shall use reasonable efforts to curtail further Patent
Costs for such application or patent when such notice of termination is received
from LICENSEE. UNIVERSITY, in its sole discretion and at its sole expense,
may
continue prosecution and maintenance of said application or patent, and LICENSEE
shall then have no further license with respect thereto. Non-payment of any
portion of Patent Costs with respect to any application or patent may be deemed
by UNIVERSITY as an election by LICENSEE to terminate its reimbursement
obligations with respect to such application or patent.
5.2
Patent Infringement.
(a) If
LICENSEE learns of any substantial infringement of Patent Rights, LICENSEE
shall
so inform UNIVERSITY and provide UNIVERSITY with reasonable evidence of the
infringement. Neither party shall notify a third party of the infringement
of
Patent Rights without the consent of the other party. Both parties shall use
reasonable efforts and cooperation to terminate infringement without
litigation.
(b) LICENSEE
may request UNIVERSITY to take legal action against such third party for the
infringement of Patent Rights. Such request shall be made in writing and shall
include reasonable evidence of such infringement and damages to LICENSEE. If
the
infringing activity has not abated ninety (90) days following LICENSEE’s
request, UNIVERSITY shall elect to or not to commence suit on its own account.
UNIVERSITY shall give notice of its election in writing to LICENSEE by the
end
of the one-hundredth (100th) day after receiving notice of such request from
LICENSEE. LICENSEE may thereafter bring suit for patent infringement at its
own
expense, if and only if UNIVERSITY elects not to commence suit and the
infringement occurred in a jurisdiction where LICENSEE has an exclusive license
under this Agreement. If LICENSEE elects to bring suit, UNIVERSITY may join
that
suit at its own expense.
(c) Recoveries
from actions brought pursuant to Paragraph 5.2(b) shall belong to the party
bringing suit. Legal actions brought jointly by UNIVERSITY and LICENSEE and
fully participated in by both shall be at the joint expense of the parties
and
all recoveries shall be shared jointly by them in proportion to the share of
expense paid by each party.
(d) Each
party shall cooperate with the other in litigation proceedings at the expense
of
the party bringing suit. Litigation shall be controlled by the party bringing
the suit, except that UNIVERSITY may be represented by counsel of its choice
in
any suit brought by LICENSEE.
5.3
Patent
Marking.
LICENSEE
shall ▇▇▇▇ all Licensed Products made, used or sold under the terms of this
Agreement, or their containers, in accordance with the applicable patent marking
laws.
6.1 Governmental
Approval or Registration.
If this
Agreement or any associated transaction is required by the law of any nation
to
be either approved or registered with any governmental agency, LICENSEE shall
assume all legal obligations to do so. LICENSEE shall notify UNIVERSITY if
it
becomes aware that this Agreement is subject to a United States or foreign
government reporting or approval requirement. LICENSEE shall make all necessary
filings and pay all costs including fees, penalties, and all other out-of-pocket
costs associated with such reporting or approval process.
6.2 Export
Control Laws.
LICENSEE
shall observe all applicable United States and foreign laws with respect to
the
transfer of Licensed Products and related technical data to foreign countries,
including, without limitation, the International Traffic in Arms Regulations
and
the Export Administration Regulations.
6. Preference
for United States Industry.
If
LICENSEE sells a Licensed Product or Combination Product in the US, LICENSEE
shall manufacture said product substantially in the US.
7.1 Termination
by The Regents.
If
LICENSEE fails to perform or violates any term of this Agreement, then
UNIVERSITY may give written notice of default ("Notice of Default") to LICENSEE.
If LICENSEE fails to cure the default within ninety (90) days of the Notice
of
Default, UNIVERSITY may terminate this Agreement and the license granted herein
by a second written notice ("Notice of Termination") to LICENSEE. If a Notice
of
Termination is sent to LICENSEE, this Agreement shall automatically terminate
on
the effective date of that notice. Termination shall not relieve LICENSEE of
its
obligation to pay any fees owed at the time of termination and shall not impair
any accrued right of UNIVERSITY.
7.2 Termination
by Licensee.
(a)
LICENSEE
shall have the right at any time and for any reason to terminate this Agreement
upon a ninety (90) day written notice to UNIVERSITY. Said notice shall state
LICENSEE’s reason for terminating this Agreement.
(b) Any
termination under Paragraph 7.2(a) shall not relieve LICENSEE of any obligation
or liability accrued under this Agreement prior to termination or rescind any
payment made to UNIVERSITY or action by LICENSEE prior to the time termination
becomes effective. Termination shall not affect in any manner any rights of
UNIVERSITY arising under this Agreement prior to termination.
7.3
Survival
on Termination.
The
following Paragraphs and Articles shall survive the termination of this
Agreement:
|
(a)
|
Article
3.1(b) - First license maintenance
fee
|
|
(b)
|
Article
4 (REPORTS, RECORDS AND PAYMENTS);
|
| (c) |
Paragraph
7.4 (Disposition of Licensed Products on
Hand);
|
| (d) |
Paragraph
8.2 (Indemnification);
|
| (e) |
Article
9 (USE OF NAMES AND TRADEMARKS);
|
| (f) |
Paragraph
10.2 hereof (Secrecy); and
|
|
(g)
|
Paragraph
10.5 (Failure to Perform).
|
|
(h)
|
Paragraph
10.6 (Governing Laws).
|
7.4 Disposition
of Licensed Products on Hand.
Upon
termination of this Agreement, LICENSEE may dispose of all previously made
or
partially made Licensed Product within a period of one hundred and eighty (180)
days of the effective date of such termination provided that the sale of such
Licensed Product by LICENSEE, its Sublicensees, or Affiliates shall be subject
to the terms of this Agreement, including but not limited to the rendering
of
reports and payment of royalties required under this Agreement.
8.1
Limited
Warranty.
(a)
UNIVERSITY warrants that it has the lawful right to grant this
license.
(b)
The
license granted herein is
provided
“AS IS” and without WARRANTY OF MERCHANTABILITY or WARRANTY OF FITNESS FOR A
PARTICULAR PURPOSE or any other warranty, express or implied. UNIVERSITY makes
no representation or warranty that the Licensed Product, Licensed Method or
the
use of Patent Rights will not infringe any other patent or other proprietary
rights.
(c) In
no
event shall UNIVERSITY be liable for any incidental, special or consequential
damages resulting from exercise of the license granted herein or the use of
the
Invention, Licensed Product, and Licensed Method.
(d)
Except
as otherwise provided in this Agreement nothing in this Agreement shall be
construed as:
(1) a
warranty or representation by UNIVERSITY as to the validity or scope of any
Patent Rights;
(2) a
warranty or representation that anything made, used, sold or otherwise disposed
of under any license granted in this Agreement is or shall be free from
infringement of patents of third parties;
(3) an
obligation to bring or prosecute actions or suits against third parties for
patent infringement except as provided in Paragraph 5.2 hereof;
(4) conferring
by implication, estoppel or otherwise any license or rights under any patents
of
UNIVERSITY other than Patent Rights as defined in this Agreement, regardless
of
whether those patents are dominant or subordinate to Patent Rights
(5) an
obligation to furnish any know-how not provided in Patent
Rights
8.2
Indemnification.
(a) LICENSEE
shall indemnify, hold harmless and defend UNIVERSITY, its officers, employees,
and agents; the sponsors of the research that led to the Invention; and the
Inventor of the patents and patent applications in Patent Rights and their
employers against any and all claims, suits, losses, damage, costs, fees, and
expenses resulting from or arising out of exercise of this license or any
sublicense. This indemnification shall include, but not be limited to, any
product liability.
(b) LICENSEE,
at its sole cost and expense, shall insure its activities in connection with
the
work under this Agreement and obtain, keep in force and maintain insurance
or an
equivalent program of self insurance as follows:
(1) comprehensive
or commercial general liability insurance (contractual liability included)
with
limits of at least: (i) each occurrence, $1,000,000; (ii) products/completed
operations aggregate, $5,000,000; (iii) personal and advertising injury,
$1,000,000; and (iv) general aggregate (commercial form only), $5,000,000;
and
(2) the
coverage and limits referred to above shall not in any way limit the liability
of LICENSEE.
(c) LICENSEE
shall furnish UNIVERSITY with certificates of insurance showing compliance
with
all requirements. Such certificates shall: (i) provide for thirty (30) day
advance written notice to UNIVERSITY of any modification; (ii) indicate that
UNIVERSITY has been endorsed as an additional insured under the coverage
referred to above; and (iii) include a provision that the coverage shall be
primary and shall not participate with nor shall be excess over any valid and
collectable insurance or program of self-insurance carried or maintained by
UNIVERSITY.
(d) UNIVERSITY
shall notify LICENSEE in writing of any claim or suit brought against UNIVERSITY
in respect of which UNIVERSITY intends to invoke the provisions of this Article.
LICENSEE shall keep UNIVERSITY informed on a current basis of its defense of
any
claims under this Article.
9.1 Nothing
contained in this Agreement confers any right to use in advertising, publicity,
or other promotional activities any name, trade name, trademark, or other
designation of either party hereto (including contraction, abbreviation or
simulation of any of the foregoing). Unless required by law, the use by LICENSEE
of the name, "The Regents Of The University Of California" or the name of any
campus of the University Of California is prohibited, without the express
written consent of UNIVERSITY.
9.2 UNIVERSITY
may disclose to the Inventor the terms and conditions of this Agreement upon
their request. If such disclosure is made, UNIVERSITY shall request the Inventor
not disclose such terms and conditions to others.
9.3 UNIVERSITY
may acknowledge the existence of this Agreement and the extent of the grant
in
Article 2 to third parties, but UNIVERSITY shall not disclose the financial
terms of this Agreement to third parties, except where UNIVERSITY is required
by
law to do so, such as under the California Public Records Act.
10.1 Correspondence.
Any
notice or payment required to be given to either party under this Agreement
shall be deemed to have been properly given and effective:
(a)
on
the date of delivery if delivered in person, or
(b)
five
(5) days after mailing if mailed by first-class or certified mail, postage
paid,
to the respective addresses given below, or to such other address as is
designated by written notice given to the other party.
If
sent
to Neoprobe Corporation:
▇▇▇
▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇ ▇▇▇▇▇
▇▇▇▇▇
▇▇▇
▇▇▇▇▇▇,
▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
Attention:
President, CEO
If
sent
to UNIVERSITY:
University
of California, San Diego
Technology
Transfer & Intellectual Property Services
▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇▇
▇▇
▇▇▇▇▇,
▇▇ ▇▇▇▇▇-▇▇▇▇
Attention:
Director
10.2 Secrecy.
(a) "Confidential
Information" shall mean information relating to the Invention and disclosed
by
UNIVERSITY to LICENSEE during the term of this Agreement, which if disclosed
in
writing shall be marked "Confidential", or if first disclosed otherwise, shall
within thirty (30) days of such disclosure be reduced to writing by UNIVERSITY
and sent to LICENSEE:
(b)
Licensee shall:
(1) use
the
Confidential Information for the sole purpose of performing under the terms
of
this Agreement;
(2) safeguard
Confidential Information against disclosure to others with the same degree
of
care as it exercises with its own data of a similar nature;
(3) not
disclose Confidential Information to others (except to its employees, agents
or
consultants who are bound to LICENSEE by a like obligation of confidentiality)
without the express written permission of UNIVERSITY, except that LICENSEE
shall
not be prevented from using or disclosing any of the Confidential Information
that:
(i) LICENSEE
can demonstrate by written records was previously known to it;
(ii) is
now,
or becomes in the future, public knowledge other than through acts or omissions
of LICENSEE; or
(iii) is
lawfully obtained by LICENSEE from sources independent of UNIVERSITY;
and
(c) The
secrecy obligations of LICENSEE with respect to Confidential Information shall
continue for a period ending five (5) years from the termination date of this
Agreement.
10.3 Assignability.
This
Agreement may be assigned by UNIVERSITY, but is personal to LICENSEE and
assignable by LICENSEE only with the written consent of UNIVERSITY.
10.4
No
Waiver. No
waiver
by either party of any breach or default of any covenant or agreement set forth
in this Agreement shall be deemed a waiver as to any subsequent and/or similar
breach or default.
10.5 Failure
to Perform. In
the
event of a failure of performance due under this Agreement and if it becomes
necessary for either party to undertake legal action against the other on
account thereof, then the prevailing party shall be entitled to reasonable
attorney's fees in addition to costs and necessary disbursements.
10.6
Governing
Laws. THIS
AGREEMENT SHALL BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF
THE
STATE OF CALIFORNIA, but the scope and validity of any patent or patent
application shall be governed by the applicable laws of the country of the
patent or patent application.
10.7 Force
Majeure.
A party
to this Agreement may be excused from any performance required herein if such
performance is rendered impossible or unfeasible due to any catastrophe or
other
major event beyond its reasonable control, including, without limitation, war,
riot, acts of terrorism, and insurrection; laws, proclamations, edicts,
ordinances, or regulations; strikes, lockouts, or other serious labor disputes;
and floods, fires, explosions, or other natural disasters. When such events
have
abated, the non-performing party's obligations herein shall resume.
10.8 Headings.
The
headings of the several sections are inserted for convenience of reference
only
and are not intended to be a part of or to affect the meaning or interpretation
of this Agreement.
10.9 Entire
Agreement. This
Agreement embodies the entire understanding of the parties and supersedes all
previous communications, representations or understandings, either oral or
written,
between the parties relating to the subject matter hereof.
10.10
Amendments. No
amendment or modification of this Agreement shall be valid or binding on the
parties unless made in writing and signed on behalf of each party.
10.11
Severability.
In the
event that any of the provisions contained in this Agreement is held to be
invalid, illegal, or unenforceable in any respect, such invalidity, illegality
or unenforceability shall not affect any other provisions of this Agreement,
and
this Agreement shall be construed as if the invalid, illegal, or unenforceable
provisions had never been contained in it.
IN
WITNESS WHEREOF, both UNIVERSITY and LICENSEE have executed this Agreement,
in
duplicate originals, by their respective and duly authorized officers on the
day
and year written.
| NEOPROBE CORPORATION: | THE REGENTS OF THE | |||
| UNIVERSITY OF CALIFORNIA: | ||||
| By |
/s/
▇▇▇▇▇ ▇▇▇▇
|
By |
/s/
▇▇▇▇ ▇. ▇▇▇▇
|
|
|
(Signature)
|
(Signature)
|
|||
|
Name:
▇▇▇▇▇ ▇▇▇▇
|
▇▇▇▇
▇. ▇▇▇▇
|
|||
|
Title:
President, CEO
|
Director,
Technology Transfer & Intellectual Property
Services
|
|||
|
Date
January 30, 2002
|
Date
January 26, 2002
|
|||
| * |
Portions
have been omitted and filed separately with the Securities and
Exchange
Commission pursuant to a request for confidential
treatment.
|
AMENDMENT
NO. 1 TO THE
LICENSE
AGREEMENT CONTROL NO. ▇▇▇▇-▇▇-▇▇▇▇
INVENTION
CASE NO. SD1998-088
TITLED
“MACROMOLECULAR DRUG CARRIER FOR DRUG AND DIAGNOSTIC AGENT
DELIVERY”
BETWEEN
NEOPROBE, INC. AND
THE
REGENTS OF THE UNIVERSITY OF CALIFORNIA
EFFECTIVE
JANUARY 30, 2002
The
parties to the License Agreement ("Agreement") cited above wish to amend such
Agreement, effective as of the date of the last signature below ("Effective
Date") to include certain corrections and modifications. These changes are
to be
substituted for those relevant paragraphs in the Agreement and are effective
on
Effective Date. For these purposes, changes are made as detailed below to the
following Articles:
CHANGES
ARTICLE 3. CONSIDERATIONS
DELETE
3.1(c)
ADD
3.1(C)
milestone
payments
in the
amounts payable according to the following 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)
|
$[*]
|
commencement
of phase 2 trial for melanoma
|
|
|
(3)
|
$[*]
|
commencement
of phase 2 trial for breast cancer
|
|
|
(4)
|
$[*]
|
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)
|
$[*]
|
completion
of phase 3 trial for melanoma
|
|
|
(9)
|
$[*]
|
completion
of phase 3 trial for breast cancer
|
|
|
(10)
|
$[*]
|
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)
|
$[*]
|
US
regulatory clearance granted for melanoma
|
|
|
(15)
|
$[*]
|
US
regulatory clearance granted for breast cancer
|
|
|
(16)
|
$[*]
|
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 State 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
|
|
| * |
Portions
have been omitted and filed separately with the Securities and
Exchange
Commission pursuant to a request for confidential
treatment.
|
ADD
3.3(a)
5. Diligently
perform clinical testing in accordance to the following schedule:
| Date and event | |
|
(i)
|
By
[*], commencement of phase 2 trial for melanoma
|
|
(ii)
|
By
[*], commencement of phase 2 trial for breast cancer
|
|
(iii)
|
By
[*], commencement of phase 2 trial for colo-rectal
cancer
|
|
(iv)
|
By
[*], completion of phase 3 trial for melanoma
|
|
(v)
|
By
[*], completion of phase 3 trial for breast cancer
|
|
(vi)
|
By
[*], completion of phase 3 trial for colo-rectal cancer
|
|
(vii)
|
By
[*], US regulatory clearance granted for melanoma
|
|
(viii)
|
By
[*], US regulatory clearance granted for breast cancer
|
|
(ix)
|
By
[*], US regulatory clearance granted for colo-rectal
cancer
|
Except
for the changes made above, all of the other terms and conditions in the
Agreement between the parties shall remain in effect.
| Neoprobe | The Regents of | |||
| The University of California | ||||
| By: |
/s/
▇▇▇▇ ▇▇▇▇
|
By: |
/s/
▇▇▇▇ ▇. ▇▇▇▇
|
|
|
Name:
▇▇▇▇ ▇▇▇▇
|
Name:▇▇▇▇
▇. ▇▇▇▇, Ph.D., MBA
|
|||
|
Title:
President
|
Title:
Assistant Vice Chancellor Technology Transfer & Intellectual Property
Services
|
|||
|
Date:
May
27, 2003
|
Date:
May
22, 2003
|
|||
| * |
Portions
have been omitted and filed separately with the Securities and
Exchange
Commission pursuant to a request for confidential
treatment.
|
AMENDMENT
NO. 2 TO THE
LICENSE
AGREEMENT CONTROL NO. ▇▇▇▇-▇▇-▇▇▇▇
INVENTION
CASE NO. SD1998-088
TITLED
“MACROMOLECULAR DRUG CARRIER FOR DRUG AND DIAGNOSTIC AGENT
DELIVERY”
BETWEEN
NEOPROBE, INC. AND
THE
REGENTS OF THE UNIVERSITY OF CALIFORNIA
EFFECTIVE
JANUARY 30, 2002
The
parties to the License Agreement ("Agreement") cited above wish to amend such
Agreement, effective as of the date of the last signature below ("Effective
Date") to include certain corrections and modifications. These changes are
to be
substituted for those relevant paragraphs in the Agreement and are effective
on
Effective Date. For these purposes, changes are made as detailed below to the
following Articles:
CHANGES
ARTICLE 3. CONSIDERATIONS
CHANGE
3.1(C)
milestone
payments
in the
amounts payable according to the following 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)
|
$[*]
|
commencement
of phase 2 trial for melanoma
|
|
|
(3)
|
$[*]
|
commencement
of phase 2 trial for breast cancer
|
|
|
(4)
|
$[*]
|
earlier
of commencement of phase 2 trial for colo-rectal cancer or regulatory
approval allowing sales of Licensed Product for colo-rectal
cancer
|
|
|
(5)
|
$[*]
|
earlier
of commencement of phase 2 trial for stomach cancer or regulatory
approval
allowing sales of Licensed Product for stomach cancer
|
|
|
(6)
|
$[*]
|
earlier
of commencement of phase 2 trial for cervical cancer or regulatory
approval allowing sales of Licensed Product for cervical
cancer
|
|
|
(7)
|
$[*]
|
earlier
of commencement of phase 2 trial for any cancer that is not melanoma,
breast, colo-rectal, stomach, or cervical or regulatory approval
allowing
sales of Licensed Product for cancer other than melanoma, breast,
colo-rectal, stomach, or cervical
|
|
|
(8)
|
$[*]
|
completion
of phase 3 trial for melanoma
|
|
|
(9)
|
$[*]
|
completion
of phase 3 trial for breast cancer
|
|
|
(10)
|
$[*]
|
earlier
of completion of phase 3 trial for colo-rectal cancer or regulatory
approval allowing sales of Licensed Product for colo-rectal
cancer
|
|
|
(11)
|
$[*]
|
earlier
of completion of phase 3 trial for stomach cancer cancer or regulatory
approval allowing sales of Licensed Product for stomach
cancer
|
|
|
(12)
|
$[*]
|
earlier
of completion of phase 3 trial for cervical cancer cancer or regulatory
approval allowing sales of Licensed Product for cervical
cancer
|
|
(13)
|
$[*]
|
earlier
of completion of phase 3 trial for any cancer that is not melanoma,
breast, colo-rectal, stomach, or cervical, or regulatory approval
allowing
sales of Licensed Product for cancer other than melanoma, breast,
colo-rectal, stomach, or cervical
|
|
|
(14)
|
$[*]
|
US
regulatory clearance granted allowing sales of Licensed Product for
use in
melanoma
|
|
|
(15)
|
$[*]
|
US
regulatory clearance granted allowing sales of Licensed Product for
use in
breast cancer
|
|
|
(16)
|
$[*]
|
US
regulatory clearance granted allowing sales of Licensed Product for
use in
colo-rectal cancer
|
|
|
(17)
|
$[*]
|
US
regulatory clearance granted allowing sales of Licensed Product for
use in
stomach cancer
|
|
|
(18)
|
$[*]
|
US
regulatory clearance granted allowing sales of Licensed Product for
use in
cervical cancer
|
|
|
(19)
|
$[*]
|
US
regulatory clearance granted for any cancer that is not melanoma,
breast,
colo-rectal, stomach, or cervical cancer;
|
|
|
Or
|
|||
|
$[*]
|
US
regulatory clearance granted for use that is independent of cancer
indication
|
||
|
(20)
|
$[*]
|
Regulatory
clearance allowing sales of Licensed Product in any EPO Member States
or
Japan for melanoma
|
|
|
(21)
|
$[*]
|
Regulatory
clearance allowing sales of Licensed Product in any EPO Member States
or
Japan for breast cancer
|
|
|
(22)
|
$[*]
|
Regulatory
clearance allowing sales of Licensed Product in any EPO Member States
or
Japan for colo-rectal cancer
|
|
|
(23)
|
$[*]
|
Regulatory
clearance allowing sales of Licensed Product in any EPO Member States
or
Japan for stomach cancer
|
|
|
(24)
|
$[*]
|
Regulatory
clearance allowing sales of Licensed Product in any EPO Member State
or
Japan for cervical cancer
|
|
|
(25)
|
$[*]
|
Regulatory
clearance allowing sales of Licensed Product in any EPO Member States
or
Japan for any cancer that is not melanoma, breast, colo-rectal, stomach,
or cervical cancer
|
CHANGE
3.3(a)
5. Diligently
perform clinical testing in accordance to the following schedule:
| Date and event | |
|
(x)
|
By
[*], commencement of phase 2 trial for melanoma
|
|
(xi)
|
By
[*], commencement of phase 2 trial for breast cancer
|
|
(xii)
|
By
[*], completion of phase 3 trial for melanoma
|
|
(xiii)
|
By
[*], completion of phase 3 trial for breast cancer
|
|
(xiv)
|
By
[*], US regulatory clearance granted allowing sales of Licensed Product
for use in melanoma
|
|
(xv)
|
By
[*], US regulatory clearance granted allowing sales of Licensed Product
for use in breast cancer
|
|
(xvi)
|
By
[*], US regulatory clearance granted allowing sales of Licensed Product
for use in colo-rectal cancer
|
As
consideration for the amendment provided herein, and in addition to the
consideration paid or payable under the Agreement, Licensee shall pay to
University an amendment fee of Five Thousand Dollars ($5000) within 30 days
after execution of this amendment. The parties agree that this Agreement may
be
executed by facsimile and in two (2) or more counterparts, each of which shall
be deemed an original and all of which together shall constitute but one and
the
same instrument.
Except
for the changes made above, all of the other terms and conditions in the
Agreement between the parties shall remain in effect.
| Neoprobe | The Regents of | |||
| The University of California | ||||
| By: |
/s/
▇▇▇▇ ▇▇▇▇
|
By: |
/s/
▇▇▇▇ ▇. ▇▇▇▇
|
|
|
Name:
▇▇▇▇ ▇▇▇▇
|
Name:
▇▇▇▇ ▇. ▇▇▇▇, Ph.D., MBA
|
|||
|
Title:
President
|
Title:
Assistant Vice Chancellor Technology Transfer & Intellectual Property
Services
|
|||
|
Date:
February 1, 2006
|
Date:
January 27, 2006
|
|||
2