Exhibit 10.1
LICENSE AGREEMENT
THIS LICENSE AGREEMENT ("Agreement") is entered into as of the 14th
day
of January, 2002, (the "Effective Date") by
and between PROFILE, LLC, a Delaware
limited liability company ("Profile") and
PRO URO CARE INC., a Minnesota
corporation ("Licensee").
RECITALS
WHEREAS, Profile owns or has licensed the Licensed Technology
(defined
below); and
WHEREAS, the parties desire for Licensee to be granted an
exclusive
license to the Licensed Technology in the
defined field of use, subject to the
terms and conditions of this Agreement.
NOW THEREFORE, in consideration of the foregoing and the covenants
and
premises contained in this Agreement, the
parties agree as follows:
ARTICLE 1
DEFINITIONS
As used herein, capitalized terms will have the meanings set
forth
below.
1.1 "Affiliate" shall mean any entity that controls, is controlled
by
or is under common control with a party
hereto. "Control" shall mean the
possession of the power to direct or cause
the direction of the management and
policies of such entity, whether through
the ownership of voting securities, by
contract or otherwise. Profile represents
that each of ArMed, Inc. and ArMed
L.L.C. are not an Affiliate of Profile,
within the meaning of this definition.
1.2 "Confidential
Information" shall mean any confidential or
proprietary information embodied in the
Devices or Licensed Technology, and any
information which relates to any research
project, work in process, future
development, scientific, engineering,
manufacturing, marketing, business plan,
financial or personnel matter relating to
either party, its present or future
products, sales, suppliers, customers,
employees, investors or business, whether
in oral, written, graphic or electronic
form.
1.3 "Devices" shall mean any composition of matter, material or
product
that is either covered by the Licensed
Patents or the Licensed Know-how, or
whose manufacture, use or sale would
constitute, but for the license granted to
Licensee pursuant to this agreement, an
infringement of any pending or issued
claim within the Licensed Patents.
1.4 "Field of Use" shall mean the diagnosis of and the treatment of
(a)
benign prostatic hyperplasia; (b)
prostatitis; (c) prostate cancer; or (d) any
other conditions of or disorders of the
prostate, whether healthy or diseased,
and any other condition of urologic
disorder which may be diagnosed, imaged or
treated using any diagnostic or imaging
process.
1.5 "Licensed Know-how" means all techniques, inventions,
practices,
methods, knowledge, skill, experience,
bench testing information, and all other
information and data relating to the
Licensed Patents or the Field of Use, and
which are now or in the future owned or
licensed, by Profile or its Affiliates.
1.6 "Licensed Names" means any Names as defined in Section 2.3
which
are included in the license, made hereunder
pursuant to the provisions of
Section 2.3 (it being understood that there
may be no such Names).
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1.7 "Licensed Patents" means (a) the patents and patent
applications
listed on Exhibit A hereto, (b) any future
patents and patent applications
pertaining to or that have application in
the Field of Use, and which are owned
or licensed, by Profile, and (c) all
foreign counterparts, all substitutions,
extensions, reissues, renewals,
continuations and continuations in part relating
to any Licensed Patents and their foreign
counterparts, and which are owned or
licensed, by Profile or its Affiliates.
Exhibit A shall be updated by the
parties as needed from time to time during
the term of this Agreement.
1.8 "Licensed Technology" means (a) the inventions,
discoveries,
processes, devices and/or claims covered
under the Licensed Patents; and (b) the
Licensed Know-how, and (c) the Licensed
Names (if any).
1.9 "Net Sales" means all revenues recognized in accordance
with
generally accepted accounting principles
relating to the sale of Devices by or
for Licensee, less transportation charges,
discounts actually taken, credits
allowed for defective or returned goods,
and other allowances (actually paid or
allowed, including but not limited to,
prompt payment and volume discounts,
charge backs from wholesalers and other
allowances granted to the end commercial
customer of the Devices, whether in cash or
trade), insurance and sales and
other taxes based on sales prices when
included in gross sales, but not
including taxes assessed on income derived
from such sales.
ARTICLE 2
GRANT OF LICENSE AND OTHER OBLIGATIONS
2.1 License Grant. Subject to the terms and conditions of this
Agreement, Profile hereby grants to
Licensee an exclusive, worldwide,
royalty-bearing, limited license under the
Licensed Technology to make, have
made, import, use, sell and have sold the
Devices solely within the Field of
Use.
2.2 Degree of Exclusivity. Except as otherwise provided herein,
the
license granted in Section 2.1 shall be
exclusive for the life of the Agreement.
As used herein, "exclusive" shall mean that
Profile may not grant any other
license to any other third party of the
Licensed Technology, in whole or in
part, within the Field of Use, and that
Profile and its Affiliates may not
practice any claim encompassed within the
foregoing within the Field of Use.
Notwithstanding the foregoing, Profile and
other third parties reserve the right
to make, to have made, use or sell,
directly or through others, for any products
embodying or otherwise using the Licensed
Technology for applications outside
the Field of Use.
2.3 Name License. To the extent Profile owns any name, trade
name,
trademark or other designation
(collectively, "Names") that are used in
connection with the Licensed Technology,
said Names shall be included in and
subject to the license granted in Section
2.1.
2.4 Sublicense. Licensee may grant to third parties a sublicense
to
manufacture, use, import or sell Devices,
provided that a least a majority of
the members of Licensee's Board of
Directors (the "Board") approves such
sublicense.
2.5 Licensed Know-how. Profile will provide or make available
all
Licensed Knowhow to Licensee in a timely
manner.
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ARTICLE 3
OWNERSHIP
Licensee acknowledges and agrees that, as between Profile and
Licensee,
Profile shall retain all rights to the
Licensed Technology, and Licensee shall
have no rights in the Licensed Technology
other than those rights expressly
granted to Licensee under this
Agreement.
ARTICLE 4
CONSIDERATION
4.1 Calculation and Payment of Royalties. Beginning on the
Effective
Date, Licensee shall pay to Profile an
ongoing royalty pursuant to this Section
4.1.
(a) Calculation of Royalties. Within thirty (30) days after
the end of each calendar quarter, Licensee
shall pay to Profile a royalty at the
percentage indicated in the chart below on
the Net Sales of all Devices sold or
distributed during such calendar quarter.
The applicable percentage rate depends
on the level of Net Sales achieved during
each calendar year, and is as follows:
Sales
During Calendar Year
Royalty Rate
--------------------------
------------
From $0 to $30,000,000
3.05%
$30,000,001 to $100,000,000
2.05%
Over $100,000,000
1.05%
(b) Payment of Royalties. At the same time that it makes
payments of royalties due with respect to a
calendar quarter, Licensee shall
deliver to Profile a true and complete
accounting of sales of Devices and
receipts from those sales during the
quarter, with a separate accounting of
sales and receipts by country and a
calculation of the royalty payment due
Profile for such calendar quarter. If no
sales of Devices were made in such
quarter, then Licensee's statement shall be
a statement to such effect. Licensee
hereby covenants that if it desires to
sell, lease or otherwise place any
Devices in exchange for consideration in a
manner that makes it impractical to
calculate the royalty due, it will not do
so without first devising a mechanism
for the calculation of royalties thereon
and obtaining Profile's prior written
consent for such mechanism.
4.2 Foreign Payments. In transactions giving rise to an obligation
to
make payment hereunder with respect to
which Licensee receives payment in a
currency other than U.S. Dollars, all
payments required to be made by Licensee
under Section 4.1 shall be. converted,
prior to payment, into U.S. Dollars at
the applicable rate of exchange of
Citibank, N.A., in New York, New York, on the
last day of the calendar quarter in which
such transaction occurred. If Licensee
is prevented from making any payment under
this Agreement by virtue of the laws
of the country from which the payment is to
be made, Licensee may deposit the
amount that has accrued to Profile's
account in the currency of such country in
a bank in such country that is acceptable
to Profile.
4.3 Overdue Payments. Payments due to Profile hereunder shall, if
not
paid when due under the terms of this
Agreement, bear simple interest at the
lesser of 1.5% per month or the highest
rate permitted by law, calculated on the
basis of a 360-day year for the number of
days actually elapsed, beginning on
the due date and ending on the day prior to
the day on which payment is made in
full. Interest accruing under this Section
shall be due to Profile on demand.
The accrual or receipt by Profile of
interest under this Section shall not
constitute a waiver by Profile of any right
it may otherwise have to declare a
default under this Agreement or to
terminate this Agreement.
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ARTICLE 5
OTHER OBLIGATIONS
5.1 Licensee Responsibility. Licensee shall direct, and shall
diligently proceed with the development,
manufacture, and sale of Devices within
the Field of Use and shall earnestly and
diligently endeavor to market the same
within a reasonable time after execution of
this Agreement and in quantities
sufficient to meet the market demands
therefor. During the time period
commencing on the Effective Date and ending
on the earlier of December 31, 2002
or the date of a Qualifying Transaction, as
defined in Section 7.2 below, it is
agreed that Licensee will fund development
of the Licensed Technology for the
Field of Use at an average rate of not less
than $25,000 per month and not in
excess of $35,000 per month. The parties
acknowledge that the nature of such
development means that payments will not
necessarily be incurred on a regular
monthly basis. Therefore, compliance with
the requirements of this Section shall
be determined based on average monthly
expenditures during six (6) month
periods, with the first such period to
commence on the Effective Date, the
second such period to commence on the date
six (6) months after the Effective
Date, and so on.
5.2 Patent Protection and Prosecution. Commencing on the
Effective
Date, Licensee shall be responsible for the
patent prosecution and legal work
necessary to maintain the Licensed Patents
for applications in the Field of Use.
In connection with these activities, the
parties have the following agreements
and understandings:
(a) During the time period commencing on the Effective Date
and through the date of a Qualifying
Transaction, all decisions about
prosecution of any patent or patent
application will be made jointly by Profile
and Licensee, with the decisions to be
mutually acceptable to both parties. In
this connection, it is understood that
expenditures shall be determined in the
exercise of the parties' reasonable
business judgment, taking into account
expected returns from the expenditures.
After the date of a Qualifying
Transaction, the decisions regarding
prosecution of any patents or patent
applications shall be made by the board of
Licensee in the exercise of its
reasonable business judgment. Wherever the
Board of Licensee makes a decision
that it will not continue to maintain a
patent, Licensee shall promptly advise
Profile of this decision so that Profile
may decide whether or not it wishes to
pay the maintenance fees.
(b) Where an expenditure is of a nature that it will provide
benefits which apply both in the Field of
Use and outside the Field of Use, the
parties shall reach agreement as to how the
expenditure shall be shared between
Profile and Licensee, based upon a
reasonable apportionment of such expenses
between Licensee and Profile. Licensee
shall not be responsible for patent
prosecution and legal work relating to the
Licensed Patents outside of the Field
of Use, and Profile shall determine, in its
discretion, whether it wishes to
incur such expenses.
(c) Exhibit B attached hereto outlines the expenditures which
are expected to be required during the next
twelve (12) months. The parties have
agreed that these are the expenditures
which will be made in or about this time
period.
(d) The Board of Licensee shall determine the nature and
extent of expenditures which will be
incurred by Licensee pursuant to this
section, in the exercise of the Board's
reasonable business judgment. For these
purposes, the Board shall consider and take
into account the amount and timing
of expenses, and the potential benefit to
Licensee, considering both possible
revenues which might be received, the risk
that the revenues will not be
achieved, and the expected cost; as well as
other germane factors.
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(e) Profile represents that Exhibit C attached hereto lists,
in reasonable detail, the type and amount
of expenditures made by Profile, or
its predecessors in interest, with respect
to the Licensed Technology for patent
prosecution and legal work for applications
in the Field of Use.
(f) The parties agree that Licensee shall determine the
professionals to be used for patent
prosecution and activities under this
Section, subject to the consent of Profile,
such consent not to be unreasonably
withheld or delayed. Without limiting
Licensee's right to designate other
professionals, Profile hereby consents to
the use of firm of Fish & Richardson
for these purposes.
(g) Licensee will keep Profile informed on a regular basis of
the status of the License Patents and the
actions taken under this Section.
5.3 Government Approvals. As between the parties, Licensee shall
be
solely obligated to obtain all necessary
governmental approvals for the
manufacture, use, and sale of Devices
within the Field of Use in the United
States or any other countries. It is
understood that decisions on what
governmental approvals should be obtained
shall be made by Licensee in the
exercise of its reasonable business
judgment.
5.4 Progress Reports. Beginning at the end of the first anniversary
of
the Effective Date and annually thereafter,
Licensee shall submit to Profile a
summary progress report covering Licensee's
activities in the preceding year
related to the development and testing of
all Devices within the Field of Use
and Licensee's progress, if any, in
obtaining governmental approvals necessary
for marketing such products. Such progress
reports shall include, but not be
limited to, a summary of the following
topics: research and development work
completed; key scientific discoveries; work
in progress; current schedule of
anticipated events or milestones; and
market plans for introduction of new or
additional Devices.
5.5 Patent Marking. Licensee shall mark all Devices made, used, or
sold
under the terms of this Agreement, or their
containers, in accordance with 35
U.S.C. ss. 287(a) or any other successor
statute in the United States and the
applicable patent marking laws of any other
country. Upon Profile' written
request, Licensee shall furnish reasonable
and representative samples of the
Devices to demonstrate compliance with this
Section.
5.6 Insurance. Licensee, at its sole cost and expense, shall insure
its
activities in connection with the exercise
of its license under this Agreement
in an appropriate amount at all times.
Without limiting the foregoing, Licensee
shall obtain, keep in force, and maintain,
at a minimum, Comprehensive or
Commercial Form General Liability Insurance
(contractual liability included) or
an equivalent program of self-insurance
with appropriate limits, which limits
will increase as needed depending on the
activities of Licensee (i.e., more
coverage once human testing begins).
Licensor shall be named as an additional
insured on any such policies.
ARTICLE 6
CONFIDENTIALITY
6.1 Confidentiality. During the term of this Agreement and
thereafter,
each party hereto will maintain in
confidence all Confidential Information
disclosed by the other party hereto.
Neither party will use, disclose or grant
use of such Confidential Information except
as expressly authorized by this
Agreement. To the extent that disclosure is
authorized by this Agreement, the
disclosing party will obtain prior
agreement from its employees, agents or
consultants to whom disclosure is to be
made to hold in confidence and not make
use of such information for any purpose
other than those permitted by this
Agreement. Each party will use at least the
same standard of care as it uses to
protect its own Confidential Information to
ensure that such employees, agents
or consultants do not disclose or make any
unauthorized use of such Confidential
Information. Each party will promptly
notify the other upon discovery of any
unauthorized use or disclosure of the
Confidential Information.
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6.2 Exceptions. The obligations of confidentiality contained in
Section
6.1 will not apply to the extent that it
can be established by the receiving
party by competent written proof that such
Confidential Information:
(a) was already known to the receiving party, other than under
an obligation of confidentiality, at the
time of disclosure by the other party;
(b) was generally available to the public or otherwise; part
of the public domain at the time of its
disclosure to the other party;
(c) became generally available to the public or otherwise part
of the public domain after its disclosure
and other than through any act or
omission of the receiving party in breach
of this Agreement;
(d) was disclosed to the receiving party, other than under an
obligation of confidentiality, by a third
party who had no obligation to the
other party not to disclose such
information to others.
The parties agree that the material financial terms of this
Agreement
will also be considered Confidential
Information of both parties.
6.3 Authorized Disclosure. Each party may disclose the
Confidential
Information to the extent such disclosure
is reasonably necessary in complying
with applicable governmental regulations,
provided that if such party is
required to make any such disclosure of the
Confidential Information it will to
the extent practicable give reasonable
advance notice to the other party of such
disclosure requirement so that confidential
treatment of the information
required to be disclosed may be
secured.
ARTICLE 7
TERM; TERMINATION
7.1 Term. This Agreement will commence on the Effective Date
and,
unless sooner terminated as provided
hereunder, will terminate upon the later of
(i) the date of the expiration of the last
to expire patent included in the
Licensed Technology, or (ii) the date that
the Licensee permanently ceases the
sale of Devices hereunder.
7.2 Termination by Profile. Profile may terminate this Agreement
in
accordance with the following:
(a) Failure to Make Timely Payment. Profile ma; y terminate
this Agreement upon ten (10) days written
notice if Licensee fails to timely
make any payment to Profile required by
this Agreement and fails to cure the
nonpayment within ten (10) days of written
notice thereof from Licensee.
(b) Failure to Capitalize. Profile may terminate this
Agreement upon thirty (30) days written
notice to Licensee, unless on or before
December 31, 2002 (i) Licensee has obtained
equity financing in an amount which
is not less than $5,000,000, and (ii)
Licensee has t least $1,500,000, which is
available and designated for the
development of a diagnostic system based on the
Licensed Technology under budgets approved
by the Board of Licensee. (For
purposes of this Agreement, achievement of
these requirements is referred to as
a "Qualifying Transaction". In this
connection, it is understood that Licensee
may obtain financing referred to in this
Section, either through direct
investments by investors, or by a merger or
other form of acquisition of
business combination, which results in the
requisite amounts being obtained.
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Notwithstanding the foregoing, if before the expiration of the 30
day
period referred to in the notice, Licensee
achieves a Qualifying Transaction
(even if it is after December 31, 2002),
the termination shall not be effective,
and this License shall remain in full force
and effect.
7.3 Termination
by Either Party. This Agreement may be terminated by
either party upon written notice if the
other party breaches a material
provision of this Agreement, and does not
cure such breach within sixty (b0)
days of written notice thereof.
7.4
Effect of Termination.
(a) Termination of License. Upon termination or expiration of
this Agreement for any reason, the license
granted to Licensee pursuant to
~3,ection 2.1 shall automatically
terminate. Licensee shall immediately cease
all use of the Licensed Technology,
including all Licensed Technology included
in the Devices, and shall provide a written
account to Profile of the following
within fifteen (15) days of
termination:
(1) All development in progress; sales of Devices made but not
shipped; inventory of Devices on hand as
well as work in process;
(2) Royalties due but not paid up to date of termination.
(b) Return of Confidential Information. Within thirty (30) days
of termination of this Agreement for any
reason, both parties shall return or
destroy all copies of the other party's
Confidential Information and shall
provide written certification of such
destruction upon request of the other
party.
(c) Royalty Obligation. Licensee acknowledges that the
termination of this Agreement by either
party for any reason shall not absolve
Licensee of its payment and other
obligations under Section 4.1(b).
(d) Survival. In the event of termination of this Agreement,
Articles 3, 4, b, 8, 9,10,11 and 12 shall
survive.
(e) Return of Stock. In the event of any termination of this
Agreement other than pursuant to clauses
(i) or (ii) of Section 7.1, Profile
shall promptly return and reconvey to
Licensee all shares of stock of Licensee
which have been issued to Profile,
including any such shares issued