EXHIBIT 10.1
MEMORANDUM OF UNDERSTANDING
This Memorandum of Understanding ("Agreement"), effective as of July 27,
2005 (the "Effective Date"), is entered into by and between PROUROCARE INC., a
Minnesota corporation ("ProUroCare"), and UROLOGIX, INC., a Minnesota
corporation ("Urologix"). ProUroCare and Urologix each may be referred to herein
individually as a "Party," or collectively as the "Parties."
Background Information
ProUroCare has acquired rights to certain proprietary knowledge and
intellectual property pertaining to electrical impedance tomography for use in
diagnosing and treating urological conditions, including the exclusive worldwide
license to certain patents for electrical current computed tomography,
three-dimensional impedance imaging processes and related inventions as
described in Exhibit A attached hereto (the "EIT Technology"). EIT Technology
provides a means to image, in real-time, the three-dimensional distribution for
the heating effect from the microwave delivery system used by Urologix, in the
form of a thermally induced image. The heating effect produces a change in the
local conductivity or resistivity in the treatment area. The local changes in
the electrical properties of the tissue are measured by an electrode system
connected to an electronically controlled low-frequency power supply. The
electrodes receive specific currents and the possible induced voltages are
measured electronically. An inversion algorithm creates a real time image of the
pattern.
Urologix has developed, and currently markets, products for the treatment
of benign prostatic hyperplasia ("BPH") using heat applied through controlled
microwave radiation, and is currently developing additional products for the
treatment of prostatitis/prostadynia, renal tumors and prostate cancer using
heat applied through controlled microwave radiation (the foregoing, collectively
"Urologix Products"). Urologix is the owner or licensee of certain patents and
other proprietary intellectual property used in the Urologix Products.
The Parties have discussed establishing a mutually beneficial business
relationship pursuant to which the EIT Technology would be incorporated into,
and complement, certain existing and future Urologix Products. However, several
phases of research and development, along with clinical testing and FDA
approval, must be undertaken and successfully completed before any such Urologix
Product will be ready for marketing on a commercial basis.
The Parties wish to memorialize their agreement with respect to the
conduct of said research, development and any subsequent commercialization of
such products, and enter into this Agreement for that reason and to that end.
NOW, THEREFORE, in consideration of the foregoing premises, the mutual
promises and covenants of the Parties contained herein, and other good and
valuable consideration, the receipt and sufficiency of which are hereby
acknowledged, the Parties hereto, intending to be legally bound, do hereby agree
as follows:
1. Overview
1.1 The Parties will work together to develop new Urologix Products that
use the EIT Technology, in combination with refinements of existing Urologix
Products which use heat applied through controlled microwave radiation, to treat
BPH, prostatitis/prostadynia, renal tumors and prostate cancer ("New EIT
Products").
1.2 While ProUroCare believes that EIT Technology may be used in
connection with diagnosing and treating urological conditions, such technology
needs to be tested, refined, developed and verified, in both laboratory and
clinical settings, to establish its efficaciousness, safety and commercial
viability in the context of any New EIT Products.
1.3 The Parties intend to undertake such testing and development as set
forth herein. If successful in that endeavor, the Parties contemplate
subsequently entering into mutually acceptable definitive agreements pursuant to
which Urologix would market New EIT Products using components supplied by
ProUroCare and licenses granted by ProUroCare (the "Project").
2. Multi-Phase Approach
2.1 The Parties expect that the following phases of research, testing and
development (the "Phases") will be required in connection with the Project:
Phase I (Electrode Array Design and Proof of Concept)
During Phase I the Parties will work with ▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇ ▇.
▇▇▇▇▇▇ and ▇▇▇▇▇ ▇▇▇▇▇▇▇▇ of the Rensselaer Polytechnic Institute, Troy, New
York ("RPI"), to develop a suitable electrode array (number of electrodes, size
and distance) for use in a rectal probe and skin surface application for the New
EIT Products. (Electrodes will not be placed on the trans-urethral catheter.)
During Phase I, electrode array configurations will be assessed by their ability
to produce measurement data that shows the needed sensitivity to localized
heating as well as their ability to avoid interaction with the antenna radiation
pattern. Also, the feasibility of achieving the required resolution/sensitivity
will be assessed. Prior to commencement of work on Phase I, ProUroCare will
obtain, for the benefit of each of ProUroCare and Urologix, a confidentiality,
non-use and non-disclosure agreement from RPI in substance and form reasonably
acceptable to Urologix. The Parties anticipate that Phase I will be completed on
or before December 31, 2006.
Phase II (Reconstruction Algorithm Development)
During Phase II the Parties will work with RPI to design, implement and
test a reconstruction algorithm to produce images from data taken using
candidate electrode arrays.
Phase III (Instrument Design and Implementation)
During Phase III the Parties will work with RPI to design and prototype an
instrument utilizing the EIT Technology that is capable of supporting the
required number of electrodes and providing the needed measurement precision and
speed.
Phase IV (Clinical Trials)
During Phase IV the Parties will conduct the requisite clinical studies
upon mutually agreeable terms reflected in a definitive agreement to be
negotiated in good faith by the Parties when appropriate; provided, however,
neither Party has agreed to incur any expenses whatsoever in connection with
Phase IV.
Phase V (FDA Approvals)
During Phase V the Parties will cooperate to obtain all required approvals
from the U.S. Food and Drug Administration ("FDA") upon mutually agreeable terms
reflected in a definitive agreement to be negotiated in good faith by the
Parties when appropriate; provided, however, neither Party has agreed to incur
any expenses whatsoever in connection with Phase V.
Phase VI (Market Release)
During Phase VI the Parties will cooperate to prepare the New EIT Products
for final market release upon mutually agreeable terms reflected in a definitive
agreement to be negotiated in good faith by the Parties when appropriate;
provided, however, neither Party has agreed to incur any expenses whatsoever in
connection with Phase VI.
2.2 The Parties will cooperate during all Phases of the Project during the
Term.
--------------------------------------------------------------------------------
Memorandum of Understanding
Page 2 of 14
2.3 Each Phase of the Project must be successfully completed before
substantial work may begin on the next Phase.
2.4 If any Phase cannot be completed due to factors affecting the ultimate
success of the Project such as (but not limited to) timeliness, cost, commercial
feasibility and technical constraints, or the Parties are unable to enter into a
definitive agreement when appropriate, or the Parties are unable to agree
regarding the responsibility for further funding of the Phases for Phases I, II
and III in excess of the $550,000 projected costs (as set forth in Section 3
hereof), either Party may, in its sole discretion and upon written notice to the
other Party, choose to abandon the Project.
2.5 Attached as Exhibit B is the agreement between RPI and ProUroCare
covering the role, responsibilities, rights and obligations of RPI and
ProUroCare with respect to work to be performed by RPI during the Phase I of the
Project.
3. Development Costs
Urologix and ProUroCare agree to equally share in the development costs
incurred by RPI or its contractors during the first three Phases. Projected
costs for the first three Phases are as follows:
--------------------------------------------------------------------------
Phase Projected Cost
--------------------------------------------------------------------------
Phase I: Electrode Array Design and Proof of Concept $150,000
--------------------------------------------------------------------------
Phase II: Reconstruction Algorithm Development $200,000
--------------------------------------------------------------------------
Phase III: Instrument Design and Implementation $200,000
--------------------------------------------------------------------------
Each Party will make timely payment to RPI of its share of the foregoing
development costs. The Parties may in each of their sole discretion mutually
agree to share costs in excess to the foregoing projected costs.
4. Development Committee
4.1 ProUroCare and Urologix shall jointly establish a development
committee (the "Development Committee"), which shall oversee the Project's
Phases, its budget, and other activities related to the Project. Each Party
shall appoint an equal number of representatives with the requisite experience
and seniority to enable them to make decisions on behalf of the Parties with
respect to the project. The Development Committee shall meet monthly, or as
otherwise agreed to by the Parties. A quorum of the Development Committee shall
exist whenever there is present at a meeting at least one representative
appointed by each Party. Members of the Development Committee may attend a
meeting either in person or by telephone, video conference or similar means in
which each participant can hear what is said by the other participants.
Representation by proxy shall not be allowed.
4.2 The Development Committee shall take action by unanimous consent of
ProUroCare and Urologix, with each such Party having a single vote, irrespective
of the number of representatives actually in attendance at a meeting, or by a
written resolution signed by the designated representatives of each of
ProUroCare and Urologix.
4.3 Each Party agrees to designate an executive sponsor to serve as its
point of escalation for resolving disputes that may arise relative to the
Development Committee and to facilitate regular communication between the
Parties as necessary.
--------------------------------------------------------------------------------
Memorandum of Understanding
Page 3 of 14
5. Initial Products
5.1 Assuming successful completion of Phases I through V, the Parties
contemplate that the first New EIT Product to be marketed and sold will be a
system for the treatment of BPH using heat applied through controlled microwave
radiation (the "Initial Product") comprised of the following:
5.1.1 External Box. An EIT external box compatible with the Urologix
product currently described as the Targis control unit as well as any
subsequent versions of the control unit ("EIT External Box"). If this
product proves efficacious and is commercially viable, the Parties expect
that subsequent versions of Urologix control unit products will either
have EIT Technology incorporated into the control unit or continue to be
used with a compatible EIT External Box. Any such EIT External Box will be
manufactured by or for Urologix. In accordance with and subject to the
terms of this Agreement, Urologix will have an exclusive, sub-licensable,
worldwide, fully paid-up license to use the EIT Technology in connection
with any sale, marketing, manufacture, importation, export and/or
distribution of the EIT External Box and any control unit containing the
EIT External Box, but only in conjunction with the Rectal Sheath and
Abdominal Belt (hereinafter described) manufactured or supplied by
ProUroCare.
5.1.2 Rectal Sheath and Abdominal Belt. A separate but integral
component of the Initial Product will be a disposable rectal sheath (the
"Rectal Sheath") and an abdominal belt containing electrodes (the
"Abdominal Belt") (collectively, together with any additional components,
products, materials or supplies provided or to be provided by ProUroCare,
the "ProUroCare Products"). ProUroCare, in consultation with Urologix,
will determine whether the Abdominal Belt is disposable or reusable. The
ProUroCare Products will be manufactured to Urologix's specifications by
ProUroCare or by a supplier to ProUroCare reasonably acceptable to
Urologix. The Parties contemplate that Urologix will purchase the kit
including the ProUroCare Products for approximately $150 based upon
ProUroCare's estimated cost of less than $50, and a minimum markup of $100
and a minimum multiple of price to cost of four times (4x). Urologix and
ProUroCare may jointly determine to purchase all rectal sheaths both with
and without EIT electrodes from the same supplier. Urologix may continue
to purchase rectal sheaths from its current supplier without EIT
capability. The details of such purchase(s) will be reflected in a
definitive agreement to be negotiated in good faith by the Parties when
appropriate.
5.2 Assuming successful completion of Phases I through V, the Parties
agree to negotiate, in good faith, the preparation of definitive agreements
covering the manufacture, sourcing, sale and distribution of the New EIT
Products and the constituent components thereof. As a guide to preparation of
such definitive agreements, the Parties expect that such agreements will include
the following provisions (among others):
5.2.1 Subject to and upon the terms of the aforementioned definitive
agreement(s), ProUroCare will be the exclusive provider of the ProUroCare
Products to Urologix, and Urologix will purchase one hundred percent
(100%) of its requirements for ProUroCare Products from ProUroCare. Such
definitive agreement will, among other things, (a) provide for alternative
sourcing and manufacture of the ProUroCare Products under certain
commercially reasonable circumstances, (b) contemplate that ProUroCare
will seek ways to reduce the cost of manufacturing or sourcing the
ProUroCare Products by methods such as elimination of components,
obtaining alternate sources of materials, redefinition of ProUroCare
Product specifications in ways that do not detract from ProUroCare Product
quality and improved assembly or test methods, (c) provide licensing
rights adequate to protect Urologix's interests, and (d) grant Urologix or
its designee the right (but not the obligation) to monitor all
manufacture, sourcing and distribution of the ProUroCare Products.
5.2.2 Urologix will convert then-existing Targis (or successor)
control units located in the United States, Europe and Japan to include
EIT Technology functionality according to the schedule immediately
following.
--------------------------------------------------------------------------------
Memorandum of Understanding
Page 4 of 14
-----------------------------------------------------------------------------------------------------------
Period (number of years Minimum percentage of existing Urologix systems to be retrofitted to use EIT
after FDA approval): Technology within Period:
-----------------------------------------------------------------------------------------------------------
1 5%
-----------------------------------------------------------------------------------------------------------
2 10%
-----------------------------------------------------------------------------------------------------------
3 15%
-----------------------------------------------------------------------------------------------------------
4 20%
-----------------------------------------------------------------------------------------------------------
5 30%
-----------------------------------------------------------------------------------------------------------
5.2.3 Urologix will sell new control systems incorporating EIT
Technology according to the following schedule:
-----------------------------------------------------------------------------------------------------------
Period (number of years Minimum percentage of new Urologix systems to use EIT Technology within Period:
after FDA approval):
-----------------------------------------------------------------------------------------------------------
1 30%
-----------------------------------------------------------------------------------------------------------
2 40%
-----------------------------------------------------------------------------------------------------------
3 50%
-----------------------------------------------------------------------------------------------------------
4 60%
-----------------------------------------------------------------------------------------------------------
5 70%
-----------------------------------------------------------------------------------------------------------
5.2.4 In the event that Urologix fails to meet the minimum
percentages set forth in Sections 5.2.2 or 5.2.3, ProUroCare may, at its
option, give written notice to Urologix that Urologix's license with
respect to the EIT Technology and/or the Patents as further described in
Section 6.2 hereof will become non exclusive (in addition to being
royalty-free, worldwide, fully paid and sub-licensable) and such non
exclusivity shall become effective upon receipt of said notice by Urologix
for the remaining Term.
6. EIT Technology - Representations, Ownership and Exclusive License Rights
6.1 ProUroCare represents and warrants:
6.1.1 That the execution and delivery of this Agreement by
ProUroCare and the performance of and compliance by ProUroCare with the
terms and conditions of this Agreement will not result in the imposition
of any lien or other encumbrance on the EIT Technology or the Patents, and
will not conflict with or result in a breach by ProUroCare of any of the
terms, conditions or provisions of any order, injunction, judgment,
decree, statute, rule or regulation applicable to ProUroCare, the EIT
Technology or the Patents, or any note, indenture or other agreement,
contract, license or instrument by which any of the EIT Technology or the
Patents may be bound or affected. No consent or approval by any person or
public authority is required to authorize or is required in connection
with, the execution, delivery or performance of this Agreement by
ProUroCare.
--------------------------------------------------------------------------------
Memorandum of Understanding
Page 5 of 14
6.1.2 That it has the necessary right, title, interest and power to
grant the licenses to Urologix set forth in this Agreement, free and clear
of any liens, claims, options, rights, mortgages, licenses(s) to any third
party, encumbrances or security interests of any kind.
6.1.3 That it is not currently the subject of any litigation or
pending claim that would affect its ability to perform under this
Agreement nor is it aware of any question or challenge to its ability to
perform under this Agreement.
6.1.4 That no agreement or understanding with any third party exists
or will exist that would interfere with its obligations hereunder;
provided, however, ProUroCare derives its exclusive rights to the EIT
Technology and Patents from a License Agreement with Renesselaer
Polytechnic Institute ("RPI") dated July 13, 2001, as amended by Amendment
#1 to License Agreement (the "RPI License"), a true and correct copy of
which is attached hereto as Exhibit C. This Agreement does not interfere
with, and will not cause a default under, the RPI License.
6.1.5 That the licenses granted and the use of the EIT Technology as
contemplated by this Agreement, does not and will not infringe any patent,
copyright, trademark, trade secret or other intellectual property right of
any third party; provided, however, Urologix's remedy for breach of the
warranty contained in this Section 6.1.5 shall be limited to the
indemnification rights set forth in Section 7 hereof.
6.1.6 In addition, ProUroCare represents and warrants that it has
sole and exclusive rights to the patents identified on Exhibit A and has
or will have such rights to any patents which issue from the applications
made with respect to such patents, including, without limitation, any
continuations, continuations-in-part, reissues, reexaminations and patent
applications ("Patents").
6.2 During the Term of this Agreement, Urologix shall have, and ProUroCare
hereby grants, an exclusive, royalty-free, worldwide, fully paid license to
make, have made, use, sell, sub-license, offer to sell, and/or import any and
all products and services embodying, incorporating, based upon or derived from
the EIT Technology and/or the Patents, in connection with or related to the
treatment of BPH, prostatitis/prostadynia, renal tumors and/or prostate cancer
using heat applied through controlled microwave radiation, but only in
conjunction with the Rectal Sheath and Abdominal Belt manufactured or supplied
by ProUroCare, in accordance with and subject to the terms hereof or any other
applicable definitive agreement subsequently executed by the Parties (the
"License"). The License is further evidenced by the Sublicense Agreement dated
of even date herewith between Urologix and ProUroCare and approved by RPI, a
true and correct copy of which is attached hereto as Exhibit D.
6.3 ProUroCare retains all right, title and interest, including the right
to grant licenses to third parties, in and to the Patents, EIT Technology,
Rectal Sheath and Abdominal Belt, but only to the extent not manifestly
inconsistent with the licenses granted to Urologix herein. Notwithstanding the
foregoing, during the Term of this Agreement ProUroCare will not, directly or
indirectly, grant any license (or right) to any third party with respect to the
Patents, the EIT Technology or the ProUroCare Products for treatment of BPH,
prostatitis/prostadynia, renal tumors or prostate cancer using heat applied
through controlled microwave radiation, to the extent, if any, these Indications
(as such term is hereafter defined) have not been terminated by ProUroCare
pursuant to Section 12.2 hereof and only for so long as Urologix's license to
the EIT Technology and Patents is exclusive.
6.4 Intellectual Property Rights.
6.4.1 Each Party agrees to provide the other Party, at its
reasonable request, all such assistance as may reasonably be required to
obtain, evidence and/or perfect such Intellectual Property Rights in any
country or jurisdiction worldwide; provided, however, such assistance
shall be at the cost and expense of the Party requesting assistance.
--------------------------------------------------------------------------------
Memorandum of Understanding
Page 6 of 14
6.4.2 Except as expressly stated herein, each Party reserves all
rights in and to its pre-existing Intellectual Property Rights.
6.4.3 For all purposes of this Section 6.4, "Intellectual Property
Rights" means all worldwide (a) patents, patent applications, and patent
rights; (b) rights associated with works of authorship including
copyrights, copyright applications, copyright restrictions, mask work
rights, mask work applications, and mask work registrations: (c) rights
relating to the protection of trade secrets and confidential information;
(d) moral rights; (e) rights analogous to those set forth herein and any
other proprietary rights relating to intangible property; and (f)
divisions, continuations, substitutions, continuations-in-part, renewals,
reissues, extensions, registration, confirmations, re-examinations,
supplementary protection certificates and the like of the foregoing (as
applicable) now existing or hereafter filed, issued or acquired.
6.4.4 If during the Term of this Agreement and in connection with
the performance thereof by the Parties, new Intellectual Property Rights
are developed, created or authored ("New Intellectual Property Rights"),
then Urologix reserves the rights to, and shall own exclusively, all New
Intellectual Property Rights pertaining to treatment of BPH,
prostates/prostadynia, renal tumors and prostate cancer using heat applied
through controlled microware radiation (whether such New Intellectual
Property Rights were created through joint efforts of the Parties or not)
and ProUroCare reserves the rights to, and shall own exclusively, all New
Intellectual Property Rights pertaining to EIT Technology whether
contained in the EIT External Box, control unit or the ProUroCare
Products, including, without limitation, new algorithms specifically
created for the EIT External Box or control unit (whether such New
Intellectual Property Rights were created through joint efforts of the
Parties or not); provided, however, that Urologix shall have the license
rights granted to it with respect to New Intellectual Property of
ProUroCare to the same extent as shall exist with respect to the License
granted herein and, provided further, this Section 6.4.4 will not prevent
the use or resale of any Urologix Products sold and delivered or placed in
service by Urologix during the Term hereof.
7. Indemnification
7.1 ProUroCare will indemnify and hold harmless Urologix, and will
reimburse Urologix for any loss, liability, claim, damage, expense (including
costs of investigation and defense and reasonable attorneys' fees and expenses),
arising from or in connection with any claim asserted by an unaffiliated third
party that any Patent or aspect of the EIT Technology infringes or violates such
third party's confidentiality rights or any patent, copyright or trademark, or
misappropriates its trade secret ("Claim"). Each Party must notify the other
promptly in writing of a Claim and agree to cooperate with each other in
defending the claim. ProUroCare shall have the right to defend such claim, and
Urologix shall have the right, at its option and expense, to participate in
defense of the claim and any settlement negotiations relating to such claim,
through counsel of its own choosing. In addition, ProUroCare shall have the
right to settle the Claim with the consent of Urologix (which consent shall not
be unreasonably withheld or delayed) including, without limitation, obtaining a
license from the third party asserting the Claim.
7.2 Notwithstanding the provisions of Section 7.1, however, and except for
any Claim asserted against ProUroCare by RPI, ProUroCare shall be obligated to
spend no more than $50,000 on costs of investigation and reasonable attorneys'
fees and expenses related to the obligations set forth in Section 7.1. After
expenditure of said $50,000 ProUroCare shall have the right to terminate this
Agreement if it reasonably determines that continued performance under this
Agreement will materially increase the liability of ProUroCare or Urologix with
respect to such Claim; except that Urologix may avoid termination of this
Agreement in such case if Urologix, at its expense, defends the Claim.
--------------------------------------------------------------------------------
Memorandum of Understanding
Page 7 of 14
7.3 Each Party acknowledges that this Section 7 is an interim
indemnification provision which the Parties agree to renegotiate in good faith
at or about the time Phase V is likely to be completed. Any such new
indemnification provision shall supersede this Section 7.
7.4 Under the foregoing indemnification, neither Party shall be liable to
the other Party for consequential, incidental, special or punitive damages.
8. Exclusivity
During the Term of this Agreement and the term of any definitive
agreements hereafter executed by the Parties with respect to the subject matter
hereof and only for so long as the license rights granted herein to Urologix are
exclusive, ProUroCare shall not, directly or indirectly, enter into any contract
or understanding, or otherwise deal with, any third party in connection with the
testing, researching, refining, developing, licensing, marketing, manufacturing,
supply or sale of any New EIT Products for Indications that have not been
terminated by ProUroCare pursuant to Section 12.2 hereof.
9. Confidentiality
9.1 Confidential information means information marked or otherwise
identified in writing by a Party as proprietary or confidential or that, under
the circumstances surrounding the disclosure, ought in good faith to be treated
as proprietary or confidential. It includes, but is not limited to, non-public
information of a confidential nature such as the terms of this Agreement; the
EIT Technology; proprietary data, knowledge, practices and processes; research
plans; engineering designs and drawings; research data; manufacturing processes
and techniques; scientific, manufacturing, marketing and business plans; and
financial and personnel matters relating to the disclosing Party or to its
present or future products, sales, suppliers, customers, employees, investors or
business ("Confidential Information").
9.2 Confidential Information does not include information which (in all
cases other than by a breach of an obligation of confidentiality): (i) the
recipient can demonstrate through pre-existing records that the recipient
developed independently; (ii) the recipient can demonstrate through pre-existing
records that the recipient knew before receiving it; (iii) is or subsequently
becomes publicly available or is received from another source, or (iv) is
disclosed under requirement of law or court order, provided that the recipient
shall have made a reasonable effort to prevent such disclosure, shall have
promptly notified the disclosing Party of any effort to compel disclosure prior
to any such disclosure, and reasonably co-operates and assists with the
disclosing Party's lawful attempts to prevent disclosure and/or to obtain a
protective order.
9.3 Except as expressly provided herein, each Party shall keep completely
confidential and shall not publish or otherwise disclose and shall not use for
any purpose except for purposes contemplated by this Agreement, any Confidential
Information of the other Party.
9.4 Press releases or other public communication (including without
limitation, by means of advertisement or professional or trade publication) by
either Party relating to this Agreement or the other Party, shall be approved in
writing in advance by the other Party, which approval shall not be unreasonably
withheld or delayed, except for those communications required by applicable law
(which shall be provided to the other Party as soon as practicable after the
release or communication thereof), disclosures of information for which written
consent has previously been obtained, and information of a similar nature which
has been previously disclosed publicly with respect to this Agreement, each of
which shall not require advance approval.
--------------------------------------------------------------------------------
Memorandum of Understanding
Page 8 of 14
10. Change in Control Involving ProUroCare
10.1 For purposes of this Section 10, "Change of Control" means the
occurrence during the Term of any of the following events:
10.1.1 The sale to a purchaser identified in Exhibit E hereof of (a)
all or substantially all of the assets of ProUroCare or (b) capital stock
representing more than 50 percent of the shares of ProUroCare entitled to
vote generally in the election of directors of ProUroCare; or
10.1.2 The merger or consolidation of ProUroCare with a corporation
or other legal entity identified in Exhibit E hereof if, immediately after
such merger or consolidation, less than a majority of the combined voting
power of the then-outstanding securities entitled to vote generally in the
election of directors of the surviving or resulting corporation in such
merger or consolidation is held, directly or indirectly, in the aggregate
by the holders immediately prior to such transaction of the outstanding
securities of ProUroCare; or
10.1.3 There is a report filed on Schedule 13D or Schedule 13G (or
any successor schedule, form, or report or item therein), each promulgated
pursuant to the Securities Exchange Act of 1934, as amended (the "Exchange
Act"), disclosing that a person identified in Exhibit E hereof (as the
term "person" is used in Section 13(d)(3) or Section 14(d)(2) of the
Exchange Act) has become the beneficial owner (as the term "beneficial
owner" is defined under Rule 13d-3 or any successor rule or regulation
promulgated under the Exchange Act) of securities representing 50 percent
or more of the combined voting power of the voting stock of ProUroCare; or
10.1.4 ProUroCare files a report or proxy statement with the
Securities and Exchange Commission pursuant to the Exchange Act disclosing
in response to Form 8-K or Schedule 14A (or any successor schedule, form,
or report or item therein) that a change in control of ProUroCare has
occurred or will occur in the future pursuant to any then existing
contract or transaction identified in Sections 10.1.1, 10.1.2 or 10.1.3
hereof.
10.2 ProUroCare shall notify Urologix in writing no later than the earlier
of sixty (60) days prior to a Change of Control described in Section 10.1.1 or
10.1.2 or five (5) calendar days after the public filing or disclosure of said
existing or proposed Change of Control described in Section 10.1.1, 10.1.2 or
10.1.3, to enable Urologix to begin undertaking arrangements for the orderly
transition to Urologix for the manufacture, distribution and/or supply of the
ProUroCare Products.
10.3 Effective immediately upon the consummation of any Change in Control,
Urologix shall have the sole and exclusive right to manufacture (or have
manufactured) and distribute the ProUroCare Products, including, without
limitation, the right to deal with any manufacturer, supplier or distributor
previously used by ProUroCare in connection with the ProUroCare Products, if it
so chooses; subject to and in accordance with the following terms and
conditions:
10.3.1 Urologix may exercise the right described in Section 10.3 by
giving written notice to ProUroCare of its intention to manufacture (or
have manufactured) and distribute the ProUroCare Products no later than
twelve (12) months after the Change of Control.
10.3.2 Urologix shall pay to ProUroCare as a royalty for the rights
granted to Urologix in this Agreement an amount equal to ProUroCare's
"Average Gross Margin" (hereinafter defined) for each ProUroCare Product
manufactured or distributed by Urologix or manufactured for Urologix as a
result of or in connection with the exercise by Urologix of its rights
pursuant to this Section 10.3.
--------------------------------------------------------------------------------
Memorandum of Understanding
Page 9 of 14
10.3.3 For purposes of this Section 10.3, "Average Gross Margin"
shall mean the revenue earned by ProUroCare for a particular ProUroCare
Product less the cost of goods sold with respect to such ProUroCare
Product. For purposes of clarification, "Average Gross Margin" shall be
determined in each case (a) as an average for the six month period
immediately preceding the Change in Control in question; (b) consistent
with the business practices of ProUroCare during such six month period;
and (c) in accordance with generally accepted accounting principles
applied on a basis consistent with the audited financial statements of
ProUroCare for the most recent fiscal year immediately preceding such
Change of Control.
10.3.4 Royalties due under Section 10.3.2 shall be payable by
Urologix to ProUroCare or its successor in interest on the tenth day of
each month for the ProUroCare Products manufactured by, manufactured for
or distributed by Urologix in connection with the exercise by Urologix of
its rights under Section 10.3 in the preceding month together with a
written report listing the ProUroCare Products for which the royalties are
being paid.
10.3.5 Each Party, at its cost and expense, shall upon request and
reasonable notice have the right to audit the applicable books and records
of the other Party to determine the accuracy of all such royalty payments;
and the Party being audited shall bear the cost of such audit if the audit
reveals an unfavorable discrepancy to the auditing Party in excess of five
percent (5%) of the royalties paid for the period audited.
10.3.6 In connection with the exercise of Urologix's rights under
this Section 10.3, ProUroCare shall cooperate with Urologix, at Urologix's
cost and expense, to facilitate Urologix's right to manufacture and
distribute the ProUroCare Products following any Change of Control.
10.3.6.1 If prior to a Change of Control ProUroCare
manufactured and distributed the ProUroCare Products exclusively to
Urologix, Urologix shall have the right to require ProUroCare or its
successor in interest to transfer title and deliver to Urologix, in
the manner and to the extent reasonably directed by Urologix, (a)
all completed ProUroCare Products, (b) all partially completed and
"work in process" ProUroCare Products, and (c) all materials, parts,
tools, dies, jigs, fixtures and contract rights produced, acquired
or used in connection with manufacture, distribution or supply of
the ProUroCare Products.
10.3.6.2 In cases covered by Section 10.3.6.1, Urologix shall
pay to ProUroCare (a) ProUroCare's customary sales price for
completed ProUroCare Products, (b) ProUroCare's actual cost for
partially completed and work in process ProUroCare Products,
materials or parts, and the greater of depreciated cost or market
for tools, dies, jigs, fixtures and contract rights, all determined
in accordance with generally accepted accounting principles applied
on a consistent basis.
10.3.6.3 If prior to a Change of Control ProUroCare contracted
with one or more third party contractors to manufacture or
distribute the ProUroCare Products, (a) in the case that such third
party manufactured ProUroCare Products for exclusive sale to
Urologix, then ProUroCare will assign to Urologix, at Urologix's
request, all of ProUroCare's rights with respect to such third party
manufacturer relationship, or (b) in the case that such third party
manufactured ProUroCare Products or other products of ProUroCare for
sale both to Urologix and other customers of ProUroCare, then
ProUroCare will cooperate in facilitating Urologix to enter into a
business relationship directly with such third party manufacturer.
--------------------------------------------------------------------------------
Memorandum of Understanding
Page 10 of 14
11. Term
This Agreement shall become effective when signed by duly authorized
representatives of each Party, and, unless sooner terminated in accordance with
the provisions of Section 12, shall continue in effect thereafter for a period
of five (5) years following the date on which the FDA first approves a New EIT
Product for sale in the United States (the "Term").
12. Termination
12.1 Either Party may terminate this Agreement:
12.1.1 Immediately in the event the other Party (a) becomes
insolvent, is dissolved or liquidated; (b) files or has filed
against it a petition in bankruptcy and fails to have said
bankruptcy dismissed within sixty (60) days after filing thereof;
(c) makes a general assignment for the benefit of its creditors; or
(d) ceases conducting business in the ordinary course for a period
of sixty (60) consecutive days or more.
12.1.2 If the other Party is in material breach or default of
any obligation that is not cured within sixty (60) calendar days
written notice of such breach.
12.1.3 If the other Party fails to pay any undisputed invoice
that is more than 60 calendar days outstanding.
12.1.4 Pursuant to Section 2.4 hereof.
12.1.5 Upon sixty (60) days' written notice of an
irreconcilable disagreement with respect to a dispute brought to the
attention of the Development Committee under Section 4 hereof.
12.1.6 Immediately if the other Party shall cease to carry on
its business.
12.2 ProUroCare may, at its option, terminate specific aspects of the
Project (and only specific aspects of the Project) if Urologix fails to develop
viable products incorporating EIT Technology and obtain FDA approval thereof on
or before the following deadlines (the "Indications"):
--------------------------------------------------------------------------------
Treatment Area Date
--------------------------------------------------------------------------------
Prostatitis/Prostadynia December 31, 2007
--------------------------------------------------------------------------------
Renal Tumor December 31, 2007 (if 510K approval is required)
December 31, 2008 (if PMA is required or sought)
--------------------------------------------------------------------------------
Prostate Cancer December 31, 2007 (if 510K approval is required)
December 31, 2008 (if PMA is required or sought)
--------------------------------------------------------------------------------
In order to exercise its option under this Section 12.2, ProUroCare must
provide Urologix with written notice specifying the particular respects in which
it believes that Urologix has failed to develop a viable product. The
termination as to a particular Indication shall then become effective thirty
(30) days later unless Urologix reasonably cures such alleged failure within
such thirty (30) day period.
12.3 In addition to the foregoing, if approval by the FDA has not been
obtained for the Initial Product (or similar) by December 31, 2007, either
ProUroCare or Urologix may, at each of their options, terminate this Agreement.
If ProUroCare terminates this Agreement pursuant to this Section 12.3,
ProUroCare shall reimburse Urologix for all development costs paid by Urologix
to RPI in connection with Phases I, II and III.
--------------------------------------------------------------------------------
Memorandum of Understanding
Page 11 of 14
12.4 Any termination by ProUroCare under Section 12.1 will also serve to
terminate the licenses granted to Urologix herein, provided, however, that
Urologix may, after the effective date of such termination and continuing for a
period not to exceed twelve (12) months thereafter, market, distribute and sell
all completed and in-process New EIT Products.
12.5 In the event Urologix has the right to terminate this Agreement under
Section 12.1.1, Section 12.1.2, or Section 12.1.6 after the passage of the time
periods designated in said Sections, and as a result thereof Urologix is unable
to obtain the benefit of the license and other rights granted herein, after
sixty (60) days written notice by Urologix to ProUroCare that it intends to
avail itself of this Section 12.5 (with the right by ProUroCare to cure during
said period), (a) the licenses granted to Urologix herein will, during the
entire period Urologix is unable to obtain the benefit of the license and other
rights granted herein, automatically and without further action of either Party
or the requirement of any notice, become irrevocable in addition to being
exclusive (but only to the extent it was exclusive prior to the date Urologix
had the right to terminate this Agreement), royalty-free, worldwide, fully paid
and sub-licensable, and (b) Urologix shall have the right, at its sole option,
to perform ProUroCare's obligations under this Agreement in order to assure
itself the full benefit of the license and other rights granted herein, until
such time as ProUroCare shall again have the ability to perform its obligations
hereunder. In order to reinstate performance under this Agreement, ProUroCare
must give Urologix reasonable notice and comfort that it is again able to
perform its obligations under the Agreement. In such case Urologix shall retain
and reserve all rights and claims against ProUroCare for any damages it has
incurred.
12.6 This Agreement shall be terminated if and to the extent the Parties
enter into subsequent definitive agreements so providing.
13. Dispute Resolution
13.1 In the event of any dispute, claim, question or disagreement based
on, arising from or relating to this Agreement or the breach or claimed breach
thereof (except for matters related to confidentiality or intellectual property
rights), the Parties will use reasonable efforts to settle the dispute, claim,
question or disagreement. To this effect, they will consult and negotiate with
each other in good faith and attempt to reach a just and equitable solution
satisfactory to both Parties. If they do not reach such a solution within a
reasonable period of time, then any controversy or claim arising out of,
relating to or based on this Agreement, or the breach or claimed breach thereof
(except for matters related to payment, confidentiality or intellectual property
rights), will be settled by arbitration, administered in the Minneapolis,
Minnesota metropolitan area by the American Arbitration Association in
accordance with its Commercial Arbitration Rules, and judgment on the award
rendered by the arbitrator(s) may be entered in any court having jurisdiction
thereof. If an action relating to this Agreement has been commenced in any court
by a third party, each Party will each have the option of presenting any
controversy or claim relating to this Agreement, or the breach or claimed breach
thereof, in such court in lieu of arbitration. This arbitration obligation and
choice of forum does not prevent either Party from seeking injunctive relief
from a court in any appropriate jurisdiction with respect to a violation of
intellectual property rights or confidentiality obligations, or to collect any
amounts due under this Agreement. Each Party agrees that the venue for such
actions shall be in Hennepin County, Minnesota and consents to exclusive
jurisdiction therein and waives any objections based on forum nonconveniens. The
provisions of this Section 13 shall not apply to disputes covered by Section 4
hereof.
14. Miscellaneous Provisions
14.1 Neither Party may assign this Agreement, or any obligation or right
hereunder, in whole or in part, without the express prior written consent of the
other, which consent shall not be unreasonably withheld.
--------------------------------------------------------------------------------
Memorandum of Understanding
Page 12 of 14
14.2 This Agreement constitutes the Parties' entire agreement concerning
the subject matter hereof, and supersedes any other prior and contemporaneous
communications. Any terms and conditions maintained by either Party or contained
in any purchase order, will not apply. The Parties may amend this Agreement only
in a writing signed by both of them.
14.3 If any provision of this Agreement is held by a court of competent
jurisdiction to be illegal, invalid or unenforceable, the remaining provisions
will remain in full force and effect and the Parties will amend this Agreement
to give effect to the stricken clause to the maximum extent possible. No waiver
of any breach of any provision of this Agreement will constitute a waiver of any
other breach, and no waiver will be effective unless made in writing and signed
by an authorized representative of the waiving Party.
14.4 In this Agreement, the non-capitalized term "third party" means any
entity or person other than the Parties hereto.
14.5 The provisions of this Agreement that, by their nature and content,
must survive the completion, rescission, termination or expiration of this
Agreement in order to achieve the fundamental purposes of this Agreement
(including without limitation the provisions of Section 7 ("Indemnification"),
Section 9 ("Confidentiality") and Section 13 ("Dispute Resolution")), shall so
survive and continue to bind the Parties.
14.6 Each Party acknowledges that a material violation of intellectual
property rights and confidentiality obligations will result in irreparable harm
and, accordingly, in the event of such violation or threatened violation, each
Party shall be entitled to seek preliminary and permanent injunctive relief in
addition to any other rights or remedies available to such Party.
14.7 This Agreement may be executed in any number of counterparts, each of
which will be an original, and such counterparts together will constitute one
and the same instrument. Execution may be effected by delivery of facsimiles of
signature pages (and the Parties will follow such delivery by prompt delivery of
originals of such pages).
[SIGNATURES ON FOLLOWING PAGE]
--------------------------------------------------------------------------------
Memorandum of Understanding
Page 13 of 14
IN WITNESS WHEREOF, the duly authorized officers of the Parties have
executed this Agreement as of the dates set forth below their respective
signatures.
PROUROCARE INC. UROLOGIX, INC.
By: /s/ ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ By: /s/ ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
--------------------------- ------------------------------------
Name: ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ Name: ▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇▇
------------------------- ----------------------------------
Title: CEO Title: VP-Product Development/Operations
------------------------ ---------------------------------
Date: 7/27/05 Date: 7/27/05
------------------------- ----------------------------------
[INCORPORATED EXHIBITS ARE ON THE FOLLOWING PAGES]
--------------------------------------------------------------------------------
Memorandum of Understanding
Page 14 of 14
MEMORANDUM OF UNDERSTANDING
EXHIBIT LIST
Exhibit A - Patents
Exhibit B - RPI Agreement re Project Role
Exhibit C - ProUroCare License Agreement with Renesselaer Polytechnic
Institute and Amendment #1 to License Agreement
Exhibit D - Sublicense Agreement between Urologix and ProUroCare
Exhibit E - Companies Identified for Purposes of a Change in Control of
ProUroCare
EXHIBIT A
PATENTS
---------------------------------------------------------------------------------------------------------------------------
Patent Name Number Date Issued
---------------------------------------------------------------------------------------------------------------------------
Process and Apparatus for Distinguishing Conductivities by Electric Current 4,920,490 April 1990
Computed Technology
---------------------------------------------------------------------------------------------------------------------------
Current Patterns for Impedance Tomography 5,272,624 December 1993
---------------------------------------------------------------------------------------------------------------------------
Three Dimensional Impedance Imaging Processes 5,284142 February 1994
---------------------------------------------------------------------------------------------------------------------------
Three Dimensional Impedance Imaging Processes 5,351,697 October 1994
---------------------------------------------------------------------------------------------------------------------------
Current Patterns for Electrical Impedance Tomography 5,381,333 January 1995
---------------------------------------------------------------------------------------------------------------------------
Layer Stripping Process for Impedance Imaging 5,390,110 February 1995
---------------------------------------------------------------------------------------------------------------------------
High Speed Electrical Tomography 5,544,662 August 1996
---------------------------------------------------------------------------------------------------------------------------
Process for Producing Optimal Current Patterns for Electrical Impedance Tomography 5,588,429 December 1996
---------------------------------------------------------------------------------------------------------------------------
EXHIBIT B
RPI Agreement re Project Role
Rensselaer Polytechnic Institute
PROPOSAL COVER PAGE
Non-Profit Educational Institution ▇▇▇▇, ▇▇▇ ▇▇▇▇ ▇▇▇▇▇-▇▇▇▇
--------------------------------------------------------------------------------------------------------------------------
RPI PROPOSAL NO. PROPOSAL TYPE AGREEMENT NO. (if applicable)
473-05-054L New
--------------------------------------------------------------------------------------------------------------------------
SPONSOR (with address and name of contact) SOLICITATION N0./CLOSING DATE
ProUroCare, Inc.
▇▇. ▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇ ▇▇
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
--------------------------------------------------------------------------------------------------------------------------
PROPOSAL WILL ALSO BE SUBMITTED TO:
--------------------------------------------------------------------------------------------------------------------------
TITLE
Impedance Imaging of Temperature Change in Response to RF Therapy of the Prostate
--------------------------------------------------------------------------------------------------------------------------
REQUESTED AMOUNT PROPOSED DURATION REQUESTED START DATE
$145,896 7 Months 2/1/2005
--------------------------------------------------------------------------------------------------------------------------
SPECIAL CONSIDERATIONS: |_| Human Subjects Cost |_| Cost Sharing/Matching Funds
|_| Animal Welfare |_| Proprietary information
|_| Recombinant DNA |_| Other
--------------------------------------------------------------------------------------------------------------------------
DEPARTMENT/CENTER/UNIT SUBMITTING PROPOSAL
Electrical, Computer & Systems Engineering
--------------------------------------------------------------------------------------------------------------------------
NAME AND TITLE DEPARTMENT TELEPHONE SIGNATURE
--------------------------------------------------------------------------------------------------------------------------
PD/PI
▇▇▇▇ ▇▇▇▇▇▇▇▇, Electrical, Computer & Systems (518) s/
Associate Professor Engineering 276-2976
--------------------------------------------------------------------------------------------------------------------------
Co-PI
▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇, Biomedical Engineering (518) s/
Professor 276-6433
--------------------------------------------------------------------------------------------------------------------------
Co-PI
▇▇▇▇▇ ▇▇▇▇▇▇▇▇, Mathematical Sciences (515) s/
Professor 276-6900
--------------------------------------------------------------------------------------------------------------------------
Co-PI
--------------------------------------------------------------------------------------------------------------------------
Co-PI
--------------------------------------------------------------------------------------------------------------------------
AUTHORIZED INSTITUTIONAL REPRESENTATIVE SIGNATURE /DATE
--------------------------------------------------------------------------------------------------------------------------
▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
Director, Office of Contracts and Grants
Voice: (▇▇▇)-▇▇▇-▇▇▇▇ Fax: (▇▇▇) ▇▇▇-▇▇▇▇
e-mail: ▇▇▇▇▇▇@▇▇▇.▇▇▇ s/
--------------------------------------------------------------------------------------------------------------------------
ADDITIONAL INFORMATION
--------------------------------------------------------------------------------------------------------------------------
Impedance Imaging of Temperature Change in Response to
RF Therapy of the Prostate.
A Proposal to
ProUroCare
Submitted by
▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇
▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇
▇▇▇▇▇ ▇▇▇▇▇▇▇▇
Impedance Imaging Laboratory
Rensselaer Polytechnic Institute
▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
December 2004
Overview
We propose to develop an imaging system to assess regional temperature change in
the prostate and its vicinity during and immediately following RF hyperthermia
treatment. This long-term goal will be approached by the development of an
Electrical Impedance Tomography (EIT) System [l]. EIT electrodes will be placed
at several sites on the skin of the lower abdomen or pelvis, on a catheter
placed in the rectum and, only if necessary, on the trans-urethral catheter that
is used to deliver RF energy to the target area. Here we propose to perform the
first phase only of a multi-phase effort towards the goal of developing a
complete system. The phases are as follows:
Phase 1: Electrode Array Design/Proof-of-Concept. Develop a suitable
electrode, array (number of electrodes, size and distance) for use in a
rectal probe and skin surface application. Electrodes will not be placed
on the trans-urethral catheter. Electrode array configurations will be
assessed by their the ability to produce measurement data that shows the
needed sensitivity to localized heating as well as their ability to avoid
interaction with the antenna radiation pattern. Also, the feasibility of
achieving the required resolution/sensitivity will be assessed.
Phase 2: Reconstruction Algorithm Development. Design, implement and test
a reconstruction algorithm to produce images from data taken using
candidate electrode arrays.
Phase 3: Instrument Design. Design and proto-type an EIT instrument that
is capable of supporting the required number of electrodes and providing
the needed measurement precision and speed.
Contingent on obtaining promising results during Phase 1, and continuted
interest on the part of ProUroCare, future proposals will be submitted for
conducting Phases 2 and 3.
Phase 1: Electrode Array Design/Proof-of-Concept
We here propose a proof-of-concept investigation to test the feasibility of this
approach. The immediate goal is to determine whether these electrodes can
collect data that would allow the development of a reconstruction algorithm to
make an image of the electrical conductivity in the target area. The ability to
make an image depends on whether the system has a sufficiently high
distinguishability to detect a conductivity change. A high distinguishability is
necessary, but not sufficient, to be able to form a useful image. It is a
measure of the ability of the system to obtain a usable voltage signal in
response to an inhomogeneity or a temporal change in conductivity. We have
investigated the distinguishability of targets or inhomogeneities in other
fields using geometries different from that proposed below, but which will serve
to illustrate the method. The theory is explained in [2, 3], and a recent paper
submitted for publication using linear rods of electrodes embedded in a solid
conductive medium appears in [4].
We will measure the distinguishability of. several candidate electrode
positions, using different numbers of electrodes on the rectal probe, and on the
skin surface. These distinguishability studies will be conducted in physical
phantom conductivity fields. One of these fields will consist of a tank of
saline 30 cm in diameter with electrodes on its inside surface, and with
catheters containing 4-8 electrodes located as if placed in the rectum. A second
field will be made of agar, cast into a shape that resembles the pelvis,
Electrode arrays as described above will be attached onto and introduced into
this `pelvis' at anatomically reasonable locations.
The electrodes described above will all be connected to the ACT 3 Impedance
Imaging System. This system will be adapted to apply suitable current patterns
among all the active electrodes, using its unique ability to produce currents
and measure voltages with high accuracy on up to 32 electrodes simultaneously.
The current patterns to be studied will be optimized to produce the highest
possible distinguishability for each electrode array placement studied.
We will introduce small `targets' or inhomogeneities in the vicinity of the
simulated prostate, and calculate values of maximum distinguishability for
several target locations in the homogeneous region of interest. This will
provide a crude map o f distinguishability for the array geometry.
When this information is in hand, we will introduce an RF catheter and source to
heat the agar phantom in the vicinity of the trans-urethral EIT probe. This work
will require close collaboration with Ray Kasevitch, from whom you will have a
complementary proposal to work in support of these studies. It is well known
that conductivity of aqueous substances such as tissue and agar exhibit a change
in electrical conductivity of about 2% per degree Celsius of temperature change.
By using RF energy to heat the agar, and embedding small thermocouples or RTD
thermometers in the vicinity to assess the needed dose, we will raise the agar
temperature and measure the resulting change in distinguishability of that
intervention.
Phase 1 Tasks/Deliverables:
1. Design electrode array configurations and excitations (electrode currents
or voltages). Evaluate candidate electrode arrays/excitations using the
ACT3 Impedance Imaging System and a physical phantom conductivity field
designed to simulate an anatomically correct prostate medium.
2. Introduce a small heater or cooler (thermocouple/▇▇▇▇▇▇▇ cooler) and
adjacent temperature measurement device (RTD or thermocouple) at defined 3
dimensional spatial locations within an approximate maximum of 40 mm
radially from the location of a CTC Catheter. Perform a distinguishability
study to demonstrate the smallest detectable temperature change as a
function of location. Also perform a study to assess the ability to
differentiate between temperature changes at different spatial locations
within a 40 mm radial region around the CTC Catheter.
3. Fine-tune electrode array and excitations with the goal of detecting a
temperature change of 1(degree) C at any point within a 40 mm radial
distance from the CTC Catheter. Provide data showing sensitivity as a
function of location.
4. Provide recommendations for further system development, including possible
changes to the electrode configuration, to improve temperature measurement
capability within a 40 mm radial distance from the RF source.
Phase 2: Reconstruction Algorithm Development
If the concept is deemed sufficiently promising to continue, a second phase of
development would be proposed, involving the development of an image
reconstruction algorithm and display system. This second stage would require
mathematical analysis and development, and significant programming effort by a
talented programmer. We estimate that this phase would require 6 months of
effort.
Phase 3: Instrument Design and Implementation
An instrument would need to be developed tailored to the technical requirements
of this application. This instrument development could be carried out in at the
same time as the algorithm development. The ACT 3 instrument will be adequate
for phase 1, but not for the second phase, and it would certainly not be usable
for in-vivo testing. We propose that a new instrument would be developed based
on the new ACT 4 system, using the same basic architecture and utilizing much of
the same system software and firmware and, where possible, the same printed
circuit boards. The new instrument would most likely differ from ACT 4 by having
fewer electrodes and a lower frame rate, both of which would result in cost and
size reductions. In addition, the current and/or voltage sources may need to be
re-designed to accommodate the different load impedances that will be seen by
electrodes that are placed on the catheter and/or in the rectum as opposed to
those placed externally on the skin. If this effort is started after ACT 4 is
fully operational, we estimate that it world required approximately 6 months to
complete.
References Cited
[1] ▇▇▇▇▇▇▇▇, ▇. ▇., R.S. Blue, ▇.▇. ▇▇▇▇▇▇, ▇. ▇▇▇▇▇▇▇▇ and P.M. Edic.
Electrical Impedance Tomography. IEEE Signal Processing Magazine 18(6):
31-43, 2001.
[2] ▇▇▇▇▇▇▇▇, D. Distinguishability of conductivities by electric current
computed tomography. IEEE Trans. on Medical Imaging MI-5(2):92-95,1986.
[3] ▇▇▇▇▇▇, M. and D, ▇▇▇▇▇▇▇▇. Distinguishability in impedance imaging. IEEE
Trans. Biomed. Eng. 39(8):852-860, 1992.
[4] Parekh, N.H., ▇-▇ ▇▇▇, ▇.▇. ▇▇▇▇▇▇▇▇ ▇. ▇▇▇▇▇▇▇▇ and ▇.▇. ▇▇▇▇▇▇. Multiple
sources for electrical impedance tomography in the hydrologic regime. J.
Appl. Geophysics (In Review, 2004)
Rensselaer Polytechnic Institute
Cost Estimate Summary: 7 months
Period: (2/1/05 - 8/31/05)
Proposal No. 073-05-054L Dec-04
PERSONNEL
Co-Principal Investigator (▇. ▇▇▇▇▇▇▇▇)
academic - 4 mos @ 10% $ 3,629
summer - 4 wks @100% 9,435
Co-Principal Investigator (▇. ▇▇▇▇▇▇)
academic - 4 mos @ 15% 6,523
summer - 4 wks @ 100% 11,307
Co-Principal Investigator (▇. ▇▇▇▇▇▇▇▇)
summer - 5 wks @ 100% 16,236
Postdoctoral Associate (TBN)
calendar - 6 mos @ 100% 15,000
TOTAL PERSONNEL PAYMENTS $ 62,130
FRINGE BENEFITS @ 30.67%* 19,055
OTHER DIRECT COSTS
Materials and Supplies 10,000
TOTAL DIRECT COSTS $ 91,185
INDIRECT COSTS @ 60%* 54,711
TOTAL FUNDS REQUESTED $145,896
*See Attachment
EXHIBIT C
ProUroCare License Agreement with Rensselaer Polytechnic Institute and
Amendment #1 to License Agreement
(Amendment #1 filed herewith as Exhibit 10.3)
EXHIBIT D
Sublicense Agreement between Urologix, Inc. and ProUroCare Inc.
(Filed herewith as Exhibit 10.2)
EXHIBIT E
Companies Identified for Purposes of a Change in Control of ProUroCare
o Boston Scientific
o ACMI
o Medtronic
o Johnson and ▇▇▇▇▇▇▇
o American Medical Systems
o Olympus
o Dornier
o Prostalund
o ▇▇▇▇
▇ ▇▇▇▇ Medical