EXCLUSIVE LICENSE AGREEMENT between THE REGENTS OF THE UNIVERSITY OF CALIFORNIA and LANTIS LASER INC. for Near-infrared Transillumination for the Imaging of Early Dental Decay UC Case No. SF2003-060
between
THE
REGENTS OF THE UNIVERSITY OF CALIFORNIA
and
XXXXXX
LASER INC.
for
Near-infrared
Transillumination for the Imaging of Early Dental Decay
XX
Xxxx
Xx. XX0000-000
TABLE
OF
CONTENTS
Title
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Page
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BACKGROUND
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1
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|
1.
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DEFINITIONS
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2
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2.
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GRANT
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8
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3.
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SUBLICENSES
|
10
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4.
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PAYMENT
TERMS
|
12
|
5.
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LICENSE
ISSUE FEE
|
14
|
6.
|
LICENSE
MAINTENANCE FEE
|
14
|
7.
|
PAYMENTS
ON SUBLICENSES
|
14
|
8.
|
EARNED
ROYALTIES AND MINIMUM ANNUAL ROYALTIES
|
15
|
9.
|
MILESTONE
PAYMENTS
|
16
|
10.
|
DUE
DILIGENCE
|
16
|
11.
|
PROGRESS
AND ROYALTY REPORTS
|
17
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12.
|
BOOKS
AND RECORDS
|
20
|
13.
|
LIFE
OF THE AGREEMENT
|
20
|
14.
|
TERMINATION
BY THE REGENTS
|
21
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15.
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TERMINATION
BY LICENSEE
|
22
|
16.
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DISPOSITION
OF LICENSED PRODUCT AND LICENSED SERVICES UPON TERMINATION OR
EXPIRATION
|
22
|
17.
|
USE
OF NAMES AND TRADEMARKS
|
22
|
18.
|
LIMITED
WARRANTY
|
23
|
19.
|
LIMITATION
OF LIABILITY
|
24
|
20.
|
PATENT
PROSECUTION AND MAINTENANCE
|
24
|
21.
|
PATENT
MARKING
|
26
|
22.
|
PATENT
INFRINGEMENT
|
26
|
23.
|
INDEMNIFICATION
|
28
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24.
|
NOTICES
|
30
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25.
|
ASSIGNABILITY
|
31
|
26.
|
WAIVER
|
31
|
27.
|
FORCE
MAJEURE
|
32
|
28.
|
GOVERNING
LAWS; ATTORNEYS’ FEES
|
32
|
29.
|
GOVERNMENT
APPROVAL OR REGISTRATION
|
32
|
30.
|
COMPLIANCE
WITH LAWS
|
33
|
31.
|
CONFIDENTIALITY
|
33
|
MISCELLANEOUS
|
35
|
|
CONSENT
TO SUBSTITUTION OF PARTY
|
37
|
for
Near-infrared
Transillumination for the Imaging of Early Dental Decay
This
license agreement ("Agreement") is made effective this 9th day of July, 2008
("Effective Date"), by and between The Regents of the University of California,
a California corporation, having its statewide administrative offices at 0000
Xxxxxxxx Xxxxxx, 00xx Xxxxx, Xxxxxxx, Xxxxxxxxxx 00000-0000 ("The Regents"),
and
acting through its Office of Technology Management, University of California,
San Francisco (“UCSF”), 000 Xxxxx Xxxxxx, Xxxxx 0000, Xxx Xxxxxxxxx, XX 00000,
and Xxxxxx Laser Inc., a New Jersey corporation, having a principal place of
business at 00 Xxxxxxxxxxx, Xxxxxxxx, Xxx Xxxxxx 00000
("Licensee").
BACKGROUND
A. Certain
inventions, generally characterized as near-infrared transillumination for
the
imaging of early dental decay and microstructural defects (collectively
"Invention"), were made in the course of research at the University of
California, San Francisco by Drs. Xxxxxx Xxxxx and Xxxxxx Xxxxx (“Inventors”)
and are claimed in Patent Rights as defined below.
B. The
development of the Invention was sponsored in part by the Department of Health
and Human Services and, as a consequence, this license is subject to overriding
obligations to the United States Federal Government under 35 U.S.C. §§ 200-212
and applicable regulations including a non-exclusive, non-transferable,
irrevocable, paid-up license to practice or have practiced the Invention for
or
on behalf of the United States Government throughout the world.
C. The
Licensee has evaluated the Invention under a Confidential Disclosure Agreement
with The Regents with an effective date of October 18, 2007.
D. The
Licensee wishes to obtain certain rights from The Regents for the commercial
development of the Invention, in accordance with the terms and conditions set
forth herein and The Regents is willing to grant those rights so that the
Invention may be developed and the benefits enjoyed by the general public.
1
E. The
scope
of such rights granted by The Regents is intended to extend to the scope of
the
patents and patent applications in Patent Rights, but only to the extent that
The Regents has proprietary rights in and to the Valid Claims of such Patent
Rights.
F. The
Licensee is a "small business firm" as defined in 15 U.S.C. §632.
G. Both
parties recognize and agree that Earned Royalties are due under this Agreement
with respect to products, services and methods and that such royalties will
be
paid with respect to both pending patent applications and issued patents, in
accordance with the terms and conditions set forth herein.
H. Both
parties recognize and agree that Earned Royalties due under this Agreement
will
be based on the Licensee's or a Sublicensee's or a Development Partner’s last
act of infringement of Patent Rights within the control of the Licensee or
a
Sublicensee or Development Partner, regardless of whether the Licensee or a
Sublicensee or Development Partner had control over prior infringing acts;
the
parties intend that Earned Royalties due under this Agreement will be calculated
based on the Net Sales of the product or service resulting from the last act
of
infringement by the Licensee and its Sublicensees or Development
Partners.
—
oo
0
oo —
The
parties agree as follows:
1. DEFINITIONS
As
used
in this Agreement, the following terms, whether used in the singular or plural,
shall have the following meanings:
1.1 "Affiliate"
of the Licensee means any entity which, directly or indirectly, Controls the
Licensee, is Controlled by the Licensee or is under common Control with the
Licensee. "Control" means (i) having the actual, present capacity to elect
a
majority of the directors of such affiliate; (ii) having the power to direct
at
least forty percent (40%) of the voting rights entitled to elect directors;
or
(iii) in any country where the local law will not permit foreign equity
participation of a majority, ownership or control, directly or indirectly,
of
the maximum percentage of such outstanding stock or voting rights permitted
by
local law.
2
1.2 "Attributed
Income" means the total gross proceeds (exclusive of Earned Royalties of
Sublicensees or Development Partners, but including, without limitation, any
license fees, maintenance fees, or milestone payments), whether consisting
of
cash or any other forms of consideration and whether any rights other than
Patent Rights are granted, which gross proceeds are received by or payable
to
the Licensee, any Affiliate and/or Joint Venture from any Sublicensee in
consideration of the grant of a sublicense and from any Development Partner
in
connection with any agreement, arrangement or other relationship described
in
Paragraph 1.4.
Notwithstanding the foregoing, Attributed Income shall not include proceeds
attributed in such sublicense or such agreement, arrangement or other
relationship to bona fide (i) debt financing; (ii) equity (and conditional
equity, such as warrants, convertible debt and the like) investments in the
Licensee at market value; (iii) reimbursements of Patent Prosecution Costs
actually incurred by the Licensee; and (iv) reimbursement for the cost of
research and/or development services to be provided on a going forward basis
by
Licensee for the applicable Sublicensee and/or Development Partner under such
sublicense or such agreement, arrangement or other relationship on the basis
of
full-time equivalent ("FTE") efforts of personnel at or below commercially
reasonable and standard FTE rates.
For the
avoidance of doubt, any gross proceeds meeting the definition set forth above
in
this Article 1.2
shall be
“Attributed Income” irrespective of whether such gross proceeds are received
under one or more separate agreements and irrespective of how such gross
proceeds are referred to or characterized by the Licensee, the Sublicensee
or
the Development Partner.
1.3 "Combination
Product" means a combined Product that contains or uses a Licensed Product
and
at least one other Product or process (a "Combination Product Component"),
where
(i) such Combination Product Component is not a Licensed Product, (ii) if such
Combination Product Component were removed from such combined Product, the
manufacture, use, Sale or import of the resulting Product in or into a
particular country would infringe, but for a license, the same Valid Claim
in
the country where such manufacture, use, Sale or import occurs as such combined
Product, (iii) such Combination Product Component and such Licensed Product
are
Sold separately from such combined Product by the Licensee or any Affiliate,
Joint Venture or Sublicensee, (iv) such Combination Product Component does
not
function together with a Licensed Product so as to achieve the purpose for
which
such Licensed Product is Sold and (v) the market price of such combined Product
is higher than the market price for such Licensed Product as a result of such
combined Product containing or using such Combination Product
Component.
3
1.4 "Development
Partner" means (i) any person or entity other than a Sublicensee that develops,
Sells, transfers, leases, exchanges or otherwise disposes or provides Licensed
Products in connection with, or as a result of, an agreement, arrangement or
other relationship with the Licensee, any Affiliate, any Joint Venture or any
Sublicensee; and (ii) any person or entity other than a Sublicensee that has
an
agreement, arrangement or other relationship with the Licensee, any Affiliate,
any Joint Venture or any Sublicensee for the research or development of Licensed
Products.
1.5 "Earned
Royalty" means Sublicensee Royalty (as defined in Paragraph 7.2)
and
Royalty (as defined in Paragraph 8.1).
1.6 "Field
of
Use" means all human and veterinary dental applications.
1.7 "FTE"
is
defined in Paragraph 1.2
(Attributed Income).
1.8 "Joint
Venture" means any separate entity established pursuant to an agreement between
a third party and the Licensee and/or Sublicensee to constitute a vehicle for
a
joint venture, in which the separate entity manufactures, uses, purchases,
Sells
or acquires Licensed Products from the Licensee or Sublicensee.
1.9 "Licensed
Method" means any process, art or method the
use
or practice of which, but for the license granted in this Agreement, would
infringe, or contribute to, or induce the infringement of, any Patent Rights
in
any country were they issued at the time of the infringing activity in that
country.
1.10 "Licensed
Product" means any Product, including, without limitation, a Product for use
or
used in practicing a Licensed Method and any Product made by practicing a
Licensed Method, the manufacture, use, Sale, offer for Sale or import of which,
but for the license granted in this Agreement, would infringe, or contribute
to,
or induce the infringement of, any Patent Rights in any country were they issued
at the time of the infringing activity in that country.
4
1.11 "Net
Invoice Price" means (a) the gross invoice price charged and the value of any
other consideration owed to the Licensee, any Sublicensee and/or any Development
Partner for a Licensed Product, or (b) in those instances where the Licensed
Product is combined in any manner with any other Product or service, the gross
invoice price charged and the value of any other consideration owed to the
Licensee any Sublicensee and/or any Development Partner for the combined Product
or service in its entirety, less the following items, but only to the extent
that they actually pertain to the disposition of such Licensed Product, are
included in the gross invoice price charged or other consideration owed, and
are
identified separately on a xxxx or invoice:
1.11.1 |
Allowances
actually granted to customers for rejections, returns and prompt
payment
and volume discounts;
|
1.11.2 |
Freight,
transport packing and insurance charges associated with
transportation;
|
1.11.3 |
Taxes,
including Deductible Value Added Tax, tariffs or import/export duties
based on Sales when included in the gross invoice price, but excluding
value-added taxes other than Deductible Value Added Tax or taxes
assessed
on income derived from Sales. "Deductible Value Added Tax" means
only the
portion of the value added tax that is actually incurred and is not
reimbursable, refundable or creditable under the tax authority of
any
country;
|
1.11.4 |
Only
those normal and customary discounts and rebates given as a part
of a
formulary program that are paid or credited to customers, third-party
payers, healthcare systems, or administrators for a Licensed Product
that
is included in such formulary program, as permitted by applicable
law;
|
1.11.5 |
Only
those normal and customary wholesaler's discounts and rebates given
as a
part of a formulary program that are paid or credited to customers,
third-party payers, health care systems, or administrators for a
Licensed
Product that is included in such formulary program, as permitted
by
applicable law;
|
and
1.11.6 |
Rebates
and discounts paid or credited pursuant to applicable
law.
|
5
1.12
"Net
Sale" means:
1.12.1 |
except
in the instances described in Paragraphs 1.12.2,
1.12.3
and 1.12.4
of
this Paragraph, the Net Invoice
Price;
|
1.12.2 |
for
any Relationship-Influenced Sale of a Licensed Product, Net Sales
shall be
based on the Net Invoice Price at which the Relationship-Influenced
Sale
Purchaser re-Sells such Licensed
Product;
|
1.12.3 |
in
those instances where Licensed Product is not Sold, but is otherwise
exploited, the Net Sales for such Licensed Product shall be the Net
Invoice Price of products of the same or similar kind and quality,
Sold in
similar quantities, currently being offered for Sale by the Licensee,
any
Sublicensee and/or any Development Partner. Where such products are
not
currently being offered for Sale by the Licensee, any Sublicensee
and/or
any Development Partner, the Net Sales for Licensed Product otherwise
exploited, for the purpose of computing royalties, shall be the average
Net Invoice Price at which products of the same or similar kind and
quality, Sold in similar quantities, are then currently being offered
for
Sale by other manufacturers. Where such products are not currently
Sold or
offered for Sale by the Licensee, any Sublicensee and/or any Development
Partner, or others, then the Net Sales shall be the Licensee's, any
Sublicensee's and/or any Development Partner's cost of manufacture
of
Licensed Product, determined according to Generally Accepted Accounting
Principles (“GAAP”), plus fifty percent (50%);
and
|
1.12.4 |
for
a Reacquisition Sale or Exploitation, Net Sales shall mean the Net
Invoice
Price upon the Reacquisition Sale or Exploitation of a Licensed
Product.
|
For
a
Combination Product, Net Sales shall be calculated as:
A/(A+B)
x [Net Sales, calculated without regard to this formula, of the Licensed
Product that is the Combination
Product],
|
Where:
(i) |
"A"
is the total of Net Sales of each Licensed Product contained
within or
used in the Combination Product when Sold separately;
and
|
6
(ii)
|
"B"
is the total of Net Sales of each Combination Product Component contained
within or used in the Combination Product when Sold separately,
|
provided,
however, that in no event shall Net Sales for a Combination Product be less
than
fifteen percent (15%) of Net Sales, calculated without regard to this formula,
of the Licensed Product that is the Combination Product.
1.13 "New
Developments" means inventions, or claims to inventions, which constitute
advancements, developments or improvements, whether or not patentable and
whether or not the subject of any patent application, which are not sufficiently
supported by the specification of a previously-filed patent or patent
application within the Patent Rights to be entitled to the priority date of
the
previously-filed patent or patent application.
1.14 "Patent
Prosecution Costs" is defined in Paragraph 20.4.
1.15 "Patent
Rights" means the Valid Claims of, to the extent assigned to or otherwise
obtained by The Regents, the United States patent application number 11/347,637,
claiming priority from United States provisional patent application number
60/493,569
filed on
August 8, 2003. Patent
Rights shall further include the Valid Claims of, to the extent assigned to
or
otherwise obtained by The Regents, any reissues, extensions, substitutions,
continuations, divisions, and continuation-in-part applications (but only those
Valid Claims in the continuation-in-part applications that are entirely
supported in the specification and entitled to the priority date of the parent
application). This definition of Patent Rights excludes any rights in and to
New
Developments.
1.16 "Product"
means any kit, article of manufacture, composition of matter, material,
compound, component or product.
1.17 “Reacquisition
Sale or Exploitation” means those instances where the Licensee, a Sublicensee or
a Development Partner acquires a Licensed Product and then subsequently Sells
or
otherwise exploits such Licensed Product.
1.18 "Related
Party" means a corporation, firm or other entity with which, or individual
with
whom, the Licensee, any Sublicensee and/or any Development Partner (or any
of
its respective stockholders, subsidiaries or Affiliates) have any agreement,
understanding or arrangement (for example, but not by way of limitation, an
option to purchase stock or other equity interest, or an arrangement involving
a
division of revenue, profits, discounts, rebates or allowances) unrelated to
the
Sale or exploitation of the Licensed Products without which such other
agreement, understanding or arrangement, the amounts, if any, charged by the
Licensee, any Sublicensee or Development Partner to such entity or individual
for the Licensed Product, would be higher than the Net Invoice Price actually
received, or if such agreement, understanding or arrangement results in the
Licensee, any Sublicensee or Development Partner extending to such entity or
individual lower prices for such Licensed Product than those charged to others
without such agreement, understanding or arrangement buying similar products
in
similar quantities.
7
1.19 "Relationship-Influenced
Sale" means a Sale of a Licensed Product, or any exploitation of the Licensed
Product or Licensed Method, between the Licensee, any Sublicensee and/or any
Development Partner and (i) an Affiliate; (ii) a Joint Venture; (iii) a Related
Party or (iv) the Licensee, a Sublicensee and/or a Development
Partner.
1.20 "Relationship-Influenced
Sale Purchaser" means the purchaser of Licensed Product in a
Relationship-Influenced Sale.
1.21 "Sale"
means the act of selling, leasing or otherwise transferring, providing, or
furnishing for use for any consideration. Correspondingly, "Sell" means to
make
or cause to be made a Sale and "Sold" means to have made or caused to be made
a
Sale.
1.22 "Sublicensee"
means any person or entity (including any Affiliate or Joint Venture) to which
any of the license rights granted to the Licensee hereunder are
sublicensed.
1.23 "Sublicense
Fee" is defined in Paragraph 7.1.
1.24 "Valid
Claim" means a claim of a patent or patent application in any country that
(i)
has not expired; (ii) has not been disclaimed; (iii) has not been cancelled
or
superseded, or if cancelled or superseded, has been reinstated; and (iv) has
not
been revoked, held invalid, or otherwise declared unenforceable or not allowable
by a tribunal or patent authority of competent jurisdiction over such claim
in
such country from which no further appeal has or may be taken.
2. GRANT
2.1 Subject
to the limitations and other terms and conditions set forth in this Agreement
including the license granted to the United States Government set forth in
the
Background and in Paragraph 2.3.1,
The
Regents grants to the Licensee a license under its rights in and to Patent
Rights to make, use, Sell, offer for Sale and import Licensed Products and
to
practice Licensed Methods, in the United States and in other countries where
The
Regents may lawfully grant such licenses, only in the Field of Use.
8
2.2 Except
as
otherwise provided for in this Agreement, the license granted under Patent
Rights in Paragraph 2.1
is
exclusive.
2.3 The
license granted in Paragraphs 2.1
and
2.2
is
subject to the following:
2.3.1 |
The
obligations to the United States Government under 35 U.S.C. §§ 200-212 and
all applicable governmental implementing regulations, as amended
from time
to time, including the obligation to report on the utilization of
the
Invention as set forth in 37 CFR. § 401.14(h), and all applicable
provisions of any license to the United States Government executed
by The
Regents; and
|
2.3.2 |
the
National Institutes of Health "Principles and Guidelines for Recipients
of
NIH Research Grants and Contracts on Obtaining and Disseminating
Biomedical Research Resources," 64 F.R. 72090 (Dec. 23, 1999), as
amended
from time to time.
|
2.4 The
license granted in Paragraphs 2.1
and
2.2
is
limited to methods and products that are within the Field of Use. For other
methods and products, the Licensee has no license under this
Agreement.
2.5 The
Regents reserves and retains the right (and the rights granted to the Licensee
in this Agreement shall be limited accordingly) to make, use and practice the
Invention and any technology relating to any of the foregoing and to make and
use any Products and to practice any process that is the subject of the Patent
Rights (and to grant any of the foregoing rights to other educational and
non-profit institutions) for educational and research purposes, including
without limitation, any sponsored research performed for or on behalf of
commercial entities and including publication and other communication of any
research results. For the avoidance of doubt, to the extent the Invention and
any technology relating to any of the foregoing are not the subject of the
exclusive license under the Patent Rights granted to the Licensee hereunder,
The
Regents shall be free to make, use, Sell, offer to Sell, import, practice and
otherwise commercialize and exploit (including to transfer, license to, or
have
exercised by, third parties) for any purpose whatsoever and in its sole
discretion, such Invention, technology and any Products or processes that are
the subject of any of the foregoing.
9
2.6 Because
the Invention was made under funding provided by the United States Government,
Licensed Products, the Invention, and any products embodying the Invention
sold
in the United States will be substantially manufactured in the United
States.
2.7 The
Agreement will terminate immediately if Licensee files a claim including in
any
way the assertion that any portion of The Regents’ Patent Rights is invalid or
unenforceable where the filing is by the Licensee, a third party on behalf
of
the Licensee, or a third party at the written urging of the
Licensee.
3. SUBLICENSES
3.1 The
Regents also grants to the Licensee the right to sublicense to third parties
(including to Affiliates and Joint Ventures) the rights granted to the Licensee
hereunder, with no right to further sublicense except as provided below, as
long
as the Licensee has current exclusive rights thereto under this Agreement.
Each
Sublicensee must be subject to a written sublicense agreement. All sublicenses
will include all of the rights of, and will require the performance of all
the
obligations due to, The Regents (and, if applicable, the United States
Government and other sponsors), other than those rights and obligations
specified in Article 5
(License
Issue Fee), Article 6
(License
Maintenance Fee) and Paragraph 8.2
(Minimum
Annual Royalty) and Paragraphs 20.4
and
20.5
(reimbursement of Patent Prosecution Costs). For the avoidance of doubt, the
Licensee shall have no right to permit any Sublicensee and no Sublicensee shall
have any right to further sublicense any of the rights granted to the Licensee
hereunder, except that each Sublicensee (except Affiliates and Joint Ventures)
may sublicense to its affiliates as affiliate is defined in Paragraph
1.1
with
Sublicensee substituted for licensee in the definition, to the extent needed
for
the development and commercialization of Licensed Products in accordance with
this Agreement. Also, for the avoidance of doubt, Affiliates and Joint Ventures
shall have no licenses under this Agreement unless such Affiliates and Joint
Ventures are granted a sublicense. For the purposes of this Agreement, the
operations of all Sublicensees shall be deemed to be the operations of the
Licensee, for which the Licensee shall be responsible.
10
3.2 In
the
event that The Regents and the Licensee each own an undivided interest in any
Patent Rights licensed hereunder, the Licensee will not separately grant a
license to any third party under its rights without concurrently granting a
license under The Regents' rights on the terms and conditions described in
this
Article 3
(Sublicenses).
3.3 The
Licensee will notify The Regents of each sublicense granted hereunder and will
provide The Regents with a complete copy of each sublicense (along with a
summary of the material terms of each such sublicense) and each amendment to
such sublicense within thirty (30) days of issuance of such sublicense or such
amendment. The Licensee will collect from Sublicensees and pay to The Regents
all fees, payments, royalties and the cash equivalent of any consideration
due
The Regents. The Licensee will guarantee all monies due The Regents from
Sublicensees. For clarity, if the Licensee grants a sublicense that contains
a
provision for payment of royalties by any Sublicensee in an amount that is
less
than the Sublicensee Royalty required to be paid under Paragraph 7.2
below,
then the Licensee will pay to The Regents a total amount equal to the
Sublicensee Royalty based on the Sublicensees’ Net Sales as provided for in
Paragraph 7.2.
The
Licensee will require Sublicensees to provide it with copies of all progress
reports and royalty reports in accordance with the provisions herein and the
Licensee will collect and deliver all such reports due The Regents from
Sublicensees.
3.4 If
Licensee licenses patent rights assigned to or otherwise acquired by it
("Licensee's Patent Rights"), and it believes, in good faith, that the recipient
of such license will infringe Patent Rights in practicing the Licensee's Patent
Rights, then the Licensee will not separately grant a license to such recipient
under Licensee's Patent Rights without concurrently granting a sublicense under
Patent Rights on the terms required under this Agreement.
3.5 Upon
any
expiration or termination of this Agreement for any reason, all sublicenses
shall automatically terminate, unless The Regents, at its sole discretion,
agrees in writing to an assignment to The Regents of any sublicense. In the
event of termination of this Agreement and if The Regents accepts assignment
of
any sublicense, The Regents will not be bound by any grant of rights broader
than or will not be required to perform any obligation other than those rights
and obligations contained in this Agreement. Moreover, The Regents will have
the
sole right to modify each such assigned sublicense to include all of the rights
of The Regents (and, if applicable, the United States Government and other
sponsors) that are contained in this Agreement, including the payment of Earned
Royalties directly to The Regents by the Sublicensee as if it were the Licensee
at a rate that is no lower than the rate set forth in Article 8
(Earned
Royalties and Minimum Annual Royalties) in accordance with Article 4
(Payment
Terms).
11
4. PAYMENT
TERMS
4.1 Paragraphs
1.9,
1.10,
and
1.15
define
Licensed Method, Licensed Product, and Patent Rights, so that Earned Royalties
are payable on products and methods covered by both pending patent applications
and issued patents. Earned Royalties will accrue in each country for the
duration of Patent Rights in that country and will be payable to The Regents
when Licensed Products are invoiced, or if not invoiced, when delivered or
otherwise exploited by the Licensee or Sublicensee in a manner constituting
a
Net Sale as defined in Paragraph 1.12.
Sublicense Fees with respect to any Attributed Income shall accrue to The
Regents within thirty (30) days of the date that such Attributed Income is
due
to the Licensee.
4.2 The
Licensee will pay to The Regents all Earned Royalties, Sublicense Fees and
other
consideration payable to The Regents quarterly on or before March 31 (for the
calendar quarter ending December 31), June 30 (for the calendar quarter ending
March 31), September 30 (for the calendar quarter ending June 30) and December
31 (for the calendar quarter ending September 30) of each calendar year. Each
payment will be for Earned Royalties, Sublicense Fees and other consideration
which has accrued within the Licensee's most recently completed calendar
quarter.
4.3 All
consideration due The Regents will be payable and will be made in United States
dollars by check payable to "The Regents of the University of California" or
by
wire transfer to an account designated by The Regents. The Licensee is
responsible for all bank or other transfer charges. When Licensed Products
are
Sold for monies other than United States dollars, the Earned Royalties and
other
consideration will first be determined in the foreign currency of the country
in
which such Licensed Products were Sold and then converted into equivalent United
States dollars. The exchange rate will be the average exchange rate quoted
in
the The
Wall Street Journal
during
the last ninety (90) days of the reporting period.
4.4 Sublicense
Fees and Earned Royalties on Net Sales of Licensed Products and other
consideration accrued in, any country outside the United States may not be
reduced by any taxes, fees or other charges imposed by the government of such
country, except those taxes, fees and charges allowed under the provisions
of
Paragraph 1.12
(Net
Sales).
12
4.5 Notwithstanding
the provisions of Article 27
(Force
Majeure) if at any time legal restrictions prevent the prompt remittance of
Earned Royalties or other consideration owed to The Regents by the Licensee
with
respect to any country where a sublicense is issued or a Licensed Product is
Sold or otherwise exploited, then the Licensee shall convert the amount owed
to
The Regents into United States dollars and will pay The Regents directly from
another source of funds in order to remit the entire amount owed to The Regents.
4.6 In
the
event that any patent or claim thereof included within the Patent Rights is
held
invalid in a final decision by a court of competent jurisdiction and last resort
and from which no appeal has or can be taken, then all obligation to pay
royalties based on that patent or claim or any claim patentably indistinct
therefrom will cease as of the date of final decision. The Licensee will not,
however, be relieved from paying any royalties that accrued before such final
decision and the Licensee shall be obligated to pay the full amount of royalties
due hereunder to the extent that The Regents licenses one or more Valid Claims
within the Patent Rights to the Licensee with respect to Licensed
Products.
4.7 No
Earned
Royalties will be collected or paid hereunder to The Regents on Licensed
Products Sold to, or otherwise exploited for, the account of the United States
Government as provided for in the license to the United States Government.
The
Licensee, its Sublicensees and Development Partners will reduce the amount
charged for Licensed Products Sold to, or otherwise exploited by, the United
States Government by an amount equal to the Earned Royalty for such Licensed
Products otherwise due The Regents. Such reduction in Earned Royalties will
be
in addition to any other reductions in price required by the United States
Government.
4.8 In
the
event that royalties, fees, reimbursements for Patent Prosecution Costs or
other
monies owed to The Regents are not received by The Regents when due, the
Licensee will pay to The Regents interest at a rate of ten percent (10%) simple
interest per annum. Such interest will be calculated from the date payment
was
due until actually received by The Regents. Such accrual of interest will be
in
addition to and not in lieu of, enforcement of any other rights of The Regents
due to such late payment.
13
5. LICENSE
ISSUE FEE
The
Licensee will pay to The Regents a one-time license issue fee of ten thousand
dollars ($10,000) within seven (7) days of the Effective Date. This fee is
non-refundable, non-cancelable and is not an advance or otherwise creditable
against any royalties or other payments required to be paid under the terms
of
this Agreement.
6. LICENSE
MAINTENANCE FEE
The
Licensee will also pay to The Regents a license maintenance fee of five thousand
dollars ($5,000) beginning on the one-year anniversary of the Effective Date
and
continuing annually on each anniversary of the Effective Date. The license
maintenance fee is not due on any anniversary of the Effective Date if on that
date, the Licensee is Selling or otherwise exploiting Licensed Products and
is
paying an Earned Royalty to The Regents on the Net Sales of such Licensed
Product. The license maintenance fee is non-refundable and is not an advance
or
otherwise creditable against any royalties or other payments required to be
paid
under the terms of this Agreement.
7. PAYMENTS
ON SUBLICENSES
7.1 The
Licensee will pay to The Regents the following non-refundable and non-creditable
sublicense fees ("Sublicense Fees"):
7.1.1 |
Forty
percent (40%) of all Attributed Income attributable to any sublicense
that
is granted prior to the generation of a prototype;
|
7.1.2 |
Twenty-five
percent (25%) of all Attributed Income attributable to any sublicense
that
is granted upon or after the occurrence of the event specified in
Paragraph 7.1.1 but prior to the initiation of clinical trials with
respect to a Licensed Product for purposes of regulatory approval
by the
United States Food and Drug Administration (“FDA”) or
equivalent;
|
7.1.3 |
Ten
percent (10%) of all Attributed Income attributable to any sublicense
that
is granted upon or after the occurrence of the event specified in
Paragraph 7.1.2 but prior to FDA market approval (or equivalent)
with
respect to a Licensed Product; or
|
14
7.1.4 |
Five
percent (5%) of all Attributed Income attributable to any sublicense
that
is granted upon or after the occurrence of FDA market approval (or
equivalent) specified in Paragraph 7.1.3.
|
7.2 The
Licensee will also pay to The Regents, with respect to each Sublicensee and
each
Development Partner (other than an Affiliate or Joint Venture), an earned
royalty of five percent (5%) of the Net Sales of each Licensed Product or
Licensed Method ("Sublicensee Royalty").
8. EARNED
ROYALTIES AND MINIMUM ANNUAL ROYALTIES
8.1 The
Licensee will also pay to The Regents an earned royalty of five percent (5%)
of
the Net Sales of Licensed Product or Licensed Method by the Licensee or any
Affiliate or Joint Venture
("Royalty").
8.2 The
Licensee will also pay to The Regents a minimum annual royalty for the life
of
Patent Rights, beginning with the year of the first Sale of Licensed Product,
but no later than calendar year 2010. The minimum annual royalty will be due
as
follows:
8.2.1 |
Ten
thousand dollars ($10,000) for the first
year;
|
8.2.2 |
Fifty
thousand dollars ($50,000) for the second
year;
|
8.2.3 |
One
hundred thousand dollars ($100,000) for the third
year;
|
8.2.4 |
One
hundred fifty thousand dollars ($150,000) for the fourth year;
and
|
8.2.5 |
Two
hundred thousand dollars ($200,000) for the fifth year and all subsequent
years.
|
The
minimum annual royalty will be paid to The Regents by February 28 of each year
and will be credited against the Earned Royalty due for the calendar year in
which the minimum payment was made. However, if the year of the first Sale
is
earlier than calendar year 2009, then the Licensee's obligation to pay the
minimum annual royalty will be pro-rated for the number of months remaining
in
that calendar year when Sales commence and will be due the following February
28
(along with the minimum annual royalty payment for that year), to allow for
crediting of the pro-rated year's Earned Royalties.
15
9. MILESTONE
PAYMENTS
9.1 With
respect to each Licensed Product, the Licensee will pay to The Regents the
following non-refundable, non-creditable amounts:
9.1.1 |
Fifteen
thousand dollars ($15,000) upon notice of allowance of United States
patent application number 11/347,637 from the United States Patent
and
Trademark Office; and
|
9.1.2 |
Twenty-five
thousand dollars ($25,000) upon United States Food and Drug Administration
(“FDA”) market approval (or
equivalent).
|
9.2 For
the
avoidance of doubt, each of the milestone payments set forth in Paragraphs
9.1.1
through 9.1.2 will be payable with respect to each Licensed Product.
Furthermore, each such milestone payment will be payable regardless of whether
the applicable milestone event has been achieved by the Licensee or any
Affiliate, Joint Venture, Sublicensee, or Development Partner.
9.3 All
milestone payments are due to The Regents within thirty (30) days of the
occurrence of the applicable milestone event.
10. DUE
DILIGENCE
10.1 The
Licensee, upon execution of this Agreement, will diligently proceed with the
development, manufacture and Sale of Licensed Products and will earnestly and
diligently market the same after execution of this Agreement and in quantities
sufficient to meet the market demands therefor.
10.2 The
Licensee will obtain all necessary governmental approvals in each country where
Licensed Products are manufactured, used, Sold, offered for Sale or
imported.
10.3 The
Licensee will:
10.3.1 |
generate
a prototype within six (6) months from the Effective
Date;
|
10.3.2 |
obtain
market approval from the United States FDA within fifteen (15) months
from
the Effective Date;
|
10.3.3 |
market
Licensed Product within eighteen (18) months from the Effective Date;
|
10.3.4 |
market
Licensed Product in the United States within six (6) months of receiving
approval of such Licensed Product from the United States FDA;
and
|
16
10.3.5 |
fill
the market demand for Licensed Products following commencement of
marketing at any time during the exclusive period of this
Agreement.
|
10.4 If
the
Licensee is unable to perform any of the above provisions, then The Regents
has
the right and option to either terminate this Agreement or reduce the exclusive
license granted to the Licensee to a nonexclusive license in accordance with
Paragraph 10.8
below.
This right, if exercised by The Regents, supersedes the rights granted in
Article 2
(Grant).
10.5 In
addition to the obligations set forth above, the Licensee shall spend an
aggregate of not less than fifty thousand dollars ($50,000) for the development
of Licensed Products during the first year of this Agreement.
10.6 The
Regents and Inventors will, to the extent possible, provide any and all
information that is reasonably requested by Licensee for the purposes of United
States FDA approval.
10.7 If
the
Licensee fails or is unable to comply with the spending requirement set forth
in
Paragraph 10.5,
then
The Regents has the right and option to either terminate this Agreement or
reduce the exclusive license granted to the Licensee to a nonexclusive license.
This right, if exercised by The Regents, supersedes the rights granted in
Article 2
(Grant).
10.8 To
exercise either the right to terminate this Agreement or to reduce the exclusive
license granted to the Licensee to a non-exclusive license for lack of diligence
required in this Article 10
(Due
Diligence), The Regents will give the Licensee written notice of the deficiency.
The Licensee thereafter has sixty (60) days to cure the deficiency. If The
Regents has not received written tangible evidence satisfactory to The Regents
that the deficiency has been cured by the end of the sixty (60)-day period,
then
The Regents may, at its option, terminate this Agreement immediately without
the
obligation to provide sixty (60) days' notice as set forth in Article
14
(Termination by The Regents) or reduce the exclusive license granted to the
Licensee to a non-exclusive license by giving written notice to the
Licensee.
11. PROGRESS
AND ROYALTY REPORTS
11.1 Beginning
on December 31, 2008, and semi-annually thereafter, the Licensee will submit
to
The Regents a written progress report as described in Paragraph 11.2
below
covering the Licensee's (and any Affiliates', Joint Ventures', Sublicensee's
or
Development Partner's) activities related to the development and testing of
all
Licensed Products and related to the obtaining of the governmental approvals
necessary for marketing and the activities required and undertaken in order
to
meet the diligence requirements set forth in Article 10
(Due
Diligence). Progress reports are required for each Licensed Product until the
first Sale or other exploitation of that Licensed Product occurs in the United
States and shall be again required if Sales of such Licensed Product are
suspended or discontinued.
17
11.2 Progress
reports submitted under Paragraph 11.1
shall
include, but are not limited to, a detailed summary of the following topics
so
that The Regents will be able to determine the progress of the development
of
Licensed Products and will also be able to determine whether or not the Licensee
has met its diligence obligations set forth in Article 10
(Due
Diligence) above:
11.2.1 |
summary
of work completed as of the submission date of the progress
report;
|
11.2.2 |
key
scientific discoveries as of the submission date of the progress
report;
|
11.2.3 |
summary
of work in progress as of the submission date of the progress
report;
|
11.2.4 |
current
schedule of anticipated events and milestones, including those event
and
milestones specified in Article 10
(Due Diligence);
|
11.2.5 |
market
plans for introduction of Licensed Products including the anticipated
and
actual market introduction dates of each Licensed
Product;
|
11.2.6 |
Sublicensees’
activities relating to the above items, if there are any Sublicensees;
and
|
11.2.7 |
a
summary of resources (dollar value) spent in the reporting
period.
|
11.3 If
the
Licensee fails to submit a timely progress report to The Regents, then The
Regents will be entitled to terminate this Agreement. If either party terminates
this Agreement before any Licensed Products are Sold or before this Agreement's
expiration, then a final progress report covering the period prior to
termination must be submitted within thirty (30) days of termination or
expiration.
11.4 The
Licensee has a continuing responsibility to keep The Regents informed of the
business entity status (small business entity status or large business entity
status as defined by the United States Patent and Trademark Office) of itself,
any Affiliates, Joint Ventures, or Sublicensees. The Licensee will notify The
Regents of any change of its status or that of any Affiliate, Joint Venture,
or
Sublicensee within thirty (30) days of the change in status.
18
11.5 The
Licensee will report to The Regents the date of first Sale or other exploitation
of a Licensed Product in each country in its first progress and royalty reports
following such first Sale of a Licensed Product.
11.6 Beginning
with the earlier of (i) the first Sale or other exploitation of a Licensed
Product or (ii) the first transaction that results in Sublicense Fees accruing
to The Regents, the Licensee will make quarterly royalty and Sublicensee Fee
reports to The Regents on or before each March 31 (for the quarter ending
December 31), June 30 (for the quarter ending March 31), September 30 (for
the
quarter ending June 30) and December 31 (for the quarter ending September 30)
of
each year. Each royalty and Sublicensee Fee report will cover Licensee's most
recently completed calendar quarter and will, at a minimum, show:
11.6.1 |
the
gross invoice prices and Net Sales of Licensed Products Sold or otherwise
exploited (itemizing the applicable gross proceeds and any deductions
therefrom) and any Attributed Income (itemizing the applicable gross
proceeds and any deductions therefrom) due to the
Licensee;
|
11.6.2 |
the
quantity of each type of Licensed Product Sold or otherwise exploited;
|
11.6.3 |
the
country in which each Licensed Product was made, used or Sold or
otherwise
exploited;
|
11.6.4 |
the
Earned Royalties, in United States dollars, payable with respect
to Net
Sales;
|
11.6.5 |
the
Sublicense Fees, in United States dollars, payable with respect to
Attributed Income;
|
11.6.6 |
the
method used to calculate the Earned Royalty, specifying all deductions
taken and the dollar amount of each such
deduction;
|
11.6.7 |
the
exchange rates used, if any;
|
11.6.8 |
the
amount of the cash and the amount of the cash equivalent of any non-cash
consideration including the method used to calculate the non-cash
consideration;
|
11.6.9 |
for
each Licensed Product, the specific Patent Rights identified by UC
Case
Number exercised by the Licensee or any Affiliate, Joint Venture,
Sublicensee, or any Development Partner in the course of making,
using,
selling, offering for Sale or importing such Licensed Product;
and
|
19
11.6.10 |
any
other information reasonably necessary to confirm Licensee's calculation
of its financial obligations
hereunder.
|
11.7 If
no
Sales of Licensed Products have been made and no Licensed Products have been
otherwise exploited and no Attributed Income is due to the Licensee during
any
reporting period, then a statement to this effect must be provided by the
Licensee in the immediately subsequent royalty and Sublicense Fee
report.
12. BOOKS
AND
RECORDS
12.1 The
Licensee will keep accurate books and records showing all Licensed Product
under
development, manufactured, used, offered for Sale, imported, Sold and or
otherwise exploited; all Net Sales, all Attributed Income and other amounts
payable hereunder; and all sublicenses granted under the terms of this
Agreement. Such books and records will be preserved for at least five (5) years
after the date of the payment to which they pertain and will be open to
examination by representatives or agents of The Regents at reasonable times
to
determine their accuracy and assess the Licensee's compliance with the terms
of
this Agreement.
12.2 The
Regents shall pay the fees and expenses of such examination. If, however, an
error in royalties of more than five percent (5%) of the total royalties due
for
any year is discovered in any examination, then the Licensee shall bear the
fees
and expenses of such examination and shall remit such underpayment to The
Regents within thirty (30) days of the examination results.
13. LIFE
OF
THE AGREEMENT
13.1 Unless
otherwise terminated by operation of law, Paragraph 13.2,
or by
acts of the parties in accordance with the terms of this Agreement, this
Agreement will remain in effect from the Effective Date until the expiration
or
abandonment of the last of the Patent Rights licensed hereunder.
13.2 This
Agreement will automatically terminate without the obligation to provide sixty
(60) days' notice as set forth in Article 14
(Termination By The Regents) upon the filing of a petition for relief under
the
United States Bankruptcy Code by or against the Licensee as a debtor or alleged
debtor.
20
13.3 Any
termination or expiration of this Agreement will not affect the rights and
obligations set forth in the following Articles:
Article 1
|
Definitions
|
Paragraph 4.8
|
Late
Payments
|
Article 5
|
License
Issue Fee
|
Article 7
|
Payments
on Sublicenses
|
Paragraphs 8.1 and 8.2
|
Earned
Royalties and Minimum Annual Royalties
|
Article 12
|
Books
and Records
|
Article 13
|
Life
of the Agreement
|
Article 16
|
Disposition
of Licensed Products and Licensed Services Upon Termination or
Expiration
|
Article 17
|
Use
of Names and Trademarks
|
Article 18
|
Limited
Warranty
|
Article 19
|
Limitation
of Liability
|
Paragraphs 20.4 & 20.5
|
Patent
Prosecution and Maintenance
|
Article 23
|
Indemnification
|
Article 24
|
Notices
|
Article 28
|
Governing
Laws; Venue; Attorneys Fees
|
Article 31
|
Confidentiality
|
13.4 The
termination or expiration of this Agreement will not relieve the Licensee of
its
obligation to pay any fees, royalties or other payments owed to The Regents
at
the time of such termination or expiration and will not impair any accrued
right
of The Regents, including the right to receive Earned Royalties in accordance
with Articles 7
(Payments on Sublicenses), 8
(Earned
Royalties and Minimum Annual Royalties) and 16
(Disposition of Licensed Products and Licensed Services Upon Termination or
Expiration).
14. TERMINATION
BY THE REGENTS
If
the
Licensee fails to perform or violates any term of this Agreement, then The
Regents may give written notice of such default ("Notice of Default") to the
Licensee. If the Licensee fails to repair such default within sixty (60) days
after the effective date of such notice, then The Regents will have the right
to
immediately terminate this Agreement and its licenses by providing a written
notice of termination ("Notice of Termination") to the Licensee.
21
15. TERMINATION
BY LICENSEE
The
Licensee has the right at any time to terminate this Agreement by providing
a
Notice of Termination to The Regents. Termination of this Agreement (but not
termination of any patents or patent applications under Patent Rights, which
termination is subject to Paragraph 20.5)
will be
effective sixty (60) days from the effective date of such notice.
16. DISPOSITION
OF LICENSED PRODUCT AND LICENSED SERVICES UPON TERMINATION
OR
EXPIRATION
16.1 Upon
termination (but not expiration) of this Agreement, within a period of one
hundred and twenty (120) days after the date of termination, the Licensee is
entitled to dispose of all previously made or partially made Licensed Product,
but no more, provided that the Sale or use of such Licensed Product are subject
to the terms of this Agreement, including, but not limited to, the rendering
of
reports and payment of Earned Royalties, Sublicense Fees and any other payments
therefor required under this Agreement. The Licensee will not otherwise make,
use, Sell, offer for Sale or import Licensed Products or practice the Licensed
Method after the date of termination.
16.2 If
applicable Patent Rights exist at the time of any making, Sale, offer for Sale,
or import of a Licensed Product, then Earned Royalties shall be paid at the
times provided herein and royalty reports shall be rendered in connection
therewith, notwithstanding the absence of applicable Patent Rights with respect
to such Licensed Product at any later time. Otherwise, no Earned Royalties
shall
be paid on the Sales of such product. Any fees or other payments owed to The
Regents at the time of expiration not based on the Sales of a Licensed Product
will be paid to The Regents at the time such fee or other payment would have
been due had this Agreement not expired.
17. USE
OF
NAMES AND TRADEMARKS
Nothing
contained in this Agreement will be construed as conferring any right to either
party to use in advertising, publicity or other promotional activities any
name,
trade name, trademark or other designation of the other party (including a
contraction, abbreviation or simulation of any of the foregoing). Without the
Licensee's consent case-by-case, The Regents may list Licensee's name as a
licensee of technology from The Regents without further identifying the
technology. Unless required by law or unless consented to in writing by the
Director, Office of Technology Management of The Regents, the use by the
Licensee of the name "The Regents of the University of California" or the name
of any campus of the University of California in advertising, publicity or
other
promotional activities is expressly prohibited.
22
18. LIMITED
WARRANTY
18.1 The
Regents warrants to the Licensee that it has the lawful right to grant this
license.
18.2 Except
as
expressly set forth in this Agreement, this license and the associated
Invention, Patent Rights, Licensed Products and Licensed Methods are provided
by
The Regents WITHOUT WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE OR ANY OTHER WARRANTY OF ANY KIND, EXPRESS OR IMPLIED. THE REGENTS
MAKES
NO EXPRESS OR IMPLIED REPRESENTATION OR WARRANTY THAT THE INVENTION, PATENT
RIGHTS, LICENSED PRODUCTS OR LICENSED METHODS WILL NOT INFRINGE ANY PATENT,
COPYRIGHT, TRADEMARK OR OTHER RIGHTS.
18.3 This
Agreement does not:
18.3.1 |
express
or imply a warranty or representation as to the validity, enforceability,
or scope of any Patent Rights; or
|
18.3.2 |
express
or imply a warranty or representation that anything made, used, Sold,
offered for Sale or imported or otherwise exploited under any license
granted in this Agreement is or will be free from infringement of
patents,
copyrights, or other rights of third parties;
or
|
18.3.3 |
obligate
The Regents to bring or prosecute actions or suits against third
parties
for patent infringement except as provided in Article 22
(Patent Infringement); or
|
18.3.4 |
confer
by implication, estoppel or otherwise any license or rights under
any
patents or other rights of The Regents other than Patent Rights,
regardless of whether such patents are dominant or subordinate to
Patent
Rights; or
|
23
18.3.5 |
obligate
The Regents to furnish any New Developments, know-how, technology
or
information not provided in Patent
Rights.
|
19. LIMITATION
OF LIABILITY
THE
REGENTS WILL NOT BE LIABLE FOR ANY LOST PROFITS, COSTS OF PROCURING SUBSTITUTE
GOODS OR SERVICES, LOST BUSINESS, ENHANCED DAMAGES FOR INTELLECTUAL PROPERTY
INFRINGEMENT OR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR OTHER
SPECIAL DAMAGES SUFFERED BY LICENSEE, SUBLICENSEES, JOINT VENTURES, AFFILIATES
OR DEVELOPMENT PARTNERS ARISING OUT OF OR RELATED TO THIS AGREEMENT FOR ALL
CAUSES OF ACTION OF ANY KIND (INCLUDING TORT, CONTRACT, NEGLIGENCE, STRICT
LIABILITY AND BREACH OF WARRANTY) EVEN IF THE REGENTS HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGES.
20. PATENT
PROSECUTION AND MAINTENANCE
20.1 As
long
as the Licensee has paid Patent Prosecution Costs as provided for in this
Article 20
(Patent
Prosecution and Maintenance), The Regents will diligently prosecute and maintain
the United States patents comprising the Patent Rights using counsel of its
choice. The Regents' counsel will take instructions only from The Regents.
The
Regents will provide the Licensee with copies of all relevant documentation
so
that the Licensee will be informed of the continuing prosecution and may comment
upon such documentation sufficiently in advance of any initial deadline for
filing a response, provided, however, that if the Licensee has not commented
upon such documentation in a reasonable time for The Regents to sufficiently
consider the Licensee’s comments prior to a deadline with the relevant
government patent office, or The Regents must act to preserve the Patent Rights,
The Regents will be free to respond without consideration of the Licensee’s
comments, if any. The Licensee agrees to keep this documentation confidential
as
provided for in Article 31
(Confidentiality).
20.2 The
Regents shall use reasonable efforts to amend any patent application to include
claims reasonably requested by the Licensee to protect the products and services
contemplated to be Sold, or the Licensed Method to be practiced, under this
Agreement.
24
20.3 The
Licensee will apply for an extension of the term of any patent included within
the 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. The Licensee shall prepare all documents and The
Regents agrees to execute the documents and to take additional action as the
Licensee reasonably requests in connection therewith. Licensee shall be liable
for all costs relating to such application.
20.4 The
Licensee will bear the costs of preparing, filing, prosecuting and maintaining
all United States patent applications contemplated by this Agreement ("Patent
Prosecution Costs"). The Regents and Licensee will make best efforts to discuss
and agree upon patent prosecution strategy and costs. Patent Prosecution Costs
billed by The Regents' counsel will be rebilled to the Licensee and are due
within thirty (30) days of rebilling by The Regents. These Patent Prosecution
Costs will include, without limitation, patent prosecution costs for the
Invention incurred by The Regents prior to the execution of this Agreement
and
any patent prosecution costs that may be incurred for patentability opinions,
re-examination, re-issue, interferences, oppositions or inventorship
determinations. Prior Patent Prosecution Costs will be due upon execution of
this Agreement and billing by The Regents and are at least thirteen thousand
dollars ($13,000).
20.5 The
Licensee will be obligated to pay any Patent Prosecution Costs incurred during
the three (3)-month period after receipt by either party of a Notice of
Termination, even if the invoices for such Patent Prosecution Costs are received
by the Licensee after the end of the three (3)-month period following receipt
of
a Notice of Termination. The Regents and Licensee will make best efforts to
discuss and agree upon patent prosecution strategy and costs. The Licensee
may
terminate its obligation to pay Patent Prosecution Costs with respect to any
given patent application or patent under Patent Rights in any or all designated
countries upon three (3)-months' written notice to The Regents. The Regents
may
continue prosecution and/or maintenance of such application(s) or patent(s)
at
its sole discretion and expense, provided, however, that the Licensee will
have
no further right or licenses thereunder. Non-payment of Patent Prosecution
Costs
may be deemed by The Regents as an election by the Licensee not to maintain
such
application(s) or patent(s).
25
20.6 The
Regents may file, prosecute or maintain patent applications or patents at its
own expense in any country in which the Licensee has not elected to file,
prosecute or maintain patent applications or patents in accordance with this
Article 20
(Patent
Prosecution and Maintenance) and those applications, resultant patents and
patents will not be subject to this Agreement.
21. PATENT
MARKING
The
Licensee will xxxx all Licensed Products made, used or Sold under the terms
of
this Agreement or their containers in accordance with the applicable patent
marking laws.
22. PATENT
INFRINGEMENT
22.1 In
the
event that The Regents (to the extent of the actual knowledge of the licensing
professional responsible for the administration of this Agreement) or the
Licensee learns of infringement of potential commercial significance of any
patent licensed under this Agreement, the knowledgeable party will provide
the
other (i) with written notice of such infringement and (ii) with any evidence
of
such infringement available to it (the "Infringement Notice"). During the period
in which, and in the jurisdiction where, the Licensee has exclusive rights
under
this Agreement, neither The Regents nor the Licensee will notify a possible
infringer of infringement or put such infringer on notice of the existence
of
any Patent Rights without first obtaining consent of the other. If the Licensee
puts such infringer on notice of the existence of any Patent Rights with respect
to such infringement without first obtaining the written consent of The Regents
and if a declaratory judgment action is filed by such infringer against The
Regents, then Licensee’s right to initiate a suit against such infringer for
infringement under Paragraph 22.2
below
will terminate immediately without the obligation of The Regents to provide
notice to the Licensee. Both The Regents and the Licensee will use their
diligent efforts to cooperate with each other to terminate such infringement
without litigation.
22.2 If
infringing activity of potential commercial significance by the infringer has
not been abated within ninety (90) days following the date the Infringement
Notice takes effect, then the Licensee may institute suit for patent
infringement against the infringer. The Regents may voluntarily join such suit
at its own expense, but may not otherwise commence suit against the infringer
for the acts of infringement that are the subject of the Licensee's suit or
any
judgment rendered in that suit. The Licensee may not join The Regents as a
party
in a suit initiated by the Licensee without The Regents' prior written consent.
If, in a suit initiated by the Licensee, The Regents is involuntarily joined
other than by the Licensee, then the Licensee will pay any costs incurred by
The
Regents arising out of such suit, including but not limited to, any legal fees
of counsel that The Regents selects and retains to represent it in the
suit.
Licensee
may reject counsel selected by The Regents, however, in the event that Licensee
has rejected three (3) representatives or agents of The Regents, The Regents
shall have the right to use representatives or agents of its choice without
Licensee's assent.
26
22.3 If,
within a hundred and twenty (120) days following the date the Infringement
Notice takes effect, infringing activity of potential commercial significance
by
the infringer has not been abated and if the Licensee has not brought suit
against the infringer, then The Regents may institute suit for patent
infringement against the infringer. If The Regents institutes such suit, then
the Licensee may not join such suit without The Regents' consent and may not
thereafter commence suit against the infringer for the acts of infringement
that
are the subject of The Regents' suit or any judgment rendered in that
suit.
22.4 Notwithstanding
anything to the contrary in this Agreement, in the event that the infringement
or potential infringement pertains to an issued patent included within the
Patent Rights and written notice is given under the Drug Price Competition
and
Patent Term Restoration Act of 1984 (and/or foreign counterparts of this Law),
then the party in receipt of such notice under the Act (in the case of The
Regents to the extent of the actual knowledge of the licensing officer
responsible for the administration of this Agreement) shall provide the
Infringement Notice to the other party promptly. If the time period is such
that
the Licensee will lose the right to pursue legal remedy for infringement by
not
notifying a third party or by not filing suit, the notification period and
the
time period to file suit will be accelerated to within forty-five (45) days
of
the date of such notice under the Act to either party.
22.5 Any
recovery or settlement received in connection with any suit will first be shared
by The Regents and the Licensee equally to cover any litigation costs each
incurred and next shall be paid to The Regents or the Licensee to cover any
litigation costs it incurred in excess of the litigation costs of the other.
In
any suit initiated by the Licensee, any recovery in excess of litigation costs
will be shared between Licensee and The Regents as follows: (a) for any recovery
other than amounts paid for willful infringement: (i) The Regents will receive
fifteen percent (15%) of the recovery if The Regents was not a party in the
litigation and did not incur any litigation costs, (ii) The Regents will receive
twenty-five percent (25%) of the recovery if The Regents was a party in the
litigation whether joined as a party under the provisions of Paragraph
22.2
or
otherwise, but The Regents did not incur any litigation costs, and (iii) The
Regents will receive fifty percent (50%) of the recovery if The Regents incurred
any litigation costs in connection with the litigation; and (b) for any recovery
for willful infringement, The Regents will receive fifty percent (50%) of the
recovery. In any suit initiated by The Regents, any recovery in excess of
litigation costs will belong to The Regents. The Regents and the Licensee agree
to be bound by all determinations of patent infringement, validity and
enforceability (but no other issue) resolved by any adjudicated judgment in
a
suit brought in compliance with this Article 22
(Patent
Infringement).
27
22.6 Any
agreement made by the Licensee for purposes of settling litigation or other
dispute shall comply with the requirements of Article 3
(Sublicenses) of this Agreement.
22.7 Each
party will cooperate with the other in litigation proceedings instituted
hereunder but at the expense of the party who initiated the suit (unless such
suit is being jointly prosecuted by the parties).
22.8 Any
litigation proceedings will be controlled by the party bringing the suit, except
that The Regents may be represented by counsel of its choice in any suit brought
by the Licensee.
23. INDEMNIFICATION
23.1 The
Licensee will, and will require its Sublicensees to, indemnify, hold harmless
and defend The Regents, the sponsors of the research that led to the Invention,
and the inventors of any invention claimed in patents or patent applications
under Patent Rights (including the Licensed Products and Licensed Methods
contemplated thereunder) and their employers, and the officers, employees and
agents of any of the foregoing, against any and all claims, suits, losses,
damage, costs, fees and expenses resulting from, or arising out of, the exercise
of this license or any sublicense. This indemnification will include, but not
be
limited to, any product liability. If The Regents, in its sole discretion,
believes that there will be a conflict of interest or it will not otherwise
be
adequately represented by counsel chosen by the Licensee to defend The Regents
in accordance with this Article 23 (Indemnification), then The Regents may
obtain counsel of its choice to represent it. If The Regents retains such
counsel due to a conflict of interest, the Licensee will pay all expenses for
such representation. If The Regents retains such counsel because it believes
it
will not otherwise be adequately represented by counsel chosen by the Licensee,
then The Regents will pay all expenses for such representation.
28
23.2 The
Licensee, at its sole cost and expense, will insure its activities in connection
with any work performed hereunder and will obtain, keep in force, and maintain
the following insurance:
23.2.1 |
Commercial
Form General Liability Insurance (contractual liability included)
with
limits as follows:
|
Each
Occurrence
|
$
|
1,000,000
|
||
Products/Completed
Operations Aggregate
|
$
|
2,000,000
|
||
$
|
1,000,000
|
|||
General
Aggregate (commercial form only)
|
$
|
2,000,000
|
23.2.2 |
Upon
United States FDA market approval (or equivalent) of its first Licensed
Product, Licensee shall increase its Commercial Form General Liability
Insurance to limits as follows:
|
Each
Occurrence
|
$
|
1,000,000
|
||
Products/Completed
Operations Aggregate
|
$
|
5,000,000
|
||
$
|
1,000,000
|
|||
General
Aggregate (commercial form only)
|
$
|
5,000,000
|
If
the
above insurance is written on a claims-made form, it shall continue for three
(3) years following termination or expiration of this Agreement. The insurance
shall have a retroactive date of placement prior to or coinciding with the
Effective Date of this Agreement; and
23.2.3 |
Worker's
Compensation as legally required in the jurisdiction in which the
Licensee
is doing business.
|
23.3 The
coverage and limits referred to in Paragraphs 23.2.1,
23.2.3,
and
23.2.3 above will not in any way limit the liability of the Licensee under
this
Article 23
(Indemnification). Upon the execution of this Agreement, the Licensee will
furnish The Regents with certificates of insurance evidencing compliance with
all requirements. Such certificates will:
29
-
|
Provide
for thirty (30) days' (ten (10) days for non-payment of premium)
advance
written notice to The Regents of any cancellation of insurance coverage;
the Licensee will promptly notify The Regents of any material modification
of the insurance coverage;
|
-
|
Indicate
that The Regents has been endorsed as an additional insured under
the
coverage described above in Paragraphs 23.2.1 and 23.2.2;
and
|
|
-
|
Include
a provision that the coverage will be primary and will not participate
with, nor will be excess over, any valid and collectable insurance
or
program of self-insurance maintained by The
Regents.
|
23.4 The
Regents will promptly notify the Licensee in writing of any claim or suit
brought against The Regents for which The Regents intends to invoke the
provisions of this Article 23
(Indemnification). The Licensee will keep The Regents informed of its defense
of
any claims pursuant to this Article 23
(Indemnification).
24. NOTICES
24.1 Any
notice or payment required to be given to either party under this Agreement
will
be in writing and will be deemed to have been properly given and to be effective
as of the date specified below if delivered to the respective address given
below or to another address as designated by written notice given to the other
party:
24.1.1 |
on
the date of delivery if delivered in
person;
|
24.1.2 |
on
the date of mailing if mailed by first-class certified mail, postage
paid;
or
|
24.1.3 |
on
the date of mailing if mailed by any global express carrier service
that
requires the recipient to sign the documents demonstrating the delivery
of
such notice or payment.
|
In
the case of Licensee:
|
Xxxxxx
Laser Inc.
|
00
Xxxxxxxxxxx
|
|
Xxxxxxxx,
XX 00000
|
|
Attention:
Xxxxxxx Xxxxx, CEO
|
30
In
the case of The Regents:
|
For
notices:
|
The
Regents of the University of California
|
|
UCSF
Office of Technology Management
|
|
000
Xxxxx Xxxxxx, Xxxxx 0000
|
|
Xxx
Xxxxxxxxx, XX 00000
|
|
Attention:
Director
|
|
RE:
XX Xxxx Xx. XX0000-000
|
|
For
remittance of payments:
|
|
The
Regents of the University of California
|
|
UCOP
Office of Technology Transfer
|
|
0000
Xxxxxxxx Xxxxxx, 0xx Xxxxx
|
|
Xxxxxxx,
XX 00000-0000
|
|
Attention:
Accounts Receivable
|
|
RE:
XX Xxxx Xx. XX0000-000
|
25. ASSIGNABILITY
This
Agreement is personal to the Licensee. The Licensee may not assign or transfer
this Agreement, including by merger, operation of law, or otherwise, without
The
Regents' prior written consent, except that such consent will not be required
in
the case of assignment or transfer to a party that succeeds to all or
substantially all of Licensee's business or assets relating to this Agreement,
whether by sale, merger, operation of law or otherwise, provided that such
assignee or transferee promptly agrees to be bound by the terms and conditions
of this Agreement and signs The Regents' standard substitution of party letter
(the form of which is attached hereto as Appendix A). Any attempted assignment
by Licensee in violation of this Article 25 (Assignment) will be null and void.
This Agreement is binding upon and will inure to the benefit of The Regents,
its
successors and assigns.
26. WAIVER
No
waiver
by either party of any breach or default of any of the agreements contained
herein will be deemed a waiver as to any subsequent and/or similar breach or
default. No waiver will be valid or binding upon the parties unless made in
writing and signed by a duly authorized officer of each party.
31
27. FORCE
MAJEURE
27.1 Except
for the Licensee's obligation to make any payments to The Regents hereunder,
the
parties shall not be responsible for any failure to perform due to the
occurrence of any events beyond their reasonable control which render their
performance impossible or onerous, including, but not limited to: accidents
(environmental, toxic spill, etc.); acts of God; biological or nuclear
incidents; casualties; earthquakes; fires; floods; governmental acts; orders
or
restrictions; inability to obtain suitable and sufficient labor, transportation,
fuel and materials; local, national or state emergency; power failure and power
outages; acts of terrorism; strike; and war.
27.2 Either
party to this Agreement, however, will have the right to terminate this
Agreement upon thirty (30) days’ prior written notice if either party is unable
to fulfill its obligations under this Agreement due to any of the causes
specified in Paragraph 27.1
for a
period of one (1) year.
28. GOVERNING
LAWS;
ATTORNEYS’ FEES
28.1 THIS
AGREEMENT WILL BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF
THE
STATE OF CALIFORNIA, excluding any choice of law rules that would direct the
application of the laws of another jurisdiction and without regard to which
party drafted particular provisions of this Agreement, but the scope and
validity of any patent or patent application will be governed by the applicable
laws of the country of such patent or patent application.
28.2 The
prevailing party in any suit related to this Agreement will be entitled to
recover its reasonable attorneys' fees in addition to its costs and necessary
disbursements.
29. GOVERNMENT
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, the Licensee
will
assume all legal obligations to do so. The Licensee will notify The Regents
if
it becomes aware that this Agreement is subject to a United States or foreign
government reporting or approval requirement. The Licensee will 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.
32
30. COMPLIANCE
WITH LAWS
The
Licensee shall comply with all applicable international, national, state,
regional and local laws and regulations in performing its obligations hereunder
and in its use, manufacture, Sale or import of the Licensed Products or practice
of the Licensed Method. The Licensee will 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 (ITAR) and the Export Administration
Regulations. The Licensee shall manufacture Licensed Products and practice
the
Licensed Method in compliance with applicable government importation laws and
regulations of a particular country for Licensed Products made outside the
particular country in which such Licensed Products are used, Sold or otherwise
exploited.
31. CONFIDENTIALITY
31.1 The
Licensee and The Regents will treat and maintain the other party’s proprietary
business, patent prosecution, software, engineering drawings, process and
technical information and other proprietary information, including the
negotiated terms of this Agreement and any progress reports and royalty reports
and any sublicense agreement issued pursuant to this Agreement ("Proprietary
Information") in confidence using at least the same degree of care as the
receiving party uses to protect its own proprietary information of a like nature
from the date of disclosure until five (5) years after the termination or
expiration of this Agreement. This
confidentiality obligation will apply to the information defined as "Data"
under
the Confidential Disclosure Agreement and such Data will be treated as
Proprietary Information hereunder.
31.2 The
Licensee and The Regents may use and disclose Proprietary Information to their
employees, agents, consultants, contractors and, in the case of the Licensee,
its Sublicensees, provided that such parties are bound by a like duty of
confidentiality as that found in this Article 31
(Confidentiality). Notwithstanding anything to the contrary contained in this
Agreement, The Regents may release this Agreement or any sublicense, including
any terms thereof, and information regarding royalty payments or other income
received in connection with this Agreement to the inventors, senior
administrative officials employed by The Regents and individual Regents upon
their request. If such release is made, The Regents will request that such
terms
be kept in confidence in accordance with the provisions of this Article
31
(Confidentiality). In addition, notwithstanding anything to the contrary in
this
Agreement, if a third party inquires whether a license to Patent Rights is
available, then The Regents may disclose the existence of this Agreement and
the
extent of the grant in Articles 2
(Grant)
and 3
(Sublicenses) and related definitions to such third party, but will not disclose
the name of the Licensee unless Licensee has already made such disclosure
publicly.
33
31.3 All
written Proprietary Information will be labeled or marked confidential or
proprietary. If the Proprietary Information is orally disclosed, it will be
reduced to writing or some other physically tangible form, marked and labeled
as
confidential or proprietary by the disclosing party and delivered to the
receiving party within thirty (30) days after the oral disclosure.
31.4 Nothing
contained herein will restrict or impair, in any way, the right of the Licensee
or The Regents to use or disclose any Proprietary Information:
31.4.1 |
that
recipient can demonstrate by written records was previously known
to it
prior to its disclosure by the disclosing
party;
|
31.4.2 |
that
recipient can demonstrate by written records is now, or becomes in
the
future, public knowledge other than through acts or omissions of
recipient;
|
31.4.3 |
that
recipient can demonstrate by written records was obtained lawfully
and
without restrictions on the recipient from sources independent of
the
disclosing party; and
|
31.4.4 |
that
The Regents is required to disclose pursuant to the California Public
Records Act or other applicable
law.
|
The
Licensee or The Regents also may disclose Proprietary Information that is
required to be disclosed (i) to a governmental entity or agency in connection
with seeking any governmental or regulatory approval, governmental audit, or
other governmental contractual requirement or (ii) by law, provided that the
recipient uses reasonable efforts to give the party owning the Proprietary
Information sufficient notice of such required disclosure to allow the party
owning the Proprietary Information reasonable opportunity to object to, and
to
take legal action to prevent, such disclosure.
34
31.5 Upon
termination of this Agreement, the Licensee and The Regents will destroy or
return any of the disclosing party’s Proprietary Information in its possession
within fifteen (15) days following the termination of this Agreement. The
Licensee and The Regents will provide each other, within thirty (30) days
following termination, with written notice that such Proprietary Information
has
been returned or destroyed. Each party may, however, retain one copy of such
Proprietary Information for archival purposes in non-working files.
32. MISCELLANEOUS
32.1 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.
32.2 This
Agreement is not binding on the parties until it has been signed below on behalf
of each party. It is then effective as of the Effective Date.
32.3 No
amendment or modification of this Agreement is valid or binding on the parties
unless made in writing and signed on behalf of each party.
32.4 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. The
Confidential Disclosure Agreement dated October 18, 2007 is hereby
superseded.
32.5 In
case
any of the provisions contained in this Agreement is held to be invalid, illegal
or unenforceable in any respect, such invalidity, illegality or unenforceability
will not affect any other provisions of this Agreement and this Agreement will
be construed as if such invalid, illegal or unenforceable provisions had never
been contained in it.
32.6 No
provisions of this Agreement are intended or shall be construed to confer upon
or give to any person or entity other than The Regents and the Licensee any
rights, remedies or other benefits under, or by reason of, this
Agreement.
32.7 In
performing their respective duties under this Agreement, each of the parties
will be operating as an independent contractor. Nothing contained herein will
in
any way constitute any association, partnership, or joint venture between the
parties hereto, or be construed to evidence the intention of the parties to
establish any such relationship. Neither party will have the power to bind
the
other party or incur obligations on the other party's behalf without the other
party's prior written consent.
35
IN
WITNESS WHEREOF, both The Regents and the Licensee have executed this Agreement,
in duplicate originals, by their respective and duly authorized officers on
the
day and year written.
XXXXXX
LASER INC.
|
THE
REGENTS OF THE UNIVERSITY OF CALIFORNIA
|
|||
By:
|
By:
|
|||
(Signature)
|
(Signature)
|
|||
Name:
|
Name:
|
Xxxx
X. Xxxxxxxxxx
|
||
(Please
Print)
|
||||
Title:
|
Title:
|
Director,
UCSF Office of
|
||
Technology
Management
|
||||
Date:
|
Date:
|
36
APPENDIX
A
CONSENT
TO SUBSTITUTION OF PARTY
This
substitution of parties ("Agreement") is effective this day
of
,
200_,
among The
Regents of the University of California ("The Regents), a California
corporation, having its statewide administrative offices at 0000 Xxxxxxxx
Xxxxxx, 00xx Xxxxx, Xxxxxxx, Xxxxxxxxxx 00000-0000, and acting through its
Office of Technology Management, University of California San Francisco, 000
Xxxxx Xxxxxx, Xxxxx 0000, Xxx Xxxxxxxxx, XX 00000; [licensee name
(“XXX”)],
a
________________ corporation, having a principal place of business at
______________________; and [new licensee name] [("YYY")] a
______________________ corporation, having a principal place of business at
_________________________________.
BACKGROUND
A. The
Regents and [XXX] entered into a license agreement effective ________________
(UC Control No. __-__-____), entitled _____________________ ("License
Agreement"), wherein [XXX] was granted certain rights.
B. [XXX]
desires that [YYY] be substituted as “Licensee” (defined in the License
Agreement) in place of [XXX], and The Regents is agreeable to such
substitution.
C.
[YYY]
has
read the License Agreement and agrees to abide by its terms and
conditions.
The
parties agree as follows:
1. [YYY]
assumes all liability and obligations under the [type] Agreement and is bound
by
all its terms in all respects as if it were the original “Licensee” of the
License Agreement in place of [XXX].
2. [YYY]
is
substituted for [XXX], provided that [YYY] assumes all liability and obligations
under the License Agreement as if [YYY] were the original party named as
“Licensee” as of the effective date of the License Agreement.
37
3. The
Regents releases [XXX] from all liability and obligations under the License
Agreement arising before or after the effective date of this
Agreement.
The
parties have executed this Agreement in triplicate originals by their respective
authorized officers on the following day and year.
[XXX]
COMPANY
|
THE
REGENTS OF THE UNIVERSITY OF CALIFORNIA
|
|||
By:
|
By:
|
|||
(Signature)
|
||||
Name:
|
Name:
|
Xxxx
X. Xxxxxxxxxx
|
||
(Please
print)
|
||||
Title:
|
Title:
|
Director
|
||
UCSF
Office of Technology
|
||||
Management
|
||||
Date:
|
Date:
|
|||
[YYY]
COMPANY
|
||||
By:
|
||||
(Signature)
|
||||
Name:
|
||||
(Please
print)
|
||||
Title:
|
||||
Date:
|
38