EXHIBIT 10.15
Exclusive License Agreement
Page 1
LICENSE AGREEMENT
This License Agreement ("License Agreement") is effective February 1, 2000
(the "Effective Date") and is between University of Kansas Medical Center
Research Institute, Inc., a non-profit 501(3)(c) corporation of the State of
Kansas, located at ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇., ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇ ▇▇▇▇▇-▇▇▇▇ (the
"Research Institute"), which is an agent of the University of Kansas Medical
Center ("KUMC"), and ▇▇▇▇▇▇ ▇▇▇▇▇▇ Medical, Inc., a for-profit Delaware
corporation, having a place of business at ▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇, ▇▇▇▇▇▇▇▇▇,
▇▇▇▇▇▇▇▇▇▇ ▇▇▇▇▇ (the "Company").
Background
KUMC owns United States Patent No. 5,057,105, United States Reissue Patent
No. 35,330, and their foreign counterparts, as are identified in License Exhibit
A (the "Patent Rights"). The Research Institute has the right to grant licenses
under the Patent Rights on behalf of KUMC.
The Company designs and develops products and techniques useful or
prospectively useful for applying radio frequency energy to tissue in the
gastro-intestinal tract, e.g., for the treatment of gastrointestinal reflux
disease (GERD) and fecal incontinence.
The Company seeks an exclusive field of use license under the Patent
Rights.
Accordingly, the parties agree as follows:
Article 1. Definition of Terms
1.1. "Affiliate" shall mean, with respect to a given business entity, any
---------
corporation or other entity which controls, is controlled by, or is under common
control with such entity. A corporation or other entity shall be regarded as in
control of another corporation or entity if it owns or directly or indirectly
controls more than fifty percent (50%) of the voting stock or other ownership
interest of the other corporation or entity, or if it possesses, directly or
indirectly, the power to direct or cause the direction of the management and
policies of the corporation or other entity or the power to elect or appoint
fifty percent (50 %) or more of the members of the governing body of the
corporation or other entity.
1.2. The "Licensor" shall mean the Research Institute.
--------
1.3. The "Gastro-Intestinal Tract" shall mean the body passage beginning at the
-----------------------
esophagus and including, but not limited to, the stomach, the small and large
intestines, and the rectum, through which food taken into the body is digested.
1.4. The "Company's Field of Use" shall mean the Gastro-Intestinal Tract.
----------------------
Exclusive License Agreement
Page 2
1.5. "Valid Patent Claim" shall mean a claim of an issued and unexpired patent
------------------
included within the Patent Rights, which has not been held permanently revoked,
unenforceable or invalid by a decision of a court or other governmental agency
of competent jurisdiction, unappealable or unappealed within the time allowed
for appeal, and which has not been admitted to be invalid or unenforceable
through reissue or disclaimer or otherwise.
1.6. "Related Materials" shall mean all technical information, know-how,
-----------------
processes, procedures, compositions, devices, methods, techniques, data or other
subject matter that is useful or prospectively useful for the practice of the
Patent Rights, and that are confidential and not publically known or available
under the provisions of Article 8 of this License Agreement.
1.7. "Third Party" shall mean any individual or entity that is not the Licensor,
-----------
KUMC, the Company, or an Affiliate or sublicensee of the Company.
1.8. "Other Licensees" shall mean any Third Party licensed by the Licensor under
---------------
the Patent Rights in a field of use outside the Company's Field of Use.
1.9. "Licensed Product' shall mean a hardware instrument or device (i) that is
----------------
designed or labeled for repeated use with multiple patients, (ii) that, during
use, generates and delivers in a controlled fashion energy to tissue in the
Gastro-Intestinal Tract, and (ii) the use, manufacture, or sale of which
infringes a Valid Patent Claim in the country where use, manufacture, or sale
occurs. The Licensed Product shall specifically not encompass any disposable
component that is designed or labeled for single use or for use with a single
patient, and intended to be disposed of after such use, and associated cabling
or connectors to couple any disposable component to the hardware instrument for
use.
1.10. "Net Sales" shall mean the sum total of all amounts invoiced for sales
---------
of Licensed Products sold by the Company, its Affiliates, sublicensees, agents
or distributors, less: (i) normal trade and case discounts actually allowed
(excluding promotional, advertising and other non-normal or special discounts);
(ii) credits or refunds actually allowed for spoiled, damaged, outdated, or
returned goods; (iii) sales and other excise taxes imposed and paid directly
with respect to the sale; (iv) any shipping costs separately invoiced to the
Company's Customers.
1.11. "GPR" shall mean the federal laws and regulations regarding inventions or
---
discoveries conceived or first actually reduced to practice in the performance
of work under a funding agreement between the U.S. federal government or agency
thereof and a small business firm or nonprofit organization,
Exclusive License Agreement
Page 3
specifically 35 U.S.C. ' 201-212, 37 C.F.R. Part 401, ' 401.1-401.16 as modified
by Executive Order No. 12618 of December 22, 1987 (published in the Federal
Register of December 24, 1987) and amendments and modifications thereto or
hereafter adopted or approved.
Article 2. Grant of Rights
2.1 Grant. Subject only to the provisions of Section 2.3, the Licensor hereby
------
grants to the Company and its Affiliates an exclusive, worldwide right under the
Patent Rights and Related Materials in the Company's Field of Use to (i) design,
develop, make, have made, use, sell, offer for sale, import, export or otherwise
distribute products in the Company's Field of Use, and (ii) practice or
authorize the practice of any method, process, or procedure in the Company's
Field of Use.
2.2 Right to Sublicense. The Company shall have the right to grant or authorize
--------------------
sublicenses within the scope of the license granted in Section 2.1, provided
that any such sublicense and sublicensee shall be subject in all respects to the
restrictions, exceptions and termination provisions contained in this Agreement,
unless otherwise mutually agreed to in writing by the parties. The Company shall
be responsible to the Licensor for all obligations of its sublicensees in the
same fashion and to the full extent that the Company is obligated to the
Licensor hereunder. If the Licensor is required to bring suit against a
sublicensee of the Company for breach of this Agreement, the Company will pay
all reasonable costs incurred by the Licensor in connection therewith,
including, but not limited to, reasonable attorneys fees and disbursements.
2.3 Retained Rights. The Licensor retains rights in all fields of use outside
----------------
the Company's Field of Use (the "Retained Rights"). No right or license is
granted by the Licensor under this Agreement to the Company, either expressly or
by implication, except those specifically set forth herein. The license granted
to the Company under Section 2.1 is also subject to certain rights and license
granted to the United States and foreign governments pursuant to provisions of
the GPR, which have been explained to the Company.
Article 3. Consideration for the Grant of Rights
3.1. Consideration. Consideration for the rights and licenses granted by the
--------------
Licensor to the Company herein, are (i) payment by the Company on the Effective
Date of a cash lump sum licensing fee of fifteen thousand dollars ($15,000) to
the Licensor; (ii) payment by the Company to the Licensor of certain royalties
based upon the sale of Licensed Products, pursuant to Article 4 that follows;
(iii) payment by
Exclusive License Agreement
Page 4
the Company to the Licensor certain reasonable expenses, including attorney's
fees, incurred after the Effective Date for prosecuting, and maintaining the
Patent Rights, pursuant to Article 6 that follows; and (iv) the issuance on the
Effective Date by the Company to the Licensor of 100,000 shares of common stock
of the Company, pursuant to and subject to the terms and conditions set forth in
License Exhibit B.
Article 4. Royalties
4.1 Product Royalty. The Company shall pay to the Licensor a running royalty
---------------
of two percent (2.0%) on the Net Sales of Licensed Products sold by the Company
or its Affiliates to Third Parties (the "Product Royalty"). Sales shall be
considered to be made, for purposes of this Section, when payment for a Licensed
Product is received by the Company. Only one Product Royalty shall be paid for
each Licensed Product sold, despite the number of Patent Rights or Valid Patent
Claims that may be applicable to the Licensed Product.
4.2. Sublicensee Royalty. The Company shall pay to the Licensor twenty percent
-------------------
(20%) of all compensation received by the Company due to sublicense of the
Patent Rights to a Third Party, including, but not limited to, royalties, fees,
equity in such Third Party sublicensees, etc (the "Sublicensee Royalty").
4.3. When Payments are Due. Payment of the Product Royalties and the
---------------------
Sublicensee Royalties under the preceding Sections 4.1 and 4.2 shall be made to
the Licensor in U.S. Dollars within sixty (60) days following the end of each
calendar quarter. Remittance of the Product Royalties and the Sublicensee
Royalties in currency issued outside the U.S. shall be made to the Licensor in
U.S. Dollars at the official rate of exchange of the currency of the country
from which the royalties are payable (as quoted by Citibank NA for the last
business day of the calendar quarter in which the royalties are payable). Each
such payment shall include the Product Royalties and the Sublicensee Royalties
that have accrued during the calendar quarter immediately preceding and shall be
accompanied by a report as described in Section 5.2 that follows. If no
royalties are due, the report shall so state.
4.4 Annual Minimum Royalty. The Company shall pay to Licensor an annual
----------------------
minimum royalty of ten thousand dollars ($10,000) for each one year term, or
prorated portion thereof, this License Agreement is in effect (the "Annual
Minimum Royalty"). The Annual Minimum Royalty shall be payable to the Licensor
within sixty (60) days after December 31 of each year. The Product Royalties
Exclusive License Agreement
Page 5
or Sublicensee Royalties for a given year under the provisions of Section 4.1
and 4.2 above shall be fully creditable against the Annual Minimum Royalty due
for that year.
Article 5. Administration of Payments
5.1 Where to Send Payment. Payments made to the Licensor under this License
---------------------
Agreement shall be made payable to "University of Kansas Medical Center Research
Institute, Inc., Tax ID: ▇▇-▇▇▇▇▇▇▇" referencing the License Agreement and
forwarded to K. M. A. ▇▇▇▇▇, M.D., President, University of Kansas Medical
Center Research Institute, ▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇., ▇▇▇▇▇▇ ▇▇▇▇, ▇▇▇▇▇▇, ▇▇▇▇▇-▇▇▇▇.
5.2 Sales Report. The Company shall prepare and sign a report each quarter
------------
which sets forth separately, the Net Sales of all Licensed Products sold by
Company, its sublicensees and Affiliates, during the quarter. This report is to
be generated whether there were sales during the quarter, or not. The Licensor
shall maintain all such financial and business information of the Company, its
Affiliates, and sublicensees in confidence and not disclose such information to
any Third Party.
5.3 Inspection of Sales Records. The Company, its Affiliates, and sublicensees
---------------------------
shall keep and maintain records of sales of Licensed Products. Upon sixty (60)
days advance written notice to the Company, such records shall be open to
inspection at any reasonable time during normal business hours not more often
than once each year within three (3) years after the royalty period to which
such records relate, by a representative of the Licensor (the "Licensor's
Representative"), who shall be approved in advance by the party whose records
are being inspected, which approval shall not be unreasonably withheld. The
Licensor's Representative shall have the right to examine and make abstracts of
the records kept pursuant to this License Agreement and report findings of said
examination of records to Licensor, insofar as it is necessary to evidence any
mistake or impropriety on the part of the Company or its respective Affiliate or
sublicensee. The Licensor's Representative and the Licensor shall be obligated
to keep all such financial and business information of the Company confidential
and not disclose such information to any Third Party.
Article 6. Patent Prosecution and Maintenance
6.1. Domestic and Foreign Patent Prosecution (The Licensor). The Licensor shall
------------------------------------------------------
retain patent counsel acceptable to the Company to control the prosecution and
maintenance of the Patent Rights. The Company shall share in equal proportion
with the Other Licensees the reasonable costs of prosecution and maintenance of
the Patent Rights. The Licensor shall (i) keep the Company reasonably informed
as
Exclusive License Agreement
Page 6
to the prosecution and maintenance of such patents and patent applications, (ii)
furnish to the Company copies of documents relevant to any such filing,
prosecution and maintenance, (iii) allow the Company reasonable opportunity to
comment on documents filed with any patent office which could affect the nature
or scope of Patent Rights, and (iv) obtain the Company's consent prior to
prosecuting any patent application in favor of claims inside the Company's Field
of Use to the detriment of claims outside the Company's Field of Use. For
purposes of this Article 6, "prosecution and maintenance" of patents and patent
applications shall be deemed to include, without limitation, the conduct of
interferences or oppositions, and/or requests for re-examinations, reissues or
extensions of patent terms.
6.2. Domestic and Foreign Patent Prosecution (The Company). If no Other Licensee
-----------------------------------------------------
exists to proportionally share in the costs as set forth in Section 6.1 above,
the Company shall have the right, at its option and at its expense, to retain
patent counsel to control the prosecution and maintenance of the Patent Rights
pertaining to the Company's Field of Use.
Article 7. Infringement
7.1 Notification of Infringement or Challenge. If any party believes that a
------------------------------------------
Third Party is making, using or selling a product that may infringe any Patent
Right in any field of use, or if any party learns of the institution by a Third
Party of any proceeding challenging the validity or enforceability of any
Patent Right in any field of use, that party shall notify the other party in
writing.
7.2. Enforcement of Patent Rights in the Company's Field of Use. The Company
------------------------------------------------------------
(or its Sublicensee, where the Company has transferred such right) shall have
the first right (itself or through others), under its own control and at its
sole expense, to bring suit to enforce the Patent Rights against infringement by
a Third Party within the Company's Field of Use, and/or to defend any
declaratory judgment action with respect thereto. The Licensor, at the Company's
request, agree to join as a party plaintiff in any such action initiated by the
Company. The Licensor shall permit any action under this Article 6 to be brought
in its name, if required by law. In the event the Company (or its Sublicensee)
elects not to initiate an action to enforce the Patent Rights against a
commercially significant infringement by a Third Party within the Company's
Field of Use, or to answer a declaratory judgment action within ninety days
after notice thereof, the Licensor shall have the right to initiate such action
under its own control and at its sole expense. The Company (or its Sublicensee)
shall have the right to participate in any action with
Exclusive License Agreement
Page 7
counsel of its own choice and at its own expense in any suit brought to enforce
the Patent Rights against infringement by a Third Party outside the Company's
Field of Use.
7.3. Defense of Third Party Claims in the Company's Field of Use. If any party
------------------------------------------------------------
is threatened or is named in an action alleging infringement of patent or other
intellectual property right owned by a Third Party, which arises out of an
activity under the Patent Rights in any field of use (the "Third Party Claim"),
that party shall notify the other party in writing. The Company (or its
Sublicensee) shall have the first right (itself or through others), under its
own control and at its sole expense, to defend and settle any Third Party Claim
in the Company's Field of Use. The Company shall keep the Licensors reasonably
informed as to the defense and/or settlement of such action. The Licensor shall
have the right to participate in any such action with counsel of its own choice
at its own expense. The Company (or its Sublicensee) shall have the right to
participate in any action with counsel of its own choice and at its own expense
in any suit involving a Third Party Claim outside the Company's Field of Use.
7.4. Voluntary Disposition of Suit. No party may enter into any settlement,
------------------------------
consent judgment, or other voluntary final disposition of a suit or action
involving the Patent Rights in any field of use without the prior approval of
the other party, which approval shall not be unreasonably withheld. The Licensor
shall not approve any settlement, consent judgment, or other voluntary final
disposition of a suit or action involving the Patent Rights in fields of use
outside the Company's Field of Use without the prior approval of the Company,
which approval shall not be unreasonably withheld.
7.5. Cooperation. Each party agrees to cooperate fully in any action under this
-------------
Article 7 which is controlled by another party, provided that the controlling
party reimburses the cooperating party promptly for any reasonable costs and
expenses incurred by the cooperating party in connection with providing such
assistance. Any recovery obtained in an action under this Article 7 shall be
used to reimburse the cooperating party, with any remaining amounts to be
retained by the controlling party.
7.6. No Implied Obligations. Except as expressly provided in this Article 7, no
----------------------
party has any obligation to bring or prosecute actions or suits against any
Third Party for patent infringement.
Article 8. Confidentiality
8.1. Designation. It is understood that it may be necessary for the Licensor,
------------
or the Company, or both, to exchange confidential information from time to time
in furtherance of the Company's rights in the Company's Field of Use. To the
extent that one party (the "Disclosing Party") desires to disclose to
Exclusive License Agreement
Page 8
another party (the "Receiving Party") information or data which reasonably
relates to the activity of the Company pursuant to this License Agreement, and
which is considered to be confidential ("Confidential Information"), the
Disclosing Party shall place the Confidential Information in a written form,
marked with an appropriate legend indicating its confidential status. If
Confidential Information is first disclosed orally or visually to the Receiving
Party, the Disclosing Party shall, within one month of the disclosure, prepare a
written summary of the Confidential Information disclosed, referencing the date
of disclosure and identifying the Receiving Party or Parties.
8.2. Obligations. Except as otherwise provided in this Article 8, the Receiving
------------
Party shall, for a period of five (5) years after disclosure of an item of
Confidential Information from the Disclosing Party, hold the Confidential
Information in confidence and shall not disclose the Confidential Information to
a Third Party, nor use the Confidential Information except in furtherance of the
Company's rights in the Company's Field of Use.
8.3. Exemptions. To the extent it is reasonably necessary or appropriate to
-----------
exercise its rights under this License Agreement, the Company may disclose
Confidential Information of the Licensor it is otherwise obligated under this
Article 8 not to disclose, to its Affiliates, sublicensees, consultants, outside
contractors, clinical investigators, directors, officers, employees, and legal
counsel on a need-to-know basis, on condition that such entities or persons
agree to keep the Confidential Information confidential for the same time
periods and to the same extent as the Company is required to keep the
Confidential Information confidential. Furthermore, the Company or its
sublicensees may disclose Confidential Information of the Licensor to government
or other regulatory authorities to the extent that such disclosure is reasonably
necessary to obtain authorizations to conduct clinical trials of, and to
commercially market, products in the Company's Field of Use. KUMC and the
Licensor, at their option, may freely publish any or all of research results and
technical information developed at KUMC with no participation by the Company.
8.4. Exceptions. The obligation not to disclose or use Confidential Information
------------
shall not apply to any part of such Confidential Information that: (i) is or
becomes part of the public domain other than by unauthorized acts of the party
obligated not to disclose such Information or its Affiliates or sublicensees:
(ii) can be shown by written documents to have been disclosed to the Receiving
Party or its Affiliates or sublicensees by a Third Party, provided such
Confidential Information was not obtained by such Third
Exclusive License Agreement
Page 9
Party directly or indirectly from the other party under this License Agreement
pursuant to a confidentiality agreement; (iii) prior to disclosure under this
License Agreement, was already in the possession of the Receiving Party or its
Affiliates or sublicensees, provided such Information was not obtained directly
or indirectly from the other party under this License Agreement pursuant to a
confidentiality agreement; (iv) can be shown by written documents to have been
independently developed by the Receiving Party or its Affiliates or sublicensees
without breach of any of the provisions of this License Agreement, or (v) is
disclosed by the Receiving Party pursuant to interrogatories, requests for
information or documents, subpoena, civil investigative demand issued by a court
or governmental agency or as otherwise required by law; provided that the
Receiving Party notifies the Disclosing Party immediately upon receipt thereof.
The burden of proof under this Section 8.4 rests with the party claiming the
existence of one of the exceptions.
8.5 Terms of this License Agreement. Except as required by law, and, in the
---------------------------------
case of the Licensor, except as may be required in order to maintain its status
as an exempt organization under 501(c)(3) of the U.S. Internal Revenue Code and
regulations thereunder, neither the Licensor nor the Company shall originate any
publicity, news release, or other public announcement, written or oral, whether
to the public press, to stockholders, or otherwise, relating to this Agreement
to any amendment thereto or to performance hereunder without the prior written
approval of the other party. The Company shall not use the name of the
University of Kansas, University of Kansas Medical Center or the University of
Kansas Medical Center Research Institute, Inc. (or any variant thereof) or any
related organization in any advertising, packaging (except for customary
technical references) or other promotional material in connection with the sale
of Licensed Product referred to in this License Agreement. If the Company
determines that it is required to file with the Securities and Exchange
Commission or other governmental agency this License Agreement for any reason,
such party shall request confidential treatment of such portions of this License
Agreement as it and the other party shall together determine. Notwithstanding
the foregoing, prior to execution of this License Agreement, the parties may
agree upon the substance of information that can be used as a routine reference
in the usual course of business to describe the terms of this transaction, and
the parties may disclose such information, as modified by mutual agreement from
time to time, without the other party's consent.
Exclusive License Agreement
Page 10
8.6. Return of Confidential Information. Upon termination of this License
-----------------------------------
Agreement, the Receiving Party shall, upon written request of the Disclosing
Party, return to the Disclosing Party all copies of the Confidential Information
then subject to the provisions of this Article 8, except that the Receiving
Party may retain one copy of such Confidential Information in the possession of
its legal counsel for the purpose of monitoring its obligations under this
License Agreement.
Article 9. Representations and Warranties
9.1. Licensor's Authorization. The Licensor represents and warrants that: (i)
-------------------------
it has the legal right, title, and power to enter into this License Agreement
and to extend the rights and/or licenses granted to the Company in this License
Agreement, (ii) the performance of such obligations will not conflict with any
agreements, contracts or other arrangements to which it is a party, (iii) it has
not previously granted and will not grant any rights in the Patent Rights and
the Related Materials that are inconsistent with the rights and licenses granted
to the Company herein; and (iv) Exhibit A lists, as of the Effective Date, all
Basic Patent Rights throughout the world. To the best of the Licensor's
knowledge, (i) there is no pending or threatened claim or litigation to which
the Licensor is a party contesting the ownership, derivation, inventorship,
validity or right to use any of the Patent Rights or Related Materials, and (ii)
the Licensor has received any notice of infringement with respect to exercise of
the Patent Rights.
9.2. Company's Authorization. The Company represents and warrants that: (i) it
-------------------------
is a corporation duly organized validly existing and in good standing under the
laws of the State of Delaware; and (ii) the execution, delivery and performance
of this License Agreement have been duly authorized by all necessary corporate
action on the part of the Company.
Article 10. Term and Termination
10.1. Term. Unless terminated earlier pursuant to this Article 10, the term
----
of this License Agreement shall commence on the Effective Date and continue in
full force and effect until expiration, revocation or invalidation of the last
patent or the abandonment of the last application within the Patent Rights.
10.2. Termination by the Licensor. The Licensor may terminate this Agreement
---------------------------
and the license herein granted upon the breach of any of the terms herein
contained upon sixty (60) days written notice to the Company; provided that, if
-------------
during said sixty (60) days, the Company cures the breach complained of, then
this Agreement shall continue in full force and effect. In the event this
Agreement shall be terminated according to this Section 10.2, the Company shall
promptly make an accounting to the
Exclusive License Agreement
Page 11
Licensor of the inventory of Licensed Products which it and its Affiliates and
sublicensees have on hand as of the date of such termination. The Company, its
Affiliates and sublicensees shall then have the right, for a period of six (6)
months after said termination, to sell such inventory, provided that the Net
-------------
Sales thereof shall be subject to the payment to the Licensor of the royalties
set forth in Article 4 above.
10.2. Termination by the Company. Any provision herein notwithstanding, the
--------------------------
Company may terminate this License Agreement, in its entirety or as to any
particular patent or patent application within the Patent Rights, at any time by
giving the Licensors at least ninety (90) days prior written notice. From and
after the effective date of a termination under this Section 10.2 with respect
to a particular patent or application, such patent(s) and patent application(s)
in the particular country shall cease to be within the Patent Rights for all
purposes of this License Agreement, and the Company shall no longer be liable
for the expenses relating to that patent or patent application under Section
6.1.
Article 11. Indemnification and Insurance
11.1. Licensee Indemnification Agreement. The Company hereby indemnifies the
----------------------------------
KUMC and the Licensor and its agents and agrees to be solely responsible and
hold KUMC and the Licensor and their employees and agents harmless from any
claims, demands, suits or causes of action, including all judgments, damages,
and costs (including reasonable attorneys' fees) resulting therefrom, arising
out of the use, manufacture, sale, storage or advertising of any Licensed
Product.
11.2. Export Administration Regulations Duties of the Company. The Company
-------------------------------------------------------
acknowledges that it has certain duties and obligations under Part 379 of the
Export Administration Regulations of the U.S. Department of Commerce (as
presently promulgated or hereafter modified or amended) concerning the export
and re-export of technical data. The Company will be solely responsible for any
breach of such Regulations by the Company, its Affiliates or sublicensees and
will defend and hold the Licensor and KUMC harmless in the event of a suit or
action involving the Licensor, KUMC occasioned by any such breach.
11.3. General and Product Liability Insurance. The Company shall be responsible
---------------------------------------
for maintaining reasonable product liability insurance coverage applicable to
the Licensed Product in accordance with the standard business practices of the
Company.
Exclusive License Agreement
Page 12
Article 12. Miscellaneous
12.1. Assignment. This License Agreement may not be assigned or otherwise
------------
transferred by any party without the consent of the other parties; provided,
however, that, without such consent, (i) the Company may assign its rights and
obligations under this License Agreement in connection with a merger,
consolidation or sale of substantially all of such party's assets to which this
License Agreement relates, and (ii) the Licensor may assign its rights and
obligations under this License Agreement to an Affiliate of the Licensor.
12.2 Force Majeure. In the event that further lawful performance of this
-------------
Agreement or any part hereof by either party shall be rendered impossible by or
as a consequence of any law, regulation, order, rule, direction, priority,
seizure, allocation, requisition, or any other official action by any
department, bureau, board, administration or other instrumentality or agency or
any government or political subdivision thereof having jurisdiction over such
party, such party shall not be considered in default hereunder by reason of any
failure to perform occasioned thereby.
12.2. Consent Neither party shall unreasonably withhold its consent or
-------
agreement when such consent or agreement is required hereunder or is requested
in good faith by the other party hereunder.
12.3 Notices. All notices to be given by each party to the other shall be
---------
made in writing by Registered or Certified Mail, return receipt requested, and
addressed, respectively, to the parties at the following:
The University of Kansas Medical Center Research Institute, Inc.
Attn.: K. M. A. ▇▇▇▇▇, M.D., President
▇▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇▇▇
▇▇▇▇▇▇ ▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
and
---
Attn.: ▇▇▇ ▇▇▇▇▇▇▇▇ ▇▇▇▇▇▇, Esq.
Office of General Counsel
University of Kansas
▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Exclusive License Agreement
Page 13
▇▇▇▇▇▇ ▇▇▇▇▇▇ Medical, Inc.
▇▇▇ ▇▇▇▇▇▇▇ ▇▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇
Attn.: ▇▇▇▇ ▇. ▇▇▇▇▇▇
President and CEO
and
---
Attn: ▇▇▇▇▇▇ ▇. ▇▇▇▇, ▇▇▇▇ ▇▇▇▇▇▇▇▇ & ▇▇▇▇▇▇, S.C.
▇.▇. ▇▇▇ ▇▇▇▇▇
▇▇▇▇▇▇▇▇▇, ▇▇ ▇▇▇▇▇-▇▇▇▇
Any notice shall be effective as of its date of receipt.
12.4. Entire Agreement. This Agreement constitutes the entire agreement
----------------
between the parties and supersedes all written or oral prior agreements or
understandings. No variation or modification of the terms or provisions of this
Agreement shall be valid unless in writing and signed by the parties hereto.
12.5. Waiver. Waiver by the Company or the Licensor of any single default or
------
breach or succession of defaults or breaches by the other shall not deprive the
other party of any right to terminate this Agreement arising out of any
subsequent default or breach.
12.6. Choice of Law. All matters affecting the interpretation, validity, and
-------------
performance of this Agreement shall be governed by the laws of Kansas
applicable to agreements made and to be performed wholly within Kansas, but the
scope and validity of Patent Rights shall be governed by the applicable laws of
the country granting the patent in question.
12.7. Captions. The captions herein are solely for convenience of reference and
--------
shall not affect the construction or interpretation of this Agreement.
12.9 Independent Contractors. It is expressly agreed that the Licensor and the
-----------------------
Company shall be independent contractors and that the relationship between the
parties shall not constitute a partnership, joint venture or agency. Neither the
Licensors nor the Company shall have the authority to make any statements,
representations or commitments of any kind, or to take any action, which shall
be binding on the other, without the prior consent of the other party to do so.
Exclusive License Agreement
Page 14
12.10 Counterparts. This License Agreement may be executed in two or more
------------
counterparts, each of which shall be deemed an original, but all of which
together shall constitute one and the same instrument.
IN WITNESS WHEREOF, the parties have executed this License Agreement as of
the Effective Date set forth above.
University of Kansas Medical Center Research ▇▇▇▇▇▇ ▇▇▇▇▇▇ Medical, Inc.
Institute
By: /s/ K.M.A. ▇▇▇▇▇, M.D. By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇
________________________ _____________________
Name: K.M.A. ▇▇▇▇▇, M.D. Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇
Title: President Title: President and Chief
Executive Officer
Date: 02/04/00 Date: 02/01/00
Exclusive License Agreement
Page 15
EXHIBIT A TO LICENSE AGREEMENT
LISTING OF BASIC PATENT RIGHTS
United States Patent No. 5,057,105
United States Patent No. RE 35,330
Australian Patent No. 633358
Canadian Patent No. 2,065,261
European Regional Patent No. 489,814 (in effect in Germany, France, Great
Britain, Italy)
Exclusive License Agreement
Page 16
EXHIBIT B TO LICENSE AGREEMENT
STOCK PURCHASE AGREEMENT
This Stock Purchase Agreement is made this 1st day of February, 2000,
between ▇▇▇▇▇▇ ▇▇▇▇▇▇ Medical, Inc., a Delaware corporation (the "Company") and
University of Kansas Medical Center Research Institute, Inc., a non-profit
501(3) (c) corporation of Kansas, which is an agent for the University of Kansas
Medical Center (the "Purchaser").
WHEREAS the Company and the Purchaser have entered into a license agreement
under which the Purchaser is licensing technology relating to United States
Patent No. 5,057,105, which is controlled by the Purchaser (the "License
Agreement"), into which License Agreement this Stock Purchase Agreement is
incorporated as Exhibit B; and
WHEREAS, as part of the consideration for the License Agreement, the
Company is willing to issue to the Purchaser 100,000 shares of Common Stock of
the Company according to the terms and conditions hereof.
THEREFORE, the parties agree as follows:
1. Sale of Stock. The Company hereby agrees to issue to the Purchaser an
-------------
aggregate of 100,000 shares of the Company's Common Stock (the "Shares"), at the
price of $0.35 per share for an aggregate purchase price of $35,000.
2. Payment of Purchase Price. The purchase price for the Shares shall be paid
-------------------------
by the license of technology to the Company pursuant to the License Agreement.
3. Issuance of Shares. The Company shall issue a duly executed certificate
------------------
evidencing the Shares in the name of the Purchaser.
4. Legends. The share certificate evidencing the Shares issued hereunder
-------
shall be endorsed with the following legends:
(a) THE SHARES REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT
AND NOT WITH A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF.
NO SUCH SALE OR DISPOSITION MAY BE EFFECTED WITHOUT AN EFFECTIVE REGISTRATION
STATEMENT RELATED THERETO OR AN OPINION OF
Exclusive License Agreement
Page 17
COUNSEL SATISFACTORY TO THE COMPANY THAT SUCH REGISTRATION IS NOT REQUIRED UNDER
THE SECURITIES ACT OF 1933.
(b) THE SHARES REPRESENTED BY THIS CERTIFICATE MAY BE TRANSFERRED ONLY IN
ACCORDANCE WITH THE TERMS OF A STOCK PURCHASE AGREEMENT BETWEEN THE COMPANY AND
THE STOCKHOLDER, A COPY OF WHICH IS ON FILE WITH THE SECRETARY OF THE COMPANY.
(c) Any legend required to be placed thereon by the California Commissioner of
Corporations or any other applicable state securities laws.
5. Investment Representations; Restriction on Transfer.
---------------------------------------------------
(a) In connection with the purchase of the Shares, the Purchaser represents to
the Company the following:
(i) Purchaser is aware of the Company's business affairs and financial
condition and has acquired sufficient information about the Company to
reach an informed and knowledgeable decision to acquire the securities.
Purchaser is purchasing these securities for investment for his own account
only and not with a view to, or for resale in connection with, any
"distribution" thereof within the meaning of the Securities Act of 1933
(the "Securities Act").
(ii) Purchaser understands that the securities have not been registered
under the Securities Act by reason of a specific exemption therefrom, which
exemption depends upon, among other things, the bona fide nature of his
investment intent as expressed herein. In this connection, Purchaser
understands that, in view of the Securities and Exchange Commission
("Commission"), the statutory basis for such exemption may not be present
if his representations meant that his present intention was to hold these
securities for a minimum capital gains period under the tax statutes, for a
deferred sale, for a market rise, for a sale if the market does not rise,
or for a year or any other fixed period in the future.
(iii) Purchaser further acknowledges and understands that the securities
must be held indefinitely unless they are subsequently registered under the
Securities Act or an exemption from such registration is available.
Purchaser further acknowledges and understands that the Company is under no
obligation to register the securities. Purchaser understands that the
certificate evidencing the securities will be imprinted with a legend that
prohibits the transfer
Exclusive License Agreement
Page 18
of the securities unless they are registered or such registration is not
required in the opinion of counsel for the Company.
(iv) Purchaser is aware of the adoption of Rule 144 by the Commission,
promulgated under the Securities Act, which permits limited public resale
of securities acquired in a non-public offering subject to the satisfaction
of certain conditions.
(v) Purchaser further acknowledges that in the event all of the
requirements of Rule 144 are not met, compliance with Regulation A or some
other registration exemption will be required; and that although Rule 144
is not exclusive, the staff of the Commission has expressed its opinion
that persons proposing to sell private placement securities other than in a
registered offering and other than pursuant to Rule 144 will have a
substantial burden of proof in establishing that an exemption from
registration is available for such offers or sales and that such persons
and the brokers who participate in the transactions do so at their own
risk.
(b) The Purchaser agrees, in connection with the Company's initial public
offering of the Company's securities, (i) not to sell, make short sales of,
loan, grant any options for the purchase of, or otherwise dispose of any shares
of Common Stock of the Company held by the Purchaser (other than those shares
included in the registration) without the prior written consent of the Company
or the underwriters managing such initial underwritten public offering of the
Company's securities for one hundred eighty (180) days from the effective date
of such registration and (ii) further agrees to execute any agreement reflecting
(i) above as may be reasonably requested by the underwriters at the time of the
public offering.
6. Adjustment for Stock Split. All references to the number of Shares and the
--------------------------
purchase price of the Shares in this Stock Purchase Agreement shall be
appropriately adjusted to reflect any stock split, stock dividend or other
change in the Shares that may be made by the Company after the date of this
Stock Purchase Agreement.
7. General Provisions.
------------------
(a) This Stock Purchase Agreement shall be governed by the internal laws of the
State of Kansas. This Stock Purchase Agreement represents the entire
agreement between the parties with respect to the purchase of Common Stock
by the Purchaser, may only be modified or amended in writing signed by both
parties and satisfies all of the Company's obligations to the Purchaser
with regard to the issuance or sale of securities.
Exclusive License Agreement
Page 19
(b) Any notice, demand or request required or permitted to be given by either
the Company or the Purchaser pursuant to the terms of this Stock Purchase
Agreement shall be in writing and shall be deemed given when delivered
personally or deposited in the U.S. mail, First Class with postage prepaid,
and addressed to the parties at the addresses of the parties set forth at
the end of this Stock Purchase Agreement or such other address as a party
may request by notifying the other in writing.
(c) The rights and benefits of the Company under this Stock Purchase Agreement
shall be transferable to any one or more persons or entities, and all
covenants and agreements hereunder shall inure to the benefit of, and be
enforceable by the Company's successors and assigns. The rights and
obligations of the Purchaser under this Stock Purchase Agreement may only
be assigned with the prior written consent of the Company, which consent
may not be unreasonably withheld.
(d) Either party's failure to enforce any provision or provisions of this Stock
Purchase Agreement shall not in any way be construed as a waiver of any
such provision or provisions, nor prevent that party thereafter from
enforcing each and every other provision of this Stock Purchase Agreement.
The rights granted both parties herein are cumulative and shall not
constitute a waiver of either party's right to assert all other legal
remedies available to it under the circumstances.
(e) The Purchaser agrees upon request to execute any further documents or
instruments reasonably necessary or desirable to carry out the purposes or
intent of this Stock Purchase Agreement.
(f) The Purchaser understands that Purchaser (and not the Company) shall be
responsible for his own federal, state, local or foreign tax liability and
any of Purchaser's other tax consequences that may arise as a result of the
transactions contemplated by this Stock Purchase Agreement. The Purchaser
shall rely solely on the determinations of Purchaser's tax advisors or
Purchaser's own determinations, and not on any statements or
representations by the Company or any of its agents, with regard to all
such tax matters.
(g) Sale of the securities which are the subject of this Stock Purchase
Agreement has not been qualified with the Commissioner of Corporations of
the State of California and the issuance of such securities or the payment
or receipt of any part of the consideration therefor prior to such
qualification is unlawful, unless the sale of securities is exempt from the
qualification by Section 25100, 25102, or 25105 of the California
Corporations Code. The rights of all parties to this Stock Purchase
Agreement are expressly conditioned upon such qualification being obtained,
unless the sale is so exempt.
Exclusive License Agreement
Page 20
IN WITNESS WHEREOF, the parties have duly executed this Stock Purchase
Agreement as of the day and year first set forth above.
University of Kansas Medical Center Research ▇▇▇▇▇▇ ▇▇▇▇▇▇ Medical, Inc.
Institute
By: /s/ K.M.A. ▇▇▇▇▇, M.D. By: /s/ ▇▇▇▇ ▇. ▇▇▇▇▇▇
________________________ ______________________
Name: K.M.A. ▇▇▇▇▇, M.D. Name: ▇▇▇▇ ▇. ▇▇▇▇▇▇
Title: President Title: President and Chief
Executive Officer
Date: [undated] Date: 02/01/00