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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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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* |
Portions
have been omitted and filed separately with the Securities and
Exchange
Commission pursuant to a request for confidential
treatment.
|
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)
|
$[*]
|
completion
of phase 3 trial for cervical cancer
|
|
(13)
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$[*]
|
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
|
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(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;
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* |
Portions
have been omitted and filed separately with the Securities and
Exchange
Commission pursuant to a request for confidential
treatment.
|
(a)
|
Article
3.1(b) - First license maintenance
fee
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(b)
|
Article
4 (REPORTS, RECORDS AND PAYMENTS);
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(c) |
Paragraph
7.4 (Disposition of Licensed Products on
Hand);
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(d) |
Paragraph
8.2 (Indemnification);
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(e) |
Article
9 (USE OF NAMES AND TRADEMARKS);
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(f) |
Paragraph
10.2 hereof (Secrecy); and
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(g)
|
Paragraph
10.5 (Failure to Perform).
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(h)
|
Paragraph
10.6 (Governing Laws).
|
NEOPROBE CORPORATION: | THE REGENTS OF THE | |||
UNIVERSITY OF CALIFORNIA: | ||||
By |
/s/
David Bupp
|
By |
/s/
Alan S. Paau
|
|
(Signature)
|
(Signature)
|
|||
Name:
David Bupp
|
Alan
S. Paau
|
|||
Title:
President, CEO
|
Director,
Technology Transfer & Intellectual Property
Services
|
|||
Date
January 30, 2002
|
Date
January 26, 2002
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* |
Portions
have been omitted and filed separately with the Securities and
Exchange
Commission pursuant to a request for confidential
treatment.
|
|
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.
|
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
|
Neoprobe | The Regents of | |||
The University of California | ||||
By: |
/s/
Dave Bupp
|
By: |
/s/
Alan S. Paau
|
|
Name:
Dave Bupp
|
Name:Alan
S. Paau, 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.
|
|
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
|
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
|
Neoprobe | The Regents of | |||
The University of California | ||||
By: |
/s/
Dave Bupp
|
By: |
/s/
Alan S. Paau
|
|
Name:
Dave Bupp
|
Name:
Alan S. Paau, Ph.D., MBA
|
|||
Title:
President
|
Title:
Assistant Vice Chancellor Technology Transfer & Intellectual Property
Services
|
|||
Date:
February 1, 2006
|
Date:
January 27, 2006
|